The Feed Additives (Authorisations) and Uses of Feed Intended for Particular Nutritional Purposes (Amendment of Commission Regulation (EU) 2020/354) (England) Regulations 2024
Part 1Introductory
Citation, commencement, extent and application1.
(1)
These Regulations may be cited as the Feed Additives (Authorisations) and Uses of Feed Intended for Particular Nutritional Purposes (Amendment of Commission Regulation (EU) 2020/354) (England) Regulations 2024 and come into force on 20th December 2024.
(2)
These Regulations extend to England and Wales but apply in relation to England only.
Interpretation2.
(1)
In these Regulations —
(2)
(3)
In Schedules 1 to 20, in the tables, in the row relating to “Species or category of animal”, expressions used that are also used in Annex 4 of Commission Regulation (EC) No 429/2008 on detailed rules for the implementation of Regulation (EC) 1831/2003 of the European Parliament and of the Council as regards the preparation and the presentation of applications and the assessment and the authorisation of feed additives (categories and definitions of target animals etc.) have the same meaning as in that Annex.
Part 2Feed additive authorisations
Authorisation of various feed additives3.
(1)
Schedules 1 to 20 (which contain authorisations for feed additives) have effect.
(2)
Subject to Article 14 (renewal of authorisation) of Regulation (EC) No 1831/2003 of the European Parliament and of the Council on additives for use in animal nutrition, the authorisations set out in Schedules 1 to 20 cease to have effect at the end of 19th December 2034.
Part 3Uses 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 hypocalcaemia4.
In Commission Regulation (EU) 2020/354 establishing a list of intended uses of feed intended for particular nutritional purposes, etc.6, in the Annex, in Part B (list of intended uses), 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 DCADs to < 100 mEq/kg dry matter DCAD”
.
Part 4Amendment of assimilated direct legislation
Modification of authorisation: a preparation of Bacillus velezensis (DSM 15544), (identification number 4b1820)5.
(1)
(a)
omit Articles 2 to 4;
(b)
in the Annex, in the table:
(i)
in the second column (name of the holder of authorisation), for “Asahi Calpis Wellness” to the end substitute “Asahi Biocycle Co., Ltd”
;
(ii)
in the third column (additive) and the fourth column (composition, etc.), for “Bacillus subtilis C-3102”, in each place, substitute “Bacillus velezensis”
;
(iii)
in the fifth column (species or category of animal), omit “Laying hens”;
(iv)
in the seventh column (minimum content), omit “3 x 108”.
(2)
(a)
in the second column (name of the holder of authorisation), for “Asahi Calpis Wellness” to the end substitute “Asahi Biocycle Co., Ltd”
;
(b)
in the third column (additive) for “Bacillus subtilis” substitute “Bacillus velezensis”
;
(c)
in the fourth column (composition, etc.)—
(i)
in the section headed “Additive composition”, for “Bacillus subtilis C-3102” substitute “Bacillus velezensis”
;
(ii)
in the section headed “Characterisation of the active substance”, for “Bacillus subtilis” substitute “Bacillus velezensis”
.
(3)
(a)
in the second column (name of the holder of authorisation), for “Asahi Calpis Wellness” to the end substitute “Asahi Biocycle Co., Ltd”
;
(b)
in the third column (additive) and the fourth column (composition, etc.), for “Bacillus subtilis C-1302”, in each place, substitute “Bacillus velezensis”
.
Modification of authorisation: selenised yeast Saccharomyces cerevisiae (CNCM I-3060), inactivated (identification number 3b810)6.
(a)
in the fourth column (composition, etc.), for the section headed “Additive composition” substitute—
“Preparation of organic selenium (Se) produced by Saccharomyces cerevisiae (CNCM I-3060) containing 2,000 to 3,500 mg Se/kg with the below components:
Organic selenium: 97% minimum of total selenium
Selenomethionine: 63% minimum of total selenium”;
(b)
“5.
The dusting potential of the additive must ensure a maximum selenium exposure of 0.2 mg Se/m3”,
Changes of authorisation holder: amendment of Commission Implementing Regulation (EU) No887/2011 and Commission Implementing Regulations (EU) 2017/961 and 2020/13957.
(1)
In Commission Implementing Regulation (EU) No887/2011 concerning the authorisation of a preparation of Enterococcus faecium CECT 4515 as feed additive for chickens for fattening, etc.11, in the Annex, in the second column of both tables (name of the holder of authorisation), for “Evonik Nutrition & Care GmbH)”, substitute “Evonik Operations GmbH”
.
(2)
In Commission Implementing Regulation (EU) 2017/961 concerning the authorisation of a preparation of Enterococcus faecium CECT 4515 as a feed additive for weaned piglets, and a new use in water for drinking for weaned piglets and chickens for fattening, etc.12, in Annex I, in the table, in the second column (name of the holder of authorisation), for “Evonik Nutrition & Care GmbH” substitute “Evonik Operations GmbH”
.
(3)
In Commission Implementing Regulation (EU) 2020/1395 concerning the renewal of the authorisation of Bacillus amyloliquefaciens CECT 5940 as a feed additive for chickens for fattening, its authorisation for chickens reared for laying, etc.13, 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”
.
Amendment of Commission Implementing Regulation (EU) 2016/10958.
Amendment of Commission Implementing Regulation (EU) 2018/10399.
Part 5Transitional Provisions
Transitional provision: a preparation of Bacillus velezensis (DSM 15544) (identification number 4b1820)10.
(1)
Any substance or product labelled “Bacillus subtilis C-3102 (DSM 15544)” or as containing “Bacillus subtilis C-3102 (DSM 15544)”, but otherwise produced and labelled in accordance with an authorisation contained in an instrument mentioned in regulation 5, may continue to be placed on the market and used under that authorisation.
(2)
Stocks of the relevant feed additive, and premixtures containing it, which are produced and labelled before the end of 19th June 2025 in accordance with the conditions of the prior authorisation and the labelling requirements applicable immediately before 20th December 2024, may continue to be placed on the market and used until they are exhausted.
(3)
Stocks of feed materials and compound feed containing the relevant feed additive, intended for food-producing animals, which are produced and labelled before the end of 19th December 2025 in accordance with the conditions of the prior authorisation and the labelling requirements applicable immediately before 20th December 2024, may continue to be placed on the market and used until they are exhausted.
(4)
Stocks of feed materials and compound feed containing the relevant feed additive, intended for non-food-producing animals, which are produced and labelled before the end of 19th December 2026 in accordance with the conditions of the prior authorisation and the labelling requirements applicable immediately before 20th December 2024, may continue to be placed on the market and used until they are exhausted.
(5)
In this regulation—
“relevant feed additive” means the feed additive of a preparation of Bacillus velezensis (DSM 15544), with the identification number 4b1820 authorised under the prior authorisation;
Transitional provision: selenised yeast Saccharomyces cerevisiae (CNCM I-3060), inactivated (identification number 3b810)11.
(1)
Stocks of the relevant feed additive, and premixtures containing it, which are produced and labelled before the end of 19th June 2025 in accordance with the conditions of the prior authorisation and the labelling requirements applicable immediately before 20th December 2024, may continue to be placed on the market and used until they are exhausted.
(2)
Stocks of feed materials and compound feed containing the relevant feed additive, intended for food-producing animals, which are produced and labelled before the end of 19th December 2025 in accordance with the conditions of the prior authorisation and the labelling requirements applicable immediately before 20th December 2024, may continue to be placed on the market and used until they are exhausted.
(3)
Stocks of feed materials and compound feed containing the relevant feed additive, intended for non-food-producing animals, which are produced and labelled before the end of 19th December 2026 in accordance with the conditions of the prior authorisation and the labelling requirements applicable immediately before 20th December 2024, may continue to be placed on the market and used until they are exhausted.
(4)
In this regulation—
“relevant feed additive” means the feed additive selenised yeast Saccharomyces cerevisiae (CNCM I-3060), inactivated, with the identification number 3b810 authorised under the prior authorisation;
Transitional provision: butylated hydroxyanisole (identification number 1b320)12.
(1)
(2)
Stocks of butylated hydroxyanisole as a feed additive for cats, and premixtures containing it, which are produced and labelled before the end of 19th June 2025 in compliance with the conditions of the authorisation and the labelling requirements applicable before 20th December 2024, may continue to be placed on the market and used until they are exhausted.
(3)
Stocks of feed materials and compound feed containing butylated hydroxyanisole, intended for cats, which are produced and labelled before the end of 19th December 2026 in compliance with the conditions of the authorisation and the labelling requirements applicable immediately before 20th December 2024, may continue to be placed on the market and used until they are exhausted.
Transitional provision: 6-phytase (EC 3.1.3.26) (identification number 4a16)13.
(1)
Stocks of the relevant feed additive, and premixtures containing it, which are produced and labelled before the end of 19th June 2025 in accordance with the conditions of the prior authorisation and the labelling requirements applicable immediately before 20th December 2024, may continue to be placed on the market and used until they are exhausted.
(2)
Stocks of feed materials and compound feed containing the relevant feed additive, intended for food-producing animals, which are produced and labelled before the end of 19th June 2025 in accordance with the conditions of the prior authorisation and the labelling requirements applicable immediately before 20th December 2024, may continue to be placed on the market and used until they are exhausted.
(3)
In this regulation—
“relevant feed additive” means the feed additive 6-phytase (EC 3.1.3.26), with the identification number 4a16 authorised under the prior authorisation;
Transitional provision: copper chelate of hydroxy analogue of methionine (identification number 3b410i)14.
(1)
Stocks of the relevant feed additive, and premixtures containing it, which are produced and labelled before the end of 19th June 2025 in accordance with the conditions of the prior authorisation and the labelling requirements applicable immediately before 20th December 2024, may continue to be placed on the market and used until they are exhausted.
(2)
Stocks of feed materials and compound feed containing the relevant feed additive, intended for food-producing animals, which are produced and labelled before the end of 19th December 2025 in accordance with the conditions of the prior authorisation and the labelling requirements applicable immediately before 20th December 2024, may continue to be placed on the market and used until they are exhausted.
(3)
Stocks of feed materials and compound feed containing the relevant feed additive, intended for non-food-producing animals, which are produced and labelled before the end of 19th December 2026 in accordance with the conditions of the prior authorisation and the labelling requirements applicable immediately before 20th December 2024, may continue to be placed on the market and used until they are exhausted.
(4)
In this regulation—
“relevant feed additive” means copper chelate of hydroxy analogue of methionine, with the identification number 3b410i authorised under the prior authorisation;
Transitional provision: manganese chelate of hydroxy analogue of methionine (identification number 3b510)15.
(1)
Stocks of the relevant feed additive, and premixtures containing it, which are produced and labelled before the end of 19th June 2025 in accordance with the conditions of the prior authorisation and the labelling requirements applicable immediately before 20th December 2024, may continue to be placed on the market and used until they are exhausted.
(2)
Stocks of feed materials and compound feed containing the relevant feed additive, intended for food-producing animals, which are produced and labelled before the end of 19th December 2025 in accordance with the conditions of the prior authorisation and the labelling requirements applicable immediately before 20th December 2024, may continue to be placed on the market and used until they are exhausted.
(3)
Stocks of feed materials and compound feed containing the relevant feed additive, intended for non-food-producing animals, which are produced and labelled before the end of 19th December 2026 in accordance with the conditions of the prior authorisation and the labelling requirements applicable immediately before 20th December 2024, may continue to be placed on the market and used until they are exhausted.
(4)
In this regulation—
“relevant feed additive” means manganese chelate of hydroxy analogue of methionine, with the identification number 3b510 authorised under the prior authorisation;
Transitional provision: zinc chelate of hydroxy analogue of methionine (identification number 3b610)16.
(1)
Stocks of the relevant feed additive, and premixtures containing it, which are produced and labelled before the end of 19th June 2025 in accordance with the conditions of the prior authorisation and the labelling requirements applicable immediately before 20th December 2024, may continue to be placed on the market and used until they are exhausted.
(2)
Stocks of feed materials and compound feed containing the relevant feed additive, intended for food-producing animals, which are produced and labelled before the end of 19th December 2025 in accordance with the conditions of the prior authorisation and the labelling requirements applicable immediately before 20th December 2024, may continue to be placed on the market and used until they are exhausted.
(3)
Stocks of feed materials and compound feed containing the relevant feed additive, intended for non-food-producing animals, which are produced and labelled before the end of 19th December 2026 in accordance with the conditions of the prior authorisation and the labelling requirements applicable immediately before 20th December 2024, may continue to be placed on the market and used until they are exhausted.
(4)
In this regulation—
“relevant feed additive” means zinc chelate of hydroxy analogue of methionine, with the identification number 3b610 authorised under the prior authorisation;
Part 6Revocation of assimilated direct legislation
Revocation of assimilated direct legislation17.
(1)
The instruments in Part 1 of Schedule 21 are revoked subject to Part 5 of these Regulations.
(2)
The instruments in Part 2 of 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, belonging to the additive category ‘zootechnical additives’ and to the functional group ‘other zootechnical’, is authorised as an additive in animal nutrition, in accordance with the specifications in the following 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 | Chromium chelate of DL-methionine ([CH3S(CH2)2CH(NH2)COO]3 Cr) | |
Analytical method27 | 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 | Not applicable | |
Content of chromium in complete feed with a moisture content of 12% | Minimum content | 0.2 mg/kg |
Maximum content | 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 extending to the use for cats, dogs and all Suidae other than sows and suckling piglets
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 x 109 Colony Forming Units (CFU)/g | |
Characterisation of the active substance | Viable cells of Saccharomyces cerevisiae (MUCL 39885) | |
Analytical method31 | For enumeration:
For identification of the yeast strain:
| |
Species or category of animal |
| |
Maximum age | Not applicable | |
Colony Forming Units (CFU) of additive/kg complete feed with a moisture content of 12% | Minimum content |
|
Maximum content | No maximum | |
Other provisions | In the directions for use of the additive and premixtures, the storage conditions must be indicated. | |
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), belonging to the additive category ‘technological’ and to the functional groups of ‘acidity regulator’ and ‘hygiene condition enhancer’, is authorised as an additive in animal nutrition, in accordance with the specifications in the following table.
Additive | Pediococcus acidilactici (CNCM I-4622) | |
Identification number | 4d1712 | |
Authorisation holder34 | None | |
Additive category | Technological | |
Functional groups | Acidity regulator and hygiene condition enhancer | |
Additive composition | Solid preparation of Pediococcus acidilactici (CNCM I-4622) containing a minimum of 1x1010 Colony Forming Units (CFU)/g | |
Characterisation of the active substance(s) | Viable cells of Pediococcus acidilactici (CNCM I-4622) | |
Analytical method 35 | For enumeration (colony count) of the feed additive:
For identification of the bacterial strain:
| |
Species or category of animal | All animal species | |
Maximum age | Not applicable | |
Colony Forming Units (CFU) of additive/kg of complete feed with a moisture content of 12% | Minimum content | 1x109 CFU/kg |
Maximum content | No maximum | |
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: decoquinate, diclazuril, halofuginone, nicarbazin, robenidine hydrochloride | |
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 extending to the use for turkeys reared for breeding
Additive | Monensin sodium | |
Identification number | 51701 | |
Authorisation holder | Huvepharma NV | |
Additive category | Coccidiostats and histomonostats | |
Functional group | No separate functional groups | |
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 method39 | 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 |
| |
Content of monensin (mg/kg of complete feed with a moisture content of 12%) | Minimum content |
|
Maximum content |
| |
Maximum residue limits (MRLs) of monensin sodium in food of animal origin |
| |
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 must be incorporated in compound feed in the form of a premixture. 3.Monensin sodium must not be mixed with other coccidiostats. 4.Declaration to be made in the directions for use: “Dangerous for equines. This feed contains an ionophore. Avoid simultaneous administration with tiamulin and monitor for possible adverse reactions when used concurrently with other medicinal substances”. 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 the post-market monitoring programme must be submitted to the appropriate authority41 by 19th 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, turkeys for fattening and its authorisation extending to the use for 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 | No separate functional groups | |
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 method44 | 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 |
| |
Content of monensin (mg/kg of complete feed with a moisture content of 12%) | Minimum content |
|
Maximum content |
| |
Maximum residue limits (MRLs) of monensin sodium in food of animal origin |
| |
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 must be incorporated in compound feed in the form of a premixture. 3.Monensin sodium must not be mixed with other coccidiostats. 4.Declaration to be made in the directions for use: “Dangerous for equines. This feed contains an ionophore. Avoid simultaneous administration with tiamulin and monitor for possible adverse reactions when use concurrently with other medicinal substances”. 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 the post-market monitoring programme must be submitted to the appropriate authority by 19th 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 extending to the use for 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 4,000 OTU/g in solid form and 8,000 OTU/g in liquid form47 | |
Characterisation of the active substance(s) | 6-phytase (EC 3.1.3.26) produced by fermentation with Komagataella phaffii (DSM 23036) | |
Analytical method50 | For the quantification of phytase activity in the feed additive, premixtures and compound feed:
| |
Species or category of animal |
| |
Maximum age | Not applicable | |
Content of 6-phytase (EC 3.1.3.26) (units of activity (OTU)/kg of complete feed with a moisture content of 12%) | Minimum content |
|
Maximum content | No maximum level | |
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 authorised uses to cover all other 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 1x1010 Colony Forming Units (CFU)/g | |
Characterisation of the active substance(s) | Viable spores of Bacillus velezensis (DSM 15544) | |
Analytical method52 | For enumeration (colony count) of the feed additive:
For identification of the feed additive:
| |
Species or category of animal |
| |
Maximum age | Not applicable | |
Colony Forming Units (CFU)/kg of complete feed with a moisture content of 12% | Minimum content | 3x10 8 CFU/kg |
Maximum content | No maximum level | |
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 80210), 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, in accordance with the specifications in the following table.
Additive | L-histidine monohydrochloride monohydrate | |
Identification number | 3c352i | |
Authorisation holder54 | 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 method57 | 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 | Not applicable | |
Content of L-histidine monohydrochloride monohydrate (mg/kg of complete feed with a moisture content of 12%) | Minimum content | No minimum |
Maximum content | No maximum | |
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 indicated on the label of the additive and premixture and must contain the following declaration on the label of the additive and the premixture: “The supplementation with L-histidine monohydrochloride monohydrate shall be limited to the nutritional requirements of the target animal, which depend on the species, the physiological state of the animal, the performance level, the environmental conditions, the level of other amino acids in the diet and the level of essential trace elements such as copper and zinc”. 4.The endotoxin content of the additive and its dusting potential must ensure a maximal endotoxin exposure of 1600 IU endotoxins/m3 air59. | |
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), 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, in accordance with the specifications in the following table.
Additive | L-tryptophan | |
Identification number | 3c440i | |
Authorisation holder60 | 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 active substance(s) | L-tryptophan produced by fermentation with Escherichia coli (KCCM 80210) (C11H12N2O2) | |
Analytical method63 | For the identification of L-tryptophan in the feed additive: • Food Chemical Codex “L-tryptophan monograph”64 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 | Not applicable | |
Content of L-tryptophan (mg/kg of complete feed with a moisture content of 12%) | Minimum content | No minimum |
Maximum content | No maximum | |
Other provisions | 1.L-tryptophan must be rumen protected when administered to ruminants. 2.Declaration to be made on the label of the additive and premixture: “The supplementation with L-tryptophan shall take into account all essential and conditionally essential amino acids in order to avoid imbalances”. 3.The endotoxin content of the additive and its dusting potential must ensure a maximal endotoxin exposure of 1600 IU endotoxins/m3 air66. | |
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), 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, in accordance with the specifications in the following table.
Additive | L-lysine sulphate | |
Identification number | 3c324i | |
Authorisation holder67 | 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 Corynebacterium glutamicum (KCCM 80227) (C12H28N4O4· H2SO4)
| |
Analytical method69 | 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 | Not applicable | |
Content of L-lysine sulphate (mg/kg of complete feed with a moisture content of 12%) | Minimum content | No minimum |
Maximum content | 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.Declaration to be made on the label of the additive and premixture: “The supplementation with L-lysine should take into account all essential and conditionally essential amino acids in order to avoid imbalances”. | |
Schedule 11Authorisation of the substance butylated hydroxyanisole (identification number 1b320) as a feed additive for cats
Additive | Butylated hydroxyanisole | |
Identification number | 1b320 | |
Authorisation holder73 | None | |
Additive category | Technological | |
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 method75 | 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 | Not applicable | |
Content of butylated hydroxyanisole (mg/kg of complete feed with a moisture content of 12%) | Minimum content | No minimum |
Maximum content | 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), 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, in accordance with the specifications in the following table.
Additive | L-lysine base (liquid) | |
Identification number | 3c320 | |
Authorisation holder77 | 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 method79 | 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 | Not applicable | |
Content of L-lysine (mg/kg of complete feed with a moisture content of 12%) | Minimum content | No minimum |
Maximum content | No maximum | |
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.Declaration to be made on the label of the additive and premixture: “The supplementation with L-lysine, in particular via water for drinking, should take into account all essential and conditionally essential amino acids in order to avoid imbalances”. | |
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), 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, in accordance with the specifications in the following table.
Additive | L-lysine monohydrochloride (technically pure) | |
Identification number | 3c322ii | |
Authorisation holder81 | None | |
Additive category | Nutritional additives | |
Functional group | Amino acids, theirs 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 method83 | 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 | Not applicable | |
Content of L-lysine monohydrochloride (mg/kg of complete feed with a moisture content of 12%) | Minimum content | No minimum |
Maximum content | No maximum | |
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.Declaration to be made on the label of the additive and the premixture: “The supplementation with L-lysine, in particular via water for drinking, should take into account all essential and conditionally essential amino acids in order to avoid imbalances.” | |
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), belonging to the additive category ‘sensory’ and to the functional group ‘flavouring compounds’, is authorised as an additive in animal nutrition, in accordance with the specifications in the following table.
Additive | Disodium 5’ -guanylate | |
Identification number | 2b627i | |
Authorisation holder86 | None | |
Additive category | Sensory | |
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 method89 | 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 | Not applicable | |
Content of disodium 5’ -guanylate (mg/kg of complete feed with a moisture content of 12%) | Minimum content | No minimum |
Maximum content | No maximum | |
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 must be incorporated into the feed in the form of a premixture. 3.On the label of the additive the following must be indicated: ‘Recommended maximum content of the active substance when used alone or in combination with other ribonucleotides up to the same level per kg of complete feedingstuff with a moisture content of 12%: 50mg’. 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 the active substance (alone or in combination with other ribonucleotides) in complete feed exceeding 50mg/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), belonging to the additive category ‘zootechnical’ and to the functional group ‘other zootechnical’, is authorised as an additive in animal nutrition, in accordance with the specifications in the following table.
Additive | Muramidase (EC 3.2.1.17) | |
Identification number | 4d16 | |
Authorisation holder | DSM Nutritional Products Ltd | |
Additive category | Zootechnical | |
Functional group | Other zootechnical | |
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)/g91 | |
Characterisation of the active substance(s) | Muramidase (EC 3.2.1.17) produced by fermentation with Trichoderma reesei (DSM 32338): | |
Analytical method94 | For the quantification of muramidase in the feed additive, premixtures and compound feed:
| |
Species or category of animal | Weaned piglets | |
Maximum age | Not applicable | |
Content of muramidase (units of activity/kg of complete feed with a moisture content of 12%) | Minimum content | 50,000 LSU(F)/kg |
Maximum content | 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 the substance of phytomenadione (Vitamin K1) (identification number 3a712) as a feed additive for horses
The substance phytomenadione (Vitamin K1), belonging to the additive category ‘nutritional additives’ and to the functional group ‘vitamins, pro-vitamins and chemically well-defined substances having similar effect’, is authorised as an additive in animal nutrition, in accordance with the specifications in the following table.
Additive | Vitamin K 1 or phytomenadione | |
Identification number | 3a712 | |
Authorisation holder95 | 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 method98 | 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 | Not applicable | |
Content of phytomenadione (Vitamin K1) (mg/kg of complete feed with a moisture content of 12%) | Minimum content | No minimum |
Maximum content | No maximum | |
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 holder102 | None | |
Additive category | Nutritional additives | |
Function 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 method104 | 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 | Not applicable | |
Content of copper (Cu) (mg/kg of complete feed with a moisture content of 12%) | Minimum content | No minimum |
Maximum content |
| |
Other provisions | 1.The additive must be incorporated into feed in the form of a premixture. 2.The following words must be included in the labelling:
| |
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 holder110 | 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 method112 | 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 | Not applicable | |
Content of manganese (Mn) (mg/kg of complete feed with a moisture content of 12%) | Minimum content | No minimum |
Maximum content |
| |
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 holder117 | 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 method119 | 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 | Not applicable | |
Content of zinc (Zn) (mg/kg of complete feed with a moisture content of 12%) | Minimum content | No minimum |
Maximum content |
| |
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), belonging to the additive category ‘technological’ and to the functional group ‘substances for reduction of the contamination of food by mycotoxins: fumonisins’, is authorised as an additive in animal nutrition, in accordance with the specifications in the following table.
Additive | Fumonisin esterase (EC 3.1.1.87) | |
Identification number | 1m03i | |
Authorisation holder124 | None | |
Additive category | Technological | |
Functional group | Substances for reduction of the contamination of feed by mycotoxins: fumonisins | |
Additive composition |
| |
Characterisation of the active substance(s) | Fumonisin esterase (EC 3.1.1.87) produced by Komagataella phaffii (DSM 32159)
| |
Analytical method126 | For the determination of fumonisin esterase activity:
| |
Species or category of animal | All animal species | |
Maximum age | Not applicable | |
Units of activity/kg of fresh material | Minimum content | 40 U/kg |
Maximum content | No maximum | |
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 use of the additive is only authorised in maize-based silages. | |
Schedule 21Revocation of assimilated direct legislation
Part 1Revocation of assimilated direct legislation in accordance with regulation 17(1)
1.
2.
3.
4.
5.
6.
7.
8.
9.
Part 2Revocation of assimilated direct legislation in accordance with regulation 17(2)
10.
11.
These Regulations make provision, in relation to England, in relation to animal feed additive authorisations, and in relation to a use of feed for a particular nutritional purpose.
Regulation 3 and Schedules 1 - 20 contain the following authorisations—
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).
Schedule 4 and 5 contain a renewal (with modification) of an authorisation 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 animals species/category (turkey) covered;
the removal of the requirement for a 1-day (before slaughter) withdrawal period.
Schedule 6 contains a renewal (with modification) of an authorisation 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 13 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 10 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 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 12 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 the substance 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 14 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 of 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 15 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) as a feed additive for all animal species, for use only in maize-based silages.
Authorisations granted by these Regulations are valid for a period of ten years in accordance with Article 9(7) of Regulation (EC) No 1831/2003 (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.
Part 3 (regulation 4) is made in exercise of powers in the Agriculture Act 1970 (1970 c. 40). Regulation 4 amends Commission Regulation (EU) 2020/354 establishing a list of intended uses of feed intended for particular nutritional purposes, etc. 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 hypocalcemia.
Regulation 5 amends 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 5(1) amends Commission Implementing Regulation (EU) 2016/897 concerning the authorisation of a preparation of Bacillus subtilis (C-3102) (DSM 1544) as a feed additive for laying hens and ornamental fish, etc., 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 6 amends Commission Implementing Regulation (EU) 2019/804 concerning the renewal of the authorisation of organic form of selenium produced by Saccharomyces cerevisiae CNCM I-3060 and of selenomethionine produced by Saccharomyces cerevisiae NCYC R397 as feed additives for all animal species, etc., 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 12 for transitional provision.
Regulation 7 amends a number a instruments to update the name of the authorisation holder.
Regulations 8 and 9 make minor consequential amendments.
Regulation 12 makes provision to remove the authorisation in relation to butylated hydroxyanisole 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. Regulation 12 makes transitional provision to allow existing products (that cannot comply with the new authorisation) produced and labelled within specified periods to continue to be markets and used until stocks are exhausted.
Part 5 (regulations 10 to 16) of these Regulations contains transitional provisions in relation to feed additive authorisations that are modified or renewed by the 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.
Regulation 17 and Schedule 21 revoke, in relation to England, assimilated direct legislation that contain previous authorisations for feed additives now authorised by Schedules 2 to 7, 11, 18 and 19.
Hard copies of the documents in the Schedules are available for inspection at the Food Standards Agency, Food House, Kings Pool, 1-2 Peasholme Green, York YO1 7PR following a written request to that address or to FeedAdditives@food.gov.uk.
An impact assessment has not been produced for this instrument as no, or no significant, impact on the public, private or voluntary sector is foreseen.