Select Committee on European Scrutiny Third Report


COM(00) 627

Draft Council Decision amending Directive 90/219/EEC as regards the criteria for establishing the safety to human health and the environment of types of genetically modified micro-organisms.

Legal base: Article 175 EC; qualified majority voting
Document originated: 19 October 2000
Forwarded to the Council: 19 October 2000
Deposited in Parliament: 21 November 2000
Department: Environment, Transport and the Regions
Basis of consideration: EM of 21 December 2000
Previous Committee Report: None; but see (17128) 5791/96: HC 51-xix (1995-96), paragraph 13 (15 May 1996) and (18909) 6378/98: HC 155-xxvi (1997-98), paragraph 5 (29 April 1998) and HC 34-iii (1998-99), paragraph 1 (9 December 1998).
To be discussed in Council: No date set
Committee's assessment: Legally and politically important
Committee's decision: Not cleared; further information requested


  6.1  Since 1990, the Community has had a legislative framework governing genetically modified organisms (GMOs), in order to protect human health and the environment. This comprises a number of specific sectoral measures covering areas such as novel foods, and a series of horizontal Directives, notably:

  • Directive 90/219/EEC on the contained use of genetically modified micro-organisms (GMM) in research and industrial facilities; and

  • Directive 90/220/EEC on the deliberate release into the environment of GMOs.

  6.2  In its 1994 Communication on Biotechnology and White Paper on Growth, Competitiveness and Employment, the Commission recognised the importance of biotechnology and the need for regulations to ensure oversight appropriate to the risks and to the competitive development of the industries involved. This led it to propose[17] in December 1995 an amendment to Directive 90/219/EEC, followed by further proposals[18] in February 1998 for changes to Directive 90/220/EEC. The changes to Directive 90/219/EEC, which were considered, and cleared, by our predecessors on 15 May 1996, sought to link the administrative procedures and notification requirements for GMMs to the likely risk, rather than (as previously) to the scale of the operation involved, and were eventually adopted in Council Directive 98/81/EC. At the same time, however, that Directive also provided for the Council to decide subsequently on the exemption of certain types of contained GMMs (to be listed in Annex II, Part C) which meet criteria (to be listed in Annex II, Part B) establishing their safety. The main purpose of the present document is to secure the Council's agreement to the relevant criteria which the Commission is now proposing should be included in Annex II, Part B for determining whether a GMM is suitable for inclusion in Part C.

The current proposal

  6.3  The introduction to the new Annex indicates that exemptions will relate on a case-by-case basis only to clearly identified GMMs used in the contained conditions set out in the main Directive (and therefore exclude the deliberate release of GMMs covered by Directive 90/220/EEC). The Annex requires the identity of the micro-organism strain to be precisely established, with documented evidence of its safety being provided, together with evidence of its stability where this could affect safety. More specifically, it also lays down that the GMM should not be capable of causing disease or harm to a healthy human, plant or animal; that it should not produce increased toxigenicity or allergenicity; that it should not harbour harmful adventitious agents; that it should not be self-transmissible or transferable at a frequency greater than other genes of the recipient or parental micro-organism; and that it must not produce adverse effects, either immediate or delayed, should any incident involving a significant or unintended release occur. In order to facilitate the application of these criteria, the proposal also refers to detailed guidance notes, which it is envisaged the Commission will adopt under the powers conferred on it by Directive 90/220/EEC (see paragraph 6.4 below).

  6.4  The document also includes a change in the comitology arrangements under Directive 90/219/EEC to bring these into line with Article 5 of Council Decision 1999/468/EC, which lays down for the generality of measures new regulatory procedures for the exercise by the Commission of its implementing powers. The Commission proposes that this procedure would be used to adopt the guidance notes referred to in paragraph 6.3 above.

The Government's view

  6.5  In his Explanatory Memorandum of 21 December 2000, the Minister for the Environment (the Rt. Hon. Michael Meacher) says that the UK fully supports the principle of allowing the exemption of GMM which meet strict safety criteria, and that those which are exempt would still have to be kept under control to prevent a release into the environment. He also points out that, once a GMM is entered into Annex IIC, Member States will still be free to decide whether or not they wish to exempt it nationally. As regards the criteria proposed, he says that the Government is satisfied that these are rigorous and comprehensive, but that it will be pursuing with the Commission some amendments and clarifications to the underlying guidance in relation to such aspects as the application of the precautionary approach and the need to clarify some ambiguity in the text as regards gene transfer. It will also want to underline that all arguments will have to be very thoroughly justified, and that worst case scenarios must be considered.

  6.6  These points apart, the Minister's main concern relates to the Commission's proposal that this guidance should be adopted through a regulatory committee procedure. He regards this as inappropriate, since such a procedure was not envisaged by Directive 90/219/EEC, and "cannot be introduced by this mechanism".

  6.7  The Minister has also provided us with a Regulatory Impact Assessment. This points out that there are approximately 500 centres in the UK which have notified the Health and Safety Executive that they undertake genetic modification activities under contained use: about 100 of these are industrial centres, and the remainder are universities and other research institutions. The RIA makes the point that work in this area has played an important part in medical, biological and chemical research, but that it also has a wide variety of industrial applications. It is estimated that one GMM each year will meet the criteria proposed, and be used in 50 projects. Exemption will mean that the centres involved will not need to undertake special risk assessment and provide specific controls, leading over a ten-year period to total savings of just under £70,000. Costs over the same period would amount to about £45,000 — just over £32,000 for organisations to produce the necessary data to support the exemptions, and about £13,000 for the HSE and other regulatory authorities to assess the applications.

Views of the Parliamentary Office of Science and Technology (POST)

  6.8  In view of the technical content of this proposal, we have sought the views of the Parliamentary Office of Science and Technology (POST). Apart from pointing out that the potential benefits in terms of cutting administrative burdens appear to be insignificant, they have commented that the general approach of exempting specific GMMs from regulations seems to be more in tune with US regulatory philosophy than the more precautionary approach traditionally adopted within the Community. They then say that the criteria and accompanying guidance seem to be comprehensive, and that nothing obvious appears to have been overlooked. They do, however, point out that there is still considerable uncertainty associated with assessing GMMs against the various criteria identified. For instance, bacteria have evolved different mechanisms for swapping genetic material, but it is not known to what extent gene transfer occurs outside of laboratory conditions: and, although consideration of the science can lead to a conclusion that such a transfer is unlikely to occur, it cannot be ruled out completely. POST also consider that similar limitations apply when assessing the allergenicity of a novel protein made by a gene, in that it is not known why some proteins cause allergenic reactions, whilst others do not (or why only some people are allergic to a particular protein). Thus, they say that, although the science can indicate that some proteins are likely to be more allergenic than others, it cannot provide a guarantee that a novel protein produced by a GMM will not cause allergic reactions.

  6.9  POST sum up by saying:

    "Overall then, the criteria and guidance represent a comprehensive list of ways in which GMMs could potentially threaten human health or the environment. But, as ever, the science will not give clear unambiguous answers (yes, this is safe; no, that is unsafe). Decisions on exemptions will thus not be based on the science alone; they will also reflect the attitude of the regulators regarding how much scientific uncertainty can be tolerated, the extent to which a precautionary approach should be adopted etc."


  6.10  We note that the Government fully supports the principle of allowing the exemption of genetically modified micro-organisms which meet strict criteria, and considers the criteria proposed to be rigorous and comprehensive. On the other hand, the Parliamentary Office of Science and Technology suggests that the answers provided by the guidance proposed cannot be clear-cut, and it also makes the valid point that the net benefits expected to arise from the exemption in the United Kingdom are minimal, even over a ten-year period. Given these concerns, the doubts over the legality of the procedure proposed by the Commission for adopting the detailed guidelines, and the points which the Government itself has said it intends to pursue with the Commission, we do have some doubts as to whether the gains from this proposal outweigh the uncertainties it will apparently create. We would, therefore welcome the Minister's comments on this. In the meantime, we are not clearing the document.

17   (17128) 5791/96; see headnotes to this paragraph. Back

18   (18909) 6378/98; see headnotes to this paragraph. Back

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