51.  The main elements of the Commission's proposed revision of the deliberate release Directive, together with the paragraphs of the opinion section of this report where they receive comment, are as follows:

RISK ASSESSMENT

52.  The revision would clarify certain terms and the scope of the risk assessment. The revision includes a statement of the principles on which the risk assessment should be based. It defines risk assessment as including direct, indirect, immediate and delayed effects (paragraphs 89-97).

PRODUCT LEGISLATION

53.  The revision would exempt trial releases as well as marketing releases from the Directive if they were covered by other Community legislation for specific products with similar risk assessments (paragraph 108). (Product legislation exists for novel foods and for drugs. It is in preparation for seeds and animal feeds.)

MONITORING

54.  The revision requires monitoring after a marketing consent has been granted. It defines the objectives of monitoring to include "any relevant direct, indirect, immediate or delayed effects on human health and/or the environment"[101] taking into account, if appropriate, potential for pathogenic, toxic or allergenic effects on human health; capacity for colonisation; potential to compromise the efficacy of therapeutic, prophylactic or diagnostic measures; potential to persist and spread in the environment; potential for interaction with target or non-target organisms; potential to affect population dynamics; effects of potential horizontal gene transfer; and the phenotypic and genetic stability of GMOs (paragraphs 102-104).

ETHICS

55.  The Commission would be able to consult any committee it establishes to advise on the ethical implications of biotechnology and on general matters that may raise ethical concerns (paragraphs 126-127).

PUBLIC CONSULTATION, TRANSPARENCY AND LABELLING

56.  The Commission would be required to make available to the public for comment the content of marketing notifications (paragraphs 118-123) and there would be greater transparency at Community level (paragraph 124). GMOs are to be labelled in accordance with Community policy, which has yet to be completed, but currently requires labelling where the gene or gene product can be detected (paragraphs 135-145).

COMMUNITY SCIENTIFIC ADVICE

57.  In the commercial release process, where an objection has been raised by a Member State, the Commission would be required to seek the opinion of the Community-level scientific committee on any case which is likely to have an effect on human health or the environment but the Directive does not specify the process by which the opinion would be taken into account or the time frame for the committee's consideration (paragraphs 163-164).

ALTERATION OF RELEASE PROCEDURES

58.  In the case of trial releases (deliberate release for the purpose of research and development), the revision would introduce, on the basis of experience and knowledge, two categories of application for release, those in the lower risk category being decided within 30 days. The procedures for these two categories would replace the current simplified procedures for research releases. There would in addition be a specific procedure for research releases in several Member States. For commercial releases, there would be the possibility of a simplified procedure for certain cases (paragraph 161).

COMITOLOGY

59.  The deliberate release Directive confers certain implementing powers on the Commission which must be exercised in accordance with the "comitology" procedures[102]. The purpose of these procedures is to establish a committee structure, comprising national representatives under the chairmanship of the Commission, which ensures Member State involvement in the exercise by the Commission of its implementing powers. The present Directive provides for a "IIIa" (regulatory committee) procedure. The Commission is required to submit its draft implementing measures to the committee. If a qualified majority of the national representatives approves the draft measures, the Commission will proceed to adopt them. If, however, there is no qualified majority in favour, or the committee fails to deliver its opinion, then a proposal relating to the draft measures must be submitted to the Council of Ministers. The Council may adopt these by a qualified majority, or amend them by unanimity, but if it fails to do either within a three month time limit, the Commission shall proceed to adopt the measures.

60.  The proposed revision of the Directive envisages switching from the IIIa to the IIIb regulatory committee procedure. The main difference is that the Council may prevent the adoption of a draft proposal referred to it by the Commission if a simple majority of Ministers opposes the draft. The effect of the change from a IIIa to IIIb procedure would be to strengthen the role of the Council by enabling it to exercise a decisive role in agreeing or blocking controversial implementing measures proposed by the Commission. It expands the options open to the Council by enabling it to agree draft proposals by a qualified majority, amend them by unanimity or reject them by simple majority (paragraph 162).

TIME LIMITS

61.  The draft Directive introduces for the first time time-periods within which the Commission has to submit proposals on marketing notifications to the comitology committee (when an objection has been raised by any Member State) and to the Council, and within which the Member State competent authority must issue a consent following the Commission's decision. A mediation period is introduced in which Member States can seek to resolve differences in views about the advisability of marketing a specific GMO product (paragraphs 165-169).

—TRIAL RELEASES

62.  For a trial release, the applicant submits its risk assessment dossier to the competent authority within the Member State in which it wishes to conduct the trial. The authority has 90 days in which to deliver its decision, not including time when the applicant has been asked to provide further information. Within the first 30 days the authority submits the dossier to the Commission who circulates it to all Member States. Within a further 30 days Member States may comment on the dossier. The proposed multi-State release works in the same way, but happens in several States at once. The simplified procedure requires a competent authority decision within 30 days and the dossier is not circulated to other Member States.

—COMMERCIAL RELEASES

63.  For a commercial (marketing) release, the applicant selects a Member State to assess its risk assessment dossier. The Member State's competent authority has 90 days in which to make a recommendation. If the recommendation is to permit the release, the dossier and recommendation is circulated to the Commission and other Member States. Member States and the Commission have 30 days in which to comment or raise objections (If there is no objection, the original Member State issues a Community-wide permit.). If any objections are raised, there is then a further 60 days in which to resolve disputes. If objections remain, the Commission has three months in which it must submit draft proposals to a committee comprising representatives from the Member States but chaired by the Commission (the "comitology" procedure) and, where appropriate, consult its scientific committee. The Commission's proposal may be approved in the comitology committee by a qualified majority. If not so approved, or if the committee fails to act, the proposal is passed to the Council. The Council then has three months in which to accept the Commission's proposal by qualified majority, amend it by unanimity, or reject it by simple majority. If the Council fails to act or accepts the proposal, the Commission shall then implement it. If there is a simple majority against the proposal (assuming it was to permit the release with whatever conditions), then the application falls. Once a decision to approve has been made, the Member State applied to has 30 days in which to issue the consent. The clock may be stopped to request further information from the applicant and to consult the EC scientific committee. If the full procedure is used to its permitted extent, the minimum duration is a year and one month plus clock stoppages plus the time taken for the Commission to act after the Council has or has not taken a decision, which is not subject to a time limit but at present takes many months.

SEVEN YEAR CONSENTS

64.  The draft Directive introduces a seven year time period for consents to market and a new procedure for renewing marketing consents. Products already approved would have to reapply for approval seven years after the adoption of the Directive (paragraph 170).