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7/31/2019 Effective REACH Strategies Next Steps
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www.steptoe.com 15 May 2012
Effect ive REACH St rategies:Next Steps
Copyright 2011 Steptoe & Johnson LLP. All Rights Reserved.
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Moderator: Seth Goldberg
Partner in Steptoes Washington office
More than 30 years of experience in a broad range of issuescentered 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 onscientific issues
Clients often call on him to represent them in complex
matters before administrative agencies and judicialchallenges to agency decisions
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Present er: Darren Abrahams
Barrister and Partner in Steptoes Brussels office
Focus on EU regulatory requirements and relatedcommercial issues in the environment, chemicals and lifesciences area
Advocacy and representation before the Court of Justice of
the European Union, EU Institutions and Agencies, andbefore the national authorities of EU Member States
Pre-market authorizations for biocides, PPPs, GMOs, andREACH substances
Due Diligence aspects of international transactions and the
structuring compliance programs
Consistently recommended by Legal 500 EMEA, Chambers &Partners Europeand PLC Which Lawyer? Yearbook
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Present er: 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 REACHregulation, agro-biotechnology, biocides, cosmetics, food andfeed, medical devices, and a range of consumer and industrial
products
Recommended by Legal 500 EMEA 2011for EU Regulatory:Environment and Chemicals (REACH)
Chair of European Commission NANOfuturesRegulation
working group and AmCham EUs Nanotechnology Task Force PhD in analytical chemistry and quantum chemistry, and a
registered European patent attorney
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Present er: Craig Simpson
UK qualified solicitor and an associate in Steptoes
Brussels office
Practice focuses on EU regulatory requirements andrelated commercial issues in the life sciences field andEC competition law
Clients include leading multinational companies andtrade associations operating at both European andinternational levels
Regularly lectures and publishes on matters affectingthe Life Sciences industries and competition law
Consistently recommended as a leading practitioner inthe Global Counsel Which Lawyer? Yearbook for EU LifeSciences
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2013 Regist rat ions:How to get t here painlessly
Darren Abrahams
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What w e w il l 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 substancesmanuf./import. inquantities reaching 100 (metric)tonnes or more per year permanufacturer or per importer, at leastonce after 1 June 2007:
If manuf./import. over threeconsecutive years: average tonnagefor a given year is based on the threepreceding calendar years.
If have not manuf./import. over threeyears: rather than calculating theaverage, the calendar year tonnagesmust be used.
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Who should be concerned?Regist rat ion Scenar ios
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PHASE- I N SUBSTANCE NON-PHASE- I N SUBSTANCE
Pre-r egistered by youData (Art. 30) and cost sharing
Existing SIEF and LR from 2010 orSIEF to be formed and LR chosen
Not already Registered by 3 rd part y orAlready Registered by 3 rd party
Must follow Article 26 Inquiry Procedure evenif LR is known to you or you know LR does not
exist
If already registeredProceed to data (Art. 27) and cost sharing
discussions
Not Pre-registered by you
Must follow Article 26 Inquiry Procedure
Unless late pre-registration applies (Art 28(6))
2013 is about pre-registered phase-in substances.
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Who should be concerned? Late Pre-regist rat ion
A few days remain during which late pre-registrationcan be carried out for 2013 phase in substances bypotential registrants if satisfy Article 28(6) conditions:
After 1 December 2008 pre-registration window,
Submit Article 28(1) information to ECHA within six months offirst manufacturing, importing or using the substance inquantities of one tonne or more per year and no later than 12months before the relevant deadline
Consider need for appointing a Third PartyRepresentative
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Pre-SI EF or SI EF?And w hat t o do
ECHA reports that:
Pre-registrants intend to register around 3,200 substances by 2013 deadline of whicharound 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 t o do?I nformat ion Requirements
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REACH REGISTRATI ONI NFORMATION REQUI REMENTS
JOI NT SUBMI SSI ON OPT OUT FROMJOI NT
SUBMI SSI ON
(if objectivelyj ust if ied)
LEAD REG. MAYSUBMI T
ORI NDI VIDUALREG. MAYSUBMI T
LEAD REG.SUBMI TS
(first)
INDIVIDUALSUBMI SSI ON
(aft er LR)
TECHNICALDOSSIER
( i ) the iden t it y o f the manufactu rer(s) or importer(s) as specified in section 1 of Annex VI; X X - -
( i i) t he iden t it y o f the substance as specified in section 2 of Annex VI; X X - -( i ii ) i nfor mat i on on the manufactu r e 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 mayinclude, if the registrant deems appropriate, the relevant use and exposure categories;
X X - -
( iv) the class if icat ion and labell ing of the substance as specified in section 4 of Annex VI; X Xtonnage specific
X
increases risk ofEvaluation
-
(v ) gu idance on safe use of the substance as specified in Section 5 of Annex VI; - X
(v i ) study summar ies of the information derived from the application of Annexes VII to XI; X Xtonnage specific
Xincreases risk of
Evaluation
-
(v i i) robust study summar ies of the information derived from the application of Annexes VII toXI, if required under Annex I;
X Xtonnage specific
X
increases risk ofEvaluation
-
( vi ii ) an i nd icat i on as to which of the information submitted under (iii), (iv), (vi), (vii) orsubparagraph (b) has been r ev iew ed by an assesso r chosen by the manufacturer or importerand having appropriate experience;
X X - X
( ix ) p roposa ls fo r test ing where listed in Annexes IX and X; X Xtonnage specific
X -
(x) for substances in quantities of1 to 10 t onnes, exposure information as specified in section6 of Annex VI;
X - -
( xi ) a r eq uest as t o w h ich of t h e i nf or m at i on i n Ar t icl e 1 19 (2 ) the manufacturer or importerconsiders 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 concernedparty's commercial interests.
X
(inferred)X
(inferred)- -
CSR
( b ) a chemical sa fety r epor t 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, therelevant use and exposure categories.
- - - X
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Data Shar ing Exist ing & New
Pre-Registered Phase-I n Substances
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PROSPECTIVE REGISTRANT DATA OWNER Compensation Terms
Data Inquirebefore testing
whether a relevant study isavailable
Request Accessfrom Data Owner
(if data is protected)
Provide Access
Existing Study
Involving VertebrateAnimal Tests
Must
Art 30(1) para. 1
Must
Art 30(1) para. 1
Must
ECHA will give access if DataOwner refuses to provide (i) proof of
costs or (ii) the study, and blockData Owners Registration.
Art. 30(3)
Calculated in a fair,transparent and non-discriminatory way
If agreement cannot be
reached on the amount ofcompensation the cost shall be
shared equally
Art 30(1) para. 1
Existing Study does
not involve testingon vertebrate
animals (wider thanjust animal i.e. non-
animal as well)
Must
Art 30(1) para. 1
May
Art 30(1) para. 1
May
ECHA has no power to obligeaccess but if a study is requested bya SIEF member, and a data owner
refuses to share, the other SIEFparticipants can proceed as if the
study did not exist.
Art. 30(4)
Any new studyinvolving tests
which is required forRegistration and is
not available
One SIEF participant conducts one new study (for the purpose of fulfilling a Registrationinformation 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 thestudy with a share
corresponding to the number ofparticipating registrants.
(This does not necessarilymean that equal shares will be
borne by each of the SIEFmembers.)
Art 30(2)
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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/legitimatepossession/right to refer & geography) and purpose (REACHonly)?
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 forunderpaying and updates)?
Share of contribution with discount for related corporateentities?
Are you being asked for commercial information notrequired by REACH (use of trustees)?
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Compliance St ructures:Non-EU manufactur ing mult inat ionals
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(1) OR ComplianceModel
(2) I mpor ters ComplianceModel
(3) Super-I mporterModel
No Aggregation of tonnagesper non-EEA entity
Aggregation of tonnages persubstance to eachimporter
Aggregation of tonnages ofeach substance to Super
Importer
ECHA fees per non-EEAentity (multiplier effect)
ECHA fees per importer(multiplier effect) not per non-
EEA entity
1 ECHA fee per substance (butpotentially >1,000 tonnes)
*Data access costs per non-EEA entity
*Data access costs per EEAimporter
*Only 1 Data access cost persubstance
Spot market gone (not aproblem if vertically
integrated) but overcomes
reliance on importer anddisclosure of CBI
Importer can source fromanyone for a substance it
(pre)registered
Super Importer can sourcefrom 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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Related
Non-EEA manufacturers
Common OR
(1) OR compliance model
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Related
Non- EEA manufacturers
(2) I mport er compliance model
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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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Related
Non- EEA manufacturers
(3) Super I mport er compliancemodel
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DU 1
DU 2
DU 3
Super
Importer
See Article 3(11) of REACH, and ECHA Registration Guidance, 2.1.2.4, on who is an importer.
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Lessons f rom Latest ECHAEvaluat ion Progress Report
ECHA has underlined a number of areas of concern including:
Substance Identity: Not sufficiently precise. Dossiers are routinely filtered and whenthe substance is not clearly identified, the likelihood of the dossier being selected forcompliance check is higher.
Testing Proposals: Justification in registration dossier, when registrant has alreadystarted or conducted a study to meet an Annex IX or X information requirement for
other thanREACH purposes (absence undermines non-duplication objective).
Use of Read Across: Assessment based on read across must be supported byrobust scientific arguments in the registration dossier when used to adapt thestandards information requirements (following Annex XI). Must have a scientificreasoning supported by experimental evidence establishing that the properties underconsideration can indeed be predicted with sufficient certainty from data obtained withanalogues or category members.
Chemical Safety Assessment: Identified as a particular weak point in all aspects ofthe CSA.
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Your secret s in t he open?
Access to Documents Regulation
ECHA Dissemination Portal:http://echa.europa.eu/web/guest/information-on-chemicals/registered-substances
Apparent that information which 2010 registrants did notexpect to see in the public domain is now finding its waythere. 2013 registrants have a clearer view on this issue.
ECHA has been reminding registrants of the ability toclaim confidentiality.
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Your secret s in t he open?
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Access to DocumentsArt. 118 + Reg. 1049/ 2001
DisseminationArt. 119
NON-DI SCLOSURE PRESUMPTI ON DI SSEMI NATI ON DI SSEMI NATI ONUNLESS 10( A)( XI ) CONFIDENTI ALI TY CLAI M GRANTED
if it is potentially harmful to commercial interests
details of the full composition of amixture
name in the I UPAC nomenclatu re for specified certain hazardclasses
if essential t o classification and labelling, the degree of purit yof t he substance and the identity of impurit ies and/ oradditives which are known t o be dangerous
precise use, function or application ofa substance or mixt ure, includinginform ation about its precise use asan intermediate
name of the substance as given in EI NECS the total t onnage band (i.e. 1 to 10 tonnes, 10 to 100 tonnes, 100to 1 000 tonnes or over 1000 tonnes) within which a particularsubstance has been registered
precise t onnage of the substance ormixture manufactured or placed on the
market
classification and labelling of substance study summaries or robust study summaries ofphysicochemical data and tox and ecotox results
links between a manufacturer orimporter and his distributors ordownstream users
physicochemical data concerning the substance and on pathwaysand environmental fate
Other SDS information
result of each toxicological and ecotoxicological study trade name(s) of the substance
DNEL or PNEC established in accordance with Annex I subject to Article 24 of CLP Reg, the name in the IUPAC nomenclaturefor non-phase-in substances for a period of six years
guidan ce on safe use provided in accordance with Sections 4
and 5 of Annex VI
subject to Article 24 of CLP Reg, the name in the IUPAC nomenclature
for substances with specified certain hazard classes that are only usedas intermediate, in scientific research and development; and/or PPORD
analytical methods if requested in accordance with Annexes IX or Xwhich make it possible to detect a dangerous substance whendischarged into the environment as well as to determine the directexposure 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 Courtcannot be bypassed):
To amend a draft decision on examination oftesting proposals,
compliance ofregistration dossier, or request further information andexamination of that information. [Articles 51, 40 and 41]
To permit other registrants to report on vertebrate testing study werestudy owner SIEF will not provide it or to refer to info in the registrationdossier where already a registration with information needed [Articles
30(3) and (4)]
Which SIEF member will carry out testing for new studies not availablein 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-insubstances or non-phase-in substances) to refer to existinginformation 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 handlingand 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 thatperson, or
Ofdirect and individual concernbut addressed to another person [Art.92(1)]
3 month time limit to bring appeal from date of notification or(ifnot 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 theEU legislator.
Many REACH compliance strategies were constructed under the timepressure of the pre-registration window in 2008. You can review yourstrategy now and find cost savings before committing to 2013 costs.
In 2013 Data and Cost sharing disputes may be more common giventhe different nature of the registrants (compared to 2010).
Think about how to submit information to ECHA. Competitors andNGOs will use dissemination and ATD tools to gather commercialinformation.
REACH presents an unusually good opportunity for legal recourse.Know your rights and be prepared to use them.
***
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EVALUATI ONWhat t o do if your substance is
on t he 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
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1. Evaluat ions: Dossier v Substance
Evaluat ions under REACH Tit le VI
Dossier evaluation
Substance evaluation
SeeEvaluation under REACH - Progress Report 2011
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1. Evaluat ion of Dossiers and Test ing
Proposals
Art . 41 Dossier evaluat ion or compliance check ECHA examines a percentage (min 5%) of registration dossiers per
tonnage band to determine ifinformation provided is in compliancewithREACH requirements
Compliance checkis different from completeness check: the latter is atechnical check (Art. 20 REACH) - no quality or adequacy assessment
Compliance check may last up to 12 months
Art . 43 Examination of t est ing proposals ECHA must examine al l testing proposals submitted by registrants
Testing can be accepted/rejected or accepted with suggestedmodifications
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1. Substance Evaluat ion
Aim of evaluation:
To clarify whether a substance with potential concern poses anactual risks to human health/environment
To request additional information (even beyond REACHrequirements) 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; ECHAcoordination role)
It starts with the selection of substances in the CommunityRolling Action Plan (CoRAP)
All registration dossiers concerning same substance areevaluated targeting a substance, not a registrant
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2. The CoRAP List / Select ion Cr it er ia
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 Select ion crit eria to prioritise substancesfor 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 disrupt ion
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 theMember State
First CoRAP List adopted on 29th February 2012, 90substances:
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 / Evaluat ion
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 receivingrequested information from the registrant
Initial concern is not resolved and/or additional grounds of concernidentified: need for risk management act ions:
Harmonised classification and labelling (CLH)
To identify the substance as SVHC
Adoption ofrestrictions Actions outside the scope of REACH, such as proposals for
occupational exposure limits
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3. The CoRAP List / Obligat ions
Inclusion in the CoRAP list does not determine immediate
obligations for registrants (cf. a contrarioCandidate List) selection criteria are risk-based
Publication of CoRAP is not a challengeable act
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3. The CoRAP List / Consequences
Potential new risk management measures (e.g. identification as
SVHC; restrictions; etc.) will be subject to a separate decisionmaking process: e.g. Member States may submit Annex XVdossiers
How can regist rant s/ stakeholders int eract with theevaluating Member State(s)?
No defined rules: ECHA provides that possibility of interactionmay 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 Development s inREACH Enforcement
Craig Simpson
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REACH Enforcement Framew ork
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 anddissuasive' 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
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EU Enforcement Coordinat ion
REACH Forum for exchange of information on enforcement
Aim: cooperation, coordination and exchange of informationbetween 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, SDSformat 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 Coordinat ion
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 ofimports
Commission March 2012 report: the majority of non-compliant products are imported products
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I nt ell igence re I nspect ion
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 inspectiondate 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?
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
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I nt ell igence re I nspect ion 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 SIEFdescription
Where relevant, compliance on-site with Annex XVII restrictions
SDS: format, translations, registration no., proof sent, uses covered
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St rategies for Dealing w it h
I nspect ions
Internal compliance manual: inspection due diligence, supply
chain responsibilities, local enforcement practices Clearly designated REACH implementation manager
External pre-inspection audit: identify and remedy compliancegaps
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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Comment s 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 Article117.4 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 (principalchemicals trade associations):
Uniform, consistent, transparent and fair
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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 ensurecustoms 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 nationaldifferences
Comparable, not uniform, enforcement (BAuA, Germany)
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Comment on Status of REACH
Enforcement
Fines to reflect size of national market (but5,000 v.55,000?)
Interpretation differences re 0.1% SVHCnotification/information requirements
Enforcement target in dissenting MemberStates (France, Austria, Belgium, Denmark,Germany, Sweden)?
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I dent if icat ion 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
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I dent if icat ion 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 consumerinformation
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 andsubstances 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)
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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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Quest ions & Answ ers
Darr en AbrahamsPartner
+32 2 626 0500
dabrahams@steptoe.com
Dr. Anna GergelyDirector, EHS Regulatory
+32 2 626 0542
agergely@steptoe.com
Craig Sim pson
Associate+32 2 626 0559
csimpson@steptoe.com
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