Opinion on the proposal for a European Parliament and Council Directive amending Directive 89/398/EEC on the approximation of the laws of the Member States relating to foodstuffs()

(95/C 256/01)

On 8 February 1995 the Council decided to consult the Economic and Social Committee, under Article 100a of the Treaty establishing the European Economic Community, on the above-mentioned proposal.

The Section for Protection of the Environment, Public Health and Consumer Affairs, which was responsible for preparing the Committee's work on the subject, adopted its Opinion on 6 June 1995. The Rapporteur was Mr Verhaeghe, Co-Rapporteurs were Mr Jaschick and Mr de Knegt.

At its 327th Plenary Session (meeting of 5 July 1995), the Economic and Social Committee unanimously adopted the following Opinion.

The Committee agrees with the Commission proposal, subject to the following considerations and comments:

1. Background

1.1. The framework directive 89/398/EEC () ('Foods intended for particular nutritional uses') applies to foods which are defined as:

'Foodstuffs which, owing to their special composition or manufacturing process, are clearly distinguishable from foodstuffs for normal consumption, which are suitable for their claimed nutritional purposes and which are marketed in such a way as to indicate such suitability.'

1.2. This encompasses a wide range of very important foods including: infant formulae, follow-on milks, baby foods, slimming foods, foods for athletes, diabetic foods and dietary foods for special medical purposes.

1.3. The directive envisages that some of these categories will have their own specific (vertical) directives while all other foods for particular nutritional uses (referred to forthwith as 'dietetic foods') will be regulated by the general framework (horizontal) directive.

1.4. The directive regulates the products for formulation or nutrient content, labelling and claims made and the marketing of these foods.

1.5. In recent years research institutes, healthcare professionals and industry have been involved in extensive research and development projects on most of the categories of dietetic foods. Consumers, patients, carers and healthcare professionals (doctors, nurses, dietitians, pharmacists, etc.) have all benefited from the innovations which have resulted from this research, especially in the areas of baby milks and foods, slimming foods, foods for athletes and foods for special medical purposes.

1.6. The introduction of new products into the European Union will be regulated by the framework directive and/or the appropriate specific vertical directive.

1.7. Serious problems arise for companies which wish to introduce products which are covered by the scope of a special and/or the framework directive but do not comply with the regulatory requirement of the directives. These products may not be marketed in Europe unless the directive(s) is (are) amended.

1.8. These products give great cause for concern. It is likely that many of the innovative products resulting from new research results will fall into this category. The current framework directive does not contain any clause which would allow the regulations on formulation or nutrient content to be quickly brought into line with scientific or technological progress.

2. General comments

2.1. Following the submission to the Commission services of a request for an amendment to a directive, the procedure for amending directive 89/398/EEC consists of three distinct time phases:

Phase 1

The time taken for scientific consideration by the Scientific Committee for Food (SCF).

Phase 2

The time taken by the Commission to prepare a proposal and the time taken by the Standing Committee for Foodstuffs to come to an opinion.

Phase 3

The time taken by the Commission to implement the change(s) to a directive and the time taken by Member States to transpose the changes into their own national law.

2.2. Experience to date has shown that Phase 1 can take over three years, Phase 2 has been shown to take approximately one year and Phase 3 is unlikely to be less than 12 months, e.g. a request for the amendment of the directive on infant formula and follow-on formula (91/321) submitted in January 1991 was approved by the Standing Committee for Foodstuffs in February 1995.

2.3. The Committee considers that the consequences of such a laborious and lengthy procedure are unsatisfactory for all parties involved in the consumption, supply and production of dietetic foods.

2.4. The slow introduction of scientific innovations in dietetic foods will delay EU consumers access to new products and significant potential health benefits. It will prevent doctors, dietitians and nurses from having valuable new developments in the nutritional management of many patients, it will slow down the achievement of potential cost benefits, it will lead to a minimising of research and development by EU based institutions and companies and as a result of this will adversely impact on EU employment and export opportunities.

2.5. In order to ensure that EU-consumers and healthcare professionals have early access to new scientific and technological developments in dietetic foods and that European research workers and companies are encouraged to invest in the required research and development expenses, it is necessary to shorten the length of time taken to allow the marketing of new innovative products while ensuring a high level of protection for the consumer.

2.6. It should be noted that the innovations covered by the present proposal do not include the use of ingredients which, because of their novel manufacturing processes, e.g. genetic modifications and bio-engineering, will be covered by other EU food legislations directives, e.g. the Novel Foods directive which is currently in draft form.

2.7. The Committee therefore welcomes the proposal of the Commission and endorses its objectives of shortening the approval times.

3. Specific comments

3.1. The Committee does, however, hold the view that the proposal only addresses a part of the problem and wishes to make the following additions, comments and recommendations to further improve the positive impact of the proposal.

3.2. The proposal for the authorization of innovative products should be extended to include a temporary authorization for substances for nutritional purposes which are not included in the nutrient list referred to in Article 4.2 of the current framework directive (89/398/EEC).

3.3. The Committee asks the Commission to reduce the length of time which can elapse between submission of a request for approval to market an innovative product and the adoption of the opinion of the Scientific Committee for Food.

3.4. The Committee feels that ways of assisting the Scientific Committee for Food to come to decisions earlier should be found, as for example:

- increase the use of SCF working parties to handle submissions;

- consider using the scientific cooperation procedures of the EU;

- increase the size of the SCF;

- reinforce the existing structure within the Commission which has the responsibility for managing and implementing food legislation.

3.4.1. It may be useful to set a target timescale for this procedure; the Committee would like to recommend 6 months.

3.5. The Commission should ensure that the necessary legal procedures are set in motion to allow amendments to the directive and transposal into national law within the two-year-authorization period.

3.6. In the event of an unfavourable opinion from the Scientific Committee for Food, the Commission should provide an opportunity for the submitting organization to submit arguments to the Commission for the Scientific Committee for Food to re-examine its opinion taking into account the new submission.

3.7. Confidentiality of the details of an innovative product should be maintained during the authorization procedure, since dietetic foods are rarely protected by a patent and there is no licensing system. As a result, competitors could exploit the lengthiness and transparency of the process to incorporate other peoples' innovations into their products.

Done at Brussels, 5 July 1995.

The Chairman

of the Economic and Social Committee

Carlos FERRER

() OJ No C 389, 31. 12. 1994, p. 21.

() OJ No L 186, 30. 6. 1989.