WRITTEN QUESTION E-3151/02

by Ilda Figueiredo (GUE/NGL) to the Commission

(4 November 2002)

Subject: Moratorium on the authorisation of new genetically modified organisms

On 17 October 2002 the Commission expressed its satisfaction regarding the implementation of Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms (GMOs)(1). It took the view that the conditions were right to resume the GMO authorisation procedure or in other words lift the de facto

moratorium that has been in place for some four years. It is now hoping that the Council and Parliament will adopt the regulation on labelling and traceability. It maintains that its chief concern is human health and the environment. These assertions, however, are at odds with the declared aim of lifting the moratorium.

Apart from the ethical issues raised by commercial exploitation and patenting of life and the natural heritage, the release of GMOs into the environment is irreversible and uncontrollable: it has a direct impact in that it pollutes traditional farming and reduces biological diversity, and the consequences for ecosystems are incalculable. Organic and traditional farmers will thus be left without a choice. In the medium to long term contamination will be unavoidable, and several NGOs and farming organisations, especially those involved in organic farming, have drawn attention to the risks. On the other hand, until such time as the consequences for human and animal health have been accurately researched, the cardinal rule should be the precautionary principle. Another point to stress is the economic dependence of farmers on the large multinationals and the dependence of countries where their food policies are concerned. Apparently, only business considerations matter, not least the import of particular products such as soya from the United States.

How does the Commission reconcile the precautionary principle and environmental protection with the lifting of the moratorium? On what research does it base its assertion that the conditions are right and how will it control the release of GMOs into the environment?

How in its opinion are traditional and organic crops likely to be affected by the release of GMOs?

How does it view the decision that traces of GMOs resulting from accidental or technically unavoidable circumstances do not have to be indicated on product labelling when they fall below a given threshold? Does it not consider that, to comply with the precautionary principle, that threshold should be zero?

(1) OJ L 106, 17.4.2001, p. 1.

Answer given by Mrs Wallström on behalf of the Commission

(27 January 2003)

The Commission considers that the more stringent and transparent provisions of the new Directive 2001/18/EC provide the necessary legislative conditions and measures to ensure a high level of protection for human health and the environment under which new applications for authorisation should be considered. As explained in recital 8, the precautionary principle has been taken into account when drafting this Directive and its implementation must also take account of this principle.

It is not the Commission's direct responsibility to control the release of genetically modified organism (GMOs) into the environment. This responsibility is addressed in Article 4(5) of the Directive, which clearly specifies that Member States shall organise inspections and other control measures, as appropriate, to ensure compliance with Directive 2001/18/EC. The Commission considers that it has created the necessary legislative conditions to re-start the authorisation procedure for GMOs. Directive 2001/18/EC requires that applications for authorisation of a GMO include, on a case by case basis, a comprehensive assessment of potential risks to human health and the environment. Clearly, applicants should provide their assessment on the basis of current scientific information that is relevant to the GMO in question. Appraisal of this assessment by the competent authorities of Member States and the European Scientific Committees, which the Directive also requires as a condition of authorisation, will also be based on such information.

The issue of co-existence has been raised largely in terms of the potential impact of cultivation of GM crops on organic and conventional crops. Some commercial cultivation of GM crops and hundreds of experimental releases of GMOs have taken place in the Community over the past decade, without any significant impact on organic and conventional crops. Nevertheless, it is clear that the potential impact varies from one crop to another. Consequently, more scientific evidence is required, and the question is being analysed in the framework of the Commission working plan on Life sciences and biotechnology(1).

However, it should be noted that commercial cultivation and use of GMOs in the Union is strictly regulated under a Community legislative framework that provides for authorisation on the basis of a comprehensive assessment of potential risks to human health and the environment. The objective of such legislation is to afford a high level of protection for human health and the environment. Where a risk is identified, then authorisation would either not be granted or would contain management measures to control this risk to an acceptable level.

Co-existence refers to the harmonised existence of different agricultural production systems and not exclusion of individual systems. Co-existence must, therefore, be considered principally as an agricultural management issue and not one of risk per se. It should allow for the principle of freedom of choice for farmers to apply different agricultural production systems. This requires consideration of the potential impact of individual production systems on other systems and the appropriate means to address this impact. The issue of co-existence between the different types of agriculture is not included in the scope of this legislation and cannot be used as justification for delaying the restart of the authorisation procedure. The Commission is fully aware of the importance of co-existence in terms of agricultural production systems and is currently investigating the most appropriate means in which to address this issue. This includes the financing of research projects through the 6th Framework Programme and further studies by the Joint Research Centre, which will continue to analyse management practices related with co-existence of different systems of agricultural production.

The Commission would firstly point to the fact that thresholds under current Community legislation and the Proposals on (i) traceability and labelling and (ii) GM Food and Feed cover only adventitious traces of GMOs that have been authorised for the placing on the market or have received a positive evaluation from a Community Scientific Committee or Authority. Consequently, these GMOs will have undergone a comprehensive scientific risk assessment and the precautionary principle will have been taken into account as part of the evaluation. The precautionary principle is, therefore, not applicable to the setting of such thresholds, which are purely for labelling purposes. The purpose of GM labelling is to enable consumers and users to make an informed choice between GM and non-GM products: it does not imply that the products are harmful to health or the environment.

The Commission views tolerance thresholds as necessary since it considers that, in practice, traces of GMOs in products may be technically unavoidable and zero tolerance is therefore not possible. In the production of food, feed and seed, it is practically impossible to achieve end products that are 100 % pure and totally free from foreign substances.

(1) COM(2002) 27 final.