Authorisation in REACH

Transcription

1 Authorisation in REACH ECHA s Fifth Stakeholders Day Helsinki, 4 October, 2010 Anna Borràs Chemicals, REACH Unit 1

2 Authorisation in REACH - Overview Aim and rationale Authorisation requirement Scope From Annex XIV to individual authorisation decisions: Including substances in Annex XIV Individual Authorisation Decisions 2

3 Aim Art 55 REACH: Ensure good functioning of the internal market Assure risks from SVHCs are properly controlled and Assure SVHCs are progressively replaced by suitable alternative substances/techniques where these are economically and technically viable 3

4 Rationale: why an authorisation requirement? Substances of Very High Concern (SVHCs): CMRs cat. 1 or 2: very serious effects on human health, cannot be normally reversed PBTs, vpvbs: accumulate in living organisms, cannot be reversed Other substances of equivalent concern Their effects have to be prevented rather than remedied How does it work? Authorisation ensures that risks related to the use of SVHCs are assessed and decided upon by the EU (COM) Burden of proof is on the applicant (to demonstrate that risks are either adequately controlled or outweighed by socio-economic benefits) 4

5 Authorisation requirement Substances subject to authorisation may not be placed on the market for a use or be used unless the use has been authorised: authorisation is always related to a use all uses are covered unless excluded from the scope exemption is foreseen in Annex XIV Imported articles are not subject to authorisation No volume threshold 5

6 Scope Substances subject to authorisation: Annex XIV Excluded uses: Intermediates Medicinal products Food and feedingstuffs Scientific R&D Plant protection products and biocidal products Motor fuels and fuel in mobile or fixed combustion plants of mineral oil products Only with regard to hazards to human health: cosmetic products food contact materials medical devices In mixtures when presence below certain % 6

7 Authorisation procedure: 3 steps Step 3: Individual authorisation decisions ECHA: RAC & SEAC opinions COM: Authorisation decision Step 2: Annex XIV ECHA recommendation COM decision Step 1: Candidate List of SVHCs ECHA: MSC agreement, ECHA decision (COM decision) 7

8 Inclusion of substances in Annex XIV Gradual process, the number of substances subjected to authorisation at the same time should be such to ensure workability of the system COM decision on inclusion of substances in Annex XIV (Art. 58) Content: transitional arrangements review period for certain uses, if appropriate exempted (categories of) uses, if any Procedure: regulatory procedure with scrutiny 8

9 Inclusion of substances in Annex XIV: State of play Annex XIV is currently empty ECHA 1st recommendation on priority for inclusion of 7 substances into Annex XIV adopted on 1 June 2009: Musk xylene SCCP HBCDD PBTs, vpvbs MDA DEHP BBP DBP COM draft regulation includes 6 of the 7 recommended substances (except SCCPs) in Annex XIV: Transitional arrangements: months (latest application date), months (sunset date) REACH Committee vote in favour on 21 September 3 month scrutiny period by EP and Council Expected adoption: January 2011 CMRs 9

10 Individual authorisation decisions Two routes to authorisation: Adequate control : if the risks are adequately controlled as documented in CSR NOTE: does not apply to PBTs, vpvbs and to other substances for which it is not possible to determine a threshold Socio-economic : if the socio-economic benefits outweigh the risk and there are no suitable alternative substances or techniques 10

11 Individual authorisation decisions: Application for authorisation May be made by M, I and/or DU (by 1 or more persons) DU may use substance in accordance with the conditions of an autorisation granted to an actor up his supply chain for that use (Art. 56(2) May be made for 1 or more uses: application must specify the use(s) applied for May be made for 1 or several substances that belong to the same group Main elements (Art.62): CSR (unless already submitted) Analysis of alternatives (risks of possible alternatives, technical and economic feasibility of substitution) Substitution plan (NOT for socio-economic route) Socio-economic analysis (optional, but de facto required for authorisations under socio-economic route) Justification for not considering risk (optional) 11

12 Role of Analysis of Alternatives and Substitution Plan Analysis of Alternatives: Required in all applications Content: identify potential alternatives Assess their risks Assess the economic and technical feasibility of substitution If appropriate, include information on R&D activities by the applicant (important to determine review date) Substitution Plan: only required where AoA concludes suitable alternatives are available ( adequate control route) Must include timetable of proposed actions by the applicant in order to substitute 12

13 Obligations resulting from authorisation decisions Respect any conditions of use specified in authorisation decision (Art. 60(9)) Include authorisation number on label for substance / mixtures containing the substance (Art. 65) DU according to Art 56(2): notify ECHA within 3 months of 1st supply of the substance (Art. 66(1)) Update the registration to take account of the granted authorisation (Art. 22(2)) Update the Safety Data Sheet or provide downstream users with details of the authorisation (Art. 31(9)(b) and Art. 32(1)(b)) Ensure that exposure is reduced to as low a level as technically and practically possible (Art. 60(10)) 13

14 Review of authorisation decisions Review report: must be submitted at least 18 months before expiry of timelimited review period Content: updates of analysis of alternatives substitution plan CSR socio-economic analysis Authorisation may be reviewed at any time if: Changes in risks to human health or environment, or in socio-economic impact, or New information on possible substitutes Outcome: extension / amendment / withdrawal of authorisation 14

15 Thank you for your attention! 15