1. 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.
2. The substances specified in the Annex, belonging to the additive category ‘technological additives’ and to the functional group ‘antioxidants’, are authorised as additives in animal nutrition subject to the conditions laid down in that Annex.
1. The substances specified in the Annex and premixtures containing those substances, which are produced and labelled before 23 January 2016 in accordance with the rules applicable before 23 July 2015 may continue to be placed on the market and used until the existing stocks are exhausted.
2. Compound feed and feed materials containing the substances specified in the Annex which are produced and labelled before 23 July 2016 in accordance with the rules applicable before 23 July 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.
3. Compound feed and feed materials containing the substances as specified in the Annex which are produced and labelled before 23 July 2017 in accordance with the rules applicable before 23 July 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
mg of active substance/kg of complete feedingstuff with a moisture content of 12 % or mg of active substance/l of water
Category of nutritional additives. Functional group: vitamins, provitamins and chemically well-defined substances having a similar effect
3a300
—
‘Ascorbic acid’ or ‘Vitamin C’
Additive composition
Ascorbic acid.
Characterisation of the active substance
L-ascorbic acid
C 6 H 8 O 6
CAS No: 50-81-7
L-ascorbic acid, solid form, produced by chemical synthesis.
Purity criteria: min 99 %.
Analytical methods
( 1 )
For the determination of L-ascorbic acid in the feed additive: titrimetry — European Pharmacopoeia monograph (Ph.Eur. 01/2011:0253).
For the quantification of L-ascorbic acid in premixtures and feedingstuffs: titrimetry.
For the quantification of L-ascorbic acid in water:
—
Titrimetry (AOAC 967.21); or
—
High Performance Liquid Chromatography coupled to UV detection at 265 nm (EN 14130:2003)
All animal species
—
—
—
1.
Ascorbic acid may be placed on the market and used as an additive consisting of a preparation.
2.
In the directions for use of the additive and premixtures, indicate the storage and stability conditions.
3.
For safety: breathing protection, safety glasses and gloves shall be worn during handling.
4.
The additive may be used in water for drinking.
23 July 2025
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 feedingstuff with a moisture content of 12 %
Category of nutritional additives. Functional group: vitamins, provitamins and chemically well-defined substances having a similar effect
3a311
‘Sodium ascorbyl phosphate’ or ‘Vitamin C’.
Additive composition
Sodium ascorbyl phosphate.
Characterisation of the active substance
Sodium ascorbyl phosphate
C 6 H 6 O 9 Na 3 P · 2H 2 O
CAS No: 66170-10-3
Sodium ascorbyl phosphate, solid form, produced by chemical synthesis.
Purity criteria: min. 95 % with a min. content of 45 % ascorbic acid.
Analytical methods
( 2 )
For the determination of the purity of sodium ascorbyl phosphate and the ascorbic acid equivalent in the feed additive: High Performance Liquid Chromatography coupled to Variable Wavelength Detector (VWD).
For the quantification of total sodium in the feed additive:
—
Atomic Absorption Spectrometry, AAS (EN ISO 6869:2000); or
—
Inductively Coupled Plasma Atomic Emission Spectrometry, ICP-AES (EN15510:2007).
For the quantification of ascorbyl monophosphate in premixtures and feedingstuffs: High Performance Liquid Chromatography coupled to UV detection at 254 nm (HPLC-UV).
All animal species
—
—
—
1.
Sodium ascorbyl phosphate may be placed on the market and used as an additive consisting of a preparation.
2.
In the directions for use of the additive and premixtures, indicate the storage and stability conditions.
3.
For safety: breathing protection, shall be used during handling.
23 July 2025
3a312
‘Sodium calcium ascorbyl phosphate’ or ‘Vitamin C’.
Additive composition
Sodium calcium ascorbyl phosphate.
Characterisation of the active substance
Sodium calcium ascorbyl phosphate
C 6 H 6 O 9 P · CaNa.
Sodium- calcium-L-ascorbyl phosphate, solid form, produced by chemical synthesis.
Purity criteria: min. 95 % with a min. content of 35 % ascorbic acid.
Analytical methods
( 2 )
For the determination of the purity of sodium calcium ascorbyl phosphate and the ascorbic acid equivalent in the feed additive: High- Performance Liquid Chromatography coupled to Variable Wavelength Detector (VWD).
For the quantification of total calcium and total sodium in the feed additive:
—
Atomic Absorption Spectrometry, AAS (EN ISO 6869:2000); or
—
Inductively Coupled Plasma Atomic Emission Spectrometry, ICP-AES (EN15510:2007).
For the quantification of ascorbyl monophosphate in premixtures and feedingstuffs: High- Performance Liquid Chromatography coupled to UV detection at 254 nm (HPLC-UV).
All animal species
1.
Sodium calcium ascorbyl phosphate may be placed on the market and used as an additive consisting of a preparation.
2.
In the directions for use of the additive and premixtures, indicate the storage and stability conditions.
3.
For user safety: breathing protection, shall be used during handling.
23 July 2025
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 feedingstuff with a moisture content of 12 %
Category of technological additives. Functional Group antioxidants
3a300
—
Ascorbic acid
Additive composition
Ascorbic acid.
Characterisation of the active substance
L-ascorbic acid
C 6 H 8 O 6
CAS No: 50-81-7
L-ascorbic acid, solid form, produced by chemical synthesis.
Purity criteria: min 99 %.
Analytical methods
( 3 )
For the determination of L-ascorbic acid in the feed additive: titrimetry — European Pharmacopoeia monograph (Ph.Eur. 01/2011:0253).
For the quantification of L-ascorbic acid in premixtures and feedingstuffs: titrimetry.
All animal species
—
—
—
1.
Ascorbic acid may be placed on the market and used as an additive consisting of a preparation.
2.
In the directions for use of the additive indicate the stability and storage conditions and for the premixtures the storage conditions.
3.
For safety: breathing protection, safety glasses and gloves shall be worn during handling.
23 July 2025
1b301
Sodium ascorbate
Additive composition
Sodium ascorbate.
Characterisation of the active substance
Sodium L ascorbate.
C 6 H 7 O 6 Na
CAS No: 134-03-2
Sodium L-ascorbate, solid form, produced by chemical synthesis.
Purity criteria: min. 99 %.
Analytical methods
( 3 )
For the determination of Sodium L-ascorbate in the feed additive: titrimetry — European Pharmacopoeia monograph (Ph.Eur. 01/2011:1791).
For the quantification of total sodium in the feed additive:
—
Atomic Absorption Spectrometry, AAS (EN ISO 6869:2000); or
—
Inductively Coupled Plasma Atomic Emission Spectrometry, ICP-AES (EN15510:2007).
For the quantification of Sodium L-ascorbate in premixtures and feedingstuffs: titrimetry.
All animal species
—
—
—
1.
In the directions for use of the additive indicate the stability and storage conditions and for the premixtures the storage conditions.
2.
For safety: breathing protection, safety glasses and gloves shall be worn during handling.
23 July 2025
1b302
Calcium ascorbate
Additive composition
Calcium ascorbate.
Characterisation of the active substance
Calcium L-(+)-ascorbate dehydrate
C 12 H 14 O 12 Ca · 2H 2 O
CAS No: 5743-28-2
Calcium L-(+)-ascorbate dehydrate, solid form, produced by chemical synthesis.
Purity criteria: min. 99 %.
Analytical methods
( 3 )
For the determination of Calcium L-ascorbate in the feed additive: Titrimetry — European Pharmacopoeia monograph (Ph.Eur. 01/2008:1182).
For the quantification of total calcium in the feed additive:
—
Atomic Absorption Spectrometry, AAS (EN ISO 6869:2000); or
—
Inductively Coupled Plasma Atomic Emission Spectrometry, ICP-AES (EN15510:2007).
For the quantification of Calcium L-ascorbate in premixtures and feedingstuffs: titrimetry.
All animal species
—
—
—
1.
In the directions for use of the additive indicate the stability and storage conditions and for the premixtures the storage conditions.
2.
For safety: breathing protection, safety glasses and gloves shall be worn during handling.
23 July 2025
1b304
Ascorbyl palmitate
Additive composition
Ascorbyl palmitate.
Characterisation of the active substance
L-ascorbyl-6-palmitate
C 22 H 38 O 7
CAS No: 137-66-6
L-ascorbyl-6- palmitate, solid form, produced by chemical synthesis.
Purity criteria: min. 98 %.
Analytical method
( 3 )
For the determination of L-ascorbyl-6-palmitate in the feed additive:
—
Titrimetry — European Pharmacopoeia monograph (Ph.Eur. 01/2008:0807).
All animal species
—
—
—
1.
In the directions for use of the additive indicate the stability and storage conditions and for the premixtures the storage conditions.
2.
For safety breathing protection, safety glasses and gloves shall be worn during handling.
23 July 2025
( 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 ) 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
( 3 ) 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
