Lowell Center Draft Report, 10/15/03: Not for Distribution or Citation
NEW DIRECTIONS IN EUROPEAN CHEMICALS POLICIES:
Drivers, Scope, and Status
Final Report
October, 2003
Ken Geiser, Ph.D. and Joel Tickner, Sc.D.
New Directions in European Chemicals Policy – Page 2
Table of Contents
Page
Summary………………………………………………………………………………….2
1. Introduction…………………………………………………………………………4
2. The European Context - Drivers of a New Chemicals Policy…………………...6
3. European Influences on a New Chemicals Policy………………………………. 11
3A. The Nordic States……………………………….…………………………... 12
Denmark……………………………………………………………. 14
Sweden……………………………….……………………………… 17
Norway……………………………….……………………………... 24
3B. The Netherlands……………………………………………………………... 29
3C. The United Kingdom……………………………….……………………….. 35
3D. Germany……………………………….…………………………………….. 41
4. International Influences on European Chemicals Policies……………………... 48
Stockholm Convention.…………………………………………….. 49
North Sea Conferences…………………………………………….. 50
Oslo and Paris Conventions………………………………………..51
Rotterdam Convention…………………………………………….. 53
Other United Nations Initiatives…………………………………... 54
OECD……………………………….………………………………. 57
5. The European Union’s Current Approach to Chemicals Policy………………. 60
The European Legislative Process………………………………… 60
Current EU Legislation……………………………………………. 63
6. Other European Chemicals Legislation Influencing REACH…………………. 76
7. The European White Paper on Chemicals and the REACH Proposal………... 82
Goals of the White Paper…………………………………………... 84
Registration, Evaluation, and Authorization…………………….. 86
Distribution of Responsibilities……………………………………. 98
Alternatives to Animal Testing…………………………………... 102
Intermediates……………………………………………………… 104
Access to Information…………………………………………….. 105
Workability of the REACH proposal……………………………. 107
May 7, 2003 Draft European Commission Legislation…………. 109
8. Economic and Innovation Impacts of the Proposed REACH Program……... 113
9. Reactions to the White Paper and REACH Proposals………………………... 119
European Governmental Responses…………………………….. 119
Non-Governmental Stakeholder Responses……………………... 121
Responses from Outside Europe…………………………………. 136
10. Lessons Learned from the European Chemicals Policy Process……………... 140
11. Conclusion………………………………………………………………………... 153
12. References Cited…………………………………………………………………. 155
13. Experts Interviewed……………………………………………………………... 161
14. About the Authors……………………………………………………………….. 163
SUMMARY
The Lowell Center for Sustainable Production (LCSP) is undertaking research on new directions in European government chemicals management policies in order to promote discussions among government authorities and other stakeholders about the future of chemicals management policy in the United States. We define chemicals policy as regulatory and voluntary policies designed to achieve long-term, integrated and prevention-oriented sustainable use of chemicals in production systems and products.
The goal of this report is to provide an in-depth understanding of the development of European chemicals policies as well as the new proposed European chemicals policy called Registration, Evaluation and Authorization of Chemicals (REACH). We examine the history, drivers, and scope of policies at the EU and Member State levels as well as responses by key stakeholder groups. We conclude with lessons learned from the European experience that could prove useful in developing integrated chemicals policies in the United States and internationally. In examining European chemicals policies we focus primarily on efforts to control industrial chemicals and not pesticides or chemicals in cosmetics. The European Union has undertaken innovative policy initiatives to control problem chemicals in these areas as well. As the landscape of chemicals policy in the European Union is rapidly changing, we view this as a dynamic document that will be periodically updated and thus represents a historical snapshot of the evolution of European chemicals management efforts.
Nordic countries, such as Denmark and Sweden have actively promoted integrated chemicals policies over the past decade to address contamination of critical waterways. They have successfully used a variety of voluntary and mandatory policy tools – such as education, procurement, lists of chemicals of concern, ecolabeling, research and development on safer substitutes, and chemical phaseout requirements - to encourage companies using chemicals to reduce their reliance on harmful substances and to develop safer substitutes.
While previously isolated to particular countries, innovative and exciting European-wide policies to promote sustainable chemicals management are now moving forward. These policies have been spurred by several factors: (1) increasing recognition of the limitations of current chemicals policies and a lack of confidence in the chemical industry; (2) concerns over health and ecosystem impacts of chemical exposures, particularly from everyday products; and (3) a long-term political commitments to environmental quality improvement and reduction of hazardous chemicals - the so-called Generational Goal.
Through a slow, thoughtful and transparent education process and public debate among various stakeholders (industry, government, advocates, academics), over the past five years, the European Union and Member States have been able to build sufficient momentum for fundamentally restructuring chemicals management policies to create an integrated chemicals policy embodied in the REACH proposal. A sweeping change in chemicals management policies in Europe is inevitable. This new policy will require basic data on all chemicals in commerce, information on risks throughout chemical lifecycles, rapid evaluation of chemical risks, and substitution of those substances of highest concern. Developing a proposal to fundamentally reform chemicals policy has involved addressing many complicated aspects of chemicals regulation as well as extensive stakeholder consultation. The new European chemicals policy is expected to be in force by 2006 and will likely set the global standard for chemicals management.
The new European policy will affect manufacturers in the United States and globally. It is important that stakeholders in the U.S. learn from the lessons being developed in Europe to stimulate discussion on an integrated approach to chemicals policy in the U.S. Some U.S. manufacturers, such as those in the electronics and auto industries, are already working to implement aspects of the REACH program and identify substitutes for those chemicals that may face restrictions. It is in the best interests of forward-looking governments and companies to be at the forefront of the global momentum to reduce the impacts of toxic substances on health and ecosystems by developing policies to gather data on chemical risks throughout their lifecycle as well as to identify and substitute harmful chemicals.
More information on the European policies, including links to policy documents and stakeholders can be found at www.chemicalspolicy.org. The Lowell Center for Sustainable Production has also produced a shorter summary of this document entitled, “Integrated Chemicals Policy: Seeking New Direction in Chemicals Management,” available at www.chemicalspolicy.org
New Directions in European Chemicals Policies
1. INTRODUCTION
In February of 2001 the European Commission released a far reaching and important policy proposal called the European White Paper on A Strategy for Future Chemicals Policy. This document outlines the intentions of the Commission in developing new regulations to manage industrial chemicals. The centerpiece of this White Paper is the proposal to establish an innovative new scheme for chemicals management, called REACH – “Registration, Evaluation, and Authorization of Chemicals”. The goal of this new policy is to ensure basic information on all chemicals in commerce, to place responsibility on industry for safety of chemicals and to allow expedited action on chemicals of highest concern. Based on feedback from the European Parliament and Council of Ministers, as well as various working groups, the Commission has drafted legislation to implement the REACH initiative. It is expected that the draft legislation will be finalized by fall 2003 and enacted by 2006.
The drafting of these sweeping new policy directions in the European Union is the result of years of extensive discussions and debates between the Commission and its Member States and stakeholder groups. The REACH proposal has been characterized as one of the most debated and developed pieces of environmental legislation in European history. Many of the Member States, particularly those in the northern tier of European countries, have been moving forward with bold new programs for the management of chemicals at the national level. These national policies have been one of the primary drivers for promoting and setting the directions for the European Commission’s proposals.
In order to promote discussions among government authorities and other stakeholders about the future of chemicals management policy in the United States, the Lowell Center for Sustainable Production (LCSP) has undertaken research on new directions in European government chemicals management policies. We define chemicals policy as regulatory and voluntary policies designed to achieve long-term, integrated and prevention-oriented sustainable use of chemicals in production systems and products.
The goals of this research are:
(1) To provide detailed background on the development of current European chemicals policy efforts;
(2) To encourage a broad public debate about the future of chemicals management policies in the United States and internationally.
The specific objectives of the project are to research chemicals policies in Europe, their implementation, and impact; to understand constituencies at the state and federal level in the U.S. who could be effectively engaged in discussing innovative chemicals policy; to stimulate discussions and networking opportunities between U.S. and European government and other stakeholder counterparts; and to develop a framework for advancing long-term chemicals policy discussions in the United States.
The goal of this paper is to characterize the landscape of European chemicals policies. We examine the history, drivers, and scope of policies at the EU and Member State levels as well as responses by key stakeholder groups. We conclude with lessons learned from the European experience that could prove useful in developing integrated chemicals policies in the United States and internationally. We attempt to provide an overview of the richness of the European debates on chemicals management, including types of policy tools being used, stakeholder positions, and experiences. As the landscape of chemicals policy in the European Union is rapidly changing, we view this as a dynamic document that will be periodically updated and thus represents a historical snapshot of the evolution of European chemicals management efforts.
In examining European chemicals policies we focus primarily on efforts to control industrial chemicals and not pesticides. Pesticides regulation has generally occurred separately from chemicals regulation and the chemicals policy debate in Europe has for the most part focused on industrial chemicals though interesting efforts have been undertaken to reduce the use of problem pesticides through the European Union’s Biocides Directive. Though there are some exceptions where pesticides have been included in chemicals policy efforts, such as discussions over persistent organic pollutants (POPs) and some pesticides used in commercial products – such as paints and wood treatment. Further, we do not focus on chemicals used in cosmetics, which are not covered under the European REACH proposal. Cosmetics have generally been regulated under health laws. However, through its Cosmetics Directive, the European Union has undertaken efforts to remove problem chemicals from cosmetics (ie carcinogens, mutagens and reproductive toxicants).
The report begins by defining the European context for chemicals policy. It then examines influences on the new chemicals policy developments, including: Member State influences, international agreements, and existing European chemicals legislation. An in-depth overview of the REACH proposal and its complicated implementation issues is then provided as well as an examination of stakeholder responses to the proposal. The last sections present an analysis of lessons learned on the strengths and limitations of the European approach, as well as recommendations for strengthening the proposal. This section provides important background for designing strategies for other countries, such as the United States, and regions.
The methodology used in compiling this report consists of document review, interviews with key stakeholders, participant observation, and dialogue with key European experts in chemicals policy. During a year and a half period, LCSP researchers collected key policy documents from the European Union and Member States as well as stakeholder positions and analyses and other reports. Through in person and telephone interviews, as well as discussions at European Chemicals policy conferences we interviewed more than 50 key actors from different stakeholder groups in the European Union. Through visits to six European Union countries and attendance at various conferences on chemicals in the region, we were able to obtain a thorough understanding of the politics, culture, nuances, and details of the European chemicals management system and emerging policies. We respectfully acknowledge the time and effort that all stakeholders provided in allowing us to gain an in-depth understanding of emerging European policies (see Section 13 Experts Interviewed).
2. THE EUROPEAN CONTEXT – THE DRIVERS OF A NEW CHEMICALS POLICY
The nations of Europe arise out of long histories with significant differences in society and culture. The Nordic countries of Northern Europe differ dramatically in terms of government, religion, language and traditions from the Mediterranean countries of Southern Europe. The differences east to west are almost as dramatic. However, with the creation of the European Union and its continued expansion, these countries are evolving into a powerful new integrated European community with a Europe-wide single market.
The European governing structure, the European Union, is still very much in the process of emerging. Created as a common market among six countries by the Treaty of Rome of 1957, the European Union is today composed of 15 countries with another ten eastern and southern countries preparing for entry in June 2004[1]. Although the common market has been in existence since the 1960s, the governing bodies of the European Union have only slowly emerged as legitimate entities with identities and functions beyond those of the Member States. Recent treaties, particularly the Single European Act of 1986 and the Maastricht Treaty on European Union of 1992, have steadily enlarged the responsibilities of these institutions. Today, the European Union is governed by several different bodies, with the European Commission being its administrative body and the Council of Ministers of the European Union (consisting of officials from Member States) and European Parliament the legislative bodies that enact laws (See Section 4). The European Commission, which consists of various agencies or Directorates- General has the lead role in proposing policy and legislation for the European Union. The Council of Ministers and Parliament revise and approve legislation, though in most cases the legislation remains structurally similar to the Commission’s original proposals.
The European Union’s judicial functions are conducted by the European Court of Justice, comprised of 15 judges and nine advocates-general appointed for renewal by agreement among the Member States. The Court interprets European Community law and hears cases where Member States are alleged to either fail to carry out European regulations or where Member States violate those statutes.
A history of feudalism and the emergence of social democratic traditions in Europe has resulted in contemporary governments dedicated to caring for the social and economic welfare of their citizenry. Long traditions suggest that national social and economic policies should be developed by elites in governments and the professions with periodic accountability to parliamentary review. Traditionally this has meant little direct participation by the wider public, but over the past two decades this has begun to change.