The substances specified in the Annex, belonging to the additive category ‘nutritional additives’ and to the functional group ‘vitamins, pro-vitamins and chemically well-defined substances having similar effect’, are authorised as additives in animal nutrition subject to the conditions laid down in that Annex.
Authorisation of retinyl acetate, retinyl palmitate and retinyl propionate, as additives belonging to the additive category ‘nutritional additives’ and to the functional group ‘vitamins, pro-vitamins and chemically well-defined substances having similar effect’, is denied for use in water.
The substances specified in the Annex and premixtures containing these substances, which are produced and labelled 26 November 2015 in accordance with the rules applicable before 26 May 2015 may continue to be placed on the market and used until the existing stocks are exhausted.
Compound feed and feed materials containing the substances specified in the Annex which are produced and labelled before 26 May 2016 in accordance with the rules applicable before 26 May 2015 may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for food-producing animals.
Compound feed and feed materials containing the substances specified in the Annex which are produced and labelled before 26 May 2017 in accordance with the rules applicable before 26 May 2015 may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for non-food-producing animals.
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .
ANNEXSupplementary provisions
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
IU of vitamin A/kg of complete feedingstuff with a moisture content of 12 %
Category of nutritional additives. Functional group: vitamins, provitamins and chemically well defined substances having a similar effect
3a672a
—
‘Retinyl acetate’, or ‘Vitamin A’
Additive composition
Retinyl acetate
Triphenylphosphine oxide (TPPO) ≤ 100 mg/kg
Characterisation of the active substance
Retinyl acetate
C 22 H 32 O 2
CAS No: 127-47-9
Retinyl acetate, solid form, produced by chemical synthesis.
Purity criteria: min. 95 % (min. 2,76 MIU/g).
Methods of analysis
( 1 )
For the determination of Vitamin A in the feed additive: thin Layer Chromatography and UV detection (TLC-UV) (Ph. Eur. 6th edition, monograph 0217).
For the determination of Vitamin A in premixtures and feedingstuffs: Reversed Phase High Performance Liquid Chromatography (RP-HPLC) with UV or fluorescence detection — Commission Regulation (EC) No 152/2009 ( 2 ) .
Piglets (suckling and weaned)
—
—
16 000
1.
The additive shall be incorporated into the feed via a premixture.
2.
Retinyl acetate may be placed on the market and used as an additive consisting of a preparation.
3.
For the content, as set out on the label the following equivalency shall be used: 1IU = 0,344 μg retinyl acetate.
4.
The mixture of retinyl acetate, retinyl palmitate or retinyl propionate shall not exceed the maximum content for the relevant species and categories.
5.
In the directions for use of the additive and premixtures indicate storage and stability conditions.
6.
For safety: breathing protection, safety glasses and gloves shall be worn during handling.
26 May 2025
Pigs for fattening
—
—
6 500
Sows
—
—
12 000
Other pigs
—
—
—
Chickens and minor poultry species
≤ 14 days
—
20 000
> 14 days
—
10 000
Turkeys
≤ 28 days
—
20 000
> 28 days
—
10 000
Other poultry
—
—
10 000
Dairy cows and cows for reproduction
—
9 000
Calves for rearing
4 months
—
16 000
Other calves and cows
—
—
25 000
Lambs and kids for rearing
≤ 2 months
—
16 000
> 2 months
—
—
Cattle, sheep and goats for fattening
—
—
10 000
Other bovines, sheep and goats
—
—
—
Mammals
—
—
Milk replacers only: 25 000
Other animal species
—
—
—
3a672b
‘Retinyl palmitate’ or ‘Vitamin A’
Additive composition
Retinyl palmitate
Triphenylphosphine oxide (TPPO) ≤ 100 mg/kg of the additive
Characterisation of the active substance
Retinyl palmitate
C 36 H 60 O 2
Cas No:79-81-2
Retinyl palmitate, solid and liquid forms, produced by chemical synthesis: min. 90 % or 1,64 MIU/g.
Methods of analysis
( 1 )
For the determination of Vitamin A in the feed additive: thin Layer Chromatography and UV detection (TLC-UV) (Ph. Eur. 6th edition, monograph 0217).
For the determination of Vitamin A in premixtures and feedingstuffs: Reversed Phase High Performance Liquid Chromatography (RP-HPLC) with UV or fluorescence detection — Regulation (EC) No 152/2009.
Piglets (suckling and weaned)
—
—
16 000
1.
The additive shall be incorporated into the feed via a premixture.
2.
Retinyl palmitate may be placed on the market and used as an additive consisting of a preparation.
3.
For the content, as set out on the label, the following equivalency shall be used: 1IU = 0,5458 μg retinyl palmitate.
4.
The mixture of retinyl acetate, retinyl palmitate or retinyl propionate shall not exceed the maximum content for the relevant species and categories.
5.
In the directions for use of the additive and premixtures indicate storage and stability conditions.
6.
For safety: breathing protection, safety glasses and gloves shall be worn during handling.
26 May 2025
Pigs for fattening
—
—
6 500
Sows
—
—
12 000
Other pigs
—
—
—
Chickens and minor poultry species
≤ 14 days
—
20 000
> 14 days
—
10 000
Turkeys
≤ 28 days
—
20 000
> 28 days
—
10 000
Other poultry
—
—
10 000
Dairy cows and cows for reproduction
—
—
9 000
Calves for rearing
4 months
—
16 000
Other calves and cows
—
—
25 000
Lambs and kids for rearing
≤ 2 months
—
16 000
> 2 months
—
—
Cattle, sheep and goats for fattening
—
—
10 000
Other bovines, sheep and goats
—
—
—
Mammals
—
—
Milk replacers only: 25 000
Other animal species
—
—
—
3a672c
‘Retinyl propionate’ or ‘Vitamin A’
Additive composition
Retinyl propionate
Triphenylphosphine oxide (TPPO) ≤ 100 mg/kg of the additive
Characterisation of the active substance
Retinyl propionate
C 23 H 34 O 2
Cas No.:7069-42-3
Retinyl propionate, liquid form, produced by chemical synthesis: min. 95 % or 2,64 MIU/g
Methods of analysis
( 1 )
For the determination of Vitamin A in the feed additive: thin Layer Chromatography and UV detection (TLC-UV) (Ph. Eur. 6th edition, monograph 0217).
For the determination of Vitamin A in premixtures and feedingstuffs: Reversed Phase High Performance Liquid Chromatography (RP-HPLC) with UV or fluorescence detection — Regulation (EC) No 152/2009.
Piglets (suckling and weaned)
—
—
16 000
1.
The additive shall be incorporated into the feed via a premixture.
2.
Retinyl propionate may be placed on the market and used as an additive consisting of a preparation.
3.
For the content, as set out on the label, the following equivalency shall be used: 1IU = 0,3585 μg retinyl propionate.
4.
The mixture of retinyl acetate, retinyl palmitate or retinyl propionate shall not exceed the maximum content for the relevant species and categories.
5.
In the directions for use of the additive and premixtures indicate storage and stability conditions
6.
For safety: breathing protection, safety glasses and gloves shall be worn during handling.
26 May 2025
Pigs for fattening
—
—
6 500
Sows
—
—
12 000
Other pigs
—
—
—
Chickens and minor poultry species
≤ 14 days
—
20 000
> 14 days
—
10 000
Turkeys
≤ 28 days
—
20 000
> 28 days
—
10 000
Other poultry
—
—
10 000
Dairy cows and cows for reproduction
—
—
9 000
Calves for rearing
4 months
—
16 000
Other calves or cows
—
—
25 000
Lambs and kids for rearing
≤ 2 months
—
16 000
> 2 months
—
—
Cattle, sheep and goats for fattening
—
—
10 000
Other bovines, sheep and goats
—
—
—
Mammals
—
—
Milk replacers only: 25 000
Other animal species
—
—
—
( 1 ) Details of the analytical methods are available at the following address of the European Union Reference Laboratory for Feed Additives: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports
( 2 ) Commission Regulation (EC) No 152/2009 of 27 January 2009 laying down the methods of sampling and analysis for the official control of feed ( OJ L 54, 26.2.2009, p. 1 ).