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CARACAL 27/11/2013

Impact Assessment of modifications of the REACH Annexes for Nanomaterials Agenda point 4.1 Mateo GALLEGO Unit A.3 Chemicals DG ENV. CARACAL 27/11/2013. PROCEDURAL ISSUES. IA led by ENV in co-responsibility with ENTR

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CARACAL 27/11/2013

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  1. Impact Assessment of modifications of the REACH Annexes for NanomaterialsAgenda point 4.1Mateo GALLEGOUnit A.3 ChemicalsDG ENV CARACAL 27/11/2013

  2. PROCEDURAL ISSUES • IA led by ENV in co-responsibility with ENTR • 1st Impact Assessment Steering Group IASG meeting on 16/01/2013 – SG, MARKT, JRC, RTD, SANCO andTRADE • PC (21/06 to 13/09) • + 2 meetings with Member States (CASGNano)

  3. CONTEXT Second Regulatory Review on Nanomaterials (COM(2012)572 from February 2012) "The Commission remains convinced that REACH sets the best possible framework for the risk management of nanomaterials when they occur as substances or mixtures butmore specific requirements for nanomaterials within the framework have proven necessary." General Report on REACH published (February 2013) "The Commission will make an impact assessment of relevant regulatory options, in particular possible amendments of REACH Annexes, to ensure further clarity on how nanomaterials are addressed and safely demonstrated in registration dossiers. If appropriate the Commission will come forward with a draft implementing act by December 2013".

  4. SCOPE Limited to: Measures that can be proposed by the Commission via the Committee procedures under the legal basis provided by REACH  Changes to the enacting terms of REACH will not be proposed

  5. THE PROBLEM AND ITS CONSEQUENCES

  6. OBJECTIVES General objective. Specific objectives. Ensure that REACH is fit for the purpose ofdealing with NM in line with the objectives of the legislation Ensure adequate demonstration of safe useof NM in registration dossiers Clarify the legislative obligations and reduce uncertaintiesfor companies on how to comply with their registration obligations

  7. Timeline 30/04 Submission of proposal(s) for the REACH Committee February Submission to CASGNano members March Launch of ISC (15 working days) 06/12 3rd meeting of the IASG 24/10 CASGNano 2014 2013 18/12 Submission to the IAB 02/12 Submission to the IASG 20-21/03 CASGNano (tentative) March Translation request TBT notification 22/01 Review by IAB

  8. Issues posed at last CASGNano 1) How many Nanomaterialswill be covered by REACH? How many nanoforms? 2) What percentage of nanoforms needs testing? 3) Are testing costs different from other difficult substances? 4) Characterising, what is already part of normal business routines and what is extra? 5) How to link specific measures with associated EHS benefits? 6) How to balance between 'need to know', 'nice to know', and the associated additional costs? 7) Consequences for industry, SMEs and Innovation?

  9. POLICY OPTIONS

  10. Main sources: • JRC Scientific technical support on assessment of nanomaterialsin REACH registration dossiers and adequacy of available information, 12 March 2012 • BiPRO Examination and assessment of consequences for industry, consumers, human health and the environment of possible options for changing the REACH requirements for nanomaterials, 14 January 2013 • Matrix A Study to support the Impact Assessment of relevant regulatory options for nanomaterials in the framework of REACH, work on progress • Public Consultation Undertaken from 21/06 until 13/09

  11. PUBLIC CONSULTATION • Highlytechnical questionnaire 37main questions + 183subquestions = 220questions in total CATEGORY OF RESPONDENTS ANSWERS Data crossing

  12. Respondents: main figures • 142 respondents

  13. Organisations: nationalities

  14. Is REACH currently clear enough for NM? LACK OF CLARITY OF REACH REGARDING NM FOR 86%

  15. Options preferences • 2 ways of assessing the preferences of the respondents: • 1.Open question: what option do you prefer? • 2.Measures impacting on:cost, safetyandefficiency

  16. 1. What option do you prefer? Exhaustive Information requirements Simplified Information requirements

  17. 1. What option do you prefer?

  18. 1. What option do you prefer?

  19. 2. Measures impacting onCosts (as administrative burden) Less costly Simplified Information requirements

  20. 2. Measures impacting onSafety Safer Clarity option

  21. 2. Measures impacting on Efficiency Most efficient Clarity option

  22. 2. Measures impacting on Cost, Safety and Efficiency

  23. ANALYSIS OF IMPACTS

  24. COMPARISON OF THE OPTIONS Magnitude of impact as compared with the baseline scenario (the baseline is indicated as 0): ++ strongly positive; + positive; – – strongly negative; – negative; ≈ marginal/neutral; ? uncertain; n.a. not applicable

  25. PROCEDURAL REMINDER • Inputs: • Technicalstudies • PC • IASG • IAB CASG Nano ISC Impact Assessment REACH Committee 30/04/2014 Proposal(s) Preferred option

  26. Thank you for your attention • Mateo GALLEGO • DG Environment • Unit A.3 Chemical substances • mateo.gallego@ec.europa.eu

  27. Option 2 - Measures

  28. Option 3 - Measures

  29. Option 4 - Measures

  30. Option 5 – Measures (1/2)

  31. Option 5 – Measures (2/2)

  32. Option 6 – Measures (1/2)

  33. Option 6 – Measures (2/2)

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