effective reach strategies next steps

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

[email protected]

Dr. Anna GergelyDirector, EHS Regulatory

+32 2 626 0542

[email protected]

Craig Sim pson

Associate+32 2 626 0559

[email protected]

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