ดูแลด้วยความรับผิดชอบ RESPONSIBLE CARE ดูแลด้วยความรับผิดชอบ GPS – REACH Workshop REACH – Evaluation, Authorization and Restrictions Athens – Greece 4 October 2011 Annamaria Frascaria Dow Belgium

Evaluation 3 independent evaluation processes with 3 different objectives: Compliance check: is the information submitted in compliance with legal requirements? At least 5% of the dossiers must go through this evaluation. Several criteria to prioritise: one of this being separate registration (opt-out)! Examination of testing proposals: to avoid unnecessary animal testing; permission to undertake certain tests by submission of a testing proposal. Testing proposals which include animal tests undergo public consultation (art 40.2). All testing proposals are examined. Substance evaluation: to clarify whether the use of a substance may cause harm to human health or the environment. Substances selected by ECHA in cooperation with Member States. Prioritised substances are evaluated. Process will start in 2012.

MSCAs Evaluation Dossier evaluation Substance evaluation* Evaluation of Testing Proposals Compliance Check Examine any information on a substance The evaluation of registration information ensures that registrants meet the REACH information requirements and generate new information when necessary, while keeping animal testing to a minimum. Draft decisions on further information (Final decisions with potential involvement of MSC) * Process in preparatory phase, evaluation to be started in 2012 MSCA = Member State Competent Authority; MSC = Member State Committee 3 3 3

Evaluation: compliance check Are information requirements fulfilled in line with regulation? Are adaptations of standard infomation requirements and related justifications in compliance with the rules (Annex VII to X and general rules in Annex XI)? ECHA to issue draft decision within 12 months of the start of the compliance check Draft decision may require registrants to submit further information Clock start ticking for registrant only when draft decision becomes final and sent to registrant Other possible outcomes: Quality Observation Letters (suggestions to improve quality of dossier and submit a ‘spontaneous update’) – clock starts ticking at receipt No further action required.

Evaluation: examination of testing proposals Proposed test adequate and justified? Unnecessary testing on animals avoided? Possible outcomes: Testing accepted as proposed with deadline for submission Testing accepted but with changed testing conditions Request to carry out additional testing Testing rejected If several registrants or downstream users of the same substance propose same test, agreement must be reached within 90 days on who performs the test otherwise ECHA decides. Timing: Non phase-in substances draft decision by ECHA within 180 days Phase-in substances registered by Dec 1 2010: Dec 1, 2012

EVALUATION : follow up actions Registrant comment on draft decisions After receiving a draft decision Registrant may comment and provide dossier update within 30 days ECHA may adapt draft decision After Member State Competent Authority provides a proposal for amendment Registrant may comment within 30 days on a proposal for amendments (and update dossier if appropriate) During Member State Committee procedure Registrant who received draft decision may participate in MSC initial discussion on draft decision ECHA and Member States may adapt draft decision

Dossier Evaluation – challenge of next years About 1000 Compliance Checks on HPV’s to meet the 5 % target Selection is concern driven & random 580 dossiers with Testing Proposals received Covering 1500 hazard endpoints All of these to be examined by Dec 2012 ECHA carries out scientific evaluation & submits draft Decisions requesting further data from registrants http://echa.europa.eu 7

Dossier Evaluation – Prioritisation Compliance check criteria set by REACH opt-out of a dossier submitted jointly records of 1-10 tons / year includes only physical-chemical data substances included in the Community Rolling Action Plan (CORAP) Compliance check selection based on concerns according to the risk of non-compliance depending on the impact of non-compliance on safe use Compliance check random selection provides an overview of the quality of records

Conclusion from evaluation reports Tips for successful registration from Identity of registered substance shall be clearly described Adaptation to standard testing regime must meet conditions of Annex XI or column 2 of Annexes VII – X of REACH  sufficient justification should be provided Robust study summaries should contain sufficient level  allow independent assessment Classification and labelling should be in line with hazards identified or harmonized classification and labelling Testing proposal shall be submitted for tests of Annex IX and X before undertaking it  potential enforcement actions Make consistent and well justified Chemical Safety Reports

Scope, aim and outcome of dossier evaluation Evaluation type ECHA questions ECHA examination conclusions Numbers and timelines Testing Proposal Examination (TPE) Proposed test adequate and justified? Unnecessary animal testing avoided? Article 40(3) draft decision: Accept testing Reject testing Change test conditions Request additional testing All testing proposals non phase-in: draft decision in 6 months phase-in submitted by 1 Dec 2010: draft decision by 1 Dec 2012 Compliance Check (CCH) Information requirements adequately fulfilled? Adaptations adequately justified? Article 41(3) draft decision: Request further information Other outcomes: Quality Observation Letter – indicates elements to be improved No further action Select at least 5% of total received for each tonnage band draft decision within 12 months of start CCH 10

Substance evaluation will start ECHA is developing the first list of substances MSCAs can identify candidates & ECHA add others from other REACH processes based on a priority setting CoRAP ‘rolling’ 3-year list – proposal by end of 2011 – adoption Feb 2012 Member States to inform ECHA about capacity for evaluation Substance evaluation is to clarify risk (i.e. to get extra hazard &/or exposure data) with a view to using regulatory instruments 11

Authorization: process and considerations Candidate List expected to grow significantly during the next two years (statement from Commission of addition of 106 substances) Communication and notification requirements exist when a substance is listed on the Candidate List Art. 33 Art. 7 The first set of Substances (6) effectively subject to Authorisation was included already in Annex XIV: http://echa.europa.eu/reach/authorisation_under_reach/authorisation_list_en.asp 12

Authorization: process – preparing an application Pre-Notify intent Echa_application_for_authorization@echa.europa.eu Allows better planning by ECHA Indicates which substances and for which uses Pre-submission meeting To focus on technical requirements of dossier (not on the content of the application); ask clarification on how to prepare and submit an application Prepare application Who? Manufacturer, Importer, DU or joint (no obligation to apply jointly). Can DU apply individually, enough information? For what? One or more uses, one or more Les, group of substances (Annex XI, Sec 1.5) Costs? Fee part of application, calculated by use(s), substances, size of company 13

Elements of an application Main elements – Art 62 of REACH Substance identity Applicants Uses applied for CSR (if not submitted as part of registration) Analysis of Alternatives Substitution Plan (if suitable alternatives available) Additionally (application may include) Socio-economic analysis Justification for not considering certain risks to human health and the environment Fee is part of the application! Legally only SEA required for socioeconomic route but may be advisable for other routes as well. Suitable : available at reasonable cost and in reasonable quantities.

Content : some reflections USE Use descriptor system as a basis More case specific details may be required Contact DU? CSR/ES CSR of registration dossier For DU potential issues to get access Letter of Access may be required? AoA Risks, technical and economical feasibility to be considered CBI & Comp law What if only little information on (eco)toxicity of alternatives? SP Ultimate goal is substitution Realistic timing! Key to determine time of validity of authorisation SEA Mandatory only for SE route but sometimes advisable for other routes as well Little expertise available Resources potential issue! Important to have a good communication with DU to know his use(s) and to crosscheck on analysis of alternatives and the substitution plan Analysis of alternatives : consider all options to pre-empty comments of third parties later in the process High level of detail required! Start preparing early! Highly regulated sectors : substitution is a long process

Possible application packages Adequate control & No suitable alternative Adequate control & Suitable alternative Socio-ec benefits > risks (No adequate control & No suitable alternative) Threshold substances Threshold substances Threshold & Non-threshold substances CSR Analysis of Alternatives SEA Substance & Applicant info CSR Analysis of Alternatives Substitution Plan SEA Substance & Applicant info CSR Analysis of Alternatives SEA Substance & Applicant info

Resources: ECHA website http://echa.europa.eu/reach/authorisation_under_reach/authorisation_application/authorisation_how_en.asp

Resources: CEFIC website http://www.cefic.org/Industry-support/Implementing-reach/Guidances-and-Tools1/

After submission Draft opinions RAC + SEAC Final opinions RAC + SEAC Publication in OJ Decision by Commission Applicant may comment Start of obligations to communicate in the supply chain What if DU authorisation is granted and producers authorisation not? No access to material? Open questions: What if authorisation is refused? What to do with stocks already in the supply chain?

Authorization: consider that... It is a lengthy, costly and labour intensive process with a large degree of uncertainty Alternatives available for all applications? Can you (and your customers) switch before the application date? (concerted action  need to consider competition law issues) If not, do you want to continue this business in Europe? Cost vs benefit? Communicate with your customers / suppliers ‘Living process’: authorisation granted for a limited time  re-submission Risk that time validity of authorisation is shorter than timing in your substitution plans : in other words once authorisation is granted you may already have to start preparing the re-submission before actually having had the possibilities to evaluate the alternatives.

Conclusions Applying for authorisation is new to everyone Data sharing not a legal obligation Large risk of infringement of anti-trust law High level of detail required in the application dossier Early start recommended! Make use of opportunities to communicate with ECHA

Restrictions Safety net in REACH, manage risks not sufficiently addressed by other processes All uses of a restricted substance not specifically restricted under Annex XVII are allowed under REACH (except if also listed on Annex XIV or subject to other legislation) within the limits of the Exposure Scenarios of manufacturers’/importers’ registration. Decision for the restriction based on the two following cumulative elements: a) an unacceptable risk to human health or environment, and b) the risk needs to be addressed at a community wide basis level. List of all restricted substances (specifying restricted uses) in Annex XVII of REACH

Restrictions Not a new concept! Existing restrictions in the Marketing and Use Directive (76/769/EEC) carried over to REACH. Directive 76/769/EEC was repealed on 1 June 2009. Pay attention to Article 67(3) referring to more severe national restrictions, to be maintained until 1 June 2013, provided they have been notified. Broad scope: Any substance on its own, in a preparation or in an article may be subject, where justified, to restrictions. Can apply to manufacturing, placing on the market (including importing) and/or all uses or to specific uses. No tonnage threshold for a substance subject to restriction provisions.

Exemptions: Restrictions in scientific research and development, for on-site isolated and non-isolated intermediates, in PPORD, if this as well as the exempted quantities are specified in the Annex XVII, for the use of substances in cosmetic products, with regard to risks to human health within the scope of the Cosmetics Directive

Restrictions- process and timeline

Restrictions- stay up-to-date! http://echa.europa.eu/reach/restriction/existing_restriction_en.asp

THANK YOU VERY MUCH FOR YOUR ATTENTION!!