Berkeley Class 2009 Final

UC Berkeley, Class on Health Risk Assessment, Regulation and Policy Berkeley, 2 November 2009 Klaus Berend, Visiting EC Fellow Chemicals Policy in the EU – history, current situation, the role of risk assessment and global perspectives Disclaimer : views expressed are personal and do not necessarily represent the views of the Commission

Basics European Commission corresponds to the executive power (government/administration) in the Member States or the US The various Directorates-General (DGs) are comparable to Ministries / Departments The Commission decides collectively – all Commissioners and DGs have to agree The Commission proposes – but the European Parliament (directly elected) and the Council (Ministers from the Member States) adopt important legislation

Chemicals Policy – Legal Basis Legislation on chemicals is mainly based on Article 95 of the Founding Treaty of the EC – Internal Market (1) The Council and the Parliament adopt …(in co-decision)... measures for the approximation of the provisions laid down by law, regulation or administrative action in Member States which have as their object the establishment and functioning of the internal market . … . (3) The C ommission, in its proposals, will take as a base a high level of protection concerning health, safety, environmental protection and consumer protection, taking account in particular of any new development based on scientific facts . Within their respective powers, the European Parliament and the Council will also seek to achieve this objective.

Historic development of EU chemicals legislation Directive 67/548/EEC on the classification, labelling and packaging of dangerous substances 7 major amendments, 31 adaptations to technical progress over the years Important amendments: 6th amendment (Directive 79/831/EEC) creating EINECS for so-called existing substances on the market on 18 September 1981 and ELINCS for new substances, which had to be notified with a set of toxicological and ecotoxicological information ( Nota bene : This was very much inspired by TSCA in the US but more demanding in terms of data requirements for new substance notifications) 7th amendment (Directive 92/32/EEC) more elaborate rules on new substances notification (tonnage triggers for more tests), a requirement for risk assessment to be made in accordance with uniform principles in all Member States Principles were codified in detail in Directive 93/67/EEC on the principles of risk assessment Directive 88/379/EEC on the classification, labelling and packaging of dangerous preparations – modernised in Directive 1999/45/EC Grown over a long time, starting in 1967 with hazard assessment …

Historic development of EU chemicals legislation Directive 76/769/EEC on restrictions of the marketing and use of dangerous substances and preparations First restrictions/bans on PCBs/TCBs (exactly like TSCA) Multiple amendments and adaptations to technical progress : Restrictions / bans for more than 60 specific chemicals / chemicals groups Including: penta/octa PBDE’s, lead paints, asbestos, PFOS/PFOA … Ban of sales to consumers of more than 1000 CMR’s In the meantime for TSCA: 6 bans/restrictions – the last one on asbestos repealed by Court. No further legally binding actions since then. Risk Management: restrictions and bans

Historic development of EU chemicals legislation Regulation (EEC) No 793/93 on the evaluation and control of risks of existing substances Created obligations for manufacturers/importers to submit available data on hazards and uses for existing substances - submission date and data amounts depending on tonnages placed on the market Introduction of a specific software package: IUCLID Selection of priority substances for risk assessment (in subsequent years: 5 lists, ca. 140 substances) Designation of Member States to act as Rapporteurs to conduct risk assessments and propose risk reduction measures Regulation (EC) No 1488/94 on the principles for the assessment of risks to man and the environment of existing substances What to do with existing substances ?

Stocktaking in 2001 Risk assessments were very slow (e.g. cadmium/cadmium oxide 15 years) Difficult to identify risks – difficult to address risks : Lack of information on “existing” substances for effective assessment and control, procedure to oblige companies to conduct additional testing was there but proved to be slow Burden of proof was on public authorities A barrier to innovation : all new chemicals had to be notified and tested starting from volumes as low as 10 kg per year, whereas no similar obligations were in place for existing substances. Problem: the chemicals management system was inefficient … Very much like TSCA ….

Aims of New Chemical Strategy To improve protection of human health and the environment from the risks of chemicals To enhance innovation and competitiveness Published in February 2001 (COM (2001)88) Contains already the basic outline of REACH ( R egistration, E valuation and A uthorisation of C hemicals) Formal proposal for REACH in October 2003 / adoption in December 2006 ( Regulation (EC) No 1907/2006) White Paper on the Strategy for a Future Chemicals Policy

REACH objectives Protection of human health and the environment Free circulation of chemicals on the internal market Enhancing competitiveness and innovation One single and coherent system for new and existing chemicals Shift of responsibilities: public authorities  industry Promote alternative methods for the assessment of hazards of substances

Core elements: Registration of substances ≥ 1 tonne/yr (staggered deadlines: 2010 – 2013 - 2018) Information to be transmitted in the supply chain Evaluation of some substances by Member States Authorisation only for substances of very high concern Restrictions - the safety net to be used when necessary European Chemicals Agency to manage system Focus on priorities: high volumes (as a proxy for potential exposure) greatest concern (substances & uses with highest risk)

Scope of the Regulation REACH applies to the manufacturing, import, placing on the market and use of substances On their own, in mixtures, and to a lesser extent when incorporated in articles Reduced obligations for R&D, polymers and intermediates

Registration  manufacturers and importers have to obtain information on their substances and  use this knowledge to ensure responsible and well-informed management of the risks these substances may present throughout their life cycle Registration Dossier = Documentation  Technical Dossier : starting at 1 tonne per year Chemical Safety Report : starting at 10 tonnes per year No formal acceptance by authorities - industry retains responsibility

Substances in Articles (Article 7) > 1 tonne / year per Manufacturer / Importer Not registered for that use Intended to be released (regardless of hazard) General obligation to register Substance of Very High Concern (CMRs, PBTs and vPvBs, etc.) Placed on candidate list for authorisation Concentration of > 0.1 % weight-by-weight except where there is no exposure At the earliest 1 June 2011, and 6 months after SVHC placed on candidate list Agency may require registration Obligation to notify the Agency Timeline in accordance with general deadlines

When to register? 100 - 1000 t/a 31 May 2013 Entry into force 1 June 2007 Registration of ‘new’ substances ≥ 1t/a 31 May 2018 ≥ 1000 t/a CMR ≥1 t/a R50/53 ≥100 t/a 30 Nov. 2010 Pre-registration 1 June 2008 – 1 Dec. 2008 Agency published List 1.1. 2009 C&L notification (independent of tonnage) 01/01/2011 Timeline REACH phase-in period (not in scale) Note that phase-in registration required pre-registration! SIEF Substance Information Exchange Forum

SIEF – Data sharing Obligatory platform to: share data among: potential registrants of the same phase-in substances (manufacturers and importers) data holders for that substance (downstream users and other stakeholders) avoid unnecessary testing + animal welfare no obligation to share non-animal data agree on classification and labelling Suitable platform to organise the mandatory joint submission of data 11/12/09

The Downstream User Must: Implement Operational Conditions and Risk Management Measures communicated to him via the exposure scenarios in the Safety Data Sheet If he uses the chemical outside the conditions described in the exposure scenario(s) Inform his supplier of this use to make it an identified use Alternatively: Conduct a safety assessment for his own use (and for his downstream uses if he is a supplier) Implement Exposure Scenarios from own safety assessment Report to the Agency Communicate further down the supply chain if he is supplier

Evaluation Dossier evaluation : Checking compliance of registration dossiers Checking of test proposals Substance evaluation : Checking whether there is a need for further information on a substance

Risk Management: Authorisation Only applies to Substances of Very High Concern , once included in Annex XIV CMR (carcinogenic, mutagenic, toxic for reproduction) PBT/vPvB (persistent, bioaccumulative, toxic / very persistent and very bioaccumulative) substances of equivalent concern (endocrine disruptors, catch-all) Substance are selected on basis of hazards and prioritised for vPvB and PBT properties, wide dispersive use, or high volume Sunset date: time limit for use and revision after a certain date Authorisation of individual uses and companies

Risk Management: Restrictions Directive 76/769/EEC has been repealed on 1 June 2009 and replaced by REACH (Title VIII and Annex XVII) All restrictions/bans from the past have been maintained in Annex XVII Safety net to manage any unacceptable risk Applicable to any substance in principle General measure applicable to anyone using the substance In addition to “marketing & use”, also the unacceptable risks to human health and the environment from the manufacture will be covered and can lead to production bans.

European Chemicals Agency: ECHA ECHA today :  300 staff Started to manage the registration and evaluation First steps in authorisation Guidance / IT tools Helpdesk(s) Committees + Forum established Stakeholder involvement + consultations started ECHA in future : Up to  460 staff Will have an important role in authorisation and restriction

REACH – current status Pre-registration period is over First registration deadline : 30/11/2010 Currently : SIEF Formation & management 156 substances on published list of registered substances Pre-registrations received > 2 700 000 Companies > 65 000 Substances > 146 000 Preliminary numbers for the Registration procedure

SIEFs: today’s main challenge Substance Exchange Information Forum (SIEF) ~10 000 substances envisaged to be registered by 2010 80% of all the SIEFs have between 10-99 companies/ importers or legal entities < 20% have appointed the Lead Registrant The clock is ticking !!!

REACH – current status (continued) Candidate list & authorisation The first 15 substances included in the Candidate list of Substances of Very High Concern ( SVHC ) (28 October 2008) First step for the Authorisation procedure 7 SVHCs prioritised Recommendation to COM (01/06/09)

Distribution of responsibilities for chemicals in the Commission Responsibilities for legislation on chemicals : DG Enterprise & Industry + DG Environment : classification & labelling, REACH, biocides, animal testing, POPs, PIC, RoHs, VOC, (hazardous) waste, ELV, WEEE … DG Joint Research Centre : scientific / technical support for alternative test methods (ECVAM). Hosted the former European Chemicals Bureau (ECB) – now replaced by ECHA DG Employment : worker protection DG Health and Consumer Protection : plant protection / food additives and food contact material / hygiene / general product safety ….. DG Transport & Energy : transport of dangerous goods, energy

Chemicals in DG Enterprise Within DG Enterprise ….. Unit G.1: REACH Unit G.2: CLP + all other existing legislation Unit F.2: (veterinary) medicinal products Unit F.3: cosmetics and to some lesser extent G.4: textiles I.2: toys I.5: construction materials

Tasks of Unit G.2 - Legislation 1.1. Horizontal legislation Dir 76/769/EEC – restrictions on the marketing and use of dangerous chemicals Has been replaced by REACH on 1 June 2009 - now in Unit G.1 Reg (EC) 1272/2008 and – until its repeal - Dir 1999/45/EC – Classification & Labelling of dangerous substances and preparations + safety data sheets has implemented GHS in the EU Good Laboratory Practise (GLP )

Tasks of Unit G.2 - legislation 1.2. Sectoral legislation Regulation 2003/2003 – fertilisers continuous update of list of EC fertilisers limit for Cd in fertilisers ammonium nitrate fertilisers – possible misuse as explosive Regulation 648/2003 – detergents report and potential measures on phosphates zeolithes (as substitutes) + phosphonates, carboxylates

Tasks of Unit G.2 - legislation 1.2. Sectoral legislation Regulation 273/2004 – drug precursors Implementation guidance Co-ordination with UN-activities Directive 93/55/EEC – explosives Very ‚acute‘ (combat against terror) Dir 2007/23/EC – pyrotechnic articles very recent – implementation to start

Tasks of Unit G.2 - legislation 1.3. Monitoring implementation in the Member States Authorisation of national derogations (Article 95) Infringements Complaints Evaluation of draft national measures in the non-harmonised area (Dir. 98/34/EC)

Tasks of Unit G.2 – sustainable development 2.1. Contributing to activities of DG Environment Biocides International (PIC / POPs / UN-ECE / UNEP) Mercury strategy PVC RoHs and WEEE Seveso and IPPC Directives Montreal protocol (F-Gases) VOC Directive Water Framework Directive Thematic Strategy Pesticides

Tasks of Unit G.2 – sustainable development 2.2. Contributing to activities of DG Health & Consumer Protection plant protection products (Pesticides) food contact material nanotechnology 2.3. Contributing to activities of DG Research 7 th framework programme nanotechnology technology platform (SusChem )

Tasks of Unit G.2 – competitiveness High Level Group on the chemical industry Contribution to the general industrial policy with regard to the chemical sector – statistical information, data banks Support to DG Competition for M&A and state aid Support to DG Trade in free trade negotiations – multilateral (WTO) or bilateral Growing number of bilateral Dialogues: USA, Canada, Russia, China …. International Rubber Study Group (IRSG )

EU chemicals industry – Some key figures 30 % of global chemical industry sales 26 % of EU’s manufacturing trade surplus 5 of the 10 largest chemical companies are European 1.9 million highly educated and skilled workforce 27 000 chemical enterprises (96 % are SME’s representing 30 % of sales and 37 % of employment )

REACH applies equally to chemicals manufactured domestically in the EU and imported ….. the EU is a big importer of chemicals Why has REACH global implications?

Some provisions of REACH apply to chemicals contained in articles produced in the EU or imported from 3rd countries …. …… EU is biggest importer globally of finished goods Strong interest in many third countries for close involvement during adoption process and today – Commission agreed to set up specific dialogues with major trading partners Why has REACH global implications ?

Co-operation with important trade partners The European Commission is engaged in a series of bilateral dialogues to discuss chemicals legislation: - China - Russia - USA - Canada - Japan Objectives: better understanding of each other’s legislative requirements – explaining REACH convergence of legislation - ‘level playing field’ improving market access for companies

EU – China Working Group on Chemicals Framework: Consultation Mechanism on Industrial Products and WTO / TBT between DG Enterprise and Chinese standardisation and Quality control body (AQSIQ) Issues for China: - Knowledge and training on REACH to support Chinese exporters to comply with requirements - Information about Guidance and IT - Recognition of test data from ‘accredited test facilities’ Issues for EU: - New substances notification requirements in China - Law on Toxic Substances - Import of active ingredients for pharmaceuticals - GHS implementation in China

EU – China Working Group on Chemicals Activities: - 3 Meetings between December 2006 – November 2008 Multiple projects on REACH and Chemicals Management in China supported by DG Environment, DG EuropeAID + Member States China is in contact with OECD regarding GLP Study tours of Chinese delegations in several Member States and to visit Commission Biggest challenges: Appropriate co-ordination in China between various Ministries and authorities involved: AQSIQ, MEP, SFDA, Min. Agriculture, Min. Health, NDRC

EU – Russia Working Group on Chemicals Framework: Dialogue on Industrial and Enterprise Policy between Commission and Russia with in the Roadmap of the Common Economic Space between the EU and Russia (adopted at summit in May 2005) Main actors: DG Enterprise and Industry and Russian Ministry of Industry and Energy Issues for Russia: - Knowledge and Training about REACH to support Russian exporters to comply with requirements + Information about Guidance and IT - Recognition of test data from ‘accredited test facilities’ Issues for EU: - Revision of the Russian Chemicals legislation to align it with REACH and GHS - Problems with the registration of Plant Protection Products - Customs issues (Fees and length of procedures)

EU – Russia Working Group on Chemicals Activities: - 5 Meetings between December 2006 – March 2009 Exchange of documents, including draft new Russian legislation on chemicals Workshop in Moscow on REACH and GHS with more than 150 participants from industry (in particular metal & mining industry and petrochemicals) and authorities Biggest challenges: Appropriate co-ordination in Russia between Ministries and Institutes involved: Min. Agriculture, Min. Health, Customs authorities Real change from current system (high responsibility for authorities) to REACH (principle of industry responsibility)

Co-operation with USA Framework: Transatlantic Economic Council (TEC) Issues: - Optimal information exchange about REACH (including Guidance, set-up of ECHA, IT, etc.) and US activities under TSCA (Champ, timing, prioritisation ….) - Full co-operation in all OECD related activities (test methods, nanomaterials, alternative testing, computational tools, global data warehouse, existing chemicals programme ….) - GHS (further harmonisation and new endpoints) - exchange of personnel EPA – ECHA - enforcement and compliance monitoring for imported products - very recently : US-TR wants to discuss trade implications

Co-operation with USA Activities: Bilateral meeting in December 2007 Trilateral meetings with Canada in December 2007 and November 2008 High Level Regulatory Forum in November 2007 Biggest challenges: Upstream consultation prior to introduction of legislation or other activities: REACH, GHS, TSCA Review Compatibility of time schedules for assessment activities Recognition of assessment results Full integration into OECD activities

Co-operation with Canada Framework: Regular consultations between EU and Canada (Environment, Trade) Issues: - Identical to those with US - Initial request from Canada to negotiate a formal agreement on exchange of confidential data on chemicals – dropped now

Co-operation with Canada Activities: Two meetings in December 2007 and March 2009 Trilateral meeting with the US in December 2007 and November 2008 ECHA staff went for a visit in June 2009 – now drafting a common roadmap of activities Biggest challenges: Upstream consultation prior to introduction of legislation or other activities: REACH, GHS, CEPA Compatibility of time schedules for assessment activities – in particular with Canadian Domestic Legislation Recognition of assessment results Full integration into OECD activities

Risks from chemicals have 2 components: Intrinsic properties (hazards) In principle: universal, independent of location Exposure (dose, duration, frequency) Can be dependent on location / situation / context Global Co-operation efforts so far primarily focussed on hazard assessment Case for global norms for Chemicals Regulation?

Long-Standing successful co-operation in the OECD on tools for hazard assessment: Test methods Quality assurance (GLP) Initial hazard assessment (HPV Programme) IT tools for data submission and data sharing Global data warehouse New, alternative test methods Computational tools (QSAR’s) Nanotechnologies Case for global norms for Chemicals Regulation?

Case for global norms for Chemicals Regulation? Transport liquid: slightly toxic; solid: not classified EU Harmful (St Andrew’s Cross) US Toxic CAN Toxic Australia Harmful India Non-toxic Japan Toxic Malaysia Harmful Thailand Harmful New Zealand Hazardous China Not Dangerous Korea Toxic Substance - oral toxicity LD 50 = 257 mg/kg Situation for C & L of the same substance prior to GHS In GHS: GHS Danger (Skull & Cross Bones)

GHS – Global Context Rio, 1992 – Chapter 19 of UNCED Agenda 21 Development by IOMC, to end 2001 UN CETDG/GHS – agreed Dec 2002 UN ECOSOC – adopted July 2003, Rev. 2 2007 WSSD, Johannesburg 2002 – operational by 2008 A Global Initiative

GHS Status Worldwide – early 2009 preparation Implementation activities

Important to implement GHS in very similar ways in the EU and other countries – this would be major step towards facilitating trade Major challenge: remaining flexibilities in GHS Desirable: consultations prior to implementation EU adopted and published legislative proposal in June 2007 – available to 3rd countries for comments and ‘inspiration’ via WTO– TBT process. Only China submitted comments/questions Final adoption by the European Parliament and the Council in December 2008 China, Russia, Canada: ‘in preparation’, ‘activities’ Constraints : Timelines and final decisions by legislators Situation in US: OSHA published proposal on 30 Sep 2009 Challenges of Implementing Global Norms

A lot has been achieved for hazard assessment … … . what about exposure and ultimately risks? For some cases: exposures and risks are actually comparable, but measures taken by countries differ: Phthalates in toys bans on certain phthalates in the EU: provisional since 1999, permanent since 2005, US followed with identical measures in 2008 Canada: voluntary withdrawal of DEHP and DINP Bisphenol-A in baby bottles in the EU migration limit value in food contact materials for many years (revised several times) Canada proposes phase-out, but not yet adopted US: Federal level no measures proposed – but individual States and even cities have adopted bans Case for Global Norms for Chemicals Regulation?

Prioritisation / Timelines for assessing chemicals REACH: all timelines established prioritisation for evaluation is flexible - Canada: timelines and schedules for many substances established – not directly compatible with REACH US – TSCA: HPV and MPV screening (CHAMP – now scrapped ) Timelines not directly compatible with REACH - Japan – will start a new system - Russia, China: no systematic reviews ongoing Can timelines be revised? Can prioritisation be agreed? Benefits for companies, authorities, public (resources saved, clearer rules, same protection levels …..) Case for Global Norms for Chemicals Regulation?

Case for Global Norms for Chemicals Regulation? Window of opportunities for more convergence in the coming years: REACH in the EU has created a new approach and ECHA will accumulate a lot of information on hazards and risks Russia is seriously working on a revision of its chemical legislation – China is in a preparatory phase – Japan is working on a reform of its chemicals legislation In the US a review of TSCA will start – weaknesses of current system identified are directly comparable to those of the earlier EU system. Principles announced by Administrator Jackson go in the direction of REACH but are still somewhat different. It will be rather straightforward for companies complying with REACH in the EU now, to do so also in other countries if they introduced identical or similar regulatory systems Governments could agree to co-operate closely in actual implementation, share common tools and results

Case for Global Norms for Chemicals Regulation? In addition, there is already a number of multilateral fora relevant for chemicals: - OECD - UNEP - SAICM - Specific Conventions: PIC, POPs, Montreal, Basel - …. Objectives: High level of protection of human health and environment Capacity building Worldwide level playing field

Case for Global Norms for Chemicals Regulation? The Commission presented an outline to a modular approach to chemicals management at the ICCM 2 of SAICM: - inspired by the GHS system, “modules” for chemicals management can be built based on the SAICM Global Plan of Action; - depending on resources, concerns and capacities, “modules” can be tailored to fit country needs; - the chosen tailored “module” would enable maximum sharing of the burden with other countries who have chosen that module Feedback: Positive feedback from participants Commission will further elaborate ideas

Conclusion Yes, there is a case for global norms in the Regulation of Chemicals !

However : many countries including the US continue to object to REACH in the WTO TBT context Alleged discrimination Substances in articles (Article 7) Application of REACH to EU and non-EU manufacturers The principle of least trade restrictiveness Other concerns Inconsistent application by EU Member States Effects on innovation Protection of confidential information Technical assistance and capacity building for developing countries

Further Information http://ec.europa.eu/enterprise/reach/index_en.htm http://ec.europa.eu/enterprise/sectors/chemicals/index_en.htm http://echa.europa.eu http://ecb.jrc.it/REACH / 11/12/09

Berkeley Class 2009 Final

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Berkeley Class 2009 Final