- Latest available (Revised) - English
- Latest available (Revised) - Welsh
- Original (As made) - English
- Original (As made) - Welsh
There are currently no known outstanding effects for the The Feed Additives (Authorisations) (Wales) Regulations 2022.
Revised legislation carried on this site may not be fully up to date. At the current time any known changes or effects made by subsequent legislation have been applied to the text of the legislation you are viewing by the editorial team. Please see ‘Frequently Asked Questions’ for details regarding the timescales for which new effects are identified and recorded on this site.
Regulation 3(1)
Commencement Information
I1Sch. 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:
|
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. |
Regulation 3(1)
Commencement Information
I2Sch. 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:
|
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. |
Regulation 3(1)
Commencement Information
I3Sch. 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.-):
|
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. |
Regulation 3(1)
Commencement Information
I4Sch. 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) | |
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. |
Regulation 3(1)
Commencement Information
I5Sch. 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:
|
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. |
Regulation 3(1)
Commencement Information
I6Sch. 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:
|
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:
|
Regulation 3(1)
Commencement Information
I7Sch. 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:
|
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:
|
Regulation 3(1)
Commencement Information
I8Sch. 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:
|
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:
|
Regulation 3(1)
Commencement Information
I9Sch. 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:
|
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. |
Regulation 3(1)
Commencement Information
I10Sch. 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 |
|
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. |
Regulation 3(1)
Commencement Information
I11Sch. 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 |
|
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. |
Regulation 8
Commencement Information
I12Sch. 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).
EUR 2009/152, to which there amendments not relevant to these Regulations.
EUR 2008/429, amended by S.I. 2019/654. S.I. 2019/654 was amended by S.I. 2020/1504.
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.
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.
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.
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.
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).
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.
EUD 2002/657, amended by S.I. 2020/1461.
EUR 2004/1289.
EUR 2009/903.
EUR 2010/8.
EUR 2010/107
EUR 2010/883.
EUR2011/168.
EUR 2011/373.
EUR 2011/515.
EUR 2011/885.
EUR 2013/357.
EUR 2013/374.
EUR 2014/291.
EUR 2014/1108.
EUR 2017/1126.
Latest Available (revised):The latest available updated version of the legislation incorporating changes made by subsequent legislation and applied by our editorial team. Changes we have not yet applied to the text, can be found in the ‘Changes to Legislation’ area. The revised version is currently only available in English.
Original (As Enacted or Made) - English: The original English language version of the legislation as it stood when it was enacted or made. No changes have been applied to the text.
Original (As Enacted or Made) - Welsh:The original Welsh language version of the legislation as it stood when it was enacted or made. No changes have been applied to the text.
Geographical Extent: Indicates the geographical area that this provision applies to. For further information see ‘Frequently Asked Questions’.
Show Timeline of Changes: See how this legislation has or could change over time. Turning this feature on will show extra navigation options to go to these specific points in time. Return to the latest available version by using the controls above in the What Version box.
Access essential accompanying documents and information for this legislation item from this tab. Dependent on the legislation item being viewed this may include:
This timeline shows the different points in time where a change occurred. The dates will coincide with the earliest date on which the change (e.g an insertion, a repeal or a substitution) that was applied came into force. The first date in the timeline will usually be the earliest date when the provision came into force. In some cases the first date is 01/02/1991 (or for Northern Ireland legislation 01/01/2006). This date is our basedate. No versions before this date are available. For further information see the Editorial Practice Guide and Glossary under Help.
Use this menu to access essential accompanying documents and information for this legislation item. Dependent on the legislation item being viewed this may include:
Click 'View More' or select 'More Resources' tab for additional information including: