Commission Implementing Regulation (EU) 2020/1375 of 1 October 2020 concerning the authorisation of the preparation of citric acid, sorbic acid, thymol and vanillin as a feed additive for suckling piglets, turkeys for fattening and turkeys reared for breeding (holder of authorisation Vetagro SpA) (Text with EEA relevance)

• CELEX: Implementing Regulation (EU) 2020/1375
• 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 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

Suckling piglets

-

1 000

-

1.

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

2.

Indicate in the instruction of use: ‘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. 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.

22.10.2030

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)

Turkeys for fattening

Turkeys reared for breeding

-

200

-

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