Commission Implementing Regulation (EU) 2021/2097 of 29 November 2021 concerning the authorisation of the preparation of benzoic acid, calcium formate and fumaric acid as a feed additive for turkeys for fattening and turkeys reared for breeding (holder of the authorisation Novus Europe NV) (Text with EEA relevance)

• CELEX: Implementing Regulation (EU) 2021/2097
• Articles: 3

Article 1

The preparation specified in the Annex, belonging to the additive category ‘zootechnical additives’ and to the functional group ‘other zootechnical additives’, is authorised as an additive in animal nutrition, subject to the conditions laid down in that Annex.

Article 2

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 of additive/kg of complete feed with a moisture content of 12 %

Category of zootechnical additives. Functional group: other zootechnical additives (improving zootechnical performance).

4d14

Novus Europe NV

Preparation of benzoic acid, calcium formate and fumaric acid

Additive composition:

Preparation of benzoic acid, calcium formate and fumaric acid having a minimum content of:

benzoic acid: 42,5-50 %,

calcium formate: 2,5-3,5 %,

fumaric acid: 0,8-1,2 %;

Granulated form

Turkeys for fattening

Turkeys reared for breeding

-

500

1 000

1.

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

2.

The additive shall not be used with other sources of benzoic acid or benzoates, calcium formate or formic acid and fumaric acid.

3.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks concerning their 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 breathing protection.

20 December 2031

Characterisation of the active substance:

Benzoic acid (purity ≥ 99,0 %); CAS number: 65-85-0; Chemical formula C 7 H 6 O 2

Calcium formate: CAS number 544-17-2; Chemical formula C 2 H 2 O 4 Ca;

Fumaric acid (purity ≥ 99,5 %): CAS number 110-17-8; Chemical formula C 4 H 4 O 4.

Analytical method

( 1 )

For the determination of benzoic acid, calcium formate and fumaric acid in the feed additive:

—

high performance liquid chromatography with UV detection (HPLC-UV);

For the determination of total calcium in the feed additive:

—

atomic absorption spectrometry (AAS) – EN ISO 6869; or

—

inductively coupled plasma atomic emission spectrometry (ICP-AES) – EN 15510;

For the determination of benzoic acid in premixtures and feedingstuffs:

—

high performance liquid chromatography with UV detection (HPLC-UV);

For the determination of calcium formate and fumaric acid in premixtures:

—

ion-exclusion high performance liquid chromatography with UV or refractive index detection (HPLC-UV/RI).

( 1 )   Details of the analytical methods are available at the following address of the Reference Laboratory: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports