Margot Wallström: "Traceability and labelling of genetically modified organisms (GMOs) and traceability of food and feed products produced from GMOs" European Parliament debate on traceability and lab

Strasbourg, 2/3 July 2002

Mr/Mrs President, Honourable Members of the European Parliament,

• I am sure you are all aware that there are many important and wider issues surrounding the Proposals we have on the table today.

• There is widespread public concern about GMOs and part of our duty as legislators is to address those concerns: by ensuring the protection of the environment and of the EU's biodiversity, the health and safety of consumers, and also their right to make an informed choice

• For these reasons, the marketing of GM products is now regulated in a manner that provides the necessary levels of safety, transparency and reassurance.

• Directive 2001/18/EC , the Novel Foods Regulation and the Proposal on GM food and feed are all designed with these requirements in mind. Authorisation for the placing on the market of GM products under this legislation, in accordance with the precautionary principle, must ensure a high level of protection for human health and the environment.

• One of the features of the EU system is a comprehensive pre-market risk assessment. Traceability is a means to implement post-market measures such as monitoring and withdrawals. This can and has been achieved by transmission of accurate information for products throughout the production and distribution chains.

• This Proposal provides for GM products to be followed at each stage of their placing on the market. It also provides for labelling of products containing GMOs at all stages of their placing on the market.

• This should ultimately provide the basis for allowing consumers and the public to make their own choice. In our view, these measures are important in restoring the confidence of consumers and the public in general.

• The Proposal introduces a number of clear obligations on operators while not placing unnecessary or unrealistic burdens on either operators or inspection authorities.

A number of important issues have been highlighted in the amendments put forward by the Parliament on which I have the following comments:

Firstly, on the scope of the proposal

The issue of the inclusion of products derived from animals fed with GM material in the scope of the Proposal will be addressed by Commissioner Byrne in further detail. I would, however, stress that the Commission carefully considered this issue whilst drafting the Proposal. We came to the conclusion, following many discussions and consultations, that this would be impracticable and not in line with current Community legislation. The Commission cannot, therefore, support the amendments to include it in the Proposal.

A number of other amendments, on the other hand, reduce the scope of the Proposal. These amendments limit traceability requirements to products only where DNA and protein are detectable. This would not permit accurate labelling of products that have been produced from GMOs but no longer contain modified DNA or protein.

This approach presents a number of shortcomings, which have been widely highlighted during our preparatory work. The most important one is that it would not ensure an informed consumer choice. Therefore, the Commission cannot accept these amendments.

Secondly, on the objectives of the proposal

It is important to stress that whilst traceability facilitates the implementation of safety measures, where appropriate, it cannot and should not be considered as a safety measure per se. Consequently, whilst the precautionary principle is applicable to the legislation concerning the authorisation of GMOs, it is not applicable to the implementation of a traceability system under this Proposal. And it is for this reason, that the Commission can not support the amendments (2 and 6) that link the precautionary principle to the Proposal.

I should also make clear that traceability is not a tool for addressing the issue of co-existence . The Commission has committed itself to address co-existence between organic, conventional and GM crops in the Communication on life sciences and biotechnology adopted in January 2002. The proposal we are discussing today provides only for traceability and labelling of GMOs. These are not tools for addressing co-existence, which incorporates policy decisions in relation to agricultural production systems. The sections of the amendments which include this issue either in full (amendment ) or in part (3) are, therefore, not acceptable to the Commission.

Thirdly, on traceability requirements

In terms of the information to be transmitted to ensure traceability, it is important to recognise that the objectives for traceability of GMOs are not identical to those for products produced from GMOs.

It is essential that the specific identity of GMOs to be intentionally introduced into the environment for cultivation can be established. This is because these products contain 'live' GMOs that are capable of reproduction and dissemination. Therefore the Proposal requires that operators specify exactly the identity of the GMOs contained in the products.

Conversely, the potential risk to the environment from products containing GMOs for direct use in food, feed or processing will be limited as they are not intended for cultivation . The Commission, therefore, considers it both appropriate and adequate that products, including bulk shipments, containing GMOs for food, feed and processing are accompanied by documentation stating this use, with a list of unique codes for the GMOs that the product or shipment may contain.

These information requirements are consistent with those provided for under the Biosafety Protocol with regard to transboundary movements of GMOs. The Commission considers that we should be consistent with and not go beyond the requirements of the Biosafety Protocol so as to ensure a harmonised and consistent approach for trade with third countries.

The Commission cannot, therefore, accept amendments (16, 41) that require individual GMOs contained in a shipment to be identified precisely, through provision of their unique codes.

The Commission also considers that retention of information (documentation) for traceability purposes should be limited to a period of 5 years. There is no practical value in extending the period for retention of information from 5 to 10 years. Such a refinement would place an unnecessary additional burden on operators. The amendments (17 and 22) extending this time-period to 10-years are, therefore, not acceptable for the Commission.

Concerning compatibility with Directive 2001/18/EC

The Commission agrees with the Parliament that the provisions of this Proposal are compatible with and do not impinge upon the provisions of Directive 2001/18/EC . In this context, repeal of Article 4(6) of the Directive, which requires that Member States take measures to ensure traceability at all stages of the placing on the market of GMOs, is necessary. Without repeal of Article 4(6), it is clear that national measures could proceed alongside those under the Proposal providing for disruption of the internal market and creating legal uncertainty. The Commission cannot, therefore, accept amendments 28 and 33 as they maintain the traceability provisions in the Directive

Similarly, the Commission rejects the amendment (32), which prohibits new approvals until unique codes are assigned to GMOs under this Proposal. The current Community framework for granting authorisation already lays down a number of conditions for approval of GMOs and GM food, notably that they do not present adverse effects for human health and the environment. The extension of current criteria for approvals to include the attribution of unique codes would introduce an element of uncertainty on the implementation of Community legislation that the Commission cannot accept.

Finally, on the adventitious presence and thresholds

The issue of the adventitious or technically unavoidable presence of GM material in conventional products is a major issue. More than 50 million hectares of GM crops are now grown in third countries. As a result, the adventitious presence of GM material in imported products, particularly bulk shipments of grain for food, feed and processing, is now inevitable and largely unavoidable. A continuing standstill on new approvals in the EU can only make this situation worse as traces of increasing numbers of GMOs without Community authorisation will be present.

Thresholds to exempt adventitious presence from labelling requirements are already present in Community legislation. It is, therefore, consistent that adventitious presence, under specified conditions, is exempt from the labelling requirements of this Proposal. On the same basis, it is logical to provide an exemption from its traceability requirements.

Setting threshold values is a complex issue and the Commission believes that a sector-based approach will provide the most effective solution . The Commission cannot, therefore, accept the amendments (45 and 56) to transfer competence for the establishment of thresholds for products intended for food, feed or processing from the Proposal on GM food and feed.

I re-iterate that the Commission fully supports the principle to create thresholds for adventitious presence as proposed in a number of amendments. However, the amendments to insert an article establishing thresholds are of more relevance to the Proposal on GM food and feed and the Commission believes it should remain here.

Commission position on the amendments

For ease of reference, I have summarised the detailed position of the Commission in terms of all amendments and this note is being made available.

By way of conclusion, Mr/Mrs Chairman, I would like to emphasise that it is in our common interest which is the interest of the European citizens to have this proposal enter into force swiftly. Comprehensive traceability and labelling systems for GM products are needed not only to facilitate the application of safety measures where appropriate but also in restoring the confidence of consumers and the public in general.

DN: SPEECH/02/313 Date: 02/07/2002