House of Commons - Science and Technology

Select Committee on Science and Technology Sixth Report

3 REGISTRATION

23. Registration of substances will involve the submission to a new European Chemicals Agency (ECA) of a technical dossier of information about the substance, including a testing package. The Regulation would prohibit the manufacture or importation of any substance which had not been registered. A substance is defined in Article 3 as "a chemical element and its compounds in the natural state or obtained by any manufacturing process, including any additive necessary to preserve its stability and any impurity deriving from the process used, but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition".

24. Registration of "phase-in" substances (i.e. those already in production) will be in three stages over 11 years after the Regulation has come into force, on the basis of production volume. Registrants would have to carry out tests to acquire the information needed to ensure the responsible management of any risks that the substances in question may present. Registration would involve the submission of a technical dossier containing the necessary information, with more information being required as different tonnage thresholds are exceeded, to reflect the increased exposure potential: and, in the case of substances where the quantities involved exceeded 10 tonnes, it would also be necessary to provide a chemical safety report, documenting the choice of measures. The deadlines for Registration and the testing requirements vary, with more onerous demands on higher volume chemicals and carcinogens, mutagens and reprotoxins (CMRs):

Year 3 for high production volume chemicals (1,000 tonnes or more per year per manufacturer or importer) and CMRs in volumes of 1 tonne or more;
Year 6 for production volumes in the range of 100-1,000 tonnes;
Year 11 for low production volume chemicals (1-100 tonnes).

25. Other Registration provisions include rules on data sharing in order to reduce animal testing; a requirement for information to be passed both up and along the supply chain by means of a safety data sheet; and an obligation on downstream users to consider the safety of their use of substances and to take appropriate risk management measures. A downstream user may use measures prepared by the manufacturer or importer, but these must be consistent with the use of the product. In cases where the use of a substance downstream is not covered by a manufacturer's safety assessment, a short report must be sent to the ECA, thus enabling any such use to be monitored.

Substances in articles

26. Provision for substances in articles is made in Article 6. It states that any producer or importer of articles shall submit a Registration to the Agency for any substance contained in those articles, if:

a) It is present in those articles in quantities totalling over 1 tonne per producer or importer per year (each article type will be considered separately);

b) It meets the criteria for classification as dangerous in accordance with Directive 67/548/EEC; and

c) It is intended to be released during normal and reasonably foreseeable conditions of use.

Scope

27. Article 4 requires that all substances manufactured or imported in quantities over 1 tonne per manufacturer/importer be registered. There are some exemptions. The chemicals listed in Annexes II and III are exempt from Registration either because their risks or properties are considered to be well known or because of historical precedent in EU legislation. These include vitamin C, sucrose, limestone, water, castor oil and tallow. Minerals, ores or substances occurring in nature are exempt if they are not technically modified during their manufacturing, unless they are classified as hazardous according to Directive 67/548. Medicines, radioactive materials and cosmetics will not be included in REACH if they are covered by other EU legislation. Substances used solely in plant protection products and biocidal products that are already covered by current legislation will be considered as registered.

28. Non-isolated intermediates (chemicals used to make other chemical substances) are fully exempt. Isolated intermediates will have to be registered, but with simplified information requirements, although more data are required if the intermediates are transported.[17] The move by the Commission to reduce the requirements for intermediates has been welcomed by industry, although the Confederation of British Industry (CBI) notes that a risk-based approach to prioritisation would resolve the issue in any case since their exposure potential would not make them a priority.[18]

29. As a result of comments received on the draft proposals, polymers (large molecules consisting of repeating chemical units, such as plastics) will be exempt from Registration and Evaluation; but this may change if a "practicable and cost-effective way of identifying dangerous polymers on the basis of sound technical and valid scientific criteria" can be established.[19] This has been welcomed by the Government and the Scientific Alliance, "an independent non-profit membership-based organisation fostering rational discussion and debate on environmental issues", although less so by WWF.[20]

30. It has been suggested to us that other chemicals should be exempted. The EEF argues that recycled materials should be exempted from REACH and says that the Proposals could clash with EU legislation, such as the End of Life Vehicles Directive, which require increased use of recycled materials.[21] We agree that this issue needs to be clarified. According to the Government's consultation document, "consideration needs to be given to whether products made from recycled or recovered material should be subject to restrictions". At present there is uncertainty as to the meaning of the term "placing on the market" used in the Proposals.[22] We believe that the REACH legislation should not be allowed to inhibit the use of recycled materials in production and that it should be amended to provide that recycled materials should be exempt on the basis that their constituent substances will have already gone through the REACH.

31. The British Cement Association (BCA) argues that cement should be exempted on the grounds that "risks associated with cement are already known; additional testing, cost and bureaucracy required by the REACH proposals are an unnecessary duplication". It argues that cement can never have been intended to be included since the Commission referred to an annual global chemical production of 400 Mt (Megatonnes) in the White Paper, whereas the world cement industry manufactures 1,750 Mt per year. The BCA is also concerned that its components are classified as persistent, although this does not mean that cement poses any persistent risk.[23] Mark Strutt from Greenpeace criticised this approach. He argued that "If the cement manufacturers believe cement is safe then they have data to show that, so why would they be wanting to exempt themselves from the REACH process?" and stating that if the industry has the data then the costs to prove cement is safe will be minimal.[24] We have sympathy with the view that cement should not be included within REACH but we are not persuaded that it should be exempt. We are in favour of high volume chemicals of demonstrably low risk being eligible for delayed Registration with less onerous testing requirements.

32. The CBI believes that REACH could conflict with the already extensive legislation on worker protection and waste management. It would also like the situation clarified with regard to waste, minerals and ores, alloys and treated natural fibres and would like to see a single provision on scope at the beginning of the legislation. The Government is "broadly content with the general principle outlined in the European Commission's criteria for exemptions". It believes that material falling within the definition of "waste" is not a substance and therefore not within the scope of REACH.[25] We too are content with the criteria for exemptions but agree with the CBI that it is important that companies should be able to determine quickly and easily whether their products are affected by the legislation. Information on which substances are or are not covered is of great importance. We recommend that the scope of the legislation should be set out clearly and comprehensively to enable unambiguous understanding of what the legislation does and does not cover.

Prioritisation

33. The prioritisation of substances in the Registration process is one of the most contentious elements in the Proposals. In general, they use production volume as the principal criterion for establishing the priority for Registration. There is widespread support in industry for a risk-based approach to prioritisation, in which both the intrinsic hazard of the chemical and its exposure to humans and the environment are factors. According to the CIA, "REACH should define the underlying scientific principles for determining the identification and prioritisation of substances for further, detailed Evaluation and allow exemptions for substances with exposures and hazards of low concern".[26] The Scientific Alliance argues that "While measures have been proposed to improve the extent to which the risk associated with any chemicals is measured more realistically, the legislation does not go far enough in this respect".[27]

34. The Royal Commission on Environmental Pollution is scathing about the risk-based approach: "many regulators and industry bodies continue to argue strongly that control must be on the basis of known risk, regardless of other indications of concern. This is in spite of the fact that problems continue to occur due to unforeseen risks and that the system is unable to react quickly to emerging concerns".[28] WWF also disagrees with risk-based prioritisation in the Registration process, for three main reasons:[29]

b) It would result in a much more labour intensive process for the regulatory authorities; and

c) It would be open to numerous challenges by industry if chemicals with what might appear to be similar toxicity and exposure data were prioritised differently.

35. The Environment Directorate General also opposes greater prioritisation on the basis that Registration is intended to be a "comprehensive information-gathering exercise" and that much had been done to reduce the administrative burden in the Proposals.[30] Commissioner Liikanen indicated that he was "intellectually open" to the issue of prioritisation and suggested that this issue would get a lot of attention from the European Parliament and Council.[31]

36. One unresolved issue is to what extent volume is an effective proxy for risk, and if it is not, whether there is a better alternative. The EEF reports that while some elements of the EU Parliament accept that prioritisation based on production tonnages is not logical, it has not heard a good proposal for an alternative based on risk.[32] A further issue is the availability of data to permit a risk-based approach, since one of the driving forces for the legislation is the concern that there are insufficient data for chemicals introduced before 1981. The CBI does not see this as a problem: "There is sufficient information and agreement at European level on enough substances that are known to pose higher risks for these to be addressed in a practical way in the first time-frame envisaged under the regulation".[33] The lack of available data could be addressed by employing European Centre for Ecotoxicology and Toxicology of Chemicals's (ECETOC's) Targeted Risk Assessment tool. This involves the screening of substances for human and environmental exposure and basic hazardous properties. Following collation of these data, decisions can be made on the need for further risk assessment to achieve greater accuracy.[34] The Royal Commission on Environmental Pollution advocates a similar screening process using advanced computational techniques. The Environment Agency describes these as crude and advocates caution.[35]

37. Any system which seeks to introduce an element of risk assessment to the Registration process would require a comprehensive pre-Registration process. The CBI says this process could be simple, demanding only:

b) Chemical name/CAS Number;[36]

c) Production volume;

d) What animal tests are available; and

e) Willingness to join consortia.[37]

38. The UK Government, in its consultation, "recognises the benefits of this approach and would be interested in developing such an approach as long as it does not introduce another layer of complexity".[38] The Proposals do provide for a pre-Registration for phase-in substances. Article 26 requires that Registrants wishing to use the phase-in provisions pre-register information on their substances so as to permit sharing of existing data. These data will form the basis of a Substance Information Exchange Forum. At present, there are two deadlines for pre-Registration; CMRs (carcinogens, mutagens and reprotoxins) and substances manufactured in volumes over 1000 tonnes must pre-register 18 months after the Regulation comes into force, while substances manufactured in volumes over 1 tonne can be pre-registered three years later.[39] Manufacturers and importers of substances in quantities of less than 1 tonne can contribute to the sharing of data voluntarily. The Government suggests a short pre-Registration phase, lasting perhaps only six months from the introduction of the Regulation.[40] We consider this an unnecessarily tight deadline. We see little value in having two stages of pre-Registration for phase-in substances and recommend that a single, compulsory pre-Registration stage 1 year after the Regulation comes into force. The volume threshold for pre-Registration should be lowered to 10 kg to provide a clearer picture of the production of highly toxic substances. Such a move need not be burdensome and would allow prioritisation based on risk during Registration.

39. We understand that the CIA has plans to establish a UK database of marketed chemicals. This is a welcome initiative and one that will enable UK be better prepared for the introduction of REACH. We recommend that the Government support this initiative and provide resources if necessary.

40. We share WWF's concerns that decisions on prioritisation could be contested. While we welcome the view from Judith Hackitt of the CIA that any decisions would need to involve all stakeholders, we believe that the three tranches of Registration based on volume should remainbut that the Registration of chemicals could be delayed or speeded up where there is sufficient data.[41] As Dr Colin Church from the Department of the Environment, Food and Rural Affairs (DEFRA) told us, a "balance of practicality and ideal" is necessary.[42] Some chemicals produced in low volumes are extremely hazardous and others produced in large volumes are known to be benign.[43] Many low-volume hazardous chemicals will be automatically subject to Authorisation and this could be extended. The UK Environment Agency wishes to see regulatory activity focused on the chemicals of highest concern and believes that more effort should be put into identifying such chemicals.[44] The reverse should also be the case. In an ideal world REACH would embrace a system of prioritisation for Registration based purely on risk. However, we are concerned about the workability of such a system. While production volume is a crude proxy for risk, it is a useful starting point. We recommend that this approach remain, but that it is refined with the introduction of a single pre-Registration phase so that highly toxic low production volume chemicals can be dealt with more quickly and high production volume chemicals of low risk dealt with later by employing advanced computational techniques. We remain concerned about the 1 tonne threshold for carcinogens, mutagens and reprotoxins. The toxicity of these chemicals is such that we believe the volume threshold should be lowered to 10 kg.

Audit

41. Article 18 of the Proposals sets out the duties of the European Chemicals Agency (ECA) in auditing the Registration dossiers. It requires that it undertake a completeness check of each Registration. This would not comprise an assessment of the quality or the adequacy of any data or justifications submitted. This lack of quality control is of concern to some. WWF would like an evaluation of the quality of the dossiers, citing evidence that only 25% of EU safety data sheets were fully accurate.[45] It argues that all submissions should be independently audited before submission to the ECA, with costs met by the registrant. Leigh's Paints is concerned that having generated so much data, there is only limited provision in the Proposals to check it.[46] The Royal Society of Chemistry regrets that only checking for completeness will encourage registrants to generate comprehensive datasets and increase the number of animals used in testing.[47] We agree that some audit of Registration dossiers is required. The WWF's suggestion that all submissions should be independently audited would bring the process to a halt, which is counterproductive. A better system would be a programme of spot checks, with a stated percentage of Registration dossiers checked for accuracy with sanctions for the submission of inaccurate data.

Data sharing

42. The Proposals include a number of measures to encourage or insist on data sharing. For non phase-in chemicals, vertebrate animal test data must be shared and procedures put in place to allow the original registrant to claim for the cost of the test (Articles 24 and 25). Any summaries of studies submitted may be made freely available by the European Chemicals Agency to any other potential registrant after 10 years.

43. The issue is more complicated for phase-in substances. An area of contention is the amount of data already held by companies on the chemicals they currently produce or have produced in the past. David Thomas of the BUAV told us, "there is a huge amount of existing animal data which is there in companies' archives, which is not available to regulators or to the general public. It would be a huge step forward if that data had to be made available".[48] Craig Barker of Ciba Specialty Chemicals told us that "In many cases most of these chemicals have already gone through several Evaluations over their lifespan. We have had the existing chemicals legislation; we have had the HPV programmes running in the States and under the OECD initiatives. These have all gone through these types of chemicals and we are not using those to the best advantage of this legislation; they have just been ignored".[49] This is not strictly the case, as Article 12 provides that alternative methods may be used if the registrant can justify their suitability, for example for substances that were already manufactured or marketed outside the Community. A further problem is that a large proportion of this information has probably been obtained by using old protocols, and not according to current Good Laboratory Practice standards.[50]

44. The BUAV believes that, by ensuring that data sharing becomes mandatory under REACH, authorities will not only be able to prevent duplicate animal testing being carried out for the purposes of Registration and Evaluation of substances that are already on the market, but also improve systems of monitoring and coordinating test plans for new substances, so that the problem of duplicate animal testing is eliminated entirely. A similar point is made by the Royal Society of Chemistry, which argues that data from other regulatory regimes, such as the US High Production Volume (HPV) system, should be acceptable to the ECA.[51] Dr Colin Church of DEFRA told us that the experience from HPV indicated that around 90% of test data on chemicals already existed and felt it was reasonable to extrapolate to REACH.[52] While a large number of chemicals to be registered will have been through the HPV programme, there is no requirement for Good Laboratory Practice, which could present problems in transferring data gathered under this programme.[53] A further problem is bringing data into REACH from overseas and from companies that no longer produce the chemical in question.

45. REACH is an excellent opportunity to draw together comprehensive chemical data to help the sharing of test data. This will form a valuable resource. We believe that the European Chemical Agency should augment this with resources to help improve the access to chemical data already held by national libraries and international and overseas bodies.

ONE SUBSTANCE-ONE REGISTRATION

46. Currently the Proposals encourage the formation of consortia, but this is not mandatory. The UK Government is presenting the case strongly for one substance-one Registration, which would require the compulsory sharing of data. The Government's proposals are set out in its consultation published in March 2004. The advantages, it argues, are:[54]

Minimising animal testing through sharing of data in consortia;
Reducing the cost of REACH to the economy by sharing costs of testing;
Maximising the sharing of existing data and creating one data package per substance;
Reducing the workload and simplifying the system for industry and Authorities;
Aiding rapid decision making through the use of one registered data package; and
Creating a level playing field for all registrants, including late entrants to the EU market.

47. A key element of the Government's proposals is a single pre-Registration phase, supported by the Substance Information Exchange Forum and run by the ECA. This would make possible the mandatory formation of consortia for joint Registration of chemicals.[55] Few would argue with the Government's aims. The CIA has produced a detailed critique of the workability of the proposals, particularly relating to the compulsory formation of consortia.[56] The Government itself recognises that several issues need to be resolved for one substance-one Registration to be workable:

Identity of the substance;
Cost-sharing;
Timing;
Access to consortia;
New substances introduced after the phase-in process of Registration; and
Commercial sensitivity.

48. The Government's proposals address the identity of a chemical but, as the CIA sets out, the situation is complicated by different companies producing the same substance to different levels of purity. The impurities will also differ according to the production process. The CIA points out that an impurity profile would indicate the process used and might reveal company secrets.[57] We also understand that there are some very similar chemicals with different uses which have the same CAS number.

Consortia

49. The Government argues that "in the interests of fair and open competition, companies must be able to join consortia". It suggests that industry should propose equitable cost sharing guidelines detailing the data sharing and charging requirements for late entrants. The issue of late joiners and free riders is of concern to industry when costs have been incurred, the outcome is known and the Registration has succeeded.[58] The CIA reports that late joiners to consortia of this kind are, on top of a share of the costs, charged a risk premium of 20-25% and interest. This is complicated by the fact that completed studies are a depreciating asset and that in theory a discount rate should be imposed. A further issue is the membership of consortia of organisation from different sectors with chemicals used for different purposes and in very different volumes.[59] The CIA points out that smaller producers will be disadvantaged as they would be forced to register earlier under the volume thresholds for Registration or pay consortia costs later even though they possess much of the Registration data already. This problem could be overcome by the introduction of a single pre-Registration deadline soon after the Regulation comes into force.[60] A further concern is that consortia tend to move more slowly than single companies.[61] However, the CBI concludes that the Government's proposal has many attractions, provided that the competition and confidentiality aspects can be managed and there is the flexibility for companies to operate outside consortia.[62] While we do not doubt the problems of late joiners and free riders on consortia formation, we consider that having identified the problems it should be possible to develop an equitable pricing formula.

50. The CIA questions the legality of DEFRA's suggestion that industry should not be made responsible for preparing guidelines for cost sharing. This issue needs to be resolved but we suspect that industry would rather draw up its own guidelines than have them forced upon them by the Commission or an ombudsman. The CBI expresses concern that some of the information required by REACH is "extremely commercially sensitive" and that competition law prevents companies from exchanging this information with others directly. It argues that further thought needs to be given to this issue with data held in a secure system and that company names should not be associated with some information.[63]

51. Mr John Kemp, Corporate Health, Safety and Environment Manager at Infineum International Limited, identified a further issue. He felt that it was important to distinguish between the generation of the physicochemical data and the data from animal testing; and information about end uses and the risks associated with end uses. He argued that for the first part, data-sharing should be maximised, but that the same chemical can have very different end uses and that trying to put all these factors together in one risk assessment would slow down the whole process and make it unworkable.[64]

52. While the Government seems keen to make one substance-one Registration a key element of its position, its enthusiasm is not shared by Commissioner Liikanen, who agreed with the suggestion that mandatory consortia formation, critical to ideas of one substance-one Registration, was a "dead duck".[65] Mr Michael responded that "One has to ask what he meant by that and what was meant by the question".[66] We see little scope for interpretation in Commissioner Liikanen's comments and are concerned that the Government's negotiating position could be undermined if it continues to take this stance. There is much to be gained from the promotion of one substance-one Registration. While the legislation could do more to provide incentives and encouragement to form consortia so that data sharing becomes the norm but not the rule, the mandatory formation of consortia is not workable. We consider the Government's position on this issue to be untenable.

Chemical Safety Reports and Safety Data Sheets

53. A chemical safety assessment (CSA) must be conducted and a chemical safety report completed for all substances produced in quantities over 10 tonnes. Where a substance is identified as dangerous the Chemical Safety Report (CSR) must also include an exposure assessment and risk characterisation. The CBI is pleased that the requirement to conduct a CSA has been removed in the Proposals for substances produced in quantities of below 10 tonnes. It would still like to see more streamlining of the requirements of the CSA and CSR with current environmental and health and safety regulation.[67]

54. Under the Proposals, manufacturers or importers have to provide downstream users with a safety data sheet (SDS) for the purposes of managing their risk when using the substance. The SDS must be consistent with the CSA. The consultation text had indicated that CSRs would be necessary and this move has been welcomed by industry as reducing the burden on downstream users.[68] The Government also welcomes the European Commission's proposal to adopt the existing SDS mechanism to improve the communication along the supply chain. WWF describes the uses of SDSs as "an adequate way of passing information to downstream users".[69] We agree that the use of safety data sheets to improve communication down the supply chain is a useful introduction.

17 Articles 15 and 16 Back

18 Ev 94 Back

19 http://europa.eu.int Back

20 Ev 102; Q 13 Back

21 Ev 65 Back

22 DEFRA, UK Consultation paper on the New EU Chemicals Strategy - REACH, March 2004, para 126 Back

23 Ev 88 Back

24 Qq 10-11 Back

25 Ev 92; DEFRA, UK Consultation paper on the New EU Chemicals Strategy - REACH, March 2004, para 55 Back

26 Ev 67 Back

27 Ev 101 Back

28 Royal Commission on Environmental Pollution, 24th Report, Chemicals in Products: Safeguarding the Environment and Human Health, Cm 5827, June 2003, para 3.206 Back