FoE Europe - GMOs

The Deliberate Release Directive

Following the discovery of DNA in 1953 and the development of the first genetically modified plants in the early 1980s, it became urgent to introduce legislation to regulate the use of this new technology. The European Union therefore adopted two new Directives, one covering genetically modified organisms and the other covering the contained use of genetically modified micro-organisms.

Directive 90/220/EEC on the Deliberate Release of Genetically Modified Organisms to the Environment was adopted on 23 April 1990, for transposition into the national legislation of Member States by 1992. The Directive laid down procedures under which GMOs could be released into the environment, either for experimentation (e.g. field trials) or for commercialisation (market release). Approval for deliberate release of GMOs required the involvement of the designated Competent Authorities in all EU Member States. In the event that Member States could not reach agreement about approval, however, the decision reverted to the European Commission.

As gene technology developed and biotechnology companies moved very rapidly to bring GMOs onto the market, it became evident in the early 1990s that Directive 90/220/EEC would have to be amended. On the one hand, industry complained that it was too restrictive and that the bureaucracy involved in product authorisations made it difficult for them to get their GMOs approved. On the other hand, NGOs and others concerned about the effects that GMOs might have on the environment and consumer health felt that the directive was not rigorous enough, and that the authorisation procedure needed to be improved.

18 GMOs, including soya, maize and oilseed rape varieties, have already been approved for deliberate release under Directive 90/220/EEC.

12 others are pending approval.

The revised directive
After several years of proposals from the European Commission and discussion in the European Parliament, the EU finally adopted a revised Deliberate Release Directive 2001/18/EC which entered into force on 17 th April 2001 and must be transposed into the national law of Member States by 17 th October 2002. Although the new directive is a considerable improvement over the previous one, in the view of many it fails to address some of the key issues such as GMO pollution (contamination of other plants by GMOs), liability of GMO producers and use of antibiotic-resistant marker genes . See FoE's assessment of the revised directive below.

Although the text mentions the need for traceability, the Directive itself fails to deal with the problem of traceability of GMOs with the aim of facilitating product labelling and providing a means for product withdrawals should problems occur. For this reason, at the time the Directive was adopted by the European Parliament, several Member States declared that they would block new GMO approvals until the question of traceability and labelling, and even liability, had been resolved (see Moratorium ). The European Commission, therefore, started work to prepare new Proposals for two new EU Regulations,: one on Traceability/Labelling of GMOs and the other on GM Food/Feed . The latter Regulation will set out authorisation procedures for GMOs approved for use both in human food, replacing the present authorisation procedure under the Novel Food Regulation, as well as in animal feed where the use of GMOs is currently not regulated at all.

Other authorisation procedures
Not all GMO authorisations are dealt with under the Deliberate Release Directive and there is indeed a fear that, with time, more and more GMOs will be approved under so-called vertical legislation for food, feed, seeds, etc., thus by-passing more stringent rules which may apply under Directive 2001/18/EC. This is already the case under the Novel Food Regulation 258/97 which allows GMOs to be put on the market in human food and food ingredients. Under this Regulation, several GMOs have already entered the food chain according to a simplified procedure which just calls for companies to demonstrate that their GM food or food ingredients are "substantially equivalent" to conventional foods.

FoE's assessment of the new Deliberate Release Directive
On the positive side, the revised directive:

requires direct and indirect, delayed and immediate adverse effects of GMOs on the environment or human health to be taken into account;
extends the risk assessment to include cumulative long-term effects on human health and the environment, including biological diversity and effects on non-agricultural eco-systems;
requires Member States to ensure traceability of GMOs at all stages of placing on the market;
improves labelling requirements, replacing the former "may contain GMOs" by the less ambiguous "this product contains GMOs".
requires mandatory monitoring of GMOs released for commercial or any other purpose;
requires public registers concerning the locations where GMOs are grown for commercial or experimental purposes;
limits GMO approvals to 10 years after which authorisations must be renewed;
requires that any unauthorised GMO releases must be terminated;
allows thresholds only for adventitious or technically unavoidable traces of authorised GMOs
changes the existing authorisation procedure under which the European Commission could act against the wishes of Member States.

On the negative side, the directive:

fails to bring in immediate bans for antibiotic marker genes (ARMs) used in GMOs, extending authorisation for ARMs until 2004 for commercial releases and 2008 for experimental releases;
does not address the problem of GMO pollution but simply says that adverse effects of gene transfer should be assessed on a case-by-case basis;
exempts medicinal products and compounds from the scope of the legislation;
allows individual Member States to accept long-term multi-site notifications for experimental releases;
retains the existing simplified authorisation procedure for plants, and introduces an option to propose new simplified "differentiated procedures" for GMO releases and for GMO products;
steamlines authorisation by imposing shorter deadlines for decision-making;
requires a centralised authorisation procedure to be examined in 2003;
fails to provide a liability regime for damage caused by GMOs.

Find the legislation

Council Directive 90/220/EEC of 23 April 1990 on the deliberate release into the environment of genetically modified organisms
Official Journal L 117 , 08/05/1990 P. 0015 - 0027
http://europa.eu.int/eur-lex/en/lif/dat/1990/en_390L0220.html

Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC
Official Journal L 106 , 17/04/2001 P. 0001 - 0039
http://europa.eu.int/eur-lex/en/lif/dat/2001/en_301L0018.html

Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients
Official Journal L 043 , 14/02/1997 P. 0001 - 0006
http://europa.eu.int/comm/food/fs/gmo/gmo_legi_authorise_en.html