52002PC0153

Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on additives for use in animal nutrition

(presented by the Commission)

EXPLANATORY MEMORANDUM

1. INTRODUCTION

With a view to bringing coherence to Community legislation in a "farm to table" approach, the Commission announced in the White Paper on Food Safety that it would propose legislation to consolidate existing rules on additives in feedingstuffs and clarify certain procedural aspects related to dossier evaluation and the types of authorisation granted to feed additives (Action 19 in the White Paper).

So far, the basic legislation (Council Directive 70/524/EEC) has undergone five major amendments and numerous modifications of the annexes (over 100). The Directive has never been consolidated.

The current legislation is rather complex. The existence of different types of authorisation (provisional, for ten years or with no time limit, linked to the applicant company or not) complicates the implementation of EC rules on this matter.

In certain cases, Member States may derogate from the common provisions (e.g. additive levels in complementary feedingstuffs, incorporation rates for additives and premixtures in feedingstuffs). The consequence is that different interpretations are possible, and enforcement of certain decisions adopted at EC level becomes ineffective.

The procedure for dossier evaluation involves two Committees: the Standing Committee for Feedingstuffs, made up of representatives of the Member States ("comitology" procedure), and the Scientific Committee for Animal Nutrition (SCAN).

The current procedure for authorising new additives or new uses of additives can be described as follows:

- the applicant company selects a Member State to act as rapporteur. When the applicant is established in a third country, he must have a representative in the Community;

- the Member State acting as rapporteur checks that the application dossier contains all the information required;

- the Member State acting as rapporteur dispatches copies of the dossier to the Commission and to the other Member States;

- Member States have a period of sixty days to check whether the dossier has been compiled in accordance with EC rules;

- if no objections are made by the Member States, the Commission has a period of thirty days to include the application for authorisation on the agenda of the Standing Committee;

- the Commission ensures that a decision on the application for Community authorisation is taken within 320 days following its inclusion on the agenda of the Standing Committee.

During this procedure, the SCAN is usually asked for an opinion. The time limit is suspended if members of the Standing Committee or the SCAN request additional information.

This arrangement does not provide for a clear separation between risk evaluation and risk management as the Standing Committee also deals with risk management. Furthermore, this methodology relies heavily on the work of the Member State acting as rapporteur. In certain cases, rapporteur Member States are not neutral and behave as ardent defenders of the applicant company.

The whole procedure is time-consuming and rather confusing for the applicant companies, which sometimes receive similar questions from different bodies (members of the Standing Committee and the SCAN).

2. GENERAL OBJECTIVES

This proposal covers the incorporation of the additive in feedingstuffs and in drinking water. The emergence of new products and new feeding techniques, as well as the need to consider the use of additives in silage, are elements that must be taken into account.

A real demonstration of the positive effect of the additive (on the feedingstuff or on the animal) is also a key element. On the other hand, only those feed additives may be authorised which do not present any risk for human health, animal health or the environment.

The European Food Safety Authority (EFSA) will have the competence and the responsibility to provide a single framework for dossier evaluation for all feed additives, and will bring clarity (guidelines will be updated and adapted to the various types of additives), efficiency (a single evaluation) and transparency (adoption of an assessment report and public consultation) to the process.

3. SCOPE

A definition of feed additives is provided by this Regulation. Processing aids and veterinary medicines are not covered within the scope of this regulation.

Only additives that are safe for humans, animals and the environment, and do not mislead the user or impair distinctive features of animal products, will be authorised.

Only additives covered by an authorisation under this Regulation will be allowed to be put on the market, used or processed.

For some well defined categories of additives, no person other than the authorisation holder shall put the additive on the market. The reason for this is the need to identify the person responsible for the supervision requirements to be met during the authorisation period.

General rules concerning the incorporation of additives in feedingstuffs and, in particular, minimum incorporation rates, are not provided for in the proposal. Likewise, labelling provisions concerning feedingstuffs are not considered in this proposed Regulation and are left to the relevant legislation.

Processing aids, which are only used during the feed production process to achieve a certain technological objective, need to be addressed separately and therefore these products fall outside the scope of this Regulation.

In absence of an equivalent level of harmonisation between Regulation (EEC) 2309/93 concerning the authorisation and surveillance procedure of medicinal products, Directive 90/167/EEC on the preparation and placing on the market of medicated feed, and of Directive 70/524/EEC, the borderline between veterinary medicinal products and feed additives is clarified. Except for coccidiostats fed to healthy animals during their entire productive life, compounds used in disease prevention, namely antibiotics, are not authorised as feed additives.

The use of coccidiostats as feed additives will thus continue to be permitted but Maximum Residue Limits (MRLs) will be fixed in order to avoid risks to human or animal health. Under the current European system of intensive husbandry, the treatment of farmed animals, in particular poultry, by coccidiostats is, according to operators, indispensable. Therefore, if such substances could not be administered as additives, they would in any case be administered as medicated feed, with a possible increase of cost and an increase of doses. However, the maintaining of the status of coccidiostats as feed additives requires that a new evaluation of these substances takes place in a maximum delay of four years after the entry into force of this Regulation.

4. CLASSES OF FEED ADDITIVES

In order to clarify the structure of the list of authorised additives, this list will be divided into a restricted number of broad additive categories:

- technological additives (e.g. preservatives);

- sensory additives (e.g. flavours, colorants);

- nutritional additives (e.g. vitamins);

- zootechnical additives (e.g. gut flora improvers, non-microbial growth promoters);

- coccidiostats.

Each category is further divided into functional groups. Sufficient flexibility must be provided within each category to allow for the emergence of new groups of products, in order to adapt the list to new developments in science or technology.

Unless otherwise specified, the mixing of authorised additives will be allowed. Consequently, mixtures of authorised additives should not be subject to specific authorisations.

5. PHASING OUT

Following concerns raised by the international scientific community, the authorisations of the following antibiotic feed additives were withdrawn: avoparcin, tylosin phosphate, spiramycin, virginiamycin and bacitracin zinc (Commission Directive 97/6/EC of 30 January 1997 and Council Regulation (EC) No 2821/98 of 17 December 1998 respectively).

The reason is the potential risk of transfer of antimicrobial resistance from microorganisms of livestock origin to human pathogens.

In its opinion adopted on 28 May 1999, the Scientific Steering Committee (SSC) recommended that the use of antimicrobials as growth promoting agents, belonging to classes that are or may be used in human or veterinary medicine, should be phased out as soon as possible and ultimately abolished.

A second opinion of the SSC on anti-microbial resistance adopted on 10-11 May 2001 confirmed the need to plan and co-ordinate the phase-out process and to make efforts to replace those antimicrobials by alternative products.

In order to comply with the SSC recommendation, the following steps are now being taken:

- exclusion of the antibiotics from the scope of the new legislation on feed additives, i.e. the request for authorisation of antibiotic feed additives will no longer be permitted;

- adoption of a transitional period for the phasing out of the four remaining antibiotics in order to allow animal production practices to be adapted. These substances will be prohibited from 1.1.2006.

6. REGISTER

The principle of a positive list is maintained: only the additives listed in a register are allowed to be placed on the market, used or processed, subject to particular conditions of use if necessary (dose, animal categories, etc.).

The list will be made available to all interested parties.

7. AUTHORISATION PROCEDURE

In summary, the procedure laid down in the proposed Regulation is as follows:

- the person responsible for placing the additive on the market will submit an application to the European Food Safety Authority (EFSA);

- the Authority will give an opinion within 6 months;

- the Authority will forward its opinion to the Commission, the Member States and the applicant, and make its opinion public as soon as possible after adoption. Following publication of the opinion, the public may make comments to the Commission;

- the Commission will prepare a draft Regulation within three months of receipt of the opinion of the EFSA. In the event of a Regulation granting an authorisation of an additive, this will be entered in the register.

The authorisation will be valid for ten years.

Existing authorised products will be dealt with, in summary, as follows:

- within one year of the entry into force of the Regulation, the person responsible for placing an authorised additive on the market will notify the Authority of this fact;

- within one year of the notification and after verification that the required information has been submitted, the Authority will notify the Commission to this effect and the additive will be entered in a register;

- at the latest one year before the expiry date of the authorisation (for additives with a limited authorisation period), or within seven years after the entry into force of the Regulation (for additives authorised without a time limit), an application for authorisation will be submitted. However, for coccidiostats an application must be submitted within four years of the entry into force of the Regulation.

Authorisations will be renewable for ten-year periods upon application to the Authority at least one year before the expiry date.

Unless the applicant demonstrates it is not necessary, the scientific assessment shall be supplemented by residues studies to be submitted by the applicant. In this case the opinion of the Authority shall include a proposal for the setting of maximum residues levels (MRLs). The Regulation according the authorisation of the feed additive shall fix MRLs for the active substance.

Additives that are either genetically modified or produced from a GMO should first comply with the requirements of and be evaluated according to the Regulation on genetically modified food and feed, prior to undergoing the authorisation procedure under this proposed Regulation.

After the authorisation of a feed additive has been granted, the authorisation holder has obligations in respect to the supervision of conditions of marketing of the additive. The authorisation holder must communicate to the Authority any new information concerning the safety of the product, in particular possible effects on particular health sensitivities of specific categories of consumers.

8. LABELLING RULES

The following particulars will be required for the labelling of all additives:

- the name of the additive, as mentioned in the register;

- the name and address of the person responsible for placing the product on the market;

- the net weight of the active component;

- directions for use and safety recommendations.

For certain categories of additives, the expiry date and specific references (such as the targeted animal category) may also be required.

The labelling will also indicate whether the additive is intended to be incorporated in feedingstuffs or in drinking water.

9. IMPLEMENTATION

Implementation of the measures proposed in the Regulation, and adaptation of the dossier requirements to new developments in scientific and technical knowledge, will be decided on by the Commission in accordance with the regulatory procedure laid down in Council Decision 1999/468/EC.

Scientific data and other information in the initial dossier submitted for the purpose of authorisation may not be used for the benefit of other applicants for a period of ten years, unless the applicant has agreed that such information may be used.

2002/0073 (COD)

Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on additives for use in animal nutrition

(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Articles 37 and 152(4)(b) thereof,

Having regard to the proposal from the Commission [1],

[1] OJ C [....], [...], p. [...].

Having regard to the opinion of the Economic and Social Committee [2],

[2] OJ C [....], [...], p. [...].

Having regard to the opinion of the Committee of the Regions [3],

[3] OJ C

Acting in accordance with the procedure laid down in Article 251 of the Treaty

Whereas:

(1) The free movement of safe and wholesome food and feed is an essential aspect of the internal market and contributes significantly to the health and well being of citizens, and to their social and economic interests.

(2) A high level of protection of human life and health should be assured in the pursuit of Community policies.

(3) In order to protect human health, animal health and the environment, feed additives should undergo a safety assessment through a Community procedure before being placed on the market, used or processed within the Community.

(4) Action by the Community relating to human health, animal health and the environment should be based on the precautionary principle.

(5) In accordance with Article 153 of the Treaty, the Community is to contribute to promoting the right of consumers to information.

(6) Experience with the application of Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs [4] has shown that it is necessary to review all the rules on additives to take into account the need to ensure a greater degree of protection of animal and human health and of the environment. It is also necessary to take into account the fact that technological progress has made available new types of additives, such as those to be used on silage or in drinking water.

[4] OJ L 270, 14.12.1970, p. 1.

(7) The basic principle in this field should be that only those additives approved under the procedure set out in this Regulation may be placed on the market, used and processed in animal feeding under conditions foreseen by the authorisation.

(8) Categories of feed additives should be defined in order to facilitate the assessment procedure in view of the authorisation. Amino acids which are currently covered by Council Directive 82/471/EEC of 30 June 1982 concerning certain products used in animal nutrition [5] should be included as a category of feed additives, and therefore transferred from the scope of that Directive to this Regulation.

[5] OJ L 213, 21.7.1982, p.8.

(9) In order to ensure a harmonised scientific assessment of feed additives such assessment should be carried out by the European Food Safety Authority. The applications should be supplemented by residue studies in order to assess the establishment of Maximum Residues Limits (MRL's).

(10) It is recognised that scientific risk assessment alone cannot, in some cases, provide all the information on which a risk management decision should be based, and that other factors relevant to the matter under consideration should legitimately be taken into account, including societal, economic or environmental factors, feasibility of controls and the benefit for the animal or for the consumer of animal products. Therefore, the authorisation of an additive should be granted by the Commission.

(11) Competence for authorising feed additives and establishing conditions for their use and for maintaining and publishing a register of authorised feed additives should be conferred on the Commission according to the procedure by which a close collaboration between Member States and the Commission is guaranteed in the frame work of Standing Committee on the Food Chain and Animal Health.

(12) It is necessary to introduce, where appropriate, an obligation to implement a post-market monitoring plan in order to trace and identify any direct or indirect, immediate, delayed, or unforeseen effect resulting from the use of feed additives on human or animal health or the environment.

(13) In order to allow technical and scientific progress to be taken into account it is necessary to revise regularly the authorisations of feed additives. Time limited authorisations will allow this review.

(14) A register of authorised feed additives should be established, including product specific information and sampling and detection methods. Non-confidential data should be made available to the public.

(15) It is necessary to establish rules to take into account additives which are already on the market and which were authorised under Directive 70/524/EEC, and amino acids currently authorised under Directive 82/471/EEC, as well as for additives for which the authorisation procedure is in progress.

(16) The Scientific Steering Committee stated in its opinion of 28 May 1999 that: "regarding the use of antimicrobials as growth promoting agents, the use of agents from classes which are or may be used in human or veterinary medicine (i.e., where there is a risk of selecting for cross-resistance to drugs used to treat bacterial infections) should be phased out as soon as possible and ultimately abolished". The second opinion of the Scientific Steering Committee on anti-microbial resistance adopted on 10-11 May 2001 confirmed the need to provide a sufficient time to replace those antimicrobials by alternative products: "Thus, the phase-out process must be planned and co-ordinated since precipitous actions could have repercussions for animal health". Therefore, it is necessary to set a date after which the use of the antibiotics still authorised for use as growth promoting agents will be forbidden, while allowing sufficient time for the development of alternative products to replace those antibiotics. Provision should also be made to forbid the authorisation of any further antibiotics for use as feed additives.

(17) Certain substances with coccidiostatic effects should be considered as feed additives for the purpose of this Regulation.

(18) Within the framework of the phasing out of antibiotics used as growth promoters and in order to ensure a high level of protection of animal health, the European Food Safety Authority will be asked to review the progress in the development of alternative substances and alternative rearing methods before 2005.

(19) Detailed labelling of the product should be required since it enables the final user to make a choice in full knowledge of the facts and creates fewest obstacles to trade and facilitates fairness of transactions.

(20) Regulation (EC) No .../... of the European Parliament and of the Council on genetically modified food and feed [6] provides for an authorisation procedure for the placing on the market of genetically modified food and feed, including feed additives consisting of, containing or produced from genetically modified organisms. Since the objectives of Regulation (EC) No.../...of the European Parliament and of the Council on genetically modified food and feed are different from those of this Regulation, feed additives should undergo an authorisation procedure in addition to the authorisation procedure provided for by this Regulation prior to their placing on the market.

[6] OJ L [...], [...], p. [...].

(21) Fees could be charged for the consideration of dossiers by the European Food Safety Authority, subject to the outcome of the report provided for in Article 45 of Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January laying down the general principles and requirements of food law, establishing the European Food Safety Authority, and laying down procedures in matters of food safety [7].

[7] OJ L 31, 28.1.2002, p.1.

(22) Articles 53 and 54 of Regulation 178/2002 establish procedures for taking emergency measures in relation to feed of Community origin or imported from a third country. They allow the Commission to adopt such measures in situations where feed is likely to constitute a serious risk to human health, animal health or the environment and where such risk cannot be contained satisfactorily by measures taken by the Member State(s) concerned.

(23) Technological progress and scientific developments should be taken into account when implementing this Regulation.

(24) Since the measures necessary for the implementation of this Regulation are measures of general scope within the meaning of Article 2 of Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission [8], they should be adopted by use of the regulatory procedure provided for in Article 5 of that Decision.

[8] OJ L 184, 17.7.1999, p. 23.

(25) The Member States should lay down rules on penalties applicable to infringements of the provisions of this Regulation and ensure that they are implemented. Those penalties must be effective, proportionate and dissuasive.

(26) Directive 70/524/EEC should be repealed. However labelling provisions applicable to compound feedingstuffs incorporating additives should be maintained until a revision of Council Directive 79/373/EEC of 2 April 1979 on the marketing of compound feedingstuffs [9] will be completed. Points 3 and 4 of the Annex of Directive 82/471/EEC should be deleted in order to enable the transfer of amino acids and their salts to this Regulation.

[9] OJ L 86, 6.4.1979,p.30.

(27) Guidelines addressed to the Member States for the presentation of a application dossier are contained in Directive 87/153/EEC. The verification of the conformity of dossiers is conferred to the European Food Safety Authority. It is therefore necessary to repeal Directive 87/153/EEC, maintaining however the Annex in place until implementing rules have been adopted.

(28) A transitional period is needed to avoid disruptions in the use of feed additives. Therefore, until the rules of this Regulation are applicable, the substances already authorised should be permitted to remain on the market and be used under the conditions of the current legislation,

HAVE ADOPTED THIS REGULATION:

I

Subject-matter, scope and Definitions

Article 1 Subject matter

1. The purpose of this Regulation is to establish a Community procedure for authorisation and supervision of feed additives and to lay down rules to ensure labelling of feed additives in order to provide the basis for the assurance of a high level of protection of human health, animal health and welfare, environment and users' interests in relation to feed additives, whilst ensuring the effective functioning of the internal market.

Article 2 Scope

1. This Regulation shall apply to chemically defined substances or micro-organisms not normally used as feed materials which are intentionally added to feedingstuffs or drinking water, hereinafter referred to as "feed additives".

2. This Regulation shall not apply to:

a) processing aids, nor to technological but unavoidable residues of processing aids in the final product;

b) veterinary medicinal products as defined in Directive 2001/82/EC [10].

[10] OJ L311, 28.11.2001,p.1.

3. Where necessary, it may be determined, in accordance with the procedure referred to in Article 21 (2), whether a substance or a microorganism is a feed additive within the scope of this Regulation.

Article 3 Definitions

For the purpose of this Regulation, the definitions of "feed" or "feedingstuff", "feed business", "feed business operator", "placing on the market" and "traceability" laid down in Regulation (EC) No178/2002 of the European Parliament and of the Council laying down the general principles and requirements of food law, establishing the European Food Safety Authority, and laying down procedures in matters of food safety shall apply.

The following definitions shall also apply:

a) "feed materials" means products as defined in Article 2(a) of Council Directive 96/25/EC [11] ;

[11] OJ L 125, 13.5.1996, p. 35; Directive as last amended by Directive 2001/46/EC of the European Parliament and of the Council (OJ L 234, 1.9.2001, p. 55).

b) "complementary feedingstuffs" means products as defined in Article 2(e) of Directive 79/373/EEC;

c) "premixtures of feed additives" means mixtures of feed additives or mixtures of one or more feed additives with feed materials used as carriers, not intended to direct feeding of animals but intended for distribution to establishments registered or approved according to Council Directive 95/69/EC [12];

[12] OJ L 332, 30.12.1995, p. 15; Directive as last amended by Directive 1999/20/EC (OJ L 80, 25.3.1999, p. 20).

d) "compound feedingstuffs" means products as defined in Article 2 (b) of Directive 79/373/EEC ;

e) "first placing on the market" means the initial placing on the market of an additive after its manufacture, the import of an additive, or, where an additive has been incorporated into feed without being placed on the market, the first placing on the market of that feed;

f) "processing aids" means any substances not consumed as a feedingstuff by itself, intentionally used in the processing of feedingstuffs or feed materials to fulfil a technological purpose during treatment or processing and which do not remain in the final product;

g) "antimicrobial agents" means substances produced either synthetically or naturally by bacteria, fungi or plants, used to kill or inhibit the growth of micro-organisms including bacteria, viruses and fungi, and of parasites, in particular protozoa;

h) "antibiotic" means antimicrobial produced by or derived from a micro-organism, which destroys or inhibits the growth of other micro-organisms;

i) "maximum residue limit" means the maximum concentration of residue resulting from the use of an additive in animal nutrition which may be accepted by the Community to be legally permitted or recognised as acceptable in or on a food;

j) "growth promoter" means a chemically defined substance which, when fed to animals, improves production performance parameters.

CHAPTER II

Authorisation, use, monitoring and transitional measures applicable for existing feed additives

Article 4 Placing on the market, processing and use

1. No person shall place on the market, process or use a feed additive unless:

a) it is covered by an authorisation granted in accordance with this Regulation;

b) the conditions for use set out in this Regulation and in the authorisation of the substance are met; and

c) the conditions on labelling set out in this Regulation are met.

2. In the case of additives belonging to categories d) and e) as provided for in Article 7(1) and of additives consisting of, containing or produced from genetically modified organisms (GMOs), no person shall place the product on the market other than the authorisation holder named in the authorisation Regulation or a person acting under his written authority.

Article 5 Authorisation

1. Any person seeking an authorisation for a feed additive shall submit an application in accordance with Article 8.

2. An authorisation shall not be granted, refused, renewed, modified, suspended or revoked except on the grounds and under the procedures set out in this Regulation, or in accordance with Articles 53 and 54 of Regulation (EC) 178/2002 of the European Parliament and of the Council laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety.

3. The applicant for an authorisation shall be established in the Community.

Article 6 Conditions for authorisation

1. No feed additive shall be authorised unless the applicant for such authorisation has adequately and sufficiently demonstrated that, when used in accordance with conditions to be set out in the Regulation authorising the use of the additive, it satisfies the requirements of paragraph 2, and has at least one of the characteristics set out in paragraph 3.

2. The feed additive must not:

a) present a risk to animal health, human health or the environment,

b) mislead the user,

c) harm the consumer by impairing the distinctive features of animal products.

3. The feed additive must :

a) favourably affect the characteristics of feed,

b) favourably affect the characteristics of animal products,

c) satisfy the nutritional needs of animals,

d) favourably affect the environmental consequences of animal production.

4. Antibiotics shall not be authorised as feed additives.

5. By derogation of paragraph 4 certain substances with a coccidiostatic effect and presented for continuous use mixed in feed or drinking water, referred to hereafter as coccidiostats, are considered as feed additives for the purpose of this Regulation.

Article 7 Categories of feed additives

1. A feed additive shall be allocated to one or more of the following categories, depending on its functions and properties, in accordance with the procedure set out at Articles 8 to 10:

a) technological additives: any substance added to feed for a technological purpose;

b) sensory additives: any substance, the addition of which to feed improves or changes the organoleptic properties of the feed, or the visual characteristics of the food derived from animals.;

c) nutritional additives: any substance used for nutritional purposes;

d) zootechnical additives: any additive used to affect favourably the performance of animals in good health or used to affect favourably the environment;

e) coccidiostats.

2. Within these categories referred to in paragraph 1, feed additives shall further be allocated within one or more of the functional groups mentioned in Annex I, according to their principal function, in accordance with the procedure specified in Articles 8 to 10.

3. Where necessary, as a result of scientific progress or technological development, additional feed additive categories and functional groups may be established in accordance with the procedure referred to in Article 21 (2).

Article 8 Application for authorisation

1 An application for an authorisation as provided for in Article 5 shall be submitted to the European Food Safety Authority, hereinafter referred to as "the Authority".

2. The Authority shall acknowledge receipt of the application, in writing, to the applicant within 15 days of its receipt. The acknowledgement shall state the date of receipt of the application.

3. The application shall be accompanied by the following particulars and documents:

a) the name and the address of the applicant;

b) the designation of the feed additive, including a proposal for its classification by category and functional group under Article 7, and its specifications, including purity criteria;

c) a description of the method of production, manufacturing and intended uses of the feed additive, of the method of analysis of the additive in feed and, where appropriate, of the analytical method for the determination of residues of the feed additive in food ;

d) a copy of the studies which have been carried out and any other material which is available to demonstrate that the feed additive satisfies the criteria laid down in Article 6(2) and (3);

e) proposed conditions for placing the feed additive on the market, including labelling requirements and, where appropriate, specific conditions for use and handling, use levels in complementary feedingstuffs and animals species for which the feed additive is intended;

f) a written statement that three samples of the feed additive have been sent by the applicant directly to the Community reference laboratory referred to in Article 20 for the purpose of validation of the method of analysis, in accordance with the requirements set out in Annex II;

g) for additives proposed in paragraph b) as not belonging to category a) and b) referred to in Article 7 (1), and in the case of additives consisting of, containing or produced from GMOs, a proposal for post-market monitoring;

h) a summary of the dossier;

i) for additives consisting of, containing or produced from GMOs, details of the Community authorisation according to Regulation (EC) No [ .../...].

4. After consultation of the Authority, rules for the implementation of this Article may be established in accordance with the procedure referred to in Article 21(2).

Until the adoption of these implementing rules the application shall be made in accordance with the Annex of Directive 87/153/EEC

5. The Authority shall publish detailed guidance concerning the preparation, presentation, and validation of the applications, not later than one year after the entry into force of this Regulation.

Article 9 Opinion of the Authority

1. The Authority shall give an opinion within six months of the receipt of a valid application.

2. The Authority may, where appropriate, request the applicant to supplement the particulars accompanying the application within a time limit specified by the Authority. Where the Authority requests supplementary information, the time limit laid down in paragraph 1 shall be suspended until such time that the information has been provided. Likewise, the applicant may at the request of the Authority, or on his own initiative prepare oral or written explanations within a specified time limit.

3. In order to prepare its opinion, the Authority:

a) shall verify that the particulars and documents submitted by the applicant are in accordance with Article 8, and undertake a risk assessment in order to determine whether the feed additive complies with the criteria laid down in Article 6(2) and (3);

b) shall verify the report of the Community Reference Laboratory.

c) shall make the application and any supplementary information supplied by the applicant available to Member States and to the Commission;

d) shall make the summary of the dossier mentioned in Article 8 (3) (h) available to the public;

e) may ask any official scientific body of the Member States working in the field of animal nutrition to contribute to the assessment of the feed additive.

4. In the event of an opinion in favour of authorising the feed additive, the opinion shall also include the following elements:

a) the name and address of the applicant;

b) the designation of the feed additive including its categorisation and allocation within functional groups provided for in Article 7, its specification, including purity criteria and method of analysis;

c) depending on the results of the risk assessment, specific conditions or restrictions in relation to handling, use levels, the proportion of incorporation when used in feed or drinking water, and animal species and categories of animal species for which the additive is to be used, and post-market monitoring requirements;

d) specific additional requirements for the labelling of the feed additive necessary as result of conditions and restrictions imposed under (c);

e) a proposal for the establishment of Maximum Residues Limits (MRLs) in the relevant foodstuffs of animal origin, unless the opinion of the Authority concludes that the establishment of MRLs is not necessary for the protection of the consumers or MRLs have already been established in Annex I or III of Council Regulation 2377/90 of 26 June 1990 laying down a Community procedure for the establishment of maximum residue limits of veterinary medicinal products in foodstuffs of animal origin [13].

[13] Oj L 224, 18.8.1990, p.1.

5. The Authority shall forward its opinion to the Commission, the Member States and the applicant, including its assessment of the feed additive and stating the reasons for its conclusion.

6. The Authority shall make its opinion public, after deletion of any information identified as confidential in accordance with Article 18(2).

Article 10 Authorisation by the Community

1. Within three months of receipt of the opinion of the Authority, the Commission shall prepare a draft of the Regulation to be adopted in respect of the application, taking into account the requirements of Article 6(2) and (3), Community law and other legitimate factors relevant to the matter under consideration and in particular benefits for animal health and welfare and for the consumer of animal products.

Where the draft Regulation is not in accordance with the opinion of the Authority, the Commission shall provide an explanation of the reasons for the differences.

In exceptionally complex cases, the three-months deadline may be extended.

2. In the event of a draft Regulation which envisages the granting of authorisation, the draft Regulation shall include the elements mentioned in Article 9(4)(b), (c) and (d).

3. In the event of a draft Regulation which envisages the granting of authorisation for additives belonging to categories d) and e) referred to in Article 7(1) and also for additives consisting of, containing or produced from GMOs, the draft Regulation shall include the name of the authorisation holder, and, where appropriate, the unique code attributed to the GMO as referred to in the Regulation (EC) No .../... [of the European Parliament and of the Council concerning traceability and labelling of genetically modified organisms and traceability of food and feed products produced from genetically modified organisms and amending Directive 2001/18/EC] [14].

[14] OJ L .....,

4. Where the Commission considers that levels of residues of an additive in food from animals fed with that additive might have a detrimental effect on human health it shall include in the draft Regulation Maximum Residues Limits (MRLs) for the active substance or for its metabolites in the relevant foodstuffs of animal origin. In this case the active substance shall be considered for the purposes of Council Directive 96/23/EC [15] as falling under Annex I to that Directive. Where an MRL for the substance concerned has already been established in Community rules, that MRL shall also apply to residues of the active substance or its metabolites originating from the use of the substance as feed additive.

[15] OJ L 125, 23.5.1993. p.10.

5. The Regulation concerning the application for authorisation of a feed additive shall be adopted in accordance with the procedure referred to in Article 21 (2).

6. The Commission shall without delay inform the applicant of the decision taken.

7. The authorisation granted in accordance with the procedure laid down in this Regulation shall be valid throughout the Community for ten years and shall be renewable in accordance with Article 15. The authorised feed additive shall be entered in the Register referred to in Article 17 (hereinafter referred to as "the Register"). Each entry in the Register shall state the date of authorisation and shall include the particulars referred to in paragraphs 2 and 3.

8. The granting of authorisation shall be without prejudice to the general civil and criminal liability of any feed operator in respect of the feed additive concerned.

Article 11 Status of existing products

1. By way of derogation from Article 4, a feed additive which has been placed on the market pursuant to Directive 70/524/EEC and an amino acid, salt of an amino acid, and analogous substance which was listed in points 3 and 4 of the Annex to Directive 82/471/EEC before the date referred to in the second paragraph of Article 26 of this Regulation, may be placed on the market and used in accordance with the conditions specified in the entries in the annexes to Directives 70/524/EEC or 82/471/EEC relating to that substance, provided that the following conditions are met:

a) within one year of the entry into force of this Regulation, each person who places the feed additive on the market shall notify this fact to the Authority. This notification shall be accompanied by the particulars mentioned in Article 8(3)(a) to (c);

b) within one year of the notification mentioned under (a), the Authority shall, after verification that all the information required has been submitted, notify the Commission that it has received the information required under this Article. The concerned products shall be entered in the Register. Each entry in the Register shall mention the date on which the concerned product was first entered in the Register and, where applicable, the expiry date of the existing authorisation.

2. An application shall be submitted in accordance with Article 8, at the latest one year before the expiry date of the authorisation given pursuant with Directive 70/524/EEC for additives with a limited authorisation period, and within a maximum of seven years after the entry into force of this Regulation for additives authorised without a time limit. For the substances belonging to the category of coccidiostats, an application shall be submitted within a maximum of four years after the entry into force of this Regulation. A detailed calendar listing the priority order for the re-evaluation of the different classes of additives may be adopted in accordance with the procedure referred to in Article 21 (2).

3. Products entered in the Register shall be subject to the provisions of this Regulation, in particular Articles 13, 14, 15 and 16, which shall apply to such products as if they had been authorised pursuant to Article 10.

4. In case of authorisations not issued to a specific holder, any person who imports or manufactures the products referred to in this Article shall submit the information or the application to the Authority.

5. Where the notification and accompanying particulars referred to in paragraph 1(a) are not supplied within the period specified or are found to be incorrect, or where an application is not submitted as required by paragraph 2 within the period specified, a regulation shall be adopted, in accordance with the procedure referred to in Article 21(2), requiring the additives concerned to be withdrawn from the market. Such a measure may provide for a limited period of time within which existing stocks of the product may be used up.

Article 12 Phasing out

By derogation from Article 5 and Article 11, the placing on the market and use as antibiotic growth promoters of the following substances mentioned in Annex B under A of Chapters I and II of Directive 70/524/EEC: sodium monensin, sodium-salinomycin, flavophospholipol and avilamycin, shall be prohibited from 1 January 2006 and, from that date, those substances shall be deleted from the Register.

Article 13 Supervision

1. After an additive has been authorised in accordance with this Regulation, any person using or placing on the market that substance, or a feedingstuff into which it has been incorporated shall ensure that any conditions or restrictions which have been imposed on the placing on the market, use and handling of the additive or feedingstuffs containing it, are respected. Where monitoring requirements, as referred to in Article 9(4)(c) have been imposed, the authorisation holder shall ensure that it is carried out and shall submit reports to the Authority in accordance with the authorisation.

2. The authorisation holder shall forthwith communicate to the Authority any new information that might influence the evaluation of the safety in use of the feed additive, in particular health sensitivities of specific categories of consumers. The authorisation holder shall forthwith inform the Authority of any prohibition or restriction imposed by the competent authority of any third country in which the feed additive is placed on the market.

Article 14 Modification, suspension and revocation of authorisations

1. Where, on its own initiative or following a request from a Member State or from the Commission, the Authority concludes that an authorisation granted in accordance with this Regulation should be modified, suspended or revoked, it shall forthwith transmit this opinion to the Commission.

2. If the authorisation holder proposes to modify the terms of the authorisation, he shall submit an application to the Authority, which includes the relevant data supporting the request for the change. The Authority shall give an opinion on the proposal.

3. The Commission shall examine the opinion of the Authority without delay, and a final decision on the modification, suspension or revocation of an authorisation shall be adopted in accordance with the procedure referred to in Article 21(2).

4. The Commission shall without delay inform the applicant of the decision taken. The Register shall be amended as appropriate.

Article 15 Renewal of authorisations

1. Authorisations under this Regulation shall be renewable for ten-year periods, on application to the Authority by the applicant at the latest one year before the expiry date of the authorisation.

In case of authorisations not issued to a specific holder, any person who imports or produces the products referred to in this Article may submit the information or the application to the Authority and shall be considered as the applicant.

The Authority shall acknowledge receipt of the application, in writing, to the applicant within 15 days of its receipt. The acknowledgement shall state the date of receipt of the application.

2. The application shall be accompanied by the following particulars and documents:

a) a copy of the authorisation for placing the feed additive on the market;

b) a report on the results of the post-market monitoring, if such monitoring requirements are included in the authorisation;

c) any other new information which has become available with regard to the evaluation of the safety in use and the efficacy of the feed additive and the risks of the feed additive to animals, humans or the environment;

d) where appropriate, a proposal for amending or complementing the conditions of the original authorisation, inter alia the conditions concerning future monitoring.

3. The applicant shall also send to the Commission at the same time as he submits an application to the Authority the particulars and documents referred to in paragraph 2.

4. The procedure set out in Articles 9 and 10 shall apply in a like manner.

5. Where, for reasons beyond the control of the applicant, no decision is taken on the renewal of an authorisation before its expiry date, the period of authorisation of the product shall automatically be extended until the Commission takes a decision. The Commission shall inform the applicant of this extension of the authorisation.

6. The implementing rules for the application of this Article shall be established after consultation of the Authority, in accordance with the procedure referred to in Article 21 (2).

7. The Authority shall publish detailed guidance concerning the preparation and the presentation of the application.

Chapter III

Labelling

Article 16 Labelling of feed additives

1. No person shall place on the market a feed additive, a mixture of feed additives or a premixture of additives, unless its packaging or container bears the following information, in a conspicuous, clearly legible and indelible manner, in relation to each additive contained in the material:

a) the specific name given to the additives upon authorisation preceded, by the name of the functional group as mentioned in the authorisation ;

b) the name or business name and the address or registered place of business of the person responsible for the particulars referred to in this paragraph;

c) the net weight or in the case of liquid additives, either the net volume or the net weight;

d) where appropriate, the approval number assigned to the establishment or the intermediary pursuant to Article 5 of Directive 95/69/EC or the registration number assigned to the establishment or the intermediary pursuant to Article 10 of that Directive;

e) directions for use, and any safety recommendations regarding the use and, where applicable, the specific requirements mentioned in the authorisation, including animal species and categories for which the additive, additive mixture or premixture of additives is intended.

2. In addition to the information specified in paragraph 1, the packaging or container of an additive belonging to a functional group specified in Annex III must bear the information, presented in a conspicuous, clearly legible and indelible manner, indicated in that Annex.

3. In the case of premixtures, the word "PREMIXTURE " must clearly appear on the label.

4. Amendments to Annex III to take technical and scientific development into account may be adopted in accordance with the procedure referred to in Article 21 (2).

Chapter IV

General provisions

Article 17 Community Register of Feed additives

1. The Commission shall establish and maintain a Community Register of Feed additives.

2. The Register shall be made available to the public.

3. The Register shall be consolidated at least once a year.

Article 18 Confidentiality

1. The applicant may indicate which information submitted under this Regulation he wishes to be treated as confidential because its disclosure may significantly harm his competitive position. Verifiable justification must be given in such cases.

2. The Authority shall determine, after consultation with the applicant, which information other than that specified in paragraph 3 should be kept confidential and shall inform the applicant of its decision.

3. Information relating to the following shall not be considered confidential:

a) name and composition of the feed additive and, where appropriate, indication of the substrate and the production strain;

b) physico-chemical and biological characteristics of the feed additive;

c) effects of the feed additive on human and animal health and on the environment;

d) effects of the feed additive on the characteristics of animal products and its nutritional properties;

e) methods for sampling, detection and identification of the feed additive and, where applicable, monitoring requirements and a summary of the results of the monitoring;

f) information on waste treatment and emergency response.

4. Notwithstanding paragraph 2, the Authority shall, on request, supply the Commission and Member States with all information in its possession, including any identified as confidential pursuant to paragraph 2.

5. The Member States, the Commission and the Authority shall keep confidential all the information identified as confidential under paragraph 2 except where it is appropriate for such information to be made public in order to protect human health, animal health or the environment.

6. If an applicant withdraws or has withdrawn an application, the Authority, the Commission and the Member States shall respect the confidentiality of commercial and industrial information, including research and development information as well as information on which the Authority and the applicant disagree as to its confidentiality.

Article 19 Data Protection

The scientific data and other information in the application dossier required under Article 8 may not be used for the benefit of another applicant for a period of ten years from the date of authorisation, unless the other applicant has agreed with the previous applicant that such data and information may be used. On expiry of the ten-year period, the findings of all or part of the evaluation conducted on the basis of the scientific data and information contained in the application dossier may be used by the Authority for the benefit of another applicant.

Article 20 Reference laboratories

The Community reference laboratory and its duties and tasks shall be those laid down in the Annex II.

National reference laboratories may be established in accordance with the procedure referred to in Article 21 (2).

Detailed rules for implementing Annex II and any amendments to that Annex shall be adopted in accordance with the procedure referred to in Article 21(2).

Article 21 Committee

1. The Commission shall be assisted by the Standing Committee on the Food Chain and Animal Health, established by Regulation EC No 178/2002 of the European Parliament and of the Council laying down general principles and requirements of food law, establishing the European Food Safety Authority, and laying down procedures in matter of food safety.

2. When reference is made to this paragraph, the regulatory procedure laid down in Article 5 of Decision 1999/468/EC shall apply, in compliance with Article 7 and Article 8 thereof.

3. The period provided for in Article 5(6) of Decision 1999/468/EC shall be three months.

Article 22 Repeals

1. Directive 70/524/EEC is repealed with effect from the date of application of this Regulation. However, Article 16 of Directive 70/524/EEC shall remain in force until Directive 79/373/EEC has been revised to include rules concerning the labelling of compound feedingstuffs incorporating additives.

2. Points 3 and 4 of the Annex of Directive 82/471/EEC are deleted with effect from the date of application of this Regulation.

3. Directive 87/153/EEC is repealed with effect from the date of application of this Regulation. However, the Annex to that Directive shall remain in force until the adoption of the implementing rules provided for in Article 8 (4) of this Regulation.

4. References to Directive 70/524/EEC shall be construed as references to this Regulation.

Article 23 Penalties

The Member States shall lay down the rules on penalties applicable to infringements of the provisions of this Regulation and shall take all measures necessary to ensure that they are implemented. The penalties provided for must be effective, proportionate and dissuasive.

The Member States shall notify those rules and measures to the Commission at the latest six months after the date of publication of this Regulation and shall notify it without delay of any subsequent amendment affecting them.

Article 24 Transitional measures

1. Applications submitted under Article 4 of Directive 70/524/EEC before the entry into force of this Regulation shall be treated as applications under Article 8 of this Regulation where the initial comments provided for under Article 4(4) of Directive 70/524/EEC have not yet been forwarded to the Commission. Any Member States selected as rapporteur in respect of such an application shall immediately transmit the dossier submitted pursuant to that application to the Authority.

2 The labelling requirements laid down in Chapter III of this Regulation shall not apply to products which have been lawfully manufactured and labelled in the Community, or which have been lawfully imported into the Community and put into free circulation, before the date of application of this Regulation.

Article 25 Entry into force

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Communities.

It shall apply from [1 year after the date of publication of this Regulation]

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels,

For the European Parliament For the Council

The President The President

ANNEX I Additive groups

1. In the category "technological additives", the following functional groups are included:

a) preservatives: substances, including silage agents or, when applicable, micro-organisms which prolong the storage life of feedingstuffs and feed materials by protecting them against deterioration caused by micro-organisms.

b) antioxidants: substances which prolong the storage life of feedingstuffs and feed materials by protecting them against deterioration caused by oxidation.

c) emulsifiers: substances that make it possible to form or maintain a homogeneous mixture of two or more immiscible phases in feedingstuffs.

d) stabilisers: substances which make it possible to maintain the physico-chemical state of feedingstuffs.

e) thickeners: substances which increase the viscosity of feedingstuffs.

f) gelling agents: substances which give a feedingstuff texture through the formation of a gel.

g) anticaking agents: substances that reduce the tendency of individual particles of a feedingstuff to adhere to one another.

h) acidity regulators: substances which adjust the pH of feedingstuffs.

2. In the category 'sensory additives', the following functional groups are included:

a) colorants:

i) substances that add or restore colour in feedingstuffs, including natural constituents of feed materials and natural sources which are normally not consumed as feed materials;

ii) substances which, when fed to animals, add or restore colours to food of animal origin;

ii) denaturants: substances which, when used for the manufacture of processed feedingstuffs, allow the identification of the origin of specific food or feed materials;

(b) flavouring and appetising compounds: natural products obtained by appropriate physical, chemical, enzymatic or microbiological processes from materials of vegetable or animal origin, or chemically defined substances, the inclusion of which in feedingstuffs increases feed palatability.

3. In the category 'nutritional additives', the following functional groups are included:

a) vitamins;

b) trace elements;

c) amino acids;

4. In the category "zootechnical additives", the following functional groups are included:

a) digestibility enhancers: substances which, when fed to animals, increase the digestibility of the diet, through action on target feed materials.

b) gut flora improvers: micro-organisms forming colonies or other chemically defined substances, which, when fed to animals, have a positive effect on the gut flora.

c) growth promoters: chemically defined substances which, when fed to animals, improve production performance parameters.

ANNEX II Duties and Tasks of the Community reference laboratory

1. The Community reference laboratory referred to in Article 20 is the Joint Research Centre of the Commission (JRC).

2. For the tasks outlined in this Annex, the Commission's Joint Research Centre shall be assisted by a consortium of national reference laboratories.

The JRC shall be notably responsible for:

- reception, preparation, storage and maintenance of the control samples;

- testing and validation of the method for sampling and detection;

- evaluating the data provided by the applicant for authorisation for placing the feed additive on the market, for the purpose of testing and validation of the method for sampling and detection;

- submitting full evaluation reports to the Authority.

3. The Community reference laboratory shall play a role in dispute settlements between Member States concerning the results of the tasks outlined in this Annex.

ANNEX III Specific labelling requirements for certain feed additives and for premixtures

a) Zootechnical additives: the expiry date of the guarantee or the storage life from the date of manufacture, the batch reference number and the date of manufacture, the directions for use and, where appropriate, a safety recommendation regarding the use in the case of additives which are the subject of special provisions upon authorisation;

b) Enzymes, in addition of the above mentioned indications: the specific name of the active component or components in accordance with their enzyme activities, in conformity with the authorisation given, the International Union of Biochemistry identification number (IUB number);

c) Micro-organisms, in addition to the above mentioned indications: the strain identification number of colony forming units (CFU per gram);

d) Nutritional additives: the active-substance level and the expiry date of the guarantee of that level or storage life from the date of manufacture;

e) Technological and sensory additives: the active-substance level.

LEGISLATIVE FINANCIAL STATEMENT

Policy area(s):Health and Consumer protection

Activit(y/ies): Feedingstuffs

Title of action: Regulation of the European Parliament and of the Council (EC) N°.....on additives for use in animal nutrition

1. BUDGET LINE(S) + HEADING(S)

A-703

A-704

B1-333 A Plant Health Measures

2. OVERALL FIGURES

2.1. Total allocation for action (Part B): EUR million for commitment

2.2. Period of application:

The activity will start in July 2003.

2.3. Overall multiannual estimate of expenditure:

(a) Schedule of commitment appropriations/payment appropriations (financial intervention) (see point 6.1.1)

EUR million (to three decimal places)

>TABLE POSITION>

(b) Technical and administrative assistance and support expenditure(see point 6.1.2)

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(c) Overall financial impact of human resources and other administrative expenditure (see points 7.2 and 7.3)

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2.4. Compatibility with financial programming and financial perspective

|X| Proposal is compatible with existing financial programming.

Proposal will entail reprogramming of the relevant heading in the financial perspective.

Proposal may require application of the provisions of the Interinstitutional Agreement.

2.5. Financial impact on revenue: [16]

[16] For further information, see separate explanatory note.

|X| Proposal has no financial implications (involves technical aspects regarding implementation of a measure)

OR

Proposal has financial impact - the effect on revenue is as follows:

(NB All details and observations relating to the method of calculating the effect on revenue should be shown in a separate annex.)

(EUR million to one decimal place)

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(Please specify each budget line involved, adding the appropriate number of rows to the table if there is an effect on more than one budget line.)

3. BUDGET CHARACTERISTICS

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4. LEGAL BASIS

Article 95 and 152(4)(b) of the EC Treaty

5. DESCRIPTION AND GROUNDS

5.1. Need for Community intervention [17]

[17] For further information, see separate explanatory note.

5.1.1. Objectives pursued

The main objective of the proposal is to ensure that the use and placing on the market of feed additives:

- does not present a risk for animal health, human health and the environment;

- does not mislead or harm the consumer by impairing the distinctive features of animal products;

- informs the user about the characteristics of the product.

- brings coherence to community legislation in a "farm to table" approach" by clarifying certain procedural aspects.

- takes into account the entry into force of the European Food Safety Authority (hereunder called "the Authority" which will be responsible for the risk evaluation of feed additives.

The proposal lays down a centralised procedure by which the Commission will authorise the placing on the market and use of feed additives.

The proposal also includes provisions to phase out antibiotics as growth promoters.

The procedure for authorisation will require that the person responsible for placing the additive on the market will submit an application to the Authority. The Authority will have the competence and the responsibility to provide a single framework for dossier evaluation for all feed additives, and will bring clarity (guidelines will be updated), efficiency (a single evaluation) and transparency (adoption of an assessment report and public consultation) to the process.

Once the Authority has forwarded its opinion, the Commission will take a decision through a comitology procedure.

The proposal also provides for:

- procedures for the modification, suspension revocation and renewal of authorisations;

- a Community Register established and maintained by the Commission.

5.1.2. Measures taken in connection with ex ante evaluation

Not applicable

5.2. Action envisaged and budget intervention arrangements

General objectives: links with the overall aim.

Performance indicators selected:

Output indicators: number of meetings held and applications for authorisations/renewal/ modification/ suspension/ revocation.

Impact indicators: number of authorisations granted, renewed, modified, suspended or revoked.

Details and frequency of planned assessments: in the interests of consumers and industry, a system for authorisation is required which allows applications for community authorisation submitted to the Authority to be examines on an on-going basis by the Standing Committee.

Assessment of the results obtained: the authorisation procedure provided for by the Regulation guarantees a high level of protection for human and animal health and the environment while preventing distortion of trade in the single market.

Target population: consumers are the ultimate beneficiaries. Other beneficiaries are livestock farmers and industries producing feed additives.

5.3. Methods of implementation

Expenditure for the legislative process will be largely based upon the cost of meetings with relevant experts of Member States.

It is foreseen that working group meetings, comprising relevant experts in the fields of animal nutrition and environment. Attendance at relevant international meetings and meetings with relevant stakeholders, including industry and consumer organisations.

Final authorisation, renewal or amendments of the authorisation will be via and meetings for the Standing Committee on the Food Chain and Animal Health. Based on the experience with some Directives in the food and feed sector an average of 5 meetings per year are necessary. One representative per Member State is necessary to attend the meeting.

A database for the Community Register will be created.

6. FINANCIAL IMPACT

6.1. Total financial impact on Part B - (over the entire programming period)

6.1.1. Financial intervention

Commitments (in EUR million to three decimal places)

>TABLE POSITION>

6.2. Calculation of costs by measure envisaged in Part B (over the entire programming period) [18]

[18] For further information, see separate explanatory note.

Commitments (in EUR million to three decimal places)

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If necessary explain the method of calculation

7. IMPACT ON STAFF AND ADMINISTRATIVE EXPENDITURE

7.1. Impact on human resources

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7.2. Overall financial impact of human resources

Using existing resources

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The amounts are total expenditure for twelve months.

7.3. Other administrative expenditure deriving from the action

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The amounts are total expenditure for twelve months.

1 Specify the type of committee and the group to which it belongs.

I. Annual total (7.2 + 7.3)

398.350

II. Duration of action indefinite

III. Total cost of action (I x II) // EUR

years

EUR

The needs for human and administrative resources shall be covered within the allocation granted to managing DG in the current allocation procedure.

8. FOLLOW-UP AND EVALUATION

8.1. Follow-up arrangements

See point 5.2

For certain categories of additives the proposal foresees a post-marketing monitoring program. The authorisation holder must submit reports to the Authority.

The Authority is required to review the progress in the development of alternative substances to antibiotics used as growth promoters and alternative rearing methods before 2005.

Member States are also required to take appropriate legal or administrative measures in case of non-compliance and communicate those measures to the Commission.

8.2. Arrangements and schedule for the planned evaluation

The Commission has to consider the effectiveness of the system on the basis of a non-exhaustive list of information. The following information, amongst others, may be relevant for this purpose: number of authorisations granted, modified, suspended, renewed or revoked, implementation of emergency measures and the information submitted by the Member States.

The planned schedule for the first evaluation is three years after the implementation of the Regulation. After this first evaluation a schedule for regular evaluations will be considered.

9. ANTI-FRAUD MEASURES

Not applicable for financial risks encountered.

IMPACT ASSESSMENT FORM THE IMPACT OF THE PROPOSAL ON BUSINESS WITH SPECIAL REFERENCE TO SMALL AND MEDIUM-SIZED ENTERPRISES (SME's)

Title of proposal

Proposal for a Regulation of the European Parliament and of the Council on Additives for use in Animal Nutrition

The proposal

1. Taking into account the principle of subsidiarity, why is Community legislation necessary in this area and what are its main aims-

The objectives of this proposal are:

a) to bring coherence to community legislation in a "farm to table approach" by clarifying certain procedural aspects related to dossier evaluation and the types of authorisation granted to feed additives (Action 19 of the White Paper on Food safety).

(b) to take into account the entry into force of the European Food Safety Authority (hereunder called "the Authority") which will be responsible for the risk evaluation of feed additives.

(c) to lay down provisions for the phasing out of antibiotics used as growth promoters.

A real demonstration of the positive effect of the additive (on the feedingstuff or on the animal) is also a very important element. This means that, not only the additive must not present a risk for animal health, human heath or the environment, but also they must present a benefit for the animal, the user or the final consumer.

The Authority will have the competence and the responsibility to provide a single framework for dossier evaluation for all feed additives, and will bring clarity (guidelines will be updated and adapted to the various types of additives), efficiency (a single evaluation) and transparency (adoption of an assessment report and public consultation) to the process.

The impact on business

2. Who will be affected by the proposal-

All sizes of businesses related to the production of additives for feedingstuffs and of feedingstuffs.

3. What will business have to do to comply with the proposal-

Business must request for authorisation to put feed additives on the market. Feed business operators can only use in feedingstuffs authorised additives. This is already the current system, the difference is that a centralised evaluation will be carried out by the Authority.

General obligations for applicants for authorisation:

* To submit an application for authorisation of feed additives, including the preparation of a dossier accompanied by the particulars and documents referred to in the proposed Regulation.

General obligations for authorisation-holders:

* The authorisation-holder is responsible for ensuring the conformity of the feed additive with the conditions specified in the authorisation, including, where appropriate description of production methods of additives, conditions of use, specifications, purity criteria, method of analysis and additional labelling requirements.

* To carry out the monitoring requirements, in the case the opinion of the Authority includes such requirements.

* To inform the Authority of any new information which may influence the evaluation of the safety in the use of the feed additives.

* To submit an application for renewal of the authorisation one year before the expiry date (renewable for ten-years periods), including presentation of complementary information.

General obligations for persons responsible for placing on the market the feed additive authorised before the date of entry into force of this Regulation:

* To notify, within one year of the entry into force of the Regulation, the marketing of the feed additive to the Authority.

* To submit an application for the renewal of the authorisation within one year before the expiring date of the authorisation for additives with a limited authorisation period, and within a maximum of seven years after the entry into force of the Regulation for additives for which the authorisation has no an expiring date in accordance with Article 11.

* General obligations for all business operators:

* To comply with the relevant conditions of the authorisation, which are available to the public via the register of feed additives.

4. What economic effects is the proposal likely to have-

The current system already provides for an evaluation previous to the authorisation of feed additives, so the proposal will not introduce major changes in this respect.

This proposal introduces the phasing out of antibiotics used as growth promoters in animal nutrition.

The effects on antibiotics on growth and feed conversion in pig poultry and beef are influenced by factors as type of animals, production system, age, and health or feed quality. In pig production growth rate increases by 2% to 20% while feed conversion improves by 1% to 10% [19]. In poultry production growth rate increases by 3% to 10%, while feed conversion improves by 3 to 5% [20]. In beef production, literature shows large variation.

[19] Weib (1989), Hudd (1983), Mordenti el al. (1979), Bickel (1983) and Robinson (1968)

[20] Hudd (1983), Mordenti et al.(1979),Birzer and Gropp (1991) and Robinson (1968)

A. de Craene and J. Viaene [21]apply an economic model to calculate the economic impact of withdrawal of performance enhancers (mainly antibiotics and copper salts). This study has been calculated on the basis of a situation "with and without" performance enhancers. The table below includes some conclusions of this study.

[21] Do performance enhancers for animals benefit consumers-. University of Ghent (1992).

Impact of withdrawal of performance enhancers (1990)

>TABLE POSITION>

The Swedish example

In 1996 the Swedish government banned antibiotics used as growth promoters in animal nutrition. Following the ban, measures to improve management and hygiene of farms and the authorisation of Zinc (Zinc has been described as a trace element having growing promoter effect) tried to offset the negative consequences. It was reported that the Swedish ban increased the feed costs for pig farmers by 8-11 ECU/tonne (improving quality of feeds to reduce intestinal disorders).

According to FEFANA (European Federation of Feed Additive Manufacturers), the overall cost in terms of reduced production has been estimated in 2.5 billion EUR, with more of 40% of that increase being supported by consumers (03-01-2000).

Dr Gerardo Santomá [22] gives the following results on the withdrawal of antibiotics used as growth promoters in broilers in Spain:

[22] Segunda Jornada Nacional de Alimentación Animal. Spain 1999

Increasing costs in broiler production in Spain %

Live animals // Carcass

5.11 // 5.35

It can be concluded, that there is not sufficient data to assess the economic impact of the withdrawal of antibiotics in animal nutrition at this moment, while some experiments and studies carried out in 1990 may allow to forecast the economic impact.

In the meantime, it is necessary to carry out studies on the most critical sectors [23]. New studies are necessary to compare not only the use versus non use of antibiotics but also use of antibiotics versus the use of new classes of antimicrobial agents.

[23] COM(2001) 333 FINAL Communication from the Commission against antimicrobial resistance

Analysis of attitudes towards traditional versus alternative systems may also contribute to understand consumer interests other than price at purchase point.

The phasing out of antibiotics will have a negative effect on the firms selling those products. However the phasing out takes into account the delay necessary to develop replacement products.

5. Does the proposal contain measures to take account of the specific situation of small and medium-sized firms (reduced or different requirements etc)-

The scope of the proposal is entirely horizontal and its provisions are generic. Therefore, it does not contain measures specifically aimed at or adapted for small and medium-sized firms.

Consultation

6. Organisations that have been consulted about the proposal and who have outlined their main points.

A working document containing the main ideas of this proposal has been discussed in the framework of the Standing Committee for Feedingstuffs where national officials take part.

Comments were received from the competent authorities of several Member States.

Several meetings with representatives of the various stakeholders (FEFAC, FEFANA, FEDESA, FEDIAF, CEFIC) have taken place.