REACH overview why, what s the objective?

Transcription

1 REACH overview why, what s the objective? Chemical Watch Expo April 2017 István Mák Dossier Submission and PIC unit European Chemicals Agency

2 Contents European Chemicals Agency the organisation and main activities REACH Processes REACH Registration REACH 2018 roadmap Integrated Regulatory Strategy 2

3 ECHA working for the safe use of chemicals Introduction to the European Chemicals Agency

4 ECHA key facts Started on 1 June staff from 27 countries Originally REACH Since 2009 Classification and Labelling Now also Biocides and Prior Informed Consent 4

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6 Main activities Manage REACH, CLP, Biocides and PIC Disseminate information on chemicals Develop scientific IT tools Provide regulatory assistance to industry, i.e. ECHA Helpdesk and guidance Support enforcement Advise on chemical safety to EU institutions and Member States Assist EU s international activities (UNEP and OECD; accession countries) 6

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8 REACH Processes

9 REACH and ECHA REACH adopted in December 2006 Registration of chemicals [ substances ] Evaluation of selected registered substances Authorisation of (certain) Chemicals Restriction of (certain) Chemicals ECHA established on 1 June

10 Aims of REACH Ensure a high level of protection of human health and the environment Promote alternatives to animal testing Ensure the free circulation of substances on the internal market Enhance competitiveness and innovation 10

11 Principles of REACH Industry responsible for safe manufacture and use Deal with the burden of the past with a systemic program for registration of old chemicals Get adequate information on hazards while minimising the use of experimental animals and the costs Targeted activities by ECHA, Member States and the European Commission to get maximum effect Enforcement at national level 11

12 Going a little deeper

13 REACH and CLP main processes and actors Pre-registration Data sharing Registration Self-classification Facilitated by ECHA, industry gathers information and ensures management of risks Member States Evaluation Dossier evaluation Substance evaluation ECHA and MSCAs control and request for further info Authorisation Restriction Harmonised C&L Commission, with support of ECHA and MSCAs, applies community wide risk management measures 13

14 Evaluation processes MSCAs* Dossier evaluation Substance evaluation Examination of testing proposals Compliance check Examine any information on a substance ECHA decision requesting further information * MSCA = Member State Competent Authority Follow-up 14

15 Compliance Check (CCH) Compliance checks evaluate the substance identity description and the safety information in the dossier including the chemical safety report or specific parts of the dossier, for example the information related to the protection of human health/environment. Substance Identity (foundation of the dossier) Hazard endpoints studies, read-across etc. Classification endpoints for use in risk assessment Chemical Safety Assessment (hazard, exposure, risk) methods/assumptions 15

16 Substance Evaluation (SEV) Member States evaluate certain substances to clarify whether their aggregate use poses a risk to human health or the environment. The objective is to request further information from the registrants of the substance to verify the suspected concern, if necessary. The evaluation may in the end conclude that the risks are sufficiently under control with the measures already in place. Otherwise, it may lead to the proposal of EU-wide risk management measures such as restrictions, identification of substances of very high concern, harmonised classification or other actions outside the scope of REACH. 16

17 Risk management: restrictions When unacceptable risks to humans or the environment have been identified Member State competent authorities can submit dossiers proposing restrictions (or European Commission instructing ECHA) European Commission Decision based on an ECHA Opinion Annex XVII of REACH lists all restrictions 17

18 Risk management: authorisation Substances of very high concern (SVHCs): CMRs, PBT/vPvB or equivalent concern Identification by Member States (or European Commission instructing ECHA) onto the Candidate List Some transferred onto the Authorisation List, Annex XIV Once on the Authorisation List, the substance can only be marketed or used after sunset date if authorised by the European Commission. It decides based on an ECHA opinion. 18

19 REACH Registration

20 REACH Registration Registration obligation for manufacturers / importers Companies are to collect data on substance 20

21 Registration achieves: Market access! No data no market Foundation of information on hazard, classification, use, exposure and risk management Information for citizens/(ngos) Authority use screen substance properties, prioritise regulatory action, check quality, and (ultimately) ensure managed risk 21

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23 What are we expecting in 2018? Many more registration dossiers More small SIEFs More lead registrants without members Higher % of SMEs More SMEs as lead registrants Less information need to generate new data Some very active sectors 23

24 Registration is hard, but it can be done Thousands of companies have done it More than 8500 registrations already received for the 2018 deadline Increasing number of SMEs We are working to make it simpler. Simplified IT tools Online submission for members Built-in, multilingual support Webinars 24

25 New 2018 web pages Advice for each phase of registration Targeted support with three levels of information Getting started - Essential reading - Going deeper Practical tips, Do s and Don ts, Checklists Information on events, webinars, new publications Predictability IT Tools & Guidance finalised 25

26 REACH 2018 roadmap

27 Six steps to successful registration Know your portfolio Find your co-registrants Share your data Gather your data Prepare your registration dossier (IUCLID) Submit to ECHA (REACH-IT) 27

28 Know your portfolio What should I register? Unambiguous substance identification = essential Ensure data can be shared and are suitable for your substance Find your co-registrants Who should I work with? Check your pre-registrations Is your substance registered? Identify the lead registrant Is your substance not registered? Find your co-registrants Discuss and establish the sameness of your substance with co-registrants 28

29 Share your data How should I work with them? Organise cooperation, or get active in your SIEF Share data Negotiate costs in a fair, transparent and nondiscriminatory manner Practical advice on data sharing negotiations Do s and Don ts, factsheet on typical cost elements What to do in case of problems One Substance, One Registration! (OSOR) 29

30 Assess hazard and risk What data do I need? Information required depends on tonnage and uses Data quality is crucial Some long-term studies require a testing proposal Animal testing is the last resort - Consider alternatives Alternatives to animal testing: Advice and practical guides on ECHA website Requires some expertise Read-across assessment framework (RAAF) Explains how your read-across will be assessed by ECHA OECD QSAR Toolbox 30

31 Prepare/submit your dossier One-click installation Integrated help New user interface for members Online access straight from REACH-IT no need to install IUCLID for basic member dossiers Improved substance identification IUCLID Cloud for SMEs More intuitive user interface Easier identification of co-registrants and existing joint submissions Built-in, multilingual support 31

32 In summary Registration is challenging but manageable Start preparing now, even for a registration in 2018 If you are a member registrant, make sure the jointly submitted data is of high quality Use all the help available ECHA website ECHA helpdesk National helpdesks Sectoral associations and remember to keep your registration up-to-date 32

33 Integrated Regulatory Strategy

34 By 2020, we want to know for all substances above 100 tonnes Are they of potential concern? Do we need more (hazard) information? Do they need to be addressed through (the most appropriate) regulatory risk management action? OR Can we safely put them aside as being currently of low priority for further work? 34

35 Focussing on substances that matter Higher-tonnage registration dossiers with Important data gaps and with High exposure potential for: Workers or Consumers or Environment 35

36 How? Prioritise substances that matter most, also taking exposure into account Target compliance check on most important human health and environment endpoints for clarifying CMR and PBT concern Tackle groups of substances e.g. by structural similarities or specific functions (e.g. plasticisers, flame retardants) Increase cooperation with other bodies worldwide Deprioritise if we can conclude low risk 36

37 From bits and pieces to a REACH/CLP machinery 37

38 In conclusion The integrated regulatory strategy is not new, but integrates all our processes, ECHA teams expert groups, in cooperation with MSCAs It gives a clear focus on where to spend our resources and time for maximum impact A lot has been achieved, the machinery is largely in place, but there are still many challenges ahead. 38

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