Select Committee on Science and Technology Sixth Report


62. For those substances which give rise to very high concern, REACH requires that their use and placing on the market would be subject to an Authorisation by the Commission, on a case-by-case basis. Chemicals of high concern are defined as:

    a)  substances meeting the criteria for classification as carcinogenic category 1 or 2[79];

    b)  substances meeting the criteria for classification as mutagenic category 1 or 2[80];

    c)  substances meeting the criteria for classification as toxic for reproduction (reprotoxins)[81]; and

    d)  substances which are persistent, bioaccumulative and toxic (PBT).[82]

    e)  substances which are very persistent and very bioaccumulative (vPvB)[83];

63. The Proposals state that "An Authorisation shall be granted if the risk to human health and/or the environment from the use of a substance … is adequately controlled … and as documented in the applicants' chemical safety report…[but that] an Authorisation may be granted if it is shown that socio-economic benefits outweigh the risk to human health and/or the environment arising from the use of the substance and if there are no suitable alternative substances or technologies".[84]

64. If the Authorisation has been granted on the basis that the socio-economic benefits of the use of the substance outweigh the risks, Authorisations would normally be time-limited, subject to review, and the burden of proof would be put on the applicant. Downstream users would be able to use a substance for an authorised use, provided that they obtained it from a company which has been granted an Authorisation (and kept within its terms). The Authorisation decision will take into account substitution plans showing, for example, that the industry is researching substitutes. Third parties will also be able to provide information to the ECA about possible substitute substances or technologies.

65. The Government, while supportive of the Commission's criteria for Authorisation, has concerns that Authorisations can only be granted to an individual producer or importer. It comments that bureaucracy could be reduced if there was one Authorisation per substance per use with all known manufacturers and importers identified on the Authorisation.[85] We are sympathetic to this suggestion but it has obvious limitations where the chemical in question has a range of uses and as a result could pose very different levels of risk. Any proposals that could increase the rate at which substances are considered at Authorisation are welcome, however.


66. The extent to which the Commission issues Authorisations rather than insist on the substitution of a substance is highly contentious. The industry has claimed that substitution already forms part of the strategies of chemical companies, that enforced substitution could diminish competitiveness and that substitutes might not necessarily be safer.[86] The CIA argues that inflexible imposition of substitution plans on EU producers would cause downstream users to switch sourcing of ingredients rather than cooperate with the substitution process.[87] The Royal Society of Chemistry is concerned that safe compounds may be withdrawn because they generate insufficient profit to cover the cost of testing. Leigh's Paints argues that the reformulation of products resulting from substitution would result in gaps in product availability and niche products might have to be withdrawn.[88] The CBI is content with the principle of substitution but argues that decisions must take "a holistic view of all relative hazards and risks on a case-by-case Evaluation" and be made in a transparent fashion.[89]

67. The environmental NGOs take a harder line and espouse the precautionary principle, as articulated by Mark Strutt from Greenpeace: "if it is possible to avoid any risk then that is what you should do … and particularly if that risk is imposed on the general public by industry".[90] WWF considers that the use of chemicals of very high concern should only be authorised when there is no safer alternative, and where there is an overwhelming societal need, and when measures to minimise exposure are in place. They are sceptical about the use of risk management strategies, suggesting that it is impossible to predict all possible scenarios.[91] The UK Environment Agency "wish to see every effort made to substitute substances of most concern with more acceptable alternatives".[92] Alun Michael's view is that "We are in favour of appropriate substitution… If you are too simplistic you say that if there is any risk at all there ought to be a substitute, but you need to be sure that there is a safe substitute".[93]

68. Greenpeace is scathing about the provision for "adequate control": "Are phthalates in toys 'adequately controlled'? When brominated flame retardants burn in an incinerator or landfill fire are they adequately controlled? If hormone disrupting chemicals are showing up in breast milk are they adequately controlled?".[94]

69. A key issue is how socioeconomic benefit is assessed. Andrew Lee from WWF said that "of course there may be some cases where chemicals will be authorised because the risks outweigh the benefits, but many more cases where there are substitutes or where the purpose to which the chemical is put is perhaps non-essential; that it is nice to have, and there we think substitution should take place".[95] The use of flame retardants is a useful example as many are toxic yet their application will have saved many lives.

70. Dr Delbeke from the Commission's Environment Directorate General felt that there had been scaremongering over the substitution issue. He felt that it was good news for industry as it would provide market and public relations value by adding "a gloss to the substances or the products that they are producing". Equally, he believed that under the current Proposals "a lot of substitution is going to happen".[96]

71. The Government supports the principles of substitution but expresses concern as to how this would work in practice; for example how the Commission will determine what is a suitable alternative chemical, how socioeconomic need will be interpreted or whether the risk management plan submitted by the company is adequate. The Government suggests that there could be an independent review of available substitutes, which could be part of the socio-economic analysis, paid for by industry as part of the Authorisation fee, but carried out by a third party.[97] It also has concerns about legally enforceable substitution, recognising that:

    a)  There have been a number of well known examples where an apparently safer substitute introduced by legislation has led to different effects to those of the substituted substance but of equivalent concern;

    b)  Substitution is seldom a simple matter of substituting one chemical for another. It can be a costly process involving the consideration of a number of new substances and their full life-cycle impacts as well as changes to production processes.[98]

72. A lot centres on the term "adequate control". The term is defined in Annex 1, section 6. This states that for any exposure scenario, the exposures of humans and the environment can be considered to be adequately controlled if:[99]

    a)  The exposure levels do not exceed the appropriate derived no-effect levels or the predicted no-effect concentration;

    b)  The likelihood and severity of an event occurring due to the physicochemical properties of the substance is negligible.

73. WWF's concerns seem to stem from how adequate control has been interpreted previously: "past experience with the risk assessment process under the current legislation, suggests that what industry considers to be "adequate control of the risk" may fall below the necessary level of health and environmental protection".[100] It argues that if the Commission accepts industry's arguments that the risks of such chemicals are adequately controlled, they must authorise the use of the chemical, even if a safer alternative is readily available.[101] WWF argues that "It is very difficult to ensure chemicals are properly controlled during their entire life cycle, and even good control measures can result in appreciable exposures".[102] The Government also has concerns over the interpretation of adequate control, on the basis that it relies on exposure ratios and that it is not clear whether such models can be applied to PBTs and vPvBs. It says that "The difficulties in defining 'adequate control' in PBTs and vPvBs could lead to inconsistencies, uncertainty for industry and, if large numbers of chemicals of high concern are authorised through the first track, a failure to protect human health and the environment from some of the most hazardous chemicals covered by REACH".[103]

74. WWF seems to have a lack of confidence in the Commission. It fears that it will accept everything that industry tells it and that substitution will never be demanded. We see little evidence to justify this fear since the legislation seems to have been initiated with high environmental ideals and the Proposals clearly state that "burden of proof is placed on the applicant to demonstrate that the risk from the use is adequately controlled or that the socio-economic benefits outweigh the risks".[104] Nevertheless, the Government's concern that the definition does not apply to PBTs and vPvBs is a genuine one and needs to be resolved.

75. A further concern is that considerations over the risk management of chemicals will result in the system "floundering".[105] This should be taken seriously but is not an excuse for making irrational decisions and refusing Authorisations when the health and environmental dangers are negligible. Instead, attention needs to be given to ensuring that the Commission's decision-making processes are rapid and transparent.

76. In an ideal world, highly toxic chemicals would not be produced, but companies must be able to argue that the risk of exposure is small during and after the lifecycle of the product. To insist that a substance is substituted in such cases could lead to a situation in which a company is disadvantaged without any health or environmental benefits. Nevertheless, the legislation's definition of adequate control needs to be tightened. WWF is concerned about the provisions for chemicals of concern for substances of "equivalent concern" in Article 54. This stems from an insertion stating that these need to have been "identified as causing serious and irreversible effects to humans or the environment" and WWF expresses concern that "there is a need to act on very persistent and very bioaccumulative chemicals, irrespective of currently known toxicity".[106] We believe these concerns to be misplaced. A previous section of Article 54 covers "substances which are very persistent and very bioaccumulative", which implies that this is indeed irrespective of known toxicity. Thus we do not find WWF's argument convincing as REACH has been designed to identify chemicals of concern.

77. The CIA rejects the requirement for a substitution plan as a condition for Authorisation. It says also that substitution plans would need to engage downstream users.[107] We do not find the Proposals' requirements for substitution excessively onerous. Where a substance of high concern is involved, it seems reasonable that any Authorisation should require that attention is given to the use of alternatives. We do not contest the fact that this imposes a burden on companies, but nor should they contest the importance of ending the production of substances of high concern.

78. The WWF's hard line on substitution is weakened by Andrew Lee's own admission that "we know there are companies already diversifying, already getting out of the production of some of these chemical concerns, retailers are already demanding substitution of chemicals because of consumer pressures".[108] This implies that substitution could occur through market mechanisms alone.

79. A further issue relating to substitution was raised by David Thomas, a legal consultant to the BUAV. The environmental NGOs have focused on those chemicals which have proven toxicity. Mr Thomas argued that abstinence was an option, that if a chemical could not be proven safe using non-animal tests then "society has the ethical choice whether to allow that substance onto the market".[109]

80. Greenpeace complains that Article 57 allows for the issuing of an Integrated Pollution and Prevention and Control permit, which sets allowable discharge limits.[110] It argues that IPPC permits were not designed to deal with persistent and bioaccumulative chemicals and that the REACH Proposals should cover emissions from industrial processes. The UK Environment Agency and the Government also express concern about this exemption.[111] The Commission says that this decision was taken so as "not to interfere with such other competences and to avoid differences between the decisions taken under different regulatory regimes as well as the resources in examining an impact twice". It is sensible for REACH to be compatible with existing EU legislation. The Proposals replace around 40 existing Directives and it is not clear why one - the IPPC Directive - is unaffected when it allows the emission of hazardous substances. We recommend that risks from emission points be considered in the Authorisation process.

81. We conclude that the current wording of the Proposals with regard to substitution is acceptable, provided that "adequate control" is interpreted so that the risks of exposure to humans or the environment are remote during and after the lifecycle of the product. Substitution is an important element of the legislation and must be encouraged but its enforcement must be pragmatic.

Review of Authorisations

82. The Proposals state that "Authorisations may be subject to conditions, including review periods and/or monitoring".[112] Greenpeace would like to strengthen this provision, arguing that all Authorisations should be temporary and not subject to renewal.[113] WWF agrees and suggests that Authorisations should be reviewed at least every five years.[114] While we appreciate that Greenpeace does not accept that a chemical can be adequately controlled, we conclude that if review and monitoring has been shown to be effective in controlling a chemical, it would be unreasonable not to renew Authorisations. This element of the Proposals could be strengthened to insist that all Authorisations should be subject to review at a stated time, at the discretion of the Commission. The Government believes that decisions about what precise time limits should apply for Authorisations can only be made on a case-by-case basis, and would need to strike the balance between acting as an effective incentive while avoiding imposing deadlines which are unrealistic. This is a sensible approach and we believe that time-limited Authorisations should be made subject to these criteria.


83. A fourth element of the REACH Proposals is Restriction.[115] Annexes XVI and XVII contain a list of restrictions for substances on their own, in preparations or in articles. If listed they may not be placed on the market or used unless in compliance with the condition of the Restriction. Restrictions will be made in response to dossiers, which can be drawn up by the ECA at the Commission's request or by Member States. The process is largely uncontroversial. The CBI wishes to see "detailed criteria for the imposition of Restrictions drawn up as soon as possible in order to assist harmonisation".[116] The Government is seeking clarification about the inclusion of products made from recycled or recovered material and whether Restrictions can be challenged or reviewed. It expresses concern that Member States and the ECA could duplicate effort if working on the same substance. We discuss the functions of the ECA in more detail below but we believe that this could be easily resolved if Member States are obliged to notify the ECA before assembling a dossier.

79   According to Directive 67/548/EEC Back

80   As above Back

81   As above Back

82   In accordance with the criteria of Annex XII. Back

83   As above Back

84   Annex XIII Back

85   DEFRA, UK Consultation paper on the New EU Chemicals Strategy - REACH, March 2004, para 99 Back

86   Ev 67 Back

87   Ev 67 Back

88   Ev 55-56 Back

89   Ev 92 Back

90   Qq 19-20 Back

91   Ev 73-74 Back

92   Ev 61 Back

93   Q 288 Back

94   Ev 57 Back

95   Q 31 Back

96   Q 135 Back

97   DEFRA, UK Consultation paper on the New EU Chemicals Strategy - REACH, March 2004, para 109 Back

98   As above, para 107 Back

99   Annex 1, Section 6 (4) Back

100   Ev 75 Back

101   Ev 73-74 Back

102   Ev 74 Back

103   DEFRA, UK Consultation paper on the New EU Chemicals Strategy - REACH, March 2004, para 110 Back

104   Proposals section 1.7 Back

105   Ev 75 Back

106   Ev 76 Back

107   Ev 67 Back

108   Q 37 Back

109   Q 89 Back

110   Ev 57; Council Directive 96/61/EC of 24 September 1996 concerning integrated pollution prevention and control Back

111   Ev 84; DEFRA, UK Consultation paper on the New EU Chemicals Strategy - REACH, March 2004, para 113 Back

112   Article 57 Back

113   Ev 57 Back

114   Ev 77 Back

115   Article 64 Back

116   Ev 96 Back

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