Select Committee on European Communities Minutes of Evidence

Memorandum by the Department of the Environment, Transport and the Regions, and on behalf of The Scottish Office and The Welsh Office[1]



  1. The regulation of all research releases of genetically modified organisms (GMOs), including those intended for use in agriculture, is governed in the EC through Directive 90/220/EEC, the Deliberate Release into the Environment of Genetically Modified Organisms (the "Directive"), which came into force in October 1991. In addition, the Directive establishes a single entry point to the Community market for certain products containing genetically modified organisms (GMOs).


  2. The Directive is based on the precautionary principle: Member States must take measures to ensure that adverse effects on human health and the environment from the release and marketing of GMOs are avoided. Development must proceed on a step-by-step basis, and proposals to release and market GMOs are assessed case-by-case. Plants intended for agricultural use are normally developed in glasshouses before being tested in different environments and at increasing scale. The organisms covered by the Directive are defined in terms of specific techniques of modern biotechnology.

  3. In order to achieve appropriate controls to implement its objective, the Directive establishes a prior consent regime for all releases and marketing. An application must be submitted to a competent authority; the application contains detailed information about the GMO and, if appropriate, about the potential receiving environment and intended risk management measures. In addition, the application has to contain an assessment of the risks to human health and the environment. The Directive does not lay down the principles or method for the risk assessment, or specify the type of effects that have to be taken into account. However, the risk assessment necessarily builds on the knowledge of the parent organism and the results from previous trials. Such results will be obtained through monitoring, but details of monitoring requirements are not laid down in the Directive.

  4. The requirements of the Directive are such that consents for research releases and marketing of GMOs must be granted provided that competent authorities consider that adverse effects will not occur, or will be avoided.


  1. Research releases


  5. Notifications of proposals to carry out research releases are submitted to the competent authority in the Member State in which the release is to be carried out, and a summary of the proposal is circulated to the Commission and to the other Member States, which have 30 days within which to comment. Decisions on releases are taken at the national level, within 90 days of the receipt of the notification. A competent authority can stop the clock in order to seek further information from the applicant.


  6. In the light of experience and the rapid increase in the number of research releases during the first two years of operation of the Directive, the UK and France submitted requests to apply simplified procedures. These were adopted at Community level in 1994. They have the effect of allowing an applicant to apply for a single consent to cover an entire development programme of a modified plant. All Member States, except Greece and Luxembourg, implemented this first simplified procedure and it is widely used. The UK, the Netherlands, France and Germany subsequently submitted further requests for simplified procedures, but the Commission has not taken these forward.

  7. In addition, the Directive has been adapted to technical progress to tailor better the information requirements for research releases of genetically modified plants.

  8. The Directive has operated well as regards control of research releases. More than 1,100 such releases have been carried out in the EC since the Directive came into force in 1992, compared with over 8,000 worldwide. Most releases outside the EC have taken place in the USA and Canada but increasingly releases are being carried out elsewhere in the world, notably in Argentina and China. The majority of releases have been of crop plants. Details of the types and numbers of releases are at Appendix 1.



  9. Before a GMO product can be marketed in the EC, an application must be submitted to the competent authority in the Member State in which the product is first intended to be marketed. Again, the notification must contain detailed information about the GMO and a full human and environmental risk assessment. At this stage, the impact on a specific receiving environment in the risk assessment is often inappropriate since an approved product can be marketed throughout the Community. Risk management measures will not usually be necessary providing that previous trials have demonstrated that adverse effects are unlikely to occur. If the competent authority considers that consent to market the product should be given, it forwards the notification to the Commission within 90 days.

  10. Other competent authorities have 60 days to review the notification after it has been circulated by the Commission. Providing no Member State objects during this period, the competent authority in the originating Member State must issue the consent. However, should any Member State object, the Commission has to submit a proposal to a regulatory committee. If, then, a qualified majority in the regulatory committee is in favour of the proposal, and the proposal is to consent to the marketing, the Commission must issue a decision requiring the Member State to grant the consent. If there is no qualified majority, the Commission has to submit a proposal to the Council which can amend the proposal only by unanimity. Should the Council fail to act within three months, the Commission is required to adopt the measures in the proposal. This is known as the IIIa procedure. The Directive does not prescribe time periods for the submission of the proposal by the Commission to the regulatory committee or to the Council, or for the issuance of the decision by the Commission.

  11. The directive was amended to technical progress for a second time in 1997 by introducing a requirement that if a product is known to contain GMOs, it must be so labelled, and if there is good reason to believe that a product contains GMOs, that the product be labelled "may contain GMOs". There were two reasons for this: first, to take account of public concerns about the labelling of GMO products; and second, in order to comply with the 1997 EC Regulation on Novel Foods and Novel Food Ingredients, manufacturers and retailers need to have adequate information about any crops intended for processing or direct sale as foods.


  12. Since the Directive came into force, 26 notifications to market GMO products have been submitted in the EC. Three of these were of vaccines, one was a microbiological kit to test for the presence of antibiotics in milk, one was for a carnation, and the remainder were of crop plants (details at Appendix 2). Only the notification to market the flower was uncontroversial and did not need to be referred to the regulatory committee. Nine consents have been issued to date and the remainder are in the pipeline. Of the four notifications submitted in 1995, only two have so far received consent; of the seven submitted in 1996, only three consents have been issued; and all five submitted last year are still under consideration. All the outstanding notifications concern crop plants.

  13. One or more Member States have raised objections to proposals to market a GMO product for three major reasons. First, some Member States objected if the applicant did not propose to label; this situation has been relieved by the 1997 technical amendment of the Directive to require labelling. Second, some Member States considered that the environmental risk assessment for crop plants genetically modified to be tolerant to certain herbicides should take into account the impact on herbicide use, a view not shared by the Commission. Third, until the adoption of the Novel Foods and Food Ingredients Regulation, those Member States that considered that the Directive covered the use of a product as a food were often not satisfied with the extent of information provided. It has come to be accepted that notifications submitted under the Directive should include a full assessment of the product for a particular use. Exemptions from the Directive apply only to GMO products covered by Community legislation with a similar environmental risk assessment. To date, the only such legislation is that governing novel foods, animal feedingstuff additives, and medicinal products for human and veterinary use.

  14. This specific product legislation requires that necessary consultations are carried out with the bodies set up by the Community or the Member States under the Directive. However, the legislation does not provide for a formal mechanism by which the results of consultation are taken into account in the final decision. No practice has as yet been developed as only one application, for a cholera vaccine, has to date been submitted under this product legislation.

  15. Proposals to amend other product legislation governing seeds and animal feeds are currently under discussion, but for the foreseeable future, such products will continue to be subject to the Directive.


  16. The Commission's proposal for amendment seeks to address most of the concerns that have been raised in the six years since the Directive came into force. The main changes are that the amendment:

    —  allows the Commission to consult a committee to advise on the ethical implications of biotechnology on general matters which may raise ethical concerns;

    —  clarifies certain terms and the scope of the risk assessment and includes the principles on which the risk assessment should be based;

    —  introduces, on the basis of experience and knowledge, two categories of research releases for which those in the lower risk category are decided within 30 days;

    —  removes the possibility for Member States to apply for simplified procedures for research releases;

    —  exempts trial releases from the Directive if they are covered by other Community legislation;

    —  introduces time periods within which the Commission has to submit proposals on marketing notifications to the regulatory committee and to Council, and within which a competent authority must issue a consent following the Commission's decision;

    —  establishes a regulatory committee procedure which would allow any draft decisions which reach the Council to be amended by unanimity or rejected by simple majority;

    —  introduces a seven year time period for consents to market and a new procedure for renewing marketing consents;

    —  requires monitoring after a marketing consent has been granted;

    —  introduces a simplified procedure for certain marketing cases;

    —  introduces a mediation period in which Member States can seek to resolve differences in views about the advisability of marketing a specific GMO product;

    —  requires the Commission to seek the opinion of the Community-level scientific committee on any case which might cause risk to human health or the environment but without specifying the process by which the opinion will be taken into account or the time frame for consideration by the committee;

    —  requires the Commission to consult the public on marketing notifications.

  17. The UK has expressed concern about the current regime, and in particular about delays in decision-making as regards marketing applications, shortcomings in the regulatory committee procedure, and the limitations to addressing public concerns. The UK is generally supportive of the Commission's proposal but considers that some changes and clarification are necessary. The UK is to take the Commission proposal forward during its Presidency in an orientation debate at the June Council of Environment Ministers.


  18. MAFF is the lead Department for novel foods and will cover regulation and labelling in its submission.


  19. The UK was one of the first countries in the world to introduce controls on modern biotechnology when it introduced regulations covering GMOs in 1978. Reflecting the state of the technology at that time, the controls only governed contained uses of GMOs and potential human health effects. By the mid-1980s, the first small releases were being carried out and increasing attention was being given to potential environmental effects. In 1989, the Royal Commission on Environmental Pollution (RCEP) reported on the release of GMOs into the environment, when they recommended a prior consent regime and public disclosure of information. Virtually all the RCEP's recommendations were implemented in the UK. The requirements imposed by the Directive were congruent with these recommendations.

  20. Part VI Environmental Protection Act 1990 (the Act) and the GMO (Deliberate Release) Regulations 1992, 1995 and 1997 implement the Directive in Great Britain. Parallel legislation has been in place in Northern Ireland since 1994. The effect of the legislation is that no GMO can be released without the consent of the Secretary of State; in England, this is the Secretary of State for the Environment, Transport and the Regions; in Scotland, the Secretary of State for Scotland; and in Wales, the Secretary of State for Wales. Before a consent can be issued, the Secretary of State has to have the agreement of the Health and Safety Executive which considers human health effects. In cases concerning agricultural applications, the relevant Secretary of State acts jointly with the Minister of Agriculture, Fisheries and Food. The Department of the Environment, Transport and the Regions consults with other interested departments on all applications under a Memorandum of Understanding.

  21. Under the Act, the Secretary of State has to consult a committee on all applications to release and market GMOs; this committee is the independent, expert Advisory Committee on Releases into the Environment (ACRE). ACRE has been chaired since its inception by Professor John Beringer of Bristol University and its members cover a wide range of expertise from ecology through molecular biology and genetics to human and veterinary medicine (details of current membership at Appendix 3).

  22. In accordance with the requirements of the Act, public registers of information about applications for consents to release and market GMOs have been set up, and applicants have to advertise intended releases in local newspapers with sufficient notice to allow members of the public to comment, either to the applicant or to the Department of the Environment, Transport and the Regions. The registers, held at Environment Agency offices and now placed on the World Wide Web, contain details of each application and the full environmental risk assessment less any commercially confidential information, the advice given by ACRE, the final decision, and in the case of a research release, the report of the release. The full application is also available, less any commercially confidential material, from DETR.

  23. Under the Directive, a Member State has to appoint one or more competent authorities which are responsible for the implementation of the measures. In the UK, there are three competent authorities for the Directive, the DETR, which has the lead, the Health and Safety Executive and the Department of the Environment (Northern Ireland).

(i) Operation of Directive with regard to research releases

  24. In the UK there have been more than 150 releases since the Directive was fully transposed. While no consent application has been refused, ACRE has advised that additional risk management measures be imposed in some releases in order to ensure that the risks were minimised. No research release has yielded unexpected results. All applications have been decided within the statutory period, and most well within it.

  25. In 1994, as a result of the experience gained, ACRE advised that research releases identified as being low risk, for which they established criteria, could be handled in a Fast Track Procedure. Under the procedure, an applicant must still provide the full information, but ACRE does not provide specific advice if the case satisfies the criteria. Decisions are reached within 30 days. This procedure has proved highly effective and useful: over the past three years, about 60 per cent of applications have qualified for the Fast Track Procedure. If officials have any doubts about whether the Fast Track criteria are fulfilled however, the case is referred to the committee.

  26. The publicly available information is used fairly widely, particularly since it has been accessible on the Web. Comments are frequently sent to DETR following the advertisement of research releases and the register information. They are taken into account before a final decision is taken on any application.

(ii) Operation of Directive with regard to marketing

  27. Five of the 26 marketing notifications have been submitted directly to the UK competent authority; one of these is still under consideration. The average time to process the notifications in the UK was four months, the extension beyond the 90 days laid down in the Directive representing the additional time when the clock was stopped in order that the applicant could supply further information to the competent authorities. However, the time until the final decision was made at Community level varied between 14 and 21 months. This demonstrates that while the UK review of marketing applications has been carried out within a short period of time, there have been prolonged delays in the Community-level procedures and the operation of the Directive as regards marketing notifications is unsatisfactory.

  28. There has been no commercial planting of genetically modified crops in the UK to date because before a plant variety can be added to the National List and freely marketed, clearance has to be to be obtained under Directive 90/220/EEC and, if appropriate, under the EC Novel Foods and Novel Food Ingredients Regulation. Such decisions are pending.

  29. The remaining 21 marketing notifications were submitted to Germany (3), Finland (1), Denmark (1), France (7), the Netherlands (4), Belgium (2) and Spain (3). We do not have information about the efficacy of handling marketing applications in the other Member States before they are forwarded to the Commission.

  30. The success of the operation of the Directive obviously should not be measured solely on the basis of the speed of processing applications. Rigorous review is necessary, in addition to a clear timetable. All marketing notifications are scrutinised by all the competent authorities.


  31. Since trial releases of GMOs are carried out in defined locations, it is appropriate that decisions about such releases are taken at national level, with some form of information exchange with other Member States. The marketing of GMO products however, presents a different scenario in which an approved product can be used anywhere in the EC. It is therefore appropriate in this case that decisions are taken collectively by the competent authorities using a procedure which allows each competent authority to review and reach a judgment on a marketing application in the light of its particular environment. Any procedure which removed this possibility would not give due attention to the property that organisms, unlike chemicals, are likely to behave differently in different environments. For these reasons, the current regime is appropriate, but the proposal in the Commission's draft amending directive to refer particular cases to the scientific committee needs to be examined carefully and in the light of the membership and expertise of that committee.

  32. The need for national controls is mirrored at the international level in the Convention on Biological Diversity which was adopted at Rio in 1992. Article 8(g) of the Convention requires each Party to establish means to control, manage or regulate the use and release of living modified organisms, thereby reflecting the importance of taking into account the behaviour of any organism in a particular environment. The Convention does not specify further how Parties might achieve this goal, but UNEP's International Technical Guidelines for Safety in Biotechnology can play a major contributing role. These guidelines were first developed by the UK and the Netherlands in response to a call in Agenda 21 for international harmonisation in biotechnology safety. The guidelines were adopted at a global consultation in Cairo in 1995. A pilot project proposed by UNEP and funded by the Global Environment Facility has just commenced and will facilitate the introduction of controls in 18 countries.

  33. However, GMOs are not only developed and used in a single country. Products are now starting to be traded on the world market, and to be moved between countries. A means for controlling such movements was initiated in 1995 by the Conference of the Parties to the Convention on Biological Diversity when the Parties decided to develop a biosafety protocol, specifically focusing on the transboundary movement of living modified organisms. Control is advisable for two main reasons: first,it will allow Parties importing such organisms to obtain, and be able to act on, information; and second, like the UNEP Guidelines, it will help to ensure that non-tariff trade barriers do not arise. The Protocol will establish a regime of advance informed agreement for the transboundary movement of living modified organisms (LMOs) that are likely to be defined to be similar to, or identical with, GMOs.

  34. The Protocol is being developed by an Open Ended Ad Hoc Working Group established by the Parties to the Convention. The current draft contains a number of options regarding the scope of the organisms and activities to be covered by the protocol, the scope of application of the advance informed agreement and other procedures, and the possible inclusion of provisions on socio-economic impacts, and liability and compensation. The EU has proposed a broad scope, with exemptions, a range of possible procedures to be invoked by a Party of import as it considers appropriate, simplified procedures and multilateral agreements. The protocol will cover at least some LMOs used in agriculture.

  35. The protocol is due to be finalised and adopted in February 1999. Only Parties to the Convention will be able to become Parties to the Protocol. Currently 171 countries and the European Community have ratified the Convention. The international level of jurisdiction which will be provided by the Protocol is appropriate for the transboundary movement of living modified organisms.


  36. The Environmental Protection Act 1990 places the responsibility for decisions on the safety of the release and marketing of GMOs on the relevant Secretary of State. There is no consideration of impacts on competition.

4 June 1998

1   The Department of Health and the Department of Trade and Industry were also asked for evidence, but they wished to add nothing to the memoranda by the Ministry of Agriculture, Fisheries and Food and the Department of the Environment, Transport and the Regions. The Health and Safety Executive submitted a separate memorandum, for which see pages 347-349. The Health and Safety Executive also submitted a separate memorandum on behalf of the Scottish Office, for which see pages 350-351. Back

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