Opinion of the Economic and Social Committee on the 'Proposal for a European Parliament and Council Directive amending Council Directive 93/74/EEC on feedingstuffs intended for particular nutritional purposes and amending Directives 74/63/EEC, 79/373/EEC and 82/471/EEC` () (98/C 129/12)

On 6 November 1997 the Council decided to consult the Economic and Social Committee, under Articles 43 and 198 of the Treaty establishing the European Community, on the above-mentioned proposal.

The Section for Agriculture and Fisheries, which was responsible for preparing the Committee's work on the subject, adopted its opinion on 5 February 1998. The rapporteur was Mr Gardner.

At its 352nd plenary session (meeting of 25 February 1998), the Economic and Social Committee adopted the following opinion with 76 votes in favour, 5 votes against and 6 abstentions.

1. General comments

(i) This proposal introduces a new category of 'Nutritional Supplements for Animals` into Community legislation. These are concentrated mixtures of trace metals, vitamins etc., which are used in supplements with other feeds. This category adds further to the considerable corpus of existing EU law on the subject, which already has:

- Compound feedingstuffs

- Complementary feedingstuffs

- Premixed feedingstuffs

- Feedingstuffs for particular nutritional purposes

(ii) The nutritional supplements are widely used in Member States. They are permitted separately in some Member States for instance ANSA products in France (Apports Nutritionnels Spécifiques d'Adaptation) while in others there is no separate legislation but they appear to be accommodated within the existing categories of feed under the national interpretation of existing directives.

(iii) The Committee therefore is not completely convinced that the new category is needed at EU level. If it is introduced, the whole system will become even more complicated. Already it has to be made more transparent. A codification would be an early start towards transparency.

(iv) This opinion is subject to the comments above and the following paragraphs.

1.1. Legal base

1.1.1. The Commission has presented this proposal under Article 100a of the Treaty (Single Market) though the normal base for this type of legislation is Article 43 (Agriculture) since it concerns production and sale of Annex II products. The legal services of the Council have confirmed Article 43 as the proper base (Advice 11180/97, 10 October 1997).

1.1.2. The Committee understands the Commission's reasons for taking Article 100a as the legal base of this directive. It would, however, point out that these reasons are also accommodated by Article 43.

1.1.3. Therefore, in order to avoid the lengthy and complex procedure that Article 100a now entails, it is proposed that the legal base be Article 43, which is already used as a legal base, for all agricultural matters. This will have to be reviewed when the new Article 129 of the Treaty of Amsterdam is in place.

1.2. Definitions

1.2.1. It is not clear from the definitions what current and prospective products are covered and the dividing line between stuffs for particular nutritional purposes, nutritional supplements, premixed feedingstuffs and other compound feedingstuffs. This is of great importance to ensure that there are no products which become illegal as the result of this proposal. It is also important owing to the interplay between this proposal and present and future additives legislation. For this aspect too there is the danger of a legal void unless all products are covered satisfactorily.

1.2.2. An illustrative list of 'nutritional supplements` would help greatly and should be included in any Directive. Appendix A gives such a list taken from practice in one Member State only.

1.2.3. Unfortunately an EU wide list is not available and the Commission therefore should establish one.

2. Detailed Comments

2.1. Article 2

2.1.1. The word 'temporary` is too vague for a legal instrument and should be deleted.

2.1.1.1. The Commission understands by 'temporary` a few days up to one week. However there are many current uses where supplements are needed for weeks or even months to be effective such as the use of trace element supplements where cattle are grazed on nutrient deficient pastures. Equally application such as weaning or 'training` for and recovery from exhaustion could take some weeks. For instance race horses are trained and raced over 6 months.

2.1.1.2. The following terms need clearer definition.

2.1.1.2.1. 'Special breeding and living conditions`.

The Commission is thinking of animals with disturbed physiology or metabolism such as chicken with heat stroke. However, many supplements are fed to normal healthy animals whose nutritional status would be compromised in the absence of their use.

2.1.1.2.2. 1(e) 'Particular nutritional purposes` appears to be the same as 'specific nutritional purposes` in 1(d). The same term should be used throughout. 'Temporarily` is used twice without any guide of what time scale is meant.

2.2. Article 4

Antibiotics, coccidiostats and other medicinal products must be specifically excluded from nutritional supplements.

2.3. Article 7

In many parts of this article there seems to be confusion between 'information` and 'claims`.

2.3.1. For instance 7.5, first indent should presumably read:

'- does not make claims for the presence or the content of analytical constituents other than those that are provided for in point 1(d).`

2.3.2. As written at present this indent would prohibit consumer information concerning the analysis of the product. Similar changes are required elsewhere.

2.3.3. Article 7.5, third indent

2.3.3.1. This indent has to be clarified and should read 'does not refer to properties for the prevention, treatment or cure of a disease other than defined in Article 6.3`; however, ...

2.4. Article 9

This proposes dossiers not only for the new nutritional supplements but also for feedingstuffs for particular nutritional purposes. The latter have been regulated by an EEC Directive since 1993 without any need for such dossiers. The Explanatory Memorandum unfortunately is totally silent on this subject.

2.4.1. The word 'dossier` here is misleading as the term normally refers to the very detailed justification needed for pharmaceutical products or new additives.

2.4.2. The word 'dossier` should be replaced by 'The information set out in Annexes A and B with appropriate scientific justification`. This is the same as it is currently required for existing dietetic foods.

2.5. Article 3 (at the end of Proposal)

2.5.1. These dates are totally unrealistic, especially with the legal base proposed by the Commission. They should be changed to:

'Two years from publication of the Directive`.

2.6. Impact Statement

2.6.1. This is missing. The impact on farms and other SMEs in particular should have been examined and given in the statement.

Brussels, 25 February 1998.

The President of the Economic and Social Committee

Tom JENKINS

() OJ C 298, 30.9.1997, p. 10.

APPENDIX A to the opinion of the Economic and Social Committee

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