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)Text with EEA relevance

Published date22 May 2008
Subject Matteralimenti per animali,ravvicinamento delle legislazioni,aliments des animaux,rapprochement des législations,alimentos para animales,aproximación de las legislaciones
Official Gazette PublicationGazzetta ufficiale dell’Unione europea, L 133, 22 maggio 2008,Journal officiel de l’Union européenne, L 133, 22 mai 2008,Diario Oficial de la Unión Europea, L 133, 22 de mayo de 2008
Consolidated TEXT: 32008R0429 — EN — 27.03.2021

02008R0429 — EN — 27.03.2021 — 001.001


This text is meant purely as a documentation tool and has no legal effect. The Union's institutions do not assume any liability for its contents. The authentic versions of the relevant acts, including their preambles, are those published in the Official Journal of the European Union and available in EUR-Lex. Those official texts are directly accessible through the links embedded in this document

►B 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) (OJ L 133 22.5.2008, p. 1)

Amended by:

Official Journal
No page date
►M1 COMMISSION IMPLEMENTING REGULATION (EU) 2020/1773 of 26 November 2020 L 398 19 27.11.2020




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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:

1.

‘pets and other non-food producing animals’ means animals belonging to species normally nourished, bred or kept, but not consumed by humans, except horses;

2.

‘minor species’ means food-producing animals other than bovines (dairy and meat animals, including calves), sheep (meat animals), pigs, chickens (including laying hens), turkeys and fish belonging to the Salmonidae.

Article 2

Application

1.

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.

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2.
Prior to the adoption of standard data formats pursuant to Article 39f of Regulation (EC) No 178/2002 of the European Parliament and of the Council ( 1 ), the application and the dossier shall be submitted through the electronic submission system provided by the Commission, in an electronic format allowing for the downloading, printing and searching of documents. After the adoption of the standard data formats pursuant to Article 39f of Regulation (EC) No 178/2002, the application and the dossier shall be submitted through the electronic submission system provided by the Commission in accordance with those standard data formats.

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Article 3

Dossier

1.
The dossier shall adequately and sufficiently demonstrate that the feed additive satisfies the conditions for authorisation provided for in Article 5 of Regulation (EC) No 1831/2003.
2.

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.

3.
By way of derogation from paragraph 2, the applicant may submit a dossier not satisfying the requirements provided for in paragraph 2, provided that he submits a justification for each element not complying with those requirements.

Article 4

Transitional measures

1.
To applications for authorisation submitted before the date of entry into force of this Regulation the Annex to Directive 87/153/EEC shall continue to apply.
2.
For applications for authorisation submitted before 11 June 2009 applicants may choose the continued application of Sections III and IV of Parts I and II of the Annex to Directive 87/153/EEC instead of points 1.3, 1.4, 2.1.3, 2.1.4, 2.2.3, 2.2.4, 3.3, 3.4, 4.1.3, 4.1.4, 4.2.3, 4.2.4, 5.3, 5.4, 6.3, 6.4, 7.3, 7.4, 8.3 and 8.4 of Annex III and instead of the provisions laid down in the column ‘Minimum duration of long term efficacy studies’ of the tables of Annex IV.

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

APPLICATION FORM REFERRED TO IN ARTICLE 2(1) AND ADMINISTRATIVE DATA

1. APPLICATION FORM

EUROPEAN COMMISSION

HEALTH AND CONSUMER PROTECTION

DIRECTORATE-GENERAL

(Address)

Date: .…

Subject : Application for authorisation of a feed additive in accordance with Regulation (EC) No 1831/2003.

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

1.2.1. Use in complete feedingstuffs

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.

1.2.2. Use in water

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

1.2.3. Special conditions of use (if appropriate)

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 …

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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...

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