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Document 02016R1768-20231218

    Consolidated text: Commission Implementing Regulation (EU) 2016/1768 of 4 October 2016 concerning the authorisation of guanidinoacetic acid and a preparation of guanidinoacetic acid as feed additives for chickens for fattening, weaned piglets and pigs for fattening (holder of authorisation: Alzchem Trostberg GmbH) and repealing Commission Regulation (EC) No 904/2009 (Text with EEA relevance)Text with EEA relevance

    ELI: http://data.europa.eu/eli/reg_impl/2016/1768/2023-12-18

    02016R1768 — EN — 18.12.2023 — 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

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    ►M1   COMMISSION IMPLEMENTING REGULATION (EU) 2016/1768

    of 4 October 2016

    concerning the authorisation of guanidinoacetic acid and a preparation of guanidinoacetic acid as feed additives for chickens for fattening, weaned piglets and pigs for fattening (holder of authorisation: Alzchem Trostberg GmbH) and repealing Commission Regulation (EC) No 904/2009 ◄

    (Text with EEA relevance)

    (OJ L 270 5.10.2016, p. 4)

    Amended by:

     

     

    Official Journal

      No

    page

    date

    ►M1

    COMMISSION IMPLEMENTING REGULATION (EU) 2023/2628 of 27 November 2023

      L 

    1

    28.11.2023




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    ▼M1

    COMMISSION IMPLEMENTING REGULATION (EU) 2016/1768

    of 4 October 2016

    concerning the authorisation of guanidinoacetic acid and a preparation of guanidinoacetic acid as feed additives for chickens for fattening, weaned piglets and pigs for fattening (holder of authorisation: Alzchem Trostberg GmbH) and repealing Commission Regulation (EC) No 904/2009

    ▼B

    (Text with EEA relevance)



    Article 1

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    The substance and the preparation specified in the Annex, belonging to the additive category ‘zootechnical additives’ and to the functional group ‘other zootechnical additives’, are authorised as additives in animal nutrition subject to the conditions laid down in that Annex.

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    Article 2

    Regulation (EC) No 904/2009 is repealed.

    Article 3

    1.  
    The substance specified in the Annex and premixtures containing that substance, which are produced and labelled before 25 April 2017 in accordance with the rules applicable before 25 October 2016 may continue to be placed on the market and used until the existing stocks are exhausted.
    2.  
    Feed materials and compound feed containing the substance referred to in paragraph 1 may be placed on the market until 25 October 2017 in accordance with the rules applicable before 25 October 2016 and used until the existing stocks are exhausted.

    Article 4

    This Regulation shall enter into force on the twentieth day following that of 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.

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    ANNEX



    Identification number of the additive

    Name of the holder of authorisation

    Additive

    Composition, chemical formula, description, analytical method.

    Species or category of animal

    Maximum age

    Minimum content

    Maximum content

    Other provisions

    End of period of authorisation

    mg guanidinoacetic acid/kg of complete feed with

    a moisture content of 12 %

    Category: Zootechnical additives. Functional group: other zootechnical additives (improvement of performance parameters)

    4d372

    Alzchem Trostberg GmbH

    Guanidinoacetic acid

    Additive composition:

    Guanidinoacetic acid 98 % on dry matter basis

    Solid form

    Characterisation of the active substance:

    Guanidinoacetic acid produced by chemical synthesis

    Chemical formula: C3H7N3O2

    CAS number: 352-97-6

    Purity: 98 %

    Impurities:

    — maximum cyanamide content 0,03 %,

    — maximum dicyandiamide content 0,5 %.

    Analytical method (1)

    For the determination of guanidinoacetic acid in the compound feed: ion chromatography coupled with ultraviolet detection (IC-UV).

    Chickens for fattening

    -

    600

    1 200

    1.  The moisture content shall be indicated on the labelling of the additive.

    2.  In the directions for use of the additive and premixtures, the storage conditions and the stability to heat treatment shall be indicated.

    3.  When using the additive, attention shall be paid to the supply with vitamin B12 and methyl donors other than methionine in the diet of the animal.

    4.  Simultaneous use of this additive in water for drinking and in feed is not permitted.

    25 October 2026

    Weaned piglets

    600

    1 200

    Pigs for fattening

    600

    1 200

    (1)   

    Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation-reports_en



    Identification number of the additive

    Name of the holder of authorisation

    Additive

    Composition, chemical formula, description, analytical method

    Species or category of animal

    Maximum age

    Minimum content

    Maximum content

    Other provisions

    End of period of authorisation

    mg guanidinoacetic acid/kg of complete feed with

    a moisture content of 12 %

    Category: Zootechnical additives. Functional group: other zootechnical additives (improvement of performance parameters)

    4d372i

    Alzchem Trostberg GmbH

    Guanidinoacetic acid

    Additive composition:

    Preparation containing a minimum of 96 % of guanidinoacetic acid.

    Solid form

    Characterisation of the active substance:

    Guanidinoacetic acid produced by chemical synthesis

    Chemical formula: C3H7N3O2

    CAS number: 352-97-6

    Purity: 98 %

    Impurities:

    — maximum cyanamide content 0,03 %,

    — maximum dicyandiamide content 0,5 %.

    Analytical method (1)

    For the determination of guanidinoacetic acid in the compound feed: ion chromatography coupled with ultraviolet detection (IC-UV).

    Chickens for fattening

    600

    1 200

    1.  The moisture content shall be indicated on the labelling of the additive.

    2.  In the directions for use of the additive and premixtures, the storage conditions and the stability to heat treatment shall be indicated.

    3.  When using the additive, attention shall be paid to the supply with vitamin B12 and methyl donors other than methionine in the diet of the animal.

    4.  Simultaneous use of this additive in water for drinking and in feed is not permitted.

    25 October 2026

    Weaned piglets

    600

    1 200

    Pigs for fattening

    600

    1 200

    (1)   

    Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation-reports_en

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