Deliberate release of GMOs in Belgium: Historical background

Fields trials with genetically modified (GM) plants began in Belgium in 1986. Belgium was the second continental European country, after France, to allow cultivation of GMO crops on its soil. In Belgium, as in other countries, the authorities viewed GM plants as potential new vegetable varieties. Transgenesis was perceived as one innovation among others which enabled new varieties to be selected more quickly. Environmental trials with these plants were therefore treated in the same way as trials with non-transgenic varieties. Consequently, the Ministry of Agriculture first granted authorisation for field trials of GM plants based on royal decrees relating to seeds.
Therefore, there was never a "legal vacuum" in Belgium with regard to field trials with GM plants. However, it was not until 1998 that a specific legal framework for this type of application was adopted in Belgium.

From 1990, Directive 90/220/EEC served as a frame of reference for the risk assessment of GMOs released into the environment. As this Directive had been adopted on the basis of Article 100 A of the Maastricht Treaty (see section “Historical background”), its transposition into national law had to be carried out in strict compliance with the provisions of the Directive.

In 1991, the Law of 20 July (Loi du 20 juillet 1991 portant des dispositions sociales et diverses / Wet van 20 juli 1991 houdende sociale en diverse bepalingen. Moniteur belge/Belgisch Staatsblad of 1.08.1991, p. 17002) set the general frame of reference for preparing the transposition of European legislation on the deliberate release of GMOs. Article 132 thereof states that "in order to ensure the fulfilment of obligations resulting from international agreements or treaties regarding the deliberate release of genetically modified organisms, the King, by means of a decree deliberated in the Council of Ministers, regulates the deliberate release of genetically modified organisms". This law was later supplemented by the Law of February 22, 1998 (Loi du 22 février 1998 portant des dispositions sociales / Wet van 22 februari 1998 houdende sociale bepalingen. Moniteur belge/Belgisch Staatsblad of 3.03.1998, p. 5683). Article 222 of this Law provides for the charging of fees in aid of Sciensano and Article 226 confers special powers to officials responsible for overseeing compliance with the legal provisions regarding the deliberate release of GMOs.

Discussions aimed at drafting the decree for enforcement of the Law of 20 July 1991 (i.e. the decree transposing Directive 90/220/EEC) began in October 1991. However, finalisation of this decree took seven long years, leading to Belgium being convicted by the European Court of Justice for failure to transpose within the prescribed period. The difficulty did not lie in the transposition of Part C of the Directive ("the placing on the market of GMOs"), as that was clearly an exclusively federal responsibility, but in the transposition of Part B ("research and development"). For this part, responsibilities were divided between different levels of power: agriculture and public health at the federal level and environmental protection at the regional level. Consequently, finalisation of the decree transposing Directive 90/220/EEC proved to be indissociable from the adoption of the Cooperation Agreement. This agreement was a necessary step to specify the respective responsibilities of the various federal and regional authorities and the arrangements for the intervention of these authorities in the administrative and scientific coordination of biosafety, particularly via the setting up of the Biosafety Advisory Council and the Service Biosafety and Biotechnology (SBB).

Once all the parties had signed the final version of the Cooperation Agreement in April 1997, the transposition of Directive 90/220/EEC was quickly completed. On 18 December 1998, the Royal Decree regulating the deliberate release into the environment and the placing on the market of genetically modified organisms or products containing them was adopted. This Royal Decree transposed Directive 90/220/EEC as well as later additions and amendments thereto concerning the exchange of information, the "Summary Notification Information Formats", the possibility of applying simplified procedures and the amendment of the annex listing the information to be provided in the case of placing on the market. It also included the provisions of the Cooperation Agreement concerning the deliberate release of GMOs into the environment (Article 3 of the agreement).

In accordance with the decree and the Cooperation Agreement, the federal authorities are responsible for issuing the authorisations required for the deliberate release of GMOs into the environment. However, in the case of experimental releases, a common authorisation procedure was established between the Federal State and the Regions. In this case, authorisations from the federal authorities are subject to the agreement of the competent regional Minister of the territory in which the trial is to take place.

Transposition into Belgian law of Directive 2001/18/EC

Directive 2001/18/EC of the European Parliament and of the Council repealing Directive 90/220/CEE came into force on 17 October 2002. This Directive was not, however, transposed into Belgian law until 2005 (resulting, notably, in Belgium being condemned by the European Court of Justice in September 2004 for delay in transposition).

This late transposition is explained, in part, by the complexity of implementing the Directive's provisions in the Belgian institutional context, a difficulty that had already been encountered in transposing Directive 90/220/EEC. But it was essentially due to the difficulty in obtaining political agreement on this highly polemic matter.

Work on transposition began, indeed, in September 2001, under the Ad Hoc Working Group on "Biosafety" of the Coordination Committee for International Environmental Policy (CCIEP), chaired by Dr William Moens (at that time Head of the SBB), and under the aegis of the Minister for Public Health. A draft Royal Decree for transposition was drawn up in October 2002, but rejected by the Council of Ministers. The political parties then in power (liberals, socialists and ecologists) could not agree on certain provisions of the draft Decree, and in particular measures relating to the precise details of the location of GMO field trials and, above all, the desire of the ecologists to ask for a socio-economic and ethical opinion (issued by a special expert committee of the Biosafety Advisory Council) on each project involving deliberate release or placing on the market, in addition to the scientific risk analysis (the European Directive allows for this possibility but does not make it mandatory).

After the change in federal coalition government in May 2003 (liberals and socialists, without the ecologists), debate of transposition restarted, but progress was slow. It was not until 21 February 2005 that the Decree transposing Directive 2001/18/EC was passed. In comparison with the previous Decree, the new regulatory provision simplified the administrative procedures for notification. It expanded and strengthened public information and participation, and established ex-post evaluation of the monitoring of the effects of field trials. The proposals for provisions concerning socio-economic and ethical evaluation were abandoned.