The additives specified in the Annex, belonging to the additive category ‘technological additives’ and to the functional group ‘preservatives’ or ‘acidity regulators’, are authorised as additives in animal nutrition, subject to the conditions laid down in that Annex.
Commission Implementing Regulation (EU) 2022/415 of 11 March 2022 concerning the authorisation of malic acid, citric acid produced by Aspergillus niger DSM 25794 or CGMCC 4513/CGMCC 5751 or CICC 40347/CGMCC 5343, sorbic acid and potassium sorbate, acetic acid, sodium diacetate and calcium acetate, propionic acid, sodium propionate, calcium propionate and ammonium propionate, formic acid, sodium formate, calcium formate and ammonium formate, and lactic acid produced by Bacillus coagulans (LMG S-26145 or DSM 23965), or Bacillus smithii (LMG S-27890) or Bacillus subtilis (LMG S-27889) and calcium lactate as feed additives for certain animal species (Text with EEA relevance)
Commission Implementing Regulation (EU) 2022/415 of 11 March 2022 concerning the authorisation of malic acid, citric acid produced by Aspergillus niger DSM 25794 or CGMCC 4513/CGMCC 5751 or CICC 40347/CGMCC 5343, sorbic acid and potassium sorbate, acetic acid, sodium diacetate and calcium acetate, propionic acid, sodium propionate, calcium propionate and ammonium propionate, formic acid, sodium formate, calcium formate and ammonium formate, and lactic acid produced by Bacillus coagulans (LMG S-26145 or DSM 23965), or Bacillus smithii (LMG S-27890) or Bacillus subtilis (LMG S-27889) and calcium lactate as feed additives for certain animal species (Text with EEA relevance)
Article 1 Authorisation
Article 2 Transitional measures
The additives specified in the Annex and premixtures containing the additives, which are produced and labelled before 3 October 2022 in accordance with the rules applicable before 3 April 2022 may continue to be placed on the market and used until the existing stocks are exhausted.
Compound feed and feed materials containing the additives as specified in the Annex which are produced and labelled before 3 April 2023 in accordance with the rules applicable before 3 April 2022 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 additives as specified in the Annex which are produced and labelled before 3 April 2024 in accordance with the rules applicable before 3 April 2022 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.
Article 3 Entry into force
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
ANNEX
Identi-fication number of the additive |
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: technological additives Functional group: preservatives |
||||||||
1a296 |
DL-Malic acid |
Additive composition DL-Malic acid ≥ 99,5 % Characterisation of the active substance DL-Malic acid ≥ 99,5 % C4H6O5 CAS No 6915-15-7 (or 617-48-1) Sulphated ash ≤ 0,02 % Fumaric acid ≤ 1 % Maleic acid ≤ 0,05 % Produced by chemical synthesis Analytical method(1) For the determination of malic acid as total malic acid in the feed additive, premixtures and feedingstuffs: Ion Chromatography with Conductivity Detection, IC-CD (EN 17294) |
All animal species |
- |
- |
- |
|
3 April 2032 |
Identi-fication number of the additive |
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: technological additives Functional group: preservatives |
||||||||
1a330 |
Citric acid |
Additive composition Citric acid ≥ 99,5 % (in dry matter) Characterisation of the active substance Citric acid ≥ 99,5 % Anhydrous form: C6H8O7 CAS No 77-92-9 Monohydrate form: C6H8O7.H2O CAS No 5949-29-1 sulphated ash < 0,05 % oxalic acid < 100 mg/kg Produced by:
Analytical method(1) For the determination of citric acid as total citric acid in the feed additive, premixtures and feedingstuffs: Ion Chromatography with Conductivity Detection, IC-CD (EN 17294) |
All animal species |
- |
- |
15 000 |
|
3 April 2032 |
Identi-fication number of the additive |
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: technological additives Functional group: acidity regulators |
||||||||
1a330 |
Citric acid |
Additive composition Citric acid ≥ 99,5 % (in dry matter) Characterisation of the active substance Citric acid ≥ 99,5 % Anhydrous form: C6H8O7 CAS No 77-92-9 Monohydrate form: C6H8O7.H2O CAS No 5949-29-1 sulphated ash < 0,05 % oxalic acid < 100 mg/kg Produced by:
Analytical method(1) For the determination of citric acid as total citric acid in the feed additive, premixtures and feedingstuffs: Ion Chromatography with Conductivity Detection, IC-CD (EN 17294) |
All animal species |
- |
- |
15 000 |
|
3 April 2032 |
Identification number of the additive |
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: technological additives Functional group: preservatives. |
||||||||
1a200 |
Sorbic acid |
Additive composition Sorbic acid ≥ 99 % Solid form Active substance Sorbic acid ≥ 99 % C6 H8O2 CAS No 110-44-1 Sulphated ash ≤ 0,2 % Aldehydes ≤ 0,1 % Produced by chemical synthesis Analytical method(1) For the determination of sorbic acid as total sorbic acid in the feed additive, premixtures and feedingstuffs: High Performance Liquid Chromatography with ultraviolet detection, HPLC-UV (EN 17298) |
All animal species other than ruminants with a non-functional rumen |
- |
- |
2 500 |
|
3 April 2032 |
Ruminants with a non-functional rumen |
- |
6 700 |
||||||
Identification number of the additive |
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: technological additives Functional group: preservatives |
||||||||
1k202 |
Potassium sorbate |
Additive composition Potassium sorbate ≥ 99 % Solid form Active substance Potassium sorbate ≥ 99 % C6 H7 KO2 CAS No 24634-61-5 Produced by chemical synthesis Analytical method(1) For the determination of potassium in the feed additive:
For the determination of potassium sorbate as total sorbic acid in the feed additive, premixtures and feedingstuffs: High Performance Liquid Chromatography with ultraviolet detection, HPLC-UV (EN 17298) |
All animal species other than ruminants with a non-functional rumen |
- |
- |
2 500 (as sorbic acid) |
|
3 April 2032 |
Ruminants with a non-functional rumen |
- |
6 700 (as sorbic acid) |
||||||
Identi-fication number of the additive |
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: technological additives Functional group: preservatives |
||||||||
1a260 |
Acetic acid |
Additive composition Acetic acid ≥ 99,8 % Liquid form Characterisation of the active substance Acetic acid ≥ 99,8 % C2H4O2 CAS No 64-19-7 Water ≤ 0,15 % Non volatile matter ≤ 30 mg/kg Formic acid and its salts and other oxidisable material ≤ 0,5 g/kg Produced by chemical synthesis including cellulose production (as a by-product) Analytical method(1) For the determination of acetic acid as total acetic acid in the feed additive, premixtures and feedingstuffs: Ion Chromatography with Conductivity Detection, IC-CD (EN 17294) |
All animal species other than fish and ruminants |
- |
- |
2 500 |
|
3 April 2032 |
Ruminants |
- |
- |
||||||
Identi-fication number of the additive |
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: technological additives Functional group: preservatives |
||||||||
1a262 |
Sodium diacetate |
Additive composition Sodium diacetate ≥ 97 % Solid form Characterisation of the active substance Sodium diacetate (anhydrous and trihydrate) NaC4H7O4 CAS no 126-96-5 Sodium acetate ≥ 58 % Acetic acid ≥ 39 % Water ≤ 2 % Formic acid and its salts and other oxidisable material ≤ 1g/kg Produced by chemical synthesis Analytical method(1) For the determination of sodium in the feed additive:
For the determination of sodium diacetate as total acetic acid in the feed additive, premixtures and feedingstuffs: Ion Chromatography with Conductivity Detection, IC-CD (EN 17294) |
All animal species other than fish and ruminants |
- |
- |
2 500 (as acetic acid) |
|
3 April 2032 |
Ruminants |
- |
- |
||||||
Identi-fication number of the additive |
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: technological additives Functional group: preservatives |
||||||||
1a263 |
Calcium acetate (anhydrous and monohydrate) |
Additive composition Calcium acetate ≥ 98,7 % Solid form Characterisation of the active substance Calcium acetate ≥ 98,7 % C4H6CaO4 CAS No 62-54-4 Water ≤ 6 % Formic acid and its salts and other oxidisable material ≤ 1g/kg Produced by chemical synthesis Analytical method(1) For the determination of calcium in the feed additive:
For the determination of calcium acetate as total acetic acid in the feed additive, premixtures and feedingstuffs: Ion Chromatography with Conductivity Detection, IC-CD (EN 17294) |
All animal species other than fish and ruminants |
- |
- |
2 500 (as acetic acid) |
|
3 April 2032 |
Ruminants |
- |
- |
||||||
Identi-fication number of the additive |
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: technological additives Functional group: preservatives |
||||||||
1k280 |
Propionic acid |
Additive composition Propionic acid ≥ 99,5 % Liquid form Characterisation of the active substance Propionic acid ≥ 99,5 % C3H6O2 CAS No 79-09-4 Non-volatile residue ≤ 0,01 % when dried at 140oC to constant weight Aldehydes ≤ 0,1 % expressed as propionaldehyde Produced by chemical synthesis Analytical method(1) For the quantification of propionic acid as total propionic acid in feed additive, premixtures, feedingstuffs: Ion Chromatography with Conductivity Detection, IC-CD (EN 17294) |
All animal species other than pigs and poultry |
- |
- |
- |
|
3 April 2032 |
Pigs |
- |
30 000 |
||||||
Poultry |
- |
10 000 |
||||||
Identi-fication number of the additive |
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 complete feedingstuff with a moisture content of 12 % |
||||||||
Category: technological additives Functional group: preservatives |
||||||||
1k281 |
Sodium propionate |
Additive composition Sodium propionate ≥ 98,5 % Solid form Characterisation of the active substance Sodium propionate ≥ 98,5 % C3H5O2Na CAS No 137-40-6 Loss on drying ≤ 4 % determined by drying for two hours at 105oC Produced by chemical synthesis Analytical method(1) For the determination of sodium in the feed additive:
For the quantification of sodium propionate as total propionic acid in feed additive, premixtures, feedingstuffs Ion Chromatography with Conductivity Detection, IC-CD (EN 17294) |
All animal species other than pigs and poultry |
- |
- |
- |
|
3 April 2032 |
Pigs |
- |
30 000 (as propionic acid) |
||||||
Poultry |
- |
10 000 (as propionic acid) |
||||||
Identi-fication number of the additive |
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: technological additives Functional group: preservatives |
||||||||
1a282 |
Calcium propionate |
Additive composition Calcium propionate ≥ 98 % on dry matter basis Solid form Characterisation of the active substance Calcium propionate ≥ 98 % C6H10O4Ca CAS No 4075-81-4 Loss on drying ≤ 6 % determined by drying for two hours at 105oC Produced by chemical synthesis Analytical method(1) For the determination of calcium in the feed additive:
For the quantification of calcium propionate as total propionic acid in feed additive, premixtures, feedingstuffs: Ion Chromatography with Conductivity Detection, IC-CD (EN 17294) |
All animal species other than pigs and poultry |
- |
- |
- |
|
3 April 2032 |
Pigs |
- |
30 000 (as propionic acid) |
||||||
Poultry |
- |
10 000 (as propionic acid) |
||||||
Identi-fication number of the additive |
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: technological additives Functional group: preservatives |
||||||||
1k284 |
Ammonium propionate |
Additive composition Preparation of ammonium propionate ≥ 19 %, propionic acid ≤ 80 %; water ≤ 30 % Liquid form Characterisation of the active substance Ammonium propionate C3H9O2N CAS No 17496-08-1 Produced by chemical synthesis Analytical method(1) For the determination of ammonium in the feed additive: ISO 5664: distillation and titration For the determination of ammonium propionate as total propionic acid in the feed additive, premixtures and feedingstuffs: Ion Chromatography with Conductivity Detection, IC-CD (EN 17294) |
All animal species other than pigs and poultry |
- |
- |
- |
|
3 April 2032 |
Pigs |
- |
30 000 (as propionic acid) |
||||||
Poultry |
- |
10 000 (as propionic acid) |
||||||
Identification number of the additive |
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: technological additives Functional group: preservatives. |
||||||||
1k236 |
Formic acid |
Additive composition Formic acid ≥ 84,5 % Liquid form Characterisation of the active substance Formic acid ≥ 84,5 % H2CO2 CAS No 64-18-6 Produced by chemical synthesis Analytical method(1) For the determination of formic acid in feed additive, premixtures and feedingstuffs: Ion Chromatography with Conductivity Detection, IC-CD (EN 17294) |
All animal species |
- |
- |
10 000 |
|
3 April 2032 |
Identification number of the additive |
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 complete feedingstuff with a moisture content of 12 % |
||||||||
Category: technological additives Functional group: preservatives. |
||||||||
1k237i |
Sodium formate |
Additive composition Sodium formate ≥ 98 % Solid form Sodium formate ≥ 15 % Formic acid ≤ 75 % Water ≤ 25 % Liquid form Characterisation of the active substance Sodium formate HCO2Na CAS No 141-53-7 Produced by chemical synthesis Analytical method(1) For the determination of sodium in the feed additives:
For the determination of sodium formate as total formic acid in the feed additives, premixtures and feedingstuffs: Ion Chromatography with Conductivity Detection, IC-CD (EN 17294) |
All animal species |
- |
- |
10 000 (as formic acid) |
|
3 April 2032 |
Identification number of the additive |
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 complete feedingstuff with a moisture content of 12 % |
||||||||
Category: technological additives Functional group: preservatives. |
||||||||
1a238 |
Calcium formate |
Additive composition Calcium formate ≥ 98 % Solid form Characterisation of the active substance Calcium formate Ca(HCO)2 CAS No 544-17-2 Produced by chemical synthesis Analytical method(1) For the determination of calcium in the feed additive: EN ISO 6869: atomic absorption spectrometry (AAS) or EN 15510: inductively coupled plasma atomic emission spectrometry (ICP-AES) For the determination of calcium formate as total formic acid in the feed additive, premixtures and feedingstuffs: Ion Chromatography with Conductivity Detection, IC-CD (EN 17294) |
All animal species |
- |
- |
10 000 (as formic acid) |
|
3 April 2032 |
Identification number of the additive |
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: technological additives Functional group: preservatives. |
||||||||
1a295 |
Ammonium formate |
Additive composition Ammonium formate ≥ 35 % Formic acid ≤ 64 % Liquid form Characterisation of the active substance Ammonium formate ≥ 35 % HCO2NH4 CAS No 540-69-2 Formamide < 3 000 mg/kg Produced by chemical synthesis Analytical method(1) Determination of ammonium in the feed additive: ISO 5664: distillation and titration For the determination of ammonium formate as total formic acid in the feed additive, premixtures and feedingstuffs: Ion Chromatography with Conductivity Detection, IC-CD (EN 17294) |
All animal species other than laying hens, sows, dairy ruminants, pet and non-food producing animals |
- |
- |
2 000 (as formic acid) |
|
3 April 2032 |
Identi-fication number of the additive |
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 active substance/kg of complete feedingstuff with a moisture content of 12 % |
||||||||
Category: technological additives Functional group: preservatives |
||||||||
1a270 |
Lactic acid |
Additive composition Lactic acid ≥ 72 % (w/w) Liquid form Characterisation of the active substance Lactic acid: D-lactic acid ≤ 5 % L-lactic acid ≥ 95 % C3H6O3 CAS No 79-33-4 Produced by fermentation of: Bacillus coagulans (LMG S-26145 or DSM 23965), or Bacillus smithii (LMG S-27890) or Bacillus subtilis (LMG S-27889). Analytical method(1) For the determination of lactic acid as total lactic acid in the feed additive, premixtures and feedingstuffs: Ion Chromatography with Conductivity Detection, IC-CD (EN 17294) |
All animal species other than pigs and ruminants |
- |
- |
20 000 |
|
3 April 2032 |
Pigs and ruminants other than ruminants with a non functional rumen |
- |
50 000 |
||||||
Identi-fication number of the additive |
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 complete feedingstuff with a moisture content of 12 % |
||||||||
Category: technological additives Functional group: preservatives |
||||||||
1a327 |
Calcium lactate |
Additive composition Calcium lactate ≥ 98 % (as dry matter w/w) Solid form Characterisation of the active substance Calcium lactate ≥ 98 % (C3H5O2) 2 •nH2O CAS No 814-80-2 Produced by chemical synthesis Analytical method(1) For the determination of calcium lactate in the feed additive:
For the determination of calcium lactate as total lactic acid in the feed additive, premixtures and feedingstuffs: Ion Chromatography with Conductivity Detection, IC-CD (EN 17294) |
All animal species other than pigs and ruminants |
- |
- |
20 000 (as lactic acid) |
|
3 April 2032 |
Pigs and ruminants other than ruminants with a non functional rumen |
- |
30 000 (as lactic acid) |
||||||