Effective REACH Strategies Next Steps
Effective REACH Strategies Next Steps
www.steptoe.com
15 May 2012
Sciences
Darren Abrahams
382 days to go - Who should be concerned? Tonnages Registration Scenarios Late Pre-Registration Pre-SIEF or SIEF (and what to do) Data & cost sharing Compliance structures: focus on non-EU manufacturing Lessons from latest ECHA evaluation progress report Your secrets in the open? Areas for legal recourse Recommendations
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If manuf./import. over three consecutive years: average tonnage for a given year is based on the three preceding calendar years. If have not manuf./import. over three years: rather than calculating the average, the calendar year tonnages must be used.
NON-PHASE-IN SUBSTANCE
Not already Registered by 3rd party or Already Registered by 3rd party
if LR is known to you or you know LR does not exist If already registered Proceed to data (Art. 27) and cost sharing discussions
After 1 December 2008 pre-registration window, Submit Article 28(1) information to ECHA within six months of first manufacturing, importing or using the substance in quantities of one tonne or more per year and no later than 12 months before the relevant deadline
Despite best efforts this suggests that 2013 may be a challenge: No prior experience Far more SMEs More potential for disputes (costs/strategy/organisation) Action: Agree on substance identity (merge/split to form 1 SIEF per substance) Consider need for 3rd party trustee SIEF Formation Facilitator and/or Lead Registrant SIEF agreement and/or LR agreement, establishment of consortia Data gap analysis CLP Competition law/anti-trust pitfalls Document each stage
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X tonnage specific
TECHNICAL DOSSIER
X X -
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Must ECHA will give access if Data Owner refuses to provide (i) proof of costs or (ii) the study, and block Data Owners Registration. Art. 30(3)
Calculated in a fair, transparent and nondiscriminatory way If agreement cannot be reached on the amount of compensation the cost shall be shared equally Art 30(1) para. 1
Existing Study does not involve testing on vertebrate animals (wider than just animal i.e. nonanimal as well)
May ECHA has no power to oblige access but if a study is requested by a SIEF member, and a data owner refuses to share, the other SIEF participants can proceed as if the study did not exist. Art. 30(4)
Any new study involving tests which is required for Registration and is not available
One SIEF participant conducts one new study (for the purpose of fulfilling a Registration information requirement) on behalf of all other SIEF participants. The SIEF participants need to agree on (or ECHA will impose on them) which party should secure the new testing. Art 30(2) (see Art 29(3) also) More likely to be necessary in 2013 where data paucity anticipated.
Costs for the elaboration of the study with a share corresponding to the number of participating registrants. (This does not necessarily mean that equal shares will be borne by each of the SIEF members.) Art 30(2)13
Transparency in a SIEF/LR/Consortia agreement? Scope of Data sharing: Which rights? full ownership/legitimate possession/right to refer & geography) and purpose (REACH only)? Distinction between costs & data? Baseline data cost on basis of actual or reimbursement cost? Data costs include a risk premium?
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Reduction for 2013 lower data requirements? CSR produced by Lead Registrant? Reimbursement mechanism for overpaying (claw-back for
underpaying and updates)? Share of contribution with discount for related corporate entities? Are you being asked for commercial information not required by REACH (use of trustees)?
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Compliance Structures: (1) OR Compliance (2) Importers Compliance (3) Super-Importer Non-EU manufacturing multinationals
Model Model Model
No Aggregation of tonnages per non-EEA entity ECHA fees per non-EEA entity (multiplier effect) *Data access costs per nonEEA entity Spot market gone (not a problem if vertically integrated) but overcomes reliance on importer and disclosure of CBI Aggregation of tonnages per substance to each importer ECHA fees per importer (multiplier effect) not per nonEEA entity *Data access costs per EEA importer Importer can source from anyone for a substance it (pre)registered Aggregation of tonnages of each substance to Super Importer 1 ECHA fee per substance (but potentially >1,000 tonnes) *Only 1 Data access cost per substance Super Importer can source from anyone for a substance it (pre)registered BUT tax, contractual, logistical issues
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Common OR
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See Article 3(11) of REACH, and ECHA Registration Guidance, 2.1.2.4, on who is an importer.
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Super Importer
DU 1
DU 2 DU 3
See Article 3(11) of REACH, and ECHA Registration Guidance, 2.1.2.4, on who is an importer.
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Substance Identity: Not sufficiently precise. Dossiers are routinely filtered and when the substance is not clearly identified, the likelihood of the dossier being selected for compliance check is higher. Testing Proposals: Justification in registration dossier, when registrant has already started or conducted a study to meet an Annex IX or X information requirement for other than REACH purposes (absence undermines non-duplication objective). Use of Read Across: Assessment based on read across must be supported by robust scientific arguments in the registration dossier when used to adapt the standards information requirements (following Annex XI). Must have a scientific reasoning supported by experimental evidence establishing that the properties under consideration can indeed be predicted with sufficient certainty from data obtained with analogues or category members. Chemical Safety Assessment: Identified as a particular weak point in all aspects of the CSA.
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details of the full composition of a mixture precise use, function or application of a substance or mixture, including information about its precise use as an intermediate precise tonnage of the substance or mixture manufactured or placed on the market links between a manufacturer or importer and his distributors or downstream users
name in the IUPAC nomenclature for specified certain hazard classes name of the substance as given in EINECS
physicochemical data concerning the substance and on pathways and environmental fate result of each toxicological and ecotoxicological study DNEL or PNEC established in accordance with Annex I guidance on safe use provided in accordance with Sections 4 and 5 of Annex VI
trade name(s) of the substance subject to Article 24 of CLP Reg, the name in the IUPAC nomenclature for non-phase-in substances for a period of six years subject to Article 24 of CLP Reg, the name in the IUPAC nomenclature for substances with specified certain hazard classes that are only used as intermediate, in scientific research and development; and/or PPORD
analytical methods if requested in accordance with Annexes IX or X which make it possible to detect a dangerous substance when discharged into the environment as well as to determine the direct exposure of humans
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To amend a draft decision on examination of testing proposals, compliance of registration dossier, or request further information and examination of that information. [Articles 51, 40 and 41] To permit other registrants to report on vertebrate testing study were study owner SIEF will not provide it or to refer to info in the registration dossier where already a registration with information needed [Articles 30(3) and (4)] Which SIEF member will carry out testing for new studies not available in SIEF where members cant agree [Article 30(2)]
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To permit potential registrant (non-pre-registered phase-in substances or non-phase-in substances) to refer to existing information where data owner does not agree to share information [Article 27(6), (7)] To reject an incomplete registration where missing information not supplied by registrant within deadlines [Article 20(2), (5)] To impose conditions on PPORD substances re. limiting handling and control conditions [Article 9(4)]
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Any natural or legal person against a decision addressed to that person, or Of direct and individual concern but addressed to another person [Art. 92(1)]
3 month time limit to bring appeal from date of notification or (if not notified) date on which it became known:
Short if you are an Appellant Immediate work needs to begin as soon as you are aware of a problem
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Recommendations
REACH requires an integrated (technical/legal/commercial) compliance strategy. Many issues taking most time are not those grasped by the EU legislator. Many REACH compliance strategies were constructed under the time pressure of the pre-registration window in 2008. You can review your strategy now and find cost savings before committing to 2013 costs. In 2013 Data and Cost sharing disputes may be more common given the different nature of the registrants (compared to 2010). Think about how to submit information to ECHA. Competitors and NGOs will use dissemination and ATD tools to gather commercial information. REACH presents an unusually good opportunity for legal recourse. Know your rights and be prepared to use them. ***
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Content
1. Evaluation processes under REACH 2. The CoRAP List 3. Consequences of inclusion in the CoRAP List
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ECHA examines a percentage (min 5%) of registration dossiers per tonnage band to determine if information provided is in compliance with REACH requirements Compliance check is different from completeness check: the latter is a technical check (Art. 20 REACH) - no quality or adequacy assessment Compliance check may last up to 12 months ECHA must examine all testing proposals submitted by registrants Testing can be accepted/rejected or accepted with suggested modifications
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1. Substance Evaluation
Aim of evaluation:
To clarify whether a substance with potential concern poses an actual risks to human health/environment To request additional information (even beyond REACH requirements) concerning such potential risks If justified, to adopt EU-wide risk managements measures
Member States volunteer to evaluate selected substances (Member State Committee decides on final allocation; ECHA coordination role) It starts with the selection of substances in the Community Rolling Action Plan (CoRAP) All registration dossiers concerning same substance are evaluated targeting a substance, not a registrant
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2.
ECHA guidance on Selection criteria to prioritise substances for Substance Evaluation (to be refined periodically)
Concerns in the first CoRAP List mainly based on known (e.g. CLH) or suspected (e.g. prediction models) properties of being
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Inclusion in the CoRAP list does not determine immediate obligations for registrants (cf. a contrario Candidate List) selection criteria are risk-based Publication of CoRAP is not a challengeable act
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Potential new risk management measures (e.g. identification as SVHC; restrictions; etc.) will be subject to a separate decision making process: e.g. Member States may submit Annex XV dossiers How can registrants/stakeholders interact with the evaluating Member State(s)?
No defined rules: ECHA provides that possibility of interaction may differ between Member States ECHA/Member States are expected to adopt recommendations (not likely to be adopted during first round of evaluation in 2012)
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Craig Simpson
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EU Enforcement Coordination
REACH Forum for exchange of information on enforcement Aim: cooperation, coordination and exchange of information between EU 27, ECHA and Commission Use of a minimum inspection criteria REACH-EN-FORCE 1: First Coordinated Enforcement Project Started 2009, extended to April 2011 No data, no market principle focus: (pre-)registration, SDS format in chemicals/chemical products, minerals and basic metals Prolongation phase (May 2010-April 2011) Forum Fact Report:
Non-compliance in 20% of companies (mostly SDS unavailable or incorrect format/not in required languages) No (pre-)registration in 55 out of 700 cases
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EU Enforcement Coordination
Future REACH-EN-FORCE 2, May 2011 on-going: Focus: downstream user formulators of mixtures (paints, cleaning products): (pre-)registration and CLP notification Inform downstream users of DU (SDS) requirements Forum RIPE tool: enforcement agency access to registration dossiers (enable targeted screening reports) Anticipated Electronic Information Exchange System (EIES) for ECHA, CAs and enforcement agencies Proposed REACH-EN-FORCE 3 starts January 2013 Focus: cooperation with customs re registration of imports
Commission March 2012 report: the majority of noncompliant products are imported products
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Inspections triggered by: Market surveillance by competent authorities Competitors: designated CA contact points in some countries ECHA (following dossier evaluation, intermediates survey etc.) Consumer organisation/NGOs (for example, Article 33 consumer information requirement) Typical procedure: Competent authority letter 3-6 weeks before proposed inspection date requesting:
Pre-inspection inventory of each substance indicating M/I or DU Relevant compliance documents for inspection
Warehouse tour focus on imports from third countries Copies of documents and emails taken follow up questions?
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Enforcement Techniques
Techniques differ in each Member State: Site visits or customs at EU border Desk-top enforcement: resource-friendly Educate as well as control
Learning experience for both inspectors and inspected Compliance means awareness: information campaigns Pragmatism: possibility of grace period with written follow up?
Wide search, sampling and seizure powers for health inspectors, customs officials
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External pre-inspection audit: identify and remedy compliance gaps On-site support during inspection Liaising with enforcement agencies in case of infringement avoid/minimise sanctions or business interruption Staff training: REACH, especially inspections, required joining the dots (sales, technical, regulatory, legal)
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Commission power to request specific national investigations (Commission report on improving enforcement March 2012) Joint industry statement on REACH enforcement March 2012 (principal chemicals trade associations): Uniform, consistent, transparent and fair
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Sanctions should distinguish deliberate and accidental breach (proportionate) Need for effective communication channels between industry and national authorities to report non-compliance REACH Enforce 3: industry and customs involvement to ensure customs controls workable:
Checks to be compatible with clearance demands Business interruption/blocking only in worst (deliberate?) cases Compliance self declaration rather than registration no. check (2018?, registerable?)
Harmonisation for level playing field but need to respect national differences Comparable, not uniform, enforcement (BAuA, Germany)
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Fines to reflect size of national market (but 5,000 v. 55,000?) Interpretation differences re 0.1% SVHC notification/information requirements Enforcement target in dissenting Member
States (France, Austria, Belgium, Denmark, Germany, Sweden)?
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ECHA Evaluation Report 2011 (February 2012) Essential reading for 2013 registrants and call for action for [existing] registrants, ECHA Executive Director 75% dossiers fail 2011 evaluation compliance checks:
Ambiguous substance identity (lack of analytical information) (72%) Insufficient scientific support for read across Chemical safety reports (inadequate risk identification and RMMs)
Perception of insufficient quality of registrations overall Quality observation letter (QOBL) requiring update if error Draft decision to submit missing info by deadline Member States informed and may take enforcement action. Chance to put house in order before national enforcement
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Conclusions
Inspection: preparation is the key ECHA and Forum reports suggest widespread non-compliance Stakeholder recognition of enforcement shortcomings Increasingly proactive role of ECHA and Commission Expanded powers? Enforcement areas to watch going forward: Incomplete registration dossier Intermediate/SCC verification Article 33 consumer information re SVHC in articles Restricted substances (Annex XVII) Act promptly if receive ECHA enquiry
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Announcements
Stay tuned for future REACH webinars Visit our REACH and Nano Resource Centers
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Dr. Anna Gergely Director, EHS Regulatory +32 2 626 0542 [email protected]
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