New Environmental Rules on the Deliberate Release of GMOs: a Stricter and Potentially "Catch All" Environmental Legislation

Date: Aug 03, 2000

Concluding a highly politicised debate, the EU Parliament – in its second reading under the so-called co-decision procedure – adopted on 12 April 2000 a legislative resolution on the Council Common position for adopting a European Parliament and Council Directive on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC of 23 April 1990, as amended.

Directive 90/220/EEC – an environmental legislation - governs the deliberate release of GMOs into the environment and the placing on the market of products containing, or consisting of, GMOs intended for subsequent deliberate release into the environment with a view to approximate the laws of the EU Member States in the field and to protect human health and the environment.

As amended, the Directive will (see its PART A) define deliberate release as "any intentional introduction into the environment of GMOs or a combination of GMOs for which no specific containment measures are used to limit their contact with, and to provide a high level of safety for, the general population and the environment". GMOs are themselves defined as "any organism (" biological entity capable of replication or of transferring genetic material"), with the exception of human beings, in which the genetic material has been altered (using certain techniques at the exclusion of others as such techniques are described in ANNEX I to the Directive) in a way that does not occur naturally by mating and/or natural recombination".

The Directive institutes (see its PART A) a general obligation for the Member States, in accordance with the precautionary principle, to ensure that all appropriate measures are taken to avoid adverse effects on human health and the environment which might arise from the deliberate release or the placing on the market of GMOs. More specifically, it provides that GMOs may only be deliberately released or placed on the market in conformity with the procedure set up in either its PART B, for the deliberate release for any other purpose than the placing on the market, or PART C, the latter being applicable to the placing on the market of GMOs as - or in – "products" (defined as "a preparation consisting of, or containing, a GMO or a combination of GMOs"). Both procedures involve the notification of a dossier to the Member State where the release will take place (ANNEX III to the Directive details the information required in the notification); the notification needs be preceded by an environmental risk assessment (ANNEX II to the Directive describes the principles for conducting that risk assessment) and followed by a dialogue between that Member State, the EU Commission and the other Member States (including consultation of the public and, where appropriate, groups) and leads, ultimately, to a consent in writing or rejection. Last but certainly not least, under ANNEX IV, the procedure applicable to the placing on the market of GMOs as - or in - products is reinforced as regards additional information and labelling requirements.

As amended, the Directive sets a definite date of 2005 for phasing out the use of GMOs that are resistant to antibiotics (the Parliament rejected amendments that would have banned such GMOs immediately). It does not establish – as had been proposed – an obligation for the party legally responsible for a deliberate release to bear strict civil liability for any damage caused; rather, the Commission will submit a proposal for legislation on liability before the end of 2001.

Many questions have been raised regarding the exact scope of the revamped directive, going as far as wondering whether it could not be construed as applying to the placingon the market of finished food products, ingredients, additives, flavourings, etc. Although the directive (see Article 11 paragraph 2) exempts from its requirements the placing on the market of GMOs as - or in - products when they are authorised by Community legislation which provides for a specific environment risk assessment carried out in accordance with the same principles and based on the same information as required under the Directive and comprising requirements as regards risk management, labelling, monitoring as appropriate, information to the public and safeguard clause at least equivalent to that laid down in the Directive, and despite the specific provisions of the Novel Food Regulation itself, it remains to be seen whether or not the provisions of the latter will ultimately be accepted to be "at least equivalent" to those of the Directive. It might appear, indeed, that the provisions of Article 11 paragraph 3 indicating successively that (1) procedures ensuring that the risk assessment, requirements as regards risk management, labelling, monitoring as appropriate, information to the public and safeguard clause are equivalent to those laid down in the Directive shall be introduced in a Regulation of the European Parliament and of the Council and that (2) until that Regulation enters into force any GMO or its products as far as they are authorised by other Community legislation shall only be placed on the market after having been accepted for placing on the market in accordance with this Directive, could be construed as implying that finished food products that would otherwise be regulated by the Novel Food Regulation (as containing or consisting of GMOs) would be caught by the provisions of the revamped 90/220.

What seems clear, in any event, is that the planned revision of the Novel Food Regulation (announced for September 2000) in the Commission’s White Paper on food safety) will provide an ideal opportunity to the EU legislator to square the provisions of the Novel Food Regulation with those of the new 90/220.

Whether the new Directive will be "ambiguous" or simply "well balanced" is a matter of perspective. Welcomed by EU Environmental Commissioner Wallström as "endorsing stricter and more transparent EU rules for GMOs" the very same vote at the European Parliament could be reported by the French newspaper "Le Monde" as "EU says yes to GMOs". And these were amongst the less extreme comments.

¬© Article from Keller and Heckman’s "European Advisory". June 2000 issue.

For further information, please contact Jean Savigny at 32 2 541 0571 or savigny@khlaw.be or Rachida Semail at 32 2 541 0594 or semail@khlaw.be.