How to address chemicals of concern: roadmap 2020

Transcription

1 How to address chemicals of concern: roadmap 2020 Technical Media Briefing 25 March 2013 / Jack de Bruijn Director of Risk Management

2 Contents Main achievements on risk management Main elements of strategic aim II Key aspects of the 2020 SVHC roadmap 2

3 Main achievements in I 43 SVHC dossiers prepared, contributing substantially to the Commission target of having 136 SVHCs on the Candidate List by the end of 2012 First substances identified on the basis of their respiratory sensitising properties Good progress made on screening of potential PBTs/vPvBs with the aim of gathering further confirmatory information Extensive support provided to MSs to help identifying potential substances of concern that may need regulatory intervention Finalised the fourth recommendation to the Commission suggesting the addition of 10 new substances onto the authorisation list 3

4 Registration status of SVHCs 4

5 Main achievements in II Much effort placed on explaining the application for authorisation process to industry and other stakeholders Clarified a number of implementation questions (e.g. publication of information for public consultation, case/stakeholder involvement) Further prepared RAC and SEAC for their tasks Ready to receive first applications (expected for May) Provided substantial support to the committees for the development of their opinions on different restriction proposals or review reports (phthalates, dichlorobenzene, chromium in leather) 5

6 Main achievements in III Support provided to RAC who finalised opinions on 31 proposals for harmonised classification and labelling Published the C&L inventory early 2012 and subsequently updated it, now containing > 5.7 million notifications for > substances Prepared the related C&L platform which brings together registrants and notifiers who have different entries in the inventory 6

7 Future perspective 7

8 Strategic Aim II Mobilising authorities to use information intelligently to identify and address chemicals of concern Three action areas: 1. Mobilising authorities and aligning views; 2. Identification of candidate substances for regulatory risk management; and 3. Addressing identified concerns through REACH, CLP and other legislation. 8

9 The Commissioners' commitments on SVHCs 2010: Vice-President Tajani and Commissioner Potočnik publicly committed to "have a candidate list of 136 Substances of Very High Concern by the end of 2012" Currently :138 "have all relevant currently known SVHCs included in the candidate list by 2020" August 2012: COM sent a letter to EU Ministers underlining the will to continue working with Competent Authorities to develop a roadmap by the end of 2012 The roadmap "should build on the RMO framework, setting out clear milestones, deliverables and division of work between the Commission, Member States and the European Chemicals Agency"

10 Roadmap 2020 outlook Collaboration of all actors needed (Commission, ECHA and Member States) to make the implementation a success. No numerical goal has been identified in the Roadmap for the number of substances that will be included in the candidate list, as it cannot be pre-judged how many or which substances will be identified as relevant SVHCs. The Roadmap focuses on presenting a credible process to ensure the 2020 objective: defining a process or methodology, with clear deliverables, planning and share of responsibilities. 10

11 What is not a "relevant" SVHC by 2020? Indications in the Roadmap: A SVHC that is not registered is not a priority (some exceptions possible in the Roadmap, e.g. category approach) A SVHC that has been registered as intermediate only is not a priority (but enforcement actions (cf. intermediate) if appropriate and some exceptions possible in the Roadmap, e.g. category approach) A SVHC that fulfils the conditions of art. 69(1) : if its use(s) pose(s) a risk to human health and environment that is not adequately controlled, a restriction process should be started (second step: SVHC for remaining uses) A SVHC with (all) uses already regulated by specific EU legislation that provides a pressure for substitution or (all) uses exempted from the authorisation (see article 5, 56 or 60) 11

12 Role of the RMO The RMO is the key step in the process of defining the "relevance" of a substance It should be built on a screening exercise aimed at identifying substances that, on the basis of the registration dossiers, do not fulfil the first 2 criteria (registered + intermediates) (for example CMR substances used as intermediate only) The RMO assessment would be made for the list of substances resulting from such screening The RMO analysis should be shared with MSCAs and COM/ECHA prior to the submission of an Annex XV SVHC dossier (with the possibility to update in case new information is received)

13 Timeline COM roadmap provides indications of the activities foreseen for different groups of substances: Remaining CMRs Petroleum streams PBTs/vPvBs Endocrine disruptors (Respiratory) Sensitisers Details will be further developed by ECHA in a roadmap implementation plan Next step: workshop with MSs and COM in April, followed by discussion in usual fora (e.g. Caracal) 13

14 Can we meet the commitment? Preliminary "worst-case" estimation between 2013 and 2020: 440 substances need to be RMO-assessed From 2009 to 2012: RMOs for around 160 substances have been prepared by ECHA and MS (around 50/year), 138 substances have been included in the Candidate List If we want to RMO-assess 440 substances, we need 55 RMOs/year (80 substances by the end of 2014, 2013 to prepare for the Roadmap implementation) We are starting to move from CMRs to less known and less regulated SVHCs!!

15 How to communicate on the Roadmap? Appropriate communication strategy needed Subject to agreement, to document the actions made to achieve the target, the following information could be considered for publication by the end of 2020: A report on how MS and COM have selected the "relevant" SVHCs (including non-confidential screening results for different groups of substances); An annual list of all the substances RMO-assessed (potentially with the conclusion of the RMO analysis); Follow-up actions after 2020 (for example, refine the preliminary screening on the basis of new registration information, assess new PBTs, CMRs or EDs).

16 Thank you. Jack de Bruijn