Common position (EC) No 9/2001

adopted by the Council on 12 February 2001

with a view to adopting Directive 2001/.../EC of the European Parliament and of the Council of ... amending Council Directive 95/53/EC fixing the principles governing the organisation of official inspections in the field of animal nutrition and Directives 70/524/EEC, 96/25/EC and 1999/29/EC on animal nutrition

(2001/C 93/01)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Article 152(4)(b) thereof,

Having regard to the proposal from the Commission(1),

Having regard to the opinion of the Economic and Social Committee(2),

Having regard to the opinion of the Committee of the Regions(3),

Acting in accordance with the procedure laid down in Article 251 of the Treaty(4),

Whereas:

(1) The safety of products destined for animal nutrition is of primary concern and it is necessary to ensure that products put into circulation in the Community for the purposes of animal nutrition are safe. Council Directive 95/53/EC of 25 October 1995 fixing the principles governing the organisation of official inspections in the field of animal nutrition(5) contributes to the achievement of that objective.

(2) Council Directive 74/63/EEC was repealed by Article 16 of Council Directive 1999/29/EC of 22 April 1999 on undesirable substances and products in animal nutrition(6). Therefore, references to Directive 74/63/EEC have to be amended pursuant to the table in Annex IV to Directive 1999/29/EC.

(3) As regards the reference to the circulation of products to be used in animal nutrition, it is necessary to harmonise the definitions used by Directives 70/524/EEC(7), 95/53/EC and 96/25/EC(8) in the animal nutrition sector.

(4) Serious dioxin contamination recently occurred twice in products to be used in animal nutrition. Taking into account the experience gained from these incidents, it is necessary to improve the procedures applicable to cases where a product for animal nutrition poses a serious risk to human or animal health or to the environment or where certain infringements of Directive 1999/29/EC are detected. The aim is in this way to improve the management of risks which would preclude the level of protection of human or animal health and of the environment provided for in the Community regulations on animal nutrition while not trivialising those special procedures by systematically applying them to minor problems.

(5) A Commission inspection carried out following dioxin contamination of the feed and food chain revealed that Member States had had difficulty in managing such an unusual crisis. In the light of the experience gained, and in order to ensure that serious risks involving a product for animal nutrition are managed with equivalent guarantees of efficiency throughout the Community, it is necessary to introduce provisions requiring the Member States to have in place contingency operational plans to deal with emergencies in the animal nutrition sector.

(6) Where a serious risk to human or animal health or to the environment arises in a Member State due to products for animal nutrition, and where that risk cannot be contained satisfactorily by the Member State(s) concerned, it is indispensable for the Commission to be able to take all the necessary precautionary measures and to have in particular the authority to suspend trade in, and exports of, products for animal nutrition from all or part of the Member State concerned or to establish special conditions for the relevant products or substances.

(7) Directive 1999/29/EC establishes the maximum permitted levels for certain undesirable substances and products in feed materials and feedingstuffs.

(8) A system has already been established to enable the Member States to be informed by operators, at all stages of the feed-producing chain, of certain cases of non-compliance with the rules on undesirable products and substances. In view of both the experience gained and the similar arrangements provided for in the Community rules on general product safety, that system should be improved and extended to render it applicable to all cases where an operator finds that a product for animal nutrition poses a serious risk to human or animal health or to the environment.

(9) At present there is an obligation to inform the other Member States and the Commission when a consignment of feed materials or feedingstuffs which is not in compliance with the maximum levels for undesirable substances or products is likely to be sent to other Member States.

(10) It is necessary to incorporate this rapid-information-exchange system into Directive 95/53/EC and set standard procedures for its operation, so that it can be applied in future in all cases where a product endangers human health, animal health or the environment and for the purpose of improving the inspection system as a whole. For reasons of simplicity and efficiency, the system should also apply where a Member State refuses a product from a third country when checking it upon importation. These standard procedures could, subject to certain amendments, be the same as those laid down for exchanging information in emergencies pursuant to Council Directive 92/59/EEC of 29 June 1992 on general product safety(9).

(11) It is not possible to list all potentially dangerous contaminations of biological or chemical origin, which may happen by accident or by illegal action, and may affect a product to be used in animal nutrition.

(12) The risk of hazards deriving from mislabelling or from handling, transport, storage or processing should be taken into consideration.

(13) To improve the efficiency of the inspection system and the relevant inspection measures, where there is a suspicion of contamination posing a serious risk to human health, animal health or to the environment, Member States should be required to verify the nature and extent of the contamination and to make every effort to identify its origin in order to detect any other possible contamination.

(14) Directive 95/53/EC requires Member States to submit to the Commission information on the results of inspections carried out each year, before 1 April 2000 for the first time. It is also laid down that those reports will be used by the Commission to prepare and submit an overall summary report on inspections carried out at Community level together with a proposal for a coordinated inspection programme for the following year. Information concerning contamination affecting the safety of a product to be used in animal nutrition shall be considered by the Member States and the Commission in fixing the priorities for annual coordinated inspection programmes. All the information gathered on risks to human health, animal health or to the environment, relating to the circulation and use of products for animal nutrition, can be better analysed when provided in harmonised and standardised form.

(15) Taking into account the foregoing, Council Directives 95/53/EC, 70/524/EEC, 96/25/EC or 1999/29/EC should be amended,

HAVE ADOPTED THIS DIRECTIVE:

Article 1

Directive 95/53/EC is hereby amended as follows:

1. Article 2(1) is hereby amended as follows:

(a) the second indent shall be replaced by the following:

"- Council Directive 1999/29/EC of 22 April 1999 on undesirable substances and products in animal nutrition(10).";

(b) point (e) shall be replaced by the following:

"(e) 'product intended for animal nutrition' or 'product': animal feed or any substance used in animal nutrition;";

(c) point (h) shall be replaced by the following:

"(h) 'putting into circulation' or 'circulation': the holding of any product intended for animal nutrition for the purposes of sale, including offering for sale, or any other form of transfer, whether free or not, to third parties, and the sale and other forms of transfer themselves.";

2. the following Article 4a shall be added after Article 4:

"Article 4a

1. Member States shall draw up contingency operational plans setting out measures to be implemented without delay where a product for animal nutrition has been found to pose a serious risk to human health, animal health or to the environment and specifying powers and responsibilities as well as channels for transmitting information. Member States shall review these plans as appropriate, particularly in the light of changes in the organisation of the inspection services and of the experience gained, including that gained in any simulation exercises.

2. Member States shall forward to the Commission the contingency operational plans drawn up by them and also any amendments thereto.

3. The Commission shall examine the plans and suggest to the Member States concerned any amendment which would help to ensure that Member States' contingency operation plans offer equivalent guarantees of efficiency. Where necessary in order to achieve that objective the Commission, acting in accordance with the procedure provided for in Article 23, may issue guidelines to harmonise the contingency operational plans.";

3. Article 12(1) shall be replaced by the following:

"1. The competent authority of the Member State of destination may, at places of destination, check the compliance of products with the provisions of Article 2(1)(a) by means of non-discriminatory random checks. In particular, and only to the extent necessary for carrying out these random checks, Member States may ask operators to report the arrival of the products to that competent authority. Member States shall inform the Commission when they avail themselves of this action.";

4) the following section 3a shall be added after Article 15:

"Section 3a

Safeguard clause

Article 15a

1. Where a problem due to a product to be used in animal nutrition, likely to pose a serious risk to human health, animal health or to the environment, appears in one or more Member States and cannot be contained satisfactorily by means of the measures taken by the Member State(s) concerned, the Commission, acting in accordance with the procedure provided for in Article 23a on its own initiative or at the request of a Member State, shall immediately, depending on the seriousness of the situation adopt the following measures:

- suspend the putting-into-circulation within the Community, the use in animal nutrition or exports to non-member countries of products from all or part of the Member State(s) concerned or from one or more establishments situated in Community territory, or

- lay down special conditions for the putting into circulation in the Community, the use in animal nutrition or exports to non-member countries of products from all or part of the Member State(s) concerned or from one or more establishments situated in Community territory.

2. However, in emergencies, the Commission may provisionally adopt the measures referred to in paragraph 1 after consulting the Member State(s) concerned and informing the other Member States. It shall submit the matter to the Standing Committee for Feedingstuffs set up by Article 1 of Decision 70/372/EEC(11) within 10 working days for its opinion, in accordance with the procedure laid down in Article 23a, with a view to the extension, amendment or repeal of those measures.

Where a Member State officially informs the Commission of the need to take protective measures and where the Commission has not had recourse to the measures referred to in paragraph 1, that Member State may adopt temporary protective measures with regard to use or putting into circulation. Where a Member State adopts such measures, it shall immediately inform the other Member States and the Commission. The Commission shall submit the question to the Standing Committee for Feedingstuffs within 10 working days for its opinion in accordance with the procedure laid down in Article 23a with a view to the extension, amendment or repeal of the temporary protective measures taken by that Member State.

Article 15b

The Commission shall inform the European Parliament of the measures taken under Articles 9a and 15a.";

5. the following Chapter IIIA shall be added after Article 16:

"CHAPTER IIIA

INFORMATION SYSTEM FOR HAZARDS FROM FEEDINGSTUFFS

Article 16a

Member States shall prescribe that the persons responsible for the establishments must immediately inform the Member States' competent authorities if they have evidence that a consignment of products for animal nutrition which they have brought into Community territory from a non-member country or put into circulation, and which they are holding or own:

- exceeds the maximum levels laid down in Section A of Annex II to Directive 1999/29/EC beyond which the product must not be fed as such to animals or mixed with other products for animal nutrition, or

- does not comply with one of the other provisions referred to in Article 2(1)(a) of this Directive and, owing to that non-compliance and, in view of the purpose for which it is intended, poses a serious risk to human health, animal health or to the environment.

The persons responsible for the establishments shall provide all details enabling precise identification of the relevant product or consignment of products and as full as possible a description of the risk posed by the product or products concerned, as well as all available information useful in tracing the product or products. They shall also inform the competent authorities of the Member States of action taken to prevent risks to human health, animal health or to the environment, describing that action.

The Member States shall lay down the same information requirements concerning the risks posed by products for animal nutrition for persons carrying out health monitoring of holdings such as those referred to in Article 10 of Council Directive 96/23/EC of 29 April 1996 on measures to monitor certain substances and residues thereof in live animals and animal products(12), and for persons responsible for laboratories carrying out analyses.

Where appropriate, the competent authorities shall apply the provisions of Articles 8, 11 or 13.

Article 16b

1. Where the competent authorities of the Member States have information indicating, on the basis of the risk assessment factors available, that a consignment of products for animal nutrition poses a serious risk to human health, animal health or to the environment, they shall verify the information received and, where appropriate, ensure that the necessary measures are taken so that the consignment is not used in animal nutrition, put the consignment under restriction and investigate immediately:

- the nature of the hazard and where appropriate the level of contamination,

- the possible origin of the contamination or of the hazard,

in order to assess the risk more closely.

Where appropriate, the risk assessment shall be extended to other consignments of the same product or to other products in the feed or food chain to which the contamination or hazard might have extended, taking into account any cross-contamination with other products for animal nutrition and possible recycling of dangerous products into the feed chain.

2. Where the existence of a serious risk is confirmed in accordance with paragraph 1, Member States shall ensure that the final destination of the contaminated consignment, including possible decontamination, reprocessing or destruction, cannot have harmful effects on human or animal health or on the environment and where it is possible that the contamination or the hazard has extended to other consignments or to the feed or food chain they shall immediately identify and put under control other consignments of the products deemed hazardous and also, where appropriate, identify live animals fed with hazardous products and implement the measures provided for in Directive 96/23/EC or in other relevant Community provisions relating to animal health or to the food safety of products of animal origin ensuring coordination between the relevant control services, in order to avoid the hazardous products being put into circulation and to ensure the enforcement of recall procedures for the products already in circulation.

Article 16c

1. Where a Member State finds that a product for animal nutrition which has been put into circulation in its own territory and in that of other Member States, or a product originating in a non-member country which has been brought into Community territory in order to be put into circulation in one or more Member States:

- exceeds the maximum levels laid down in section A of Annex II to Directive 1999/29/EC beyond which the product must not be fed as such to animals or mixed with other products for animal nutrition, or

- does not comply with one of the other provisions referred to in Article 2(1)(a) of this Directive and, owing to that non-compliance and the purpose for which it is intended, poses a serious risk to human health, animal health or to the environment,

that Member State shall forthwith alert the Commission by way of notification.

It shall provide sufficient information to identify the products concerned, trace and put them under control and, where appropriate, the live animals fed with them, and shall specify safeguard measures envisaged or already taken, in order to enable the Commission properly to inform the other Member States.

2. Any Member State concerned shall immediately alert the Commission of any follow-up measure taken in respect of the notified hazards, including information concerning the end of the risk situation.

3. The Commission and the Member States shall set up and operate a system for rapid exchange of information under conditions set in accordance with the procedure provided for in Article 23, with a view to expediting transmission and dissemination of the alerts referred to in paragraph 1 and the information referred to in Article 8(1).

4. The Commission shall inform the European Parliament of measures taken to expedite the transmission and dissemination of alerts.";

6. Article 17(2) shall be replaced by the following:

"2. Member States shall provide that officials responsible for inspection are subject to professional confidentiality. However, this provision shall not affect the possibility for the competent authorities of the Member States of disseminating information necessary to prevent a serious risk to human health, animal health or to the environment.";

7. Article 22 shall be amended as follows:

(a) the following sentence shall be added at the end of paragraph 2:

"This information shall be presented in the form of annual reports in accordance with a specimen to be drawn up pursuant to Article 23.";

(b) the following subparagraph shall be added at the end of paragraph 3:

"The overall summary report referred to in the first subparagraph shall be communicated to the European Parliament."

Article 2

In Directive 70/524/EEC, Article 2(k) shall be replaced by the following:

"(k) 'putting into circulation' or 'circulation': the holding of any product intended for animal nutrition for the purposes of sale, including offering for sale, or any other form of transfer, whether free or not, to third parties, and the sale and other forms of transfer themselves."

Article 3

In Directive 96/25/EC, Article 2(b) shall be replaced by the following:

"(b) 'putting into circulation' or 'circulation': the holding of any product intended for animal nutrition for the purposes of sale, including offering for sale, or any other form of transfer, whether free or not, to third parties, and the sale and other forms of transfer themselves."

Article 4

Article 12(3) and (4) of Directive 1999/29/EC is hereby repealed.

Article 5

1. Member States shall adopt and publish, not later than ...(13), the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith inform the Commission thereof.

They shall apply these provisions from ...(14).

When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States.

2. Member States shall communicate to the Commission the main provisions of national law which they adopt in the field covered by this Directive.

Article 6

This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities.

Article 7

This Directive is addressed to the Member States.

Done at Brussels ...

For the European Parliament

The President

For the Council

The President

(1) OJ C 274 E, 26.9.2000, p. 28.

(2) OJ C ...

(3) OJ C ...

(4) Opinion of the European Parliament of 4 October 2000 (not yet published in the Official Journal), Council Common Position of 12 February 2001 and decision of the European Parliament of ... (not yet published in the Official Journal).

(5) OJ L 265, 8.11.1995, p. 17. Directive as last amended by Directive 2000/77/EC of the European Parliament and of the Council (OJ L 333, 29.12.2000, p. 81).

(6) OJ L 115, 4.5.1999, p. 32.

(7) Council Directive 70/524/EC of 23 November 1970 concerning additives in feedingstuffs (OJ L 270, 14.12.1970, p. 1). Directive as last amended by Directive 1999/20/EC (OJ L 80, 25.3.1999, p. 20).

(8) Council Directive 96/25/EC of 29 April 1996 on the circulation of feed materials. (OJ L 125, 23.5.1996, p. 35). Directive as last amended by Directive 2000/16/EC of the European Parliament and of the Council (OJ L 105, 3.5.2000, p. 36).

(9) OJ L 228, 11.8.1992, p. 24.

(10) OJ L 115, 4.5.1999, p. 32.

(11) OJ L 170, 3.8.1970, p. 1.

(12) OJ L 125, 23.5.1996, p. 10.

(13) Twelve months after the entry into force of this Directive.

(14) Twenty months after the entry into force of this Directive.

STATEMENT OF THE COUNCIL'S REASONS

I. INTRODUCTION

1. On 21 March 2000 the Commission submitted a proposal for a Directive of the European Parliament and of the Council, based on Article 152(4) of the Treaty, amending Council Directive 95/53/EC fixing the principles governing the organisation of official inspections in the field of animal nutrition and Council Directive 1999/29/EC on undesirable substances and products in animal nutrition.

2. The European Parliament delivered its first-reading opinion on 4 October 2000. The Economic and Social Committee delivered its opinion on 20 September 2000. The Committee of the Regions, duly consulted, did not take any action.

3. The Council adopted its Common Position at its meeting on 12 February 2001, in accordance with the procedure laid down in Article 251 of the Treaty.

II. PURPOSE

The proposal for a Directive seeks to improve the effectiveness of inspections carried out to check that legislation on the safety of products intended for animal nutrition is being applied.

The text provides, inter alia, for:

- the implementation in each Member State of contingency operational plans setting out the measures to be taken if a serious health risk is detected,

- a safeguard clause enabling the Commission to take protective measures at an early stage,

- the setting-up, at Community level, of an information system for hazards from feedingstuffs.

III. ANALYSIS OF THE COMMON POSITION

A. GENERAL COMMENTS

The Council, while confirming the objectives proposed by the Commission and supported by Parliament, considered it necessary, when drawing up its Common Position, to make a number of amendments to the proposal.

The Council's amendments essentially set out to:

- specify the scope of certain provisions, especially those relating to emergency safeguard measures and the information system,

- make the wording of the Directive more explicit in order to improve its legal clarity,

- ensure consistency of the different legislative texts on animal nutrition.

It should also be noted that the Council added a reference in the title to Directives 70/524/EEC and 96/25/EC: for reasons of legal consistency, the Council considered it necessary to include in those two Directives the new definition, introduced in Directive 95/53/EC, of putting into circulation products intended for animal nutrition.

B. SPECIFIC COMMENTS

1. Main amendments to the Commission proposal

(a) Contingency operational plans drawn up by the Member States to deal with emergencies (Article 1(2))

The Council reworded Article 4a proposed by the Commission in order to define more clearly the demarcation of roles and responsibilities between the Commission and the Member States in drawing up the Member States' contingency operational plans and to ensure that those plans offer equivalent guarantees of efficiency.

(b) Checks at places of destination (Article 1(3))

To improve the efficiency of random checks which the Member States may carry out at places of destination to check the compliance of products with the Community rules in the area of animal nutrition, the Council supplemented Article 12(1) of Directive 95/53/EC with a provision enabling Member States to ask operators to report the arrival of products which should be checked.

The Council takes the view, however, that the application of this provision should not lead to any quantitative restrictions and should not jeopardise normal trading relations. It therefore considers it necessary that Member States be informed, within the Standing Committee for Feedingstuffs, whenever this possibility is availed of.

(c) Safeguard clause (Article 1(4))

Article 15a of the Common Position allows the Commission to take all the necessary precautionary measures if a serious health risk related to products intended for animal nutrition appears in a Member State and cannot be contained satisfactorily by that State. The Council has, however, reworded this article to make it more consistent with the corresponding provisions introduced by Directive 2000/77/EC of 14 December 2000 on the subject of products from non-member countries.

The following two procedures are laid down for taking such measures:

- the procedure laid down in Article 23 of Directive 95/53/EC which provides for the involvement of the Standing Committee for Feedingstuffs,

- the emergency procedure, under which the Commission may adopt provisional measures after simply consulting the Member State(s) concerned and informing the others. It then has 10 days to submit the matter to the Standing Committee for Feedingstuffs with a view to the extension, amendment or repeal of the measures.

(d) Information system for hazards from feedingstuffs (Article 1(5))

The Council considered it necessary to make extensive changes to the proposed information system, for rapid and efficient information exchange, by dividing the provisions adopted into three separate articles (Articles 16a, 16b and 16c).

In Article 16a, the Council first extended the scope of the information system to consignments of products imported from non-member countries, considering that the system would be incomplete if it was limited to products put into circulation in the Community.

Moreover, this Article specifies the circumstances in which there is an information requirement under the system and with whom the obligation lies.

As regards the persons who must supply the information required, the Council wished to include persons carrying out health monitoring of holdings, without prejudice, however, to the professional secrecy by which they are bound under national law.

In Article 16b the Council included most of the provisions proposed by the Commission concerning the measures to be taken in the event that a consignment of a product intended for animal nutrition poses a serious risk to health or the environment, and merely added some clarifications.

Article 16c describes the measures which must be taken in the case of non-compliance with the regulations governing animal nutrition.

(e) Member States' annual reports on the implementation of their inspection programmes and the Commission's overall summary report (Article 1(7))

As regards the content of the annual reports, the text of the Common Position refers to a specimen to be drawn up pursuant to Article 23 of Directive 95/53/EC. As for the Commission's overall summary report on the results of checks carried out at Community level, the Council added to the text currently in force to provide also for its transmission to the European Parliament.

2. Council position on the European Parliament amendments

The Council endorsed the Commission's position in incorporating into its Common Position, in part or in principle, Parliament amendments 2, 7, 17, 18, 19, 21, 23 and 25, and not taking account of amendments 5, 14 and 22.

The Council's reasons for not taking up the other amendments were as follows:

- the changes made to the text of the proposal for a Directive render amendments 1, 3 and 26 redundant,

- since the list of biological or chemical contaminants has already been established by the Directive on undesirable substances and products in animal nutrition, there is no point in referring to it as proposed in amendment 4,

- it was not considered necessary to state that the obligation to inform the authorities under the information system must not be seen as encouraging denunciation, as proposed in amendment 6, given that the obligation is on professionals and not on the general public,

- amendments 8, 11, 12 and 13, which are essentially linguistic or stylistic, were not considered indispensable for inclusion in the Common Position,

- amendment 10 does not take account of the fundamental principles of the single market according to which inspections are normally carried out in the products' country of origin and only in exceptional cases at the place of destination or during transit,

- amendments 15, 16 and 20 which aim to provide greater guarantees than the texts they seek to amend no longer seem necessary in the light of the changes made by the Council.