Commission Implementing Regulation (EU) No 803/2013 of 22 August 2013 concerning the authorisation of folic acid as a feed additive for all animal species Text with EEA relevance

• CELEX: Implementing Regulation (EU) No 803/2013
• Articles: 4

Article 1

The preparation specified in the Annex, belonging to the additive category ‘nutritional additives’ and to the functional group ‘vitamins, pro-vitamins and chemically well-defined substances having similar effect’, is authorised as an additive in animal nutrition subject to the conditions laid down in that Annex.

Article 2

The preparation specified in the Annex and feed containing that preparation, which are produced and labelled before 12 March 2014 in accordance with the rules applicable before 12 September 2013 may continue to be placed on the market and used until the existing stocks are exhausted.

Article 3

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

Schedules & Appendices

ANNEX

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/kg of complete feedingstuff with a moisture content of 12 %

Category of nutritional additives. Functional group: vitamins, pro-vitamins and chemically well-defined substances having similar effect

3a316

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Folic acid

Additive composition

Preparation of folic acid, solid form

Characterisation of the active substance

Name: folic acid

Chemical formula: C 19 H 19 N 7 O 6

CAS No: 59-30-3

Produced by chemical synthesis

Purity: not less than 96 % folic acid, anhydrous basis

Purity criteria: as laid down by European Pharmacopeia 6th edition 01/2008/0067

Method of Analysis

( 1 )

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For the quantification of folic acid in feed additive and premixtures: Reverse Phase High-Performance Liquid Chromatography coupled to UV detection (RP-HPLC-UV).

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For the quantification of total folates (including added folic acid) in feedingstuffs and water: microbiological assay — based on CEN-ring trial validated method EN 14131.

All animal species

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—

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1.

If the preparation contains a technological additive or feed materials for which a maximum content is set or which is subject to other restrictions, the feed additive manufacturer shall provide this information to the customers.

2.

In the directions for use of the additive and premixture, indicate the storage and stability conditions.

3.

Folic acid may be used also via water for drinking.

4.

For safety: breathing, eye and skin protection shall be used during handling.

12 September 2023

( 1 )   Details of the analytical methods are available at the following address of the Reference Laboratory: http://irmm.jrc.ec.europa.eu/EURLs/EURL_feed_additives/Pages/index.aspx