BAILII is celebrating 24 years of free online access to the law! Would you consider making a contribution?
No donation is too small. If every visitor before 31 December gives just £1, it will have a significant impact on BAILII's ability to continue providing free access to the law.
Thank you very much for your support!
 |
[Home] [Databases] [World Law] [Multidatabase Search] [Help] [Feedback] | |
Statutory Instruments made by the National Assembly for Wales |
||
|
You are here: BAILII >> Databases >> Statutory Instruments made by the National Assembly for Wales >> The Feed Additives (Authorisations) (Wales) Regulations 2022 No. 1118 (W. 233) URL: http://www.bailii.org/wales/legis/num_reg/2022/wsi_20221118_en_1.html |
||
[New search] [Help]
This is the original version (as it was originally made). This item of legislation is currently only available in its original format.
Welsh Statutory Instruments
Agriculture, Wales
Made
31 October 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 1831/2003of the European Parliament and of the Council on additives for use in animal nutrition( 1).
There has been consultation as required by Article 9 of Regulation (EC) No 178/2002of 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( 2).
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.
2.—(1) In these Regulations—
“ Regulation 1831/2003” (“Rheoliad 1831/2003”) means Regulation (EC) No 1831/2003of the European Parliament and of the Council on additives for use in animal nutrition;
“ Regulation 767/2009” (“Rheoliad 767/2009”) means Regulation (EC) No 767/2009of the European Parliament and of the Council on the placing on the market and use of feed( 3).
(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.
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.
4.—(1) Commission Implementing Regulation (EU) No 306/2013 concerning the authorisation of a preparation ofBacillus subtilis(ATCC PTA-6737) for weaned piglets and weaned Suidae other thanSus scrofa domesticus( 4) 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 ofBacillus subtilis(ATCC PTA-6737) as a feed additive for turkeys for fattening and turkeys reared for breeding( 5) 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 ofBacillus subtilis(ATCC PTA-6737) as a feed additive for laying hens and minor poultry species for laying( 6) 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 ofBacillus subtilis(ATCC PTA-6737) as a feed additive for sows( 7) 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”.
8. The instruments listed in Schedule 12 are revoked.
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 additiveSaccharomyces cerevisiaeCNCM 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 ofSaccharomyces cerevisiaeNCYC Sc 47 as a feed additive for calves for rearing( 8).
10.—(1) Any substance or product labelled “Bacillus subtilisATCC PTA-6737” or as containing “Bacillus subtilisATCC 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 anifeiliaidperthnasol”) refers to the feed additiveBacillus velezensisATCC PTA-6737 or, as formerly designated,Bacillus subtilisATCC 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 107/2010concerning the authorisation ofBacillus subtilisATCC PTA-6737 as a feed additive for chickens for fattening ( 9), or
Commission Implementing Regulation (EU) No 885/2011 concerning the authorisation ofBacillus 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( 10).
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 ymlaenllaw”) refers to the authorisation contained in Commission Regulation (EC) No 1289/2004concerning the authorisation for 10 years of the additive Deccox®in feedingstuffs, belonging to the group of coccidiostats and other medicinal substances( 11).
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)
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 Institutionhttps://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 Institutionhttps://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 Institutionhttps://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 Institutionhttps://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 Institutionhttps://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)
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 Institutionhttps://knowledge.bsigroup.com. | |
|
(3)
Content of elementLactobacillus buchneriDSM 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 429/2008on detailed rules for the implementation of Regulation (EC) No 1831/2003of 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( 13). | |
| Additive | Lactobacillus buchneriDSM 29026 |
| Identification number of the additive | 1k20759 |
| Authorisation holder | None specified |
| Additive category | Technological additives |
| Functional group | Silage additives |
| Additive composition | Preparation ofLactobacillus buchneriDSM 29026 containing a minimum of 2 × 1010CFU/g additive |
| Characterisation of the active substance(s) | Viable cells ofLactobacillus buchneriDSM 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 × 107CFU/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)
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 Servicehttps://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)
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( 14).
|
(1)
CAS Registry Number® assigned to this preparation by the Chemical Abstracts Servicehttps://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 B6by high performance chromatography”. Published by the British Standards Institution on 30 June 2014 (ISBN 978 0 580 77941 1). Available from the British Standards Institutionhttps://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)
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( 15).
|
(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 Institutionhttps://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 Institutionhttps://knowledge.bsigroup.com. | |
|
(4)
Content ofSaccharomyces cerevisiaeCNCM I-4407 in CFU/kg of complete feed with a moisture content of 12%. | |
| Additive | Saccharomyces cerevisiaeCNCM 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 ofSaccharomyces cerevisiaeCNCM I-4407 containing a minimum of 5x109CFU/g |
| Characterisation of the active substance(s) | Viable dried cellsSaccharomyces cerevisiaeCNCM 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 109CFU/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)
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( 16).
|
(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 ofBacillus velezensisATCC PTA-6737 in feed materials and compound feed at concentrations below the minimum content level. | |
|
(3)
Content ofBacillus velezensisATCC PTA-6737 in CFU/kg of complete feed with a moisture content of 12%. | |
| Additive | Bacillus velezensisATCC 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 ofBacillus velezensis ATCC PTA-6737 containing a minimum of 8 x 1010CFU/g additive |
| Characterisation of the active substance(s) | Viable spores ofBacillus velezensisATCC 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 107CFU/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. IfBacillus velezensisATCC 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)
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 Institutionhttps://knowledge.bsigroup.com. | |
|
(3)
Content ofBacillus licheniformisDSM 28710 in CFU/kg of complete feed with a moisture content of 12%. | |
| Additive | Bacillus licheniformisDSM 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 ofBacillus licheniformisDSM 28710 containing a minimum of 3.2 × 109CFU/g of additive |
| Characterisation of the active substance(s) | Viable spores ofBacillus licheniformisDSM 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 109CFU/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. IfBacillus licheniformisDSM 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)
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( 17).
|
(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 Institutionhttps://knowledge.bsigroup.com. | |
|
(3)
Content ofClostridium butyricumFERM BP-2789 in CFU/kg of complete feed with a moisture content of 12%. | |
| Additive | Clostridium butyricumFERM 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 ofClostridium butyricumFERM BP-2789 containing a minimum of 5 × 108CFU/g of additive |
| Characterisation of the active substance(s) | Viable spores ofClostridium butyricumFERM 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 108CFU/kg |
| For the other species/categories: 2.5 x 108CFU/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. IfClostridium butyricumFERM 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)
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, 8thsupplement 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 Institutionhttps://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 byKomagataella phaffiiDSM 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 withKomagataella phaffiiDSM 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)
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( 18).
|
(1)
CAS Registry Number® assigned to this preparation by the Chemical Abstracts Servicehttps://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 Institutionhttps://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 andEimeriaspp. 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)
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( 19).
|
(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 Institutionhttps://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 andEimeriaspp. A report containing the outcome of that programme must be submitted to the Welsh Ministers by the end of 23 November 2031. | |
Regulation 8
Commission Regulation (EC) No 1289/2004concerning the authorisation for 10 years of the additive Deccox®in feedingstuffs, belonging to the group of coccidiostats and other medicinal substances( 21).
Commission Regulation (EC) No 903/2009concerning the authorisation of the preparation ofClostridium butyricumFERM-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 8/2010concerning the authorisation of the serine protease produced byBacillus 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 107/2010concerning the authorisation ofBacillus subtilisATCC PTA-6737 as a feed additive for chickens for fattening (holder of authorisation Kemin Europa NV)( 24).
Commission Regulation (EU) No 883/2010concerning the authorisation of a new use ofSaccharomyces cerevisiaeNCYC Sc 47 as a feed additive for calves for rearing (holder of the authorisation Société industrielle Lesaffre)( 25).
Commission Regulation (EU) No 168/2011amending Regulation (EU) No 107/2010 as regards the use of the feed additiveBacillus subtilisATCC PTA-6737 in feed containing maduramycin ammonium, monensin sodium, narasin, or robenidine hydrochloride( 26).
Commission Implementing Regulation (EU) No 373/2011 concerning the authorisation of the preparation ofClostridium butyricumFERM-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 B6as a feed additive for all animal species( 28).
Commission Implementing Regulation (EU) No 885/2011 concerning the authorisation ofBacillus 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 903/2009and Implementing Regulation (EU) No 373/2011 as regards the minimum content of a preparation ofClostridium 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 ofClostridium 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 1289/2004as regards the withdrawal time and maximum residues limits of the feed additive decoquinate( 32).
Commission Implementing Regulation (EU) No 1108/2014 concerning the authorisation of a preparation ofClostridium 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 903/2009and 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 ofClostridium butyricum(FERM-BP 2789)( 34).
(This note is not part of the Regulations)
The Welsh Ministers make these Regulations pursuant to Regulation (EC) No 1831/2003of 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 ofLactobacillus buchneri DSM 29026 (identification number 1k20759);
Schedule 3 is a new authorisation, for a preparation of Serine protease (EC 3.4.21.-) produced byBacillus 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 ofSaccharomyces cerevisiaeCNCM I-4407 (identification number 4b1702). The name of the bacterial strain is changed from “Saccharomyces cerevisiaeNCYC Sc 47” to “Saccharomyces cerevisiaeCNCM I-4407”;
Schedule 6 is a renewal of the authorisation of a preparation ofBacillus 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 1x1010to 8x1010colony forming units per gram (CFU/g);
Schedule 7 is a new authorisation of a preparation ofBacillus licheniformisDSM 28710 (identification number 4b1828);
Schedule 8 is a renewal of the authorisations of a preparation ofClostridium 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 byKomagataella phaffiiDSM 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 additiveBacillus subtilisATCC 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 [email protected].
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.
EUR 2003/1831, amended by S.I. 2019/654and 2022/377. S.I. 2019/654was amended by S.I. 2020/1504. The terms “ prescribe” and “ appropriate authority” are defined in Article 2 of EUR 2003/1831.
EUR 2002/178, amended by S.I. 2019/641. S.I. 2019/641was amended by S.I 2020/1504.
EUR 2009/767, amended by S.I. 2019/654. S.I 2019/654was amended by S.I. 2020/1504.
EUR 2013/306.
EUR 2013/787.
EUR 2015/1020.
EUR 2017/2276.
EUR 2010/883. This Regulation is revoked by regulation 8 of these Regulations.
EUR 2010/107. This Regulation is revoked by regulation 8 of these Regulations.
EUR 2011/885. This Regulation is revoked by regulation 8 of these Regulations.
EUR 2004/1289. This Regulation is revoked by regulation 8 of these Regulations.
EUR 2009/152, to which there amendments not relevant to these Regulations.
EUR 2008/429, amended by S.I. 2019/654. S.I. 2019/654was 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 107/2010and 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.
