An ambitious programme

78. The Commission has set out a highly ambitious programme in the White Paper, which Mr Visser of OECD went as far as to call "quite courageous" (Q 421). Chemicals policy is young, and the evidence we have received shows it to be a difficult subject, given the large number of chemicals that society finds useful but which present uncertain risks.

79. EU chemicals policy has evolved in three phases: from ad hoc restrictions on individual chemicals which were known to be harmful (starting in 1976); followed by a system for evaluating all new chemicals before they were marketed (starting in 1981); to a system for drawing up priority lists of existing chemicals to be evaluated (starting in 1994). It is because this third phase has developed much more slowly than foreseen that the White Paper has been produced.

80. Paradoxically the White Paper proposes to speed up the process of evaluating the large number of existing chemicals by replacing a system that focused on priority lists, by what it calls "a single coherent system"—known as REACH—which is comprehensive in the sense of dealing both with new and existing chemicals, and which foresees relevant information being registered over a tight timetable ending in 2012 for all chemicals (about 30,000) produced in quantities over 1 tonne per annum. It hopes that this will be achieved by placing much greater responsibility on industry (including downstream users) to supply data on hazards, on uses, and on exposure, and to carry out preliminary risk assessments, and also by creating a central entity (possibly an expanded European Chemicals Bureau) to administer the REACH system.

81. 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. This point has been recognised in the Environment Council conclusions of 7 June[32], which call for (no 18) the development of "streamlined, pragmatic and effective procedures to overcome the present lack of knowledge about the properties, use and exposure of existing substances as well as the slow pace in the development of risk assessment and risk management measures. The requirements for registration of substances must set out what is realistically achievable in the Community while providing a high level of protection for human health and the environment."

82. Much of the evidence we received reinforced this view in calling for a means of prioritisation so that attention is focused on the chemicals of greatest concern and so that testing on animals is minimised. In our opinion not only is the programme in the White Paper overambitious but we also 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.

The Current Schemes

83. The evidence we received supported the view of the White Paper that the "current EU legislation for new substances is generally considered to have been successful" (paragraph 3.1), although the Royal Society for the Prevention of Cruelty to Animals said "We would like to know how this conclusion was reached, what criteria of success were considered, and how broad the consultation was" (p 86).

84. Mr Warner of the Health and Safety Executive said "If we say that the original objective was to make sure that there was a portfolio of good quality data for the new substance before it was placed on the market, yes, I think it has been successful. There is now, which there was not hitherto, high quality and reliable information available for the users of a chemical to make sure that they take the right precautions for the environment and for people" (Q 24). Mr Warner went on to say that the scheme may also have resulted in manufacturers not placing some chemicals on the market which in the absence of the scheme they might have done, because "in the course of being tested and evaluated they were found to be much more unpleasant than they were thought to be" (Q 25). If this is correct it is an encouraging example of the principle of precaution or prevention being applied.

85. The only report that we have seen that examines the new chemicals scheme in detail—the so-called SLIM Report[33]—comes to a favourable conclusion while suggesting improvements.[34] The SLIM Report is however part of a programme which is primarily concerned with ensuring that single market rules are not unnecessarily cumbersome rather than reviewing policy. 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.

86. The failure of the Existing Substances Regulation is generally acknowledged. The Environment Agency says "there is a self-evident need to modify the system for assessing existing chemicals" (p 2). DEFRA submitted a paper analysing the deficiencies which we have summarised above (paragraph 68). The Chemical Industries Association said "We are where we are today because existing regulation has not delivered" (Q 139). However, there is not complete agreement as to why. Professor Taylor, speaking on behalf of the Royal Society of Chemistry, said "It has not worked because the risk assessment process that is associated with that particular Regulation has been painfully slow" (Q 62). He believed that the data had been available but that the risk assessments had not been done because "governments have not put the resource into doing it" (Q 64). Dr Inch, also from the Royal Society of Chemistry, took a slightly different view: "I think the problem with a lot of the risk assessment is that the data, in particular the data for long-term chronic exposure . . . is very poor. The acute data, the exposure of people in the workplace data, is very good and people can react to that. The long-term exposure (data) . . . is very poor and nobody quite knows what it means when doing some of the risk assessment" (Q 66).

87. These views underline one of the differences between the schemes for new and existing chemicals. For new chemicals there can be no practical experience of either acute or chronic effects and the testing may well reveal acute effects which on their own may lead to a decision not to market the chemical. For existing chemicals, data about acute effects will have built up perhaps over many years, but data on chronic effects may be lacking. Another difference between the two schemes is that a manufacturer cannot market a new chemical before carrying out tests and an assessment, whereas an existing chemical is already on the market and there is no similar pressure to conduct tests and an assessment. Indeed the White Paper, in the passage (page 19) already quoted in paragraph 69 above, identifies this as a major flaw in the Existing Substances Regulation. 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".

A single system

88. Many of those giving us evidence supported the Commission's proposal for a single system, although the National Council of Women of Great Britain thought it was too soon to introduce a single regime (p 233). DEFRA said in written evidence that "in principle there is a case for treating all new and existing chemicals equally". However DEFRA then went on to point out the practical and ethical (animal testing) considerations of getting the same data for all existing chemicals as is now required for new chemicals and concluded that "the requirements for existing and new substances may not need to be identical" (p 178).

89. The Chemical Industries Association pointed out that there had to be differences in the approach to new and existing substances since "for an existing substance there will be a body of experience in its use that should be taken into account, while for a new substance it will be possible only to estimate use patterns and, therefore, potential exposure" (p 54).

90. 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.

Prioritisation and deadlines

91. For different reasons many of our witnesses agreed that the White Paper proposals for the amount of data to be provided by industry at the registration stage could not or should not be produced by the deadlines proposed. The Chemical Industries Association called the White Paper proposals "a hugely expensive and bureaucratic system for which no justification is provided" and believed that the "target of 2012 for completion of the testing programme is not achievable, because of fundamental resource constraints" (p 54). The Association explained that these resource constraints concerned test house facilities and trained toxicologists (Q 142).

92. A report from the Institute for Environment and Health doubts that testing facilities in Europe have the capacity for the deadlines to be met (see paragraph 190). Friends of the Earth, while believing that the stricter deadlines in Sweden's new chemicals policy were achievable (p 34), was concerned that the registration system did not prioritise rapid gathering of preliminary data of all chemicals, and said that rather than delivery of a full data set by a given date, there should be a requirement to deliver data on persistence and bioaccumulation, with any other data that are available, including data from any testing that has already been done, and preferably some computer-based Quantitative Structure Activity Relationship (QSAR) data and in vitro data by this date (Q 106).

93. WWF-UK considered that the proposed deadlines were achievable, and that if the deadlines were enforced with prohibitions on marketing if the data were not provided, then the necessary resources would be made available (p 134). DEFRA believed that if the full set of testing requirements envisaged in the White Paper were implemented in legislation the deadlines would not be achievable. However, if the data set were limited to what was achievable and sufficient to allow initial prioritisation of chemicals of concern, then they could support the deadlines (p 178).

94. 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.

The authorisation system

95. The authorisation system is proposed only for chemicals of very high concern (see paragraphs 54-56). It raises three issues: the principle of the system; the details of how it will operate in practice; and the definition of the chemicals that are to be regarded as of very high concern. The last of these is proving controversial.

96. Given that the system is intended to shift the burden of proof on to industry we were interested that the Chemical Industries Association are not opposed in principle. They told us (Q 141) that "some of our colleagues in Europe appeared at the start to be objecting to authorisation in principle. We in the UK did not say that from the start; in fact, from the start we felt there was a place for authorisation, but that it would be the detail of the design of the authorisation process that would be critical."

97. DEFRA, in written evidence, said the main aim must be to ensure that action is taken quickly on chemicals of concern and that experience of positive approval schemes suggest that they can be slow and very resource-intensive. "It is not clear that the authorisation process would achieve faster action than bans or restrictions on specific uses of a chemical. The UK Government, therefore, believes that there will be a continued role for action on specific uses under a revised Marketing and Use Directive." (p 179; cf paragraph 34).

98. In oral evidence, the Minister, Mr Meacher, said that he thought a revised Marketing and Use Directive could co-exist with an authorisation system, but that it was probably too early to say. Dr Hinchcliffe of DEFRA added that it was not quite clear how the authorisation process would operate and that one of the options was amendments under the Marketing and Use Directive (Q 502). The Government thus appears to have an open mind on authorisation. 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. The Chemical Industries Association, despite not being opposed in principle, warned that the authorisation system could create "legal uncertainty and be more bureaucratic, slower and less effective than the existing system." If, says the Association, authorisation is regarded as necessary, "then it is essential that it be restricted to a small number of high priority substances." This brings us to the controversial issue of what chemicals should be subject to authorisation.

99. The White Paper proposes that the only substances to be subject to authorisation would be CMRs (carcinogenic, mutagenic and reprotoxic substances) and those with POP characteristics (persistent organic pollutants as defined in the Stockholm Convention[35]). The list does not include PBT (persistent, bio-accumulative and toxic) and VPVB (very persistent, very bio-accumulative) chemicals although we understand, inter alia from Friends of the Earth (p 34), that "an earlier draft of the White Paper included a proposal that such chemicals be incorporated into the authorisation regime, but that this was removed due to industry lobbying." The Chemical Industries Association told us (Q 166) that "we really cannot support the proposal coming from Sweden" (ie the addition of PBTs and VPVBs).

100. The Council in its conclusions of 7 June (no 45) unambiguously called on the Commission to add PBTs and VPVBs as soon as the necessary criteria for their identification were established, and envisaged the addition of endocrine disrupters when agreed scientifically valid test methods and criteria are established. The European Parliament's Committee on the Environment, Public Health and Consumer Affairs (rapporteur Inger Schörling) "insisted" that these substances should be included, but after hearing the Commissioner (Mrs Wallström), the plenary session of the Parliament on 15 November, for reasons not fully explained, amended on a majority vote the clause of the Resolution so that it only "asks the Commission to study whether it is necessary to extend the authorisation procedure to other substances such as PBTs, whose use is of high concern." The subject has thus divided the EU Institutions.[36]

101. To underline the difficulty of the subject, we received a supplementary memorandum from the Royal Society of Chemistry on "Persistence in Environmental Risk Assessment", which explained that there were no satisfactory standard methods to measure persistence but agreed that "half-lives have a significant part to play in environmental risk assessment and substantially more work needs to be undertaken to identify suitable test methods to measure them under realistic environmental conditions." (p 32).

102. In considering whether PBTs and VPVBs should be subject to authorisation it is important to recognise that this is not the same as the Swedish Government's policy that new products introduced on to the market should be largely free of man-made organic substances that are persistent and liable to bioaccumulate (irrespective of toxicity). The present debate in the EU is about whether PBTs and VPVBs 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.

Resources for regulatory authorities

103. The White Paper says that "a net increase in public resources is not expected since the REACH system refocuses the resources and removes resource intensive tasks from the authorities."[37] This view was not shared by many of our witnesses, and the Environment Agency said bluntly that it did not agree: "The timetable within the White Paper will inevitably require more regulatory effort to ensure appropriate actions are taken as data are generated. The number of substances requiring evaluation and authorisation vastly exceeds current programmes and public expectation will be that actions on these high priority chemicals will be taken forward rapidly. We believe that there must be substantially more effort from the regulatory authorities to ensure that data and assessments provided by industry are of acceptable quality. We anticipate innovative approaches being suggested by industry, such as grouping similar chemicals. While this may help industry meet registration deadlines, and reduce testing requirements, it will entail more effort from regulators to ensure that assumptions made by industry are acceptable."(p 3) This comment from the Environment Agency underlines the point that the amount of extra regulatory effort is dependent on prioritisation and deadlines, as we have discussed above.

104. The Chemical Industries Association believed that "the administrative requirements for registration of 30,000 substances and the further evaluation and authorisation that will be required for some of the substances, will be demanding, and the track record for similar systems with much smaller numbers of substances (eg the regimes for pesticides and biocides) is not encouraging."(p 52)

105. We believe that extra regulatory effort will be needed both in the Member States and by the "central entity" or expanded European Chemicals Bureau, which we discuss below. The White Paper's optimistic view of no net increase in public resources seems to be based partly on the decrease that would result from some changes proposed to the regime for new chemicals, and partly because more of the burden of contributing to risk assessments is being transferred to industry. But there is a question of credibility here.

106. If the preliminary risk assessments performed by industry are not scrutinised adequately by the authorities, then the public will lack confidence in the results. This point was made by WWF-UK, who argued not only that any risk assessments conducted by industry should be fully checked by the regulatory experts of the Member States, or by certified agencies under control of the regulatory authorities, but also that chemicals that are likely to be problematic should have their risk assessments conducted, rather than just checked, by the regulatory authorities of the Member States. (p 129)

107. In oral evidence Mrs Lyons of WWF-UK said "My real concerns are not how to prioritise but how to make sure we get the resources to do what we need to do at this stage . . . What we need is robust and accurate risk assessments to be brought forward in a timely manner . . . Whichever way you look at that, that will take both resources from industry and it will take resources from the regulatory authorities. The fact that there are no new real resources being made available for the regulatory authorities of the Member States is a real concern to me."(Q 360)

108. 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.

A "Central Entity"—the European Chemicals Bureau

109. If the REACH system is introduced there will be a need for a "central entity", as the White Paper calls it, to receive and maintain the registration dossiers. The White Paper also sets out other tasks for the central authority (see paragraph 57 above) but it is not yet clear to what extent it would be involved in the evaluation of chemicals and in the authorisation procedure. Nor is it clear whether it would be an entirely new body or an expanded European Chemicals Bureau (ECB), currently located at the Joint Research Centre (JRC) at Ispra, Italy. The White Paper says the Commission will carry out a feasibility study and a cost benefit analysis before establishing the central entity.

110. The Chemical Industries Association stated that "while we fully recognise the contributions that some of the Member States can bring to the system, our preference would be for a more centralised system operated by the ECB to ensure standardisation of performance in terms of both effectiveness and efficiency"(p 54). They envisage a powerful ECB, with some loss of power at national level (presumably for evaluation) and that "within the UK this would be quite regrettable, because the HSE, the Environment Agency, DEFRA, do a particularly good job. . . . However, standards do vary quite widely across Europe" (Q 146).

111. The Environment Agency saw a more limited role, and while supporting the development of the ECB to screen chemicals, help prioritise and co-ordinate activities and hold central databases, believed that Member States should retain a key role within the process, particularly through the evaluation stage (p 2).

112. Dr Levy of the Institute for Environment and Health, when talking about the need to filter existing data on chemicals and about who could do it at a European level, referred to the ECB but said "I would probably prefer not to put all my eggs in one basket, and tend to have maybe a number of centres collaborating to a uniform standard" (Q 268). So one possibility could be to have a network organisation so that a number of toxicologists, who are in short supply, would not all have to move to wherever the hub of the central entity was located.

113. Friends of the Earth pointed out one disadvantage of the current arrangement of the ECB, which is not a research body despite being located within the JRC. When the research budget was cut for the JRC the budget of the ECB was also automatically cut, even though its role is quite different. This could be overcome by having a separate body on the lines of the Medicines Agency (Q 116).

114. Dr King from the Royal Society of Chemistry pointed out the limitations of a scientific body being involved in evaluation and authorisation because of the socio-political elements that need to be taken into account (Q 71); we discuss this further below under the heading of decision making.

115. Mr Meacher admitted that his thoughts on the relationship between national authorities and the central entity were not yet developed, and Dr Hinchcliffe of DEFRA said that this was one of the key issues which would have to be addressed during the Commission's process of working out the details (Q 527). Mr Meacher felt that on balance he would strengthen the existing ECB rather than set up an alternative (QQ 490-1).

116. 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.

117. 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.

Decision Making

118. At present any decision to restrict marketing and use of a chemical has to go through the full EC legislative procedure (proposal from the Commission and involvement of Parliament and the Council under the co-decision procedure)[38]. The White Paper proposes (paragraph 8.1) that for the authorisation procedure "generally, a committee-driven mechanism will be applied for all decisions taken at Community level". By this we understand the so-called "comitology procedure"[39] is intended.

119. The White Paper also proposes a change in decision making at the evaluation stage. It points out that the current procedure under the Existing Substances Regulation to request additional testing from industry has proved extremely slow and cumbersome. Under the proposed system Member State authorities will be responsible for deciding on the additional testing procedures (which implies that they will have to have the necessary powers) and a committee procedure will be invoked only in cases where agreement cannot be reached between Member State authorities (paragraph 8.1).

120. The White Paper does not elaborate on this brief and opaque description, nor does it discuss other decisions that will need to be taken, such as whether a registration dossier is to be regarded as complete, and if incomplete whether a ban on marketing should be imposed as proposed in the Council conclusions (no 28). There may be little disagreement that the central entity should express a view on the completeness of the dossier, but should it on its own have the power to impose a ban? The Chemical Industries Association, who want a powerful ECB (see paragraph 110 above), imply that it should have some powers over evaluation.

121. We recognise that there is a dilemma between wanting quick decisions and wanting political consensus and that there are some decisions that should not be delegated to a primarily scientific central entity. Dr King of the Royal Society of Chemistry put it like this: "I think everyone also agrees that when it comes to risk management, bans and restrictions, there is not only science involved, there are socio-political elements, and there are economic questions to put as well. To a large extent I suspect the European Chemicals Bureau will be immune to those kinds of pressures. So somewhere along the way I think there has to be brought back into the system the political oversight that exists at the moment. Thus, if something is banned or restricted in the European Community ultimately it has to be agreed at a ministerial level at present. These proposals indicate it could be done by a technical committee in the future and that worries me somewhat." (Q 71) When we put to him the counter argument that an effective body was needed which could stand up to political pressures and say "this is the scientific position", Dr King replied "Yes, but I hope by that you are not saying that science should overrule the political, economic and social arguments, because I do not think that is real life" (Q 72).

122. Mr Meacher noted that the White Paper proposed use of the comitology procedure and said "there is a case for saying we would not want to bypass the political process in all cases, and maybe one should have some kind of compromise here by saying committee procedures should only apply where urgent action is required in the case of substances. I think we are content with the comitology procedure, if it reduces the excessive delays that exist, but we should reserve perhaps that kind of fast-tracking where really urgent action is needed." (Q 485)

123. 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.

Role and Responsibility of Industry

124. The White Paper devotes a complete section (5) to the role, rights and responsibilities of industry. It notes that although there is legislation in place along the whole manufacturing chain allocating the responsibility for the safe use of chemicals to manufacturers and users, this has not led to a satisfactory evaluation of the safety of chemicals. It accordingly sees a need for additional legal provisions setting out the obligations of industry more precisely. The most significant of these—indeed of the White Paper as a whole—is that industry, including downstream users, should be responsible for performing preliminary risk assessments which the authorities can then evaluate. We discuss the role of downstream users more fully in paragraphs 135-145 below.

125. Whereas the Chemical Industries Association has welcomed the proposal to transfer to industry the responsibility for initial (sic) risk assessment (p 52), both Friends of the Earth and WWF-UK were concerned at the proposal and have heavily qualified their support.

126. Friends of the Earth find it "unacceptable" that risk assessment should be delegated to the chemical industry, since this creates a dangerous conflict of interest (p 35). Instead they support the idea of industry providing a "preliminary risk assessment", but only if this is given a meaning different from that apparently intended by the White Paper. Dr Warhurst said: "we would see a preliminary risk assessment as something which includes what is known about the hazards of a chemical and also what is known about the exposure, but not necessarily any particularly elaborate combination of the two, whereas a risk assessment is a far more complex process, particularly with difficult chemicals. The evidence has shown that because there are so many judgements involved in risk assessments, particularly how to deal with uncertainties, you get very different answers depending who does them."(Q 112)

127. The difficulty and uncertainty of the risk assessment process were also emphasised by the Royal Society of Chemistry. Professor Taylor said: "Hazard assessment is primarily scientifically structured and relatively easy to do. Risk assessment is more complex. People have tried to say this is a purely scientific process. It clearly is not, because which risks you assess and what criteria you use to assess them have other than scientific components in them."(Q 83)

128. The White Paper does not say precisely what it means by a "preliminary risk assessment" but in the light of the statement (in Action 5B) that "industry should have responsibility for performing risk assessments" we understand it to be the assessment performed by industry before it is evaluated by the authorities, which could result in modifications by the authorities, but which if accepted by them without modification could stand as the accepted risk assessment.

129. As we have noted above (paragraph 106), WWF-UK considers that any risk assessment conducted by industry should be fully checked by the authorities, and that for problematical chemicals the risk assessments should be conducted by the authorities. WWF-UK believes that "guidance should be set out for how industry should conduct its risk assessments and some areas should be made very prescriptive" (Q 362). Mrs Lyons went into these in some detail, ending with the recommendation that the risk assessment should be in the public domain on the internet (ibid).

130. The Council, in its conclusions, recognised the "need to shift to industry, including downstream industrial users, the responsibility to generate knowledge about chemical substances and to assess and manage the risks arising from their use, enabling the authorities to focus on chemicals of highest priority" (no 19). However it also recognised the point about conflict of interests by saying "industry should also ensure the quality of their risk assessments and risk reduction strategies eg through auditing/peer review or by other means" (no 27).

131. 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 (see paragraph 145 below).

132. This transfer of responsibility to industry will be a considerable challenge, even with the modifications to the White Paper proposals that we are suggesting, but we believe it to be a challenge to which the industry should rise. Industry will know that its reputation will depend on the quality of its risk assessments. Other safeguards are that the authorities can choose to evaluate a preliminary risk assessment at any time; the interested public, including environmental bodies, can examine the registration dossier (see paragraphs 175 and 182) and can draw deficiencies to the attention of the authorities, as can competitors manufacturing a safer chemical; and the arrangements for post-marketing surveillance will provide an additional check on how well the system is working (see paragraphs 151-163).

133. The White Paper devotes a section (5.5) to the property rights of industry for test data and the sharing of such data to reduce costs and avoid duplicate tests on animals. We have not examined this issue of property rights, but we support the Council in its conclusion (no 49) which invites the Commission to "develop mechanisms and define practical rules . . . through which the industry makes testing data and other information available in order to avoid duplication of tests and market distortions, while ensuring an equitable sharing of costs taking due account of the property rights of the party who generates the data."

134. The Netherlands Government, who sent us their detailed comments on the White Paper, have emphasised the strengthening of the responsibility of industry as one of three main points that should be added to the White Paper.[40] The Netherlands believes that the responsibility of industry is "insufficiently anchored in the White Paper" and that it "must be fleshed out emphatically in the form of a formal duty of care and further specification of elements for which companies bear responsibility" (p 236). We note that the Council conclusions (no 25) underline that "a general obligation should apply for industry to obtain enough knowledge to take the measures needed to ensure the safety of chemicals (duty of care) irrespective of production volume and even if no specific data requirements have been established". We have not pursued these ideas and in particular we have not examined to what extent they are more appropriately developed in national rather than EU policy.

33   See paragraph 47. Back

34   The Commission working document SEC(1998)1986 reporting on the operation of four Directives and Regulations on chemicals does not evaluate the effectiveness of the new chemicals scheme in protecting people and the environment. Back

35   See paragraph 41. Back

36   See, for example, press reports in Europe Environment, No 600, 20 November 2001, pp I.23-I.24 and by Geoffrey Lean in The Independent on Sunday, 25 November 2001. An official account of the proceedings in the European Parliament was given by the Secretary of State for Trade and Industry in a written answer of 10 December 2001 (House of Commons Hansard, col 653W). Back

37   See footnote 12 on page 15 of the White Paper. Back

38   An exception is when a restriction has already been made and it is "adapted to technical progress" by a committee procedure provided for by Directive 89/678 ( OJ L 398, 30.12.89) that amended Directive 76/769. Some "adaptations" can be politically contentious. In 1999 an existing restriction on the marketing and use of some forms of asbestos was extended to most uses of white asbestos by 2005 under Commission Directive 1999/77 (OJ L 207, 6.8.99). This was opposed by Canada, a major exporter of asbestos, which referred the matter to the WTO. The WTO dispute settlement panel recommended rejection of Canada's complaint. Back

39   See European Communities Committee 2nd Report (1997-98) Community Environmental Law: Making it Work, HL Paper 12, 1 July 1997, paragraphs 29-35; HL Debates Vol 583 11 November 1997, Baroness Park of Monmouth at col 118; European Communities Committee 3rd Report (1998-99) Delegation of Powers to the Commission: Reforming Comitology, HL Paper 23, 2 February 1999. Back

40   The other two are a screening phase within the REACH system to set priorities and a strategy for taking risk reduction measures. Back