Document originated:	23 February 1998
Original language:	French
Forwarded to the Council:	24 February 1998
Circulated by the Council in the original language:	26 February 1998
Circulated by the Council in English:	2 March 1998
Deposited in Parliament:	9 March 1998
Department:	Environment, Transport and the Regions
Basis of consideration:	EM of 23 March 1998
Previous consideration:	None
Committee's assessment:	Politically important
Committee's decision:	Not cleared; more information requested

Background

5.1  Since 1990, the Community has had a legislative framework governing the release of genetically modified organisms (GMOs), in order to protect human health and the environment. This comprises both 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 in research and industrial facilities;

        —  Directive 90/220/EEC on the deliberate release into the environment of GMOs; and

        —  Directive 90/679/EEC on the protection of workers from biological agents.

5.2  In its 1994 Communication on Biotechnology and the 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. In particular, it concluded that Directive 90/220/EEC[18] (which established a system of controls, requiring prior consent from a Member State competent authority for any release of GMOs for research and development and approval at Community level before any product containing GMOs can be placed on the Community market) was flexible enough to satisfy the needs of the time, but that there were aspects that might be improved in the future.

5.3  It subsequently produced in 1996[19] a review of that Directive, which confirmed a number of problem areas. The Commission therefore indicated that it would come forward with amending proposals. These are now set out in the present document.

5.4  Whilst the proposal retains the basic framework of the earlier Directive, it nevertheless seeks to make a number of significant amendments to the procedures for approving releases of GMOs for research and development purposes (Part B) and for placing products on the market (Part C). In particular, it aims:

        —  to set for the first time a set of common principles for risk assessment;

        —  to apply a simplified set of procedures where this is justified;

        —  to introduce greater transparency into the decision making process; and

        —  to impose on the Commission an obligation to consult the relevant scientific committees on issues likely to affect human health and/or the environment.

5.5  This would involve the following main changes.

5.6  At present, there is one procedure under which an applicant submits a technical dossier to its national control authority (CA). The authority then has 90 days in which to decide whether to issue a consent; a summary of the dossier has to be sent to the Commission within 30 days, and is forwarded to the other Member States, who have 30 days in which to comment; any release is based solely upon the consent of the original lead CA.

5.7  In future, this standard procedure would require the assessment to be based on specified common principles; and all other national CAs would be informed about the results of the release. In addition, there would be a simplified procedure for material where the existing knowledge and degree of safety complied with conditions laid down in an Annex to the Directive (Category I status). The information needed in the dossier would be reduced; the lead CA would have 30 (rather than 90) days in which to take a decision; and information in the dossier would not be circulated to the other national CAs or the Commission, who would instead receive annual lists of releases under the new procedure and of rejected notifications.

5.8  The proposal would also make two other changes for Part B releases, by providing for:

        —  applications covering multi-state releases, in recognition of the increasing need to test GMOs in more than one Member State;

        —  the possibility of releases being covered in specific EC product legislation, thereby strengthening the link between releases for research and product releases (ii) Product (Part C) releases

5.9  At present, a technical dossier is submitted to the national CA; it has 90 days in which to examine the application; and, if it intends to issue a favourable opinion, the dossier (but not the applicant CA's assessment) is circulated to the Commission and other Member States; the latter (but not the Commission) then have 60 days in which to comment or raise an objection. If there are no objections, the consent is granted by the original national CA, and the product may circulate freely; if there is an objection, the matter is referred for a decision to the Committee of Member States provided for in Article 21 of the directive.

5.10  In future, the standard procedure would require the dossier to be copied straightaway to the Commission and other Member States, who would also receive subsequently the national CA's assessment report (as with Part B releases, these would, for the first time, be based on common principles set out in the Directive); they would then have 30 days in which to comment or lodge an objection. If there were no objections, the consent would be granted by the lead CA, but it would be subject to a seven year time limit and to mandatory monitoring within that period; if there was an objection, the parties would have 60 days in which to resolve the matter, following which it would be referred to the Article 21 Committee.

5.11  However, the Commission is proposing a procedural amendment. If the Committee fails to endorse the Commission's recommendation on any matter referred to it, the issue is put to the Council. At present, the Council may adopt a proposal by qualified majority, or reject it unanimously, but, if it does neither of these things, formal responsibility rests with the Commission. In future, the Council would also be able to reject a proposal by simple majority. There would therefore be a rather greater degree of Council involvement than at present.

5.12  There would in future also be a simplified procedure, where specific criteria and information requirements have been established on the basis of safety and experience. This would involve the submission of the dossier to the lead CA, which would have 15 days in which to decide if the simplified procedure was appropriate; if it considered that procedure should apply, it would circulate the information to the Commission and other Member States, who would have 30 days in which to comment or object. If they did not do so, the lead CA would issue a consent within a further 15 days; if, however, there were an objection, the parties concerned would have 45 days in which to resolve the matter. If they could not, it would then be referred to the Article 21 Committee, using the amended procedure described in the previous paragraph.

5.13  A similar procedure would for the first time apply to applications for the renewal of consents.

5.14  The proposal would also make a number of other changes for Part C releases, by:

        —  placing an obligation on the Commission to consult its relevant scientific committees on any aspect of a release likely to affect human health or the environment, before the matter was referred to the Article 21 committee;

        —  allowing public access to a summary of the notification dossier;

        —  requiring publication of any subsequent assessment report by the lead CA. The Government's view

5.15  In her Explanatory Memorandum of 23 March, the Parliamentary Under-Secretary of State at the Department of the Environment, Transport and the Regions (Angela Eagle) says that the Government is fully committed to ensuring that the release and marketing of GMOs does not have an adverse effect on human health and environmental safety. She further points out that, since Directive 90/220/EEC came into force in 1991, concern has grown about the potential environmental impact of GMOs; the labelling of products containing them; the lack of transparency of the regulatory régime; its unpredictability, arising from different national approaches to risk assessment; and the time taken to reach decisions on marketing notifications.

5.16  She suggests that "implementation of the Directive has proceeded well as regards research releases, but that the procedures for authorisation of GMO products are not satisfactory, particularly in respect of the timetable". She says that the Government is primarily concerned that "the Directive does not provide the framework necessary to address the increasing concerns of the public and industry". However, whilst the Government thus accepts the need for reforming procedures, it believes that some amendments to the proposal are necessary in order to ensure that, whilst maintaining a high level of protection, the Directive "meets growing public concerns regarding ethical, environmental and social issues and achieves a more transparent regulatory régime".

5.17  The Minister says that risk assessment and scientific justification "does not appear applicable as this is an amendment to an existing Directive". She adds that, although the existing Directive already imposes strict conditions on business, a detailed cost benefit analysis will follow once work on the net effect of the Commission proposal has been completed. In general, however, she would expect the proposed changes to reduce the current delays in the operation of the Directive and hence lead to business efficiency savings, but that there would be increased costs arising from the introduction of compulsory monitoring, the limitation of consents to seven years, and some of the increased safeguards.

5.18  This is clearly a proposal of some significance, both in terms of its substance and public perception of this area of activity. In principle, it must be right to revise the existing procedures to meet those defects which have been identified by the Commission and others. Nevertheless, a number of important questions remain, such as the basis on which releases can be subject to the simplified procedure; the degree of information required for such releases; and the information made available to other Member States where this procedure is applied to Part B releases.

5.19  In addition, the Government's Explanatory Memorandum says that it believes some amendments to the proposal are necessary, and that a detailed cost benefit analysis will follow. We would like to see that analysis, and also to have a more specific indication of the points the Government will be pursuing. We also note that the Minister considers that risk assessment and scientific justification does not appear necessary as this is an amendment to an existing Directive. However, as we have already indicated, the amendments proposed are significant, and go to the heart of the approval process. We would, therefore, have regarded risk analysis and scientific justification as appropriate in this case, and we invite the Minister to reconsider her view on this. In the meantime, we do not clear the document.