
PART 1
1 

(1) These Regulations may be cited as the Feed Additives (Authorisations) and Uses of Feed Intended for Particular Nutritional Purposes (Miscellaneous Amendment) (Scotland) Regulations 2024 and come into force on 20 December 2024.
(2) These Regulations extend to Scotland only.
2 

(1) In these Regulations—
 “Regulation 1831/2003” means Regulation (EC) No 1831/2003 of the European Parliament and of the Council on additives for use in animal nutrition,
 “Regulation 429/2008” means Commission Regulation (EC) No 429/2008 on detailed rules for the implementation of Regulation (EC) No 1831/2003 of the European Parliament and of the Council as regards the preparation and the presentation of applications and the assessment and the authorisation of feed additives,
 “Regulation 767/2009” means Regulation (EC) No 767/2009 of the European Parliament and of the Council on the placing on the market and use of feed, amending European Parliament and Council Regulation (EC) No 1831/2003 and repealing Council Directive 79/373/EEC, Commission Directive 80/511/EEC, Council Directives 82/471/EEC, 83/228/EEC, 93/74/EEC, 93/113/EC and 96/25/EC and Commission Decision 2004/217/EC.
(2) Expressions used in these Regulations and in Regulation 1831/2003 or Regulation 767/2009 have the same meaning as in Regulation 1831/2003 or Regulation 767/2009, respectively.
(3) In schedules 1 to 20—
(a) expressions used to refer to species or categories of animals that are also used in Annex 4 (categories and definitions of target animals and indication of the minimum duration of efficacy studies) of Regulation 429/2008 have the same meaning as in that Annex,
(b) any reference to a minor species is to be read in accordance with the definition of “minor species” in Article 1 (definitions) of Regulation 429/2008.
PART 2
3 

(1) Schedules 1 to 20 have effect.
(2) Subject to Article 14(4) (renewal of authorisation) of Regulation 1831/2003, the authorisations set out in schedules 1 to 20 cease to have effect at the end of 19 December 2034.
4 

(1) Commission Implementing Regulation (EU) 2016/897 concerning the authorisation of a preparation of Bacillus subtilis (C-3102) (DSM 15544) as a feed additive for laying hens and ornamental fish (holder of authorisation Asahi Calpis Wellness Co. Ltd, represented in the European Union by Pen & Tec Consulting S.L.U.) and amending Regulations (EC) No 1444/2006, (EU) No 333/2010 and (EU) No 184/2011 is amended as follows.
(2) Omit Articles 2 to 4.
(3) In the Annex, in the table—
(a) in the second column (name of the holder of authorisation), for “Asahi Calpis Wellness Co. Ltd, represented by Asahi Calpis Wellness Co. Ltd Europe Representative Office” substitute “Asahi Biocycle Co., Ltd, (represented by Pen & Tec Consulting S.L.U., now trading as Argenta)”,
(b) in the third column (additive) and the fourth column (composition, chemical formula, description, analytical method), for “Bacillus subtilis C-3102”, in each place it occurs, substitute “Bacillus velezensis”,
(c) in the fifth column (species or category of animal), omit “Laying hens”,
(d) in the sixth column (minimum content), omit “3 × 108”.
5 

(1) In Commission Implementing Regulation (EU) 2017/2312 concerning the authorisation of a new use of the preparation of Bacillus subtilis C-3102 (DSM 15544) as a feed additive for sows, suckling piglets and dogs (holder of the authorisation Asahi Calpis Wellness Co. Ltd, represented in the European Union by Pen & Tec Consulting S.L.U.), in the Annex, the table is amended as follows.
(2) In the second column (name of the holder of authorisation), for “Asahi Calpis Wellness Co. Ltd, represented in the European Union by Pen & Tec Consulting S.L.U.” substitute “Asahi Biocycle Co., Ltd (represented by Pen & Tec Consulting S.L.U., now trading as Argenta)”.
(3) In the third column (additive), for “Bacillus subtilis” substitute “Bacillus velezensis”.
(4) In the fourth column (composition, chemical formula, description, analytical method)—
(a) in the section headed “Additive composition”, for “Bacillus subtilis C-3102” substitute “Bacillus velezensis”,
(b) in the section headed “Characterisation of the active substance”, for “Bacillus subtilis” substitute “Bacillus velezensis”.
6 

(1) In Commission Implementing Regulation (EU) 2018/1081 concerning the authorisation of the preparation of Bacillus subtilis C-3102 (DSM 15544) as a feed additive for pigs for fattening (holder of the authorisation Asahi Calpis Wellness Co. Ltd, represented in the European Union by Pen & Tec Consulting S.L.U.), in the Annex, the table is amended as follows.
(2) In the second column (name of the holder of authorisation), for “Asahi Calpis Wellness Co. Ltd, represented in the European Union by Pen & Tec Consulting S.L.U.” substitute “Asahi Biocycle Co., Ltd (represented by Pen & Tec Consulting S.L.U., now trading as Argenta)”.
(3) In the third column (additive) and the fourth column (composition, chemical formula, description, analytical method), for “Bacillus subtilis C-3102”, in each place it occurs, substitute “Bacillus velezensis”.
7 

(1) In Commission Implementing Regulation (EU) 2019/804 concerning the renewal of the authorisation of organic form of selenium produced by Saccharomyces cerevisiae CNCM I-3060 and of selenomethionine produced by Saccharomyces cerevisiae NCYC R397 as feed additives for all animal species(, in the Annex, the entry for “3b810” is amended as follows.
(2) In the third column (composition, chemical formula, description, analytical method), for the section headed “Additive composition”, substitute—“
Additive composition
Preparation of organic selenium (Se) produced by Saccharomyces cerevisiae (CNCM I-3060) containing 2000 to 3500 mg Se/kg with the below components:

• Organic selenium: 97% minimum of total selenium
• Selenomethionine: 63% minimum of total selenium”.
(3) 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.
”
8 
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 of these Regulations.
9 

(1) Commission Implementing Regulation (EU) No887/2011 concerning the authorisation of a preparation of Enterococcus faecium CECT 4515 as feed additive for chickens for fattening (holder of the authorisation Evonik Nutrition & Care GmbH) is amended as follows.
(2) In the Annex, in the second column of both tables (name of the holder of authorisation), for “Evonik Nutrition & Care GmbH)”, in each place it occurs, substitute “Evonik Operations GmbH”.
10 

(1) Commission Implementing Regulation (EU) 2017/961 concerning the authorisation of a preparation of Enterococcus faecium CECT 4515 as a feed additive for weaned piglets, and a new use in water for drinking for weaned piglets and chickens for fattening, and amending Regulation (EC) No 2036/2005 and Regulation (EU) No887/2011 (holder of authorisation Evonik Nutrition & Care GmbH) is amended as follows.
(2) In Annex 1, in the table, in the second column (name of the holder of authorisation), for “Evonik Nutrition & Care GmbH)” substitute “Evonik Operations GmbH”.
11 

(1) Commission Implementing Regulation (EU) 2020/1395 concerning the renewal of the authorisation of Bacillus amyloliquefaciens CECT 5940 as a feed additive for chickens for fattening, its authorisation for chickens reared for laying, and repealing Regulation (EC) No 1292/2008 (holder of authorisation Evonik Nutrition & Care GmbH) is amended as follows.
(2) In the Annex, in the table, in the second column (name of the holder of authorisation), for “Evonik Nutrition & Care GmbH” substitute “Evonik Operations GmbH”.
PART 3
12 

(1) In Commission Regulation (EU) 2020/354 establishing a list of intended uses of feed intended for particular nutritional purposes, in the Annex, in Part B (list of intended uses), the table is amended as follows.
(2) In entry 60 (reduction of the risk of milk fever and subclinical hypocalcaemia), in column number 2 (essential nutritional characteristics), in the section of the entry starting “Low cations/anions ratio”, for “Objective: 0 < DCADs (mEq/kg dry matter) < 100” substitute “Objective: Range from -200 mEq/kg dry matter DCADs to <100 mEq/kg dry matter DCAD”.
PART 4
13 

(1) Any substance or product labelled “Bacillus subtilis (C-3102)”, or as containing “Bacillus subtilis (C-3102)”, but otherwise produced and labelled in accordance with an authorisation contained in assimilated direct legislation mentioned in regulations 4 to 6, may continue to be placed on the market and used under that authorisation.
(2) The relevant feed additive, and premixtures containing it, which are produced and labelled before the end of 19 June 2025 in accordance with the conditions of the prior authorisations and the labelling requirements applicable before 20 December 2024, may continue to be placed on the market and used until stocks are exhausted.
(3) Compound feed and feed materials containing the relevant feed additive, and intended for food-producing animals, which are produced and labelled before the end of 19 December 2025 in accordance with the conditions of the prior authorisations and the labelling requirements applicable before 20 December 2024, may continue to be placed on the market and used until stocks are exhausted.
(4) Compound feed and feed materials containing the relevant feed additive, and intended for non-food-producing animals, which are produced and labelled before the end of 19 December 2026 in accordance with the conditions of the prior authorisations and the labelling requirements applicable before 20 December 2024, may continue to be placed on the market and used until stocks are exhausted.
(5) In this regulation—
 “relevant feed additive” means the feed additive of a preparation of Bacillus velezensis (DSM 15544) (formerly Bacillus subtilis C-3102), with the identification number 4b1820, authorised under the prior authorisations;
 “prior authorisations” means the authorisations contained in—
(i) Commission Regulation (EU) No 333/2010 concerning the authorisation of a new use of Bacillus subtilis C-3102 (DSM 15544) as a feed additive for weaned piglets,
(ii) Commission Regulation (EU) No 184/2011 concerning the authorisation of 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,
(iii) Commission Implementing Regulation (EU) 2016/897 concerning the authorisation of a preparation of Bacillis subtilis C-3102 (DSM 15544) as a feed additive for laying hens and ornamental fish,
(iv) Commission Implementing Regulation (EU) 2019/893 concerning the renewal of the authorisation of Bacillus subtilis DSM 15544 as a feed additive for chickens for fattening.
14 

(1) The relevant feed additive, and premixtures containing it, which are produced and labelled before the end of 19 June 2025 in accordance with the conditions of the prior authorisation and the labelling requirements applicable before 20 December 2024, may continue to be placed on the market and used until stocks are exhausted.
(2) Compound feed and feed materials containing the relevant feed additive, and intended for food-producing animals, which are produced and labelled before the end of 19 December 2025 in accordance with the conditions of the prior authorisation and the labelling requirements applicable before 20 December 2024, may continue to be placed on the market and used until stocks are exhausted.
(3) Compound feed and feed materials containing the relevant feed additive, and intended for non-food-producing animals, which are produced and labelled before the end of 19 December 2026 in accordance with the conditions of the prior authorisation and the labelling requirements applicable before 20 December 2024, may continue to be placed on the market and used until stocks are exhausted.
(4) In this regulation—
 “relevant feed additive” means the feed additive selenised yeast Saccharomyces cerevisiae (CNCM 1-3060), inactivated, with the identification number 3b810 authorised under the prior authorisation,
 “prior authorisation” means the authorisation contained in Commission Implementing Regulation (EU) 2019/804 concerning the renewal of the authorisation of organic form selenium produced by Saccharomyces cerevisiae CNCM I-3060 and of selenomethionine produced by Saccharomyces cerevisiae NCYC R397 as feed additives for all animal species.
15 

(1) Butylated hydroxyanisole as a feed additive for cats, and premixtures containing it, which are produced and labelled before the end of 19 June 2025 in accordance with the conditions of authorisation and the labelling requirements applicable before 20 December 2024, may continue to be placed on the market and used until stocks are exhausted.
(2) Compound feed and feed materials containing butylated hydroxyanisole, intended for cats, which are produced and labelled before the end of 19 December 2026 in accordance with the conditions of authorisation and the labelling requirements applicable before 20 December 2024, may continue to be placed on the market and used until stocks are exhausted.
16 

(1) The relevant feed additive, and premixtures containing it, which are produced and labelled before the end of 19 June 2025 in accordance with the conditions of the prior authorisation and the labelling requirements applicable before 20 December 2024, may continue to be placed on the market and used until stocks are exhausted.
(2) Compound feed and feed materials containing the relevant feed additive, and intended for food-producing animals, which are produced and labelled before the end of 19 June 2025 in accordance with the conditions of the prior authorisation and the labelling requirements applicable before 20 December 2024, may continue to be placed on the market and used until stocks 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 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).
17 

(1) The relevant feed additive, and premixtures containing it, which are produced and labelled before the end of 19 June 2025 in accordance with the conditions of the prior authorisation and the labelling requirements applicable before 20 December 2024, may continue to be placed on the market and used until stocks are exhausted.
(2) Compound feed and feed materials containing the relevant feed additive, and intended for food-producing animals, which are produced and labelled before the end of 19 December 2025 in accordance with the conditions of the prior authorisation and the labelling requirements applicable before 20 December 2024, may continue to be placed on the market and used until stocks are exhausted.
(3) Compound feed and feed materials containing the relevant feed additive, and intended for non-food-producing animals, which are produced and labelled before the end of 19 December 2026 in accordance with the conditions of the prior authorisation and the labelling requirements applicable before 20 December 2024, may continue to be placed on the market and used until stocks 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 Commission Regulation (EU) No 349/2010 concerning the authorisation of copper chelate of hydroxy analogue of methionine as a feed additive for all animal species.
18 

(1) The relevant feed additive, and premixtures containing it, which are produced and labelled before the end of 19 June 2025 in accordance with the conditions of the prior authorisation and the labelling requirements applicable before 20 December 2024, may continue to be placed on the market and used until stocks are exhausted.
(2) Compound feed and feed materials containing the relevant feed additive, and intended for food-producing animals, which are produced and labelled before the end of 19 December 2025 in accordance with the conditions of the prior authorisation and the labelling requirements applicable before 20 December 2024, may continue to be placed on the market and used until stocks are exhausted.
(3) Compound feed and feed materials containing the relevant feed additive, and intended for non-food-producing animals, which are produced and labelled before the end of 19 December 2026 in accordance with the conditions of the prior authorisation and the labelling requirements applicable before 20 December 2024, may continue to be placed on the market and used until stocks 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 Commission Regulation (EU) No 350/2010 concerning the authorisation of manganese chelate of hydroxy analogue of methionine as a feed additive for all animal species.
19 

(1) The relevant feed additive, and premixtures containing it, which are produced and labelled before the end of 19 June 2025 in accordance with the conditions of the prior authorisation and the labelling requirements applicable before 20 December 2024, may continue to be placed on the market and used until stocks are exhausted.
(2) Compound feed and feed materials containing the relevant feed additive, and intended for food-producing animals, which are produced and labelled before the end of 19 December 2025 in accordance with the conditions of the prior authorisation and the labelling requirements applicable before 20 December 2024, may continue to be placed on the market and used until stocks are exhausted.
(3) Compound feed and feed materials containing the relevant feed additive, and intended for non-food-producing animals, which are produced and labelled before the end of 19 December 2026 in accordance with the conditions of the prior authorisation and the labelling requirements applicable before 20 December 2024, may continue to be placed on the market and used until stocks 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 Commission Regulation (EU) No 335/2010 concerning the authorisation of zinc chelate of hydroxy analogue of methionine as a feed additive for all animal species.
PART 5
20 
In Commission Implementing Regulation (EU) 2016/1095 concerning the authorisation of Zinc acetate dihydrate, Zinc chloride anhydrous, Zinc oxide, Zinc sulphate heptahydrate, Zinc sulphate monohydrate, Zinc chelate of amino acids hydrate, Zinc chelate of protein hydrolysates, Zinc chelate of glycine hydrate (solid) and Zinc chelate of glycine hydrate (liquid) as feed additives for all animal species, omit Article 4 (Amendment to Regulation (EU) No335/2010).
21 
In Commission Implementing Regulation (EU) 2018/1039 concerning the authorisation of Copper(II) diacetate monohydrate, Copper(II) carbonate dihydroxy monohydrate, Copper(II) chloride dihydrate, Copper(II) oxide, Copper(II) sulphate pentahydrate, Copper(II) chelate of amino acids hydrate, Copper(II) chelate of protein hydrolysates, Copper(II) chelate of glycine hydrate (solid) and Copper(II) chelate of glycine hydrate (liquid) as feed additives for all animal species, omit Article 5 (Amendment to Regulation (EU) No349/2010).
22 

(1) The instruments listed in paragraphs 2, 3, 4, 5, 7, 8 and 10 of schedule 21 are revoked subject to Part 4.
(2) The instruments listed in paragraphs 1, 6, 9 and 11 of schedule 21 are revoked.
JENNI MINTO
Authorised to sign by the Scottish Ministers
St Andrew’s House,
Edinburgh
6th November 2024
SCHEDULE 1
Regulation 3(1)
1 
The preparation specified in the table, belonging to the additive category “zootechnical additives” and to the functional group “other zootechnical”, is authorised as an additive in animal nutrition, subject to the conditions set out in the table.
Additive Chromium chelate of DL-methionine
Identification number GB4d0001
Authorisation holder Zinpro Animal Nutrition (Europe), Inc
Additive category Zootechnical additives
Functional group Other zootechnical
Additive composition Solid preparation of chelates of chromium (Cr) with DL-methionine with the below components:
• Calcium carbonate: 95.6%
• Chromium-DL-Methionine: 3.4%
• Vegetable oil: 1.0%
Characterisation of the active substance(s) Chromium chelate of DL-methionine ([CH3S(CH
2)2CH(NH2)COO]3 Cr)
Analytical methods For quantification of chromium in the feed additive:
• Inductively coupled plasma-mass spectrometry (ICP-MS) in accordance with BS EN 17053:2018
For 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
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 No maximum
Content of chromium in complete feed with a moisture content of 12% Minimum content 0.2 mg/kg
Maximum content 0.5 mg/kg
Other provisions The storage conditions and stability to heat treatment must be stated in the directions for use of the feed additive and premixture
SCHEDULE 2
Regulation 3(1)
1 
The preparation specified in the table, belonging to the additive category “zootechnical additives” and to the functional group “gut flora stabilisers”, is authorised as an additive in animal nutrition, subject to the conditions set out in the table.
Additive Saccharomyces cerevisiae (MUCL 39885)
Identification number 4b1710
Authorisation holder Prosol S.p.A
Additive category Zootechnical additives
Functional group Gut flora stabilisers
Additive composition Solid preparation of Saccharomyces cerevisiae (MUCL 39885) containing a minimum of 1 × 10
9 colony forming units (CFU)/g
Characterisation of the active substance(s) Viable cells of Saccharomyces cerevisiae (MUCL 39885)

Analytical methods For enumeration:
• Pour plate method CGYE (chloramphenicol, glucose, yeast extract) agar in accordance with BS EN 15789:2021
For identification of the yeast strain:
• Polymerase chain reaction (PCR) method (DD CEN/TS 15790:2008)
Species or category of animal All Suidae other than sows and suckling pigletsCatsDogs
Maximum age No maximum
Colony forming units of additive/ kg complete feed with a moisture content of 12% Minimum content For all Suidae other than sows and suckling piglets, and Suidae for reproduction purposes:
• 3 × 109 CFU/kg
For all Suidae for reproduction purposes, other than sows:
• 6.4 × 109 CFU/kg
For cats and dogs:
• 7 × 1010 CFU/kg
Maximum content No maximum
Other provisions The storage conditions must be indicated in the directions for use of the feed additive and premixture
SCHEDULE 3
Regulation 3(1)
1 
The preparation specified in the table, belonging to the additive category “technological additives” and to the functional groups “acidity regulators” and “hygiene condition enhancers”, is authorised as an additive in animal nutrition, subject to the conditions set out in the table.
Additive Pediococcus acidilactici (CNCM I-4622)
Identification number 4d1712
Authorisation holder None
Additive category Technological additives
Functional groups 
• Acidity regulators
• Hygiene condition enhancers
Additive composition Solid preparation of Pediococcus acidilactici (CNCM I-4622) containing a minimum of 1×10
10 colony forming units (CFU)/g
Characterisation of the active substance(s) Viable cells of Pediococcus acidilactici (CNCM I-4622)

Analytical methods For enumeration (colony count) of the feed additive:
• Spread plate method using MRS agar in accordance with BS EN 15786:2021
For identification of the bacterial strain:
• Pulsed-Field Gel Electrophoresis (PFGE)
Species or category of animal All animal species
Maximum age No maximum
Colony forming units of additive/ kg complete feed with a moisture content of 12% Minimum content 1 × 109 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 hydrocholoride
SCHEDULE 4
Regulation 3(1)
1 
The preparation specified in the table, belonging to the additive category “coccidiostats and histomonostats”, is authorised as an additive in animal nutrition, subject to the conditions set out in the table.
Additive Monensin sodium
Identification number 51701
Authorisation holder Huvepharma NV
Additive category Coccidiostats and histomonostats
Functional group None
Additive composition Preparation of monensin sodium produced by fermentation with Streptomyces cinnamonensis (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 (NBIMCC 3419):
• Monensin sodium A (C36H61NaO11)
• Monensin sodium B (C35H59NaO11)
• Monensin sodium C (C37H63NaO11)
• CAS number: 22373-78-0
Analytical methods For 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
For 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 For chickens for fattening:
• No maximum
For chickens reared for laying; turkeys for fattening; turkeys reared for breeding:
• 16 weeks
Content of monensin (mg/kg of complete feed with a moisture content of 12%) Minimum content For chickens for fattening; chickens reared for laying:
• 100 mg/kg
For turkeys for fattening; turkeys reared for breeding:
• 60 mg/kg
Maximum content For chickens for fattening; chickens reared for laying:
• 125 mg/kg
For turkeys for fattening; turkeys reared for breeding:
• 100 mg/kg
Maximum residue limits (MRLs) of monensin sodium in food of animal origin For wet skin and fat:
• 25 µg/kg
For wet liver; wet kidney; 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 feed additive must be incorporated into compound feed in the form of a premixture
3. Monensin sodium must not be mixed with other coccidiostats
4. The following must be stated in 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 that programme must be submitted to the Scottish Ministers before the end of 19 December 2033

SCHEDULE 5
Regulation 3(1)
1 
The preparation specified in the table, belonging to the additive category “coccidiostats and histomonostats”, is authorised as an additive in animal nutrition, subject to the conditions set out in the table.
Additive Monensin sodium
Identification number 51701
Authorisation holder Huvepharma NV
Additive category Coccidiostats and histomonostats
Functional group No functional group
Additive composition Preparation of monensin sodium produced by fermentation with Streptomyces cinnamonensis (NBIMCC 3419) in powder form with the below components:
• Monensin sodium technical substance: 250g/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 (NBIMCC 3419):
• Monensin sodium A (C36H61NaO11)
• Monensin sodium B (C35H59NaO11)
• Monensin sodium C (C37H63NaO11)
• CAS number: 22373-78-0
Analytical methods For 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
For 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 For chickens for fattening:
• No maximum
For chickens reared for laying; turkeys for fattening; turkeys reared for breeding:
• 16 weeks
Content of monensin (mg/kg of complete feed with a moisture content of 12%) Minimum content For chickens for fattening; chickens reared for laying:
• 100 mg/kg
For turkeys for fattening; turkeys reared for breeding:
• 60 mg/kg
Maximum content For chickens for fattening; chickens reared for laying:
• 125 mg/kg
For turkeys for fattening; turkeys reared for breeding:
• 100 mg/kg
Maximum residue limits (MRLs) of monensin sodium in food of animal origin For wet skin and fat:
• 25 µg/kg
For wet liver; wet kidney; 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 feed additive must be incorporated into compound feed in the form of a premixture
3. Monensin sodium must not be mixed with other coccidiostats
4. The following must be stated in 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 that programme must be submitted to the Scottish Ministers before the end of 19 December 2033

SCHEDULE 6
Regulation 3(1)
1 
The preparation specified in the table, belonging to the additive category “zootechnical additives” and to the functional group “digestibility enhancers”, is authorised as an additive in animal nutrition, subject to the conditions set out in the table.
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
• 8,000 OTU/g in liquid form
Characterisation of the active substance(s) 6-phytase (EC 3.1.3.26) produced by fermentation with Komagataella phaffii (DSM 23036):
• CAS number: 9001-89-2
• EC (IUBMB) number: 3.1.3.26
Analytical methods 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 species
Maximum age No maximum
Content of 6-phytase (EC 3.1.3.26) (units of activity (OUT/kg) of complete feed with a moisture content of 12%) Minimum content For all avian species other than turkeys, and all Suidae species other than piglets:
• 125 OTU/kg
For turkeys and piglets:
• 250 OTU/kg
Maximum content No maximum
Other provisions The storage conditions and stability to heat treatment must be stated in the directions for use of the feed additive and premixture
SCHEDULE 7
Regulation 3(1)
1 
The preparation specified in the table, belonging to the additive category “zootechnical additives” and to the functional group “gut flora stabilisers”, is authorised as an additive in animal nutrition, subject to the conditions set out in the table.
Additive Bacillus velezensis (DSM 15544)
Identification number 4b1820
Authorisation holder Asahi Biocycle Co., Ltd
Additive category Zootechnical additives
Functional group Gut flora stabilisers
Additive composition Solid preparation of Bacillus velezensis (DSM 15544) containing a minimum of 1 × 10
10 colony forming units (CFU)/g
Characterisation of the active substance(s) Viable spores of Bacillus velezensis (DSM 15544)

Analytical methods 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
For identification of the feed additive:
• Pulsed-field gel electrophoresis (PFGE)
Species or category of animal 
• Weaned piglets
• All avian species
Maximum age No maximum
Colony forming units of additive/ kg complete feed with a moisture content of 12% Minimum content 3 × 108 CFU/kg
Maximum content No maximum
Other provisions The storage conditions and stability to heat treatment must be stated in the directions for use of the feed additive and premixture
SCHEDULE 8
Regulation 3(1)
1 
The preparation specified in the table, belonging to the additive category “nutritional additives” and to the functional group “amino acids, their salts and analogues”, is authorised as an additive in animal nutrition, subject to the conditions set out in the table.
Additive L-histidine monohydrochloride monohydrate
Identification number 3c352i
Authorisation holder None
Additive category Nutritional additives
Functional group Amino acids, their salts and analogues
Additive composition L-histidine monohydrochloride monohydrate with a purity criteria not less than 98% as a powder with the following components:
• 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) (C6H12ClN3O3):
• CAS number: 5934-29-2
• EINECS number: 611-821-4
Analytical methods For 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, or
• Ion-exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS/FLD)
For quantification of histidine in premixtures, feed materials and compound feed:
• Ion-exchange chromatography coupled to post-column derivatisation and photometric detection (IEC-VIS) in accordance with Commission Regulation (EC) No 152/2009 laying down the methods of sampling and analysis for the official control of feed (Annex 3-F)
For 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 No maximum
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 must contain the following declaration on the label of the additive and premixture:
 “The supplementation with L-histidine monohydrochloride monohydrate shall be limited to the nutritional requirements of the target animal, which depends on the environmental conditions, the species, physiological state, performance level of the animal and level of other amino acids and 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/m3air

SCHEDULE 9
Regulation 3(1)
1 
The preparation specified in the table, belonging to the additive category “nutritional additives” and to the functional group “amino acids, their salts and analogues”, is authorised as an additive in animal nutrition, subject to the conditions set out in the table.
Additive L-tryptophan
Identification number 3c440i
Authorisation holder None
Additive category Nutritional additives
Functional group Amino acids, their salts and analogues
Additive composition L-tryptophan with a purity criteria on a dry matter basis not less than 98% as a powder with the following components:
• Moisture content: 1% maximum
• 1,1’-ethylidene-bis-L-tryptophan: 10 mg/kg maximum
Characterisation of the active substance(s) L-tryptophan produced by fermentation with Escherichia coli (KCCM 80210) (C11H12N2O2):
• CAS number: 73-22-3
• EINECS number: 200-795-6
Analytical methods For identification of L-tryptophan in the feed additive:
• Food Chemical Codex “L-tryptophan monograph”
For 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
For determination of tryptophan in feed materials and compound feed:
• High performance liquid chromatography with fluorescence detection (HPLC-FLD) in accordance with Commission Regulation (EC) No 152/2009 laying down the methods of sampling and analysis for the official control of feed (Annex 3-G)
Species or category of animal All animal species
Maximum age No maximum
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 must 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/m3air

SCHEDULE 10
Regulation 3(1)
1 
The preparation specified in the table, belonging to the additive category “nutritional additives” and to the functional group “amino acids, their salts and analogues”, is authorised as an additive in animal nutrition, subject to the conditions set out in the table.
Additive L-lysine sulphate
Identification number 3c324i
Authorisation holder None
Additive category Nutritional additives
Functional group Amino acids, their salts and analogues
Additive composition Granulated preparation of L-lysine sulphate with a minimum of 52% L-lysine, a maximum of 24% sulphate and a maximum moisture content of 4%
Characterisation of the active substance(s) L-lysine sulphate produced by fermentation with Corynebacterium glutamicum (KCCM 80227) (C12H28N4O4·H2SO4):
• CAS Number: 60343-69-3
Analytical methods For 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
For identification of sulphate in the feed additive:
• European Pharmacopoeia Monograph 20301
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 (EC) No 152/2009 laying down the methods of sampling and analysis for the official control of feed (Annex 3-F)
For 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 No maximum
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. The following must be stated on the labelling of the additive and premixture:“The supplementation with L-lysine should take into account all essential and conditionally essential amino acids in order to avoid imbalances.”
SCHEDULE 11
Regulation 3(1)
1 
The substance specified in the table, belonging to the additive category “technological additives” and to the functional group “antioxidants”, is authorised as an additive in animal nutrition, subject to the conditions set out in the table.
Additive Butylated hydroxyanisole (BHA)
Identification number 1b320
Authorisation holder None
Additive category Technological additives
Functional group Antioxidants
Additive composition Butylated hydroxyanisole (BHA) with a minimum content of 98.5% in a waxy solid form
Characterisation of the active substance(s) Butylated hydroxyanisole containing a mixture of 2-tert-butyl-4-hydroxyanisole and a minimum of 85% 3-tert-butyl-4-hydroxyanisole (C11H16O2):
• CAS number: 25013-16-5
Analytical methods For quantification of butylated hydroxyanisole (BHA) in feed additives:
• Gas chromatography coupled to flame ionization detection (GC-FID) Food Chemical Codex 7th edition method
For quantification of butylated hydroxyanisole (BHA) 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 No maximum
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 (BHA) is authorised to be used in combination with butylated hydroxytoluene (BHT) only up to a maximum combined content of 150 mg/kg of complete feed
SCHEDULE 12
Regulation 3(1)
1 
The preparation specified in the table, belonging to the additive category “nutritional additives” and to the functional group “amino acids, their salts and analogues”, is authorised as an additive in animal nutrition, subject to the conditions set out in the table.
Additive L-lysine base (liquid)
Identification number 3c320
Authorisation holder None
Additive category Nutritional additives
Functional group Amino acids, their salts and analogues
Additive composition Aqueous solution with a minimum of 50% L-lysine
Characterisation of the active substance(s) L-lysine base (liquid) (NH2(CH2)CH(NH2)COOH) produced by fermentation with Corynebacterium glutamicum (KCCM 80183):
• CAS no: 56-87-1
Analytical methods For 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
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 (EC) No 152/2009 laying down the methods of sampling and analysis for the official control of feed (Annex 3, F)
For 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 (EC) No 152/2009 laying down the methods of sampling and analysis for the official control of feed (Annex 3-F)
Species or category of animal All animal species
Maximum age No maximum
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. The following must be stated on the labelling of the additive and premixture:“The supplementation with L-lysine, in particular via water for drinking, should take into account all essential and conditionally essential amino acids in order to avoid imbalances.”
SCHEDULE 13
Regulation 3(1)
1 
The substance specified in the table, belonging to the additive category “nutritional additives” and to the functional group “amino acids, their salts and analogues”, is authorised as an additive in animal nutrition, subject to the conditions set out in the table.
Additive L-lysine monohydrochloride (technically pure)
Identification number 3c322ii
Authorisation holder None
Additive category Nutritional additives
Functional group Amino acids, their salts and analogues
Additive composition Powder of L-lysine monohydrochloride with a minimum of 78% L-lysine and a maximum moisture content of 1.5%
Characterisation of the active substance(s) L-lysine monohydrochloride (technically pure) (NH2(CH2)4CH(NH2)COOH) produced by fermentation with Corynebacterium glutamicum (KCCM 80183):
• CAS number: 657-27-2
Analytical methods For identification of L-lysine monohydrochloride in the feed additive:
• Food Chemicals Codex “L-lysine monohydrochloride monograph”
For 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
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 (EC) No 152/2009 laying down the methods of sampling and analysis for the official control of feed (Annex 3, F)
For 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 (EC) No 152/2009 laying down the methods of sampling and analysis for the official control of feed (Annex 3, F)
Species or category of animal All animal species
Maximum age No maximum
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. The following must be stated on the labelling of the additive and premixture:“The supplementation with L-lysine, in particular via water for drinking, should take into account all essential and conditionally essential amino acids in order to avoid imbalances.”
SCHEDULE 14
Regulation 3(1)
1 
The substance specified in the table, belonging to the additive category “sensory additives” and to the functional group “flavouring compounds”, is authorised as an additive in animal nutrition, subject to the conditions set out in the table.
Additive Disodium 5’-guanylate
Identification number 2b627i
Authorisation holder None
Additive category Sensory additives
Functional group Flavouring compounds
Additive composition Powder of disodium 5’-guanylate with a minimum purity criteria of 97%
Characterisation of the active substance(s) Hydrated form of disodium 5’-guanylate (GMP) produced by fermentation with Corynebacterium stationis (KCCM 10530) and Escherichia
 coli K-12 (KFCC 11067) (C10H12N5Na2O8P):
• CAS number: 5550-12-9
• EINECS number: 226-914-1
Analytical methods For identification of disodium 5’-guanylate (GMP) in the feed additive:
• FAO JECFA monograph “disodium 5’-guanylate”
For 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 No maximum
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. The following must be stated on the labelling of the additive:“Recommended maximum content of the active substance when used alone or in combination with other ribonucleotides up to the same level per kg (mg/kg of complete feed with a moisture content of 12%): 50 mg.”
4. The functional group, identification number, name and added amount of the active substance must be indicated on the label of the premixture where the use level on the label of the premixture would result in the level of active substance (alone or in combination with other ribonucleotides) in complete feed exceeding 50 mg/kg
SCHEDULE 15
Regulation 3(1)
1 
The preparation specified in the table, belonging to the additive category “zootechnical additives” and to the functional group “other zootechnical additives”, is authorised as an additive in animal nutrition, subject to the conditions set out in the table.
Additive Muramidase (EC 3.2.1.17)
Identification number 4d16
Authorisation holder DSM Nutritional Products Ltd
Additive category Zootechnical additives
Functional group Other zootechnical additives
Additive composition Solid and liquid preparations of muramidase (EC 3.2.1.17) produced by fermentation with Trichoderma reesei (DSM 32338) having a minimum enzyme activity of 60,000 LSU(F)/g
Characterisation of the active substance(s) Muramidase (EC 3.2.1.17) produced by fermentation with Trichoderma reesei (DSM 32338):
• CAS number: 9001-63-2
• EINECS number: 232-620-4
• EC (IUBMB) number: 3.2.1.17
Analytical methods For 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 No maximum
Content of muramidase (LSU(F)/kg of complete feed with a moisture content of 12%) Minimum content 50,000 LSU(F)/kg
Maximum content 65,000 LSU(F)/kg
Other provisions The storage conditions and stability to heat treatment must be stated in the directions for use of the feed additive and premixture
SCHEDULE 16
Regulation 3(1)
1 
The substance specified in the table, belonging to the additive category “nutritional additives” and to the functional group “vitamins, pro-vitamins and chemically well-defined substances having a similar effect”, is authorised as an additive in animal nutrition, subject to the conditions set out in the table.
Additive Vitamin K1 or Phytomenadione
Identification number 3a712
Authorisation holder None
Additive category Nutritional additives
Functional group Vitamins, pro-vitamins and chemically well-defined substances having similar effect
Additive composition Produced by chemical synthesis:
• Solid preparation containing a minimum of 4.2% of phytomenadione (vitamin K1)
Characterisation of the active substance(s) 2-methyl-3-[(E-7R,11R)-3,7,11,15-tetramethylhexadec-2- enyl] naphthalene-1,4-dione (phytomenadione) (C31H46O2):
• CAS number: 84-80-0
• EINECS number: 201-564-2with 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 methods For determination of phytomenadione (vitamin K1) in the feed additive:
• High performance liquid chromatography (HPLC) in accordance with the European Pharmacopoeia monograph
For 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
Species or category of animal Horses
Maximum age No maximum
Content of phytomenadione (vitamin K1) (mg/kg of complete feed with a moisture content of 12%) Minimum content No minimum
Maximum content No maximum
Other provisions The storage conditions and stability to heat treatment must be stated in the directions for use of the feed additive and premixture
SCHEDULE 17
Regulation 3(1)
1 
The preparation specified in the table, belonging to the additive category “nutritional additives” and to the functional group “compounds of trace elements”, is authorised as an additive in animal nutrition, subject to the conditions set out in the table.
Additive Copper chelate of hydroxy analogue of methionine
Identification number 3b410i
Authorisation holder None
Additive category Nutritional additives
Functional group Compounds of trace elements
Additive composition Copper chelate of hydroxy analogue of methionine in solid form containing a minimum of 16% copper and the following components:
• (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(CH3S(CH2)2-CH(OH)-COO)2):
• CAS number: 292140-30-8
Analytical methods For quantification of the hydroxy analogue of methionine content in the feed additive:
• Titrimetry, potentiometric titration after oxidation reduction reaction
For quantification of total copper in the feed additive:
• Inductively coupled plasma atomic emission spectrometry (ICP-AES) in accordance with BS EN 15510:2017 or BS EN 15621:2017); or

• Atomic absorption spectrometry (AAS) in accordance with BS EN ISO 6869:2001
For quantification of total copper in premixtures:
• Inductively coupled plasma atomic emission spectrometry (ICP-AES) in accordance with BS EN 15510:2017 or BS EN 15621:2017;
• Atomic absorption spectrometry (AAS) in accordance with BS EN ISO 6869:2001; or
• Inductively coupled plasma mass spectrometry (ICP-MS) in accordance with BS EN 17053:2018
For quantification of total copper in feed materials and compound feed:
• Inductively coupled plasma atomic emission spectrometry (ICP-AES) in accordance with BS EN 15510:2017 or BS EN 15621:2017;
• Atomic absorption spectrometry (AAS) in accordance with Commission Regulation (EC) No 152/2009 (Annex 4-C) or BS EN ISO 6869:2001; or
• Inductively coupled plasma mass spectrometry (ICP-MS) in accordance with BS EN 17053:2018
Species or category of animal All animal species
Maximum age No maximum
Content of copper (Cu) (mg/kg of complete feed with a moisture content of 12%) Minimum content No minimum
Maximum content For bovines:
• before the start of rumination - 15 mg/kg (total)
• other - 30 mg/kg (total)
For ovines:
• 15 mg/kg (total)
For caprines:
• 35 mg /kg
For piglets:
• suckling and weaned up 4 weeks after weaning – 150 mg/kg (total)
• from 5th week up to 8 weeks after weaning – 100 mg/kg (total)
For crustaceans:
• 50 mg/kg (total)
For all other animal species:
• 25 mg/kg (total)
Other provisions 1. The additive must be incorporated into feed in the form of a premixture
2. For feed for sheep, where the level of copper in the feed exceeds 10 mg/kg, the following must be stated on the labelling of the feed:“The level of copper in this feed may cause poisoning in certain breeds of sheep.”
3. For feed for bovines after the start of rumination, where the level of copper in the feed is less than 20 mg/kg, the following must be stated on the labelling of the feed:“The level of copper in this feed may cause copper deficiencies in cattle grazing pastures with high contents of molybdenum or sulphur.”
SCHEDULE 18
Regulation 3(1)
1 
The preparation specified in the table, belonging to the additive category “nutritional additives” and to the functional group “compounds of trace elements”, is authorised as an additive in animal nutrition, subject to the conditions set out in the table.
Additive Manganese chelate of hydroxy analogue of methionine
Identification number 3b510
Authorisation holder None
Additive category Nutritional
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(CH3S(CH2)2-CH(OH)-COO)2):
• CAS number: 292140-29-5
Analytical methods For quantification of the hydroxy analogue of methionine content in the feed additive:
• Titrimetry, potentiometric titration after oxidation reduction reaction
For quantification of total manganese in the feed additive and premixtures:
• Atomic absorption spectrometry, (AAS) in accordance with BS EN ISO 6869:2001,
• Inductively coupled plasma atomic emission spectrometry (ICP-AES) in accordance with BS EN 15510:2017, or
• Inductively coupled plasma atomic absorption spectrometry (AAS) after pressure digestion, (ICP-AES) in accordance with BS EN 15621:2017
For quantification of total manganese in feed materials and compound feed:
• Atomic absorption spectrometry (AAS) in accordance with Commission Regulation (EC) No 152/2009 (Annex 4-C),
• Atomic absorption spectrometry (ASS) in accordance with BS EN ISO 6869:2001,
• Inductively coupled plasma – atomic emission spectrometry, (ICP-AES) in accordance with BS EN 15510:2017, or
• Inductively coupled plasma – atomic emission spectrometry after pressure digestion, (ICP-AES) in accordance with BS EN 15621:2017
Species or category of animal All animal species
Maximum age No maximum
Content of manganese (Mn) (mg/kg of complete feed with a moisture content of 12%) Minimum content No minimum
Maximum content For fish:
• 100 mg/kg (total)
For all 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
SCHEDULE 19
Regulation 3(1)
1 
The preparation specified in the table, belonging to the additive category “nutritional additives” and to the functional group “compounds of trace elements”, is authorised as an additive in animal nutrition, subject to the conditions set out in the table.
Additive Zinc chelate of hydroxy analogue of methionine
Identification number 3b610
Authorisation holder None
Additive category Nutritional
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(CH3S(CH2)2-CH(OH)-COO)2):
• CAS number: 292140-29-5
Analytical methods For quantification of the hydroxy analogue of methionine content in the feed additive:
• Titrimetry, potentiometric titration after oxidation reduction reaction
For quantification of total zinc in the feed additive:
• Inductively coupled plasma atomic emission spectrometry (ICP-AES) in accordance with BS EN 15510:2017 or BS EN 15621:2017, or

• Atomic absorption spectrometry (AAS) in accordance with BS EN ISO 6869:2001
For quantification of total zinc in premixtures:
• Inductively coupled plasma atomic emission spectrometry (ICP-AES) in accordance with BS EN 15510:2017 or BS EN 15621:2017,
• Atomic absorption spectrometry (AAS) in accordance with BS EN ISO 6869:2001, or
• Inductively coupled plasma mass spectrometry (ICP-MS) in accordance with BS EN 17053:2018
For quantification of total zinc in feed materials and compound feed:
• Inductively coupled plasma atomic emission spectrometry (ICP-AES) in accordance with BS EN 15510:2017 or BS EN 15621:2017,
• Atomic absorption spectrometry (AAS) in accordance with Commission Regulation (EC) No 152/2009 (Annex 4-C) or BS EN ISO 6869:2001, or
• Inductively coupled plasma mass spectrometry (ICP-MS) in accordance with BS EN 17053:2018
Species or category of animal All animal species
Maximum age No maximum
Content of zinc (Zn) (mg/kg of complete feed with a moisture content of 12%) Minimum content No minimum
Maximum content For cats:
• 200 mg/kg (total)
For dogs:
• 200mg/kg (total)
For fish:
• Salmonids – 180 mg/kg (total)
• Other – 150 mg/kg (total)
For milk replacers for calves:
• 180 mg/kg (total)
For rabbits:
• 150 mg/kg (total)
For Suidae:
• Piglets, sows – 150 mg/kg (total)
• Other – 120 mg/kg (total)
For all 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
SCHEDULE 20
Regulation 3(1)
1 
The preparation specified in the table, belonging to the additive category “technological additives” and to the functional group “substances for reduction of the contamination of feed by mycotoxins”, is authorised as an additive in animal nutrition, subject to the conditions set out in the table.
Additive Fumonisin esterase (EC 3.1.1.87)
Identification number 1m03i
Authorisation holder None
Additive category Technological additives
Functional group Substances for reduction of the contamination of feed by mycotoxins
Additive composition Preparation of fumonisin esterase (EC 3.1.1.87) produced by fermentation with Komagataella phaffii (DSM 32159) having a minimum enzyme activity of 3000 U/g
Characterisation of the active substance(s) Fumonisin esterase (EC 3.1.1.87) produced by Komagataella phaffii (DSM 32159):
• EC (IUBMB) Number: 3.1.1.87
Analytical methods For 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 B1 at pH 8.0 and 30 ºC
Species or category of animal All animal species
Maximum age No maximum
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 additive is authorised for use only in maize-based silages
SCHEDULE 21
Regulation 22
1 
Commission Regulation (EC) No 109/2007 concerning the authorisation of monensin sodium (Coxidin) as a feed additive.
2 
Commission Regulation (EU) No 333/2010 concerning the authorisation of a new use of 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.).
3 
Commission Regulation (EU) No 335/2010 concerning the authorisation of zinc chelate of hydroxy analogue of methionine as a feed additive for all animal species.
4 
Commission Regulation (EU) No 349/2010 concerning the authorisation of copper chelate of hydroxy analogue of methionine as a feed additive for all animal species.
5 
Commission Regulation (EU) No 350/2010 concerning the authorisation of manganese chelate of hydroxy analogue of methionine as a feed additive for all animal species.
6 
Commission Regulation (EU) No 170/2011 concerning the authorisation of Saccharomyces cerevisiae MUCL 39885 as a feed additive for piglets (weaned) and amending Regulation (EC) No 1200/2005 (holder of authorisation Prosol SpA).
7 
Commission Regulation (EU) No 184/2011 concerning the authorisation of 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.).
8 
Commission Implementing Regulation (EU) No98/2012 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).
9 
Commission Implementing Regulation (EU) No140/2012 concerning the authorisation of monensin sodium as a feed additive for chickens reared for laying (holder of authorisation Huvepharma NV Belgium).
10 
Commission Implementing Regulation (EU) 2019/893 concerning the renewal of the authorisation of Bacillus subtilis DSM 15544 as a feed additive for chickens for fattening and repealing Regulation (EC) No 1444/2006 (holder of authorisation Asahi Calpis Wellness Co. Ltd, represented in the European Union by Pen & Tec Consulting S.L.U.).
11 
Commission Implementing Regulation (EU) 2020/146 amending Regulation (EU) No333/2010, Implementing Regulation (EU) 2017/2312, Implementing Regulation (EU) 2018/1081, Implementing Regulation (EU) 2016/897, Implementing Regulation (EU) 2019/893 and Regulation (EU) No184/2011 concerning the authorisations of the preparation of Bacillus subtilis C-3102 (DSM 15544) as a feed additive.