
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.
This Regulation shall be binding in its entirety and directly applicable in all Member States.Done at Brussels, 22 August 2013.
For the Commission
The President
José Manuel BARROSO
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 — Folic acid 
 Additive composition
Preparation of folic acid, solid form
 Characterisation of the active substance
Name: folic acid
Chemical formula: C19H19N7O6
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
— For the quantification of folic acid in feed additive and premixtures: Reverse Phase High-Performance Liquid Chromatography coupled to UV detection (RP-HPLC-UV).
— 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 — — — 
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
