Commission Regulation (EC) No 429/2008Show full title

ANNEX I U.K. APPLICATION FORM REFERRED TO IN ARTICLE 2(1) AND ADMINISTRATIVE DATA

1. APPLICATION FORM U.K.

[F1 THE APPROPRIATE AUTHORITY]

Textual Amendments

F1 Words in Annex 1 point 1 substituted (31.12.2020) by The Animal Feed (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/654), regs. 1, 82(a)(i); 2020 c. 1, Sch. 5 para. 1(1)

(Address)

Date: .…

Subject

:

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

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

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

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

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

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

(Please indicate clearly by ticking one of the boxes)

[F2 The Applicant (name, address…)]

Textual Amendments

F2 Words in Annex 1 point 1 substituted (31.12.2020) by The Animal Feed (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/654), regs. 1, 82(a)(ii); 2020 c. 1, Sch. 5 para. 1(1)

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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 U.K.

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):

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

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under the category/ies and functional group/s of additives(1) (list):

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target species:

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

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

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

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for use in

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

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unique identifier (Commission Regulation (EC) No 65/2004(2) (where appropriate):

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either the details of any authorisation granted in accordance with Regulation (EC) No 1829/2003 of the European Parliament and of the Council(3):

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

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1.2. Conditions of use U.K.

1.2.1. Use in complete feedingstuffs U.K.

Animal species or category:

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Maximum age or weight:

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Minimum dose (if appropriate): mg or Units of activity(4) or colony forming units (CFU) or ml/kg of complete feedingstuffs with a moisture content of 12 %

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

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

1.2.2. Use in water U.K.

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

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

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1.2.3. Special conditions of use (if appropriate) U.K.

Animal species or category:

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Maximum age:

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

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

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

Conditions or restrictions for use (if appropriate):

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Specific conditions or restrictions for handling (if appropriate):

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Maximum residue limit (if appropriate):

animal species or category:

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marker residue:

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target tissues or products:

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

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Withdrawal period:

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1.3. Reference samples U.K.

[F3 reference laboratory] sample number (if applicable):

Textual Amendments

F3 Words in Annex 1 point 1.3 substituted (31.12.2020) by The Animal Feed (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/654), regs. 1, 82(b); 2020 c. 1, Sch. 5 para. 1(1)

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Lot number/batch code:

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Manufacturing date:

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Expiry date:

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Concentration:

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Weight:

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Physical description:

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Container description:

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Storage requirements:

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[F4 Note: where applicable, in accordance with Regulation (EC) No 378/2005, reference samples, documentation and payment will be requested after submission of the feed additive application by the reference laboratory.]

Textual Amendments

F4 Words in Annex 1 point 1.3 inserted (E.W.S.) (31.12.2022) by The Food and Feed (Miscellaneous Amendments) Regulations 2022 (S.I. 2022/1351), regs. 1(1), 14(2)(a)

F5 1.4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . U.K.

Textual Amendments

F5 Annex 1 point 1.4 omitted (E.W.S.) (31.12.2022) by virtue of The Food and Feed (Miscellaneous Amendments) Regulations 2022 (S.I. 2022/1351), regs. 1(1), 14(2)(b)

1.5. Enclosures: U.K.

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complete dossier (only to the [F6 Food Safety Authority]);

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public summary of the dossier;

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detailed summary of the dossier;

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list of the parts of the dossier requested to be treated as confidential and a copy of the respective concerned parts of the dossier (only to [F7 appropriate authority] and [F6 Food Safety Authority]);

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copy of administrative data of applicant(s);

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F8 ...

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F8 ...

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F8 ...

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F8 ...

Textual Amendments

F6 Words in Annex 1 point 1.5 substituted (31.12.2020) by The Animal Feed (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/654), regs. 1, 82(d)(i); 2020 c. 1, Sch. 5 para. 1(1)

F7 Words in Annex 1 point 1.5 substituted (31.12.2020) by The Animal Feed (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/654), regs. 1, 82(d)(ii); 2020 c. 1, Sch. 5 para. 1(1)

F8 Words in Annex 1 point 1.5 omitted (E.W.S.) (31.12.2022) by virtue of The Food and Feed (Miscellaneous Amendments) Regulations 2022 (S.I. 2022/1351), regs. 1(1), 14(2)(c)

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 [F9 appropriate authority].

Textual Amendments

F9 Words in Annex 1 point 1.5 substituted (31.12.2020) by The Animal Feed (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/654), regs. 1, 82(d)(iv); 2020 c. 1, Sch. 5 para. 1(1)

2. ADMINISTRATIVE DATA OF APPLICANT(S) U.K.

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

(1) Applicant company or person U.K.

(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 [F10 appropriate authority, Food Safety Authority and reference laboratory]) U.K.

(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)

Textual Amendments

F10 Words in Annex 1 point 2.2 substituted (31.12.2020) by The Animal Feed (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/654), regs. 1, 82(e); 2020 c. 1, Sch. 5 para. 1(1)

(1)

For the functional group ‘other zootechnical additives’ under the category of zootechnical additives, it shall be necessary to define clearly which function is sought for the additive.

(2)

OJ L 10, 16.1.2004, p. 5.

(3)

OJ L 268, 18.10.2003, p. 1. Regulation as last amended by Regulation (EC) No 298/2008 (OJ L 97, 9.4.2008, p. 64).

(4)

Definition of ‘Unit’ shall be provided by the applicant.