Select Committee on European Union Thirteenth Report


12 FEBRUARY 2002

By the Select Committee appointed to consider European Union documents and other matters relating to the European Union.



Regulating Industrial Chemicals

6671/01  Commission White Paper Strategy for a future Chemicals Policy (COM(2001)88 final)



1. The European Commission presented its White Paper, Strategy for a future Chemicals Policy, in February 2001. The White Paper has stimulated a wide ranging debate over the future shape of a policy designed to regulate the manufacture, marketing and use of industrial chemicals in order to protect human health and the environment. The White Paper is to be followed by detailed proposals for new legislation, following guidance given by the Environment Council at its meeting on 7 June 2001.


2. Manufactured chemicals play a key role in the provision of goods and services on which modern society is dependent, and the chemical industry is Europe's third largest, employing 1.7 million people directly and with up to 3 million additional jobs dependent on it. However, some chemicals have the potential for causing serious damage to the environment and human health; it is the purpose of chemicals policy to minimise or eliminate the adverse effects of chemicals while securing the benefits that they bring.


3. The UK Government in its 1999 Chemicals Strategy says that it is "very concerned that we do not have even a basic assessment of the possible risks of most chemicals released into the environment in large quantities". The White Paper states that "the lack of knowledge about the impact of many chemicals on human health and the environment is a cause for concern", and proposes a strategy to assess existing chemicals so that those that are harmful can be regulated.


4. The existing EU regime for the notification and evaluation of new (post-1981) chemicals appears to have worked well; and there is now a useful body of data on the approximately 2,700 chemicals marketed since 1981. However, the EU regime introduced by Regulation in 1994 for the evaluation of existing (that is to say pre-1981) chemicals has proved far less satisfactory. The process has been so slow that little more is known about the 30,000 chemicals marketed in quantities of more than 1 tonne per annum; and not much has been achieved in reducing the risks from those considered potentially the most hazardous.

5. Since 1994 four priority lists of 140 existing chemicals requiring immediate attention have been drawn up by the Commission. Nearly eight years after the first priority list was prepared only a handful of risk assessments and risk reduction strategies have been published by the Commission, followed by only two proposals for banning the use of particular chemicals. This very slow progress suggests that there is a fundamental flaw in the existing Regulation.


6. The White Paper proposes a new regime, to be known as REACH, with three main elements: Registration, Evaluation and Authorisation. It seeks to overcome the deficiencies that have been identified by requiring industry to submit much more data than are currently required, including preliminary risk assessments. The idea is that the same sort of data that are provided for the 2,700 chemicals marketed since 1981 will be made available for 30,000 or so older chemicals marketed in quantities of more than 1 tonne per annum. Manufacturers will have a powerful incentive to submit a complete registration dossier because a failure to do so may result in marketing being banned.

7. The proposed system places much reliance on the preliminary risk assessment that industry is required to provide. The authorities are likely to evaluate only some of these assessments. The White Paper estimates that 80 per cent of the 30,000 substances "would only require registration", with evaluation being limited to chemicals where production has exceeded 100 tonnes per annum and, at lower tonnages, to chemicals identified as being of concern. Authorisation will be required for chemicals identified as of very high concern and the onus will be on industry to justify the use of such chemicals. These will be banned unless a particular use is authorised.


8. The White Paper programme is highly ambitious. While, in our opinion, it is right to set deadlines by which relevant information must be made available, the timetables set for a great deal of the work that is proposed are unrealistic. We have received much evidence of the need for prioritisation to focus attention on chemicals of greatest concern and in order to minimise the amount of testing on animals that will result. It may be a mistake to move at the outset to a single system that seeks to combine the arrangements for new and existing chemicals, since the information obtainable for new and existing chemicals is necessarily different. The new legislation that will be needed will be extremely complicated and contentious, and the Commission will be adding to the difficulties of having the legislation adopted quickly if it tries to reform everything at once. Its priority must be the reform of the regime for existing chemicals.

9. We agree with many of the conclusions of the Environment Council of 7 June 2001 and, in particular, with the need for "streamlined, pragmatic and effective procedures" which are "realistically achievable". The failure of the present Existing Substances Regulation arises in part because there is no pressure on industry to conduct tests and assessments. We therefore agree with the Council that a chemical should not be marketed or used "if the information required under the REACH system is not provided by the industry within the reasonable time periods to be set within the system".

10. Many of our witnesses agreed that it would not be possible to provide the amount of data that the White Paper wishes to have available at the registration stage by the intended deadlines, and that the target of 2012 for completion of the testing programme is not achievable. Furthermore, some witnesses doubt whether testing facilities in Europe have the capacity to meet the deadlines even if animal testing on that scale were acceptable to public opinion. It is, therefore, important that definitions should be provided of the minimum amount of hazard data required that will enable prioritisation of those chemicals needing risk assessment and risk management measures. We welcome the fact that the Commission has established task forces to study the matter.

11. The proposal to transfer responsibility to industry, including downstream users, to conduct preliminary risk assessments is a centrepiece of the White Paper. The authorities, who previously did these assessments, will not have the resources to undertake so many and we therefore support the proposed transfer. But given the difficulty and uncertainty of the risk assessment process, and that confidence in the system will depend on their quality, we believe the Commission should provide guidance and detailed rules on how industry should conduct and present risk assessments.

12. Downstream users have hitherto had no formal role in the existing EU regimes but will now have to contribute to the risk assessment process. The complexity of the supply chain and the very large number of uses of chemicals, often unknown to manufacturers, pose real problems for the preparation of risk assessments, which we do not believe are reflected in the White Paper. A solution may be to limit them to chemicals meeting certain priority criteria.


13. We believe that a main aim must be to ensure that action is taken on chemicals of very high concern. It has not been established that an authorisation system will achieve speedy results, because positive approval schemes can be slow and resource-intensive. There may be a continued role for action on specific uses under a revised Marketing and Use Directive. The White Paper proposes that authorisation would apply to CMRs (carcinogenic, mutagenic and reprotoxic substances) and those with POP characteristics (persistent organic pollutants as defined in the Stockholm Convention).

14. A vigorous debate is taking place involving, among others, the European Commission, the Council and the European Parliament as to whether the list should include PBT (persistent, bio-accumulative and toxic) and VPVB (very persistent, very bio-accumulative) chemicals (and possibly endocrine disrupters). We think that PBT and VPVB chemicals should be regarded as of very high concern and be subject to authorisation, and we support the Council's position against the current position of the Commission and the Parliament.


15. The success of the regime proposed in the White Paper will in two crucial respects be dependent on adequate resources being made available. We find it impossible to accept the White Paper's optimistic view that the substantial extra regulatory effort that will be required can be provided with no net increase in public resources. We agree with the Council that "Member States and the Commission must commit themselves fully to an effective implementation of the new system by ensuring sufficient resources at all levels and through Community measures to facilitate the implementation by Member States".

16. We also agree with the Council that adequate resources must be provided for research, development and validation of globally accepted test guidelines for alternatives to the existing techniques of animal testing. Animal testing is an extremely sensitive subject. Concerns have been expressed by many of our witnesses that the White Paper proposals will lead to a big increase in animal testing; and the majority of those witnesses believe that finding acceptable alternatives will take much longer than the deadlines that the White Paper proposes for the implementation of the new regime. The British Union for the Abolition of Vivisection provided arguments that alternatives could be found and was more optimistic than other witnesses about the timescales.

17. In our view the White Paper provides a rare opportunity to generate the political will in the EU to promote non-animal testing. The United Kingdom Government must take a lead in this and should make it clear in the Council that it cannot accept a new chemicals strategy that leads to significantly increased animal testing. This would be unacceptable to the public and could well cause the strategy to fail. The EU chemicals strategy must therefore be linked to an EU strategy for minimising animal testing. All witnesses agreed that the search for acceptable alternatives would require the commitment of substantial additional resources. The United Kingdom Government is more likely to be successful in pressing this argument if it has its own well-funded programme for finding alternatives.


18. Our report covers many other aspects of what is a complex subject and includes our initial conclusions on the responsibilities of the proposed "central entity" that would administer the system; the need for transparency and stakeholder involvement; the need for post-marketing surveillance; difficult issues involving imported products; and the manner in which the White Paper proposals relate to other international arrangements. We refer to extremely important and sensitive matters still to be decided in relation to the political process and the manner in which decisions are to be reached.

19. Following the guidance given by the Environment Council in June 2001 the Commission has established a number of task forces to work on problem areas and the numerous unresolved issues. It is not now expected to come forward with its legislative proposals before the middle of 2002. In these circumstances this can only be seen as an interim report. The Committee will, no doubt, have to return to the subject again when those proposals emerge.

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