Commission Implementing Regulation (EU) 2020/2119 of 16 December 2020 concerning the renewal of the authorisation of the preparation of citric acid, sorbic acid, thymol and vanillin as a feed additive for all porcine species (weaned), chickens for fattening, chickens reared for laying, all minor avian species for fattening and all minor avian species reared for laying and repealing Regulations (EU) No 1117/2010 and (EU) No 849/2012 (holder of authorisation Vetagro SpA) (Text with EEA relevance)

• CELEX: Implementing Regulation (EU) 2020/2119
• Articles: 5

Article 1

The authorisation of the preparation specified in the Annex, belonging to the additive category ‘zootechnical additives’ and to the functional group ‘other zootechnical additives’, is renewed subject to the conditions laid down in that Annex.

Article 2

Regulations (EU) No 1117/2010 and (EU) No 849/2012 are repealed.

Article 3

The preparation of citric acid, sorbic acid, thymol and vanillin, as set out in Regulations (EU) No 1117/2010 and (EU) No 849/2012, premixtures and compound feed containing that additive, which are produced and labelled before 6 January 2021 in accordance with the rules applicable before 6 January 2021 may continue to be placed on the market and used until the existing stock 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/kg of additive in complete feedingstuff with a moisture content of 12 %

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

4d3

Vetagro SpA

Preparation of protected citric acid, sorbic acid,

thymol and vanillin

Additive composition

Preparation of protected microbeads containing citric acid, sorbic acid, thymol and vanillin with a minimum of:

Citric acid: 25 g/100 g

Thymol: 1,7 g/100 g

Sorbic acid: 16,7 g/100 g

Vanillin: 1 g/100 g

Chickens for fattening

Chickens reared for laying

All minor avian species for fattening and reared for laying

-

200

-

1.

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

2.

The instructions of use shall include the following: ‘The total maximum content by the different sources of citric acid and sorbic acid in complete feed shall not be exceeded’.

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: skin and eyes irritant and a skin sensitiser. 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.

6.1.2031

Characterisation of active substance

Citric acid C 6 H 8 O 7 (purity ≥ 99,5 %)

2-hydroxy-1,2,3-propanetricarboxylic acid, CAS number 77-92-9 anhydrous

Sorbic acid C 6 H 8 O 2 (purity ≥ 99,5 %)

2,4-hexadienoic acid, CAS number 110-44-1

Thymol (purity ≥ 98 %)

5-methyl-2-(1-methylethyl)phenol, CAS number 89-83-8)

Vanillin (purity ≥ 99,5 %)

4-hydroxy-3-methoxybenzaldehyde, CAS number 121-33-5)

All porcine species (weaned)

1 000

Analytical method

( 1 )

Determination of sorbic acid and thymol in feed additive, premixtures and feedingstuffs:

—

Reversed phase high performance liquid chromatography equipped with ultraviolet/diode array detection (RP-HPLC-UV/DAD)

Determination of citric acid in the additive and premixtures:

—

Reversed phase high performance liquid chromatography equipped with ultraviolet/diode array detection (RP-HPLC-UV/DAD)

Determination of citric acid in feedingstuffs:

—

enzymatic determination of citric acid content – NADH (reduced form of nicotinamide adenine dinucleotide) spectrometric method

-

( 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