The Feed Additives (Authorisations) (Wales) Regulations 2022

Regulation 3(1)

SCHEDULE 1 E+W Authorisation of a preparation of manganese chelate of lysine and glutamic acid (identification number 3b509) as a feed additive for all animal species

Commencement Information

I1 Sch. 1 in force at 24.11.2022, see reg. 1(2)(c)

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.

(1) Details of the analytical methods are set out in the document referenced “Ares(2018)3918699 - 24/07/2018” and the document referenced “Ares(2019)7167892 - 20/11/2019” and last updated 28 January 2020. These documents are available at the following address: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports/fad-2018-0009?search&form-return
(2) Under reference BS EN ISO 6869:2001 “Animal feeding stuffs. Determination of the contents of calcium, copper, iron, magnesium, manganese, potassium, sodium and zinc. Method using atomic absorption spectrometry”. Published by the British Standards Institution on 15 March 2001 (ISBN 0 580 36933 1). Available from the British Standards Institution https://knowledge.bsigroup.com.
(3) Under reference BS EN 15510:2017 “Animal feeding stuffs. Methods of sampling and analysis. Determination of calcium, sodium, phosphorus, magnesium, potassium, iron, zinc, copper, manganese, cobalt, molybdenum and lead by ICP-AES”. Published by the British Standards Institution on 30 August 2017 (ISBN 978 0 580 94541 0). Available from the British Standards Institution https://knowledge.bsigroup.com.
(4) Under reference BS EN 15621:2017 “Animal feeding stuffs: Methods of sampling and analysis. Determination of calcium, sodium, phosphorus, magnesium, potassium, sulphur, iron, zinc, copper, manganese and cobalt after pressure digestion by ICP-AES”. Published by the British Standards Institution on 31 August 2017 (ISBN 978 0 580 94543 4). Available from the British Standards Institution https://knowledge.bsigroup.com.
(5) Under reference BS EN 17053:2018 “Animal feeding stuffs: Methods of sampling and analysis. Determination of trace elements, heavy metals and other elements in feed by ICP-MS (multi-method)”. Published by the British Standards Institution on 28 February 2018 (978 0 580 94471 0). Available from the British Standards Institution https://knowledge.bsigroup.com.
(6) Under reference BS EN ISO 13903:2005 “Animal feeding stuffs. Determination of amino acids content”. Published by the British Standards Institution on 24 October 2005 (ISBN 0 580 46218 8). Available from the British Standards Institution https://knowledge.bsigroup.com.
(7) Content of element (Mn) in mg/kg of complete feed with a moisture content of 12%.
Additive	Manganese chelate of lysine and glutamic acid
Identification number of the additive	3b509
Authorisation holder	None specified
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 methods (1)	For quantification of total manganese in the feed additive: Atomic Absorption Spectrometry (AAS) (BS EN ISO 6869:2001(2)), or Inductively Coupled Plasma-Atomic Emission Spectrometry after pressure digestion (ICP-AES) (BS EN 15621:2017(4)).
	For quantification of total manganese in premixtures: Atomic Absorption Spectrometry (AAS) (BS EN ISO 6869:2001(2)), Inductively Coupled Plasma-Atomic Emission Spectrometry (ICP-AES) (BS EN 15510:2017(3)), Inductively Coupled Plasma-Atomic Emission Spectrometry after pressure digestion (ICP-AES) (BS EN 15621:2017(4)), or Inductively Coupled Plasma-Mass Spectrometry (ICP-MS) (BS EN 17053:2018(5)).
	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)(1), Atomic Absorption Spectrometry (AAS) (BS EN ISO 6869:2001(2)), Inductively Coupled Plasma-Atomic Emission Spectrometry (ICP-AES) (BS EN 15510:2017(3)), Inductively Coupled Plasma-Atomic Emission Spectrometry after pressure digestion (ICP-AES) (BS EN 15621:2017(4)), or Inductively Coupled Plasma-Mass Spectrometry (ICP-MS) (BS EN 17053:2018(5)).
	For quantification of lysine and glutamic acid content in the feed additive: Ion exchange chromatography coupled with post-column derivatisation and photometric detection (IEC-VIS) (BS EN ISO 13903:2005(6)).
	For determination of the chelated form 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	None
Minimum content (7)	None
Maximum content (7)	Fish: 100mg/kg (total)
	All other animal species: 150mg/kg (total)
Other provisions	The feed additive must be incorporated into the feed in the form of a premixture.

Regulation 3(1)

SCHEDULE 2 E+W Authorisation of a preparation of Lactobacillus buchneri DSM 29026 (identification number 1k20759) as a feed additive for all animal species

Commencement Information

I2 Sch. 2 in force at 24.11.2022, see reg. 1(2)(c)

The preparation specified in the table, 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.

(1) Details of the analytical methods set out in the document referenced “Ares(2019)4747322 - 22/07/2019” and last updated 18 October 2019. The document is available at the following address: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports/fad-2018-0093.
(2) Under reference BS EN 15787:2021 “Animal feeding stuffs: Methods of sampling and analysis. Detection and enumeration of Lactobacillus spp. used as feed additive”. Published by the British Standards Institution on 31 December 2021 (ISBN 978 0 580 99831 7). Available from the British Standards Institution https://knowledge.bsigroup.com.
(3) Content of element Lactobacillus buchneri DSM 29026 in CFU of additive/kg of fresh material.
(4) Easy to ensile forage: > 3% soluble carbohydrates in fresh material; moderately difficult to ensile forage: 1.5-3.0% soluble carbohydrates in the fresh material in accordance with 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(2).
Additive	Lactobacillus buchneri DSM 29026
Identification number of the additive	1k20759
Authorisation holder	None specified
Additive category	Technological additives
Functional group	Silage additives
Additive composition	Preparation of Lactobacillus buchneri DSM 29026 containing a minimum of 2 × 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 (BS EN 15787:2021(2)).
	For identification of bacterial strain: Pulsed Field Gel Electrophoresis (PFGE).
Species or category of animal	All animal species
Maximum age	None
Minimum content (3)	Minimum content of the feed additive when not combined with other micro-organisms as silage additives: 5 × 107 CFU/kg of easy and moderately difficult to ensile fresh material(4)
Maximum content(3)	None
Other provisions	In the directions for use of the feed additive and premixtures, the storage conditions must be indicated.

Regulation 3(1)

SCHEDULE 3 E+W Authorisation of a preparation of serine protease (EC 3.4.21.-) produced by Bacillus licheniformis DSM 19670 (identification number 4a13) as a feed additive for chickens for fattening

Commencement Information

I3 Sch. 3 in force at 24.11.2022, see reg. 1(2)(c)

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.

(1) One PROT is the amount of serine protease that liberates one micromole/minute of para-nitroaniline (pNA) from 1 millimolar (mM) Suc-Ala-Ala-Pro-Phe-pNA substrate at pH 9 & 37°C.
(2) CAS Registry Number® assigned to this preparation by the Chemical Abstracts Service https://www.cas.org/cas-data/cas-registry.
(3) European Inventory of Existing Commercial Substances, number as published in OJ No C 146 A, 15.6.90, p.1.
(4) Identification number assigned by the International Union of Biochemistry (IUB), now the International Union of Biochemistry and Molecular Biology (IUBMB) iubmb.org.
(5) Details of the analytical methods set out in the document referenced “Ares(2019)6802984 - 04/11/2019” and last updated 27 January 2020. The document is available at the following address: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports/fad-2019-0010.
(6) Content of Serine protease in PROT/kg of complete feed with a moisture content of 12%.
Additive	Serine protease (EC 3.4.21.-)
Identification number of the additive	4a13
Authorisation holder	DSM Nutritional Products Ltd (Switzerland)
Additive category	Zootechnical additives
Functional group	Digestibility enhancers
Additive composition	Solid and liquid preparation of serine protease (EC 3.4.21.-): produced by Bacillus licheniformis DSM 19670 having a minimum activity of 75,000 PROT(1)/g
Characterisation of the active substance(s)	Serine protease (EC 3.4.21.-) produced by Bacillus licheniformis DSM 19670 CAS number(2): 37259-58-8 (serine protease) EINECS number(3): 253-431-3 IUB number(4): 3.4.21.-
Analytical methods (5)	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	None
Minimum content(6)	15,000 PROT(1)/kg
Maximum content(6)	None
Other provisions	In the directions for use of the feed additive and premixtures, the storage conditions and stability to heat treatment must be indicated.

Regulation 3(1)

SCHEDULE 4 E+W Renewal of authorisation of pyridoxine hydrochloride (vitamin B₆) (identification number 3a831) as a feed additive for all animal species

Commencement Information

I4 Sch. 4 in force at 24.11.2022, see reg. 1(2)(c)

The substance specified in the table, belonging to the additive category “nutritional additives” and to the functional group “vitamins, pro-vitamins and chemical well-defined substances having a similar effect”, is authorised as an additive in animal nutrition subject to the conditions set out in the table(3).

(1) CAS Registry Number® assigned to this preparation by the Chemical Abstracts Service https://www.cas.org/cas-data/cas-registry.
(2) European Inventory of Existing Commercial Substances, number as published in OJ No C 146 A, 15.6.90, p.1.
(3) Details of the analytical methods set out in the document referenced “JRC.DG.D.6/CvH/GB/ag/ARES(2011)356822” and last updated 6 June 2016. The document is available at the following address: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports/fad-2010-0139.
(4) European Pharmacopoeia, European Directorate for the Quality of Medicines and Healthcare, 10th edition. Published 1 July 2019 (ISBN 9789999146111).
(5) The Association of German Agricultural Analytical and Research Institutes (VDLUFA) Method Book, Volume III, 6th supplement 2006, the Chemical Analysis of Feedingstuffs (ISBN 978 3 941273 14 6), https://vdlufa.de.
(6) Under reference BS EN 14164:2014 “Foodstuffs. Determination of vitamin B6 by high performance chromatography”. Published by the British Standards Institution on 30 June 2014 (ISBN 978 0 580 77941 1). Available from the British Standards Institution https://knowledge.bsigroup.com.
(7) Content of pyridoxine hydrochloride(vitamin B6) in mg of additive/kg of complete feed with a moisture content of 12%.
Additive	Pyridoxine hydrochloride (vitamin B6)
Identification number of the additive	3a831
Authorisation holder	None specified
Additive category	Nutritional additives
Functional group	Vitamins, pro-vitamins and chemically well-defined substances having similar effect
Additive composition	Pyridoxine hydrochloride, with a purity criteria not less than 98.5%
Characterisation of the active substance(s)	Pyridoxine hydrochloride: C8H11NO3·HCl CAS number(1): 58-56-0 EINECS number(2): 200-386-2
Analytical methods(3)	For determination of pyridoxine hydrochloride (vitamin B6) in the feed additive: Titration with perchloric acid (Ph. Eur. 10th edition, monograph 0245(4)).
	For determination of pyridoxine hydrochloride (vitamin B6) in premixtures: Reversed phase High Performance Liquid Chromatography coupled to UV detector (RP-HPLC-UV) (VDLUFA 13.9.1(5)).
	For 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 on BS EN 14164:2014(6).
Species or category of animal	All animal species
Maximum age	None
Minimum content(7)	None
Maximum content(7)	None
Other provisions	1. In the directions for use of the feed additive and premixtures, the storage conditions and stability to heat treatment and in water must be indicated.
	2. Pyridoxine hydrochloride (vitamin B6) may be used via water for drinking.

Regulation 3(1)

SCHEDULE 5 E+W Renewal of authorisation of a preparation of Saccharomyces cerevisiae CNCM I-4407 (formerly Saccharomyces cerevisiae NCYC Sc 47) (identification number 4b1702) as a feed additive for calves for rearing

Commencement Information

I5 Sch. 5 in force at 24.11.2022, see reg. 1(2)(c)

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(4).

(1) Details of the analytical methods set out in the document referenced “JRC.DG.D.6/CvH/DM/mds/ARES(2010)967257” and last updated 6 June 2016. The document is available at the following address: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports/fad-2010-0038.
(2) Under reference BS EN 15789:2021 “Animal feeding stuffs: Methods of sampling and analysis. Detection and enumeration of Saccharomyces cerevisiae used as feed additive”. Published by the British Standards Institution on 30 November 2021 (ISBN 978 0 580 99832 4). Available from the British Standards Institution https://knowledge.bsigroup.com.
(3) Under reference DD CEN/TS 15790:2008 “Animal Feeding Stuffs – PCR typing of probiotic strains of Sacccharomyces cerevisiae (yeast)”. Published by British Standards Institution on 31 January 2009 (ISBN 978 0 580 61806 2). Available from the British Standards Institution https://knowledge.bsigroup.com.
(4) Content of Saccharomyces cerevisiae CNCM I-4407 in CFU/kg of complete feed with a moisture content of 12%.
Additive	Saccharomyces cerevisiae CNCM I-4407
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) in the feed additive, premixtures, feed materials and compound feed: Pour plate method using CGYE (chloramphenicol, glucose, yeast extract) agar (BS EN 15789:2021(2)).
	For identification of yeast strain: Polymerase chain reaction (PCR) method (DD CEN/TS 15790:2008(3)).
Species or category of animal	Calves for rearing
Maximum age	None
Minimum content(4)	1.5 x 109 CFU/kg
Maximum content(4)	None
Other provisions	In the directions of use of the feed additive and premixtures, the storage conditions and stability to heat treatment must be indicated.

Regulation 3(1)

SCHEDULE 6 E+W Renewal of authorisation (with modification) of a preparation of Bacillus velezensis ATCC PTA-6737 (formerly Bacillus Subtilis ATCC PTA-6737) (identification number 4b1823) as a feed additive for chickens for fattening, chickens reared for laying, ducks for fattening, quails, pheasants, partridges, guinea fowl, pigeons, geese for fattening and ostriches, and its authorisation as a feed additive extending existing uses to cover all minor poultry species (except for laying), ornamental birds, sporting birds and game birds

Commencement Information

I6 Sch. 6 in force at 24.11.2022, see reg. 1(2)(c)

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(5).

(1) Details of the analytical methods set out in the document referenced “D08/FSQ/CVH/SY/Ares(2009)61627” and last updated 6 June 2016. This document is available at the following address: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports/fad-2008-0039.
(2) This method is not suitable for the detection of Bacillus velezensis ATCC PTA-6737 in feed materials and compound feed at concentrations below the minimum content level.
(3) Content of Bacillus velezensis ATCC PTA-6737 in CFU/kg of complete feed with a moisture content of 12%.
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) in the feed additive, premixtures, feed materials and compound feed: 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 birds Sporting birds Game birds
Maximum age	None
Minimum content(3)	1 x 107 CFU/kg
Maximum content(3)	None
Other provisions	1. In the directions for use of the feed additive and premixtures, the storage conditions and stability to heat treatment must be indicated.
	2. If 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 A sodium Maduramicin ammonium Monensin sodium Narasin Narasin/Nicarbazin (as combined use only) Robenidine hydrochloride Salinomycin sodium

Regulation 3(1)

SCHEDULE 7 E+W Authorisation of a preparation of Bacillus licheniformis DSM 28710 (identification number 4b1828) as a feed additive for laying hens, minor poultry species for laying, poultry species for breeding and ornamental birds

Commencement Information

I7 Sch. 7 in force at 24.11.2022, see reg. 1(2)(c)

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.

(1) Details of the analytical methods set out in the document referenced “Ares(2015)4524025 – 23/10/2015” and last updated 6 June 2016. The document is available at the following address: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports/fad-2015-0016.
(2) Under reference BS EN 15784:2021 “Animal feeding stuffs: Methods of sampling and analysis. Detection and enumeration of Bacillus spp. Used as feed additive”. Published by the British Standards Institution on 30 November 2021 (ISBN 978 0 580 99829 4). Available from the British Standards Institution https://knowledge.bsigroup.com.
(3) Content of Bacillus licheniformis DSM 28710 in CFU/kg of complete feed with a moisture content of 12%.
Additive	Bacillus licheniformis DSM 28710
Identification number of the additive	4b1828
Authorisation holder	HuvePharma NV
Additive category	Zootechnical feed additive
Functional group	Gut flora stabilisers
Additive composition	Solid form preparation of Bacillus licheniformis DSM 28710 containing a minimum of 3.2 × 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 feed additive, premixtures, feed materials and compound feed: Spread plate method (BS EN 15784:2021(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 Ornamental birds
Maximum age	None
Minimum content(3)	1.6 x 109 CFU/kg
Maximum content(3)	None
Other provisions	1. In the directions for use of the feed additive and premixtures, the storage conditions and stability to heat treatment must be indicated.
	2. If 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

Regulation 3(1)

SCHEDULE 8 E+W Renewal of authorisation of a preparation of Clostridium butyricum FERM BP-2789 (identification number 4b1830) as a feed additive for chickens reared for laying, turkeys for fattening, turkeys reared for breeding, minor avian species (excluding laying birds), weaned piglets and weaned minor porcine species, and its authorisation as a feed additive for chickens for fattening, suckling piglets and suckling minor porcine species

Commencement Information

I8 Sch. 8 in force at 24.11.2022, see reg. 1(2)(c)

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(6).

(1) Details of the analytical methods set out in the document referenced “JRC.DG.D.6.CvH/DM/hn/ARES (2010)-355411” and last updated 6 June 2016. The document is available at the following address: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports/fad-2010-0005.
(2) Under reference BS ISO 15213:2003 “Microbiology of food and animal feeding stuffs – Horizontal method for the enumeration of sulfite-reducing bacteria growing under anaerobic conditions”. Published by the British Standards Institution on 16 May 2003 (ISBN 0 580 41892 8). Available from the British Standards Institution https://knowledge.bsigroup.com.
(3) Content of Clostridium butyricum FERM BP-2789 in CFU/kg of complete feed with a moisture content of 12%.
Additive	Clostridium butyricum FERM BP-2789
Identification number of the additive	4b1830
Authorisation holder	Miyarisan Pharmaceutical Co Ltd
Additive category	Zootechnical additive
Functional group	Gut flora stabilisers
Additive composition	Solid form preparation of Clostridium butyricum FERM BP-2789 containing a minimum of 5 × 108 CFU/g of additive
Characterisation of the active substance(s)	Viable spores of Clostridium butyricum FERM BP-2789
Analytical methods(1)	For enumeration (colony count) in the feed additive, premixtures, feed materials and compound feed: Pour plate method based on BS ISO 15213:2003(2).
	For identification of bacterial strain: Pulsed-field gel electrophoresis (PFGE).
Species or category of animal	Chickens for fattening Chickens reared for laying Turkeys for fattening Turkeys reared for breeding Minor avian species (excluding laying birds) Piglets (suckling and weaned) Minor porcine species (suckling and weaned)
Maximum age	None
Minimum content(3)	For turkeys for fattening and turkeys reared for breeding: 1.25 x 108 CFU/kg
	For the other species/categories: 2.5 x 108 CFU/kg
Maximum content(3)	None
Other provisions	1. In the directions for use of the feed additive and premixtures, the storage conditions and stability to heat treatment must be indicated.
	2. If 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 A sodium Maduramicin ammonium Monensin sodium Narasin Narasin/Nicarbazin (as combined use) Robenidine hydrochloride Salinomycin sodium Semduramicin sodium

Regulation 3(1)

SCHEDULE 9 E+W Authorisation of a preparation of 6-phytase (EC 3.1.3.26) (identification number 4a32) as a feed additive for all poultry species, ornamental birds, piglets, pigs for fattening, sows, minor porcine species for fattening or reproduction

Commencement Information

I9 Sch. 9 in force at 24.11.2022, see reg. 1(2)(c)

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.

(1) FTU = phytase enzyme units. One FTU is the amount of enzyme that releases 1 micromole (µm) of inorganic phosphate from sodium phytate per minute under reaction conditions of pH 5.5 and 37°C.
(2) Details of the analytical methods set out in the document referenced “Ares(2020)762221 – 06/02/2020“ and last updated 4 May 2020. The document is available at the following address: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports/fad-2019-0052.
(3) The Association of German Agricultural Analytical and Research Institutes (VDLUFA) Method Book, Volume III, New single methods 2016, the Chemical Analysis of Feedingstuffs (ISBN 978 3 941273 14 6), https://vdlufa.de.
(4) The Association of German Agricultural Analytical and Research Institutes (VDLUFA) Method Book, Volume III, 8th supplement 2012, the Chemical Analysis of Feedingstuffs (ISBN 978 3 941273 14 6), https://vdlufa.de.
(5) Under reference BS EN ISO 30024:2009 “Animal feeding stuffs. Determination of phytase activity”. Published by the British Standards Institution on 30 September 2009 (ISBN 978 0 580 62651 7). Available from the British Standards Institution https://knowledge.bsigroup.com.
(6) Content of 6-phytase in FTU/kg of complete feed with a moisture content of 12%.
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 with a minimum activity of 5000 FTU (1)/g in granular, coated or liquid forms
Characterisation of the active substance(s)	6-phytase (EC 3.1.3.26) produced by fermentation with Komagataella phaffii DSM 32854
Analytical methods(2)	For quantification of phytase activity in the feed additive: Colorimetric method based on the enzymatic reaction of phytase on the phytate (VDLUFA 27.1.4(3)).
	For quantification of phytase activity in premixtures: Colorimetric method based on the enzymatic reaction of phytase on the phytate (VDLUFA 27.1.3(4)).
	For quantification of phytase activity in feed materials and compound feed: Colorimetric method based on the enzymatic reaction of phytase on the phytate (BS EN ISO 30024:2009(5)).
Species or category of animal	All poultry species Ornamental birds Piglets Pigs for fattening Sows Minor porcine species for fattening or reproduction
Maximum age	None
Minimum content(6)	250 FTU/kg
Maximum content(6)	None
Other provisions	In the directions for use of the feed additive and premixtures, the storage conditions and stability to heat treatment must be indicated.

Regulation 3(1)

SCHEDULE 10 E+W Authorisation of decoquinate (Deccox^®) (identification number 51756i) as a feed additive for chickens for fattening

Commencement Information

I10 Sch. 10 in force at 24.11.2022, see reg. 1(2)(c)

The substance decoquinate 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(7).

(1) CAS Registry Number® assigned to this preparation by the Chemical Abstracts Service https://www.cas.org/cas-data/cas-registry.
(2) Details of the analytical methods set out in the document referenced “Ares(2013)3639174 - 04/12/2013 ” and last updated 6 June 2016. The document is available at the following address: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports/fad-2013-0034.
(3) Under reference BS EN 16162:2012 “Animal feeding stuffs. Determination of decoquinate by HPLC with fluorescence detection”. Published by the British Standards Institution on 31 March 2012 (ISBN 978 0 580 67002 2). Available from the British Standards Institution https://knowledge.bsigroup.com.
(4) “Safety and efficacy of Deccox® (decoquinate) for chickens for fattening”. Published by the European Food Safety Authority (EFSA) in the EFSA Journal, Volume 17, Issue 1 on 14 January 2019. This document is available at the following address: https://www.efsa.europa.eu/en/efsajournal/pub/5541.
(5) Content of decoquinate (Deccox®) in mg/kg of complete feed with a moisture content of 12%.
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, 60.0 g/kg Refined deodorised soya oil, 28.5 g/kg Colloidal silica, 0.6 g/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 number(1): 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(2)	For quantification of decoquinate in the feed additive, premixtures, feed materials and compound feed: Reversed-Phase High Performance Liquid Chromatography with fluorescence detection (RP-HPLC-FL) (BS EN 16162:2012(3)).
	For quantification of decoquinate in tissues: Reversed-Phase High Performance Liquid Chromatography coupled to a triple quadrupole mass spectrometer (RP-HPLC-MS/MS(4)).
Species or category of animal	Chickens for fattening
Maximum age	None
Minimum content(5)	30 mg/kg
Maximum content(5)	40 mg/kg
Other provisions	1. In the directions for use of the feed additive and premixtures, the storage conditions and stability to heat treatment must be indicated.
	2. The feed 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. A post-market monitoring programme must be carried out by the holder of authorisation for resistance to bacteria and Eimeria spp. A report containing the outcome of that programme must be submitted to the Welsh Ministers by the end of 23 November 2031.

Regulation 3(1)

SCHEDULE 11 E+W Authorisation of decoquinate (Avi-Deccox^® 60G) (identification number 51756ii) as a feed additive for chickens for fattening

Commencement Information

I11 Sch. 11 in force at 24.11.2022, see reg. 1(2)(c)

The substance decoquinate 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(8).

(1) CAS Registry Number® assigned to this preparation by the Chemical Abstracts Service https://www.cas.org/cas-data/cas-registry.
(2) Details of the analytical methods set out in the document referenced “Ares(2014)2704635 - 18/08/2014” and “JRC.D.5/SFB/CvH/MGH /mds/Ares” and last updated 6 June 2016. The document is available at the following address: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports/fad-2014-0014.
(3) Under reference BS EN 16162:2012 “Animal feeding stuffs. Determination of decoquinate by HPLC with fluorescence detection”. Published by the British Standards Institution on 31 March 2012 (ISBN 978 0 580 67002 2). Available from the British Standards Institution https://knowledge.bsigroup.com.
(4) “Safety and efficacy of Deccox® (decoquinate) for chickens for fattening”. Published by the European Food Safety Authority (EFSA) in the EFSA Journal, Volume 17, Issue 1 on 14 January 2019. This document is available at the following address: https://www.efsa.europa.eu/en/efsajournal/pub/5541.
(5) Content of decoquinate (Avi-Deccox®) in mg/kg of complete feed with a moisture content of 12%.
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 1kg
Characterisation of the active substance(s)	Decoquinate: (Ethyl 6-decycloxy-7-ethoxy-4-hydroxyquinoline-3-carboxylate) Chemical formula: C24H35NO5 CAS number(1): 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(2)	For quantification of decoquinate in the feed additive, premixtures, feed materials and compound feed: Reversed-Phase High Performance Liquid Chromatography with fluorescence detection (RP-HPLC-FL) (BS EN 16162:2012(3)).
	For quantification of decoquinate in tissues: Reversed-Phase High Performance Liquid Chromatography coupled to a triple quadrupole mass spectrometer (RP-HPLC-MS/MS(4)) or any other analytical method complying with the requirements set by Commission Decision 2002/657/EC concerning the performance of analytical methods and the interpretation of results(9).
Species or category of animal	Chickens for fattening
Maximum age	None
Minimum content(5)	30 mg/kg
Maximum content(5)	40 mg/kg
Other provisions	1. In the directions for use of the feed additive and premixtures, the storage conditions and stability to heat treatment must be indicated.
	2. The feed 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. A post-market monitoring programme must be carried out by the holder of authorisation for resistance to bacteria and Eimeria spp. A report containing the outcome of that programme must be submitted to the Welsh Ministers by the end of 23 November 2031.

Regulation 8

SCHEDULE 12 E+W Revocation of retained direct EU legislation

Commencement Information

I12 Sch. 12 in force at 24.11.2022, see reg. 1(2)(c)

• 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(10).

• 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)(11).

• 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)(12).

• 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)(13).

• 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)(14).

• 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(15).

• 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)(16).

• Commission Implementing Regulation (EU) No 515/2011 concerning the authorisation of vitamin B₆ as a feed additive for all animal species(17).

• 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 authorisation Kemin Europa NV)(18).

• 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.)(19).

• 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)(20).

• 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(21).

• 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 reared for breeding (holder of authorisation Miyarisan Pharmaceutical Co. Ltd represented by Huvepharma NV Belgium)(22).

• Commission Implementing Regulation (EU) 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)(23).

(1)

EUR 2009/152, to which there amendments not relevant to these Regulations.

(2)

EUR 2008/429, amended by S.I. 2019/654. S.I. 2019/654 was amended by S.I. 2020/1504.

(3)

This authorisation is a renewal of the authorisation granted under Commission Implementing Regulation (EU) No 515/2011. That Regulation is revoked by regulation 8 of these Regulations.

(4)

This authorisation is a renewal of the authorisation granted under Commission Regulation (EU) No 883/2010. That Regulation is revoked by regulation 8 of these Regulations but see the transitional provision in regulation 9.

(5)

This authorisation is a renewal of the authorisations granted under Commission Regulation (EU) No 107/2010 and Commission Implementing Regulation (EU) No 885/2011. Those Regulations are revoked by regulation 8 of these Regulations but see the transitional provision in regulation 10.

(6)

This authorisation is a renewal of the authorisations granted under Commission Implementing Regulations (EU) No 373/2011, No 374/2013 and No 1108/2014. Those Regulations are revoked by regulation 8 of these Regulations.

(7)

This authorisation replaces the authorisation of decoquinate (Deccox^®) under Commision Regulation (EC) No 1289/2004. That Regulation is revoked by regulation 8 of these Regulations but see the transitional provision in regulation 11. See also Schedule 11 to these Regulations, which contains a separate re-authorisation of decoquinate (Deccox^®), but in a modified form - decoquinate (Avi-Deccox^® 60G).

(8)

This authorisation is for a modified form of decoquinate (Deccox^®), which was previously authorised under Commission Regulation (EC) No 1289/2004, and now authorised under Schedule 10 to these Regulations.

(9)

EUD 2002/657, amended by S.I. 2020/1461.

(10)

EUR 2004/1289.

(11)

EUR 2009/903.

(12)

EUR 2010/8.

(13)

EUR 2010/107

(14)

EUR 2010/883.

(15)

EUR2011/168.

(16)

EUR 2011/373.

(17)

EUR 2011/515.

(18)

EUR 2011/885.

(19)

EUR 2013/357.

(20)

EUR 2013/374.

(21)

EUR 2014/291.

(22)

EUR 2014/1108.

(23)

EUR 2017/1126.