Select Committee on European Scrutiny Sixth 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
Department: Environment, Transport and the Regions
Basis of consideration: Minister's letter of 7 February 2001
Previous Committee Report: HC 28-iii (2000-01), paragraph 6 (17 January 2001)
To be discussed in Council: February 2001
Committee's assessment: Legally and politically important
Committee's decision: Cleared


  9.1  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 and a series of horizontal Directives, including Directive 90/219/EEC on the contained use of genetically modified micro-organisms (GMM) in research and industrial facilities.

  9.2  In a 1994 Communication and White Paper, 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[22] in December 1995 an amendment to Directive 90/219/EEC, which 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. The proposal was eventually adopted in Council Directive 98/81/EC,[23] which 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.

  9.3  In October 2000, the Commission put forward the present proposal to secure the Council's agreement to the relevant criteria in Annex II, Part B for determining whether a GMM is suitable for inclusion in Part C. This envisages exemptions on a case-by-case basis for clearly identified GMMs used in the contained conditions set out in the main Directive, with documented evidence of their safety being provided, together with evidence of stability where this could affect safety. The proposal also contains a number of more specific criteria of the kind set out in paragraph 6.3 of our Report of 17 January 2001, together with a set of detailed guidance notes.

  9.4  In an Explanatory Memorandum of 21 December 2000, the Minister for the Environment (the Rt. Hon. Michael Meacher) told us that the UK fully supports the principle of allowing the exemption of GMM which meet strict safety criteria, and that it is satisfied that those proposed are rigorous and comprehensive (though it will be clarifying with the Commission such aspects as the application of the precautionary approach and gene transfer). It will also want to underline that all arguments will have to be very thoroughly justified, and worst-case scenarios considered.

  9.5  A Regulatory Impact Assessment provided with the Explanatory Memorandum pointed out that there are approximately 500 centres in the UK undertaking genetic modification activities under contained use, which have played an important part in medical, biological and chemical research and in 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, 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.

  9.6  The Minister was concerned at the Commission's proposal that the detailed guidance should be adopted through a regulatory committee procedure, which he regarded as inappropriate, since such a procedure was not envisaged in the parent Directive.

  9.7  In view of the technical content of this proposal, we sought views from the Parliamentary Office of Science and Technology (POST), which commented that the general approach of exempting specific GMMs from regulations appears to be more in tune with US regulatory philosophy than the more precautionary approach traditionally adopted within the Community, but that the criteria and accompanying guidance seemed to be comprehensive, with nothing obvious having been overlooked. However, POST also pointed out that there is still considerable uncertainty associated with assessing GMMs against the various criteria identified, and that the science will not give clear unambiguous answers. It therefore concluded that decisions on exemptions will also reflect the attitude of the regulators as to how much scientific uncertainty can be tolerated.

  9.8  In the conclusion to our Report of 17 January 2001, we noted that, whilst the Government supported the proposal, POST felt that the guidance proposed cannot be clear-cut: also, the net benefits expected to arise from the exemption in the UK were minimal, even over a ten-year period. In view of this, the doubts over the legality of the procedure proposed by the Commission for adopting the detailed guidelines, and the points which the Government itself intended to pursue with the Commission, we expressed doubts as to whether the gains from the proposal would outweigh its uncertainties. We therefore decided not to clear the document, and to ask the Minister to comment.

Minister's letter of 7 February 2001

  9.9  We have now received a letter of 7 February 2001 from the Minister in response to our request. As regards the major point about the uncertainty involved, he says that absolute certainty is never possible, and that it is therefore important to recognise this, to test the implications, and to take a precautionary approach. He adds that, in applying such an approach to the exemption of a GMM from the contained use Directive, an exemption will not be allowed if "the margin of uncertainty is such that it cannot with reasonable certainty be said to be of acceptable risk". He also points out that GMMs encompass an enormous range of organisms, some of which are clearly hazardous and will never be considered for exemption, whilst others for which there is significant uncertainty would also not be exempted. However, he suggests that there are some GMMs where there is a great deal of data available, which could be considered for exemption (where he says they would have to be equivalent to yoghurt or bakers yeast in terms of harmfulness and degree of uncertainty).

  9.10  On the net benefits of the proposal, the Minister accepts that the assessed benefits are low, but he says they are based on "very conservative" projections, and that, once the possibility for exemptions exists, it might provide the impetus for development of useful products. He also says that the Government's earlier concerns about the legal basis have been met as a result of changes which the Commission has since made, and that it is continuing to press the various points referred to in paragraph 9.4 above.

  9.11  The Minister concludes by saying that he completely accepts the need to be cautious about exempting GMMs, and that any decisions taken must fully acknowledge uncertainty by explicitly incorporating a precautionary approach. He also points out that, even if a GMM has been accepted in Europe as exempt, it will still be possible for the UK to take a different view. In short, he considers that the safeguards are "robust", and that the UK should support the criteria proposed for the Annex to the contained use Directive.


  9.12  We are grateful to the Minister for this further information, and, in the light of the assurances he has given, we are now clearing this proposal.

22   (17128) 5791/96; HC 51-xix (1995-96), paragraph 13 (15 May 1996). Back

23   OJ No. L 330, 5.12.98, p.13. Back

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