1. No category

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II
(Ikke-lovgivningsmæssige retsakter)
FORORDNINGER
KOMMISSIONENS DELEGEREDE FORORDNING (EU) Nr. 492/2014
af 7. marts 2014
om udbygning af Europa-Parlamentets og Rådets forordning (EU) nr. 528/2012 for så vidt angår
regler for fornyelse af godkendelser af biocidholdige produkter, der er omfattet af gensidig
anerkendelse
(EØS-relevant tekst)
EUROPA-KOMMISSIONEN HAR —
under henvisning til traktaten om Den Europæiske Unions funktionsmåde,
under henvisning til Europa-Parlamentets og Rådets forordning (EU) nr. 528/2012 af 22. maj 2012 om tilgængeliggø­
relse på markedet og anvendelse af biocidholdige produkter (1), særlig artikel 40, første afsnit, og
ud fra følgende betragtninger:
(1)
Der bør fastsættes supplerende regler for fornyelse af nationale godkendelser, som er omfattet af gensidig aner­
kendelse i overensstemmelse med artikel 4 i Europa-Parlamentets og Rådets direktiv 98/8/EF (2) eller artikel 33 og
34 i forordning (EU) nr. 528/2012, både i de medlemsstater, der har meddelt den oprindelige godkendelse, og i
de medlemsstater, som har udstedt godkendelser i kraft af gensidig anerkendelse af denne oprindelige godken­
delse.
(2)
For at undgå unødvendigt dobbeltarbejde og for sikre sammenhæng bør fornyelse af godkendelser, der er omfattet
af gensidig anerkendelse, i første omgang forvaltes af den kompetente myndighed i en enkelt referencemedlems­
stat. Med henblik på at skabe fleksibilitet for ansøgere og kompetente myndigheder bør ansøgeren have mulighed
for at vælge referencemedlemsstat med forbehold af sidstnævntes samtykke.
(3)
Med henblik på at lette proceduren og de opgaver, som de kompetente myndigheder skal udføre, bør denne
forordnings anvendelsesområde begrænses til de godkendelser, bortset fra enkelte undtagelser, der har samme
vilkår og betingelser i alle medlemsstaterne på tidspunktet for ansøgningen om fornyelse. For andre nationale
godkendelser bør en ansøgning om fornyelse indgives til den pågældende medlemsstat i overensstemmelse med
artikel 31 forordning (EU) nr. 528/2012.
(4)
Indholdet af en ansøgning om fornyelse af en national godkendelse er fastsat i artikel 31 forordning (EU)
nr. 528/2012. For ansøgninger om fornyelse af nationale godkendelser, der er tildelt på grundlag af gensidig aner­
kendelse, bør ansøgningens indhold imidlertid specificeres yderligere bl.a. for at lette arbejdet for de medlems­
stater, der er involveret i fornyelse af disse godkendelser.
(5)
Af hensyn til arbejdsbyrden i forbindelse med vurderingen bør den tid, der afsættes til at behandle en ansøgning,
afhænge af, om der er behov for en fuldstændig vurdering.
(1) EUT L 167 af 27.6.2012, s. 1.
(2) Europa-Parlamentets og Rådets direktiv 98/8/EF af 16. februar 1998 om markedsføring af biocidholdige produkter (EFT L 123 af
24.4.1998, s. 1).
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(6)
For at opnå samme grad af beskyttelse, når en godkendelse fornys, som ved den oprindelige meddelelse, bør den
fornyede godkendelses maksimale gyldighedsperiode ikke overstige den oprindelige godkendelses gyldighedspe­
riode. Desuden bør der fastsættes udfasningsbestemmelser for de eksisterende produkter på medlemsstaternes
markeder for de godkendelser, for hvilke en ansøgning om fornyelse ikke indgives eller afvises.
(7)
Enhver tvist om vurderingen af ansøgninger om fornyelse bør forelægges koordinationsgruppen, der er nedsat
ved forordning (EU) nr. 528/2012, med henblik på at undersøge tvister vedrørende produkternes godkendelse og
åbne mulighed for undtagelser fra princippet om gensidig anerkendelse på grundlag af den generelle begrundelse
for sådanne undtagelser, der er fastsat i nævnte forordnings artikel 37.
(8)
For at opnå større forudsigelighed bør agenturet opstille retningslinjer for, hvordan fornyelser af ansøgninger
håndteres, og retningslinjerne ajourføres regelmæssigt på grundlag af erfaringerne og den videnskabelige eller
tekniske udvikling —
VEDTAGET DENNE FORORDNING:
Artikel 1
Genstand og anvendelsesområde
1.
Ved denne forordning fastsættes bestemmelser om fornyelse af en national godkendelse af et biocidholdigt produkt
eller en familie af biocidholdige produkter, der har været omfattet af gensidig anerkendelse efter artikel 4 direktiv
98/8/EF eller artikel 33 og 34 i forordning (EU) nr. 528/2012, eller en national godkendelse, der er meddelt ved en
sådan gensidig anerkendelse (i det følgende benævnt en »godkendelse«).
2.
Denne forordning gælder for godkendelser, der har samme vilkår og betingelser på tidspunktet for ansøgningen
om fornyelse i alle de medlemsstater, hvori der ansøges om fornyelse.
3.
Denne forordning gælder også godkendelser på forskellige vilkår og betingelser med hensyn til et eller flere af
følgende aspekter:
a) De vedrører alene oplysninger, der kan være genstand for en administrativ ændring i overensstemmelse med Kommis­
sionens gennemførelsesforordning (EU) nr. 354/2013 (1).
b) De følger af en tilpasning af den oprindelige godkendelse på grundlag af artikel 4, stk. 1, andet og tredje afsnit, i
direktiv 98/8/EF.
c) De er fastsat ved en kommissionsafgørelse, der er vedtaget i henhold til enten artikel 4, stk. 4, i direktiv 98/8/EF eller
artikel 37, stk. 2, litra b), i forordning (EU) nr. 528/2012.
d) De følger af en aftale med ansøgeren i henhold til artikel 37, stk. 2, første afsnit, i forordning (EU) nr. 528/2012, eller
fra tilsvarende aftaler, der er indgået ved gennemførelsen af bestemmelserne i artikel 4 i direktiv 98/8/EF.
Artikel 2
Ansøgningens indhold
1.
En ansøgning om fornyelse af en godkendelse skal foretages ved hjælp af det ansøgningsskema, der findes i regi­
steret over biocidholdige produkter, og den skal indeholde følgende:
a) navnet på den medlemsstat, der har vurderet den oprindelige ansøgning om godkendelse, eller i givet fald den
medlemsstat, som ansøgeren har valgt, sammen med en skriftlig bekræftelse af, at medlemsstaten indvilger i at være
ansvarlig for vurderingen af ansøgningen om fornyelse (i det følgende benævnt »referencemedlemsstaten«)
b) en liste over alle andre medlemsstater, hvori der ansøges om fornyelse af en godkendelse (i det følgende benævnt de
»berørte medlemsstater«), som også skal omfatte numrene på de godkendelser, der er udstedt af referencemedlems­
staten og de berørte medlemsstater
(1) Kommissionens gennemførelsesforordning (EU) nr. 354/2013 af 18. april 2013 om ændringer af biocidholdige produkter, der er
godkendt i henhold til Europa-Parlamentets og Rådets forordning (EU) nr. 528/2012 (EUT L 109 af 19.4.2013, s. 4).
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c) bekræftelse fra ansøgeren om, at disse godkendelser er omfattet af denne forordnings anvendelsesområde, jf. artikel 1,
stk. 2 og 3
d) alle relevante data, som kræves i henhold til artikel 31, stk. 3, litra a), i forordning (EU) nr. 528/2012, og som ansø­
geren har tilvejebragt siden den oprindelige godkendelse eller i givet fald den foregående fornyelse, medmindre disse
oplysninger allerede er forelagt agenturet i det krævede format
e) et udkast til resumé af det biocidholdige produkts egenskaber med de oplysninger, der kræves i henhold til artikel 22,
stk. 2, i forordning (EU) nr. 528/2012, på referencemedlemsstatens og de berørte medlemsstaters officielle sprog, og
som i relevante tilfælde kan afvige mellem medlemsstaterne i overensstemmelse med denne forordnings artikel 1,
stk. 3
f) ansøgerens vurdering af, om konklusionerne af den første eller foregående vurdering af det biocidholdige produkt
eller familien af biocidholdige produkter fortsat er gyldige, herunder en kritisk gennemgang af alle oplysninger, der
meddeles efter artikel 47 i forordning (EU) nr. 528/2012, herunder eventuelle supplerende oplysninger af værdi for
denne vurdering, medmindre de allerede findes i registret over biocidholdige produkter.
2.
Ved anvendelsen af stk. 1, litra d), skal ansøgningen om fornyelse af en godkendelse i givet fald også indeholde:
a) en liste over de foranstaltninger, som skal gennemføres af indehaveren af godkendelsen ifølge betingelserne for gyldig­
heden af godkendelsen i en hvilken som helst medlemsstat, og en bekræftelse af, at disse foranstaltninger er truffet
b) en liste over afgørelser om ændringer, som en medlemsstat har godkendt før den 1. september 2013
c) en liste over de afgørelser om ændringer, som en medlemsstat har godkendt ifølge gennemførelsesforordning (EU)
nr. 354/2013
d) en liste over meddelelser eller ansøgninger om ændringer, som er indgivet til en medlemsstat i henhold til gennemfø­
relsesforordning (EU) nr. 354/2013, men som ikke er færdigbehandlet på tidspunktet for indgivelsen af ansøgningen
om fornyelse.
Referencemedlemsstatens kompetente myndighed kan ved vurderingen af ansøgningen anmode om at få forelagt en kopi
af de afgørelser, der er nævnt i litra b) og c).
Artikel 3
Indgivelse og validering af ansøgningen
1.
Ansøgere, som ønsker at ansøge om en fornyelse af en godkendelse af eller på vegne af en godkendelsesindehaver
(i det følgende benævnt »ansøgeren«), skal indgive en ansøgning til referencemedlemsstatens kompetente myndighed
mindst 550 dage før godkendelsens udløbsdato.
2.
Ansøgeren skal samtidig med indgivelsen af ansøgningen til referencemedlemsstaten forelægge de kompetente
myndigheder i de berørte medlemsstater en ansøgning om fornyelse af de godkendelser, der er meddelt i de berørte
medlemsstater.
3.
De kompetente myndigheder i referencemedlemsstaten og i de berørte medlemsstater oplyser ansøgeren om de
gebyrer, der skal erlægges i henhold til artikel 80 i forordning (EU) nr. 528/2012, og afviser ansøgningen, hvis ansøgeren
ikke har betalt gebyrerne inden for 30 dage. De giver ansøgeren og de øvrige kompetente myndigheder meddelelse
herom.
4.
Ved modtagelsen af disse gebyrer accepterer de kompetente myndigheder i referencemedlemsstaten og i de berørte
medlemsstater ansøgningen og giver ansøgeren meddelelse herom med angivelse af datoer for accept.
5.
Inden 30 dage efter referencemedlemsstatens accept skal denne medlemsstat validere ansøgningen, hvis den inde­
holder alle de relevante oplysninger, der er omhandlet i artikel 2. Referencemedlemsstaten underretter ansøgeren og de
andre berørte medlemsstater herom.
Ved valideringen af ansøgningen vurderer referencemedlemsstaten ikke de fremlagte datas eller begrundelsers kvalitet,
eller om de er fyldestgørende.
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6.
Senest 30 dage efter en berørt medlemsstats accept skal den pågældende medlemsstat verificere, om godkendelsen
er omfattet af denne forordnings anvendelsesområde, jf. artikel 1, stk. 2, og 3.
Hvis godkendelsen ikke er omfattet af denne forordnings anvendelsesområde, skal den kompetente myndighed i den
berørte medlemsstat behandle ansøgningen som en ansøgning, der er indgivet i henhold til artikel 31, stk. 1, i forord­
ning (EU) nr. 528/2012, og den skal underrette ansøgeren og de kompetente myndigheder i andre medlemsstater herom.
7.
Hvis referencemedlemsstatens kompetente myndighed finder, at ansøgningen er ufuldstændig, anmoder den ansø­
geren om supplerende oplysninger med henblik på at validere ansøgningen, og den fastsætter en rimelig frist for indgi­
velse af disse oplysninger. Fristen må normalt ikke overstige 90 dage.
Referencemedlemsstatens kompetente myndighed validerer ansøgningen senest 30 dage efter modtagelsen af de supple­
rende oplysninger, hvis disse oplysninger er tilstrækkelige til, at ansøgningen opfylder kravene i artikel 2.
Referencemedlemsstatens kompetente myndighed afviser en ansøgning, hvis ansøgeren ikke inden for tidsfristen frem­
lægger de oplysninger, der kræves, og underretter ansøgeren og de øvrige berørte medlemsstater herom.
Artikel 4
Vurdering af ansøgningen
1.
På grundlag af de foreliggende oplysninger og i lyset af den aktuelle videnskabelige viden skal referencemedlemssta­
tens kompetente myndighed senest 90 dage efter valideringen af ansøgningen afgøre, om en fuldstændig vurdering af
ansøgningen om fornyelse er nødvendig.
2.
Såfremt en fuldstændig vurdering er nødvendig, skal referencemedlemsstatens kompetente myndighed udarbejde en
vurderingsrapport efter den procedure og de tidsfrister, der er fastsat i artikel 30 forordning (EU) nr. 528/2012. I vurde­
ringsrapporten skal det konkluderes, om betingelserne for at meddele godkendelsen, jf. forordningens artikel 19, fortsat
er opfyldt, og der tages hensyn til resultaterne af den sammenlignende vurdering, som er foretaget i overensstemmelse
med nævnte forordnings artikel 23, hvor dette er relevant.
Uden at dette berører artikel 30, stk. 2, første afsnit, i forordning (EU) nr. 528/2012, skal vurderingsrapporten og et
udkast til resumé af det biocidholdige produkts egenskaber sendes til de berørte medlemsstater og til ansøgeren senest
365 dage efter, at ansøgningen er valideret.
3.
Såfremt en fuldstændig vurdering ikke er nødvendig, udarbejder referencemedlemsstaten en vurderingsrapport efter
proceduren i litra a), b) og c) i artikel 30, stk. 3, i forordning (EU) nr. 528/2012. I denne rapport skal det konkluderes,
om betingelserne for at meddele godkendelsen, jf. forordningens artikel 19, er opfyldt, og der tages hensyn til resulta­
terne af den sammenlignende vurdering, som er foretaget i overensstemmelse med nævnte forordnings artikel 23, hvor
dette er relevant.
Vurderingsrapporten og udkastet til resumé af det biocidholdige produkts egenskaber skal sendes til de berørte medlems­
stater og til ansøgeren senest 180 dage efter, at ansøgningen er valideret.
Artikel 5
Afgørelse om fornyelse
1.
Senest 90 dage efter modtagelsen af vurderingsrapporten og udkastet til resumé af det biocidholdige produkts
egenskaber, og med forbehold af artikel 6, skal de berørte medlemsstater nå til enighed om resuméet af det biocidholdige
produkts egenskaber undtagen, i givet fald, de forskelle, der er nævnt i artikel 1, stk. 3, litra a), og de skal registrere deres
godkendelse i registret over biocidholdige produkter.
Referencemedlemsstaten indfører det godkendte resumé af det biocidholdige produkts egenskaber og den endelige vurde­
ringsrapport i registret over biocidholdige produkter sammen med godkendte vilkår og betingelser, som pålægges i
forbindelse med tilgængeliggørelsen på markedet eller anvendelsen af det biocidholdige produkt eller familien af biocid­
holdige produkter.
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2.
Senest 30 dage efter, at der er opnået enighed, fornyer referencemedlemsstaten og hver berørt medlemsstat godken­
delserne i overensstemmelse med det godkendte resumé af det biocidholdige produkts egenskaber.
Uden at dette berører bestemmelserne i artikel 23, stk. 6, i forordning (EU) nr. 528/2012, skal godkendelsen fornys i en
periode på højst 10 år.
3.
Uden at dette berører artikel 7, gælder det, at når der ikke er opnået enighed inden 90 dage, kan hver medlemsstat,
der godkender resuméet af det biocidholdige produkts egenskaber, jf. stk. 1, forny godkendelsen i overensstemmelse
hermed.
4.
Såfremt der på grund af forhold, der ikke kan tilskrives indehaveren af en godkendelse, ikke er truffet afgørelse om
fornyelsen af denne godkendelse, inden den udløber, fornyer den pågældende kompetente myndighed godkendelsen i en
periode, der er tilstrækkelig til, at vurderingen kan afsluttes.
Artikel 6
Overgangsperiode
Artikel 52 i forordning (EU) nr. 528/2012 finder anvendelse på eksisterende beholdninger af biocidholdige produkter,
som tilgængeliggøres på følgende markeder:
a) på en medlemsstats marked, hvor der ikke er indgivet ansøgning om fornyelse, eller hvor en ansøgning afvises i
henhold til artikel 3, stk. 3, i denne forordning
b) på referencemedlemsstatens og de berørte medlemsstaters marked, hvis referencemedlemsstaten afviser ansøgningen
om fornyelse i henhold til artikel 3, stk. 3, eller artikel 3, stk. 7, tredje afsnit, i denne forordning.
Artikel 7
Koordinationsgruppe, voldgift og undtagelse fra gensidig anerkendelse
1.
En berørt medlemsstat kan foreslå at afvise at forny en godkendelse eller at ændre vilkår og betingelser i en
godkendelse, jf. artikel 37 i forordning (EU) nr. 528/2012.
2.
I andre tilfælde end dem, som er nævnt i stk. 1, hvor de berørte medlemsstater ikke når til enighed om vurderings­
rapportens konklusioner, eller, hvis det er relevant, resuméet af det biocidholdige produkts egenskaber som foreslået af
referencemedlemsstaten i henhold til artikel 5, stk. 1, forelægger referencemedlemsstaten spørgsmålet for den koordinati­
onsgruppe, som er nedsat ved artikel 35 i forordning (EU) nr. 528/2012.
Hvis en berørt medlemsstat er uenig med referencemedlemsstaten, giver førstnævnte medlemsstat en detaljeret begrun­
delse for sine synspunkter til de øvrige berørte medlemsstater og ansøgeren.
3.
Artikel 35 og 36 i forordning (EU) nr. 528/2012 er gældende for de uenigheder, der er nævnt i stk. 2.
Artikel 8
Retningslinjer for håndtering af fornyelser i procedurerne for gensidig anerkendelse
1.
Efter høring af medlemsstaterne, Kommissionen og interesseparterne opstiller agenturet retningslinjer for håndte­
ringen af fornyelser af godkendelser, som er omfattet af denne forordning.
2.
Disse retningslinjer ajourføres regelmæssigt, idet der tages højde for bidragene fra medlemsstater og interesseparter
om gennemførelsen heraf såvel som den videnskabelige og tekniske udvikling.
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Artikel 9
Denne forordning træder i kraft på tyvendedagen efter offentliggørelsen i Den Europæiske Unions Tidende.
Denne forordning er bindende i alle enkeltheder og gælder umiddelbart i hver
medlemsstat.
Udfærdiget i Bruxelles, den 7. marts 2014.
På Kommissionens vegne
José Manuel BARROSO
Formand
14.5.2014
Official Journal of the European Union
EN
L 139/1
II
(Non-legislative acts)
REGULATIONS
COMMISSION DELEGATED REGULATION (EU) No 492/2014
of 7 March 2014
supplementing Regulation (EU) No 528/2012 of the European Parliament and of the Council as
regards the rules for the renewal of authorisations of biocidal products subject to mutual recogni­
tion
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012
concerning the making available on the market and use of biocidal products (1), and in particular the first paragraph of
Article 40 thereof,
Whereas:
(1)
It is appropriate to lay down supplementary rules for the renewal of national authorisations having been subject
to mutual recognition in accordance with Article 4 of Directive 98/8/EC of the European Parliament and of the
Council (2) or with Articles 33 and 34 of Regulation (EU) No 528/2012, both in the Member States where the
first authorisations were granted and in those Member States having granted authorisations through mutual
recognition of the first authorisations.
(2)
In order to avoid unnecessary duplication of work and to ensure consistency, renewal of authorisations having
been subject to mutual recognition should in the first place be managed by the competent authority of one single
reference Member State. In order to provide flexibility to applicants and competent authorities, the applicant
should have the opportunity to choose the reference Member State subject to the latter's agreement.
(3)
In order to facilitate the smooth running of the procedure and the tasks to be carried out by the competent
authorities, the scope of this Regulation should be limited to those authorisations having, apart from limited
exceptions, the same terms and conditions in all the Member States at the time of the application for renewal.
For other national authorisations, an application for renewal should be submitted to the Member State in ques­
tion in accordance with Article 31 of Regulation (EU) No 528/2012.
(4)
The content of an application for renewal of a national authorisation is specified under Article 31 of Regulation
(EU) No 528/2012. However, for applications for renewal of national authorisations granted on the basis of
mutual recognition, the content of the application should be further specified, in particular to facilitate the work
of the Member States involved in the renewal of these authorisations.
(5)
To take into account the workload associated with the evaluation, the time allowed for processing an application
should depend on whether or not a full evaluation needs to be performed.
(1) OJ L 167, 27.6.2012, p. 1.
(2) Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on
the market (OJ L 123, 24.4.1998, p. 1).
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(6)
In order to provide the same level of protection when an authorisation is renewed as when it is first granted, the
maximum validity of the renewed authorisations should not exceed that of the initial authorisations. In addition,
phasing-out provisions for the existing products on the market of Member States should be set for those authori­
sations for which an application for renewal is not submitted or is rejected.
(7)
It is appropriate to refer any disagreement in the evaluation of renewal applications to the coordination group
established under Regulation (EU) No 528/2012 for the purpose of examining disagreements relating to product
authorisation, and to allow derogations from mutual recognition based on the general grounds for such deroga­
tions laid down in Article 37 of that Regulation.
(8)
In order to bring further predictability, guidelines on the details related to the handling of renewals should be
developed by the Agency and regularly updated on the basis of experience and scientific or technical progress,
HAS ADOPTED THIS REGULATION:
Article 1
Subject matter and scope
1.
This Regulation lays down rules for the renewal of a national authorisation of a biocidal product or a biocidal
product family that has been subject to mutual recognition in accordance with Article 4 of Directive 98/8/EC or with
Articles 33 and 34 of Regulation (EU) No 528/2012, or of a national authorisation granted through such mutual recog­
nition (hereinafter referred to as an ‘authorisation’).
2.
This Regulation shall apply to authorisations having the same terms and conditions at the time of the application
for renewal in all the Member States where the renewal is sought.
3.
This Regulation shall also apply to authorisations having different terms and conditions on one or more of the
following aspects:
(a) concerning merely information which can be the subject of an administrative change in accordance with Commis­
sion Implementing Regulation (EU) No 354/2013 (1);
(b) derived from an adjustment of the initial authorisation based on the second and third subparagraphs of Article 4(1)
of Directive 98/8/EC;
(c) established by a Commission Decision adopted either in accordance with Article 4(4) of Directive 98/8/EC or in
accordance with Article 37(2)(b) of Regulation (EU) No 528/2012;
(d) derived from an agreement with the applicant under the first subparagraph of Article 37(2) of Regulation (EU)
No 528/2012, or from equivalent agreements reached when implementing the provisions of Article 4 of Directive
98/8/EC.
Article 2
Content of the application
1.
An application for renewal of an authorisation shall be made by using the application form available from the
Register for Biocidal Products and shall contain the following:
(a) the name of the Member State which evaluated the initial application for authorisation or, where relevant, the
Member State having been chosen by the applicant together with written confirmation that the Member State agrees
to be responsible for the evaluation of the application for renewal (hereinafter referred to as the ‘reference Member
State’);
(b) a list of all other Member States where the renewal of an authorisation is sought (hereinafter the ‘Member States
concerned’), which shall also include the numbers of the authorisations granted by the reference Member State and
the Member States concerned;
(1) Commission Implementing Regulation (EU) No 354/2013 of 18 April 2013 on changes of biocidal products authorised in accordance
with Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 109, 19.4.2013, p. 4).
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(c) confirmation from the applicant that those authorisations fall within the scope of this Regulation as provided for by
Article 1(2) and (3);
(d) all relevant data required under Article 31(3)(a) of Regulation (EU) No 528/2012 that the applicant has generated
since the initial authorisation or, as appropriate, previous renewal, unless those data have already been submitted to
the Agency in the required format;
(e) a draft summary of the biocidal product characteristics containing the information required under Article 22(2) of
Regulation (EU) No 528/2012, in the official languages of the reference Member State and of the Member States
concerned which, where relevant, may differ between Member States in accordance with Article 1(3) of this Regu­
lation;
(f) the applicant's assessment of whether the conclusions of the initial or previous assessment of the biocidal product or
biocidal product family remain valid, including a critical review of any information notified in accordance with
Article 47 of Regulation (EU) No 528/2012, including any supporting information to that assessment where it is
not already available on the Register for Biocidal Products.
2.
For the purposes of paragraph 1(d), where applicable, the application for renewal of an authorisation shall also
contain:
(a) a list of the actions to be completed by the authorisation holder according to the conditions for the validity of the
authorisation in any Member State and confirmation that these actions have been completed;
(b) a list of the decisions on changes agreed by any Member State before 1 September 2013;
(c) a list of the decisions on changes agreed by any Member State in accordance with Implementing Regulation (EU)
No 354/2013;
(d) a list of the notifications or applications for changes submitted to any Member State in accordance with Imple­
menting Regulation (EU) No 354/2013, which are pending at the time of the submission of the application for
renewal.
The competent authority of the reference Member State may, for the purposes of the evaluation of the application,
request the submission of a copy of the decisions referred to in points (b) and (c).
Article 3
Submission and validation of the application
1.
An applicant wishing to seek the renewal of an authorisation by or on behalf of an authorisation holder (herein­
after ‘the applicant’) shall submit an application to the competent authority of the reference Member State at least
550 days before the expiry date of the authorisation.
2.
The applicant shall, at the same time when submitting the application to the reference Member State, submit to
the competent authorities of the Member States concerned an application for renewal of the authorisations granted in
those Member States.
3.
The competent authorities of the reference Member State and of the Member States concerned shall inform the
applicant of the fees payable under Article 80 of Regulation (EU) No 528/2012 and shall reject the application if the
applicant fails to pay the fees within 30 days. They shall inform the applicant and the other competent authorities
accordingly.
4.
Upon receipt of those fees, the competent authorities of the reference Member State and of the Member States
concerned shall accept the application and inform the applicant indicating the dates of acceptance.
5.
Within 30 days of the acceptance in the reference Member State, that Member State shall validate the application if
it contains all the relevant information referred to in Article 2. The reference Member State shall inform the applicant
and the Member States concerned accordingly.
When validating the application, the reference Member State shall not make an assessment of the quality or adequacy of
the data or justifications submitted.
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6.
Within 30 days of acceptance by a Member State concerned, that Member State shall verify whether the authorisa­
tion falls within the scope of this Regulation as provided for by Article 1(2) and (3).
Where the authorisation does not fall within the scope of this Regulation, the competent authority in the Member State
concerned shall process the application as an application submitted in accordance with Article 31(1) of Regulation (EU)
No 528/2012 and it shall inform the applicant and the competent authorities in other Member States accordingly.
7.
Where the competent authority of the reference Member State considers that the application is incomplete, it shall
require additional information for the validation of the application from the applicant and shall set a reasonable time
limit for the submission of that information. The time limit shall not normally exceed 90 days.
The competent authority of the reference Member State shall, within 30 days of receipt of the additional information,
validate the application if the additional information is sufficient for the application to comply with the requirements
laid down in Article 2.
The competent authority of the reference Member State shall reject the application if the applicant fails to submit the
required information within the deadline and shall inform the applicant and the Member States concerned accordingly.
Article 4
Evaluation of the application
1.
On the basis of an assessment of the available information and in the light of current scientific knowledge, the
competent authority of the reference Member State shall, within 90 days of validating the application, decide whether a
full evaluation of the application for renewal is necessary.
2.
Where a full evaluation is necessary, the competent authority of the reference Member State shall draft an assess­
ment report, following the procedure and timelines set out in Article 30 of Regulation (EU) No 528/2012. The assess­
ment report shall conclude on whether the conditions for granting the authorisation set out in Article 19 of that Regu­
lation are still satisfied, and take into account the results of the comparative assessment carried out in accordance with
Article 23 of that Regulation, where appropriate.
Without prejudice to the first subparagraph of Article 30(2) of Regulation (EU) No 528/2012, the assessment report and
the draft summary of biocidal product characteristics shall be sent to the Member States concerned and to the applicant
within 365 days of validating the application.
3.
Where a full evaluation is not necessary, the reference Member State shall draft an assessment report, following the
procedure laid down in points (a), (b) and (c) of Article 30(3) of Regulation (EU) No 528/2012. This report shall
conclude on whether the conditions for granting the authorisation set out in Article 19 of that Regulation are met, and
take into account the results of the comparative assessment carried out in accordance with Article 23 of that Regulation,
where appropriate.
The assessment report and the draft summary of biocidal product characteristics shall be sent to the Member States
concerned and to the applicant within 180 days of validating the application.
Article 5
Decision on renewal
1.
Within 90 days of receipt of the assessment report and the draft summary of biocidal product characteristics, and
subject to Article 6, the Member States concerned shall agree on the summary of biocidal product characteristics, with
the exception, where relevant, of the differences referred to in Article 1(3)(a), and shall record their agreement in the
Register for Biocidal Products.
The reference Member State shall enter the agreed summary of biocidal product characteristics and the final assessment
report in the Register for Biocidal Products, together with any agreed terms or conditions imposed on the making avail­
able on the market or use of the biocidal product or biocidal product family.
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2.
Within 30 days of reaching agreement, the reference Member State and each of the Member States concerned shall
renew the authorisations in conformity with the agreed summary of biocidal product characteristics.
Without prejudice to the provisions of Article 23(6) of Regulation (EU) No 528/2012, the authorisation shall be
renewed for a maximum period of 10 years.
3.
Without prejudice to Article 7, where no agreement is reached within 90 days, each Member State that agrees to
the summary of biocidal product characteristics referred to in paragraph 1 may renew the authorisation accordingly.
4.
Where, for reasons beyond the control of the holder of an authorisation, no decision is taken on the renewal of
that authorisation before its expiry, the respective competent authority shall grant a renewal for the period necessary to
complete the evaluation.
Article 6
Period of grace
Article 52 of Regulation (EU) No 528/2012 shall apply to existing stocks of the biocidal product made available on the
following markets:
(a) on the market of a Member State to which no application for renewal has been submitted or which has rejected an
application pursuant to Article 3(3) of this Regulation;
(b) on the market of the reference Member State and of the Member States concerned, where the reference Member
State rejects the application for renewal in accordance with Article 3(3) or the third subparagraph of Article 3(7) of
this Regulation.
Article 7
Coordination group, arbitration and derogation from mutual recognition
1.
A Member State concerned may propose to refuse to renew an authorisation or to adjust the terms and conditions
of the authorisation in accordance with Article 37 of Regulation (EU) No 528/2012.
2.
Where, regarding matters other than those referred to in paragraph 1, the Member States concerned do not reach
an agreement on the conclusions of the assessment report or, where relevant, on the summary of the biocidal product
characteristics proposed by the reference Member State in accordance with Article 5(1), the reference Member State shall
refer the matter to the coordination group established under Article 35 of Regulation (EU) No 528/2012.
Where a Member State concerned is in disagreement with the reference Member State, the former shall give a detailed
statement of the reasons for its position to all Member States concerned and to the applicant.
3.
Articles 35 and 36 of Regulation (EU) No 528/2012 shall apply to matters of disagreement referred to in para­
graph 2.
Article 8
Guidance on handling renewals in the mutual recognition procedures
1.
The Agency shall, after consulting the Member States, the Commission and interested parties, draw up guidelines
on the details related to the handling of renewals of authorisations covered by this Regulation.
2.
Those guidelines shall be regularly updated, taking into account the contributions from Member States and stake­
holders on its implementation as well as scientific and technical progress.
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Article 9
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the
European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 7 March 2014.
For the Commission
The President
José Manuel BARROSO
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(Ikke-lovgivningsmæssige retsakter)
FORORDNINGER
KOMMISSIONENS DELEGEREDE FORORDNING (EU) Nr. 1062/2014
af 4. august 2014
om det arbejdsprogram for systematisk undersøgelse af alle eksisterende aktivstoffer i biocidhol­
dige produkter, der er omhandlet i Europa-Parlamentets og Rådets forordning (EU) nr. 528/2012
(EØS-relevant tekst)
EUROPA-KOMMISSIONEN HAR —
under henvisning til traktaten om Den Europæiske Unions funktionsmåde,
under henvisning til Europa-Parlamentets og Rådets forordning (EU) nr. 528/2012 af 22. maj 2012 om tilgængeliggø­
relse på markedet og anvendelse af biocidholdige produkter (1), særlig artikel 89, stk. 1, første afsnit, og
ud fra følgende betragtninger:
(1)
I Kommissionens forordning (EF) nr. 1451/2007 (2) fastsættes der detaljerede regler for undersøgelsesprogrammet
for eksisterende aktivstoffer i biocidholdige produkter (»undersøgelsesprogrammet«), som blev indledt i overens­
stemmelse med artikel 16, stk. 2, i Europa-Parlamentets og Rådets direktiv 98/8/EF (3). Da direktivet er blevet
ophævet og erstattet af forordning (EU) nr. 528/2012, bør de detaljerede regler for videreførelse af undersøgelses­
programmet tilpasses den forordnings bestemmelser.
(2)
Det er vigtigt at udpege, hvilke kombinationer af aktivstof og produkttype der, medmindre andet fremgår af de
nationale bestemmelser, kan markedsføres og anvendes i henhold til de overgangsbestemmelser, der er fastlagt i
artikel 89 i forordning (EU) nr. 528/2012. Dette bør være tilfældet med kombinationer af aktivstof og produkt­
type, der vurderes under undersøgelsesprogrammet.
(3)
Når et produkt er omfattet af undtagelsen for fødevarer og foderstoffer i artikel 6 i forordning (EF) nr. 1451/2007,
men ikke af undtagelsen for fødevarer og foderstoffer i artikel 2, stk. 5, litra a), i forordning (EU) nr. 528/2012,
bør de aktivstoffer, det indeholder, vurderes i undersøgelsesprogrammet for den relevante produkttype.
Medmindre andet er fastlagt i de nationale bestemmelser, bør produktet kunne markedsføres og anvendes, indtil
vurderingen er afsluttet. En ordning med forhåndsgodkendelse bør definere, hvilke produkter der er omfattet af
denne bestemmelse. Det samme gælder, når den manglende anmeldelse af en kombination af aktivstof og
produkttype skyldes den nye definition af produkttyper i forordning (EU) nr. 528/2012 sammenholdt med
(1) EUT L 167 af 27.6.2012, s. 1.
(2) Kommissionens forordning (EF) nr. 1451/2007 af 4. december 2007 om den anden fase af det tiårs arbejdsprogram, der er omhandlet i
artikel 16, stk. 2, i Europa-Parlamentets og Rådets direktiv 98/8/EF om markedsføring af biocidholdige produkter (EUT L 325 af
11.12.2007, s. 3).
(3) Europa-Parlamentets og Rådets direktiv 98/8/EF af 16. februar 1998 om markedsføring af biocidholdige produkter (EFT L 123 af
24.4.1998, s. 1).
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direktiv 98/8/EF eller er begrundet i en afgørelse truffet af Kommissionen i henhold til artikel 3, stk. 3, i forord­
ning (EU) nr. 528/2012, i retspraksis som f.eks. sag C-420/10 (1) eller i en bindende vejledning fra Kommissionen
eller medlemsstaternes kompetente myndigheder, som efterfølgende undersøges.
(4)
Hvis et biocidholdigt produkt indeholder, består af eller genererer et aktivstof, som ikke længere indgår i undersø­
gelsesprogrammet, men anvendelsen af dette biocidholdige produkt er nødvendigt i en medlemsstat, bør denne
anvendelse og tilgængeliggørelsen på markedet med henblik på denne anvendelse tillades i den pågældende
medlemsstat på medlemsstatens ansvar, på visse betingelser og i et begrænset tidsrum.
(5)
For at sikre konsekvens og forenkling bør proceduren for vurdering af aktivstoffer i undersøgelsesprogrammet i
alle de relevante dele være identisk med proceduren i forbindelse med ansøgninger, der indsendes i henhold til ar­
tikel 7 i forordning (EU) nr. 528/2012 eller i henhold til Kommissionens gennemførelsesforordning
(EU) nr. 88/2014 (2).
(6)
I forbindelse med stoffer, der opfylder udelukkelses- og substitutionskriterierne, bør den kompetente vurderings­
myndighed fremsende et forslag til agenturet om en harmoniseret klassificering og mærkning i henhold til arti­
kel 37, stk. 1, i Europa-Parlamentets og Rådets forordning (EF) nr. 1272/2008 (3) for så vidt angår de effektpara­
metre, der giver anledning til bekymring, men bevarer samtidig retten til at fremsende et forslag vedrørende andre
eller alle effektparametre. Den kompetente myndighed, der foretager vurderingen, bør også høre agenturet om
stoffer, som opfylder kriterierne for at være persistente, bioakkumulerende eller toksiske, og om stoffer, der kan
anses for at være hormonforstyrrende.
(7)
For at sikre, at undersøgelsesprogrammet afsluttes på datoen i artikel 89, stk. 1, i forordning (EU) nr. 528/2012,
bør vurderingerne begrænses til de kombinationer af aktivstof og produkttype, for hvilke de relevante data er
indsendt inden for tidsfristerne i forordning (EF) nr. 1451/2007 eller denne forordning. Endvidere bør der fast­
sættes passende tidsfrister for afslutning af vurderingerne under hensyntagen til den mulighed, at ansøgningerne
bliver valideret mindre end et år før disse tidsfrister.
(8)
Der er endnu ikke fastsat nogen datakrav for optagelse i kategori 7 i bilag I til forordning (EU) nr. 528/2012.
Derfor bør ansøgningerne om optagelse i dette bilag til kategori 1, 2, 3, 4, 5 eller 6 på nuværende tidspunkt
begrænses.
(9)
Uanset artikel 90, stk. 2, i forordning (EU) nr. 528/2012 følger det af samme forordnings artikel 91, at kriterierne
i forordningens artikel 10 bør være relevante for den efterfølgende godkendelse af biocidholdige produkter i alle
tilfælde. Derfor bør de stoffer, der opfylder disse kriterier, udpeges i alle vurderinger af aktivstoffer.
(10)
En potentiel deltager i undersøgelsesprogrammet bør kunne slutte sig til eller indtræde i stedet for en eksisterende
deltager efter fælles overenskomst, forudsat at vurderingen ikke derved forsinkes af begrænset dataadgang, idet
den potentielle ansøger ellers ville være nødt til at fremlægge dataene igen.
(11)
Eftersom deltagelse i undersøgelsesprogrammet er frivillig, bør en deltager kunne udtræde af programmet. Sker
det, bør potentielle deltagere kunne overtage støtten, medmindre den mulighed allerede har været benyttet én
gang, således at undersøgelsesprogrammet allerede er blevet forsinket, og hvis agenturet ikke allerede er begyndt
at arbejde på sin udtalelse.
(12)
Når det under vurderingen af et aktivstof viser sig, at den identitet, der formelt indgår i undersøgelsesprogrammet,
ikke svarer nøjagtigt til det stof, der rent faktisk vurderes, og vurderingen ikke gør det muligt at drage konklusi­
oner vedrørende den formelt optagne stofidentitet, bør det være muligt at omdefinere stoffet under vurderingen
og tillade andre at overtage støtten til det formelt optagne stof.
(1) Sag C-420/10:Domstolens dom (Tredje Afdeling) af 1. marts 2012 — Söll GmbH mod Tetra GmbH (anmodning om præjudiciel afgø­
relse fra Landgericht Hamburg — Tyskland) (Markedsføring af biocidholdige produkter — direktiv 98/8/EF — artikel 2, stk. 1, litra a) —
begrebet »biocidholdige produkter« — et produkt, der bevirker flokkulation af skadegørere, uden at disse ødelægges, hindres eller uskade­
liggøres).
(2) Kommissionens gennemførelsesforordning (EU) nr. 88/2014 af 31. januar 2014 om fastlæggelse af en procedure for ændring af bilag I til
Europa-Parlamentets og Rådets forordning (EU) nr. 528/2012 om tilgængeliggørelse på markedet og anvendelse af biocidholdige pro­
dukter (EUT L 32 af 1.2.2014, s. 3).
3
( ) Europa-Parlamentets og Rådets forordning (EF) nr. 1272/2008 af 16. december 2008 om klassificering, mærkning og emballering af
stoffer og blandinger og om ændring og ophævelse af direktiv 67/548/EØF og 1999/45/EF og om ændring af forordning
(EF) nr. 1907/2006 (EUT L 353 af 31.12.2008, s. 1).
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(13)
Visse stoffer, der indgår i undersøgelsesprogrammet, støttes ikke af nogen deltagere på tidspunktet for vedtagelsen
af denne forordning. Det samme gælder visse nanomaterialer, selv om sådanne materialer i henhold til artikel 4,
stk. 4, i forordning (EU) nr. 528/2012 kun godkendes, hvor dette specifikt er nævnt. Deltagelsen for disse stoffer
og nanomaterialer bør kunne overtages af andre personer, og ellers bør disse stoffer og nanomaterialer udelukkes
fra undersøgelsesprogrammet.
(14)
For at sikre, at ingen stoffer uberettiget forbliver i eller medtages i undersøgelsesprogrammet uden efterfølgende
at blive vurderet, bør et stof, der endnu ikke er under vurdering, kun forblive eller medtages i programmet, hvis
der indsendes væsentlige data om stoffet —
VEDTAGET DENNE FORORDNING:
KAPITEL 1
GENSTAND OG DEFINITIONER
Artikel 1
Genstand
I denne forordning fastsættes reglerne for gennemførelse af det arbejdsprogram for systematisk undersøgelse af alle
eksisterende aktivstoffer i biocidholdige produkter, der er omhandlet i artikel 89 i forordning (EU) nr. 528/2012.
Artikel 2
Definitioner
I denne forordning forstås ved:
a) »afgørelse om afvisning af godkendelse«: en afgørelse om ikke at godkende en kombination af stof og produkttype i
medfør af artikel 9, stk. 1, litra b), eller artikel 89, stk. 1, tredje afsnit, i forordning (EU) nr. 528/2012, eller om ikke
at optage det i bilag I eller IA til direktiv 98/8/EF
b) »kombination af stof og produkttype, der indgår i undersøgelsesprogrammet«: en kombination af stof og produkt­
type på listen i bilag II, som opfylder følgende krav:
i) det er ikke omfattet af nogen af følgende:
— et direktiv om optagelse i bilag I eller IA til direktiv 98/8/EF
— en forordning om, at det er godkendt i medfør af artikel 89, stk. 1, tredje afsnit, i forordning
(EU) nr. 528/2012
ii) det er ikke omfattet af en afgørelse om afvisning af godkendelse, eller den seneste afgørelse om afvisning af
godkendelse er trukket tilbage
c) »deltager«: en person, som har indsendt en ansøgning vedrørende en kombination af stof og produkttype, der indgår
i undersøgelsesprogrammet, eller som har indsendt en anmeldelse, der er i overensstemmelse med artikel 17, stk. 5,
eller på hvis vegne en sådan ansøgning eller anmeldelse er blevet indsendt
d) »kompetent vurderingsmyndighed«: den kompetente myndighed, som den medlemsstat, der er anført i bilag II, har
udpeget i henhold til artikel 81 i forordning (EU) nr. 528/2012.
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KAPITEL 2
PROCEDURE FOR VURDERING AF DOSSIERER
Artikel 3
Ansøgning om godkendelse eller optagelse i bilag I til forordning (EU) nr. 528/2012
1.
En ansøgning om godkendelse eller optagelse i bilag I til forordning (EU) nr. 528/2012 kan kun fremsendes af en
deltager, hvis anmeldelse agenturet mener, opfylder kravene i henhold til denne forordnings artikel 17, stk. 5.
Når ansøgningen vedrører optagelse i bilag I til forordning (EU) nr. 528/2012, kan den kun vedrøre kategori 1, 2, 3, 4,
5 eller 6 i dette bilag.
2.
De i stk. 1 nævnte ansøgninger skal indsendes til agenturet senest to år efter udstedelsen af den i artikel 17, stk. 5,
omhandlede overensstemmelseserklæring.
Artikel 4
Accept af ansøgninger
1.
Agenturet oplyser deltageren om de gebyrer, der skal erlægges i henhold til Kommissionens gennemførelsesforord­
ning (EU) nr. 564/2013 (1), og afviser ansøgningen, hvis deltageren ikke har betalt gebyrerne inden for 30 dage. Det giver
deltageren og den kompetente vurderingsmyndighed meddelelse herom.
2.
Ved modtagelsen af de gebyrer, der skal erlægges i henhold til gennemførelsesforordning (EU) nr. 564/2013, accep­
terer agenturet ansøgningen og giver deltageren og den kompetente vurderingsmyndighed meddelelse herom med angi­
velse af datoen for accept af ansøgningen og dens entydige identifikationskode.
3.
De afgørelser, som agenturet træffer i henhold til artikel 77, stk. 1, i forordning (EU) nr. 528/2012, kan påklages i
overensstemmelse med denne artikel.
4.
Den kompetente vurderingsmyndighed informerer deltageren om de gebyrer, der skal erlægges i henhold til arti­
kel 80, stk. 2, i forordning (EU) nr. 528/2012 inden for 30 dage fra agenturets accept af ansøgningen, og afviser ansøg­
ningen, hvis deltageren ikke betaler gebyrerne inden for 30 dage. Den giver deltageren og agenturet meddelelse herom.
Artikel 5
Validering af ansøgninger om godkendelse eller optagelse i kategori 6 i bilag I til forordning (EU) nr. 528/2012
1.
Når agenturet i medfør af artikel 4, stk. 2, har accepteret en ansøgning om godkendelse eller optagelse i kategori 6
i bilag I til forordning (EU) nr. 528/2012 indeholdende de data, der kræves i henhold til artikel 6, stk. 1 og 2, og gebyret
er betalt i overensstemmelse med artikel 4, stk. 4, validerer den kompetente vurderingsmyndighed ansøgningen inden
for 30 dage fra betalingen af gebyrerne.
2.
Når den kompetente vurderingsmyndighed har modtaget dossieret fra deltageren i henhold til forordning
(EF) nr. 1451/2007, men endnu ikke har accepteret dossieret som fuldstændigt i henhold til denne forordnings artikel 13,
validerer den kompetente vurderingsmyndighed ansøgningen senest den 3. januar 2015.
3.
Den kompetente vurderingsmyndighed foretager ikke i de i stk. 1 og 2 omhandlede tilfælde en vurdering af kvali­
teten eller tilstrækkeligheden af de fremlagte data eller begrundelser.
4.
Finder den kompetente vurderingsmyndighed, at ansøgningen er ufuldstændig, informerer den deltageren om,
hvilke supplerende oplysninger der er nødvendige for, at ansøgningen kan valideres, og den fastsætter en rimelig frist for
fremsendelse af disse oplysninger. Denne frist må normalt ikke overstige 90 dage.
(1) Kommissionens gennemførelsesforordning (EU) nr. 564/2013 af 18. juni 2013 om gebyrer og afgifter til Det Europæiske Kemikalie­
agentur i henhold til Europa-Parlamentets og Rådets forordning (EU) nr. 528/2012 om tilgængeliggørelse på markedet og anvendelse af
biocidholdige produkter (EUT L 167 af 19.6.2013, s. 17).
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Den kompetente vurderingsmyndighed validerer ansøgningen senest 30 dage efter modtagelsen af de supplerende oplys­
ninger, hvis den vurderer, at disse oplysninger er tilstrækkelige til, at ansøgningen opfylder kravet i stk. 2.
Den kompetente vurderingsmyndighed afviser ansøgningen, hvis deltageren ikke inden for tidsfristen fremlægger de
krævede oplysninger, og underretter deltageren og agenturet herom. I så fald tilbagebetales en del af det gebyr, der er
indbetalt i henhold til artikel 80, stk. 1 og 2, i forordning (EU) nr. 528/2012.
Når den kompetente vurderingsmyndighed har valideret en ansøgning, giver den straks deltageren, agenturet og andre
kompetente myndigheder meddelelse herom med angivelse af datoen for valideringen.
Artikel 6
Vurdering af ansøgninger
1.
Denne artikel finder anvendelse, når en af følgende betingelser gør sig gældende:
a) en ansøgning er blevet valideret i henhold til artikel 5
b) den kompetente vurderingsmyndighed har accepteret dossieret som fuldstændigt i henhold til artikel 13 i forordning
(EF) nr. 1451/2007, men har endnu ikke sendt rapporten fra den kompetente myndighed til Kommissionen i henhold
til samme forordnings artikel 14, stk. 4
c) agenturet har accepteret en ansøgning om optagelse i kategori 1, 2, 3, 4 eller 5 i bilag I til forordning
(EU) nr. 528/2012 i overensstemmelse med artikel 4, stk. 2, og gebyret er blevet betalt i henhold til artikel 4, stk. 4.
2.
Den kompetente vurderingsmyndighed vurderer en ansøgning i overensstemmelse med artikel 4 og 5 i forordning
(EU) nr. 528/2012, herunder i givet fald ethvert forslag om at tilpasse datakravene, som fremlægges i henhold til samme
forordnings artikel 6, stk. 3, og fremsender en vurderingsrapport og konklusionerne af sin vurdering til agenturet.
3.
Når flere deltagere støtter den samme kombination af stof og produkttype, udarbejder den kompetente vurderings­
myndighed kun en enkelt vurderingsrapport. Vurderingsrapporten og konklusionerne fremsendes inden for en af
følgende tidsfrister, afhængigt af hvilken der er senest:
a) 365 dage efter den seneste validering nævnt i stk. 1, litra a), accept af fuldstændighed som omhandlet i stk. 1, litra b),
eller betaling af det i stk. 1, litra c), omhandlede gebyr for den pågældende kombination af stof og produkttype
b) de i bilag III fastsatte tidsfrister.
4.
Inden den kompetente vurderingsmyndighed fremlægger sine konklusioner for agenturet, giver den deltageren
mulighed for inden for 30 dage at indgive skriftlige bemærkninger til vurderingsrapporten og konklusionerne af vurde­
ringen. Den kompetente vurderingsmyndighed tager behørigt hensyn til disse bemærkninger i forbindelse med udarbej­
delsen af den endelige vurdering.
5.
Viser det sig, at der, for at vurderingen kan gennemføres, er behov for supplerende oplysninger, anmoder den
kompetente vurderingsmyndighed deltageren om at fremsende sådanne oplysninger inden for en nærmere fastsat tids­
frist, og underretter agenturet herom.
Den i stk. 3 omhandlede frist på 365 dage stilles i bero fra den dato, hvor der anmodes om supplerende oplysninger, og
den genoptages først på den dato, hvor oplysningerne modtages. Berostillelsen må ikke overstige følgende tidsfrister,
medmindre det er begrundet i arten af de ønskede oplysninger eller særlige omstændigheder:
a) 365 dage, når de supplerende oplysninger vedrører spørgsmål, der ikke er omhandlet i direktiv 98/8/EF eller i den
praksis, der er indført i forbindelse med gennemførelse af dette direktiv
b) 180 dage i alle andre tilfælde.
6.
Finder den kompetente vurderingsmyndighed, at den kumulative virkning af anvendelsen af biocidholdige produk­
ter indeholdende de samme eller andre aktivstoffer giver anledning til bekymring for menneskers sundhed, dyrs sundhed
eller miljøet, skal den dokumentere dette i overensstemmelse med de i de relevante bestemmelser i afsnit II.3 i bilag XV
til Europa-Parlamentets og Rådets forordning (EF) nr. 1907/2006 (1) omhandlede krav og tilføje dette som en del af sine
konklusioner.
(1) Europa-Parlamentets og Rådets forordning (EF) nr. 1907/2006 af 18. december 2006 om registrering, vurdering og godkendelse af samt
begrænsninger for kemikalier (REACH), om oprettelse af et europæisk kemikalieagentur og om ændring af direktiv 1999/45/EF og ophæ­
velse af Rådets forordning (EØF) nr. 793/93 og Kommissionens forordning (EF) nr. 1488/94 samt Rådets direktiv 76/769/EØF og
Kommissionens direktiv 91/155/EØF, 93/67/EØF, 93/105/EF og 2000/21/EF (EUT L 396 af 30.12.2006, s. 1).
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7.
Når den kompetente vurderingsmyndighed har afsluttet sin risikovurdering, skal den straks og senest ved fremsen­
delsen af vurderingsrapporten i henhold til stk. 3, alt efter omstændighederne:
a) fremsende et forslag til agenturet i henhold til artikel 37, stk. 1, i forordning (EF) nr. 1272/2008, når den mener, at
et af de i denne forordnings artikel 36, stk. 1, opstillede kriterier er opfyldt og ikke er behandlet korrekt i del 3 i
bilag VI til denne forordning
b) konsultere agenturet, når den mener, at et af kriterierne i artikel 5, stk. 1, litra d) eller e), i forordning
(EU) nr. 528/2012 eller betingelsen i artikel 10, stk. 1, litra d), i denne forordning er opfyldt og ikke er behandlet
korrekt i bilag XIV til forordning (EF) nr. 1907/2006 eller i den i denne forordnings artikel 59, stk. 1, omhandlede
kandidatliste.
Artikel 7
Agenturets udtalelse
1.
Denne artikel finder anvendelse, når en af følgende betingelser gør sig gældende:
a) den kompetente vurderingsmyndighed har fremsendt en vurderingsrapport i henhold til artikel 6, stk. 2, og, hvor det
er relevant, et forslag eller en konsultation i henhold til artikel 6, stk. 7
b) den kompetente myndigheds rapport er blevet fremsendt til Kommissionen i henhold til artikel 14, stk. 4, i forord­
ning (EF) nr. 1451/2007, men Det Stående Udvalg for Biocidholdige Produkter har endnu ikke gennemgået vurde­
ringsrapporten i henhold til den pågældende forordnings artikel 15, stk. 4.
2.
Når rapporten er accepteret, udarbejder og fremlægger agenturet en udtalelse for Kommissionen om godkendelse af
kombinationen af stof og produkttype eller dens optagelse i kategori 1, 2, 3, 4, 5 eller 6 i bilag I til forordning
(EU) nr. 528/2012 eller begge dele afhængigt af den kompetente vurderingsmyndigheds konklusioner.
Agenturet påbegynder udarbejdelsen af udtalelsen inden for en af følgende tidsfrister, afhængigt af hvilken der er senest:
a) tre måneder fra accept af rapporten
b) de i bilag III fastsatte tidsfrister.
Agenturet fremlægger udtalelsen for Kommissionen senest 270 dage efter, at det har påbegyndt udarbejdelsen af den.
Artikel 8
Aktivstoffer, som er kandidater til substitution
1.
Agenturet undersøger ved udarbejdelsen af sin udtalelse i henhold til artikel 7, stk. 2, om aktivstoffet opfylder et
eller flere af kriterierne i artikel 10, stk. 1, i forordning (EU) nr. 528/2012, og nævner dette i sin udtalelse.
2.
Inden agenturet fremsender sin udtalelse til Kommissionen, offentliggør det oplysninger om potentielle kandidater
til substitution i en periode på højst 60 dage, hvor andre interesserede parter kan indgive relevante oplysninger, herunder
oplysninger om tilgængelige erstatningsstoffer, jf. artikel 66 og 67 i forordning (EU) nr. 528/2012. Agenturet tager i
forbindelse med udarbejdelsen af den endelige udtalelse behørigt hensyn til de oplysninger, der modtages.
3.
Når aktivstoffet er godkendt og opfylder et af kriterierne i artikel 10, stk. 1, i forordning (EU) nr. 528/2012, skal
det anføres som kandidat til substitution i den forordning, der vedtages i henhold til den pågældende forordnings arti­
kel 89, stk. 1, første afsnit.
Artikel 9
Kommissionens afgørelse
Når Kommissionen har modtaget agenturets udtalelse i henhold til artikel 7, stk. 2, udarbejder den straks et udkast til
afgørelse, som skal vedtages i henhold til artikel 89, stk. 1, eller alt efter omstændighederne artikel 28, stk. 1, i forord­
ning (EU) nr. 528/2012.
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KAPITEL 3
ÆNDRINGER AF ELEMENTER I UNDERSØGELSESPROGRAMMET
Artikel 10
Tilslutning og udskiftning af deltagere efter fælles overenskomst
1.
Hvervet som deltager kan efter fælles overenskomst overtages eller deles mellem en eksisterende deltager og en
potentiel deltager, såfremt den potentielle deltager har ret til at henvise til alle de oplysninger, som den eksisterende
deltager har fremsendt eller henvist til.
2.
Den potentielle og den eksisterende deltager fremsender i fællesskab via det i artikel 71 i forordning
(EU) nr. 528/2012 omhandlede register over biocidholdige produkter (i det følgende benævnt »registeret«) en meddelelse
herom til agenturet, som skal omfatte alle relevante adgangstilladelser.
3.
Når agenturet har modtaget en meddelelse i henhold til stk. 2, opdaterer det oplysningerne i registeret vedrørende
deltagerens identitet.
4.
En person, som er etableret i Unionen, og som har overtaget eller tilsluttet sig hvervet som deltager i henhold til
denne artikel, anses for at have fremsendt et dossier eller en dataadgangstilladelse til et dossier i henhold til artikel 95 i
forordning (EU) nr. 528/2012.
Artikel 11
Deltageres udtræden
1.
En deltager anses for at have trukket sin støtte til en kombination af stof og produkttype i undersøgelsespro­
grammet tilbage i følgende tilfælde:
a) når deltageren via registeret har underrettet agenturet eller den kompetente vurderingsmyndighed om, at denne agter
at udtræde
b) når deltageren ikke har fremsendt en ansøgning inden for de i artikel 3, stk. 2, fastsatte tidsfrister
c) når deltagerens ansøgning er blevet afvist i henhold til artikel 4, stk. 1, artikel 4, stk. 4 eller artikel 5, stk. 4
d) når deltageren ikke har fremsendt supplerende oplysninger inden for de i artikel 6, stk. 5, fastsatte tidsfrister
e) når deltageren på har undladt at erlægge de gebyrer, der skal betales til den kompetente vurderingsmyndighed eller
agenturet.
2.
En udtræden anses for at være sket rettidigt, medmindre den indtræder efter den dato, hvor den kompetente vurde­
ringsmyndighed fremsender rapporten fra den kompetente myndighed til ansøgeren i henhold til artikel 6, stk. 4.
Artikel 12
Konsekvenser af en rettidig udtræden
1.
Når den kompetente vurderingsmyndighed, men ikke agenturet bliver bekendt med en rettidig udtræden, under­
retter den straks agenturet herom via registeret.
2.
Når agenturet bliver bekendt med en rettidig udtræden, opdaterer det oplysningerne i registeret om deltagerens
identitet.
3.
Når alle de deltagere, der støtter den samme kombination af stof og produkttype, er udtrådt rettidigt af undersøgel­
sesprogrammet, og når hvervet som deltager i forbindelse med denne kombination tidligere er blevet overtaget, under­
retter agenturet Kommissionen herom via registeret.
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Artikel 13
Omdefinering af aktivstoffer
1.
Når vurderingen af et eksisterende aktivstof ikke gør det muligt at drage konklusioner om stoffet som identificeret i
bilag II, skal den kompetente vurderingsmyndighed efter høring af den pågældende deltager, fastsætte en ny stofidentitet.
Den underretter agenturet herom.
2.
Agenturet ajourfører oplysningerne i registeret vedrørende stoffets identitet.
Artikel 14
Overtagelse af hvervet som deltager
1.
Agenturet offentliggør en åben invitation til at overtage hvervet som deltager for kombinationen af stof og
produkttype, når et af følgende krav er opfyldt:
a) alle de deltagere, der støtter den samme kombination af stof og produkttype er udtrådt rettidigt i henhold til arti­
kel 11, og hvervet som deltager for denne kombination er ikke tidligere blevet overtaget
b) efter en omdefinering i henhold til artikel 13, hvor invitationen kun vedrører et stof, der er omfattet af den eksiste­
rende identitet i bilag II, men ikke af den nye stofidentitet.
2.
Inden for 12 måneder fra den i stk. 1 nævnte offentliggørelsesdato kan alle fremsende en anmeldelse vedrørende
kombinationen i henhold til artikel 17.
3.
Inden for 12 måneder fra datoen for denne forordnings ikrafttræden, kan alle anmelde en kombination af et stof
og en produkttype, som indgår i del 2 i bilag II i henhold til artikel 17.
Artikel 15
Kombinationer af stof og produkttype, der kan indgå i undersøgelsesprogrammet
Når et biocidholdigt produkt, der er omfattet af anvendelsesområdet for forordning (EU) nr. 528/2012, og som gøres
tilgængeligt på markedet, indeholder eller genererer et eksisterende aktivstof, som hverken er godkendt eller indgår i
undersøgelsesprogrammet for produkttypen og ikke er opført i bilag I til den pågældende forordning, kan dette stof
indgå i undersøgelsesprogrammet for den pågældende produkttype med en af følgende begrundelser:
a) den person, der gør produktet tilgængeligt på markedet, har baseret sig på vejledning offentliggjort af eller skriftlig
rådgivning fra Kommissionen eller en kompetent myndighed udpeget i henhold til artikel 26 i direktiv 98/8/EF eller
artikel 81 i forordning (EU) nr. 528/2012, når denne vejledning eller rådgivning indeholdt objektive begrundelser for
at mene, at produktet var udelukket fra anvendelsesområdet for direktiv 98/8/EF eller forordning (EU) nr. 528/2012,
eller at den pågældende produkttype var en produkttype, for hvilken aktivstoffet var blevet meddelt, og når denne
vejledning eller rådgivning efterfølgende vurderes i en afgørelse vedtaget i henhold til artikel 3, stk. 3, i forordning
(EU) nr. 528/2012 eller i en ny offentlig vejledning udgivet af Kommissionen
b) stoffet er omfattet af undtagelsen for fødevarer og foderstoffer i artikel 6 i forordning (EF) nr. 1451/2007
c) det biocidholdige produkt henhører i forordning (EU) nr. 528/2012 under en anden produkttype end den, det tilhørte
i direktiv 98/8/EF, som følge af en ændring af anvendelsesområdet for disse produkttyper, og indeholder et stof, der
indgik i undersøgelsesprogrammet for den oprindelige produkttype, men ikke for den nye produkttype.
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Artikel 16
Interessetilkendegivelse om anmeldelse
1.
En interessetilkendegivelse om anmeldelse af et stof, der kan optages i undersøgelsesprogrammet i henhold til arti­
kel 15, fremsendes via registeret af enhver, som har interesse i at anmelde en kombination af et stof og en produkttype,
til en af følgende modtagere:
a) til Kommissionen senest 12 måneder efter offentliggørelsen af den i artikel 15, litra a), nævnte afgørelse eller vejled­
ning
b) til agenturet senest den 30. oktober 2015 i de i artikel 15, litra b), nævnte tilfælde
c) til Kommissionen senest den 30. oktober 2015 i de i artikel 15, litra c), nævnte tilfælde.
2.
En erklæring skal angive den relevante kombination af stof og produkttype. I de i artikel 15, litra a), nævnte tilfælde
skal erklæringen underbygges af en begrundelse, hvoraf fremgår, at alle de deri opstillede betingelser er opfyldt.
3.
Når en erklæring er blevet fremsat i et af de i artikel 15, litra a) eller c), nævnte tilfælde, og finder Kommissionen
efter høring af medlemsstaterne, at artikel 6 ikke finder anvendelse, og de i artikel 15, litra a), nævnte betingelser for
anmeldelse er opfyldt, underretter den agenturet.
4.
Når en erklæring er blevet fremsat i det i artikel 15, litra b), nævnte tilfælde, eller når Kommissionen har under­
rettet agenturet i henhold til stk. 3, offentliggør agenturet disse oplysninger elektronisk med angivelse af den relevante
kombination af stof og produkttype. I denne forordning anses en offentliggørelse i henhold til artikel 3a, stk. 3, tredje
afsnit, i forordning (EF) nr. 1451/2007 for at være en offentliggørelse i henhold til dette stykke.
5.
Enhver person, der har interesse i at anmelde kombinationen af stof og produkttype, kan inden for seks måneder
fra den i stk. 4 omhandlede offentliggørelsesdato gøre dette i henhold til artikel 17.
6.
I de i artikel 15, litra a) og c), nævnte tilfælde anses en kombination af stof og produkttype for at være blevet
anmeldt af en deltager og kan ikke gøres til genstand for en ny anmeldelse, når følgende betingelser er opfyldt:
a) det relevante aktivstof er allerede medtaget i undersøgelsesprogrammet
b) et af de dossierer, der er fremsendt til den vurderende medlemsstat for det pågældende aktivstof, indeholder allerede
alle de oplysninger, der er nødvendige for vurderingen af produkttypen
c) den deltager, som har fremsendt dossieret, udtrykker interesse for at støtte kombinationen af stof og produkttype.
Artikel 17
Anmeldelsesprocedure
1.
Anmeldelser i henhold til artikel 14, stk. 2 og 3, eller artikel 16, stk. 5, foretages til agenturet via registeret.
2.
Anmeldelsen forelægges i Iuclid-format. Den indeholder de oplysninger, der er fastsat i bilag I.
3.
Når ingen kompetent vurderingsmyndighed er anført i bilag II for det pågældende aktivstof, informerer anmelderen
agenturet om navnet på den kompetente myndighed udpeget i henhold til artikel 81 i forordning (EU) nr. 528/2012,
som anmelderen har valgt, og fremlægger en skriftlig bekræftelse på, at den pågældende kompetente myndighed har
accepteret at vurdere dossieret.
4.
Ved modtagelsen af en sådan anmeldelse informerer agenturet Kommissionen herom og informerer anmelderen
om de gebyrer, der skal erlægges ifølge forordning (EU) nr. 564/2013. Undlader en anmelder at betale gebyret inden
30 dage fra modtagelsen af denne oplysning, afviser agenturet anmeldelsen og informerer anmelderen og Kommissionen
herom.
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5.
Efter at betalingen af gebyrerne er modtaget, kontrollerer agenturet inden 30 dage, om anmeldelsen opfylder
kravene i stk. 2. Opfylder anmeldelsen ikke disse krav, giver Kommissionen anmelderen en frist på 30 dage til at fuld­
stændiggøre eller rette anmeldelsen. Efter udløbet af fristen på 30 dage skal agenturet inden 30 dage enten erklære, at
anmeldelsen opfylder kravene i stk. 2, eller afvise anmeldelsen og underrette anmelderen og Kommissionen herom.
6.
De afgørelser, som agenturet træffer i henhold til denne artikels stk. 4 eller 5, kan påklages i henhold til artikel 77
i forordning (EU) nr. 528/2012.
7.
Når anmeldelsen anses for at være overensstemmende i henhold til stk. 5, skal agenturet straks:
a) når anmeldelsen er fremsendt i henhold til artikel 14, stk. 2 eller 3, ajourføre oplysningerne i registeret om deltage­
rens og, hvor det er relevant, stoffets identitet
b) når anmeldelsen er fremsendt i henhold til artikel 16, stk. 5, informere Kommissionen om overensstemmelsen.
Artikel 18
Optagelse i undersøgelsesprogrammet
Når kombinationen af stof og produkttype anses for at være anmeldt i henhold til artikel 16, stk. 6, eller når agenturet
informerer Kommissionen om overensstemmelse i henhold til artikel 17, stk. 7, litra b), optager Kommissionen kombina­
tionen af stof og produkttype i undersøgelsesprogrammet.
Artikel 19
Information om stoffer, der ikke længere støttes under undersøgelsesprogrammet
Når agenturet ikke har modtaget en anmeldelse inden for den i artikel 16, stk. 5, nævnte tidsfrist, eller når det har
modtaget en anmeldelse omhandlet i denne artikel og efterfølgende afvist den i medfør af artikel 17, stk. 4 og 5, infor­
merer agenturet medlemsstaterne herom via registeret og offentliggør denne information elektronisk.
Artikel 20
Kommissionens afgørelser om stoffer, der ikke længere støttes under undersøgelsesprogrammet
Kommissionen udarbejder et udkast til en afgørelse om afvisning af godkendelse i henhold til artikel 89, stk. 1, tredje
afsnit, i forordning (EU) nr. 528/2012 i følgende tilfælde:
a) når agenturet informerer Kommissionen om alle deltagernes rettidige udtræden i henhold til artikel 12, stk. 3, i denne
forordning
b) når ingen har indsendt en anmeldelse inden for de i denne forordnings artikel 14, stk. 2, eller artikel 13, stk. 3, fast­
satte tidsfrister, eller når en sådan anmeldelse er blevet fremsendt og afvist i henhold til forordningens artikel 17,
stk. 4, eller artikel 17, stk. 5
c) når en anmeldelse er fremsendt inden for de tidsfrister, der er fastsat i denne forordnings artikel 14, stk. 2, eller arti­
kel 14, stk. 3, og er i overensstemmelse med forordningens artikel 17, stk. 5, men stofidentiteten i anmeldelsen kun
omfatter en del af den eksisterende identitet i bilag II til denne forordning.
I det i litra c) i første afsnit nævnte tilfælde, omfatter udkastet til afgørelse om afvisning af godkendelse alle stoffer
omfattet af den eksisterende identitet i bilag II til denne forordning, men ikke af anmeldelsen eller af en godkendelsesaf­
gørelse.
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KAPITEL 4
OVERGANGSFORANSTALTNINGER
Artikel 21
Overgangsforanstaltninger for de i artikel 15 nævnte stoffer
1.
En medlemsstat kan fortsætte med at anvende sin aktuelle ordning eller praksis for markedsføring og anvendelse af
biocidholdige produkter, som består af, indeholder eller genererer et eksisterende aktivstof omhandlet i artikel 15, litra b)
og c). I sådanne tilfælde:
a) markedsføres det biocidholdige produkt ikke længere med virkning fra 24 måneder efter datoen for denne forord­
nings ikrafttræden
b) anvendelsen af eksisterende lagre af det biocidholdige produkt kan fortsætte indtil 30 måneder efter datoen for denne
forordnings ikrafttræden.
2.
En medlemsstat kan fortsætte med at anvende sin aktuelle ordning eller praksis for markedsføring og anvendelse af
biocidholdige produkter, som består af, indeholder eller genererer et eksisterende aktivstof omhandlet i artikel 15, litra b)
og c). I sådanne tilfælde:
a) markedsføres det biocidholdige produkt ikke længere med virkning fra 24 måneder efter en af nedenstående datoer,
afhængigt af hvilken der er senest:
i) datoen for denne forordnings ikrafttræden
ii) meddelelsen eller offentliggørelsen af den i artikel 15, litra a), nævnte afgørelse eller vejledning
b) anvendelsen af eksisterende lagre af det biocidholdige produkt kan fortsætte indtil 30 måneder efter en af neden­
stående datoer, afhængigt af hvilken der er senest:
i) datoen for denne forordnings ikrafttræden
ii) meddelelsen eller offentliggørelsen af den i artikel 15, litra a), nævnte afgørelse eller vejledning.
3.
En medlemsstat kan fortsætte med at anvende sin aktuelle ordning eller praksis for markedsføring og anvendelse af
biocidholdige produkter, som består af, indeholder eller genererer et eksisterende aktivstof omhandlet i artikel 16, stk. 4,
for den relevante produkttype. I sådanne tilfælde:
a) markedsføres det biocidholdige produkt ikke længere med virkning fra 12 måneder efter den dato, hvor agenturet har
foretaget den i artikel 19 omhandlede elektroniske offentliggørelse
b) kan anvendelsen af eksisterende lagre af det biocidholdige produkt fortsætte indtil 18 måneder efter datoen for denne
offentliggørelse.
Artikel 22
Nødvendig anvendelse
1.
Uanset artikel 55, stk. 1, i forordning (EU) nr. 528/2012, kan en medlemsstat inden for 18 måneder fra datoen for
en afgørelse om ikke at godkende et eksisterende aktivstof, når den mener, at dette eksisterende aktivstof er nødvendigt
af en af de i første afsnit i artikel 5, stk. 2, litra b) eller c), nævnte årsager, fremsende en begrundet ansøgning til
Kommissionen om en dispensation fra denne forordnings artikel 89, stk. 2, andet afsnit.
2.
Den ansøgende medlemsstat fremsender den begrundede ansøgning til agenturet via registeret. Når ansøgningen
indeholder fortrolige oplysninger, fremsender den ansøgende medlemsstat samtidig en udgave, der ikke er fortrolig.
3.
Agenturet offentliggør ansøgningen, eller hvor det er relevant den udgave, der ikke er fortrolig, elektronisk.
Medlemsstaterne eller en person kan fremsende kommentarer inden for 60 dage fra denne offentliggørelse.
L 294/12
DA
Den Europæiske Unions Tidende
10.10.2014
4.
Kommissionen kan under hensyntagen til de modtagne kommentarer indrømme en dispensation fra artikel 89,
stk. 2, andet afsnit, i forordning (EU) nr. 528/2012, og tillade biocidholdige produkter, der består af, indeholder eller
genererer det stof, der skal markedsføres i den ansøgende medlemsstat og anvendes i denne medlemsstat i henhold til
nationale bestemmelser og på de i stk. 5 opstillede betingelse og eventuelle andre betingelser, Kommissionen måtte stille.
5.
En medlemsstat, som indrømmes dispensation, skal:
a) sikre, at den fortsatte anvendelse begrænses til tilfælde og perioder, hvor betingelserne i stk. 1 er opfyldt
b) indføre passende risikobegrænsende foranstaltninger for at sikre, at eksponeringen af mennesker, dyr og miljø mini­
meres
c) sikre, at der søges alternativer, eller at en ansøgning om godkendelse af aktivstoffet udarbejdes i henhold til artikel 7 i
forordning (EU) nr. 528/2012 i god tid inden dispensationens udløb.
KAPITEL 5
AFSLUTTENDE BESTEMMELSER
Artikel 23
Ophævede retsakter
Forordning (EF) nr. 1451/2007 ophæves.
Henvisninger til den ophævede forordning læses som henvisninger til nærværende forordning.
Artikel 24
Ikrafttræden
Denne forordning træder i kraft på tyvendedagen efter offentliggørelsen i Den Europæiske Unions Tidende.
Denne forordning er bindende i alle enkeltheder og gælder umiddelbart i hver
medlemsstat.
Udfærdiget i Bruxelles, den 4. august 2014.
På Kommissionens vegne
José Manuel BARROSO
Formand
Oplysninger, der kræves ved anmeldelse efter artikel 17
10.10.2014
BILAG I
En anmeldelse efter artikel 17 skal indeholde følgende oplysninger:
2) angivelse af, hvilke produkttyper anmeldelsen vedrører
DA
1) dokumentation for, at stoffet er et eksisterende aktivstof som defineret i artikel 3, stk. 1, litra d), i forordning (EU) nr. 528/2012
3) oplysning om, hvilke undersøgelser der er sat i gang med henblik på godkendelse eller optagelse i bilag I til forordning (EU) nr. 528/2012, herunder den dato, de forventes afsluttet
4) de oplysninger, der er omhandlet i:
a) punkt 1, 2 og 7.1-7.5 i tabellen i afsnit 1 i bilag II til forordning (EU) nr. 528/2012 for kemiske stoffer
b) punkt 1, 2 og 6.1-6.4 i tabellen i afsnit 2 i bilag II til forordning (EU) nr. 528/2012 for mikroorganismer
5) hvis anmeldelsen er forelagt i et tilfælde som omhandlet i artikel 15, litra a), dokumentation for, at stoffet var på markedet som et aktivstof i et biocidholdigt produkt af den pågældende
produkttype på datoen for den anmeldelse eller offentliggørelse af den afgørelse eller vejledning, der er omhandlet i nævnte litra.
Den Europæiske Unions Tidende
L 294/13
L 294/14
BILAG II
KOMBINATIONER AF STOF OG PRODUKTTYPE, DER ER OMFATTET AF UNDERSØGELSESPROGRAMMET DEN 4. AUGUST 2014
DEL 1
Nr.
Stof
Rapporterende
medlemsstat
EF-nr.
CAS-nr.
1
2
3
x
x
1
formaldehyd
DE
200-001-8
50-00-0
6
2-(2-butoxyethoxy)ethyl-6-propylpipero­
nylether (piperonylbutoxid/PBO)
EL
200-076-7
51-03-6
9
bronopol
ES
200-143-0
52-51-7
29
chlorcresol
FR
200-431-6
59-50-7
x
x
36
ethanol
EL
200-578-6
64-17-5
x
x
37
myresyre
BE
200-579-1
64-18-6
40
propan-2-ol
DE
200-661-7
67-63-0
43
salicylsyre
NL
200-712-3
69-72-7
45
propan-1-ol
DE
200-746-9
71-23-8
52
ethylenoxid
N
200-849-9
75-21-8
60
citronsyre
BE
201-069-1
77-92-9
69
glycolsyre
LT
201-180-5
79-14-1
70
pereddikesyre
FI
201-186-8
79-21-0
71
L-(+)-mælkesyre
DE
201-196-2
79-33-4
4
5
6
7
8
9
10
11
12
13
17
18
19
21
DA
Kombinationer af aktivstof og produkttype, der støttes den 4. august 2014, eksklusive alle nanomaterialer, der ikke udtrykkelig er nævnt i stof nr. 1017 og 1019.
22
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
Den Europæiske Unions Tidende
x
x
x
x
x
x
x
x
x
x
x
x
x
x
10.10.2014
x
x
Stof
Rapporterende
medlemsstat
EF-nr.
CAS-nr.
79
(2R,6aS,12aS)-1,2,6,6a,12,12a-hexa­
hydro-2-isopropenyl-8,9-dimethoxychro­
meno[3,4-b]furo[2,3-h]chromen-6-on
(rotenon)
UK
201-501-9
83-79-4
85
symclosen
UK
201-782-8
87-90-1
92
biphenyl-2-ol
ES
201-993-5
90-43-7
113
kanelaldehyd/3-phenylpropen-2-al
UK
203-213-9
104-55-2
117
geraniol
FR
203-377-1
106-24-1
122
glyoxal
FR
203-474-9
107-22-2
133
hexa-2,4-diensyre (sorbinsyre)
DE
203-768-7
110-44-1
136
glutaral
FI
203-856-5
111-30-8
x
x
154
chlorophen
N
204-385-8
120-32-1
x
x
171
2-phenoxyethanol
UK
204-589-7
122-99-6
172
cetylpyridiniumchlorid
UK
204-593-9
123-03-5
179
carbondioxid
FR
204-696-9
124-38-9
180
natriumdimethylarsinat
PT
204-708-2
124-65-2
185
tosylchloramidnatrium (chloramin T)
ES
204-854-7
127-65-1
187
kaliumdimethyldithiocarbamat
UK
204-875-1
128-03-0
x
x
x
188
natriumdimethyldithiocarbamat
UK
204-876-7
128-04-1
x
x
x
1
2
3
4
5
6
7
8
9
10
11
12
13
17
18
19
x
x
21
22
10.10.2014
Nr.
x
DA
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
Den Europæiske Unions Tidende
x
x
x
x
x
x
x
x
x
L 294/15
Stof
Rapporterende
medlemsstat
EF-nr.
CAS-nr.
1
2
3
4
x
x
x
x
5
6
7
x
8
10
x
x
x
x
x
natrium-2-biphenylat
ES
205-055-6
132-27-4
198
N-(trichlormethylthio)phthalimid (folpet)
IT
205-088-6
133-07-3
206
thiram
BE
205-286-2
137-26-8
x
210
metamnatrium
BE
205-293-0
137-42-8
x
227
2-thiazol-4-yl-1H-benzoimidazol
bendazol)
ES
205-725-8
148-79-8
x
235
diuron
DK
206-354-4
330-54-1
x
239
cyanamid
DE
206-992-3
420-04-2
253
tetrahydro-3,5-dimethyl-1,3,5-thiadiazin2-thion (dazomet)
BE
208-576-7
533-74-4
279
dichlor-N-[(dimethylamino)sulfonyl]fluorN-(p-tolyl)methansulfenamid (tolylfluanid)
FI
211-986-9
731-27-1
x
283
terbutryn
SK
212-950-5
886-50-0
x
288
N-(dichlorfluormethylthio)-N′,N′-dime­
thyl-N-phenylsulfamid (dichlofluanid)
UK
214-118-7
1085-98-9
x
289
kobberthiocyanat
FR
214-183-1
1111-67-7
292
(1,3,4,5,6,7-hexahydro-1,3-dioxo-2Hisoindol-2-yl)methyl-(1R-trans)-2,2-dime­
thyl-3-(2-methylprop-1-enyl)cyclopropan­
carboxylat (d-tetramethrin)
DE
214-619-0
1166-46-7
(thia­
x
12
13
17
18
19
21
22
x
x
x
Den Europæiske Unions Tidende
195
11
DA
9
L 294/16
Nr.
x
x
x
x
x
x
x
x
x
x
10.10.2014
x
Stof
Rapporterende
medlemsstat
EF-nr.
CAS-nr.
1
2
3
4
calciumdihydroxid/calciumhydroxid/
læsket kalk/kalkhydrat
UK
215-137-3
1305-62-0
x
x
959
calciumoxid/brændt kalk/ulæsket kalk
UK
215-138-9
1305-78-8
x
x
306
dikobberoxid
FR
215-270-7
1317-39-1
315
2-butanon, peroxid
HU
215-661-2
1338-23-4
321
monolinuron
UK
217-129-5
1746-81-2
x
330
N-(3-aminopropyl)-N-dodecylpropan-1,3diamin
PT
219-145-8
2372-82-9
x
336
2,2′-dithiobis[N-methylbenzamid]
(DTBMA)
PL
219-768-5
2527-58-4
339
1,2-benzisothiazol-3(2H)-on
ES
220-120-9
2634-33-5
341
2-methyl-2H-isothiazol-3-on (MIT)
SI
220-239-6
2682-20-4
346
natriumdichlorisocyanuratdihydrat
UK
220-767-7
51580-86-0
x
x
x
345
troclosennatrium
UK
220-767-7
2893-78-9
x
x
x
348
mecetroniumethylsulfat (MES)
PL
221-106-5
3006-10-8
x
354
triclosan
DK
222-182-2
3380-34-5
x
359
(ethylendioxy)dimethanol (reaktionspro­
dukter af ethylenglycol og paraformal­
dehyd (EGForm))
PL
222-720-6
3586-55-8
x
365
pyridin-2-thiol-1-oxid,
(natriumpyrithion)
SE
223-296-5
3811-73-2
x
7
8
9
10
11
12
13
17
18
19
21
22
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
L 294/17
x
Den Europæiske Unions Tidende
natriumsalt
6
DA
958
5
10.10.2014
Nr.
EF-nr.
CAS-nr.
368
methenamin-3-chlorallylochlorid (CTAC)
PL
223-805-0
4080-31-3
x
377
2,2′,2″-(hexahydro-1,3,5-triazin-1,3,5triyl)triethanol (HHT)
PL
225-208-0
4719-04-4
x
382
tetrahydro-1,3,4,6-tetrakis(hydroxyme­
thyl)imidazo[4,5-d]imidazol-2,5(1H,3H)dion (TMAD)
ES
226-408-0
5395-50-6
x
387
N,N′-methylenbismorpholin (MBM)
AT
227-062-3
5625-90-1
392
methylendithiocyanat
FR
228-652-3
6317-18-6
393
1,3-bis(hydroxymethyl)-5,5-dimethylimi­
dazolidin-2,4-dion (DMDMH)
PL
229-222-8
6440-58-0
397
didecyldimethylammoniumchlorid
(DDAC)
IT
230-525-2
7173-51-5
401
sølv
SE
231-131-3
7440-22-4
403
kobber
FR
231-159-6
7440-50-8
405
svovldioxid
DE
231-195-2
7446-09-5
424
natriumbromid
NL
231-599-9
7647-15-6
432
natriumhypochlorit
IT
231-668-3
7681-52-9
434
tetramethrin
DE
231-711-6
7696-12-0
439
hydrogenperoxid
FI
231-765-0
7722-84-1
444
7a-ethyldihydro-1H,3H,5H-oxazolo[3,4-c]
oxazol (EDHO)
PL
231-810-4
7747-35-5
1
2
3
4
5
x
6
7
8
9
10
11
12
13
x
x
x
x
x
x
x
x
x
17
18
19
21
x
x
x
x
x
x
x
x
x
x
x
22
x
x
x
x
x
x
x
Den Europæiske Unions Tidende
Rapporterende
medlemsstat
DA
Stof
L 294/18
Nr.
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
10.10.2014
x
x
Stof
Rapporterende
medlemsstat
EF-nr.
CAS-nr.
1
x
2
3
4
5
6
450
sølvnitrat
SE
231-853-9
7761-88-8
453
dinatriumperoxodisulfat/natriumpersulfat
PT
231-892-1
7775-27-1
455
calciumhypochlorit
IT
231-908-7
7778-54-3
x
457
chlor
IT
231-959-5
7782-50-5
x
458
ammoniumsulfat
UK
231-984-1
7783-20-2
473
pyrethriner og pyrethroider
ES
232-319-8
8003-34-7
491
chlordioxid
PT
233-162-8
10049-04-4
x
494
2,2-dibrom-2-cyanacetamid (DBNPA)
DK
233-539-7
10222-01-2
x
501
carbendazim
DE
234-232-0
10605-21-7
515
ammoniumbromid
SE
235-183-8
12124-97-9
522
pyrithionzink
SE
236-671-3
13463-41-7
524
dodecylguanidinmonohydrochlorid
ES
237-030-0
13590-97-1
x
526
kalium-2-biphenylat
ES
237-243-9
13707-65-8
x
529
bromchlorid
NL
237-601-4
13863-41-7
531
(benzyloxy)methanol
UK
238-588-8
14548-60-8
534
bis(1-hydroxy-1H-pyridin-2-thionato-O,S)
kobber (kobberpyrithion)
SE
238-984-0
14915-37-8
541
natrium-p-chlor-m-cresolat
FR
239-825-8
15733-22-9
7
8
9
10
11
12
13
17
18
19
x
x
21
x
x
DA
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
Den Europæiske Unions Tidende
x
22
10.10.2014
Nr.
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
L 294/19
x
Rapporterende
medlemsstat
EF-nr.
CAS-nr.
1
2
3
550
D-gluconsyre, forbindelse med N,N″-bis
(4-chlorphenyl)-3,12-diimino-2,4,11,13tetraazatetradecandiamidin (2:1) (CHDG)
PT
242-354-0
18472-51-0
x
x
x
554
p-[(diiodmethyl)sulfonyl]toluen
UK
243-468-3
20018-09-1
559
(benzothiazol-2-ylthio)methylthiocyanat
(TCMTB)
N
244-445-0
21564-17-0
562
2-methyl-4-oxo-3-(prop-2-ynyl)cyclopent2-en-1-yl-2,2-dimethyl-3-(2-methylprop1-enyl)cyclopropancarboxylat (prallethrin)
EL
245-387-9
23031-36-9
563
kalium-(E,E)-hexa-2,4-dienoat
sorbat)
DE
246-376-1
24634-61-5
566
α,α′,α′′-trimethyl-1,3,5-triazin-1,3,5
(2H,4H,6H)-triethanol (HPT)
AT
246-764-0
25254-50-6
571
2-octyl-2H-isothiazol-3-on (OIT)
UK
247-761-7
26530-20-1
577
dimethyloctadecyl[3-(trimethoxysilyl)
propyl]ammoniumchlorid
ES
248-595-8
27668-52-6
578
N′-tert-butyl-N-cyclopropyl-6-(methyl­
thio)-1,3,5-triazin-2,4-diamin (cybutryn)
NL
248-872-3
28159-98-0
588
bromchlor-5,5-dimethylimidazolidin-2,4dion (BCDMH/bromchlordimethylhydan­
toin)
NL
251-171-5
32718-18-6
590
3-(4-isopropylphenyl)-1,1-dimethylurin­
stof/isoproturon
DE
251-835-4
34123-59-6
4
5
6
7
x
x
8
9
10
x
x
11
12
13
17
18
19
21
22
DA
Stof
L 294/20
Nr.
x
x
x
x
x
x
x
x
Den Europæiske Unions Tidende
(kalium­
x
x
x
x
x
x
x
x
x
x
x
x
x
x
10.10.2014
x
x
Stof
Rapporterende
medlemsstat
EF-nr.
CAS-nr.
1
2
3
597
1-[2-(allyloxy)-2-(2,4-dichlorphenyl)
ethyl]-1H-imidazol (imazalil)
DE
252-615-0
35554-44-0
599
S-[(6-chlor-2-oxooxazolo[4,5-b]pyridin-3
(2H)-yl)methyl]-O,O-dimethylthiophos­
phat (azamethiphos)
UK
252-626-0
35575-96-3
600
2-brom-2-(brommethyl)pentandinitril
(DBDCB)
CZ
252-681-0
35691-65-7
961
calciummagnesiumoxid
UK
253-425-0
37247-91-9
x
x
962
calciummagnesiumtetrahydroxid/calcium­
magnesiumhydroxid
UK
254-454-1
39445-23-3
x
x
606
α-cyan-3-phenoxybenzyl-2,2-dimethyl-3(2-methylprop-1-enyl)cyclopropancarbo­
xylat (cyphenothrin)
EL
254-484-5
39515-40-7
608
dimethyltetradecyl
[3-(trimethoxysilyl)
propyl]ammoniumchlorid
PL
255-451-8
41591-87-1
609
blanding af cis- og trans-p-menthan-3,8diol (citriodiol)
UK
255-953-7
42822-86-6
614
(RS)-α-cyan-3-phenoxybenzyl-(1RS)-cis,
trans-3-(2,2-dichlorvinyl)-2,2-dimethylcy­
clopropancarboxylat (cypermethrin)
BE
257-842-9
52315-07-8
615
3-phenoxybenzyl-(1RS,3RS;1RS,3SR)-3(2,2-dichlorvinyl)-2,2-dimethylcyclopro­
pancarboxylat (permethrin)
IE
258-067-9
52645-53-1
4
5
6
7
8
9
10
11
12
13
17
18
19
21
22
10.10.2014
Nr.
x
DA
x
x
Den Europæiske Unions Tidende
x
x
x
x
x
L 294/21
x
Stof
Rapporterende
medlemsstat
EF-nr.
CAS-nr.
618
1-ethynyl-2-methylpent-2-enyl-2,2-dime­
thyl-3-(2-methylprop-1-enyl)cyclopropan­
carboxylat (empenthrin)
BE
259-154-4
54406-48-3
619
3-iod-2-propynylbutylcarbamat (IPBC)
DK
259-627-5
55406-53-6
620
tetrakis(hydroxymethyl)phosphoniums­
ulfat (2:1) (THPS)
MT
259-709-0
55566-30-8
628
1-[[2-(2,4-dichlorphenyl)-4-propyl-1,3dioxolan-2-yl]methyl]-1H-1,2,4-triazol
(propiconazol)
FI
262-104-4
60207-90-1
635
kokosalkyltrimethylammoniumchlorid
(ATMAC/TMAC)
IT
263-038-9
61789-18-2
648
4,5-dichlor-2-octylisothiazol-3(2H)-on
(4,5-dichlor-2-octyl-2H-isothiazol-3-on
(DCOIT))
N
264-843-8
64359-81-5
649
2-chlor-N-[[[4-(trifluormethoxy)phenyl]
amino]carbonyl]benzamid (triflumuron)
IT
264-980-3
64628-44-0
656
3,3′-methylenbis[5-methyloxazolidin]
(oxazolidin/MBO)
AT
266-235-8
66204-44-2
657
N-cyclopropyl-1,3,5-triazin-2,4,6-triamin
EL
266-257-8
66215-27-8
x
666
α-cyan-4-fluor-3-phenoxybenzyl-3-(2,2dichlorvinyl)-2,2-dimethylcyclopropancar­
boxylat (cyfluthrin)
DE
269-855-7
68359-37-5
x
1
2
3
4
5
6
7
8
9
10
11
12
13
17
18
19
21
22
L 294/22
Nr.
x
DA
x
x
x
x
x
x
x
x
Den Europæiske Unions Tidende
x
x
x
x
x
x
x
x
x
x
x
x
10.10.2014
Stof
Rapporterende
medlemsstat
EF-nr.
CAS-nr.
1
2
3
4
5
6
7
8
9
10
11
12
13
17
18
19
21
22
alkyl(C12-18)dimethylbenzylammonium­
chlorid (ADBAC (C12-18))
IT
269-919-4
68391-01-5
x
x
x
x
x
x
x
x
671
alkyl(C12-16)dimethylbenzylammonium­
chlorid (ADBAC/BKC (C12-16))
IT
270-325-2
68424-85-1
x
x
x
x
x
x
x
x
673
didecyldimethylammoniumchlorid (DDAC
(C8-10))
IT
270-331-5
68424-95-3
x
x
x
x
x
x
x
690
kvaternære
ammoniumforbindelser,
benzyl-C12-18-alkyldimethyl, salte med
1,2-benzisothiazol-3(2H)-on-1,1-dioxid
(ADBAS)
MT
273-545-7
68989-01-5
691
natrium-N-(hydroxymethyl)glycinat
AT
274-357-8
70161-44-3
692
aminer, C10-16-alkyldimethyl, N-oxider
PT
274-687-2
70592-80-2
693
pentakalium-bis(peroxymonosulfat)-bis
(sulfat)
SI
274-778-7
70693-62-8
x
701
magnesiummonoperoxyphthalathexahy­
drat (MMPP)
PL
279-013-0
84665-66-7
x
1015
margosaekstrakt
DE
283-644-7
84696-25-3
724
alkyl(C12-C14)dimethylbenzylammonium­
chlorid (ADBAC (C12-C14))
IT
287-089-1
85409-22-9
x
x
x
x
x
x
x
x
725
alkyl(C12-C14)ethylbenzylammonium­
chlorid (ADEBAC (C12-C14))
IT
287-090-7
85409-23-0
x
x
x
x
x
x
x
x
731
Chrysanthemum cinerariaefolium, ekstrakt
ES
289-699-3
89997-63-7
744
lavendel, Lavandula hybrida, ekstrakt
PT
294-470-6
91722-69-9
DA
667
10.10.2014
Nr.
x
x
x
Den Europæiske Unions Tidende
x
x
x
x
x
x
x
L 294/23
x
Stof
Rapporterende
medlemsstat
EF-nr.
CAS-nr.
776
1-(3,5-dichlor-4-(1,1,2,2-tetrafluorethoxy)
phenyl)-3-(2,6-difluorbenzoyl)urinstof
(hexaflumuron)
PT
401-400-1
86479-06-3
779
reaktionsprodukter af glutaminsyre og N(C12-14-alkyl)propylendiamin
(glucopro­
tamin)
DE
403-950-8
164907-72-6
785
6-(phthalimido)peroxyhexansyre (PAP)
IT
410-850-8
128275-31-0
791
2-butyl-benzo[d]isothiazol-3-on (BBIT)
CZ
420-590-7
4299-07-4
792
tetrachlordecaoxidcomplex (TCDO)
DE
420-970-2
92047-76-2
x
x
x
811
sølvnatriumhydrogenzirconiumphosphat
SE
422-570-3
265647-11-8
x
x
x
794
sec-butyl-2-(2-hydroxyethyl)piperidin-1carboxylat (icaridin)
DK
423-210-8
119515-38-7
797
cis-1-(3-chlorallyl)-3,5,7-triaza-1-azoniaa­
damantanchlorid (cis-CTAC)
PL
426-020-3
51229-78-8
800
[2,4-dioxo-(2-propyn-1-yl)imidazolidin-3yl]methyl-(1R)-cis-chrysanthemat;
[2,4dioxo-(2-propyn-1-yl)imidazolidin-3-yl]
methyl-(1R)-trans-chrysanthemat
(imiprothrin)
UK
428-790-6
72963-72-5
790
5-chlor-2-(4-chlorphenoxy)phenol (DCPP)
AT
429-290-0
3380-30-1
807
(E)-1-(2-chlor-1,3-thiazol-5-ylmethyl)-3methyl-2-nitroguanidin (chlothianidin)
DE
433-460-1
210880-92-5
1
2
3
4
5
6
7
8
9
10
11
12
13
17
18
19
21
22
L 294/24
Nr.
x
DA
x
x
x
x
x
x
x
x
x
x
x
x
x
x
Den Europæiske Unions Tidende
x
x
x
x
x
x
10.10.2014
x
Stof
Rapporterende
medlemsstat
EF-nr.
CAS-nr.
952
Bacillus sphaericus 2362, stamme ABTS1743
IT
mikroorga­
nisme
143447-72-7
x
955
Bacillus thuringiensis subsp. israelensis,
stamme SA3A
IT
mikroorga­
nisme
ikke relevant
x
DE
mikroorga­
nisme
ikke relevant
928
blanding
af
5-chlor-2-methyl-2Hisothiazol-3-on (EINECS 247-500-7) og
2-methyl-2H-isothiazol-3-on
(EINECS
220-239-6) (blanding af CMIT og MIT)
FR
blanding
55965-84-9
x
939
aktiv chlor: fremstillet in situ ved reaktion
mellem hypochlorsyrling og natriumhy­
pochlorit
SK
blanding
ikke relevant
x
x
x
FR
ikke rele­
vant
33734-57-5
x
x
x
SE
ikke rele­
vant
ikke relevant
x
1014
peroxyoctansyre
sølvzeolit
3
4
5
6
7
8
9
10
11
12
13
17
18
19
21
22
3-phenoxybenzyl-(1R)-cis,trans-2,2-dime­
thyl-3-(2-methylprop-1-enyl)cyclopropan­
carboxylat (d-phenothrin)
IE
ikke rele­
vant
188023-86-1
931
aminer, N-C12-14(lige kulstofantal)-alkyltrimethy­
lendi-, reaktionsprodukter med chloreddi­
kesyre (ampholyt 20)
IE
ikke rele­
vant
139734-65-9
152
reaktionsprodukter af 5,5-dimethylhydan­
toin, 5-ethyl-5-methylhydantoin med
brom og chlor (DCDMH)
NL
foreligger
ikke
foreligger
ikke
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
L 294/25
849
x
Den Europæiske Unions Tidende
813
Bacillus subtilis
2
DA
957
1
10.10.2014
Nr.
Stof
Rapporterende
medlemsstat
EF-nr.
CAS-nr.
1
2
459
reaktionsmasse af titandioxid og sølv­
chlorid
SE
foreligger
ikke
foreligger
ikke
x
x
777
reaktionsprodukter af 5,5-dimethylhydan­
toin, 5-ethyl-5-methylhydantoin med
chlor (DCEMH)
NL
foreligger
ikke
foreligger
ikke
SE
foreligger
ikke
308069-39-8
x
SE
foreligger
ikke
130328-20-0
x
x
SE
foreligger
ikke
130328-19-7
x
x
3
4
5
6
7
x
x
8
9
10
11
x
x
x
12
13
17
18
19
21
22
L 294/26
Nr.
DA
810
1013
sølvzinkzeolit
sølvkobberzeolit
x
x
x
x
x
x
x
x
Den Europæiske Unions Tidende
824
sølvphosphatglas
x
sølv adsorberet på siliciumdioxid (som
nanomateriale i form af et stabilt aggregat
af primærpartikler i nanoskala)
SE
foreligger
ikke
foreligger
ikke
1019
siliciumdioxid
(som
nanomateriale
bestående af aggregater og agglomerater)
FR
foreligger
ikke
68909-20-6
x
FR
plantebe­
skyttelses­
middel
61790-53-2
x
DE
plantebe­
skyttelses­
middel
231937-89-6
x
siliciumdioxid (kiselgur)
831
854
(RS)-3-allyl-2-methyl-4-oxocyclopent-2enyl-(1R,3R;1R,3S)-2,2-dimethyl-3-(2methylprop-1-enyl)-cyclopropancarbo­
xylat (blanding af 4 isomerer: 1R-trans,
1R:1R-trans, 1S:1R-cis, 1R:1R-cis, 1S,
4:4:1:1) (d-allethrin)
x
10.10.2014
1017
Stof
Rapporterende
medlemsstat
EF-nr.
CAS-nr.
855
(RS)-3-allyl-2-methyl-4-oxocyclopent-2enyl-(1R,3R)-2,2-dimethyl-3-(2-methyl­
prop-1-enyl)-cyclopropancarboxylat
(blanding af kun 2 isomerer: 1R-trans:1R/
S, 1:3) (esbiothrin)
DE
plantebe­
skyttelses­
middel
260359-57-7
x
BE
plantebe­
skyttelses­
middel
160430-64-8
x
N-((6-chlor-3-pyridinyl)methyl)-N′-cyanN-methylethanimidamid (acetamiprid)
2
3
4
5
6
7
8
9
10
11
12
13
17
18
19
21
22
DA
848
1
10.10.2014
Nr.
esfenvalerat/(S)-α-cyan-3-phenoxybenzyl(S)-2-(4-chlorphenyl)-3-methylbutyrat
(esfenvalerat)
PT
plantebe­
skyttelses­
middel
66230-04-4
x
836
[1α(S*),3α]-(α)-cyan-(3-phenoxyphenyl)
methyl-3-(2,2-dichlorethenyl)-2,2-dichlor­
vinyl)-2,2-dimethylcyclopropancarboxylat
(alpha-cypermethrin)
BE
plantebe­
skyttelses­
middel
67375-30-8
x
843
4-brom-2-(4-chlorphenyl)-1-ethoxyme­
thyl-5-trifluormethylpyrrol-3-carbonitril
(chlorfenapyr)
PT
plantebe­
skyttelses­
middel
122453-73-0
x
859
polymer
af
N-methylmethanamin
(EINECS 204-697-4) og (chlormethyl)
oxiran (EINECS 203-439-8)/polymer
kvaternær
ammoniumchlorid
(PQpolymer)
HU
polymer
25988-97-0
863
monohydrochlorid af polymer af
N,N″′-1,6-hexandiylbis[N′-cyanguanidin]
(EINECS 240-032-4) og hexamethylen­
diamin (EINECS 204-679-6)/polyhexame­
thylenbiguanid (monomer: 1,5-bis(trime­
thylen)guanylguanidiniummonohydroch­
lorid) (PHMB)
FR
polymer
27083-27-8/
32289-58-0
x
x
x
Den Europæiske Unions Tidende
835
x
x
x
x
x
x
x
L 294/27
Stof
Rapporterende
medlemsstat
EF-nr.
CAS-nr.
1
2
3
4
x
x
x
x
poly(hexamethylenbiguanid)
FR
polymer
91403-50-8
869
poly(oxy-1,2-ethandiyl), α-[2-(didecylme­
thylammonio)ethyl]-, ω-hydroxy-, propa­
noat (salt) (bardap 26)
IT
polymer
94667-33-1
872
N-didecyl-N-dipolyethoxyammonium­
borat/didecylpolyoxethylammoniumborat
(polymer betain)
EL
polymer
214710-34-6
x
6
7
8
9
10
x
x
x
11
12
13
17
18
19
21
22
x
DA
868
5
L 294/28
Nr.
x
x
Den Europæiske Unions Tidende
DEL 2
Kombinationer af aktivstof og produkttype, der ikke støttes den 4. august 2014
Denne del af bilaget omfatter
— den kombination af stof og produkttype, der er anført i tabellen nedenfor, også i nanomaterialeform
— alle nanomaterialeformer af alle kombinationer af stof og produkttype, som er opregnet på listen i del 1, undtagen dem, der er anført i nævnte tabel
— alle nanomaterialeformer af alle kombinationer af aktivstof og produkttype, som er godkendt den 4. august 2014, undtagen dem, der er udtrykkelig godkendt.
For de kombinationer af stof og produkttype og de nanomaterialer, der er omfattet af denne del, bliver der efter artikel 20 vedtaget en afgørelse om afvisning af godkendelse, hvis ingen
inden 12 måneder efter denne forordnings ikrafttræden har indsendt en anmeldelse efter artikel 14, stk. 3, eller hvis en sådan anmeldelse er afvist efter artikel 17, stk. 4 eller 5.
Nr.
Stof
Rapporterende
medlemsstat
EF-nr.
CAS-nr.
NL
204-258-7
118-52-5
1,3-dichlor-5,5-dimethylhydantoin
(omdefineret, jf. stof nr. 152)
166
cetalkoniumchlorid (se nr. 948)
204-526-3
122-18-9
167
benzyldimethyl(octadecyl)ammonium­
chlorid (se nr. 948)
204-527-9
122-19-0
2
3
4
5
6
7
8
9
10
11
12
13
17
18
19
21
22
x
10.10.2014
1021
1
Rapporterende
medlemsstat
Stof
EF-nr.
CAS-nr.
139-07-1
214
miristalkoniumchlorid (se nr. 948)
205-352-0
139-08-2
227
2-thiazol-4-yl-1H-benzoimidazol
bendazol)
205-725-8
148-79-8
331
didecyldimethylammoniumbromid
nr. 949)
(se
219-234-1
2390-68-3
384
dimethyldioctylammoniumchlorid
nr. 949)
(se
226-901-0
5538-94-3
399
benzyldodecyldimethylammoniumbromid
(se nr. 948)
230-698-4
7281-04-1
401
sølv
SE
231-131-3
7440-22-4
418
siliciumdioxid — amorft
FR
231-545-4
7631-86-9
449
kobbersulfat
FR
231-847-6
7758-98-7
1016
sølvklorid
SE
232-033-3
7783-90-6
554
p-[(diiodmethyl)sulfonyl]toluen
UK
243-468-3
20018-09-1
587
decyldimethyloctylammoniumchlorid (se
nr. 949)
251-035-5
32426-11-2
601
benzyldimethyloleylammoniumchlorid (se
nr. 948)
253-363-4
37139-99-4
615
3-phenoxybenzyl-(1RS,3RS;1RS,3SR)-3(2,2-dichlorvinyl)-2,2-dimethylcyclopro­
pancarboxylat (permethrin)
258-067-9
52645-53-1
(thia­
ES
IE
4
5
6
7
8
9
10
11
12
13
17
18
19
21
22
x
x
x
x
x
x
x
x
x
x
x
x
x
L 294/29
205-351-5
3
Den Europæiske Unions Tidende
benzododeciniumchlorid (se nr. 948)
2
DA
213
1
10.10.2014
Nr.
Stof
637
Rapporterende
medlemsstat
CAS-nr.
kvaternære
ammoniumforbindelser,
benzylkokosalkyldimethyl, chlorider (se
nr. 948)
263-080-8
61789-71-7
638
kvaternære ammoniumforbindelser, diko­
kosalkyldimethyl, chlorider (se nr. 949)
263-087-6
61789-77-3
639
kvaternære ammoniumforbindelser, bis
(hydrogeneret talgalkyl)dimethyl, chlo­
rider (se nr. 949)
263-090-2
61789-80-8
647
kvaternære
ammoniumforbindelser,
benzyl-C8-18-alkyldimethyl, chlorider (se
nr. 948)
264-151-6
63449-41-2
668
kvaternære ammoniumforbindelser,
di-C6-12-alkyldimethyl,
chlorider
nr. 949)
(se
269-925-7
68391-06-0
670
kvaternære
ammoniumforbindelser,
benzyl-C8-16-alkyldimethyl, chlorider (se
nr. 948)
270-324-7
68424-84-0
689
kvaternære
ammoniumforbindelser,
benzyl-C10-16-alkyldimethyl, chlorider (se
nr. 948)
273-544-1
68989-00-4
692
aminer, C10-16-alkyldimethyl, N-oxider
274-687-2
70592-80-2
697
kvaternære ammoniumforbindelser,
di-C8-18-alkyldimethyl,
chlorider
nr. 949)
277-453-8
73398-64-8
1000
dihydrogenbis[monoperoxyphthalato(2-)O1,OO1]magnesat(2-)hexahydrat
279-013-0
14915-85-4
1
2
3
4
5
6
7
8
9
10
11
12
13
17
18
19
21
22
DA
EF-nr.
L 294/30
Nr.
(se
x
x
10.10.2014
PL
Den Europæiske Unions Tidende
PT
Rapporterende
medlemsstat
EF-nr.
CAS-nr.
998
anden margosaekstrakt end fra kerner af
Azadirachta indica, der er ekstraheret med
vand og yderligere behandlet med orga­
niske opløsningsmidler
DE
283-644-7
84696-25-3
741
kvaternære
ammoniumforbindelser,
benzyl-C8-18-alkyldimethyl, bromider (se
nr. 948)
293-522-5
91080-29-4
1020
1,3-dichlor-5-ethyl-5-methylimidazolidin2,4-dion (omdefineret, jf. stof nr. 777)
NL
401-570-7
89415-87-2
778
1-(4-chlorphenyl)-4,4-dimethyl-3-(1,2,4triazol-1-ylmethyl)pentan-3-ol
(tebuco­
nazol)
DK
403-640-2
107534-96-3
805
reaktionsprodukt af dimethyladipat, dime­
thylglutarat, dimethylsuccinat og hydro­
genperoxid (perestan)
HU
432-790-1
ikke relevant
923
alkylbenzyldimethylammoniumchlorid/
benzalkoniumchlorid (se nr. 948)
blanding
8001-54-5
949
kvaternære
ammoniumforbindelser
(dialkyldimethyl (alkyl fra C6-C18, mættede
og umættede, samt talgalkyl, kokosalkyl
og sojaalkyl) chlorider, bromider eller
methylsulfater) (DDAC)
IT
blanding af
stoffer, der
er optaget i
EINECS
ikke relevant
950
kvaternære ammoniumforbindelser (alkyl­
trimethyl (alkyl fra C8-C18, mættede og
umættede, samt talgalkyl, kokosalkyl og
sojaalkyl) chlorider, bromider eller
methylsulfater) (TMAC)
IT
blanding af
stoffer, der
er optaget i
EINECS
ikke relevant
1
2
3
4
5
6
7
8
9
10
11
12
13
17
18
19
21
22
x
DA
Stof
10.10.2014
Nr.
x
Den Europæiske Unions Tidende
x
x
x
x
x
x
x
x
x
L 294/31
x
x
CAS-nr.
1
2
3
4
948
kvaternære
ammoniumforbindelser
(benzylalkyldimethyl (alkyl fra C8-C22,
mættede og umættede, samt talgalkyl,
kokosalkyl og sojaalkyl) chlorider,
bromider eller hydroxider) (BKC)
IT
blanding af
stoffer, der
er optaget i
EINECS
ikke relevant
x
x
x
x
849
3-phenoxybenzyl-(1R)-cis,trans-2,2-dime­
thyl-3-(2-methylprop-1-enyl)cyclopropan­
carboxylat (d-phenothrin)
IE
ikke rele­
vant
188023-86-1
1001
kvaternære
ammoniumforbindelser,
benzyl-C12-16-alkyldimethyl, chlorider (der
ikke er omfattet af nr. 671)
IT
ikke rele­
vant
ikke relevant
x
x
x
x
1002
kvaternære
ammoniumforbindelser,
benzyl-C12-18-alkyldimethyl, chlorider (der
ikke er omfattet af nr. 667)
IT
ikke rele­
vant
ikke relevant
x
x
x
1003
kvaternære ammoniumforbindelser,
C12-14-alkyl[(ethylphenyl)methyl]dimethyl,
chlorider (der ikke er omfattet af nr. 725)
IT
ikke rele­
vant
ikke relevant
x
x
1005
kvaternære
ammoniumforbindelser,
benzyl-C12-14-alkyldimethyl, chlorider (der
ikke er omfattet af nr. 724)
IT
ikke rele­
vant
ikke relevant
x
x
1006
sølv-zink-aluminium-bor-phosphatglas/
glasoxid, med sølv- og zinkindhold
SE
ikke rele­
vant
398477-47-9
1009
kvaternære ammoniumforbindelser,
di-C8-10-alkyldimethyl, chlorider (der ikke
er omfattet af nr. 673)
IT
ikke rele­
vant
ikke relevant
5
6
7
8
9
x
10
11
12
x
x
x
13
17
18
19
21
22
DA
EF-nr.
Stof
L 294/32
Rapporterende
medlemsstat
Nr.
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
10.10.2014
x
x
Den Europæiske Unions Tidende
x
Rapporterende
medlemsstat
EF-nr.
CAS-nr.
1011
kvaternære ammoniumforbindelser, koko­
salkyltrimethyl, chlorider (der ikke er
omfattet af nr. 635)
IT
ikke rele­
vant
ikke relevant
1012
aluminiumnatriumsilicat-sølv-zinkcomplex/sølv-zink-zeolit
SE
ikke rele­
vant
130328-20-0
DE
plantebe­
skyttelses­
middel
73790-28-0
598
(±)-1-(β-allyloxy-2,4-dichlorphenylethyl)
imizadol (teknisk imazalil)
1
2
3
4
5
6
7
8
9
10
11
12
13
17
18
19
21
22
x
DA
Stof
10.10.2014
Nr.
x
x
x
x
Den Europæiske Unions Tidende
L 294/33
L 294/34
DA
Den Europæiske Unions Tidende
10.10.2014
BILAG III
Tidsfrister
Produkttype
Tidsfrist for indsendelse af
vurderingsrapporten, jf. artikel 6, stk. 3, litra b)
Tidsfrist for påbegyndelse af udarbejdelse af
udtalelsen, jf. artikel 7, stk. 2, litra b)
8, 14, 16, 18, 19 og 21
31.12.2015
31.3.2016
3, 4 og 5
31.12.2016
31.3.2017
1 og 2
31.12.2018
31.3.2019
6 og 13
31.12.2019
31.3.2020
7, 9 og 10
31.12.2020
31.3.2021
11, 12, 15, 17, 20 og 22
31.12.2022
31.9.2023
10.10.2014
Official Journal of the European Union
EN
L 294/1
II
(Non-legislative acts)
REGULATIONS
COMMISSION DELEGATED REGULATION (EU) No 1062/2014
of 4 August 2014
on the work programme for the systematic examination of all existing active substances contained
in biocidal products referred to in Regulation (EU) No 528/2012 of the European Parliament and
of the Council
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012
concerning the making available on the market and use of biocidal products (1), and in particular the first subparagraph
of Article 89(1) thereof,
Whereas:
(1)
Commission Regulation (EC) No 1451/2007 (2) lays down the detailed rules for the programme of review of
existing biocidal active substances (the ‘review programme’) commenced in accordance with Article 16(2) of Dir­
ective 98/8/EC of the European Parliament and of the Council (3). Since that Directive has been repealed and
replaced by Regulation (EU) No 528/2012, the detailed rules for the continuation of the review programme
should be adapted to the provisions of that Regulation.
(2)
It is important to identify the active substance/product-type combinations that may be made available on the
market and used, subject to national rules, by virtue of the transitional provisions laid down in Article 89 of
Regulation (EU) No 528/2012. Such should be the case for active substance/product-type combinations that are
under evaluation in the review programme.
(3)
Where a product has benefitted from the derogation for food and feed provided for by Article 6 of Regulation
(EC) No 1451/2007, but is not covered by the exemption for food and feed laid down in Article 2(5)(a) of Regu­
lation (EU) No 528/2012, the active substances it contains should be evaluated in the review programme for the
relevant product-type. Subject to national rules, it should be allowed to be made available on the market and
used until the end of that evaluation. A system of prior declaration should define which products benefit from
this provision. The same should apply where the failure to notify an active substance/product-type combination
is due to the new definition of product-types in Regulation (EU) No 528/2012 compared with that in Direct­
ive 98/8/EC, or is well justified based on a Commission decision taken in accordance with Article 3(3) of
(1) OJ L 167, 27.6.2012, p. 1.
(2) Commission Regulation (EC) No 1451/2007 of 4 December 2007 on the second phase of the 10-year work programme referred to in
Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the
market (OJ L 325, 11.12.2007, p. 3).
(3) Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on
the market (OJ L 123, 24.4.1998, p. 1).
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Regulation (EU) No 528/2012, on the case law, such as case C-420/10 (1), or on authoritative guidance from the
Commission or Member States' competent authorities, which is subsequently reviewed.
(4)
Where a biocidal product contains, consists of or generates an active substance which is no longer included in
the review programme but the use of that biocidal product is essential in a Member State, that use and the
making available on the market for that use should be allowed in that Member State, under the responsibility of
the Member State, subject to certain conditions and for a limited period of time.
(5)
With a view to ensure consistency and simplification, the procedure for evaluation of active substances in the
review programme should, in all relevant parts, be identical with that for applications submitted pursuant
to Article 7 of Regulation (EU) No 528/2012 or pursuant to Commission Implementing Regulation (EU)
No 88/2014 (2).
(6)
For substances meeting the exclusion or substitution criteria, the evaluating Competent Authority should submit
to the Agency a proposal for harmonised classification and labelling pursuant to Article 37(1) of Regulation (EC)
No 1272/2008 of the European Parliament and of the Council (3) for the endpoints of concern, while preserving
the right of the Member State to submit a proposal on other or all endpoints. The evaluating Competent
Authority should also consult the Agency on substances which would meet the criteria for being persistent, bioac­
cumulative or toxic, or on substances that would be considered as having endocrine disrupting properties.
(7)
In order to ensure that the review programme is finalised by the target date indicated in Article 89(1) of Regu­
lation (EU) No 528/2012, the evaluations should be limited to active substance/product-type combinations for
which the relevant data has been submitted within the deadlines laid down in Regulation (EC) No 1451/2007 or
this Regulation. Furthermore, appropriate time limits should be established for finalising the evaluations, taking
into account the possibility that applications could be validated less than a year before those deadlines.
(8)
No data requirements have yet been established for inclusion in category 7 of Annex I to Regulation (EU)
No 528/2012. It is therefore appropriate at this time to limit applications for inclusion in that Annex to cat­
egory 1, 2, 3, 4, 5 or 6.
(9)
Notwithstanding Article 90(2) of Regulation (EU) No 528/2012, it follows from Article 91 of that Regulation
that the criteria listed in Article 10 of that Regulation should be relevant for the subsequent authorisation of
biocidal products in all cases. It is therefore appropriate to identify substances fulfilling those criteria in all active
substance evaluations.
(10)
A prospective participant in the review programme should be allowed to join or replace an existing participant
by mutual agreement, provided that the evaluation is not thereby delayed by limited data access, as the prospec­
tive applicant would otherwise have to generate data again.
(11)
Since participation in the review programme is voluntary, a participant should be allowed to withdraw from that
programme. Where that occurs, prospective participants should be allowed to take over the support, unless that
opportunity has already been granted once, thereby already causing delay to the review programme, and unless
the Agency has already begun working on its opinion.
(12)
Where the evaluation of an active substance demonstrates that the identity formally included in the review
programme does not exactly match that of the substance actually being evaluated, and the evaluation does not
allow conclusions to be drawn regarding the formally included substance identity, it should be possible to redefine
the substance in the course of the evaluation and allow other persons to take over the support of the formally
included substance.
(1) Case C-420/10: Judgment of the Court (Third Chamber) of 1 March 2012 (reference for a preliminary ruling from the Landgericht
Hamburg — Germany) — Söll GmbH v Tetra GmbH (Placing on the market of biocidal products — Directive 98/8/EC — Article 2(1)(a)
— Concept of ‘biocidal products’ — Product causing flocculation of harmful organisms without destroying or deterring them or
rendering them harmless).
(2) Commission Implementing Regulation (EU) No 88/2014 of 31 January 2014 specifying a procedure for the amendment of Annex I to
Regulation (EU) No 528/2012 of the European Parliament and of the Council concerning the making available on the market and use of
biocidal products (OJ L 32, 1.2.2014, p. 3).
3
( ) Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and
packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC)
No 1907/2006 (OJ L 353, 31.12.2008, p. 1).
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(13)
Certain substances included in the review programme are not supported by any participant at the time of adop­
tion of this Regulation. The same applies to certain nanomaterials, although, pursuant to Article 4(4) of Regu­
lation (EU) No 528/2012, such materials cannot be approved unless explicitly mentioned. Persons should be
allowed to take over the participation for those substances and those nanomaterials, failing which those
substances and nanomaterials should be excluded from the review programme.
(14)
In order to ensure that no substance is unduly maintained or included in the review programme without subse­
quently being evaluated, maintenance or inclusion of a substance not yet under evaluation should be subject to a
notification of essential data regarding the substance,
HAS ADOPTED THIS REGULATION:
CHAPTER 1
SUBJECT MATTER AND DEFINITIONS
Article 1
Subject matter
This Regulation lays down rules for the carrying out of the work programme for the systematic examination of all
existing active substances referred to in Article 89 of Regulation (EU) No 528/2012.
Article 2
Definitions
For the purposes of this Regulation, the following definitions shall apply:
(a) ‘non-approval decision’ means a decision not to approve a substance/product-type combination pursuant to
Article 9(1)(b) of Regulation (EU) No 528/2012 or to the third subparagraph of Article 89(1) of that Regulation, or
not to include it in Annex I or IA to Directive 98/8/EC;
(b) ‘substance/product-type combination included in the review programme’ means a substance/product-type combina­
tion listed in Annex II which complies with the following conditions:
(i) it has not been the subject of either of the following:
— a Directive on inclusion in Annex I or IA to Directive 98/8/EC,
— a Regulation providing that it is approved pursuant to the third subparagraph of Article 89(1) of Regulation
(EU) No 528/2012;
(ii) it has not been the subject of any non-approval decision or the latest non-approval decision concerning it has
been repealed;
(c) ‘participant’ means a person who has submitted an application for a substance/product-type combination included in
the review programme, or has submitted a notification found compliant pursuant to Article 17(5) of this Regulation,
or on whose behalf such application or notification has been submitted.
(d) ‘evaluating competent authority’ means the competent authority designated pursuant to Article 81 of Regulation
(EU) No 528/2012 of the Member State indicated in Annex II to this Regulation.
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10.10.2014
CHAPTER 2
PROCESS FOR EVALUATION OF DOSSIERS
Article 3
Application for approval or inclusion in Annex I to Regulation (EU) No 528/2012
1.
An application for approval or inclusion in Annex I to Regulation (EU) No 528/2012 may be submitted only by a
participant whose notification has been found compliant by the Agency pursuant to Article 17(5) of this Regulation.
Where the application concerns inclusion in Annex I to Regulation (EU) No 528/2012, it may only concern category 1,
2, 3, 4, 5 or 6 of that Annex.
2.
Applications referred to in paragraph 1 shall be submitted to the Agency within two years of the declaration of
compliance pursuant to Article 17(5).
Article 4
Acceptance of applications
1.
The Agency shall inform the participant of the fees payable under Commission Implementing Regulation (EU)
No 564/2013 (1) and shall reject the application if the participant fails to pay the fees within 30 days. It shall inform the
participant and the evaluating competent authority accordingly.
2.
Upon receipt of the fees payable under Implementing Regulation (EU) No 564/2013, the Agency shall accept the
application and inform the participant and the evaluating competent authority accordingly, indicating the date of the
acceptance of the application and its unique identification code.
3.
An appeal may be brought, in accordance with Article 77 of Regulation (EU) No 528/2012 against decisions of
the Agency taken pursuant to paragraph 1 of this Article.
4.
The evaluating competent authority shall inform the participant of the fees payable under Article 80(2) of Regu­
lation (EU) No 528/2012 within 30 days after the Agency has accepted the application, and shall reject the application
if the participant fails to pay the fees within 30 days. It shall inform the participant and the Agency accordingly.
Article 5
Validation of applications for approval or inclusion in category 6 of Annex I to Regulation (EU) No 528/2012
1.
Where an application for approval or inclusion in category 6 of Annex I to Regulation (EU) No 528/2012
containing the data required in accordance with Article 6(1) and (2) thereof has been accepted by the Agency pursuant
to Article 4(2) and the fee has been paid pursuant to Article 4(4) the evaluating competent authority shall validate the
application within 30 days of the payment of the fees.
2.
Where the evaluating competent authority has received from the participant the dossier pursuant to Regulation
(EC) No 1451/2007 but not yet accepted the dossier as complete pursuant to Article 13 thereof, the evaluating compe­
tent authority shall validate the application at the latest 3 January 2015.
3.
In the cases referred to in paragraphs 1 and 2, the evaluating competent authority shall not make an assessment of
the quality or the adequacy of the data or justifications submitted.
4.
Where the evaluating competent authority considers that the application is incomplete, it shall inform the partici­
pant as to what additional information is required for the validation of the application and shall set a reasonable time
limit for the submission of that information. That time limit shall not normally exceed 90 days.
(1) Commission Implementing Regulation (EU) No 564/2013 of 18 June 2013 on the fees and chargespayable to the European Chemicals
Agency pursuant to Regulation (EU) No 528/2012 of the European Parliament and of the Council concerning the making available on
the market and use of biocidal products (OJ L 167, 19.6.2013, p. 17).
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The evaluating competent authority shall, within 30 days of receipt of the additional information, validate the applica­
tion if it determines that the additional information submitted is sufficient to comply with the requirement laid down in
paragraph 2.
The evaluating competent authority shall reject the application if the participant fails to submit the requested informa­
tion within the deadline and shall inform the participant and the Agency accordingly. In such cases, part of the fees paid
in accordance with Article 80(1) and (2) of Regulation (EU) No 528/2012 shall be reimbursed.
On validating an application, the evaluating competent authority shall without delay inform the participant, the Agency
and other competent authorities accordingly, indicating the date of the validation.
Article 6
Evaluation of applications
1.
This Article shall apply where any of the following conditions applies:
(a) where an application has been validated pursuant to Article 5;
(b) where the evaluating competent authority has accepted the dossier as complete pursuant to Article 13 of
Regulation (EC) No 1451/2007 but not yet submitted the competent authority report to the Commission pursuant
to Article 14(4) of that Regulation;
(c) where an application for inclusion in category 1, 2, 3, 4 or 5 of Annex I to Regulation (EU) No 528/2012 has been
accepted by the Agency pursuant to Article 4(2) and the fee has been paid pursuant to Article 4(4).
2.
The evaluating competent authority shall evaluate the application in accordance with Articles 4 and 5 of Regu­
lation (EU) No 528/2012, including, where relevant, any proposal to adapt data requirements submitted in accordance
with Article 6(3) of that Regulation, and send an assessment report and the conclusions of its evaluation to the Agency.
3.
Where several participants support the same substance/product-type combination, the evaluating competent
authority shall draft only one assessment report. The assessment report and the conclusions shall be sent within either
of the following time-limits, whichever is the later:
(a) 365 days of the last validation referred to in paragraph 1(a), acceptance of completeness referred to in
paragraph 1(b) or payment of the fee referred to in paragraph 1(c), for the substance/product-type combination in
question;
(b) the time limits provided for by Annex III.
4.
Prior to submitting its conclusions to the Agency, the evaluating competent authority shall give the participant the
opportunity to provide written comments on the assessment report and on the conclusions of the evaluation within
30 days. The evaluating competent authority shall take due account of those comments when finalising its evaluation.
5.
Where it appears that additional information is necessary to carry out the evaluation, the evaluating competent
authority shall ask the participant to submit such information within a specified time limit, and shall inform the Agency
accordingly.
The 365-day period referred to in paragraph 3 shall be suspended from the date of issue of the request until the date the
information is received. Unless it is justified by the nature of the data requested or by exceptional circumstances, the
suspension shall not exceed the following time-limits:
(a) 365 days in cases where the additional information relates to concerns which were not addressed under
Directive 98/8/EC or under the practice established for application of that Directive;
(b) 180 days in other cases.
6.
Where the evaluating competent authority considers that there are concerns for human health, animal health or
the environment as a result of the cumulative effects from the use of biocidal products containing the same or different
active substances, it shall document its concerns in accordance with the requirements of the relevant parts of Section II.3
of Annex XV to Regulation (EC) No 1907/2006 of the European Parliament and of the Council (1) and include this as
part of its conclusions.
(1) Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evalu­
ation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive
1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Direct­
ive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, p. 1).
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7.
Upon finalisation of its hazard evaluation, the evaluating competent authority shall without undue delay and no
later than at the time of submission of the assessment report pursuant to paragraph 3, as appropriate:
(a) submit a proposal to the Agency pursuant to Article 37(1) of Regulation (EC) No 1272/2008, where it considers
that one of the criteria referred to in Article 36(1) thereof is fulfilled and not properly addressed in part 3 of
Annex VI to that Regulation;
(b) consult the Agency where it considers that one of the criteria of Article 5(1)(d) or (e) of Regulation (EU)
No 528/2012, or the condition of Article 10(1)(d) of that Regulation, is fulfilled and not properly addressed in
Annex XIV to Regulation (EC) No 1907/2006 or in the candidate list referred to in Article 59(1) of that Regulation.
Article 7
Opinion of the Agency
1.
This Article shall apply where either of the following conditions applies:
(a) where the evaluating competent authority has submitted an assessment report pursuant to Article 6(2) and, where
relevant, a proposal or a consultation pursuant to Article 6(7);
(b) where a competent authority report has been submitted to the Commission pursuant to Article 14(4) of Regulation
(EC) No 1451/2007, but the assessment report has not yet been reviewed within the Standing Committee on
Biocidal Products pursuant to Article 15(4) of that Regulation.
2.
Upon acceptance of the report, the Agency shall prepare and submit to the Commission an opinion on the
approval of the substance/product-type combination or its inclusion in category 1, 2, 3, 4, 5 or 6 of Annex I to Regu­
lation (EU) No 528/2012, or both, having regard to the conclusions of the evaluating competent authority.
The Agency shall start the preparation of the opinion within either of the following deadlines, whichever is the later:
(a) three months of the acceptance of the report;
(b) the time limits provided for by Annex III.
The Agency shall submit the opinion to the Commission within 270 days of the start of the preparation.
Article 8
Active substances which are candidates for substitution
1.
When preparing its opinion pursuant to Article 7(2), the Agency shall examine whether the active substance fulfils
any of the criteria listed in Article 10(1) of Regulation (EU) No 528/2012 and address the matter in its opinion.
2.
Prior to submitting its opinion to the Commission, the Agency shall make publicly available, without prejudice to
Articles 66 and 67 of Regulation (EU) No 528/2012, information on potential candidates for substitution during a
period of no more than 60 days, during which time interested third parties may submit relevant information, including
information on available substitutes. The Agency shall take due account of the information received when finalising its
opinion.
3.
Where the active substance is approved and fulfils one of the criteria laid down in Article 10(1) of Regulation (EU)
No 528/2012, it shall be identified as a candidate for substitution in the Regulation adopted pursuant to the first sub­
paragraph of Article 89(1) of that Regulation.
Article 9
Commission decision
Upon receipt of the opinion of the Agency pursuant to Article 7(2), the Commission shall without undue delay prepare
a draft decision for adoption pursuant to Article 89(1) or, as appropriate, Article 28(1) of Regulation (EU)
No 528/2012.
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CHAPTER 3
CHANGES OF ELEMENTS OF THE REVIEW PROGRAMME
Article 10
Joining or replacing participants by mutual agreement
1.
The role of participant may be taken over or shared by mutual agreement between an existing participant and a
prospective participant, provided that the prospective participant has the right to refer to all the data submitted or
referred to by the existing participant.
2.
A notification for the purpose of this Article shall be submitted jointly to the Agency by the prospective and the
existing participant through the Register for Biocidal Products referred to in Article 71 of Regulation (EU) No 528/2012
(hereinafter ‘the Register’), and shall include all relevant letters of access.
3.
Upon receipt of a notification complying with paragraph 2, the Agency shall update the information in the
Register with respect to the identity of the participant.
4.
A person established in the Union having taken over or joined the role of participant pursuant to this Article shall
be considered as having submitted a dossier or a letter of access to a dossier for the purpose of Article 95 of Regulation
(EU) No 528/2012.
Article 11
Participants' withdrawal
1.
A participant shall be considered to have withdrawn its support for a substance/product-type combination in the
review programme in the following cases:
(a) where it has informed the Agency or the evaluating competent authority through the Register of its intention to
withdraw;
(b) where it has failed to submit an application within the time limits specified in Article 3(2);
(c) where its application has been rejected pursuant to Article 4(1), Article 4(4) or Article 5(4);
(d) where it has failed to provide the additional information within the time limits provided for by Article 6(5);
(e) where it has otherwise failed to pay the fees payable to the evaluating competent authority or the Agency.
2.
A withdrawal shall be considered as timely unless it occurs after the date when the evaluating competent authority
submits its competent authority report to the applicant pursuant to Article 6(4) of this Regulation.
Article 12
Consequences of a timely withdrawal
1.
Where a timely withdrawal is known to the evaluating competent authority but not to the Agency, the evaluating
competent authority shall without undue delay inform the Agency thereof through the Register.
2.
Where a timely withdrawal is known to the Agency, it shall update the information in the Register with respect to
the identity of the participant.
3.
Where all participants supporting the same substance/product-type combination have made a timely withdrawal
from the review programme, and where the role of participant for that combination has previously been taken over, the
Agency shall inform the Commission thereof through the Register.
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Article 13
Redefinition of active substances
1.
Where the evaluation of an existing active substance does not allow for conclusions to be drawn relating to the
substance as identified in Annex II, the evaluating competent authority shall, after consultation with the participant
concerned, establish a new substance identity. The evaluating competent authority shall inform the Agency thereof.
2.
The Agency shall update the information in the Register with respect to the identity of the substance.
Article 14
Taking over the role of participant
1.
The Agency shall publish an open invitation to take over the role of participant for a substance/product-type
combination where one of the following cases applies:
(a) where all participants supporting the same substance/product-type combination have made a timely withdrawal
pursuant to Article 11, and the role of participant for that combination has not previously been taken over;
(b) following a redefinition pursuant to Article 13, in which case, the invitation shall only concern any substance
covered by the existing identity in Annex II, but not by the new substance identity.
2.
Within 12 months from the date of the publication referred to in paragraph 1, any person may submit a notifica­
tion for the combination pursuant to Article 17.
3.
Within 12 months from the date of entry into force of this Regulation, any person may notify a substance/
product-type combination included in part 2 of Annex II pursuant to Article 17.
Article 15
Substance/product-type combinations eligible for inclusion in the review programme
Where a biocidal product covered by the scope of Regulation (EU) No 528/2012 and being placed on the market
consists of, contains or generates an existing active substance which is neither approved, nor included in the review
programme, for the product-type, and is not included in Annex I to that Regulation, that substance shall be eligible for
inclusion in the review programme for the relevant product-type on any of the following grounds:
(a) the person placing the product on the market has relied on guidance published by, or written advice received from,
the Commission or a competent authority designated in accordance with Article 26 of Directive 98/8/EC or
Article 81 of Regulation (EU) No 528/2012, where that guidance or advice gave objectively justified reasons to
believe that the product was excluded from the scope of Directive 98/8/EC or of Regulation (EU) No 528/2012, or
that the relevant product-type was one for which the active substance had been notified and where that guidance or
advice is subsequently reviewed in a decision adopted pursuant to Article 3(3) of Regulation (EU) No 528/2012 or
in new, authoritative guidance published by the Commission;
(b) the substance has benefitted from the derogation for food and feed provided for by Article 6 of Regulation (EC)
No 1451/2007;
(c) the biocidal product belongs under Regulation (EU) No 528/2012 to a different product-type than the one it
belonged to under Directive 98/8/EC, as a result of a modification of scope of those product-types, and contains a
substance included in the review programme for the original product-type but not for the new one.
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Article 16
Declaration of interest to notify
1.
A declaration of interest to notify a substance which is eligible for inclusion in the review programme pursuant to
Article 15 shall be submitted through the Register by any person with an interest to notify a substance/product-type
combination to one of the following recipients:
(a) to the Commission at the latest 12 months after the publication of the decision or guidance referred to in point (a)
of Article 15;
(b) to the Agency at the latest 30 October 2015 in cases referred to in point (b) of Article 15;
(c) to the Commission at the latest 30 October 2015 in cases referred to in point (c) of Article 15.
2.
A declaration shall indicate the relevant substance/product-type combination. In cases referred to in point (a) of
Article 15, the declaration shall provide a substantiated justification showing that all the conditions listed therein are
fulfilled.
3.
Where a declaration has been made in a case referred to in point (a) or (c) of Article 15, and the Commission
finds, in consultation with the Member States, that paragraph 6 is not applicable, and, where relevant, that the condi­
tions for notification listed in point (a) of Article 15 are fulfilled, it shall inform the Agency thereof.
4.
Where a declaration has been made in the case referred to in point (b) of Article 15, or where the Commission has
informed the Agency pursuant to paragraph 3, the Agency shall make that information publicly available by electronic
means, mentioning the relevant substance/product-type combination. For the purposes of this Regulation, a publication
made pursuant to the third subparagraph of Article 3a(3) of Regulation (EC) No 1451/2007 shall be considered as a
publication made pursuant to this paragraph.
5.
Within 6 months from the date of a publication referred to in paragraph 4, any person with an interest to notify
the substance/product-type combination may do so pursuant to Article 17.
6.
In cases referred to in points (a) and (c) of Article 15, a substance/product-type combination shall be considered as
notified by a participant, and shall not be eligible for additional notification where the following conditions apply:
(a) the relevant active substance is already included in the review programme;
(b) one of the dossiers submitted to the evaluating Member State for the relevant active substance already contains all
the data required for the evaluation of the product-type;
(c) the participant which has submitted that dossier indicates an interest to support the substance/product-type
combination.
Article 17
Notification procedure
1.
Notifications pursuant to Article 14(2) and (3) or Article 16(5) shall be made to the Agency through the Register.
2.
The notification shall be submitted in IUCLID format. It shall contain the information referred to in Annex I.
3.
Where no evaluating competent authority is indicated in Annex II for the active substance in question, the notifier
shall inform the Agency of the name of its choice of competent authority designated in accordance with Article 81 of
Regulation (EU) No 528/2012, and provide written confirmation that that competent authority agrees to evaluate the
dossier.
4.
Upon receipt of a notification, the Agency shall inform the Commission thereof, and inform the notifier of the fees
payable under Regulation (EU) No 564/2013. If the notifier fails to pay the fee within 30 days from the receipt of that
information, the Agency shall reject the notification and inform the notifier and the Commission thereof.
L 294/10
EN
Official Journal of the European Union
10.10.2014
5.
Upon receipt of payment of the fees, the Agency shall verify within 30 days whether the notification complies
with the requirements of paragraph 2. If the notification does not comply with those requirements, the Agency shall
grant the notifier a period of 30 days in which to complete or correct the notification. After the expiry of that 30-day
period, the Agency shall, within 30 days, either declare that the notification complies with the requirements of para­
graph 2 or reject the notification, and inform the notifier and the Commission thereof.
6.
An appeal may be brought, in accordance with Article 77 of Regulation (EU) No 528/2012 against decisions of
the Agency taken pursuant to paragraph 4 or paragraph 5.
7.
Where a notification has been found compliant pursuant to paragraph 5, the Agency shall without delay:
(a) where the notification has been submitted pursuant to Article 14(2) or (3), update the information in the Register
with respect to the identity of the participant and, where relevant, of the substance;
(b) where the notification has been submitted pursuant to Article 16(5), inform the Commission of the compliance.
Article 18
Inclusion in the review programme
Where a substance/product-type combination is considered notified in accordance with Article 16(6), or where the
Agency informs the Commission of compliance in accordance with Article 17(7)(b), the Commission shall include the
substance/ product-type combination in the review programme.
Article 19
Information on substances no longer supported under the review programme
Where no notification has been received within the time limit referred to in Article 16(5), or where a notification
referred to in that Article has been received and subsequently rejected by the Agency pursuant to Article 17(4) or (5),
the Agency shall inform the Member States thereof through the Register and publish that information electronically.
Article 20
Commission decisions on substances no longer supported under the review programme
The Commission shall prepare a draft non-approval decision pursuant to the third subparagraph of Article 89(1) of
Regulation (EU) No 528/2012 in the following cases:
(a) where the Agency informs the Commission of all participants' timely withdrawal pursuant to Article 12(3) of this
Regulation;
(b) where no person has submitted a notification within the time limits provided for by Article 14(2) or 14(3) of this
Regulation, or where such a notification has been submitted and rejected pursuant to Article 17(4) or 17(5) thereof;
(c) where a notification has been submitted within the time limits provided for by Article 14(2) or 14(3) of this Regu­
lation and has been found compliant pursuant to Article 17(5) thereof, but the substance identity in the notification
only covers part of the existing identity in Annex II to this Regulation.
In case referred to in point (c) of first paragraph, the draft non-approval decision shall cover any substance covered by
the existing identity in Annex II to this Regulation, but not by the notification or any approval decision.
10.10.2014
EN
Official Journal of the European Union
L 294/11
CHAPTER 4
TRANSITIONAL MEASURES
Article 21
Transitional measures for substances referred to in Article 15
1.
A Member State may continue to apply its current system or practice of making available on the market and using
a biocidal product consisting of, containing or generating an existing active substance referred to in points (b) and (c) of
Article 15. In such cases:
(a) the biocidal product shall no longer be made available on the market with effect from 24 months after the date of
entry into force of this Regulation;
(b) the use of existing stocks of the biocidal product may continue until 30 months after the date of entry into force of
this Regulation.
2.
A Member State may continue to apply its current system or practice of making available on the market and using
a biocidal product consisting of, containing or generating an existing active substance referred to in point (a) of
Article 15. In such cases:
(a) The biocidal product shall no longer be made available on the market with effect from 24 months after of either of
the following, whichever is the later:
(i) the date of entry into force of this Regulation;
(ii) the notification or publication of the decision or guidance referred to in point (a) of Article 15.
(b) Use of existing stocks of the biocidal product may continue until 30 months after either of the following, whichever
is the later:
(i) the date of entry into force of this Regulation;
(ii) the notification or publication of the decision or guidance referred to in point (a) of Article 15.
3.
A Member State may continue to apply its current system or practice of making available on the market or using a
biocidal product consisting of, containing or generating an existing active substance for which the Agency has made a
publication pursuant to Article 16(4) for the relevant product-type. In such cases:
(a) The biocidal product shall no longer be made available on the market with effect from 12 months after the date
when the Agency has made the electronic publication referred to in Article 19; and
(b) Use of existing stocks of the biocidal product may continue until 18 months after the date of that publication.
Article 22
Essential use
1.
Without prejudice to Article 55(1) of Regulation (EU) No 528/2012, within 18 months of the date of a decision
not to approve an existing active substance, where a Member State considers this existing active substance essential for
one of the reasons referred to in points (b) or (c) of the first subparagraph of Article 5(2) of Regulation (EU)
No 528/2012, that Member State may submit a reasoned application to the Commission for a derogation from the
second subparagraph of Article 89(2) of that Regulation.
2.
The requesting Member State shall submit the reasoned application to the Agency through the Register. Where the
application contains confidential information, the requesting Member State shall at the same time submit a non-confi­
dential version.
3.
The Agency shall make the application or, where relevant, the non-confidential version, publicly available by elec­
tronic means. Member States or any other person may submit comments within 60 days of the publication.
L 294/12
EN
Official Journal of the European Union
10.10.2014
4.
Taking account of the comments received, the Commission may grant a derogation from the second sub-paragraph
of Article 89(2) of Regulation (EU) No 528/2012 allowing biocidal products consisting of, containing or generating the
substance to be made available on the market of the requesting Member State and used in that Member State in accord­
ance with national rules and subject to the conditions in paragraph 5 and any further conditions imposed by the
Commission.
5.
The Member State to which the derogation is granted shall:
(a) ensure that continued use is limited to such cases where and such time during which the conditions of paragraph 1
are fulfilled;
(b) impose appropriate risk mitigation measures to ensure that exposure of humans, animals and the environment is
minimised;
(c) ensure that alternatives are being sought, or that an application for approval of the active substance is being
prepared for submission in accordance with Article 7 of Regulation (EU) No 528/2012 in due time before the expiry
of the derogation.
CHAPTER 5
FINAL PROVISIONS
Article 23
Repeal
Regulation (EC) No 1451/2007 is repealed.
References to that Regulation shall be construed as references to this Regulation.
Article 24
Entry into force
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the
European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 4 August 2014.
For the Commission
The President
José Manuel BARROSO
Information requirements for notifications pursuant to Article 17
10.10.2014
ANNEX I
A notification pursuant to Article 17 shall contain the following information:
(2) an indication of the product-type(s) concerned by the notification;
EN
(1) evidence that the substance is an existing active substance within the meaning of Article 3(1)(d) of Regulation (EU) No 528/2012;
(3) information on any studies that have been commissioned for the purpose of application for approval or inclusion in Annex I to Regulation (EU) No 528/2012, as well as the expected
date of completion;
(4) the information referred to in Sections
(a) 1, 2 and 7.1 to 7.5 of the table in Title 1 of Annex II to Regulation (EU) No 528/2012 for chemical substances;
(b) 1, 2 and 6.1 to 6.4 of the table in Title 2 of Annex II to Regulation (EU) No 528/2012 for micro-organisms;
Official Journal of the European Union
(5) where the notification has been made in a case referred to in point (a) of Article 15, evidence that the substance was on the market as an active substance of a biocidal product falling
under the relevant product-type on the date of notification or publication of the decision or guidance referred to in that point.
L 294/13
L 294/14
ANNEX II
SUBSTANCE/PRODUCT-TYPE COMBINATIONS INCLUDED IN THE REVIEW PROGRAMME ON 4 AUGUST 2014
PART 1
Active substance/product-type combinations supported on 4 August 2014, excluding any other nanomaterial than those explicitly mentioned in entries 1017 and 1019
EN
Entry
number
Substance name
Rapporteur
Member
State
EC number
CAS number
1
2
3
x
x
Formaldehyde
DE
200-001-8
50-00-0
6
2-(2-butoxyethoxy)ethyl 6-propylpiper­
onyl ether (Piperonyl butoxide/PBO)
EL
200-076-7
51-03-6
9
Bronopol
ES
200-143-0
52-51-7
29
Chlorocresol
FR
200-431-6
59-50-7
x
x
36
Ethanol
EL
200-578-6
64-17-5
x
x
37
Formic acid
BE
200-579-1
64-18-6
40
Propan-2-ol
DE
200-661-7
67-63-0
43
Salicylic acid
NL
200-712-3
69-72-7
45
Propan-1-ol
DE
200-746-9
71-23-8
52
Ethylene oxide
N
200-849-9
75-21-8
60
Citric acid
BE
201-069-1
77-92-9
69
Glycolic acid
LT
201-180-5
79-14-1
70
Peracetic acid
FI
201-186-8
79-21-0
71
L-(+)-lactic acid
DE
201-196-2
79-33-4
5
6
7
8
9
10
11
12
13
17
18
19
21
22
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
Official Journal of the European Union
1
4
x
x
x
x
x
x
x
x
x
x
x
x
x
10.10.2014
x
x
Substance name
Rapporteur
Member
State
EC number
CAS number
79
(2R,6aS,12aS)-1,2,6,6a,12,12a-hexa­
hydro-2-isopropenyl-8,9-dimethoxychro­
meno[3,4-b]furo[2,3-h]chromen-6-one
(Rotenone)
UK
201-501-9
83-79-4
85
Symclosene
UK
201-782-8
87-90-1
92
Biphenyl-2-ol
ES
201-993-5
90-43-7
113
Cinnamaldehyde/3-phenyl-propen-2-al
(Cinnamic aldehyde)
UK
203-213-9
104-55-2
117
Geraniol
FR
203-377-1
106-24-1
122
Glyoxal
FR
203-474-9
107-22-2
133
Hexa-2,4-dienoic acid (Sorbic acid)
DE
203-768-7
110-44-1
136
Glutaral (Glutaraldehyde)
FI
203-856-5
111-30-8
x
x
154
Clorophene (Chlorophene)
N
204-385-8
120-32-1
x
x
171
2-Phenoxyethanol
UK
204-589-7
122-99-6
172
Cetylpyridinium chloride
UK
204-593-9
123-03-5
179
Carbon dioxide
FR
204-696-9
124-38-9
180
Sodium dimethylarsinate (Sodium
Cacodylate)
PT
204-708-2
124-65-2
185
Tosylchloramide sodium (Tosylchloramide
sodium — Chloramin T)
ES
204-854-7
127-65-1
187
Potassium dimethyldithiocarbamate
UK
204-875-1
128-03-0
x
x
x
188
Sodium dimethyldithiocarbamate
UK
204-876-7
128-04-1
x
x
x
1
2
3
4
5
6
7
8
9
10
11
12
13
17
18
19
x
x
21
22
10.10.2014
Entry
number
x
EN
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
Official Journal of the European Union
x
x
x
x
x
x
x
x
L 294/15
Substance name
Rapporteur
Member
State
EC number
CAS number
1
2
3
4
x
x
x
x
5
6
7
x
8
10
x
x
x
x
x
ES
205-055-6
132-27-4
198
N-(trichloromethylthio)phthalimide
(Folpet)
IT
205-088-6
133-07-3
206
Thiram
BE
205-286-2
137-26-8
x
210
Metam-sodium
BE
205-293-0
137-42-8
x
227
2-thiazol-4-yl-1H-benzoimidazole
(Thiabendazole)
ES
205-725-8
148-79-8
x
235
Diuron
DK
206-354-4
330-54-1
x
239
Cyanamide
DE
206-992-3
420-04-2
253
Tetrahydro-3,5-dimethyl-1,3,5-thiadia­
zine-2-thione (Dazomet)
BE
208-576-7
533-74-4
279
Dichloro-N-[(dimethylamino)sulphonyl]
fluoro-N-(ptolyl)methanesulphenamide
(Tolylfluanid)
FI
211-986-9
731-27-1
x
283
Terbutryn
SK
212-950-5
886-50-0
x
288
N-(Dichlorofluoromethylthio)-N′,N′dimethyl-N-phenylsulfamide
(Dichlofluanid)
UK
214-118-7
1085-98-9
x
289
Copper thiocyanate
FR
214-183-1
1111-67-7
292
(1,3,4,5,6,7-hexahydro-1,3-dioxo-2Hisoindol-2-yl)methyl
(1R-trans)-2,2dimethyl-3-(2-methylprop-1-enyl)cyclo­
propanecarboxylate (d-Tetramethrin)
DE
214-619-0
1166-46-7
x
13
17
18
19
21
x
x
x
x
x
x
x
x
x
x
22
x
x
x
x
10.10.2014
Sodium 2-biphenylate
12
Official Journal of the European Union
195
11
EN
9
L 294/16
Entry
number
Substance name
Rapporteur
Member
State
EC number
CAS number
958
Calcium dihydroxide/calcium hydroxide/
caustic lime/hydrated lime/slaked lime
UK
215-137-3
959
Calcium oxide/lime/burnt lime/quicklime
UK
306
Dicopper oxide
315
3
1305-62-0
x
x
215-138-9
1305-78-8
x
x
FR
215-270-7
1317-39-1
2-Butanone, peroxide
HU
215-661-2
1338-23-4
321
Monolinuron
UK
217-129-5
1746-81-2
x
330
N-(3-aminopropyl)-N-dodecylpropane1,3-diamine (Diamine)
PT
219-145-8
2372-82-9
x
336
2,2′-dithiobis[N-methylbenzamide]
(DTBMA)
PL
219-768-5
2527-58-4
339
1,2-benzisothiazol-3(2H)-one (BIT)
ES
220-120-9
2634-33-5
341
2-methyl-2H-isothiazol-3-one (MIT)
SI
220-239-6
2682-20-4
346
Sodium dichloroisocyanurate dihydrate
UK
220-767-7
51580-86-0
x
x
x
345
Troclosene sodium
UK
220-767-7
2893-78-9
x
x
x
348
Mecetronium ethyl sulphate (MES)
PL
221-106-5
3006-10-8
x
354
Triclosan
DK
222-182-2
3380-34-5
x
359
(ethylenedioxy)dimethanol
(Reaction
products of ethylene glycol with parafor­
maldehyde (EGForm))
PL
222-720-6
3586-55-8
x
365
Pyridine-2-thiol 1-oxide,
(Sodium pyrithione)
SE
223-296-5
3811-73-2
x
5
6
7
8
9
10
11
12
13
17
18
19
21
22
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
L 294/17
x
Official Journal of the European Union
salt
4
EN
2
sodium
1
10.10.2014
Entry
number
Substance name
3-chloroallylochloride
EC number
CAS number
PL
223-805-0
4080-31-3
x
x
x
377
2,2′,2′′-(hexahydro-1,3,5-triazine-1,3,5triyl)triethanol (HHT)
PL
225-208-0
4719-04-4
382
Tetrahydro-1,3,4,6-tetrakis(hydroxy­
methyl)imidazo[4,5-d]imidazole-2,5
(1H,3H)-dione (TMAD)
ES
226-408-0
5395-50-6
387
N,N′-methylenebismorpholine (MBM)
AT
227-062-3
5625-90-1
392
Methylene dithiocyanate
FR
228-652-3
6317-18-6
393
1,3-bis(hydroxymethyl)-5,5-dimethylimi­
dazolidine-2,4-dione (DMDMH)
PL
229-222-8
6440-58-0
397
Didecyldimethylammonium chloride
(DDAC)
IT
230-525-2
7173-51-5
401
Silver
SE
231-131-3
7440-22-4
403
Copper
FR
231-159-6
7440-50-8
405
Sulphur dioxide
DE
231-195-2
7446-09-5
424
Sodium bromide
NL
231-599-9
7647-15-6
432
Sodium hypochlorite
IT
231-668-3
7681-52-9
434
Tetramethrin
DE
231-711-6
7696-12-0
439
Hydrogen peroxide
FI
231-765-0
7722-84-1
444
7a-ethyldihydro-1H,3H,5H-oxazolo[3,4-c]
oxazole (EDHO)
PL
231-810-4
7747-35-5
3
4
5
x
6
7
8
9
10
11
12
13
x
x
x
x
x
x
x
x
x
17
18
19
21
x
x
x
x
x
x
x
x
x
x
x
22
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
10.10.2014
Methenamine
(CTAC)
2
Official Journal of the European Union
368
1
EN
Rapporteur
Member
State
L 294/18
Entry
number
Substance name
Rapporteur
Member
State
EC number
CAS number
1
SE
231-853-9
7761-88-8
x
PT
231-892-1
7775-27-1
2
3
4
5
6
450
Silver nitrate
453
Disodium
persulphate
455
Calcium hypochlorite
IT
231-908-7
7778-54-3
x
457
Chlorine
IT
231-959-5
7782-50-5
x
458
Ammonium sulphate
UK
231-984-1
7783-20-2
473
Pyrethrins and Pyrethroids
ES
232-319-8
8003-34-7
491
Chlorine dioxide
PT
233-162-8
10049-04-4
x
494
2,2-dibromo-2-cyanoacetamide (DBNPA)
DK
233-539-7
10222-01-2
x
501
Carbendazim
DE
234-232-0
10605-21-7
515
Ammonium bromide
SE
235-183-8
12124-97-9
522
Pyrithione zinc (Zinc pyrithione)
SE
236-671-3
13463-41-7
524
Dodecylguanidine monohydrochloride
ES
237-030-0
13590-97-1
x
526
Potassium 2-biphenylate
ES
237-243-9
13707-65-8
x
529
Bromine chloride
NL
237-601-4
13863-41-7
531
(benzyloxy)methanol
UK
238-588-8
14548-60-8
534
Bis(1-hydroxy-1H-pyridine-2-thionatoO,S)copper (Copper pyrithione)
SE
238-984-0
14915-37-8
541
Sodium p-chloro-m-cresolate
FR
239-825-8
15733-22-9
8
9
10
11
12
13
17
18
19
x
x
21
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
Official Journal of the European Union
x
22
EN
peroxodisulphate/Sodium
7
10.10.2014
Entry
number
x
x
x
x
x
x
x
x
x
x
x
x
x
L 294/19
x
CAS number
1
2
3
550
D-gluconic acid, compound with
N,N′′-bis(4-chlorophenyl)-3,12-diimino2,4,11,13-tetraazatetradecanediamidine
(2:1) (CHDG)
PT
242-354-0
18472-51-0
x
x
x
554
p-[(diiodomethyl)sulphonyl]toluene
UK
243-468-3
20018-09-1
559
(benzothiazol-2-ylthio)methyl thiocyanate
(TCMTB)
N
244-445-0
21564-17-0
562
2-methyl-4-oxo-3-(prop-2-ynyl)cyclopent2-en-1-yl 2,2-dimethyl-3-(2-methylprop1-enyl)cyclopropanecarboxylate
(Prallethrin)
EL
245-387-9
23031-36-9
563
Potassium (E,E)-hexa-2,4-dienoate (Potas­
sium Sorbate)
DE
246-376-1
24634-61-5
566
.alpha.,.alpha.′,.alpha.′′-trimethyl-1,3,5triazine-1,3,5(2H,4H,6H)-triethanol (HPT)
AT
246-764-0
25254-50-6
571
2-octyl-2H-isothiazol-3-one (OIT)
UK
247-761-7
26530-20-1
577
Dimethyloctadecyl[3-(trimethoxysilyl)
propyl]ammonium chloride
ES
248-595-8
27668-52-6
578
N′-tert-butyl-N-cyclopropyl-6(methylthio)-1,3,5-triazine-2,4-diamine
(Cybutryne)
NL
248-872-3
28159-98-0
588
Bromochloro-5,5-dimethylimidazolidine2,4-dione
(BCDMH/Bromochlorodi­
methylhydantoin)
NL
251-171-5
32718-18-6
590
3-(4-isopropylphenyl)-1,1-dimethylurea/
Isoproturon
DE
251-835-4
34123-59-6
4
5
6
7
x
x
8
9
10
x
x
11
12
13
17
18
19
21
22
EN
EC number
Substance name
L 294/20
Rapporteur
Member
State
Entry
number
x
x
Official Journal of the European Union
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
10.10.2014
x
x
Substance name
Rapporteur
Member
State
EC number
CAS number
1
2
3
597
1-[2-(allyloxy)-2-(2,4-dichlorophenyl)
ethyl]-1H-imidazole (Imazalil)
DE
252-615-0
35554-44-0
599
S-[(6-chloro-2-oxooxazolo[4,5-b]pyridin3(2H)-yl)methyl] O,O-dimethyl thiopho­
sphate (Azamethiphos)
UK
252-626-0
35575-96-3
600
2-bromo-2-(bromomethyl)pentanedini­
trile (DBDCB)
CZ
252-681-0
35691-65-7
961
Calcium magnesium oxide/dolomitic lime
UK
253-425-0
37247-91-9
x
x
962
Calcium magnesium tetrahydroxide/
calcium magnesium hydroxide/hydrated
dolomitic lime
UK
254-454-1
39445-23-3
x
x
606
.alpha.-cyano-3-phenoxybenzyl
2,2-dimethyl-3-(2-methylprop-1-enyl)
cyclopropanecarboxylate (Cyphenothrin)
EL
254-484-5
39515-40-7
608
Dimethyltetradecyl[3-(trimethoxysilyl)
propyl]ammonium chloride
PL
255-451-8
41591-87-1
609
Mixture of cis- and trans-p-menthane-3,8
diol (Citriodiol)
UK
255-953-7
42822-86-6
614
(RS)-α-cyano-3phenoxybenzyl-(1RS)- cis,
trans-3-(2,2-dichlorovinyl)-2,2-dimethyl­
cyclopropanecarboxylate (Cypermethrin)
BE
257-842-9
52315-07-8
615
3-phenoxybenzyl (1RS,3RS;1RS,3SR)-3(2,2-dichlorovinyl)-2,2-dimethylcyclopro­
panecarboxylate (Permethrin)
IE
258-067-9
52645-53-1
4
5
6
7
8
9
10
11
12
13
17
18
19
21
22
10.10.2014
Entry
number
x
EN
x
x
Official Journal of the European Union
x
x
x
x
x
L 294/21
x
Substance name
Rapporteur
Member
State
EC number
CAS number
1
2
3
4
5
6
7
8
9
10
11
12
13
17
18
618
1-ethynyl-2-methylpent-2-enyl
2,2-dimethyl-3-(2-methylprop-1-enyl)
cyclopropanecarboxylate (Empenthrin)
BE
259-154-4
54406-48-3
619
3-iodo-2-propynylbutylcarbamate (IPBC)
DK
259-627-5
55406-53-6
620
Tetrakis(hydroxymethyl)phosphonium
sulphate(2:1) (THPS)
MT
259-709-0
55566-30-8
628
1-[[2-(2,4-dichlorophenyl)-4-propyl-1,3dioxolan-2-yl]methyl]-1H-1,2,4-triazole
(Propiconazole)
FI
262-104-4
60207-90-1
635
Coco alkyltrimethylammonium chloride
(ATMAC/TMAC)
IT
263-038-9
61789-18-2
648
4,5-Dichloro-2-octylisothiazol-3(2H)-one
(4,5-Dichloro- 2-octyl-2H- isothiazol-3one (DCOIT))
N
264-843-8
64359-81-5
649
2-chloro-N-[[[4-(trifluoromethoxy)
phenyl]amino]carbonyl]benzamide
(Triflumuron)
IT
264-980-3
64628-44-0
656
3,3′-methylenebis[5-methyloxazolidine]
(Oxazolidin/MBO)
AT
266-235-8
66204-44-2
657
N-cyclopropyl-1,3,5-triazine-2,4,6-tria­
mine (Cyromazine)
EL
266-257-8
66215-27-8
x
666
.alpha.-cyano-4-fluoro-3-phenoxybenzyl
3-(2,2-dichlorovinyl)-2,2-dimethylcyclo­
propanecarboxylate (Cyfluthrin)
DE
269-855-7
68359-37-5
x
19
21
22
L 294/22
Entry
number
x
EN
x
x
x
x
x
x
x
x
Official Journal of the European Union
x
x
x
x
x
x
x
x
x
x
x
x
10.10.2014
Substance name
Rapporteur
Member
State
EC number
CAS number
1
2
3
4
667
Alkyl (C12-18) dimethylbenzyl ammonium
chloride (ADBAC (C12-18))
IT
269-919-4
68391-01-5
x
x
x
671
Alkyl (C12-16) dimethylbenzyl ammonium
chloride (ADBAC/BKC (C12-C16))
IT
270-325-2
68424-85-1
x
x
673
Didecyldimethylammonium
(DDAC (C8-10))
IT
270-331-5
68424-95-3
x
x
690
Quaternary ammonium compounds,
benzyl-C12-18-alkyldimethyl, salts with
1,2-benzisothiazol-3(2H)-one 1,1-dioxide
(1:1) (ADBAS)
MT
273-545-7
68989-01-5
691
Sodium N-(hydroxymethyl)glycinate
AT
274-357-8
70161-44-3
692
Amines, C10-16-alkyldimethyl, N-oxides
PT
274-687-2
70592-80-2
693
Pentapotassium bis(peroxymonosulphate)
bis(sulphate)
SI
274-778-7
70693-62-8
x
701
Magnesium monoperoxyphthalate hexa­
hydrate (MMPP)
PL
279-013-0
84665-66-7
x
1015
Margosa extract
DE
283-644-7
84696-25-3
724
Alkyl (C12-C14) dimethylbenzylammonium
chloride (ADBAC (C12-C14))
IT
287-089-1
85409-22-9
x
x
x
x
x
x
x
x
725
Alkyl (C12-C14) ethylbenzylammonium
chloride (ADEBAC (C12-C14))
IT
287-090-7
85409-23-0
x
x
x
x
x
x
x
x
731
Chrysanthemum cinerariaefolium, ext.
ES
289-699-3
89997-63-7
744
Lavender, Lavandula hybrida, ext./Lavandin
oil
PT
294-470-6
91722-69-9
6
7
8
9
10
11
12
13
17
18
19
21
22
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
EN
chloride
5
10.10.2014
Entry
number
x
Official Journal of the European Union
x
x
x
x
x
x
x
x
x
L 294/23
x
Substance name
Rapporteur
Member
State
EC number
CAS number
1
2
3
4
776
1-(3,5-dichloro-4-(1,1,2,2-tetrafluor­
oethoxy)phenyl)-3-(2,6-difluorobenzoyl)
urea (Hexaflumuron)
PT
401-400-1
86479-06-3
779
Reaction products of: glutamic acid and
N-(C12-C14-alkyl)propylenediamine
(Glucoprotamin)
DE
403-950-8
164907-72-6
785
6-(phthalimido)peroxyhexanoic acid (PAP)
IT
410-850-8
128275-31-0
791
2-butyl-benzo[d]isothiazol-3-one (BBIT)
CZ
420-590-7
4299-07-4
792
Tetrachlorodecaoxide complex (TCDO)
DE
420-970-2
92047-76-2
x
x
x
811
Silver sodium hydrogen zirconium
phosphate
SE
422-570-3
265647-11-8
x
x
x
794
sec-butyl 2-(2-hydroxyethyl)piperidine-1carboxylate/Icaridine (Icaridine)
DK
423-210-8
119515-38-7
797
cis-1-(3-chloroallyl)-3,5,7-triaza-1azoniaadamantane chloride (cis CTAC)
PL
426-020-3
51229-78-8
800
[2,4-Dioxo-(2-propyn-1-yl)imidazolidin3-yl]methyl(1R)-cis-chrysanthemate;[2,4Dioxo-(2-propyn-1-yl)imidazolidin-3-yl]
methyl(1R)-trans-chrysanthemate (Imipro­
thrin)
UK
428-790-6
72963-72-5
790
5-chloro-2-(4-chlorphenoxy)phenol
(DCPP)
AT
429-290-0
3380-30-1
807
(E)-1-(2-Chloro-1,3-thiazol-5-ylmethyl)-3methyl-2-nitroguanidine (Clothianidin)
DE
433-460-1
210880-92-5
5
6
7
8
9
10
11
12
13
17
18
19
21
22
L 294/24
Entry
number
x
EN
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
Official Journal of the European Union
x
x
x
x
x
10.10.2014
x
EC number
CAS number
IT
Microorganism
143447-72-7
x
IT
Microorganism
Not applic­
able
x
DE
Microorganism
Not applic­
able
928
Mixture
of
5-chloro-2-methyl-2Hisothiazol-3-one (EINECS 247-500-7) and
2-methyl-2H-isothiazol-3-one
(EINECS
220-239-6) (Mixture of CMIT/MIT)
FR
Mixture
55965-84-9
x
939
Active Chlorine: manufactured by the
reaction of hypochlorous acid and
sodium hypochlorite produced in situ
SK
Mixture
Not applic­
able
x
x
x
FR
Not applic­
able
33734-57-5
x
x
x
SE
Not applic­
able
Not applic­
able
x
Substance name
Bacillus sphaericus 2362, strain
ABTS-1743
955
Bacillus thuringiensis
strain SA3A
957
1014
israelensis,
Bacillus subtilis
Peroxyoctanoic acid
Silver zeolite
3-phenoxybenzyl
(1R)-cis,trans-2,2dimethyl-3-(2-methylprop-1-enyl)cyclo­
propanecarboxylate (d-Phenothrin)
IE
Not applic­
able
188023-86-1
931
Amines, N-C12-C14 (even-numbered)-alkyl­
trimethylenedi-, reaction products with
chloroacetic acid (Ampholyt 20)
IE
Not applic­
able
139734-65-9
152
Reaction products of 5,5-dimethylhydan­
toin, 5-ethyl-5-methylhydantoin with
bromine and chlorine (DCDMH)
NL
Not avail­
able
Not available
4
5
6
7
8
9
10
11
12
13
17
18
19
21
22
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
L 294/25
849
3
Official Journal of the European Union
813
subsp.
2
EN
952
1
10.10.2014
Rapporteur
Member
State
Entry
number
Substance name
Rapporteur
Member
State
EC number
CAS number
1
2
459
Reaction mass of titanium dioxide and
silver chloride
SE
Not avail­
able
Not available
x
x
777
Reaction products of 5,5-dimethylhydan­
toin, 5-ethyl-5-methylhydantoin with
chlorine (DCEMH)
NL
Not avail­
able
Not available
SE
Not avail­
able
308069-39-8
x
SE
Not avail­
able
130328-20-0
x
x
SE
Not avail­
able
130328-19-7
x
x
1017
Silver adsorbed on silicon dioxide (as a
nanomaterial in the form of a stable
aggregate with primary particles in the
nanoscale)
SE
Not avail­
able
Not available
1019
Silicon dioxide (as a nanomaterial formed
by aggregates and agglomerates)
FR
Not avail­
able
68909-20-6
x
FR
Plant
protection
product
61790-53-2
x
DE
Plant
protection
product
231937-89-6
x
3
4
5
6
7
x
x
8
9
10
11
x
x
x
12
13
17
18
19
21
22
L 294/26
Entry
number
EN
810
1013
831
Silver copper zeolite
Silicium dioxide (Silicium dioxide/Kiesel­
guhr)
(RS)-3-Allyl-2-methyl-4-oxocyclopent-2enyl-(1R,3R;1R,3S)-2,2-dimethyl-3-(2methylprop-1-enyl)-cyclopropanecarboxy­
late (mixture of 4 isomers 1R trans, 1R:
1R trans, 1S: 1R cis, 1R: 1R cis,
1S 4:4:1:1) (d-Allethrin)
x
x
x
x
x
x
x
x
10.10.2014
854
Silver zinc zeolite
x
Official Journal of the European Union
824
Silver phosphate glass
x
Substance name
Rapporteur
Member
State
EC number
CAS number
855
(RS)-3-Allyl-2-methyl-4-oxocyclopent-2enyl (1R,3R)-2,2-dimethyl-3-(2-methyl­
prop-1-enyl)-cyclopropanecarboxylate
(mixture of 2 isomers 1R trans: 1R/S
only 1:3) (Esbiothrin)
DE
Plant
protection
product
260359-57-7
x
848
N-((6-Chloro-3-pyridinyl)methyl)-N′cyano-N-methylethanimidamide (Aceta­
miprid)
BE
Plant
protection
product
160430-64-8
x
835
Esfenvalerate/(S)-.alpha.-Cyano-3-phenox­
ybenzyl (S)-2-(4-chlorophenyl)-3-methyl­
butyrate (Esfenvalerate)
PT
Plant
protection
product
66230-04-4
x
836
[1.alpha.(S*),3.alpha.]-(.alpha.)-cyano-(3phenoxyphenyl)methyl
3-(2,2-dichlor­
oethenyl)-2,2-dichlorovinyl)-2,2-dimethyl­
cyclopropanecarboxylate (alpha-Cyperme­
thrin)
BE
Plant
protection
product
67375-30-8
x
843
4-bromo-2-(4-chlorophenyl)-1-ethoxy­
methyl-5-trifluoromethylpyrrole-3-carbo­
nitrile (Chlorfenapyr)
PT
Plant
protection
product
122453-73-0
x
859
Polymer
of
N-Methylmethanamine
(EINECS 204-697-4 with (chloromethyl)
oxirane (EINECS 203-439-8)/Polymeric
quaternary ammonium chloride (PQ
Polymer)
HU
Polymer
25988-97-0
863
Monohydro chloride of polymer of
N,N′′′-1,6-hexanediylbis[N′-cyanoguani­
dine] (EINECS 240-032-4) and hexam­
ethylenediamine (EINECS 204-679-6)/
Polyhexamethylene biguanide (monomer:
1,5-bis(trimethylen)-guanylguanidinium
monohydrochloride) (PHMB)
FR
Polymer
27083-27-8/
32289-58-0
1
2
3
4
5
6
7
8
9
10
11
12
13
17
18
19
21
22
10.10.2014
Entry
number
EN
x
x
Official Journal of the European Union
x
x
x
x
x
x
x
x
L 294/27
Substance name
Rapporteur
Member
State
EC number
CAS number
1
2
3
4
x
x
x
x
Poly(hexamethylenebiguanide)
FR
Polymer
91403-50-8
869
Poly(oxy-1,2-ethanediyl), .alpha.-[2-(dide­
cylmethylammonio)ethyl].omega.hydroxy-, propanoate (salt) (Bardap 26)
IT
Polymer
94667-33-1
872
N-Didecyl-N-dipolyethoxyammonium
borate/Didecylpolyoxethylammonium
borate (Polymeric betaine)
EL
Polymer
214710-34-6
x
6
7
8
9
10
x
x
x
11
12
13
17
18
19
21
22
x
EN
868
5
L 294/28
Entry
number
x
x
Official Journal of the European Union
PART 2
Active substance/product-type combinations not supported on 4 August 2014
This part of this Annex includes
— the substance/product-type combinations listed in the table below, including any nanomaterial forms,
— any nanomaterial forms of all substance/product-type combinations listed in the table in part 1, except those listed in that table, and
— any nanomaterial forms of all active substance/product-type combinations approved by 4 August 2014, except those explicitly approved.
The substance/product-type combinations and nanomaterials included in this part will be the subject of a non-approval decision pursuant to Article 20 if no person makes a notification
within 12 months of the entry into force of this Regulation pursuant to Article 14(3), or if such a notification is rejected pursuant to Article 17(4) or 17(5).
Entry
number
Substance name
Rapporteur
Member
State
EC number
CAS number
NL
204-258-7
118-52-5
1,3-dichloro-5,5-dimethylhydantoin
(redefined as per entry 152)
166
Cetalkonium chloride (see entry 948)
204-526-3
122-18-9
167
Benzyldimethyl(octadecyl)ammonium
chloride (see entry 948)
204-527-9
122-19-0
2
3
4
5
6
7
8
9
10
11
12
13
17
18
19
21
22
x
10.10.2014
1021
1
Rapporteur
Member
State
Substance name
chloride
(see
CAS number
205-351-5
139-07-1
205-352-0
139-08-2
205-725-8
148-79-8
214
Miristalkonium chloride (see entry 948)
227
2-thiazol-4-yl-1H-benzoimidazole
(Thiabendazole)
331
Didecyldimethylammonium bromide (see
entry 949)
219-234-1
2390-68-3
384
Dimethyldioctylammonium chloride (see
entry 949)
226-901-0
5538-94-3
399
Benzyldodecyldimethylammonium
bromide (see entry 948)
230-698-4
7281-04-1
401
Silver
SE
231-131-3
7440-22-4
418
Silicon dioxide — amorphous
FR
231-545-4
7631-86-9
449
Copper sulphate
FR
231-847-6
7758-98-7
1016
Silver chloride
SE
232-033-3
7783-90-6
554
p-[(diiodomethyl)sulphonyl]toluene
UK
243-468-3
20018-09-1
587
Decyldimethyloctylammonium
(see entry 949)
251-035-5
32426-11-2
601
Benzyldimethyloleylammonium chloride
(see entry 948)
253-363-4
37139-99-4
615
3-phenoxybenzyl (1RS,3RS;1RS,3SR)-3(2,2-dichlorovinyl)-2,2-dimethylcyclopro­
panecarboxylate (Permethrin)
258-067-9
52645-53-1
ES
chloride
IE
3
4
5
6
7
8
9
10
11
12
13
17
18
19
21
22
x
x
x
x
x
x
x
x
x
x
x
x
x
L 294/29
Benzododecinium
entry 948)
2
Official Journal of the European Union
213
1
EN
EC number
10.10.2014
Entry
number
Substance name
637
Rapporteur
Member
State
CAS number
Quaternary ammonium compounds,
benzylcoco alkyldimethyl, chlorides (see
entry 948)
263-080-8
61789-71-7
638
Quaternary
dicocoalkyl
entry 949)
263-087-6
61789-77-3
639
Quaternary ammonium compounds, bis
(hydrogenated tallow alkyl)dimethyl,
chlorides (see entry 949)
263-090-2
61789-80-8
647
Quaternary ammonium compounds,
benzyl-C8-18-alkyldimethyl, chlorides (see
entry 948)
264-151-6
63449-41-2
668
Quaternary ammonium compounds, diC6-12-alkyldimethyl,
chlorides
(see
entry 949)
269-925-7
68391-06-0
670
Quaternary ammonium compounds,
benzyl-C8-16-alkyldimethyl, chlorides (see
entry 948)
270-324-7
68424-84-0
689
Quaternary ammonium compounds,
benzyl-C10-16-alkyldimethyl, chlorides (see
entry 948)
273-544-1
68989-00-4
692
Amines, C10-16-alkyldimethyl, N-oxides
274-687-2
70592-80-2
697
Quaternary ammonium compounds, diC8-18-alkyldimethyl,
chlorides
(see
entry 949)
277-453-8
73398-64-8
1000
Dihydrogen
bis[monoperoxyphthalato­
(2-)-O1,OO1]magnesate(2-) hexahydrate
279-013-0
14915-85-4
1
2
3
4
5
6
7
8
9
10
11
12
13
17
18
19
21
22
EN
EC number
L 294/30
Entry
number
ammonium compounds,
dimethyl, chlorides (see
x
x
10.10.2014
PL
Official Journal of the European Union
PT
Rapporteur
Member
State
EC number
CAS number
998
Margosa extract other than from the
kernels of Azadirachta indica extracted
with water and further processed with
organic solvents.
DE
283-644-7
84696-25-3
741
Quaternary ammonium compounds,
benzyl-C8-18-alkyldimethyl, bromides (see
entry 948)
293-522-5
91080-29-4
1020
1,3-dichloro-5-ethyl-5-methylimidazoli­
dine-2,4-dione
(redefined
as
per
entry 777)
NL
401-570-7
89415-87-2
778
1-(4-chlorophenyl)-4,4-dimethyl-3-(1,2,4triazol-1-ylmethyl)pentan-3-ol (Tebucona­
zole)
DK
403-640-2
107534-96-3
805
Reaction product of dimethyl adipate,
dimethyl glutarate, dimethyl succinate
with hydrogen peroxide (Perestane)
HU
432-790-1
Not applic­
able
923
Alkyl-benzyl-dimethylammonium
chloride/Benzalkonium chloride
entry 948)
Mixture
8001-54-5
949
Quaternary ammonium compounds
(dialkyldimethyl (alkyl from C6-C18, satu­
rated and unsaturated, and tallow alkyl,
coco alkyl, and soya alkyl) chlorides,
bromides, or methylsulphates) (DDAC)
IT
Mixture of
EINECS
listed
substances
Not applic­
able
950
Quaternary ammonium compounds
(alkyltrimethyl (alkyl from C8-C18, satu­
rated and unsaturated, and tallow alkyl,
coco alkyl, and soya alkyl) chlorides,
bromides, or methylsulphates) (TMAC)
IT
Mixture of
EINECS
listed
substances
Not applic­
able
1
2
3
4
5
6
7
8
9
10
11
12
13
17
18
19
21
22
x
EN
Substance name
10.10.2014
Entry
number
Official Journal of the European Union
(see
x
x
x
x
x
x
x
x
x
x
L 294/31
x
x
CAS number
1
2
3
4
948
Quaternary ammonium compounds
(benzylalkyldimethyl (alkyl from C8-C22,
saturated and unsaturated, tallow alkyl,
coco alkyl, and soya alkyl) chlorides,
bromides, or hydroxides) (BKC)
IT
Mixture of
EINECS
listed
substances
Not applic­
able
x
x
x
x
849
3-phenoxybenzyl
(1R)-cis,trans-2,2dimethyl-3-(2-methylprop-1-enyl)cyclo­
propanecarboxylate (d-Phenothrin)
IE
Not applic­
able
188023-86-1
1001
Quaternary ammonium compounds,
benzyl-C12-16-alkyldimethyl,
chlorides
(other than the substance covered by
entry 671)
IT
Not applic­
able
Not applic­
able
x
x
x
x
1002
Quaternary ammonium compounds,
benzyl-C12-18-alkyldimethyl,
chlorides
(other than the substance covered by
entry 667)
IT
Not applic­
able
Not applic­
able
x
x
x
1003
Quaternary ammonium compounds, C1214-alkyl[(ethylphenyl)methyl]dimethyl,
chlorides (other than the substance
covered by entry 725)
IT
Not applic­
able
Not applic­
able
x
x
1005
Quaternary ammonium compounds,
benzyl-C12-14-alkyldimethyl,
chlorides
(other than the substance covered by
entry 724)
IT
Not applic­
able
Not applic­
able
x
x
1006
Silver-zinc-aluminium-boronphosphate
glass/Glass oxide, silver- and zinccontaining
SE
Not applic­
able
398477-47-9
1009
Quaternary ammonium compounds, diC8-10-alkyldimethyl, chlorides (other than
the substance covered by entry 673)
IT
Not applic­
able
Not applic­
able
5
6
7
8
9
x
10
11
12
x
x
x
13
17
18
19
21
22
EN
EC number
Substance name
L 294/32
Rapporteur
Member
State
Entry
number
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
10.10.2014
x
x
Official Journal of the European Union
x
Rapporteur
Member
State
EC number
CAS number
1011
Quaternary ammonium compounds,
coco alkyltrimethyl, chlorides (other than
the substance covered by entry 635)
IT
Not applic­
able
Not applic­
able
1012
Aluminium sodium silicate-silver zinc
complex/Silver-Zinc-Zeolite
SE
Not applic­
able
130328-20-0
DE
Plant
protection
product
73790-28-0
598
(±)-1-(.beta.-allyloxy-2,4-dichloropheny­
lethyl)imidazole (Technical grade imazalil)
1
2
3
4
5
6
7
8
9
10
11
12
13
17
18
19
21
22
x
EN
Substance name
10.10.2014
Entry
number
x
x
x
x
Official Journal of the European Union
L 294/33
L 294/34
EN
Official Journal of the European Union
10.10.2014
ANNEX III
Time limits
Product-types
Time limits for submitting the assessment
report pursuant to Article 6(3)(b)
Time limits for starting the preparation of the
opinion pursuant to Article 7(2)(b)
8, 14, 16, 18, 19 and 21
31.12.2015
31.3.2016
3, 4 and 5
31.12.2016
31.3.2017
1 and 2
31.12.2018
31.3.2019
6 and 13
31.12.2019
31.3.2020
7, 9 and10
31.12.2020
31.3.2021
11, 12, 15, 17, 20 and 22
31.12.2022
31.9.2023
26.6.2014
DA
Den Europæiske Unions Tidende
L 186/111
KOMMISSIONENS GENNEMFØRELSESAFGØRELSE
af 25. juni 2014
om forlængelse af godkendelsen af difethialon og difenacoum til anvendelse i biocidholdige pro­
dukter af produkttype 14
(EØS-relevant tekst)
(2014/397/EU)
EUROPA-KOMMISSIONEN HAR —
under henvisning til traktaten om Den Europæiske Unions funktionsmåde,
under henvisning til Europa-Parlamentets og Rådets forordning (EU) nr. 528/2012 af 22. maj 2012 om tilgængeliggø­
relse på markedet og anvendelse af biocidholdige produkter (1), særlig artikel 14, stk. 5, og
ud fra følgende betragtninger:
(1)
Aktivstofferne difethialon og difenacoum er optaget i bilag I til Europa-Parlamentets og Rådets direktiv
98/8/EF (2) til anvendelse i biocidholdige produkter af produkttype 14 og anses ifølge artikel 86 i forordning (EU)
nr. 528/2012 for godkendt i henhold til den forordning, så længe de specifikationer og betingelser, der er anført i
bilag I til nævnte direktiv, overholdes.
(2)
Godkendelserne udløber henholdsvis den 31. oktober 2014 og den 31. marts 2015. Der er i overensstemmelse
med artikel 13, stk. 1, i forordning (EU) nr. 528/2012 ansøgt om fornyelse af godkendelserne af disse aktiv­
stoffer.
(3)
Som følge af de konstaterede risici og egenskaberne ved aktivstofferne difethialon og difenacoum, som betyder, at
de er potentielt persistente, potentielt bioakkumulerende og toksiske, eller meget persistente og meget potentielt
bioakkumulerende, forudsætter en fornyelse af godkendelserne, at et eller flere alternative aktivstoffer undersøges.
De nævnte egenskaber betyder endvidere, at godkendelserne af aktivstofferne kun kan fornys, hvis det påvises, at
mindst én af betingelserne i artikel 5, stk. 2, første afsnit, i forordning (EU) nr. 528/2012 er opfyldt.
(4)
For at kunne foreslå de foranstaltninger, der er bedst egnede til at begrænse de risici, som egenskaberne ved anti­
koagulansrodenticider indebærer, har Kommissionen iværksat en undersøgelse af, hvilke risikobegrænsende foran­
staltninger der kan træffes for sådanne aktivstoffer.
(5)
Undersøgelsen er endnu ikke afsluttet, og de, der ansøger om fornyelse af godkendelserne af disse aktivstoffer,
bør have mulighed for at henvise til undersøgelsens konklusioner i deres ansøgninger. Endvidere bør undersøgel­
sens resultater tages med i betragtning ved enhver afgørelse om fornyelse af godkendelser af antikoagulansrodenti­
cider.
(6)
For at gøre det lettere at gennemgå og sammenligne fordele og risici ved alle antikoagulansrodenticider og de risi­
kobegrænsende foranstaltninger, der gælder for sådanne aktivstoffer, bør vurderingen af difethialon og difenacoum
udskydes, indtil den sidste ansøgning om fornyelse af det sidste antikoagulansrodenticid er indgivet. Ansøgninger
om fornyelse af godkendelserne af de sidste antikoagulansrodenticider, dvs. brodifacoum, warfarin og warfarinnat­
rium, ventes at være indgivet inden den 31. juli 2015.
(7)
Under disse omstændigheder, som ansøgerne ikke har nogen indflydelse på, vil godkendelsen af difethialon og
difenacoum formentlig udløbe, inden der er truffet afgørelse om en fornyelse. Derfor bør de gældende godken­
delser af disse aktivstoffer forlænges i så lang tid, at ansøgningerne kan behandles.
(8)
Stofferne bør bortset fra godkendelsens udløbsdato fortsat være godkendt under forudsætning af, at specifikatio­
nerne og betingelserne i bilag I til direktiv 98/8/EF overholdes.
(9)
Foranstaltningerne i denne afgørelse er i overensstemmelse med udtalelse fra Det Stående Udvalg for Biocidhol­
dige Produkter —
(1) EUT L 167 af 27.6.2012, s. 1.
(2) Europa-Parlamentets og Rådets direktiv 98/8/EF af 16. februar 1998 om markedsføring af biocidholdige produkter (EFT L 123 af
24.4.1998, s. 1).
L 186/112
DA
Den Europæiske Unions Tidende
26.6.2014
VEDTAGET DENNE AFGØRELSE:
Artikel 1
Godkendelsen af difethialon og difenacoum til anvendelse i biocidholdige produkter af produkttype 14 forlænges til den
30. juni 2018.
Artikel 2
Denne afgørelse træder i kraft på tyvendedagen efter offentliggørelsen i Den Europæiske Unions Tidende.
Udfærdiget i Bruxelles, den 25. juni 2014.
På Kommissionens vegne
José Manuel BARROSO
Formand
26.6.2014
EN
Official Journal of the European Union
L 186/111
COMMISSION IMPLEMENTING DECISION
of 25 June 2014
postponing the expiry date of approval of difethialone and difenacoum for use in biocidal products
for product-type 14
(Text with EEA relevance)
(2014/397/EU)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012
concerning the making available on the market and use of biocidal products (1), and in particular Article 14(5) thereof,
Whereas:
(1)
The active substances difethialone and difenacoum were included into Annex I to Directive 98/8/EC of the Euro­
pean Parliament and of the Council (2) for use in biocidal products for product-type 14, and pursuant to
Article 86 of Regulation (EU) No 528/2012 are considered approved under that Regulation subject to the specifi­
cations and conditions set out in Annex I to that Directive.
(2)
Their approval will expire on 31 October 2014 and 31 March 2015, respectively. In accordance with
Article 13(1) of Regulation (EU) No 528/2012, applications have been submitted for the renewal of the approval
of these active substances.
(3)
Because of the identified risks and the characteristics of the active substances difethialone and difenacoum, which
render them potentially persistent, liable to bioaccumulate and toxic, or very persistent and very liable to bioaccu­
mulate, the renewal of their approval is subject to an assessment of an alternative active substance or substances.
In addition, due to these characteristics, the approval of those active substances may be renewed only if it is
shown that at least one of the conditions of the first subparagraph of Article 5(2) of Regulation (EU)
No 528/2012 is fulfilled.
(4)
The Commission has launched a study on the risk-mitigation measures that may be applied to anticoagulant
rodenticides with a view to proposing the measures that are most suitable for mitigating the risks associated to
the properties of those active substances.
(5)
That study is currently on-going, and the possibility should be given to the applicants for the renewal of approval
of those active substances to address the conclusions of the study in their application. Furthermore, the conclu­
sions of that study should be taken into account when deciding on the renewal of the approval of all anticoagu­
lant rodenticides.
(6)
In order to facilitate the review and comparison of the risks and benefits of all anticoagulant rodenticides as well
as of the risk-mitigation measures applied to them, the assessment of difethialone and difenacoum should be
postponed until the last application for the renewal of the last anticoagulant rodenticide is submitted. Applica­
tions for the renewal of the approval of the last anticoagulant rodenticides, namely brodifacoum, warfarin and
warfarin sodium, are expected to be submitted by 31 July 2015.
(7)
Consequently, for reasons beyond the control of the applicants, the approval of difethialone and difenacoum is
likely to expire before a decision has been taken on their renewal. It is therefore appropriate to postpone the
expiry date of approval of those active substances for a period of time sufficient to enable the examination of the
applications.
(8)
Except for the expiry date of the approval, those substances should remain approved subject to the specifications
and conditions set out in Annex I to Directive 98/8/EC.
(9)
The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on
Biocidal Products,
(1) OJ L 167, 27.6.2012, p. 1.
(2) Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on
the market (OJ L 123, 24.4.1998, p. 1).
L 186/112
EN
Official Journal of the European Union
26.6.2014
HAS ADOPTED THIS DECISION:
Article 1
The expiry date of approval of difethialone and difenacoum for use in biocidal products for product-type 14 shall be
postponed to 30 June 2018.
Article 2
This Decision shall enter into force on the twentieth day following that of its publication in the Official Journal of the
European Union.
Done at Brussels, 25 June 2014.
For the Commission
The President
José Manuel BARROSO
27.6.2014
DA
Den Europæiske Unions Tidende
L 188/85
KOMMISSIONENS GENNEMFØRELSESAFGØRELSE
af 25. juni 2014
om begrænsninger af godkendelser af biocidholdige produkter, der indeholder IPBC, meddelt af
Tyskland i overensstemmelse med Europa-Parlamentets og Rådets direktiv 98/8/EF
(meddelt under nummer C(2014) 4167)
(EØS-relevant tekst)
(2014/402/EU)
EUROPA-KOMMISSIONEN HAR —
under henvisning til traktaten om Den Europæiske Unions funktionsmåde,
under henvisning til Europa-Parlamentets og Rådets forordning (EU) nr. 528/2012 af 22. maj 2012 om tilgængeliggø­
relse på markedet og anvendelse af biocidholdige produkter (1), særlig artikel 36, stk. 3, og
ud fra følgende betragtninger:
(1)
Bilag I til Europa-Parlamentets og Rådets direktiv 98/8/EF (2) indeholder en liste over aktive stoffer, der er
godkendt på EU-plan til anvendelse i biocidholdige produkter. Ved Kommissionens direktiv 2008/79/EF (3) blev
det aktive stof IPBC til anvendelse i produkter tilhørende produkttype 8, træbeskyttelsesmidler, optaget på listen,
jf. bilag V til direktiv 98/8/EF. I henhold til artikel 86 i forordning (EU) nr. 528/2012 anses IPBC således for at
være et godkendt aktivstof, som er optaget på den liste, der er omhandlet i artikel 9, stk. 2, i samme forordning.
(2)
Det Forenede Kongerige har godkendt produkter, der indeholder IPBC, og som er beregnet til industriel brug og
brug af fagfolk, til anvendelse på træ ved automatiseret neddypning i form af fuldstændig nedsænkning i en
dyppetank, der indeholder træbeskyttelsesmidlet. Godkendelserne er efterfølgende blevet gensidigt anerkendt af
andre medlemsstater.
(3)
Tysklands kompetente myndighed for biocidholdige produkter har modtaget ansøgninger om gensidig anerkend­
else af godkendelser af nogle af disse produkter (i det følgende benævnt »de omtvistede produkter«) i medfør af ar­
tikel 4, stk. 1, i direktiv 98/8/EF. De omtvistede produkter er opført på listen i bilaget til denne afgørelse.
(4)
Tyskland meddelte den 4. oktober 2012 og den 6. november 2012 Kommissionen, de andre medlemsstater og
ansøgerne sit forslag om at begrænse godkendelserne af de omtvistede produkter i overensstemmelse med arti­
kel 4, stk. 4, i direktiv 98/8/EF. Tyskland foreslog at afslå godkendelse af produkterne til automatiseret neddyp­
ning, da produkterne under sådanne forhold ikke opfylder kravene i artikel 5, stk. 1, i direktiv 98/8/EF med
hensyn til deres indvirkning på menneskers sundhed. Ifølge meddelelserne havde Tyskland identificeret en række
problemer for så vidt angår professionelle operatører, hvis hud eksponeres for IPBC, når produktet anvendes til
automatiseret neddypning. Disse problemer har særlig relevans for Tyskland, hvor en betydelig andel af de anlæg,
der benytter denne metode, har et lavt automatiseringsniveau, og der derfor er en højere risiko for, at de pågæl­
dende operatørers hud kommer i kontakt med det behandlede træ eller med kontaminerede overflader.
(5)
Kommissionen opfordrede de øvrige medlemsstater og ansøgerne til skriftligt at fremsætte bemærkninger til hver
enkelt af meddelelserne inden 90 dage, jf. artikel 27, stk. 1, i direktiv 98/8/EF. Flere medlemsstater og ansøgerne
indsendte bemærkninger inden for fristen. Meddelelserne blev også drøftet mellem repræsentanter for Kommissi­
onen og medlemsstaternes kompetente myndigheder vedrørende biocidholdige produkter, og i givet fald ansø­
gerne, på møder i gruppen for produktgodkendelse og lettere gensidig anerkendelse, jf. artikel 35 i forordning
(EU) nr. 528/2012.
(1) EUT L 167 af 27.6.2012, s. 1.
(2) Europa-Parlamentets og Rådets direktiv 98/8/EF af 16. februar 1998 om markedsføring af biocidholdige produkter (EFT L 123 af
24.4.1998, s. 1).
(3) Kommissionens direktiv 2008/79/EF af 28. juli 2008 om ændring af Europa-Parlamentets og Rådets direktiv 98/8/EF med henblik på at
optage IPBC som et aktivt stof i bilag I hertil (EUT L 200 af 29.7.2008, s. 12).
L 188/86
DA
Den Europæiske Unions Tidende
27.6.2014
(6)
Af disse drøftelser og bemærkninger fremgår det, at de eksisterende modeller til vurdering af menneskers ekspo­
nering i forbindelse med neddypningsprocesser bør tilpasses. Ekspertgruppen om menneskelig eksponering udar­
bejdede tilpassede modeller til vurdering af eksponeringen af professionelle operatører, der udfører industriel
behandling af træ i form af fuldautomatiseret neddypning, og gruppens udtalelse blev godkendt på det tekniske
møde om biocider den 16.-20. september 2013 (1). De tilpassede modeller viser, at i tilfælde hvor de omtvistede
produkter anvendes i fuldautomatiserede neddypningsprocesser, skønnes professionelle operatørers eksponering
for IPBC ikke at have nogen uacceptabel indvirkning på menneskers sundhed, jf. artikel 5, stk. 1, i direktiv
98/8/EF.
(7)
Derfor bør de omtvistede produkter godkendes på betingelse af, at det af mærkningen fremgår, at produktet kun
må anvendes i fuldautomatiserede neddypningsprocesser.
(8)
Forordning (EU) nr. 528/2012 finder anvendelse på de omtvistede produkter i overensstemmelse med bestemmel­
serne i samme forordnings artikel 92, stk. 2. Da retsgrundlaget for denne afgørelse er artikel 36, stk. 3, i nævnte
forordning, bør afgørelsen rettes til samtlige medlemsstater, jf. artikel 36, stk. 4, i forordning (EU) nr. 528/2012.
(9)
Foranstaltningerne i denne afgørelse er i overensstemmelse med udtalelse fra Det Stående Udvalg for Biocidhol­
dige Produkter —
VEDTAGET DENNE AFGØRELSE:
Artikel 1
Tysklands forslag om at afslå godkendelser af de biocidholdige produkter til anvendelse ved automatiseret neddypning,
der er opført i bilaget, afvises.
Artikel 2
Godkendelser af de biocidholdige produkter, der er opført i bilaget, omfatter et krav om, at følgende skal fremgå af
mærkningen på produktet:
»Produktet (indsæt navnet på produktet) må kun anvendes i fuldautomatiserede neddypningsprocesser, hvor alle trin
i behandlings- og tørringsprocessen er mekaniserede, og ikke omfatter manuelle handlinger, herunder når de
behandlede artikler transporteres gennem dyppetanken til drænings-/tørringsområdet og lageret (hvis de ikke allerede
er tørre på overfladen, inden de flyttes til lageret). Om nødvendigt skal de træartikler, der skal behandles, fastgøres
helt (f.eks. med spændebånd eller fastspændingsanordninger) inden behandling og under neddypningsprocessen og
må ikke håndteres manuelt, før overfladen på de behandlede artikler er tør.«
Artikel 3
Denne afgørelse er rettet til medlemsstaterne.
Udfærdiget i Bruxelles, den 25. juni 2014.
På Kommissionens vegne
Janez POTOČNIK
Medlem af Kommissionen
(1) Tilgængelig på http://echa.europa.eu/documents/10162/19680902/heeg_opinion_18_fully_automated_dipping_en.pdf.
27.6.2014
DA
Den Europæiske Unions Tidende
L 188/87
BILAG
De biocidholdige produkter, som er omhandlet i artikel 1 og 2, omfatter de biocidholdige produkter, der er opført i
tabellen nedenfor under ansøgningens referencenummer i registret over biocidholdige produkter, samt produkter, der er
berørt af en ansøgning om gensidig anerkendelse af godkendelserne af produkterne:
2010/7969/7206/UK/AA/8794
2010/7969/7232/UK/AA/8805
2010/7969/7206/UK/AA/9165
2010/7969/7232/UK/AA/9172
2010/7969/7226/UK/AA/8795
2010/7969/7233/UK/AA/8806
2010/7969/7226/UK/AA/9166
2010/7969/7233/UK/AA/9173
2010/7969/7227/UK/AA/8796
2010/7969/7234/UK/AA/8807
2010/7969/7227/UK/AA/9167
2010/7969/7234/UK/AA/9174
2010/7969/7228/UK/AA/8797
2010/7969/7759/UK/AA/8808
2010/7969/7228/UK/AA/9168
2010/7969/7786/UK/AA/8825
2010/7969/7229/UK/AA/8798
2010/7969/7786/UK/AA/9176
2010/7969/7229/UK/AA/9169
2010/7969/7787/UK/AA/8826
2010/7969/7230/UK/AA/8799
2010/7969/7787/UK/AA/9177
2010/7969/7230/UK/AA/9170
2010/7969/7788/UK/AA/8827
2010/7969/7231/UK/AA/8800
2010/7969/7788/UK/AA/9175
2010/7969/7231/UK/AA/9171
2010/1349/8153/UK/AA/10515
2010/8209/8150/UK/AA/10438
27.6.2014
EN
Official Journal of the European Union
L 188/85
COMMISSION IMPLEMENTING DECISION
of 25 June 2014
regarding restrictions of authorisations of biocidal products containing IPBC notified by Germany
in accordance with Directive 98/8/EC of the European Parliament and of the Council
(notified under document C(2014) 4167)
(Text with EEA relevance)
(2014/402/EU)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012
concerning the making available on the market and use of biocidal products (1), and in particular Article 36(3) thereof,
Whereas:
(1)
Annex I to Directive 98/8/EC of the European Parliament and of the Council (2) contained the list of active
substances approved at Union level for use in biocidal products. By Commission Directive 2008/79/EC (3), the
active substance IPBC for use in products belonging to product-type 8, Wood preservatives, as defined in
Annex V to Directive 98/8/EC, was added to the list. By virtue of Article 86 of Regulation (EU) No 528/2012,
IPBC is therefore an approved active substance included in the list referred to in Article 9(2) of that Regulation.
(2)
The United Kingdom has authorised products containing IPBC for industrial and professional application on
wood by automated dipping through immersion in a dip tank containing the wood preservative. The authorisa­
tions have subsequently been mutually recognised by other Member States.
(3)
The German competent authority for biocidal products received applications for mutual recognition of authorisa­
tions according to Article 4(1) of Directive 98/8/EC for some of those products (‘the contested products’). The
contested products are listed in the Annex to this Decision.
(4)
On 4 October 2012 and 6 November 2012, Germany notified the Commission, the other Member States and the
applicants of its proposal to restrict the authorisations of the contested products in accordance with Article 4(4)
of Directive 98/8/EC. Germany proposed not to authorise the products for automated dipping since it considered
that the products would not meet the requirements of Article 5(1) of Directive 98/8/EC with regards to effects on
the human health under such circumstances. According to the notifications, Germany identified some concerns
with regard to the dermal exposure to IPBC of professional users when the products are applied by automated
dipping. Those concerns were of particular relevance for Germany, where a significant share of premises using
this application method are reported to have a low level of automation, and thus high likelihood of skin contact
with treated wood or contaminated surfaces.
(5)
For each notification, the Commission invited the other Member States and the applicants to submit comments
in writing within 90 days in accordance with Article 27(1) of Directive 98/8/EC. Comments were submitted
within that deadline by several Member States and the applicants. The notifications were also discussed between
the Commission and Member States' Competent Authorities for biocidal products and, where appropriate the
applicants, in meetings of the Product Authorisation and Mutual Recognition Facilitation Group and of the Co­
ordination Group referred to in Article 35 of Regulation (EU) No 528/2012.
(1) OJ L 167, 27.6.2012, p. 1.
(2) Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on
the market (OJ L 123, 24.4.1998, p. 1).
(3) Commission Directive 2008/79/EC of 28 July 2008 amending Directive 98/8/EC of the European Parliament and of the Council to
include IPBC as an active substance in Annex I thereto (OJ L 200, 29.7.2008, p. 12).
L 188/86
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Official Journal of the European Union
27.6.2014
(6)
From those discussions and comments received, it followed that existing models for assessing human exposure
for dipping processes should be adapted. Adapted models for exposure assessment for professional operators
undertaking industrial treatment of wood by fully automated dipping were developed by the Human Exposure
Expert Group, whose opinion was endorsed by the Biocides Technical Meeting of 16-20 September 2013 (1). The
adapted models show that, where the contested products are used in fully automated processes, exposure to IPBC
of professional operators is not expected to have unacceptable effects for human health within the meaning of
Article 5(1) of Directive 98/8/EC.
(7)
Consequently, the contested products should be authorised subject to instructions on the label restricting the use
to fully automated dipping.
(8)
Regulation (EU) No 528/2012 applies to the contested products in accordance with the provisions of Article 92(2)
of that Regulation. Since the legal basis for this Decision is Article 36(3) of that Regulation, this Decision should
be addressed to all Member States in accordance with Article 36(4) of Regulation (EU) No 528/2012.
(9)
The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on
Biocidal Products,
HAS ADOPTED THIS DECISION:
Article 1
The proposal by Germany not to authorise the biocidal products listed in the Annex for automated dipping is rejected.
Article 2
Authorisations of the biocidal products listed in the Annex shall include a condition that the label of the products
contains the following instruction:
‘Product (insert name of the product) must only be used in fully automated dipping processes where all steps in the
treatment and drying process are mechanised and no manual handling takes place, including when the treated arti­
cles are transported through the dip tank to the draining/drying and storage (if not already surface dry before
moving to storage). Where appropriate, the wooden articles to be treated must be fully secured (e.g. via tension belts
or clamping devices) prior to treatment and during the dipping process, and must not be manually handled until
after the treated articles are surface dry.’
Article 3
This Decision is addressed to the Member States.
Done at Brussels, 25 June 2014.
For the Commission
Janez POTOČNIK
Member of the Commission
(1) Available at http://echa.europa.eu/documents/10162/19680902/heeg_opinion_18_fully_automated_dipping_en.pdf
27.6.2014
EN
Official Journal of the European Union
L 188/87
ANNEX
The biocidal products referred to in Article 1 and 2 of this Decision include the biocidal products listed in the table
below, identified by their application reference number in the Register for Biocidal Products, as well as all products
concerned by an application for mutual recognition of the authorisations of these products:
2010/7969/7206/UK/AA/8794
2010/7969/7232/UK/AA/8805
2010/7969/7206/UK/AA/9165
2010/7969/7232/UK/AA/9172
2010/7969/7226/UK/AA/8795
2010/7969/7233/UK/AA/8806
2010/7969/7226/UK/AA/9166
2010/7969/7233/UK/AA/9173
2010/7969/7227/UK/AA/8796
2010/7969/7234/UK/AA/8807
2010/7969/7227/UK/AA/9167
2010/7969/7234/UK/AA/9174
2010/7969/7228/UK/AA/8797
2010/7969/7759/UK/AA/8808
2010/7969/7228/UK/AA/9168
2010/7969/7786/UK/AA/8825
2010/7969/7229/UK/AA/8798
2010/7969/7786/UK/AA/9176
2010/7969/7229/UK/AA/9169
2010/7969/7787/UK/AA/8826
2010/7969/7230/UK/AA/8799
2010/7969/7787/UK/AA/9177
2010/7969/7230/UK/AA/9170
2010/7969/7788/UK/AA/8827
2010/7969/7231/UK/AA/8800
2010/7969/7788/UK/AA/9175
2010/7969/7231/UK/AA/9171
2010/1349/8153/UK/AA/10515
2010/8209/8150/UK/AA/10438
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KOMMISSIONENS GENNEMFØRELSESAFGØRELSE
af 29. oktober 2014
om begrænsninger af godkendelserne af biocidholdige produkter, der indeholder IPBC og
propiconazol, meddelt af Tyskland i overensstemmelse med Europa-Parlamentets og Rådets
direktiv 98/8/EF
(meddelt under nummer C(2014) 7909)
(EØS-relevant tekst)
(2014/756/EU)
EUROPA-KOMMISSIONEN HAR —
under henvisning til traktaten om Den Europæiske Unions funktionsmåde,
under henvisning til Europa-Parlamentets og Rådets forordning (EF) nr. 528/2012 af 22. maj 2012 om tilgængeliggørelse
på markedet og anvendelse af biocidholdige produkter (1), særlig artikel 36, stk. 3, og
ud fra følgende betragtninger:
(1)
Bilag I til Europa-Parlamentets og Rådets direktiv 98/8/EF (2) indeholder en liste over aktivstoffer, der er godkendt
på EU-plan til anvendelse i biocidholdige produkter. Ved Kommissionens direktiv 2008/78/EF (3) og
2008/79/EF (4) tilføjedes aktivstofferne propiconazol og IPBC til anvendelse i produkttype 8, træbeskyttelses­
midler, jf. bilag V til direktiv 98/8/EF. I henhold til artikel 86 i forordning (EU) nr. 528/2012 anses disse aktiv­
stoffer således for at være godkendte aktivstoffer, som er optaget på den liste, der er omhandlet i artikel 9, stk. 2,
i samme forordning.
(2)
I overensstemmelse med artikel 8 i direktiv 98/8/EF indgav virksomheden Janssen PMP ansøgninger til Det
Forenede Kongerige om godkendelse af tre træbeskyttelsesmidler i form af biocidholdige produkter, der inde­
holder IPBC og propiconazol (»de omtvistede produkter«). Det Forenede Kongeriges produktgodkendelser dækkede
forskellige påføringsmetoder, herunder automatiseret neddypning til industriel brug og sprøjtning (indendørs og
udendørs) til erhvervsmæssig og ikke-erhvervsmæssig brug. Flere medlemsstater har efterfølgende godkendt de
omtvistede produkter ved gensidig anerkendelse.
(3)
Janssen PMP (»ansøgeren«) indgav fyldestgørende ansøgninger til Tyskland om gensidig anerkendelse af godkendel­
serne af de omtvistede produkter, der er meddelt af Det Forenede Kongerige.
(4)
Den 28. august 2013 meddelte Tyskland Kommissionen, de andre medlemsstater og ansøgeren sit forslag om at
begrænse godkendelserne i overensstemmelse med artikel 4, stk. 4, i direktiv 98/8/EF. Tyskland finder, at de
omtvistede produkter ikke opfylder kravene angående menneskers sundhed og miljøet, jf. artikel 5, stk. 1, i
direktiv 98/8/EF.
(5)
Ifølge Tyskland var godkendelsen af påføringsmetoden ved sprøjtning udendørs ikke vurderet behørigt i Det
Forenede Kongerige med hensyn til miljørisici. I Tysklands vurderinger af de tre produkter blev der konstateret
uacceptable risici for dybereliggende jordbundslag.
(1) EUT L 167 af 27.6.2012, s. 1.
(2) Europa-Parlamentets og Rådets direktiv 98/8/EF af 16. februar 1998 om markedsføring af biocidholdige produkter (EFT L 123 af
24.4.1998, s. 1).
(3) Kommissionens direktiv 2008/78/EF af 25. juli 2008 om ændring af Europa-Parlamentets og Rådets direktiv 98/8/EF med henblik på at
optage propiconazol som et aktivt stof i bilag I hertil (EUT L 198 af 26.7.2008, s. 44).
(4) Kommissionens direktiv 2008/79/EF af 28. juli 2008 om ændring af Europa-Parlamentets og Rådets direktiv 98/8/EF med henblik på at
optage IPBC som et aktivt stof i bilag I hertil (EUT L 200 af 29.7.2008, s. 12).
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(6)
Tyskland er endvidere af den opfattelse, at for et af produkternes vedkommende bør påføring ved automatiseret
neddypning begrænses til systemer med en tilstrækkelig høj grad af automatisering på grund af uacceptable sund­
hedsrisici for erhvervsmæssige brugere.
(7)
Kommissionen opfordrede de andre medlemsstater og ansøgeren til skriftligt at fremsætte bemærkninger til
meddelelserne inden 90 dage i overensstemmelse med artikel 27, stk. 1, i direktiv 98/8/EF. Det Forenede Konge­
rige, Tyskland og ansøgeren fremsatte bemærkninger inden fristens udløb. Meddelelsen blev også drøftet mellem
Kommissionen og medlemsstaternes kompetente myndigheder vedrørende biocidholdige produkter den
24. september 2013 på mødet i koordinationsgruppen, der er nedsat ved artikel 35 i forordning (EU)
nr. 528/2012.
(8)
Med hensyn til risiciene for miljøet fremgår det af disse drøftelser og bemærkninger, at konklusionerne af Det
Forenede Kongeriges miljømæssige vurdering var baseret på det relevante scenario i OECD's serie af emissionssce­
nariedokumenter (1), der stod til rådighed på vurderingstidspunktet.
(9)
Det følger ligeledes heraf, at Tysklands konklusioner bygger på et revideret scenarie i OECD's emissionsscenarie­
dokumenter (2), der først stod til rådighed efter tidspunktet for Det Forenede Kongeriges godkendelser og Tysk­
lands meddelelse.
(10)
Dertil kommer, at ifølge de aftalte retningslinjer fra det 47. møde blandt repræsentanter for medlemsstaternes
kompetente myndigheder med henblik på gennemførelsen af direktiv 98/8/EF om markedsføring af biocidholdige
produkter (3), kan nye retningslinjer kun tages i betragtning, hvis de stod til rådighed før datoen for indgivelsen af
ansøgningen om produktgodkendelse, medmindre de videnskabelige fremskridt viser, at det at forlade sig på
gamle retningslinjer giver anledning til alvorlige betænkeligheder. I disse retningslinjer fastslås det endvidere, at
alvorlige betænkeligheder ville udløse en revision af eksisterende godkendelser. Imidlertid fandt hverken Det
Forenede Kongerige eller de medlemsstater, der har godkendt produktet via gensidig anerkendelse, at betænkelig­
hederne var så alvorlige, at dette kunne berettige til at revidere de eksisterende godkendelser.
(11)
I lyset af ovenstående bemærkninger støtter Kommissionen konklusionerne af Det Forenede Kongeriges vurdering
og de andre medlemsstater, der har godkendt produkterne via gensidig anerkendelse, i betragtning af at de omtvi­
stede produkter opfylder kravene i artikel 5, stk. 1, i direktiv 98/8/EF med hensyn til miljøet. Kommissionen
finder derfor, at Tysklands anmodning om at begrænse godkendelserne ikke er berettiget med den anførte begrun­
delse.
(12)
Med hensyn til anvendelsen af automatiseret neddypning finder Kommissionen, at det omtvistede produkt bør
være underlagt de bestemmelser, der er fastlagt i en tidligere kommissionsafgørelse (4) vedrørende beskyttelse af
sundheden for erhvervsmæssige brugere, når denne påføringsmetode anvendes sammen med produkter, der inde­
holder IPBC. Derfor bør det omtvistede produkt godkendes på betingelse af, at det af mærkningen fremgår, at
produktet kun må anvendes i fuldautomatiserede neddypningsprocesser, og produktgodkendelsen bør ændres
tilsvarende.
(13)
Forordning (EU) nr. 528/2012 finder anvendelse på det omtvistede produkt i overensstemmelse med bestemmel­
serne i samme forordnings artikel 92, stk. 2. Da retsgrundlaget for nærværende afgørelse er artikel 36, stk. 3, i
den nævnte forordning, bør afgørelsen rettes til samtlige medlemsstater, jf. forordningens artikel 36, stk. 4.
(14)
Foranstaltningerne i denne afgørelse er i overensstemmelse med udtalelse fra Det Stående Udvalg for Biocidhol­
dige Produkter —
(1) Se Emission scenarios for outdoor treatments i Part II i OECD's Emission Scenario Document (ESD) for Wood Preservatives (2003), der
findes på webstedet http://echa.europa.eu/documents/10162/16908203/pt8_wood_preservatives_2_en.pdf.
(2) Se Outdoor spraying emission scenario i OECD's Revised Emission Scenario Document for Wood Preservatives (ENV/JM/MONO(2013)
21),
der
findes
på
webstedet
http://search.oecd.org/officialdocuments/displaydocumentpdf/?cote=env/jm/mono(2013)
21&doclanguage=en.
(3) Se dokumentet CA-July12-Doc.6.2d — Final — Relevance of new guidance becoming available during the process of authorisation and
mutual recognition of authorisations of biocidal products, der findes på webstedet https://circabc.europa.eu/w/browse/03bce60b-cf0449aa-8172-e9c6a75205a7.
4
( ) Kommissionens gennemførelsesafgørelse 2014/402/EU af 25. juni 2014 om begrænsninger af godkendelser af biocidholdige produkter,
der indeholder IPBC, meddelt af Tyskland i overensstemmelse med Europa-Parlamentets og Rådets direktiv 98/8/EF (EUT L 188 af
27.6.2014, s. 85).
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VEDTAGET DENNE AFGØRELSE:
Artikel 1
Denne afgørelse finder anvendelse på produkter, som er identificeret ved følgende referencenumre i referencemedlems­
staten som fastsat i registret over biocidholdige produkter:
2010/2709/7626/UK/AA/8666
2010/2709/8086/UK/AA/9499
2010/2709/7307/UK/AA/8801
Artikel 2
Tysklands forslag om at afslå godkendelser af de biocidholdige produkter, der er nævnt i artikel 1, til sprøjtning udendørs
afvises.
Artikel 3
Ved brug til automatiseret neddypning skal godkendelser af biocidholdige produkter med referencenummer
2010/2709/7626/UK/AA/8666 indeholde en betingelse om, at mærkningen af produktet skal indeholde følgende
instruks:
»Produktet (indsæt navnet på produktet) må kun anvendes i fuldautomatiserede neddypningsprocesser, hvor alle trin
i behandlings- og tørringsprocessen er mekaniserede og ikke omfatter manuel håndtering, herunder når de behand­
lede artikler transporteres gennem dyppetanken til drænings-/tørringsområdet og lageret (hvis de ikke allerede er
tørre på overfladen, inden de flyttes til lageret). Om nødvendigt skal de træartikler, der skal behandles, fastgøres helt
(f.eks. med spændebånd eller fastspændingsanordninger) inden behandling og under neddypningsprocessen og må
ikke håndteres manuelt, før overfladen på de behandlede artikler er tør.«
Artikel 4
Denne afgørelse er rettet til medlemsstaterne.
Udfærdiget i Bruxelles, den 29. oktober 2014.
På Kommissionens vegne
Janez POTOČNIK
Medlem af Kommissionen
31.10.2014
EN
Official Journal of the European Union
L 311/69
COMMISSION IMPLEMENTING DECISION
of 29 October 2014
concerning restrictions of the authorisations of biocidal products containing IPBC and propicona­
zole notified by Germany in accordance with Directive 98/8/EC of the European Parliament and of
the Council
(notified under document C(2014) 7909)
(Text with EEA relevance)
(2014/756/EU)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012
concerning the making available on the market and use of biocidal products (1), and in particular Article 36(3) thereof,
Whereas:
(1)
Annex I to Directive 98/8/EC of the European Parliament and of the Council (2) contained the list of active
substances approved at Union level for inclusion in biocidal products. Commission Directives 2008/78/EC (3) and
2008/79/EC (4) added the active substances propiconazole and IPBC, respectively, for use in products belonging
to product-type 8, wood preservatives, as defined in Annex V to Directive 98/8/EC. By virtue of Article 86 of
Regulation (EU) No 528/2012, those substances are therefore approved active substances included in the list
referred to in Article 9(2) of that Regulation.
(2)
In accordance with Article 8 of Directive 98/8/EC, the company Janssen PMP submitted applications to the
United Kingdom for authorisation of three wood preservative biocidal products containing IPBC and propicona­
zole (‘the contested products’). The product authorisations granted by the United Kingdom covered different appli­
cation methods, including automated dipping for industrial use and spraying (indoors and outdoors) for profes­
sional and non-professional use. A number of Member States have subsequently authorised the contested
products through mutual recognition.
(3)
Janssen PMP (‘the applicant’) submitted complete applications to Germany for mutual recognition of the authori­
sations of the contested products granted by the United Kingdom.
(4)
Germany notified the Commission, the other Member States and the applicant on 28 August 2013 of its proposal
to restrict the authorisations in accordance with Article 4(4) of Directive 98/8/EC. Germany considers that the
contested products do not meet the requirements of Article 5(1) of Directive 98/8/EC with regard to human
health and the environment.
(5)
According to Germany, the authorisation of the application method by spraying outdoors was not appropriately
assessed by the United Kingdom in terms of environmental risks. The assessment performed by Germany for the
three products concluded in unacceptable risks for the distant soil compartment.
(1) OJ L 167, 27.6.2012, p. 1.
(2) Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on
the market (OJ L 123, 24.4.1998, p. 1).
(3) Commission Directive 2008/78/EC of 25 July 2008 amending Directive 98/8/EC of the European Parliament and of the Council to
include propiconazole as an active substance in Annex I thereto (OJ L 198, 26.7.2008, p. 44).
(4) Commission Directive 2008/79/EC of 28 July 2008 amending Directive 98/8/EC of the European Parliament and of the Council to
include IPBC as an active substance in Annex I thereto (OJ L 200, 29.7.2008, p. 12).
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Official Journal of the European Union
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(6)
Germany also considers that for one of the products, the application by automated dipping should be limited to
systems with a sufficiently high degree of automation due to unacceptable risks for the health of professional
users.
(7)
The Commission invited the other Member States and the applicant to submit comments to the notifications in
writing within 90 days in accordance with Article 27(1) of Directive 98/8/EC. Comments were submitted within
that deadline by Germany, the United Kingdom and the applicant. The notification was also discussed between
the Commission and Member States' Competent Authorities for biocidal products on 24 September 2013 in the
meeting of the coordination group established under Article 35 of Regulation (EU) No 528/2012.
(8)
With regard to the risks for the environment, from those discussions and comments it follows that the conclu­
sions of the environmental assessment carried out by the United Kingdom were based on the relevant scenario of
the Series on Emission Scenario Documents of the Organisation for Economic Co-operation and Development
(OECD) (1) available at the time of the evaluation.
(9)
It also follows that the conclusions from Germany are based on a revised scenario of the OECD Series on Emis­
sion Scenario Documents (2), available since the authorisations were granted by the United Kingdom and also
since the notification made by Germany.
(10)
In addition, according to agreed guidance by the 47th meeting of representatives of Members States Competent
Authorities for the implementation of Directive 98/8/EC concerning the placing of biocidal products on the
market (3), new guidance can only be taken into consideration if it was available before the date of submission of
the application for product authorisation, unless scientific progress shows that the reliance on old guidance gives
rise to serious concern. This guidance further establishes that a serious concern would trigger revision of existing
authorisations. However, neither the United Kingdom nor the other Member States having approved the products
through mutual recognition considered that the concern was such as to justify a revision of existing authorisa­
tions.
(11)
In the light of the above comments, the Commission supports the conclusions of the evaluation carried out by
the United Kingdom and the other Member States having approved the products through mutual recognition,
considering that the contested products fulfil the requirements set by Article 5(1) of Directive 98/8/EC with
regard to the environment. The Commission therefore considers that the request by Germany to restrict the
authorisations cannot be justified on the grounds put forward.
(12)
With regard to the application by automated dipping, the Commission considers that the contested product
should be subject to the provisions established by a previous Commission Decision (4) addressing the protection
of the health of professional users when applying IPBC containing products by this application method. Conse­
quently, the contested product should be authorised subject to instructions on the label restricting the use to fully
automated dipping processes and the product authorisation should be amended accordingly.
(13)
Regulation (EU) No 528/2012 applies to the contested product in accordance with the provisions of Article 92(2)
of that Regulation. Since the legal basis for this Decision is Article 36(3) of that Regulation, this Decision should
be addressed to all Member States by virtue of Article 36(4) of that Regulation.
(14)
The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on
Biocidal Products,
(1) See Emission scenarios for outdoor treatments from Part II of OECD Emission Scenario Document (ESD) for Wood Preservatives (2003),
available on the website http://echa.europa.eu/documents/10162/16908203/pt8_wood_preservatives_2_en.pdf
(2) See Outdoor spraying emission scenario from OECD Revised Emission Scenario Document for Wood Preservatives (ENV/JM/MONO
(2013)21), available on the website http://search.oecd.org/officialdocuments/displaydocumentpdf/?cote=env/jm/mono(2013)
21&doclanguage=en
(3) See document CA-July12-Doc.6.2d — Final on Relevance of new guidance becoming available during the process of authorisation and
mutual recognition of authorisations of biocidal products, available on the website https://circabc.europa.eu/w/browse/03bce60b-cf0449aa-8172-e9c6a75205a7
4
( ) Commission Implementing Decision 2014/402/EU of 25 June 2014 regarding restrictions of authorisations of biocidal products
containing IPBC notified by Germany in accordance with Directive 98/8/EC of the European Parliament and of the Council (OJ L 188,
27.6.2014, p. 85).
31.10.2014
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Official Journal of the European Union
L 311/71
HAS ADOPTED THIS DECISION:
Article 1
This Decision applies to products identified by the following application reference numbers in the Reference Member
State, as provided for by the Register for Biocidal Products:
2010/2709/7626/UK/AA/8666
2010/2709/8086/UK/AA/9499
2010/2709/7307/UK/AA/8801
Article 2
The proposal by Germany not to authorise the biocidal products referred to in Article 1 for spraying outdoors, is
rejected.
Article 3
Where used for automated dipping, authorisations of biocidal products identified by the application reference number
2010/2709/7626/UK/AA/8666 shall include a condition that the label of the products contains the following instruc­
tion:
‘Product (insert name of the product) must only be used in fully automated dipping processes where all steps in the
treatment and drying process are mechanised and no manual handling takes place, including when the treated arti­
cles are transported through the dip tank to the draining/drying and storage (if not already surface dry before
moving to storage). Where appropriate, the wooden articles to be treated must be fully secured (e.g. via tension belts
or clamping devices) prior to treatment and during the dipping process, and must not be manually handled until
after the treated articles are surface dry.’
Article 4
This Decision is addressed to the Member States.
Done at Brussels, 29 October 2014.
For the Commission
Janez POTOČNIK
Member of the Commission
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KOMMISSIONENS GENNEMFØRELSESAFGØRELSE
af 29. oktober 2014
om begrænsning af godkendelse af et biocidholdigt produkt, der indeholder IPBC, meddelt af
Tyskland i overensstemmelse med Europa-Parlamentets og Rådets direktiv 98/8/EF
(meddelt under nummer C(2014) 7914)
(EØS-relevant tekst)
(2014/757/EU)
EUROPA-KOMMISSIONEN HAR —
under henvisning til traktaten om Den Europæiske Unions funktionsmåde,
under henvisning til Europa-Parlamentets og Rådets forordning (EU) nr. 528/2012 af 22. maj 2012 om tilgængeliggø­
relse på markedet og anvendelse af biocidholdige produkter (1), særlig artikel 36, stk. 3, og
ud fra følgende betragtninger:
(1)
Bilag I til Europa-Parlamentets og Rådets direktiv 98/8/EF (2) indeholder en liste over aktive stoffer, der er
godkendt på EU-plan til anvendelse i biocidholdige produkter. Ved Kommissionens direktiv 2008/79/EF (3) blev
det aktive stof IPBC optaget til anvendelse i produkter tilhørende produkttype 8, træbeskyttelsesmidler, jf. bilag V
til direktiv 98/8/EF. I henhold til artikel 86 i forordning (EU) nr. 528/2012 anses dette stof således for at være et
godkendt aktivstof, som er optaget på den liste, der er omhandlet i artikel 9, stk. 2, i samme forordning.
(2)
I overensstemmelse med artikel 8 i direktiv 98/8/EF har virksomheden ISP Cologne Holding GmbH den
22. december 2010 indgivet en ansøgning til Danmark om godkendelse af et biocidholdigt træbeskyttelsesmiddel
indeholdende IPBC (»det omtvistede produkt«). Danmark godkendte det omtvistede produkt den 19. december
2011 til brugsklasse 2 og 3 for behandlet træ som omhandlet i Technical Notes for Guidance on Product Evalua­
tion (4). Produktgodkendelsen dækker forskellige påføringsmetoder, herunder automatiseret dypning i professionelt
øjemed. To medlemsstater har efterfølgende godkendt det omtvistede produkt ved gensidig anerkendelse.
(3)
ISP Cologne Holding GmbH (»ansøgeren«) indsendte den 20. februar 2012 en fuldstændig ansøgning til Tyskland
med henblik på at opnå gensidig anerkendelse af Danmarks godkendelse af det omtvistede produkt.
(4)
Den 30. august 2013 meddelte Tyskland Kommissionen, de øvrige medlemsstater og ansøgeren sit forslag om at
begrænse godkendelsen i overensstemmelse med artikel 4, stk. 4, i direktiv 98/8/EF. Tyskland finder ikke, at det
omtvistede produkt opfylder kravene i artikel 5, stk. 1, i direktiv 98/8/EF, hvad angår folkesundheden og miljøet.
(5)
Ifølge Tyskland tog den danske vurdering ikke i tilstrækkeligt omfang højde for de miljøproblemer, som det
omtvistede produkt rejser. Tyskland konkluderede i sin miljørisikovurdering af brugslevetiden for behandlet træ
under brugsklasse 3-vilkår, at risikoen for jordbunden på dag 30 (»tidspunkt 1«) er uacceptabel — uanset påfø­
ringsmetoden. Tyskland foreslår derfor, at man ikke godkender anvendelse af træ, der er behandlet med det omtvi­
stede produkt, under brugsklasse 3-vilkår.
(6)
Tyskland finder desuden, at påføring ved automatiseret dypning bør begrænses til systemer med en tilstrækkeligt
høj automatiseringsgrad på grund af uacceptable risici for professionelle brugeres sundhed.
(7)
Kommissionen opfordrede de øvrige medlemsstater og ansøgeren til skriftligt at fremsætte bemærkninger til
meddelelsen inden for en frist på 90 dage i overensstemmelse med artikel 27, stk. 1, i direktiv 98/8/EF. Der blev
fremsat bemærkninger fra Tyskland, Danmark og ansøgeren inden for den pågældende frist. Meddelelsen blev
også drøftet af Kommissionen og medlemsstaternes myndigheder med ansvar for biocidholdige produkter på
mødet den 24. september 2013 i den koordineringsgruppe, der er nedsat ved artikel 35 i forordning (EU)
nr. 528/2012.
(1) EUT L 167 af 27.6.2012, s. 1
(2) Europa-Parlamentets og Rådets direktiv 98/8/EF af 16. februar 1998 om markedsføring af biocidholdige produkter (EFT L 123 af
24.4.1998, s. 1).
(3) Kommissionens direktiv 2008/79/EF af 28. juli 2008 om ændring af Europa-Parlamentets og Rådets direktiv 98/8/EF med henblik på at
optage IPBC som et aktivt stof i bilag I hertil (EUT L 200 af 29.7.2008, s. 12).
(4) Tilgængelig på nedenstående adresse http://echa.europa.eu/documents/10162/16960215/bpd_guid_tnsg-product-evaluation_en.pdf
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(8)
Hvad angår miljørisiciene, fremgår det af disse drøftelser og bemærkninger, at den evaluering, Danmark har
gennemført, er i overensstemmelse med de gældende retningslinjer (1). Selv om der identificeres en risiko på tids­
punkt 1 som resultat af et worst-case-scenarie, kan det antages, at anvendelsen af behandlet træ under brugs­
klasse 2- og 3-vilkår er sikker, når miljørisikoen ved udløbet af brugslevetiden anses for at være acceptabel.
(9)
Kommissionen bemærker også, at tilfælde, hvor der påvises en uacceptabel risiko på tidspunkt 1, er under drøf­
telse på EU-plan med henblik på fastlæggelse af en harmoniseret tilgang. Kommissionen finder på den baggrund,
at indtil en sådan tilgang er vedtaget formelt, bør konklusionerne af den danske vurdering af det omtvistede
produkt anses for at være gyldig, indtil produktgodkendelsen fornys.
(10)
I lyset af de fremsatte bemærkninger støtter Kommissionen konklusionerne af den evaluering, der er foretaget af
Danmark og de øvrige medlemsstater, der har godkendt produktet ved gensidig anerkendelse, idet det vurderes, at
det omtvistede produkt opfylder de miljøkrav, der er fastsat i artikel 5, stk. 1, i direktiv 98/8/EF. Kommissionen
finder derfor ikke, at Tysklands anmodning om at begrænse godkendelsen er berettiget ud fra den fremførte
begrundelse.
(11)
Hvad angår påføring ved automatiseret dypning, finder Kommissionen, at det omtvistede produkt bør være
underlagt de bestemmelser, der er fastsat ved en tidligere kommissionsafgørelse (2), som omhandler beskyttelse af
professionelle brugere ved påføring af produkter, der indeholder IPBC, med denne påføringsmetode. Det omtvi­
stede produkt bør derfor godkendes på betingelse af, at det af mærkningen fremgår, at produktet kun må
anvendes i fuldautomatiserede dyppeprocesser, og produktgodkendelsen bør ændres i overensstemmelse hermed.
(12)
Forordning (EU) nr. 528/2012 finder anvendelse på det omtvistede produkt i overensstemmelse med bestemmel­
serne i samme forordnings artikel 92, stk. 2. Da retsgrundlaget for nærværende afgørelse er artikel 36, stk. 3, i
den nævnte forordning, bør afgørelsen rettes til samtlige medlemsstater, jf. forordningens artikel 36, stk. 4.
(13)
Foranstaltningerne i denne afgørelse er i overensstemmelse med udtalelse fra Det Stående Udvalg for Biocidhol­
dige Produkter —
VEDTAGET DENNE AFGØRELSE:
Artikel 1
Denne afgørelse finder anvendelse på produkter, der er identificeret ved nedenstående ansøgningsreferencenummer i
referencemedlemsstaten som fastsat i registeret for biocidholdige produkter:
2010/5411/6906/DK/AA/8325
Artikel 2
Tysklands forslag om at begrænse den godkendelse, der er indrømmet af Danmark den 19. december 2011, af de pro­
dukter, der er omhandlet i artikel 1, kan ikke imødekommes.
Artikel 3
Godkendelser af biocidholdige produkter, der anvendes til automatiseret dypning, og som er identificeret ved ansøgnings­
referencenummeret i artikel 1, skal omfatte et krav om, at følgende skal fremgå af mærkningen på produktet:
»Produktet (indsæt navnet på produktet) må kun anvendes i fuldautomatiserede neddypningsprocesser, hvor alle trin
i behandlings- og tørringsprocessen er mekaniserede, og ikke omfatter manuel håndtering, herunder når de behand­
lede artikler transporteres gennem dyppetanken til drænings-/tørringsområdet og lageret (hvis de ikke allerede er
tørre på overfladen, inden de flyttes til lageret). Om nødvendigt skal de træartikler, der skal behandles, fastgøres helt
(f.eks. med spændebånd eller fastspændingsanordninger) inden behandling og under neddypningsprocessen og må
ikke håndteres manuelt, før overfladen på de behandlede artikler er tør.«
(1) Report of leaching workshop (Arona, Italien, 13.-14. juni 2005), der er tilgængelig på nedenstående websted http://ihcp.jrc.ec.europa.eu/
our_activities/public-health/risk_assessment_of_Biocides/doc/ESD/ESD_PT/PT_08/PT_8_Leaching_Workshop_2005.pdf/at_download/
file
2
( ) Kommissionens gennemførelsesafgørelse 2014/402/EU af 25. juni 2014 om begrænsninger af godkendelser af biocidholdige produkter,
der indeholder IPBC, meddelt af Tyskland i overensstemmelse med Europa-Parlamentets og Rådets direktiv 98/8/EF (EUT L 188 af
27.6.2014, s. 85).
L 311/74
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Artikel 4
Denne beslutning er rettet til medlemsstaterne.
Udfærdiget i Bruxelles, den 29. oktober 2014.
På Kommissionens vegne
Janez POTOČNIK
Medlem af Kommissionen
L 311/72
EN
Official Journal of the European Union
31.10.2014
COMMISSION IMPLEMENTING DECISION
of 29 October 2014
concerning restrictions of the authorisation of a biocidal product containing IPBC notified by
Germany in accordance with Directive 98/8/EC of the European Parliament and of the Council
(notified under document C(2014) 7914)
(Text with EEA relevance)
(2014/757/EU)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012
concerning the making available on the market and use of biocidal products (1), and in particular Article 36(3) thereof,
Whereas:
(1)
Annex I to Directive 98/8/EC of the European Parliament and of the Council (2) contained the list of active
substances approved at Union level for inclusion in biocidal products. Commission Directive 2008/79/EC (3)
added the active substance IPBC for use in products belonging to product-type 8, wood preservatives, as defined
in Annex V to Directive 98/8/EC. By virtue of Article 86 of Regulation (EU) No 528/2012, this substance is
therefore an approved active substance included in the list referred to in Article 9(2) of that Regulation.
(2)
In accordance with Article 8 of Directive 98/8/EC, the company ISP Cologne Holding GmbH submitted on
22 December 2010 an application to Denmark for authorisation of a wood preservative biocidal product
containing IPBC (‘the contested product’). Denmark authorised the contested product on 19 December 2011 for
Use classes 2 and 3 of the treated wood, as described in the Technical Notes for Guidance on Product Evalu­
ation (4). The product authorisation covers different application methods, including automated dipping for profes­
sional use. Two Member States have subsequently authorised the contested product through mutual recognition.
(3)
ISP Cologne Holding GmbH (‘the applicant’) submitted on 20 February 2012 a complete application to Germany
for mutual recognition of the authorisation of the contested product granted by Denmark.
(4)
Germany has notified the Commission, the other Member States and the applicant on 30 August 2013 of its
proposal to restrict the authorisation in accordance with Article 4(4) of Directive 98/8/EC. Germany considers
that the contested product does not meet the requirements of Article 5(1) of Directive 98/8/EC with regard to the
human health and the environment.
(5)
According to Germany, the assessment performed by Denmark did not appropriately address the environmental
concerns raised by the contested product. The environmental risk assessment performed by Germany of the
service life of treated wood under Use Class 3 conditions concluded in an unacceptable risk for the soil compart­
ment at day 30 (‘time 1’) regardless of the application method. As a result, Germany proposes not to authorise
the use of wood treated with the contested product under Use class 3 conditions.
(6)
Germany also considers that the application by automated dipping should be limited to systems with a suffi­
ciently high degree of automation due to unacceptable risks on the human health of professional users.
(7)
The Commission invited the other Member States and the applicant to submit comments to the notification in
writing within 90 days in accordance with Article 27(1) of Directive 98/8/EC. Comments were submitted within
that deadline by Germany, Denmark and the applicant. The notification was also discussed between the Commis­
sion and Member States' Competent Authorities for biocidal products on 24 September 2013 in the meeting of
the coordination group established under Article 35 of Regulation (EU) No 528/2012.
(1) OJ L 167, 27.6.2012, p. 1.
(2) Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on
the market (OJ L 123, 24.4.1998, p. 1).
(3) Commission Directive 2008/79/EC of 28 July 2008 amending Directive 98/8/EC of the European Parliament and of the Council to
include IPBC as an active substance in Annex I thereto (OJ L 200, 29.7.2008, p. 12).
(4) Available on the website http://echa.europa.eu/documents/10162/16960215/bpd_guid_tnsg-product-evaluation_en.pdf
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(8)
With regard to the risks for the environment, from those discussions and comments it follows that the evaluation
carried out by Denmark is compatible with current guidance (1). Where a risk is identified at time 1 as a result of
a worst-case assumption, safe use of treated wood under Use classes 2 and 3 conditions can be assumed when
the risk for the environment at the end of the service life is deemed acceptable.
(9)
The Commission also notes that cases where an unacceptable risk is identified at time 1 are currently under
discussion at Union level in order to establish a harmonised approach. Against this background the Commission
considers that, until such an approach is formally adopted, the conclusions of the assessment of the contested
product by the Denmark should be considered as valid until the renewal of the product authorisation.
(10)
In the light of those comments, the Commission supports the conclusions of the evaluation carried out by
Denmark and the other Member States having approved the product through mutual recognition, considering
that the contested product fulfils the requirements set by Article 5(1) of Directive 98/8/EC with regard to the
environment. The Commission therefore considers that the request by Germany to restrict the authorisation
cannot be justified on the grounds put forward.
(11)
With regard to the application by automated dipping, the Commission considers that the contested product
should be subject to the provisions established by a previous Commission Decision (2) addressing the protection
of the health of professional users when applying IPBC containing products by this application method. Conse­
quently, the contested product should be authorised subject to instructions on the label restricting the use to fully
automated dipping processes and the product authorisation should be amended accordingly.
(12)
Regulation (EU) No 528/2012 applies to the contested product in accordance with the provisions of Article 92(2)
of that Regulation. Since the legal basis for this Decision is Article 36(3) of that Regulation, this decision should
be addressed to all Member States by virtue of Article 36(4) of that Regulation.
(13)
The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on
Biocidal Products,
HAS ADOPTED THIS DECISION:
Article 1
This Decision applies to products identified by the following application reference number in the Reference Member
State, as provided for by the Register for Biocidal Products:
2010/5411/6906/DK/AA/8325
Article 2
The proposal by Germany to restrict the authorisation granted by Denmark on 19 December 2011 of the products
referred to in the Article 1, is rejected.
Article 3
Where used for automated dipping, authorisations of biocidal products identified by the application reference number
listed in Article 1 shall include a condition that the label of the products contains the following instruction:
‘Product (insert name of the product) must only be used in fully automated dipping processes where all steps in the
treatment and drying process are mechanised and no manual handling takes place, including when the treated arti­
cles are transported through the dip tank to the draining/drying and storage (if not already surface dry before
moving to storage). Where appropriate, the wooden articles to be treated must be fully secured (e.g. via tension belts
or clamping devices) prior to treatment and during the dipping process, and must not be manually handled until
after the treated articles are surface dry.’
(1) Report of leaching workshop (Arona, Italy, 13-14 June 2005), available on the website http://ihcp.jrc.ec.europa.eu/our_activities/publichealth/risk_assessment_of_Biocides/doc/ESD/ESD_PT/PT_08/PT_8_Leaching_Workshop_2005.pdf/at_download/file
(2) Commission Implementing Decision 2014/402/EU of 25 June 2014 regarding restrictions of authorisations of biocidal products
containing IPBC notified by Germany in accordance with Directive 98/8/EC of the European Parliament and of the Council (OJ L 188,
27.6.2014, p. 85).
L 311/74
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Official Journal of the European Union
31.10.2014
Article 4
This Decision is addressed to the Member States.
Done at Brussels, 29 October 2014.
For the Commission
Janez POTOČNIK
Member of the Commission
31.10.2014
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KOMMISSIONENS GENNEMFØRELSESAFGØRELSE
af 29. oktober 2014
om afvisning af et afslag på godkendelse af biocidholdige produkter, der er meddelt af Tyskland i
henhold til Europa-Parlamentets og Rådets direktiv 98/8/EF
(meddelt under nummer C(2014) 7915)
(EØS-relevant tekst)
(2014/758/EU)
EUROPA-KOMMISSIONEN HAR —
under henvisning til traktaten om Den Europæiske Unions funktionsmåde,
under henvisning til Europa-Parlamentets og Rådets forordning (EF) nr. 528/2012 af 22. maj 2012 om tilgængeliggørelse
på markedet og anvendelse af biocidholdige produkter (1), særlig artikel 36, stk. 3, og
ud fra følgende betragtninger:
(1)
Bilag I til Europa-Parlamentets og Rådets direktiv 98/8/EF (2) indeholder en liste over aktivstoffer, der er godkendt
på EU-plan til anvendelse i biocidholdige produkter. Ved Kommissionens direktiv 2008/78/EF (3), 2008/79/EF (4)
og 2008/86/EF (5) tilføjedes aktivstofferne propiconazol, IPBC og tebuconazol til anvendelse i produkttype 8,
træbeskyttelsesmidler, jf. bilag V til direktiv 98/8/EF. I henhold til artikel 86 i forordning (EU) nr. 528/2012 anses
disse aktivstoffer således for at være godkendte aktivstoffer, som er optaget på den liste, der er omhandlet i arti­
kel 9, stk. 2, i samme forordning.
(2)
I overensstemmelse med artikel 8 i direktiv 98/8/EF indgav virksomheden Arch Timber Protection Ltd. den 2. april
2010 en ansøgning til Det Forenede Kongerige om godkendelse af et træbeskyttelsesmiddel i form af et biocidhol­
digt produkt, der indeholder propiconazol, IPBC og tebuconazol (»det omtvistede produkt«). Den 7. juni 2012
godkendte Det Forenede Kongerige det omtvistede produkt udelukkende til industriel anvendelse og midlertidig
beskyttelse af nysavet/nyfældet træ og råtømmer, idet det også blev angivet, at træ, der er behandlet med dette
produkt, kan anvendes som træ til brugsklasse 2 og 3 som beskrevet i Technical Notes for Guidance on Product
Evaluation (6). Produktet består af to pakninger, der blandes og fortyndes på industrianlæg og alt efter lokale
produktionsforhold påføres ved nedsænkning eller i en sprøjtetunnel. Ti medlemsstater har efterfølgende
godkendt det omtvistede produkt ved gensidig anerkendelse.
(3)
Arch Timber Protection Ltd. (»ansøgeren«) indgav den 16. juli 2012 en fyldestgørende ansøgning til Tyskland om
gensidig anerkendelse af den godkendelse af det omtvistede produkt, der er meddelt af Det Forenede Kongerige.
(4)
Den 19. august 2013 meddelte Tyskland Kommissionen, de andre medlemsstater og ansøgeren sit forslag om at
afvise godkendelsen i overensstemmelse med artikel 4, stk. 4, i direktiv 98/8/EF. Tyskland fandt, at det omtvistede
produkt ikke opfylder miljøkravene i artikel 5, stk. 1, i direktiv 98/8/EF.
(5)
Ifølge Tyskland fremgik det ikke i tilstrækkeligt grad af godkendelsen, at produktet er bestemt til midlertidig
træbeskyttelse, og produktet er ikke vurderet behørigt af Det Forenede Kongerige med hensyn til miljørisici. Tysk­
land konkluderede i sin vurdering, at der foreligger en uacceptabel risiko for miljøet på 30. dagen efter anven­
delsen af produktet (»tidspunkt 1«), hvilket også giver anledning til betænkeligheder angående den potentielle
anvendelse af træ, som er behandlet med det omtvistede produkt, som træ til brugsklasse 2 og 3.
(1) EUT L 167 af 27.6.2012, s. 1.
(2) Europa-Parlamentets og Rådets direktiv 98/8/EF af 16. februar 1998 om markedsføring af biocidholdige produkter (EFT L 123 af
24.4.1998, s. 1).
(3) Kommissionens direktiv 2008/78/EF af 25. juli 2008 om ændring af Europa-Parlamentets og Rådets direktiv 98/8/EF med henblik på at
optage propiconazol som et aktivt stof i bilag I hertil (EUT L 198 af 26.7.2008, s. 44).
(4) Kommissionens direktiv 2008/79/EF af 28. juli 2008 om ændring af Europa-Parlamentets og Rådets direktiv 98/8/EF med henblik på at
optage IPBC som et aktivt stof i bilag I hertil (EUT L 200 af 29.7.2008, s. 12).
(5) Kommissionens direktiv 2008/86/EF af 5. september 2008 om ændring af Europa-Parlamentets og Rådets direktiv 98/8/EF med henblik
på at optage tebuconazol som et aktivt stof i bilag I hertil (EUT L 239 af 6.9.2008, s. 9).
(6) Findes på webstedet http://echa.europa.eu/documents/10162/16960215/bpd_guid_tnsg-product-evaluation_en.pdf/
L 311/76
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(6)
Tyskland fandt desuden, at eftersom forholdet mellem aktivstoffer og ikke-aktivstoffer i produktets brugsopløs­
ning er variabel, opfylder produktet ikke definitionen af biocidholdige produkter i artikel 2, litra a), i direktiv
98/8/EF, og det burde have været godkendt som en rammeformulering, jf. definitionen i artikel 2, litra j), i
direktiv 98/8/EF.
(7)
Kommissionen opfordrede de andre medlemsstater og ansøgeren til skriftligt at fremsætte bemærkninger til
meddelelsen inden 90 dage i overensstemmelse med artikel 27, stk. 1, i direktiv 98/8/EF. Det Forenede Kongerige,
Tyskland og ansøgeren fremsatte bemærkninger inden fristens udløb. Meddelelsen blev også drøftet den
24. september 2013 på et møde i koordinationsgruppen, der er nedsat ved artikel 35 i forordning (EU)
nr. 528/2012.
(8)
Med hensyn til miljørisici fremgår det af disse drøftelser og bemærkninger, at Det Forenede Kongeriges vurdering
— i mangel af en fælles model for midlertidig beskyttelse af træ — fulgte den på daværende tidspunkt bedste
disponible vejledning (1), som bygger på modeller for behandlet træ, der skal markedsføres som træ til brugs­
klasse 2 og 3. Vurderingen byggede også på en antagelse om det værst tænkelige tilfælde, hvorved aktivstofferne
frigives fuldstændigt på tidspunkt 1.
(9)
Det fremgår endvidere, at Det Forenede Kongeriges vurdering i henhold til disse modeller kan forenes med de
aktuelle retningslinjer (2). Påpeges en risiko på tidspunkt 1 som følge af en antagelse om det værst tænkelige
tilfælde, kan anvendelsen af behandlet træ som træ til brugsklasse 2 og 3 antages at være sikker, når risikoen for
miljøet ved udløbet af brugslevetiden anses for acceptabel.
(10)
Kommissionen bemærker ligeledes, at tilfælde, hvor der påvises en uacceptabel risiko på tidspunkt 1, i øjeblikket
drøftes på EU-plan med henblik på at fastlægge en harmoniseret fremgangsmåde. På den baggrund finder
Kommissionen, at indtil en sådan metode er formelt godkendt, bør konklusionerne af Det Forenede Kongeriges
vurdering af det omtvistede produkt anses for gyldig indtil fornyelsen af produktgodkendelsen.
(11)
Med hensyn til produktets identitet fremgår det af disse drøftelser og bemærkninger, at det omtvistede produkt i
den form, hvori det leveres til industrielle brugere, har specifikt fastlagte koncentrationer af aktivstoffer og ikkeaktivstoffer. Det forhold, at industrielle brugere kan blande forskellige produktopløsninger på industrianlægget alt
afhængig af produktionsprocessen, kan efter Kommissionens opfattelse ikke tolkes således, at godkendelsesindeha­
veren markedsfører en gruppe forskellige biocidholdige produkter som omhandlet i artikel 2, litra j), i direktiv
98/8/EF.
(12)
I lyset af disse argumenter støtter Kommissionen konklusionerne af Det Forenede Kongeriges vurdering og de
andre medlemsstater, der har godkendt produktet via gensidig anerkendelse, i betragtning af, at det omtvistede
produkt er omfattet af definitionen i artikel 2, litra a), i direktiv 98/8/EF og opfylder kravene i direktivets artikel 5,
stk. 1, med hensyn til miljøet. Kommissionen finder derfor, at Tysklands anmodning om at afslå godkendelsen
ikke er berettiget med den anførte begrundelse.
(13)
På baggrund af drøftelserne forekommer det endvidere nødvendigt udtrykkeligt at anføre i produktgodkendelsen,
at produktet skal anvendes til midlertidig træbeskyttelse, og som betingelse for meddelelse af godkendelse at sikre,
at industrielle brugere forsynes med specifikke instrukser i anvendelsen af produktet, idet der tages hensyn til
særlige produktionsforhold på industrianlæg, hvor produktet skal anvendes.
(14)
Forordning (EU) nr. 528/2012 finder anvendelse på det omtvistede produkt i overensstemmelse med bestemmel­
serne i samme forordnings artikel 92, stk. 2. Da retsgrundlaget for nærværende afgørelse er artikel 36, stk. 3, i
den nævnte forordning, bør afgørelsen rettes til samtlige medlemsstater, jf. forordningens artikel 36, stk. 4.
(15)
Foranstaltningerne i denne afgørelse er i overensstemmelse med udtalelse fra Det Stående Udvalg for Biocidhol­
dige Produkter —
(1) Se OECD's emissionsscenariedokumenter (EDS) om træbeskyttelsesmidler: del 1-4 (2003), der kan findes på webstedet http://echa.
europa.eu/guidance-documents/guidance-on-biocides-legislation/emission-scenario-documents/
(2) Report of leaching workshop (Arona, Italien, 13.-14. juni 2005), der kan findes på webstedet http://ihcp.jrc.ec.europa.eu/our_activities/
public-health/risk_assessment_of_Biocides/doc/ESD/ESD_PT/PT_08/PT_8_Leaching_Workshop_2005.pdf/at_download/file/
31.10.2014
DA
Den Europæiske Unions Tidende
L 311/77
VEDTAGET DENNE AFGØRELSE:
Artikel 1
Denne afgørelse finder anvendelse på produkter, som er identificeret ved følgende referencenummer i referencemedlems­
staten som fastsat i registret over biocidholdige produkter:
2010/2509/5687/UK/AA/6745
Artikel 2
Tysklands forslag om at afslå Det Forenede Kongeriges godkendelse af 7. juni 2012 af det i artikel 1 nævnte produkt
afvises.
Artikel 3
Den tiltænkte anvendelse, der er beskrevet i produktgodkendelsen, affattes således:
»Udelukkende til midlertidig beskyttelse af nysavet/nyfældet træ og råtømmer mod svampe og overfladeskimmel.
Træ, der er behandlet med dette produkt, kan anvendes som træ til brugsklasse 2 og 3 (dvs. tømmer, som ikke er i
kontakt med jord, og som enten er vedvarende udsat for vejrliget eller er beskyttet mod vejrliget, men udsat for
lejlighedsvis fugt).«
Artikel 4
Følgende betingelse for godkendelse pålægges for de produkter, der er nævnt i artikel 1:
»Som en betingelse for godkendelse skal godkendelsesindehaveren sikre, at udførlige instrukser for anvendelse af
produktet — hvori der tages hensyn til særlige produktionsforhold på det industrianlæg, hvor produktet skal
anvendes — stilles til rådighed for brugerne på påføringsstedet.«
Artikel 5
Denne afgørelse er rettet til alle medlemsstater.
Udfærdiget i Bruxelles, den 29. oktober 2014.
På Kommissionens vegne
Janez POTOČNIK
Medlem af Kommissionen
31.10.2014
EN
Official Journal of the European Union
L 311/75
COMMISSION IMPLEMENTING DECISION
of 29 October 2014
rejecting the refusal of the authorisation of a biocidal product notified by Germany in accordance
with Directive 98/8/EC of the European Parliament and of the Council
(notified under document C(2014) 7915)
(Text with EEA relevance)
(2014/758/EU)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012
concerning the making available on the market and use of biocidal products (1), and in particular Article 36(3) thereof,
Whereas:
(1)
Annex I to Directive 98/8/EC of the European Parliament and of the Council (2) contained the list of active
substances approved at Union level for inclusion in biocidal products. Commission Directives 2008/78/EC (3),
2008/79/EC (4) and 2008/86/EC (5) added the active substances propiconazole, IPBC and tebuconazole, respect­
ively, for use in products belonging to product-type 8, wood preservatives, as defined in Annex V to Directive
98/8/EC. By virtue of Article 86 of Regulation (EU) No 528/2012, these substances are therefore approved active
substances included in the list referred to in Article 9(2) of that Regulation.
(2)
In accordance with Article 8 of Directive 98/8/EC, the company Arch Timber Protection Ltd submitted on
2 April 2010 an application to The United Kingdom for authorisation of a wood preservative biocidal product
containing propiconazole, IPBC and tebuconazole (‘the contested product’). The United Kingdom authorised the
contested product on 7 June 2012 for industrial use and temporary protection of freshly sawn/felled wood and
unseasoned timber only, also indicating that wood treated with this product can be used for Use Classes 2 and 3
as described in the Technical Notes for Guidance on Product Evaluation (6). The product consists of two packs to
be mixed and diluted at industrial premises depending on site-specific application conditions by dipping or
enclosed deluge. Ten Member States have subsequently authorised the contested product through mutual recogni­
tion.
(3)
Arch Timber Protection Ltd (‘the applicant’) submitted on 16 July 2012 a complete application to Germany for
mutual recognition of the authorisation of the contested product granted by the United Kingdom.
(4)
Germany notified the Commission, the other Member States and the applicant on 19 August 2013 of its proposal
to refuse the authorisation in accordance with Article 4(4) of Directive 98/8/EC. Germany considered that the
contested product does not meet the requirements of Article 5(1) of Directive 98/8/EC with regard to the envir­
onment.
(5)
According to Germany, the authorisation did not reflect well that the product was intended for temporary wood
protection and the product was not appropriately assessed by the United Kingdom in terms of environmental
risks. The assessment performed by Germany concluded in an unacceptable risk for the environment at day 30
following the application of the product (‘time 1’), which also raised concerns regarding the potential use of
wood treated with the contested product under Use Classes 2 and 3 conditions.
(1) OJ L 167, 27.6.2012, p. 1.
(2) Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on
the market (OJ L 123, 24.4.1998, p. 1).
(3) Commission Directive 2008/78/EC of 25 July 2008 amending Directive 98/8/EC of the European Parliament and of the Council to
include propiconazole as an active substance in Annex I thereto (OJ L 198, 26.7.2008, p. 44).
(4) Commission Directive 2008/79/EC of 28 July 2008 amending Directive 98/8/EC of the European Parliament and of the Council to
include IPBC as an active substance in Annex I thereto (OJ L 200, 29.7.2008, p. 12).
(5) Commission Directive 2008/86/EC of 5 September 2008 amending Directive 98/8/EC of the European Parliament and of the Council to
include tebuconazole as an active substance in Annex I thereto (OJ L 239, 6.9.2008, p. 9).
(6) Available on the website http://echa.europa.eu/documents/10162/16960215/bpd_guid_tnsg-product-evaluation_en.pdf
L 311/76
EN
Official Journal of the European Union
31.10.2014
(6)
Germany also considered that, since the ratio of the active substances and non-active substances in the working
solutions of the product is variable, the product does not meet the definition of biocidal products in Article 2(a)
of Directive 98/8/EC and should have been authorised as a frame formulation as defined by Article 2(j) of Direct­
ive 98/8/EC.
(7)
The Commission invited other Member States and the applicant to submit comments to the notification in
writing within 90 days in accordance with Article 27(1) of Directive 98/8/EC. Comments were submitted within
that deadline by Germany, The United Kingdom and the applicant. The notification was also discussed on
24 September 2013 in the meeting of the coordination group established under Article 35 of Regulation (EU)
No 528/2012.
(8)
With regard to the risks for the environment, from those discussions and comments it follows that the evaluation
carried out by the United Kingdom, in the absence of an agreed model for temporary wood protection, followed
the best guidance available at the time (1), which is based on models for treated wood to be placed on the market
under Use Classes 2 and 3 conditions. The assessment was also based on a worst-case assumption of a complete
release of the active substances at time 1.
(9)
It also follows that the evaluation performed by the United Kingdom following those models is compatible with
current guidance (2). Where a risk is identified at time 1 as a result of a worst-case assumption, safe use of treated
wood under Use Classes 2 and 3 conditions can be assumed when the risk for the environment at the end of the
service life is considered acceptable.
(10)
The Commission also notes that cases where an unacceptable risk is identified at time 1 are currently under
discussion at Union level in order to establish a harmonised approach. Against this background the Commission
considers that, until such an approach is formally adopted, the conclusions of the assessment of the contested
product by the United Kingdom should be considered as valid until the renewal of the product authorisation.
(11)
With regard to the identity of the product, from those discussions and comments it follows that the contested
product, in the form in which it is supplied to the industrial users, has specific fixed concentrations of the active
and non-active substances. The Commission considers that the fact that industrial users can prepare different
solutions of the product at the work place, which are process dependant, cannot be interpreted in a way as if the
authorisation holder was placing on the market a group of different biocidal products as referred to in Article 2(j)
of Directive 98/8/EC.
(12)
In the light of those arguments, the Commission supports the conclusions of the evaluation carried out by the
United Kingdom and the other Member States having approved the product through mutual recognition, consid­
ering that the contested product meets the definition in Article 2(a) of Directive 98/8/EC and fulfils the require­
ments set by Article 5(1) of that Directive with regard to the environment. The Commission therefore considers
that the request by Germany to refuse the authorisation cannot be justified on the grounds put forward.
(13)
Finally, on the basis of the discussions held, it appears necessary to explicitly mention in the product authorisa­
tion that the use of the product is for temporary wood protection and to ensure, as a condition for the authorisa­
tion, that specific instructions for use of the product are provided to industrial users taking into consideration the
characteristics of the industrial sites where the product is to be used.
(14)
Regulation (EU) No 528/2012 applies to the contested product in accordance with the provisions of Article 92(2)
of that Regulation. Since the legal basis for this Decision is Article 36(3) of that Regulation, this decision should
be addressed to all Member States by virtue of Article 36(4) of that Regulation.
(15)
The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on
Biocidal Products,
(1) See OECD Emission Scenario Documents (EDS) for Wood Preservatives: Part 1 — 4 (2003), available on the website http://echa.europa.
eu/guidance-documents/guidance-on-biocides-legislation/emission-scenario-documents
(2) Report of leaching workshop (Arona, Italy, 13-14 June 2005), available on the website http://ihcp.jrc.ec.europa.eu/our_activities/publichealth/risk_assessment_of_Biocides/doc/ESD/ESD_PT/PT_08/PT_8_Leaching_Workshop_2005.pdf/at_download/file
31.10.2014
EN
Official Journal of the European Union
L 311/77
HAS ADOPTED THIS DECISION:
Article 1
This Decision applies to products identified by the following application reference number in the Reference Member
State, as provided for by the Register for Biocidal Products:
2010/2509/5687/UK/AA/6745
Article 2
The proposal by Germany to refuse the authorisation granted by the United Kingdom on 7 June 2012 of the products
referred to in Article 1, is rejected.
Article 3
The intended use described in the product authorisation shall be amended as follows:
‘For temporary wood protection use against wood staining fungi and surface moulds on freshly sawn/felled wood
and unseasoned timber only. Wood treated with this product can be used for Use Classes 2 and 3 (i.e. timbers not in
ground contact, either continually exposed to the weather or protected from the weather but subject to frequent
wetting).’.
Article 4
The following condition for authorisation is imposed to the products referred to in Article 1:
‘As a condition of the authorisation, the authorisation holder must ensure that detailed instructions for use of the
product, taking into account the characteristics of the industrial site where the product is to be used, are provided to
users at the site of application.’.
Article 5
This Decision is addressed to the Member States.
Done at Brussels, 29 October 2014.
For the Commission
Janez POTOČNIK
Member of the Commission
EUROPEAN
COMMISSION
Brussels, XXX
SCBP41-Doc.11.1
[…](2014) XXX draft
COMMISSION IMPLEMENTING DECISION
of XXX
pursuant to Article 3(3) of Regulation (EU) No 528/2012 on cationic polymeric binders
with quaternary ammonium compounds incorporated in paints and coatings
(Text with EEA relevance)
EN
EN
COMMISSION IMPLEMENTING DECISION
of XXX
pursuant to Article 3(3) of Regulation (EU) No 528/2012 on cationic polymeric binders
with quaternary ammonium compounds incorporated in paints and coatings
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the
Council of 22 May 2012 concerning the making available on the market and use of biocidal
products1, and in particular Article 3(3) thereof,
Whereas:
EN
(1)
Pursuant to Article 3(3) of Regulation (EU) No 528/2012, on 30 October 2013, the
Netherlands submitted a request to the Commission to decide whether a series of
products (cationic polymeric binders with quaternary ammonium compounds) placed
on the market with a view to be incorporated in paints and coatings (hereafter referred
as 'paints') and confer to those paints the property to kill harmful and pathogenic
microorganisms on the paints dried surface, were biocidal products as defined under
Article 3(1)(a) first indent of that Regulation, or not, and whether the paints
themselves should be considered as biocidal products or not.
(2)
According to the information provided by the company placing the products on the
market (hereafter referred as 'the company'), those products consist of polymers
modified with quaternary ammonium groups. The polymer used varies from one
product to another depending on the request of paint manufacturers. The products
themselves do not have an antimicrobial activity. The company sells those products to
paint manufacturers, who then mix them with other polymers used for paint
manufacturing and a hardener thereby cross-linking all polymers. The cross-linked
polymers form a cationic surface in the dried paint, which exerts the antimicrobial
effect.
(3)
After a first round of discussions with experts from the Member States, the
Commission requested on 2 February 2014 an opinion from the European Chemicals
Agency in accordance with Article 75(1)(g) of Regulation (EU) No 528/2012 as to
whether the products of the company contribute to the antimicrobial properties of
paints in which it may be incorporated, if those properties result from the action of an
active substance, and if so, what is the identity of the active substance.
(4)
The opinion of the European Chemicals Agency was formulated on 9 April 2014 by
the Biocidal Product Committee.
(5)
According to that opinion, the mode of action under consideration involves an active
substance as it is based on a substance, within the meaning of Article 3 of Regulation
1
OJ L 167, 27.6.2012, p. 1.
2
EN
(EC) No 1907/2006 of the European Parliament and of the Council2, which has an
action on harmful organisms.
(6)
The active substance is formed in the paint in which it is incorporated by a chemical
reaction of three constituents: the cationic polymeric binder, with quaternary
ammonium groups, of variable chain length and equipped with a functional group; a
polymeric dispersion equipped with the same functional group as the cationic
polymeric binder and a polymeric hardener for cross-linking the above mentioned
polymeric constituents.
(7)
Furthermore, according to that opinion, the mode of action of the active substance
relies on electrostatic attractions leading to modifications of physiological and
biochemical mechanisms (e.g. bacterial signal transduction systems) and to the death
of the target organisms. The mode of action can therefore not be considered to be
merely physical or mechanical.
(8)
In accordance with Article 3(1)(a) of Regulation (EU) No 528/2012, destroying,
deterring, rendering harmless, preventing the action of, or otherwise exerting a
controlling effect on any harmful organism is a biocidal function.
(9)
The cationic polymeric binders are not intended to have a biocidal function in the form
in which they are supplied by the company to paint manufacturers and therefore do not
comply with the definition of a biocidal product.
(10)
Paints incorporating those products are mixtures, which, in the form they are supplied
by paint manufacturers to their customers, generate an active substance and are
intended to have a biocidal function other than by mere physical or mechanical action,
and therefore comply with the definition of a biocidal product.
(11)
The measures provided for in this Regulation are in accordance with the opinion of the
Standing Committee on Biocidal Products,
HAS ADOPTED THIS DECISION:
Article 1
The cationic polymeric binders with quaternary ammonium compounds placed on the market
to be incorporated in paints and coatings (hereafter referred as 'paints') by paint manufacturers
with a view to confer to those paints a biocidal function shall not be considered biocidal
products.
The paints, in which the cationic polymeric binders with quaternary ammonium compounds
are incorporated by paint manufacturers with a view to confer to those paints a biocidal
function, shall be considered biocidal products.
Article 2
This Decision shall enter into force on the twentieth day following that of its publication in
the Official Journal of the European Union.
2
EN
Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006
concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH),
establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council
Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council
Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and
2000/21/EC (OJ L 396, 30.12.2006, p. 1–849).
3
EN
Done at Brussels,
For the Commission
The President
EN
4
EN
L 299/10
Official Journal of the European Union
EN
17.10.2014
COMMISSION IMPLEMENTING REGULATION (EU) No 1090/2014
of 16 October 2014
approving permethrin as an existing active substance for use in biocidal products for producttypes 8 and 18
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012
concerning the making available on the market and use of biocidal products (1), and in particular the third subparagraph
of Article 89(1) thereof,
Whereas:
(1)
Commission Regulation (EC) No 1451/2007 (2) establishes a list of active substances to be assessed, with a view
to their possible inclusion in Annex I, IA or IB to Directive 98/8/EC of the European Parliament and of the
Council (3). That list includes permethrin.
(2)
Permethrin has been evaluated in accordance with Article 90(2) of Regulation (EU) No 528/2012 for use in
biocidal products for product-type 8, wood preservatives, and product-type 18, insecticides, acaricides and
products to control other arthropods, as defined in Annex V to Regulation (EU) No 528/2012.
(3)
Ireland was designated as evaluating Competent Authority and submitted the assessment reports, together with
its recommendations, to the Commission on 7 December 2010 in accordance with paragraphs 4 and 6 of
Article 14 of Commission Regulation (EC) No 1451/2007.
(4)
The opinion of the European Chemicals Agency was formulated on 8 April 2014 by the Biocidal Product
Committee, having regard to the conclusions of the evaluating Competent Authority.
(5)
According to those opinions, biocidal products used for product-types 8 and 18 and containing permethrin may
be expected to satisfy the requirements laid down in Article 5 of Directive 98/8/EC of the European Parliament
and of the Council provided that certain specifications and conditions relating to its use are satisfied.
(6)
It is therefore appropriate to approve permethrin for use in biocidal products for product-type 8 and 18 subject
to compliance with certain specifications and conditions.
(7)
Since the evaluations did not address nanomaterials, the approvals should not cover such materials pursuant to
Article 4(4) of Regulation (EU) No 528/2012.
(8)
A reasonable period should be allowed to elapse before an active substance is approved, in order to permit inter­
ested parties to take the preparatory measures necessary to meet the new requirements laid down.
(9)
The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on
Biocidal Products,
(1) OJ L 167, 27.6.2012, p. 1.
(2) Commission Regulation (EC) No 1451/2007 of 4 December 2007 on the second phase of the 10-year work programme referred to in
Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the
market (OJ L 325, 11.12.2007, p. 3).
(3) Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on
the market (OJ L 123, 24.4.1998, p. 1).
17.10.2014
EN
Official Journal of the European Union
L 299/11
HAS ADOPTED THIS REGULATION:
Article 1
Permethrin shall be approved as an active substance for use in biocidal products for product-types 8 and 18, subject to
the specifications and conditions set out in the Annex.
Article 2
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the
European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 16 October 2014.
For the Commission
The President
José Manuel BARROSO
L 299/12
ANNEX
Common
Name
IUPAC Name:
3-phenoxybenzyl
(1RS,3RS;1RS,3SR)-3-(2,2dichlorovinyl)-2,2-dimethylcy­
clopropanecarboxylate
EC No: 258-067-9
CAS No: 52645-53-1
The cis:trans ratio is 25:75.
Minimum degree of
purity of the active
substance (1)
Date of approval
Expiry date of approval
Product
type
930 g/kg
1 May 2016
30 April 2026
8
Specific conditions (2)
The product assessment shall pay particular
attention to the exposures, the risks and the
efficacy linked to any uses covered by an appli­
cation for authorisation, but not addressed in
the Union level risk assessment of the active
substance.
For biocidal products, authorisations
subject to the following conditions:
EN
Permethrin
IUPAC Name
Identification Numbers
are
(2) Appropriate risk mitigation measures shall
be taken to protect the soil and aquatic
compartments. In particular: labels and,
where provided, safety data sheets of
products authorised shall indicate that
industrial application shall be conducted
within a contained area or on impermeable
hard standing with bunding, that freshly
treated timber shall be stored after treat­
ment under shelter or on impermeable
hardstanding, or both, to prevent direct
losses to soil or water, and that any losses
from the application of the product shall
be collected for reuse or disposal.
17.10.2014
(3) Products shall not be authorised for wood
that will be exposed to frequent weathering
unless data is submitted to demonstrate
that the product will meet the requirements
of Article 19 and Annex VI of Regulation
(EU) No 528/2012, if necessary by the
application of appropriate risk mitigation
measures.
Official Journal of the European Union
(1) For industrial or professional users, safe
operational procedures and appropriate
organizational measures shall be estab­
lished. Where exposure cannot be reduced
to an acceptable level by other means,
products shall be used with appropriate
personal protective equipment.
IUPAC Name
Identification Numbers
Minimum degree of
purity of the active
substance (1)
Date of approval
Expiry date of approval
Product
type
Specific conditions (2)
18
The product assessment shall pay particular
attention to the exposures, the risks and the
efficacy linked to any uses covered by an appli­
cation for authorisation, but not addressed in
the Union level risk assessment of the active
substance.
For biocidal products, authorisations
subject to the following conditions:
Official Journal of the European Union
For treated articles, the following condition
applies: Where a treated article has been
treated with or intentionally incorporates
permethrin, and where necessary due to the
possibility of skin contact as well as the release
of permethrin under normal conditions of use,
the person responsible for placing the article
on the market shall ensure that the label
provides information on the risk of skin sensi­
tisation, as well as the information referred to
in the second subparagraph of Article 58(3) of
Regulation (EU) No 528/2012.
EN
(4) Products shall not be authorized for treat­
ment of outdoor constructions near or
above water or for the treatment of wood
that will be used for outdoor constructions
near or above water, unless data are
submitted to demonstrate that the product
will not present unacceptable risks, if
necessary by the application of appropriate
mitigation measures.
17.10.2014
Common
Name
are
L 299/13
(1) For industrial or professional users, safe
operational procedures and appropriate
organisational measures shall be estab­
lished. Where exposure cannot be reduced
to an acceptable level by other means,
products shall be used with appropriate
personal protective equipment.
IUPAC Name
Identification Numbers
Minimum degree of
purity of the active
substance (1)
Date of approval
Expiry date of approval
Product
type
Specific conditions (2)
Where a treated article has been treated with
or intentionally incorporates permethrin, and
where necessary due to the possibility of skin
contact as well as the release of permethrin
under normal conditions of use, the person
responsible for placing the article on the
market shall ensure that the label provides
information on the risk of skin sensitisation, as
well as the information referred to in the
second subparagraph of Article 58(3) of Regu­
lation (EU) No 528/2012.
Official Journal of the European Union
For treated articles, the following condition
applies:
EN
(2) Appropriate risk mitigation measures shall
be taken to protect the soil and aquatic
compartments. Labels and, where provided,
safety data sheets of products authorised
shall indicate such measures required. In
particular, products authorised for the
application to textile fibres or other mater­
ials to control insect damage shall indicate
that freshly treated fibres and other appro­
priate materials shall be stored to prevent
direct losses to soil or water, and that any
losses from the application of the product
shall be collected for reuse or disposal.
L 299/14
Common
Name
(1) The purity indicated in this column was the minimum degree of purity of the active substance used for the evaluation made in accordance with Article 8 of Regulation (EU) No 528/2012. The active
substance in the product placed on the market can be of equal or different purity if it has been proven technically equivalent with the evaluated active substance.
(2) For the implementation of the common principles of Annex VI to Regulation (EU) No 528/2012, the content and conclusions of assessment reports are available on the Commission website: http://ec.europa.
eu/environment/chemicals/biocides/index_en.htm.
17.10.2014
17.10.2014
Official Journal of the European Union
EN
L 299/15
COMMISSION IMPLEMENTING REGULATION (EU) No 1091/2014
of 16 October 2014
approving tralopyril as a new active substance for use in biocidal products for product-type 21
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012
concerning the making available on the market and use of biocidal products (1), and in particular Article 90(2) thereof,
Whereas:
(1)
The United Kingdom has received on 17 July 2007 an application, in accordance with Article 11(1) of Directive
98/8/EC of the European Parliament and of the Council (2), for the inclusion of the active substance tralopyril in
its Annex I for use in product-type 21, antifouling products, as defined in Annex V to that Directive.
(2)
Tralopyril was not on the market on 14 May 2000 as an active substance of a biocidal product.
(3)
The United Kingdom submitted the assessment report, together with its recommendations, to the Commission on
1 September 2009 in accordance with Article 11(2) of Directive 98/8/EC.
(4)
The opinion of the European Chemicals Agency was formulated on 8 April 2014 by the Biocidal Product
Committee, having regard to the conclusions of the evaluating competent authority.
(5)
It appears from that opinion that biocidal products used for product-type 21 and containing tralopyril may be
expected to satisfy the requirements laid down in Article 5 of Directive 98/8/EC provided that certain specifica­
tions and conditions relating to its use are satisfied.
(6)
It is therefore appropriate to approve tralopyril for use in biocidal products for product-type 21 subject to
compliance with certain specifications and conditions.
(7)
Since the evaluations did not address nanomaterials, the approvals should not cover such materials pursuant to
Article 4(4) of Regulation (EU) No 528/2012.
(8)
A reasonable period should be allowed to elapse before an active substance is approved, in order to permit inter­
ested parties to take the preparatory measures necessary to meet the new requirements laid down.
(9)
The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on
Biocidal Products,
HAS ADOPTED THIS REGULATION:
Article 1
Tralopyril shall be approved as an active substance for use in biocidal products for product-type 21, subject to the speci­
fications and conditions set out in the Annex.
(1) OJ L 167, 27.6.2012, p. 1.
(2) Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on
the market (OJ L 123, 24.4.1998, p. 1).
L 299/16
EN
Official Journal of the European Union
17.10.2014
Article 2
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the
European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 16 October 2014.
For the Commission
The President
José Manuel BARROSO
Common
Name
IUPAC Name:
4-bromo-2-(4-chlorophenyl)-5(trifluoromethyl)-1H-pyrrole-3carbonitrile
EC No: N/A
CAS No: 122454-29-9
Minimum degree of
purity of the active
substance (1)
Date of approval
Expiry date of approval
Product
type
975 g/kg
1 April 2015
31 March 2025
21
Specific conditions (2)
The product assessment shall pay particular
attention to the exposures, the risks and the
efficacy linked to any uses covered by an
application for authorisation, but not
addressed in the Union level risk assessment
of the active substance.
Authorisations are subject to the following
conditions:
(1) For industrial or professional users, safe
operational procedures and appropriate
organisational measures shall be estab­
lished. Where exposure cannot be
reduced to an acceptable level by other
means, products shall be used with appro­
priate personal protective equipment.
Official Journal of the European Union
In the event that products containing tralo­
pyril are subsequently authorised for use in
non-professional
antifouling
products,
persons making products containing tralo­
pyril available on the market for non-profes­
sional users shall ensure that the products are
supplied with appropriate gloves.
EN
Tralopyril
IUPAC Name
Identification Numbers
17.10.2014
ANNEX
(2) Labels and, where provided, instructions
for use shall indicate that children shall be
kept away until treated surfaces are dry.
L 299/17
(3) Labels and, where provided, safety data
sheets of products authorised shall indi­
cate that application, maintenance and
repair activities shall be conducted within
a contained area, on impermeable hard
standing with bunding or on soil covered
with an impermeable material to prevent
losses and minimise emissions to the
environment, and that any losses or waste
containing tralopyril shall be collected for
reuse or disposal.
IUPAC Name
Identification Numbers
Minimum degree of
purity of the active
substance (1)
Date of approval
Expiry date of approval
Product
type
Specific conditions (2)
Official Journal of the European Union
(1) The purity indicated in this column was the minimum degree of purity of the active substance used for the evaluation made in accordance with Article 8 of Regulation (EU) No 528/2012. The active
substance in the product placed on the market can be of equal or different purity if it has been proven technically equivalent with the evaluated active substance.
(2) For the implementation of the common principles of Annex VI to Regulation (EU) No 528/2012, the content and conclusions of assessment reports are available on the Commission website: http://ec.europa.
eu/environment/chemicals/biocides/index_en.htm
(3) Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of pharmacologically active
substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC)
No 726/2004 of the European Parliament and of the Council (OJ L 152, 16.6.2009, p. 11).
(4) Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending
Council Directive 91/414/EEC (OJ L 70, 16.3.2005, p. 1).
EN
(4) For products that may lead to residues in
food or feed, the need to set new or to
amend existing maximum residue levels
(MRLs) in accordance with Regulation
(EC) No 470/2009 of the European Parlia­
ment and of the Council (3) or Regulation
(EC) No 396/2005 of the European Parlia­
ment and of the Council (4) shall be veri­
fied, and any appropriate risk mitigation
measures shall be taken to ensure that the
applicable MRLs are not exceeded.
L 299/18
Common
Name
17.10.2014
EUROPEAN
COMMISSION
Brussels, XXX
SCBP41-Doc.2.1
[…](2014) XXX draft
COMMISSION IMPLEMENTING REGULATION (EU) No …/..
of XXX
approving propan-2-ol as an active substance for use in biocidal products for producttypes 1, 2 and 4
(Text with EEA relevance)
EN
EN
COMMISSION IMPLEMENTING REGULATION (EU) No …/..
of XXX
approving propan-2-ol as an active substance for use in biocidal products for producttypes 1, 2 and 4
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the
Council of 22 May 2012 concerning the making available on the market and use of biocidal
products1, and in particular the third subparagraph of Article 89(1) thereof,
Whereas:
(1)
Commission Delegated Regulation (EU) No 1062/20142 establishes a list of active
substances to be evaluated with a view to their possible approval for use in biocidal
products or inclusion into Annex I to Regulation (EU) No 528/2012. That list includes
propan-2-ol.
(2)
Propan-2-ol has been evaluated in accordance with Article 90(2) of Regulation (EU)
No 528/2012 for use in biocidal products for product-type 1, human hygiene
disinfectants, product-type 2, disinfectants and algaecides not intended for direct
application to humans or animals, and product-type 4, food and feed area disinfectants,
as defined in Annex V to Regulation (EU) No 528/2012.
(3)
Germany was designated as evaluating competent authority and submitted the
assessment reports, together with its recommendations, to the Commission on 5
November 2012 in accordance with paragraphs 4 and 6 of Article 14 of Commission
Regulation (EC) No 1451/20073.
(4)
The opinions of the European Chemicals Agency were formulated on 18 June 2014 by
the Biocidal Product Committee, having regard to the conclusions of the evaluating
competent authority.
(5)
According to those opinions, biocidal products used for product-types 1, 2 and 4 and
containing propan-2-ol may be expected to satisfy the requirements laid down in
1
OJ L 167, 27.6.2012, p. 1.
Commission Delegated Regulation (EU) No 1062/2014 of 4 August 2014 on the work programme for
the systematic examination of all existing active substances contained in biocidal products referred to in
Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 294, 10.10.2014, p.
1).
Commission Regulation (EC) No 1451/2007 of 4 December 2007 on the second phase of the 10-year
work programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of
the Council concerning the placing of biocidal products on the market (OJ L 325, 11.12.2007, p. 3).
2
3
EN
2
EN
Article 5 of Directive 98/8/EC of the European Parliament and of the Council4
provided that certain specifications and conditions relating to its use are satisfied.
(6)
It is therefore appropriate to approve propan-2-ol for use in biocidal products for
product-types 1, 2 and 4 subject to compliance with certain specifications and
conditions.
(7)
Since the evaluations did not address nanomaterials, the approvals should not cover
such materials in accordance with Article 4(4) of Regulation (EU) No 528/2012.
(8)
For the use in product-type 4, the evaluation did not address the incorporation of
biocidal products containing propan-2-ol in materials and articles intended to come
into contact directly or indirectly with food within the meaning of Article 1(1) of
Regulation (EC) No 1935/2004 of the European Parliament and of the Council5. Such
materials may require the establishment of specific limits on the migration into food,
as referred to in Article 5(1)(e) of Regulation (EC) No 1935/2004. The approval
should therefore not cover such use unless the Commission has established such limits
or it has been established pursuant to that Regulation that such limits are not
necessary.
(9)
A reasonable period should be allowed to elapse before an active substance is
approved, in order to permit interested parties to take the preparatory measures
necessary to meet the new requirements.
(10)
The measures provided for in this Regulation are in accordance with the opinion of the
Standing Committee on Biocidal Products,
HAS ADOPTED THIS REGULATION:
Article 1
Propan-2-ol shall be approved as an active substance for use in biocidal products for producttypes 1, 2 and 4, subject to the specifications and conditions set out in the Annex.
Article 2
This Regulation shall enter into force on the twentieth day following that of its publication in
the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels,
For the Commission
The President
4
5
EN
Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the
placing of biocidal products on the market (OJ L 123, 24.4.1998, p. 1).
Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on
materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and
89/109/EEC (OJ L 338, 13.11.2004, p. 4).
3
EN
EN
ANNEX
Common Name IUPAC Name Identification Numbers Minimum degree of Date of purity of the active approval substance1 Propan‐2‐ol IUPAC Name : 99% w/w 1 July 2016 Product type 30 June 2026 1
The product assessment shall pay particular attention to the exposures, the risks and the efficacy linked to any uses covered by an application for authorisation, but not addressed in the Union level risk assessment of the active substance. 2 The product assessment shall pay particular attention to the exposures, the risks and the efficacy linked to any uses covered by an application for authorisation, but not addressed in the Union level risk assessment of the active substance. 4 The product assessment shall pay particular attention to the exposures, the risks and the efficacy linked to any uses covered by an application for authorisation, but not addressed in the Union level risk assessment of the active 2‐Propanol EC n° : 200‐661‐7 CAS n° : 67‐63‐0 Specific conditions2 Expiry date of approval 1
2
The purity indicated in this column was the minimum degree of purity of the active substance used for the evaluation made in accordance with Article 8 of Regulation (EU)
No 528/2012. The active substance in the product placed on the market can be of equal or different purity if it has been proven technically equivalent with the evaluated
active substance.
For the implementation of the common principles of Annex VI to Regulation (EU) No 528/2012, the content and conclusions of assessment reports are available on the
Commission website: http://ec.europa.eu/environment/chemicals/biocides/index_en.htm.
1 Common Name IUPAC Name Identification Numbers Minimum degree of Date of purity of the active approval substance1 Expiry date of approval Product type Specific conditions2 substance.
For biocidal products, authorisations are subject to the following conditions: (1) For products that may lead to residues in food or feed, the need to set new or to amend existing maximum residue levels (MRLs) in accordance with Regulation (EC) No 470/2009 of the European Parliament and of the Council3 or Regulation (EC) No 396/2005 of the European Parliament and of the Council4 shall be verified, and any appropriate risk mitigation measures shall be taken to ensure that the applicable MRLs are not exceeded. (2) Biocidal products containing propan‐2‐ol shall not be incorporated in materials and articles intended to come into contact with food within the meaning of Article 1(1) of Regulation (EC) No 1935/2004, unless the Commission has established specific limits on the migration of propan‐2‐ol into food or it has been established pursuant to that Regulation that such limits are not necessary. 3
4
Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of
pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European
Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council (OJ L 152, 16.6.2009, p. 11).
Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant
and animal origin and amending Council Directive 91/414/EEC (OJ L 70, 16.3.2005, p. 1).
2 EUROPEAN
COMMISSION
Brussels, XXX
SCBP41-Doc.5.1
[…](2014) XXX draft
COMMISSION IMPLEMENTING REGULATION (EU) No …/..
of XXX
approving carbon dioxide as an active substance for use in biocidal products for
product-type 15
(Text with EEA relevance)
EN
EN
COMMISSION IMPLEMENTING REGULATION (EU) No …/..
of XXX
approving carbon dioxide as an active substance for use in biocidal products for
product-type 15
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the
Council of 22 May 2012 concerning the making available on the market and use of biocidal
products1, and in particular Article 90(2) thereof,
Whereas:
(1)
The Netherlands received on 22 February 2012 an application, in accordance with
Article 11(1) of Directive 98/8/EC of the European Parliament and of the Council2, for
the inclusion of the active substance carbon dioxide in its Annex I for use in producttype 15, avicides, as defined in Annex V to that Directive.
(2)
The Netherlands submitted an assessment report, together with its recommendations,
to the Commission on 30 August 2013 in accordance with Article 11(2) of
Directive 98/8/EC.
(3)
The opinion of the European Chemicals Agency was formulated on 17 June 2014 by
the Biocidal Product Committee, having regard to the conclusions of the evaluating
competent authority.
(4)
According to that opinion, biocidal products used for product-type 15 and containing
carbon dioxide may be expected to satisfy the requirements laid down in Article 5 of
Directive 98/8/EC provided that certain specifications and conditions relating to its use
are satisfied.
(5)
It is therefore appropriate to approve carbon dioxide for use in biocidal products for
product-type 15 subject to compliance with certain specifications and conditions.
(6)
Since the evaluations did not address nanomaterials, the approval should not cover
such materials in accordance with Article 4(4) of Regulation (EU) No 528/2012.
(7)
The measures provided for in this Regulation are in accordance with the opinion of the
Standing Committee on Biocidal Products,
1
OJ L 167, 27.6.2012, p. 1.
Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the
placing of biocidal products on the market (OJ L 123, 24.4.1998, p. 1).
2
EN
2
EN
HAS ADOPTED THIS REGULATION:
Article 1
Carbon dioxide shall be approved as an active substance for use in biocidal products for
product-type 15, subject to the specifications and conditions set out in the Annex.
Article 2
This Regulation shall enter into force on the twentieth day following that of its publication in
the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels,
For the Commission
The President
EN
3
EN
EN
ANNEX
Common
Name
IUPAC Name
Identification Numbers
Minimum degree of
purity of the active
substance1
Carbon dioxide
IUPAC Name :
999 mL/L
Carbon dioxide
EC n° : 204-696-9
CAS n° : 124-38-9
Date of
approval
1 June
2015
Expiry date
of approval
Product
type
31 May
2025
15
Specific conditions2
The product assessment shall pay particular attention to
the exposures, the risks and the efficacy linked to any
uses covered by an application for authorisation, but not
addressed in the Union level risk assessment of the active
substance.
For biocidal products, authorisations are subject to the
following conditions:
(1) Products shall only be supplied to and used by
trained professionals .
(2) Appropriate measures , including, if necessary,
the availability of personal protective equipment
(PPE), shall be taken to protect users.
(3) Appropriate measures, such as exclusion from
the treatment area, shall be taken to protect
bystanders.
1
2
The purity indicated in this column was the minimum degree of purity of the active substance used for the evaluation made in accordance with Article 8 of Regulation (EU)
No 528/2012. The active substance in the product placed on the market can be of equal or different purity if it has been proven technically equivalent with the evaluated
active substance.
For the implementation of the common principles of Annex VI to Regulation (EU) No 528/2012, the content and conclusions of assessment reports are available on the
Commission website: http://ec.europa.eu/environment/chemicals/biocides/index_en.htm.
1
Common
Name
IUPAC Name
Identification Numbers
Minimum degree of
purity of the active
substance1
Date of
approval
Expiry date
of approval
Product
type
Specific conditions2
(4) Application doses and instructions for use shall
ensure that birds are killed without unnecessary
pain and suffering.
(5) Conditions of use shall specify that carbon
dioxide shall be used as a meaure of last resort,
in the context of an integrated pest management
strategy, whose aim shall be to limit to the
minimum the recourse to such a product.
2
EUROPEAN
COMMISSION
Brussels, XXX
SCBP41-Doc.6.1
[…](2014) XXX draft
COMMISSION IMPLEMENTING REGULATION (EU) No …/..
of XXX
approving dinotefuran as an active substance for use in biocidal products for producttype 18
(Text with EEA relevance)
EN
EN
COMMISSION IMPLEMENTING REGULATION (EU) No …/..
of XXX
approving dinotefuran as an active substance for use in biocidal products for producttype 18
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the
Council of 22 May 2012 concerning the making available on the market and use of biocidal
products1, and in particular Article 90(2) thereof,
Whereas:
(1)
The United Kingdom received on 29 March 2012 an application, in accordance with
Article 11(1) of Directive 98/8/EC of the European Parliament and of the Council2, for
the inclusion of the active substance dinotefuran in its Annex I for use in product-type
18, insecticides, acaricides and products to control other arthropods, as defined in
Annex V to that Directive.
(2)
Dinotefuran was not on the market on 14 May 2000 as an active substance of a
biocidal product.
(3)
The United Kingdom submitted an assessment report, together with its
recommendations, to the European Chemicals Agency on 15 October 2013 in
accordance with Article 8(1) of Regulation (EU) No 528/2012.
(4)
The opinion of the European Chemicals Agency was formulated on 17 June 2014 by
the Biocidal Product Committee, having regard to the conclusions of the evaluating
competent authority.
(5)
According to that opinion, biocidal products used for product-type 18 and containing
dinotefuran may be expected to satisfy the requirements laid down in Article 19(1)(b)
of Regulation (EU) No 528/2012, provided that certain specifications and conditions
relating to its use are satisfied.
(6)
It also appears from that opinion that the characteristics of dinotefuran render it very
persistent (vP) and toxic (T) in accordance with the criteria laid down in Annex XIII to
Regulation (EC) No 1907/2006 of the European Parliament and of the Council3.
1
OJ L 167, 27.6.2012, p. 1.
Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the
placing of biocidal products on the market (OJ L 123, 24.4.1998, p. 1).
Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006
concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH),
establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council
Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council
Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and
2000/21/EC (OJ L 396, 30.12.2006, p. 1).
2
3
EN
2
EN
Therefore, dinotefuran should be considered as a candidate for substitution pursuant to
Article 10(1)(d) of Regulation (EU) No 528/2012 for the purpose of authorising
products in accordance with Article 23 of that Regulation.
(7)
It is therefore appropriate to approve dinotefuran for use in biocidal products for
product-type 18 subject to compliance with certain specifications and conditions.
(8)
Since the evaluations did not address nanomaterials, the approvals should not cover
such materials in accordance with Article 4(4) of Regulation (EU) No 528/2012.
(9)
Since the conditions of the first subparagraph of Article 90(2) of Regulation (EU) No
528/2012 are met, the provisions of that Regulation should apply. Dinotefuran should
be approved for a period not exceeding 7 years in accordance with Article 10(4) of that
Regulation.
(10)
The measures provided for in this Regulation are in accordance with the opinion of the
Standing Committee on Biocidal Products,
HAS ADOPTED THIS REGULATION:
Article 1
Dinotefuran shall be approved as an active substance for use in biocidal products for producttype 18, subject to the specifications and conditions set out in the Annex.
Article 2
This Regulation shall enter into force on the twentieth day following that of its publication in
the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels,
For the Commission
The President
EN
3
EN
EN
ANNEX
Common
Name
IUPAC Name
Identification Numbers
Minimum degree of
purity of the active
substance1
Dinotefuran
IUPAC Name :
991 g/kg
(RS)-1-methyl-2-nitro-3-(tetrahydro-3furylmethyl)guanidine
EC n° : Not available
CAS n° : 165252-70-0
Date of
approval
1 June
2015
Expiry date
of approval
Product
type
31 May
2022
18
Specific conditions2
Dinotefuran is considered a candidate for substitution in
accordance with Article 10(1)(d) of Regulation (EU) No
528/2012.
The product assessment shall pay particular attention to
the exposures, the risks and the efficacy linked to any
uses covered by an application for authorisation, but not
addressed in the Union level risk assessment of the active
substance.
For biocidal products, authorisations are subject to the
following condition:
For industrial or professional users, safe operational
procedures and appropriate organisational measures shall
be established. Where exposure cannot be reduced to an
acceptable level by other means, products shall be used
with appropriate personal protective equipment.
1
2
The purity indicated in this column was the minimum degree of purity of the active substance used for the evaluation made in accordance with Article 8 of Regulation (EU)
No 528/2012. The active substance in the product placed on the market can be of equal or different purity if it has been proven technically equivalent with the evaluated
active substance.
For the implementation of the common principles of Annex VI to Regulation (EU) No 528/2012, the content and conclusions of assessment reports are available on the
Commission website: http://ec.europa.eu/environment/chemicals/biocides/index_en.htm.
1
EUROPEAN
COMMISSION
Brussels, XXX
SCBP41-Doc.7.1
[…](2014) XXX draft
COMMISSION IMPLEMENTING REGULATION (EU) No …/..
of XXX
approving alpha-cypermethrin as an active substance for use in biocidal products for
product-type 18
(Text with EEA relevance)
EN
EN
COMMISSION IMPLEMENTING REGULATION (EU) No …/..
of XXX
approving alpha-cypermethrin as an active substance for use in biocidal products for
product-type 18
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the
Council of 22 May 2012 concerning the making available on the market and use of biocidal
products1, and in particular the third subparagraph of Article 89(1) thereof,
Whereas:
(1)
Commission Delegated Regulation (EU) No 1062/20142 establishes a list of active
substances to be evaluated with a view to their possible approval for use in biocidal
products or inclusion into Annex I to Regulation (EU) No 528/2012. That list includes
alpha-cypermethrin.
(2)
Alpha-cypermethrin has been evaluated in accordance with Article 90(2) of
Regulation (EU) No 528/2012 for use in biocidal products for product-type 18,
insecticides, acaricides and products to control other arthropods, as defined in Annex
V to Regulation (EU) No 528/2012.
(3)
Belgium was designated as evaluating competent authority and submitted an
assessment report, together with its recommendations, to the Commission on 17
November 2011 in accordance with paragraphs 4 and 6 of Article 14 of Commission
Regulation (EC) No 1451/20073.
(4)
The opinion of the European Chemicals Agency was formulated on 17 June 2014 by
the Biocidal Product Committee, having regard to the conclusions of the evaluating
competent authority.
(5)
According to that opinion, biocidal products used for product-type 18 and containing
alpha-cypermethrin may be expected to satisfy the requirements laid down in Article 5
of Directive 98/8/EC of the European Parliament and of the Council4 provided that
certain specifications and conditions relating to its use are satisfied.
1
OJ L 167, 27.6.2012, p. 1.
Commission Delegated Regulation (EU) No 1062/2014 of 4 August 2014 on the work programme for
the systematic examination of all existing active substances contained in biocidal products referred to in
Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 294, 10.10.2014, p.
1).
Commission Regulation (EC) No 1451/2007 of 4 December 2007 on the second phase of the 10-year
work programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of
the Council concerning the placing of biocidal products on the market (OJ L 325, 11.12.2007, p. 3).
Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the
placing of biocidal products on the market (OJ L 123, 24.4.1998, p. 1).
2
3
4
EN
2
EN
(6)
It is therefore appropriate to approve alpha-cypermethrin for use in biocidal products
for product-type 18 subject to compliance with certain specifications and conditions.
(7)
Since the evaluations did not address nanomaterials, the approval should not cover
such materials pursuant to Article 4(4) of Regulation (EU) No 528/2012.
(8)
A reasonable period should be allowed to elapse before an active substance is
approved, in order to permit interested parties to take the preparatory measures
necessary to meet the new requirements.
(9)
The measures provided for in this Regulation are in accordance with the opinion of the
Standing Committee on Biocidal Products,
HAS ADOPTED THIS REGULATION:
Article 1
Alpha-cypermethrin shall be approved as an active substance for use in biocidal products for
product-type 18, subject to the specifications and conditions set out in the Annex.
Article 2
This Regulation shall enter into force on the twentieth day following that of its publication in
the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels,
For the Commission
The President
EN
3
EN
EN
ANNEX
Common
Name
IUPAC Name
Identification Numbers
Minimum degree of
purity of the active
substance1
Alphacypermethrin
IUPAC Name :
930 g/kg
Reaction mass of (S)-α-cyano-3phenoxybenzyl-(1R,3R)-3-(2,2
dichlorovinyl)-2,2dimethylcyclopropanecarboxylate and (R)α-cyano-3-phenoxybenzyl-(1S,3S)-3-(2,2dichlorovinyl)-2,2
imethylcyclopropanecarboxylate (1:1)
Sum of the isomers in
a 1:1 ratio
EC n° : Not available
CAS n° : 67375-30-8
Date of
approval
1 July
2016
Expiry date
of approval
Product
type
30 June
2026
18
Specific conditions2
The product assessment shall pay particular attention to
the exposures, the risks and the efficacy linked to any
uses covered by an application for authorisation, but not
addressed in the Union level risk assessment of the active
substance.
For biocidal products, authorisations are subject to the
following conditions:
(1) For professional users, safe operational
procedures and appropriate organisational
measures shall be established. Where exposure
cannot be reduced to an acceptable level by
other means, products shall be used with
appropriate personal protective equipment.
(2) To prevent risks for the aquatic compartment,
for the treament of surfaces prone to frequent
wet cleaning, products shall only be used to treat
1
2
The purity indicated in this column was the minimum degree of purity of the active substance used for the evaluation made in accordance with Article 8 of Regulation (EU)
No 528/2012. The active substance in the product placed on the market can be of equal or different purity if it has been proven technically equivalent with the evaluated
active substance.
For the implementation of the common principles of Annex VI to Regulation (EU) No 528/2012, the content and conclusions of assessment reports are available on the
Commission website: http://ec.europa.eu/environment/chemicals/biocides/index_en.htm.
1
Common
Name
IUPAC Name
Identification Numbers
Minimum degree of
purity of the active
substance1
Date of
approval
Expiry date
of approval
Product
type
Specific conditions2
crack and crevices, unless it can be demonstrated
in the application for product authorisation that
risks for the aquatic compartment can be
reduced to an acceptable level.
2
EUROPEAN
COMMISSION
Brussels, XXX
SCBP41-Doc.9.1
[…](2014) XXX draft
COMMISSION IMPLEMENTING REGULATION (EU) No …/..
of XXX
approving Bacillus sphaericus 2362 serotype H5a5b, strain ABTS1743 as an active
substance for use in biocidal products for product-type 18
(Text with EEA relevance)
EN
EN
COMMISSION IMPLEMENTING REGULATION (EU) No …/..
of XXX
approving Bacillus sphaericus 2362 serotype H5a5b, strain ABTS1743 as an active
substance for use in biocidal products for product-type 18
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the
Council of 22 May 2012 concerning the making available on the market and use of biocidal
products1, and in particular the third subparagraph of Article 89(1) thereof,
Whereas:
(1)
Commission Delegated Regulation (EU) No 1062/20142 establishes a list of active
substances to be evaluated with a view to their possible approval for use in biocidal
products or inclusion into Annex I to Regulation (EU) No 528/2012. That list includes
Bacillus sphaericus.
(2)
Bacillus sphaericus has been evaluated in accordance with Article 90(2) of Regulation
(EU) No 528/2012 for use in biocidal products for product-type 18, insecticides,
acaricides and products to control other arthropods, as defined in Annex V to
Regulation (EU) No 528/2012.
(3)
The data submitted for the purpose of the evaluation allowed conclusions to be drawn
only regarding a certain form of Bacillus sphaericus, i.e. Bacillus sphaericus 2362
serotype H5a5b, strain ABTS1743. The evaluation did not allow conclusions to be
drawn regarding any other substance complying with the definition of Bacillus
sphaericus in the abovementioned list of active substances in Regulation (EU) No
XX/2014. Therefore, only Bacillus sphaericus 2362 serotype H5a5b, strain
ABTS1743 should be covered by this approval.
(4)
Italy was designated as evaluating competent authority and submitted an assessment
report, together with its recommendations, to the Commission on 9 January 2009 in
accordance with paragraphs 4 and 6 of Article 14 of Commission Regulation (EC) No
1451/20073.
1
OJ L 167, 27.6.2012, p. 1.
Commission Delegated Regulation (EU) No 1062/2014 of 4 August 2014 on the work programme for
the systematic examination of all existing active substances contained in biocidal products referred to in
Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 294, 10.10.2014, p.
1).
Commission Regulation (EC) No 1451/2007 of 4 December 2007 on the second phase of the 10-year
work programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of
the Council concerning the placing of biocidal products on the market (OJ L 325, 11.12.2007, p. 3).
2
3
EN
2
EN
(5)
The opinion of the European Chemicals Agency was formulated on 19 June 2014 by
the Biocidal Product Committee, having regard to the conclusions of the evaluating
competent authority.
(6)
According to that opinion, biocidal products used for product-type 18 and containing
Bacillus sphaericus 2362 serotype H5a5b, strain ABTS1743 may be expected to
satisfy the requirements laid down in Article 5 of Directive 98/8/EC of the European
Parliament and of the Council4 provided that certain specifications and conditions
relating to its use are satisfied.
(7)
It is therefore appropriate to approve Bacillus sphaericus 2362 serotype H5a5b, strain
ABTS1743 for use in biocidal products for product-type 18 subject to compliance with
certain specifications and conditions.
(8)
Since the evaluations did not address nanomaterials, the approval should not cover
such materials in accordance with Article 4(4) of Regulation (EU) No 528/2012.
(9)
A reasonable period should be allowed to elapse before an active substance is
approved, in order to permit interested parties to take the preparatory measures
necessary to meet the new requirements.
(10)
The measures provided for in this Regulation are in accordance with the opinion of the
Standing Committee on Biocidal Products,
HAS ADOPTED THIS REGULATION:
Article 1
Bacillus sphaericus 2362 serotype H5a5b, strain ABTS1743 shall be approved as an active
substance for use in biocidal products for product-type 18, subject to the specifications and
conditions set out in the Annex.
Article 2
This Regulation shall enter into force on the twentieth day following that of its publication in
the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels,
For the Commission
The President
4
EN
Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the
placing of biocidal products on the market (OJ L 123, 24.4.1998, p. 1).
3
EN
EN
ANNEX
Common
Name
IUPAC Name
Identification Numbers
Minimum degree of
purity of the active
substance1
Bacillus
sphaericus
2362 serotype
H5a5b, strain
ABTS1743
Not applicable
No relevant impurities
Date of
approval
1 July
2016
Expiry date
of approval
Product
type
30 June
2026
18
Specific conditions2
The product assessment shall pay particular attention to
the exposures, the risks and the efficacy linked to any
uses covered by an application for authorisation, but not
addressed in the Union level risk assessment of the active
substance.
For biocidal products, authorisations are subject to the
following conditions:
(1) For professional users, safe operational
procedures and appropriate organisational
measures shall be established. Where exposure
cannot be reduced to an acceptable level by
other means, products shall be used with
appropriate personal protective equipment.
(2) For products that may lead to residues in food or
feed, the need to set new or to amend existing
maximum residue levels (MRLs) in accordance
1
2
The purity indicated in this column was the minimum degree of purity of the active substance used for the evaluation made in accordance with Article 8 of Regulation (EU)
No 528/2012. The active substance in the product placed on the market can be of equal or different purity if it has been proven technically equivalent with the evaluated
active substance.
For the implementation of the common principles of Annex VI to Regulation (EU) No 528/2012, the content and conclusions of assessment reports are available on the
Commission website: http://ec.europa.eu/environment/chemicals/biocides/index_en.htm.
1
Common
Name
IUPAC Name
Identification Numbers
Minimum degree of
purity of the active
substance1
Date of
approval
Expiry date
of approval
Product
type
Specific conditions2
with Regulation (EC) No 470/2009 of the
European Parliament and of the Council3 or
Regulation (EC) No 396/2005 of the European
Parliament and of the Council4 shall be verified,
and any appropriate risk mitigation measures
shall be taken to ensure that the applicable MRLs
are not exceeded.
3
4
Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of
pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European
Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council (OJ L 152, 16.6.2009, p. 11).
Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant
and animal origin and amending Council Directive 91/414/EEC (OJ L 70, 16.3.2005, p. 1).
2
EUROPEAN
COMMISSION
Brussels, XXX
SCBP41-Doc.8.1
[…](2014) XXX draft
COMMISSION IMPLEMENTING REGULATION (EU) No …/..
of XXX
approving Bacillus thuringiensis subsp. israelensis serotype H14, strain SA3A as an
active substance for use in biocidal products for product-type 18
(Text with EEA relevance)
EN
EN
COMMISSION IMPLEMENTING REGULATION (EU) No …/..
of XXX
approving Bacillus thuringiensis subsp. israelensis serotype H14, strain SA3A as an
active substance for use in biocidal products for product-type 18
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the
Council of 22 May 2012 concerning the making available on the market and use of biocidal
products1, and in particular the third subparagraph of Article 89(1) thereof,
Whereas:
(1)
Commission Delegated Regulation (EU) No 1062/20142 establishes a list of active
substances to be evaluated with a view to their possible approval for use in biocidal
products or inclusion into Annex I to Regulation (EU) No 528/2012. That list includes
Bacillus thuringiensis subsp. israelensis serotype H14.
(2)
Bacillus thuringiensis subsp. israelensis serotype H14 has been evaluated in
accordance with Article 90(2) of Regulation (EU) No 528/2012 for use in biocidal
products for product-type 18, insecticides, acaricides and products to control other
arthropods, as defined in Annex V to Regulation (EU) No 528/2012.
(3)
The data submitted for the purpose of the evaluation allowed conclusions to be drawn
only regarding a certain form of Bacillus thuringiensis subsp. israelensis serotype
H14, i.e. Bacillus thuringiensis subsp. israelensis serotype H14, strain SA3A. The
evaluation did not allow conclusions to be drawn regarding any other substance
complying with the definition of Bacillus thuringiensis subsp. israelensis serotype
H14 in the abovementioned list of active substances in Regulation (EU) No XX/2014.
Therefore, only Bacillus thuringiensis subsp. israelensis serotype H14, strain SA3A
should be covered by this approval.
(4)
Italy was designated as evaluating competent authority and submitted an assessment
report, together with its recommendations, to the Commission on 12 June 2009 in
accordance with paragraphs 4 and 6 of Article 14 of Commission Regulation (EC) No
1451/20073.
1
OJ L 167, 27.6.2012, p. 1.
Commission Delegated Regulation (EU) No 1062/2014 of 4 August 2014 on the work programme for
the systematic examination of all existing active substances contained in biocidal products referred to in
Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 294, 10.10.2014, p.
1).
Commission Regulation (EC) No 1451/2007 of 4 December 2007 on the second phase of the 10-year
work programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of
the Council concerning the placing of biocidal products on the market (OJ L 325, 11.12.2007, p. 3).
2
3
EN
2
EN
(5)
The opinion of the European Chemicals Agency was formulated on 19 June 2014 by
the Biocidal Product Committee, having regard to the conclusions of the evaluating
competent authority.
(6)
According to that opinion, biocidal products used for product-type 18 and containing
Bacillus thuringiensis subsp. israelensis serotype H14, strain SA3A may be expected
to satisfy the requirements laid down in Article 5 of Directive 98/8/EC of the
European Parliament and of the Council4 provided that certain specifications and
conditions relating to its use are satisfied.
(7)
It is therefore appropriate to approve Bacillus thuringiensis subsp. israelensis serotype
H14, strain SA3A for use in biocidal products for product-type 18 subject to
compliance with certain specifications and conditions.
(8)
Since the evaluations did not address nanomaterials, the approval should not cover
such materials in accordance with Article 4(4) of Regulation (EU) No 528/2012.
(9)
A reasonable period should be allowed to elapse before an active substance is
approved, in order to permit interested parties to take the preparatory measures
necessary to meet the new requirements.
(10)
The measures provided for in this Regulation are in accordance with the opinion of the
Standing Committee on Biocidal Products,
HAS ADOPTED THIS REGULATION:
Article 1
Bacillus thuringiensis subsp. israelensis serotype H14, strain SA3A shall be approved as an
active substance for use in biocidal products for product-type 18, subject to the specifications
and conditions set out in the Annex.
Article 2
This Regulation shall enter into force on the twentieth day following that of its publication in
the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels,
For the Commission
The President
4
EN
Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the
placing of biocidal products on the market (OJ L 123, 24.4.1998, p. 1).
3
EN
EN
ANNEX
Common
Name
IUPAC Name
Identification Numbers
Minimum degree of
purity of the active
substance1
Bacillus
thuringiensis
subsp.
israelensis
serotype H14,
strain SA3A
Not applicable
No relevant impurities
Date of
approval
1 July
2016
Expiry date
of approval
Product
type
30 June
2026
18
Specific conditions2
The product assessment shall pay particular attention to
the exposures, the risks and the efficacy linked to any
uses covered by an application for authorisation, but not
addressed in the Union level risk assessment of the active
substance.
For biocidal products, authorisations are subject to the
following conditions:
(1) For professional users, safe operational
procedures and appropriate organisational
measures shall be established. Where exposure
cannot be reduced to an acceptable level by
other means, products shall be used with
appropriate personal protective equipment.
(2) For products that may lead to residues in food or
feed, the need to set new or to amend existing
maximum residue levels (MRLs) in accordance
1
2
The purity indicated in this column was the minimum degree of purity of the active substance used for the evaluation made in accordance with Article 8 of Regulation (EU)
No 528/2012. The active substance in the product placed on the market can be of equal or different purity if it has been proven technically equivalent with the evaluated
active substance.
For the implementation of the common principles of Annex VI to Regulation (EU) No 528/2012, the content and conclusions of assessment reports are available on the
Commission website: http://ec.europa.eu/environment/chemicals/biocides/index_en.htm.
1
Common
Name
IUPAC Name
Identification Numbers
Minimum degree of
purity of the active
substance1
Date of
approval
Expiry date
of approval
Product
type
Specific conditions2
with Regulation (EC) No 470/2009 of the
European Parliament and of the Council3 or
Regulation (EC) No 396/2005 of the European
Parliament and of the Council4 shall be verified,
and any appropriate risk mitigation measures
shall be taken to ensure that the applicable MRLs
are not exceeded.
3
4
Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of
pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European
Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council (OJ L 152, 16.6.2009, p. 11).
Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant
and animal origin and amending Council Directive 91/414/EEC (OJ L 70, 16.3.2005, p. 1).
2
EUROPEAN
COMMISSION
Brussels, XXX
SCBP41-Doc.10.1
[…](2014) XXX draft
COMMISSION IMPLEMENTING REGULATION (EU) No …/..
of XXX
approving tolylfluanid as an active substance for use in biocidal products for producttype 21
(Text with EEA relevance)
EN
EN
COMMISSION IMPLEMENTING REGULATION (EU) No …/..
of XXX
approving tolylfluanid as an active substance for use in biocidal products for producttype 21
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the
Council of 22 May 2012 concerning the making available on the market and use of biocidal
products1, and in particular the third subparagraph of Article 89(1) thereof,
Whereas:
(1)
Commission Delegated Regulation (EU) No 1062/20142 establishes a list of active
substances to be evaluated with a view to their possible approval for use in biocidal
products or inclusion into Annex I to Regulation (EU) No 528/2012. That list includes
tolylfluanid.
(2)
Tolylfluanid has been evaluated in accordance with Article 90(2) of Regulation (EU)
No 528/2012 for use in biocidal products for product-type 21, antifouling products, as
defined in Annex V to Regulation (EU) No 528/2012.
(3)
The United Kingdom was designated as evaluating competent authority and submitted
an assessment report, together with its recommendations, to the Commission on 18
September 2012 in accordance with paragraphs 4 and 6 of Article 14 of Commission
Regulation (EC) No 1451/20073.
(4)
The opinion of the European Chemicals Agency was formulated on 17 June 2014 by
the Biocidal Product Committee, having regard to the conclusions of the evaluating
competent authority.
(5)
According to that opinion, biocidal products used for product-type 21 and containing
tolylfluanid may be expected to satisfy the requirements laid down in Article 5 of
Directive 98/8/EC of the European Parliament and of the Council4 provided that
certain specifications and conditions relating to its use are satisfied.
1
OJ L 167, 27.6.2012, p. 1.
Commission Delegated Regulation (EU) No 1062/2014 of 4 August 2014 on the work programme for
the systematic examination of all existing active substances contained in biocidal products referred to in
Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 294, 10.10.2014, p.
1).
Commission Regulation (EC) No 1451/2007 of 4 December 2007 on the second phase of the 10-year
work programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of
the Council concerning the placing of biocidal products on the market (OJ L 325, 11.12.2007, p. 3).
Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the
placing of biocidal products on the market (OJ L 123, 24.4.1998, p. 1).
2
3
4
EN
2
EN
(6)
Nevertheless, the acceptability of the risks related to the use of antifouling products, as
well as the suitability of the proposed risk mitigation measures, need to be further
confirmed. In order to facilitate, at the time of the renewal of the approvals of existing
antifouling active substances, the review and comparison of the risks and benefits of
these substances as well as of the risk mitigation measures applied, the expiry date of
approval of these substances should be the same.
(7)
It is therefore appropriate to approve tolylfluanid for use in biocidal products for
product-type 21 subject to compliance with certain specifications and conditions.
(8)
Since the evaluations did not address nanomaterials, the approval should not cover
such materials in accordance with Article 4(4) of Regulation (EU) No 528/2012.
(9)
A reasonable period should be allowed to elapse before an active substance is
approved, in order to permit interested parties to take the preparatory measures
necessary to meet the new requirements.
(10)
The measures provided for in this Regulation are in accordance with the opinion of the
Standing Committee on Biocidal Products,
HAS ADOPTED THIS REGULATION:
Article 1
Tolylfluanid shall be approved as an active substance for use in biocidal products for producttype 21, subject to the specifications and conditions set out in the Annex.
Article 2
This Regulation shall enter into force on the twentieth day following that of its publication in
the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels,
For the Commission
The President
EN
3
EN
EN
ANNEX
Common
Name
IUPAC Name
Identification Numbers
Minimum degree of
purity of the active
substance1
Tolylfluanid
IUPAC Name :
960 g/kg
N-(Dichlorofluoromethylthio)-N',N'dimethyl-N-p-tolylsulfamide
EC n° : 211-986-9
CAS n° : 731-27-1
Date of
approval
Expiry date
of approval
Product
type
1 July
2016
31
December
2025
21
Specific conditions2
The product assessment shall pay particular attention to
the exposures, the risks and the efficacy linked to any
uses covered by an application for authorisation, but not
addressed in the Union level risk assessment of the active
substance.
In the event that products containing tolylfluanid are
subsequently authorised for use by non-professional
users, persons making products containing tolylfluanid
available on the market for non-professional users shall
ensure that the products are supplied with appropriate
gloves.
For biocidal products, authorisations are subject to the
following conditions:
(1) Products containing tolylfluanid shall not be
1
2
The purity indicated in this column was the minimum degree of purity of the active substance used for the evaluation made in accordance with Article 8 of Regulation (EU)
No 528/2012. The active substance in the product placed on the market can be of equal or different purity if it has been proven technically equivalent with the evaluated
active substance.
For the implementation of the common principles of Annex VI to Regulation (EU) No 528/2012, the content and conclusions of assessment reports are available on the
Commission website: http://ec.europa.eu/environment/chemicals/biocides/index_en.htm.
1
Common
Name
IUPAC Name
Identification Numbers
Minimum degree of
purity of the active
substance1
Date of
approval
Expiry date
of approval
Product
type
Specific conditions2
authorised or used to control the growth and
settlement of fouling organisms on freshwater
going vessels.
(2) For industrial or professional users, safe
operational procedures and appropriate
organiszational measures shall be established.
Where exposure cannot be reduced to an
acceptable level by other means, products shall
be used with appropriate personal protective
equipment.
(3) Labels and, where provided, instructions for use
shall indicate that children shall be kept away
until treated surfaces are dry.
(4) Labels and, where provided, safety data sheets of
products authorised shall indicate that
application, maintenance and repair activities
shall be conducted within a contained area, on
an impermeable hard standing with bunding or
on soil covered with an impermeable material to
prevent losses and minimisze emissions to the
environment, and that any losses or waste
containing tolylfluanid shall be collected for
reuse or disposal.
(5) For products that may lead to residues in food or
feed, the need to set new or to amend existing
maximum residue levels (MRLs) in accordance
2
Common
Name
IUPAC Name
Identification Numbers
Minimum degree of
purity of the active
substance1
Date of
approval
Expiry date
of approval
Product
type
Specific conditions2
with Regulation (EC) No 470/2009 of the
European Parliament and of the Council 3 or
Regulation (EC) No 396/2005 of the European
Parliament and of the Council4 shall be verified,
and any appropriate risk mitigation measures
shall be taken to ensure that the applicable MRLs
are not exceeded.
For treated articles, the following condition applies :
Where a treated article has been treated with or
intentionally incorporates one or more biocidal products
containing tolylfluanid, and where necessary due to the
possibility of skin contact as well as the release of
tolylfluanid under normal conditions of use of the treated
article, the person responsible for placing the treated
article on the market shall ensure that the label provides
information on the risk of skin sensitisation, as well as the
information referred to in the second subparagraph of
Article 58(3) of Regulation (EU) No 528/2012.
3
4
Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of
pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European
Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council (OJ L 152, 16.6.2009, p. 11).
Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant
and animal origin and amending Council Directive 91/414/EEC (OJ L 70, 16.3.2005, p. 1).
3