22/02/2019 REACH REACH update

The Current EU Chemicals Policy 22/02/2019 The Current EU Chemicals Policy Problems Existing substances can be used without testing lack of knowledge about their properties and uses Burden of proof on public authorities Current system slow to act no efficient instrument to deal with problematic substances Lack of incentives for innovation in particular for less hazardous substitutes EU review of Directives revealed a number : Existing substances can be used without testing lack of knowledge about their properties and uses Burden of proof on public authorities Current system slow to act no efficient instrument to deal with problematic substances Lack of incentives for innovation in particular for less hazardous substitutes Burden of the Past

REACH One System A Tiered Approach 22/02/2019 REACH One System Single, coherent system for new/existing chemicals Elements: Registration of substances above 1 tonne Evaluation by the Member States Authorisation for substances of very high concern Restrictions - the safety net Agency to manage system Focus on: high volumes greatest concern. Single, coherent system for new/existing chemicals Elements: Registration of substances above 1 tonne Evaluation by the Member States Authorisation for substances of very high concern Restrictions - the safety net Agency to manage system Focus on: high volumes greatest concern. A Tiered Approach

Development of the new legislation: REACH 22/02/2019 Development of the new legislation: REACH White Paper (Feb 2001) Reactions: Council (Jun 2001) and Parliament (Oct 2001) Reactions: stakeholders Fact-finding (Sep 2001 - Mar 2002): Technical consultation (Working Groups), Studies Drafting stage (Mar 2002 - May 2003) Internet Consultation (15 May 2003 to 10 July 2003) 6000 consultation responses White Paper published Feb 2001 Reactions from Council (Jun 2001) and Parliament (Oct 2001) generally supportive of aims Reactions from stakeholders - very varied Extremely high interest in proposals extending beyond EU Responsibility shared between DGs ENV and ENTR Fact-finding stage (Sep 2001 - Mar 2002): Technical consultation with stakeholders (Working Groups) - attended also by services Studies Business impact assessment Central Entity feasibility study Occupational health impact study Drafting stage (Mar 2002 - Mar 2003): Text developed as Building Blocks JRC contributed significant technical and scientific support Agreement stage: All issues resolved within ENTR and ENV by Mar 2003 First inter-service consultation April 2003 7 May 2003 - Commission discussion & Press Release 15 May 2003 - Launch of internet consultation Internet Consultation Why ? Reality check at an early stage Workability - optimal design Technical and scientific soundness Involvement of all stakeholders Commission commitment:Better Governance

Internet Consultation (1) Total replies 22/02/2019 Internet Consultation (1) Total replies

Internet Consultation (2) Replies by MS 22/02/2019 Internet Consultation (2) Replies by MS

Internet Consultation (3) Type of stakeholder 22/02/2019 Internet Consultation (3) Type of stakeholder

Internet Consultation (4) Where in the world? 22/02/2019 Internet Consultation (4) Where in the world?

Internet Consultation (5) Main issues raised 22/02/2019 Internet Consultation (5) Main issues raised Issues: Scope of the system - polymers, intermediates, articles. Legal certainty - Duty of care. Costs Bureaucracy/Powers of the Agency vs MS. Confidentiality/right to know Substitution Animal testing Issues: Scope of the system - polymers, intermediates, articles. Legal certainty - Duty of care. Costs Bureaucracy/Powers of the Agency vs MS. Confidentiality/right to know Substitution Animal testing Conclusion Cut costs and bureaucracy, particularly for DU and SME, without lowering protection of health and environment

Development of the new legislation: REACH 22/02/2019 Development of the new legislation: REACH White Paper (Feb 2001) Reactions: Council (Jun 2001) and Parliament (Oct 2001) Reactions: stakeholders Fact-finding (Sep 2001 - Mar 2002): Technical consultation (Working Groups), Studies Drafting stage (Mar 2002 - May 2003) Internet Consultation (15 May 2003 to 10 July 2003) 6000 consultation responses Review of replies & re-drafting (Jul - Aug 2003) 2nd inter-service consultation (Sept - Oct 2003) Adoption of proposals by Commission and start of co-decision procedure (29 Oct 2003) Decision making in EP and Council: 2004-2005? REACH in force: 2006? White Paper published Feb 2001 Reactions from Council (Jun 2001) and Parliament (Oct 2001) generally supportive of aims Reactions from stakeholders - very varied Extremely high interest in proposals extending beyond EU Responsibility shared between DGs ENV and ENTR Fact-finding stage (Sep 2001 - Mar 2002): Technical consultation with stakeholders (Working Groups) - attended also by services Studies Business impact assessment Central Entity feasibility study Occupational health impact study Drafting stage (Mar 2002 - Mar 2003): Text developed as Building Blocks JRC contributed significant technical and scientific support Agreement stage: All issues resolved within ENTR and ENV by Mar 2003 First inter-service consultation April 2003 7 May 2003 - Commission discussion & Press Release 15 May 2003 - Launch of internet consultation Internet Consultation Why ? Reality check at an early stage Workability - optimal design Technical and scientific soundness Involvement of all stakeholders Commission commitment:Better Governance

Duty of Care Duty of care removed; Replaced by principle: manufacturers, importers and downstream users to … manufacture, place on the market, import or use .. do not adversely affect human health or the environment. provisions underpinned by the precautionary principle.

DU‘S rights and duties CSA: choice for downstream users 22/02/2019 DU‘S rights and duties CSA: choice for downstream users Right to make a use known to his supplier supplier performs the assessment Choice to keep his use confidential: duty to perform CSA if use is not covered in supplied SDS. Duty to report information if (>=1 tonne) his use is not covered in the SDS supplied he applies or recommends different RMM

Registration Polymers: Intermediates: 1 to 10 tonnes: 22/02/2019 Registration Polymers: no registration but authorisation/restrictions review on basis of sound technical + valid scientific criteria Intermediates: isolated transported: no limitation to 2 sites 1 to 10 tonnes: reduced testing requirements no CSA/CSR

CSR > 10 tonnes; For identified uses; Hazard assessment; PBT/vPvB assessment; exposure assessment; exposure scenarios developed; Show RMM adequately control risk; Communicated by SDS

Registration – role of Agency Agency solely responsible for registration: Preregistration and data sharing R&D exemptions Handling of all registrations Rejections of incomplete registrations Decisions on confidentiality Agency will have a board of appeal

Evaluation Dossier evaluation Substance evaluation Examination of testing proposals Compliance check CA = where registrant based. Substance evaluation Follow-up to suspicion of risk: request further info MS rolling plans to decide on CA

Authorisation AIM Prioritisation For not adequately controlled risks 22/02/2019 Authorisation AIM : …to ensure that the risks from substances of very high concern are properly controlled or replaced by suitable alternative substances or technologies Prioritisation PBTs, vPvBs, wide dispersive use, high volumes For not adequately controlled risks Normally time limited Assessment of alternative substances or technologies Substitution plans may be submitted

In granting authorisations, the Commission shall not consider: 22/02/2019 Authorisation and WFD In granting authorisations, the Commission shall not consider: risks to and via the aquatic environment of discharges of a substance in Directive 2000/60/EC. Review: If the environmental objectives of Directive 2000/60/EC are not met: review of authorisations granted for the use of the substance in the relevant river basin. The authorisation application and decision shall not address risks to human health and/or the environment of emissions of the substance from an installation for which a permit was granted in accordance with the IPPC Directive (Directive 96/61/EC) or from a point source governed by requirement for prior regulation under the Water Framework Directive (Directive 2000/60/EC) or arising from the use in a medical device as these emissions are adequately controlled under other Community instruments which are applied by the Member States. Therefore, this is necessary not to interfere with such other competences and to avoid differences between the decisions taken under different regulatory regimes as well as the resources in examining an impact twice Authorisation decisions may need to be amended or withdrawn as a result of a review which can be done at any time when there is a change of circumstances. Such a change of circumstances can for example be changes in the scientific basis for an authorisation decision or that environmental quality objectives as defined under the IPPC Directive or Water Framework Directive are not met because of diffuse emissions to water or the air. Emissions from point sources however are dealt with under those Directives.

Substances in Articles 22/02/2019 Substances in Articles Registration: only if substance is intended to be released Notification: producer knows or is made known that substance is released and quantity released may adversely affect human health or environment Both: only substances classified as dangerous and in quantities of 1 tonne or more Agency: may require notified substances to be registered

Agency Registration Evaluation Substances in articles Board of appeal 22/02/2019 Agency Registration Evaluation Ensuring a harmonised approach: monitor decisions and develop criteria and priorities Substances in articles Require registration Board of appeal Decisions on registration, R&D, confidentiality

Confidentiality Text defines some types of information 22/02/2019 Confidentiality Text defines some types of information to be always kept confidential except in case of an immediate risk; to be always non-confidential; Other information may be claimed to be confidential All non-confidential information will be made available defined information on the database other information on request