Commission Implementing Regulation (EU) 2022/538 of 4 April 2022 concerning the renewal of the authorisation of sodium benzoate as feed additive for weaned piglets, the new authorisation for weaned piglets of other Suidae and repealing Implementing Regulation (EU) No 496/2011 (holder of the authorisation Taminco Finland Oy) (Text with EEA relevance)

• CELEX: Implementing Regulation (EU) 2022/538
• Articles: 5

Article 1

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

Article 2

Implementing Regulation (EU) No 496/2011 is repealed.

Article 3

1.   The substance referred to in Article 1 and premixtures containing it, which are produced and labelled before 25 October 2022 in accordance with the rules applicable before 25 April 2022 may continue to be placed on the market and used until the existing stocks are exhausted.

2.   Feed materials and compound feed containing the substance referred to in paragraph 1, which are produced and labelled before 25 April 2023 in accordance with the rules applicable before 25 April 2022 may continue to be placed on the market and used until the existing stocks are exhausted.

Article 4

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 active substance/kg of complete feed with a moisture content of 12 %

Category: zootechnical additives. Functional group: other zootechnical additives (improvement of zootechnical performances)

4d5

Taminco Finland Oy

Sodium benzoate

Additive composition

Granular or powder formulation with a minimum of 99 % sodium benzoate

Weaned piglets of all Suidae

-

4 000

1.

In the directions for use of the additive and premixture, 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.

3.

Recommended minimum dose: 4 000 mg/kg of complete feed with a moisture content of 12 %.

4.

The directions of use shall indicate: ‘Complementary feed containing sodium benzoate shall not be fed to weaned piglets of all Suidae as such. Complementary feed containing sodium benzoate shall be thoroughly mixed with other compounds of the daily ration’.

5.

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 or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including eyes, skin and breathing protection.

25 April 2032

Characterisation of active substance

Sodium benzoate

Chemical formula: C 7 H 5 O 2 Na

CAS number: 532-32-1

Analytical method

( 1 )

For the determination of sodium benzoate (as total benzoic acid) in the feed additive, premixtures compound feed and feed materials:

—

High performance liquid chromatography with ultraviolet detection (HPLC-UV) – EN 17298

For the determination of total sodium in the feed additive:

—

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

—

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

( 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