EU Commission Press Release on GMO Labeling
EUROPEAN COMMISSION PRESS RELEASE: IP/97/528

DOCUMENT DATE: JUNE 18, 1997

The European Commission approves the labelling of Genetically Modified Organisms

The European Commission today adopted a Commission Directive which will make labelling compulsory for all new products containing or consisting of genetically modified organisms (GMOs) notified for placing on the market under Directive 90/220/EEC on the deliberate release into the environment of genetically modified organisms (OJ L117, 8.5.1990). Under the new Directive notifiers of new products must indicate on the label or in an accompanying document that the product may contain or may consist of genetically modified organisms. For products placed on the market in mixtures with non-genetically modified organisms, the label would indicate the possibility that genetically modified organisms may be present. The Directive should be transposed into law in Member States by 31 July 1997. This does not prejudge any further considerations by the Commission concerning the need for comprehensive labelling of GMOs in horizontal legislation and in product legislation.

On a proposal from Environment Commissioner Ritt Bjerregaard, the Commission has adopted a Commission Directive adapting to technical progress Annex III of Directive Directive 90/220/EEC which outlines additional data requirements for products containing or consisting of GMOs, including labelling. According to the new Directive notifiers must include in their dossiers on new products: 1) specific label for the GMOs they intend to place on the market; 2) certain molecular data in the form which can be included in a potential register.

The proposed measure was adopted by the Commission on 2 April 1997 (See IP/97/259, of 2.4.1997). On 29 May 1997, the Regulatory Committee of Member States established under Article 21 of Directive 90/220/EEC delivered a favourable opinion on the Commission's proposal. With the adoption today, the new measure should be transposed into Member States' National legislation by 31 July 1997.

The new Directive does not prejudge the Commission's current revision of Directive 90/220/EEC or any further considerations concerning the need for comprehensive labelling of GMOs in horizontal and sectoral legislation.

The new measure does not automatically apply to currently pending notifications because this would constitute a retroactive obligation in relation to the notifications submitted. However, on 7 April 1997 Commissionner Bjerregaard invited notifiers to label their pending products on a voluntary basis. Most companies (Plant Genetics System, AgrEvo and Monsanto, whose offers seem to be in line with the requirements of the new Annex III, - and to a certain extent Pioneer and Novartis) have responded positively. The request will result in products being labelled when approved under Directive 90/220/EEC and on this basis it was possible for the Commission on 6 June to approve the placing on the market of two kinds of genetically modified oilseed rape fra PGS (cfr. IP/97/501).

Valio Ltd has not responded, but had already indicated in the notification that they would label their product (test kit) and given the caracteristics of the product, they could not see what else they could offer. Bejo Zaden has not responded at all, but offered in January 1997 to label their seeds. On 11 June, Commissioner Bjerregaard thanked the companies who had responded. In particular she reminded Pioneer and Monsanto that the revised Annex III goes beyond the labelling of seed bags and invited them to consider further the issue of bulk consignments of mixtures.

Foods or food ingredients containing, consisting of or derived from GMOs and approved under Directive 90/220 will fall under the scope of the Novel Foods Regulation (OJ L43, of 14.2.1997) if they have not been consumed to a significant degree in the European Union at the moment of entry into force of the Regulation. Such products will then be subject to the labelling provisions of the Novel Foods Regulation.

Upon adoption of this Directive Commissioner Bjerregaard expressed deep satisfaction with ``the breakthrough in the Commission of the new principle of labelling of GMO's: As a valuable information for the consumer and not as a warning.'' She also took the opportunity ``to thank those companies who had responded positively to the Commission's invitation to consider labelling as a modification of their original notification'' and stressed the point that ``the recent approval of the two products from PGS underlines that labelling clearly makes a strong difference in the somewhat cumbersome and delicate process of approving GMO's.'' The Commissioner recalled her intention to present a thorough revision of Directive 90/220 to the Commission before the summer break.

Background

In the last 12 months the placing on the market of genetically modified products has led to growing concern on the part of the general public. This was illustrated when in May 1996 genetically modified soya beans were given consent to be placed on the market and more recently by the consent granted to Novartis' (former Ciba-Geigy) Bt-maize. Public concern is focused in particular on the absence of specific labelling of such products. In addition the public is equally concerned about the limited experience with this new technology, in that current scientific knowledge may in certain cases be disproved in the future.

The public first and foremost wishes to see a full application of the precautionary principle which would allow prompt detection of any adverse effects not currently foreseeable. The public has also expressed the need for users of genetically modified products to be fully aware of the method by which these products have been produced so that they can make an informed choice.

The same concerns are routinely expressed by a number of Member States in the course of the decision-making procedure for authorisation of GMO products under Directive 90/220/EEC. The number of Member States with objections has lately increased to the extent that a qualified majority in favour of clearing most products currently notified under Directive 90/220/EEC is unlikely.

Under Directive 90/220/EEC products containing or consisting of genetically modified organisms (GMOs) do not require labelling in the absence of safety reasons. Thus, in the absence of safety reasons and unless the notifier has voluntarily offered to label the product in the original application or in the course of the decision-making procedure, products placed on the market following a consent under Directive 90/220/EEC are not labelled as produced by genetic modification.

On 2 April 1997, the Commission addressed the above-mentioned concerns by endorsing a technical adaptation of Annex III of Directive 90/220/EEC to allow mandatory labelling for all GMOs approved for placing on the market under this Directive. In accordance with the scope of the Directive, which is limited to GMOs as defined in the Directive, the proposed measure will ensure that products approved under the Directive are labelled to indicate that they contain or consist of genetically modified organisms. In the case of products placed on the market in mixtures with non-genetically modified organisms, the label would indicate the possibility that genetically modified organisms may be present.


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