Implementation of Regulation in the EU

GMOs have been regulated by the EU since the beginning of the 1990s. The EU directive on the contained use of GMOs (Directive 9 0/219/EEC) and on their deliberate release (Directive 90/220/EEC) were the first regulations which tried to establish a system for controlling research and development (R&D) and commercialization of GMOs in the EU. These regulations were designed to protect citizens' health and the environment, and addressed authorization, labelling and trace-ability issues relevant for GMOs. Directive 90/220/EEC covered the deliberate release of GMOs into the environment for R&D purposes as well as commercialization of such organisms. In contrast to the US regulation, the EU directive takes a preventive approach emphasizing prior assessment and approval of GMOs. One main element of this directive constitutes that an environmental risk assessment has to be carried out before any experimental or commercial release of GMOs into the environment. For market approval of GMOs a two-step procedure is foreseen: first the competent authority in a member state has 90 days, either to forward the notification dossier to the European Commission with a favourable opinion, or to inform the notifier that the proposed commercial release does not fulfil the requirements of the Directive. Afterwards, a EU-wide risk assessment procedure takes place in which all member states can raise objections concerning the notification (Menrad et al., 2003).

Since its enpassment in the year 1990, Directive 90/220/EEC was criticized by different stakeholder groups. In addition, all notifications for market approval of agricultural GMOs raised concerns of one or several EU member states during the 1990s (Sauter and Meyer, 2000). Therefore, in June 1999 a de facto moratorium on commercialization of GMOs was agreed by the community's Council of Environmental Ministers to suspend all approval applications for GMOs until implementation of the revised Directive 90/220/EEC, in order to provide a more strict legal framework covering not only safety issues but also labelling and trace-ability of GMOs (Lheureux et al., 2003).

Specific rules on GMOs for human consumption were introduced in EU Regulation 258/9 7/EC on novel foods and novel food ingredients, which came into force in 199 7. This regulation distinguishes six categories of novel food products of which two refer directly to products derived from GMOs (European Commission, 199 7). In contrast to traditional food products, novel foods are subject to pre-market approval in the EU. In order to ensure the consumers' right to information and freedom of choice, EU legislation mandates labelling to indicate the presence of GMOs, which was laid down in art. 8 of Regulation 258/9 7/EC. According to this article 'additional specific labelling requirements shall apply to foodstuffs . . . which renders a novel food or food ingredient no longer equivalent to an existing food or food ingredient. A novel food or food ingredient shall be deemed to be no longer equivalent for the purpose of this Article if scientific assessment, based upon an appropriate analysis of existing data, can demonstrate that the characteristics assessed are different in comparison with a conventional food or food ingredient, having regard to the accepted limits of natural variations for such characteristics' (European Commission, 199 7). However, the linking of labelling requirements of GMOs with the rapidly developing analytical tools for such organisms has led to serious implementation problems in nearly all member states of the EU (Sauter and Meyer, 2000).

After 5 years of intensive discussion Directive 2001/18/EC on the deliberate release into the environment of GMOs was passed in February 2001 (European Commission, 2001), which replaced Directive 1990/220/EEC. A commercial approval of GMOs will be given only for a 10-year period and can be extended for another 10 years. In addition, starting 2005 no commercial release of GMOs will be allowed, which contains antibiotic resistance marker genes, for which harmful impacts on human health and the environment are discussed (Schütte et al., 2001). Directive 2001/18/EC requires a post-market monitoring of each approved GMO in order to detect unanticipated effects of such organisms to the environment and human health. Furthermore, labelling of GMOs is foreseen in this directive without giving details concerning traceability requirements for products, which contain GMOs or are derived from GMOs (Loureiro, 2003). The same relates to tolerance levels for unadventitious mixture of GM material with non-GM crops or products (Menrad et al., 2003).

In November 2003 the regulation on GM food and feed (Regulation 1829/2003/EC) came into force (European Commission, 2003a), which partly replaced the Novel Foods Regulation. In the 1829/2003 regulation it is foreseen that notifications for market approval of food and feed products produced from GMOs have to be delivered to a central authority within the EU, i.e. the newly established European Food Safety Agency (EFSA). Learning from the US experience with StarLink, the regulation provides that GMOs likely to be used as food and feed can only be authorized for both purposes or not at all. Concerning labelling of GM-derived foods the regulation extends the labelling requirements of Regulation 258/97/EC to all foods produced from GMOs, irrespective of whether there is DNA or protein of GM origin in the final food product or feed. This means that the use of genetic engineering approaches at any step of the food production and processing process will lead to labelling requirements even if GMOs cannot be identified in the final product (e.g. soybean oil). Such a regulatory system requires the establishment of a traceability system for GMOs in the food processing chain, as well as the delivery of information to whom and from whom GM foods are made available (Menrad et al., 2003). The labelling requirement will not apply for adventitious presence of GMOs approved for commercialization in the EU below a 0.9% threshold. Products that have not received permission to be marketed in the EU, but for which the scientific risk assessment is positive, will have to be labelled if the GM content exceeds 0.5% adventitiously (Kinderlerer, 2003).

In July 2003 the European Commission has published guidelines for developing strategies and best practices to ensure the coexistence of GM crops with conventional and organic agriculture (European Commission, 2003b). They are intended to support the member states to develop workable measures for coexistence in conformity with the EU legislation. The guidelines set out the general principles, as well as the technical and procedural aspects, which should be taken into account during this process. In the guidelines it is underlined to ensure a fair balance between the interests of farmers of all types of production, i.e. farmers should be able to choose the production type they prefer. During the phase of introduction the European Commission proposed the general principle that farmers who introduce a new production type should be responsible for implementing the measures necessary to limit admixture during the phase of introduction of a new production type in a region (European Commission, 2003b).

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