
Article 1 
The substance 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 

1. The substance specified in the Annex and premixtures containing that substance, which are produced and labelled before 26 November 2015 in accordance with the rules applicable before 26 May 2015 may continue to be placed on the market and used until the existing stocks are exhausted.
2. Compound feed and feed materials containing the substance specified in the Annex which are produced and labelled before 26 November 2015 in accordance with the rules applicable before 26 May 2015 may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for food producing animals.
3. Compound feed and feed materials containing the substance specified in the Annex which are produced and labelled before 26 May 2017 in accordance with the rules applicable before 26 May 2015 may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for non-food producing animals.
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, 5 May 2015.
For the Commission
The President
Jean-Claude JUNCKER
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 of active substance/kg of complete feedingstuff with a moisture content of 12 % or mg active substance/l of water.
Category of nutritional additives. Functional group: vitamins, provitamins and chemically well defined substances having a similar effect
3a880 — Biotin 
Biotin

D-(+)-biotin

C10H16N2O3S


— CAS No: 58-85-5
— Biotin, solid form, produced by chemical synthesis
— Purity criteria: min. 97 %

For the determination of D-(+)-biotin in feed additive: a potentiometric titration assay and an optical rotation identification (European Pharmacopeia 6.0, method 01/2008:1073).

For the determination of D-(+)-biotin in premixtures and feedingstuffs: Reversed Phase High Performance Liquid Chromatography coupled to mass spectrometry (RP-HPLC-MS/MS).

For the determination of D-(+)-Biotin in water: microbiological assay (US Pharmacopoeia 21, 3rd supplement, method (88) 1986)
 All animal species — — — 
1. Biotin may be placed on the market and used as an additive consisting of a preparation.

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

3. For safety: breathing protection shall be worn during handling.

4. The additive may be used in water for drinking.
 26 May 2025
