Select Committee on European Union Thirteenth Report

Downstream users

135. Under the existing regimes for regulating chemicals, downstream users have had no formal role and only manufacturers or importers of chemicals have had to supply information. The White Paper now proposes that downstream users as well as manufacturers will carry out adequate risk assessments (Action 5B); that authorities will be able to require downstream users to carry out additional testing where uses differ from those originally envisaged by manufacturers (Action 5A); and that downstream users must inform the authorities of uses not envisaged by the manufacturer and therefore not addressed in the preliminary risk assessment (Action 5C).

136. These proposals have generated concern among downstream users, many of whom are small and medium-sized enterprises (SMEs), aggravated by a lack of clarity in the White Paper as to how responsibility is to be shared between manufacturers and downstream users. Downstream users are also concerned that the "palette of chemicals" used by them to formulate their products may be reduced because manufacturers may withdraw some useful chemicals rather than go to the expense of testing them and conducting risk assessments.[41] A related concern that products containing chemicals no longer available in the EU will simply be imported is discussed in paragraphs 146-150 below.

137. The subject is rather more complicated than the White Paper suggests. The Royal Society of Chemistry point out that "supply chains can be very long, with a new chemical entity being compounded into several products which themselves are compounded into further products. The key question is who will notify whom about a new use and on what criteria? This requires considerable additional thought, otherwise systems established for this purpose could prove both exceedingly bureaucratic and probably ineffective" (p 18).

138. The Chemical Industries Association, which primarily represents manufacturers on whom will fall the main duty to conduct preliminary risk assessments, saw the problem thus: "Questions remain on how to ensure that downstream users are full participants in the system and contribute their knowledge of the uses of and potential exposure to substances, and, at the same time, protect commercially confidential information (p 55). When asked how responsibility should be shared, the Association—which had been discussing the White Paper with the trade associations representing downstream users (Q 153)—said "we would regard ourselves as the primary source of hazard data in relation to the substances that we produce. . . . The exposure data that are then necessary to compile the risk assessment associated with these substances is where we need to co-operate and collaborate with downstream users" (Q 154).

139. When we asked about the hazards of combinations of chemicals we were told how products of virtually no environmental concern (eg a mild shampoo) may have constituents which started life as intrinsically extremely hazardous. Such products "are a mixture of complex products and often the putting-together of the chemicals brings about normally highly desirous effects, and that is the skill of the formulator. . . . The process of how we are actually going to tackle the risk assessment of the intrinsic hazards of those products is something which is stretching our minds. We do not have a solution today. . . . We still have much to do in bringing together our combined expertise in such a way as to come up with something positive." (Q 155)

140. The British Coatings Federation "believe that the less than satisfactory proposals relating to downstream use are due to a lack of understanding in the EC and elsewhere of the distinction between chemicals manufacture and their subsequent downstream use"; they also "do not believe the EU institutions realistically can come to any conclusion on a chemicals policy that impacts on and requires the involvement of downstream users of chemicals without a greater appreciation of its complexity" (pp 70-71). To illustrate the complexity we were told that "one of our members uses about 2,000 raw materials and has about 50,000 active, live formulations on his data base, that is individual, separate, distinct products. Another has 4,000 and 80,000. Our best estimate for the UK coatings manufacturing industry is probably of the order of about 10,000 individual substances, 6,000 raw materials and 500,000 formulations." (Q 182)

141. We were also told that there are many examples of established uses of chemicals of which the manufacturers are unaware. The British Coatings Federation recommend that all current uses should be considered as intended uses and that catalogues should be drawn up of such uses (p 71). They also suggested an EU procedure for registering chemical uses (p 73).

142. The Environment Agency emphasised the lack of knowledge: "Unlike the Scandinavian countries the UK does not have a product register and we do not know which chemicals are used on the UK market and their use pattern. Information for any risk assessment therefore has to be collected on a case-by-case basis with the co-operation of industry, and there are often significant gaps on downstream uses" (p 4). The Agency has accordingly commissioned a study to consider a product register in the UK, which they will discuss with DEFRA "because if there were to be a product register it is potentially a major commitment, and it is quite right that we should demonstrate some real benefits, which is what we are trying to do at this stage." (Q 472)

143. DEFRA note the concern that the costs of the new responsibilities on downstream users might fall disproportionately on SMEs and that the requirement to inform authorities on uses is likely to be difficult to enforce and to generate a large volume of information. The Royal Society of Edinburgh made the same comment, adding that bodies such as schools, colleges, universities and hospitals would be similarly affected (p 252). DEFRA said "an alternative might be to restrict this requirement to chemicals where the information would be useful to regulators, perhaps to those chemicals meeting priority criteria" (p 180).

144. The Environment Council mentions downstream users several times in its conclusions (eg nos. 11, 19, 32, 36) but without indicating that there is a real problem here. The conclusions endorse the placing of responsibility on downstream users, encourage manufacturers and downstream users to develop an effective communication process, and call upon the Commission to clarify the responsibilities of manufacturers and downstream users.

145. 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.

Imported Products

146. The White Paper explains (Action 3E) that whereas chemicals placed on the market on their own or as constituents of preparations (ie mixtures or solutions of two or more chemicals) already have to be notified, this is not the case with chemicals placed on the market as constituents of products (eg toys and textiles). "Nevertheless, most of the substances included in such products are covered as they are marketed either as such (sic) or as components of preparations before being included into products." However, the White Paper goes on to point out that some products, in particular products manufactured outside the EU, may contain untested and unregistered chemicals which may be released during use and disposal. The Commission proposes to set up a working group to "identify the product categories..., the relevant exposure situations and all other practical implications. On the basis of this working group's findings, producers or importers should be requested to identify products containing such substances and provide any information, as appropriate." (ibid)

147. Many witnesses agreed that imported products had to be covered by the new system both to ensure protection of health and the environment and to ensure that EU manufacturers remained competitive with finished products originating from outside the EU. These included the Confederation of British Industry (p 220), the Chemical Industries Association (p 55), the British Coatings Federation (p 74), the Development Initiative for Chemical Dependent Areas in the United Kingdom (DICIDA­UK) (p 224), the Royal Commission on Environmental Pollution (p 247), the Federation of Chemical Associations (p 229), WWF-UK (Q 362) and Friends of the Earth (Q 122). The British Retail Consortium said that "retailers will only place a product on the market if it meets product safety requirements; however, it is not their area of expertise to define what the requirements are and subsequently be responsible for policing them" (p 217). The Consortium was not clear what exactly was being proposed in relation to the chemical constituents of products: "If…it is proposed that any importer of a product that contained a chemical, about which no details are held by an authority, should then have to register the chemical through the REACH system, then the Consortium would have to strongly oppose this part of the strategy. This would lead to duplication of efforts and an unwillingness to import products from outside the European Union." (p 218)

148. DEFRA, in its written evidence (p 180), said the Government accepted that there was a case for imported products to be covered but noted the difficulties. It supported the Commission's proposal to consider the issue further in a working group. It also noted that the proposals seemed to raise World Trade Organisation (WTO) issues, including for example the case of a chemical which was part of a product and was subject to EU authorisation but where a third country allowed the manufacture and export of products containing that same chemical to the EU.

149. The difficulty of this area was illustrated for us by a witness from the CIA. Dr Hayward, whose company makes a product which is found in tennis balls at one quarter of one per cent (and also in tyres), said "by the time it gets into the tennis ball as a finished product, it is no longer recognisable, it has been formulated, it has been reacted, it is no longer the product as it started out its life." Accordingly, "it will be impossible to detect my product entering in imported tennis balls. If . . . we end up with an authorisation that is over-heavy . . . the chances are that it is a product which will no longer be made in this country." The same point applies to tyres. (Q 152)

150. 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.

Post-Marketing Surveillance

151. The purpose of any post-marketing surveillance should be to add to our knowledge of exposure to chemicals by vulnerable targets (human and environmental), both so that appropriate action can be taken and as a check that past decisions are well founded. The White Paper proposes that "an information system should be established on environmental concentrations and releases. Monitoring data ascertained by Member States or by industry should be made available in an easily accessible form" (Action 3H).

152. Our present lack of information is emphasised by the White Paper: "Adequate knowledge about exposure is an absolute requirement for any reliable risk assessment. However, the process under (the Existing Substances) Regulation 793/93 highlighted a general lack of knowledge on the exposure to the existing substances under review. Furthermore, in many cases, the Member State authorities responsible for the assessment were not able to establish all the relevant uses of these chemicals. This lack of knowledge and restricted access by authorities to these data hampers efficient surveillance of the chemical sector." (paragraph 3.3) The White Paper proposes to put the burden on both manufacturers and downstream users to provide "exposure estimates or, if appropriate, analytical determination of the exposure" (Action 3G). This is to be part of the risk assessment process that we have discussed above under "Downstream Users" (paragraphs 135-145).

153. There are several kinds of data that can be gathered under what we are here calling "post-marketing surveillance": knowledge of uses, knowledge of exposure experienced by users or others close to the point of use, and knowledge of environmental concentrations (which may be widely dispersed). Some kind of product register, as discussed in paragraph 142 above, would be one way to provide information on uses. The White Paper attempts to deal with exposure by users (consumers, workers, etc) by putting responsibilities on downstream (industrial) users to contribute to risk assessments. We now discuss the question of monitoring environmental concentrations, responsibility for which must fall largely on public authorities.

154. We took evidence from two bodies with responsibilities for monitoring the state of the environment—English Nature and the Environment Agency—as well as the government department to which they are answerable (DEFRA), but we did not take evidence directly from bodies responsible for public health, food safety and drinking water quality, nor from the Department of Health. We were surprised at the present unco-ordinated state of monitoring for the presence of industrial chemicals.

155. English Nature told us that industrial chemicals were "not a particularly high priority issue" for them and fell "more into the area of potential risk and potential areas of concern rather than actual evidence of significant wildlife problems at the moment, with some exceptions. . . ." Their interest in industrial chemicals had increased recently, largely because of requirements in the EU Directives on birds and habitats that anyone undertaking any plan or project which might affect sites identified for nature conservation must demonstrate that there would be no adverse effect on site integrity. The result had been a programme to review discharge consents granted by the Environment Agency that might affect such sites. (Q 302)

156. English Nature is also involved in a surveillance programme part-funded by the Joint Nature Conservation Committee and carried out by the Centre for Ecology and Hydrology. This started about 30 years ago looking particularly at organochlorine pesticides (eg DDT) and was extended to include some industrial chemicals—PCBs (polychlorinated biphenyls) and mercury. Other pesticides (including rodenticides) had since been added. We were told by Dr Burn that the programme "was reviewed by the Joint Committee last year [ie 2000] and we are taking some quite radical steps to refocus it. At the moment the focus is largely . . . on the organochlorines and the PCBs, so it is dealing largely with historical issues. What we are keen to do is to encourage it or develop it so that it provides information that is more directly of relevance to policy makers on new and developing issues, rather than issues which are largely dealt with already through risk management. . . . What I am keen to develop the programme towards is to offer a general indicator of wildlife health in so far as we can. So we are trying to develop it so that it makes use of new bio-markers which are indicators of stress in general." (Q 314) We were also told that DEFRA had recently commissioned a study to "assemble all the ongoing monitoring programmes and try and make some sense of them" (Q 316).

157. The Environment Agency stated that for existing substances it "may be preferable to base risk assessments on real data as opposed to modelled data", that "where appropriate targeted monitoring should be used to help evaluate the success of any risk management measures introduced", and that "monitoring costs should be borne by the appropriate industry sectors". They also would "support a more strategic and flexible approach to the monitoring of environmental media and biota for substances with the potential to persist and bioaccumulate as a means of identifying substances that may need accelerated risk management measures". (p 4)

158. At the moment the Agency's monitoring work "is primarily focused on regulatory monitoring (that is . . . compliance monitoring in terms of discharges and environmental impact), together with a wide range of environmental monitoring, some derived from European and UK statute and some in terms of surveillance monitoring or so-called state of the environment reporting" (Q 445). When questioned about a more strategic approach, they spoke of the need to act collectively with other organisations and also referred to DEFRA's scoping study (QQ 446-7).

159. Mrs Lyons of WWF-UK gave us a more global view: "Persistent and bioaccumulating substances are certainly building up in some animal populations. We are particularly concerned about those at the polar regions where some of these pollutants globally re-distil. They are carried on air and water currents to the northern latitudes. There we are finding high levels in polar bears, in fish in the Arctic, in the blubber of seals and whales, and indeed in human beings. They have been associated with phenomena such as deficits in the immune system, effects on breeding populations and structural effects on the reproductive tract. I think there is now coming to be a lot of evidence on the harmful potential of these chemicals." (Q 343)

160. Mrs Lyons tried to put the question of monitoring into perspective: "In terms of who should do the post-marketing surveillance, I think it is a very difficult area because again there are very little resources. I am sure the Environment Agency is not adequately resourced to monitor all the chemicals it would like to monitor in the environment. In terms of picking up effects in human health, epidemiology is anyway a very blunt tool, so I do not think we should rely on those sorts of safeguards. One needs a proper gate keeper approach so that chemicals with unsafe properties do not come on to the market . . . rather than to try and rely on post-marketing surveillance." (Q 373)

161. We asked the Minister, Mr Meacher, about the Government's views on the priority that should be given to monitoring. He replied that monitoring is obviously useful and is complementary to risk assessment but is not a substitute for it. "It helps because it indicates whether legislation has been effective in protecting the environment. It identifies problems which may not be foreseen at the testing stage" (Q 516). It was a matter of priorities and resources (Q 517). He did not, however, mention the DEFRA study to review existing monitoring programmes (see paragraphs 156 and 158 above).

162. The Environment Council makes no reference to monitoring or surveillance (although it talks of the need for additional research on the impact of chemicals, in conclusion no 24)—perhaps because this is mostly seen as a national responsibility. But there is obvious sense in having comparable data collection systems in the Member States and this presumably is behind the White Paper's proposal. When we took evidence from English Nature, Dr Burn supported the idea that the European Environment Agency might play a more active part, "particularly in driving requirements for monitoring. . . . To some extent it is starting to do that now as it begins to review the sorts of indicators that it might use" (Q 321). 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.[42]

163. The evidence suggests that existing environmental monitoring systems are largely concerned with checking compliance with authorisations to discharge to air and water from point sources, with meeting ambient quality standards for traditional pollutants in air and water, and with evaluating the effects on wildlife of pesticides that are deliberately released. Monitoring programmes have not been designed for the purposes of newly developing concerns about industrial chemicals. 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 (paragraph 142), and DEFRA's study of existing monitoring arrangements (paragraph 156), 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.

International Experience

164. The advantages of avoiding duplication of testing and carrying out assessments was recognised by witnesses both to improve efficiency (reduced costs and information gathered faster) and to reduce experiments on animals. The White Paper in a section on "Recognising non-EU test results (page 9) refers to the "Gore initiative" in the USA and says that "studies . . . performed in the US will not have to be repeated in the Community and vice versa, since testing must be carried out using globally harmonised testing methodology. Accordingly, test results of the HPV/SIDS programme of OECD will be taken into account to reduce the number of tests to be performed in the EU."   This is a condensed and slightly misleading statement as we explain below. We have briefly described the "Gore initiative" and the OECD's HPV (high production volume) programme above (paragraphs 74-76). It is important to recognise that the OECD programme results in agreed hazard assessments but not risk assessments (Q 392).

165. We received evidence from Mr Visser, Head of OECD's Environment, Health and Safety Division. OECD has 29 Member countries but several non-member countries participate in its chemicals work. OECD has worked in the chemicals field since 1971 and much EU chemicals legislation has drawn on OECD work. In particular OECD has produced guidelines for mutual acceptance of data (MAD) for new and existing chemicals including test guidelines and principles of good laboratory practice. It has also produced minimum pre-market data sets for new chemicals (MPD) and screening information data sets for existing chemicals (SIDS).

166. Mr Visser explained that the test guidelines are agreed at a political level by the OECD Council in a Council Decision, which is a legally binding agreement for all Member countries. "If these two elements are achieved, test guidelines and good laboratory practice, then all governments in OECD countries and governments that participate outside OECD are obliged to accept the tests for the purposes of regulatory hazard assessment" (Q 386). A study had confirmed that the system had saved much duplication of effort in industry and money. There were some complaints from industry that countries asked for different tests (which countries are free to do), "but if they ask for a test for which there is a test guideline, then they have to accept the data" (ibid). There are now about 100 test guidelines. The average time to produce a test guideline is three to four years, and perhaps two years for updating (Q 388).

167. Mr Visser was encouraging about the avoidance of duplication resulting from the HPV programme but explained that discussions were only beginning on non-HPV chemicals (30,000 referred to in the White Paper and 75,000 referred to by the US Environmental Protection Agency). "We know that discussion about testing of high production volume chemicals is basically the tip of the iceberg. That is done in a strict and organised way. We have the SIDS data package. All the countries and industry participate. So that at least is an area where there is no duplication at all. That system works. Other activities are being proposed for the other chemicals which are not the high production volume chemicals. As I have said, the US is going into that and the EU is now proposing to do that. In OECD we are starting to bring people together and ask what we are going to do with the non-HPV chemicals. That will take some time" (ibid).

168. Mr Visser explained the US approach to non-HPV chemicals: "The US is basically running them through computer models. They try to sort them by groupings and by structure-activity relationships and relating them to problematic chemicals. That is different from testing and from actual data. They are just trying to get an idea about what are the types of chemicals that could cause problems. The EU wants the data for 30,000 chemicals" (Q 401).

169. We have not seen any critical assessment of what the US is doing about non-HPV chemicals and cannot comments on its value. The White Paper proposes to go in a different direction by requiring both hazard assessments and risk assessments for 30,000 chemicals. 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.

170. Mr Visser appears already to have eliminated one approach to non-HPV chemicals and has speculated about others: "We cannot ask for SIDS for all these 30,000 chemicals because there is not the testing capacity and it would go too slowly. What about another type of SIDS? What computer models could we use in a few years time when we have these tests and how can we go further to address the other chemicals?" (Q 399). We accordingly recommend that the Government and EU Member States ask OECD to attach greater urgency to developing ideas on how to handle non-HPV chemicals in order both to inform the new EU policy and to ensure that duplication between OECD Member countries is minimised.

171. There are many other international organisations dealing with chemicals. The UN Conference on Environment and Development (UNCED) in Rio in 1992 adopted a document called Agenda 21 which included a chapter on chemicals, and following the conference two co-ordinating bodies were set up: the Intergovernmental Forum of Chemical Safety (IFCS) and the Inter-Organisation Programme for the Sound Management of Chemicals (IOMC). IFCS has no resources, no legal status and cannot take decisions, but provides a forum for now over 100 countries, many of which have not done much about chemical safety before and are beginning to develop their own policies. IOMC is a co-ordinating body for seven international organisations working in the field of chemicals (FAO, ILO, UNEP, UNIDO[43], UNITAR[44], WHO and OECD) (Q 424).

172. Mr Visser gave us an example of collaboration between OECD and the UN which will require EU legislation to be changed. For the UN the OECD has developed harmonised criteria for the classification of chemicals "with huge negotiations which took a long time" (Q 418). "We have developed the criteria, they are agreed in OECD countries and by the main non-OECD countries. They went to the UN, who agreed on the criteria and now the UN is setting up a system to implement them. The EU will have to use the same classification and labelling criteria now as in the US for the land transport, or marine transport, or inland water transport, of chemicals for consumers and professionals." (Q 418) Given the global nature of the chemicals industry we welcome the growing attention in international organisations to chemicals policy and the co-ordination 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.

41   See, for example, the written evidence of the Royal Society of Chemistry (p 18, section 3) and the British Coatings Federation (p 73, at the end of section 5). Back

42   The European Environment Agency was established by EC Regulation 1210/90 (OJ L120 11.5.90), which inter alia requires the Agency to furnish information which can be directly used in the implementation of Community environmental policy, with priority being given to a number of areas of work including "chemical substances which are hazardous for the environment" (Article 3(c)). Back

43   UN Industrial Development Organisation. Back

44   UN Institute for Training and Research. Back

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