Commission Implementing Regulation (EU) 2022/1249 of 19 July 2022 concerning the authorisation of vitamin B12 in the form of cyanocobalamin produced by Ensifer adhaerens CNCM I-5541 as a feed additive for all animal species (Text with EEA relevance)

• CELEX: Implementing Regulation (EU) 2022/1249
• Articles: 4

Article 1 Authorisation

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 Transitional measures

1.   The substance specified in the Annex and premixtures containing this substance, which are produced and labelled before 9 February 2023 in accordance with the rules applicable before 9 August 2022 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 as specified in the Annex which are produced and labelled before 9 August 2023 in accordance with the rules applicable before 9 August 2022 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 as specified in the Annex which are produced and labelled before 9 August 2024 in accordance with the rules applicable before 9 August 2022 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 Entry into force

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

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 additive/kg of complete feeding stuff with a moisture content of 12 %

Category of nutritional additives

Functional group: vitamins, pro-vitamins and chemically well-defined substances having similar effect

3a835

‘Vitamin B 12 ’ or ‘cyanocobalamin’

Additive composition

Preparation of cyanocobalamin produced by Ensifer adhaerens CNCM I-5541 containing ≤ 1 % of cyanocobalamin

Solid form

Characterisation of active substance

Cyanocobalamin

C 63 H 88 CoN 14 O 14 P

CAS number: 68-19-9

Purity: ≥ 96 %

All animal species

-

-

-

1.

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

2.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from its use. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including skin, eyes and breathing protection.

3.

The endotoxin content of the additive and its dusting potential shall ensure a maximal endotoxin exposure of 1 600 IU endotoxins/m 3 air  ( 2 ) .

9 August 2032

Analytical method

( 1 )

For the quantification of Vitamin B 12 /cyanocobalamin in the feed additive preparation and feeding stuffs:

—

reversed phase high performance liquid chromatography coupled to spectrophotometric detection (HPLC-UV)

( 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

( 2 )   Exposure calculated based on the endotoxin level and the dusting potential of the additive according to the method used by EFSA (EFSA Journal 2018;16(7):5336).