2022 No. 1118 (W. 233)
The Feed Additives (Authorisations) (Wales) Regulations 2022
Made
Laid before Senedd Cymru
Coming into force
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 nutrition1.
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 safety2.
Title, extent, application and commencementI11
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.
InterpretationI22
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 feed3.
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 F1Regulation 1831/2003 or Regulation 767/2009, respectively.
AuthorisationsI33
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
I44
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 domesticus4 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”.
I55
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 breeding5 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”
.
I66
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 laying6 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”
.
I77
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 sows7 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”
.
RevocationsI88
The instruments listed in Schedule 12 are revoked.
Transitional provisions: Saccharomyces cerevisiae CNCM I-4407 (formerly Saccharomyces cerevisiae NCYC Sc 47) (identification number 4b1702)I99
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 rearing8.
Transitional provisions: Bacillus velezensis ATCC PTA-6737 (formerly Bacillus subtilis ATCC PTA-6737) (identification number 4b1823)I1010
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 9, 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 ostriches10.
Transitional provision: Decoquinate (Deccox®) (identification number 51756i (formerly E756))I1111
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 substances11.
I12SCHEDULE 1Authorisation of a preparation of manganese chelate of lysine and glutamic acid (identification number 3b509) as a feed additive for all animal species
I12The preparation specified in the table, belonging to the additive category “nutritional additives” and to the functional group “compounds of trace elements”, is authorised as an additive in animal nutrition subject to the conditions set out in the table.
Additive | Manganese chelate of 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:
|
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:
| |
For quantification of total manganese in feed materials and compound feed:
| |
For quantification of lysine and glutamic acid content in the feed additive:
| |
For determination of the chelated form of 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. |
(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%. | |
I13SCHEDULE 2Authorisation of a preparation of Lactobacillus buchneri DSM 29026 (identification number 1k20759) as a feed additive for all animal species
Sch. 2 in force at 24.11.2022, see reg. 1(2)(c)
I13The 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.
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:
|
For identification of bacterial strain:
| |
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. |
(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 additives13. | |
I14SCHEDULE 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
Sch. 3 in force at 24.11.2022, see reg. 1(2)(c)
I14The preparation specified in the table, belonging to the additive category “zootechnical additives” and to the functional group “digestibility enhancers”, is authorised as an additive in animal nutrition subject to the conditions set out in the table.
Additive | 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.-):
|
Characterisation of the active substance(s) | |
Analytical methods(5) | For quantification of serine protease activity in the feed additive, premixtures, compound feed and feed materials:
|
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. |
(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%. | |
I15SCHEDULE 4Renewal of authorisation of pyridoxine hydrochloride (vitamin B6) (identification number 3a831) as a feed additive for all animal species
Sch. 4 in force at 24.11.2022, see reg. 1(2)(c)
I15The 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 table14.
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(3) | For determination of pyridoxine hydrochloride (vitamin B6) in the feed additive:
|
For determination of pyridoxine hydrochloride (vitamin B6) in premixtures:
| |
For determination of pyridoxine hydrochloride (vitamin B6) in feed and water:
| |
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. | |
(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%. | |
I16SCHEDULE 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
Sch. 5 in force at 24.11.2022, see reg. 1(2)(c)
I16The 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 table15.
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:
|
For identification of yeast strain:
| |
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. |
(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%. | |
I17SCHEDULE 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
Sch. 6 in force at 24.11.2022, see reg. 1(2)(c)
I17The 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 table16.
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:
|
For identification of bacterial strain: Pulsed-field gel electrophoresis (PFGE). | |
Species or category of animal |
|
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:
| |
(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%. | |
I18SCHEDULE 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
Sch. 7 in force at 24.11.2022, see reg. 1(2)(c)
I18The preparation specified in the table, belonging to the additive category “zootechnical additives” and to the functional group “gut flora stabilisers”, is authorised as an additive in animal nutrition subject to the conditions set out in the table.
Additive | Bacillus 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:
|
For identification of bacterial strain:
| |
Species or category of animal |
|
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:
| |
(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%. | |
I19SCHEDULE 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
Sch. 8 in force at 24.11.2022, see reg. 1(2)(c)
I19The 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 table17.
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:
|
For identification of bacterial strain:
| |
Species or category of animal |
|
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:
| |
(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%. | |
I20SCHEDULE 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
Sch. 9 in force at 24.11.2022, see reg. 1(2)(c)
I20The preparation specified in the table, belonging to the additive category “zootechnical additives” and to the functional group “digestibility enhancers”, is authorised as an additive in animal nutrition subject to the conditions set out in the table.
Additive | 6-phytase (EC 3.1.3.26) |
Identification number 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:
|
For quantification of phytase activity in premixtures:
| |
For quantification of phytase activity in feed materials and compound feed:
| |
Species or category of animal |
|
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. |
(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%. | |
I21SCHEDULE 10Authorisation of decoquinate (Deccox®) (identification number 51756i) as a feed additive for chickens for fattening
Sch. 10 in force at 24.11.2022, see reg. 1(2)(c)
I21The 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 table18.
Additive | Decoquinate (Deccox®) |
Identification number of the additive | 51756i |
Authorisation holder | Zoetis Belgium SA |
Additive category | Coccidiostats and Histomonostats |
Functional group | None |
Additive composition |
|
Characterisation of the active substance(s) | Decoquinate: (Ethyl 6-decycloxy-7-ethoxy-4-hydroxyquinoline-3-carboxylate)
|
Related impurities:
| |
Analytical methods(2) | For quantification of decoquinate in the feed additive, premixtures, feed materials and compound feed:
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For quantification of decoquinate in tissues:
| |
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. | |
(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%. | |
I22SCHEDULE 11Authorisation of decoquinate (Avi-Deccox® 60G) (identification number 51756ii) as a feed additive for chickens for fattening
Sch. 11 in force at 24.11.2022, see reg. 1(2)(c)
I22The 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 table19.
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 |
|
Characterisation of the active substance(s) | Decoquinate: (Ethyl 6-decycloxy-7-ethoxy-4-hydroxyquinoline-3-carboxylate)
|
Related impurities:
| |
Analytical methods(2) | For quantification of decoquinate in the feed additive, premixtures, feed materials and compound feed:
|
For quantification of decoquinate in tissues:
| |
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. | |
(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%. | |
I23SCHEDULE 12Revocation of retained direct EU legislation
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 substances21.
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)22.
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)23.
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)24.
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)25.
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 hydrochloride26.
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)27.
Commission Implementing Regulation (EU) No 515/2011 concerning the authorisation of vitamin B6 as a feed additive for all animal species28.
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)29.
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.)30.
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)31.
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 decoquinate32.
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)33.
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)34.
(This note is not part of the Regulations)
Sch. 1 in force at 24.11.2022, see reg. 1(2)(c)