The decision-making process

Transcription

1 The decision-making process Seminar on applications for authorisation Helsinki, June, 2015 Anna Borràs Unit D1 - REACH Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs European Commission

2 The role of the Commission Article 60(1) REACH: The Commission shall be responsible for taking decisions on applications for authorisations in accordance with this Title. Article 64(8) REACH: The Commission shall prepare a draft authorisation decision within three months of receipt of the opinions from the Agency. A final decision granting or refusing authorisation shall be taken in accordance with the procedure referred to in Article 133(3). Article 61 REACH: Review of authorisation decisions 2

3 What does the Commission decide on? Is the risk adequately controlled? OR (If no adequate control / non-threshold substance / PBT or vpvb or equivalent concern to PBT/vPvB:) Do the socio-economic benefits outweigh the risk to human health or the environment arising from the use of the substance? AND Are there no suitable alternative substances or technologies? 3

4 Content of an authorisation decision Article 60(9) REACH: Legal entity to whom the authorisation is granted Substance (s) identity Use(s) for which authorisation is granted Any conditions under which the authorisation is granted Time-limited review period Any monitoring arrangement In addition: Obligation to provide, upon request, summary of RMM/OC in the language of the MS where the use takes place 4

5 The decision-making process European Commission RAC and SEAC opinions Draft Commission decision REACH Committee Opinion Commission decision Draft agreed by all relevant DGs Positive vote by majority of MS Decision as draft voted in REACH Committee 5

6 Beyond the formal procedure Commission closely follows the opinion-making process in RAC and SEAC (observer in RAC and SEAC meetings and in trialogues) Ongoing dialogue with ECHA Secretariat on interpretation questions that may arise during the process (e.g. case of recycled PVC containing DEHP) COM to consider new developments appearing after procedure in ECHA 6

7 Decision-making experience so far Decisions adopted so far: 4 decisions (DEHP, DBP, diarsenic trioxide) 3 based on adequate control, 1 based on "socio-economic route" All downstream applications All of them followed the RAC and SEAC opinions Pending decisions: 16 applications pending (DEHP, DBP, diarsenic trioxide, lead chromates, HBCDD, TCE) A few upstream applications Most of them under "socio-economic route" 7

8 Decision-making experience so far REACH Authorisation Decisions List of authorisation decisions adopted on the basis of Article 64(8) of Regulation (EC) No 1907/2006 (REACH). The list also includes reference to related documentation concerning all applications for authorisation on which an opinion has been adopted by the Committee for Risk Assessment and the Committee for Socio-economic Analysis of ECHA on the basis of Article 64(5) REACH. Substance name Authorisation decision Summary in OJ Applicant(s) Exposure scenario(s) from application (CSR) Further details Bis(2-ethylhexyl) phthalate (DEHP) C(2014) 5551 final OJ C 260, , p. 10 Rolls-Royce plc DEHP 1-CSR-ES ECHA documentation DEHP1 PENDING ADOPTION Submission planned to REACH Committee in September 2015 PENDING ADOPTION OF DECISION Vinyloop Ferrara S.p.A. Stena Recycling AB Plastic Planet srl DEHP 4-use-1-CSR-ES DEHP 4-use-2-CSR-ES ECHA documentation - DEHP4 use 1 ECHA documentation - DEHP4 use 2 PENDING ADOPTION Submission planned to REACH Committee in September 2015 PENDING ADOPTION OF DECISION Arkema France DEHP 2a-CSR-ES ECHA documentation DEHP2a use 1 ECHA documentation DEHP 2a use 2 8

9 Disclaimer All views expressed are purely personal and should not be considered as representative of the European Commission s official position. Neither the European Commission nor any person acting on behalf of the Commission is responsible for the use which might be made of the information provided. 9