
1 

(1) These Regulations may be cited as the Feed Additives (Authorisations) (Scotland) Regulations 2022 and come into force on 24 November 2022.
(2) These Regulations extend to Scotland only.
2 

(1) In these Regulations—
 “Regulation (EC) 1831/2003” means Regulation (EC) No. 1831/2003 of the European Parliament and of the Council on additives for use in animal nutrition, and
 “Regulation (EC) 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) Unless the contrary intention appears, any expression used both in these Regulations and in Regulation (EC) 1831/2003 or Regulation (EC) 767/2009 has the same meaning as it has in those Regulations.
3 

(1) The terms of modifications of authorisations in these Regulations are to be in the same form as authorisations under Article 9 of Regulation (EC) 1831/2003.
(2) Schedules 1 to 11 have effect.
(3) Subject to Article 14(4) (renewal of authorisation) of Regulation (EC) 1831/2003, the authorisations set out in schedules 1 to 11 cease to have effect at the end of 23 November 2032.
4 

(1) Commission Implementing Regulation (EU) No. 306/2013 concerning the authorisation of a preparation of Bacillus subtilis (ATCC PTA-6737) for weaned piglets and weaned Suidae other than Sus scrofa domesticus (holder of authorisation Kemin Europa N.V.) is amended as follows.
(2) In the Annex, in the table, in the column headed—
(a) “Additive”, for “Bacillus subtilis” substitute “Bacillus velezensis”, and
(b) “Composition, chemical formula, description, analytical method”, for “Bacillus subtilis”, in each place it occurs, substitute “Bacillus velezensis”.
5 

(1) Commission Implementing Regulation (EU) No. 787/2013 concerning the authorisation of a preparation of Bacillus subtilis (ATCC PTA-6737) as a feed additive for turkeys for fattening and turkeys reared for breeding (holder of authorisation Kemin Europa N.V.) is amended as follows.
(2) In the Annex, in the table, in the column headed—
(a) “Additive”, for “Bacillus subtilis” substitute “Bacillus velezensis”, and
(b) “Composition, chemical formula, description, analytical method”, for “Bacillus subtilis”, in each place it occurs, substitute “Bacillus velezensis”.
6 

(1) Commission Implementing Regulation (EU) 2015/1020 concerning the authorisation of the preparation of Bacillus subtilis (ATCC PTA-6737) as a feed additive for laying hens and minor poultry species for laying (holder of the authorisation Kemin Europa NV) is amended as follows.
(2) In the Annex, in the table, in the column headed—
(a) “Additive”, for “Bacillus subtilis” substitute “Bacillus velezensis”, and
(b) “Composition, chemical formula, description, analytical method”, for “Bacillus subtilis”, in each place it occurs, substitute “Bacillus velezensis”.
7 

(1) Commission Implementing Regulation (EU) 2017/2276 concerning the authorisation of a new use of the preparation of Bacillus subtilis (ATCC PTA-6737) as a feed additive for sows (holder of the authorisation Kemin Europa N.V.) is amended as follows.
(2) In the Annex, in the table, in the column headed—
(a) “Additive”, for “
Bacillus subtilis” substitute “Bacillus velezensis”, and
(b) “Composition, chemical formula, description, analytical method”, for “Bacillus subtilis”, in each place it occurs, substitute “Bacillus velezensis”.
8 

(1) The relevant feed additive, and premixtures containing it, which are produced and labelled before the end of 23 May 2023 in accordance with the conditions of the prior authorisation, may continue to be placed on the market and used until the existing stocks are exhausted.
(2) Compound feed, and feed materials containing the relevant feed additive, intended for food-producing animals, which are produced and labelled before the end of 23 November 2023 in accordance with the conditions of the prior authorisation, may continue to be placed on the market and used until the existing stocks are exhausted.
(3) In this regulation—
 “relevant feed additive” means the feed additive Saccharomyces cerevisiae CNCM I-4407, with the identification number 4b1702, which was previously authorised under the prior authorisation, and
 “the prior authorisation” means Commission Regulation (EU) No. 883/2010 concerning the authorisation of a new use of Saccharomyces cerevisiae NCYC Sc 47 as a feed additive for calves for rearing (holder of the authorisation Société industrielle Lesaffre).
9 

(1) Any substance or product labelled “Bacillus subtilis (ATCC PTA-6737)”, or as containing “Bacillus subtilis (ATCC PTA-6737)”, but otherwise produced and labelled in accordance with an authorisation contained in retained direct EU legislation mentioned in regulations 4 to 7, 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 23 May 2023 in accordance with the conditions of the prior authorisation, may continue to be placed on the market and used until the existing stocks are exhausted.
(3) Compound feed, and feed materials containing the relevant feed additive, intended for food-producing animals, which are produced and labelled before the end of 23 November 2023 in accordance with the conditions of the prior authorisation, may continue to be placed on the market and used until the existing stocks are exhausted.
(4) Compound feed, and feed materials containing the relevant feed additive, intended for non-food-producing animals, which are produced and labelled before the end of 23 November 2024 in accordance with the conditions of the prior authorisation, may continue to be placed on the market and used until the existing stocks are exhausted.
(5) In this regulation—
 “relevant feed additive” means the feed additive Bacillus velezensis ATCC PTA-6737 or, as formerly designated, Bacillus subtilis ATCC PTA-6737, with the identification number 4b1823, which was previously authorised under the prior authorisation, and
 “the prior authorisation” means—
 Commission Regulation (EU) No. 107/2010 concerning the authorisation of Bacillus subtilis ATCC PTA-6737 as a feed additive for chickens for fattening (holder of authorisation Kemin Europa NV), or
 Commission Implementing Regulation (EU) No. 885/2011 concerning the authorisation of Bacillus subtilis (ATCC PTA-6737) as a feed additive for chickens reared for laying, ducks for fattening, quails, pheasants, partridges, guinea fowl, pigeons, geese for fattening and ostriches (holder of the authorisation Kemin Europa N.V.).
10 

(1) The relevant feed additive, and feed containing it, which are produced and labelled before the end of 23 May 2023 in accordance with the conditions of the prior authorisation, may continue to be placed on the market and used until the existing stocks are exhausted.
(2) In this regulation—
 “relevant feed additive” means the feed additive decoquinate (Deccox®), which was previously authorised under the prior authorisation with the identification number E756, and
 “the prior authorisation” means Regulation (EC) No. 1289/2004 concerning the authorisation for 10 years of the additive Deccox® in feedingstuffs, belonging to the group of coccidiostats and other medicinal substances.
11 
The retained direct EU legislation listed in schedule 12 is revoked subject to regulations 8, 9(2) to (5) and 10.
MAREE TODD
Authorised to sign by the Scottish Ministers
St Andrew’s House,
Edinburgh
27th September 2022
SCHEDULE 1
Regulation 3(2)
1 
The preparation specified in the table in this schedule, 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 in this schedule.

Column 1 Column 2
Additive Manganese chelate of lysine and glutamic acid
Identification number of the additive 3b509
Authorisation holder 
Additive category Nutritional additives
Functional group Compounds of trace elements
Additive composition A preparation of chelates of manganese with lysine and chelates of manganese with glutamic acid in a ratio of 1:1 as a powder with the following components:

• Manganese 15-17%
• Lysine 20-21.5%
• Glutamic acid 22-24%
• Moisture 3.5% maximum
• Nickel 4 ppm maximum
Characterisation of the active substance(s) Manganese-2,6-diaminohexanoic acid, chloride and hydrogen sulphate salt (C6H19ClN2O8SMn).Manganese-2-aminopentanedioic acid, sodium and hydrogen sulphate salt (C5H10NNaO9SMn).
Analytical method 1. For quantification of total manganese in the feed additive and premixtures:

• Atomic Absorption Spectrometry (AAS) in accordance with international standard BS EN ISO 6869:2000 entitled “Animal feeding stuffs. Determination of the contents of calcium, copper, iron, magnesium, manganese, potassium, sodium and zinc. Method using atomic absorption spectrometry”;
• Inductively Coupled Plasma-Atomic Emission Spectrometry, (ICP-AES) in accordance with European standard EN 15510:2017 entitled “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” (for premixtures and feed only); or
• Inductively Coupled Plasma-Atomic Emission Spectrometry after pressure digestion (ICP-AES) in accordance with European standard EN 15621:2017 entitled “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”.
2. For quantification of total manganese in feed materials and compound feed:

• Atomic Absorption Spectrometry (AAS) – Commission Regulation (EC) No. 152/2009 laying down the methods of sampling and analysis for the official control of feed (Annex 4-C);
• Atomic Absorption Spectrometry, AAS in accordance with international standard BS EN ISO 6869:2001;
• Inductively Coupled Plasma-Atomic Emission Spectrometry, (ICP-AES) in accordance with European standard EN 15510:2017 entitled “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” (for premixtures and feed only); or
• Inductively Coupled Plasma – Atomic Emission Spectrometry after pressure digestion, ICP-AES (EN 15621).
3. For quantification of lysine and glutamic acid in the feed additive:

• Ion exchange chromatography coupled with post-column derivatisation and photometric detection (IEC-VIS).
4. For proving the chelated structure of the feed additive:

• Mid-infrared (IR) spectrometry together with the determination of the content of trace element and lysine and glutamic acid in the feed additive.
Species or category of animal All animal species
Maximum age Not applicable
Content of Manganese chelate of lysine and glutamic acid in mg/kg of complete feed with a moisture content of 12% Minimum content No minimum
Maximum content Fish 100 (total)All other animal species 150 (total)
Other provisions The additive must be incorporated into the feed in the form of a premixture.
SCHEDULE 2
Regulation 3(2)
1 
The preparation specified in the table in this schedule, belonging to the additive category ‘technological additives’ and to the functional group ‘silage additives’, is authorised as an additive in animal nutrition, subject to the conditions set out in the table in this schedule.

Column 1 Column 2
Additive Lactobacillus buchneri DSM 29026
Identification number of the additive 1k20759
Authorisation holder 
Additive category Technological additives
Functional group Silage additives
Additive composition A preparation of Lactobacillus buchneri DSM 29026 containing a minimum of 2 x 1010 CFU/g additive
Characterisation of the active substance(s) Viable cells of Lactobacillus buchneri DSM 29026
Analytical methods 1. For enumeration (colony count) of the feed additive:

• Spread plate method on MRS agar in accordance with European standard EN 15787:2021 entitled “Animal feeding stuffs: Methods of sampling and analysis – Detection and enumeration of Lactobacillus spp. used as feed additive”
2. For identification of bacterial strain:

• Pulsed Field Gel Electrophoresis (PFGE)
Species or category of animal All animal species
Maximum age Not applicable
Content of Lactobacillus buchneri DSM 29026 in CFU of additive/kg of fresh material Minimum content Minimum content of the additive when not combined with other micro-organisms as silage additives: 5x107 CFU/kg of easy and moderately difficult to ensile fresh material.
Maximum content No maximum
Other provisions In the directions for use of the additive and premixtures, the storage conditions must be indicated.
SCHEDULE 3
Regulation 3(2)
1 
The preparation specified in the table in this schedule, 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 in this schedule.

Column 1 Column 2
Additive Serine protease
Identification number of the additive 4a13
Authorisation holder DSM Nutritional Products Ltd in Switzerland
Additive category Zootechnical additives
Functional group Digestibility enhancers
Additive composition Solid and liquid preparation of serine protease (EC 3.4.21.-1)

• Produced by 
Bacillus licheniformis DSM 19670
• Having a minimum activity of 75,000 PROT/g
Characterisation of the active substance(s) Serine protease (EC 3.4.21.-1) produced by Bacillus licheniformis DSM 19670CAS number: 37259-58-8 (serine protease)EINECS number: 253-431-3IUB number: 3.4.21.-1
Analytical methods For quantification of serine protease activity in the feed additive, premixtures, compound feed and feed materials:

• Colourimetric method based on the enzymatic reaction of serine protease on the Suc-Ala-Ala-Pro-Phe-pNA substrate
Species or category of animal Chickens for fattening
Maximum age Not applicable
Content of Serine protease (units of activity/kg of complete feed with a moisture content of 12%) Minimum content 15,000 PROT/kg
Maximum content No maximum
Other provisions In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment must be indicated.
SCHEDULE 4
Regulation 3(2)
1 
The additive specified in the table in this schedule, 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, subject to the conditions set out in the table in this schedule.

Column 1 Column 2
Additive Pyridoxine hydrochloride (vitamin B6)
Identification number of the additive 3a831
Authorisation holder 
Additive category Nutritional additives
Functional group Vitamins, pro-vitamins and chemically well-defined substances having similar effect
Additive composition Pyridoxine hydrochloride: C8H11NO3.HCIPurity criteria not less than 98.5%
Characterisation of the active substance(s) Pyridoxine hydrochlorideCAS no:58-56-0EINECS no:200-386-2
Analytical methods 1. For the determination of pyridoxine hydrochloride (Vitamin B6) in the feed additive:

• Titration with perchloric acid (Ph.Eur. 10th edition, monograph 0245)
2. For the determination of pyridoxine hydrochloride (Vitamin B6) in premixtures:

• Reversed phase High Performance Liquid Chromatography coupled to UV detector (RP-HPLC-UV) in accordance with the VDLUFA Method Book, Volume III, 13.9.1
3. For the determination of pyridoxine hydrochloride (Vitamin B6) in feed and water:

• Reversed phase High Performance Liquid Chromatography coupled to fluorescence detector (RP-HPLC-FLD) – method based in accordance with European standard EN 14164:2014 entitled “
Foodstuffs – Determination of vitamin B6 by high performance chromatography”
Species or category of animal All animal species
Maximum age Not applicable
Content of Pyridoxine hydrochloride (Vitamin B6) in mg/kg of complete feed with a moisture content of 12% Minimum content No minimum
Maximum content No maximum
Other provisions 1. In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment must be indicated.
2. Pyridoxine hydrochloride (Vitamin B
6) may be used via water for drinking.

SCHEDULE 5
Regulation 3(2)
1 
The preparation specified in the table in this schedule, 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 in this schedule.

Column 1 Column 2
Additive Saccharomyces cerevisiae CNCM I-4407 (ACTISAF® Sc 47)

Identification number of the additive 4b1702
Authorisation holder S.I. Lesaffre
Additive category Zootechnical additives
Functional group Gut flora stabilisers
Additive composition Solid form preparation of Saccharomyces cerevisiae CNCM I-4407 containing a minimum of 5x109 CFU/g
Characterisation of the active substance(s) Viable dried cells Saccharomyces cerevisiae CNCM I-4407
Analytical methods 1. For enumeration (colony count):

• Pour plate method using CGYE (yeast extract glucose chloramphenicol) agar in accordance with European standard EN 15789:2021 entitled “
Animal feeding stuffs: Methods of sampling and analysis – Detection and enumeration of Saccharomyces cerevisiae used as feed additive”
2. For identification of yeast strain:

• Polymerase chain reaction (PCR) method in accordance with DD CEN/TS 15790:2008 entitled “Animal Feeding Stuffs – PCR typing of probiotic strains of Sacccharomyces cerevisiae (yeast)”
Species or category of animal Calves for rearing
Maximum age Not applicable
Content of Saccharomyces cerevisiae CNCM I-4407 in CFU/kg of complete feed with a moisture content of 12% Minimum content 1.5 x 109 CFU/kg
Maximum content No maximum
Other provisions In the directions of use of the additive and premixtures, the storage conditions and stability to heat treatment must be indicated.
SCHEDULE 6
Regulation 3(2)
1 
The preparation specified in the table in this schedule, 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 in this schedule.

Column 1 Column 2
Additive Bacillus velezensis (ATCC PTA-6737)
Identification number of the additive 4b1823
Authorisation holder Kemin Europa N.V.
Additive category Zootechnical additives
Functional group Gut flora stabilisers
Additive composition Preparation of Bacillus velezensis ATCC PTA-6737 containing a minimum of 8 x 1010 CFU/g additive
Characterisation of the active substance(s) Viable spores of Bacillus velezensis (ATCC PTA-6737)
Analytical methods 1. For enumeration (colony count):

• Spread plate method using tryptone soya agar with pre-heat treatment of feed samples
2. For identification of bacterial strain

• Pulsed-field gel electrophoresis (PFGE)
Species or category of animal Chickens for fattening, chickens reared for laying, minor poultry species (except for laying), ornamental, sporting and game birds
Maximum age Not applicable
Content of Bacillus velezensis (ATCC PTA-6737) in CFU/kg of complete feed with a moisture content of 12% Minimum content 1 x 107 CFU/kg
Maximum content No maximum
Other provisions 1. In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment must be indicated.2. Where Bacillus velezensis (ATCC PTA-6737) 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,
• Lasalocid,
• Maduramycin,
• Monensin,
• Narasin,
• Narasine/Nicarbazin (as combined use only),
• Robenidine,
• Salinomycin.
SCHEDULE 7
Regulation 3(2)
1 
The preparation specified in the table in this schedule, 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 in this schedule.

Column 1 Column 2
Additive Bacillus licheniformis DSM 28710

Identification number of the additive 4b1828
Authorisation holder HuvePharma NV
Additive category Zootechnical additives
Functional group Gut flora stabilisers
Additive composition Solid form preparation of Bacillus licheniformis DSM 28710 containing a minimum of 3.2 x 109 CFU/g of additive
Characterisation of the active substance(s) Viable spores of Bacillus licheniformis DSM 28710

Analytical methods 1. For enumeration (colony count) in the additive, premixture and feed:

• Spread plate method in accordance with European standard EN 15784:2021 entitled “Animal feeding stuffs: Methods of sampling and analysis – Detection and enumeration of Bacillus spp. used as feed additive”
2. For identification of bacterial strain:

• Pulsed field gel electrophoresis (PFGE)
Species or category of animal Laying hens, minor poultry species for laying, poultry species for breeding and ornamental birds
Maximum age Not applicable
Content of Bacillus licheniformis DSM 28710 in CFU/kg of complete feed with a moisture content of 12% Minimum content 1.6 x 109 CFU/kg

Maximum content No maximum
Other provisions 1. In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment must be indicated.2. Where Bacillus licheniformis DSM 28710 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:

• Diclazuril
• Lasalocid A sodium
SCHEDULE 8
Regulation 3(2)
1 
The preparation specified in the table in this schedule, 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 in this schedule.

Column 1 Column 2
Additive Clostridium butyricum (FERM BP-2789)

Identification number of the additive 4b1830
Authorisation holder Miyarisan Pharmaceutical Co. Ltd
Additive category Zootechnical additives
Functional group Gut flora stabilisers
Additive composition Solid form preparation of Clostridium butyricum (FERM BP-2789) containing a minimum of 5 x 108 CFU/g additive

Characterisation of the active substance(s) Viable spores of Clostridium butyricum FERM BP-2789

Analytical methods 1. For enumeration (colony count):

• Pour plate method in accordance with international standard BS ISO 15213:2003 entitled “Microbiology of food and animal feeding stuffs. Horizontal method for the enumeration of sulphite-reducing bacteria growing under anaerobic conditions”
2. For identification of bacterial strain:

• Pulsed-field gel electrophoresis (PFGE)
Species or category of animal Turkeys for fattening; turkeys reared for breeding; chickens for fattening; chickens reared for laying; minor avian species (excluding laying birds); piglets and piglets of minor porcine species
Maximum age Not applicable
Content of Clostridium butyricum (FERM BP-2789) in CFU/kg of complete feed with a moisture content of 12% Minimum content Turkeys: 1.25 x 108 CFU/kgChickens, minor avian species, piglets and minor porcine species: 2.5 x 108 CFU/kg
Maximum content All species and categories of animal as provided for above: no maximum
Other provisions 1. In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment must be indicated.2. Where Clostridium butyricum (FERM BP-2789) 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,
• Lasalocid,
• Maduramicin ammonium,
• Monensin sodium,
• Narasin,
• Narasin/Nicarbazin (as combined use only),
• Robenidine,
• Salinomycin sodium,
• Semduramicin sodium.
SCHEDULE 9
Regulation 3(2)
1 
The preparation specified in the table in this schedule, 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 in this schedule.

Column 1 Column 2
Additive 6-phytase (EC 3.1.3.26)
Identification number of the additive 4a32
Authorisation holder Huvepharma EOOD
Additive category Zootechnical additives
Functional group Digestibility enhancers
Additive composition Preparation of 6-phytase (EC 3.1.3.26) produced by Komagataella phaffii (DSM 32854)In granular, coated and liquid forms, minimum activity 5000 FTU/g
Characterisation of the active substance(s) 6-phytase (EC 3.1.3.26) produced by Komagataella phaffii (DSM 32854)

Analytical methods 1. For quantification of phytase activity in the feed additive:

• Colorimetric method based on the enzymatic reaction of phytase on the phytate in accordance with the VDLUFA Method Book, Volume III, Part 27.1.4
2. For quantification of phytase activity in feed materials and compound feed:

• Colorimetric method based on the enzymatic reaction of phytase on the phytate in accordance with international standard BS EN ISO 30024:2009 entitled “Animal feeding stuffs. Determination of phytase activity”
3. For quantification of phytase activity in premixtures:

• Colorimetric method based on the enzymatic reaction of phytase on the phytate in accordance with the VDLUFA Method Book, Volume III, Part 27.1.3
Species or category of animal All poultry species; ornamental birds; piglets; pigs for fattening; sows; minor porcine species for fattening or reproduction
Maximum age Not applicable
Content of 6-phytase (units of activity/kg of complete feed with a moisture content of 12%) Minimum content 250 FTU
Maximum content No maximum
Other provisions In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment must be indicated.
SCHEDULE 10
Regulation 3(2)
1 
The substance Decoquinate specified in the table in this schedule, 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 in this schedule.

Column 1 Column 2
Additive Decoquinate (Deccox®)
Identification number of the additive 51756i
Authorisation holder Zoetis Belgium SA
Additive category Coccidiostats and Histomonostats
Functional group None
Additive composition 
• Decoquinate: 60.0g/kg
• Refined deodorised soya oil: 28.5g/kg
• Colloidal silica: 0.6g/kg
• Wheat middlings: q.s. 1kg
Characterisation of the active substance(s) 
• Decoquinate: (Ethyl 6-decycloxy-7-ethoxy-4-hydroxyquinoline-3-carboxylate)
• Chemical formula: C24H35NO5
• CAS No: 18507-89-6
• Related impurities:
• Methyl-6-decycloxy-7-ethoxy-4-hydroxyquinoline-3-carboxylate:<1.0%
• 6-decycloxy-7-ethoxy-4-hydroxyquinoline-3-carboxylic acid:<0.5%
• Diethyl-4-decycloxy-3-ethoxyanilinomethylenemalonate: <0.5%
Analytical methods 1. For quantification of Decoquinate in the feed additive, premixtures and feed:

• Reversed-Phase High Performance Liquid Chromatography with fluorescence detection (RP-HPLC-FL) in accordance with European standard EN 16162:2012 entitled “Animal feeding stuffs – Determination of decoquinate by HPLC with fluorescence detection”
2. For quantification of Decoquinate in tissues:

• Reversed-Phase High Performance Liquid Chromatography coupled to a triple quadrupole mass spectrometer (RP-HPLC-MS/MS)
Species or category of animal Chickens for fattening
Maximum age Not applicable
Content of Decoquinate (Deccox®) in mg/kg of complete feed with a moisture content of 12% Minimum content 30 mg/kg
Maximum content 40 mg/kg
Other provisions 1. In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment must be indicated.2. The additive must be incorporated in compound feed in the form of a premixture.3. Decoquinate must not be mixed with other coccidiostats.4. Decoquinate must not be used in feed containing bentonite.5. Post-market monitoring programmes must be carried out by the holder of authorisation for resistance to bacteria and Eimeria spp and submitted to the Scottish Ministers by the end of 23 November 2031.
SCHEDULE 11
Regulation 3(2)
1 
The substance Decoquinate specified in the table in this schedule, 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 in this schedule.

Column 1 Column 2
Additive Decoquinate (Avi-Deccox® 60G)
Identification number of the additive 51756ii
Authorisation holder Zoetis Belgium SA
Additive category Coccidiostats and Histomonostats
Functional group None
Additive composition 
• Decoquinate: 60.0 g/kg
• Colloidal silica: 0.6 g/kg
• Silicon dioxide: 4.0 g/kg
• Carboxymethylcellulose sodium: 30.0 g/kg
• Calcium sulphate dihydrate: q.s. ad 1,000 g
Characterisation of the active substance(s) Decoquinate: (Ethyl 6-decycloxy-7-ethoxy-4-hydroxyquinoline-3-carboxylate)

• Chemical Formula: C24H35NO5
• CAS No: 185-7-89-6
Related impurities:

• Methyl-6-decycloxy-7-ethoxy-4-hydroxyquinoline-3-carboxylate:<1.0%
• 6-decycloxy-7-ethoxy-4-hydroxyquinoline-3-carboxylic acid: <0.5%
• Diethyl-4-decycloxy-3-ethoxyanilinomethylenemalonate:<0.5%
Analytical methods 1. For the quantification of Decoquinate in the feed additive, premixtures and feed:

• Reversed-Phase High Performance Liquid Chromatography with fluorescence detection (RP-HPLC-FL) in accordance with European standard EN 16162:2012 entitled “Animal feeding stuffs – Determination of decoquinate by HPLC with fluorescence detection”
2. For quantification of Decoquinate in tissues:

• Reversed-Phase High Performance Liquid Chromatography coupled to a triple quadrupole mass spectrometer (RP-HPLC-MS/MS) or any other analytical method complying with the requirements set by Retained EU Decision 2002/657/EC
Species or category of animal Chickens for fattening
Maximum age Not applicable
Content of Decoquinate (Avi-Deccox®) in mg/kg of complete feed with a moisture content of 12% Minimum content 30 mg/kg
Maximum content 40 mg/kg
Other provisions 1. In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment must be indicated.2. The additive must be incorporated in compound feed in the form of a premixture.3. Decoquinate must not be mixed with other coccidiostats.4. Decoquinate must not be used in feed containing bentonite.5. Post-market monitoring programmes must be carried out by the holder of the authorisation for resistance to bacteria and Eimeria spp and submitted to the Scottish Ministers by the end of 23 November 2031.
SCHEDULE 12
Regulation 11
1 
Commission Regulation (EC) No. 1289/2004 concerning the authorisation for 10 years of the additive Deccox® in feedingstuffs, belonging to the group of coccidiostats and other medicinal substances.
2 
Commission Regulation (EC) No. 903/2009 concerning the authorisation of the preparation of Clostridium butyricum (FERM-BP 2789) as a feed additive for chickens for fattening (holder of authorisation Miyarisan Pharmaceutical Co. Ltd, represented by Huvepharma NV Belgium).
3 
Commission Regulation (EU) No. 8/2010 concerning the authorisation of the serine protease produced by Bacillus licheniformis (DSM 19670) as a feed additive for chickens for fattening (holder of authorisation DSM Nutritional Products Ltd, represented by DSM Nutritional Products Sp.Z.o.o).
4 
Commission Regulation (EU) No. 107/2010 concerning the authorisation of Bacillus subtilis ATCC PTA-6737 as a feed additive for chickens for fattening (holder of authorisation Kemin Europa NV).
5 
Commission Regulation (EU) No. 883/2010 concerning the authorisation of a new use of Saccharomyces cerevisiae NCYC Sc 47 as a feed additive for calves for rearing (holder of the authorisation Société industrielle Lesaffre).
6 
Commission Regulation (EU) No. 168/2011 amending Regulation (EU) No. 107/2010 as regards the use of the feed additive Bacillus subtilis ATCC PTA-6737 in feed containing maduramycin ammonium, monensin sodium, narasin, or robenidine hydrochloride.
7 
Commission Implementing Regulation (EU) No. 373/2011 concerning the authorisation of the preparation of Clostridium butyricum FERM-BP 2789 as a feed additive for minor avian species except laying birds, weaned piglets and minor porcine species (weaned) and amending Regulation (EC) No. 903/2009 (holder of authorisation Miyarisan Pharmaceutical Co. Ltd, represented by Huvepharma NV Belgium).
8 
Commission Implementing Regulation (EU) No. 515/2011 concerning the authorisation of vitamin B6 as a feed additive for all animal species.
9 
Commission Implementing Regulation (EU) No. 885/2011 concerning the authorisation of Bacillus subtilis (ATCC PTA-6737) as a feed additive for chickens reared for laying, ducks for fattening, quails, pheasants, partridges, guinea fowl, pigeons, geese for fattening and ostriches (holder of the authorisation Kemin Europa N.V.).
10 
Commission Implementing Regulation (EU) No. 357/2013 amending Regulation (EC) No. 903/2009 and Implementing Regulation (EU) No. 373/2011 as regards the minimum content of a preparation of Clostridium butyricum (FERM-BP 2789) as a feed additive for chickens for fattening and minor avian species (excluding laying birds) (holder of authorisation Miyarisan Pharmaceutical Co. Ltd represented by Miyarisan Pharmaceutical Europe S.L.U.).
11 
Commission Implementing Regulation (EU) No. 374/2013 concerning the authorisation of a preparation of Clostridium butyricum (FERM-BP 2789) as a feed additive for chickens reared for laying (holder of authorisation Miyarisan Pharmaceutical Co. Ltd represented by Huvepharma NV Belgium).
12 
Commission Implementing Regulation (EU) No. 291/2014 amending Regulation (EC) No. 1289/2004 as regards the withdrawal time and maximum residues limits of the feed additive decoquinate.
13 
Commission Implementing Regulation (EU) No. 1108/2014 concerning the authorisation of a preparation of Clostridium butyricum (FERM-BP 2789) as a feed additive for turkeys for fattening and turkeys reared for breeding (holder of authorisation Miyarisan Pharmaceutical Co. Ltd represented by Huvepharma NV Belgium).
14 
Commission Implementing Regulation (EU) No. 2017/1126 amending Regulation (EC) No. 903/2009 and Implementing Regulations (EU) No. 373/2011, (EU) No. 374/2013 and (EU) No. 1108/2014 as regards the name of the EU representative of the holder of the authorisation of a preparation of Clostridium butyricum (FERM-BP 2789).