Brussels, 18 December 1997
Labelling of genetically modified organisms
Measures taken by the European Union on the labelling of GMOs and their derivatives are a recent development in Community legislation, in particular in the nutritional area. They were first adopted in 1997, the year when the novel foods regulation of the European Parliament and the Council entered into force. The regulation is the first European act which lays down specific labelling conditions for products emanating from biotechnology, including GMOs and their derivatives. On 23 July 1997 the European Commission presented general guidelines to ensure that consumers and users are provided with as complete and transparent information as possible on "live" GMOs, processed GMOs and their derivatives, whether of Community origin or imported. The purpose of such labelling is to give consumers clear, honest, neutral and scientifically sound information on the genetically modified origin of products. These guidelines have in the meantime been incorporated in several Commission proposals.
In recent years science has made it possible to develop genetically modified organisms (GMO). The European Union has gradually responded to this development. Community legislation on GMOs took account, first of all, of the concern to establish a Community safety assessment and authorisation procedure.
The safety and labelling of products are two aspects that should be clearly distinguished. No product consisting of, containing or derived from GMOs can be authorised for marketing without first having undergone appropriate safety assessment.
For "live" GMOs (e.g. cereals) the European Union adopted a "horizontal" directive in 1990, establishing an authorisation procedure at Community level (Directive 90/220 on the deliberate release into the environment of genetically modified organisms). The aim of this directive is to ensure a high protection level of health and the environment and the efficient functioning of the internal market.
For biotechnological products that may contain GMOs or GMO derivatives sectoral legislation has been adopted (Regulation 97/258/EC of the European Parliament and the Council on novel foods) or will be proposed shortly (animal feedingstuffs and seeds). These texts entail a "one-stop office" policy (i.e. adopting a regulation per type of product) and include a risk analysis similar to that provided for in Directive 90/220.
Guidelines for a Community labelling system
Labelling should make it possible for consumers to make choices. While it is a "plus" for the consumer it does not replace the appropriate safety assessment that is a precondition to marketing authorisation in all cases. On 23 July 1997 the Commission adopted general guidelines on the labelling of products based on GMOs (see IP/97/700). The purpose of these guidelines is twofold: to ensure coherent information for consumers under current and under planned legislation.
The guidelines are based on a number of principles:
- science-based labelling of products consisting of, containing or derived from GMOs throughout the food chain;
- labelling intended to give consumers clear, honest and neutral information about the GMO origin of products;
- labelling in accordance with the European Union's international obligations.
In the guidelines the following labelling categories are proposed:
- mandatory labelling for products of which it can be proved scientifically that they consist of, contain or are derived from GMOs (e.g. "contains GMO-based substances");
- mandatory labelling in cases where material of GMO origin cannot be excluded ("may contain GMO-based substances"). This applies in particular to supplies with mixed modified and non-modified products;
- voluntary labelling for products that do not contain any GMOs or substances derived from GMOs ("this does not contain GMO-based substances").
- Council Directive 90/220/EEC of 23 April 1990 is intended to approximate legislation in force in the Member States to ensure that there are uniform market conditions and uniform protection of human health and the environment throughout the Union with regard to "live" GMOs. It does not apply to processed or derived products but provides explicitly for the development of sectoral legislation to be adopted as and when new GMO types and new applications emerge. Directive 90/220 retains a catch-all function in respect of products not covered by sectoral legislation.
- Originally Directive 90/220 made virtually no provision with regard to labelling. In order to fill this lacuna the Commission has adopted a two-pronged approach:
- to meet immediate needs: adoption, on 18 June 1997, of a Commission Directive (97/35/EC) amending Council Directive 90/220 (see IP/97/528). Through this act the Commission made use of its institutional prerogatives in an emergency situation. The Commission Directive of 18 June 1997 establishes mandatory labelling when a product consists of or contains genetically modified organisms. For products consisting of a mixture of GMOs and organisms not genetically modified, the possible presence of GMOs must be indicated. This Directive does not have retrospective effect. Voluntary labelling has been negotiated with producers in respect of products notified prior to 18 June 1997 for authorisation under Directive 90/200;
- to adopt a more complete framework: presentation on 26 November 1997 of a proposal to amend Directive 90/220 to the European Parliament and the Council (see IP/97/1044). This proposal contains precise labelling measures confirming and integrating the guidelines adopted by the Commission in July 1997. It is due to be discussed in view of its adoption by the European Parliament and the Council.
- Regulation 97/258/EC of the European Parliament and the Council on novel foods, which entered into force on 15 May 1997, concerns end products. It applies to novel foods and novel food ingredients, including those resulting from genetic engineering. The safety assessment required before a product can be authorised must include assessment adapted to the use for which the product is authorised.
- The novel foods regulation is the first European act incorporating specific labelling rules for products developed through biotechnology. It lays down mandatory labelling and requires that consumers be informed of differences between a new product and existing equivalent products. This refers to the differences resulting from the use of biotechnological processes, including the presence of "live" and/or processed GMOs. Additives, flavourings and extraction solvents are expressly excluded from the scope of the novel foods regulation because special rules have been laid down for these products which already provide for a specific authorisation and labelling procedure (which, however, do not include the indication of GMOs or GMO origin). This approach has been unanimously supported by the Council and also by the European Parliament with a large majority.
- In two other areas, animal feedingstuffs and seeds, the Commission intends shortly to present proposals including labelling rules in accordance with the guidelines it adopted in July 1997. Other fields (e.g. pesticides) will be covered at a later stage.
Soya and maize
A genetically modified soya variety and a genetically modified maize variety were authorised under Directive 90/220 before its amendment in June 1997 and before the novel foods regulation entered into force. The labelling rules for these two varieties and the products derived from them thus had to be specified. The Commission discussed with the producers concerned the possibility of voluntary labelling for these particular varieties. Their derivatives, however, were not subject to labelling rules. This would have created a contradiction with the products to be authorised in the future which would automatically fall within the scope of the amended Directive 90/220 and/or the novel foods regulation, with the mandatory labelling these acts require.
To solve these specific problem of food and food ingredients produced from genetically modified soya beans or maize, already authorised but not subject to mandatory labelling, the Commission has taken the following initiatives:
- to meet immediate needs: adoption of Commission Regulation 1813/97 of 19 September 1997 which, with effect from 1 November 1997, provides for the labelling of products containing genetically modified soya or maize or products derived from these. This obligation is similar to the one imposed by the novel foods regulation (see IP/97/814). This ad hoc measure, taken under the Commission's prerogatives, provides that the detailed labelling procedures must be specified subsequently;
- to secure a more complete framework: adoption on 3 December 1997 of a Commission draft regulation based on the July 1997 guidelines as well as on the provisions of the novel foods regulation, laying down detailed labelling procedures for foodstuffs based on genetically modified soya and maize (see IP/97/1081). This draft meets the concern expressed by the Member States and the parties involved. In this draft the Commission proposes scientific criteria for labelling. It has chosen the criterion of the presence of modified DNA which will make it possible to label a larger number of foodstuffs than the protein criterion. However, a comparison of proteins of modified products and those of their classic equivalent will be made where the DNA criterion is not conclusive. This draft should carry a qualified majority in the Standing Committee on Foodstuffs to become a regulation, replacing Commission Regulation 1813/97.
Over and above the main objective of ensuring a transparent labelling approach for consumer products, the guidelines adopted by the Commission in July 1997 are intended to facilitate the flow of information between the various parties involved by ensuring "from the stable to the table" labelling, covering the various stages of the production process. This has not yet been achieved. The sectoral legislation currently being drafted, in particular for animal feedingstuffs, seeds and pesticides, will extend mandatory labelling and reduce the gap between products covered and those not covered by mandatory labelling.
With regard to the principle of voluntary labelling of products not containing GMOs or GMO derivatives ("does not contain GMO-based substances") provided for in the guidelines of 23 July 1997), the Commission is currently contemplating the establishment of a Community certification and labelling framework.
- List of existing legislation
- Directive 90/220/EEC on the deliberate release into the environment of genetically modified organisms. Concerns live GMOs. Virtually silent on labelling.
- Commission Directive 97/35/EC amending Directive 90/220 of 18 June 1997. Adapts Annex 3 to Directive 90/220, introducing mandatory labelling.
- Draft directive amending Directive 90/220 of 26 November 1997. Proposal containing precise labelling measures based on the guidelines adopted by the Commission in July 1997. Once adopted by the European Parliament and the Council, this text will replace Commission Directive 97/35/EC.
- Regulation 97/258/EC of the European Parliament and the Council on novel foods. This Regulation, which entered into force on 15 May 1997, lays down mandatory labelling for novel foods and novel food ingredients, requiring that the consumer be informed of the differences between a new product and existing equivalent products.
- Commission Regulation 1813/97 of 19 September 1997. Concerns the labelling of products containing or derived from genetically modified soya and maize varieties. This Regulation was rendered necessary by the fact that these products are covered neither by the novel foods regulation nor by Commission Directive 97/35/EC.
- Draft for a Commission Regulation of 3 December 1997. Intended to replace Commission Regulation 18/3/97, introducing more detailed rules in it. Based both on the Commission's guidelines of July 1997 and on the provisions of the novel foods regulation. Requires a qualified majority in the Standing Committee on Foodstuffs.