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 date | 22 May 2008 |
Subject Matter | alimenti per animali,ravvicinamento delle legislazioni,aliments des animaux,rapprochement des législations,alimentos para animales,aproximación de las legislaciones |
Official Gazette Publication | Gazzetta 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 |
02008R0429 — EN — 27.03.2021 — 001.001
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►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:
‘pets and other non-food producing animals’ means animals belonging to species normally nourished, bred or kept, but not consumed by humans, except horses;
‘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
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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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
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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