The Feed Additives (Authorisations) and Uses of Feed Intended for Particular Nutritional Purposes (Amendment of Commission Regulation (EU) 2020/354) (Wales) Regulations 2024
PART 1Introduction
Title, extent, application and coming into force1.
(1)
The title of these Regulations is the Feed Additives (Authorisations) and Uses of Feed Intended for Particular Nutritional Purposes (Amendment of Commission Regulation (EU) 2020/354) (Wales) Regulations 2024.
(2)
These Regulations—
(a)
extend to England and Wales;
(b)
apply in relation to Wales;
(c)
come into force on 20 December 2024.
Interpretation2.
(1)
(2)
PART 2Feed additive authorisations
Authorisations
3.
(1)
Schedules 1 to 20 contain authorisations of feed additives.
(2)
Subject to Article 14(4) (renewal of authorisation) of Regulation (EC) No 1831/2003, the authorisations set out in Schedules 1 to 20 cease to have effect at the end of 19 December 2034.
Modification of authorisations: preparation of Bacillus velezensis (DSM 15544) (identification number 4b1820)
4.
(1)
(2)
Omit Articles 2 to 4.
(3)
In the Annex, in the table—
(a)
in the second column (name of the holder of authorisation), for “Asahi Calpis Wellness Co. Ltd, represented in the European Union by Pen & Tec Consulting S.L.U.” substitute “Asahi Biocycle Co., Ltd”
;
(b)
in the third column (additive) and the fourth column (composition, chemical formula, description, analytical method), for “Bacillus subtilis C-3102”, in each place it occurs, substitute “Bacillus velezensis”;
(c)
in the fifth column (species or category of animal), omit “Laying hens”;
(d)
in the seventh column (minimum content), omit “3 × 108”.
5.
(1)
(2)
In the second column (name of the holder of authorisation), for “Asahi Calpis Wellness Co. Ltd, represented in the European Union by Pen & Tec Consulting S.L.U.” substitute “Asahi Biocycle Co., Ltd”
.
(3)
In the third column (additive), for “Bacillus subtilis” substitute “Bacillus velezensis”
.
(4)
In the fourth column (composition, chemical formula, description, analytical method)—
(a)
in the section headed “Additive composition”, for “Bacillus subtilis C-3102” substitute “Bacillus velezensis”
;
(b)
in the section headed “Characterisation of the active substance, for “Bacillus subtilis” substitute “Bacillus velezensis”.
6.
(1)
(2)
In the second column (name of the holder of authorisation), for “Asahi Calpis Wellness Co. Ltd, represented in the European Union by Pen & Tec Consulting S.L.U.” substitute “Asahi Biocycle Co., Ltd”
.
(3)
In the third column (additive) and the fourth column (composition, chemical formula, description, analytical method), for “Bacillus subtilis C-3102”, in each place it occurs, substitute “Bacillus velezensis”
.
Modification of authorisation: selenised yeast produced by fermentation with Saccharomyces cerevisiae CNCM I-3060, inactivated (identification number 3b810)
7.
(1)
(2)
“Additive composition
Preparation of organic selenium (Se) produced by fermentation with Saccharomyces cerevisiae (CNCM I-3060) containing 2000 to 3500 mg Se/kg with the below components:
Organic selenium: 97% minimum of total selenium
Selenomethionine: 63% minimum of total selenium.”
(3)
“5. The dusting potential of the additive must ensure a maximum selenium exposure of 0.2 mg Se/m3.”
Removal of authorisation of butylated hydroxyanisole as an existing product for the purposes of Article 10 of Regulation (EC) No 1831/2003
8.
Changes of authorisation holder: amendment of Commission Implementing Regulation (EU) No887/2011 and Commission Implementing Regulations (EU) 2017/961 and 2020/1395
9.
(1)
(2)
In the Annex, in the second table (authorisation expiring 28 June 2027), in the second column (name of the holder of authorisation), for “Evonik Nutrition & Care GmbH)” substitute “Evonik Operations GmbH”
.
10.
(1)
(2)
In Annex 1, in the table, in the second column (name of the holder of authorisation), for “Evonik Nutrition & Care GmbH)” substitute “Evonik Operations GmbH”
.
11.
(1)
(2)
In the Annex, in the table, in the second column (name of the holder of authorisation), for “Evonik Nutrition & Care GmbH” substitute “Evonik Operations GmbH”
.
PART 3Transitional provisions
Transitional provision: 6-phytase (EC 3.1.3.26) produced by fermentation with Komagataella phaffii (formerly Komagataella pastoris) (DSM 23036) (identification number 4a16)12.
(1)
The relevant feed additive and premixtures, compound feed or feed materials containing it, which are produced and labelled before the end of 19 June 2025 in compliance with the conditions of authorisation and the labelling requirements applicable immediately before 20 December 2024, may continue to be placed on the market and used until stocks are exhausted.
(2)
Transitional provision: Bacillus velezensis (formerly Bacillus subtilis C-3102) (DSM 15544) (identification number 4b1820)13.
(1)
Any substance or product labelled “Bacillus subtilis C-3102” or as containing “Bacillus subtilis C-3102”, but otherwise produced and labelled in accordance with an authorisation contained in an instrument mentioned in regulations 4 to 6 of these Regulations, may continue to be placed on the market and used under that authorisation.
(2)
The relevant feed additive and premixtures containing it, which are produced and labelled before the end of 19 June 2025 in compliance with the conditions of authorisation and the labelling requirements applicable immediately before 20 December 2024, may continue to be placed on the market and used until stocks are exhausted.
(3)
Compound feed and feed materials containing the relevant feed additive and intended for food-producing animals, which are produced and labelled before the end of 19 December 2025 in compliance with the conditions of authorisation and the labelling requirements applicable immediately before 20 December 2024, may continue to be placed on the market and used until stocks are exhausted.
(4)
Compound feed and feed materials containing the relevant feed additive and intended for non-food-producing animals, which are produced and labelled before the end of 19 December 2026 in compliance with the conditions of the authorisation and the labelling requirements applicable immediately before 20 December 2024, may continue to be placed on the market and used until stocks are exhausted.
(5)
(a)
(b)
(c)
(d)
Transitional provision: Selenised yeast produced by fermentation with Saccharomyces cerevisiae CNCM I-3060, inactivated (identification number 3b810)14.
(1)
The relevant feed additive and premixtures containing it, which are produced and labelled before the end of 19 June 2025 in compliance with the conditions of authorisation and the labelling requirements applicable immediately before 20 December 2024, may continue to be placed on the market and used until stocks are exhausted.
(2)
Compound feed and feed materials containing the relevant feed additive and intended for food-producing animals, which are produced and labelled before the end of 19 December 2025 in compliance with the conditions of authorisation and the labelling requirements applicable immediately before 20 December 2024, may continue to be placed on the market and used until stocks are exhausted.
(3)
Compound feed and feed materials containing the relevant feed additive and intended for non-food-producing animals, which are produced and labelled before the end of 19 December 2026 in compliance with the conditions of the authorisation and the labelling requirements applicable immediately before 20 December 2024, may continue to be placed on the market and used until stocks are exhausted.
(4)
Transitional provision: Butylated hydroxyanisole as a feed additive for cats15.
(1)
Butylated hydroxyanisole as a feed additive for cats and premixtures containing it, which are produced and labelled before the end of 19 June 2025 in compliance with the conditions of authorisation and the labelling requirements applicable immediately before 20 December 2024, may continue to be placed on the market and used until stocks are exhausted.
(2)
Compound feed and feed materials containing butylated hydroxyanisole intended for cats, which are produced and labelled before the end of 19 December 2026 in compliance with the conditions of authorisation and the labelling requirements applicable immediately before 20 December 2024, may continue to be placed on the market and used until stocks are exhausted.
Transitional provisions: Copper, manganese and zinc chelates of hydroxy analogue of methionine (identification numbers 3b410i, 3b510 and 3b610 respectively)16.
(1)
A relevant feed additive and premixtures containing it, which are produced and labelled before the end of 19 June 2025 in compliance with the conditions of authorisation and the labelling requirements applicable immediately before 20 December 2024, may continue to be placed on the market and used until stocks are exhausted.
(2)
Compound feed and feed materials containing a relevant feed additive and intended for food-producing animals, which are produced and labelled before the end of 19 December 2025 in compliance with the conditions of authorisation and the labelling requirements applicable immediately before 20 December 2024, may continue to be placed on the market and used until stocks are exhausted.
(3)
Compound feed and feed materials containing a relevant feed additive and intended for non-food-producing animals, which are produced and labelled before the end of 19 December 2026 in compliance with the conditions of the authorisation and the labelling requirements applicable immediately before 20 December 2024, may continue to be placed on the market and used until stocks are exhausted.
(4)
In this regulation, references to a “relevant feed additive” are references to each of the following feed additives.
(a)Copper chelate of hydroxy analogue of methionine
(b)Manganese chelate of hydroxy analogue of methionine
(c)Zinc chelate of hydroxy analogue of methionine
PART 4Uses of feed intended for particular nutritional purposes
Modification of an essential nutritional characteristic for feed intended to reduce the risk of milk fever and subclinical hypocalcaemia17.
(1)
(2)
In entry 60 (reduction of the risk of milk fever and subclinical hypocalcaemia), in column number 2 (essential nutritional characteristics), in the section of the entry starting “Low cations/anions ratio”, for “Objective: 0 < DCADs (mEq/kg dry matter) < 100” substitute “Objective: Range from -200 mEq/kg dry matter DCAD s to <100 mEq/kg dry matter DCAD”
.
PART 5Revocations
Amendment of Commission Implementing Regulation (EU) 2016/109518.
Amendment of Commission Implementing Regulation (EU) 2018/103919.
Revocations20.
The instruments listed in Schedule 21 are revoked.
SCHEDULE 1Authorisation of a preparation of chromium chelate of DL-methionine (identification number GB4d0001) as a feed additive for dairy cows
The preparation of chromium chelate of DL-methionine specified in the table, belonging to the additive category “zootechnical additives” and to the functional group “other zootechnical”, is authorised as an additive in animal nutrition subject to the conditions set out in the table.
Additive | Chromium chelate of DL-methionine |
Identification number | GB4d0001 |
Authorisation holder | Zinpro Animal Nutrition (Europe), Inc |
Additive category | Zootechnical additives |
Functional group | Other zootechnical |
Additive composition | Solid preparation of chelates of chromium (Cr) with DL-methionine with the below components:
|
Characterisation of the active substance(s) | Chromium chelate of DL-methionine ([CH3S(CH2)2CH(NH2)COO]3 Cr) |
Analytical methods(1) | For the quantification of chromium in the feed additive:
|
For the quantification of methionine in the feed additive:
| |
For proving the chelated structure of the feed additive:
| |
Species or category of animal | Dairy cows |
Maximum age | None |
Minimum content(4) | 0.2 mg/kg |
Maximum content(4) | 0.5 mg/kg |
Other provisions | The storage conditions and stability to heat treatment must be stated in the directions for use of the feed additive and premixture |
SCHEDULE 2Renewal of authorisation of a preparation of Saccharomyces cerevisiae (MUCL 39885) (identification number 4b1710) as a feed additive for weaned piglets, and its authorisation as a feed additive extending existing uses to cover all Suidae other than sows and suckling piglets, cats, and dogs
Additive | Saccharomyces cerevisiae (MUCL 39885) |
Identification number | 4b1710 |
Authorisation holder | Prosol S.p.A |
Additive category | Zootechnical additives |
Functional group | Gut flora stabilisers |
Additive composition | Solid preparation of Saccharomyces cerevisiae (MUCL 39885) containing a minimum of 1 × 10 9 colony forming units (CFU)/g |
Characterisation of the active substance(s) | Viable cells of Saccharomyces cerevisiae (MUCL 39885) |
Analytical methods(1) | For enumeration:
|
For identification of the yeast strain:
| |
Species or category of animal |
|
Maximum age | None |
Minimum content(4) | For Suidae:
|
For cats
| |
For dogs:
| |
Maximum content(4) | None |
Other provisions | The storage conditions must be indicated in the directions for use of the feed additive and premixtures |
SCHEDULE 3Authorisation of a preparation of Pediococcus acidilactici (CNCM I-4622) (identification number 4d1712) as a feed additive for all animal species
The preparation of Pediococcus acidilactici (CNCM I-4622) specified in the table, belonging to the additive category “technological additives” and to the functional groups “acidity regulator” and “hygiene condition enhancer”, is authorised as an additive in animal nutrition subject to the conditions set out in the table.
Additive | Pediococcus acidilactici (CNCM I-4622) |
Identification number | 4d1712 |
Authorisation holder | None |
Additive category | Technological additives |
Functional group |
|
Additive composition | Solid preparation of Pediococcus acidilactici (CNCM I-4622) containing a minimum of 1×10 10 colony forming units (CFU)/g |
Characterisation of the active substance(s) | Viable cells of Pediococcus acidilactici (CNCM I-4622) |
Analytical methods(1) | For enumeration (colony count) of the feed additive:
|
For identification of the bacterial strain:
| |
Species or category of animal | All animal species |
Maximum age | None |
Minimum content(3) | 1 × 109 CFU/kg |
Maximum content(3) | None |
Other provisions | 1. The storage conditions and stability to heat treatment must be stated in the directions for use of the feed additive and premixture. |
2. To be used only in mash compound feed intended for preparation of liquid feed on farm, or solid feed materials intended for preparation of liquid feed on farm. | |
3. If Pediococcus acidilactici (CNCM I-4622) is to be used in feed containing coccidiostats, this feed additive is authorised for use with the following coccidiostats only, and in accordance with their individual authorisation criteria:
|
SCHEDULE 4Renewal of authorisation (with modification) of a preparation of monensin sodium produced by fermentation with Streptomyces cinnamonensis 28682 (NBIMCC 3419) (carrier: perlite, calcium carbonate) (identification number 51701) as a feed additive for chickens for fattening, chickens reared for laying, and turkeys for fattening, and its authorisation as a feed additive extending existing uses to cover turkeys reared for breeding
Additive | Monensin sodium |
Identification number | 51701 |
Authorisation holder | Huvepharma NV |
Additive category | Coccidiostats and histomonostats |
Functional group | None |
Additive composition | Preparation of monensin sodium produced by fermentation with Streptomyces cinnamonensis 28682 (NBIMCC 3419) in powder form with the below components:
|
Characterisation of the active substance(s) | Monensin sodium technical substance produced by fermentation with Streptomyces cinnamonensis 28682 (NBIMCC 3419).
|
Analytical methods(2) | For the quantification of monensin in the feed additive, premixtures and compound feed:
|
For the quantification of monensin sodium in chicken and turkey tissues:
| |
Species or category of animal |
|
Maximum age | For chickens for fattening:
|
For chickens reared for laying:
| |
For turkeys for fattening, turkeys reared for breeding:
| |
Minimum content(4) | For chickens for fattening; chickens reared for laying:
|
For turkeys for fattening; turkeys reared for breeding:
| |
Maximum content(4) | For chickens for fattening; chickens reared for laying:
|
For turkeys for fattening; turkeys reared for breeding:
| |
Maximum residue limits (MRLs) of monensin sodium in food of animal origin | For wet skin in combination with wet fat:
|
For wet liver; wet kidney; wet muscle:
| |
Other provisions | 1. The storage conditions and stability to heat treatment must be stated in the directions for use of the feed additive and premixture. |
2. The feed additive must be incorporated into compound feed in the form of a premixture. | |
3. Monensin sodium must not be mixed with other coccidiostats. | |
4. The following must be stated, in English or in English and Welsh, in the directions for use:
| |
5. A post-market monitoring programme must be carried out by the holder of the authorisation for resistance to bacteria and Eimeria spp. A report containing the outcome of that programme must be submitted to the Welsh Ministers before the end of 19 December 2033. |
SCHEDULE 5Renewal of authorisation (with modification) of a preparation of monensin sodium produced by fermentation with Streptomyces cinnamonensis 28682 (NBIMCC 3419) (carrier: perlite, wheat bran) (identification number 51701) as a feed additive for chickens for fattening, and turkeys for fattening, and its authorisation as a feed additive extending existing uses to cover chickens reared for laying, and turkeys reared for breeding
Additive | Monensin sodium |
Identification number | 51701 |
Authorisation holder | Huvepharma NV |
Additive category | Coccidiostats and histomonostats |
Functional group | None |
Additive composition | Preparation of monensin sodium produced by fermentation with Streptomyces cinnamonensis 28682 (NBIMCC 3419) in powder form with the below components:
|
Characterisation of the active substance(s) | Monensin sodium technical substance produced by fermentation with Streptomyces cinnamonensis 28682 (NBIMCC 3419).
|
Analytical methods(2) | For the quantification of monensin in the feed additive, premixtures and compound feed:
|
For the quantification of monensin sodium in chicken and turkey tissues:
| |
Species or category of animal |
|
Maximum age | For chickens for fattening:
|
For chickens reared for laying:
| |
For turkeys for fattening; turkeys reared for breeding:
| |
Minimum content(4) | For chickens for fattening; chickens reared for laying:
|
For turkeys for fattening; turkeys reared for breeding:
| |
Maximum content(4) | For chickens for fattening; chickens reared for laying:
|
For turkeys for fattening; turkeys reared for breeding:
| |
Maximum residue limits (MRLs) of monensin sodium in food of animal origin | For wet skin in combination with wet fat:
|
For wet liver; wet kidney; wet muscle:
| |
Other provisions | 1. The storage conditions and stability to heat treatment must be stated in the directions for use of the feed additive and premixture. |
2. The feed additive must be incorporated into compound feed in the form of a premixture. | |
3. Monensin sodium must not be mixed with other coccidiostats. | |
4. The following must be stated, in English or in English and Welsh, in the directions for use:
| |
5. A post-market monitoring programme must be carried out by the holder of the authorisation for resistance to bacteria and Eimeria spp. A report containing the outcome of that programme must be submitted to the Welsh Ministers before the end of 19 December 2033. |
SCHEDULE 6Renewal of authorisation (with modification) of a preparation of 6-phytase (EC 3.1.3.26) produced by fermentation with Komagataella phaffii (formerly Komagataella pastoris) (DSM 23036) (identification number 4a16) as a feed additive for chickens for fattening, chickens reared for laying, laying hens, turkeys for fattening, turkeys reared for breeding, other avian species for fattening and laying, sows, pigs for fattening and weaned piglets, and its authorisation as a feed additive extending existing uses to cover all avian species and all Suidae
Additive | 6-phytase (EC 3.1.3.26) |
Identification number | 4a16 |
Authorisation holder | Huvepharma NV |
Additive category | Zootechnical additives |
Functional group | Digestibility enhancers |
Additive composition | Preparation of 6–phytase (EC 3.1.3.26) produced by fermentation with Komagataella phaffii (DSM 23036) having a minimum enzyme activity of:
|
Characterisation of the active substance(s) | 6-phytase (EC 3.1.3.26) produced by fermentation with Komagataella phaffii (DSM 23036) |
Analytical methods(4) | For the quantification of phytase activity in the feed additive, premixtures and compound feed:
|
Species or category of animal |
|
Maximum age | None |
Minimum content(5) | For avian species:
|
For Suidae:
| |
Maximum content(5) | None |
Other provisions | The storage conditions and stability to heat treatment must be stated in the directions for use of the feed additive and premixture. |
SCHEDULE 7Renewal of authorisation (with modification) of a preparation of Bacillus velezensis (formerly Bacillus subtilis) (DSM 15544) (identification number 4b1820) as a feed additive for weaned piglets, chickens reared for laying, turkeys, minor avian species, ornamental birds and game birds; consolidation of existing authorised uses for laying hens and chickens for fattening; and its authorisation as a feed additive extending existing uses to cover all avian species
Additive | Bacillus velezensis (DSM 15544) |
Identification number | 4b1820 |
Authorisation holder | Asahi Biocycle Co., Ltd |
Additive category | Zootechnical additives |
Functional group | Gut flora stabilisers |
Additive composition | Solid preparation of Bacillus velezensis (DSM 15544) containing a minimum of 1 × 10 10 colony forming units (CFU)/g |
Characterisation of the active substance(s) | Viable spores of Bacillus velezensis (DSM 15544) |
Analytical methods(1) | For enumeration (colony count) of the feed additive:
|
For identification of the feed additive
| |
Species or category of animal |
|
Maximum age | None |
Minimum content(3) | 3 × 108 CFU/kg |
Maximum content(3) | None |
Other provisions | The storage conditions and stability to heat treatment must be stated in the directions for use of the feed additive and premixture. |
SCHEDULE 8Authorisation of a preparation of L-histidine monohydrochloride monohydrate produced by fermentation with Escherichia coli K-12 (KCCM 80212) (identification number 3c352i) as a feed additive for all animal species
The preparation of L-histidine monohydrochloride monohydrate produced by fermentation with Escherichia coli K-12 (KCCM 80212) specified in the table, belonging to the additive category “nutritional additives” and to the functional group “amino acids, their salts and analogues”, is authorised as an additive in animal nutrition subject to the conditions set out in the table.
Additive | L-histidine monohydrochloride monohydrate |
Identification number | 3c352i |
Authorisation holder | None |
Additive category | Nutritional additives |
Functional group | Amino acids, their salts and analogues |
Additive composition | L-histidine monohydrochloride monohydrate with a purity criteria not less than 98% as a powder with the following components:
|
Characterisation of the active substance(s) | L-histidine monohydrochloride monohydrate produced by fermentation with Escherichia coli K-12 (KCCM 80212) (C6H12ClN3O3) |
Analytical methods(3) | For the quantification of histidine in the feed additive:
|
For the quantification of histidine in premixtures, feed materials and compound feed:
| |
For the quantification of histamine in the feed additive:
| |
Species or category of animal | All animal species |
Maximum age | None |
Minimum content(5) | None |
Maximum content(5) | None |
Other provisions | 1. The storage conditions and stability to heat treatment must be stated in the directions for use of the feed additive and premixture. |
2. L-histidine monohydrochloride monohydrate may be placed on the market and used as an additive consisting of a preparation. | |
3. The histidine content must be stated on the labelling of the additive and premixture. | |
4. The following must be stated, in English or in English and Welsh, on the labelling of the additive and premixture:
| |
5.The endotoxin content of the additive and its dusting potential must ensure a maximal endotoxin exposure of 1600 IU endotoxins/m3 air
(6). |
SCHEDULE 9Authorisation of a preparation of L-tryptophan produced by fermentation with Escherichia coli (KCCM 80210) (identification number 3c440i) as a feed additive for all animal species
The preparation of L-tryptophan produced by fermentation with Escherichia coli (KCCM 80210) specified in the table, belonging to the additive category “nutritional additives” and to the functional group “amino acids, their salts and analogues”, is authorised as an additive in animal nutrition subject to the conditions set out in the table.
Additive | L-tryptophan |
Identification number | 3c440i |
Authorisation holder | None |
Additive category | Nutritional additives |
Functional group | Amino acids, their salts and analogues |
Additive composition | L-tryptophan with a purity criteria on a dry matter basis not less than 98% as a powder with the following components:
|
Characterisation of the active substance(s) | L-tryptophan produced by fermentation with Escherichia coli (KCCM 80210) (C11H12N2O2) |
Analytical methods(3) | For the identification of L-tryptophan in the feed additive:
|
For the determination of tryptophan in the feed additive and premixtures:
| |
For the determination of tryptophan in feed materials and compound feed:
| |
Species or category of animal | All animal species |
Maximum age | None |
Minimum content(6) | None |
Maximum content(6) | None |
Other provisions | 1. L-tryptophan must be rumen protected when administered to ruminants. |
2. The following must be stated, in English or in English and Welsh, on the labelling of the additive and premixture:
| |
3. The endotoxin content of the additive and its dusting potential must ensure a maximal endotoxin exposure of 1600 IU endotoxins/m3 air
(7). |
SCHEDULE 10Authorisation of a preparation of L-lysine sulphate produced by fermentation with Corynebacterium glutamicum (KCCM 80227) (identification number 3c324i) as a feed additive for all animal species
The preparation of L-lysine sulphate produced by fermentation with Corynebacterium glutamicum (KCCM 80227) specified in the table, belonging to the additive category “nutritional additives” and to the functional group “amino acids, their salts and analogues”, is authorised as an additive in animal nutrition subject to the conditions set out in the table.
Additive | L-lysine sulphate |
Identification number | 3c324i |
Authorisation holder | None |
Additive category | Nutritional additives |
Functional group | Amino acids, their salts and analogues |
Additive composition | Granulated preparation of L-lysine sulphate with a minimum of 52% L-lysine, a maximum of 24% sulphate and a maximum moisture content of 4% |
Characterisation of the active substance(s) | L-lysine sulphate produced by fermentation with Corynebacteriumglutamicum (KCCM 80227) (C12H28N4O4· H2SO4)
|
Analytical methods(2) | For the quantification of lysine in the feed additive and premixtures containing more than 10% lysine:
|
For the identification of sulphate in the feed additive:
| |
For quantification of lysine in premixtures, feed materials and compound feed:
| |
For the quantification of lysine in water:
| |
Species or category of animal | All animal species |
Maximum age | None |
Minimum content(5) | None |
Maximum content(5) | 10,000 mg/kg |
Other provisions | 1. The storage conditions and stability to heat treatment must be stated in the directions for use of the feed additive and premixture. |
2. The L-lysine content must be stated on the labelling of the additive. | |
3. The following must be stated, in English or in English and Welsh, on the labelling of the additive and premixture:
|
SCHEDULE 11Authorisation of the substance butylated hydroxyanisole (identification number 1b320) as a feed additive for cats
Additive | Butylated hydroxyanisole |
Identification number | 1b320 |
Authorisation holder | None |
Additive category | Technological additives |
Functional group | Antioxidants |
Additive composition | Butylated hydroxyanisole with a minimum content of 98.5% in a waxy solid form |
Characterisation of the active substance(s) | Butylated hydroxyanisole containing a mixture of 2-tert-butyl-4-hydroxyanisole and a minimum of 85% 3-tert-butyl-4-hydroxyanisole (C11H16O2)
|
Analytical methods(2) | For the quantification of butylated hydroxyanisole in feed additives:
|
For the quantification of butylated hydroxyanisole in premixtures and compound feed:
| |
Species or category of animal | Cats |
Maximum age | None |
Minimum content(4) | None |
Maximum content(4) | 150 mg/kg |
Other provisions | 1. The storage conditions and stability to heat treatment must be stated in the directions for use of the feed additive and premixture. |
2. Butylated hydroxyanisole is authorised to be used in combination with butylated hydroxytoluene up to a maximum combined content of 150 mg/kg of complete feed. |
SCHEDULE 12Authorisation of a preparation of L-lysine base (liquid) produced by fermentation with Corynebacterium glutamicum (KCCM 80183) (identification number 3c320) as a feed additive for all animal species
The preparation of L-lysine base (liquid) produced by fermentation with Corynebacterium glutamicum (KCCM 80183) specified in the table, belonging to the additive category “nutritional additives” and to the functional group “amino acids, their salts and analogues”, is authorised as an additive in animal nutrition subject to the conditions set out in the table.
Additive | L-lysine base (liquid) |
Identification number | 3c320 |
Authorisation holder | None |
Additive category | Nutritional additives |
Functional group | Amino acids, their salts and analogues |
Additive composition | Aqueous solution with a minimum of 50% L-lysine |
Characterisation of the active substance(s) | L-lysine base (liquid) (NH2(CH2)CH(NH2)COOH) produced by fermentation with Corynebacterium glutamicum (KCCM 80183).
|
Analytical methods(2) | For the quantification of lysine in the feed additive and premixtures containing more than 10% lysine:
|
For quantification of lysine in premixtures, feed materials and compound feed:
| |
For the quantification of lysine in water:
| |
Species or category of animal | All animal species |
Maximum age | None |
Minimum content(4) | None |
Maximum content(4) | None |
Other provisions | 1. The L-lysine content must be stated on the labelling of the additive. |
2. The additive may be used via water for drinking. | |
3. The following must be stated, in English or in English and Welsh, on the labelling of the additive and premixture:
|
SCHEDULE 13Authorisation of the substance L-lysine monohydrochloride (technically pure) produced by fermentation with Corynebacterium glutamicum (KCCM 80183) (identification number 3c322ii) as a feed additive for all animal species
The substance L-lysine monohydrochloride (technically pure) produced by fermentation with Corynebacterium glutamicum (KCCM 80183) specified in the table, belonging to the additive category “nutritional additives” and to the functional group “amino acids, their salts and analogues”, is authorised as an additive in animal nutrition subject to the conditions set out in the table.
Additive | L-lysine monohydrochloride (technically pure) |
Identification number | 3c322ii |
Authorisation holder | None |
Additive category | Nutritional additives |
Functional group | Amino acids, their salts and analogues |
Additive composition | Powder of L-lysine monohydrochloride with a minimum of 78% L-lysine and a maximum moisture content of 1.5% |
Characterisation of the active substance(s) | L-lysine monohydrochloride (technically pure) (NH2(CH2)4CH(NH2)COOH) produced by fermentation with Corynebacterium glutamicum (KCCM 80183)
|
Analytical method(2) | For the identification of L-lysine monohydrochloride in the feed additive:
|
For the quantification of lysine in the feed additive and premixtures containing more than 10% lysine:
| |
For the quantification of lysine in premixtures, feed materials and compound feed:
| |
For the quantification of lysine in water:
| |
Species or category of animal | All animal species |
Maximum age | None |
Minimum content(5) | None |
Maximum content | None |
Other provisions | 1. The L-lysine content must be stated on the labelling of the additive. |
2. The additive may be used via water for drinking. | |
3. The following must be stated, in English or in English and Welsh, on the labelling of the additive and premixture:
|
SCHEDULE 14Authorisation of the substance disodium 5’-guanylate (GMP) produced by fermentation with Corynebacterium stationis (KCCM 10530) and Escherichia coli K-12 (KFCC 11067) (identification number 2b627i) as a feed additive for all animal species
The substance disodium 5’-guanylate (GMP) produced by fermentation with Corynebacterium stationis (KCCM 10530) and Escherichia coli K-12 (KFCC 11067) specified in the table, belonging to the additive category “sensory additives” and to the functional group “flavouring compounds”, is authorised as an additive in animal nutrition subject to the conditions set out in the table.
Additive | Disodium 5’-guanylate |
Identification number | 2b627i |
Authorisation holder | None |
Additive category | Sensory additives |
Functional group | Flavouring compounds |
Additive composition | Powder of disodium 5’-guanylate with a minimum purity criteria of 97%. |
Characterisation of the active substance(s) | Hydrated form of disodium 5’-guanylate (GMP) produced by fermentation with Corynebacterium stationis (KCCM 10530) and Escherichia coli K-12 (KFCC 11067) (C10H12N5Na2O8P) |
Analytical methods(3) | For the identification of disodium 5’-guanylate (GMP) in the feed additive:
|
For the determination of disodium 5’-guanylate (GMP) in the feed additive, flavouring premixtures and water:
| |
Species or category of animal | All animal species |
Maximum age | None |
Minimum content(5) | None |
Maximum content(5) | None |
Other provisions | 1. The storage condition-s and stability to heat treatment must be stated in the directions for use of the feed additive and premixture. |
2. The additive must be incorporated into the feed in the form of a premixture. | |
3. The following must be stated, in English or in English and Welsh, on the labelling of the additive:
| |
4. The functional group, identification number, name and added amount of the active substance must be indicated on the label of the premixture where the use level on the label of the premixture would result in the level of active substance (alone or in combination with other ribonucleotides) in complete feed exceeding 50 mg/kg. |
SCHEDULE 15Authorisation of a preparation of muramidase (EC 3.2.1.17) produced by fermentation with Trichoderma reesei (DSM 32338) (identification number 4d16) as a feed additive for weaned piglets
The preparation of muramidase (EC 3.2.1.17) produced by fermentation with Trichoderma reesei (DSM 32338) specified in the table, 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 set out in the table.
Additive | Muramidase (EC 3.2.1.17) |
Identification number | 4d16 |
Authorisation holder | DSM Nutritional Products Ltd |
Additive category | Zootechnical additives |
Functional group | Other zootechnical additives |
Additive composition | Solid and liquid preparations of muramidase (EC 3.2.1.17) produced by fermentation with Trichoderma reesei (DSM 32338) having a minimum enzyme activity of 60,000 LSU(F)/g(1) |
Characterisation of the active substance(s) | Muramidase (EC 3.2.1.17) produced by fermentation with Trichoderma reesei (DSM 32338) |
Analytical methods(5) | For the quantification of muramidase in the feed additive, premixtures and compound feed:
|
Species or category of animal | Weaned piglets |
Maximum age | None |
Minimum content(6) | 50,000 LSU(F)/kg |
Maximum content(6) | 65,000 LSU(F)/kg |
Other provisions | The storage conditions and stability to heat treatment must be stated in the directions for use of the feed additive and premixture. |
SCHEDULE 16Authorisation of a preparation of phytomenadione (vitamin K1) (identification number 3a712) as a feed additive for horses
The preparation of phytomenadione (vitamin K1) specified in the table, belonging to the additive category “nutritional additives” and to the functional group “vitamins, pro-vitamins and chemically well-defined substances having a similar effect”, is authorised as an additive in animal nutrition subject to the conditions set out in the table.
Additive | Phytomenadione or vitamin K1 |
Identification number | 3a712 |
Authorisation holder | None |
Additive category | Nutritional additives |
Functional group | Vitamins, pro-vitamins and chemically well-defined substances having similar effect |
Additive composition | Produced by chemical synthesis
|
Characterisation of the active substance(s) | 2-methyl-3-[(E-7R,11R)-3,7,11,15-tetramethylhexadec-2- enyl] naphthalene-1,4-dione (phytomenadione) (C31H46O2) with the following components:
|
Analytical methods(3) | For the determination of phytomenadione (vitamin K1) in the feed additive:
|
For the determination of phytomenadione in the additive preparation and in complimentary feed:
| |
Species or category of animal | Horses |
Maximum age | None |
Minimum content(6) | None |
Maximum content(6) | None |
Other provisions | The storage conditions and stability to heat treatment must be stated in the directions for use of the feed additive and premixture. |
SCHEDULE 17Renewal of authorisation (with modification) of a preparation of copper chelate of hydroxy analogue of methionine (identification number 3b410i (formerly 3b4.10)) as a feed additive for all animal species
Additive | Copper chelate of hydroxy analogue of methionine |
Identification number | 3b410i |
Authorisation holder | None |
Additive category | Nutritional additives |
Functional group | Compounds of trace elements |
Additive composition | Copper chelate of hydroxy analogue of methionine in solid form containing a minimum of 16% copper and the following components:
|
Characterisation of the active substance(s) | Copper chelate of hydroxy analogue of methionine (Cu(CH3S(CH2)2-CH(OH)-COO)2)
|
Analytical methods(2) | For the quantification of the hydroxy analogue of methionine content in the feed additive:
|
For the quantification of total copper in the feed additive:
| |
For the quantification of total copper in premixtures: | |
For the quantification of total copper in feed materials and compound feed:
| |
Species or category of animal | All animal species |
Maximum age | None |
Minimum content(7) | None |
Maximum content(7) | For bovines:
|
For ovines:
| |
For caprines:
| |
For piglets:
| |
For crustaceans:
| |
For all other animal species:
| |
Other provisions | 1. The additive must be incorporated into feed in the form of a premixture. |
2. For feed for sheep, where the level of copper in the feed exceeds 10 mg/kg, the following must be stated, in English or in English and Welsh, on the labelling of the feed:
| |
3. For feed for bovines after the start of rumination, where the level of copper in the feed is less than 20 mg/kg, the following must be stated, in English or in English and Welsh, on the labelling of the feed:
|
SCHEDULE 18Renewal of authorisation (with modification) of a preparation of manganese chelate of hydroxy analogue of methionine (identification number 3b510 (formerly 3b5.10)) as a feed additive for all animal species
Additive | Manganese chelate of hydroxy analogue of methionine |
Identification number | 3b510 |
Authorisation holder | None |
Additive category | Nutritional additives |
Functional group | Compounds of trace elements |
Additive composition | Manganese chelate of hydroxy analogue of methionine in solid form containing a minimum of 14% manganese and the following components:
|
Characterisation of the active substance(s) | Manganese chelate of hydroxy analogue of methionine (Mn(CH3S(CH2)2-CH(OH)-COO)2)
|
Analytical methods(2) | For the quantification of the hydroxy analogue of methionine content in the feed additive:
|
For the quantification of total manganese in the feed additive and premixtures | |
For the quantification of total manganese in feed materials and compound feed:
| |
Species or category of animal | All animal species |
Maximum age | None |
Minimum content(6) | None |
Maximum content(6) | For fish:
|
For all other animal species:
| |
Other provisions | 1. The additive must be incorporated into feed in the form of a premixture. |
2. Manganese chelate of hydroxy analogue of methionine may be placed on the market and used as an additive consisting of a preparation. |
SCHEDULE 19Renewal of authorisation (with modification) of a preparation of zinc chelate of hydroxy analogue of methionine (identification number 3b610 (formerly 3b6.10)) as a feed additive for all animal species
Additive | Zinc chelate of hydroxy analogue of methionine |
Identification number | 3b610 |
Authorisation holder | None |
Additive category | Nutritional additives |
Functional group | Compounds of trace elements |
Additive composition | Zinc chelate of hydroxy analogue of methionine in solid form containing a minimum of 17% zinc and the following components.
|
Characterisation of the active substance(s) | Zinc chelate of hydroxy analogue of methionine (Zn(CH3S(CH2)2-CH(OH)-COO)2)
|
Analytical methods(2) | For the quantification of the hydroxy analogue of methionine content in the feed additive:
|
For the quantification of total zinc in the feed additive:
| |
For the quantification of total zinc in premixtures: | |
For the quantification of total zinc in feed materials and compound feed:
| |
Species or category of animal | All animal species |
Maximum age | None |
Minimum content(7) | None |
Maximum content(7) | For cats:
|
For dogs:
| |
For fish:
| |
For milk replacers for calves:
| |
For rabbits:
| |
For Suidae:
| |
For all other animal species:
| |
Other provisions | 1. The additive must be incorporated into feed in the form of a premixture. |
2. Zinc chelate of hydroxy analogue of methionine may be placed on the market and used as an additive consisting of a preparation. |
SCHEDULE 20Authorisation of a preparation of fumonisin esterase (EC 3.1.1.87) produced by fermentation with Komagataella phaffii (DSM 32159) (identification number 1m03i) as a feed additive for all animal species, for use only in maize-based silages
The preparation of fumonisin esterase (EC 3.1.1.87) produced by fermentation with Komagataella phaffii (DSM 32159) specified in the table, belonging to the additive category “technological additives” and to the functional group “substances for reduction of the contamination of feed by mycotoxins”, is authorised as an additive in animal nutrition subject to the conditions set out in the table.
Additive | Fumonisin esterase (EC 3.1.1.87) |
Identification number | 1m03i |
Authorisation holder | None |
Additive category | Technological additives |
Functional group | Substances for reduction of the contamination of feed by mycotoxins |
Additive composition | Preparation of fumonisin esterase (EC 3.1.1.87) produced by fermentation with Komagataella phaffii (DSM 32159) having a minimum enzyme activity of 3000 U/g(1) |
Characterisation of the active substance(s) | Fumonisin esterase (EC 3.1.1.87) produced by Komagataella phaffii (DSM 32159)
|
Analytical methods(3) | For the determination of fumonisin esterase activity:
|
Species or category of animal | All animal species |
Maximum age | None |
Minimum content(4) | 40 U/kg |
Maximum content(4) | None |
Other provisions | 1. The storage conditions and stability to heat treatment must be stated in the directions for use of the feed additive and premixture. |
2. The additive is authorised for use only in maize-based silages. |
SCHEDULE 21Revocations
These Regulations make provision, in relation to Wales, in relation to animal feed additive authorisations, and in relation to a use of feed for a particular nutritional purpose.
Part 2 of these Regulations (regulations 3 to 11, and Schedules 1 to 20) is made in exercise of powers in Regulation (EC) No 1831/2003 of the European Parliament and of the Council on additives for use in animal nutrition (EUR 2003/1831). Part 2 makes provision in relation to the authorisation for the placing on the market, processing and use of certain feed additives.
Regulation 3, and Schedules 1 to 20, provide for the authorisation of feed additives.
Schedule 1 contains a new authorisation for a preparation of chromium chelate of DL-methionine (identification number GB4d0001).
Schedule 2 contains a renewal of an authorisation of a preparation of Saccharomyces cerevisiae (MUCL 39885) (identification number 4b1710), and new authorisation extending authorised uses to cover additional species/categories of animal.
Schedule 3 contains a new authorisation for a preparation of Pediococcus acidilactici (CNCM I-4622) (identification number 4d1712).
Schedules 4 and 5 contain renewals of authorisations (with modification) of preparations of monensin sodium produced by fermentation with Streptomyces cinnamonensis 28682 (NBIMCC 3419) (carriers: perlite and (respectively) calcium carbonate or wheat bran) (identification number 51701), and new authorisation extending authorised uses to cover an additional category of animal. The modifications on renewal are:
A correction to the description of an animal species/category (turkey) covered.
The removal of the requirement for a 1-day (before slaughter) withdrawal period.
Schedule 6 contains a renewal of an authorisation (with modification) of a preparation of 6-phytase (EC 3.1.3.26) produced by fermentation with Komagataella phaffii (DSM 23036) (identification number 4a16), and new authorisation extending authorised uses to cover additional species/categories of animals. See regulation 12 for transitional provision. The modifications on renewal are:
The name of the bacterial strain is updated to Komagataella phaffii (formerly Komagataella pastoris).
A requirement as to use listed under “other provisions” (relating to phosphorus content in feed) is removed.
Schedule 7 contains a renewal of authorisations (with modification) of a preparation of Bacillus velezensis (DSM 15544) (identification number 4b1820), and new authorisation extending and consolidating authorised uses to cover additional species of animal. See regulation 13 for transitional provision. The modifications on renewal are:
The name of the authorisation holder is updated.
The name of the bacterial strain is updated to Bacillus velezensis (formerly Bacillus subtilis).
The minimum content requirement for chickens reared for laying is reduced (from 5 × 108 to 3 × 108 CFU/kg) to align with the minimum content requirement for other avian species/categories.
Schedule 8 contains a new authorisation for a preparation of L-histidine monohydrochloride monohydrate produced by fermentation with Escherichia coli K-12 (KCCM 80212) (identification number 3c352i).
Schedule 9 contains a new authorisation for a preparation of L-tryptophan produced by fermentation with Escherichia coli (KCCM 80210) (identification number 3c440i).
Schedule 10 contains a new authorisation for a preparation of L-lysine sulphate produced by fermentation with Corynebacterium glutamicum (KCCM 80227) (identification number 3c324i).
Schedule 11 contains a new authorisation of the substance butylated hydroxyanisole (BHA) (identification number 1b320) as a feed additive for cats. BHA as a feed additive for cats is separately an ‘existing product’ for the purpose of Article 10 of EUR 2003/1831 – see regulation 8 for removal of the ‘existing product’ status.
Schedule 12 contains a new authorisation of a preparation of L-lysine base (liquid) produced by fermentation with Corynebacterium glutamicum (KCCM 80183) (identification number 3c320).
Schedule 13 contains a new authorisation of the substance L-lysine monohydrochloride (technically pure) produced by fermentation with Corynebacterium glutamicum (KCCM 80183) (identification number 3c322ii).
Schedule 14 contains a new authorisation of the substance disodium 5’-guanylate (GMP) produced by fermentation with Corynebacterium stationis (KCCM 10530) and Escherichia coli K-12 (KFCC 11067) (identification number 2b627i).
Schedule 15 contains a new authorisation of a preparation of muramidase produced by fermentation with Trichoderma reesei (DSM 32338) (identification number 4d16).
Schedule 16 contains a new authorisation of a preparation of phytomenadione (vitamin K1) (identification number 3a712).
Schedule 17 contains a renewal of authorisation (with modification) of a preparation of copper chelate of hydroxy analogue of methionine (identification number 3b410i). See regulation 16 for transitional provision. The modifications on renewal are:
The identification number is changed from 3b4.10 to 3b410i.
There are changes to the composition of the authorised preparation.
A maximum level for nickel (20 ppm) is added.
The analytical methods are updated.
Schedule 18 contains a renewal of authorisation (with modification) of a preparation of manganese chelate of hydroxy analogue of methionine (identification number 3b510). See regulation 16 for transitional provision. The modifications on renewal are:
The identification number is changed from 3b5.10 to 3b510.
There are changes to the specification of the authorised preparation.
A maximum level for nickel (170 ppm) is added.
The analytical methods are updated.
Schedule 19 contains a renewal of authorisation (with modification) of a preparation of zinc chelate of hydroxy analogue of methionine (identification number 3b610). See regulation 16 for transitional provision. The modifications on renewal are:
The identification number is changed from 3b6.10 to 3b610.
There are changes to the specification of the authorised preparation.
A maximum level for nickel (1.7 ppm) is added.
The analytical methods have been updated.
Schedule 20 contains a new authorisation of a preparation of fumonisin esterase (EC 3.1.1.87) (identification number 1m03i).
Regulation 3(2) provides that authorisations granted by these Regulations are valid for a period of ten years in accordance with Article 9(7) of EUR 2003/1831. This is subject to Article 14(4) of that Regulation, which provides for an extension of the authorisation period in certain circumstances where an application for renewal has been submitted.
Regulations 4 to 6 amend certain instruments containing authorisations for the feed additive Bacillus velezensis (DSM 15544). The authorisations are modified to update the name of the authorisation holder, and to update the name of the bacterial strain Bacillus velezensis (formerly Bacillus subtilis C-3102).
Regulation 4 also amends Commission Implementing Regulation (EU) 2016/897 (EUR 2016/897) to remove the authorisation for Bacillus velezensis (DSM 15544) in relation to laying hens. That authorisation is superseded by, and consolidated within, the authorisation contained in Schedule 7.
Regulation 7 amends Commission Implementing Regulation (EU) 2019/804 (EUR 2019/804), which contains an authorisation for the feed additive selenised yeast produced by fermentation with Saccharomyces cerevisiae CNCM I-3060, inactivated, with the identification number 3b810. The authorisation is modified in relation to the permitted selenium content of the additive, and to introduce a requirement in relation to the dusting potential of the additive. See regulation 14 for transitional provision.
Regulation 8 makes provision to remove the authorisation in relation to butylated hydroxyanisole (BHA) as a feed additive for cats as an ‘existing product’ under Article 10 of EUR 2003/1831. To remain on the market as feed additive for cats, the additive must comply with the conditions of the new authorisation contained in Schedule 11 to these Regulations. But regulation 15 makes transitional provision to allow existing products (that cannot comply with the new authorisation) produced and labelled within specified periods to continue be marketed and used until stocks are exhausted.
Regulations 9 to 11 amend a number of instruments to update the name of the authorisation holder.
Part 3 (regulations 12 to 16) contain transitional provisions in relation to feed additive authorisations that are modified or renewed by these Regulations. The transitional provisions allow the continued production and labelling of specified feed additives and products containing them, for limited time periods, under the conditions of authorisation applicable immediately before these Regulations come into force. Products produced and labelled within the transitional periods may be marketed and used until stocks are exhausted.
Part 4 (regulation 17) is made in exercise of powers in the Agriculture Act 1970 (1970 c.40). Regulation 17 amends Commission Regulation (EU) 2020/354 establishing a list of intended uses of feed intended for particular nutritional purposes (EUR 2020/354). An amendment is made to an essential nutritional characteristic for the lawful marketing of feed intended for use for the reduction of the risk of milk fever and subclinical hypocalcaemia.
Part 5 (regulations 18 to 20, and Schedule 21) is made in exercise of powers in EUR 2003/1831 and contains revocations in consequence of provision made by Part 2.
Regulations 18 and 19 make minor consequential amendments.
Regulation 20 and Schedule 21 revoke, in relation to Wales, spent instruments including those containing prior authorisations for the feed additives now renewed by these Regulations (contained in Schedules 2, 4 to 7, and 17 to 19).
Further information, including in relation to any documentation referenced in the Schedules, can be obtained from the Food Standards Agency in Wales, 4th Floor, Welsh Government Building, Cathays Park, Cardiff, CF10 3NQ or by writing to regulated.products.wales@food.gov.uk.
The Welsh Ministers’ Code of Practice on the carrying out of Regulatory Impact Assessments was considered in relation to these Regulations. As a result, it was not considered necessary to carry out a regulatory impact assessment as to the likely costs and benefits of complying with these Regulations.