# 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), Annex

Extent: E+W+S+N.I.

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
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
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200
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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 C6H8O7 (purity ≥ 99,5 %)
2-hydroxy-1,2,3-propanetricarboxylic acid, CAS number 77-92-9 anhydrous
Sorbic acid C6H8O2 (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
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
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Source: https://www.legislation.gov.uk/eur/2020/2119/annex (the official version)
Page: https://openlegislation.uk/eu-regulation-2020-2119/annex
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.

