Commission Implementing Regulation (EU) 2024/1194 of 24 April 2024 concerning the renewal of the authorisation of nicotinic acid and niacinamide as feed additives for all animal species and repealing Implementing Regulation (EU) No 642/2013

• CELEX: Implementing Regulation (EU) 2024/1194
• Articles: 5

Article 1 Renewal of the authorisation

The authorisation of the substances 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 renewed, subject to the conditions laid down in that Annex.

Article 2 Repeal

Implementing Regulation (EU) No 642/2013 is repealed.

Article 3 Transitional measures

1.   The substance nicotinic acid specified in the Annex and premixtures containing that substance which are produced and labelled before 15 November 2024 in accordance with the rules applicable before 15 May 2024 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 nicotinic acid specified in the Annex, which are produced and labelled before 15 May 2025 in accordance with the rules applicable before 15 May 2024 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 nicotinic acid specified in the Annex, which are produced and labelled before 15 May 2026 in accordance with the rules applicable before 15 May 2024 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 4 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 feed 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 active substance/kg of complete feedingstuff with a moisture content of 12 %

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

3a314

Nicotinic acid

Additive composition

Nicotinic acid

Characterisation of active substance

Nicotinic acid

Solid form

Purity: ≥ 99 %

Chemical name: nicotinic acid

Chemical formula: C 6 H 5 NO 2

CAS number: 59-67-6

Einecs number: 200-441-0

Analytical method

( 1 )

—

For the determination of nicotinic acid in the feed additive: titration with sodium hydroxide; European Pharmacopoeia monograph 0459.

—

For the determination of nicotinic acid in premixtures, compound feed and water: Ion-pair Reversed Phase High Performance Liquid Chromatography coupled to UV detector (RP-HPLC-UV).

All animal species

—

—

—

1.

Nicotinic acid may be used also via water for drinking.

2.

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

3.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal breathing, eye and skin protective equipment.

15 May 2034

Identification number of the feed 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 active substance/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

3a315

Niacinamide

Additive composition

Niacinamide

Characterisation of active substance

Niacinamide

Solid form

Purity: ≥ 99 %

Chemical name: niacinamide, nicotinamide Chemical formula: C 6 H 6 N 2 O

CAS number: 98-92-0

Einecs number: 202-713

Analytical method

( 2 )

—

For the determination of niacinamide (nicotinamide) in the feed additive: Titration with perchloric acid; European Pharmacopoeia monograph 0047.

—

For the determination of niacinamide (nicotinamide) in premixtures, compound feed and water: Ion-pair Reversed Phase High Performance Liquid Chromatography coupled to UV detector (RP-HPLC-UV).

All animal species

—

—

—

1.

Niacinamide may be used also via water for drinking.

2.

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

3.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal breathing, eye and skin protective equipment.

15 May 2034

( 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 .

( 2 )   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 .