REACH Otevřené otázky ve 2. čtení

REACHOtevřené otázky ve 2. čtení Karel Bláha Odbor environmentálních rizik Ministerstvo životního prostředí Kouty n. Desnou, 18. 5. 2006

Registrace Hlavní změny v těchto oblastech • Rozsah • Preregistrace, existující látky • Požadavky na registraci především v pásmu 1-10 t/rok • Látky ve výrobcích • Sdílení dat, společné předložení

Rozsah registrace Hlava I Článek 2 Přílohy II a III

Scope of Registration • Clarification of exemptions for foods and feedingstuffs and recycled materials • Little change to Annex II; cellulose pulp • Annex III • Minerals, ores and ore concentrates • Cement clinker • Other substances occurring in nature if not dangerous

Pre-registration and phase-in Titles II and III • Article 21 • Article 26

Pre-registration and phase-in • A single pre-registration phase 12 – 18 months after entry into force • Information on possible groups to be submitted for read across • Those entering market after entry into force may use phase-in period • Early registration of PBTs/vPvBs over 100 tonnes

Pre-registration and phase-in Notification of SVHCs in SIA Agency start up Pre-registration • 1000+ tonnes • CMRs 1+ tonne • PBTs/vPvBs (R50-53) • 100+ tonnes 100-1000 tonnes 1-100 tonnes Non-phase-in substances [6 months] EIF 12 months 3 years 6 years 11 years 18 months

Registration requirements Title II • Articles 9, 11, 12 Annexes Ic, IV – IX

Registration requirements • 1 – 10 tonnes, targeted approach: • Maintains industry responsibility • For phase-in substances only • Minimum physchem always • Full Annex V (+3) if one of two criteria met • 10 – 100 tonnes: • One reproductive toxicity test only • Possibility of exposure-based waiving

Data sharing and joint submission Title II • Articles 10 and 17 Title III

Data sharing and joint submission • Key elements of OSOR included • Sharing of animal data mandatory • Sharing of non-animal data mandatory if requested • Joint submission of key parts of the dossier with possibility of “opt-out”; • Disproportionate cost • Disclosure of confidential information • Disagreement on data

Substances in articles Title II • Article 6 Title IV • Article 30 Title VII • Article 55

Substances in articles • Provisions closer to those for substances • Registration – substances intentionally released above 1 tonne • Notification – SVHCs contained in articles • Agency power to request registration • Duty for suppliers to provide information on SVHCs in articles • Restrictions possible for SVHCs

Authorisation Changes made to: • Identification of substances • Granting of authorisations • Conditions of authorisation

Identification of substances Title VII • Articles 54 and 56

Identification of substances • Scope of authorisation as in Commission proposal but… • Substances of equivalent concern clarified in Article 54(f) – “irreversible” removed • Agency to develop and publish a candidate list

Granting of authorisations Title VII • Articles 57 and 59

Granting of authorisations • Authorisation clarified and strengthened • Adequate control NOT applicable: • To CMRs and equivalent concern where a safe threshold cannot be determined • PBTs and vPvBs • All applications to include an analysis of alternatives

Conditions of authorisation Title VII • Articles 57 and 58

Conditions of authorisation • All authorisation to be subject to a time-limited review • Set on a case-by-case basis; no specific maximum time-limit • Authorisations shall normally subject to monitoring

Issues subject to changes in the EP Key changes made to: • Information and downstream users • Evaluation • Fees and the Agency • Access to information • Scope of the Regulation

Scope of the Regulation Title I • Articles 1 to 3a

Scope of the Regulation • Exemption for wastes • Consolidation of all exemptions under Article 2 • Important definitions eg: alloys, phase-in substances, use and exposure categories • New provision for appointment of third party representative

Supply chain and downstream users Titles IV and V • Articles 29, 34, 35

Supply chain and downstream users • Safety data sheets for PBTs/vPvBs and preparations containing them • Downstream user CSR threshold of 1 tonne of substance or preparation • Must assess risks and report to Agency • Deletion of Annex Ib

Evaluation Title VI

Evaluation • Agency responsible for dossier evaluation • Minimum 5% with priorities • One EU-wide rolling plan for substance evaluation • Agency responsible for co-ordinating, relying on Competent Authorities

Fees and the Agency New Title VIIIa Title IX • Articles 75, 101a

Fees and the Agency • New Title on fees, which are to be established in a Commission Regulation • Help for SMEs – lower fees • Incentives on OSOR, 1 – 10 tonnes • Management board – one member per MS • Language regime of the Agency

Access to information Title XI

Access to information • Rules for access to information to be agreed by Management Board • Some information always to be made public on website • Subject to Agency decision and payment of fee, possibility for industry to justify not publishing some information

Conclusion • Political agreement – good balance between health, environment and competitiveness • Impact on industry in particular SMEs minimised • Benefits maximised

Zdroj:Summary of Council’s political agreementGian Marco CurradoChemicals & GM Policy DivisionDefra, UKVienna, March 29, 2006

Děkuji za pozornostkarel_blaha@env.cz

REACH Otevřené otázky ve 2. čtení