Select Committee on Science and Technology Written Evidence


APPENDIX 1

Memorandum from the Government

1.  SUMMARY

  1.1  The current system of assessing chemicals on the market has made slow progress in subjecting chemicals of concern to regulatory action. There are an estimated 30,000 chemicals (supplied to the EU market in quantities over 1 tonne) for which little information is known on their potentially hazardous properties or what risks they pose. The UK Government therefore supports the overall objectives of the new EU chemicals strategy, to protect human health and the environment through increasing knowledge about potentially hazardous chemicals.

  1.2  In negotiating the proposal, the Government has three key objectives:

    —  to develop a fast, efficient and workable process to test and screen chemicals and tackle those of most concern;

    —  to minimise animal testing; and

    —  to maintain the competitiveness of the chemicals industry and downstream users.

  1.3  We welcome the changes made by the Commission to improve the draft regulations following the internet consultation in May-July 2003. Whilst the proposals adopted by the European Commission show improvement on previous drafts, there remains room for further development to make the system more effective and workable.

  1.4  In particular, measures aimed at minimising animal testing through data sharing should be strengthened. Although the Commission has included financial and other incentives to encourage data sharing at registration, the Government considers that the proposal must find a way of making data sharing compulsory if we are to avoid duplicate animal testing. We believe that a system of "one substance: one registration" would simplify the system, lead to a reduction in animal testing and reduce the impact on industry whilst maximising the benefits to human health and the environment.

  1.5  The proposals include several aspects which encourage innovation compared to the current system. For instance, the level at which new substances must be tested and notified has been raised from 10 kg to 1 tonne and the derogation for substances used in process-orientated research and development has been increased to a maximum of 10 years. In addition, the process of authorisation should stimulate innovation in the development of new, safer chemicals.

  1.6  The Government continues to consult widely with all stakeholders including industry, trade unions, environment and consumer groups. A formal UK Government consultation document following publication of the Commission proposal will be published in early 2004.

2.  INTRODUCTION

  2.1  In February 2001 the Commission issued a White Paper on a "Strategy for a Future Chemicals Policy" (COM(2001) 88) based on a review of the existing EU system for regulating the safe use of chemicals. The Commission concluded that reform of the current legislation was necessary and the proposals are based on the White Paper.

  2.2  The present system for general industrial chemicals distinguishes between "existing substances" ie all chemicals declared to be on the market in September 1981, and "new substances" ie those placed on the market since that date. Existing substances are regulated by Regulation 793/93 and new substances by Directive 67/548. There are approximately 3,000 new substances which have been tested and assessed for some possible risks to human health and the environment before being marketed in volumes starting at 10 kg per annum under Directive 67/548.

  2.3  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, although the current number of such substances marketed in volumes of 1 tonne per annum or more is estimated at 30,000. Approximately 140 of these substances have been identified as priority substances and are subject to comprehensive risk assessment carried out by Member State authorities under Regulation 793/93. However, only 11 Member State-led risk assessment and risk reduction strategies have been completed, and only four subject to marketing and use restrictions.

  2.4  Restrictions on the marketing and use of certain dangerous substances and preparations are applied, where necessary, under Directive 76/769. Risk assessments and adequate analyses of the costs and the benefits are required prior to any proposal or adoption of a regulatory measure controlling the marketing and use of chemicals.

  2.5  On 29 October 2003, the Commission agreed legislative proposals for the Registration, Evaluation, Authorisation and Restriction of Chemicals, known as REACH. These were formally published on 28 November 2003. The proposals address the short-comings of the current system which were identified in the White Paper. These include: the lack of available information on risks to human health and the environment of the majority of substances on the EU market; the slow and resource-intensive nature of the current system, primarily for existing substances; the need for responsibility for the assessment of chemicals to shift from the regulatory authorities to industry; and the lack of information on uses of substances.

  2.6  The UK Government supports the overall objectives of REACH, which are to protect human health and the environment through increasing knowledge about potentially hazardous chemicals. We want to see a rapid, efficient system for collecting the necessary information on chemicals and for tackling those of most concern, whilst minimising animal testing and maintaining the competitiveness of the chemical industry and downstream users.

  2.7  The Government is determined to ensure that the new legislation controls the use of those chemicals of most concern without imposing unnecessary bureaucracy or burdens on business. It is important that the costs—both direct and more broadly the indirect cost passed down the supply chain—and the benefits of the proposal to the UK are carefully assessed. This is why the UK Government is preparing its own Regulatory Impact Assessment on the Commission's proposal. The new system must also be enforceable and consistent with our international trade obligations.

  2.8  We welcome the changes made by the Commission to improve the draft regulations. Whilst the final proposal shows improvement on previous drafts there remains room for further development.

3.  KEY ISSUES

  3.1  Overall: We continue to have some concerns regarding certain aspects of the proposal, in particular the workability of a number of provisions. A system that is not workable will fail to deliver the environmental and human health benefits we all wish, whilst placing unnecessary burdens on industry and public authorities.

  3.2  Registration: Measures aimed at minimising animal testing through data sharing should be strengthened. Although the Commission has included financial and other incentives to encourage data sharing at registration, we feel that the proposal must find a way of making data sharing compulsory if we are to avoid duplicate animal testing. We believe that a system of one substance: one registration would simplify the system, lead to a reduction in animal testing and reduce the impact on industry whilst maximising the benefits to human health and the environment.

  3.3  In order to ensure that maximum benefit can be gained from the generation of new data, as well as that already produced, we propose that all organisations who wish to register for REACH should share data on an equitable basis by using compulsory consortia formation with the goal of one substance: one registration.

  3.4  The main advantages of "one substance: one registration" are:

    —  Minimising animal testing through sharing of data in consortia.

    —  Reducing the cost of REACH to the economy by sharing costs of testing.

    —  Maximising the sharing of existing data and creating one data package per substance.

    —  Reducing the workload and simplifying the system for industry and Authorities.

    —  Aiding rapid decision making through the use of one registered data package.

    —  Creating a level playing field for all registrants, including late entrants to the EU-market.

  3.5  Evaluation: We welcome the inclusion of the concept of prioritisation in the Commission's proposal as this is a key element in ensuring the success of the new system. This should in particular ensure a risk-based approach to prioritising substances for further evaluation based on the information submitted as part of the registration package. There is still some discretion as to how many evaluations will be undertaken and, as proposed, the system may not yield an acceptable throughput of substances being reviewed, which risks repeating the problems of the current regime. We are considering whether a prioritised system of evaluation—coordinated by the Agency—to ensure a harmonised approach and focus on substances of concern first would be more effective.

  3.6  Authorisation: The UK Government agrees that persistent and bioaccumulative chemicals are of particular concern. In this context, we support the Commission's decision to include persistent, bioaccumulative and toxic (PBT), very persistent and very bioaccumulative (vPvB) chemicals and endocrine disrupters—when scientifically validated test methods have been developed and criteria established—in the authorisation process.

  3.7  The proposal encourages applicants to submit substitution plans to replace harmful chemicals with cleaner, safer alternatives. Although we are still considering how substitution plans might work in practice, we welcome the changes in the Commission's final proposal for greater encouragement of substitution. The extent to which substitution plans can stimulate innovation is to be welcomed, especially if that can help direct some of the chemical industry's spending on research and development.

  3.8  Role of the Agency: The Commission has taken steps towards simplifying the administrative arrangements and clarifying the relative roles of the Central Agency and the Member States. In particular, we welcome the move towards increased decision-making power for the Central Agency at registration, on data sharing, research and development exemptions and confidentiality. We are considering whether the administration of the system can be streamlined further.

  3.9  Scope: The scope of the system has been reduced by excluding polymers from the first stages of registration and limiting the requirements for intermediates. The inclusion of these substances in the early stages of REACH did give rise to concerns related to the workability of the REACH system because of the expected large numbers involved. We welcome the changes, but here, too, we will be considering the implications.

  3.10  In addition, several aspects have been introduced which encourage innovation compared to the current system. For instance, the level at which new substances must be tested and notified has been raised from 10 kg to 1 tonne and the derogation for substances used in process-orientated research and development has been increased to a maximum of 10 years.

  3.11  Information provision in the supply chain: One of our main concerns regarding the draft proposal was the complexity of supplying information up and down the supply chain using Chemical Safety Reports. We welcome the change in the proposal whereby information will be supplied via the existing system of Safety Data Sheets. The Commission has also reduced the burden on smaller manufacturers by reducing some of the testing requirements and removing the requirement to provide a Chemical Safety Report for substances supplied between 1-10 tonnes (believed to be around 20,000). We are currently considering the impact of this change.

  3.12  Downstream users: The potential impact on downstream users has also been reduced. The proposal allows downstream users to inform their suppliers of a use they wish to be covered under the supplier's Chemical Safety Report. This should greatly reduce the burden on small and medium-sized companies.

  3.13  Confidentiality: The proposal includes specific information that should be considered as confidential. There needs to be adequate protection of intellectual property rights whilst ensuring that as much information as possible is made publicly available.

  3.14  Substances in Articles: The Commission has also decreased requirements for registration of substances in articles. We are still considering the implication of these changes, as this is a difficult issue to resolve both in terms of the workability of the system and the important trade implications.

4.  CONCLUSIONS

  4.1  The UK Government supports the overall objectives of the new EU chemicals strategy, to protect human health and the environment through increasing knowledge about potentially hazardous chemicals.

  4.2  Whilst the final proposal shows improvement on previous drafts, it will be clear from the comments above that the Government is continuing to assess the proposals overall, including several key aspects where there remains room for further development to make the system workable.

  4.3  In particular, we believe that a system of "one substance: one registration" would simplify the system, lead to a reduction in animal testing and reduce the impact on industry whilst maximising the benefits to human health and the environment.

  4.4  The Government continues to consult widely with all stakeholders including industry, trade unions, environment and consumer groups. A formal UK Government consultation document following publication of the Commission proposal will be published in early 2004.

December 2003



 
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