1. No category

Posvet o biocidnih proizvodih, 7. november 2013, GZS, Center za poslovno usposabljanje
Asist.Dr. Darja Duh, univ.dipl.mikrobiol.
UČINKOVITOST BIOCIDNIH PROIZVODOV
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Univerzitetni diplomirani mikrobiolog
Doktorica znanosti (molekularna biologija in biokemija)
Asistentka na medicinski fakulteti v Mariboru
NLZOH - klinični molekularni laboratorij
URSK - področje učinkovitosti od leta 2008
EU delovna skupina (2009-2012) - TNsG (poglavje PT2,…)
PREDPISI O BIOCIDIH - UČINKOVITOST
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BPR No. 528/2012 (predhodnik: BPD 98/8/EC)
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… dovolj učinkovit… (člen 25, poglavje V)
AKTIVNA SNOV – PODATKI ZA UČINKOVITOST
1.
2.
3.
4.
5.
6.
7.
8.
9.
Uporaba (npr: baktericid…) in način kontrole
Organizmi, ki jih je treba nadzirati in zaščititi
Učinki na ciljne organizme
Verjetna koncentracija a.s. v proizvodih in tretiranih materialih
Način delovanja (zapoznelo delovanje)
Uporabnik…
Predlagano besedilo na etiketi…
Omejitve glede učinkovitosti…
Predvidena teža v tonah…
BIOCIDNI PRIPRAVEK– POD. ZA UČINKOVITOST
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
Vrsta pripravka in področje uporabe
Uporaba (npr: baktericid…) in način kontrole
Organizmi, ki jih je treba nadzirati in zaščititi
Učinki na ciljne organizme
Verjetna koncentracija a.s. v proizvodih
Način delovanja (zapoznelo delovanje)
Uporabnik…
Predlagana etiketa pripravka in oznaka za tretirane materiale
Predlagano besedilo na etiketi…
Omejitve glede učinkovitosti…
Povzetek in ocena
SEZNAMI TESTOV IN STANDARDOV

http://www.cen.eu/cen/pages/default.aspx
CEN on-line catalogue/international classification of standards
(plačljivi)

swedish chemicals agency (kemikalieinspektionen),
department of pesticides and biotechnical products:
efficacy testing of biocidal products - overview of available
tests, Göteborg 2008. (zastonj na internetu)
PT
PT- description
available methods and other information
Maingroup 1 - Disinfectants and general biocidal products
•CEN on-line catalogue/international classification of Standards (ICS)
EN 14885:2006 Application of European Standards for chemical disinfectants and antiseptics
1
Humanarea
hygiene
biocidal
Private
and public
healthproduct
area disinfectants and other biocidal
Maingroup
2 - Preservatives
2
3
Veterinary
hygiene
biocidal
products
4
Food
and
feedsuspension
areatestdisinfectants
•EN
1040: 2005
Quantitative
for the evaluation of basic bactericidal activity of chemical disinfectants and
products
In-can preservatives
- Test method and requirements (phase 1)
6
•EN 12353:2006
1656:2000 Quantitative
test for used
the evaluation
of bactericidal
activity of chemical
disinfectants
and
Maingroup 3 - Pest control antiseptics
•EN
Preservationsuspension
of test organisms
for the determination
of bactericidal,
mycobactericidal,
sporicidal
and
•EN
13610:2002
suspension
test forand
therequirements(pahse
evaluation of virucidal
activity
antiseptics
used inQuantitative
veterinary field
- Test method
2, step
1) against bacteriophages of chemical
14
7
15
16
8
5
17
18
•EN 14347:2005 Basic sporicidal activity - Test method and requirements (phase 1)
•EN
14348:2005
Quantitative suspension test for the evaluation of mycobactericidal activity of chemical disinfectants in the medical area
fungicidal
activity
disinfectants
used
in food andsuspension
industrial
areas
- Test
method
andof2,
requirements
(phase 2, step 1) of chemical disinfectants
including
•EN 1275:2005
1657:2005
instrument
Quantitative
disinfectants
- Test
methods
test
andfor
requirements
the evaluation
evaluation
(phase
fungicidal
step 1) or yeasticidal
Rodenticides
•EN
Quantitative
suspension
test
for
the
of basic
fungicidal or basic activity
yeasticidal activity of chemical
Film preservatives •EN
Virucidal
quantitative
suspension
for
disinfectants
and
in human
medicine
- Test
•EN
13697:2001
Quantitative
non-porous
testtest
forand
thechemical
evaluation
of bactericidal
and/or
fungicidal
activity
of chemical
and14476:2005+A1:2006
antiseptics
used
in the
veterinary
areasurface
-and
Testrequirements
method
requirements
(phase
2,antiseptics
step
1) used
disinfectants
and
antiseptics
Test
method
(phase
1)
method
and requirements
(phase
2, step 1)domestic and institutional areas - Test method and requirements without mechanical
disinfectants
used
in
food,
industrial,
Avicides
•EN
12791:2005
Surgical lists
handtest
disinfection
- Test
requirement
(phase
2/step/2)treated materials (3.3 surface coatings )
An OECD report (ENV/JM
/MONO(2007)4)
methods
formethod
efficacyand
testing
of treated
articles
action
(phase 2/step2)
•EN 13624:2003 Quantitative suspension test for the evaluation of fungicidal activity of chemical disinfectants for instruments used in the
•EN 1657:2005/AC:2007
test
Molluscicides
medical
area - Test method andQuantitative
requirementssuspension
(phase 2, step
1) for the evaluation of fungicidal or yeasticidal activity of chemical
•EN
disinfectants
13727:2003
and
Quantitative
antiseptics
suspension
used in test
the for
veterinary
the evaluation
area of
- Test
bactericidal
methodactivity
and requirements
of chemical disinfectants
(phase 2,for
step
instruments
1)
used in the
medical Piscicides
method and requirements (phase 2, step 1)
•CEN/TR 14723:2003
Fieldarea
and- Test
accelerated
conditioning tests (FACT) for wood preservative out of ground contact (2003-12-17)
•EN 14561:2006 Quantitative carrier test for the evaluation of bactericidal activity for instruments used in the medical area - Test method and
•CEN/TR 14839:2004
Determination
the preventive
efficacy against wood destroying basidiomycetes fungi
requirements
(phase of
2, step
2)
•ENField
14204:2004
Quantitative
suspension
test
for
theofevaluation
mycobactericidal
activity
of chemical
disinfectants
•CEN/TS 12037:2003
test
method
for determining
thethe
relative
protective
effectiveness
of aactivity
woodfor
preservative
exposed
out
of ground
contact
•EN
14562:
2006
Quantitative
carrier
test for
evaluation
fungicidal
orof
yeasticidal
instruments
used in the
medical
area -and
Test
antiseptics
used in the (phase
veterinary
area
- Horizontal lap-jointmethod
method
and requirements
2, step
2) - Test method and requirements (phase 2, step 1)
Wood preservative
Drinking water disinfectants
Insecticides, acaricides and products to control other arthropods
•ENDetermination
14675:2006 of
Quantitative
suspension
test foragainst
the evaluation
virucidal
activityfungi
of chemical
disinfectants
•CEN/TS 15082:2005
the preventive
effectiveness
sapstainoffungi
and mould
on freshly
sawn timberand
- Field test
antiseptics
used
in thepreconditioning
veterinary
- Test
methodPerformance
and requirements
(phase
2, step 1)prior to biological laboratory test
•CEN/TS 15397:2006
Method
for
natural
out
of ground
contact
of treated
wood
specimens
•US-EPA-OPPTS:
Seriesarea
810
Product
Test
Guidelines—Finals
•CR 14244:2001 ecommendations
for measurement
of emissions
to theofenvironment
fromfor
treated
wood
in service
•WHO Guidelines
for efficacy
testing
insecticides
indoor
and
outdoor ground-applied space
•EN 113:1996 Document title Wood preservatives - Test method for determining the protective effectiveness against wood destroying
spray
applications.
(The
document
provides
specific
and
standardized
procedures and criteria
basidiomycetes - Determination of the toxic values
formethod
efficacy
andthe
evaluation
of insecticides
forwood
indoor
and outdoor,
ground-applied
space
•EN 113:1996/A1:2004 Test
fortesting
determining
protective effectiveness
against
destroying
basidiomycetes
- Determination
of the
toxic values
spray applications against vectors and pests of public health importance)
•EN 117:2005 Determination
of toxic values against Reticulitermes species (European termites) (Laboratory method)
Ref:WHO/CDS/NTD/WHOPES/2009.2
•EN 118:2005 Document title Wood preservatives - Determination of preventive action against Reticulitermes species (European termites)
•WHO Guidelines for efficacy testing of mosquito repellents for human skin. (The document
(Laboratory method)
•Report of the OECD Efficacy Workshop On Certain Antimicrobial
Biocides(published on OECD homepage)
provides specific and standardized procedures and criteria for efficacy testing and evaluation of
mosquito repellents for human skin)
Ref:WHO/CDS/NTD/WHOPES/2009.4
•WHO Guidelines for efficacy testing of household insecticide products - Mosquito coils,
vaporizer mats, liquid vaporizers, ambient emanators and aerosols. (The document provides
specific and standardized procedures and criteria for efficacy testing and evaluation of specific
household insecticide products intended for indoor use against mosquitoes, namely, mosquito
coils, vaporizer mats, liquid vaporizers, ambient emanators and aerosols)
Ref:WHO/CDS/NTD/WHOPES/2009.3
PRISTOP PRI IZBIRI TESTOV

Standardne metode - mednarodne (CEN, OECD, AOAC, EPA, ASTM)
Standardne metode na državnem nivoju

Metode, ki jih uporablja industrija*
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Metode, ki jih uporablja posamezni proizvajalec*

Podatki iz same proizvodnje BP*
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* - ocenjevalec odloči o kredibilnosti testa
DEZINFEKCIJSKA SREDSTVA

1. GLAVNA SKUPINA

1. – 5. vrsta izdelkov
1.
2.
3.
4.
5.
BP za človekovo osebno higieno
Razkužila in drugi BP
Veterinarsko higienski BP
Dezinfekcijska sredstva za območja s hrano in krmo
Sredstva za razkuževanje vode
EN 14885/2006!

Kemična razkužila in antiseptiki – uporaba evropskih
standardov za kemična razkužila in antiseptike

Pripravila ga je komisija: CEN/TC 216
DEFINICIJA RAZKUŽILA (EN 14885/2006)

reduction of the number of micro-organisms in or on an
inanimate matrix, achieved by the irreversible action of a
product on their structure or metabolism, to a level judged to
be appropriate to a defined purpose

Reduction / Irreversible action / Micro-organisms
TNSG: 7. POGLAVJE – UČINKOVITOST, PT2

Predstavniki/strokovnjaki iz držav članic, CEN in industrije

Novost: claims matrix – matrika oznak/etiket:
zahtevana informacija v strnjeni obliki, živ dokument!
NORMALLY the following
is applicable:
SOFT
FURNISHINGS
Product Description
Type
Use area
target site (examples)
purpose
min. spectrum of
activity
Description of product
within a specific PT:
Intended sector of
application:
Where the product is
typically used:
Primary ob jective of
the product and
expected result b y
the user
Ob ligatory range of
targeted harmful
organisms
soft furnishings and
fabrics biocidal
products
health care and
health care
facilities and
institutions
matrass, nonremovable soft
furnishings,
upholstery, carpets
household
matrass, nonremovable soft
furnishings,
upholstery, carpets
reducing risk of
infection
household
matrass, nonremovable soft
furnishings,
upholstery, carpets
control of
malodour by
antimicrobial
activity, aesthetics bacteriostatic or
incl. staining
fungistatic
soft furnishings and
fabrics biocidal
products
soft furnishings and
fabrics biocidal
products
reducing risk of
infection
Vers ion:
February 2012
additional optional
activity
User Type
application
type
Appropriate
methodology
As defined b y BPD
(Professional/
industrial, nonprofessional)
Method how
the product is
applied
Types of test to b e
used
professional
wiping,
scrubbing,
spraying,
foaming,
soaking
suspension and
(soft)surface test
non-professional
wiping,
scrubbing,
spraying,
foaming,
soaking
suspension and
(soft)surface test
bactericidal and/or
fungicidal
non-professional
wiping,
scrubbing,
spraying,
foaming,
soaking
suspension and
(soft)surface test
and odour test
bactericidal,
yeasticidal
fungicidal,
mycobactericidal,
virucidal
bactericidal,
yeasticidal
fungicidal,
virucidal,
mycobactericidal
Appropriate
performance
standard relevant to
target site
EN14885 for
suspension test,
Japanese test
Modification of the
AOAC Germicidal
Spray Products Test
method (961.02).
(recognized test
standard in
accordance to U.S.
EPA Pesticide
Assessment
Guidelines
Subdivision G,
Series 91-52 (b)
(1)).
MATRIKA OZNAK/ETIKET
Kategorija
Vrsta izdelka
Območje uporabe
Ciljno mesto
Namen uporabe
Učinek izdelka
Uporabnik
Način uporabe
Metodologija
Obstoječi standardi
Primer (PT2)
Razkužila za mehke površine
Zdravstvene inštitucije, dom,…
Ležišča, preproge,…
Zmanjšati možnost okužbe,…
Baktericiden, fungiciden, viruciden,…
Industrijski, poklicni, splošni
Brisanje, namakanje, močenje, pršenje,…
suspenzijski, površinski testi
EN 14885,…
VRSTA RAZKUŽILA
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


za trdne površine
za mehke površine
za prostore (uplinjanje)
za bazene (kopališča, terme, masažne kopeli)
za straniščne školjke
za prezračevalne in klimatske naprave
za opremo (namakanjem)
za perilo in tekstil
za odstranjevanje biofilmov
za odpadne materiale in drugo
SUSPEZIJSKI TESTI



organizmi so prosti v raztopini
določeno fiziološko okolje
optimalen stik z razkužilom
POVRŠINSKI TESTI




METODOLOGIJA
organizmi so pritrjeni na površino
dodatek organskih spojin
manj določeno fiziološko okolje
slabši stik z razkužilom
STOPENJSKI PRISTOP
1. stopnja
2. stopnja,
1. korak
2. stopnja,
2. korak
3. stopnja
Enostaven suspenzijski test,
splošna učinkovitost
Suspenzijski test,
specifična učinkovitost
Površinski test,
specifična učinkovitost,
simulacija uporabe
Testi na terenu,
praktična učinkovitost
Bakterije
EN 1040
Glive
EN 1275
Virusi
--
Bakterije
EN 1276/14348/12054
Glive
EN 1650
Virusi
EN 14476
Površine
EN 13697
Roke
EN 1499/1500/12791
Brisače
v razvoju
Perilo
v razvoju
Nedefinirani
ČAS IN UČINEK DELOVANJA

Določeni s standardom
primer (EN1276):
temperatura: 20°C
čas delovanja: 5 min
učinek:
zmanjšanje (redukcija) števila bakterij: 5 log
UČINEK RAZKUŽILA

Razkužilo - ciden učinek!
definicija BPR (člen 3)
definicija razkužila (EN14885)
RAZKUŽILO
―… with the intention of destroying,
deterring, rendering harmless,
preventing the action or otherwise
exerting a controlling effect…‖
= ireverzibilno delovanje (- ciden)
= statičen učinek, odbijajoč učinek,
saniteten učinek, idr.
DRUGI BIOCIDNI PROIZVODI
ETIKETA - MIKROORGANIZMI
Odprto vprašanje: izpis posameznih mikroorganizmov na etiketi?
ETIKETA - MIKROORGANIZMI
BPD (člen 20):
―…labels should not be misleading or give an exaggerated
impression of the product…‖
BPR (člen 69):
―…that labels are not misleading in respect of the risks from the
product to human health, animal health or the environment or
its efficacy,…‖
ETIKETA - MIKROORGANIZMI

ZA:
Imenovanje referenčnih in dodatnih mikroorganizmov (EN1276)
P. aeruginosa ATCC15442
E. coli ATCC10536
S. aureus ATCC6538
E. hirae ATCC10541
S. typhimurium ATCC13311
L. brevis DSM 6235
E. cloacae DSM 6234
ETIKETA - MIKROORGANIZMI

ZA:
Utemeljitev:
- etiketa mora biti poučna
- uporabnik ne pozna standarda
- ni zavajanje, podprto z rezultati
ETIKETA - MIKROORGANIZMI

PROTI:
Spekter delovanja:
bakteriociden, fungiciden, viruciden, sporociden!
Utemeljitev:
- v standardu opisano kateri
- zavajanje uporabnika
- vtis večje kvalitete
ETIKETA MIKROORGANIZMI

PROTI:
S. aureus in MRSA:
- odpornosti na antibiotike!
- odpornosti na razkužila!
BIOFILMI – DVE VRSTI DELOVANJA
BIOFILM – kooperativni konzorcij mikroorganizmov, ki je z
ekstracelularnim materialom zaščiten in pritrjen na površino.
1. Preprečitev nastanka biofilma
- ni adhezije,
- redukcija mikroorganizmov
2. Odstranjevanje formiranega biofilma
- ločitev biofilma od podlage,
- redukcija mikroorganizmov
BIOFILMI – UČINKOVITOST

Ni standardnih metod!

Testi za učinkovitost razkužil ne vključujejo:
ekstracelularni material – fizična bariera

Statični in tekoči pogoji pri nastanku biofilma!

Testna organizma: P. aeruginosa in S. aureus
NAJLEPŠA HVALA ZA POZORNOST!
UČINKOVITOST!
(3. GLAVNA SKUPINA,
18. VRSTA IZDELKOV:
Insekticidi,…)