Select Committee on European Union Thirteenth Report


215. We now draw together the conclusions and recommendations of this Report, as shown in bold type in the main text above. (Numbers in brackets are cross-references to the corresponding paragraphs in Part 4 of the Report.)


216. In our opinion the White Paper is right to set deadlines, by which relevant information on existing chemicals will have to be made available by industry, but in other respects it is unrealistically overambitious. (81)


217. We doubt the necessity, or indeed the desirability, of creating a "single system". The new EU 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. (82)

218. We are encouraged that the new chemicals scheme is generally thought a success, and since the White Paper proposes to extend to existing chemicals some of the principles and procedures that now apply to new chemicals we think it is important that a more thorough review of the success of the scheme for new chemicals (both benefits in preventing adverse effects, and costs in terms of money and animal lives) should be carried out than is provided by the anecdotal evidence we have heard. In particular we would like to know more about chemicals that have been developed but never marketed because of the scheme. (85)

219. We agree that an important reason why the Existing Substances Regulation has been so slow to produce results is that industry has had no incentive to provide all the necessary data; we therefore agree with the Environment Council's conclusion (no 28) that "it must be ensured in the new system that a chemical cannot 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". (87)

220. To merge the regime for new and existing chemicals seems to us to be an added complication. Since the regime for new chemicals has not been the subject of criticism in the same way as the regime for existing chemicals, we recommend that the Commission focus attention first on reforming the regime for existing chemicals. (90)


221. We believe that the setting of deadlines is necessary to focus the minds of industry, and we agree with DEFRA that the data must be limited to what are sufficient to allow initial prioritisation. What is now required is for a definition at EU level of the minimum amount of hazard data that would have to be provided for all chemicals in different tonnage categories to enable prioritisation of those chemicals needing risk assessment and risk management measures. We recognise that the more information is regarded as essential the longer the time-scales will have to be, and that the less information that is required the more difficult it will be to prioritise chemicals with confidence. We are aware that the Commission have established task forces to study this matter. (94)


222. We certainly favour an authorisation system if it can be made to produce faster results for chemicals of very high concern, but in the absence of knowledge of the detail the Committee does not want to come to a final view on whether a revised Marketing and Use Directive could co-exist with an authorisation system. (98)

223. The present debate in the EU is about whether PBTs (persistent, bio-accumulative and toxic substances) and VPVBs (very persistent, very bio-accumulative substances) should be regarded as of very high concern and so subject to authorisation. We think they should be and we support the Council's position against the current position of the Commission and the Parliament. (102)


224. The Council, in its conclusions of 7 June (no 34), "underlined that Member States and the Commission need to 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 the Member States." Although this Council statement does not explicitly say that the resources must be increased, and the extent of the necessary increase is dependent on any modifications that can be made to the scheme, it says clearly that the resources must be provided to make the system work. We agree. (108)


225. We agree with the Council conclusion that "responsibility for administration of the REACH system has to be shared between public authorities in the Member States, the Commission and a central entity" (no 33), and also that the organisation of a central entity requires further investigation (no 48). We believe it should not be difficult to agree that the entity should take on the burden of maintaining the registration database and have some powers to require extra information if the registration dossier is incomplete, but that the extent that it is involved in evaluation and authorisation will prove more difficult. (116)

226. We have an open mind about the organisation of the central entity and whether it should be an expansion of the existing European Chemicals Bureau, be a network of linked bodies, or be an entirely new body. We await the outcome of the Commission's feasibility study. (117)


227. We recognise that the powers and procedures for taking the many kinds of decision implied by the REACH system are important and sensitive issues, on which the White Paper is, frankly, opaque. We have ourselves not explored this area in any depth. We would, however, wish to be assured that the need to study it carefully has been recognised. We await the Commission's further proposals with interest. (123)


228. We recognise that the proposal to transfer responsibility to industry to conduct preliminary risk assessments is one of the most important in the White Paper. Since the authorities will not have the resources to conduct them all themselves, we support the proposed transfer. We understand the reservations of environmental bodies and we welcome the recognition by the Council that industry should take steps to ensure the quality of their risk assessments, since public confidence in the system will depend on it. However we go further than the Council in recommending that the Commission, when it makes its legislative proposals, should include guidance and detailed rules on how industry should conduct and present risk assessments. These should deal with peer review, openness, and the need to distinguish factual information and value judgements. They should recognise the complexity of downstream uses and deal realistically with what downstream users can contribute. (131)


229. We believe that 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 by manufacturers or downstream users as proposed in the White Paper. We do not believe that the complexity of downstream uses is adequately reflected in either the White Paper or the Council's conclusions, and consider that it requires much closer study. Product registers at national and EU level should certainly be considered. A solution may be to limit the requirement on industry to provide preliminary risk assessments to chemicals meeting certain priority criteria. We suggest that estimates be prepared of the number of preliminary risk assessments that industry is likely to have to produce (a) under the current White Paper proposals and (b) as modified if certain criteria are laid down limiting them either by the intrinsic hazards of the chemicals and/or by the uses to which they are put. (145)


230. We agree with the Council conclusions that "all uses of concern of chemicals in products must be covered by the new system" (no 31) and that "the new chemicals policy . . . must be consistent with WTO rules" (no 17). Given the difficulties, we welcome the establishment of the Commission's working group to develop more detailed proposals. We urge the Commission to consider carefully the possible effects on retailers and to be clear on what is expected of them. (150)


231. We support the proposal for an EU-wide information system on environmental concentrations and releases, which could well be a matter for the European Environment Agency to manage. (162)

232. We recommend that Government should develop a policy on post-marketing surveillance for industrial chemicals. This should be broader than just concentrations in the environment and should include uses of chemicals and effects on users. It should draw on experience in other countries and deal with the contribution that the chemicals industry can make. We see the study by the Environment Agency of a product register, and DEFRA's study of existing monitoring arrangements, as contributions to the process. Such a policy could influence the proposed European information system and could contribute to the development of indicators of environmental exposure to harmful chemicals. (163)


233. We have already recommended (paragraph 94) that there should be a definition at EU level of the minimum amount of hazard data that would have to be provided to enable prioritisation of those chemicals needing risk assessment and risk management measures, and we now add the recommendation that this definition should be informed by US experience and other international experience. (169)

234. We recommend that the Government and EU Member States ask OECD to attach greater urgency to developing ideas on how to handle non-High Production Volume chemicals in order both to inform the new EU policy and to ensure that duplication between OECD Member countries is minimised. (170)

235. Given the global nature of the chemicals industry we welcome the growing attention in international organisations to chemicals policy and the co­ordination that is taking place. The EU will sometimes have to adapt its legislation in response to international developments but is in a powerful position, particularly through the OECD, to influence international developments. (172)


236. We agree with the Commission that there should be continued involvement of stakeholders, and urge them to draw on existing experience in proposing how this should be done. (177)

237. We recognise the reluctance of formulators to give away information that gives them a competitive advantage, particularly if a chemical introduced cannot easily be discovered by analysis. We recommend that, while in general the registration database should be publicly open, some information on use that can legitimately be regard as commercially confidential should not be disclosed. There is a need for guidelines to clarify what can legitimately be regarded as commercially confidential and who decides. The same point applies to the constituents of products. We also agree that there is scope for improving the presentation of information. (182)


238. We endorse the view expressed both in the White Paper and by the Council on the need to promote non-animal testing, but go further in saying that the very success of any chemicals strategy depends on the public being reassured that a serious effort is being made to develop alternatives to animal testing. (191)

239. 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, since this would be unacceptable to the public and lead to failure of the strategy. The EU chemicals strategy must be linked to an EU strategy for minimising animal testing. 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. (199)


240. We recommend that over time the legislation should come to consist of separate items covering the following five topics:

·  Classification, packaging and labelling of chemicals and preparations

·  Registration and evaluation of new chemicals

·  Registration and evaluation of existing chemicals

·  Restrictions on marketing and use

·  Authorisation of chemicals of very high concern (207)

241. The highest priority should now be given to developing two items of legislation: authorisation of chemicals of very concern; and registration and evaluation of existing chemicals. Modification of the others need not be tied to the same timetable. (208)

242. Whatever scheme of new legislation is brought forward we will only be satisfied if it:

·  speeds the process of identifying chemicals that require risk management,

·  enables risk reduction measures to be adopted without delay following identification,

·  creates a sense of ownership among stakeholders and

·  provides for appropriate post-marketing surveillance. (209)

243. Meanwhile the present Existing Substances Regulations must not be neglected just because work is in hand to replace it. Indeed it may be some years before it is superseded by a fully functioning new scheme. The programme of evaluating 140 priority chemicals already identified for special attention, and the selection of more priority chemicals, should continue and we look forward to many more published risk reduction strategies. (210)

244. We believe that both the UK Government's Chemicals strategy and the UK Chemicals Stakeholder Forum have an important role to play nationally which can contribute to EU policy. (212)

245. Particularly in the present debate about the future of EU chemicals policy it is important to know what action the Environment Agency is now taking on industrial chemicals, what it can do, what it cannot do, and what it thinks it should do. We therefore urge it to publish the expected strategy document. (214)

Recommendation to the House

246. The Committee considers that the European Commission's White Paper, Strategy for a future Chemicals Policy, raises important issues of policy to which the attention of the House should be drawn. It therefore makes this Report for Debate.

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