Welsh Statutory Instruments
2022 No. 1118 (W. 233)
Agriculture, Wales
The Feed Additives (Authorisations) (Wales) Regulations 2022
Laid before Senedd Cymru
2 November 2022
Coming into force
24 November 2022
The Welsh Ministers make these Regulations in exercise of the powers conferred by Articles 9(1) and 18A(3) of Regulation (EC) No 1831/2003 of the European Parliament and of the Council on additives for use in animal nutrition().
There has been consultation as required by Article 9 of Regulation (EC) No 178/2002 of the European Parliament and of the Council laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety().
Title, extent, application and commencement
1.—(1) The title of these Regulations is the Feed Additives (Authorisations) (Wales) Regulations 2022.
(2) These Regulations—
(a)extend to England and Wales;
(b)apply in relation to Wales;
(c)come into force on 24 November 2022.
Interpretation
2.—(1) In these Regulations—
“Regulation 1831/2003” (“Rheoliad 1831/2003”) means Regulation (EC) No 1831/2003 of the European Parliament and of the Council on additives for use in animal nutrition;
“Regulation 767/2009” (“Rheoliad 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().
(2) Any expression used both in these Regulations and in Regulation 1831/2003 or Regulation 767/2009 has the same meaning as it has in those retained EU Regulations.
Authorisations
3.—(1) Schedules 1 to 11 contain authorisations of feed additives.
(2) Subject to Article 14(4) (renewal of authorisation) of Regulation 1831/2003, the authorisations set out in Schedules 1 to 11 cease to have effect at the end of 23 November 2032.
Amendment of existing Bacillus velezensis ATCC PTA-6737 authorisations
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() is amended as follows.
(2) In the Annex, in the table, in columns 3 (additive) and 4 (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() is amended as follows.
(2) In the Annex, in the table, in columns 3 (additive) and 4 (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() is amended as follows.
(2) In the Annex, in the table, in columns 3 (additive) and 4 (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() is amended as follows.
(2) In the Annex, in the table, in columns 3 (additive) and 4 (composition, chemical formula, description, analytical method), for “Bacillus subtilis”, in each place it occurs, substitute “Bacillus velezensis”.
Revocations
8. The instruments listed in Schedule 12 are revoked.
Transitional provisions: Saccharomyces cerevisiae CNCM I-4407 (formerly Saccharomyces cerevisiae NCYC Sc 47) (identification number 4b1702)
9.—(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 and 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” (“chwanegyn bwyd anifeiliaid perthnasol”) refers to the feed additive Saccharomyces cerevisiae CNCM I-4407, or as formerly designated, Saccharomyces cerevisiae NCYC Sc 47, with the identification number 4b1702, which was previously authorised under the prior authorisation;
“the prior authorisation” (“yr awdurdodiad ymlaen llaw”) refers to the authorisation contained in Commission Regulation (EU) Regulation No 883/2010 concerning the authorisation of a new use of Saccharomyces cerevisiae NCYC Sc 47 as a feed additive for calves for rearing().
Transitional provisions: Bacillus velezensis ATCC PTA-6737 (formerly Bacillus subtilis ATCC PTA-6737) (identification number 4b1823)
10.—(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 an instrument 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 and 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 and 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” (“ychwanegyn bwyd anifeiliaid perthnasol”) refers to 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;
“the prior authorisation” (“yr awdurdodiad ymlaen llaw”) refers to an authorisation contained in—
Commission Regulation (EU) No 107/2010 concerning the authorisation of Bacillus subtilis ATCC PTA-6737 as a feed additive for chickens for fattening (), 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().
Transitional provision: Decoquinate (Deccox®) (identification number 51756i (formerly E756))
11.—(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” (“ychwanegyn bwyd anifeiliaid perthnasol”) refers to the feed additive Decoquinate (Deccox®)which was previously authorised under the prior authorisation with the identification number E756;
“the prior authorisation” (“yr awdurdodiad ymlaen llaw”) refers to the authorisation contained in 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().
Lynne Neagle
Deputy Minister for Mental Health and Wellbeing, under the authority of the Minister for Health and Social Services, one of the Welsh Ministers
31 October 2022
Regulation 3(1)
SCHEDULE 1Authorisation of a preparation of manganese chelate of lysine and glutamic acid (identification number 3b509) as a feed additive for all animal species
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.
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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
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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 | For quantification of total manganese in the feed additive:
Atomic Absorption Spectrometry (AAS) (BS EN ISO 6869:2001), or
Inductively Coupled Plasma-Atomic Emission Spectrometry after pressure digestion (ICP-AES) (BS EN 15621:2017).
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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)).
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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) (BS EN ISO 6869:2001),
Inductively Coupled Plasma-Atomic Emission Spectrometry (ICP-AES) (BS EN 15510:2017),
Inductively Coupled Plasma-Atomic Emission Spectrometry after pressure digestion (ICP-AES) (BS EN 15621:2017), or
Inductively Coupled Plasma-Mass Spectrometry (ICP-MS) (BS EN 17053:2018).
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For quantification of lysine and glutamic acid content in the feed additive:
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For determination of the chelated form of the feed additive:
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Species or category of animal | All animal species |
Maximum age | None |
Minimum content | None |
Maximum content | 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 2Authorisation of a preparation of Lactobacillus buchneri DSM 29026 (identification number 1k20759) as a feed additive for all animal species
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.
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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 | For enumeration (colony count) of the feed additive:
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For identification of bacterial strain:
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Species or category of animal | All animal species |
Maximum age | None |
Minimum content | 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 |
Maximum content | None |
Other provisions | In the directions for use of the feed additive and premixtures, the storage conditions must be indicated. |
Regulation 3(1)
SCHEDULE 3Authorisation 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
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.
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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.-):
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Characterisation of the active substance(s) | |
Analytical methods | For quantification of serine protease activity in the feed additive, premixtures, compound feed and feed materials:
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Species or category of animal | Chickens for fattening |
Maximum age | None |
Minimum content | 15,000 PROT/kg |
Maximum content | 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 4Renewal of authorisation of pyridoxine hydrochloride (vitamin B6) (identification number 3a831) as a feed additive for all animal species
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().
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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) | |
Analytical methods | For determination of pyridoxine hydrochloride (vitamin B6) in the feed additive:
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For determination of pyridoxine hydrochloride (vitamin B6) in premixtures:
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For determination of pyridoxine hydrochloride (vitamin B6) in feed and water:
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Species or category of animal | All animal species |
Maximum age | None |
Minimum content | None |
Maximum content | 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 5Renewal 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
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().
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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 | For enumeration (colony count) in the feed additive, premixtures, feed materials and compound feed:
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For identification of yeast strain:
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Species or category of animal | Calves for rearing |
Maximum age | None |
Minimum content | 1.5 x 109 CFU/kg |
Maximum content | 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 6Renewal 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
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().
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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 | For enumeration (colony count) in the feed additive, premixtures, feed materials and compound feed:
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For identification of bacterial strain:
Pulsed-field gel electrophoresis (PFGE).
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Species or category of animal | |
Maximum age | None |
Minimum content | 1 x 107 CFU/kg |
Maximum content | 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:
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Regulation 3(1)
SCHEDULE 7Authorisation 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
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.
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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 | For enumeration (colony count) in the feed additive, premixtures, feed materials and compound feed:
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For identification of bacterial strain:
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Species or category of animal | |
Maximum age | None |
Minimum content | 1.6 x 109 CFU/kg |
Maximum content | 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
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Regulation 3(1)
SCHEDULE 8Renewal 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
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().
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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 | For enumeration (colony count) in the feed additive, premixtures, feed materials and compound feed:
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For identification of bacterial strain:
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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)
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Maximum age | None |
Minimum content | 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 | 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:
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Regulation 3(1)
SCHEDULE 9Authorisation 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
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.
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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 /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 | For quantification of phytase activity in the feed additive:
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For quantification of phytase activity in premixtures:
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For quantification of phytase activity in feed materials and compound feed:
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Species or category of animal | |
Maximum age | None |
Minimum content | 250 FTU/kg |
Maximum content | 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 10Authorisation of decoquinate (Deccox®) (identification number 51756i) as a feed additive for chickens for fattening
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().
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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
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Characterisation of the active substance(s) | Decoquinate: (Ethyl 6-decycloxy-7-ethoxy-4-hydroxyquinoline-3-carboxylate)
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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%
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Analytical methods | For quantification of decoquinate in the feed additive, premixtures, feed materials and compound feed:
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For quantification of decoquinate in tissues:
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Species or category of animal | Chickens for fattening |
Maximum age | None |
Minimum content | 30 mg/kg |
Maximum content | 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 11Authorisation of decoquinate (Avi-Deccox® 60G) (identification number 51756ii) as a feed additive for chickens for fattening
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().
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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
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Characterisation of the active substance(s) | Decoquinate: (Ethyl 6-decycloxy-7-ethoxy-4-hydroxyquinoline-3-carboxylate)
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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%
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Analytical methods | For quantification of decoquinate in the feed additive, premixtures, feed materials and compound feed:
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For quantification of decoquinate in tissues:
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Species or category of animal | Chickens for fattening |
Maximum age | None |
Minimum content | 30 mg/kg |
Maximum content | 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 12Revocation of retained direct EU legislation
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().
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)().
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)().
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)().
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)().
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().
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)().
Commission Implementing Regulation (EU) No 515/2011 concerning the authorisation of vitamin B6 as a feed additive for all animal species().
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)().
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.)().
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)().
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().
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)().
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)().
EXPLANATORY NOTE
The Welsh Ministers make these Regulations pursuant to Regulation (EC) No 1831/2003 of the European Parliament and of the Council on additives for use in animal nutrition (“Regulation 1831/2003”). These Regulations make provision for the authorisation of eleven feed additives.
Regulation 3 and Schedules 1 to 11 provide for the authorisation of the following feed additives—
Schedule 1 is a new authorisation, for a preparation of Manganese chelate of lysine and glutamic acid (identification number 3b509);
Schedule 2 is a new authorisation, for a preparation of Lactobacillus buchneri DSM 29026 (identification number 1k20759);
Schedule 3 is a new authorisation, for a preparation of Serine protease (EC 3.4.21.-) produced by Bacillus licheniformis (DSM 19670) (identification number 4a13);
Schedule 4 is a renewal of the authorisation of Pyridoxine hydrochloride (vitamin B6) (identification number 3a831);
Schedule 5 is a renewal of the authorisation of a preparation of Saccharomyces cerevisiae CNCM I-4407 (identification number 4b1702). The name of the bacterial strain is changed from “ Saccharomyces cerevisiae NCYC Sc 47” to “Saccharomyces cerevisiae CNCM I-4407”;
Schedule 6 is a renewal of the authorisation of a preparation of Bacillus velezensis (ATCC PTA-6737) (identification number 4b1823), and an extension of existing authorised uses to cover all minor poultry species (except for laying), ornamental birds, sporting birds and game birds. The authorisation has been modified as follows:
the bacterial strain name is changed from “Bacillus subtilis” to “Bacillus velezensis”;
the minimum content of the feed additive in the preparation is increased from 1x1010 to 8x1010 colony forming units per gram (CFU/g);
Schedule 7 is a new authorisation of a preparation of Bacillus licheniformis DSM 28710 (identification number 4b1828);
Schedule 8 is a renewal of the authorisations of a preparation of Clostridium butyricum (FERM BP-2789) (identification number 4b1830) and authorises it for a new use in feed for chickens for fattening, suckling piglets and minor porcine species (suckling);
Schedule 9 is a new authoristion, for a preparation of 6-phytase produced by Komagataella phaffii DSM 32854 (identification number 4a32);
Schedule 10 authorises a new formulation of decoquinate (Deccox®) (identification number E756) as decoquinate (Deccox®) (identification number 51756i);
Schedule 11 authorises a modifed form of decoquinate (Deccox®) (identification number E756) as decoquinate (Avi-Deccox® 60G) (identification number 51756ii). This feed additive differs from decoquinate (Deccox®) in physical form and in the dilutant used being calcium sulphate dihydrate.
Regulation 3(2) provides that authorisations granted by these Regulations are valid for a period of ten years in accordance with Article 9(7) of Regulation 1831/2003. This is subject to Article 14(4) of that Regulation, which provides for an extension of the authorisation period in certain circumstances where an application for renewal has been submitted.
Regulations 4 to 7 amend four retained EU Regulations that authorise the feed additive Bacillus subtilis ATCC PTA-6737 for differing poultry and pig sub-groups. The name of the bacterial strain is updated from “Bacillus subtilis” to “Bacillus velezensis”. Regulation 10(1) contains a transitional provision that allows products labelled using the name “Bacillus subtilis” to continue to be marketed and used under the relevant authorisations despite the change to the name.
Regulation 8 and Schedule 12 revoke, in relation to Wales, retained EU Regulations that contain prior authorisations for the feed additives now authorised by Schedules 3, 4, 5, 6, 8 and 10.
Regulations 9, 10(2) to (5) and 11 contain transitional provisions that allow the continued production and labelling of products, for limited time periods, under the conditions of prior authorisations of the relevant feed additives. Those feed additives are now authorised by Schedules 5, 6 and 10 respectively.
Further information, including in relation to any documentation referenced in the Schedules, can be obtained from the Food Standards Agency, 11th Floor, Southgate House, Cardiff, CF10 1EW or by writing to regulated.products.wales@food.gov.uk.
The Welsh Ministers’ Code of Practice on the carrying out of Regulatory Impact Assessments was considered in relation to these Regulations. As a result, it was not considered necessary to carry out a regulatory impact assessment as to the likely costs and benefits of complying with these Regulations.