European Regulation of GMOs and the WTO

9 Colum. J. Eur. L. 213 (2003)

Joanne Scott. Faculty of Law, University of Cambridge, Visiting Professor, Columbia Law School.

Currently pending before the Community legislative institutions are two proposals concerning genetically modified (hereinafter GM) food and feed. As the subject matter of continuing conflict between the Member States and between the different Community institutions, these proposals look set to stoke the GM fire, notably at the level of the WTO. This paper will focus on the proposal for a regulation on GM food and feed. The European Parliament has proposed numerous, significant, amendments to the original proposal, only some of which have been incorporated into the Commission’s amended proposal. Political agreement on this amended proposal was reached in November 2002, resulting in further significant changes. For the products concerned, the proposal is intended to oust the application of the horizontal regime embodied by Directive 2001/18.5. The time-frame for adoption remains unclear, but continuing lengthy debate may be anticipated in view of the strong disagreements generated by the proposal. Nonetheless, on the political level, the entry into force of these regulations has emerged as a prerequisite for lifting the de facto moratorium in the EU on the approval of new GMOs. The GM food and feed proposal highlights a number of crucial issues in Community law. These include the status and implications of the so-called precautionary principle, the pre-emptive effect of Community food safety norms, and the evolving governance arrangements concerning risk regulation and food safety in the EU. Each of these dimensions will be highlighted below.

Like the horizontal regime, the proposed regulation seeks to establish a system of prior authorization and labeling of GM food and feed. No person shall place on the market a GM organism for food or feed use, nor any food or feed falling within the scope of the regulation, unless it is covered by a relevant authorization and adheres to the relevant conditions for authorization. As one might expect, in a system of multi-level governance, in an area characterized by deep contestation, the proposed authorization process is elaborate and complex. To obtain authorization an application shall be submitted to the competent Member State authority, accompanied by the information and documents laid down. The competent authority concerned shall forward the application to the newly established European Food Safety Authority (EFSA), which shall inform the other Member States and the Commission of the application, and shall make a summary of the dossier available to the public. EFSA is made responsible for the preparation of detailed guidance to assist applicants in the preparation and presentation of the application. Also, crucial is the fact that the EFSA is required to issue an opinion on the application which, subject to the exclusion of confidential information, shall be made public. The EFSA Scientific Committees and permanent Scientific Panels are to be responsible for providing this opinion. EFSA shall forward its opinion to the Commission, the Member States and the applicant, together with its assessment report and reasons for its opinion. In the case of GM food or feed containing or consisting of GMOs, EFSA will be obliged to consult national competent authorities. Taking the EFSA opinion into account, along with Community law and other legitimate factors, the Commission shall issue a draft decision. A final decision on the application will be adopted on the basis of a regulatory committee procedure. Though the EFSA opinion is not binding, the Commission is obliged to provide an explanation for the differences.

This (regulatory) comitology procedure establishes a subtle balance of power between the various actors involved. The bottom line may, however, be thought to lie in the fact that the Commission may enact measures that are not in accordance with the views of the relevant standing committee (comprising Member State representatives), only in the event that the Council (comprising Member State ministers) neither pre-empts this by adopting measures itself, nor precludes it by casting a veto. We will return below to the theme of governance under the proposed regulation.

One of the most contested points of the proposed regulation is the scope of application. While the Commission accepts that the regulation should extend not only to GM food and feed containing or consisting of GMOs, but also to food and feed produced from GMOs, or containing ingredients produced from GMOs, the Commission, unlike the European Parliament, does not accept that the regulation extends to GM food or feed produced with GMOs. The Commission’s explanatory memorandum, which accompanies the original proposal provides:”

The proposed Regulation would cover products ‘produced from a GMO’ but not products ‘produced with a GMO.’ The former implies that a proportion of the end product, whether it is the food or feed itself or one of its ingredients, has been derived from the original genetically modified material. The latter is produced with the assistance of a genetically modified organism, but no material derived from the genetically modified organism is present in the end product. Thus, cheese produced with a genetically modified enzyme that does not remain in the final product and products obtained from animals fed with genetically modified feed or treated with genetically modified medicinal products would be subject neither to the authorization, nor to the labeling requirements laid down in the proposed Regulation.

The concept of produced with is thus distinct from produced from in that it would encompass food or feed produced with the aid of GMOs, food produced from animals fed with feed produced from or with GMOs, including a GM processing aid, or from animals to which GM medicine has been administered. Thus, while both the Commission and the European Parliament concede that the presence of GM material is not the only factor triggering application of the regime, how far the regulation should extend beyond mere presence remains a matter of debate.

Before moving on to consider the substantive premises upon which the proposed regulation rests, one further issue relating to scope of application may be highlighted. This concerns the practically important question of adventitious and technically unavoidable GM presence in food and feed. The Commission proposes that authorization not be required where adventitious or technically unavoidable presence does not exceed 1%, even when the GM material concerned has not been authorized, subject to a requirement that the GM material has undergone a scientific risk assessment by the relevant scientific committee or EFSA, which concludes that it does not present a risk for human health or the environment. Application of the labeling rules would also be waived, subject to a threshold requirement yet to be determined, on the basis of a comitology procedure. The European Parliament is proposing narrower derogations in respect to adventitious or technically unavoidable presence, insisting not only that the authorization requirements never be waived, but also that the labeling rules be waived only for products produced from GMOs, and even then made subject to a maximum threshold of 0.5% to be laid down in the regulation itself, rather than established by way of a regulatory committee procedure. The Council walks on middle ground, laying down a 0.5% maximum for adventitious presence, provided that the material has benefited from a favorable opinion from the relevant committee or EFSA. The limit in respect of the labeling requirement is to be 0.9%. Whereas in respect of the former, this maximum will apply for a period of three years (after which the threshold will revert to 0%), the latter is conceived as permanent, subject to the possibility of lowering the threshold over time.