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Brussels, April 2, 2001

Conference Report

Disclaimer

Neither the European Commission, nor any person acting on its behalf, may be held responsible for the use to which information contained in this report may be put, or for any errors which, despite careful preparation and checking, may appear. The Commission has striven to summarise accurately the proceedings of the Conference. Please refer to the speeches and/or presentations provided by the speakers for more detail

Table of Contents

Executive Summary

1. Introduction

1.1. The European Commission White Paper on the Strategy for a Future Chemicals Policy

1.2. Objectives of the Stakeholders' Conference

2. Conference Proceedings

2.1. Putting the White Paper into Context.

2.2. Stakeholders Workshops

2.3. Conference Conclusions

3. Appendixes

3.1. Conference Programme (pdf ~50K)

3.2. List of Participants (pdf ~60K)

3.3. Speeches/Presentations

Executive Summary

The European Commission organised a conference to launch the new Chemicals Strategy as introduced in the White Paper for a Future Chemicals Policy and to gather input from key stakeholders on its implementation. The Conference was opened by the Commissioner for the Environment, Margot Wallström and the Commissioner for Enterprise, Erkki Liikanen.

Stakeholders gave their input during two workshops. The first workshop addressed the process and how to implement the new policy in the most cost-effective way. The second concentrated on major stakeholder contributions. This Executive Summary presents an overview of stakeholder inputs during the presentations and discussions.

- Common Views -

All stakeholders present agreed that sustainable development and the safe use of chemicals are, and should be, the main objectives of the new European chemicals policy. Stakeholders were also in agreement on the need to find a right balance of responsibilities, to make best use of and reinforce international co-ordination, and to improve communication flows. Participants all agreed that the further development of alternative testing methods was necessary to limit animal testing, and stressed and that the development of a generic rather than an individual approach to chemicals was the most realistic path to take.

All stakeholders agreed with the political objectives of the strategy, i.e. the objective of improving chemicals legislation, the foundation of risk management on sound science and risk assessment, and the search for a simple, coherent and workable system. In this context, targeted risk assessments were generally considered as an improvement. Consensus also seemed to exist on the need to use data wisely, to maximise the information obtained from the data set and to avoid duplication of tests.

Many of the stakeholders from industry and some representatives of Member States stressed the need for the new policy to maintain and enhance competitiveness, while environmental and consumer NGOs stressed the Strategy's objectives for the protection of human health and the environment and increased transparency to enable an informed choice about chemicals. Animal welfare groups emphasised the importance of the White Paper's promotion of non-animal testing.

- Diverging Views -

Some elements of the proposed strategy were judged inappropriate by certain stakeholders.

Industry and trade union representatives considered the authorisation process as unnecessary in view of the registration and evaluation steps, and would prefer a system that uses restrictions rather than authorisation. Moreover, the time schedule proposed in the White Paper is too tight, according to industry, in particular for the in-depth testing requirements and it does not take into account socio-economic consequences.

The Trade Union representative disagreed with the fact that substances should be banned solely on the basis of intrinsic properties, the policy should include assessments of risks and benefits before bans are decided, and risks of alternative options must also be considered.

The Environmental NGOs viewed the Strategy developed in the White Paper as too narrow and as catering too much to industry self-interest. As it stands, they believed that it is not adequate to protect human health and the environment.

The consumer NGO representative requested downstream liability in industry - the new chemicals policy should set out the minimum requirements for all other sectors.

Several Member States expressed concerns about the resources that would be necessary within MS authorities and within the EU Commission to implement the new strategy. Representatives from SMEs and some downstream users expressed similar concerns about the proportionately high costs that they might have to face.

Stakeholders also held diverging views on the scope for authorisation, some calling for inclusion of other categories than CMR and POPs.

Stakeholders from NGOs and from some Member States called for a prudent approach, particularly concerning testing requirements in the 1-10 tonne range because most of the in-vitro tests have yet to be developed.

- Elements needing more work, reflection and precision -

The discussions brought to light many elements that need more analysis when preparing the legislative proposals. These are listed in no particular order:

• The practical implementation of the precautionary principle
• Prioritisation and decision-trees for testing
• Public access to information, allowance for responsible choices by consumers
• Inclusion of social aspects and the human factor
• The balance of responsibilities and clarification of roles (in particular between MSs and the Commission)
• Future participation of stakeholders
• Scope for authorisation and comprehensiveness of the legislation
• The treatment of harmful substances in products, especially imported products
• Timeframe, deadlines, and time discipline
• Workload for the different actors, especially the role of downstream users
• Sanctions, incentives for compliance, and liability regime
• The impact of the policy on SMEs
• Communication flows
• Quality assurance of data and of the overall process
• Data requirements for substances marketed in quantities between 1 and 10 tonnes
• Data sharing, confidentiality, and property rights
• Risk assessment guidelines and exposure estimates
• Incentives for innovation, for substitution
• The development of alternative testing methods
• The flexibility, transparency and simplicity of the legislation
• The economic and social cost of the system to all actors (i.e. financial and human resource concerns)
• The effects of the new policy on competitiveness
• International co-ordination and compliance with international trade rules
• Horizontal and vertical policy integration
• The transition period before implementation of the new legislation

As indicated by the European Commission several times during the Conference stakeholders will be able to express their opinion during the next stages of the development of the new chemicals policy. Mr McSweeney, Director General of the Joint Research Centre, re-affirmed this when closing the Conference and insisted that due to the many outstanding questions, stakeholders must be involved further in the process, so that the future chemicals legal framework will work properly and swiftly.

Introduction

The European Commission White Paper on the Strategy for a Future Chemicals Policy

The achievement of sustainable development and the competitiveness of the European Chemical Industry and should be mutually supportive goals. To achieve this objective, the European Commission has proposed a radical overhaul to the EU's existing strategy on chemicals, as described in the European Commission's White Paper: Strategy for a Future Chemicals Policy, adopted on 13 February 2001.

The White Paper strives to balance the essential need to protect human health, and environment with the requirement to maintain and enhance innovation and the competitiveness of the EU chemical industry. It pushes for more innovative products on the market and responds to consumer desires for chemicals, which are safe for our health and environment.

The proposed EU Chemicals Strategy entails a new division of labour and responsibility between industry, Member States and the European Community. The "burden of proof" is hereinafter shifted from authorities to industry under a clear set of legal obligations with a view to ensuring a high level of protection of human health and the environment through making industry responsible for the safety of its products.

The lack of knowledge about the properties, uses, exposure, and health and environmental impacts of chemical substances across the world, particularly for the so-called "existing substances", is a major cause of concern. There are potentially 100,000 such chemicals produced and used in the EU that existed before new assessment procedures came into force in 1981 for "new" substances marketed after that date. Sufficient information is available for a very limited number of existing substances on the risks they pose to human health and the environment. It is therefore essential that the gap in knowledge between existing and new substances be closed.

The current data collection and risk assessment process for "existing" substances is cumbersome, resource intensive for Member States and therefore slow and ineffective. To better address data gathering needs, responsibility for the drawing up of chemical knowledge portfolios for existing and new substances produced in volumes exceeding identified thresholds must be allocated to industry. Authorities will evaluate data and preliminary risk assessments provided by industry in order to identify substances or uses that may be of concern and, where necessary, will be subject to restrictions or authorisation.

Risk management of chemicals in the EU needs to be improved, in particular as concerns existing substances. This should lead to safer handling of substances, and to less exposure of the public and the environment to dangerous substances, hence to better protection of the environment and human health. For substances of very high concern, risk management will be based on a system of authorising the specific uses of a substance, to be granted by authorities on the basis of risk assessments demonstrating that such uses present negligible - or in some cases acceptable - risks. For other existing substances, risk management will be based on a system of accelerated restrictions. However, the White Paper upholds that when scientific uncertainties remain on the precise nature or the magnitude of potential damage, decision-making must be based on the Precautionary Principle.

The new system will encourage substitution of dangerous by less dangerous substances where suitable alternatives exist, and will provide incentives for technical innovation and the development of safer chemicals.

The lack of publicly available knowledge for existing substances and the overall opacity of the system were identified as important deficiencies of current EU chemicals legislation. A major objective of the new chemicals strategy is to improve transparency of chemicals regulation across the EU, to increase public access to information, to provide for stakeholders' involvement in the implementation, management and review stages of the Strategy and to maintain an active role in international discussions on chemicals. In order to ensure the success of a new open and publicly accessible EU-wide chemicals policy, the European Commission has identified a variety of information channels, which must be properly developed and used at the government and industry levels, and which will increase public access to information, information transmission along the product's life-cycle, and international information exchange.

The White Paper sets the framework for legislative proposals. The Commission intends to present its proposals by the end of 2001 to the Council and the Parliament. It is intended that the new legislation will be in place well before 2005 to ensure that the ambitious deadlines of the White Paper can be maintained.

Objectives of the Stakeholders' Conference

Within this context, the European Commission organised a major stakeholder conference to gather input from key stakeholders on the new Chemicals Strategy as described in the White Paper.

The objective of the Conference was to present the strategy proposed in the White Paper and collect views and feedback from key stakeholders - e.g. regulators, scientists, industry, downstream users, environmental and consumer NGOs, animal welfare groups, as well as representatives from applicant countries - on the remaining problems, potential solutions, and the way forward. The elements of this debate will feed into the Commission's chemicals policy analysis with a view to helping the Commission develop the legislative instruments necessary for a sustainable chemicals policy which will provide for an effective balance between environmental, economic, and social objectives.

The Conference convened in Brussels on 2 April 2001 and brought together more than 150 stakeholders.

Conference Proceedings

Putting the White Paper into Context.

In the opening session, Commissioners Margot Wallström and Erkki Liikanen put the proposed chemicals strategy into context.

The text of Environment Commissioner, Margot Wallström's speech can be found here. Click here (pdf ~100K) for accompanying slides.

The text of Enterprise Commissioner, Erkki Liikanen's speech can be found here.

Stakeholders Workshops

Stakeholders provided input on the important issues pertaining to the White Paper and future policy implementation during two half-day workshops.

The first workshop addressed the REACH process and other process issues proposed in the White Paper, and focused on expectations from stakeholders regarding the REACH system and the most cost-effective way to implement the system. Each speaker had the task of focusing on one aspect of the new Chemicals Strategy. The second workshop concentrated on major stakeholder positions regarding the White Paper, their respective role and contribution to make it work.

The following section presents the key points emerging from the speakers' presentations and the subsequent debates.

Workshop I - Making it Happen: The Process

(Key Question: What is expected at each step and how do you make it happen in the most cost-effective way?)

Workshop I was chaired by Ms Elisabeth Surkovic, from the International Council of Chemical Associations (ICCA). She made the following opening remarks:

• It is essential to develop an appropriate and manageable system that inspires confidence, and is transparent and flexible.
• Given the heavy criticism of the White Paper from all sides, it is important to seek stakeholder views as much as possible during the crucial process of turning the White Paper into legislation. It is thus the role of the Stakeholders present in the meeting to make suggestions and find solutions for the problems which have been identified.
• Has sufficient thought been given to what has worked in the past and why?
• Recalling the conclusions of the 1999 Stakeholders Conference that identified a lack of political will to make regulation work, does the strategy proposed in the White Paper solve this problem?

Workshop I: Presentations

Mr Michael Balls, from the Commission's European Centre for the Validation of Alternative Methods (JRC/ECVAM), addressed the question of Data Collection. Mr Balls made the following key remarks:

• It is important to identify which chemicals involve a risk and how big the risk is. Thus regarding risk assessments, the question really comes down to how committed we are to the development of advanced testing methods to predict hazard, evaluate exposure and the subsequent risks on human health and the environment while minimising animal testing. Because it is not raw data but information that we need, we have to use data wisely to produce information and to maximise the information obtained from a set of data.
• According to the 1991 Commission Communication, ECVAM's duty is the co-ordination of the validation of alternative test methods at EU level. It must act as a focal point for information exchange on the development of alternative test methods and set-up, maintain, and manage a data-base on alternative procedures. It must promote a dialogue between legislators, industries, biomedical scientists, consumer organisations and animal welfare groups, with a view to the development, validation, and international recognition of alternative test methods. ECVAM must also participate in the expansion of the JRC's role on pre-normative research.
• Regarding animal testing, in addition to economic, logistical, ethical, legal and political reasons, there are also good scientific reasons for developing alternatives to animal tests, because these can be more directly relevant to human risk. With political and scientific will, it would only take 5 years to validate many alternative methods to laboratory animal procedures for a variety of effects, e.g. eye and skin irritation, skin sensitisation and absorption, nephrotoxicity, hepatotoxicity, neurotoxicity, blood-brain barrier, acute systemic toxicity, chemical carcinogenesis.
• ECVAM's Working Group on the Integrated Use of Alternative Methods and Strategies will reconvene soon to pursue its reflection in the framework of the emerging chemicals policy. A conference with experts and stakeholders will be organised before the end of 2001 to consider proposals of this Working Group.

[Click here (pdf ~800K) for presentation]

Mr Wolf-Rüdiger Bias, from BASF, addressed the issue of Registration. Mr Bias made the following key remarks:

• The registration process increases transparency and offers greater information access to the public and all actors involved in handling chemicals.
• In view of the high number of chemicals and high number of actors (e.g. estimated 36,000 SMEs), the registration process must be structured efficiently and industry must be willing to contribute to this. The chemical industry insists that registration is not a one step process and proposes to submit a "basics" screening information set - which would serve as a starting point - consisting of: physical and chemical properties, acute oral toxicity, irritation / corrosiveness, Ames test, degradability, and aquatic toxicity to fish and daphnia. The data generation and gathering of the "basics" data set could be completed within 5 years from entry into force of the legislation. The central entity would then assemble the data and eliminate duplicates. Authorities and industry would have to work together to determine the information that is still necessary in order to estimate possible risks. The outstanding information (exposure-oriented testing, risk estimates, proposed risk management) would then be completed 18 years after entry into force of the legislation. A rigid time schedule for all actors involved in meeting obligations regarding registration, evaluation and decision making is essential for success. No production, marketing and use should be allowed if compliance and time frames are not met.
• The intended use of the chemical should determine the level of knowledge necessary for that particular chemical or substance. In this context, downstream users need to be involved in the process to provide information on uses not intended by the manufacturer or importer, which are often niche uses.
• Data sharing between competitors should be based on mutual agreement.

[Click here (pdf ~50K) for presentation]

Mr Reiner Arndt, from the German Institute for Occupational Safety and Health, addressed the REACH system, in particular the Evaluation phase. Mr Arndt made the following key remarks:

• Quality control of registration is needed. This could be organised through a certification scheme for people making notifications. Authorities cannot control everything since Member States do not have enough staff to guarantee quality.
• Evaluation is the core activity in the REACH system and has to be combined with the authorisation phase.
• The evaluation phase must target priority chemicals. The advisory task force proposed in the White Paper should start as soon as possible after the June 2001 Environment Council and work on prioritising. Exposures should be looked at for priority setting, as well as expected risks, in particular the focus should be on High Expected Regulatory Outcome chemicals (HEROs) where one expects that new information will identify risks not previously addressed or known.
• Downstream users (in particular SMEs) have responsibilities in the evaluation phase. Although the testing of chemicals should be carried out by manufacturers, downstream users should help pay a portion of the costs.
• Authorities have a responsibility regarding the confidentiality of data, in particular on new ideas and uses.
• Member State authorities will have to decide about additional testing for certain chemicals above 1t and below 10t. For chemicals below 10t, information on sensitising properties is necessary.
• For chemicals above 10t, all the base set data must be available as a minimum for hazard-based classification and labelling. Additional testing above 10 t will be based on proposals from industry, approved by authorities.
• There is a need for clear guidance to industry on how to do evaluations above 100 t and more testing facilities will be required for the in-depth testing. Quality control of industry evaluations is necessary.
• It is important to set interim deadlines for industry, to avoid peaks in the system. Governments should also have deadlines.
• On authorisation, PBT should be defined and added into the scope for authorisation, as well as highly potent, sensitising and chronic toxic substances. Exemptions should be restricted to intermediates. The restriction system has to be flexible, thus unacceptable uses identified in the evaluation should be banned, as well as unknown uses, while acceptable uses should be allowed. Finally, the authorisation process should be fast and allow other acceptable uses identified later.
• A shift from reaction to action is needed, whereby industries develop and authorities promote safer chemicals.

[Click here (pdf ~20K) for presentation]

Mr J. Van der Kolk, from the Dutch Ministry of Housing, Spatial Planning and the Environment, addressed the issue of Risk Management. Mr Van der Kolk made the following key remarks:

• The overall goal of the White Paper is to significantly improve conditions for the safe handling of chemicals and re-establish society's trust in the chemical sector.
• Industry is responsible for its products (including risk reduction measures) while authorities are responsible for a framework within which industry can operate. It is impossible to base risk management measures on individual chemicals - or even less individual uses - because of the enormous bulk of non-assessed chemicals.
• The White Paper does not fulfil the demands of the Council on major issues: the goals are unclear; horizontal integration is lacking (e.g. products dealt with separately, same for workers safety); vertical integration (with sectoral regulations) is lacking; the burden of proof is reversed only in the authorisation step, for other steps authorities still have to prove risks; substitution is not clearly included, except under the authorisation phase; limited attention is given to public availability of data; and finally, sanctions need to be included, "no data, no market" or better: "no safety guaranteed, no market".
• Future decision-making should be based on generic criteria, with clear rules for classes of chemicals (e.g. no CMR, no PBT, no ED in consumer products). The framework for socially acceptable or unacceptable risks associated with uses of chemicals should be clearly communicated. This would define general standards that would reduce the number of cases to be regulated individually and allow for more targeted R&D, investment choices and optimisation by industry.
• The new policy should not protect part of the industry and its outdated chemicals. Industry should assume its role, including the taking of adequate control measures. Partnership and a multi-stakeholders process is necessary, but if industry wants to be part of a sustainable production system, then it should develop and market safer products, substitute, act as a partner in society, and demonstrate that safety to man and the environment is its core business.
• The new policy should not reduce the current level of safety for new chemicals, hence raising thresholds is not appropriate. Authorisation, should be limited to small numbers, hence certain classes of chemicals e.g. CMR, PBT, VPVB.
• A clear framework is needed. And rules for substitution should be part of the framework of this policy.

[Click here (pdf ~210K) for presentation] [Click here (pdf~10K) for speech]

Mr Michael Warhurst, from Friends of the Earth Europe (FoE), and Ms Charlotte de Roo, from the European Consumer's Organisation (BEUC) addressed the issues of Information and Transparency.

Mr Michael Warhurst made the following key remarks:

• Information is not a substitute for regulation and should be targeted to different users.
• There is a need for comprehensive and precautionary regulation, based on the needs of all society and not of narrow industry sectors. Regulation is too often avoided just to protect industry. Furthermore, regulation should be designed to avoid future problems, not just to cope with present ones.
• There is a need for openness in the generation and communication of safety information, the legal "Right to Know" for all, and a need of information to assist substitution. All chemicals, must have adequate safety information publicly available. And ignorance about exposures must be ended. Furthermore, independent reviews - by Member States or consultants - of information and risk evaluations are needed.
• Data should be protected by property rights, not through secrecy. Uncertainties, ignorance and assumptions should be honestly communicated with the data.
• Information can assist substitution. Downstream industries should be obliged to use the safest available chemicals, we must create an obligation (a duty) to substitute. One way to do this is through the publication lists of more dangerous chemicals, such as in Sweden and Denmark. This would also encourage innovation.
• There is a need for regulation that includes deadlines, and phases out persistent, bio-accumulative or endocrine disrupting chemicals.
• The sanction for insufficient safety data should be "no marketing" and the burden of evidence required for action should be reduced. In addition, the new policy should create an obligation to use the safest chemicals possible - a duty to substitute.

[Click here (pdf ~120K) for presentation]

Mrs. Charlotte de Roo made the following key remarks:

• Consumers need to have the power to exercise choice. Safe products in the EU should be expected, and a safe product should be safe from production to waste. In this context the total exposure through a product's lifetime is important.
• There is concern about products marketed under 1 t, in particular aggregated amounts of products can be far higher than thresholds without it being known by the public or the authorities.
• BEUC supports the shift of responsibility to industry.
• The regulation should apply to chemicals in products, including imported ones. Manufacturers and importers should be obliged to provide a datasheet with information about the content of chemical substances in each product when it is put on the market.
• Manufacturer liability should apply to the safety information provided by them. Vulnerable groups such as children, elderly, pregnant women, etc. should be given special attention in the Strategy. The limits of no harm for these groups must be defined and be part of the Chemicals Strategy.
• The chemicals strategy should cover all substances including CMR, PBT, ED and substances in products.
• On information and consumer choice, the Strategy lacks precision on how information will be provided to the public. A simple system to inform the public and encourage responsible consumer behaviour should be put in place, but this will take time as there is much to do in very little time if we want to enable consumers to make informed choices.

Workshop I: Discussion

Before opening the discussion, the Chair, Ms Surkovic, summarised the important issues that had come out of the presentations. These related to the number of chemicals to be dealt with, the definition of criteria, the time scale, the number of animals used in tests, the responsibility of Member States, the extension of the European Chemicals Bureau, and testing between 1 and 10 tonnes.

The discussion then addressed the following issues:

The present chemicals legislation

• The unproven effectiveness and success of the present new substance regulation system.

Risk management

• The impossibility of guaranteeing absolute safety and the need to understand and manage potential risks.
• The need to decide on the type of risk management necessary.
• The need for some kind of safeguard regulation in order to make sure that everything is taken into account and handled properly, given the enormous number of chemicals to handle and the subsequent need to focus on HEROs.
• The importance of setting out the conditions ahead to decide what will be socially acceptable, and the need for a clear framework, e.g. a clear establishment of safety levels commonly acceptable within society.

Scope for Registration and data requirements

• The misunderstanding about the possible 70,000 substances below 1 tonne supposedly not addressed in the new strategy. The 1 tonne threshold often corresponds to where there is a commercial use of a substance, hence below 1 t, it is not really the problem of the general consumer, but rather concerns research applications for which there will be a different framework.
• The option of registering all substances against the impossibility of controlling everything and the consequent need for quality assessment and some sort of certification process. The related problem of data handling: for chemicals below 1 t, data should be provided by industry, upon request by authorities, but all information should not be systematically collected if there is no plan on what to do with it.
• The differences in data requirements and information sharing needs for chemicals that are used by consumers, chemicals used as intermediates, chemicals in the R&D process, etc.

Availability and provision of industry data

• The question of availability of industry data for chemicals that have been around for more than 20 years. The need to have more precise information on the number of chemicals and available data from industry and Member States. The need for industry to clarify to Member States what information/data can be made available and in what timeframe so that the burden can be evaluated. The contradictory messages from industry - to the public or to regulators - on availability of data. The issue of why industry does not just publish its data, if it has already tested its chemicals.
• The requirements for industry regarding long-term studies. The possible existence of much information at company level for substances between 1 and 10 t. The willingness of industry to help with the design of the central system. The need for more thinking (by industry and authorities) on how to make information publicly available because of confidentiality issues. The risks of excessive bureaucracy arising from data delivery requirements.
• The need to address risks separately, given the numerous different uses of substances. The fact that industry claims to have sufficient knowledge about the safety of chemicals for their handling for known uses. The fact that gaps in knowledge do not necessarily equate gaps in safe handling.
• The handling of the information flow from suppliers to downstream users. And the importance of communication between people, which raises questions of training for instance. The supplier's and clients mutual need of each other's help is an incentive for good communication.
• The intellectual property problems relating to information provided free of charge.

Compliance, enforcement, sanctions

• The problem of securing the provision of data by industry and industry's willingness to take up the challenge to stop the production of and marketing of substances on the basis that these substances are proven to be persistent, bioaccumulative and/or toxic.
• The fact that legislation and sanctions are the most effective way to enforce the system, in particular regarding SMEs.
• The importance of the regime gaining public confidence and the need for sanctions. The understanding that no (sufficient) data on time means no market e.g. the chemical cannot be used.

Limitation of animal testing, and testing methodology

• The lack of a strategy outlined in the White Paper regarding the limitation of animal testing to ensure that there is no duplication of tests, that there is data-sharing, that there is international co-operation, that there is funding to speed up the development of alternative methods and that there is a clear priority on non-animal testing. The need for practical steps on all these issues and for regulations regarding non-animal testing.
• The need to collect data from modelling and to accept data from earlier years.
• The need to explicitly fund the development of specific testing methods under the 6th Community Framework Programme for research and technological development.

Workers protection

• The problem of workers' protection for substances on which the necessary data is not available, in particular those substances below 10 t for which there will be less than current base set.

International co-ordination

• The need to increase the link between the EU process and OECD efforts. The need for ECVAM to collaborate with the OECD. The fact that OECD processes are based on consensus and complement what can be accomplished bilaterally with the US or internally at EU level. The issue regarding duplication of risk assessments already made elsewhere, in particular within the framework of the OECD.
• The importance of having more co-ordination at international level. The need for the European Commission to think more about how to efficiently use resources from both sides of the Atlantic. In particular the sub-optimality of the EU devising its own system and later trying to have it adopted by partners.

Stakeholders involvement

• The question of further follow-up work on the White Paper with stakeholders.

Workshop I: Conclusions

The Chair summed up the discussions by identifying common views, outstanding questions, and specific points made by some stakeholders.

Agreement exists on the following:

• It is safe use of chemicals that we are trying to achieve;
• We need to develop alternative testing methods;
• We need a generic approach and not an approach based on individual chemicals;
• We need international co-ordination;
• We have to find the right balance of responsibilities.

Outstanding questions are:

• What timeline will we be able to achieve?
• How to prioritise, how to identify HEROs?
• How to organise communication flows?
• What flexibility should there be on intermediates?
• Does the White Paper answer all of the Council conclusions of 1999 and does it meet the conclusions of the 1999 Stakeholders' Brainstorming?
• How to ensure the quality of data?
• What can we realistically achieve?
• How much registration and evaluation has been done already?
• What about PBTs?
• What sanctions should be imposed for no data or insufficient data at the deadlines set?

Some stakeholders insist that:

• Risk must be regulated
• Regulation must be comprehensive and precautionary
• Regulation must allow for responsible and informed choices by consumers
• A tailored approach to data is needed

[Click here (pdf ~10K) for conclusions of moderator for Workshop I]

**

Workshop II - Contributions of the Stakeholders

(Key Questions: What is expected of each stakeholder, what can they do, and how do you find the best balance?)

Workshop II allowed for the further harvesting of contributions from stakeholders. It was chaired by Mr Bob Warner of the UK Health and Safety Executive (HSE). Mr Warner made the following opening remarks:

• The European Commission's response to stakeholder pressure to review chemicals policy has been innovative and effective in that it has made an effort to draw in stakeholders and Member States.
• Reaching a consensus however has been difficult. The White Paper is a statement of intended policy. We should not reopen the package, but work on the way forward in order to achieve the implementation of a programme without excessive delay.

[Click here (pdf ~10K) for opening remarks of moderator for Workshop II]

Workshop II - Presentations

Mr Paul Van Eijsden, from CEFIC, presented the contributions which can be made by industry. Mr Van Eijsden made the following key remarks:

• Industry agrees with the political objectives of the strategy and welcomes the recognition by the European Commission that risk management must be based on sound science and risk assessment. Targeted risk assessments are an improvement and industry favours central co-ordination through the ECB. However, the time schedule is not feasible, as it is too tight and even de-motivating.
• Industry supports the search for a simple, coherent and workable system.
• Industry has a lot of data available and is working on the data gaps but it needs priority setting and grouping of substances into categories because the time scale is not feasible.
• Socio-economic consequences should be taken into account in the policy design. Negative economic impacts on some 40,000 SMEs could be significant. Test requirements should be carefully designed, as an example, notification of new substances, founded on a "Base" set, reduced the number of innovations to 10% in comparison with the US.
• Efforts should be focused on bringing the new accelerated risk management system into operation. If the system works well, then there is no need for the authorisation process. Authorisation is an unnecessary bypass and it undermines the new system. The system can use restrictions.
• Global participation is important, and will help industry.
• To conclude, the chemical industry will extend its voluntary initiatives and is willing to participate in a constructive dialogue to rapidly develop detailed and pragmatic proposals for Registration, Evaluation, Risk Assessment and Restriction.

[Click here (pdf ~190K) for presentation]

Mr Heinrich Van Megen, from the European Association of Chemicals Distributors (FECC) presented the contributions which can be made by downstream users. Mr Van Megen made the following key remarks:

• The FECC agrees on the development of a single system for existing and new chemicals, the changing focus from intrinsic properties to risk management, the increased thresholds for notification, the integration of international efforts and the involvement of downstream users.
• It is important to take note of the importance and variety of downstream users and realise that downstream users are mostly affected by registration and authorisation.
• A global approach to registration is recommended since not taking such an approach could have a negative impact on free trade. For example, regarding imported substances, only the imported tonnage will bear the registration costs, whereas for EU-produced substances the total tonnage will bear these costs thus inducing the potential disadvantage for imported materials.
• Downstream users propose the extension of existing registration dossiers for limited (niche) applications to avoid disproportionately high registration costs. There is a need for a simple, categorised, and workable scheme for registration, in particular for exposure estimates - which will be difficult to obtain given the number of applications - and for downstream user information. High registration costs will negatively impact innovation, mainly for SMEs who are strong in proposing innovative uses of substances in new applications.
• With regard to evaluation, the system must avoid duplication as well as national views on substance-tailored Level 1 & 2 testing programmes. It should provide for EU-wide conformity and coordination of testing programmes.
• In conclusion, downstream users are willing to participate to a constructive dialogue concerning the integration of downstream-use sectors in chemicals policy.

[Click here (pdf ~260K) for presentation] [Click here (pdf~10K) for statement of FECC]

Mr Esa Nikunen, from the Finnish Environment Institute, presented the contributions that can be made by Member States. Mr Nikunen made the following key remarks:

• There is a need to discuss the rules for practical implementation of the precautionary principle.
• Industry has to have the main responsibility for data provision, and firm deadlines and sanctions are needed. A key question is whether industry is able to fulfil its obligations properly and whether other stakeholders are able to rely on the assessments done by industry. We need a transparent system and quality certification in order to ensure political and public confidence in the system and avoid duplication of work.
• It is a significant improvement if downstream users are required to inform the authorities of any new uses that have not been addressed in the preliminary risk assessment.
• On procedures, there is a need for new risk assessment guidelines. New methods and tools are currently under investigation for the submission and evaluation of data under the framework of the Biocidal Product Directive. These guidelines are transparent and resource saving for the risk assessment and could be used elsewhere.
• Authorisations are extremely resource intensive therefore it is a positive development that the system is planned for a limited number of substances. Nonetheless, the scope for authorisation should be broadened from POPs to include other PBTs and possibly highly potent sensitisers and endocrine disrupters.
• There is a need for the further clarification of roles between Member States, the ECB and the Commission in the REACH system. Proper utilisation of information from Member States concerning uses and exposures, as well as national and local expertise, should also be ensured, for example through the establishment of an information system on environmental concentrations and releases.
• On vertical integration, a wider approach integrating more of the existing legal instruments would be fruitful in the future, for example those relating to legislation on pesticides and biocides, food packaging, drinking water, toys, cosmetics, etc. It is also important to avoid unnecessary differences between policies, e.g. in risk assessments. As for horizontal integration, it is necessary to improve the utilisation of information on chemicals in other sectors to which it is relevant, such as pollution control, workers and consumers protection, eco-labels, environmental management systems, environmental indicators, etc.
• It is crucial that the functioning of the current system does not stop during the preparatory phase of the new system. During the transition period, the present legislative framework should be implemented in a flexible way, taking into account the main principles of the White Paper.
• One of the main outstanding questions is how to tackle the problem of products containing harmful substances, and how to make sure that we have sufficient resources for the research, validation and development of alternative in vivo test methods, for animal welfare considerations.
• In conclusion, Mr Nikunen congratulated the Commission on a White Paper which fulfils quite well the needs identified in the 1999 stakeholders' brainstorming session and the 1999 Council Conclusions. Extra effort must be made to ensure that the future legislation is as user-friendly and easy to implement as possible.

[Click here (pdf ~320K) for presentation]

Mr Giorgio Squinzi, from Federchimica, presented the position of SMEs. Mr Squinzi made the following key remarks:

• The consequences of the White Paper do not fall only on "chemical giants". Special care is needed for chemical SMEs, because there are no marginal actors in the chemical industry in terms of jobs, outputs and innovation. What is acceptable for big companies can be too high a burden for SMEs. SMEs are far more vulnerable to regulatory frameworks than their big colleagues. It is time- and resource-consuming, it can impact on their speed and flexibility - their key success factors - and on their ability to innovate.
• We need to develop an intelligent global regulatory framework, while ensuring administrative simplification. A feasible REACH system should be well-defined in the details, be flexible, provide safeguard from extra-EU competitors, include supporting measures in the 6^th Community RTD Framework Programme, and be simultaneously adopted by all Member States to avoid distortions of competition.
• The White Paper includes little on competitiveness and benchmarking. The EU chemical industry suffers a competitiveness problem that mostly stems from the existing regulatory framework. SMEs suffer most from this.
• In conclusion, we must work together to improve the strategy. An awareness of the importance of SMEs can help us better achieve the goals of the White Paper and sustainable development.

[Click here (pdf ~80K) for presentation]

Mr Gerald Vollmer, from the European Chemicals Bureau (ECB), addressed the role of the Central Entity. Mr Vollmer made the following key remarks:

• The Central Entity must provide support to all stakeholders - the Commission, Member States and other countries, citizens, industry and NGOs - for registration, evaluation, assessment authorisation, classification, labelling, information and biocides. Support from the central entity will allow for faster and streamlined procedures.
• On timing, it would be preferable for the central entity if data set submissions would be spread over the years to avoid work peaks. Some companies submit information in time, others not, the smallest companies have fewer resources. We need to find ways to improve compliance of companies with deadlines. Fees could be reduced for those who submit data in advance. Also, a better access to the ECB database could enhance performance in data submission.
• During the registration and evaluation phases, the central entity will administer and evaluate data sets. This includes tasks such as data loading (technical check), amalgamation of different data sets, evaluation of fulfilment of base set requirements and of in-depth testing requirements, and requesting additional tests. Today, there is lots of data on chemicals above the 1000 t threshold and little data below 10 t, thus we need more toxicological and ecological information about these chemicals.
• For the new risk assessment procedure, the central entity will check the completeness of data sets, suggest selection of substances, and organise agreement on the type of risk assessment to be carried out. Part of the registration fees should go to Member States to evaluate risk assessments and design tailor-made testing programmes, however a portion of the fee should be paid upon delivery.
• In the authorisation phase, the central entity will facilitate agreement on hazards, draft restrictions and general exemptions and prepare Community authorisations.
• The ECB will also issue a complete list of dangerous and (possibly) non-dangerous substances that will include both the official list (Annex I) and industry's list.
• In conclusion, although, the new Chemicals Policy will substantially increase the ECB's workload, it is happy to provide more service (in quantity and in quality), however there is a need for a sound financial platform to implement this.

[Click here (pdf ~90K) for presentation]

Ms Elisabeth Salter Green, from World Wildlife Fund (WWF), addressed the role of NGOs. Ms Salter made the following key remarks:

• Her role as an NGO representative is to be thought provoking and to push for a safe and precautionary chemicals policy. Thus WWF has two key messages to the Commission and industry:
• The first is to the Commission: The White Paper is a first step, but the development of the strategy needs more commitment, enlightened thinking and greater precautionary attitude. The White Paper is the product of industry self-interest, and it is not adequate to protect humans and wildlife.
• The second is to industry: Little regulatory pressure or manufacturing control has been put on the chemical industry for the last 50 years. Industry can, and needs to, go significantly further than the concessions made up to now. Drastic changes are needed in chemicals policy, but industry and DG Enterprise are dragging their feet.
• Two points need to be changed within the Policy. Firstly, the new policy must put an end to exposure from EDCs and VPVB substances. Secondly, the financing of the system must be sound and there must be enough money in the system to ensure that the job can be done properly.
• In conclusion, chemical production and use patterns are the major problem, yet with the right policy in place solutions can be found. Thus, the chemical industry, with its wealth and innovative capabilities, can provide these solutions should they choose to do so. The chemicals policy must make sure that industry adopts its 'expected' and 'required' responsible role, and puts the health of future generations first.

[Click here (pdf ~200K) for presentation] [Click here (pdf~20K) for speech]

Mr Reinhard Reibsch, from the European Mine, Chemical and Energy Workers' Federation (EMCEF), addressed the role of trade unions. Mr Reibsch made the following key remarks:

• EMCEF considers the discussions on European regulation on chemicals as important and necessary.
• The experience, proper training, and qualifications of workers is critical when discussing the handling of chemicals, since they might be exposed to potential risks.
• The social aspects and the human factor should be taken into account in the Policy. Both are presently missing in the White Paper. In particular, the consequences of the new Chemicals Policy might have for the quality and the number of jobs are not addressed, and the sustainability of social development is treated as a point of minor significance.
• Chemicals legislation is not sufficiently more transparent and comprehensible through the new strategy. The objective of a sustainable chemicals policy must be the safe use of substances over their entire life cycle. Bans solely on the basis of intrinsic properties are not acceptable. The policy should include assessments of risks and benefits before bans, and risks attached to alternatives must also be considered.
• Compliance with international trade regulation should be assessed, in particular as regards imported products. Competitiveness is not properly addressed. Chemicals and products produced in Europe must not suffer any disadvantages as compared to imports, and EU chemicals should not suffer on the international market. Authorisation poses a threat to competitiveness since it does not exist for our major non-EU competitors. Moreover, leaving implementation to national authorities could create differences in terms of competitiveness within the Union.

[Click here (pdf ~10K) for the position of EMCEF]

Workshop II: Discussion

Mr Robert Warner of the UK Health and Safety Executive launched the second workshop discussion by stating that the European Commission's White Paper is a sound response to Member State pressure for a thorough review of EU chemicals policy and praised the European Commission for the release of an innovative new Chemicals Strategy and review process, which has drawn in a broad stakeholder base.

The discussion in Workshop II addressed the following issues:

Competitiveness and jobs

• The idea that industry could see the Strategy not as a blow to its competitiveness, but rather as a means to move ahead on the world market. Green markets are likely to expand quickly, hence this could lead to overall job creation and not losses.
• The possibility that international competitiveness might actually be improved if industry is innovative. The White Paper will induce some costs to industry in the short term, but in the long run environmentally friendly investments can be positive in terms of competitiveness.

Responsibilities and involvement

• One participant reflected on the fact that no stakeholder so far has addressed the key question in Workshop II of what is really expected from each stakeholder. Stakeholders want to be part of the process and contribute to the fine-tuning and determination of details. Stakeholders also want to participate in the determination of risk management strategies, in the definition of testing strategies, and in priority setting. However, the exact role of stakeholders in the policy process and final system as well as the way forward regarding stakeholders' involvement in general is still an outstanding issue.
• The question of whether the authorisation procedure really transfers responsibility to industry or simply transfers it back to authorities.
• The issue of the responsibility of industry if they want to put chemicals on the market.
• The issue that industry views voluntary programs as a way to delay or avoid legislation; and that industry only provides sufficient data to keep the voluntary programs alive.
• The fact that there is no need, nor possibility, for a comprehensive risk assessment of all chemicals. Based on pre-assessments from industry, authorities will be responsible for deciding where more complete risk assessments are needed.

Timing

• The willingness of industry to accelerate data submission. And the related suggestion that it will take industry more time than that allowed in the White Paper unless it can accelerate the process through grouping and priority setting. Industry sees a time frame of approximately 15 years for providing the base data set and level 1 & 2 testing, but not for all chemicals on the market.

Downstream users and SMEs

• The positive benefits that downstream uses and products bring to the environment and health. The lack of differentiation between manufacturers and downstream users. The fact that downstream users are not a simple supply chain, but a complex and diverse group. The concern that the costs will be excessively high for downstream users and SMEs. The need to think about ways to reduce these costs.
• The need for clear guidelines and easy / manageable procedures for downstream users. And the need to involve downstream users in the discussions at an early stage. The need to address what is truly new for downstream users.
• The need for downstream users to take into account not only the benefits and technical performance of the chemicals they use, but also their health and environmental consequences.

Human resources

• The importance of looking at the human factor. Many qualified people will be needed to produce, collect, communicate, evaluate and monitor data. The ensuing question of where to find the necessary people and expertise (for industry and authorities) and to already plan in terms of educational programmes at Universities.

Authorisation and precaution

• The amount of work and resources required for Member States to carry out the authorisation process and the issue of whether authorisation is the exception or the rule. Thus the need for Authorities to have more information on this and the complexity and scope of the authorisation procedure.
• The lack of clarity regarding the authorisation scheme as described in the White Paper. For instance, who makes the decision to apply the authorisation process to a certain substance a Member State or the EU? Also the criteria for an authorisation procedure as compared to a ban procedure need to be clarified. For example, asbestos could only be subject to a ban because there were/are no acceptable uses for it.
• The importance of the scope for authorisation. The need for the strategy to address other groups than CMRs and POPS, which are now seen as problematic, an important example being PBTs. The idea that certain substances should not be allowed and substances with certain inherent properties should be phased out (CMRs, PBTs). This would not be an absolute ban since there could be exemptions. However, substances proven to be PBTs do not need to be further tested but forbidden. If there are no substitutes, then it is necessary to address toxicity issues and/or other factors and undertake a thorough analysis through a decision tree process. It is important not to forget past lessons and to take a precautionary approach.
• The question of whether an authorisation process is actually necessary for those CMRs that are already heavily regulated.

Integration

• The need to look at horizontal integration issues, in particular as regards policies for SMEs, which are vital for small Member States and applicant countries.

Workshop II: Conclusions

The chair concluded by thanking all participants for valuable contributions. He noted that if the consensus represented by the White Paper was to be preserved several stakeholders needed to reflect on their positions. Indeed more work by and between stakeholders and the Commission is crucial, particularly on:

• Authorisation;
• Scope;
• Costs, resources and delivery (more facts seem to exist that expected, these should be drawn together so that a complete estimate can be provided).

On the other hand some very encouraging comments had been made, especially concerning audits, checks and voluntary action.

[Click here (pdf ~10K) for closing remarks of moderator for Workshop II]

Conference Conclusions

The speakers in the concluding session highlighted what they had retained from the debate, proposed some additional remarks, and reflected on practical next steps.

Mr McSweeney, Director General of the Joint Research Centre, and Chairman of the closing Session, stressed that the fundamental task of the JRC was to protect the health of EU citizens. Thus decision making on chemicals has to be founded on a sound scientific basis, to use the best available testing practices, to avoid the duplication of testing efforts, and to use non-animal testing methods where possible. The ECB is ready to assume a greater role in EU Chemicals policy, but Mr Mc Sweeney warned that in order to properly fulfil its role, the optimisation of the ECB's (central entity) relationship with the Member States is crucial in order to define the most efficient way to regulate chemicals and to swiftly move forward in the application of the new Strategy.

[Click here (pdf ~40K) for accompanying slides]

Mr J. Keck Deputy Director General of DG Enterprise thanked the participants for a debate that helped the Commission Services to better understand areas where difficulties exist. The next step is to turn the White Paper into legislation. Mr Keck identified the key points of agreement, namely that the objectives of the new policy are sustainable development and the safe use of chemicals, that testing should be tailored to needs, and that international co-ordination is needed. He then addressed areas where worries exist.

Industry has clearly stated that the time-scale is not achievable, but it has said that a lot can be achieved within 15 years if good use is made of grouping, priority setting and international harmonisation.

Concerning authorisation, industry and the trade unions seem to think that it is not useful. But, said Mr Keck, this is a serious challenge to the core part of the new system set out in the White Paper and industry should think again about objecting to this, because in doing so, industry basically objects to the whole package. He insisted that internal Commission compromises on the White Paper have not been reached easily. The White Paper is a policy intention. It is a groundbreaking proposal even though more work is needed. The Commission will not easily change the general outlook of the White Paper.

Concerning scope, the White Paper is clear enough said Mr Keck, it identifies about 1,500 substances for authorisation. It leaves open the question of PBTs and VPVBs but they will be dealt with and will end up in one category or another.

Worries seem to exist about the workload that the new policy will put on the expanded European Chemicals Bureau and Member States. It is very important, said Mr Keck, that we are able to fulfil any commitments that we undertake.

Other concerns relate to international competitiveness, in particular for downstream users and SMEs. Clearly, said the Deputy Director General, we have to be careful about this. However, the new system will be more innovation-friendly than the existing one.

The next step is to start legal drafting. DG Enterprise will assess the business impact of the Strategy, but this should not delay the process. The White Paper was well received by the Council in March 2001. It will soon be subject to a first opinion from the Environment and Industry Committees of the European Parliament. The aim is to have Commission draft proposals by the end of the year in order to proceed to the decision making process in the Council and Parliament.

Mr J.-F. Verstrynge, Deputy Director General of DG Environment affirmed that all input from the Conference will help the Commission in its development of the necessary legislative instruments to implement the White Paper. The Commission will address points raised during the discussion, for example: the importance of enabling consumers to make informed choices, the need to generate more information on properties and uses, the need to place priority on HEROs, the need for generic approaches in particular to make the system workable for SMEs, the importance of international co-ordination, and the need to take account of animal welfare.

Mr Verstrynge then clarified a misunderstanding that appeared in the course of discussions. Downstream users, he explained are to complement risk assessments by the producer only for new uses different from intended uses, and cost sharing will be expected to take place between the producer/importer and the downstream user in case.

A remaining unclear point, he continued, is the availability of existing data. On the one hand, industry insists that large amounts of data are available but, on the other hand, it calls for longer time lines. The sooner the information will be made available and shared, the lower the costs will be, and the more animals we can spare, said Mr Verstrynge.

He noted that general agreement about sanctions seemed to be within reach, namely: no registration - no production - no marketing. On authorisation for substances of most concern, Mr Verstrynge reminded industry that this is an integral part of the package, and the driving force for substitution. Authorisation is flexible because it allows the possibility of banning "unsafe" uses, but continuing "safe" uses. He asked for more information on why industry opposes Authorisation.

[Click here (pdf ~15K) for speech]

Mr Alain Perroy, Director General of CEFIC, said that it is a priority for the EU chemical industry to keep a living dialogue with its stakeholders. He reminded the audience that the EU chemical industry is vital to the EU economy and that it is one of the last European sectors that is the global leader. The White Paper should not only deal with health and the environment, it should also deal in more depth with competitiveness, compliance with international trade rules, and the integrity of the internal market.

The chemical industry, said Mr Perroy, has a long tradition of safety in manufacturing and handling chemicals. The European Union, for its part, has a strong regulatory culture to chemicals. Europe is certainly a region where chemical safety is well covered and assured. It can be further improved and the White Paper must be seen as an opportunity to produce feasible legislation, balancing the protection of health and the environment with the competitiveness of the industry, in particular SMEs.

The chemical industry runs many voluntary initiatives. The crucial challenge is to find the right balance between legislative measures and voluntary action. The concept of co-regulation must be applied to chemicals policy. The chemical industry has a wealth of available technical expertise and practical experience. Please use it. There exists also a lot of data but public access to it should be improved. The industry wants to be involved in studying the quality of available data. It is also willing to discuss the next steps but within a feasible timetable, and wants to promise what can be delivered.

The current system has been identified as being too slow, but not bad in principle, said Mr Perroy. For existing substances, the key objective must be to improve its management rather than to establish a completely new system that would only add to the bureaucracy and create delays and additional burden for the industry. CEFIC questions the added value of an authorisation scheme and would oppose such a system applied to thousands of substances; such a process will not improve management and will not bring additional protection for so-called substances of high concern - such as CMRs - which are already regulated. However he carefully noted the remarks from the Commission that authorisation is part of the total package in the White Paper.

In conclusion, industry supports the objectives of the White Paper but believes that there is still much room for improvement in implementation. The industry is committed to delivering real progress through its voluntary initiatives and an open dialogue.

Mr Hans Wolters, Director of Greenpeace Europe, proposed to add a critical note to the session. We want political results, he said, we are trying to deal with the increasing toxic burden of the past. Technicalities should not distract us from the need to achieve a toxic-free future, hence timetables should be achieved and accelerated. There are real problems that need to be solved as soon as possible and this is no time to postpone. The European Commission has shown leadership by proposing the White Paper, however the White Paper needs to be sharpened to work.

The scope for authorisation must be better defined. As authorisation constitutes the core of the White Paper, Mr Wolters challenged industry to show that they are - as they advertise - part of the solution, to make decent, clean products for a toxic-free future and to clean-up the mess of the past.

PBTs should be put back in, the strategy is not credible without them. Timelines should be respected, and if possible sped-up. Industry is trying to buy time. But a more generic system and intrinsic property screening may help to accelerate. Furthermore, the system needs credible sanctions and the White Paper is vague on this. The only credible sanction is: "no data, no market".

Substitution, said Mr Wolters, should not only be encouraged but also promoted. Because substitution is a driver for innovation. If we take the objective of the EU becoming a knowledge-based economy seriously, then this is important. Also authorisations should be granted for a limited time, after which there should be an evaluation of availability of alternatives.

The proposed working group on substances in products is not needed since the same criteria should apply to substances in imported products and those in EU-made products.

[Click here (pdf ~10K) for speech]

Ms. Laurence Musset, from the French Ministry for the Environment, addressed the participants in her personal capacity. She affirmed the key comments she had heard during the Conference e.g. all chemical substances should be evaluated by industry, no tests should be conducted if not needed, and quantity is not the only criteria to be taken into account (hazardous properties and uses are at least as relevant as quantities). If these are the key issues then, Ms Musset stressed that it is important to acknowledge that it is impossible to know today how many substances will justify an evaluation / validation by Member States (HEROs). Thus she made the following proposal for chemicals over 100t after the base set:

1. Industry should conduct additional tests, defined in advance by decision trees, and not wait for a waiver agreed by Member States on each chemical. The decision trees should take into account dangerous properties, uses and quantities. These trees should be defined by an expert group and the ECB.
2. When the results of these additional tests are available, the ECB should identify HEROs (priority substances) using again the criteria relating to dangerous properties, uses and quantities.
3. With regard to HEROs, Member States should decide which complementary tests, if any, would be needed, and assess the danger and / or the risk in a limited length of time.

Ms Musset stressed that the efficacy of labelling, safety data sheets, risk reduction measures provided for by nearly 30 directives on the basis of classification, will be greatly improved by the registration of data on hazardous properties of substances. She also expressed concern that no simplified registration for new substances below the 1 t threshold is provided in the White Paper, which poses the question of their identification. She insisted on the importance of inspection, as an essential part of the future chemical policy.

She concluded that a future chemicals policy should not start from scratch and should be based on experience with the existing chemicals policy.

Mr Andrew Fasey, UK Health and Safety Executive (HSE), identified from the day's discussion three overarching issues in the development of an effective approach to the management of chemicals:

First, learning lessons from the past: the new system must be flexible and the data required must be focussed on the chemicals and end-points of concern, and on what is needed to ensure effective chemicals management only. We must bear in mind what we are trying to achieve. Criteria for priority chemicals and the data required for different circumstances have to be defined.

Second, the current system has its strengths, we should not lose them in the new system and disregard what works in the current system e.g. there is a high level of protection for workers. Also the implementation of the new system is a massive opportunity to make sustainable development a reality and it should give the chemical industry a real incentive to be increasingly innovative and contribute to sustainable development.

Third, the new system must be practicable and realistic in using finite resources, in particular animals for testing and human resources. To achieve this, creating synergies with international programmes and data sharing are important, as well as the use of information technologies. Above all, said Mr Fasey, we need to be flexible and creative and work in partnership with all stakeholders, the goal for all of us being the achievement of sustainable development. Let us not forget that the needs of many different audiences must be considered, including SMEs.

[Click here (pdf ~30K) for presentation] [Click here (pdf~10K) for speech]

In closing the Conference, Mr McSweeney insisted that stakeholders must be involved further in the process, so that the future chemicals legal framework will work properly and swiftly.

**

3. Appendixes
3.1	Conference Programme (pdf ~50K)
3.2	List of Participants (pdf ~60K)
3.3	Speeches/Presentations