1. business and industrial

How to proceed with 2013 REACH Registrations?
www.reachlaw.fi
Overview of REACH
REACH is a Strategic issue
 REACH (and CLP) are not mere compliance issues, but business
decisions
 Keeping entire EU market open
 REACH & CLP are not a short term operational issue but a very
strategic one. It will affect:
 Future investments at plants
 Process changes
 Supply chain changes (e.g. raw material quality)
 REACH will be a tool for competition
 Suppliers will be divided into compliant vs. non-compliant
companies with an economic effect
 What has happened after 2010?
 EU buyers prefer to buy from fully REACH compliant suppliers
regardless of registration deadline?
www.reachlaw.fi
Overview of REACH
Scope of REACH: General
OBJECTS
IN SCOPE
OUT OF
SCOPE
SUBJECTS
• Substances, on their own or in
mixtures
• Articles containing substances
of very high concern (SVHC) or
intended to be released
• Manufacturers (M), importers
(I) and DUs of substances on
their own or in mixtures
• Producers, importers and
suppliers of articles with SVHC
• Complete exemptions (e.g.
waste, transport, radio-active
substances)
• Process-specific (e.g. no
registration, if below 1 t/y)
• Non-EEA companies (may
appoint only representative)
• Programme co-ordinators with
no direct involvement in the
product flow (no M, I, DU, etc.)
www.reachlaw.fi
REACH & CLP: New Processes Entering the Stage
late pre/registrations
CLP
(e.g. new
harmonized
C&L)
legal issues
compliance
record keeping
& enforcement
www.reachlaw.fi
(e)SDS
Authorisation
SIEFs active till
2018
Updates
(dossiers, SDSs
labels, etc.)
SVHC in
articles
Restrictions
Substance
evaluation
Dossier
evaluation
Emerging ”new” processes
Downstream
user
obligations
Other
regulations
(GHS, REACH
goes global)
Current Status of REACH (1)
Overview
 Registration (No registration, No market)
 Pre-registration deadline passed on 1.12.2008 for existing (”phase-in”) substances: 2.7
million submissions for ca. 143 000 substances
 1st Registration deadline passed on 30.11.2010 for existing pre-registered substances
manufactured or imported ≥ 1 000 t/y, CMR 1/2 ≥ 1 t/y, R50/53 ≥ 100 t/y; ca. 25 000
registrations for 3 400 substances
 Evaluation of testing proposals and of dossiers for REACH compliance ongoing at
ECHA
 Authorisation (No authorisation, No market)
 53 substances identified as SVHC on ECHA Candidate List
 First six substances placed on REACH Authorisation List on 21.2.2011
 CLP Regulation (EC) 1272/2008 (No CLP compliance, No market)
 Since 1.12.2010: substances to be classified, labelled and packaged according to CLP
 First C&L notification deadline passed on 3.1.2011 for substances hazardous or subject to
REACH registration
www.reachlaw.fi
Current Status of REACH (2)
 Safety data sheets
 Since 1.12.2010, SDS should in principle be according to REACH Annex II, as amended by
Commission Regulation (EU) No 453/2010 of 20 May 2010, Incl. CLP classification and
labelling for substances
Substances of Very High Concern (SVHC) in Articles
 Article Producers and Importers to notify ECHA: first deadline passed on 1.6.2011
(175notifications)
 Article Suppliers to communicate SVHC info downstream: following each update of
Candidate List
www.reachlaw.fi
Current Status of REACH
...cont’d
← 370+ (>1%)
registrations
submitted
← 5% of all OR
registrations
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Current Status of REACH
Substances Registered and CLP notified in 2010
Submission type Number
Registrations - Full: 26 337 (end Q1/2011)
Registrations - Intermediates: 5 455
Phase in substances: Ca. 3 400 phase-in (7.3.2011: 3 483)
CMR substances: Ca. 400
R50/53 (toxic to aquatic organisms): Ca. 150
Notifications: 3.2 million
Testing proposals submitted: over 1 500
www.reachlaw.fi
REACH & CLP compliance after 2010
Next deadlines for companies*…
Milestones
June 1
2011
Nov 30
2010
Registration compliant (e)SDS
DU compliance with ends
•
•
If your use is covered: comply with eSDS
If your use is not covered: notify ECHA within 6 months, prepare
chemical safety report within 12 months
within 6 months after inclusion on the candidate list
Registration of pre-registered
substances of 100 – 999 tpa
Prepare (as lead or member)
Registration compliant (e)SDS
Optional (advisable if all components are registered)
CLP C&L for mixtures
www.reachlaw.fi
Now
June 1
2015
without delay after registration
SVHC notification for articles
2010
May 31
2013
2011
2012
2013
* NB: Authorisation-related deadlines are
excluded here, as they are substance-specific
2014
2015
mandatory
2016
REACH & CLP compliance after 2010
Deadlines after 2010
 3.1.2011 - industry to apply CLP to substances
 28.2.2011 – ECHA to process registrations submitted between
1.10.-30.11.2010 (= run completeness check)
 1.6.2011 – industry to notify SVHC in articles
 1.12.2011 – ECHA to submit the first draft Community Rolling Action
Plan for substances subject to substance evaluation to the MS
 1.6.2012 – Commission to review REACH Regulation (scope)
 30.11.2012 – ECHA to decide on testing proposals for 2010 reg’s
 31.5.2013 – industry to register substances 100-999 t/a
 1.6.2015 – industry to apply CLP to mixtures
 31.5.2018 – industry to register substances 1-99 t/a
 1.6.2018 – SIEF enters out of operation
www.reachlaw.fi
REACH and the affects on Business
www.reachlaw.fi
REACH&CLP compliance after 2010 (4/4)
General feedback from ECHA Stakeholders’ Day…
 ”Company responsibility for the safe use of chemicals never ends.” (Geert
Dancet, ECHA Executive Director)
 Number of REACH issues to follow up on is higher then ever before
(registration, authorisation & restrictions, safety data sheets, downstream
user obligations, SVHC in articles, etc.)
 Regular and systematic compliance assurance and monitoring post 2010,
incl. but not limited to the need for dossier updates, is key (Jan Schüller,
Eastman Chemical B.V.)
 Many of current uncertainties are related to the new processes
www.reachlaw.fi
Substances under surveillance
 SIN list useful indicator: currently 378 substances (Version
2.0, May 2011, incl. now 22 suspected endocrine disruptors)
 CLP Regulation Annex VI Table 3.1.: Harmonized
classifications as CMR 1A or 1B
 ECHA Registry of Intentions (RoI) to see which ones
authorities pick next
useful “early warning systems” for companies to anticipate
risk of future phase-out
www.reachlaw.fi
SVHC’s : Aim of authorization (REACH Art 55)

Ensure good functioning of the internal market

Assure risks from SVHCs are properly controlled and

Assure SVHCs are progressively replaced by suitable alternative
substances/technologies where these are economically and
technically viable
www.reachlaw.fi
Future development of SVHC lists
 Candidate List
 Update twice per year (June and Dec, but no official schedule)
 European Commission target for 2012: 136; all relevant
currently known SVHC by 2020 (ca. 300 – 500); ECHA expects to
make 5 SVHC proposals per year
 ECHA estimate: +30 – 40 substances per year from 2012 - 2014
 ECHA recommendations
 Once per year (REACH legal text: at least every second year)
 Annex XIV inclusions
 Following ECHA recommendations
www.reachlaw.fi
REACH is a Legal issue
 REACH Regulation creates a great deal of legal uncertainties
 Definitions: substance, mixture, article, intermediate, importer, etc.
 Scope of obligations and prohibitions: Article 5 ”no data, no market”, SCC, etc.
 Exemptions: Annex V, ”existing specific Community legislation” for Annex XIV, etc.
 REACH Regulation leaves a lot of room for private law agreements
 Only representative, SIEF and consortia, data sharing, clauses in supply contracts,
etc.
 REACH Regulation has to be seen in context with other EU and national
legislation
 Interfaces with other EU legislation: biocides, food & feed, medicinal products, etc.
 EU Competition Law to be observed for collaboration between companies under
REACH
 Product Liability Directive and national implementing legislation
 National REACH enforcement by EU/EEA Member States
 Major differences in penalties and enforcement processes
 Diverging interpretations on REACH, e.g. 0.1 % issue for SVHC in articles
 Sophisticated legal expertise/support needed to ensure compliance
www.reachlaw.fi
Taking The Point of View of You Customers:
Key concerns in the Supply Chain
 Availability of chemicals after 2010

Substances not at all covered by REACH compliance work?

Certain Uses not covered?

Wrong type of registration (Regular substance vs. Intermediate)?
 Other new regulations, obligations for supply chain

E.g. EU Biocides Regulation scheduled for 2013
 Structural changes in the market

Potential replacement of substances and suppliers

Re-direction of supply chains affecting customer REACH role
 Need of internal process updates

E.g. Strictly Controlled Conditions for transported intermediates

E.g. Compliance with SDSs and annexed exposure scenarios
www.reachlaw.fi
17
Conclusions for Businesses
REACH & CLP compliance post 2010 is a real
”patchwork”; to cope with it, companies should
 Put in place an overall compliance plan and organisation
 Also look at other global regulatory requirements
 Consider outsourcing - in full or parts – to professionals with
multidisciplinary background
www.reachlaw.fi
Registration Post 2010
Different Scenarios to Get Your Registration Number
www.reachlaw.fi
Valid Reasons for No Registration in 2010
 Manufacturer, importer or only representative have
correctly pre-registered and their individual deadline is
31.5.2013 or 31.5.2018; or
 An exemption from REACH registration applies (e.g. REACH
Annex IV, V or other cases listed in REACH Article 2)
Recommendation for all actors in the supply chain:
Make sure you are able to prove that the conditions
are fulfilled for all substances in your chemicals.
Document in line with REACH provisions.
www.reachlaw.fi
Registration by 31.5.2013
Scope
Pre-registered phase-in substances
manufactured or imported in
quantities over 100 tonnes per
annum per manufacturer or
importer
www.reachlaw.fi
Registration by 31.5.2013
Way Forward
2010 joint registration available?
YES
Prepare dossier,
purchase LoA
and register
NO
YES
Leadership for 2013
registration already taken up
by trustable company ?
Decide whether you want
to participate in
leadership team /
consortium or monitor
the progress and purchase
LoA later
www.reachlaw.fi
NO
Consider whether you
want to take the lead /
initiate formation of
leadership team for
2013 registration
Registration by 31.5.2013
What Will Be Different Comparing to 2010?
 Registrants can draw on 2010 experience and ECHA registration
tools are in place, but..
 More substances
 More companies registering, incl. SMEs
 Smaller SIEFs and less consortia?
 Data gaps likely to be bigger
 More Annex IX test proposals
 But saving Annex X
Higher risk than in 2010 that certain substances remain
unregistered due to lack of registrant’s capability and / or
resources to compile a registration file
www.reachlaw.fi
Timing for New 2013 Registrations: Ideal Case
www.reachlaw.fi
Source: ECHA
Not Pre-Registered (”New”) Substances
Right to continue
business until
31.5.2013/18
Do you manufacture or import for the first time a phase-in substance (mainly those
with EINECS numbers, see REACH Art 3(20)) in quantities of ≥1 tonne or more per
year, which is not classified as CMR Cat. 1 or 2 (acc. to Directive 67/548/EEC), not
R50/53 (and ≥ 100 tonnes per year) and not reaching 1000 tonnes per year?
(unless exemption from registration applies according to REACH Article 2)?
YES
NO
Submit late pre-registration
within 6 months (Art. 28(6)) ¹
Submit inquiry
(Art. 26(1))
SIEF
Data
sharing
Joint & individual registration
Right to continue business also
after 31.5.2013/18
Right to start manufacture / import at
≥ 1 t/y only after registration
¹ and latest by 31.5.2012 for quantities ≥ 100 tonnes / y
www.reachlaw.fi
and latest by 31.5.2017 for quantities ≥ 1 tonne / y
Complexities of Inquiry Process – 55% failure
rate of inquiries submitted
 ECHA verifies/establishes substance identity based on analytical data submitted
 No such verification in case of registration submission (technical completeness
check only)
 Information submitted by inquirers often not deemed sufficient by ECHA, esp.
for UVCBs
 Substance Identity Profile agreed by SIEF / lead registrant may be different..
 ECHA has no deadline to process the inquiry (QA: ”as quickly as possible”)
 If there is not yet a lead registrant for the substance, you may have to become
lead registrant yourself in order to register and start business!
 We know of several cases where the previous notifiers of ELINCS substances do not
respond to data sharing requests and thus keep new competitors out of the market
 Have to initiate data sharing dispute with ECHA according to REACH Art 27(5)
 Registration without accepted inquiry is technically possible, but
enforcement risk due to potential violation of inquiry procedural rules
www.reachlaw.fi
Registration: Main Steps
Pre-registration or inquiry to ECHA – purpose: data sharing for same substance
Lead Registrant / consortium: building and submission to ECHA of Joint
Dossier
Co-Registrants: purchase of access to Joint Dossier (”letter of access”),
preparation and submission to ECHA of Individual Dossier
Registration number granted, if dossier complete – right to continue business
(Dossier evaluation by ECHA, possible request for further testing or info)
www.reachlaw.fi
Pre-registered Phase-In Substance
NB: substance
sameness to be
determined first
2010 joint registration available?
YES
Prepare dossier,
purchase LoA
and register
NO
YES
Leadership for 2013
registration already taken up
by trustable company ?
Decide whether you want
to participate in
leadership team /
consortium or monitor
the progress and purchase
LoA later
www.reachlaw.fi
NO
Consider whether you
want to take the lead /
initiate formation of
leadership team for
2013 registration
Decision Tree for
Pre-registration of
Phase-In Substances
www.reachlaw.fi
Source: Cefic, Late Pre-registration
Guidance, September 2011
Not Pre-Registered (”New”) Substance
Right to continue
business until
31.5.2013/18
Do you manufacture or import for the first time (since 1.6.08) a phase-in substance
(mainly those with EINECS numbers, see REACH Art 3(20)) in quantities of ≥1 tonne per
year, which is not classified as CMR Cat. 1 or 2 (acc. to Directive 67/548/EEC), not
R50/53 (and ≥ 100 tonnes per year) and not reaching 1000 tonnes per year? (unless
exemption from registration applies according to REACH Article 2)?
YES
NO
Submit late pre-registration
within 6 months (Art. 28(6)) ¹
Submit inquiry
(Art. 26(1))
SIEF
Data
sharing
Joint & individual registration
Right to continue business also
after 31.5.2013/18
Right to (re-)start manufacture / import at
≥ 1 t/y only after registration
¹ and latest by 31.5.2012 for quantities ≥ 100 tonnes / y
and latest by 31.5.2017 for quantities ≥ 1 tonne / y
www.reachlaw.fi
From Inquiry to Registration
Substance requires registration
late pre-registration ( REACH Art. 28(6)) not possible
Submit inquiry to ECHA
notably incl. substance ID acc. to Section 2 of Annex VI
Inquiry
accepted by
ECHA
ECHA releases
• Inquiry number,
• other registrants’
contacts (if any)
• data older than 12 yrs.
Pending
answer by
ECHA
Inquiry not
accepted by
ECHA
On your own
responsibility
(normally not
recommended!)
Proceed with data sharing, joint & individual registration
www.reachlaw.fi
Re-submit as
instructed by
ECHA
How to register?
SIEF vs. Consortium
 SIEF = Substance Information Exchange Forum
•All pre-registered substances are automatically part of the (pre)SIEF.
•After sameness of the substances is agreed the SIEF officially starts
•Purpose of SIEF: data sharing and agree on classification & labeling
 Consortium
 “Voluntary”
 Formalized co-operation between companies
 Main current practice:
• major companies are dominant and go ahead with compilation of joint
registration dossier, either alone or in consortia (“leaders”)
• other (pre-)SIEF members are in a weak position, as many leaders delay provision
of SIEF agreements / letters of access and access to information limited
• Consortium Membership turns out to be best option to safeguard timely
registration for strategic substances
www.reachlaw.fi
How to register?
SIEF vs. Consortium
ACTIONS
Company
mandatory
on pre-reg
SIEF
optional
at any time
Consortium
Submit Pre-registration
Determine SIEF and
consortium strategy
Understand own data
ownership
Prepare Chemical Safety
Report (optional)
Submit registration
Obligations to
1. Share hazard data
2. Agree upon
classification and labelling
Agreement on rules of
data/ cost sharing
Preparation of technical
registration dossier
Preparation of Chemical
Safety Report (optional)
Actions of the company as registrant, as a SIEF participant and a consortium member
www.reachlaw.fi
Cefic, SIEF Guidance
September 2011
Compliance with EU Competition Law
DO NOT SHARE
OK TO SHARE
Non-public sensitive
Most of the required
information: individual
information for REACH coprices, terms of sales, credit operation (mostly purely
terms, cost of production or scientific or technical
distribution, sales
information)
Information on future plans of
individual companies
concerning actual
manufacture and or import Tonnage bands
volumes, technology,
investments, production,
distribution, marketing.
Matters relating to individual
suppliers or customers,
particularly in respect of any OR representing several non
action that might have the
EU manufacturers
effect of excluding them from
the market
www.reachlaw.fi
BE CAREFUL WITH
Scientific or technical information may
provide competitors the ability to
identify individual sensitive company
information, alignment of market
behaviour and information that are not
necessary for REACH.
To be on the “safe side” only share
information necessary for REACH
Source: Cefic, SIEF Guidance,
21.09.2011
How to register?
Concept of joint submission
 When a substance is intended to be manufactured / EUimported by one or more actors (usually the case), joint
submission of core registration data is required
 Joint submission is done by the ”lead registrant” acting
in agreement with the other co-registrants
 If there is no lead registrant, there is no registration at all !
 Co-registrants submit their individual dossiers following
joint submission
www.reachlaw.fi
Lead Registrant vs Co-registrant
Joint Dossier
One Lead Registrant
Optional part
Individual
Dossier
Co-registrant
Co-registrant
Co-egistrant
www.reachlaw.fi
Joint submission: Minimum / Maximum
Joint submission
Separate submission
Joint or separate
submission: free
decision
Classification and Labelling Identity of manufacturer or Guidance of safe use of the
of the substance
importer of the substance
substance
Study summaries
Identity of substance
Robust study summaries
Info on the manufacturer
and use(s) of the substance
MIN
Proposal for testing
Chemical safety report
Exposure information for
substance (1-10 t/y)
Optional: Indication of
Optional: Indication of
Optional: Indication of
information reviewed by an information reviewed by an information reviewed by an
assessor
assessor
assessor
www.reachlaw.fi
MAX
Opting Out from the Joint Submission
 Justification required according to REACH Article 11(3), esp.
Disproportionate costs: (from the ECHA guidance on data sharing)
 “a potential registrant already has a complete set of the necessary
test data for his product in his possession, and that Joint Submission
would cause him disproportionate costs”
 No opt out from data sharing obligations and SIEF !
www.reachlaw.fi
Registration work – Main Steps for Lead
Registrants
 Data Gap analysis and detailed / extensive data collection
 Sameness discussion and finalization
 Planning of laboratory testing for the additional required information
 Laboratory testing (no extensive testing for intermediates)
 Technical work (Dossier preparation)
 Chemical Safety Assessment (CSA) (not for intermediates)
 Exposure assessment (not for intermediates)
 Preparation of Chemical Safety Report (Past A and B) (not for
intermediates)
 Preparation of eSDS (not for intermediates)/ SDS
 Lead Registrant SIEF information sharing (if applicable)
 Lead Registrant dossier review & Dossier submission ...etc.
www.reachlaw.fi
Lead registrant work: Main Steps
1. Analyze role of Lead registrant
Substance
id
Resources available
vs. needed
Seek feedback from
pre-SIEF
Lead Registrant
nomination
(also to ECHA)
Leadership
(consortium)
Agreement
2. Collect / generate joint registration
information – build IUCLID file
Gather and
evaluate
existing
data
Consider
data
needs
Use
collection &
identification
www.reachlaw.fi
Identify
total
data gap
Close data
gap using
tests, nontest methods
or purchase
Hazard Assessment &
Classification and Labelling
SIEF COMMUNICATION
2. Solve co-operation and cost sharing
issues
Scope of
cooperation
4. Conduct chemical safety assessment –
build Chemical Safety Report
Exposure Assessment
& Risk characterisation
5. Finalize and submit Joint Registration
Dossier to ECHA
Joint Registration
Dossier
Chemical
Safety Report
extended
safety data sheet
6. Enable other SIEF members to refer to
joint dossier and submit their own
SIEF
agreements
Invoicing
Token and
other reg info
Letter of
access
7. Maintain joint registration beyond 2018
Keep lead dossier
up to date
Answer to ECHA
evaluation
Include
Newcomers
Lead Registrant Work: Resources Needed
Project Manager
Technical Manager
• overall planning and
timing
• main customer contact
• managment of change
• data collection and lead dossier preparation
• supervise technical expert(s)
• main customer contact in technical issues
• management of change
Technical
expert(s)
• filling IUCLID
• prepare
(robust) study
summaries
• chemical safety
assessment
www.reachlaw.fi
Administrative
support
• SIEF communication
• information
collection (data,
uses)
• meetings & minutes
• record keeping
Legal expert
Financial expert
• leadership agreements
• SIEF agreements
• data sharing agreements
• REACH legal advice
• competition law
• copyrights, IPR
• cost sharing calculations
• budgeting and invoicing
First steps of Lead Registrant process
SIEF
SIEF
communication
REACHLaw
Co-operation feasibility study
Study reports
Sameness discussion
Substance
identity
Literature search
LR data gap identification
Data gap filling
Available data & Data waiving
Laboratory testing
Non test methods
www.reachlaw.fi
Customer
Use
information
Downstream
users
Next steps in the registration process if the LR
registration process will be continued
SIEF
SIEF
communication
REACHLaw
Customer
Dossier preparation
Study reports
Chemical Safety Report
Substance
identity
Classification & Labelling
Compilation of SDS
Use collection
Use
information
Downstream
users
ECHA
- Dossier evaluation
- Registration number assignement
- Test proposal evaluation
www.reachlaw.fi
Lead Registrant: SIEF Surveys
 Registration intentions, Sameness, Data availability, scope of
registration (esp. joint or separate CSR?), LR vote
 Information on results of 1)
 After hazard assessment: Propose C&L and ask for agreement
 SIEF agreement to potential registrants
www.reachlaw.fi
Registration work – Main Steps for Co-registrants
 Pre-registration or inquiry to ECHA
 Verification of substance sameness with lead registrant / consortium
 Collect substance uses to be supported in the registration
 Determine scope of joint registration dossier
 Preparation of individual registration dossier
 Purchase of access to joint registration dossier (via ”SIEF agreement” and
/ or ”letter of access”); alternatively join the consortium
 (Joint registration submission by lead registrant)
 Individual registration submission by co-registrant
 Payment of ECHA registration fee
 If requested by ECHA: submit additional information to complete dossier
 If dossier complete: Issuance of registration number by ECHA
www.reachlaw.fi
Process after Submission
Inside ECHA
Submission
of dossier
Ensure
”compatibility”
with the system
www.reachlaw.fi
BR check
ECHA fee
invoice
TCC check
FCC check
OCC
check
Ensure technical
(not qualitative)
completeness
Registration
number
Completeness of
previous steps,
reg. number
generation
Access to information held by ECHA

In principle kept confidential – REACH 118(2)

Always publicly available free of charge over the internet –
REACH 119(1)

Potentially

Publicly available free of charge over internet unless confidentiality
claim accepted – 119(2)

Disclosed on request – Reg. (EC) 1049/2001
www.reachlaw.fi
Lessons learnt from Registration 2010
 Being a non-lead member may be risky
 No influence on timetable and budget
 Uncertainty about scope of joint dossier
 LoA may be even more expensive (”sweat equity”)
 Try to keep it simple, REACH is difficult enough
 organisation of leadership team, agreements, process of LoA purchase
 Transparent and regular communication with non-lead members
cannot be wrong
 E-platforms cannot replace a personal contact & e-mail
 You cannot start early enough
 Data gaps for 2013 substances will be bigger
 CSR preparation was a time-consuming challenge for many
www.reachlaw.fi
What to do if your substances are under the
group of SVHC?
Authorisation
www.reachlaw.fi
Aim of Authorisation



Ensure good functioning of the internal market
Assure risks from SVHCs are properly controlled and
Assure SVHCs are progressively replaced by suitable
alternative substances/technologies where these are
economically and technically viable
www.reachlaw.fi
Scope of Authorisation
Substances of Very High Concern ( Art. 57)
CMR cat. 1A or 1B; PBTs; vPvBs; substances of equivalent concern ( case by
case: e.g. Endocrine distruptors)
• Once included in Authorisation list ( REACH Annex XIV)
• No volume treshold
To get Authorization for the specific use of the substance as defined by REACH
Art. 3 (24): ”any processing, formulation, consumption, storage, keeping,
treatment, filling into containers, transfer from one container to another,
mixing, production of an article or any other utilisation ”
• Out of Scope: Import of articles containing SVHC ( may subject to restrictions);
substances used outside EU/EEA
• Substance uses in REACH text or Annex XIV
www.reachlaw.fi
Checking if your use is or can be exempted from autorisation
Substance used ..
Legal basis
Reason for exemption
is outside the scope of REACH
Article 2 (1) – (3)
Several, mainly existing Community legislation
in medicinal products for human or veterinary use
Article 2 (5) (a)
Existing Community legislation covers risk management
in food or feedingstuffs
Article 2 (5) (b)
Existing Community legislation covers risk management
As on-site isolated and transported isolated
intermediates (Article 3 (15))
Article 2 (8) (b)
Transformation into another substance
in scientific research and development (Article 3 (23))
Article 56 (3) 1
Carried out under controlled conditions in volumes < 1 t/y;
encourage innovation
in plant protection products (”pesticides”)
Article 56 (4) (a)
Existing Community legislation covers risk management
in biocidal products
Article 56 (4) (b)
Existing Community legislation covers risk management
as motor fuels
Article 56 (4) (c)
Existing Community legislation covers risk management
as fuel in mobile or fixed combustion plants of mineral
oil products and use as fuels in closed systems
Article 56 (4) (d)
in cosmetic products
Article 56 (5) (a)
In food contact materials
Article 56 (5) (b)
Existing Community legislation covers risk management
Exemption only applies if SVHC status is based on CMR
properties or ”equivalent level of concern ” for human
health
in mixtures below certain concentration limits
Article 56 (6)
considered as not giving rise to concern
in medical devices
Article 60 (2)
Existing Community legislation covers risk management
Exemption limited to risks for human health
for product and process orientated research and
development - PPORD (Article 3 (22))
Article 56 (3) 2, IF specified
in Annex XIV with maximum
quantity exempted
Encourage innovation
Risk from (categories of) use(s) is properly controlled
Article 58 (2), IF specified in
Annex XIV , intitially or
later (on a case and
substance basis )
Existing specific Community legislation imposing minimum
requirements relating to the protection of human health or
the environment for the use of the substance
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Exemption in the Regulation
Exemp. Annex XIV (TBIncluded)
Authorisation process & counterparts
EU Member States (MS) + NO, IS, LS
ECHA on request of Commission
ECHA (+ its MS Committee + Commission)
ECHA (+ its MS Committee’s opinion)
Commission
ECHA + its Committees for Risk Assessment
(RAC) and Socio-Economic Analysis (SEAC)
Commission
Each Authorisation is time limited!
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Application for authorisation: content (Art 62)
Information requirement
Applicant:
Comment
Manufacturer, importer, downstream user (DU),
Only Representative ? (Commission checking)
Joint application possible; DU may
rely on upstream authorisation
Substance identity (Annex VI, Section 2)
Also for group of substances (Annex
XI, Section 1.5)
Use:
Request for authorisation, specifying the use(s)
applied for
One or several uses; own uses and /
or DU uses
Chemical Safety
Report (CSR):
Covering the risks from use to HH and Env that
trigger inclusion in Annex XIV
if already submitted with
registration, update wrt ES and uses
Considering their availability, risks and the
technical and economic feasibility of
substitution and incl. relevant R&D activities by
applicant
Alternatives may be alternative
substances or technologies; critical
element for application, especially
SEA route (with negative outcome)
Including a timetable for proposed actions by
the applicant to replace the Annex XIV
substance with the suitable alternative(s).
Only where AoA shows that suitable
alternatives are available; only for
AC route
According to Annex XVI: socio-economic benefits
of the continued use?
Not mandatory for application, but
in fact required forSEA route !
Risks covered by IPPC permit or prior regulation
under Water Framework Directive (point
sources)
Not mandatory for application
Substance:
Analysis of
Alternatives (AoA):
Substitution plan:
Socio-Economic
Analysis (SEA):
Justification for not
considering risks:
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+ Fee
Considered issues at different stages
Stage in the
Authorisation process
Actor
Considered issues
Before the submission of an
Annex XV dossier
MS/COM
The most appropiated risk
management instrument
Identification of
SVHC/inclusion on the
candidate list
MS/ECHA/MSC
Hazardous properties
Prioritisation and Annex XIV
recommendation
ECHA/MSC
PBT/vPvB. Indication of
exposure. Justified
exemptions
(Authorisation application)
Authorisation decission
( applicant) RAC/SEACCOM
Control of Risks?
Suitable alternatives
available? Socio-economic
uses for continued use?
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Authorisation Process & Consultations
MS or
ECHA
prepares
and
Annex
XV
dossier
COM
Decision
Indentification
Candidate list Priority Setting
Authorities and
interested parties:
Comment on SVHC
properties.
Info on uses &
alternatives
www.reachlaw.fi
Authorisation
list ( Annex
XIV)
Authorities and
interested parties:
Comment on
priority setting and
exemptions
Authorisation Process: SVHC Identified to Date (53)
Trichloroethylene
(draft)
2,4-Dinitrotoluene
(2,4-DNT) (17.12.10)
Diisobutyl phthalate
(DIBP) (17.12.10)
Boric acid
Acrylamide
Lead chromate
(17.12.10)
Aluminosilicate
Disodium tetraborate,
Refractory Ceramic
anhydrous
Fibres
Lead chromate
molybdate sulphate
red (C.I. Pigment Red
104) (17.12.10)
Tetraboron disodium
heptaoxide, hydrate
Anthracene oil
Lead sulfochromate
yellow (C.I. Pigment
Yellow 34) (17.12.10)
Potassium dichromate
(draft)
Anthracene oil,
anthracene-low
Pitch, coal tar, high
temp.
Ammonium
dichromate
(draft)
Anthracene oil,
anthracene paste
Potassium chromate
(draft)
Sodium chromate
(draft)
1,2benzenedicarboxylic
acid, di-C7-11
branched and linear
alkyl esters (DHNUP)
www.reachlaw.fi
Anthracene oil,
anthracene paste,
anthracene fraction
Anthracene oil,
anthracene
paste,distn. lights
5-tert-butyl-2,4,6trinitro-m-xylene
(musk xylene)
(21.2.11)
Alkanes, C10-13,
chloro (Short Chain
Chlorinated Paraffins)
Anthracene
Benzyl butyl
phthalate (BBP)
(21.2.11.)
Bis (2ethylhexyl)phthalate
(DEHP) (21.2.11)
Tris(2Bis(tributyltin)oxide
chloroethyl)phosphate
(TBTO)
(TCEP) (17.12.10)
Zirconia
Aluminosilicate
Refractory Ceramic
Fibres
Cobalt dichloride
(draft)
4,4'Diarsenic pentaoxide
Diaminodiphenylmeth
(17.12.10)
ane (MDA) (21.2.11)
1-methyl-2hydrazine
pyrrolidone
(added 20.6.11)
20.6.11)
(only) (added
included
on
1,2,3trichloropropane
(added 20.6.11)
Candidate
List
recommended for Annex XIV inclusion
(already) included in Annex XIV
Diarsenic trioxide
(17.12.10)
Cobalt(II) carbonate
(draft)
Dibutyl phthalate
(DBP) (21.2.11)
Cobalt(II) diacetate
(draft)
Hexabromocyclodode
cane (HBCDD) and all
major
diastereoisomers
identified (21.2.11)
2-Methoxyethanol
Lead hydrogen
arsenate
2-Ethoxyethanol
Sodium dichromate
(draft)
Chromium trioxide
(draft)
Triethyl arsenate
(draft) Chromic acid,
Oligomers of chromic
acid and dichromic
acid, Dichromic acid
Cobalt(II) sulphate
(draft)
2ethoxyethylacetate
(added 20.6.11)
Cobalt(II) dinitrate
(draft)
strontium
chromate
(added 20.6.11)
1,2benzenedicarboxylic
acid, di-C6-8branched alkyl esters,
C7-rich (DIHP) (added
20.6.11)
2nd List of Substances to Be Placed on Annex XIV¹
Substance name
Latest application date
Sunset date
Diisobutyl phthalate (DIBP)
[Date of entry into
force + 18 months or
21 August 2013,
whichever is the latest]
[Date of entry into
force + 36 months or
21 February 2015,
whichever is the latest]
[Date of entry into
force + 21 months or
21 November 2013,
whichever is the latest]
[Date of entry into
force + 39 months or
21 May 2015,
whichever is the latest]
[Date of entry into
force + 24 months or
21 February 2014,
whichever is the latest]
[Date of entry into
force + 42 months or
21 August 2015,
whichever is the latest]
Diarsenic trioxide
Diarsenic pentaoxide
Lead chromate
Lead sulfochromate yellow
(C.I. Pigment Yellow 34)
Lead chromate molybdate sulphate red
(C. I. Pigment Red 104)
Tris (2-chloroethyl) phosphate
(TCEP)
2,4-Dinitrotoluene (2,4-DNT)
Agreed unanimously in EU REACH Committee on 28/29 Sepember 2011
¹Commission proposal to EU REACH Committee on ECHA 2nd recommendation (August 2011)
www.reachlaw.fi
First list of substances placed on Annex XIV
• Commission Regulation (EU) No 143/2011
of 17.2.2011:
” Kind of pre”Similar than
Entry
Substance name
No
1 5-tert-butyl-2,4,6-trinitro-m-xylene (musk xylene)
2 4,4'- Diaminodiphenylmethane (MDA)
4
5
6
7
Hexabromocyclododecane (HBCDD) and all major
diastereoisomers identified:
Alpha-hexabromocyclododecane
Beta-hexabromocyclododecane
Gamma-hexabromocyclododecane
Bis (2-ethylhexyl)phthalate
(DEHP)
Benzyl butyl phthalate (BBP)
Dibutyl phthalate (DBP)
registration
EC
benefit”
Latestdealine
application
date
(CAS No.)
201-329-4
21 Feb 2013
202-974-4
21 Feb 2013
247-148-4 and 22121 Feb 2014
695-9
”Sunset date” Inquiry”
Comments
(+18 months )
21 Aug 2014
vPvB - SEA route only
21 Aug 2014
Carc Cat 1B
21 Aug 2015
PBT - SEA route only
(134237-50-6)
(134237-51-7)
(134237-52-8)
204-211-0
21 Aug 2013
21 Feb 2015
201-622-7
201-557-4
21 Aug 2013
21 Aug 2013
21 Feb 2015
21 Feb 2015
• Reprotox Cat 1B
• exempted: uses in the
immediate packaging of
medicinal products
Next 8 candidates (recommended in Dec 2010): Diisobutyl phthalate (DIBP), Diarsenic trioxide, Diarsenic
pentaoxide, Lead chromate, Lead sulfochromate yellow (C.I. Pigment Yellow 34), Lead chromate molybdate
sulfate red (C.I. Pigment Red 104), Tris (2-chloroethyl) phosphate (TCEP), 2,4 – Dinitrotoluene (2,4-DNT)
INCLUSION IN ANNEX XIV NOT BEFORE END 2011, RATHER BEGINNING 2012
www.reachlaw.fi
Future Development of SVHC List
Candidate List
– Update twice per year (June and Dec, but no official
schedule)
– COM target for 2012: 136; all relevant currently known SVHC
by 2020 (ca. 300 – 500); ECHA expects to make 5 SVHC
– proposals per year
– ECHA estimate: +30 – 40 substances per year from 2012 2014
ECHA recommendations
Once per year (REACH legal text: at least every second year)
• Annex XIV inclusions
– Following ECHA recommendations
www.reachlaw.fi
Applications granting - Overview
www.reachlaw.fi
Granting or Refusing The Authorisation
2 months
Interested
parties. Info on
alternatives
Applicant
applies for
authorisation
for a
substance on
Annex XIV
~2.5
months
Applicants
Comments
10 months
(5 months)
RAC and
SEAC draft
opinions
3 months to
draft
Time limit case by
case
Review report by
Holder of authorization
www.reachlaw.fi
RAC & SEAC
opinions
ECHA initial
Checks; invoice
& Acknowledge
of submission
~6 – 12 moths
2 months +
15 days
Applicant´s
review report
COM decision
comitology
~1.5 –
2.0
Years
From
start
Publication in OJ &
ECHA website
Authorization
granted/not granted
Review of
authorization
Update
Label, SDS and registration
Authorisation fees to ECHA (in €)
1 applicant, 1 substance, 1 use
Item
Large (at
least 1)
Medium-sized¹
Small¹
Micro¹
Base fee
50 000
40 000
25 000
7 500
Additional fee per
substance
10 000
8 000
5 000
1 500
Additional fee per
additional use
10 000
8 000
5 000
1 500
a) Non SME
37 500
Not applicable
Not applicable
Not applicable
b) Medium-sized
30 000
30 000
Not applicable
Not applicable
c) Small
18 750
18 750
18 750
Not applicable
d) Micro
5 625
5 625
5 625
5 625
Additional fee per
Joint Submission
additional participant
NB: Same fees for submission of review reports (necessary to maintain
authorisation) + Application preparation costs: very complex task !
www.reachlaw.fi
See Annex VI to Commission Regulation (EC) No
340/2008 of 16 April 2008
¹ + same size or smaller
Conclusions on Authorisation
•
Authorisation process: new to everyone, highly complex, labour intensive,
costly, strict deadlines, lengthy (never ending..)
•
High level of detail required for application dossier
•
Application checked thoroughly by RAC, SEAC and Commission
•
Final aim is substitution with safer alternatives
•
Multiple ways for companies
– to influence the process via public consultations
– to pursue strategies (joint vs. individual authorisation, reliance on other supply
chain actors, description of uses, data sharing, etc.)
•
Follow competition law
•
Good communication with downstream users and ECHA is crucial
•
Authorisation is highly interdisciplinary work
•
Start as early as possible!
•
Ways out from authorisation (exemptions) to be established carefully
www.reachlaw.fi
REACH a Moving Target
Remember that REACH Compliance is a Continuous Challenge
www.reachlaw.fi
Next Deadlines for Companies*…
Milestones
June 1
2011
Nov 30
2010
Registration compliant (e)SDS
DU compliance with eSDS
•
•
If your use is covered: comply with eSDS
If your use is not covered: notifiy ECHA within 6 months,
prepare chemical safety report within 12 months
within 6 months after inclusion on the candidate list
Registration of pre-registered
substances of 100 – 999 tpa
Prepare (as lead or member)
Registration compliant (e)SDS
Optional (advisable if all components are registered)
CLP C&L for mixtures
www.reachlaw.fi
Now
June 1
2015
without delay after registration
SVHC notification for articles
2010
May 31
2013
2011
2012
2013
2014
* Authorisation-related deadlines are excluded here, as
they are substance-specific
2015
mandatory
2016
Continuous Update Obligation
 What?
 When?
 Registration dossiers
 Legal entity changes
 Authorisation applications
 Composition changes
 Safety Data Sheets
 Classification & labelling changes
 Hazard Labels
 New identified uses
 ORs: EU customer &
 New data affecting the Chemical
Safety Report

volume info
 Increase of tonnage band
 Upgrade from intermediate to full
dossier
 Request by ECHA or enforcing
authority
 ETC. ..
www.reachlaw.fi
Future Development of SVHC Lists
 Candidate List
 Annex XV SVHC proposals submitted bi-annually in Feb and August
 Update twice per year (June and Dec/Jan, but no official schedule)
 European Commission target for 2012: 136; all relevant currently
known SVHC by 2020 (ca. 300 – 500); ECHA expects to make 5 SVHC
proposals per year
 ECHA estimate: +30 – 40 substances per year from 2012 - 2014
 ECHA recommendations
 Once per year (REACH legal text: at least every second year)
 Annex XIV inclusions
 Following ECHA recommendations
www.reachlaw.fi
Changes to ECHA Guidance
Need to assess
impact on your
REACH project !
Update dossiers,
SDSs, labels, as
needed.
www.reachlaw.fi
Review of REACH 2012
 To be carried out and published by EU Commission by 1 June 2012
 Possible outcome
 Update of existing guidance or preparation of new guidance
 Legislative proposal - at a later stage - based on the review outcomes
 Amongst the ECHA recommendations for REACH review:
An explicit reference to remedies for severe non compliance could be
considered to be added to the REACH Regulation, namely an explicit
provision on withdrawal or revocation of registration numbers in case
of incompleteness identified ex-post or non-compliance with
compliance check decision and/or enforcement actions
 REACH requirements are expected to become tighter rather than
looser in the future
www.reachlaw.fi
Enforcement
Be Prepared to Show REACH and CLP Compliance
www.reachlaw.fi
Plenty to Enforcement After 2010 Deadlines
 Registration obligation for 1000+ tpa, R50/53 ≥ 100 tpa &
CMR1/2 ≥ 1tpa
 Showing that pre-registration is sufficient for unregistered
substances (i.e. later deadline)
 Substances classified, labelled, packaged and notified acc.
to CLP
 Substances (subject to REACH reg. or making mixture
hazardous) in mixtures notified acc. to CLP by importer
 Safety Data Sheet for substances and (with limitations)
mixtures according to revised Annex II (format; CLP; ES and
other registration info, if registered)
www.reachlaw.fi
Enforcement System in EU
• Member States are
responsible for REACH
& CLP enforcement; coordination through
ECHA’s Forum
REACH-EN-FORCE-1
2009 - 2011
Manufacturers,
importers, ORs
REACH-EN-FORCE-2
May 2011 – Dec 2011
Formulators
MSCA
MSCA access to
Reach-IT
REACH-EN-FORCE-3
2012 - ?
Customs and imports
MSCA
MSCA
MSCA
MSCA
MSCA
Cooperation with
Customs
MSCA
MSCA
Data exchange
among MSCA
www.reachlaw.fi
• ECHA ensures quality
of registration dossiers,
may delete invalid preregistrations and makes
registration information
available to MSCA for
enforcement purposes
• Customs authorities
may stop non-compliant
goods at the border
Big Variations in Maximum Penalties:
Administrative and Criminal Fines in EU
Other possible sanctions
apart from fines:
• Imprisonment
• Suspension of activity or
ban on use
• Destruction of the
substance
• publication of the
judgment
www.reachlaw.fi
Dealing With Enforcement - Recommendations
 Have a Compliance Management System in place
 Ensure timely compliance with all obligations
 Ensure documentation is ready
 Establish and maintain good communication channels
with your suppliers and customers
 Know local requirements/priorities in Member States
 Prepare for inspections
www.reachlaw.fi
Documentation is Key
REACH Article 36 (1) 1: “Each manufacturer, importer, downstream user and distributor
shall assemble and keep available all the information he requires to carry out his
duties under this Regulation for a period of at least 10 years after he last
manufactured, imported, supplied or used the substance or mixture.”












Up-to-date safety data sheets and proof of sending
Dossiers (registration, authorisation, etc.)
ECHA submission reports (on pre- /registration, notification, etc.) and decision letters
SIEF agreements and letters of access
For only representatives also: appointment letters and agreements with non-EU manufacturer; up-to-date lists of
quantities imported and customers sold to and information on the supply of the latest update of the SDS
For intermediates: confirmations of strictly controlled conditions from the customer; documentation of strictly
controlled conditions on your own site
Exemptions justified (exemption studies)
Test reports, e.g. showing that the substance is not hazardous under CLP
Volume
First-time manufacturer / importer confirmation
calculation
Registration deadline confirmation and supporting volume records
rules observed?
Product and substance inventories, info on legal entity structure, REACH roles, procedures
ETC.
www.reachlaw.fi
Enforcement Projects
REACH-EN-FORCE 3
 2012 - ?
 Targeting imports to EEA
 Focus on registration obligations, including
 Verification of registrations by Only Representatives
 Cooperation with customs authorities controlling imports of
substances
 A working group has been established for the project
 Separately from this project, some Member States will pilot
the verification of registrations for intermediates.
www.reachlaw.fi
Some Conclusions on Enforcement
 Inspectors are becoming increasingly equipped with
knowledge and enforcement tools and will be
decreasingly lenient with non-compliant companies, as
REACH matures
 Best way to meet enforcement demands is to put a
compliance management system in place that addresses
all aspects of REACH and CLP
 Documentation is key (actions, decisions, ..)
 Companies need to continuously monitor their own
compliance and regulatory changes in REACH, CLP and
beyond, and react appropriately
www.reachlaw.fi
Continuous Compliance Objectives
 Ensuring that only compliant (REACH/CLP) products
are placed on the market (or manufactured for that
matter)
 Ensuring continued supply of products to the
customers
 Providing customers with the required and proper and
relevant Safe Use Guidance concerning our products
(Safety Data Sheets, Extended Safety Data Sheets)
 Complying with requirements placed on the substances
that have been registered by client (namely keeping
registration up-to-date)
www.reachlaw.fi
Priorities For Companies For 2012
 Registration
 Prepare dossiers for 2013 deadline
 Intermediates - under special attention of authorities →
updates to full dossier required if intermediate definition or
SCC cannot be upheld.
 Authorisation
 Follow development of Candidate List and Annex XIV
 Prepare authorisation applications for substances on Annex XIV
or implement substitutes
 Enforcement
 Becoming increasinlgy developed and stricter, as REACH
matures
 REACH-EN-FORCE-3 “Customs and imports” to be launched
www.reachlaw.fi