Select Committee on European Union Thirteenth Report



Transparency and Stakeholder involvement

173. The White Paper devotes a section to "Information to the Public" (section 9) which says the Commission is "committed to ensuring the continued involvement of stakeholders representing the full range of interests in the implementation, management and review stages of the Strategy", and that "EU citizens should have access to information about chemicals to which they are exposed." The White Paper argues that better access to information will increase public awareness which in turn leads to greater accountability on the part of industry and authorities.

174. The Commission proposes to develop further its published collection of data on chemicals, and that indicators on the risk of chemical use should be established. It believes that industry, including downstream users, should mainly be responsible for providing information about the health and environmental effects, other serious hazards, and "safe instructions for use" (sic) of chemical products. The Commission notes the lack of public awareness of the requirements of current chemicals legislation and believes, perhaps optimistically, that the new system should be more easily understood.

175. The one firm action proposed is that the public should have access to the non-confidential information on the central system database, and that easy to read summaries will be prepared, including "a short profile of the hazardous properties, labelling requirements and relevant Community legislation, including authorised uses and risk management measures" (Action 9A).

176. The Council conclusions of 7 June twice refer to public involvement and stakeholder involvement. They call on the Commission to set up a taskforce, limited in time and involving stakeholders, to explore ways in which chemicals of concern can be identified to allow prioritisation for taking action (no 37) and they say that "Stakeholder access to the non-confidential information on the central system database is important but not sufficient." (no 32) They go on to say that "further measures to improve access to information should be worked out to enable consumers and professional users to make the best choice from an environmental and health point of view. Such measures should be based on a general duty for manufacturers, downstream users and distributors to provide comprehensive information on the content of chemicals in products and their hazards and risks in an accessible and understandable form and to label products appropriately, while taking intellectual property rights into account." (ibid)

177. The Council, while calling for stakeholder involvement in the task force on prioritisation (conclusion 37), does not talk of any continuing role for stakeholders as policy develops. The Commission, on the other hand, talks of "ensuring the continued involvement of stakeholders" without spelling out how this should be done. The Green Alliance refers to the UK Chemicals Stakeholder Forum and says that "The Commission should give serious consideration to ways of involving the public in its chemicals strategy" (p 231) and the Netherlands Government says that "the possible role of an independent body (such as the British Chemicals Stakeholder Forum . . . ) . . . could be considered" (p 242). 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. We were interested to learn from WWF-UK that the risk assessment meetings for industrial chemicals (unlike those for pesticides) held by the Commission—presumably under the Existing Substances Regulation—are already open to bona fide observers (Q 349).

178. WWF-UK believes the registration database should be made publicly available and regrets that the draft strategy does not clearly lay down that the public should have the right to know all the constituent of products (p 138). Friends of the Earth, in a section of their written evidence headed "Right to Know", notes the same two elements: "a right to know all the safety data about the chemical—there is no justification for commercial confidentiality—and the right to know what chemicals are used in the product we buy" (p 35).

179. The Environment Agency believes that firmer proposals are required on how public access could be achieved, and notes that environmental sections of safety data sheets are often poorly addressed and not generally available to the public (p 4).

180. There appears to be no dispute that in general information on the registration database should be public but there is a dispute about whether some information should be withheld on the grounds of commercial confidentiality. We foresee little difficulty in finding general agreement that all hazard assessment data should be public once the issue of sharing test data is resolved (see paragraph 133), but we foresee disagreement on publishing all exposure data if this involves revealing all specific uses to which a chemical is put. This confidentiality point also arises with the constituents of products.

181. We received some anecdotal evidence that illustrates the difficulty. Mr Rieck from the British Coatings Federation referred to a product 80 or 90 per cent of which may be "a well known chemical which we buy and which becomes a part of the mix of our product. However as little as 0.01 per cent or smaller may be an additive which could come from anywhere in the world, which will mean the difference between our product either being successful in the task it is designed to achieve, or giving us a competitive edge" (Q 186). He gave the example of plastic headlamps which are now favoured by the automotive industry for safety and fuel consumption reasons. The plastic is polycarbonate, which "has a real problem when you meet winter salt and you try to scrape it off on the garage forecourt, it scratches like the devil. We have come up with a coating which resurfaces the polycarbonate and withstands exterior conditions. That product was in the order of five to seven years in development . . . and enabled three SMEs to conquer a global market. . . . Almost all our multinational competitors, the giants of the industry, would give their eye teeth to know what we have put in that. What we have actually put in it are a series of chemicals. I am not going to give you a list of them now, but what I will tell you is that once they are actually on that headlamp lens they are completely inert, they have no side effects, no causes of problems, beyond that which the plastic itself has. Under those circumstances . . . the actual ability to detect exactly what is in there is relatively limited." (ibid) We have already quoted a similar example relating to tennis balls and tyres (paragraph 149).

182. 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.

Animal testing

183. All our witnesses who referred to the subject, as is to be expected, wanted animal testing minimised. Indeed the very success of the strategy is dependent on this, according to the Royal Commission on Environmental Pollution (RCEP), who said "there must be grave doubts as to whether the public will accept the increased level of animal testing that seems to be implied" (p 247). Many recognised that some animal testing would have to continue, while some were totally opposed.

184. The White Paper lists promotion of non-animal testing as one of the key elements of the proposed strategy (paragraph 2.3) and sets out three approaches: minimising test programmes, maximising use of non-animal test methods, and encouraging development of new non-animal test methods. It lists five elements of the new system that have been developed to minimise animal testing (paragraph 3.2), but nowhere does it say explicitly that an increased level of animal testing is bound to result from the proposal to register, over a tight timetable, some 10,000 chemicals produced in quantities of over 10 tonnes per annum (and therefore requiring "base set" testing), as well as the need for some testing of the remaining 20,000 or so chemicals.

185. The Royal Society of Chemistry said "the strategy will inevitably lead, at least initially, to a very significant increase in animal experiments" (p 18), and the Royal Society said "implementation of the proposals is likely to lead to a substantial increase in animal testing for the foreseeable future" (p 249). We were given some estimates of the number of tests required by the Royal Society for the Prevention of Cruelty to Animals (RSPCA) (pp 83-84, 87; QQ 226-228) and by the Institute for Environment and Health (QQ 261-265; pp 115-122).

186. There is already EU legislation intended to minimise animal testing. One Directive requires the principles of Reduction, Refinement and Replacement (known as the "three Rs") to be applied to animal experiments[45] and another group of Directives requires inspection of laboratories and for them to certify that their tests are carried out in accordance with the OECD principles of good laboratory practice.[46] As explained by Mr Visser of OECD (see paragraph 166 above) this, together with the OECD test guidelines, enables test results to be accepted by other countries and so helps avoid duplication. The White Paper describes the OECD Test Guidelines Programme as a "major breakthrough in minimising animal testing" (paragraph 3.2).

187. The White Paper refers to the requirements of the present schemes for new and existing chemicals for the sharing of data between manufacturers but proposes (Action 5F) new provisions to avoid duplicate tests involving vertebrate animals. The White Paper also proposes to foster research on development and validation of alternative methods (ibid). The European Centre for the Validation of Alternative Methods (ECVAM) of the Commission's Joint Research Centre is already active in this area.

188. The Environment Council in its conclusions of 7 June (no 23) recognised the need to limit animal testing and set out four aims:

·  industry should make all existing data available to avoid duplication

·  mechanisms are needed to ensure that unnecessary testing requirements are avoided

·  adequate resources must be provided for research, development and validation of test guidelines for alternative in vitro test methods, and this should be a priority for the new Framework Programme for Research

·  the EU should play a more active role in OECD to encourage non-animal testing, as well as promoting this in ECVAM.

189. The second of these aims was developed in another conclusion (no 43), which calls on the Commission to develop procedures to simplify the identification of relevant testing strategies including the use of decision trees and screening methods, such as validated computer modelling and testing to identify chemicals that are persistent and bioaccumulative.

190. In a report prepared for the then DETR in April 2001[47] the Institute for Environment and Health (IEH) estimated that at least 12 million vertebrates (8.4m mammals and 4.4m fish) would be required for the testing proposed. The RSPCA gave two estimates based on different assumptions (pp 83-84). The two organisations discussed each other's estimates (QQ 226-228 and 261-265). Dr Phillips of RSPCA was quoted as agreeing that their 3m figure was probably too low and that the IEH estimate of 8.5m (sic) should be regarded as a maximum (Q 226). However, his colleague Dr Hawkins stressed that "numbers are important but it is very important not to get too hung up on numbers. It is a question of what these animals are actually going to experience and it is likely to be extremely unpleasant in some of the tests. We are clearly talking about a significant number of animals whichever way we calculate it." (ibid)

191. The IEH report also concluded that "It is estimated that the testing facilities in Europe alone do not currently have sufficient capacity to meet the proposed schedules for testing" and that therefore the deadlines in the White Paper could not be met. This conclusion serves to reinforce the ethical argument that the amount of animal testing must be reduced. 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. Professor Combes of Focus on Alternatives proposed that there should be a White Paper on developing alternatives (Q 232).

192. We asked Dr Levy of the IEH what the prospects were for developing alternatives to animal testing within the time-scale of the White Paper (Q 258); in response the IEH undertook a further review and submitted further written evidence, which we were grateful to receive. The conclusion states that "in several key areas (particularly non-genotoxic carcinogenesis and repeat dose and reproduction toxicity) it is unlikely that it will prove possible within the foreseeable future to introduce further replacements for existing in vivo tests to any significant extent. Possible exceptions . . . (relate to) skin/eye corrosivity and severe irritancy." (p 119) The IEH is more encouraging with respect to the more limited testing proposed by the White Paper for chemicals produced in quantities of under 10 tonnes per annum, where the White Paper says "testing should generally be limited to in vitro methods". The IEH's further evidence concludes that "it is possible that a battery of non-animal tests, capable of adequately assessing a range of endpoints, could be developed within the required time-scales, provided sufficient funding and resources were made available. However it is unrealistic to expect such a screen to be capable of replacing either the in vivo acute or 28-day toxicity studies specified for the base set level." (ibid)

193. The view that some animal testing will be necessary was shared by the Royal Society, which quoted the example of tributyl tin (TBT), a substance which has led to major declines and extinctions in mollusc populations. "This is the only well-documented example to date of an identified endocrine disrupting chemical (EDC) causing abundant, undisputed and world-wide population-level effects in wildlife. In cases like this only in vivo testing will give us the information required." The Royal Society underlined the need for a programme of research into alternatives but pointed out that at least in the UK it is not "cutting edge" research so unlikely to attract Research Council funding (p 249).

194. A strong statement of the need for animal testing was made by RCEP when inviting evidence on 24 October 2001 for its study on the long-term effects of chemicals in the environment. We found their comment particularly interesting given their views quoted above on public unacceptability of increased animal testing. The RCEP said: "The ability to predict human or environmental toxicity without recourse to animal or tissue experiments seems very limited at the moment. Quantitative Structure Activity Relationships (QSARs) and rule based expert systems might be useful for priority setting, but they seem too unreliable and limited in application to provide any real help in risk assessment. In vitro test methods exist for only a few endpoints and there seems little prospect of any dramatic shift away from in vivo testing, without acceptance of much greater uncertainty in the assessment of the adverse human effects." The need for continued animal testing was accepted, no doubt reluctantly, by many of our witnesses, including the National Council of Women (p 234) and WWF-UK (Q 380).

195. A contrary view came from the British Union for the Abolition of Vivisection (BUAV). They start from the ethical position that "irrespective of the development of alternatives, we would be opposed to the use of animals for toxicity testing", but their approach is also practical and they believe that "implementing a non-animal strategy for the testing of chemicals would not only be more humane but would also meet the needs of the chemical strategy more effectively, it would be more cost effective, it would be more practical, and it would enable the Commission to meet some of its objectives of actually testing the number of chemicals required within that time frame." (Q 533). As Dr Langley of BUAV put it, "we are caught between a rock and a hard place, are we not? Because if we proceed down the conventional toxicology line, equally we will not meet the EU deadline, not by a long shot." (Q 541)

196. The BUAV sent us their published document called "The Way Forward: A Non-Animal Testing Strategy for Chemicals", which considers the toxic endpoints required for the White Paper's strategy, looks at the current failings of animal tests, looks at the current state of alternatives and recommends priority action for each of those endpoints that would bring a new system of non-animal testing into play (Q 533).

197. We were impressed by the evidence from the BUAV and believe that their a priori opposition to animal testing should not be regarded as a reason to discount their arguments that non-animal testing may produce better results (Q 538), more reproducible results (QQ 538-9) and faster results (Q 562). We believe their scientific arguments should be examined carefully as well as their arguments about the blockages to progress on the acceptance of non-animal tests. They summarise these as lack of resources and lack of political will (pp 200-1). We are not ourselves able to judge the arguments about total replacement of animal tests, and given the evidence of such authoritative bodies as the Royal Society and RCEP, as well as the report written for us by IEH, we reluctantly have to accept that some animal testing will have to continue within the time frame of the White Paper. We do however agree that there is a lack of resources and of political will in the EU to bring non-animal tests into use.

198. Among the Member States, the United Kingdom Government particularly recognises the importance of the issue. Mr Meacher said "I agree, too, that we must put resources into trying to develop those (alternative validated test methods) as rapidly as we can. I have carried the flag—I am not alone in this—in the Council. I do care very strongly about this. I think there is something like 2.7 million in vivo tests on animals in this country. I have always thought that that was far too high and that there is nothing like enough effort put into finding acceptable alternatives. . . . Other Member States did support that position in the Council, but I accept that it is the UK that probably is, I think rightly of course, most influenced by this consideration." (Q 503). Dr Hinchcliffe of DEFRA said "we are trying to secure an additional substantial budget specifically for research into this area. If we are successful, that will allow us to go ahead with a major programme of funding alternatives to animal testing, alternative test methods" (Q 504).

199. 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.

In conclusion—the Way Forward

200. In criticising the White Paper for being unrealistically overambitious, we do not wish to be misunderstood. We are not saying that the proposed strategy is so misguided that it should be completely abandoned, but for the following reasons we believe it will not succeed in its present form:

·  The production of thousands of hazard assessments will involve a significant increase in animal testing, which will be unacceptable to public opinion and will anyway overstretch the testing facilities available;

·  Producing risk assessments is a difficult process, involving judgement, and the production of thousands is unprecedented;

·  The obligatory involvement of the very many small downstream users in the risk assessment process is a step into the unknown; and

·  For the system to be credible significant resources will have to be directed to the public authorities in order to oversee it effectively.

201. Despite this critical conclusion we have welcomed many of the proposals in the White Paper and recognise the stimulus it has provided for discussing the future of EU chemicals policy. We have not called in question the starting point for a new strategy: that chemicals bring many benefits to society but some may be presenting long-term risks to the environment and human health and need to be regulated. This issue cannot be neglected, and while the White Paper may be overambitious we prefer to have examined an overambitious proposal to one that was excessively cautious. What we are calling for is a modified strategy that would generate enough information so that attention can be focused initially on chemicals of greatest concern. We therefore firmly support one of the principal recommendations of the White Paper, that industry should carry the responsibility for providing the necessary information.

202. Since one of our conclusions is that we doubt the necessity or indeed desirability of creating "a single system", we offer another way forward. It is clear that chemicals policy is a complicated subject that is evolving rapidly and that whatever proposals are finally adopted by the Council and Parliament arising out of the White Paper will not be the last word. Experience of existing chemicals legislation shows that it is being almost continuously amended as knowledge develops and to take account of international agreements. It is therefore helpful if the policy is broken down into a number of separate items of legislation any one of which can be amended without disturbing the others, so long as together they form a coherent whole. Coherence neither requires a "single system" nor a single piece of legislation.

203. We have outlined existing EU chemicals legislation above (paragraphs 32-40) and for the purposes of the White Paper there are four relevant items:

·  Directive on classification, packaging and labelling of chemicals which also includes the scheme for notifying new chemicals

·  Directive on classification, packaging and labelling of dangerous preparations

·  Regulation on evaluation of existing chemicals

·  Directive on restrictions on marketing and use

204. By historical accident the scheme for notifying new chemicals was introduced as an amendment to the Directive on classification, packaging and labelling of chemicals and thus added complication to an already complicated Directive. (Arguably this is now the single most difficult item of EU environmental legislation to understand, not helped by having been amended seven times and adapted to technical progress twenty-five times and by there being no official consolidated text.) We suggest that the scheme for notifying new chemicals be separated out and made the subject of another Directive. Classification, packaging and labelling will have to be reviewed to take account of the new UN Globally Harmonised Classification and Labelling System (see paragraph 172 and Action 7C of the White Paper), and possibly both chemicals and preparations could be combined into one Directive.

205. The Regulation on evaluating existing chemicals should be replaced with a new one introducing the first two elements of REACH (registration and evaluation) along the lines suggested in the White Paper but taking account of the recommendations made above. Arrangements for post-marketing surveillance can be set out in the legislation on new and on existing chemicals.

206. Even when there is a new Directive or Regulation dealing with authorisation, the scheme for restricting marketing and use will almost certainly need to continue, possibly in modified form, if only to keep alive the existing restrictions until such time as they are made redundant by the authorisation system.

207. In summary therefore 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

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

209. 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.

210. 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.

211. Finally we pass a comment on national policy. In taking evidence we have not concentrated on the Government's chemicals strategy, set out in the December 1999 document Sustainable production and use of chemicals—a strategic approach[48], which recognises that most legislative action including restrictions and bans has to be taken at EU level. Instead the strategy is intended to make information about risks widely available, to stimulate research on environmental impacts, to encourage industry to speed up assessments, to take risk reduction measures voluntarily when a chemical is of concern, to preserve the competitiveness of industry, and, by establishing the Stakeholder Forum, to encourage involvement and build trust.

212. The UK Chemicals Stakeholder Forum's first report[49] says that its role is to try to speed the process by advising the Government on the voluntary action industry should take to reduce risks. In particular it has advised on the criteria for identifying chemicals of concern. We believe that both the strategy and the Forum have an important role to play nationally which can contribute to EU policy. The Government can also put in place its own policy for post-marketing surveillance independently of any EU legislation, and we have recommended that it does so (paragraph 163).

213. The Government's strategy document refers (para 1.4) to development by the Environment Agency of "a new strategic approach to chemicals in the environment which will be published in 2001." When the Agency gave evidence to us in May 2001 they told us of the objective of their strategy on chemicals (Q 4) and said they were consulting on it (QQ 41-42). We were therefore disappointed to learn in November that while there were hopes for what the chemical strategy would achieve no document had appeared, and there was no immediate plan to launch one (Q 438).

214. It is clear that the Environment Agency has a key role to play in chemicals policy. Nationally it is the most important environmental regulator of industry. It is the authority that (together with the Health and Safety Executive) both conducts risk assessments and evaluates risk assessments carried out by industry, regulates industrial plants with powers over inputs as well as emissions, regulates waste management, and is responsible for monitoring the state of the environment. We were told it was not responsible for products (Q 431). 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.


45   Directive 86/609/EEC, OJ L358, 18.12.86. Back

46   87/18/EEC, OJ L15, 17.1.87; 88/320/EEC, OJ L145, 11.6.88; 90/18/EEC, OJ L11, 13.1.90. Back

47   Testing Requirements for Proposals under the EC White Paper "Strategy for a Future Chemicals Policy", MRC Institute for Environment and Health, University of Leicester, 2001. Back

48   See paragraph 43, footnote 19 Back

49   See paragraph 43, footnote 20. Back


 
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