The proposed legislation 2/24/2019 REACH The proposed legislation P:\10.14.8.1.1.013

The Current EU Chemicals Policy 2/24/2019 The Current EU Chemicals Policy Problems Existing substances can be used without testing Burden of proof on public authorities No efficient instrument to deal with problematic substances Lack of incentives for innovation, in particular of less hazardous substitutes Burden of the Past P:\10.14.8.1.1.013

A New EU Chemicals Policy 2/24/2019 A New EU Chemicals Policy Objectives Sustainable Development Protection of human health and the environment Maintain/enhance innovation/competitiveness Maintain the Internal Market Increased transparency and consumer awareness Integration with international efforts Promotion of non-animal testing Guiding Principles - substitution and precaution P:\10.14.8.1.1.013

The REACH System One System 2/24/2019 The REACH System One System Single, coherent system for new/existing chemicals Three new elements: Registration Evaluation Authorisation Focus on substances: high volumes of greatest concern. A Tiered Approach P:\10.14.8.1.1.013

> 100 tonnes. (+ priority) 2/24/2019 REACH - White Paper Registration Evaluation Authorisation > 100 tonnes. (+ priority) > 1 tonne CMR (cat 1&2) POPS plus Restrictions Central Entity P:\10.14.8.1.1.013

Reversed Burden of Proof 2/24/2019 And in practice? New Responsibilities Industry responsible for generating the knowledge Downstream users - assess the safety of their products Member State Authorities responsible for evaluating data submitted under Registration New Agency - technical, scientific and administrative framework   Reversed Burden of Proof P:\10.14.8.1.1.013

REACH - since the White Paper? 2/24/2019 REACH - since the White Paper? Duty of care Pre-registration Registration intermediates polymers Authorisation PBTs, vPvBs, ‘Other substances’ Agency Council Conclusions European Parliament Working groups Studies P:\10.14.8.1.1.013

Manufacturers/Importers/Downstream users: Duty of care Manufacturers/Importers/Downstream users: manufacture/use of substance reasonably foreseeable conditions health/environment not adversely affected. Chemical Safety Assessment (Downstream user assessment) Chemical Safety Report Updated Transmitted through supply chain

Registration Substances produced/imported > 1 tonne/year 2/24/2019 Registration Industry demonstrate chemicals managed safely Substances produced/imported > 1 tonne/year Phased approach P:\10.14.8.1.1.013

Registration of Chemicals: A Phased Approach 2/24/2019 Registration of Chemicals: A Phased Approach 1 - 10 t >1000 t + CMR 100 - 1000 t 10 - 100t Yr 0 Yr 0 +3 Yr 0 + 6 Yr 0 + 11 P:\10.14.8.1.1.013

Registration Substances produced/imported > 1 tonne/year 2/24/2019 Registration Industry demonstrate chemicals managed safely Substances produced/imported > 1 tonne/year Phased approach Central data base run by an independent agency Information requirements increase with volume > 100 tonnes testing proposals Intermediates/polymers - reduced requirements Updated - new information P:\10.14.8.1.1.013

Evaluation Data examined by Competent authorities. 2/24/2019 Evaluation Confidence that industry is meeting obligations Prevent unnecessary testing Data examined by Competent authorities. Standard (>100 tonnes) - testing proposals Priority (concern about risks) Additional information/testing can be required. “Mutual recognition” system P:\10.14.8.1.1.013

Control uses of very high concern substances 2/24/2019 Authorisation (1) Control uses of very high concern substances Very high concern? CMR, PBT, vPvB, ‘Substances of equivalent concern’ produced/sold for specific uses/under certain conditions – for supply chain. may include a review period. Applicant to show: adequate control of risks, or social and economic benefits outweigh the risks. Substitution considered Prioritised. P:\10.14.8.1.1.013

How does the Water Framework Directive fit in? Current draft: Authorisation (2) How does the Water Framework Directive fit in? Current draft: risks to health and environment from emission to aquatic compartment not considered if binding emission limit or eqs in a permit granted in accordance with 2000/60/EC. Still under discussion

Restrictions Community concern For manufacture/marketing/use 2/24/2019 Restrictions Safety net Community concern For manufacture/marketing/use MS (or Com) initiate Dossier (MS) to justify RA and SEA produced – Committee opinion Transparency via website Commission proposal – commitology. P:\10.14.8.1.1.013

2/24/2019 Who does what? P:\10.14.8.1.1.013

Increased animal testing Impact on downstream users 2/24/2019 Stakeholder concerns High costs Increased animal testing Impact on downstream users Production moving outside the EU EU industry disadvantaged internationally Loss of marketed substances P:\10.14.8.1.1.013

Costs Business Impact Assessment study 2002: 2/24/2019 Costs Business Impact Assessment study 2002: Direct costs: €1.4—7 billion; most likely € 3.6 billion. less than 0.1 % of yearly turnover over 11 years. Proposal adapted e.g. less data on intermediates, greater scope to waive testing will now revise the study Indirect costs: under assessment 90 % of costs from testing Industry has very little information about its chemicals? The knowledge gap REACH is designed to fill P:\10.14.8.1.1.013

Benefits (1) For new and existing substances, equivalent: 2/24/2019 Benefits (1) For new and existing substances, equivalent: levels of protection competitive advantages (Ex:hazardous v Nw: non-hazardous) > 30,000 existing substances investigated Acute (and long-term) toxicity Improved innovation more R&D flexibility no significant loss of protection Testing requirements: 1 - 10 tonnes generally in-vitro P:\10.14.8.1.1.013

Conclusion: benefits significantly outweigh costs 2/24/2019 Benefits (2) Benefits: occupational health, public health & environment Occupational Health Study Commission will publish a study today benefits estimated at between €18 and 54 billion Public health study underway initial results suggest substantial benefits Environmental benefits hard to express in cash terms reduced pollution of air, water, soil, reduced pressure on biodiversity Conclusion: benefits significantly outweigh costs P:\10.14.8.1.1.013

REACH = large-scale information collection, = large-scale testing. 2/24/2019 Limit animal testing REACH = large-scale information collection, = large-scale testing. Information requirements - smart/targeted: exposure often taken into account. not always necessarily to do new testing (eg (Q)SAR). Low volume production/import chemicals (1-10 tonnes/year): as far as possible no animal testing. For higher volumes: testing only if existing information/validated alternative methods not sufficient. Testing programmes - decided by the competent authorities Data sharing encouraged, but eventually compulsory; fair cost sharing. P:\10.14.8.1.1.013

Internet consultation 2/24/2019 Timing Internet consultation May - July 2003 Focused on workability www.europa.eu.int/comm/environment/chemicals/whitepaper.htm Adoption Planned - autumn 2003 Council and Parliament P:\10.14.8.1.1.013

Benefits significantly outweigh costs 2/24/2019 Conclusions - REACH High level of protection Changing burden of proof Improved knowledge Encourage innovation Substitution of most dangerous substances Better: tracking of chemicals use of resources reaction to emerging risks information for downstream users better consumer confidence Benefits significantly outweigh costs P:\10.14.8.1.1.013