Background Paper 1
The Legal Framework for Decision Making on the Release and Marketing of GMOs in the European Union
Paper by the UK Joint Regulatory Authority and Secretariat to ACRE
Introduction
1. The purpose of this paper is to outline the legal framework against which decisions are made about the release and marketing of genetically modified organisms (GMOs) in the UK and EU. Releases and marketing of GMOs can only take place in the EU with the explicit consent of the regulatory authorities. Under the legislation, decisions on the granting of consents are based solely on the safety of the proposed GMO release.
2. The legislation governing GMOs covers many issues, including notifications, consents, provision of information to the public and enforcement. This paper concentrates specifically on the legal framework for decision making. The decision making process is underpinned by risk assessment. The risk assessment process is discussed in more detail in a companion paper.
European Framework
3. The release and marketing of GMOs is controlled in the EU under Council Directive 90/220/EEC1. On 14 February 2001, Directive 2001/18/EC1a was adopted and will replace Directive 90/220/EEC on 17 October 2002. At this time references made to the repealed Directive shall be construed as being made to Directive 2001/18/EC and read in accordance with the correlation table provided in the amended Directive. The Directive defines a GMO as “an organism… in which the genetic material has been altered in a way that does not occur naturally by mating and/or natural recombination”. The Directive requires Member States to ensure that all appropriate measures are taken to avoid adverse effects on human health and the environment that might arise from the release or marketing of GMOs.
4. Directive 90/220/EEC sets out some important basic principles for the regulation of GMO releases in the EU. These are:
A case-by-case environmental risk assessment should always be carried out prior to a release of a GMO;
The deliberate release of GMOs at the research stage is in most cases a necessary step in the development of new products derived from, or containing GMOs;
The introduction of GMOs into the environment should be carried out according to the ‘step by step’ principle, whereby initial releases are small and the scale of the releases increased gradually step by step, but only if the evaluation of the next steps indicate that the next step can be taken; and
No product containing or consisting of GMOs and intended for deliberate release shall be considered for placing on the market without it first having been subjected to satisfactory field testing at the research and development stage in ecosystems which could be affected by its use.
5. The Directive sets out two regulatory regimes; Part B for controlling releases for research and development, and Part C for placing GMOs on the market in the EU. Essentially, the Directive requires any person, before undertaking a release of a GMO or placing a GMO on the EU market, to submit a notification to the competent authority of the Member State within whose territory the release is to take place, or where the GMO is to be placed on the market for the first time. The key difference between Part B and Part C is that for research and development releases, decisions are made by individual Member States, whereas for placing GMO products on the market, decisions are made by all Member States. Part C decision making often necessitates a voting procedure to address differences in opinion on risk, and hence delays in decision making if the Commission, lead Member State and the notifier fail to find an acceptable way forward.
Part B: Research and Development Releases
6. Any person intending to carry out a research and development release of a GMO must first submit a Part B notification to the competent authority of the Member State in which the release is to take place. The notification must include a technical dossier supplying information necessary for evaluating foreseeable risks, whether immediate or delayed, that the GMO(s) may pose to human health and the environment. The detailed information required in notifications is set out in an Annex II of the Directive, which is included as an appendix to this paper. In summary, the Directive requires the following information on the:
GMO (e.g. recipient organism, details of modification and novel trait);
proposed release and the receiving environment;
interactions between the GMO and the environment;
monitoring regime and procedures for controlling the release; and
a statement evaluating the impacts and risks posed by the GMO(s) to human health and the environment from the uses envisaged.
7. The competent authority of the Member State that receives the notification examines it for compliance with the Directive, evaluates the risks posed by the release. The information provided must be sufficient to enable a decision to be made, but further information and clarification can be sought at any time. A decision must be made within 90 days of receiving the notification, during which period comments may be received from other Member States who are informed of the notification soon after its receipt. The decision on whether or not to grant consent is made on the basis of safety to human health and the environment. No other criteria are considered in the decision making process. The notifier may proceed with the release only after receipt of written consent of the competent authority, and in conformity with any conditions required in the consent.
8. In 1994, the First Simplified Procedure was agreed by Member States and implemented in the UK in 1995. This procedure allows releases of more than one GMO at more than one site. In the original directive a notification could only cover releases of one GMO at one or more sites or releases of one or more GMOs at one site, which raised practical problems for granting consents for official seed listing trials.
9. Under the First Simplified Procedure, one site has to be notified in the main application, but others do not have to be notified until 15 days before each proposed release takes place. However, the regulatory authorities can stop the proposed releases within this timescale, if they consider that the risk assessment in the notification is not applicable for a particular site. Certain criteria apply for this procedure to apply. The GMO has to be well characterised, and there must be information to demonstrate safety to human health and the environment. The releases must also be within a well-defined programme of work. Such a procedure would not, therefore, apply to first time releases of GMOs that have not been previously considered by regulatory authorities.
Part C: Marketing GMOs in the EU
10. A Part C notification for placing a GMO on the EU market must be submitted to the competent authority of the Member State where the product is to be placed on the market first. For example, the UK has handled notifications for GM herbicide tolerant oilseed rape, whereas France has handled notifications for GM insect resistant maize. Notifications for placing GMOs on the EU market must, in addition to the information required under Annex II for a Part B release, provide the following extra information:
Extended information taking into account the diversity of sites of use of the product, including information gained from research and development releases carried out under Part B consents;
Information concerning the ecosystems that could be affected by the use of the product and an assessment of the risks posed to human health and the environment; and
Conditions for placing the GMO product on the market, including conditions for use and handling and a proposal for labelling and packaging.
11. The competent authority then reviews the notification and forms an opinion, which must be within 90 days of receipt. If that opinion is favourable, the lead competent authority will forward the dossier to the European Commission. The Commission circulates the dossier to the other 14 Member States who are given 60 days to evaluate the application in detail, taking into account the particular health and environmental safety issues unique to their territories. If no objections are made, the lead competent authority issues the marketing consent, which applies throughout the European Community.
12. If, however, another Member State objects to the GMO being placed on the market, then the Directive provides for committee procedures (‘Article 21 Committee Procedure’) to come to a resolution. The European Commission drafts a decision that reflects the concerns raised by Member States, on which a vote is taken using the qualified majority voting procedure. If a resolution is not possible, it falls to the Council of Environment Ministers to decide. If the Council fails to decide within three months, the Commission can adopt its proposal. While there are procedures in place under the Directive, the decision making process has been subject to significant delays.
Recent negotiations to amend 90/220/EEC sought to address these serious delays and set timescales for the European Commission to work under.13. Twelve GM plants already have Part C marketing approval in Europe. These include soya beans, oilseed rape, chicory, carnations and 4 types of GM maize. The maize and soya are already imported in bulk into Europe for processing and use in animal feed.
United Kingdom Legislation
14. In the UK, Directive 90/220/EEC (and its replacement Directive 2001/18/EC) is implemented by Part VI of the Environmental Protection Act 1990 and the Genetically Modified Organisms (Deliberate Release) Regulations 19922, as amended in 19953 and 19974. Essentially, and in line with the Directive, releases and marketing of GMOs cannot take place unless consent has been granted. Consents for releases in England are signed on behalf of DETR and MAFF Ministers, acting jointly, with the agreement of the Health and Safety Executive. Consents for releases in Wales or Scotland are signed on behalf of the appropriate Ministers of the devolved administrations, again with the agreement of the HSE. There is separate but equivalent legislation in Northern Ireland
15. In making decisions on releases and marketing of GMOs, the Government is advised by the statutory Advisory Committee on Releases to the Environment (ACRE), established under Part VI of the Environmental Protection Act 1990. ACRE consists of a number of independent experts (currently thirteen), each specialising in a particular discipline, such as plant ecology, toxicology, farming, entomology, and microbiology. The joint Secretariat of ACRE is provided by DETR, and all interested Government Departments attend meetings, together with a representative of the Statutory Nature Conservation bodies.
16. ACRE’s main statutory role is to advise the Government on the safety of proposed releases and marketing of GMOs and non-native species. Notifications, known in the UK as consent applications, are evaluated critically by experts on ACRE, and only if the risks of the proposed release or marketing of a GMO are considered to be low will the Committee advise that consent may be issued. . When making decisions In issuing a consent, the Ministers will also take account of safety issues raised by experts in other Government departments, the Statutory Nature Conservation Agencies and the general public.
17. ACRE’s remit also includes giving advice on the supporting GMO safety research programme (excluding the farm-scale evaluations that are overseen by an independent specialist steering group). ACRE also advise on GMO policy issues where they touch on scientific and safety related issues, particularly commenting on the development of legislation such as the amendments to Directive 90/220/EEC and the biosafety protocol. ACRE also advised on the development of the UNEP International Technical Guidelines for Safety in Biotechnology.
18. However, ACRE’s remit does not extend to giving advice on strategic (e.g. need for GMO products), ethical or public acceptance issues; the membership does not include specific expertise in these areas. The committee concentrates on scientific appraisal and advice on risks. Where ACRE identify wider issues covered under other legislation, ACRE will write to other advisory committees via the Secretariats to alert them of their concerns. For example, ACRE contacted the Advisory Committee on Pesticides (ACP) regarding their concerns about impact of herbicide use on GM herbicide tolerant crops and discussed their respective remits in detail to identify any gaps in the legislation5.
19. The UK legislation has additional requirements than Directive 90/220/EEC (and replacement Directive 2001/18/EC) in that there are statutory obligations to set up a Public Register on which information on consent applications and ACRE’s advice are placed. Also, there are statutory requirements for Part B applicants to place advertisements in newspapers circulating in the areas where proposed releases are to take place. This enables comments to be made on proposed releases that ACRE can take into account if they pose questions about the safety of the GMO.
Recent Changes to Directive 90/220/EEC and its replacement by Directive 2001/18/EC
20. In 1998, negotiations started on the amendment of Directive 90/220/EEC. Many procedural changes have been made to the Directive. Among these are two new annexes, one on Risk Assessment (Annex 2) and another on Post-Market Monitoring (Annex 7). Until December 1998, the EU competent authorities had not agreed a harmonised approach to risk assessment. Therefore, it was important that some clear principles that reflect current best practice in EU Member States for risk assessment were formalised. These are covered in more detail in the companion paper on risk assessment.
21. During the period of the negotiations to amend the technical annexes to the Directive, the UK was also preparing a paper considering the commercial introduction of GM crops in the light of significant farmland wildlife declines6. It is important that the Government’s commitments under the UK Biodiversity Action Plan to reduce, and where possible reverse, such declines are not compromised by allowing GM crops to be commercially used if their use exacerbates existing wildlife declines. In order to ensure that this is addressed in subsequent risk assessments, the UK successfully introduced one key addition to the scope of the risk assessment process: the consideration of the possible adverse effects of the management of the GMO, where it was unique, in addition to the effects of the GMO itself. ACRE’s remit was consequently expanded to enable to accommodate this and the ACRE Sub-Group on wider biodiversity issues has since been considering how best consent applicants consider this in future applications.
22. A further addition was that marketing notifications must now include a monitoring plan which has two objectives:
to confirm that any assumption about the occurrence of adverse effects of the GMO made in the risk assessment are correct; and
to identify the occurrence of adverse effects of the GMO or its use on human health and the environment which were not anticipated.
23. The Environment Council agreed in December 1998 that the principles in for risk assessment and monitoring be taken into account as an interim measure until the amended Directive was adopted. The UK published guidance requiring, with immediate effect, applicants for consent to apply the agreed approach to risk assessment, and that for marketing applications, a monitoring plan must be submitted, and subject to any changes by ACRE, implemented if consent was granted7. The amended Directive was adopted on 14 February 2001 as Directive 2001/18/EC and will replace Directive 90/220/EEC on 17 October 2002.
Joint Regulatory Authority and ACRE Secretariat: August 2000 (amended April 2001)
1 Council Directive of 23 April 1990 on the deliberate release into the environment of genetically modified organisms (90/220/EEC); OJ N0 L117/15. 1a OJ L 106 17.4.2001.
2 The Regulation & Control of the Deliberate Release of Genetically Modified Organisms; DoE/ACRE
Guidance Note 1.
3 Guidance to the Genetically Modified Organisms (Deliberate Release) Regulations 1995; DoE/ACRE
Guidance Note 7.
4 Guidance to the Genetically Modified Organisms (Deliberate Release and Risk Assessment - Amendment) Regulations 1997; DoE/ACRE Guidance Note 10.
5 Genetically modified herbicide tolerant crops; Chapter 3 of the Advisory Committee on Releases to the Environment Annual Report No 4:1996/97.
6 The Commercial Use of Genetically Modified Crops in the United Kingdom: the Potential Wider Impact on Farmland Wildlife. A Discussion paper prepared by the Secretariat to the Advisory Committee on Releases to the Environment; published in ACRE Annual Report No 5: 1998
7 Guidance on Principles of Risk Assessment and Monitoring for the Release of Genetically Modified Organisms: DETR/ACRE Guidance Note 12
Published 31 July 2001
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