Commission Regulation (EC) No 429/2008 of 25 April 2008 on detailed rules for the implementation of Regulation (EC) No 1831/2003 of the European Parliament and of the Council as regards the preparation and the presentation of applications and the assessment and the authorisation of feed additives (Text with EEA relevance)

Article 1

Definitions

The following definitions shall apply for the purpose of this Regulation:

Article 2

Application

An application for the authorisation of a feed additive, as provided for in Article 7 of Regulation (EC) No 1831/2003, shall be submitted using the form set out in Annex I.

It shall be accompanied by a dossier as provided for in Article 3 (hereinafter ‘the dossier’), containing the particulars and documents referred to in Article 7(3) of Regulation (EC) No 1831/2003.

Article 3

Dossier

The general requirements for the preparation and presentation of the dossier shall be as set out in Annex II.

The specific requirements to be satisfied by the dossier, in the case concerned, shall be as set out in Annex III.

The minimum duration of long term studies shall be as set out in Annex IV.

Article 4

Transitional measures

Article 5

Entry into force

This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union.

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

ANNEX I

1. APPLICATION FORM

EUROPEAN COMMISSION

HEALTH AND CONSUMER PROTECTION

DIRECTORATE-GENERAL

(Address)

Date: .…

 Authorisation of a feed additive or a new use of a feed additive (Article 4(1) of Regulation (EC) No 1831/2003)

 Authorisation of an existing product (Article 10(2) or 10(7) of Regulation (EC) No 1831/2003)

 Modification of an existing authorisation (Article 13(3) of Regulation (EC) No 1831/2003)

 Renewal of a feed additive authorisation (Article 14 of Regulation (EC) No 1831/2003)

 Urgent authorisation (Article 15 of Regulation (EC) No 1831/2003)

(Please indicate clearly by ticking one of the boxes)

The Applicant(s) and/or his/their Representative(s) in the Community (Article 4(3) of Regulation (EC) No 1831/2003), under the conditions required in Article 7(3)(a) of Regulation (EC) No 1831/2003 (name, address….)

…

…

submit(s) the present application in order to obtain an authorisation for the following product as a feed additive:

1.1.   Identification and characterisation of additive

Additive name (characterisation of the active substance(s) or agent(s) as defined in the subsections 2.2.1.1 and 2.2.1.2 of Annex II):

…

…

Trade name (if appropriate for the authorisations linked to the holder):

…

…

under the category/ies and functional group/s of additives (²) (list):

…

…

target species:

…

…

…

Name of the authorisation holder: (Article 9(6) of Regulation (EC) No 1831/2003)

…

…

This additive is already authorised in feed legislation by Directive …/…/(E)EC or Regulation (EC) No …/… under number … as (additive category)

…

This additive is already authorised in food legislation by Directive …/…/(E)EC or Regulation (EC) No …/… under number … as

…

for use in

…

If the product consists of, contains or is produced from a Genetically Modified Organism (GMO), please provide the following information:

 unique identifier (Commission Regulation (EC) No 65/2004 (³) (where appropriate): …

 either the details of any authorisation granted in accordance with Regulation (EC) No 1829/2003 of the European Parliament and of the Council (⁴): …

 or the details of any pending application for authorisation under Regulation (EC) No 1829/2003: …

1.2.   Conditions of use

Animal species or category:

…

…

Maximum age or weight:

…

…

Minimum dose (if appropriate): mg or Units of activity (⁵) or colony forming units (CFU) or ml/kg of complete feedingstuffs with a moisture content of 12 %

…

…

Maximum dose (if appropriate): mg or Units of activity or CFU or ml/kg of complete feedingstuffs with moisture content of 12 %

…

…

For liquid feeds the minimum and maximum doses can be expressed per litre.

Minimum dose (if appropriate): mg or Units of activity or CFU or ml/l of water

…

…

Maximum dose (if appropriate): mg or Units of activity or CFU or ml/l of water

…

…

Animal species or category:

…

…

Maximum age:

…

…

Minimum dose (if appropriate): mg or Units of activity or CFU/kg of complementary feedingstuffs with moisture content of 12 %

…

…

Maximum dose (if appropriate): mg or Units of activity or CFU/kg of complementary feedingstuffs with moisture content of 12 %

…

…

For liquid feeds the minimum and maximum doses can be expressed per litre.

Conditions or restrictions for use (if appropriate):

…

…

…

Specific conditions or restrictions for handling (if appropriate):

…

…

…

…

Maximum residue limit (if appropriate):

animal species or category:

…

…

marker residue:

…

…

target tissues or products:

…

…

…

Maximum residue in tissues or products (μg/kg):

…

…

…

Withdrawal period:

…

1.3.   Reference samples

Community Reference Laboratory (CRL) sample number (if applicable):

…

Lot number/batch code:

…

Manufacturing date:

…

Expiry date:

…

Concentration:

…

Weight:

…

Physical description:

…

Container description:

…

Storage requirements:

…

1.4.   Modification requested (where appropriate)

…

…

…

…

Copy of this application has been sent directly to the Authority with the dossier and to the CRL with the reference samples.

Signature …

1.5.   Enclosures

□ complete dossier;

□ summary of the dossier in accordance with Article 7(3)(h) of Regulation (EC) No 1831/2003;

□ scientific summary of the dossier;

□ all information concerning the notification of the studies in accordance with Article 32b of Regulation (EC) No 178/2002;

□ confidentiality request in accordance with Article 18 of Regulation (EC) No 1831/2003;

□ copy of the administrative data of the applicant(s);

□ three samples of the feed additive to the CRL in accordance with Article 7(3)(f) of Regulation (EC) No 1831/2003;

□ to the CRL: material safety data sheet;

□ to the CRL: certificate of identification and analysis; and

□ confirmation that the fee to the CRL has been paid (Article 4 of Commission Regulation (EC) No 378/2005 (⁶)).

Complete the parts of the form where appropriate, and delete those parts that are not relevant. The original application form (with other enclosures requested) shall be sent directly to the European Commission.

2. ADMINISTRATIVE DATA OF APPLICANT(S)

Contact details for submitting an application for the authorisation of a feed additive under Regulation (EC) No 1831/2003

(1)Applicant company or person

(a) Name of the applicant or company

(b) Address (street, number, post code, city, country)

(c) Telephone

(d) Fax

(e) E-mail (if available)

(2)Contact person (for all correspondence with Commission, Authority and CRL)

(a) Name of contact person

(b) Position

(c) Address (street, number, post code, city, and country)

(d) Telephone

(e) Fax

(f) E-mail (if available)

ANNEX II

GENERAL ASPECTS

This Annex sets out the requirements for establishing the list and the characteristics of studies and information on substances, micro-organisms and preparations to be submitted with dossiers under Article 7 of Regulation (EC) No 1831/2003 for:

— an authorisation as a new feed additive,

— an authorisation of a new use of a feed additive,

— a modification of an existing authorisation of a feed additive, or

— a renewal of the authorisation of a feed additive.

The dossiers must enable an assessment to be made of additives based on the current state of knowledge and permit verification of the compliance of these additives with the fundamental principles for authorisation, which are laid down in Article 5 of Regulation (EC) No 1831/2003.

The studies to be submitted and the extent of them will depend on the additive nature, the category and functional group, the type of authorisation (non-holder specific vs. holder specific), the substance itself, the target animals and the conditions of use. The applicant shall refer to this Annex and to Annex III in order to evaluate which studies and information shall be submitted with the application.

The applicant shall clearly provide the reasons for the omission or deviation from the dossier of any data prescribed in this Annex, Annex III and Annex IV.

The dossier shall include detailed reports of all the studies performed, presented in accordance with the numbering system proposed in this Annex. The dossier shall include references and copies of all published scientific data mentioned and the copies of any other relevant opinions which have already been produced by any recognised scientific body. Where these studies have already been evaluated by a European scientific body following the legislation in force in the Community, a reference to the result of the evaluation shall be sufficient. Data from studies that have been conducted and published previously or coming from peer review shall clearly refer to the same additive as the one subject to the application for authorisation.

Studies, including those that have been conducted and published previously or coming from peer review, shall be performed and documented according to appropriate quality standards (e.g. Good Laboratory Practice (GLP)) in accordance with Directive 2004/10/EC of the European Parliament and of the Council of 11 February 2004 on the harmonisation of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances (⁷) or International Organisation for Standardisation (ISO).

Where in vivo or in vitro studies are carried out outside the Community, the applicant shall demonstrate that the facilities concerned comply with the Organisation for Economic Cooperation and Development (OECD) principles of Good Laboratory Practice or ISO standards.

The determination of physico-chemical, toxicological and eco-toxicological properties must be performed in accordance with the methods established by Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances (⁸), as last amended by Commission Directive 2004/73/EC (⁹), or with updated methods recognised by international scientific bodies. The use of methods other than these must be justified.

The use of in vitro methods or of methods refining or replacing the usual tests using laboratory animals or reducing the number of animals used in these test shall be encouraged. Such methods shall be of the same quality and provide the same level of assurance as the method they aim to replace.

The description of the methods of analysis in feed or water shall be in conformity with the rules of GLP as laid down in Directive 2004/10/EC and/or EN ISO/IEC 17025. These methods shall comply with the requirements laid down in Article 11 of Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules (¹⁰).

Each dossier shall contain a summary and a scientific summary in order to enable the additive concerned to be identified and characterised.

Each dossier shall contain a post-market monitoring proposal where required by Article 7(3)(g) of Regulation (EC) No 1831/2003 and a labelling proposal as referred to in Article 7(3)(e) of Regulation (EC) No 1831/2003.

Safety assessment

This is based on studies intended to demonstrate the safety of the use of the additive in relation to:

(a) the target species at the highest proposed levels of incorporation in the feed or water and at a multiple of that level to establish a margin of safety;

(b) consumers who ingest food products obtained from animals that have received the additive, its residues or its metabolites. In this case, safety will be ensured by the setting of maximum residue limits (MRLs) and withdrawal periods based on an Acceptable Daily Intake (ADI) or an Tolerable Upper Intake Level (UL);

(c) persons likely to be exposed to the additive by respiratory, mucosal, eye or cutaneous contact while handling the additive or incorporating it into premixtures or complete feed or water or using feed or water containing the additive concerned;

(d) animals and humans with respect to the selection and spread of antimicrobial resistance genes; and

(e) the environment, as a result of the additive itself or products derived from the additive, either directly and/or as excreted by animals.

Where an additive has multiple components, each one may be separately assessed for consumer safety and then consideration given to the cumulative effect (where it can be shown that there are no interactions between the components). Alternatively, the complete mixture shall be assessed.

Efficacy assessment

This is based on studies that are intended to demonstrate the efficacy of an additive in terms of the aims of its intended use as defined in Article 6 (1) and Annex I of Regulation (EC) No 1831/2003.

1. SECTION I: SUMMARY OF THE DOSSIER

1.1.   Summary in accordance with Article 7(3)(h) of Regulation (EC) No 1831/2003

The applicant shall submit a summary indicating the main features of the additive concerned. The summary shall not contain any confidential information and shall be structured as follows:

(a) name of the applicant(s);

(b) identification of the additive;

(c) method of production and method of analysis;

(d) studies on safety and efficacy of the additive, along with all information concerning the notification of the studies in accordance with Article 32b of Regulation (EC) No 178/2002;

(e) proposed conditions for use; and

(f) proposal for post-market monitoring.

(a) name and address of the applicant(s) This information shall be provided in all cases, independent of the type of feed additive authorisation (holder-specific or non-holder specific). When a dossier is submitted by a group of applicants, the name of each of them shall be indicated.

(b) identification of the additive The identification of the additive shall contain a summary of the information required according to Annex II or III, depending on the type of the feed additive authorisation. In particular: name of the additive, proposed classification by category and functional group, target species/animal categories and doses.

(c) method of production and method of analysis The manufacturing process shall be described. The general procedures of the analytical methods to be used for the analysis for the official controls of the additive as such, in premixtures, and in feedingstuffs, as required in this Annex and Annex III shall be described. If appropriate, on the basis of the information submitted in this Annex and Annex III, the procedure of the method(s) to be used for the analysis for the official controls of the additives or its metabolites in food of animal origin shall be included.

(d) studies on safety and efficacy of the additive The conclusion regarding the safety and efficacy of the additive based on the different studies performed shall be given. The results of the studies may be included in a tabular form to support the conclusion of the applicant(s). Only studies required according to Annex III shall be indicated in the summary.

(e) proposed conditions for use The proposal for conditions of use shall be provided by the applicant(s). In particular the applicant shall describe the level of use in water or feed, together with the detailed conditions of use in complementary feedingstuffs. Information is also required where other methods of administration or incorporation in feed or water are used. Any specific conditions for use (e.g. incompatibilities), specific labelling requirements and animal species for which the additive is intended shall be described.

(f) proposal for post-market monitoring This part shall only relates to additives, which according to point (g) of Article 7(3) of Regulation (EC) No 1831/2003, do not belong to categories shown as (a) or (b) in Article 6(1) of the same Regulation and to additives falling within the scope of Community legislation relating to the marketing of products consisting of, containing or produced from GMOs.

1.2.   Scientific summary of the dossier

A scientific summary including details of each part of the documents submitted to support the application, according to this Annex and Annex III shall be submitted. This summary shall include the conclusions made by the applicant(s).

The summary must follow the order of this Annex and address all the different parts with reference to the relevant pages of the dossier.

1.3.   List of documents and other particulars

The applicant must identify the number and titles of volumes of documentation submitted in support of the application. A detailed index with reference to volumes and pages shall be added.

1.4.   List of parts of the dossier requested to be treated as confidential, where necessary

The list shall make reference to the relevant volumes and pages of the dossier.

2. SECTION II: IDENTITY, CHARACTERISATION AND CONDITIONS OF USE OF THE ADDITIVE; METHODS OF ANALYSIS

The additive has to be fully identified and characterised.

2.1.   Identity of the additive