Opinion on the proposal for a Council Regulation (EEC) laying down the conditions and arrangements for approving certain establishments operating in the animal feed sector and amending Directives 70/524/EEC and 74/63/EEC (94/C 148/06)

On 20 December 1993, the Council decided to consult the Economic and Social Committee under Articles 43 and 198 of the Treaty establishing the European Community on the abovementioned proposal.

The Section for Agriculture and Fisheries, which was responsible for preparing the Committee's work on the subject, adopted its Opinion on 3 March 1994. The Rapporteur was Mr Gardner.

At its 314th Plenary Session (meeting of 23 March 1994), the Economic and Social Committee unanimously adopted the following Opinion.

1. Introduction

1.1. Existing EEC legislation on additives and undesirable substances places restrictions on their use and handling. In the light of the experience obtained, and in the context of the operation of a single market, it is proposed to extend the legislation.

1.2. However almost all this legislation is in the form of Directives whereas this proposal is for a Regulation.

2. General comments

2.1. The Committee welcomes the intention of the Commission specified in the third recital 'to avoid distortions of competition caused by the Member States' different applications and interpretation of already existing approval conditions and to prevent any potentially adverse effects on animals, humans or the environment, given the risks inherent in using certain additives.'

2.2. On balance the Committee accepts that Community legislation is desirable and therefore approves this proposal subject to the comments below.

2.3. There are doubts whether a Regulation rather than a Directive is the appropriate instrument. A Regulation often has the advantage that it can be directly applied. However in this case far too much has to be further defined before being applicable in national law (see 3.9.2 and 3.9.3).

2.4. The conditions in the proposal on farm mixing units are too complex and, given the multiplicity of such units throughout Member States, would be incapable of enforcement. The Commission is therefore urged to simplify their proposals as affect the mixing of feed.

3. Specific comments

3.1. Third Recital

3.1.1. This needs completing as follows:

'... given the risks in using certain additives incorrectly.'

3.2. Fifth Recital

3.2.1. In order to clarify the reference to 'other persons' in line 4 the Committee suggests that the recital be altered to read:

'... and the recording of other persons, such as intermediaries, in an official register.'

3.3. Eighth Recital

3.3.1. A key objective of the proposal is to ensure that all establishments are treated in a like manner. In order to facilitate this the recital should be completed by adding the words:

'... in order to ensure uniform treatment of all establishments.'

3.4. Article 2

3.4.1. This Article specifies the date by which establishments shall apply for inclusion in an official register. It makes no reference to the date by which Member States shall have completed their approval process. In order to ensure equal treatment of establishments in all Member States the Article should be extended as follows:

'Member States shall complete the approval process within one year of this date.'

3.5. Article 4

3.5.1. This Article is difficult to understand. It appears to relate to establishments which manufacture compound feedingstuffs to be fed to animals on their premises e.g. farmers. In addition the word 'products' in line 3 is not defined in the Proposal and needs defining. Also to get uniform conditions the words 'may apply for approval' should be changed to: 'must apply for approval'.

3.6. Article 6

3.6.1. Article 6(1) requires Member States to satisfy themselves that the conditions laid down by the Proposal are met before an establishment is entered in the official register.

3.6.2. Article 6(2) deals with the updating of the official register, but is silent about the need for Member States to ensure that the conditions of the Proposal are met before a change in the activity to be registered is made. In order to ensure uniform treatment of all establishments the Committee recommends that Article 6(2) be completed by the addition of the following sentence:

'Prior to any change to an entry in the official register Member States shall satisfy themselves that the conditions laid down in the Annex are met.'

3.7. Article 11

3.7.1. This covers the Committee procedure used to implement or amplify several Articles in this proposal. The Committee has reservations on using a purely consultative procedure. They are the same as given in the Opinion on another Proposal when the Committee said that in such cases 'it is essential to maintain [a] procedure which involves a decision by the Council or at least to use the procedure followed in all other veterinary matters, involving a decision by the Standing Veterinary Committee by qualified majority vote in each case' (1).

3.8. Article 12

3.8.1. This Article replaces Article 13(1) of Directive 70/524. As such it should only apply to high tech additives. However as written it covers a number of generics as well. In particular it covers vitamins and minerals almost all of which represent no danger in any conceivable circumstances.

3.8.2. It should therefore be modified to cover only those vitamins and minerals for which the Standing Committee for Feedingstuffs requires a quantitative limitation of intake.

3.8.3. Also to preserve the existing distribution channels for vitamins and minerals Article 13(2) of Directive 70/524 also has to be changed. This could be done by adding to Article 13(2) the words:

'This paragraph does not apply to vitamins and minerals.'

3.9. Annex

3.9.1. The annex is divided into three chapters, each of which lists the conditions which must be fulfilled by manufacturing establishments in order to obtain approval. In some sections the conditions are precise, in others they are general statements which are imprecise and will need to be defined to 'ensure legal clarity and to improve transparency' (third recital) and to impose only those conditions which can be interpreted and enforced without ambiguity.

3.9.2. For instance, taking Chapter 1 as an example the conditions associated with the following examples of imprecise requirements should be deleted or rewritten so as to remove all ambiguity.

1. line 10 appropriate and regular checks

2. line 2 knowledge and experience necessary

3. line 4 qualified person

3. line 8 regularly checked

4. line 4 qualified person

5. line 3 authorized persons, etc.

N.B.: The line numbers above relate to the English text.

3.9.3. If this remains a Regulation, these and the many others need to be defined at operational level at the time the 'practical arrangements' required in Article 7 are being established using the procedure in Article 11.

3.9.4. As written at present they cannot be applied directly and will have to be defined in national law. For practical reasons therefore this proposal should be changed to a Directive in line with similar animal feed measures.

3.10. Annex Chapter II Condition 6.2

3.10.1. The manufacture of a premixture may not always be associated with an order at the time of its preparation. In many cases a standard premixture may be made for stock. Given this situation the reference in line 6 to 'for whom the premixture is intended' is inappropriate. The Committee recommends that the last two lines of this condition be changed to read:

'to whom the raw materials and/or premixtures are sold and the nature and quantity of the premixture delivered.'

3.11. Annex Chapter III, A 6.2 and B 6.2

3.11.1. Instead of 'Commercial Register', the heading should be: 'Records'.

3.12. Annex Chapter III, A 7

3.12.1. Change heading to:

'Non-conformity and product recall.'

3.12.2. Also add the following after the first sentence:

'Where products have already arrived at the farm there may be sanitary reasons why they are not suitable for return to the manufacturing establishment. In such cases a solution has to be found between seller and buyer, where necessary with the advice of the competent authority.'

Done at Brussels, 23 March 1994.

The Chairman

of the Economic and Social Committee

Susanne TIEMANN

(1) OJ No C 34, 2. 2. 1994, p. 23.