Statutory Instruments

2024 No. 1101

AGRICULTURE, ENGLAND

The Feed Additives (Authorisations) and Uses of Feed Intended for Particular Nutritional Purposes (Amendment of Commission Regulation (EU) 2020/354) (England) Regulations 2024

Made

4th November 2024

Laid before Parliament

5th November 2024

Coming into force

20th December 2024

The Secretary of State makes these Regulations in exercise of the powers conferred by Articles 9(1), 10(5) and 18A(3) of Regulation 1 ) and sections 74A(1)(a) and (b) of the Agriculture Act 1970( 2 ).

There has been open and transparent public consultation during the preparation and evaluation of Article 9 of Regulation 3 ).

Part 1 Introductory

Citation, commencement, extent and application

1. —(1) These Regulations may be cited as the Feed Additives (Authorisations) and Uses of Feed Intended for Particular Nutritional Purposes (Amendment of Commission

(2) These Regulations extend to England and Wales but apply in relation to England only.

Interpretation

2. —(1) In these Regulations —

“ Regulation ” means Regulation (EC) No 152/2009 4 ).

(2) Any expression used both in these Regulations and in Regulation (EC) No 1831/2003 (EC) No 767/2009 5 ) has the same meaning as it has in those Regulations.

(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 Regulation (EC) No 429/2008 (EC) 1831/2003

Part 2 Feed additive authorisations

Authorisation of various feed additives

3. —(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

Part 3 Uses 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 hypocalcaemia

4. In Commission 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<DCAD ^s (mEq/kg dry matter) < 100” substitute “Objective: range from -200 mEq/kg dry matter DCAD ^s to < 100 mEq/kg dry matter DCAD” .

Part 4 Amendment of assimilated direct legislation

Modification of authorisation: a preparation of Bacillus velezensis (DSM 15544), (identification number 4b1820)

5. —(1) Commission Implementing Bacillus subtilis (C-3102) (DSM 15544) as a feed additive for laying hens and ornamental fish, etc.( 7 ), is amended as follows—

(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 10 ⁸ ”.

(2) In Commission Implementing Regulation (EU) 2017/2312 Bacillus subtilis C-3102 (DSM 15544) as a feed additive for sows, suckling piglets and dogs, etc.( 8 ), in the Annex, the table is amended as follows—

(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 ” ;

(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) In Commission Implementing Regulation (EU) 2018/1081 Bacillus subtilis C-3102 (DSM 15544) as a feed additive for pigs for fattening, etc.( 9 ), in the Annex, the table is amended as follows—

(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. In Commission Implementing Saccharomyces cerevisiae CNCM I-3060 and of selenomethionine produced by Saccharomyces cerevisiae NCYC R397 as feed additives for all animal species, etc.( 10 ), in the Annex, the entry for “3b810” is amended as follows—

(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) in the ninth column (other provisions), after point 4 insert—

“ 5. The dusting potential of the additive must ensure a maximum selenium exposure of 0.2 mg Se/m ^{3 ” ,}

Changes of authorisation holder: amendment of Commission Implementing Regulation (EU) No887/2011 and Commission Implementing Regulations (EU) 2017/961 and 2020/1395

7. —(1) In Commission Implementing Regulation (EU) No887/2011 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 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 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) 2016/1095

8. In Commission Implementing Regulation (EU) 2016/1095 14 ), omit Article 4.

Amendment of Commission Implementing Regulation (EU) 2018/1039

9. In Commission Implementing Regulation (EU) 2018/1039 15 ), omit Article 5.

Part 5 Transitional 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;

“ prior authorisation ” means the authorisations contained in Commission Implementing Bacillus subtilis (C-3102) (DSM 1544) as a feed additive for laying hens and ornamental fish, etc., Commission Implementing Regulation (EU) 2017/2312 Bacillus subtilis C-3102 (DSM 15544) as a feed additive for sows, suckling piglets and dogs, etc., and Commission Implementing Regulation (EU) 2018/1081 Bacillus subtilis C-3102 (DSM 15544) as a feed additive for pigs for fattening, etc.( 16 ), as the Regulations had effect immediately before 20th December 2024.

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;

“ prior authorisation ” means the authorisation contained in Commission Implementing Saccharomyces cerevisiae CNCM I-3060 and of selenomethionine produced by Saccharomyces cerevisiae NCYC R397 as feed additives for all animal species( 17 ).

Transitional provision: butylated hydroxyanisole (identification number 1b320)

12. —(1) Butylated hydroxyanisole (E 320) is authorised to be placed on the market, processed or used as a feed additive for cats only to the extent that it is covered by and meets the conditions of the authorisation contained in Schedule 11 to these Regulations( 18 ), and in consequence of that authorisation butylated hydroxyanisole (E 320) shall no longer be treated as an existing product under, and for the purposes of, Article 10 of Regulation

(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;

“ prior authorisation ” means the authorisation contained in Commission Implementing Regulation (EU) No98/2012 19 ), as it had effect immediately before 20th December 2024, concerning the authorisation of 6-phytase (EC 3.1.3.26) produced by Pichia pastoris (DSM 23036) as a feed additive for chickens and turkeys for fattening, chickens reared for laying, turkeys reared for breeding, laying hens, other avian species for fattening and laying, weaned piglets, pigs for fattening and sows (holder of authorisation Huvepharma AD)( 20 ).

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.

(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;

“ prior authorisation ” means the authorisation contained in Regulation (EU) No 349/2010 21 ), as it had effect immediately before 20th December 2024, concerning the authorisation of copper chelate of hydroxy analogue of methionine as a feed additive for all animal species( 22 ).

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.

(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;

“ prior authorisation ” means the authorisation contained in Regulation (EU) No 350/2010 23 ), as it had effect immediately before 20th December 2024, concerning the authorisation of manganese chelate of hydroxy analogue of methionine as a feed additive for all animal species( 24 ).

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.

(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;

“ prior authorisation ” means the authorisation contained in Regulation (EU) No 335/2010 25 ), as it had effect immediately before 20th December 2024, concerning the authorisation of zinc chelate of hydroxy analogue of methionine as a feed additive for all animal species( 26 ).

Part 6 Revocation of assimilated direct legislation

Revocation of assimilated direct legislation

17. —(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.

Andrew Gwynne

Parliamentary Under-Secretary of State,

Department of Health and Social Care

4th November 2024

Regulation 3

Schedule 1 Authorisation 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: Calcium carbonate: 95.6% Chromium-DL-Methionine: 3.4% Vegetable oil:1.0%
Characterisation of the active substance		Chromium chelate of DL-methionine ([CH ₃ S(CH ₂ ) ₂ CH(NH ₂ )COO] ₃ Cr)
Analytical method ( 27 )		For the quantification of chromium in the feed additive: inductively coupled plasma mass spectrometry (ICP-MS) in accordance with European standard BS EN 17053:2018( 28 ) For the quantification of methionine in the feed additive: ion-exchange chromatography coupled to post-column derivatisation and photometric detection (IEC-VIS) in accordance with BS EN ISO 13903:2005( 29 ) For proving the chelated structure of the feed additive: mid-infrared (IR) spectrometry together with the determination of the content of chromium and methionine in 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.

Regulation 3

Schedule 2 Renewal 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

The preparation of Saccharomyces cerevisiae (MUCL 39885), belonging to the additive category ‘zootechnical additives’ and to the functional group ‘gut flora stabilisers’, is authorised as an additive in animal nutrition, in accordance with the specifications in the following table( 30 ).

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 10 ⁹ Colony Forming Units (CFU)/g
Characterisation of the active substance		Viable cells of Saccharomyces cerevisiae (MUCL 39885)
Analytical method ( 31 )		For enumeration: Pour plate method CGYE (chloramphenicol, glucose, yeast extract) agar in accordance with BS EN 15789:2021( 32 ) For identification of the yeast strain: Polymerase chain reaction (PCR) method in accordance with DD CEN/TS15790:2008( 33 )
Species or category of animal		All Suidae other than suckling piglets or sows Cats Dogs
Maximum age		Not applicable
Colony Forming Units (CFU) of additive/kg complete feed with a moisture content of 12%	Minimum content	For all Suidae (other than suckling piglets, sows and Suidae for reproduction) 3 x 10 ⁹ CFU/kg For all Suidae for reproduction purposes other than sows: 6.4 x 10 ⁹ CFU/kg For cats and dogs: 7 x 10 ¹⁰ CFU/kg
	Maximum content	No maximum
Other provisions		In the directions for use of the additive and premixtures, the storage conditions must be indicated.

Regulation 3

Schedule 3 Authorisation 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 holder ( 34 )		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 1x10 ¹⁰ 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: Spread plate method using MRS agar in accordance with BS EN 15786:2021( 36 ) For identification of the bacterial strain: Pulsed-Field Gel Electrophoresis (PFGE)
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	1x10 ⁹ 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

Regulation 3

Schedule 4 Renewal 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

The preparation of monensin sodium produced by fermentation with Streptomyces cinnamonensis 28682 (NBIMCC 3419) (carrier: perlite, calcium carbonate), belonging to the additive category ‘coccidiostats and histomonostats’, is authorised as an additive in animal nutrition, in accordance with the specifications in the following table( 37 ).

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: Monensin sodium technical substance: 250 g/kg containing: Monensin A: 90% minimum Monensin A + B: 95% minimum Monensin C: 0.2% – 0.3% Perlite: 150 – 200 g/kg Calcium carbonate: 550 – 600 g/kg
Characterisation of the active substance(s)		Monensin sodium technical substance produced by fermentation with Streptomyces cinnamonensis 28682 (NBIMCC 3419) Monensin sodium A (C ₃₆ H ₆₁ NaO ₁₁ ) Monensin sodium B (C ₃₅ H ₅₉ NaO ₁₁ ) Monensin sodium C (C ₃₇ H ₆₃ NaO ₁₁ ) CAS no: 22373-78-0( 38 )
Analytical method ( 39 )		For the quantification of monensin in the feed additive, premixtures and compound feed: Reversed phase high performance liquid chromatography using post-column derivatisation coupled to spectrophotometric detection (RP-HPLC-PCD-UV-Vis) in accordance with BS EN ISO 14183:2008( 40 ) For the quantification of monensin sodium in chicken and turkey tissues: Reversed phase high performance liquid chromatography coupled to a triple quadrupole mass spectrometer (RP-HPLC-MS/MS) or any equivalent methods
Species or category of animal		Chickens for fattening Chickens reared for laying Turkeys for fattening Turkeys reared for breeding
Maximum age		Chickens for fattening: none Chickens reared for laying, turkeys for fattening and turkeys reared for breeding: 16 weeks
Content of monensin (mg/kg of complete feed with a moisture content of 12%)	Minimum content	Chickens for fattening and chickens reared for laying: 100 mg/kg Turkeys for fattening and turkeys reared for breeding: 60 mg/kg
	Maximum content	Chickens for fattening and chickens reared for laying: 125 mg/kg Turkeys for fattening and turkeys reared for breeding: 100 mg/kg
Maximum residue limits (MRLs) of monensin sodium in food of animal origin		Wet skin and fat: 25 µg/kg Wet liver, wet kidney, and wet muscle: 8 µg/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 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 authority( 41 ) by 19th December 2033.

Regulation 3

Schedule 5 Renewal 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

The preparation of monensin sodium produced by fermentation with Streptomyces cinnamonensis 28682 (NBIMCC 3419) (carrier: perlite, wheat bran), belonging to the additive category ‘coccidiostats and histomonostats’, is authorised as an additive in animal nutrition, in accordance with the specifications in the following table( 42 ).

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: Monensin sodium technical substance: 250 g/kg containing: Monensin A: 90% minimum Monensin A + B: 95% minimum Monensin C: 0.2% – 0.3% Perlite: 150 – 200 g/kg Wheat bran: 550 – 600 g/kg
Characterisation of the active substance(s)		Monensin sodium technical substance produced by fermentation with Streptomyces cinnamonensis 28682 (NBIMCC 3419) Monensin sodium A (C ₃₆ H ₆₁ NaO ₁₁ ) Monensin sodium B (C ₃₅ H ₅₉ NaO ₁₁ ) Monensin sodium C (C ₃₇ H ₆₃ NaO ₁₁ ) CAS no: 22373-78-0( 43 )
Analytical method ( 44 )		For the quantification of monensin in the feed additive, premixtures and compound feed: Reversed phase high performance liquid chromatography using post-column derivatisation coupled to spectrophotometric detection (RP-HPLC-PCD-UV-Vis) in accordance with BS EN ISO 14183:2008( 45 ) For the quantification of monensin sodium in chicken and turkey tissues: Reversed phase high performance liquid chromatography coupled to a triple quadrupole mass spectrometer (RP-HPLC-MS/MS) or any equivalent methods
Species or category of animal		Chickens for fattening Chickens reared for laying Turkeys for fattening Turkeys reared for breeding
Maximum age		Chickens for fattening: None Chickens reared for laying, turkeys for fattening and turkeys reared for breeding: 16 weeks
Content of monensin (mg/kg of complete feed with a moisture content of 12%)	Minimum content	Chickens for fattening and chickens reared for laying: 100 mg/kg Turkeys for fattening and turkeys reared for breeding: 60 mg/kg
	Maximum content	Chickens for fattening and chickens reared for laying: 125 mg/kg Turkeys for fattening and turkeys reared for breeding: 100 mg/kg
Maximum residue limits (MRLs) of monensin sodium in food of animal origin		Wet skin and fat: 25 µg/kg Wet liver, wet kidney, and wet muscle: 8 µg/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 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.

Regulation 3

Schedule 6 Renewal 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

The preparation of 6-phytase (EC 3.1.3.26) produced by fermentation with Komagataella phaffii (formerly Komagataella pastoris ) (DSM 23036), belonging to the additive category ‘zootechnical’ and to the functional group ‘digestibility enhancers’, is authorised as an additive in animal nutrition, in accordance with the specifications in the following table( 46 ).

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 form( 47 )
Characterisation of the active substance(s)		6-phytase (EC 3.1.3.26) produced by fermentation with Komagataella phaffii (DSM 23036) CAS no: 9001-89-2( 48 ) EC (IUBMB) no: 3.1.3.26( 49 )
Analytical method ( 50 )		For the quantification of phytase activity in the feed additive, premixtures and compound feed: Colorimetric method based on the quantification of the inorganic phosphate released by the enzyme from the sodium phytate
Species or category of animal		All avian species All Suidae
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	All avian species other than turkeys and all Suidae other than piglets: 125 OTU/kg Turkeys and piglets: 250 OTU/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.

Regulation 3

Schedule 7 Renewal 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

The preparation of Bacillus velezensis (formerly Bacillus subtilis ) (DSM 15544), belonging to the additive category ‘zootechnical’ and to the functional group ‘gut flora stabilisers’, is authorised as an additive in animal nutrition, in accordance with the specifications in the following table( 51 ).

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 1x10 ¹⁰ Colony Forming Units (CFU)/g
Characterisation of the active substance(s)		Viable spores of Bacillus velezensis (DSM 15544)
Analytical method ( 52 )		For enumeration (colony count) of the feed additive: Spread plate method using tryptone soya agar in all target matrices in accordance with BS EN 15784:2021( 53 ) For identification of the feed additive: Pulsed-field gel electrophoresis (PFGE)
Species or category of animal		Weaned piglets All avian species
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.

Regulation 3

Schedule 8 Authorisation 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 holder ( 54 )		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: Moisture: 1% maximum Histidine: 72% minimum Histamine: 100ppm maximum
Characterisation of the active substance(s)		L-histidine monohydrochloride monohydrate produced by fermentation with Escherichia coli K-12 (KCCM 80212) (C ₆ H ₁₂ ClN ₃ O ₃ ) CAS no: 5934-29-2( 55 ) EINECS no: 611-821-4( 56 )
Analytical method ( 57 )		For the quantification of histidine in the feed additive: High performance liquid chromatography coupled with photometric detection (HPLC-UV) in accordance with BS EN ISO 13903:2005( 58 ); or Ion-exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS/FLD) For the quantification of histidine in premixtures, feed materials and compound feed: Ion-exchange chromatography coupled to post-column derivatisation and photometric detection (IEC-VIS), Commission Regulation For the quantification of histamine in the feed additive: High performance liquid chromatography coupled with photometric detection (HPLC-UV) in accordance with BS EN ISO 13903:2005
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/m ³ air( 59 ).

Regulation 3

Schedule 9 Authorisation 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 holder ( 60 )		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: Moisture content: 1% maximum 1,1’-ethylidene-bis-L-tryptophan: 10 mg/kg maximum
Characterisation of active substance(s)		L-tryptophan produced by fermentation with Escherichia coli (KCCM 80210) (C ₁₁ H ₁₂ N ₂ O ₂ ) CAS no: 73-22-3( 61 ) EINECS no: 200-795-6( 62 )
Analytical method ( 63 )		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: High performance liquid chromatography with fluorescence detection (HPLC-FLD) in accordance with BS EN ISO 13904:2016( 65 ) For the determination of tryptophan in feed materials and compound feed: High performance liquid chromatography with fluorescence detection (HPLC-FLD) in accordance with Commission Regulation
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/m ³ air( 66 ).

Regulation 3

Schedule 10 Authorisation 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 holder ( 67 )		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) (C ₁₂ H ₂₈ N ₄ O ₄ · H ₂ SO ₄ ) CAS no: 60343-69-3( 68 )
Analytical method ( 69 )		For the quantification of lysine in the feed additive and premixtures containing more than 10% lysine: •on exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS/FLD) in accordance with BS EN ISO 17180:2013( 70 ) For the identification of sulphate in the feed additive: European Pharmacopoeia Monograph 20301( 71 ) For quantification of lysine in premixtures, feed materials and compound feed: •on-exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS) in accordance with Commission Regulation For the quantification of lysine in water: Ion exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS/FLD) in accordance with BS EN ISO 17180:2013
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”.

Regulation 3

Schedule 11 Authorisation of the substance butylated hydroxyanisole (identification number 1b320) as a feed additive for cats

The substance butylated hydroxyanisole, belonging to the additive category ‘technological feed additive’ and to the functional group ‘antioxidants’, is authorised as an additive in animal nutrition, in accordance with the specifications in the following table( 72 ).

Additive		Butylated hydroxyanisole
Identification number		1b320
Authorisation holder ( 73 )		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 (C ₁₁ H ₁₆ O ₂ ) CAS no: 25013-16-5( 74 )
Analytical method ( 75 )		For the quantification of butylated hydroxyanisole in feed additives: Gas chromatography coupled to flame ionization detection (GC-FID) (Food Chemical Codex 7th edition method)( 76 ) For the quantification of butylated hydroxyanisole in premixtures and compound feed: Reversed phase high performance liquid chromatography coupled to ultraviolet-diode-array detection (RP-HPLC-UV-DAD, 285 nm)
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.

Regulation 3

Schedule 12 Authorisation 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 holder ( 77 )		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) (NH ₂ (CH ₂ )CH(NH ₂ )COOH) produced by fermentation with Corynebacterium glutamicum (KCCM 80183) CAS no: 56-87-1( 78 )
Analytical method ( 79 )		For the quantification of lysine in the feed additive and premixtures containing more than 10% lysine: Ion-exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS/FLD) in accordance with BS EN ISO 17180:2013( 80 ) For quantification of lysine in premixtures, feed materials and compound feed: Ion-exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS) in accordance with Commission Regulation For the quantification of lysine in water: Ion exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS/FLD) in accordance with BS EN ISO 17180:2013; or Ion exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS) in accordance with Commission Regulation
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”.

Regulation 3

Schedule 13 Authorisation 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 holder ( 81 )		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) (NH ₂ (CH ₂ ) ₄ CH(NH ₂ )COOH) produced by fermentation with Corynebacterium glutamicum (KCCM 80183) CAS no: 657-27-2( 82 )
Analytical method ( 83 )		For the identification of L-lysine monohydrochloride in the feed additive: Food Chemicals Codex “L-lysine monohydrochloride monograph”( 84 ) For the quantification of lysine in the feed additive and premixtures containing more than 10% lysine: Ion-exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS/FLD) in accordance with BS EN ISO 17180:2013( 85 ) For the quantification of lysine in premixtures, feed materials and compound feed: Ion-exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS) in accordance with Commission Regulation For the quantification of lysine in water: Ion exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS/FLD) in accordance with BS EN ISO 17180:2013; or Ion exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS) in accordance with Commission Regulation
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.”

Regulation 3

Schedule 14 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) 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 holder ( 86 )		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) (C ₁₀ H ₁₂ N ₅ Na ₂ O ₈ P) CAS no: 5550-12-9( 87 ) EINECS no: 226-914-1( 88 )
Analytical method ( 89 )		For the identification of disodium 5’ -guanylate (GMP) in the feed additive: FAO JECFA monograph “disodium 5’-guanylate”( 90 ) For the determination of disodium 5’ -guanylate (GMP) in the feed additive, flavouring premixtures and water: High performance liquid chromatography coupled to UV detection (HPLC-UV)
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.

Regulation 3

Schedule 15 Authorisation 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)/g( 91 )
Characterisation of the active substance(s)		Muramidase (EC 3.2.1.17) produced by fermentation with Trichoderma reesei (DSM 32338): CAS no: 9001-63-2( 92 ) EINECS no: 232-620-4( 93 ) EC (IUBMB) no: 3.2.1.17
Analytical method ( 94 )		For the quantification of muramidase in the feed additive, premixtures and compound feed: Fluorescence-based enzyme assay method that determines the enzyme-catalysed depolymerisation of a fluorescein-labelled peptidoglycan preparation at pH 6.0 and 30°C
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.

Regulation 3

Schedule 16 Authorisation of the substance of phytomenadione (Vitamin K ₁ ) (identification number 3a712) as a feed additive for horses

The substance phytomenadione (Vitamin K ₁ ), 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 holder ( 95 )		None
Additive category		Nutritional additives
Functional group		Vitamins, pro-vitamins and chemically well-defined substances having similar effect
Additive composition		Produced by chemical synthesis Solid preparation containing a minimum of 4.2% of phytomenadione (Vitamin K ₁ )
Characterisation of the active substance(s)		2-methyl-3-[(E-7R,11R)-3,7,11,15-tetramethylhexadec-2-enyl] naphthalene-1, 4-dione (phytomenadione) (C ₃₁ H ₄₆ O ₂ ) CAS no: 84-80-0( 96 ) EINECS no: 201-564-2( 97 ) with the following components: E-phytomenadione: 75% minimum E-epoxyphytomenadione: 4% maximum Total purity of E-phytomenadione, E-epoxyphytomenadione and Z-phytomenadione isomers: 97% minimum
Analytical method ( 98 )		For the determination of phytomenadione (Vitamin K ₁ ) in the feed additive: High performance liquid chromatography (HPLC) in accordance with the European Pharmacopoeia( 99 ) For the determination of phytomenadione in the additive preparation and in complimentary feed: High performance liquid chromatography with fluorescence detection (HPLC-FLD) in accordance with BS EN 14148:2003( 100 )
Species or category of animal		Horses
Maximum age		Not applicable
Content of phytomenadione (Vitamin K ₁ ) (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.

Regulation 3

Schedule 17 Renewal 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

The preparation of copper chelate of hydroxy analogue of methionine, belonging to the additive category ‘nutritional additives’ and to the functional group ‘compounds of trace elements’, is authorised as an additive in animal nutrition, in accordance with the specifications in the following table( 101 ).

Additive		Copper chelate of hydroxy analogue of methionine
Identification number		3b410i
Authorisation holder ( 102 )		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: (2-hydroxy-4-methylthio) butanoic acid: 78% minimum Nickel: 20 ppm maximum
Characterisation of the active substance(s)		Copper chelate of hydroxy analogue of methionine (Cu(CH ₃ S(CH ₂ ) ₂ -CH(OH)-COO) ₂ ) CAS no: 292140-30-8( 103 )
Analytical method ( 104 )		For the quantification of the hydroxy analogue of methionine content in the feed additive: Titrimetry, potentiometric titration after oxidation reduction reaction For the quantification of total copper in the feed additive: Inductively coupled plasma atomic emission spectrometry, ICP-AES (BS EN 15510:2017( 105 ) or BS EN 15621:2017( 106 )); or Atomic absorption spectrometry, AAS (BS EN ISO 6869:2001( 107 )) For the quantification of total copper in premixtures: Inductively coupled plasma atomic emission spectrometry, ICP-AES (BS EN 15510:2017 or BS EN 15621:2017); or Atomic absorption spectrometry, AAS (BS EN ISO 6869:2001); or Inductively coupled plasma mass spectrometry, ICP-MS (BS EN 17053:2018( 108 )) For the quantification of total copper in feed materials and compound feed: Inductively coupled plasma atomic emission spectrometry, ICP-AES (BS EN 15510:2017 or BS EN 15621:2017); or Atomic absorption spectrometry, AAS (in accordance with Commission Regulation Inductively coupled plasma mass spectrometry, ICP-MS (BS EN 17053:2018)
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	Bovines before the start of rumination and ovines: 15 mg/kg (total) Other bovines: 30 mg/kg (total) Caprines: 35 mg/kg (total) Piglets Suckling and weaned up to 4 weeks after weaning: 150 mg/kg (total) From 5th week up to 8 weeks after weaning: 100 mg/kg (total) Crustaceans: 50 mg/kg (total) Other animal species: 25 mg/kg (total)
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: for feed for sheep if the level of copper in the feed exceeds 10 mg/kg: ‘The level of copper in this feed may cause poisoning in certain breeds of sheep.’ for feed in bovines after the start of rumination if the level of copper in the feed is less than 20 mg/kg: ‘The level of copper in this feed may cause copper deficiencies in cattle grazing pastures with high contents of molybdenum or sulphur.’

Regulation 3

Schedule 18 Renewal 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

The preparation of manganese chelate of hydroxy analogue of methionine, belonging to the additive category ‘nutritional additives’ and to the functional group ‘compounds of trace elements’, is authorised as an additive in animal nutrition, in accordance with the specifications in the following table( 109 ).

Additive		Manganese chelate of hydroxy analogue of methionine
Identification number		3b510
Authorisation holder ( 110 )		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: (2-hydroxy-4-methylthio) butanoic acid: 76% minimum Nickel: 170 ppm maximum
Characterisation of the active substance(s)		Manganese chelate of hydroxy analogue of methionine (Mn(CH ₃ S(CH ₂ ) ₂ -CH(OH)-COO) ₂ ) CAS no: 292140-29-5( 111 )
Analytical method ( 112 )		For the quantification of the hydroxy analogue of methionine content in the feed additive: Titrimetry, potentiometric titration after oxidation reduction reaction For the quantification of total manganese in the feed additive and premixtures: Atomic absorption spectrometry, AAS (BS EN ISO 6869:2001( 113 )); or Inductively coupled plasma atomic emission spectrometry, ICP-AES (BS EN 15510:2017( 114 )); or Inductively coupled plasma atomic emission spectrometry after pressure digestion, ICO-AES (BS EN 15621:2017( 115 )) For the quantification of total manganese in feed materials and compound feed: Atomic absorption spectrometry, AAS (in accordance with Commission Regulation Inductively coupled plasma atomic emission spectrometry, ICP-AES (BS EN 15510:2017); or Inductively coupled plasma atomic emission spectrometry after pressure digestion, ICP-AES (BS EN 15621:2017)
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	Fish: 100 mg/kg (total) Other animal species: 150 mg/kg (total)
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.

Regulation 3

Schedule 19 Renewal 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

The preparation of zinc chelate of hydroxy analogue of methionine, belonging to the additive category ‘nutritional additives’ and to the functional group ‘compounds of trace elements’, is authorised as an additive in animal nutrition, in accordance with the specifications in the following table( 116 ).

Additive		Zinc chelate of hydroxy analogue of methionine
Identification number		3b610
Authorisation holder ( 117 )		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: (2-hydroxy-4-methylthio) butanoic acid: 79% minimum Nickel: 1.7 ppm maximum
Characterisation of the active substance(s)		Zinc chelate of hydroxy analogue of methionine (Zn(CH ₃ S(CH ₂ ) ₂ -CH(OH)-COO) ₂ ) CAS no: 292140-29-5( 118 )
Analytical method( 119 )		For the quantification of the hydroxy analogue of methionine content in the feed additive: Titrimetry, potentiometric titration after oxidation reduction reaction For the quantification of total zinc in the feed additive: Inductively coupled plasma atomic emission spectrometry, ICP-AES (BS EN 15510:2017( 120 ) or BS EN 15621:2017( 121 )); or Atomic absorption spectrometry, AAS (BS EN ISO 6869:2001( 122 )) For the quantification of total zinc in premixtures: Inductively coupled plasma atomic emission spectrometry, ICP-AES (BS EN 15510:2017 or BS EN 15621:2017); or Atomic absorption spectrometry, AAS (BS EN ISO 6869:2001); or Inductively coupled plasma mass spectrometry, ICP-MS (BS EN 17053:2018( 123 )) For the quantification of total zinc in feed materials and compound feed: Inductively coupled plasma atomic emission spectrometry, ICP-AES (BS EN 15510:2017 or BS EN 15621:2017); or Atomic absorption spectrometry, AAS (in accordance with Commission Regulation Inductively coupled plasma mass spectrometry, ICP-MS (BS EN 17053:2018)
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	Dogs and cats: 200 mg/kg (total) Salmonids and milk replacers for calves: 180 mg/kg (total) Piglets, sows, rabbits and all fish other than salmonids: 150 mg/kg (total) Other animal species: 120 mg/kg (total)
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.

Regulation 3

Schedule 20 Authorisation 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 holder ( 124 )		None
Additive category		Technological
Functional group		Substances for reduction of the contamination of feed by mycotoxins: fumonisins
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 3,000 U/g ( 125 )
Characterisation of the active substance(s)		Fumonisin esterase (EC 3.1.1.87) produced by Komagataella phaffii (DSM 32159) EC (IUBMB) no: 3.1.1.87
Analytical method ( 126 )		For the determination of fumonisin esterase activity: High performance liquid chromatography coupled with a tandem mass spectrometry (HPLC-MS/MS) method based on the quantification of the tricarballylic acid released from the action of the enzyme on fumonisin B ₁ at pH 8.0 and 30°C
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.

Regulation 17

Schedule 21 Revocation of assimilated direct legislation

Part 1 Revocation of assimilated direct legislation in accordance with regulation 17(1)

1. Regulation (EU) No 333/2010 Bacillus subtilis C-3102 (DSM 15544) as a feed additive for weaned piglets (holder of authorisation Asahi Calpis Wellness Co. Ltd, represented in the European Union by Pen & Tec Consulting S.L.U.)( 127 ).

2. Regulation (EU) No 335/2010 128 ).

3. Regulation (EU) No 349/2010 129 ).

4. Regulation (EU) No 350/2010 130 ).

5. Regulation (EU) No 170/2011 Saccharomyces cerevisiae MUCL 39885 as a feed additive for piglets (weaned) and amending Regulation 131 ).

6. Regulation (EU) No 184/2011 Bacillus subtilis C-3102 (DSM 15544) as a feed additive for chickens reared for laying, turkeys, minor avian species and other ornamental and game birds (holder of authorisation Asahi Calpis Wellness Co. Ltd, represented in the European Union by Pen & Tec Consulting S.L.U.)( 132 ).

7. Commission Implementing Regulation (EU) No98/2012 Pichia pastoris (DSM 23036) as a feed additive for chickens and turkeys for fattening, chickens reared for laying, turkeys reared for breeding, laying hens, other avian species for fattening and laying, weaned piglets, pigs for fattening and sows (holder of authorisation Huvepharma AD)( 133 ).

8. Commission Implementing Bacillus subtilis DSM 15544 as a feed additive for chickens for fattening and repealing Regulation 134 ).

9. Commission Implementing Regulation (EU) No333/2010Regulation (EU) 2017/2312Regulation (EU) 2018/1081Regulation (EU) No184/2011 Bacillus subtilis C-3102 (DSM 15544) as a feed additive( 135 ).

Part 2 Revocation of assimilated direct legislation in accordance with regulation 17(2)

10. Regulation (EC) No 109/2007 136 ).

11. Commission Implementing Regulation (EU) No140/2012 137 ).

( 1 )

EUR 2003/1831, amended by S.I. 2019/654 , 2022/377 and 1351 . See Article 2 for the definitions of “appropriate authority” and “prescribe”.

( 2 )

1970 c. 40 . Section 74A was inserted by paragraph 6 of Schedule 4 to the European Communities Act 1972 (c. 68) and amended by section 33(3) of the Agriculture Act 2020 (c. 21) . There are other amendments, but these are not relevant for this instrument. The terms “the Minister”, “ prescribed ” and “ regulations ” are defined in section 66(1) of the Agriculture Act 1970.

( 3 )

EUR 2002/178, amended by S.I. 2019/641 .

( 4 )

EUR 2009/152, amended by S.I. 2019/654 and 2022/1351 .

( 5 )

EUR 2009/767, amended by S.I. 2019/654 and 2022/1351 . 2019/654 was itself amended by S.I. 2020/1504 .

( 6 )

EUR 2020/354.

( 7 )

EUR 2016/897.

( 8 )

EUR 2017/2312.

( 9 )

EUR 2018/1081.

( 10 )

EUR 2019/804.

( 11 )

EUR 2011/887.

( 12 )

EUR 2017/961.

( 13 )

EUR 2020/1395.

( 14 )

EUR 2016/1095.

( 15 )

EUR 2018/1039.

( 16 )

EUR 2016/897, EUR 2017/2312, EUR 2018/1081.

( 17 )

EUR 2019/804.

( 18 )

Prior to the coming into force of these Regulations, butylated hydroxyanisole has been treated as an ‘existing product’ for the purposes of Article 10 of Regulation (EC) 1831/2003 .

( 19 )

EUR 2012/98.

( 20 )

Save to the extent that its continued operation is needed for the operation of this transitional provision, this Regulation is revoked by regulation 17(1) of, and Part 1 of Schedule 21 to, these Regulations.

( 21 )

EUR 2010/349.

( 22 )

( 23 )

EUR 2010/350.

( 24 )

( 25 )

EUR 2010/335.

( 26 )

( 27 )

Details of the analytical methods set out in the document referenced “Ares(2019) 611519 - 03/10/2019” and “JRC F.5/CvH/ZE/AS/Ares” last updated on 18th October 2019 are available at: https://joint-research-centre.ec.europa.eu/publications/fad-2018-0021_en.

( 28 )

BS EN 17053:2018 “ Animal feeding stuffs: Methods of sampling and analysis. Determination of trace elements, heavy metals and other elements in feed by ICP-MS (multi-method ”. Published by the British Standards Institution on 28th February 2018 (ISBN 978 0 580 94471 0). Available from the British Standards Institution at: http://knowledge.bsigroup.com.

( 29 )

BS EN ISO 13903:2005 “ Animal feeding stuffs - Determination of amino acids content ”. Published by the British Standards Institution on 24th October 2005 (ISBN 0 580 46218 8). Available from the British Standards Institution at: http://knowledge.bsigroup.com .

( 30 )

This authorisation is a renewal and a replacement of the authorisation granted under Commission Regulation (EU) No 170/2011 . That Regulation is revoked by regulation 17(1) of, and Part 1 of Schedule 21 to, these Regulations.

( 31 )

Details of the analytical methods set out in the document referenced “D06/FSQ/CVH/CMP/mdr/ARES (2010)58412” and last updated on 6th June 2016 are available at: https://joint-research-centre.ec.europa.eu/publications/fad-2009-0028_en .

( 32 )

BS EN 15789:2021 “ Animal feeding stuffs. Methods of sampling and analysis. Detection and enumeration of Saccharomyces cerevisiae used as feed additive ”. Published by the British Standards Institution on 30th November 2021 (ISBN 978 0 580 99832 4) and available at: https://knowledge.bsigroup.com .

( 33 )

DD CEN/TS:15790:2008 “ Animal Feeding Stuffs - PCR typing of probiotic strains of Saccharomyces cerevisiae (yeast) ”. Published by the British Standards Institution on 31st January 2009 (ISBN 978 0 580 61806 2). Available from the British Standards Institution at: https://knowledge.bsigroup.com .

( 34 )

There is no requirement to include the name of the holder of this authorisation as this authorisation does not fall within the scope of Article 9(5) of Regulation (EC) 1831/2003 .

( 35 )

Details of the analytical methods set out in the document referenced “Ares (2014) 1202206 - 16/04/2014” and “JRC.D.5/SFB/CvH/JO/mds/Ares” last updated on 6th June 2016 are available at: https://joint-research-centre.ec.europa.eu/publications/fad-2013-0031_en .

( 36 )

BS EN 15876:2021 “ Animal feeding stuffs. Methods of sampling and analysis. Detection and enumeration of Pediococcus spp. used as feed additive ”. Published by the British Standards Institution on 30th November 2021 (ISBN 978 0 580 99830 0) and available at: https://knowledge.bsigroup.com .

( 37 )

This authorisation is a renewal (with modification) and a replacement of the authorisation granted under Commission Regulation (EC) No 109/2007 and Commission Implementing Regulation (EU) No140/2012 . Those Regulations are revoked by regulation 17(1) of, and Part 1 of Schedule 21 to, these Regulations.

( 38 )

This is a reference to the CAS Registry Number assigned to this preparation by the Chemical Abstracts Service: https://cas.org/cas-data/cas-registry .

( 39 )

Details of the analytical methods set out in the document referenced “Ares (2017) 1087313 - 01/03/2017” and “JRC F.5/CvH/MGH/mds/Ares” last updated on 27th April 2017 are available at: https://joint-research-centre.ec.europa.eu/publications/fad-2016-0009_en .

( 40 )

BS EN ISO 14183:2008 “ Animal feeding stuffs. Determination of monensin, narasin and salinomycin contents. Liquid chromatographic method using post-column derivatisation ”. Published by the British Standards Institution on 24th January 2006 (ISBN 978 0 580 62955 6) and available at: https://knowledge.bsigroup.com .

( 41 )

Article 2 of Regulation (EC) No. 1831/2003 .

( 42 )

This authorisation is a renewal (with modification) and a replacement of the authorisation granted under Commission Regulation (EC) No 109/2007 . That Regulation is revoked by regulation 17(1) of, and Part 1 of Schedule 21 to, these Regulations.

( 43 )

This is a reference to the CAS Registry Number assigned to this preparation by the Chemical Abstracts Service: https://cas.org/cas-data/cas-registry .

( 44 )

( 45 )

( 46 )

This authorisation is a renewal (with modification) and a replacement of the authorisation granted under Commission Implementing Regulation (EC) No 98/2012 . That Regulation is revoked by regulation 17(1) of, and Part 1 of Schedule 21 to, these Regulations.

( 47 )

1 OTU is the amount of enzyme that catalyses the release of 1 µmol of inorganic phosphate per minute from 5.1mM sodium phytate in pH 5.5 citrate buffer at 37°C, measured as the blue P-molybdate complex colour at 820 nm.

( 48 )

This is a reference to the CAS Registry Number assigned to this preparation by the Chemical Abstracts Service: https://cas.org/cas-data/cas-registry .

( 49 )

This is the identification number allocated by the International Union of Biochemistry and Molecular Biology (IUBMB): https://iubmb.org .

( 50 )

Details of the analytical methods set out in the document referenced “Ares (2016) 5971303 - 17/10/2016” and “JRC F.5/CvH/MGH/mds/Ares” last updated on 17th November 2016 are available at: https://joint-research-centre.ec.europa.eu/publications/fad-2016-0019_en .

( 51 )

This authorisation is a renewal and a replacement of the authorisation granted under Commission Regulation (EU) No 333/2010 (EUR 2010/333), a renewal (with modification) and a replacement of the authorisation granted under Commission Regulation (EU) No 184/2011 (EUR 2011/184) and a consolidation of authorisations granted under Commission Implementing Regulations (EU) 2016/897 (EUR 2016/897) and 2019/893 (EUR 2019/893). EUR 2016/897 is amended by regulation 5 of these Regulations. EUR 2010/333, EUR 2011/184 and EUR 2019/893 are revoked by regulation 17(1) of, and Part 1 of Schedule 21 to, these Regulations.

( 52 )

Details of the analytical methods set out in the document referenced “D08/FSQ/CvH/CMP/mds/ARES (2009)347415” and last updated on 6th June 2016 are available at: https://joint-research-centre.ec.europa.eu/publications/fad-2009-0013_en.

( 53 )

BS EN 15784:2021 “ Animal feeding stuffs. Methods of sampling and analysis. Detection and enumeration of Bacillus spp. used as feed additive ”. Published by the British Standards Institution on 30th November 2021 (ISBN 978 0 580 99829 4) and available at: https://knowledge.bsigroup.com .

( 54 )

There is no requirement to include the name of the holder of this authorisation as this authorisation does not fall within the scope of Article 9(5) of Regulation (EC) 1831/2003 .

( 55 )

This is a reference to the CAS Registry Number assigned to this preparation by the Chemical Abstracts Service https://cas.org/cas-data/cas-registry .

( 56 )

The EINECS number is given in the European Inventory of Existing Commercial Substances, as published in O.J. No. C146A, 15.6.90, p.1.

( 57 )

Details of the analytical methods set out in the document referenced “Ares (2020) 3718494 - 14/07/2020” and “JRC F.5/CvH/ZE/AS/Ares” last updated on 16th October 2020 are available at: https://joint-research-centre.ec.europa.eu/publications/fad-2020-0016_en .

( 58 )

BS EN ISO 13903:2005 “ Animal feeding stuffs. Determination of amino acids content ”. Published by the British Standards Institution on 24th October 2005 (ISBN 0 580 46218 8) and available at: https://knowledge.bsigroup.com .

( 59 )

Exposure calculated based on the endotoxin level and the dusting potential of the additive according to the method used by EFSA (EFSA Journal 2015;13(2):4015); analytical method: European Pharmacopoeia (Ph. Eur.): Supplement 6.6 (official January 1, 2010), Bacterial Endotoxins (reference 01/2010:20614).

( 60 )

There is no requirement to include the name of the holder of this authorisation as this authorisation does not fall within the scope of Article 9(5) of Regulation (EC) 1831/2003 .

( 61 )

This is a reference to the CAS Registry Number assigned to this preparation by the Chemical Abstracts Service https://cas.org/cas-data/cas-registry .

( 62 )

The EINECS number is given in the European Inventory of Existing Commercial Substances, as published in O.J. No. C146A, 15.6.90, p.1.

( 63 )

Details of the analytical methods set out in the document referenced “Ares (2020) 7146784 - 27/11/2020” and “JRCF.5/CvH/ZE/AS/Ares” last updated on 19th December 2020 are available at: https://joint-research-centre.ec.europa.eu/publications/fad-2020-0038_en .

( 64 )

Food Chemicals Codex (FCC), 13th edition (Method: FCC L-tryptophan monograph published). Published by the United States Pharmacopeial Convention on 1st March 2022 (ISSN 2153-1455) and available at https://www.foodchemicalscodex.org .

( 65 )

BS EN ISO 13904:2016 - TC “ Animal feeding stuffs. Determination of tryptophan content ”. Published by the British Standards Institution on 31st March 2016 (ISBN 978 0 580 84452 2) and available at: https://knowledge.bsigroup.com .

( 66 )

( 67 )

There is no requirement to include the name of the holder of this authorisation as this authorisation does not fall within the scope of Article 9(5) of Regulation (EC) 1831/2003 .

( 68 )

This is a reference to the CAS Registry Number assigned to this preparation by the Chemical Abstracts Service https://cas.org/cas-data/cas-registry .

( 69 )

Details of the analytical methods set out in the document referenced “Ares (2021) 2533252 - 14/04/2021” and “JRC F.5/CvH/ZE/AS/Ares” last updated on 2nd July 2021 are available at the following address: https://joint-research-centre.ec.europa.eu/publications/fad-2020-00820085_en .

( 70 )

BS EN ISO 17180:2013 “ Animal feeding stuffs. Determination of lysine, methionine and threonine in commercial amino acid products and premixtures ”. Published by the British Standards Institution on 30th April 2013 (ISBN 978 0 580 76077 8) and available at: https://knowledge.bsigroup.com .

( 71 )

European Pharmacopoeia, monograph - Ph. Eur. 6.0, 01/2008:20301. Published online by the European Directorate for the Quality of Medicines and Healthcare on 1st January 2024 and available at: https://pher.edqm.eu/home .

( 72 )

This Schedule is a new authorisation of a substance that has, prior to these Regulations, been on the market as an existing product for the purposes of Article 10 of Regulation (EC) 1831/2003 . Prior to IP completion day, an application was submitted to the European Commission, pursuant to Article 10(2) of Regulation (EC) 1831/2003 , for the re-evaluation of butylated hydroxyanisole (BHA) as a feed additive for all animal species. The applicant later withdrew the application with regard to cats. BHA was re-evaluated and was subsequently authorised as a feed additive for all species except cats under Commission Implementing Regulation (EU) 2020/1399 . Subject to regulation 12 of these Regulations, BHA as a feed additive for cats as an existing product must (unless it complies with the conditions of new authorisation in this Schedule) be withdrawn from the market.

( 73 )

There is no requirement to include the name of the holder of this authorisation as this authorisation does not fall within the scope of Article 9(5) of Regulation (EC) 1831/2003 .

( 74 )

This is a reference to the CAS Registry Number assigned to this preparation by the Chemical Abstracts Service https://cas.org/cas-data/cas-registry .

( 75 )

Details of the analytical methods are set out in the document referenced “JRC.D.5/CvH/SB/ag/ARES(2012)40826” and last updated on 6th June 2016 and available at: https://joint-research-centre.ec.europa.eu/publications/fad-2010-0132_en .

( 76 )

Food Chemicals Codex (FCC), 7th edition (Method: BHA-FCC V1 monograph_published). Published by the United States Pharmacopeial Convention on 1st March 2022 and available at: https://www.foodchemicalscodex.org .

( 77 )

There is no requirement to include the name of the holder of this authorisation as this authorisation does not fall within the scope of Article 9(5) of Regulation (EC) 1831/2003 .

( 78 )

This is a reference to the CAS Registry Number assigned to this preparation by the Chemical Abstracts Service https://cas.org/cas-data/cas-registry .

( 79 )

Details of the analytical methods are set out in the document referenced “Ares (2019) 7003671 - 12/11/2019” and “JRC F.5/CvH/SB/AS/Ares” last updated on 27th January 2020 and available at: https://joint-research-centre.ec.europa.eu/publications/fad-2019000160028_en .

( 80 )

BS EN ISO 17180:2013 “ Animal feeding stuffs. Determination of lysine, methionine and threonine in commercial amino acid products and premixtures ”. Published by the British Standards Institutions on 30th April 2013 (ISBN 978 0 580 76077 8) and available at: https://knowledge.bsigroup.com.

( 81 )

There is no requirement to include the name of the holder of this authorisation as this authorisation does not fall within the scope of Article 9(5) of Regulation (EC) 1831/2003 .

( 82 )

This is a reference to the CAS Registry Number assigned to this preparation by the Chemical Abstracts Service https://cas.org/cas-data/cas-registry .

( 83 )

( 84 )

Food Chemicals Codex (FCC), 13th edition (method: FCC L-lysine monohydrochloride monograph published). Published by the United States Pharmacopeial Convention on 1st March 2022 (ISSN 2153-1455) and available at: https://www.foodchemicalscodex.org .

( 85 )

( 86 )

There is no requirement to include the name of the holder of this authorisation as this authorisation does not fall within the scope of Article 9(5) of Regulation (EC) 1831/2003 .

( 87 )

This is a reference to the CAS Registry Number assigned to this preparation by the Chemical Abstracts Service https://cas.org/cas-data/cas-registry .

( 88 )

The EINECS number is given in the European Inventory of Existing Commercial Substances, as published in O.J. No. C146A, 15.6.90, p.1.

( 89 )

Details of the analytical methods are set out in the document referenced “Ares (2020) 4619276 - 04/09/2020” and “JRC G.5/CvH/ZE/AS/Ares” last updated on 16th October 2020 and available at: https://joint-research-centre.ec.europa.eu/publications/fad-2019-0085_en .

( 90 )

Food and Agriculture Organisation of the United Nations (FAO) Joint FAO/WHO Expert Committee on Food Additives (JECFA) - Combined Compendium of Food Additive Specifications, “Disodium 5’-guanylate” Monograph 1 (2006). Published by the FAO and last updated (Web version) August 2011 (ISBN 92-5-105569-6). Available at: https://www.fao.org/food/food-safety-quality/scientific-advice/jecfa/jecfa-additives/detail/en/c/255 .

( 91 )

LSU(F) is defined as the amount of enzyme that increases the fluorescence of 12.5 µg/ml fluorescein-labelled peptidoglycan per minute at pH 6.0 and 30 °C by a value that corresponds to the fluorescence of approximately 0.06 nmol fluorescein isothiocyanate isomer.

( 92 )

This is a reference to the CAS Registry Number assigned to this preparation by the Chemical Abstracts Service: https://cas.org/cas-data/cas-registry .

( 93 )

The EINECS number is given in the European Inventory of Existing Commercial Chemical Substances, as published in O.J. No. C146A, 15.6.90, p.1.

( 94 )

Details of the analytical methods are set out in the document referenced “Ares (2018) 811287 - 12/02/2018” and “JRC F.5/CvH/SB/AS/Ares” last updated on 2nd March 2018 and available at: https://joint-research-centre.ec.europa.eu/publications/fad-2017-0046_en .

( 95 )

There is no requirement to include the name of the holder of this authorisation as this authorisation does not fall within the scope of Article 9(5) of Regulation (EC) 1831/2003 .

( 96 )

This is a reference to the CAS Registry Number assigned to this preparation by the Chemical Abstracts Service https://cas.org/cas-data/cas-registry .

( 97 )

The EINECS (European Inventory of Existing Commercial Chemical Substances) number as published in O.J. No. C146A, 15.6.90, p.1.

( 98 )

Details of the analytical method are set out in the document referenced “Ares (2021) 145311 - 07/01/2021” and “JRC F.5/CvH/SB/AS/Ares” last updated on 17th February 2021, available at: https://joint-research-centre.ec.europa.eu/publications/fad-2020-0006_en .

( 99 )

European Pharmacopoeia monograph - Ph. Eur. 8.0, 01/2014:1036. Published online by the European Directorate for the Quality of Medicines and Healthcare on 1st January 2024. Available at: https://pheur.edqm.eu/home .

( 100 )

BS EN 14148:2003 “ Foodstuffs. Determination of Vitamin K ₁ by HPLC ”. Published by the British Standards Institution on 25th July 2003 (ISBN 0 580 42317 4) and available at: https://knowledge.bsigroup.com .

( 101 )

This authorisation is a renewal and a replacement of the authorisation granted under Commission Regulation (EU) No 349/2010 . That Regulation is revoked by regulation 17(1) of, and Part 1 of Schedule 21 to, these Regulations.

( 102 )

There is no requirement to include the name of the holder of this authorisation as this authorisation does not fall within the scope of Article 9(5) of Regulation (EC) 1831/2003 .

( 103 )

This is a reference to the CAS Registry Number assigned to this preparation by the Chemical Abstracts Service: https://cas.org/cas-data/cas-registry .

( 104 )

Details of the analytical methods are set out in the document referenced “D08-FSQ(2007)D/29104” and last updated on 6th June 2016 and available at: https://joint-research-centre.ec.europa.eu/publications/fad-2007-0012_en .

( 105 )

BS EN 15510:2017 “ Animal feeding stuffs. Methods of sampling and analysis. Determination of calcium, sodium, phosphorus, magnesium, potassium, iron, zinc, copper, manganese, cobalt, molybdenum and lead by ICP-AES ”. Published by the British Standards Institution on 31st August 2017 (ISBN 978 0 580 94541 0) and available at: https://knowledge.bsigroup.com .

( 106 )

BS EN 15621:2017 “ Animal feeding stuffs. Methods of sampling and analysis. Determination of calcium, sodium, phosphorus, magnesium, potassium, sulphur, iron, zinc, copper, manganese and cobalt after pressure digestion by ICP-AES ”. Published by the British Standards Institution on 31st August 2017 (ISBN 978 0 580 94543 4) and available at: https://knowledge.bsigroup.com .

( 107 )

BS EN ISO 6869:2001 “ Animal feeding stuffs. Determination of the contents of calcium, copper, iron, magnesium, manganese, potassium, sodium and zinc. Method using atomic absorption spectrometry ”. Published by the British Standards Institution on 15th March 2001 (ISBN 0 580 36933 1) and available at: https://knowledge.bsigroup.com .

( 108 )

BS EN 17053:2018 “ Animal feeding stuffs. Methods of sampling and analysis. Determination of trace elements, heavy metals and other elements in feed by ICP-MS (multi-method) ”. Published by the British Standards Institution on 28th February 2018 (ISBN 978 0 580 94471 0) and available at: https://knowledge.bsigroup.com .

( 109 )

This authorisation is a renewal and a replacement of the authorisation granted under Commission Regulation (EU) No 350/2010 . That Regulation is revoked by regulation 17(1) of, and Part 1 of Schedule 21 to, these Regulations.

( 110 )

There is no requirement to include the name of the holder of this authorisation as this authorisation does not fall within the scope of Article 9(5) of Regulation (EC) 1831/2003 .

( 111 )

This is a reference to the CAS Registry Number assigned to this preparation by the Chemical Abstracts Service: https://cas.org/cas-data/cas-registry .

( 112 )

Details of the analytical methods are set out in the document referenced “D08-FSQ(2007)D/29224” and last updated on 6th June 2016 and available at: https://joint-research-centre.ec.europa.eu/publications/fad-2007-0011_en .

( 113 )

( 114 )

( 115 )

( 116 )

This authorisation is a renewal and a replacement of the authorisation granted under Commission Regulation (EU) No 355/2010 . That Regulation is revoked by regulation 17(1) of, and Part 1 of Schedule 21 to, these Regulations.

( 117 )

There is no requirement to include the name of the holder of this authorisation as this authorisation does not fall within the scope of Article 9(5) of Regulation (EC) 1831/2003 .

( 118 )

This is a reference to the CAS Registry Number assigned to this preparation by the Chemical Abstracts Service: https://cas.org/cas-data/cas-registry .

( 119 )

Details of the analytical methods are set out in the document referenced “D08-FSQ(2007)D/29110” and last updated on 6th June 2016 and available at: https://joint-research-centre.ec.europa.eu/publications/fad-2007-0010_en .

( 120 )

( 121 )

( 122 )

( 123 )

( 124 )

There is no requirement to include the name of the holder of this authorisation as this authorisation does not fall within the scope of Article 9(5) of Regulation (EC) 1831/2003 .

( 125 )

1 U is the enzymatic activity that releases 1 µmol tricarballylic acid per minute from 100 µM fumonisin B ₁ in 20 mM Tris-Cl buffer pH 8.0 with 0.1mg/ml bovine serum albumin at 30°C.

( 126 )

Details of the analytical methods are set out in the document referred “JRC F.5/CvH/MGH/mds/Ares” and last updated on 18th May 2017 and available at: https://joint-research-centre.ec.europa.eu/publications/fad-2017-0005_en .

( 127 )

EUR 2010/333, amended by EUR 2020/146 . EUR 2020/146 is revoked by regulation 17(1) of, and Schedule 21 to, these Regulations. See regulation 10 of these Regulations for transitional provision.

( 128 )

EUR 2010/335, amended by EUR 2016/1095 . EUR 2016/1095 is amended by regulation 8 of these Regulations. See regulation 16 of these Regulations for transitional provision.

( 129 )

EUR 2010/349, amended by EUR 2018/1039 . EUR 2018/1039 is amended by regulation 9 of these Regulations. See regulation 14 of these Regulations for transitional provision.

( 130 )

EUR 2010/350. See regulation 15 of these Regulations for transitional provision.

( 131 )

EUR 2011/170. See regulation 11 of these Regulations for transitional provision.

( 132 )

EUR 2011/184, amended by EUR 2020/146 . EUR 2020/146 is revoked by regulation 17(1) of, and Schedule 21 to, these Regulations. See regulation 10 of these Regulations for transitional provision.

( 133 )

EUR 2012/98. See regulation 13 of these Regulations for transitional provision.

( 134 )

EUR 2019/893, amended by EUR 2020/146 . EUR 2020/146 is revoked by regulation 17(1) of, and Schedule 21 to, these Regulations. See regulation 10 of these Regulations for transitional provision.

( 135 )

EUR 2020/146. See regulation 10 of these Regulations for transitional provision.

( 136 )

EUR 2007/109.

( 137 )

EUR 2012/140.

footnote	commentary	transitional and savings	in force status	related provisions	geo extent	insert/omit	source count	in force adj

Defined Term	Section/Article	ID
50mg	para Schedule 14	50mg_msqnH48y
nutritional additives	para Schedule 16	nutritiona_rtFm3Xi
prior authorisation	reg. 10. of Part 5	legTerm1yJW1wJg
prior authorisation	reg. 11. of Part 5	legTerm65CgHFBt
prior authorisation	reg. 13. of Part 5	legTermnfYoC6zy
prior authorisation	reg. 14. of Part 5	legTermud4np9Su
prior authorisation	reg. 15. of Part 5	legTermiZV5Udzw
prior authorisation	reg. 16. of Part 5	legTermgzbh3Jtv
Regulation\n \n (EC) 152/2009	reg. 2. of Part 1	legTermpp7ra0iL
relevant feed additive	reg. 10. of Part 5	legTermZWChilVx
relevant feed additive	reg. 11. of Part 5	legTermwOOJXJT4
relevant feed additive	reg. 13. of Part 5	legTermAtDZS1WZ
relevant feed additive	reg. 14. of Part 5	legTerm12yr8n45
relevant feed additive	reg. 15. of Part 5	legTermoZdkKDZJ
relevant feed additive	reg. 16. of Part 5	legTermRp6VH5tr
vitamins, pro-vitamins and chemically well-defined substances having similar effect	para Schedule 16	vitamins,__rt0Z8Dt

2024 No. 1101

The Feed Additives (Authorisations) and Uses of Feed Intended for Particular Nutritional Purposes (Amendment of Commission Regulation (EU) 2020/354) (England) Regulations 2024

Part 1 Introductory

Citation, commencement, extent and application

Interpretation

Part 2 Feed additive authorisations

Authorisation of various feed additives

Part 3 Uses 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 hypocalcaemia

Part 4 Amendment of assimilated direct legislation

Modification of authorisation: a preparation of Bacillus velezensis (DSM 15544), (identification number 4b1820)

Modification of authorisation: selenised yeast Saccharomyces cerevisiae (CNCM I-3060), inactivated (identification number 3b810)

Changes of authorisation holder: amendment of Commission Implementing Regulation (EU) No887/2011 and Commission Implementing Regulations (EU) 2017/961 and 2020/1395

Amendment of Commission Implementing Regulation (EU) 2016/1095

Amendment of Commission Implementing Regulation (EU) 2018/1039

Part 5 Transitional Provisions

Transitional provision: a preparation of Bacillus velezensis (DSM 15544) (identification number 4b1820)

Transitional provision: selenised yeast Saccharomyces cerevisiae (CNCM I-3060), inactivated (identification number 3b810)

Transitional provision: butylated hydroxyanisole (identification number 1b320)

Transitional provision: 6-phytase (EC 3.1.3.26) (identification number 4a16)

Transitional provision: copper chelate of hydroxy analogue of methionine (identification number 3b410i)

Transitional provision: manganese chelate of hydroxy analogue of methionine (identification number 3b510)

Transitional provision: zinc chelate of hydroxy analogue of methionine (identification number 3b610)

Part 6 Revocation of assimilated direct legislation

Revocation of assimilated direct legislation

Schedule 1 Authorisation of a preparation of chromium chelate of DL-methionine (identification number GB4d0001) as a feed additive for dairy cows

Schedule 2 Renewal 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

Schedule 3 Authorisation of a preparation of Pediococcus acidilactici (CNCM I-4622) (identification number 4d1712) as a feed additive for all animal species

Schedule 8 Authorisation 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

Schedule 9 Authorisation 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

Schedule 10 Authorisation 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

Schedule 11 Authorisation of the substance butylated hydroxyanisole (identification number 1b320) as a feed additive for cats

Schedule 12 Authorisation 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

Schedule 13 Authorisation 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

Schedule 14 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) as a feed additive for all animal species

Schedule 15 Authorisation 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

Schedule 16 Authorisation of the substance of phytomenadione (Vitamin K 1 ) (identification number 3a712) as a feed additive for horses

Schedule 17 Renewal 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

Schedule 18 Renewal 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

Schedule 19 Renewal 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

Schedule 20 Authorisation 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

Schedule 21 Revocation of assimilated direct legislation

Part 1 Revocation of assimilated direct legislation in accordance with regulation 17(1)

Part 2 Revocation of assimilated direct legislation in accordance with regulation 17(2)

Status of changes to instrument text

Schedule 16 Authorisation of the substance of phytomenadione (Vitamin K ₁ ) (identification number 3a712) as a feed additive for horses