Select Committee on European Communities Second Report

Regulation at present


35.  The competence of the European Community to legislate on biotechnological matters is based on a number of Treaty provisions covering the environment, health and safety of workers, and the approximation of laws to establish an internal market. There are, in addition, regulations in place that apply to the agricultural use of all products, whether genetically modified or not. Micro-organisms modified in the research or development laboratory are subject to regulation under the terms of the contained use Directive (90/219/EEC)[62] and the Biological Agents at Work Directive (90/679/EEC)[63]. The latter applies only to micro-organisms, but the definition includes animal and plant cells in tissue culture. There are specific United Kingdom regulations governing the use and treatment of animals.

36.  If there is an expectation that the organisms may be deliberately released[64] into the environment, Part B of the deliberate release Directive (90/220/EEC)[65] imposes a notification requirement and specifies the information which must be provided to the competent national authorities. This comprises a technical dossier and an evaluation of the impact and risks to human health or the environment[66]. Part C of the Directive establishes a Community procedure for authorising consents for marketing genetically modified organisms (whether released into the environment or not). This includes a requirement for an environmental risk assessment, except if such or a similar assessment is mandatory in respect of products covered by other EC legislation[67]. The Commission's proposed revision of Directive 90/220/EEC was published on 26 February 1998, and it is on this text that we base our specific comments on the reform of the regulatory system.


37.  Specific legislation exists for novel foods and food ingredients and also for products intended for use as drugs for human or animal use[68]. On 15 May 1997 the European Community's Novel Foods Regulation came into effect and introduced a mandatory pre-market approval system for novel foods throughout the Community[69], substantially based on the approach developed by the United Kingdom[70]. In the United Kingdom, the Advisory Committee on Novel Foods and Processes (ACNFP), established in 1988, advises the Minister of Agriculture, Fisheries and Food and the Secretary of State for Health on applications. The scope of the Regulation includes foods and food ingredients derived from genetically modified organisms and has been supplemented by Council Regulation (EC) 1139/98[71] which requires foods derived from genetically modified soya and maize to be labelled as genetically modified, from 1 September 1998, if either protein or DNA resulting from genetic modification is present.


38.  The final adoption of Directive 98/44/EEC[72] in July 1998 on the legal protection of biotechnological inventions follows years of debate about patenting living organisms. The Directive will have to be implemented by Member States no later than 30 July 2000. One aim of the Directive is to harmonise the legal protection of biotechnological inventions between Member States, so as to remove any possible barriers to trade created by different laws and practices in the Member States. It may have a significant effect on the application of biotechnology in agriculture as it clarifies the distinction between plant variety registration and patents in relation to genetically modified plants[73]. It prohibits the patenting of processes that modify the genetic identity of animals, and which are likely to cause them suffering without any substantial medical benefit to man or animal[74]. While also prohibiting the patenting of plant and animal varieties, the Directive provides that "Inventions which concern plants or animals shall be patentable if the technical feasibility of the invention is not confined to a particular plant or animal variety."[75]

62  90/219/EEC on the contained use of genetically modified micro-organisms (OJ L117 (8 May 1990) pp 1-14). A revised contained use Directive was adopted by the Council of Ministers on 5 December 1998 (OJ L330, 5.12.98, p.1). Back
63  90/679/EEC on the protection of workers from risks related to exposure to biological agents at work (OJ L374 (31 December 1990) pp 1-12). This Directive (which includes genetically modified micro-organisms) is implemented in the United Kingdom within the Control of Substances Hazardous to Health (COSHH) Regulations. Back
64  See footnote 6. Back
65  Directive 90/220/EEC on the deliberate release into the environment of genetically modified organisms (OJ L117 (8 May 1990) pp 15-27). The Directive was first implemented in 1990. The text of the proposed revision is COM(98) 85 final, published 26 February 1998. Back
66  90/220/EEC Article 5(2)(b). Back
67  90/220/EEC Article 10(2). Back
68  Medicines Act 1968 and 1971 and EC Regulation No. 209/93 (OJ L25 (2 February 1993) p 18) for human and veterinary medicines; Food and Environment Protection Act 1985 for pesticides. Back
69  Novel Foods and Novel Food Ingredients Regulation, No. 258/97 (OJ L43 (14 February 1997) pp 1-7). The Regulation is described in detail in the Report for 1997 of the Advisory Committee on Novel Foods and Processes. Back
70  Professor Bainbridge, Q 673. Back
71  Concerning the compulsory indication of the labelling of certain foodstuffs produced from genetically modified organisms (OJ L159 (3 June 1998) pp 4-7). Back
72  OJ L213 (30 July 1998) pp 13-21. Back
73  Directive 98/44/EEC (OJ L213 (30 July 1998) pp 13-21), preamble paras 29 -33, where an attempt is made to distinguish between the production of a new plant variety and the insertion of a transgene into a 'plant grouping'. Back
74  Ibid., preamble para. 45 and Article 6(2)(d). Back
75  Ibid., Article 4(2). Back

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