REACH ”No Data, No Market”

1. REACH”No Data, No Market” Elin Simonsson Lena Lundahl Anna Johansson

2. ”No data, no market” • Art. 5 REACH; EC 1907/2006

3. Outline • Introduction • Provisions • Controversy • Status/Discussion

4. History Behind Regulating Information • Expensive and administratively heavy • Internalizing cost of information • Market failure • Internal market – art. 114 TFEU

5. Market-Based Regulation • Compare with the EU ETS • International aviation • Global impact

6. Art. 5 REACH • […] substances on their own, in preparations or in articles, shall not be manufactured in the Community or placed on the market unless they have been registered […]

7. Definitions • Art. 3 REACH • 3(1) Substance […] a chemical element and its compounds in the natural state or obtained by any manufacturing process […] • 3(2) Article […] an object which during production is given a special shape, surface or design which determines its function to a greater degree than does its chemical composition […]

8. Obligation to Register • Art. 6 REACH • General obligation to register substances • If the quantity exceeds 1 tonneannually, per manufacturer

9. Registration • Art. 7 REACH • Criteria for registration of articles: • Quantity exceeding 1 tonne per year and producer • Substance in article is intended to be released under normal/reasonably foreseeable conditions of use

10. Registration (cont’d) • Art. 10 REACH: Technical dossier • Information about themanufacturer • Identity of the substance • Information on the manufacture and uses of the substance • Classification and labeling • Guidance of use • Chemical safety report • Study summary • The tonnage range decides what information the registrant needs to submit (Annexes VII-XI)

11. Notification • Art. 7 REACH • Basic information about the substance might lead to an obligation to register • Criteria for notification: • Substance concentration in article exceeds 0.1%, and • The substance has been classified as: • Cancerogenic • Mutagenic • Toxic to reproduction • Persistent, bioaccumulative and toxic, or • Substances for which there is scientific evidence of probable serious effects to human health or to the environment

12. Joint Submission of Data • Art. 11 REACH • The lead registrant shall notify the Agency about: • Classification and labeling • Guidance on safe use • Study summaries • Proposals for testing • Every registrant submits information specific to their own import/production • Every single registrant responsible only for the information of their own manufacture or import

13. Sharing of Costs • Rules dispensed in different parts of the regulation • Art. 27 REACH • ”The previous registrant and potential registrant(s) shall make every effort to ensure that the costs of sharing the information are determined in a fair, transparent and non-discriminatory way.”

14. Controversy • Privatization of information provision • Obligation on private actors • Explicit responsibility for the industry for the safety of its chemicals • Internalization of costs

15. Controversy (cont’d) • Perverse incentives for the industry? • Underestimation of risk • Key governance problem of REACH • Two principal mechanisms: • Hierarchical control • Peer review

16. i. Hierarchical Control • Dossier evaluation • Examination of testing proposals • Compliance check of registration

17. ii. Data Sharing/Joint Registration (Peer Review) • Title III, articles 25-30 of REACH • REACH requires multiple registrants of the same substance to share data and to jointly submit their registration dossier • Core principle to avoid unnecessary animal testing and reduce registration costs • Mechanism differs depending on whether the chemical is a new (non phase-in) or an existing (phase-in) substance

18. a. Non Phase-In Substances: Inquiry • Duty to inquire whether a registration has already been submitted for that substance • The Agency has to facilitate joint registration

19. b. Phase-In Substances: SIEF • Duty to pre-register and to join a Substance Information Exchange Forum (SIEF) • One joint submission for each substance • Cost reduction • Unnecessary animal testing avoided • SIEFs have no prescribed legal form and are independently managed by the industry • ECHA not involved

20. Controversy (cont’d) • Accountability • Is it a workable regulatory strategy? • Assessment of the quality of the data • Risk assessment • Risk assessment rather than hazard assessment • Costs • Do the costs to private actors exceed the public benefits?

21. Controversy (cont’d) • Practicalities • Decisions need to be made about different issues: • Risk identification • Information quality • Publication and sharing of information • How is the information to be acted on?

22. REACH Review 2012 • ”…special attention to the costs and administrative burden and otherimpacts on innovation.”

23. Discussion • Is a focus on information a goodway to regulate? • From a market perspective? • From an environmentalperspective? • Is it reasonable to put the obligation of information provision on the industry? Is it safe?