Current and future EU policy on Substance Restrictions. Halogen-free Symposium Brussels October 27-28, 2009

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1 Current and future EU policy on Substance Restrictions Halogen-free Symposium Brussels October 27-28, 2009

2 Outline 1. EU Regulations on substances and substances in articles restrictions 2. REACH & RoHS : the experience so far? 3. RoHS recast : substances aspects 4. REACH & RoHS : complementary? 5. Other EU policies 6. Conclusions

3 1. EU Approach to chemical substance Regulation/Restriction Hazardous substance Classification Registration Information on use? Risk assessment Risk Management Risk Management Restriction Authorisation

4 1. EU Approach to chemical substance Regulation/Restriction Hazardous substance CLP REACH Information on use? REACH Risk Management Risk Management Restriction Other Regulations REACH

5 1. EU Approach to chemical substance Regulation (2) : different possibilities Risk-based REACH Autorisation Restrictions Hazard-based POP ODS Restriction/authorisation Hazardous substance Lifecycle approach Site-specific Stage-specific IPPC Seveso Worker Protection Reg. Waste WEEE Water Priority Substances Sector-specific Toys Cosmetics RoHS Biocide PPP Etc..

6 1. EU Regulations on substances and substances in articles 2. REACH & RoHS : the experience so far? 3. RoHS recast : substances aspects 4. REACH & RoHS : complementary? 5. Other EU policies 6. Future approach to substance restrictions

7 2. The experience with REACH so far Pre-registration : big success : substances pre-registered by companies (2,7 million pre-registrations) 1800 SIEFs formed with a lead registrants 15 substances on the candidate list (october 2008) a.o. : HBCDD, SCCP, DEHP,DBP, BBP recommended by ECHA for listing on annex XIV (subject to autorisation) : COM is drafting proposal

8 2. The experience with REACH so far (2) 2nd candidate list (september 2009) : another list of 15 substances Restrictions : no proposal so far (3 substances on the register of intentions) Annex XVII has been «recasted» (59 entries) Restrictions under preparation : CMRs from CLP 1stATP, borates, substances in transition 23 Guidance documents Committees (RAC,SEAC, Forum, CARACAL) are in place

9 2. The experience with REACH so far (3) Annex XV restriction dossier Submitted by MS / ECHA Conforming Annex XV dossier Published Consultation of Third Parties on Annex XV dossier RAC Opinion SEAC opinion Annex XVII amended Comitology Draft Amendment of Annex XVII COM prepares a draft amendment Intentions : NO (mercuric compounds in PU ), FR (DMF in articles ), FR (lead in jewellery )

10 2. The experience with RoHS so far «Prevention through restriction» Art.4 : list of substances banned (Pb, Hg, Cd, Cr6+, PBB, PBDE) Art.5 : Max.conc.values for banned substances in EEE Exemptions Art. 6 : review of list of banned substances «based on scientific facts and taking precautionary principle into account»

11 2. The experience with RoHS so far (2) «but exemptions» art.5 of RoHS : review exemptions from Annex at least every 4 years or 4 years after decision for exemption (by July 2010) Check whether substitution is technically or scientifically possible, provided that substitute does not impact negatively environmental, health and/or consumer safety 29 existing exemptions + 5 new requests

12 2. What does REACH do? «as regards autorisation of substances» Art. 55 to 66 REACH outline: outlines procedure to identify «priority» Substances of Very High Concern (SVHC - annex XIV), to fix sunset date (placing on the market and use) outlines procedures for granting autorisation (equivalent to «RoHS art.5»).

13 2.What does REACH do? «as regards restriction of substances» Art. 67 to 72 REACH outline : procedures for preparing a proposal for restriction at request of COM or Member States how ECHA gives its scientific and technical opinion how Commission is taking final decision (equivalent to «RoHS art.4»).

14 1. EU Regulations on substances and substances in articles 2. REACH & RoHS : the experience so far? 3. RoHS recast : substances aspects 4. REACH & RoHS : complementary? 5. Other EU policies 6. Future approach to substance restrictions

15 3. Observations while preparing RoHS recast Scientific basis for banning substances is questioned Lack of transparency in procedures for scientific and technical adaption Scientific and technical review of substances prohibited and exempted : externalised to contractant. Study of alternative substances (exemptions only) No provision on compliance check and enforcement

16 3. RoHS recast : what REACH is not doing similarly as RoHS? Scope is not specific to EEE Risk assessment considers life-cycle but is not concentrating on waste phase or for instance does not give importance to environmentally sound recovery and disposal of wasted EEE Enforcement is not specific to EEE sector Import of articles containing not authorised SVHC should be addressed by decision for restriction (min. 2 years)

17 3. RoHS Recast Key issues No changes to the list of prohibited substances Alignment with REACH mechanism for future substance bans socio-economic criteria for exemptions Clarification of the scope Product categories and binding list of products defining the scope are set under RoHS Products list amendable through comitology Inclusion of two new product categories (with specific exemptions) Medical Devices and Measurement and Control Equipment

18 3. RoHS recast - substance restrictions Current RoHS Ban on the use of heavy metals (Pb, Hg,Cd,Cr VI ) and brominated flame retardants (PBB&PBDE) in EEE put on the market after 1/7/2006 Amendments to substance ban codecision Proposal No changes to the list of substances Amendments to substance ban comitology New: 4 substances identified for priority assessment (HBCDD, DEHP, BBP,DBP) New: Substance restriction mechanism in line with the REACH methodology

19 3. RoHS Recast Exemptions Current RoHS Criteria for granting exemptions: if elimination or substitution is technically or scientifically impracticable, or where the negative environmental, health and/or consumer safety impacts caused by substitution are likely to outweigh the environmental, health and/or consumer safety benefits Review at least every 4 years or 4 years after Proposal New additional exemption criteria: availability and reliability of substitutes and socio-economic impacts. No more review, but a 4- year maximum validity period, with possibility of requesting renewals

20 3. RoHS alignment with REACH Whereas (12) RoHS recast proposal : «As soon as scientific evidence is available and taking into account the precautionary principle, the prohibition of other hazardous substances and their substitution by more environmentally friendly alternatives which ensure at least the same level of protection of consumers should be examined, paying attention to coherency with other Community legislation, and in particular to REACH»

21 3. RoHS alignment with REACH Article 4(7) : «When there is an unacceptable risk to human health or the environment, arising from the use of substances, and in particular the substances listed in Annex III, which needs to be addressed on a Community-wide basis, the list of prohibited substances in Annex IV shall be reviewed using a methodology based on the process set out in Articles 69 to 72 of REACH» Detailed rules on RoHS methodology to be developed through comitology

22 3. RoHS alignment with REACH Substances listed in RoHS Annex 3 (candidate) : HBCDD,DEHP,BBP,DBP also on candidate list of SVHC in REACH not a living list to be updated permanently decision taken by comitology with scrutiny (as for REACH)

23 3. RoHS alignment with REACH Substitution through exemption procedure: see whereas (14) : «Exemptions from the prohibition for certain specific materials or components should be limited in their scope, in order to achieve a gradual phase-out of hazardous substances in electrical and electronic equipment, given that the use of those substances in such applications should become avoidable.»

24 3. RoHS recast : development in codecision* In Council : different trends REACH as basis for substance prioritisation or for their assessment? RoHS developped as a separate tool (waste management)? Specific criteria to screen substances of RoHS concern? Methodology : headlines in the text, details adopted by comitology Risk-based approach? Involvement of ECHA? EP : Works will start soon? * (at the date of drafting this presentation, discussions were ongoing : an updated debriefing could be given on 27 Oct.)

25 1. EU Regulations on substances and substances in articles 2. REACH & RoHS : the experience so far? 3. RoHS recast : substances aspects 4. REACH & RoHS : complementary? 5. Other EU policies 6. Future approach to substance restrictions

26 Hazardous substance X (in EEE ) REACH and RoHS Duplication or complentary COM Substance X on Annex XIV Users Yes No No Specific request REACH Authorisation ECHA REACH Restriction RoHS MS COM REACH Risk Assessment (ENV + Health incl. Waste phase) Annex XV OR RoHS methodology? (ENV + Health + Recovery of Waste phase )? ECHA? RoHS TAC? COM No Authorised for EEE uses Yes Risk for ENV or HH (incl. Waste phase ) to be managed at Community level?? Risk for ENV or HH not already addressed by REACH restriction OR Risk for recovery of waste?? Yes Yes No EU Manufacturing of EEE containing X EU Manufacturing and import of EEE containing X Restriction Annex XVII Substance X on RoHS annex IV Specific Use of subst. X exempted (annex V or VI) Import of EEE containing X No EU Manufacturing of EEE containing X No Import of EEE containing X EU Manufacturing and import of specific EEE containing X

27 4. REACH and RoHS complementarity EEE are not excluded from REACH scope REACH might do the job if RoHS was not existing Will depend on RoHS methodology and additional (?) criterion : «environmentally sound management of waste» Risk based or precautionary principle? Overlaps : what if, substance authorised under REACH and banned under RoHS? Council and EP will give final political orientation to the future RoHS anyway Question : is it justified to proceed differently to restrict substances in EEE via RoHS or via REACH?

28 1. EU Regulations on substances and substances in articles 2. REACH & RoHS : the experience so far? 3. RoHS recast : substances aspects 4. REACH & RoHS : complementary? 5. Other EU policies 6. Future approach to substance restrictions

29 5. Other EU legislations Ecolabels (some examples) Backlights in laptops not containing Hg Flame retardants with R40, R45, R46, R50, to be banned in PC s Eco-design Energy Using Products (EuP) encouraging manufacturers to design products with the environmental impacts in mind throughout their entire life cycle, the Commission implements an Integrated Product Policy (IPP) and accelerates the move towards improving the environmental performance of energy-using products expected to increase the effectiveness and synergies of other EU legislative acts (like WEEE and RoHS)

30 1. EU approach to substance regulation/restrictions 2. REACH & RoHS : the experience so far? 3. RoHS recast : substances aspects 4. REACH & RoHS : complementary? 5. Other EU policies 6. Conclusion

31 6. Conclusion + RoHS recast proposal comes closer to REACH methodology (outcome after co-decision?) + RoHS is maintained for several reasons : + specific health and environmental concerns addressed for EEE + more targetted work for exemptions (including assessment of alternatives) + under REACH, restrictions in articles if risks identified at earlier stage + Targeted enforcement activities + RoHS works as a stand alone legislation (in principle: specific methodology to decide on restriction of substances, no ECHA involvement) + Synergies with Ecolabel, Eco-design to promote alternative technology before their possible generalisation + REACH review : by 1/06/2012, assess overlaps with other relevant Community provisions (169 texts identified!!).

32 THANK YOU! Unit G2, Chemicals Unit