Evaluation perspectives: Part I - Dossier Evaluation - Where are we so far? ETUI annual seminar Worker Protection and Chemicals Andrew Phillips ECHA, Evaluation Directorate Friday 28 June 2013

Headline news 3 June 2013 ECHA website 2923 more chemicals registered 9084 new registrations 3215 companies

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Perspectives from Evaluation of Dossiers Dossier & Substance Evaluation – the Process under REACH Where are we so far Testing Proposals Compliance Check strategies Substance Evaluation Quality issues with dossiers and CSRs ECHA’s strategy to improve the quality of registration dossiers – the CSA Programme and CSR Roadmap 22/11/2012 4

Dossier & Substance Evaluation A brief description of Evaluation Processes under REACH

22/11/ Report 2012 Facts and figures

Testing Proposals

Testing proposals REACH aim is to ensure tests address actual information needs and to avoid unnecessary testing on vertebrate animal REACH dossiers need to pass Technical Completeness Check Rules Registrants can choose options to address an endpoint Provide a study Provide a waiver Provide a read across argument Provide a Testing Proposal Some intended, some not Generally higher tier endpoints for high tonnage chemicals Sub chronic endpoints: 90-day studies Reproductive toxicity endpoints: two-generation studies, pre-natal developmental studies 22/11/2012 8

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Testing proposals Evaluation acts as scientific evaluator and secretariat before presentation to Member States Committee: Appropriateness of the proposal Most appropriate test, route of administration and species Any specific requirements for testing Acceptance (or otherwise) of read across Proposes timeframe 22/11/

Testing proposals – the process Phase-in substances – 1 year, Non phase-in 6 months Third party consultation Scientific evaluation – then internal processes to ensure consistency and develop policy lines Draft Decision sent Registrant Registrant options to comment and informally discuss Formal process with deadlines after referral to Member States Member States Competent Authorities comments Member States Committee discussions and agreement Final Decision sent Registrant Appeal Process open to Registrants 22/11/

Compliance Check and strategies

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Compliance check – the hazard What is compliance? Substance identity, classification and labelling Hazard endpoints ( REACH Annexes VII to X) Physico-chemical properties Environment (soil, water, air) Human Health (toxicokinetics, acute, irritation, sensitisation, repeat dose, mutagenicity, carcinogenicity, toxicity to reproduction) DNEL (PNEC) derivation 22/11/

Compliance check – exposure and risk Do identified uses match expectations Scope of environmental assessment PBT assessment Environmental exposure assessment and risk characterisation Worker exposure assessment and risk characterisation Consumer exposure assessment and risk characterisation 22/11/

Dossier selection Specific endpoints – Areas of Concern Dossiers flagged for compliance check through other processes Random dossiers Lead dossiers Member dossiers Poor quality dossiers 22/11/

Substance Evaluation

8/6/ /6/ Dossier evaluationSubstance evaluation Testing proposal examination Compliance check Output: Get more information on chemicals (if necessary) Examine any information on a substance MSCAs Evaluation under REACH

8/6/ /6/ Aim of Substance Evaluation To clarify whether a “substance” constitutes risk to human health or environment Potential formal outcome of substance evaluation: Request for further information to clarify risk (a decision) Can go beyond REACH standard data requirements. Risk confirmed or under control  no further information needs to be requested If risk is already demonstrated, substance evaluation is not the appropriate route. Other processes should be initiated instead (e.g. authorisation, harmonised classification and labelling, restrictions).

22/11/ /6/2015INTERNAL 20 Substance evaluation: decision making Substance evaluation (draft) decisions are adopted in accordance with Articles 50 and 52  similar to CCH and TPE with the necessary changes being made (‘mutatis mutandis’ – only those things that need be changed). But: multiple addressees for a decision! ECHA intends to notify the DD/FD to all registrants at the same time All registrants can comment, but recommendation is to coordinate

8/6/ /6/2015INTERNAL 21 Substance Evaluation Evaluation to a draft decisionUp to 12 months If draft decision: decision making procedure 2 – 8 months (if MSC) Generation of the information by registrant(s) From ~6 months to several years Evaluation of the obtained information (flagging) up to 12 months Conclusion on the need for C&L, SVHC, restriction ? ∑ in minimumMin 2.5 –3 years? Timelines

Where are we so far?

Testing Proposals – lessons learnt Streamlined processes to meet pressing targets Drafting process – standardisation of texts Agreement on issues for PfA and comment Try to limit formal discussions in MSC meetings – time consuming Written procedures Prior agreement, informal technical discussions Plenty of in-depth discussion on issues of toxicology Plenty of discussions around animal welfare issues But generally highly focussed on defining hazard 22/11/

Testing proposals Some registrants understand the process Some registrants misunderstand the process Inappropriate tests included in IUCLID Some debate on exposure related issues – route issues Are tests necessary at all? Different perspectives of members of a joint submission After informal discussions some registrants understand they have other options Awaiting outcome in most cases as tests take time – Follow- up process 22/11/

Compliance check Early emphasis on hazard endpoints Missing endpoints Deficient endpoints Assessment of waivers Generally issues with higher tier endpoints Complicated rules over use of exposure-based waiving Substance identity is not always easy Read across – great concept – tough in practice 22/11/

Compliance check 2013 – the year of the compliance check! Areas of concern (AoC) – mass screening for specific endpoint deficiencies Evaluation directorate restructuring – specialisation Addressing exposure and risk – CSR issues Easy substances – difficult substances 22/11/

22/11/ Substance Evaluation experience I Exposure frequently addressed in the DDs Initially in some cases the requests could be too general and a little vague (”refinement of exposure assessment”) In many cases decisions concerned: Parameters/modifiers used in the models Details about the exposure scenarios Tasks in the scenarios RRMs in place and their efficacy Information about the gloves, respiratory protection Releases MSCA need more information to confirm, through their own assessment, if the proposed RMMs are adequate … and if agreement can be reached with the Registrant assessment It is possible to ask for these details in a SEv DD, but … 27

22/11/ Substance Evaluation experience II The Registrant must understand how to improve the CSR, and the decision from the MSCA must be enforceable Substance Evaluation Draft Decision is a ‘heavy’ tool, and it takes some time before the data is with the MSCA to consider Could this information could be more easily provided during the evaluation period? Evaluating MSCA may also conclude its exposure assessment using default (worst case?) parameters … 28

8/6/ Substance Evaluation experience III If modelled data are not considered reliable enough for risk assessment, the evaluating MSCA may consider asking for … A survey for defining parameters for modelling A monitoring study – but beware! When is this justified and proportionate? When there is potential for (serious) adverse effects and the current available information/modelling indicate RCRs may be exceeded. A higher tier assessment may be necessary to confirm if: Workers/consumers/environment are at risk and Basis for possible RRM (restriction) is needed Realistically, the Registrants must be able to collect the data Early interaction between evaluating MSCA and Registrants may prove useful and provide a quicker/better outcome 29

8/6/ Information requests on exposure MSCAs need to consider when further information on exposure really is needed? Would interaction between the evaluating MSCA and Registrants increase efficiency, clarity and level of reassurance? Can recommendations be made as a result of the request? 30

8/6/ /6/2015INTERNAL 31 CCH versus SEV Compliance Check is a powerful tool at the highest tonnage level Substance Evaluation is more powerful in lower tonnage levels, but with fairly high aggregated tonnages lots of maunfacturers and importers address them all at once In the years to come Dossier Evaluation could be important route for detecting CoRAP candidates

Thank You. Questions and discussion