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Effective REACH Strategies Next Steps

Seth goldberg is a partner in Steptoe's Washington office. He has More than 30 years of experience in a broad range of issues centered on chemical regulation. His Clients include leading multinational companies and trade associations.

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0% found this document useful (0 votes)
147 views52 pages

Effective REACH Strategies Next Steps

Seth goldberg is a partner in Steptoe's Washington office. He has More than 30 years of experience in a broad range of issues centered on chemical regulation. His Clients include leading multinational companies and trade associations.

Uploaded by

Olga Burns
Copyright
© Attribution Non-Commercial (BY-NC)
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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Effective REACH Strategies: Next Steps

www.steptoe.com

15 May 2012

Copyright 2011 Steptoe & Johnson LLP. All Rights Reserved.

Moderator: Seth Goldberg



Partner in Steptoes Washington office More than 30 years of experience in a broad range of issues centered on chemical regulation In the US, practice focuses on FIFRA and TSCA; in Europe, on biocides, pesticides, and REACH Devotes substantial time to direct advocacy before regulatory agencies Heavily involved in organization and management of data generation consortia, data compensation and advocacy on scientific issues Clients often call on him to represent them in complex matters before administrative agencies and judicial challenges to agency decisions

Presenter: Darren Abrahams



Barrister and Partner in Steptoes Brussels office Focus on EU regulatory requirements and related commercial issues in the environment, chemicals and life sciences area Advocacy and representation before the Court of Justice of the European Union, EU Institutions and Agencies, and before the national authorities of EU Member States Pre-market authorizations for biocides, PPPs, GMOs, and REACH substances Due Diligence aspects of international transactions and the structuring compliance programs Consistently recommended by Legal 500 EMEA, Chambers & Partners Europe and PLC Which Lawyer? Yearbook
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Presenter: Dr. Anna Gergely



Director, EHS Regulatory in Steptoes Brussels office where, in a role equivalent to partner, she is the firms principal scientist Practice covers chemicals with a sharp focus on nanotechnology; including food-contact materials, the REACH regulation, agro-biotechnology, biocides, cosmetics, food and feed, medical devices, and a range of consumer and industrial products Recommended by Legal 500 EMEA 2011 for EU Regulatory: Environment and Chemicals (REACH) Chair of European Commission NANOfutures Regulation working group and AmCham EUs Nanotechnology Task Force PhD in analytical chemistry and quantum chemistry, and a registered European patent attorney

Presenter: Craig Simpson



UK qualified solicitor and an associate in Steptoes Brussels office Practice focuses on EU regulatory requirements and related commercial issues in the life sciences field and EC competition law Clients include leading multinational companies and trade associations operating at both European and international levels Regularly lectures and publishes on matters affecting the Life Sciences industries and competition law Consistently recommended as a leading practitioner in the Global Counsel Which Lawyer? Yearbook for EU Life

Sciences

2013 Registrations: How to get there painlessly

Darren Abrahams

What we will cover

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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Who should be concerned? Tonnages


31 May 2013 registration deadline for phase-in substances manuf./import. in quantities reaching 100 (metric) tonnes or more per year per manufacturer or per importer, at least once after 1 June 2007:

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.

Who should be concerned? Registration Scenarios


2013 is about pre-registered phase-in substances.
PHASE-IN SUBSTANCE
Data (Art. 30) and cost sharing Existing SIEF and LR from 2010 or SIEF to be formed and LR chosen
Pre-registered by you

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

Must follow Article 26 Inquiry Procedure even

Not Pre-registered by you Must follow Article 26 Inquiry Procedure

Unless late pre-registration applies (Art 28(6))


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Who should be concerned? Late Pre-registration


A few days remain during which late pre-registration can be carried out for 2013 phase in substances by potential registrants if satisfy Article 28(6) conditions:

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

Consider need for appointing a Third Party Representative


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Pre-SIEF or SIEF? And what to do


ECHA reports that: Pre-registrants intend to register around 3,200 substances by 2013 deadline of which
around 2300 or 72% were not registered in 2010

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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What to do? Information Requirements


REACH REGISTRATION INFORMATION REQUIREMENTS JOINT SUBMISSION LEAD REG. INDIVIDUAL SUBMITS SUBMISSION (first) (after LR) X X X X X X OPT OUT FROM JOINT SUBMISSION (if objectively justified) LEAD REG. MAY SUBMIT OR INDIVIDUAL REG. MAY SUBMIT (i) the identity of the manufacturer(s) or importer(s) as specified in section 1 of Annex VI; (ii) the identity of the substance as specified in section 2 of Annex VI; (iii) information on the manufacture and use(s) of the substance as specified in section 3 of Annex VI; this information shall represent all the registrant's identified use(s). This information may include, if the registrant deems appropriate, the relevant use and exposure categories; (iv) the classification and labelling of the substance as specified in section 4 of Annex VI; (v) guidance on safe use of the substance as specified in Section 5 of Annex VI; (vi) study summaries of the information derived from the application of Annexes VII to XI; (vii) robust study summaries of the information derived from the application of Annexes VII to XI, if required under Annex I; (viii) an indication as to which of the information submitted under (iii), (iv), (vi), (vii) or subparagraph (b) has been reviewed by an assessor chosen by the manufacturer or importer and having appropriate experience; (ix) proposals for testing where listed in Annexes IX and X; (x) for substances in quantities of 1 to 10 tonnes, exposure information as specified in section 6 of Annex VI; (xi) a request as to which of the information in Article 119(2) the manufacturer or importer considers should not be made available on the Internet in accordance with Article 77(2)(e), including a justification as to why publication could be harmful for his or any other concerned party's commercial interests. (b) a chemical safety report when required under Article 14, in the format specified in Annex I. The relevant sections of this report may include, if the registrant Considers appropriate, the relevant use and exposure categories. CSR X X X X X tonnage specific X tonnage specific X X tonnage specific X X (inferred) X (inferred)

X tonnage specific

TECHNICAL DOSSIER

X increases risk of Evaluation X increases risk of Evaluation X increases risk of Evaluation X -

X X -

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Data Sharing Existing & New Pre-Registered Phase-In Substances


PROSPECTIVE REGISTRANT Data Inquire before testing whether a relevant study is available Must Art 30(1) para. 1 Request Access from Data Owner (if data is protected) Must Art 30(1) para. 1 DATA OWNER Provide Access Compensation Terms

Existing Study Involving Vertebrate Animal Tests

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)

Must Art 30(1) para. 1

May Art 30(1) para. 1

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

Data & Cost Sharing


No legislative detail or common practice on valuation and sharing. However, see latest April 2012 ECHA Data Sharing Guidance. Issues to consider include:

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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Data & Cost Sharing


Issues to consider include:
Bundling of data costs for groups of substances?

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

*Data citation and cost sharing formulae determinative of cost-saving potential

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(1) OR compliance model

Related Non-EEA manufacturers

Common OR

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(2) Importer compliance model

Related Non- EEA manufacturers

Importer 1 Importer 2 Importer 3

See Article 3(11) of REACH, and ECHA Registration Guidance, 2.1.2.4, on who is an importer.

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(3) Super Importer compliance model

Related Non- EEA manufacturers

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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Lessons from Latest ECHA Evaluation Progress Report


ECHA has underlined a number of areas of concern including:

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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Your secrets in the open?


Access to Documents Regulation ECHA Dissemination Portal:
http://echa.europa.eu/web/guest/information-onchemicals/registered-substances

Apparent that information which 2010 registrants did not


expect to see in the public domain is now finding its way there. 2013 registrants have a clearer view on this issue.

ECHA has been reminding registrants of the ability to


claim confidentiality.
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Your secrets in the open?


Access to Documents Art. 118 + Reg. 1049/2001 NON-DISCLOSURE PRESUMPTION DISSEMINATION Dissemination Art. 119 DISSEMINATION UNLESS 10(A)(XI) CONFIDENTIALITY CLAIM GRANTED if it is potentially harmful to commercial interests if essential to classification and labelling, the degree of purity of the substance and the identity of impurities and/or additives which are known to be dangerous the total tonnage band (i.e. 1 to 10 tonnes, 10 to 100 tonnes, 100 to 1 000 tonnes or over 1000 tonnes) within which a particular substance has been registered study summaries or robust study summaries of physicochemical data and tox and ecotox results Other SDS information

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

classification and labelling of substance

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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Areas for Legal Recourse


Areas where ECHAs acts are potentially subject to a prompt and efficient legal review before ECHAs Board of Appeal (and the General Court cannot be bypassed):

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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Areas for Legal Recourse


Review before ECHAs Board of Appeal:

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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Areas for legal recourse


Appeal can be brought against an Agency decision by:

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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EVALUATION What to do if your substance is on the CoRAP list

Dr. Anna Gergely

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Content

1. Evaluation processes under REACH 2. The CoRAP List 3. Consequences of inclusion in the CoRAP List

28

1. Evaluations: Dossier v Substance


Evaluations under REACH Title VI

Dossier evaluation Substance evaluation

See Evaluation under REACH - Progress Report 2011

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1. Evaluation of Dossiers and Testing Proposals


Art. 41 Dossier evaluation or compliance check

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

Art. 43 Examination of testing proposals


30

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
31

2. The CoRAP List / Selection Criteria

Selection following risk-based approach, taking into account:


1. General criteria defined in REACH:
Hazard information (structural alerts) Exposure (human and environment) Tonnages (aggregated, from all registrants)

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

PBT Endocrine disruption CMR

combined with wide dispersive use or consumer uses.


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2. The 1st CoRAP List



A list of substances selected for evaluation over a 3 years period, divided in 3 groups. First list: 2012, 2013, 2014 Evaluation must be conducted within 12 months by the Member State First CoRAP List adopted on 29th February 2012, 90 substances:

36 to be evaluated in 2012, by 28th February 2013

Rolling nature: list is updated/amended every year by 28th February


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2. The CoRAP List / Evaluation



Evaluating Member States must adopt a draft decision within 12 months from publication of CoRAP on ECHAs website (no decision = evaluation completed) Draft decision will include a deadline for the registrant to comment Final decision taken within additional 12 months from receiving requested information from the registrant Initial concern is not resolved and/or additional grounds of concern identified: need for risk management actions:

Harmonised classification and labelling (CLH) To identify the substance as SVHC Adoption of restrictions Actions outside the scope of REACH, such as proposals for occupational exposure limits

34

3. The CoRAP List / Obligations

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

35

3. The CoRAP List / Consequences

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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Latest Developments in REACH Enforcement

Craig Simpson

37

REACH Enforcement Framework Basics



Not one jurisdiction, 27 Member States National inspection authorities or courts Member States shall maintain a system of official controls Member States shall adopt 'effective, proportionate and dissuasive' sanctions for infringements Sanctions implemented in national laws: Requirement to withdraw from market (marketing gap prior to registration) Criminal and/or administrative Fines (EUR 5,000 to 55,000) on M/I and ORs Injunctions (incl. market withdrawal) Prison sentences (1 month to 25 years) for M/I or OR Naming and shaming - negative effect on supply chain

38

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

39

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
40

Intelligence re Inspection Procedures

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?
41

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?

Sampling and analysis of products on shelf


Restricted substances (for example, PAHs in tyres, toluene in superglues)

Wide search, sampling and seizure powers for health inspectors, customs officials
42

Intelligence re Inspection Target Areas

Substance of inspections: Inspectors follow pre-prepared questionnaire, verification of:



SVHC and/or high tonnage (already registered) substances on site CLP notification (2010 registration or notification number) Eligibility for pre-registration? Match previous years tonnage records with invoices ECHA/supplier (pre-)registration confirmations Support for application of exemptions Evidence of sameness agreement, cross check IUCLID and SIEF description Where relevant, compliance on-site with Annex XVII restrictions SDS: format, translations, registration no., proof sent, uses covered

43

Strategies for Dealing with Inspections



Internal compliance manual: inspection due diligence, supply chain responsibilities, local enforcement practices
Clearly designated REACH implementation manager

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)

44

Comments on Status of REACH Enforcement



ECHA: Enforcement key to REACH success or failure Limited resources of national enforcement bodies recognised ECHA/Commission support role in identifying non-compliance ECHA initiate remedies for non-compliance (contribution to Article 117.4 Commission report on operation of REACH)
Withdrawal of registration numbers if deficient dossier

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

45

Comment on Status of REACH Enforcement

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)
46

Comment on Status of REACH Enforcement

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)?

47

Identification of Enforcement Targets

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

48

Identification of Enforcement Targets



Article 36 registrant requests on intermediate qualification and use under strictly controlled conditions ECHA dossier compliance, or national on-site, checks anticipated Forum to enforce compliance with Article 33 SVHC consumer information Surveys suggest no or inadequate answers to consumers Information campaigns for retailer obligation awareness Commission report March 2012 on improving enforcement : Focus on exposure scenarios, supply chain communications and substances in articles Increase enforcement of restricted substances by:
Commission identifying analytical methods and available testing labs Site visits only if desk-based inspections require (resources)
49

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
50

Announcements

Stay tuned for future REACH webinars Visit our REACH and Nano Resource Centers

51

Questions & Answers

Darren Abrahams Partner +32 2 626 0500 [email protected]

Dr. Anna Gergely Director, EHS Regulatory +32 2 626 0542 [email protected]

Craig Simpson Associate +32 2 626 0559 [email protected]

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