Select Committee on European Communities Second Report

Principles of regulation


39.  Any specific regulation of biotechnology relies on the assumption that there is risk that is in some sense different from the risks that attend similar products. In 1986 the OECD group of national experts on safety in biotechnology recommended "that there is no scientific basis for specific legislation to regulate the use of recombinant DNA organisms"[76].This recommendation depended on there being in place legislation capable of being used to ensure the safe handling of these organisms. The primary reason for the introduction of specific legislation in Europe was seen to be the need for provision of a "harmonised regulatory framework" and "to provide for the protection of human health and the environment"[77].


40.  Risks arise not from the technology used to create a new organism but rather from the characteristics of the new organism itself. This includes the properties of the introduced genetic material and the organism's interaction with the environment. It is arguable that legislation that addressed all the implications of the introduction or use of novel organisms for human and animal health and safety and for the environment would have been preferable to a system for which the trigger is the use of particular techniques. The alternative to the introduction of specific legislation in 1990 would have been the harmonisation of all law applicable to the protection of human health and the environment. The Commission recognised that this was not practicable in one step, but it also envisaged that the scope of application of the EC Directives on GMOs would gradually be reduced as new product-specific legislation was adopted. Products covered by other EC legislation are exempted from certain provisions of the deliberate release Directive[78] concerning environmental risk assessment. Moreover, the Commission has given an undertaking that "when preparing legislation on marketing authorisation for products consisting of, containing or which could contain GMOs, to include in its proposals provisions for a specific environmental risk assessment of the product similar to that provided in this Directive. The Commission also undertakes, where appropriate, to propose modifications to existing product legislation in order to provide for such environmental risk assessment." [79]


41.  Article 130r(2) of the EC Treaty states that "Community policy on the environment shall aim at a high level of protection taking into account the diversity of situations in the various regions of the Community. It shall be based on the precautionary principle and on the principles that preventative action should be taken, that environmental damage should as a priority be rectified at source and that the polluter should pay. Environmental protection requirements must be integrated into the definition and implementation of other Community policies". The 1992 Rio declaration on environment and development (Principle 15) states: "In order to protect the environment, the precautionary approach shall be widely applied by States according to their capabilities. Where there are threats of serious or irreversible damage, lack of full scientific certainty shall not be used as a reason for postponing cost-effective measures to prevent environmental degradation."

42.  This precautionary principle is reflected in the EC directives on genetically modified organisms. It has been asserted that the deliberate release Directive 90/220/EEC "is the first piece of international legislation in which the precautionary principle is translated into precautionary regulation"[80]. The preamble to the Directive identifies the necessity for "harmonised procedures and criteria for the case-by case evaluation of the potential risks arising from the deliberate release of GMOs into the environment". It also states that the introduction of GMOs into the environment should be carried out according to the 'step-by-step' principle. Under this principle "the containment of GMOs is reduced and the scale of release increased gradually, step by step, but only if evaluation of the earlier steps in terms of protection of human health and the environment indicates that the next step can be taken."[81]

76  Recommendation of the Council of the OECD, 16 July 1986 and Mr Cantley, of the OECD, p 300. Back
77  Explanatory Notes on 90/219/EEC (XI/596/91-Rev. 1 and the Explanatory Notes on 90/220/EEC (XI/401/91-Rev. 2), explaining the reasoning behind Article 1 of the Directives. See also Mr Cantley, p 301. Back
78  Article 10(2). Back
79  90/220/EEC, Article 10 and Commission Declaration in the Minutes of the Council Meeting of 23 April 1990 (see Mr Cantley, p 301). Back
80  Dr von Schomberg, author of a report to the European Parliament on the working of 90/220/EEC (see footnote 9), pp 401-2. Back
81  90/220/EEC, OJ L117 (8 May 1990) p15. Back

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