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Archive for the ‘REACH’ Category

COMMISSION OF THE EUROPEAN COMMUNITIES
Brussels, 27.2.2001 COM(2001) 88 final
WHITE PAPER Strategy for a future Chemicals Policy
(presented by the Commission)

INTRODUCTION

This White Paper presents Commission proposals for a strategy on future chemicals policy in the Community with the overriding goal of sustainable development.

Chemicals1 bring about benefits on which modern society is entirely dependent, for example, in food production, medicines, textiles, cars etc. They also make a vital contribution to the economic and social wellbeing of citizens in terms of trade and employment.

The global production of chemicals has increased from 1 million tonnes in 1930 to 400 million tonnes today. We have about 100,000 different substances registered in the EU market of which 10,000 are marketed in volumes of more than 10 tonnes2, and a further 20,000 are marketed at 1-10 tonnes. The world chemical production in 1998 was estimated at € 1,244 billion, with 31% for the EU chemical industry, which generated a trade surplus of € 41 billion. In 1998, it was the world’s largest chemical industry, followed by that of the US with 28% of production value and a trade surplus of € 12 billion.
The chemical industry is also Europe’s third largest manufacturing industry. It employs 1.7 million people directly and up to 3 million jobs are dependent on it. As well as several leading multinationals, it also comprises around 36,000 SMEs. These SMEs represent 96% of the total number of enterprises and account for 28% of chemical production.

On the other hand, certain chemicals have caused serious damage to human health resulting in suffering and premature death and to the environment. Well-known examples amongst many are asbestos, which is known to cause lung cancer and mesothelioma or benzene which leads to leukaemia. Abundant use of DDT led to reproductive disorders in birds. Though these substances have been totally banned or subjected to other controls, measures were not taken until after the damage was done because knowledge about the adverse impacts of these chemicals was not available before they were used in large quantities.

The incidence of some diseases, e.g. testicular cancer in young men and allergies, has increased significantly over the last decades. While the underlying reasons for this have not yet been identified, there is justified concern that certain chemicals play a causative role for allergies. According to the Scientific Committee on Toxicity, Ecotoxicity and the Environment of the Commission (CSTEE), links have been reported between reproductive and developmental effects and endocrine disrupting substances in wildlife populations. The CSTEE concluded that there is a potential global problem. This concern is based on the recent findings of high levels of persistent potential endocrine disrupting chemicals in several marine mammalian species inhabiting oceanic waters3.

The lack of knowledge about the impact of many chemicals on human health and the environment is a cause for concern. Understandably, the public is worried when hearing about the exposure of their children to certain phthalates released from toys and about increasing amounts of the flame retardant pentabromo diphenyl ether in human breast milk. Though these too are the subject of Commission proposals for bans, legislative action takes too long before yielding a result.

These examples expose the weaknesses of the current EU chemicals policy. However, the problem is not unique to the Community. Government agencies in Canada and the United States have recently launched initiatives to acquire testing data for large numbers of chemical substances currently on their markets in high volumes on which little is known about the risks. In fact, not one country has yet been successful in overcoming the huge gap in knowledge of substances.

EU chemicals policy must ensure a high level of protection of human health and the environment as enshrined in the Treaty both for the present generation and future generations while also ensuring the efficient functioning of the internal market and the competitiveness of the chemical industry. Fundamental to achieving these objectives is the Precautionary Principle4. Whenever reliable scientific evidence is available that a substance may have an adverse impact on human health and the environment but there is still scientific uncertainty about the precise nature or the magnitude of the potential damage, decision-making must be based on precaution in order to prevent damage to human health and the environment. Another important objective is to encourage the substitution of dangerous by less dangerous substances where suitable alternatives are available.

It is also essential to ensure the efficient functioning of the internal market and the competitiveness of the chemical industry. EU policy for chemicals should provide incentives for technical innovation and development of safer chemicals. Recent experience has shown that innovation (e.g. in developing new and often safer chemicals) has been hindered by the burdens of the present notification system. Ecological, economic and social aspects of development have to be taken into account in an integrated and balanced manner in order to reach the goal of sustainability.

THE EU CHEMICALS POLICY

Increasing concern that current EU chemicals policy does not provide sufficient protection led to a debate at the informal Council of Environment Ministers in Chester in April 1998. Recognising that a review of the current policy on chemicals was necessary, the Commission made a commitment to assess the operation of four important legal instruments governing chemicals in the Community5. The report on the findings6 was adopted by the Commission in November 1998 and welcomed by the Council in December 1998.

These four instruments cover a broad range of substances of different origins (e.g. industrial chemicals, substances produced from natural products, metals, minerals etc.). They regulate the testing of these substances and determine risk reduction measures. Furthermore, they establish duties regarding the safety information to be provided to users (labelling, safety data sheets). Beyond these four instruments, specific legislation exists for certain sectors and areas, for example plant protection products or cosmetics or the transport of dangerous goods.

In view of the findings, the Commission held a Brainstorming with more than 150 stakeholders in February 1999 – regulators, scientists, industry, environmental and consumer NGOs as well as representatives from applicant countries – providing the Commission with an all round view of the problems and potential solutions.

In June 1999, the Council adopted a set of conclusions for a future strategy on chemicals in the Community which provided important input to the recommendations in this White Paper, which concerns revision of the above mentioned four legal instruments.

Major problems identified by review

The present system for general industrial chemicals distinguishes between “existing substances” i.e. all chemicals declared to be on the market in September 1981, and “new substances” i.e. those placed on the market since that date.
There are some 2,700 new substances. Testing and assessing their risks to human health and the environment according to Directive 67/548 are required before marketing in volumes above 10 kg. For higher volumes more in-depth testing focussing on long-term and chronic effects has to be provided.

In contrast, existing substances amount to more than 99% of the total volume of all substances on the market, and are not subject to the same testing requirements. The number of existing substances reported in 1981 was 100,106, the current number of existing substances marketed in volumes above 1 tonne is estimated at 30,000. Some 140 of these substances have been identified as priority substances and are subject to comprehensive risk assessment carried out by Member State authorities.

There is a general lack of knowledge about the properties and the uses of existing substances. The risk assessment process is slow and resource-intensive and does not allow the system to work efficiently and effectively. The allocation of responsibilities is inappropriate because authorities are responsible for the assessment instead of enterprises which produce, import or use the substances. Furthermore, current legislation only requires the manufacturers and importers of substances to provide information, but not the downstream users (industrial users and formulators). Thus, information on uses of substances is difficult to obtain and information about the exposure arising from downstream uses is generally scarce. Decisions on further testing of substances can only be taken via a lengthy committee procedure and can only be requested from industry after authorities have proven that a substance may present a serious risk. Without test results, however, it is almost impossible to provide such proof. Final risk assessments have therefore only been completed for a small number of substances.

Under Directive 76/769 on restriction of marketing and use of dangerous substances and preparations, the Commission has committed itself to carry out risk assessments and adequate analyses of the costs and the benefits prior to any proposal or adoption of a regulatory measure affecting the chemical industry. Indications of unacceptable risk (typically arising from notifications of restrictions at national level) are the subject of reports, which are peer-reviewed by the Scientific Committee on Toxicology, Ecotoxicology and Environment (CSTEE) of the Commission.

Current liability regimes are insufficient to remedy the problems found by the review. Liability is usually based on the principle that those who cause damage should pay compensation for that damage. However, in order to be held liable, it is generally requiredthat a causal connection be proven between the cause and the resulting damage. This is often virtually impossible for injured parties if cause and effect occur far apart in time and if adequate test data on the effects of substances are not available. Even if a causal connection can be established, compensations awarded by courts of EU Member States are generally not as high as, for example, in the US, and hence have a limited deterrent effect. In order to improve this situation and to make producers assume responsibility for their products, the Commission has announced its intention to propose Community legislation in this field7.

Political objectives of the proposed Strategy

In order to achieve the overriding goal of sustainable development, the Commission has identified a number of objectives that must be met in order to achieve sustainable development in the chemicals industry within the framework of the Single Market.

– Protection of human health and the environment.

– Maintenance and enhancement of the competitiveness of the EU chemical industry.

– Prevent fragmentation of the internal market.

– Increased transparency. Consumers need access to information on chemicals to enable them to make informed decisions about the substances that they use and enterprises need to understand the regulatory process.

– Integration with international efforts. The global nature of the chemicals industry and the trans-boundary impact of certain chemical substances have made chemical safety an international issue.

– Promotion of non-animal testing. Protection of human health and the environment, including wildlife, should be balanced against protection of the welfare of laboratory animals. The Commission will therefore promote further development and validation of non-animal test methods.

– Conformity with EU international obligations under the WTO. No unnecessary barriers to trade should be created and there must not be discrimination against imported substances and products.

The strategy which is proposed must meet these objectives.

Key elements of the proposed strategy

Protection of human health and promotion of a non-toxic environment

The Commission proposes that existing and new substances should in the future, following the phasing in of existing substances until 2012, be subject to the same procedure under a single system. The current new substances system should be revised to become more effective and efficient and the revised obligations be extended to existing substances. The proposed system is called REACH, for the Registration, Evaluation and Authorisation of CHemicals. The requirements, including the testing requirements, of the REACH-system depend on the proven or suspected hazardous properties, uses, exposure and volumes of chemicals produced or imported. All chemicals above 1 tonne should be registered in a central database. At higher tonnage special attention should be given to long-term and chronic effects.

Setting deadlines: The Commission proposes to implement a step by step process to address the ‘burden of the past’ and develop adequate knowledge for existing substances that industry wants to continue marketing. Given the vast number of existing substances on the market, the Commission proposes that first priority is given to substances that lead to a high exposure or cause concern by their known or suspected dangerous properties – physical, chemical, toxicological or ecotoxicological. All such substances should be tested within five years and subsequently be properly assessed for their impact on human health and the environment. The other existing substances should follow in accordance with the proposals in Chapter 6.

Making industry responsible for safety: Responsibility to generate knowledge about chemicals should be placed on industry. Industry should also ensure that only chemicals that are safe for the intended uses are produced and/or placed on the market. The Commission proposes to shift responsibility to enterprises, for generating and assessing data and assessing the risks of the use of the substances. The enterprises should also provide adequate information to downstream users.

Extending the responsibility along the manufacturing chain: Downstream users, as well as manufacturers and importers, of chemicals should be responsible for all the aspects of the safety of their products and should provide information on use and exposure for the assessments of chemicals. Producers of preparations and other downstream users will be obliged to assess the safety of their products for the part of the life cycle to which they contribute, including disposal and waste management.

Authorisation of substances of very high concern: Substances with certain hazardous properties that give rise to very high concern will have to be given use-specific permission before they can be employed in particular uses. Evidence demonstrating that the specific use only presents a negligible risk or, in other cases, that the use is acceptable taking into account socio-economic benefits, lack of ‘safer’ chemicals for the same task and measures minimising the exposure of consumers, workers, the general public and the environment will be considered before granting an authorisation. Uses which do not give rise to concern may be subject to general exemptions from the authorisation procedure.

Substitution of hazardous chemicals: Another important objective is to encourage the substitution of dangerous by less dangerous substances where suitable alternatives are available. The increased accountability of downstream users and better public information will create a strong demand for substitute chemicals that have been sufficiently tested and that are safe for the envisaged use.

Maintenance and enhancement of the competitiveness of the EU chemical industry

Stimulating innovation: It is essential to promote the competitiveness of the chemical industry and encourage innovation, and in particular the development of safer chemicals. Regulations are a major factor in shaping the innovation behaviour of firms in the chemical industry. The Commission proposes to increase the current thresholds for notification and testing of new substances, to extend the conditions for derogation for research and development and enable test data to be used and submitted in a flexible way.

Realistic timetable for submission of data: In proposing a timescale for the submission of data, the strategy takes account of resource implications. Together with the measures to increase testing thresholds and more flexible test data, this should limit the cost for enterprises to the absolute minimum needed.

Prevent fragmentation of the internal market

Any Commission strategy on chemicals should aim at ensuring a high level of health, safety and environmental protection while at the same time ensuring the proper functioning of the Internal Market in that sector – as in any other industrial sector within the Union. The achievement of these objectives requires that the new policy be based on full harmonisation at Community level.

Increasing transparency

Providing full information to the public: The public has a right to access to information about the chemicals to which they are exposed. This will enable them to make informed choices and to avoid products containing harmful chemicals, so creating pressure on industry to develop safer substitutes. However, commercially sensitive information will be suitably protected.

A more transparent regulatory system: The creation of a single system to be applied to all chemicals, once the existing substances have been phased in, will improve the transparency of the regulation of chemicals.

Integration with international aspects

Contributing to safe use of chemicals at a global level: A global network of industrialised and developing countries and international organisations has developed over the past decades to promote global safe use of chemicals. The Intergovernmental Forum on Chemical Safety (IFCS) was established to co-ordinate the many national and international activities, to promote chemical safety and to oversee implementation of the programme on environmentally sound management of chemicals as set out in Chapter 19 of Agenda 21, adopted by the 1992 UN Conference on Environment and Development (UNCED) at the Earth Summit in Rio. The recommendations in this White Paper will feed into the international programmes and make a major contribution to achieving safe use of chemicals at a global level.

Testing in a global market: Testing obligations will not only affect the EU chemicals industry. Importers will also be obliged to assess the safety of their chemicals, to deliver information and to share the costs of testing. This avoids distortion of the global market and ensures that the competitiveness of the EU chemical industry is not compromised.

Recognising non-EU test results: The lack of data on existing chemicals is a global concern. For example, the US have recently launched initiatives. The US initiative aims to complete testing of 2,800 high production volume chemicals by 2004 (the Gore initiative). This initiative is regarded as the first approach to systematically obtain toxicological and ecotoxicological information about the most abundant existing chemicals on the US market. Studies on the dangerous properties of chemicals performed in the US will not have to be repeated in the Community and vice versa, since testing must be carried out using globally harmonised testing methodology. Accordingly, test results of the HPV/ICCA SIDS programme of the OECD will be taken into account to reduce the number of tests to be performed in the EU.

Complying with OSPAR: The Convention for the Protection of the Marine Environment of the North East Atlantic8 aims to prevent and eliminate pollution and to protect the maritime area of the North East Atlantic against the harmful effects of human activities (land-based sources, off-shore sources, dumping and incineration of wastes). The strategy supports this aim, in particular through the proposals for improved controls on downstream users of chemicals.

Persistent organic pollutants (POPs): POPs represent a special threat since they persist in the environment for a long time, they travel over long distances from their sources, accumulate in the tissues of most living organisms and poison humans and wildlife. It has been internationally recognised that there is a need for strict control of these substances. Following a mandate issued by the Governing Council of the UNEP, negotiations on an international treaty to eliminate production, use, emissions and discharges of initially 12 specified POPs – a group of highly stable organic substances – have recently been concluded. Criteria have been developed to identify further POPs among the existing substances. Furthermore, parties to the Convention will be obliged to prevent the production and use of new substances with POPs characteristics9.

Developing countries: One of the Community’ s major objectives is to strengthen developing countries’ capabilities and capacities for managing chemicals. Many developing countries do not have adequate legislation, administrative capacity or infrastructure to ensure the safe use of chemicals. The Rotterdam Convention on prior informed consent (PIC Convention, 1998) for certain hazardous industrial chemicals and pesticides obliged exporters of such chemicals to get the consent of the receiving country before delivery and by bilateral and multilateral programmes of training and technical assistance in respect of particular chemicals.

Developing countries are mostly importers and not exporters of chemicals. The testing requirements in the EU will ensure that imported chemicals, which constitute the large majority of chemicals used in these countries, have been evaluated. This benefit will by far outweigh the potential economic effort, such as for testing, required by chemical companies located in developing countries when manufacturing chemicals for export to the EU.

Promotion of non-animal testing

Maximising use of non-animal test methods: Testing requirements will be met as far as practicable through use of existing non-animal test methods.

Encouraging development of new non-animal test methods: Development of new non- animal test methods will be encouraged.

Minimising test programmes: Measures to increase testing thresholds and more flexible test regimes will limit the need for testing.

Conformity with EU international obligations under the WTO

Trade barriers: The new policy shall not discriminate against imported products. In that respect, the EU should conform with Article 2.1 of the WTO’s Technical Barriers to Trade, which sets out that imported products shall be accorded treatment no less favourable than that accorded to like products on national origin. Without a sound scientific evaluation of the potential threats to human health and the environment, the EU will not be able to defend a measure being challenged by third countries. In accordance with Article 2.2 of the TBT, the EU shall ensure that “technical regulations will not create unnecessary obstacles to international trade”.

KNOWLEDGE ABOUT CHEMICALS

The principal objective of assessing the risks of chemicals is to provide a reliable basis for deciding on adequate safety measures (risk management) when using them. The risk assessment provides an evaluation of whether a chemical used in a particular way could cause adverse effects. This encompasses a description of the nature of these effects and a calculation of the probability that they will occur, as well as an estimation of their extent.
Any risk assessment on chemicals is composed of two distinct elements, (1) an evaluation of the properties which are intrinsic to the chemical, called hazard assessment, and (2) an estimation of the exposure which depends on the use of the chemical. The hazard assessment identifies the hazardous properties (e.g. sensitising, carcinogenic, toxic for the aquatic environment) and determines the potency of the chemical with respect to these hazardous properties. The exposure assessment identifies the sources of the chemicals which lead to exposure and calculates the dose taken up by an exposed organism or estimates the releases of the chemical into a particular compartment of the environment.

Precise knowledge on the intrinsic properties as well as on the exposure arising as a result of a particular use and of the disposal is an indispensable prerequisite for decision making on the safe management of chemicals. Reliable knowledge on intrinsic properties is important because it also constitutes the basis for the classification of chemicals. A large part of the management measures laid down in sector specific legislation to protect human health or the environment are directly linked to the classification of chemicals:

• it triggers the labelling of the packaging of the chemicals to inform the user about the properties of the chemicals and gives advice for the safe use,

• a chemical classified as carcinogenic, mutagenic or toxic for reproduction currently initiates an examination of restriction measures in the consumer sector,

• it triggers numerous safety measures laid down in sector specific legislation in respect of occupational health, water protection, waste management, prevention of major accident hazards and air pollution.

Intrinsic Properties

The extent of testing required for detecting the intrinsic hazardous properties of a substance is often the subject of controversy. While, at first glance, it would seem reasonable to test chemicals until all hazardous properties (i.e. all adverse effects on all organisms at all potential doses) are known, theoretical and practical considerations reveal that it is neither possible nor desirable to meet this objective. First, the available testing methodology has limitations, as demonstrated by the recent discussion on the identification of endocrine disrupters. The review and the development of our testing methodology must therefore be regarded as a continual challenge. Second, ethical considerations on animal welfare as well as on the costs of testing strongly advocate for a balanced approach to the testing of chemicals so that the acquired knowledge offers proportionate benefits in terms of managing risks. This is particularly important for testing requirements for substances marketed in low volumes where extensive testing is not compensated by the income from sales.

New substances: Current EU legislation on new substances is generally considered to have been successful in testing and assessing chemicals. The testing requirements are tiered according to the volume placed on the market. The lowest volume triggering the need for testing amounts to 10 kg. More extensive testing is required when the volume reaches 100 kg, 1 t, 10 t, 100 t and 1,000 t, respectively. Generally, testing requirements at the lower volumes (10 kg to 1 t) focus on acute hazards (immediate or slightly delayed effects after short term exposure) while those at the higher tonnage levels include more expensive studies on the effects of (sub-) chronic exposure, on reproductive toxicity and on carcinogenicity. The testing package at 1 t is termed ‘base set’ while those triggered by higher tonnage are called Level 1 (100 t) and Level 2 (1,000 t).

Existing substances: In contrast to new substances, existing substances have never been subjected to such a systematic testing regime. When the requirement for testing and notification of new substances was introduced in 1981, substances already on the market were exempted. A study performed by the European Chemicals Bureau on the availability of the data for high production volume existing substances10 (substances exceeding a production volume of 1,000 t) revealed significant gaps in publicly available knowledge about these chemicals. This lack of public knowledge was identified as the major deficiency throughout the entire review process.

Action 3A: Equivalent level of information on new and existing substances
The gap in knowledge about intrinsic properties for existing substances should be closed to ensure that equivalent information to that on new substances is available. According to the timetable presented in chapter 6, existing substances will be subjected to the same procedure as for new substances. The available information should be thoroughly examined and best use made of it in order to waive testing, wherever appropriate.

Action 3B: Testing of new and existing substances
Testing and assessment of the many existing substances will require a substantial effort from industry and authorities. To meet this challenge available resources must be focussed on the most relevant chemicals. The current 10 kg threshold for mandatory testing of new substances should be increased. The following general testing regime for new and existing substances is recommended. Waiving of testing will be acceptable on due justification according to recommendations 3A and 3C. Further testing may be required by the authorities as described in chapter 4.2:

• Substances produced/imported in quantities between 1 – 10 t: data on the physico- chemical, toxicological and ecotoxicological properties of the substance; testing should generally be limited to in vitro methods,
• Substances produced/imported in quantities between 10 – 100 t: ‘base set’ testing according to Annex VII A of Directive 67/548/EEC. Waiving of testing will be acceptable on due justification according to Action 3A. This will in particular apply for existing substances,

• Substances produced/imported in quantities between 100 – 1000 t: ‘Level 1’ testing (substance-tailored testing for long-term effects). The scope of the additional testing will be based on the requirements set out in Annex VIII of Directive 67/548/EEC. Guidelines, including decision trees for the testing strategy will be developed tailoring testing according to the results of the available information, physico-chemical properties, the use and the exposure to the substance.

• Substances produced/imported in quantities above 1000 t: ‘Level 2’ testing (further substance-tailored testing for long-term effects). The scope of the additional testing will be based on the requirements set out in Annex VIII of Directive 67/548/EEC. Guidelines, including decision trees for the testing strategy will be developed tailoring testing according to the results of the available information, physico-chemical properties, the use and the exposure to the substance.

Action 3C: Exposure-triggered testing
The current testing regime for new substances has been criticised for not taking sufficiently into account differences in the exposure to chemicals. Hence, the future system should include sufficient flexibility to waive or extend the needed testing as appropriate on the basis of particular exposure scenarios. For example, testing requirements for strictly controlled and rigorously contained intermediates should be reduced.

Action 3D: Exemptions for substances used in research and development
The volume threshold of 100 kg currently in place for research and development should be increased to 1 t. For substances undergoing process-oriented research and development, the current time period limit should be extended from one to three years. This three-year period should be extendable up to a maximum of five years.

Action 3E: Obligations for substances marketed as constituents of products
Current notification requirements cover substances placed on the market on their own or as constituents of preparations. Substances used and placed on the market as constituents of products (e.g. toys, textiles) other than preparations, however, are exempted. Nevertheless, most of the substances included in such products are covered as they are marketed either as such or as components of preparations before being included into products. However, some products, in particular products where the whole manufacturing process has been carried out outside the Community, may contain untested and unregistered substances. Where such substances may be released during use and disposal in significant amounts thus causing exposure of humans and of the environment, they cannot generally be neglected. The issue needs to be properly addressed.

As regards substances in products that can lead to significant exposure of humans and environment, the Commission proposes to set up a working group which would identify the product categories (e.g. toys or textiles), the relevant exposure situations and all other practical implications. On the basis of this working group’s findings, producers or importers should be requested to identify products containing such substances and provide any information, as appropriate.

Research and Validation

Development of alternative methods

International acceptance of results of animal tests has been a major breakthrough in minimising animal testing. This has been achieved by complying with methods developed by the OECD under its Test Guidelines Programme and obtained in accordance with the principles of Good Laboratory Practice. Once a company has carried out such a test, the results can be used for notification purposes in the Community as well as in Australia, Japan or the USA.

The Community has already taken steps to reduce duplicate testing: both Directive 67/548 and Regulation 793/93 contain provisions which avoid the need for different companies to carry out the same test. Chapter 5 describes actions to develop this approach further.

The Commission is fully committed to the legislation on the protection of animals used for experimental and other scientific purposes11. According to this legislation, experiments using animals must be replaced by other scientific satisfactory methods not entailing the use of animals, requiring fewer animals or causing less pain to the animals wherever possible.

The following elements of the new system have been developed with a view to keep animal testing to a minimum:
• existing information on the toxicity and ecotoxicity of substances, including epidemiological studies, will be taken into account,
• the general testing requirements will be modified to incorporate exposure-driven testing where appropriate,
• tailor-made testing programmes for substances will be developed under the control of authorities for Level 1 and 2 testing,
• the development of further alternative testing methods using fewer or no animals will be fostered,
• existing substances will be grouped to minimise testing, where appropriate.

One of the major tasks of the European Centre for the Validation of Alternative Methods (ECVAM) of the Joint Research Centre of the Commission is to validate alternative methods that reduce, refine or replace animal experiments (’3 R approach’). Once these methods are established the Commission proposes their inclusion in the relevant Community legislation. Furthermore it submits them to the OECD Test Guidelines Programme, through which the Commission makes every effort to ensure that the methods are recognised internationally. Some international test methods have already been amended to reduce the number of animals required or the distress caused.

Research to minimise the use of animal tests and develop methods that do not require animal experiments is also a priority within the OECD Test Guidelines Programme, which is actively supported by the Commission.

Action 3 F: To foster research on development and validation of alternative methods both at the Community and at the level of Member States and to enhance the relevant information that can be obtained from testing without simultaneously increasing the number of animals involved.

ECVAM’s central role will be maintained and the development of alternative methods should be accelerated. Further research will be carried out both at Community and national level in order to develop and validate novel testing strategies involving fewer or no animals and enhancing the relevant information that can be obtained from testing without simultaneously increasing the number of animals involved.

Other research priorities

In order to meet the goals of this White Paper, a continuous effort of research has to be made both at the Community and at the national level in order to cover the many knowledge gaps. At the community level, the Commission, through its Framework Programmes for Research, Technological Development and Demonstration, is supporting research in several other areas, like:

• Improvementandsimplificationofrisk-assessmentprocedures.

• Improvementanddevelopmentofnewtoxicologicalandeco-toxicologicalmethods;

• particular research efforts need to be made for developing and validating in-vivo and in- vitro test methods as well as modelling (e.g. QSAR) and screening methods for assessing the potential adverse effects of chemicals on endocrine systems of humans and animals. Research on endocrine disrupters is also – among others – addressing the effect of low doses, long term exposure and exposure to mixtures of chemicals, and the impact of the endocrine alterations on carcinogenesis.

• Development of clean chemical production processes to reduce and to eliminate the use and generation of hazardous substances.

• Research on improved Life Cycle Assessment methodologies for chemicals.

Exposure and Use

Adequate knowledge about exposure is an absolute requirement for any reliable risk assessment. However, the process under Regulation 793/93 highlighted a general lack of knowledge on the exposure to the existing substances under review. Furthermore, in many cases, the Member State authorities responsible for the assessment were not able to establish all the relevant uses of these chemicals. This lack of knowledge and restricted access by authorities to these data hampers efficient surveillance of the chemical sector.

Action 3 G: Obligation of manufacturers, importers and downstream users to assess exposure
The general shortage of exposure data must be addressed. Exposure estimates or, if appropriate, analytical determination of the exposure should be obligatory for manufacturers and downstream users (formulators and industrial users) of chemicals. Further detail on this proposal is given in chapters 4 and 5.

Action 3 H: Information system on environmental concentrations
An information system should be established on environmental concentrations and releases. Monitoring data ascertained by the Member States or by industry should be made available in an easily accessible form.

Cost and benefit

It is estimated that base-set testing will cost about € 85,000 per substance. The cost of long- term testing is more uncertain as there is less experience. However, level 1 testing for new substances costs approximately € 250,000 per substance and level 2 testing costs approximately € 325,000 per substance. It would not only be EU industry that has to pay these costs: everyone who imports substances into the Community would make a fair contribution to these costs ensuring a global approach, see section 5.5 below. It is estimated that the testing of the approximately 30,000 existing substances would result in total costs of about € 2.1 billion, over the next 11 years until 2012.12

The administrative costs of the system will be recovered through a fee-based system.

As a result of the systematic testing of new substances about 70% have been identified as being dangerous. On the other hand, as little is known about the intrinsic properties of existing substances it can be assumed that the majority of these chemicals cannot be properly classified today and adequate risk management measures cannot be taken. Introducing mandatory testing for these substances would generate the necessary information to substantially improve the risk management for existing substances. If as a result the adverse impacts could be even slightly reduced, the money spent for these tests would have proven to be well spent.

The potential benefits of this policy would stem from improved risk management, in all likelihood leading to safer handling of substances, and to less exposure of consumers and the environment to dangerous substances. Although it is difficult to estimate accurately and in monetary terms the potential benefits from this change some indications are possible. Indeed, if as a result of this improved risk management some human lives could be saved or the incidence and prevalence of allergic or chronic diseases could be reduced by some percent the money would have been well spent.13 Further details are given in annex I.

A NEW SYSTEM OF CHEMICALS CONTROL – THE REACH SYSTEM

The current volume-triggered notification system for new substances has resulted in substantial and reliable knowledge about these chemicals. However, it involves a considerable workload for the authorities requiring a large amount of their resources even though all this effort only addresses a limited part of the chemicals on the market. Existing substances dominate the market over new substances by a factor of 15. The challenge therefore is to establish a system that can cope with the large number of existing substances. The overriding goal must be to ensure adequate information, made publicly available, and appropriate risk management of existing and new substances within the timeframe set out in chapter 6.

Action 4: To establish a single coherent system focussing public resources on those substances, where, according to experience, the involvement of authorities is indispensable and the added value in terms of the provision of safety is substantial.

The system, called REACH, will be composed of the following three elements:

(a) Registration of basic information for around 30,000 substances (all existing and new substances exceeding a production volume of 1 t) submitted by companies in a central database. It is estimated that around 80 % of these substances would only require registration;

(b) Evaluation of the registered information for all substances exceeding a production volume of 100 t (around 5,000 substances corresponding to 15 %) or, in case of concern, also for substances at lower tonnage; the evaluation will be carried out by authorities and include the development of substance-tailored testing programmes focussing on the effects of long-term exposure;

(c) Authorisation of substances with certain hazardous properties that give rise to very high concern (CMR substances14 (categories 1 and 2) 15 and POPs). Authorisation requires authorities to give a specific permission before a substance can be used for particular purposes demonstrated to be safe. The number of substances subject to authorisation is estimated at 1,400 (5% of the registered substances). This estimate is based on

– 850substancescurrentlyclassifiedasCMRsubstances(categories1and2)

– Substances with POPs characteristics16

– 500 additional CMR substances (categories 1 and 2) which may be identified through future testing.

The REACH-system will be applied to new and existing substances. However, in contrast to new substances, a transitional period of 11years is required to phase in the large number of existing substances. In general, existing substances produced in higher volumes will have to be registered first. Yet the system will be flexible enough to allow for earlier registration of substances of concern produced in lower tonnage. The work programme and timetable for the transitional phase is described in detail in chapter 6.

Registration

Registration requires a manufacturer or importer to notify an authority17 of the intention to produce or import a substance and to submit a dossier containing the information required by the legislation. The authority puts this information into an electronic database, assigns a registration number and performs spot-checks and computerised screening of the registered substances for properties raising particular concern.

Registration will be obligatory for new and existing (according to the time table set out in chapter 6) substances produced in volumes exceeding 1 t. The currently required general conformity check for new notified substances above 1 t will be replaced by spot-checks and computerised screening. The registration dossier will include the following information:

– Data/information on the identity and properties of the substance (including data on toxicological and ecotoxicological properties as set out in chapter 3),

– Intended uses, estimated human and environmental exposure,

– Production quantity envisaged,

– Proposal for the classification and labelling of the substance,

– Safety Data Sheet,

– Preliminary risk assessment covering the intended uses,

– Proposed risk management measures.

Evaluation

Evaluation requires authorities to carefully examine the data provided by industry. It also requires them to decide on substance-tailored testing programmes, following industry proposals, as set out in chapter 3 .

Substances above 100 t: When the quantity produced or imported reaches 100 t or 1,000 t (or, for existing substances, already exceeds these volume thresholds), the manufacturer or importer will be required to submit to an authority all available information and to propose a strategy for further testing based on the general information requirements defined in the legislation. The authority will evaluate the information and the testing strategy submitted by industry and will decide on the appropriate course of action.

In essence, the current approach for new substances will be maintained for substances above 100 t. The availability of a risk assessment drawn up by the manufacturer or importer will reduce the workload of the authorities. Testing programmes at Level 1 (100 t) and Level 2 (1,000 t) will be substance-tailored as set out in chapter 3.

Substances below 100 t: Substances which are suspected to be persistent and liable to bioaccumulation, substances with certain hazardous properties such as mutagenicity or high toxicity, or substances with molecular structures giving rise to concern (e.g. identified by quantitative structure activity relationships, QSAR) will require an evaluation by the authorities at volume levels below 100 t. Based on this evaluation, immediate safety measures and/or further testing may be needed. Thus, the authorities’ right to request additional information for low volume substances on a case by case basis, as possible under the current notification system, will be retained. Furthermore, authorities should be empowered to require additional testing, when the aggregate volume produced and/or imported by all manufacturers and/or importers exceeds the next higher tonnage threshold for a single producer or importer to a considerable degree.

Authorisation of substances of very high concern

For substances of very high concern, authorities will have to give a specific permission before such a substance can be used for a particular purpose, marketed as such or as a component of a product. The scope will be clearly defined and strict deadlines will be set for both industry and authorities.

Substances subject to authorisation: The following new and existing substances, including those produced in volumes below 100 t, which either have hazardous properties giving rise to very high concern will be progressively subjected to an authorisation regime. However, uses that do not give rise to concern will generally be exempted:

• Substances that are carcinogenic, mutagenic or toxic to reproduction (CMR substances categories 1 and 2)

• Substances with POPs characteristics.

Further research: Further research is needed to develop criteria for the identification of PBT and VPVB19 substances other than POPs. The Commission will decide at a later stage how substances with these properties should be treated.

Endocrine disrupters: The majority of the endocrine disrupting chemicals would have to undergo authorisation in the REACH system. Serious human health effects which have so far been associated with endocrine disrupting chemicals are testicular cancer, breast cancer, prostate cancer, decrease in sperm concentration and semen volume, cryptorchidism, hypospadia and impaired development of the immune system and the nervous system. All these effects would qualify a substance either to be classified as carcinogenic or as toxic for reproduction and so would trigger its submission to authorisation. Furthermore, adverse effects on the endocrine system of wildlife species have been causally linked to certain POPs, which will be subject to authorisation.

Implementation of the authorisation process: A substantial number of substances qualifying for authorisation will be identified only through Level 1 and Level 2 testing when they are already used in substantial amounts. In order to allow for implementation of the authorisation procedure, transition periods to generate the required information and to draw up the dossiers for authorisation are necessary. Also, the time period needed to decide
upon the authorisation needs to be taken into account. A two-step decision-making process is therefore proposed:

• Step 1 – identification of the substances, or particular uses of substances, which will be subject to authorisation. Once identified, a precise date when all unauthorised uses of the substance will be prohibited. Furthermore, step 1 will identify, as appropriate, the scope of the uses to be exempted generally from the requirement for authorisation. Relevant substances will be fed into the system as soon as practicable, with substances of most concern being considered first.

• Step 2 – particular uses of a substance will be authorised on the basis of a risk assessment submitted by the applicant to the authorities. This assessment will cover the whole life- cycle of the substance, including disposal, with respect to the particular use. Manufacturers and importers will be permitted to submit jointly this information and/or to submit simultaneously for the use of several substances (group applications). The authorities will generally not require the applicant to carry out further testing but to establish the required exposure data to allow authorities to take a decision. An authorisation will be granted if the use presents a negligible risk. A conditioned authorisation may be granted if this is justified by the overall socio-economic benefits arising from the use. The authorities will be required to decide upon the authorisation within a reasonable time from submission of the risk assessment to avoid banning of substances by default.

Exemptions: Uses which do not give rise to concern – such as well controlled industrial uses or uses in research laboratories – may be subject to general exemptions from the authorisation procedure.

Pro-active role of industry: The current approach requires authorities to provide convincing arguments, usually in the context of a risk assessment, before restriction measures are taken. Their task is further complicated because the current system does not encourage industry to support the assessment. On the contrary, delaying the process is “rewarded” with an extended marketing period. Industry has usually provided data when such data were deemed suitable to avoid the restrictions under consideration. An apparent lack of data aggravates the situation and often leads to a risk assessment conclusion that ‘further information is required’ before an informed decision on risk management can be taken. Other delays are caused in cases where analytical methods must be developed to check compliance with a potential restriction. Authorities have to carry the main burden of the development of the analytical methodology. Such an approach is not amenable to attaining a high level of safety.

Authorisation, in contrast, requires industry to take a pro-active role in the evaluation process. If analytical tools need to be developed to control exposure, their availability should be a prerequisite for authorisation.

Increased flexibility: At the authorisation stage, a consideration of the socio-economic impact may be required. In contrast to the current system, which requires authorities to carry out cost/benefit analyses, the producer or user of the substance should be obliged to provide information substantiating any claim that the benefits from the continued use of a substance outweighs the potential adverse effects on human health and the environment. The REACH-system offers clear advantages to industry. Currently, Directive 76/769 restricts certain uses of substances without providing a mechanism to reverse such provisions on a case by case basis. In this perspective the REACH-system offers increased flexibility on condition that adequate safety measures are taken. It is more open to technological developments and will lead to a custom-tailored safety net for problematic substances.

Accelerated risk management of other substances

Specific uses of substances which do not have one of the properties listed under the authorisation system but for which restrictions are needed should be addressed in an improved and accelerated procedure.

Accelerated risk assessments: the following four elements will bring about the necessary acceleration of assessments:

(1) Due to the registration requirement of all chemicals above 1 t there will be extensive data available on the health and safety properties of all substances marketed (see chapter 5 below).

(2) The obligation on enterprises to submit a preliminary risk assessment will provide the authorities with valuable and comprehensive information on whether or not the chemical substance in question can be handled safely thereby avoiding unacceptable risks for workers, the population at large and the environment. Thus, for the large majority of substances (estimated at more than 80 %), there would be no need for further assessment. In the minority of cases where there is need for further assessment, it would be clear where the further assessment should be focussed. The gain in time would be substantial compared to the present system.

(3) Under the new system, the industry will be responsible for preliminary risk assessments and will assume responsibility for the safety of its products. It will be under an obligation to co-operate on the establishment of Community Risk Assessments where these are considered necessary. The delays encountered under the present system, where Member State authorities assumed full responsibility for risk assessments without the necessary means at their disposal, will be eliminated.

(4) Targeted risk assessments will in most cases replace the comprehensive risk assessments of the past. The latter were the main cause of delays under Regulation 793/93 as they required consideration of all dangerous effects, all exposed populations and all environmental compartments.

These four factors taken together will substantially reduce the time needed for assessment.

Accelerated legislation: two factors will contribute to an acceleration of the legislative process:

(1) The precautionary principle will be invoked whenever the risk assessment process is unduly delayed and where there is an indication of unacceptable risk. In particular, should a producer of a given substance delay the filing of information or test results, the central entity would be entitled to conclude the assessment. It would then pass the dossier to the Commission with a recommendation to apply the precautionary principle and to proceed to risk management measures to the possible extent of a total ban.

(2) A further acceleration is needed in order to proceed to risk management decisions for other substances in a reasonably short time frame. Thus, the Commission should be authorised to use the Committee procedure under Directive 76/769 more extensively than in the past.

This approach would take account of the full range of implications of possible restrictions; in particular, it would consider whether possible substitutes are more or less dangerous.

ROLE, RIGHTS AND RESPONSIBILITIES OF INDUSTRY

There is already legislation in place along the whole manufacturing chain generally allocating the responsibility for the safe use of chemicals to manufacturers and users of chemicals. Directive 92/59/EEC on General Product Safety20 extends the responsibility to products intended for consumer use, which should not present unacceptable risks under normal or reasonably foreseeable conditions of use. The review found that this general allocation of responsibilities has not led to a satisfactory evaluation of the safety of chemicals. Additional legal provisions stating more precisely the obligations of industry are essential. These provisions shall include ensuring that the substances they place on the market are safe for their intended use, irrespective of the tonnage produced.

Data Generation

The current system only established duties for producers and manufacturers to test chemicals, but not for downstream users. The role of downstream users in testing of chemicals needs to be further considered.

Action 5A: Obligation of downstream users to perform testing
Downstream users must assume responsibility for the safety of their products. Authorities should be empowered to require downstream users to carry out additional testing where uses differ from those originally envisaged by manufacturers or importers and the resulting exposure patterns also differ substantially from those evaluated by them. Additional testing programmes should be developed in close consultation with the authorities.

Risk/safety Assessment

Directive 67/548 and Regulation 793/93 oblige the authorities to carry out risk assessment. This imposes a considerable burden on them, particularly in assessing existing substances. As industry is responsible for safe use and disposal of chemicals and risk assessment is the preferred method to assess safety, the current work distribution between authorities and industry is inappropriate. Chemicals are used in millions of products so it is impractical for authorities to perform or be involved in these assessments. Instead, the Commission believes that, as the Council suggested, authorities should focus on areas of major concern.

Action 5B: Manufacturers and downstream users to perform risk assessment
Industry should have responsibility for performing risk assessments. This will require the manufacturer or importer as well as the downstream user to carry out adequate risk assessments for substances and preparations.

Information to be provided by Industry to the Authorities

Industry should provide authorities with information about all substances as set out in Chapter 4. Below the Chapter 4 thresholds, industry should generate the necessary safety data and keep the records available.

Action 5C: Obligation of downstream users to inform authorities
The Commission proposes that the authorities must be informed about any downstream use which has not been envisaged by a manufacturer or importer and which has not therefore been addressed in the preliminary risk assessment.

Information to be provided by manufacturers and importers to downstream users, other professional users and consumers

Information relevant for the safe use of chemicals must be available to all users, including consumers. Fundamentally, the safety system depends on the quality and the comprehensibility of the information passed on down the production chain. Safety data sheets and the Labelling of the packaging are the main carriers of this information. Shortcomings have been identified in both information systems. Safety data sheets are considered below while classification and labelling is addressed in chapter 7.

Action 5D: Information to industrial and professional users through safety data sheets

Safety data sheets are generally considered to be suitable communication tools to provide safety information to users, in spite of the noted shortcomings. The Commission proposes to establish a working group of Member States experts including participation of the European Chemicals Bureau to advise it on:

• ensuring better quality of safety data sheets,

• examining the current information requirements with a view to expand them in order to enable users to carry out risk assessment.

Property rights for test data

The specific provisions in Directive 67/548 and Regulation 793/93 for the sharing of test data and testing costs were designed to avoid duplicate animal testing. However, such provisions also have a benefit for industry because they reduce the overall testing costs. Furthermore, legislation for sharing of test data and the costs of testing is essential to ensure fair competition, otherwise some companies might delay testing in the hope that competitors producing the same substance would be obliged to do it before them and pick up the full costs.

The introduction of exposure-triggered testing and new obligations on downstream users to test could accentuate this problem. For example, if a downstream user carried out additional testing because of substantially different exposure patterns than those foreseen by a manufacturer of the substance, the latter might use these data to enlarge the scope of the uses of the substance. This would increase the number of potential customers and the marketed volumes, in some cases at a disadvantage to the original downstream user. Such a system would encourage the manufacturers to strictly limit the number of intended uses to a minimum, waive testing as far as possible and wait for downstream users to complete the testing. This would be a clear distortion of the market.

Action 5E: Property rights for test data

Anybody who generates testing data under the new system should be encouraged to share them and anyone who uses such data obliged to pay a fair and equitable contribution to the generator of the data.

Action 5F: Discouragement of duplicate testing

Specific provisions should be included in the legislation that duplicate tests involving vertebrate animals should be avoided. Any duplicate testing will not result in an exemption from the duty to reimburse the party who owns the property rights for the first test.

TIMETABLE FOR EXISTING SUBSTANCES

The testing and evaluation of the large number of existing substances on the market requires a phased approach. This chapter describes the necessary provisions and a timeframe for the testing and evaluation of existing substances. It also addresses the future role of the authorities in risk assessment.

Action 6A: Tiered approach for registration

Precise deadlines will be established for the submission of registration dossiers for existing substances. In general, substances produced in higher volumes will have to be registered first. However, the system will be flexible enough to allow for earlier registration of substances of concern (e.g. intended for consumer use or having particular proven or suspected hazardous properties) produced in lower tonnage. Under these presumptions and given rapid progress in adoption of the revised legislation, the suggested deadlines for submission of registration dossiers are basically:

• substances exceeding a production volume of 1,000 t – at the latest by end of 2005,

• substances exceeding a production volume of 100 t – at the latest by end of 2008,

• substances exceeding a production volume of 1 t – at the latest by end of 2012.

Dossiers drawn up in the context of the voluntary initiative on the part of the International Council of Chemicals Associations (ICCA) which comply with the OECD format will be valid for this purpose. However, the information contained in these dossiers will have to be supplemented in order to meet the requirements described in the previous chapters.

Action 6B: Tiered approach for testing and evaluation of high production volume existing substances

There should be a tiered approach for the testing and evaluation of high production volume existing substances. Level 2 testing should be completed for substances above 1,000 t by 2010 and Level 1 testing of substances above 100 t should be completed by 2012.

Action 6C: Establishment of a task force to review available data

An advisory task force composed of around 15 Member States experts, should be seconded to the European Chemicals Bureau in the interim period before the new legislation is implemented. This task force will be assigned the following responsibilities:

An advisory task force composed of around 15 Member States experts, should be seconded to the European Chemicals Bureau in the interim period before the new legislation is implemented. This task force will be assigned the following responsibilities:

– evaluation of the information of the IUCLID database submitted by industry for substances exceeding 1,000 t:

(a) examination of the proposed classification and labelling

(b) assessment of IUCLID information on properties, exposure and uses

(c) proposal of additional testing programmes in co-operation with ECVAM

CLASSIFICATION AND LABELLING

Current legislation requires that dangerous substances are either classified and labelled in accordance with Annex I of Directive 67/548 (harmonised classification) or, if they are not included in this Annex, in accordance with the principles laid down in Annex VI of this Directive by industry (self-classification). Annex I covers around 5,000 dangerous chemicals and has been established over several decades.

Systematic evaluation of new substances has revealed that around 70 % of them are classified as dangerous (e.g. carcinogenic, toxic, sensitising, irritant, dangerous for the environment). In view of the large number of existing substances and assuming that a comparable percentage of them need to be classified, the establishment of a comprehensive harmonised list of all substances is not a viable option using the current approach.

Classification according to some hazardous properties has automatic consequences for the risk management of these substances (see chapter 3). To avoid ambiguities in respect of the required management measures, the new system must retain parts of the harmonised classification.

Action 7A: Restrict harmonised classification to the most relevant properties

Authorities’ resources should be focussed on the most relevant hazardous properties, such as carcinogenicity, mutagenicity and reproduction toxicity (CMR), where classification gives rise to important risk management measures.

Action 7B: Commission to seek industry list of dangerous substances
The Commission will ask Industry to provide a list containing comprehensive information about the classification and the labelling of all dangerous substances on the market. This list should be made available on the Internet and be publicly accessible free of charge.

Action7C: To simplify the current labelling system and improving comprehensibility through Globally Harmonised System.

The current negotiations on the elaboration of a Globally Harmonised System provides an opportunity to fundamentally review the current labelling provisions, to consider simplification and to improve comprehensibility of the labels.

ADMINISTRATION OF THE SYSTEM

This chapter summarises the administration of the REACH system presented in chapter 4.

Decision-making in the REACH system

There are basically two different kinds of decision to be taken under the REACH-system: decisions on the information to be submitted following the evaluation of the substances and decisions on risk management in the context of the authorisation procedure.

Decision-making at the Evaluation stage: The system must provide a mechanism to ensure that, on the basis of the preliminary risk assessments provided by industry, decisions on further information or substance-tailored testing programmes can rapidly be taken for a large number of substances. The procedure under Regulation 793/93 to request additional testing for existing substances from industry has proven extremely slow and cumbersome. Under the new system, the approach taken for new substances will be followed: Member State authorities will be responsible for deciding on the additional testing and a committee procedure will only be invoked in cases where agreement cannot be reached between Member States authorities.

Decision-making

Decision making at the authorisation stage: Depending on the anticipated impact of a substance, an authorisation for actual use should either be granted by Member States or by a decision at Community level. Member States should grant authorisations for uses, which mainly need to be considered for their potential impact on workers and on the local environment. In contrast, the authorisation of the use of a substance of concern in products marketed in the Community may have a wider impact on human health or the environment as well as on the functioning of the internal market. This would imply that a Community- wide decision on the actual use of a substance is justified.

As described in chapter 4, the authorisation would encompass a two step procedure:

• Step 1 – the identification of substances or particular uses of a substance which will be subject to future authorisation, establishing a precise date when all uses which have not been authorised will be prohibited;

• Step 2 – the actual authorisation of particular uses.

Given the Community-wide internal market impact of prohibiting the use of a substance, the step 1 decision, together with identification of the uses that Member States may authorise, should be taken at Community level. Step 2, the authorisation of specific uses, would be taken at the appropriate level defined in step 1. Generally, a committee driven mechanism will be applied for all decisions taken at Community level.

Decision making in the accelerated risk management procedure:

The accelerated risk management procedure will work as follows:

• Step 1 – the identification of substances or particular uses of a substance which will be subject to future restriction, defining the scope of the restriction,

• Step 2 – the actual decision restricting or banning the use of the substance.

Given the Community-wide internal market impact of prohibiting the use of a substance, both decisions should be taken at Community level. Step 2 would imply legislation in the framework of a modernised Directive 76/769. Generally, a committee driven mechanism will be applied for all decisions taken at Community level. It would leave present working arrangements intact.

Establishment of a central entity

The Commission proposes at this stage to establish a central entity (an expanded European Chemicals Bureau) for the administration of the REACH-system and the provision of technical and scientific support. Building on its existing experience, the expanded European Chemicals Bureau should be a receiving body for the registration dossier, and forward the copies of the registration dossiers to the Member State authorities, establish and maintain a comprehensive central database on all registered chemicals, perform spot-checks and computerised screening of the registered substances for properties raising particular concern. It will also support Member States authorities in the evaluation of substances.

The central entity will provide access to non-confidential submitted information for the general public and establish an efficient and secure data exchange network with Member States for commercially sensitive information. It should support and co-ordinate the Member States with respect to the decision-making at the evaluation stage in order to ensure a coherent approach. Furthermore, the European Chemicals Bureau would provide the operational framework for the authorisation procedure and seek the views of Member State experts and of the CSTEE . Prior to the establishment of the central entity, the Commission will carry out a feasibility study and a cost/benefit analysis.

Role of Member States

Member States authorities would broadly retain their current responsibilities. They would be collectively responsible for substance registration and evaluation, similar to their current responsibilities for new substances notifications. Better consistency of decisions between Member States authorities would be achieved by the co-ordination through the European Chemicals Bureau and by developing guidelines for substances-tailored testing. The experience gained by the task force (see chapter 6) will help to prepare such guidelines.

To rectify the current unequal workload distribution between Member States authorities, the registered substances will be allocated to Member States on a proportionate basis. Current provisions concerning information exchange and the option to invoke a committee procedure in cases where agreement cannot be reached between Member States authorities should be retained.

INFORMATION TO THE PUBLIC

The Commission has consulted and involved all stakeholders and in particular the NGOs representing consumer interests. Full openness is essential if the public is to understand the intended benefits of the Strategy and to ensure the Commission has addressed the public interest. The Commission is therefore committed to ensuring the continued involvement of stakeholders representing the full range of interests in the implementation, management and review stages of the Strategy.

EU citizens should have access to information about chemicals to which they are exposed. Information must be presented in such a way that it enables a person to understand the risks and to develop a sense of proportion in order to make a judgement on the acceptability of those risks. Better public access to information on chemicals will increase public awareness and will lead in turn to greater accountability on the part of industry and authorities. The Commission already publishes an up-to-date multi-lingual collection of chemical substances data and this could be further developed. Furthermore, indicators on the risk of chemical use should be established.

The Commission acknowledges consumers ‘right of choice’. Information should enable the consumer to make a judgement on whether alternative products on the market are more favourable in terms of their intrinsic properties and risks.
The findings of the review highlighted the need of consumers for information about the health effects, environmental effects, other serious hazards and safe instructions for use of chemical products. The Commission believes that industry, including downstream users, should mainly be responsible for providing this information to consumers. This will lead to better informed purchasing decisions about such products.

There is currently no central tracking system by which the public can determine whether regulatory measures are in place or in progress for individual chemicals. There is a lack of public awareness of the requirements of current chemicals legislation. The new system should be more easily understood by the general public helping to address this lack of awareness.

Action 9A: Stakeholder access to non-confidential information in the new-system database

All stakeholders, including the general public and SMEs (small and medium sized enterprises employing less than 250 workers), should have access to the non-confidential information on the central system database (see Chapter 4). Easy to read summaries for substances will promote use by the general public. These summaries will include a short profile of the hazardous properties, labelling requirements and relevant Community legislation, including authorised uses and risk management measures.

IMPLEMENTATION AND ENFORCEMENT

The Commission proposes to review the effectiveness and the efficiency of the chemicals strategy following implementation of the new legislation. The review will include an element of testing and questioning of all stakeholders.

Member States will be responsible for the enforcement of the new legislation in their territories. However, a number of enforcement projects and studies have highlighted shortcomings in compliance by industry of the current legislation on chemicals and inconsistencies in the level of enforcement activities by the Member States. Even if non- compliance can be demonstrated and damage to human health or environment has occurred, compensations awarded by courts of EU Member States often have a limited deterrent effect. The Community must address these problems by requiring Member States to establish dissuasive, effective and proportionate sanctions.

Recent studies in the Netherlands and the United Kingdom found high levels of non- compliance with the Safety Data Sheets legislation. Flaws in compliance and enforcement activities related to current legislation for new and existing substances were also noted by recent Community-wide enforcement projects (SENSE, NONS and EUREX21).

Action 10 A: Review of the chemicals policy

The Commission proposes to review the effectiveness and the efficiency of the chemicals policy including all the different elements that constitute its information policy, following implementation of the new legislation. The review will include an element of testing and questioning of all stakeholders.

Action 10B: Network of Enforcement Authorities

The Commission proposes to create a network of the Member States and Candidate Countries authorities responsible for enforcement of new legislation on chemicals to spread good practice and to highlight problems at Community level. This will be of increased importance when the current Candidate Countries join the Community, thus enlarging the Internal Market. One of the issues this network will be asked to consider is the need to develop minimum criteria for enforcement of the proposed legislation in the Member States. Such criteria might be set out in a Commission Recommendation in future.

GLOSSARY OF TERMS AND ABBREVIATIONS

Burden of the Past: The 30,000 ‘existing’ chemicals estimated to be on the EU market, for which little or no information is available, in particular about their long-term effects on human health or the environment.

Chemicals: General term to cover both substances and preparations (see separate entries).

Competent Authorities: A national authority or authorities designated by each Member State to
implement legislation.

CMR chemicals: Chemicals classified as carcinogenic, mutagenic or toxic to reproduction under Directive 67/548 (see ‘legislation’).

CSTEE: Scientific Committee on the Toxicity, Ecotoxicity and the Environment of the Commission. Downstream users: Formulators and industrial users of chemicals. ECVAM: the JRC’s European Centre for the Validation of Alternative Methods.

ELINCS: European List of Notified Chemical Substances. ELINCS, currently contains some 2,700 substances and is an ever expanding list, following notification to Competent Authorities of the placing of a ‘new’ substance on the market.

EINECS: European Inventory of Existing Commercial Chemical Substances, deemed to be on the EU Market between 1 January 1971 and 18 September 1981. It is a closed list of 100,106 ‘existing’ chemicals governed by Regulation 793/93 (see ‘legislation’).

Existing substances: Substances in use within the EU before September 1981 and listed in EINECS. EINECS contains 100,106 entries including chemicals, substances produced from natural products by chemical modifications or purification, such as metals, minerals, cement, refined oil and gas; substances produced from animals and plants; active substances of pesticides, medicaments, fertilisers and cosmetic products; food additives; a few natural polymers; some waste and by-products. They can be mixtures of different chemicals occurring naturally or as an unintentional result of the production process.

‘Existing’ substances do not include: synthetic polymers (which are registered in EINECS under their building block monomers), intentional mixtures, medical preparations, cosmetic preparations and pesticide preparations as intentional mixtures; food; feedstuffs; alloys, such as stainless steel (but individual components of alloys are included); most naturally occurring raw materials, including coal and most ores.

Global Harmonisation: The Community together with its trading partners is committed to developing a global system for managing chemicals. Work is underway with the candidate countries for accession to the EU, in the framework of the OECD and at a global level in the framework of the United Nations.

Hazard assessment: Hazard identification and establishment of dose-response relationship for observed adverse effects in the specified (eco)toxicological endpoints.

Hazard identification: Identification of the adverse effects that a substance has the inherent capacity to cause.

HPV chemicals: High Production Volume chemicals. Chemicals placed on the EU market in volumes exceeding 1000 tonnes per year per manufacturer or importer.

ICCA: International Council of Chemical Associations.

IFCS: Intergovernmental Forum on Chemical Safety.

ILO: International Labour Organisation.

IUCLID: International Uniform Chemical Information Database. A Commission database used to store and distribute information collected under Regulation 793/93.

JRC: Joint Research Centre of the Commission.

Legislation: Reference in the White Paper mainly refers to four legal instruments on chemicals currently in force in the Community:
• Council Directive 67/548/EEC relating to the classification, packaging and labelling of dangerous substances, as amended,
• Directive 88/379/EEC relating to the classification, packaging and labelling of dangerous preparations, recently replaced by 1999/45/EC,
• Council Regulation (EEC) 793/93 on the evaluation and control of the risks of existing substances,
• Directive 76/769/EEC relating to restrictions on the marketing and use of certain dangerous substances and preparations.

LPV chemicals: Low Production Volume chemicals. Chemicals placed on the market in volumes between 10 tonnes and 1000 tonnes per year per producer/importer.

New substances: Substances not in use in the EU before September 1981 and so not in EINECS. They must be notified before being placed on the market, after which they are registered in ELINCS. New substances are governed by Directive 67/548, as amended by Directive 92/32.

NGOs: Non-governmental or ganisations representing particular stakeholders’ interests (e.g. consumers, environment).

Notification procedure for a new substance: Submission of a technical dossier by industry to a Competent Authority, containing information specified by Directive 67/548, as amended by Directive 92/32 (see ‘legislation’).

OECD: Organisation for Economic Co-operation and Development. OSPAR: Oslo – Paris Convention for the Protection of the Marine Environment of the North East Atlantic.

PBT chemicals: Persistent, bio-accumulative and toxic chemicals. POPs: Persistent Organic Pollutants.

Precautionary Principle: This principle is contained in Article 174 of the Treaty and the subject of a Commission Communication of 2 February 2000. It applies when there is a preliminary objective scientific evaluation indicating reasonable grounds for concern that the potentially dangerous effects on the environment, human, animal or plant health may be inconsistent with the high level of protection chosen for the Community.

Preparations: Intentional mixtures or solutions composed of two or more chemicals. They are governed by Directive 88/379/EEC, recently replaced by Directive 1999/45/EC.

QSAR: Quantitative Structure Activity Relationship. Models used to predict the properties of chemicals from the molecular structure.

REACH System: Registration, Evaluation and Authorisation of Chemicals.

Regulatory Committee: A committee composed of representatives from the EU Member States and chaired by the representative of the Commission. Its opinion is delivered by a qualified majority.

Risk Assessment: A process to determine the relationship between the predicted exposure and adverse effects in four steps: hazard identification, dose-response assessment, exposure assessment and risk characterisation. See also ‘targeted risk assessment’.

Risk characterisation: Estimation of the incidence and severity of the adverse effects likely to occur in a human population or environmental compartment due to actual or predicted exposure to a substance.

SIDS: Screening Information Data Set (SIDS) outlining the minimum data elements for determining whether an existing HPV chemical requires further investigation in the OECD’s HPV/ICCA programme.

SMEs: Small to medium size enterprises employing less than 250 workers.

Substances: Substances are chemical elements and their compounds in the natural state or obtained by any production process, including any additive necessary to preserve the stability of the product and any impurity deriving from the process used, but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition. While ingredients of pesticides, biocides, medicaments or cosmetics might be included in this definition, intentional mixtures or preparations of them for final use would not.

Sustainable Development: Enshrined in Articles 2 and 6 of the Treaty, it was defined by the World Commission on Environment and Development (the Brundtland Commission) as development that ‘meets the needs of the present generation without compromising the ability of future generations to meet their own needs’. This objective includes the economic, social and ecological aspects of development as set out in the Final Document of the 19th Extra Session of the UN General Assembly, which was held on 23-27 June 1997. These three aspects are mutually dependent, and in order to achieve sustainable development they must be integrated and taken into account in a balanced manner. These notions are at the core of the Fifth EU Environment Action Program ‘Towards Sustainability’ and the Cardiff Strategy on Integration.

Targeted risk assessment: A less extensive, more specifically focused evaluation (because of a specific concern) than a comprehensive risk assessment.

Tiered Approach: Proportionate effort in relation to the volumes, intrinsic properties, exposure and/or use of chemicals; see chapter 3 for further explanation.

UN: United Nations.

UNCED: UN Conference on Environment and Development at the 1992 Earth Summit in Rio.

VPVB chemicals: Very persistent and very bio-accumulative chemicals.

WHO: World Health Organisation.

ANNEX I

Costs and Benefits of the new Chemicals Policy

Model

• Single coherent system for all chemical substances. REACH model (registration, evaluation and authorisation/rapid restriction of chemicals);

• Management by Member States and European Chemicals Bureau (ECB).

Coverage

• 30,000 existing substances (= all existing substances above 1tonne/year/manufacturer);

• Acute and long-term toxicity tested. Tailor-made testing for long-term effects (such as cancer,
reproductive effects) for substances above 100 tonne/year/manufacturer;

• Waiving of testing on due justification, all available test data used and registered;

• Reduced testing for low exposure substances and R&D (research and development) substances.

• Limited in vitro testing for substances between 1 and 10 t.

Costs

Cost of action. It is very difficult to give a reliable estimate of the “cost of action” implied, such as for the testing of existing substances where availability of test data generated earlier is largely unknown. However, a first estimate is given in the following.

• Testing costs for existing substances. € 2.1 billion over 11 years = € 0.2 billion/year, to be borne by the chemicals industry.

• Human resources for an expanded European Chemicals Bureau (ECB). A staff of 190 people at the ECB to provide the technical and administrative framework.

• Public human resources in the Member States. Member States will reallocate their current staff. Extra resources will be allocated to evaluation of existing substances. These resources will be freed from their current tasks by the following measures:
– Computerised screening and sport checks will replace the current general conformity check for new substances below 100 t
– Risk assessments will generally be carried out by industry rather than authorities
– in view of the expanded ECB and the reduced efforts needed for the authorisation process instead of the current restrictions process under Directive 76/769.

• Industry human resources. An estimate is hardly possible because an increase can be expected for processes such as the authorisation process, but a reduction can be expected because of
– no notification of substances between 10 kg and 1 tonne/year/manufacturer;
– less strict requirements for certain substances such as intermediates with low exposure;
– less strict requirements for R&D substances (research and development).
(The staff for the testing of existing substances is already covered by the above-mentioned testing costs.)

Benefits

Better protection of the environment and human health through appropriate risk management based on adequate information about the dangerous properties of chemicals. This will reduce the incidence of certain diseases related to chemicals (such as cancer or allergies) and reduce the risks that chemicals can pose to the environment (such as through the accumulation of persistent chemicals in the food chains). The main difficulty is that neither the dangerous properties nor the uses of chemicals are sufficiently known. For illustrative purposes reference is made to allergies.

Allergy costs are estimated at € 29 billion/year in Europe. Chemical substances are considered to play a major role in inducing allergies either directly or by increasing susceptibility to natural allergens (e.g. pollen). For example a US study has shown that asthma cases have risen by 40% since the 1970s. If the new strategy makes even a small reduction in the € 29 billion of allergy costs, this will outweigh the costs of the strategy.

• Improved framework for innovation in the chemicals sector. This will

– contribute to the development of novel chemicals that may substitute current chemicals of concern,
thus decreasing the risks from chemicals;

– strengthen the competitiveness of the EU chemicals industry.

• Increased transparency and better access of the public to information, thus enabling them to make an “informed choice” about the chemicals they want to use.

Direct link is below
http://eur-lex.europa.eu/LexUriServ/site/en/com/2001/com2001_0088en01.pdf

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Bulldozing REACH – the industry offensive to crush EU chemicals regulation by Corporate Europe Observatory, March 2005

The EU’s REACH proposal for improved regulation of chemicals has sparked the largest ever industry lobbying campaign in Europe. The chemical industry council CEFIC took the lead, with German giant BASF in a key role, and with active backing from US chemical corporations and the Bush administration. Scare mongering, flawed impact studies and delay tactics are part of this aggressive counter-campaign that has seriously weakened REACH. First proposed in 2001, REACH will go through the last phases of the legislative process during 2005 and 2006. More than ever, it is time for citizens to stand up against industry attempts to undermine progressive environment and health legislation.

Free-riding chemicals

The original motive behind REACH (Registration, Evaluation and Authorisation of Chemicals) was to end the largely uncontrolled and hazardous vacuum that currently exists for chemical products in the EU market.[1] The existing patchwork of chemical regulations is a dream come true for industry. It allows most chemicals to be introduced without safety guarantees, and up to 99% of the total chemicals sold in the EU have in fact not passed any environmental or health test process.[2] It is up to the authorities to prove undesired effects if the chemical is to be regulated. The current EU regulation on chemicals, based on what is called “risk assessment”, only allows regulators to take action after many years of lengthy evaluations. Regulation is only possible if there is sufficient information available on the product. Of the 141 existing substances that were identified for closer scrutiny, only one third have undergone a risk assessment, and less than five have actually been regulated.[3] Many thousands of untested chemicals are used in a vast array of everyday consumer products. Numerous chemicals have already entered the food chain, and were found in breast milk as well as in the blood of polar bears in far-away Arctic regions.[4] Some of these substances are strongly suspected of causing cancer and other health problems, such as allergies, birth defects and reduced fertility as well as damaging wildlife and polluting the environment.[5]

It was on this background that the EU Council of Ministers in April 1998 with consensus decided to review the EU chemical policy and asked the European Commission to develop a proposal aimed to better protect the human health and the environment. The Commission undertook an evaluation which confirmed the failure of the existing policy. It concluded that work should start on a new chemical policy that reflects the precautionary and sustainability principles. In June 1999, the EU’s Environment Council gave the Commission a mandate to draft a White Paper outlining the proposed new chemical policy. The White Paper presented in February 2001 was ambitious and proposed to reverse the burden of proof for industry to demonstrate the safety of a product. Industry was to provide crucial safety information on tens of thousands of chemicals, and would be forced to register 30,000 substances with a new agency.

Furthermore, chemicals classified as “very high concern” would be need to be substituted when a safer alternative is viable. This category of very high concern chemicals (substances causing cancer, damaging genetic material, reproductive toxins, chemicals that can not be broken down by nature and which build up in bodies of human beings or wildlife as well as substances that interfere with the hormone system) would require a special license for production: authorisation. Nowadays, “very high concern” chemicals are used in a wide array of consumer products. For instance, a study by Greenpeace found them in children pyjamas, toys, household paint cleaners, computers, televisions, carpets and furniture among other things.[6]

The Council of Ministers and the European Parliament decided on the White Paper in June and November 2001 respectively. Both bodies not only supported REACH but wanted to further strengthen the text, proposing amendments to further increase protection for the health of humans and the environment.

REACH Chronology

April 1998: the EU Council of Environment Ministers asks the Commission to review the existing chemicals regulation.
October 1998: the chemical industry launches the HPV (High Production Volume) Initiative to provide information on 1,000 chemicals before the end of 2004 and the LRI (Long-range Research Initiative) to fund research on how chemicals impact human health and the environment.
November 1998: the Commission presents its chemical policy review to the Council of Ministers.
June 1999: at the 24-25th of June meeting, the Council adopts a document outlining the background of a new chemical strategy based on the sustainability and precautionary principles. Another element is to reverse the burden of the proof, increasing the responsibility of industry. The Council asks the Commission to develop a proposal before the end of 2000.
April 2000: industry calls for partnership between the chemical industry, academics and governments.
12 February 2001: the Commission adopts the White Paper on a Strategy for a Future Chemicals Policy.
June 2001: on 7th of June the Council adopts conclusions on the White Paper, asking for amendments to make the text stronger. The Council also asks the Commission to present a proposal for a regulatory framework by the end of 2001.
November 2001: on 15 November the European Parliament approves its resolution on the White Paper, including amendments to further improve protection of the environment and human health.
March 2003: the European Council decides that competitiveness must take centre stage in the EU and requests the new Competitiveness Council to get involved in the REACH process.
May 2003: the Commission presents the Draft Regulation and its strategy for consulting stakeholders and public.
* September 2003: Blair, Chirac and Schröder send a letter to Commission President Prodi asking him to review REACH.
October 2003: the European Commission presents the final regulatory proposal, which will be discussed in the European Parliament during 2005.
The chemical industry enters the stage

At this stage, alarm bells had long started ringing at the headquarters of CEFIC, the European Chemical Industry Council. The European chemical industry, employing 1.7 million people in the EU and used to have a major say in European politics, was not pleased and started a large-scale campaign against the Commission’s REACH White Paper proposal. CEFIC, which employs around 140 staff people at its Brussels headquarters, consists of both national chemical associations and individual corporations like BP, Bayer, BASF, Dow, DuPont, ExxonMobil, Novartis, Shell, Solvay, Total and Unilever.[7]

A prime target was the European Parliament which was to vote on the White Paper by the end of 2001. According to Green MEP Inger Schörling, the Parliament’s rapporteur on REACH, the industry lobbied parliamentarians through “seminars, workshops, meetings, lunches, dinners, letters, mail-outs, phone-calls, visits to plants, media releases and any other component that could be used”.[8] Particularly MEPs from major chemicals producing countries like Germany, France, UK and Italy were constantly warned about the massive job losses and reduced production which CEFIC claimed would be the consequence of REACH. “There is comprehensive EC legislation already in place for the control of chemicals and there is little direct evidence of widespread ill health or ecosystem damage being caused by the use of man-made chemicals,” CEFIC director-general Alain Perroy argued in a letter to MEPs.[9]

From the start, CEFIC’s strategy was to dismiss the Commission proposal as overly bureaucratic and costly, and to call for “a workable chemicals legislation”. Another consistent element in CEFIC’s strategy has been the attempt to move the spotlight away from big multinationals and towards the proclaimed negative impacts on SMEs instead. CEFIC has successfully courted the chemical workers union EMCEF. CEFIC’s doom scenario’s about massive job losses seem to have made the unionists forget about the positive impacts which improved chemicals regulation will have on occupational health.

In the first phase of the REACH battle, CEFIC was led by Jean-Pierre Tirouflet of French chemicals producer Rhodia.[10] Tirouflet was eager to cultivate a good image for the industry: CEFIC’s general strategy was to be seen as a constructive ally on health and environment issues. With the UN’s World Summit on Sustainable Development ahead (September 2002), industry was trying to portray itself as “part of the solution”. In practice this often meant promoting voluntary industry initiatives on environment and health as alternatives to government regulation. This was certainly the case for CEFIC, which for instance tried to hype its High Production Volume (HPV) chemicals programme (that was to provide information on 1,000 chemicals before the end of 2004) as an alternative to the REACH proposals. But when the Commission’s REACH proposals started taking shape such relatively soft lobbying approaches were gradually replaced by more confrontational ones.

This change of strategy was primarily driven by the German chemical industry, which includes some of the world’s major producers. In the autumn of 2001, the German chemicals lobby VCI published a series of advertisements in the European Voice, Der Spiegel and other well-read newspapers, calling MEPs to vote against the Schörling report.[11] Inspired by these industry messages, major German media ran articles highlighting the proclaimed flaws of REACH. The REACH proposal, industry claimed, was basically an initiative from Sweden, a country that had nothing to lose as it does not have a large chemicals production, whereas impacts on Germany were portrayed as a catastrophe. Both then Environment Commissioner Wallström and then EP rapporteur Inger Schörling are Swedes.

Despite the fierce industry counter-campaign, the European Parliament in November 2001 voted in favour of the White Paper. Although industry had managed to water down some of the proposals in the Schörling report, the Parliament also introduced amendments going beyond the White Paper.

BASF takes over

In June 2002, Eggert Voscherau took over from Jean-Pierre Tirouflet and became the new CEFIC president. Voscherau, vice-chairman of the German chemical giant BASF, was quick at changing the group’s strategy in the REACH battle. He dropped the conciliatory facade of his predecessor and moved the campaign against REACH into a higher gear. “Gone were the phrases calling for cooperation and dialogue”, recounts Inger Schörling.[12]

Voscherau stepped up the scare-mongering about the impacts of REACH for jobs and economic growth. “We are in effect going to de-industrialise Europe [with these proposals]”, Voscherau claimed in July 2003, calling the Commission to “review the whole thing and redraft the whole project. European industry, including the chemicals industry, must not be a test laboratory for a bureaucratic regulatory experiment”.[13] Crucial in Voscherau’s strategy was to make optimal use of the Lisbon Agenda for international competitiveness, which the EU had agreed to in the spring of 2000.[14] “The costs of the plan far exceed the benefits,” Voscherau states in a typical quote. “It is completely out of balance. This plan is contrary to commitments made by member states to make the EU the most competitive economy in the world by 2010.”[15]

Threats to relocate became standard part of the industry campaign against REACH. Take for instance the statement by John Condon of Merck Sharpe & Dohme, one of the companies writing to the Irish government in the run up to the Irish EU presidency in the first half of 2004. Condon threatened that “If regulations hold up the availability of raw materials in particular, then we may have to make the products elsewhere”.[16] According to Inger Schörling, the constant hammering on the competitiveness impacts and the Lisbon strategy really changed the parameters of the debate: “While REACH was still an unacceptable proposal, it was now an example of a regulatory proposal that did not comply with the Lisbon strategy and needed to be stopped if the over-arching goals were to be reached”.[17]

Flawed studies

A key weapon in the campaign against REACH has been a series of industry-funded studies and reports predicting hugely exaggerated implementation cost and job loss figures. The European Commission White Paper was not detailed enough to allow for sharp estimates of costs, a circumstance that industry has abused to fullest extent. CEFIC initially estimated that the costs for testing substances alone would be some 8 billion euro over a 10 year period. When the EU in May 2002 presented a study estimating that these costs would in fact be only 3.6 billion euro over 11 years, CEFIC replied that there are other costs beyond testing and estimated total REACH costs to industry to be between 20 and 30 billion euro.[18]

The most prominent of the industry-commissioned reports was released in December 2002, written by consultancy Arthur D. Little for the German Industry confederation BDI.[19] In its worst-case scenario, the report estimated that REACH would mean the loss of no less than 2,350.000 jobs in Germany and a production loss of over 20%.[20] These conclusions were disputed from many sides, including by a group of leading German research institutes who argued that the report was “based on a static model that does not take into account the dynamics and innovative drive of the economy”.[21] Despite the fact that the figures were grossly exaggerated, the BDI report became a favourite industry tool in the campaign against REACH.

In April 2003 a report written by Mercer Management Consultants presented similarly excessive figures on the likely costs, growth and employment impacts of REACH for French industry and society in general.[22] Finally, in August 2003 came a follow-up report on the impacts for Germany, again by Arthur D. Little, this time predicting that 1,7 million jobs would disappear and a gross value added loss for Germany industry of 4.7%.[23] None of these reports took into account the economic benefits of REACH. A report commissioned by WWF puts the cumulative health benefits of REACH for European society at between 57 and 283 billion euro.[24]

Multi-pronged offensive

At this stage, the chemical industry had also mobilised the powerful employers’ confederation UNICE. The added value of teaming up with UNICE was that it also represents the downstream users, such as manufacturing companies that do not produce chemicals but use them. The chemical industry has long been a major player within UNICE, and kept its grip when in the summer of 2003 Jürgen Strube (CEO of chemical giant BASF) became the new president, replacing Georges Jacobs (chairman of Belgian chemical group UCB). This meant that BASF controlled the top positions in both CEFIC and UNICE – a sign of the company’s determination to mobilise business lobbying power against REACH.

UNICE made the battle against REACH a top priority. It produced a flood of papers and letters warning that REACH would create bureaucracy, high costs, job losses and trade conflicts. “Industry is not against the REACH objectives but with (our) recommendations, we can make it more cost-efficient and more workable,” UNICE Secretary General Philippe de Buck explained.[25] In practice, the group is determined to postpone and weaken REACH as much as practically possible.

BASF was also very active within the Transatlantic Business Dialogue (TABD). This club of US and EU corporate giants has since 1995 championed a US-EU free trade area and tried to redefine environment and health regulations as ‘barriers to trade’. In 2002, BASF was co-chairing the TABD’s chemical expert group. This clearly helped to co-ordinate lobbying between CEFIC and its US counterpart, the American Chemistry Council (ACC). Relations between the groups had not always been very close, but the fight against REACH provided a common cause. At the November 2002 TABD meeting in Chicago, REACH was identified as one of the TABD’s priorities. “It would clearly create an unnecessary obstacle to free international trade,” said CEFIC boss Voscherau in Chicago.[26] Industry used the occasion to warn US and EU government officials about the potential WTO implications of REACH, including then EU Trade Commissioner Pascal Lamy. “We think we convinced [Lamy] to consider its trade implications. It would create a real quagmire,” said Tom Reilly, chairman of the American Chemistry Council.[27]

Not only the usual arguments of jobs and costs were voiced, the TABD also warned that that REACH would require no less than 12 million animals for testing. This figure came out of the blue, but it paid off and also parts of the animal protection movement started attacking REACH. Ironically, the TABD had for several years been fiercely resisting EU attempts to ban animal testing for cosmetics.

An avalanche of lobbying

In May 2003 the Commission presented a Draft Regulation. Stakeholders were invited to submit comments via an internet consultation. In response to demands by industry and the US government, the consultation period was extended from 5 to 8 weeks. This extension significantly delayed the European Parliament’s decision-making on REACH.[28] The Commission received over 6,500 comments, half of them from industry.[29] Most of the industry submissions predicted high costs and unemployment impacts.[30]

The submissions to the internet consultation are only the visible tip of the iceberg. According to Environment Commissioner Wallström and Enterprise Commissioner Erkki Liikanen, “the lobbying and political pressure the EU executive body faced concerning the REACH proposal was more intense than any other legislation the current Commission has proposed since taking office in 1999”.[31] Industry has had countless meetings with Commission officials on the issue of REACH. Indeed, the volume of correspondence was such that the Commission angrily rejected an access-to-documents request stating it would require “several man-months of research and verification.”[32]

In order to get a clearer picture of industry lobbying towards the European Commission, Corporate Europe Observatory in the summer of 2004 submitted a request for access to documents under the EU’s freedom of information regulation. The European Commission, however, rejected this request for copies of correspondence and minutes of meetings between the Commission and the chemical industry on REACH. In its reply, the European Commission called the request “disproportionate and abusive”[33] Concerning the correspondence between industry and the Commission, the number of such documents registered by DG Enterprise and DG Environment “is estimated at well over 1,000.”[34]

The US Government Reaches Out

Another heavy attack on REACH was to come from an unholy alliance from the other side of the Atlantic. The Bush administration has a general ambition of trying to export their blunt anti-environmental policies to the rest of the world.[35] Rarely has this been clearer than in the case of REACH, where the Bush administration has worked hand in hand with the US chemical industry, primarily the American Chemistry Council (ACC).

In April 2004, Democrat Congressman Henry Waxman issued a report revealing how the ACC had literally written the official US position on REACH.[36] This position, of which large parts were later even adopted by a number of EU Head of States, aimed to obstruct REACH on the grounds that it would threaten billions of dollars worth of US exports to Europe. US industry and the Bush administration fear that such progressive legislation could spread to other parts of the world. Other motives were less explicit, for instance the fact that European chemical industry may win markets if the high standards in REACH would help it to become the world most innovative and environmentally advanced.

The Bush administration left no doubt about its position in its submission to the European Commission’s internet consultation: “The chemicals regulation appears to adopt a particularly costly, burdensome and complex approach, which could prove unworkable in its implementation, adversely impact innovation, and disrupt global trade.”[37] But the US governments went beyond mere words. Greenpeace has described the attack on REACH by the Bush administration as “one of the most aggressive foreign lobby efforts ever to influence a proposed piece of EU legislation.”[38]

The highest levels of power play were used, with Colin Powell sending a series of cables to US embassies in Europe. The US Secretary of State wanted diplomats to focus their lobbying efforts on national governments, arguing that they would be “much more sensitive to impacts on EU competitiveness, employment and other implications that other commission bureaucrats.”[39] This strategy indeed paid off. A leaked email from an official of the US trade representative throws light on the tactics of the US government: “We need to get to the Swedes and Finns and neutralise their environmental arguments… But who will take on [Environment Commissioner Margot] Wallström – the answer is only other ministers or heads of state.”[40]

In its multi-pronged attack on REACH, the US government also used the World Trade Organisation (WTO). In July 2004, after recruiting the support of the Asia Pacific Economic Forum countries (APEC), the US complained to the WTO’s Technical Barriers to Trade Committee (TBT). The US claimed that REACH does not meet the “least trade restrictive” test in the WTO’s TBT agreement. However, as a common statement of Friends of the Earth, European Environment Bureau and Greenpeace pointed out, the US submission “failed to indicate any specific trade law objections whatsoever.”[41] The green groups called on the European Commission to reject the US complaint at the WTO.

Proud Lobbyists

Talking to colleagues from the chemical industry in May 2004, Greg Lebedev (President and CEO of the ACC) was very proud of the job done. He described REACH as “the most serious risk to our industry in a generation.”[42] To heat up the audience, he did not hesitate to inflate numbers, “There are the immediate – and knee buckling – costs of compliance. For example, an estimated $80 billion of costs would be born by companies doing business in France alone”. Lebedev warned the audience that “the authors of REACH have said on several occasions that their goal is to export their regulatory system to other parts of the world, including the US, so we could share the benefits of their flawed regulatory system.” Lebedev then recounted how the ACC intervened: “we knew the cards the EU authorities were holding and we called their hand. Because 21st century advocacy is global in nature, we teamed with our sister organisation in Europe, CEFIC, whose job it is to confront this massive EU initiative. CEFIC took the lead, but the ACC put its shoulder to the EU wheel and it paid off.” The ACC President describes a long list of ‘achievements’, among them the fact that “We arranged for multiple elements of our government – the Department of Commerce, the U.S. Trade Representative, the Environmental Protection Agency, and the Department of State – all to express the understandable reservations about this proposed rule and its trans-Atlantic implications.” The ACC had also been busy garnering the support of the Asia Pacific Economic Community (APEC) and the TABD to fight REACH, and to lobby new EU members from Central and Eastern Europe so they take a stance against REACH after joining the EU. Lebedev scorned Congressman Waxman for accusing the ACC of exerting “undue influence” on the US government, and committed to work even harder to stop REACH, “We’re not going to let the Henry Waxman’s carry the day.”

The Big Three Get Cold Feet

The sustained attack of the chemical industry in combination with the strong pressure of the Bush administration had a dramatic impact on the governments of the EU countries with major chemical industries: France, Germany and the UK. On 20 September 2003, Chirac, Blair and Schröder sent a joint open letter about REACH to Commission President Prodi, a show of political muscle. Both France and Germany were at the time permanently in the defensive because their public deficits exceeded the disciplines of the EU’s Stability Pact. This made them more susceptible to industry warnings of REACH causing massive recession. The heavyweight trio warned Prodi that the proposed REACH endangered the competitiveness of the European chemical industry. They reminded the Commission of the Council decision of reducing the bureaucracy faced by industry to foster economic growth and comply with the Lisbon Agenda. “It is also essential to comprehensively assess all important Community projects with respect to their potential effects on industrial competitiveness,” the open letter stresses.[43] According to Julian Scola, European communications officer at WWF, the intervention of the three heavyweight politicians was unprecedented. “Departmental ministers are usually unaware [of legislation], so to have heads of states getting involved even before the directive is published is extraordinary.”[44]

Meanwhile, tensions were running high also within the European Commission itself. The very industry-friendly DG Enterprise, then led by Commissioner Liikanen, had been fairly successful in getting a bigger role in European Commission decision-making on REACH, initially the territory of DG Environment. The more DG Enterprise muscled in on REACH, the more the focus of the policy drifted away from its original mission of improving the protection of human health and the environment.

REACH Light

When the final Draft Regulation was presented on 29 October 2003, environmental and consumer campaigners were furious. “It is a mere shadow of plans drafted earlier this year as it has been watered down to suit many unjustified industry demands,” a coalition of environmental groups said in a joint statement.[45] The combined pressures from the chemical industry, EU Heads of States, the US government, DG Enterprise, the employers’ organisations and other lobby groups, some trade unions and other groups had made the Commission retreat. “Industry lobbying was obviously absolutely crucial, and let’s not kid ourselves,” confided an anonymous EU diplomat, “German industry lobbying was really crucial. German industry is one of those sacred cows to the EU and, like French farmers, is not to be sacrificed”.[46]

Indeed, the new text reduces the scope of REACH, which will only ensure now an appropriate safety assessment for about 10% of existing chemicals, and will leave most chemicals entering the EU via consumer products largely untouched.[47] Transparency is also reduced by extending industry confidentiality rights and reducing the info available to the public. Industry, according to the changed proposal, would have 11 years to register some 30,000 substances, but the data that they would have to provide are much more basic than the 2001 White Paper had suggested. “The United States has got 90% of what it wanted”, Stefan Scheuer of the European Environmental Bureau commented.[48]

Green groups complained that the new proposal includes a huge loophole. It will allow industry to continue production and sales of chemicals of ‘very high concern’, even if safer alternatives are available. The producer just needs to demonstrate ‘adequate control’. As groups such as Greenpeace, FoE or WWF explain, experience has shown that it is impossible to exert control over substances that are persistent or bioaccumulative and they end up finding their way to the human body and the environment sooner or later.[49] Oliver Knowles, Greenpeace Toxics campaigner, says that “unless REACH specifically requires dangerous chemicals to be substituted with safer alternatives, then this legislation will do nothing to protect either human health or the environment.”[50]

The future of REACH

REACH follows the EU’s co-decision procedure, in which the proposal has to be approved by both the Council and the European Parliament. Defenders and opponents of REACH are now focusing lobbying efforts at the European Parliament. Corporate lobbying efforts managed to delay the Parliament’s decision-making so much that the first reading could only start long after a new Parliament was elected in June 2004.[51] Two-thirds of the MEPs are newly elected, many of them from the new EU member states in Central and Eastern Europe. Few MEPs know first hand both the original REACH proposal from 2001 and the heavy hand which industry has had in the new one.

The EU Council of Ministers seems to be firmly in the grip of the competitiveness craze, having forgotten the original goals of a new chemical policy. At the last Spring Summit in April 2004, EU governments agreed to test all new EU legislation on its impact on business.[52] REACH and the EU climate policies are top candidates for being re-assessed and further adapted to industry interests.

As for the new European Commission which took office in November 2004, it has made clear that the Lisbon competitiveness strategy is the main priority. Commission President Barroso was heavily criticised by green and social democratic MEPs, trade unions and civil society campaigners when he unveiled his economic blueprint on February 2nd 2005. The plans leave no doubt that Barroso intends to downgrade the social and environmental aspects of the Lisbon agenda and of EU policy-making in general.[53] Trying to dismiss critics, he later explained that “it is as if I have three children – the economy, our social agenda and the environment. Like any modern father, if one of my children is sick, I am ready to drop everything and focus on him until he is back to health … but it does not mean I love the others any less”.[54]

Flawed Business Impact Assessment

After the Draft REACH proposal was presented in October 2003, there was a flood of reports containing widely diverging estimates of implementation costs of REACH. The Commission itself presented an Extended Impact Assessment in which they estimated the costs of REACH for companies to be some 2.3 billion euros over an 11 year transition period (0.04 % of the yearly turnover of the European chemical industry).[55] Considerable benefits for business were also foreseen, in the form of health costs savings, improved worker safety, as well as enhanced innovation and competitiveness. This sparked heavy industry lobbying, which in March 2004 prompted the Commission to sign a Memorandum of Understanding with CEFIC and UNICE.[56] The Commission and industry agreed to jointly collect case studies with factual evidence on how REACH would impact business. To secure support for this business impact assessment, they established a working group involving various stakeholders. The consultancy firm KPMG was commissioned by industry to undertake the work, with a focus on the innovation impacts. In July 2004, WWF and the European Environmental Bureau (EEB), two of the members of this working group, withdrew their support. The groups complain that “the mistakes of previous studies conducted by industry are being repeated”.[57]

Despite evidence that the costs of implementing REACH will not cause any major problems, the Business Impact Assessment (BIA) expected in April 2005 may end up playing a major role in the final stage of decision-making on REACH. It may also lead to a further delay. This became clear during the European Parliament hearing on REACH in January 2005, where 1,000 NGO and business representatives, consumers, scientists, decision-makers and others presented their views. MEPs like Hartmut Nassauer (Industry Committee) and Guido Sacconi (Environment Committee) expressed doubts about proceeding with the first reading of the REACH proposal if the Commission may still make major changes to that proposal depending on the outcome of the impact assessment. Industry Commissioner Günter Verheugen commented that the Commission “will consider changes based on the results of the impact assessment studies.”[58] In its own report of the hearing, CEFIC highlighted how Verheugen had stressed the need to be “very attentive” regarding the problems of the industry and how he had confirmed that the Commission would be open towards all new proposals on how to make REACH workable.[59] Yet, in his response to Green MEP Caroline Lucas, Verheugen had admitted that the business impact work being done for the Commission is indeed driven by the industry, that the work has been launched by the previous Commission and that personally he does not agree. According to Verheugen the work should be based on a methodology that all parties can agree with.[60] European Commission officials, Joe Delbeke, Director at DG environment and Patrick Hennessy, Director at DG Enterprise, tried to soothe concerns affirming that the text would be neither withdrawn nor formally modified before the end of the Parliament’s first reading.[61]

What REACH Will Really Cost

WWF and EEB pointed out in a number of submissions to the impact assessment working group that the KPMG study method lacks transparency, is inconsistent and imbalanced, and has a clear focus on business risks as opposed to opportunities. The environmental organisations argued that the study is not about innovation as was agreed with the Commission, and that they were denied access to raw data. KPMG refused to change course, causing the civil society groups to conclude that “we do not believe that the study – the results of which are expected in April – will produce new insights in order to improve REACH so as to increase benefits AND reduce costs.”[62]

WWF and EEB also referred to the more than 30 national and international assessments of the likely business and societal impacts of REACH. In October 2004 the Dutch EU presidency presented an overview study of 36 impact assessments, showing a broad consensus on the direct costs.[63] Industry-sponsored studies are criticised for turning a blind eye to the economic benefits of REACH and for being obsessed by the idea that the production of many chemicals would cease due to registration costs. Industry claims that this would create massive additional costs for chemical users further down the value chain. The European Commission and the Nordic Council of Environment Ministers estimate these additional costs to be on roughly the same scale as the direct registration costs, while the studies commissioned by industry magnify additional costs as being up to 650 times the direct costs. These figures are then converted directly into figures for job losses.

Another report, issued by ING Financial Markets in October 2004, considers the Commission’s own estimates of 2.3 billion cost over 11 years as “being the best available”.[64] Putting the implementation costs into context, the report compares this figure to the industry turnover in that same period (around 5,000 billion euro), The report concludes that “the estimated costs (EU estimate) do not represent a structural problem for the chemicals industry”.

Pulling the last teeth out of REACH?

Despite their successes in weakening REACH, UNICE and CEFIC have by no means relaxed their campaign. The new business lobby buzzword heard in the corridors of the Parliament and Commission is now ‘imbalanced risk based prioritisation’. On January 17th, on the eve of the Parliament hearing on REACH, UNICE launched its new position. Camouflaged with declarations of support for a workable regulation of chemicals, their main demand is ‘risk based prioritisation’, meaning that the registration of a chemical will depend on the risk it poses rather than its hazardous properties (whether it, for example, is carcinogenic or toxic to reproduction).[65] Five green groups (EEB, Greenpeace, FoEE, WWF and the European Environment Network (of the European Public Health Alliance) reacted in a common statement: “UNICE proposes a flawed and irresponsible self-regulatory approach: that industry should alone estimate whether there might be a risk based on minimum information requirements”.[66]

At the Parliament’s REACH Hearing on 19 January, Stephan Scheuer from the EEB opposed the industry proposals for ‘risk based prioritisation’: “Industry basically wants self-regulation. We cannot accept that. This would not lead to a system where 30 000 chemicals would be registered after 11 years, and we would go back to the old system where the public and the authorities are responsible for proving the guilt of a chemical.” CEFIC’s director general Alain Perroy insisted that “without risk-based prioritisation, the REACH process would be just overloaded. It would generate a lot of bureaucratic activities with little added value”.[67]

Although parliamentary support for risk prioritisation is still undecided, there seems to be a shift towards industry positions. MEP Hartmut Nassauer, examining REACH for the internal market committee, thinks that ‘risk based prioritisation’ will be accepted. “Otherwise a small quantity of chemical will not be able to be produced profitably,” he argues.[68] Influential Christian-Democrat MEP Karl Heinz Florenz, who chairs the Committee for the Environment, also supports the industry approach. But Socialist MEP Guido Sacconi, examining the proposal for the Environmental Committee, rejects the proposal, “This is just trying to reduce the number of chemicals registered. We must remember that the long term objective is to include all the 100,000 chemicals that we don’t know about in this system.”[69]

As it stands now, there is a serious risk that REACH will get further weakened during the last phases of the legislative process, which can take until late 2005 or well into 2006. One by one, industry hopes to remove those features of the proposal that they consider most threatening for their short-term interests. Among lobbying consultants, this strategy is called “the dentist”: if a company or lobby group dislikes proposed legislation, it will try to “pull out the worst teeth” first and come back for the rest later.[70]

Lobbying Consultants Addicted to Secrecy

It is virtually impossible to estimate how much industry has invested in dismantling the original REACH proposal over the last four years, directly and through trade associations, PR firms, contributions to think tanks and other various means. Clearly they have by far outspent those who are defending environment and health protection. Financial power, the REACH experience shows, enables corporations to exert an undue, excessive and illegitimate influence over EU policy-making.

To get a clearer picture of how much industry has spent on obstructing REACH, Corporate Europe Observatory (CEO) wrote to 35 Brussels-based public affairs companies that are offering services to the chemical industry.[71] The list of firms includes Hill and Knowlton, Edelman, Burson-Marsteller and the rest of the top-10 global PR giants.[72] We asked them for “an overview of the clients for which your firm in the last 12 months has provided PA/PR services on the proposed EU system for Registration, Evaluation, Authorisation of Chemicals (REACH), the relevant budget and towards which EU institutions the efforts were directed.” The request was first e-mailed, followed by a reminder by fax a week later. A month later, only three out of the 35 firms had replied.[73] Metzdorff & Associates responded that they had not conducted any work for any client on REACH, A.T. Kearney responded that the questions did not apply to the type of services they provide, whereas Single Market Ventures explained they are not a public relations or lobby firm, but only do analysis and research. None of the other firms bothered to reply.

The willingness of Brussels-based public affairs firms to provide transparency about who they are lobbying for is clearly non-existing. There is an obvious need for lobbying disclosure legislation, which would oblige firms to report on lobbying activities, including issues and aims, clients and budgets, meetings and correspondence with officials. Reporting obligations would not make an end to the inequality in financial means, but it would allow the general public access to key information needed to facilitate more effective public scrutiny of EU decision-making.

Lessons from the REACH drama?

Lobbying in EU capital Brussels is often described as being softer and more consensus-seeking than the often very aggressive approaches that are common practice in Washington D.C.[74] While there are obviously differences, the REACH battle is yet another example that the gap is narrowing fast. Not only are controversial US lobbying and PR techniques getting increasingly popular in Brussels[75], industry is also increasingly choosing for aggressive counter-campaigning, including threats of relocation and other scare mongering. Lobbying consultants describe this as “the gunship strategy”. The shift to the right in many EU governments and the growing obsession with the Lisbon Agenda and its strategy of economic growth through international competitiveness have provided a very fertile ground for these tactics.

The lobbying battle around REACH is an example of deeply irresponsible and reactionary lobbying by industry. This scandal happens despite the fact that large chemical companies continue to be among the most vocal claiming their commitment to social corporate responsibility (CSR), as a visit to their website will show. The behaviour of these corporations in the decision-making around REACH reveals a very different reality.

The role of trade associations, such as CEFIC or UNICE, has been a crucial factor in the battle around REACH. A recent report by the Halifax Bank of Scotland (HBOS), titled Insight Investment, polled 22 chemical companies to find out how REACH would impact on them financially (including BASF, Bayer, BOC Group and ICI). The report concluded that “most seem not to be in a position to estimate the likely financial impact of REACH on their business though many expresses confidence that the impact would not be material – in stark contrast to the statements being made by some of their own industry associations.”[76]

BASF is probably the one European company that has most aggressively fought against REACH. This is in stark and provoking contradiction with its self-proclaimed commitment to sustainability.[77] BASF is one the many transnational corporations that have signed up to the Global Compact, the UN’s non-binding ethical principles. The company’s lobbying efforts on REACH violate the Compact’s principles, which includes “support a precautionary approach to environmental challenges”. Many other large corporations that are complicit in the scandalous anti-REACH lobbying are less visible, as they can easily hide behind lobby groups and trade associations. Companies involved directly, such as BASF, or indirectly via industry associations, must be held accountable for their increasingly successful attempts to obstruct the only real possibility of improving the dangerous vacuum around chemicals regulation in Europe for many years.

Notes

REACH creates a single system for existing and new substances, replacing some 40 pieces of legislation currently in force.
Current legislation distinguishes between so-called existing substances and new substances. Existing substances have been put on the market before 1981, and account for ca. 99% of total market volume. 100,106 existing chemicals are registered, however, the exact number of existing chemicals put on the market is not known, as there are no reporting requirements for production volumes below 10 tonnes per year and manufacturer. Above 10 tonnes, around 10,000 substances are marketed. New substances were first put on the market after 1981. They currently amount to around 2700 chemicals, ca. 1% of total market volume.” Source: European Parliament, Committee on the Environment, Public Health and Consumer Policy, 2001/2118(COS) 24 July 2001, DRAFT REPORT on the Commission White Paper on Strategy for a future Chemicals Policy (COM(2001) 88 – C5-0258/2001 – 2001/2118(COS)).
“New Chemicals Policy in the EU – Good or Bad for Companies? International Chemical Secretariat. May 2003. See also Swedish Society for the Conservation of Nature website.
“More than 350 chemicals that are harmful to nature have been found in breast milk. PCBs, brominated fire retardants and dioxins are present in all of our common foods. Long-lived substances that have never been used in the Arctic are found in the blood and fat of polar bears. In nine out of ten cases we do not know what harm this will cause, as knowledge of the effects of chemicals is extremely limited. But the lessons that we have learnt (PCBs, DDT, freons, heavy metals, …) are frightening. From: New Chemicals Policy in the EU – Good or Bad for Companies? By the International Chemical Secretariat. May 2003.
See for instance: “Chemicals Beyond Control. Ensuring EU Chemicals Policy Protects Human Health and the Environment. September 2004. Greenpeace International, Chemical Reaction (c/o EEB), EPHA Environmental Network, Friends of the Earth Europe.
Beginners guide to REACH (The new European chemicals regulation), 31 October 2003, Greenpeace.
CEFIC consists of national chemical associations of 25 European countries, some 30 corporate members (including giants such as BP, Bayer, BASF, Dow, DuPont, ExxonMobil, Novartis, Shell, Solvay, Total or Unilever) and about 500 business members. See CEFIC website.
REACH – The Only Planet Guide to the Secrets of Chemicals Policy in the EU. What Happened and Why? Brussels, April 2004. Published by: Inger Schörling, Member of the Greens/European Free Alliance in the European Parliament. Written by Gunnar Lind.
Part One and Part Two.
This highly recommendable publication offers a clarifying and comprehensive account of the battle around REACH, including the corporate campaigns and the interventions of other actors such as the US government and some EU Head of States. Much information of this article is taken from this publication.
CEFIC director-general Alain Perroy in letter to MEPs, 12 November 2001. Quoted from The Private Life of Public Affairs, Simon Caulkin and Joanna Collins, Green Alliance, August 2003.
Tirouflet was CEFIC President between June 2000 and June 2002. He was succeeded by Eggert Voscherau of BASF, who was CEFIC President from June 2002 – June 2004. The current President is Peter Elverding, of Royal DSM.
The draft report, which was to be voted on first by the Environment Committee and later in the plenary, was named after Inger Schörling, the European Parliament’s rapporteur for the REACH dossier.
REACH – The Only Planet Guide to the Secrets of Chemicals Policy in the EU. What Happened and Why? Brussels, April 2004. By Inger Schörling. Refer to note 8 for URL.
2m jobs ‘at risk’ in chemicals sector, The Guardian, 15 July 2004.
The aim of the Lisbon Agenda is to make “the European economy the most competitive and dynamic knowledge-based economy in the world, capable of sustainable economic growth with more and better jobs and greater social cohesion”.
“Chemicals Industry Wants EU Commission To Scale Back Plan to Overhaul Regulation”, Chemical Regulation Reporter, Volume 27 Number 29, July 21 2003.
“Firms urge EU presidency move on chemicals proposals”, Irish Independent, August 14 2003.
REACH – The Only Planet Guide to the Secrets of Chemicals Policy in the EU. What Happened and Why? Brussels, April 2004. By Inger Schörling. Refer to note 8 for URL.
REACH – The Only Planet Guide to the Secrets of Chemicals Policy in the EU. What Happened and Why? Brussels, April 2004. By Inger Schörling. Refer to note 8 for URL.
Arthur D. Little, Economic effects of the EU Substances Policy, 18 December 2002.
Ibid.
Methodological problems of assessing the economic impacts of EU chemicals policy: Summary results of the conference of experts, German Federal Environment Agency, 6 February 2003.
The Likely Impact of Future European Legislation in the Area of Chemical Substances, April 2003, Mercer Management Consulting study commissioned by the UIC (Union des Industries Chimiques), the French Ministry of Ecology and Sustainable Development, and the French Ministry of the Economy, Finance and Industry.
Arthur D. Little, Supplement to the Report on the BDI Research Project, 3 August 2003.
Pearce e.a. (2003) referred to in EEB and WWF, Business Impact Assessments and the work by KPMG for UNICE and CEFIC, January 2005.
UNICE Secretary General Philippe de Buck speaking at a UNICE press conference on 17 January 2005.
Chemical Regulation Reporter, Volume 26 Number 45, November 18, 2002.
Ibid.
“Chemical Warfare”, EuroBusiness, August-September 2003.
DG Enterprise and Industry, Contributions Stakeholder consultation, 7 May – 10 July 2004.
REACH – The Only Planet Guide to the Secrets of Chemicals Policy in the EU. What Happened and Why? Brussels, April 2004. By Inger Schörling. Refer to note 8 for URL.
“European Commission Issues Proposal For Chemical Regulations After Compromise”, Chemical Regulation Reporter, Volume 27 Number 43, November 3 2003.
Letter dated 19 July 2004, from Yvon Slingenberg, Deputy Head of Unit C3, DG Environment.
The Commission states that there is no comprehensive list of such meetings, and as “According to the Regulation, the Commission is only required to give access to existing documents… your request cannot be answered positively”. Letter dated 19 July 2004, from Yvon Slingenberg, Deputy Head of Unit C3, DG Environment.
Ibid.
US government officials are actively promoting the “more business-friendly regulatory analyses” of the Bush Administration, for instance in meetings with EU officials. “It’s very important for the United States to promote a cost-effective approach to regulation not only in this country but also in other nations”, explains John Graham, administrator of the Office of Information and Regulatory Affairs in the White House. “White House Touts Approaches on Cost, Risk Analyses in Talks With EU Officials”, Chemical Regulation Reporter, February 7 2005.
United States House of Representatives Committee on Government Reform – Minority Staff Special Investigations Division, 1 April 2004. A special interest case study: The chemical industry, the Bush Administration, and European efforts to regulate chemicals, prepared for rep. Henry A. Waxman.
“European Commission’s REACH Proposal Comes Under Fire From Bush Administration”, Chemical Regulation Reporter, Volume 27 Number 28, July 14, 2003.
“Powell in chemical reaction as US resists EU pollution drive”, The Independent, 28 November 2004.
“EU chemicals law causes stink”, by Gareth Harding, UPI Chief European correspondent, Brussels, 30 September 2003.
“US REACH-bashing gets short shrift from Congress”, by Roger Falk, European Voice, Vol 10 No 13, 15 April 2004.
Joint letter (EEB, Friends of the Earth and Greenpeace) to Commissioners Wallstrom, Lamy and Rehn about attempts by the US and other governments to use the World Trade Organisation (WTO) to undermine REACH, 26 July 2004.
Greg Lebedev, President and CEO of the ACC, Chemistry Means Business, keynote address for Pittsburgh Chemical Day, Pittsburgh, Pennsylvania, 11 May 2004.
Tony Blair, Jacques Chirac and Gerhard Schröder, Letter to European Commission President Romano Prodi, Berlin, September 20, 2003.
Green policy: just add water, by Andrew Osborn, 5 November 2003, The Guardian.
“European Commission Issues Proposal For Chemical Regulations After Compromise”, Chemical Regulation Reporter, Volume 27 Number 43, November 3 2003.
Green policy: just add water, by Andrew Osborn, 5 November 2003, The Guardian.
EEB Position on Commission proposal for a Regulation on REACH, 10 Dec 2003.
“EU chemicals law causes stink”, by Gareth Harding, UPI Chief European correspondent, Brussels, 30 September 2003.
See for instance Beginners guide to REACH (The new European chemicals regulation), 31 October 2003, Greenpeace.
European Commission puts chemical producers’ interests before public health and environment, Greenpeace, 29 October 2003.
The Industry and the Legal Affairs Committees in the parliament unsuccessfully challenged the leading role of the Environment Committee, but the row caused enough delay to pass the dossier on to the newly elected Parliament.
See Competing Ourselves to Death?, Corporate Europe Observatory, April 2003.
“The European Commission president tells George Parker and Andrew Gowers that he detects a ‘new sense of urgency’ about the need to deliver economic reforms”, Financial Times, February 2 2005.
Lisbon ‘relaunch’ sparks fierce debate, EUobserver, 2 February 2005, by Richard Carter.
EEB and WWF, Business Impact Assessments and the work by KPMG for UNICE and CEFIC, January 2005.
Memorandum of Understanding between the European Commission side (DG Enterprise and DG Environment) and industry (UNICE/CEFIC) to Undertake Further Work Concerning the Impact Assessment of REACH, 3 March 2004.
EEB and WWF, Business Impact Assessments and the work by KPMG for UNICE and CEFIC, January 2005. In the explanatory statement for their withdrew of the process, they state that representatives of trade-unions, consumer NGOs and Commission consultants in the Working Group have also expressed concerns about the credibility of the anticipated results.
European Parliament, Verbatim report of joint public hearing “The new REACH legislation”, Wednesday, 19 January 2005.
CEFIC website, Public hearing on REACH paves the way for parliamentary debate, 4 February 2005.
European Parliament, Verbatim report of joint public hearing “The new REACH legislation”, Wednesday, 19 January 2005.
European Parliament, How to make REACH more workable: many experts in search of answer, 20 January 2005.
EEB and WWF, Business Impact Assessments and the work by KPMG for UNICE and CEFIC, January 2005.
Witmond, B., S. Groot, W. Groen, and E. Dönszelmann, The impact of REACH: Overview of 36 studies on the impact of the new EU chemicals policy on society and business. October 2004, Ecorys and OpdenKamp Adviesgroep for Dutch Presidency: The Hague, Netherlands.
Pan European Chemicals, report by ING Financial Markets issued in October 2004, as quoted in REACH no threat to chemical industry predict financial market experts,17 January 2005, WWF Detox campaign website.
Currently the Commission proposal prioritises the more than 50,000 chemicals that will require testing in order to be authorized based on volume as well as special consideration to CMRs (cancerous, mutagenic and reproductive substances) and PBTs (persistent bioaccumulative toxic substances).
UNICE, An EU industry recommendation to improve the efficiency and workability of REACH, Brussels, 17 January 2005.
UNICE in Bid to Wreck REACH, Brussels, 17 January 2005, EEB, European Environment Network (of the European Public Health Alliance), Greenpeace, Friends of the Earth Europe, and WWF.
European Parliament, Verbatim report of joint public hearing “The new REACH legislation”, Wednesday, 19 January 2005.
Anna McLauchlin, “Industry’s message to MEPs: ‘REACH must not cripple us'”, European Voice, vol.11, n.1, 13 January 2005.
Ibid.
At a training course on lobbying in Brussels in 2004, Chrissie Kimmons from the lobbying consultancy Kimmons & Kimmons, ‘the dentist’ was presented as one of wide range of possible lobbying strategies which industry uses depending on the circumstances.
All of these firms are listed in the European Public Affairs Directory 2004 as specialising in EU public affairs and “chemical industry” being among their “sectors of activity. European Public Affairs Directory 2004, Landmarks Publishing.
The list of firms approached is: Hill & Knowlton, Interel (Ketchum), Edelman, Kreab, Weber Shandwick Adamson, Burson Marsteller, GPC, APCO, Gplus Europe, EPPA, Global Europe Consulting, Fleishman-Hillard, Incepta, PR Force, Porter Novelli, Ogilvy, Blueprint, ERM, Value Added Europe, Single Market Ventures, Russel Reynolds, PRM European Lobbyists, Nicholas Phillips Associates, Metzdorff & Associates, Logos Public Affairs, Icoda, European Research & Communication, Euroc, Euro RSCG Corporate, Enhesa, Business Environment Europe, C.B. Europa, DLA Upstream, Clan Public Affairs, Cabinet Steward, and A.T. Kerney.
Responses by email on file with Corporate Europe Observatory (CEO).
See for instance EU and US approaches to lobbying, Euractiv.com, 1 March 2005.
See for instance: Corporate Europe Observatory, House of Mirrors; House of Mirrors Burson-Marsteller Brussels lobbying for the bromine industry, January 2005.
REACH no threat to chemical industry predict financial market experts, 17 January 2005, WWF Detox campaign website.
See BASF sustainability website.

http://archive.corporateeurope.org/lobbycracy/BulldozingREACH.html

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REACH and the long arm of the chemical industry by Joseph DiGangi

Publication: Multinational Monitor
Date: Wednesday, September 1 2004

IN FEBRUARY 2001, the European Union released a plan for a sweeping reform of chemical regulatory policy. The plan, known as REACH, requires manufacturers to provide safety information about chemicals before putting them on the market, and proposes a method for restricting use of the most dangerous chemicals.

REACH was designed to address a previous European regulatory system that left the majority of chemicals out of requirements for safety data. This system resembles the current situation in the United States, where 95 percent of the chemicals in use today lack basic safety data about possible hazards to human health and the environment.
Unlike current U.S. regulations, the underlying basis of REACH is the Precautionary Principle. This principle advocates taking precautionary action when chemicals pose possible threats to human health and the environment, rather than waiting for complete scientific proof of cause and effect. This prevents damage while new information accumulates. The U.S. government does not accept the Precautionary Principle as a basis for policy. As one U.S. government official told the New York Times, “We consider it to be a mythical concept, perhaps like a unicorn.”

But REACH is no myth, and chemical companies and their political allies in Washington have reacted aggressively to subvert the European proposal.

Documents obtained from anonymous sources and through the Freedom of Information Act lay out elements of a full-fledged, closely coordinated lobby campaign to weak en REACH waged by narrow chemical industry interests and the Bush administration’s Environmental Protection Agency (EPA), State Department, Commerce Department and United States Trade Representative (USTR). By the estimates of its leading propagators, the campaign, which remains ongoing, has had some considerable success.

THE BIRTH OF REACH

In the 1980s, European Union (EU) regulations divided chemicals into two classes: existing substances and new substances marketed since 1981. Risk assessments were required for the new chemicals, but existing chemicals effectively received a “grandfathered” exemption–manufacturers of these chemicals did not have to provide any toxicity data to regulators or the public. Since existing chemicals constituted 99 percent of the chemicals in use, this system led to a situation in which there was inadequate safety information for most of the chemicals in widespread use.

In 1993, the European Union adopted the Existing Substances Regulation. This law marked 141 existing chemicals for toxicity testing, placing the burden for this process on the government. In 10 years, less than 50 of those chemicals have been examined and fewer than five have been regulated.

The ineffectiveness of chemical regulation polices spurred an EU review of the regulatory process, which began in 1998. In 2001, the EU issued a “White Paper on a Future Chemicals Policy.” In May 2003, the EU formally proposed its REACH–Registration, Evaluation and Authorization of Chemicals–policy. Registration requires companies to provide data on their products including toxicity and information about how humans or the environment might be exposed to them. This places the responsibility and cost for information about the industry’s products on the industry. Evaluation is required for chemicals produced in large amounts or chemicals that are especially toxic. One consequence of evaluation might be to ban certain uses of a chemical. The most toxic chemicals would require authorization. These chemicals could include carcinogens, mutagens, reproductive toxicants and chemicals that persist and accumulate in the environment. One consequence of authorization is an outright ban on certain chemicals in favor of safer alternatives.

The European Union estimates the direct cost of REACH to be approximately $4 billion; or less than 0.1 percent of EU chemical industry sales. The indirect costs of the proposal have been estimated at approximately $15 billion to $30 billion. Though not easily quantified, the monetary benefits of REACH have also been estimated. The European Union estimates approximately $20 billion to $50 billion in savings, taking into account only occupational health benefits. By expanding the health benefits of REACH to the general public–but not taking into account environmental benefits–the World Wildlife Fund estimates approximately $180 billion in net health benefits, over and above the costs of implementation.

GALVANIZING U.S. OPPOSITION

In February 2001, the European Union published the White Paper that described the REACH proposal. Internal documents reveal that the U.S. government began to work on REACH the same year with personnel from EPA, the State Department, the Commerce Department and USTR working with each other and with the chemical industry. From the beginning, the goal appeared to be intervening and changing REACH before the legislation became finalized.

A document drafted by Charlie Auer, director of the EPA Office of Pollution Prevention and Toxics, reveals the key role of the EPA in making and framing regulatory arguments against REACH. The paper points out that the United States does not recognize the Precautionary Principle as a principle of international law. The document also comments on the EU’s reluctance to adopt the U.S. form of voluntary regulation of chemicals, and makes clear EPA’s coordination with industry in this regard: “EPA is quite comfortable with a collaborative relationship with industry in such voluntary efforts.”

U.S. government and industry leaders began a host of meetings to coordinate their campaign against REACH. A June 14, 2001 document describes U.S. government meetings with industry and coordination among government agencies with the goal of influencing REACH in agreement with industry interests. “Staff from TD [Trade Development] and MAC [Market Access and Compliance] have met with the American Chemistry Council and the American Plastics Council and have consulted with individual chemical companies to solicit their views on the strategy and its impact on he U.S. chemicals industry and European chemicals trade. … USEU/FCS [United States Mission to the European Union] has also met with a number of U.S. chemical companies based in Europe.”

But the chemical industry complained the administration was not being responsive enough to its demands. In September 2001, Fred McEldowney of the American Chemistry Council e-mailed Stuart Keitz of the Department of Commerce, that “government officials engaged in the discussion have not viewed their role as joint partners in the search for opportunities for creating more freedom in the Atlantic marketplace. Instead, they have chosen to respond only to the specifics of industry proposals without setting forth ideas of their own.”

The U.S. government responded by attending a meeting at American Chemistry Council headquarters on January 17 and 18, 2002. Present were members of State, Commerce, EPA, USTR, EU officials and industry representatives. The group was welcomed by Bush “Pioneer” fundraiser and American Chemistry Council CEO Fred Webber, and the two-day meeting provided the chemical industry access to high-level government officials from the United States and EU.

The chemical industry pushed for greater U.S. involvement in EU policy-making, for U.S.-style risk assessment, and for no regulation of existing chemicals. The U.S. government echoed this position in a “white paper” on the EU policy: “U.S. concerns with EU chemicals proposals are related to transparency, risk assessment and mutual acceptance of existing chemicals.”

By now, the Bush administration was complaining that the U.S. chemical industry was not defending its interests sufficiently. A briefing paper for Assistant Secretary of Commerce Linda Conlin reveals the Department’s impatience with the chemical industry and its active solicitation of the industry to lobby against REACH.

The U.S. government agencies were so anxious to begin lobbying on the industry’s behalf; they did not wait for the industry’s position paper to begin the campaign. According to the Commerce Department briefing paper, “because of the slow pace of industry response to the Strategy and growing concerns about trade effects and the influence of the Strategy on international environmental programs/activities for chemicals, Commerce, USTR and EPA drafted a preliminary set of questions on the Strategy and provided them to the Commission in December. USTR also met with Commission officials at that time.”

But it wasn’t as if the industry was sitting on its hands. Lots of lobby and strategy meetings were going on. “Commerce and USTR have met with representatives from the Synthetic Organic Chemical Manufacturers Association (SOCMA), the American Chemistry Council (ACC), the American Plastics Council, ISAC 3, DuPont and Dow to identify, industry concerns,” according to the briefing paper for Conlin.

THE U.S. “NONPAPER”

The connections between the administration and chemical industry solidified with the publication of the U.S. government position, in a “nonpaper.” Curiously, the “non paper” was an undated document lacking letterhead that no government agency wanted to take credit for writing. USTR and other agencies claim that the “nonpaper” was not an “official” U.S. position, though it would be utilized in official State Department communications, and despite the fact that a nearly identical version of it appeared in the June 2002 issue of the magazine of the American Chemistry Council in an article entitled, “U.S. Government Responds to the EU Chemicals Policy.” The author was Jennifer Yoder Prescot, of the Office of the U.S. Trade Representative.

The “nonpaper” effectively replicated the viewpoint of the chemical industry as the U.S. government position. For example, the “nonpaper” asserted that REACH would reduce consumer choice due to restrictions on four toxic chemicals; acrylonitrile, propylene oxide, 1,3-butadiene, and phenol. The document quoted chemical industry cost estimates nearly word for word, claiming these restrictions would result in a loss of $8.8 billion in U.S. exports.

In fact, these figures were mostly based on the groundless assumption that U.S. computer sales to Europe would be blocked by REACH.

This financial estimate was widely quoted in press reports on the possible impact of REACH on the chemical industry.

The “nonpaper” also attacked several measures strongly opposed by the chemical industry. Like the chemical industry, the “nonpaper” attacked the substitution of safer chemicals for hazardous ones, calling it “arbitrary discrimination.” The “nonpaper” also attacked the Precautionary Principle, describing it as a way to “provide cover for politically motivated bans and other severe restrictions.”

ENTER COLIN POWELL

On March 21, 2002, Colin Powell responded to the chemical industry’s call for help by sending an “action request” cable to the U.S. embassies in EU Member States and 35 other countries. “There is a perception among industry that their views have not been heard by key policymakers,” the cable stated.

Powell’s cable outlined chemical industry concerns that REACH “would be significantly more burdensome to industry and government than current U.S. and EU regulatory approaches.” The memo outlined chemical industry arguments against the proposal and used financial estimates generated by the American Chemistry Council to make cost arguments against REACH.

Finally, Powell’s memo issued a call to action to distribute the U.S. government “nonpaper.” “Posts are requested to raise the EU chemicals policy with relevant government officials (e.g. officials from the Environment Ministry, Economics/Trade Ministry, and Foreign Affairs Ministry) and the local business community and offer the nonpaper as a brief description of USG [U.S. government] views.”

CHIPPING AWAY

A high-level meeting between U.S. and EU officials took lace December 16, 2002. Participants included European Commissioner for Enterprise and Information Erkki Lukanen, Under Secretary of Commerce Grant Aldonas, Deputy Assistant Secretary of Commerce Henry Levine and other Department of Commerce officials. A key agenda item was U.S. concerns about the White Paper.

The U.S. team invoked international trade rules in its lobbying efforts, suggesting that REACH was incompatible with the EU’s obligations under the rules of the World Trade Organization.

The proposal “must be applied in ways that are consistent with the EU’s obligations to its trading partners under the WTO,” the U.S. officials warned their EU counterparts. “The proposals could also violate the non-discrimination requirements of the WTO, and could impose more trade-restrictive measures than are necessary to accomplish the EU’s health and safety objectives.” WTO rules require countries to adopt the least-trade restrictive alternatives to achieve legitimate health objectives.

The Commerce Department briefing paper pointed to heavy U.S. industry lobbying of the Europeans on REACH. “Both sides of the Trans-Atlantic Business Dialogue Chemical Working Group have been very active in lobbying the Commission, as well as Member States, on the draft legislation.”

The briefing paper also stated that U.S. government efforts were beginning to have an effect on the EU policy. “The U.S. Government has had an ongoing dialogue with the Commission on the issue, and succeeded in getting some proposals modified to address U.S. concerns.”

GOVERNMENT-INDUSTRY COLLABORATION

An April 4, 2003 e-mail message from an official of the U.S. Trade Representative to industry trade associations and consultants reveals that Catherine Novelli, the Assistant U.S. Trade Representative for Europe and the Mediterranean, had “tasked” the chemical industry and the company Intel to develop “themes” for the U.S. government to use in opposing REACH.

According to the e-mail, “At the last meeting, Cathy had tasked the industries to come up with ‘themes’ for their concerns about the proposed legislation. The chemical industry had done a list of themes dealing with the EU process. Intel had done a list of substantive themes.” The e-mail indicates that industry representatives met with USTR officials on April 3, 2003, to present these “themes.”

According to the e-mail, USTR officials indicated that the U.S. government would convey “all the issues from the [American Chemistry Council] and Intel themes” to the European Union.

The e-mail states that the USTR officials and the industry representatives agreed that the prominence of the messenger for these themes must be elevated and discussed how to “take on” Margot Wallstrom, Commissioner for the Environment at the European Commission, who is responsible for developing the REACH proposal. “The only thing that will get the EU to stop is having the EU heavyweights come in and say that the Commission can’t take this forward until a real cost-benefit analysis is done,” asserts the e-mail. “But who will take on Wallstrom–the answer is only other Ministers or Heads of State.”

The April 4, 2003 e-mail from USTR to industry groups reveals the extent to which the administration worked with U.S. industry to create this opposition to REACH within the European Union.

The e-mail states: “It was agreed that the following Member States needed to be particularly targeted: Germany, UK, France, Italy, Netherlands and Ireland because they all have large production of chemicals and downstream products. In Italy, it will be important to get to [European Commission President Roman] Prodi. In addition, we need to get to the Swedes and Finns and neutralize their environmental arguments.”

The e-mail made specific suggestions for companies that should be enlisted in this effort. As part of the effort to “neutralize” Sweden and Finland, the e-mail states, “it was agreed that the electronics industry would see if Nokia and Ericsson might be helpful, although it was noted that neither manufacture in Europe anymore. It was then suggested that Volvo (and Saab) might be helpful, as well as the paper industry, with its huge papermaking operations in Scandinavia.”

The e-mail from USTR even made specific assignments to companies and industry groups. According to the e-mail “The following industry reps agreed to coordinate comments for particular countries (note: this does not mean that they intended to do all the work, but just to coordinate, so we know the full extent of our efforts): Bill Primosch (NAM [National Association of Manufacturers])–Italy and UK; Patricia Sherman (Siemens)–Germany; Robbins Pancake (Agilent)–France; Steve Harper (Intel)–Ireland; Jason Linnell (EIA [Electronics Industries Alliance])–Sweden.”

POWELL REDUX

On April 29, 2003, just several days before REACH was released for public comment, Colin Powell sent a cable on a “priority” basis to diplomatic posts in European Union nations. The cable repeated industry objections to REACH and urged U.S. government agencies “to reiterate to the European Commission and EU Member States our general concerns before the Commission finalizes its formal proposal in early May.

Powell’s talking points included objections to the Precautionary Principle, REACH’s “complex regulatory approach,” and its overly broad focus on “tens of thousands of chemicals.” In its place, the State Department memo proposed the industry-favored U.S.-style, regulatory system as one where “environmentally sound management of chemicals can be achieved through approaches that better balance risk and economic considerations.”

The language in Secretary Powell’s cable closely tracked the industry “themes” summarized in the April 4, 2003 e-mail from USTR. For example, an industry theme highlighted in the April 4 e-mail was that “REACH will work to stifle innovation and the introduction of new safer chemicals.” Powell’s cable stated, “These compliance costs may negatively impact renovation and EU develop merit of new, more effective, and safer chemicals and downstream products.”

In total, the April 4 e-mail indicates that there were 11 themes that the industry wanted U.S. officials to pursue. All 11 of these themes are reflected in Secretary Powell’s cable.

WATERING DOWN REACH

The extensive U.S. efforts had an impact on the REACH proposal. The draft REACH proposal was released in February 2001. Over two years later, on October 29, 2003, the European Union released a final proposal, which was watered down in response to the concerns raised by the industry and the U.S. government.

For example, Powell’s April 29 cable had advocated “the exclusion or more limited treatment of certain low risk types of chemicals–such as certain polymers and intermediates where exposure is negligible–and most constituents of articles.” The final REACH proposal was revised to exempt polymers from registration, and the requirements for chemical substances in articles were relaxed. Additionally, the European Commission announced that it would present a new impact assessment as advocated by the Bush administration.

The U.S. lobbying efforts also appeared to succeed in building opposition within the European Union. In April 2003, a USTR e mail had discussed the importance of getting the “EU heavyweights”–ministers or heads of state–to “take on” the European Commission and “say that the Commission can’t take this forward until a real cost-benefit analysis is done.” Five months later, in September 2003, the leaders of the United Kingdom, France and Germany wrote to the President of the European Commission to express concern about REACH and request additional analysis and an assessment of the effects on industry.

The net effect of the changes was a significantly weaker proposal.

For its part, the American Chemistry Council acknowledged that the “major intervention by the U.S. government” resulted in “significant concessions” in REACH. “ACC rallied opposition to the draft proposal,” brags the trade association’s 2003 annual report, “including a major intervention by the U.S. government, and ACC actively supported the European industry’s advocacy efforts with the leaders of Britain, France and Germany, and many Southeast Asian nations. These efforts helped to build an aggressive position worldwide, and brought about significant concessions in the draft now being considered by the European parliament.”

NEVER ENOUGH

But the industry and its Bush administration allies were still not satisfied. In early January 2004, the administration produced a new internal analysis of REACH that called for further watering down of the proposal, including by excluding more chemicals from its purview.

The U.S. position echoed chemical industry calls to guarantee that “useful” chemicals remain in commerce regardless of risk and raised doubts about whether REACH would comply with World Trade Organization rules.

The paper also signaled a new direction in U.S. lobbying: coordination by the White House Council on Environmental Quality (CEQ), which requested its preparation. Senior administration officials characterize CEQ’s chair, James Connaughton, as “the architect of the administration’s environmental policy.” Connaughton is a former corporate lobbyist and attorney with clients that included General Electric, Asarco and the Chemical Manufacturers Association (currently called the American Chemistry Council).

In the spring of 2004, the aggressive administration-industry lobbying campaign to undermine REACH caught the attention of the Congress. The House Committee on Government Reform-Minority Staff Special Investigations Division produced a report for Representative Henry Waxman, D-California, that outlined the administration’s efforts to weaken REACH at the behest of the U.S. chemical industry. The report described the effort as “a case study of how a well-connected special interest can reverse U.S. policy and enlist the support of numerous federal officials, including a cabinet secretary, to intervene in the environmental policies of other countries.”

The European Commission responded to the Congressional report by expressing concern over the lack of “balance” in development of U.S. policy. “We certainly are not prepared to give special attention to the demands of the U.S. chemical industry at the expense of sustainable development, the quality of the environment, our duty to protect public health or indeed other industry sectors such as downstream chemicals users whose concerns are sometimes very different,” the Commission stated.

The Bush administration opened a new front on the anti-REACH lobbying campaign by recycling a litany of criticisms in a World Trade Organization (WTO) committee. While a full WTO challenge is premature until the draft law is final (sometime in 2006), the administration launched a preemptive attack through the WTO Technical Barriers to Trade Committee.

On June 21, 2004, the Bush administration submitted comments to the committee that strongly criticized REACH as “costly, burdensome and complex,” and asserted that the proposal would disrupt global trade.

The administration’s broadside provoked a letter from Senators James Jeffords, I-Vermont, and Frank Lautenberg, D-New Jersey, to U.S. Trade Representative Robert Zoellick. They expressed concern that the U.S. position reflected only chemical industry viewpoints, “without the consideration of the broader ramifications for the U.S. economy, national interest, public health and the environment.”

Questions were raised about another key element of the lobbying effort against REACH in August 2004. One of the administration arguments against REACH is that it unnecessarily duplicates current regulatory initiatives and could even undercut these efforts. One U.S. example that the administration cites is a voluntary EPA effort called the High Production Volume (HPV) Challenge Program. This program encourages the chemical industry to test, and provide to the public safety information on, chemicals produced in large amounts. The key designer of the program was the environmental organization Environmental Defense, which collaborated with the American Chemistry Council and EPA to develop it.

As the principal creator of the HPV program, Environmental Defense took issue with the administration’s complaint about its incompatibility with REACH.

In a letter to the U.S. Trade Representative, Environmental Defense rejected the administration claim that REACH would undercut the HPV program, since REACH requires industry to provide information on chemicals–the same aim as HPV. Environmental Defense endorsed REACH’s more stringent requirements, and suggested that “most concerns raised by the U.S. government regarding REACH continue to be comprised of assertions that are either unsubstantiated generalities or factually erroneous (or both).”

The erosion of White House credibility on REACH has been somewhat contained by support from an unexpected source; an important Member of the European Parliament. The new chair of the European Parliament Environment Committee, Karl-Heinz Florenz declared in September that REACH should take U.S. policies into account.

“I think it’s important to have a regulation that is consistent with other major parts of the world, such as the USA,” Florenz told Environment Daily. Florenz’s committee will play a key role in guiding the fate of REACH in the Parliament.

Florenz’s comments make clear that the compelling evidence of REACH’s benefits will not by itself be enough to protect the environmental and public health initiative. The raw political power of the chemical industry and its U.S. governmental allies, as well as its friends in European governments, stands as an ongoing threat to the REACH approach of precautionary-based protection of public health.

Joseph DiGangi works with the Environmental Health Fund and is the author of the September 2003 report, “U.S. Intervention in EU Chemical Policy.”

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European Union REACH

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The Conclusion

XI. THE EXCLUSION OF THE PUBLIC

While the chemical industry had extensive access to federal policymakers, the public was largely shut out. Although USTR held two small meetings for public interest nongovernmental organizations, the concerns of these groups appear never to have been seriously considered. On November 11, 2002, more than 50 public health professionals, labor unions, children’s health advocates, environmental organizations, and community groups wrote to President Bush to express their concerns about the U.S. efforts to undermine proposed reforms of the European Union chemicals policy.

The letter stated:

We urge the U.S. government to recognize the potential benefits to American consumers and businesses and cease all efforts to undermine EU chemicals policy reforms. . . . The [U.S. position] runs counter to the public interest and to the transparency that is critical to our democracy. For this reason, we request that the Administration, through the U.S. Environmental Protection Agency, the U.S. Trade Representative, Commerce Department, and State Department, solicit public comments from the American people — including but not limited to NGOs and business — to formulate a forward looking position on chemicals policy and prepare for new economic realities of the 21st century.54

On September 9, 2003, more than 70 public health professionals, physicians, nurses, children’s health advocates, environmental organizations, and community groups again wrote to the President to urge the Administration to discontinue efforts to oppose REACH and constructively engage in efforts to protect public health. The letter states:

We request that you instruct key officials within your administration to stop using federal funds to undermine this important proposed legislation, and seek ways to support progressive reform of chemicals policy that benefit public health.55

These individuals and groups never received a response from the President.

The International Herald Tribune reported on May 8, 2003, that at public meetings the Commerce Department and industry groups would discuss their opposition to REACH.56 Similarly, William Lash, Assistant Secretary of Commerce for Market Access and Compliance, told the trade press that the Commerce Department was planning a series of town meetings around the country to prepare U.S. companies to comment on the European policy.57 But when public interest organizations inquired about the meetings and the possibility of participating, Commerce Department officials provided vague, unresponsive answers. 58 Ultimately, the public meetings appear to have been cancelled. Environmental groups such as the Environmental Health Fund that closely followed the development of the REACH initiative are not aware of any public meetings held to offer the public a chance to comment on the proposal.59

There also does not appear to have been any independent analysis of the REACH proposal or its environmental or economic impacts conducted by the Administration. None of the documents obtained by the Environmental Health Fund since April 2001 under the Freedom of Information Act or from other sources indicate that government scientists or other experts independent from the chemical industry were ever called upon to analyze the REACH proposal.60

XII. CONCLUSION

Taken together, the documents described in this report provide a case study of how a well-connected special interest can reverse U.S. policy and enlist the support of numerous federal officials, including a cabinet secretary, to intervene in the environmental policies of other countries. Under President Clinton, the United States adopted a policy of recognizing the authority of other nations to act
to protect their public health and environment. At the urging of the chemical industry, however, the Bush Administration reversed this policy and actively opposed European Union efforts to improve the regulatory system for chemicals. The Administration’s opposition to the initiative was extensive, involving multiple government agencies, cables from Secretary of State Colin Powell, and an international lobbying strategy closely coordinated with representatives from industry. Ultimately, the European Union adopted numerous changes proposed by the Administration.
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Here’s where the entire report can be located

http://oversight.house.gov/documents/20040817125807-75305.pdf

Sorry – they have removed the report and the link is no longer accessed above. Still trying to find the other documents as well. The link I put above was to the investigation including all the documents – it’s no longer there. They removed the entire investigation from the Oversight & Government Reform site.

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