LegalizeThe Feed Additives (Authorisations) and Uses of Feed Intended for Particular Nutritional Purposes (Amendment of Commission Regulation (EU) 2020/354) (Wales) Regulations 2024
Made: 27 November 2024
Laid before Senedd Cymru: 29 November 2024
Coming into force: 20 December 2024
There has been consultation as required by Article 9 of Regulation (EC) No 178/2002 of the European Parliament and of the Council laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety.
PART 1 — Introduction
Title, extent, application and coming into force
1
- (1) The title of these Regulations is the Feed Additives (Authorisations) and Uses of Feed Intended for Particular Nutritional Purposes (Amendment of Commission Regulation (EU) 2020/354) (Wales) Regulations 2024.
- (2) These Regulations—
- (a) extend to England and Wales;
- (b) apply in relation to Wales;
- (c) come into force on 20 December 2024.
Interpretation
2
- (1) Expressions used in these Regulations and in Regulation (EC) No 1831/2003 of the European Parliament and of the Council on additives for use in animal nutrition or Regulation (EC) No 767/2009 of the European Parliament and of the Council on the placing on the market and use of feed[^f00004] have the same meaning as in Regulation (EC) No 1831/2003 or Regulation (EC) No 767/2009, respectively.
- (2) In Schedules 1 to 20, expressions used to refer to species or categories of animals that are also used in Annex 4 (categories and definitions of target animals etc.) to Commission Regulation (EC) No 429/2008 on detailed rules for the implementation of Regulation (EC) No1831/2003 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[^f00005] have the same meaning as in that Annex.
PART 2 — Feed additive authorisations
Authorisations
3
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Modification of authorisations: preparation of Bacillus velezensis (DSM 15544) (identification number 4b1820)
4
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
5
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Modification of authorisation: selenised yeast produced by fermentation with Saccharomyces cerevisiae CNCM I-3060, inactivated (identification number 3b810)
7
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Removal of authorisation of butylated hydroxyanisole as an existing product for the purposes of Article 10 of Regulation (EC) No 1831/2003
8
Butylated hydroxyanisole (E 320) may no longer be placed on the market or used as a feed additive for cats under Article 10 of Regulation (EC) No 1831/2003[^f00010].
Changes of authorisation holder: amendment of Commission Implementing Regulation (EU) No887/2011 and Commission Implementing Regulations (EU) 2017/961 and 2020/1395
9
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
10
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
11
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
PART 3 — Transitional provisions
Transitional provision: 6-phytase (EC 3.1.3.26) produced by fermentation with Komagataella phaffii (formerly Komagataella pastoris) (DSM 23036) (identification number 4a16)
12
- (1) The relevant feed additive and premixtures, compound feed or feed materials containing it, which are produced and labelled before the end of 19 June 2025 in compliance with the conditions of authorisation and the labelling requirements applicable immediately before 20 December 2024, may continue to be placed on the market and used until stocks are exhausted.
- (2) In paragraph (1), the reference to the “relevant feed additive” is a reference to the feed additive 6-phytase (EC 3.1.3.26) (identification number 4a16)[^f00014] as authorised immediately before 20 December 2024 under Commission Implementing Regulation (EU) No98/2012 concerning the authorisation of 6-phytase (EC 3.1.3.26) produced by Pichia pastoris (DSM 23036) as a feed additive for chickens and turkeys for fattening, chickens reared for laying, turkeys reared for breeding, laying hens, other avian species for fattening and laying, weaned piglets, pigs for fattening and sows[^f00015].
Transitional provision: Bacillus velezensis (formerly Bacillus subtilis C-3102) (DSM 15544) (identification number 4b1820)
13
- (1) Any substance or product labelled “Bacillus subtilis C-3102” or as containing “Bacillus subtilis C-3102”, but otherwise produced and labelled in accordance with an authorisation contained in an instrument mentioned in regulations 4 to 6 of these Regulations, 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 19 June 2025 in compliance with the conditions of authorisation and the labelling requirements applicable immediately before 20 December 2024, may continue to be placed on the market and used until 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 19 December 2025 in compliance with the conditions of authorisation and the labelling requirements applicable immediately before 20 December 2024, may continue to be placed on the market and used until 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 19 December 2026 in compliance with the conditions of the authorisation and the labelling requirements applicable immediately before 20 December 2024, may continue to be placed on the market and used until stocks are exhausted.
- (5) In this regulation, references to the “relevant feed additive” are references to the feed additive Bacillus velezensis (formerly Bacillus subtilis C-3102) (DSM 15544), with the identification number 4b1820[^f00016], as authorised immediately before 20 December 2024 under—
- (a) Commission Regulation (EU) No 333/2010 concerning the authorisation of a new use of Bacillus subtilis C-3102 (DSM 15544) as a feed additive for weaned piglets[^f00017];
- (b) Commission Regulation (EU) No 184/2011 concerning the authorisation of Bacillus subtilis C-3102 (DSM 15544) as a feed additive for chickens reared for laying, turkeys, minor avian species and other ornamental and game birds[^f00018];
- (c) Commission Implementing Regulation (EU) 2016/897 concerning the authorisation of a preparation of Bacillus subtilis (C-3102) (DSM 15544) as a feed additive for laying hens and ornamental fish[^f00019];
- (d) Commission Implementing Regulation (EU) 2019/893 concerning the renewal of the authorisation of Bacillus subtilis DSM 15544 as a feed additive for chickens for fattening[^f00020].
Transitional provision: Selenised yeast produced by fermentation with Saccharomyces cerevisiae CNCM I-3060, inactivated (identification number 3b810)
14
- (1) The relevant feed additive and premixtures containing it, which are produced and labelled before the end of 19 June 2025 in compliance with the conditions of authorisation and the labelling requirements applicable immediately before 20 December 2024, may continue to be placed on the market and used until 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 19 December 2025 in compliance with the conditions of authorisation and the labelling requirements applicable immediately before 20 December 2024, may continue to be placed on the market and used until stocks are exhausted.
- (3) 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 19 December 2026 in compliance with the conditions of the authorisation and the labelling requirements applicable immediately before 20 December 2024, may continue to be placed on the market and used until stocks are exhausted.
- (4) In this regulation, references to the “relevant feed additive” are references to the feed additive selenised yeast produced by fermentation with Saccharomyces cerevisiae CNCM I-3060, inactivated, with the identification number 3b810, as authorised immediately before 20 December 2024 under Commission Implementing Regulation (EU) 2019/804[^f00021].
Transitional provision: Butylated hydroxyanisole as a feed additive for cats
15
- (1) Butylated hydroxyanisole as a feed additive for cats and premixtures containing it, which are produced and labelled before the end of 19 June 2025 in compliance with the conditions of authorisation and the labelling requirements applicable immediately before 20 December 2024, may continue to be placed on the market and used until stocks are exhausted.
- (2) Compound feed and feed materials containing butylated hydroxyanisole intended for cats, which are produced and labelled before the end of 19 December 2026 in compliance with the conditions of authorisation and the labelling requirements applicable immediately before 20 December 2024, may continue to be placed on the market and used until stocks are exhausted.
Transitional provisions: Copper, manganese and zinc chelates of hydroxy analogue of methionine (identification numbers 3b410i, 3b510 and 3b610 respectively)
16
- (1) A relevant feed additive and premixtures containing it, which are produced and labelled before the end of 19 June 2025 in compliance with the conditions of authorisation and the labelling requirements applicable immediately before 20 December 2024, may continue to be placed on the market and used until stocks are exhausted.
- (2) Compound feed and feed materials containing a relevant feed additive and intended for food-producing animals, which are produced and labelled before the end of 19 December 2025 in compliance with the conditions of authorisation and the labelling requirements applicable immediately before 20 December 2024, may continue to be placed on the market and used until stocks are exhausted.
- (3) Compound feed and feed materials containing a relevant feed additive and intended for non-food-producing animals, which are produced and labelled before the end of 19 December 2026 in compliance with the conditions of the authorisation and the labelling requirements applicable immediately before 20 December 2024, may continue to be placed on the market and used until stocks are exhausted.
- (4) In this regulation, references to a “relevant feed additive” are references to each of the following feed additives.
Copper chelate of hydroxy analogue of methionine a The feed additive copper chelate of hydroxy analogue of methionine, with the identification number 3b410i (formerly 3b4.10)[^f00022] as authorised immediately before 20 December 2024 under Commission Regulation (EU) No 349/2010 concerning the authorisation of copper chelate of hydroxy analogue of methionine as a feed additive for all animal species[^f00023].
Manganese chelate of hydroxy analogue of methionine b The feed additive manganese chelate of hydroxy analogue of methionine, with the identification number 3b510 (formerly 3b5.10)[^f00024] as authorised immediately before 20 December 2024 under Commission Regulation (EU) No 350/2010 concerning the authorisation of manganese chelate of hydroxy analogue of methionine as a feed additive for all animal species[^f00025].
Zinc chelate of hydroxy analogue of methionine c The feed additive zinc chelate of hydroxy analogue of methionine, with the identification number 3b610 (formerly 3b6.10)[^f00026] as authorised immediately before 20 December 2024 under Commission Regulation (EU) No 335/2010 concerning the authorisation of zinc chelate of hydroxy analogue of methionine as a feed additive for all animal species[^f00027].
PART 4 — Uses of feed intended for particular nutritional purposes
Modification of an essential nutritional characteristic for feed intended to reduce the risk of milk fever and subclinical hypocalcaemia
17
- (1) In Commission Regulation (EU) 2020/354 establishing a list of intended uses of feed intended for particular nutritional purposes[^f00028], in the Annex, in Part B (list of intended uses), the table is amended as follows.
- (2) In entry 60 (reduction of the risk of milk fever and subclinical hypocalcaemia), in column number 2 (essential nutritional characteristics), in the section of the entry starting “Low cations/anions ratio”, for “Objective: 0 < DCADs(mEq/kg dry matter) < 100” substitute “Objective: Range from -200 mEq/kg dry matter DCADs to <100 mEq/kg dry matter DCAD”.
PART 5 — Revocations
Amendment of Commission Implementing Regulation (EU) 2016/1095
18
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Amendment of Commission Implementing Regulation (EU) 2018/1039
19
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Revocations
20
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
SCHEDULE 1 — ...
The preparation of chromium chelate of DL-methionine specified in the table, belonging to the additive category “zootechnical additives” and to the functional group “other zootechnical”, 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(2019)6115119 - 03/10/2019” and “JRC F.5/CvH/ZE/AS/Ares”, and last updated on 18 October 2019. Available at: https://joint-research-centre.ec.europa.eu/publications/fad-2018-0021_en. | (1) Details of the analytical methods are set out in the document referenced “Ares(2019)6115119 - 03/10/2019” and “JRC F.5/CvH/ZE/AS/Ares”, and last updated on 18 October 2019. Available at: https://joint-research-centre.ec.europa.eu/publications/fad-2018-0021_en. |
|---|---|
| (2) 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 (ISBN 978 0 580 94471 0). Available at: https://knowledge.bsigroup.com. | (2) 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 (ISBN 978 0 580 94471 0). Available at: https://knowledge.bsigroup.com. |
| (3) 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 at: https://knowledge.bsigroup.com. | (3) 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 at: https://knowledge.bsigroup.com. |
| (4) Content of chromium (mg/kg of complete feed with a moisture content of 12%). | (4) Content of chromium (mg/kg of complete feed with a moisture content of 12%). |
| Additive | Chromium chelate of DL-methionine |
| Identification number | GB4d0001 |
| Authorisation holder | Zinpro Animal Nutrition (Europe), Inc |
| Additive category | Zootechnical additives |
| Functional group | Other zootechnical |
| Additive composition | Solid preparation of chelates of chromium (Cr) with DL-methionine with the below components: Calcium carbonate: 95.6% Chromium-DL-Methionine: 3.4% Vegetable oil: 1.0% |
| Characterisation of the active substance(s) | Chromium chelate of DL-methionine ([CH₃S(CH₂)₂CH(NH₂)COO]₃ Cr) |
| Analytical methods[^f01000] | For the quantification of chromium in the feed additive: Inductively coupled plasma mass spectrometry (ICP-MS) (BS EN 17053:2018[^f01001]) |
| Analytical methods[^f01000] | For the quantification of methionine in the feed additive: Ion-exchange chromatography coupled to post-column derivatisation and photometric detection (IEC-VIS) (BS EN ISO 13903:2005[^f01002]) |
| Analytical methods[^f01000] | For proving the chelated structure of the feed additive: Mid-infrared (IR) spectrometry together with the determination of the content of chromium and methionine in the feed additive |
| Species or category of animal | Dairy cows |
| Maximum age | None |
| Minimum content[^f01003] | 0.2 mg/kg |
| Maximum content[^f01003] | 0.5 mg/kg |
| Other provisions | The storage conditions and stability to heat treatment must be stated in the directions for use of the feed additive and premixture |
SCHEDULE 2 — ...
The preparation of Saccharomyces cerevisiae (MUCL 39885) 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[^f00031].
| (1) Details of the analytical methods are set out in the document referenced “D06/FSQ/CVH/CMP/mdr/ARES (2010)58412”, and last updated on 6 June 2016. Available at: https://joint-research-centre.ec.europa.eu/publications/fad-2009-0028_en. | (1) Details of the analytical methods are set out in the document referenced “D06/FSQ/CVH/CMP/mdr/ARES (2010)58412”, and last updated on 6 June 2016. Available at: https://joint-research-centre.ec.europa.eu/publications/fad-2009-0028_en. |
|---|---|
| (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 at: https://knowledge.bsigroup.com. | (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 at: https://knowledge.bsigroup.com. |
| (3) Under reference DD CEN/TS 15790:2008 “Animal feeding stuffs. PCR typing of probiotic strains of Saccharomyces cerevisiae (yeast)”. Published by the British Standards Institution on 31 January 2009 (ISBN 978 0 580 61806 2). Available at: https://knowledge.bsigroup.com. | (3) Under reference DD CEN/TS 15790:2008 “Animal feeding stuffs. PCR typing of probiotic strains of Saccharomyces cerevisiae (yeast)”. Published by the British Standards Institution on 31 January 2009 (ISBN 978 0 580 61806 2). Available at: https://knowledge.bsigroup.com. |
| (4) Colony forming units (CFU) of additive/kg complete feed with a moisture content of 12%. | (4) Colony forming units (CFU) of additive/kg complete feed with a moisture content of 12%. |
| Additive | Saccharomyces cerevisiae (MUCL 39885) |
| Identification number | 4b1710 |
| Authorisation holder | Prosol S.p.A |
| Additive category | Zootechnical additives |
| Functional group | Gut flora stabilisers |
| Additive composition | Solid preparation of Saccharomyces cerevisiae (MUCL 39885) containing a minimum of 1 × 10 ⁹ colony forming units (CFU)/g |
| Characterisation of the active substance(s) | Viable cells ofSaccharomyces cerevisiae (MUCL 39885) |
| Analytical methods[^f01004] | For enumeration: Pour plate method CGYE (chloramphenicol, glucose, yeast extract) agar (BS EN 15789:2021[^f01005]) |
| Analytical methods[^f01004] | For identification of the yeast strain: Polymerase chain reaction (PCR) method (DDCEN/TS 15790:2008[^f01006]) |
| Species or category of animal | All Suidae other than suckling piglets or sows Cats Dogs |
| Maximum age | None |
| Minimum content[^f01007] | For Suidae: Suidae other than suckling piglets, sows and Suidae for reproduction purposes: 3 × 10⁹ CFU/kg Suidae for reproduction purposes other than sows: 6.4 × 10⁹ CFU/kg |
| Minimum content[^f01007] | For cats 7 × 10¹⁰ CFU/kg |
| Minimum content[^f01007] | For dogs: 7 × 10¹⁰ CFU/kg |
| Maximum content[^f01007] | None |
| Other provisions | The storage conditions must be indicated in the directions for use of the feed additive and premixtures |
SCHEDULE 3 — ...
The preparation of Pediococcus acidilactici (CNCM I-4622) specified in the table, belonging to the additive category “technological additives” and to the functional groups “acidity regulator” and “hygiene condition enhancer”, 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(2014)1202206 - 16/04/2014” and “JRC.D.5/SFB/CvH/JO /mds/Ares”, and last updated on 6 June 2016. Available at: https://joint-research-centre.ec.europa.eu/publications/fad-2013-0031_en. | (1) Details of the analytical methods are set out in the document referenced “Ares(2014)1202206 - 16/04/2014” and “JRC.D.5/SFB/CvH/JO /mds/Ares”, and last updated on 6 June 2016. Available at: https://joint-research-centre.ec.europa.eu/publications/fad-2013-0031_en. |
|---|---|
| (2) Under reference BS EN 15786:2021 “Animal feeding stuffs: Methods of sampling and analysis. Detection and enumeration of Pediococcus spp. used as feed additive”. Published by the British Standards Institution on 30 November 2021 (ISBN 978 0 580 99830 0). Available at: https://knowledge.bsigroup.com. | (2) Under reference BS EN 15786:2021 “Animal feeding stuffs: Methods of sampling and analysis. Detection and enumeration of Pediococcus spp. used as feed additive”. Published by the British Standards Institution on 30 November 2021 (ISBN 978 0 580 99830 0). Available at: https://knowledge.bsigroup.com. |
| (3) Colony forming units (CFU) of additive/kg of complete feed with a moisture content of 12%. | (3) Colony forming units (CFU) of additive/kg of complete feed with a moisture content of 12%. |
| Additive | Pediococcus acidilactici (CNCM I-4622) |
| Identification number | 4d1712 |
| Authorisation holder | None |
| Additive category | Technological additives |
| Functional group | Acidity regulators Hygiene condition enhancers |
| Additive composition | Solid preparation of Pediococcus acidilactici (CNCM I-4622) containing a minimum of 1×10 ¹⁰ colony forming units (CFU)/g |
| Characterisation of the active substance(s) | Viable cells ofPediococcus acidilactici (CNCM I-4622) |
| Analytical methods[^f01008] | For enumeration (colony count) of the feed additive: Spread plate method using MRS agar (BS EN 15786:2021[^f01009]) |
| Analytical methods[^f01008] | For identification of the bacterial strain: Pulsed-field gel electrophoresis (PFGE) |
| Species or category of animal | All animal species |
| Maximum age | None |
| Minimum content[^f01010] | 1 × 10⁹ CFU/kg |
| Maximum content[^f01010] | None |
| Other provisions | 1. The storage conditions and stability to heat treatment must be stated in the directions for use of the feed additive and premixture. |
| Other provisions | 2. To be used only in mash compound feed intended for preparation of liquid feed on farm, or solid feed materials intended for preparation of liquid feed on farm. |
| Other provisions | 3. If Pediococcus acidilactici (CNCM I-4622) is to be used in feed containing coccidiostats, this feed additive is authorised for use with the following coccidiostats only, and in accordance with their individual authorisation criteria: Decoquinate Diclazuril Halofuginone Nicarbazin Robenidine |
SCHEDULE 4 — ...
The preparation of monensin sodium produced by fermentation with Streptomyces cinnamonensis 28682 (NBIMCC 3419) 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[^f00032].
| (1) CAS Registry Number® assigned to this preparation by the Chemical Abstracts Servicehttps://www.cas.org/cas-data/cas-registry. | (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 are set out in the document referenced “Ares(2017)1087313 - 01/03/2017” and “JRC F.5/CvH/MGH /mds/Ares”, and last updated on 27 April 2017. Available at: https://joint-research-centre.ec.europa.eu/publications/fad-2016-0009_en. | (2) Details of the analytical methods are set out in the document referenced “Ares(2017)1087313 - 01/03/2017” and “JRC F.5/CvH/MGH /mds/Ares”, and last updated on 27 April 2017. Available at: https://joint-research-centre.ec.europa.eu/publications/fad-2016-0009_en. |
| (3) Under reference BS EN ISO 14183:2008 “Animal feeding stuffs. Determination of monensin, narasin and salinomycin contents. Liquid chromatographic method using post-column derivatization”. Published by the British Standards Institution on 24 January 2006 (ISBN 978 0 580 62955 6). Available at: https://knowledge.bsigroup.com. | (3) Under reference BS EN ISO 14183:2008 “Animal feeding stuffs. Determination of monensin, narasin and salinomycin contents. Liquid chromatographic method using post-column derivatization”. Published by the British Standards Institution on 24 January 2006 (ISBN 978 0 580 62955 6). Available at: https://knowledge.bsigroup.com. |
| (4) Content of monensin (mg/kg of complete feed with a moisture content of 12%). | (4) Content of monensin (mg/kg of complete feed with a moisture content of 12%). |
| Additive | Monensin sodium |
| Identification number | 51701 |
| Authorisation holder | Huvepharma NV |
| Additive category | Coccidiostats and histomonostats |
| Functional group | None |
| Additive composition | Preparation of monensin sodium produced by fermentation with Streptomyces cinnamonensis 28682 (NBIMCC 3419) in powder form with the below components: Monensin sodium technical substance: 250 g/kg containing: Monensin A: 90% minimum Monensin A + B: 95% minimum Monensin C: 0.2 – 0.3% Perlite: 150 – 200 g/kg Calcium carbonate: 550 – 600 g/kg |
| Characterisation of the active substance(s) | Monensin sodium technical substance produced by fermentation with Streptomyces cinnamonensis 28682 (NBIMCC 3419). Monensin sodium A (C₃₆H₆₁NaO₁₁) Monensin sodium B (C₃₅H₅₉NaO₁₁) Monensin sodium C (C₃₇H₆₃NaO₁₁) CAS number[^f01011]: 22373-78-0 |
| Analytical methods[^f01012] | For the quantification of monensin in the feed additive, premixtures and compound feed: Reversed phase high performance liquid chromatography using post-column derivatisation coupled to spectrophotometric detection (RP-HPLC-PCD-UV-Vis) (BS EN ISO 14183:2008[^f01013]) |
| Analytical methods[^f01012] | For the quantification of monensin sodium in chicken and turkey tissues: Reversed phase high performance liquid chromatography coupled to a triple quadrupole mass spectrometer (RP-HPLC-MS/MS) or any equivalent methods. |
| Species or category of animal | Chickens for fattening Chickens reared for laying Turkeys for fattening Turkeys reared for breeding |
| Maximum age | For chickens for fattening: None |
| Maximum age | For chickens reared for laying: 16 weeks |
| Maximum age | For turkeys for fattening, turkeys reared for breeding: 16 weeks |
| Minimum content[^f01014] | For chickens for fattening; chickens reared for laying: 100 mg/kg |
| Minimum content[^f01014] | For turkeys for fattening; turkeys reared for breeding: 60 mg/kg |
| Maximum content[^f01014] | For chickens for fattening; chickens reared for laying: 125 mg/kg |
| Maximum content[^f01014] | For turkeys for fattening; turkeys reared for breeding: 100 mg/kg |
| Maximum residue limits (MRLs) of monensin sodium in food of animal origin | For wet skin in combination with wet fat: 25 µg/kg |
| Maximum residue limits (MRLs) of monensin sodium in food of animal origin | For wet liver; wet kidney; wet muscle: 8 µg/kg |
| Other provisions | 1. The storage conditions and stability to heat treatment must be stated in the directions for use of the feed additive and premixture. |
| Other provisions | 2. The feed additive must be incorporated into compound feed in the form of a premixture. |
| Other provisions | 3. Monensin sodium must not be mixed with other coccidiostats. |
| Other provisions | 4. The following must be stated, in English or in English and Welsh, in the directions for use: In English: “Dangerous for equines. This feed contains an ionophore. Avoid simultaneous administration with tiamulin and monitor for possible adverse reactions when used concurrently with other medicinal substances”. In Welsh: “Yn beryglus i geffylau. Mae’r bwyd anifeiliaid hwn yn cynnwys ionoffor. Dylid osgoi ei roi ar yr un pryd â tiamwlin, a dylid monitro ar gyfer adweithiau andwyol posibl wrth ei ddefnyddio gyda sylweddau meddygol eraill”. |
| Other provisions | 5. A post-market monitoring programme must be carried out by the holder of the authorisation for resistance to bacteria and Eimeria spp. A report containing the outcome of that programme must be submitted to the Welsh Ministers before the end of 19 December 2033. |
SCHEDULE 5 — ...
The preparation of monensin sodium produced by fermentation with Streptomyces cinnamonensis 28682 (NBIMCC 3419) 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[^f00033].
| (1) CAS Registry Number® assigned to this preparation by the Chemical Abstracts Service https://www.cas.org/cas-data/cas-registry. | (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 are set out in the document referenced “Ares(2017)1087313 - 01/03/2017” and “JRC F.5/CvH/MGH /mds/Ares”, and last updated on 27 April 2017. Available at: https://joint-research-centre.ec.europa.eu/publications/fad-2016-0009_en. | (2) Details of the analytical methods are set out in the document referenced “Ares(2017)1087313 - 01/03/2017” and “JRC F.5/CvH/MGH /mds/Ares”, and last updated on 27 April 2017. Available at: https://joint-research-centre.ec.europa.eu/publications/fad-2016-0009_en. |
| (3) Under reference BS EN ISO 14183:2008 “Animal feeding stuffs. Determination of monensin, narasin and salinomycin contents. Liquid chromatographic method using post-column derivatization”. Published by the British Standards Institution on 24 January 2006 (ISBN 978 0 580 62955 6). Available at: https://knowledge.bsigroup.com. | (3) Under reference BS EN ISO 14183:2008 “Animal feeding stuffs. Determination of monensin, narasin and salinomycin contents. Liquid chromatographic method using post-column derivatization”. Published by the British Standards Institution on 24 January 2006 (ISBN 978 0 580 62955 6). Available at: https://knowledge.bsigroup.com. |
| (4) Content of monensin (mg/kg of complete feed with a moisture content of 12%). | (4) Content of monensin (mg/kg of complete feed with a moisture content of 12%). |
| Additive | Monensin sodium |
| Identification number | 51701 |
| Authorisation holder | Huvepharma NV |
| Additive category | Coccidiostats and histomonostats |
| Functional group | None |
| Additive composition | Preparation of monensin sodium produced by fermentation with Streptomyces cinnamonensis 28682 (NBIMCC 3419) in powder form with the below components: Monensin sodium technical substance: 250g/kg containing: Monensin A: 90% minimum Monensin A + B: 95% minimum Monensin C: 0.2 – 0.3% Perlite: 150 – 200 g/kg Wheat bran: 550 – 600 g/kg |
| Characterisation of the active substance(s) | Monensin sodium technical substance produced by fermentation with Streptomyces cinnamonensis 28682 (NBIMCC 3419). Monensin sodium A (C₃₆H₆₁NaO₁₁) Monensin sodium B (C₃₅H₅₉NaO₁₁) Monensin sodium C (C₃₇H₆₃NaO₁₁) CAS number[^f01015] 22373-78-0 |
| Analytical methods[^f01016] | For the quantification of monensin in the feed additive, premixtures and compound feed: Reversed phase high performance liquid chromatography using post-column derivatisation coupled to spectrophotometric detection (RP-HPLC-PCD-UV-Vis) (BS EN ISO 14183:2008[^f01017]) |
| Analytical methods[^f01016] | For the quantification of monensin sodium in chicken and turkey tissues: Reversed phase high performance liquid chromatography coupled to a triple quadrupole mass spectrometer (RP-HPLC-MS/MS) or any equivalent methods. |
| Species or category of animal | Chickens for fattening Chickens reared for laying Turkeys for fattening Turkeys reared for breeding |
| Maximum age | For chickens for fattening: None |
| Maximum age | For chickens reared for laying: 16 weeks |
| Maximum age | For turkeys for fattening; turkeys reared for breeding: 16 weeks |
| Minimum content[^f01018] | For chickens for fattening; chickens reared for laying: 100 mg/kg |
| Minimum content[^f01018] | For turkeys for fattening; turkeys reared for breeding: 60 mg/kg |
| Maximum content[^f01018] | For chickens for fattening; chickens reared for laying: 125 mg/kg |
| Maximum content[^f01018] | For turkeys for fattening; turkeys reared for breeding: 100 mg/kg |
| Maximum residue limits (MRLs) of monensin sodium in food of animal origin | For wet skin in combination with wet fat: 25 µg/kg |
| Maximum residue limits (MRLs) of monensin sodium in food of animal origin | For wet liver; wet kidney; wet muscle: 8 µg/kg |
| Other provisions | 1. The storage conditions and stability to heat treatment must be stated in the directions for use of the feed additive and premixture. |
| Other provisions | 2. The feed additive must be incorporated into compound feed in the form of a premixture. |
| Other provisions | 3. Monensin sodium must not be mixed with other coccidiostats. |
| Other provisions | 4. The following must be stated, in English or in English and Welsh, in the directions for use: In English: “Dangerous for equines. This feed contains an ionophore. Avoid simultaneous administration with tiamulin and monitor for possible adverse reactions when used concurrently with other medicinal substances”. In Welsh: “Yn beryglus i geffylau. Mae’r bwyd anifeiliaid hwn yn cynnwys ionoffor. Dylid osgoi ei roi ar yr un pryd â thiamwlin, a dylid monitro ar gyfer adweithiau andwyol posibl wrth ei ddefnyddio gyda sylweddau meddygol eraill”. |
| Other provisions | 5. A post-market monitoring programme must be carried out by the holder of the authorisation for resistance to bacteria and Eimeria spp. A report containing the outcome of that programme must be submitted to the Welsh Ministers before the end of 19 December 2033. |
SCHEDULE 6 — ...
The preparation of 6-phytase (EC 3.1.3.26) produced by fermentation with Komagataella phaffii (DSM 23036) 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[^f00034].
| (1) OptiPhos technical units (phytase activity): 1 OTU is the amount of enzyme that catalyses the release of 1 µmol of inorganic phosphate per minute from 5.1 mM sodium phytate in pH 5.5 citrate buffer at 37ºC, measured as the blue P-molybdate complex colour at 820 nm | (1) OptiPhos technical units (phytase activity): 1 OTU is the amount of enzyme that catalyses the release of 1 µmol of inorganic phosphate per minute from 5.1 mM sodium phytate in pH 5.5 citrate buffer at 37ºC, measured as the blue P-molybdate complex colour at 820 nm |
|---|---|
| (2) CAS Registry Number® assigned to this preparation by the Chemical Abstracts Service https://www.cas.org/cas-data/cas-registry. | (2) CAS Registry Number® assigned to this preparation by the Chemical Abstracts Service https://www.cas.org/cas-data/cas-registry. |
| (3) Identification number allocated by the International Union of Biochemistry and Molecular Biology (IUBMB) https://iubmb.org. | (3) Identification number allocated by the International Union of Biochemistry and Molecular Biology (IUBMB) https://iubmb.org. |
| (4) Details of the analytical methods are set out in the document referenced “Ares(2016)5971303 - 17/10/2016” and “JRC F.5/CvH/MGH /mds/Ares”, and last updated on 17 November 2016. Available at: https://joint-research-centre.ec.europa.eu/publications/fad-2016-0019_en. | (4) Details of the analytical methods are set out in the document referenced “Ares(2016)5971303 - 17/10/2016” and “JRC F.5/CvH/MGH /mds/Ares”, and last updated on 17 November 2016. Available at: https://joint-research-centre.ec.europa.eu/publications/fad-2016-0019_en. |
| (5) Content of 6-phytase (EC 3.1.3.26) (units of activity (OTU)/kg of complete feed with a moisture content of 12%). | (5) Content of 6-phytase (EC 3.1.3.26) (units of activity (OTU)/kg of complete feed with a moisture content of 12%). |
| Additive | 6-phytase (EC 3.1.3.26) |
| Identification number | 4a16 |
| Authorisation holder | Huvepharma NV |
| Additive category | Zootechnical additives |
| Functional group | Digestibility enhancers |
| Additive composition | Preparation of 6–phytase (EC 3.1.3.26) produced by fermentation with Komagataella phaffii (DSM 23036) having a minimum enzyme activity of: 4,000 OTU/g[^f01019] in solid form 8,000 OTU/g in liquid form |
| Characterisation of the active substance(s) | 6-phytase (EC 3.1.3.26) produced by fermentation with Komagataella phaffii (DSM 23036) CAS number[^f01020]: 9001-89-2 EC (IUBMB) number[^f01021]: 3.1.3.26 |
| Analytical methods [^f01022] | For the quantification of phytase activity in the feed additive, premixtures and compound feed: Colorimetric method based on the quantification of the inorganic phosphate released by the enzyme from the sodium phytate |
| Species or category of animal | All avian species All Suidae |
| Maximum age | None |
| Minimum content[^f01023] | For avian species: All avian species other than turkeys: 125 OTU/kg Turkeys: 250 OTU/kg |
| Minimum content[^f01023] | For Suidae: All Suidae other than piglets: 125 OTU/kg Piglets: 250 OTU/kg |
| Maximum content[^f01023] | None |
| Other provisions | The storage conditions and stability to heat treatment must be stated in the directions for use of the feed additive and premixture. |
SCHEDULE 7 — ...
The preparation of Bacillus velezensis (DSM 15544) 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[^f00035].
| (1) Details of the analytical methods are set out in the document referenced “D08/FSQ/CVH/CMP/mds/ARES (2009)347415” and last updated on 6 June 2016. Available at: https://joint-research-centre.ec.europa.eu/publications/fad-2009-0013_en. | (1) Details of the analytical methods are set out in the document referenced “D08/FSQ/CVH/CMP/mds/ARES (2009)347415” and last updated on 6 June 2016. Available at: https://joint-research-centre.ec.europa.eu/publications/fad-2009-0013_en. |
|---|---|
| (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 at: https://knowledge.bsigroup.com. | (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 at: https://knowledge.bsigroup.com. |
| (3) Colony forming units (CFU)/kg of complete feed with a moisture content of 12%. | (3) Colony forming units (CFU)/kg of complete feed with a moisture content of 12%. |
| Additive | Bacillus velezensis (DSM 15544) |
| Identification number | 4b1820 |
| Authorisation holder | Asahi Biocycle Co., Ltd |
| Additive category | Zootechnical additives |
| Functional group | Gut flora stabilisers |
| Additive composition | Solid preparation of Bacillus velezensis (DSM 15544) containing a minimum of 1 × 10 ¹⁰ colony forming units (CFU)/g |
| Characterisation of the active substance(s) | Viable spores ofBacillus velezensis (DSM 15544) |
| Analytical methods[^f01024] | For enumeration (colony count) of the feed additive: Spread plate method using tryptone soya agar in all target matrices (BS EN 15784:2021[^f01025]) |
| Analytical methods[^f01024] | For identification of the feed additive Pulsed-field gel electrophoresis (PFGE) |
| Species or category of animal | Weaned piglets All avian species |
| Maximum age | None |
| Minimum content[^f01026] | 3 × 10⁸CFU/kg |
| Maximum content[^f01026] | None |
| Other provisions | The storage conditions and stability to heat treatment must be stated in the directions for use of the feed additive and premixture. |
SCHEDULE 8 — ...
The preparation of L-histidine monohydrochloride monohydrate produced by fermentation with Escherichia coli K-12 (KCCM 80212) specified in the table, belonging to the additive category “nutritional additives” and to the functional group “amino acids, their salts and analogues”, is authorised as an additive in animal nutrition subject to the conditions set out in the table.
| (1) CAS Registry Number® assigned to this preparation by the Chemical Abstracts Service https://www.cas.org/cas-data/cas-registry. | (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, as published in OJ No C146A, 15.6.90, p.1. | (2) European Inventory of Existing Commercial Substances, as published in OJ No C146A, 15.6.90, p.1. |
| (3) Details of the analytical methods are set out in the document referenced “Ares(2020)3718494 – 14/07/2020” and “JRC F.5/CvH/ZE/AS/Ares”, and last updated on 16 October 2020. Available at: https://joint-research-centre.ec.europa.eu/publications/fad-2020-0016_en. | (3) Details of the analytical methods are set out in the document referenced “Ares(2020)3718494 – 14/07/2020” and “JRC F.5/CvH/ZE/AS/Ares”, and last updated on 16 October 2020. Available at: https://joint-research-centre.ec.europa.eu/publications/fad-2020-0016_en. |
| (4) 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 at: https://knowledge.bsigroup.com. | (4) 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 at: https://knowledge.bsigroup.com. |
| (5) Content of L-histidine monohydrochloride monohydrate (mg/kg of complete feed with a moisture content of 12%). | (5) Content of L-histidine monohydrochloride monohydrate (mg/kg of complete feed with a moisture content of 12%). |
| (6) Exposure calculated based on the endotoxin level and the dusting potential of the additive according to the method used by the European Food Safety Authority (EFSA Journal 2015;13(2):4015); analytical method: European Pharmacopoeia (Ph. Eur.): Supplement 6.6 (official January 1, 2010), Bacterial Endotoxins (reference 01/2010:20614). | (6) Exposure calculated based on the endotoxin level and the dusting potential of the additive according to the method used by the European Food Safety Authority (EFSA Journal 2015;13(2):4015); analytical method: European Pharmacopoeia (Ph. Eur.): Supplement 6.6 (official January 1, 2010), Bacterial Endotoxins (reference 01/2010:20614). |
| Additive | L-histidine monohydrochloride monohydrate |
| Identification number | 3c352i |
| Authorisation holder | None |
| Additive category | Nutritional additives |
| Functional group | Amino acids, their salts and analogues |
| Additive composition | L-histidine monohydrochloride monohydrate with a purity criteria not less than 98% as a powder with the following components: Moisture: 1% maximum Histidine: 72% minimum Histamine: 100ppm maximum |
| Characterisation of the active substance(s) | L-histidine monohydrochloride monohydrate produced by fermentation with Escherichia coli K-12 (KCCM 80212) (C₆H₁₂ClN₃O₃) CAS number: 5934-29-2[^f01027] EINECS number[^f01028]: 611-821-4 |
| Analytical methods[^f01029] | For the quantification of histidine in the feed additive: High performance liquid chromatography coupled with photometric detection (HPLC-UV) (BS EN ISO 13903:2005[^f01030]), or Ion-exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS/FLD) |
| Analytical methods[^f01029] | For the quantification of histidine in premixtures, feed materials and compound feed: Ion-exchange chromatography coupled to post-column derivatisation and photometric detection (IEC-VIS) (Commission Regulation (EC) No 152/2009 laying down the methods of sampling and analysis for the official control of feed[^f00036] - Annex 3, F) |
| Analytical methods[^f01029] | For the quantification of histamine in the feed additive: High performance liquid chromatography coupled with photometric detection (HPLC-UV) (BS EN ISO 13903:2005[^f01030]) |
| Species or category of animal | All animal species |
| Maximum age | None |
| Minimum content[^f01031] | None |
| Maximum content[^f01031] | None |
| Other provisions | 1. The storage conditions and stability to heat treatment must be stated in the directions for use of the feed additive and premixture. |
| Other provisions | 2. L-histidine monohydrochloride monohydrate may be placed on the market and used as an additive consisting of a preparation. |
| Other provisions | 3. The histidine content must be stated on the labelling of the additive and premixture. |
| Other provisions | 4. The following must be stated, in English or in English and Welsh, on the labelling of the additive and premixture: In English: “The supplementation with L-histidine monohydrochloride monohydrate shall be limited to the nutritional requirements of the target animal, which depend on the species, the physiological state of the animal, the performance level, the environmental conditions, the level of other amino acids in the diet and the level of essential trace elements such as copper and zinc”. In Welsh: “Rhaid i’r ychwanegiad â L-histidin monohydroclorid monohydrad fod yn gyfyngedig i ofynion maethol yr anifail targed, sy’n dibynnu ar y rhywogaeth, cyflwr ffisiolegol yr anifail, lefel perfformiad, yr amodau amgylcheddol, lefel asidau amino eraill yn y diet a lefel elfennau hybrin hanfodol fel copor a zinc”. |
| Other provisions | 5.The endotoxin content of the additive and its dusting potential must ensure a maximal endotoxin exposure of 1600 IU endotoxins/m³ air [^f01032]. |
SCHEDULE 9 — ...
The preparation of L-tryptophan produced by fermentation with Escherichia coli (KCCM 80210) specified in the table, belonging to the additive category “nutritional additives” and to the functional group “amino acids, their salts and analogues”, is authorised as an additive in animal nutrition subject to the conditions set out in the table.
| (1) CAS Registry Number® assigned to this preparation by the Chemical Abstracts Service https://www.cas.org/cas-data/cas-registry. | (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, as published in OJ No C146A, 15.6.90, p.1. | (2) European Inventory of Existing Commercial Substances, as published in OJ No C146A, 15.6.90, p.1. |
| (3) Details of the analytical methods are set out in the document referenced “Ares(2020)7146784 – 27/11/2020” and “JRC F.5/CvH/ZE/AS/Ares”, and last updated on 19 December 2020. Available at: https://joint-research-centre.ec.europa.eu/publications/fad-2020-0038_en. | (3) Details of the analytical methods are set out in the document referenced “Ares(2020)7146784 – 27/11/2020” and “JRC F.5/CvH/ZE/AS/Ares”, and last updated on 19 December 2020. Available at: https://joint-research-centre.ec.europa.eu/publications/fad-2020-0038_en. |
| (4) Food Chemicals Codex (FCC), 13th edition (Method: FCC L-tryptophan monograph published). Published by the United States Pharmacopeial Convention on 1 March 2022 (ISSN 2153-1455). Available at: https://www.foodchemicalscodex.org . | (4) Food Chemicals Codex (FCC), 13th edition (Method: FCC L-tryptophan monograph published). Published by the United States Pharmacopeial Convention on 1 March 2022 (ISSN 2153-1455). Available at: https://www.foodchemicalscodex.org . |
| (5) Under reference BS EN ISO 13904:2016 “Animal feeding stuffs. Determination of tryptophan content”. Published by the British Standards Institution on 31 March 2016 (ISBN 978 0 580 84452 2). Available at: https://knowledge.bsigroup.com. | (5) Under reference BS EN ISO 13904:2016 “Animal feeding stuffs. Determination of tryptophan content”. Published by the British Standards Institution on 31 March 2016 (ISBN 978 0 580 84452 2). Available at: https://knowledge.bsigroup.com. |
| (6) Content of L-tryptophan (mg/kg of complete feed with a moisture content of 12%). | (6) Content of L-tryptophan (mg/kg of complete feed with a moisture content of 12%). |
| (7) Exposure calculated based on the endotoxin level and the dusting potential of the additive according to the method used by the European Food Safety Agency (EFSA Journal 2015;13(2):4015); analytical method: European Pharmacopoeia (Ph. Eur.): Supplement 6.6 (official January 1, 2010), Bacterial Endotoxins (reference 01/2010:20614). | (7) Exposure calculated based on the endotoxin level and the dusting potential of the additive according to the method used by the European Food Safety Agency (EFSA Journal 2015;13(2):4015); analytical method: European Pharmacopoeia (Ph. Eur.): Supplement 6.6 (official January 1, 2010), Bacterial Endotoxins (reference 01/2010:20614). |
| Additive | L-tryptophan |
| Identification number | 3c440i |
| Authorisation holder | None |
| Additive category | Nutritional additives |
| Functional group | Amino acids, their salts and analogues |
| Additive composition | L-tryptophan with a purity criteria on a dry matter basis not less than 98% as a powder with the following components: Moisture content: 1% maximum 1,1’-ethylidene-bis-L-tryptophan: 10 mg/kg maximum |
| Characterisation of the active substance(s) | L-tryptophan produced by fermentation with Escherichia coli (KCCM 80210)(C₁₁H₁₂N₂O₂) CAS number: 73-22-3[^f01033] EINECS number[^f01034]: 200-795-6 |
| Analytical methods[^f01035] | For the identification of L-tryptophan in the feed additive: Food Chemical Codex[^f01036] “L-tryptophan monograph” |
| Analytical methods[^f01035] | For the determination of tryptophan in the feed additive and premixtures: High performance liquid chromatography with fluorescence detection (HPLC-FLD) (BS EN ISO 13904:2016[^f01037]) |
| Analytical methods[^f01035] | For the determination of tryptophan in feed materials and compound feed: High performance liquid chromatography with fluorescence detection (HPLC-FLD) (Commission Regulation (EC) No 152/2009 laying down the methods of sampling and analysis for the official control of feed - Annex 3, G) |
| Species or category of animal | All animal species |
| Maximum age | None |
| Minimum content[^f01038] | None |
| Maximum content[^f01038] | None |
| Other provisions | 1. L-tryptophan must be rumen protected when administered to ruminants. |
| Other provisions | 2. The following must be stated, in English or in English and Welsh, on the labelling of the additive and premixture: In English: “The supplementation with L-tryptophan shall take into account all essential and conditionally essential amino acids in order to avoid imbalances”. In Welsh: “Rhaid i’r atchwanegiad ag L-tryptophan ystyried yr holl asidau amino hanfodol ac amodol hanfodol er mwyn osgoi anghydbwysedd”. |
| Other provisions | 3. The endotoxin content of the additive and its dusting potential must ensure a maximal endotoxin exposure of 1600 IU endotoxins/m³ air [^f01039]. |
SCHEDULE 10 — ...
The preparation of L-lysine sulphate produced by fermentation with Corynebacterium glutamicum (KCCM 80227) specified in the table, belonging to the additive category “nutritional additives” and to the functional group “amino acids, their salts and analogues”, is authorised as an additive in animal nutrition subject to the conditions set out in the table.
| (1) CAS Registry Number® assigned to this preparation by the Chemical Abstracts Service https://www.cas.org/cas-data/cas-registry. | (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 are set out in the document referenced “Ares(2021)2533252 – 14/04/2021” and “JRC F.5/CvH/ZE/AS/Ares”, and last updated on 2 July 2021. Available at: https://joint-research-centre.ec.europa.eu/publications/fad-2020-00820085_en | (2) Details of the analytical methods are set out in the document referenced “Ares(2021)2533252 – 14/04/2021” and “JRC F.5/CvH/ZE/AS/Ares”, and last updated on 2 July 2021. Available at: https://joint-research-centre.ec.europa.eu/publications/fad-2020-00820085_en |
| (3) Under reference BS EN ISO 17180:2013 “Animal feeding stuffs. Determination of lysine, methionine and threonine in commercial amino acid products and premixtures”. Published by the British Standards Institution on 30 April 2013 (ISBN 978 0 580 76077 8). Available at: https://knowledge.bsigroup.com. | (3) Under reference BS EN ISO 17180:2013 “Animal feeding stuffs. Determination of lysine, methionine and threonine in commercial amino acid products and premixtures”. Published by the British Standards Institution on 30 April 2013 (ISBN 978 0 580 76077 8). Available at: https://knowledge.bsigroup.com. |
| (4) European Pharmacopoeia monograph – Ph. Eur. 6.0, 01/2008:20301: “Identification reactions of ions and functional groups – sulphates”. Published online by the European Directorate for the Quality of Medicines and Healthcare. Available at: https://pheur.edqm.eu/home. | (4) European Pharmacopoeia monograph – Ph. Eur. 6.0, 01/2008:20301: “Identification reactions of ions and functional groups – sulphates”. Published online by the European Directorate for the Quality of Medicines and Healthcare. Available at: https://pheur.edqm.eu/home. |
| (5) Content of L-lysine sulphate (mg/kg of complete feed with a moisture content of 12%). | (5) Content of L-lysine sulphate (mg/kg of complete feed with a moisture content of 12%). |
| Additive | L-lysine sulphate |
| Identification number | 3c324i |
| Authorisation holder | None |
| Additive category | Nutritional additives |
| Functional group | Amino acids, their salts and analogues |
| Additive composition | Granulated preparation of L-lysine sulphate with a minimum of 52% L-lysine, a maximum of 24% sulphate and a maximum moisture content of 4% |
| Characterisation of the active substance(s) | L-lysine sulphate produced by fermentation with Corynebacteriumglutamicum (KCCM 80227) (C₁₂H₂₈N₄O₄· H₂SO₄) CAS Number[^f01040]: 60343-69-3 |
| Analytical methods[^f01041] | For the quantification of lysine in the feed additive and premixtures containing more than 10% lysine: Ion-exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS/FLD) (BS EN ISO 17180:2013[^f01042]) |
| Analytical methods[^f01041] | For the identification of sulphate in the feed additive: European Pharmacopoeia Monograph[^f01043] 20301 |
| Analytical methods[^f01041] | For quantification of lysine in premixtures, feed materials and compound feed: Ion-exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS - Commission Regulation (EC) No 152/2009 laying down the methods of sampling and analysis for the official control of feed - Annex 3, F) |
| Analytical methods[^f01041] | For the quantification of lysine in water: Ion exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS/FLD) (BS EN ISO 17180:2013[^f01042]) |
| Species or category of animal | All animal species |
| Maximum age | None |
| Minimum content[^f01044] | None |
| Maximum content[^f01044] | 10,000 mg/kg |
| Other provisions | 1. The storage conditions and stability to heat treatment must be stated in the directions for use of the feed additive and premixture. |
| Other provisions | 2. The L-lysine content must be stated on the labelling of the additive. |
| Other provisions | 3. The following must be stated, in English or in English and Welsh, on the labelling of the additive and premixture: In English: “The supplementation with L-lysine should take into account all essential and conditionally essential amino acids in order to avoid imbalances”. In Welsh: “Dylai’r atchwanegiad ag L-lysin ystyried yr holl asidau amino hanfodol ac amodol hanfodol er mwyn osgoi anghydbwysedd”. |
SCHEDULE 11 — ...
The substance butylated hydroxyanisole (identification number 1b320) specified in the table, belonging to the additive category “technological additives” and to the functional group “antioxidants”, is authorised as an additive in animal nutrition subject to the conditions set out in the table[^f00037].
| (1) CAS Registry Number® assigned to this preparation by the Chemical Abstracts Service https://www.cas.org/cas-data/cas-registry. | (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 are set out in the document referenced “JRC.D.5/CvH/SB/ag/ARES(2012)40826”, and last updated on 6 June 2016. Available at: https://joint-research-centre.ec.europa.eu/publications/fad-2010-0132_en. | (2) Details of the analytical methods are set out in the document referenced “JRC.D.5/CvH/SB/ag/ARES(2012)40826”, and last updated on 6 June 2016. Available at: https://joint-research-centre.ec.europa.eu/publications/fad-2010-0132_en. |
| (3) Food Chemicals Codex (FCC), 7th edition (Method: BHA-FCC V1 monograph _ published). Published by the United States Pharmacopeial Convention on 1 March 2010. Available at: https://www.foodchemicalscodex.org. | (3) Food Chemicals Codex (FCC), 7th edition (Method: BHA-FCC V1 monograph _ published). Published by the United States Pharmacopeial Convention on 1 March 2010. Available at: https://www.foodchemicalscodex.org. |
| (4) Content of butylated hydroxyanisole (mg/kg of complete feed with a moisture content of 12%). | (4) Content of butylated hydroxyanisole (mg/kg of complete feed with a moisture content of 12%). |
| Additive | Butylated hydroxyanisole |
| Identification number | 1b320 |
| Authorisation holder | None |
| Additive category | Technological additives |
| Functional group | Antioxidants |
| Additive composition | Butylated hydroxyanisole with a minimum content of 98.5% in a waxy solid form |
| Characterisation of the active substance(s) | Butylated hydroxyanisole containing a mixture of 2-tert-butyl-4-hydroxyanisole and a minimum of 85% 3-tert-butyl-4-hydroxyanisole (C₁₁H₁₆O₂) CAS number[^f01045]: 25013-16-5 |
| Analytical methods[^f01046] | For the quantification of butylated hydroxyanisole in feed additives: Gas chromatography coupled to flame ionization detection (GC-FID) (Food Chemicals Codex 7th edition method[^f01047]) |
| Analytical methods[^f01046] | For the quantification of butylated hydroxyanisole in premixtures and compound feed: Reversed phase high performance liquid chromatography coupled to ultraviolet-diode-array detection (RP-HPLC-UV-DAD, 285 nm) |
| Species or category of animal | Cats |
| Maximum age | None |
| Minimum content[^f01048] | None |
| Maximum content[^f01048] | 150 mg/kg |
| Other provisions | 1. The storage conditions and stability to heat treatment must be stated in the directions for use of the feed additive and premixture. |
| Other provisions | 2. Butylated hydroxyanisole is authorised to be used in combination with butylated hydroxytoluene up to a maximum combined content of 150 mg/kg of complete feed. |
SCHEDULE 12 — ...
The preparation of L-lysine base (liquid) produced by fermentation with Corynebacterium glutamicum (KCCM 80183) specified in the table, belonging to the additive category “nutritional additives” and to the functional group “amino acids, their salts and analogues”, is authorised as an additive in animal nutrition subject to the conditions set out in the table.
| (1) CAS Registry Number® assigned to this preparation by the Chemical Abstracts Service https://www.cas.org/cas-data/cas-registry. | (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 are set out in the document referenced “Ares(2019)7003671 - 12/11/2019” and “JRC F.5/CvH/SB/AS/Ares”, and last updated on 27 January 2020. Available at: https://joint-research-centre.ec.europa.eu/publications/fad-2019-00160028_en. | (2) Details of the analytical methods are set out in the document referenced “Ares(2019)7003671 - 12/11/2019” and “JRC F.5/CvH/SB/AS/Ares”, and last updated on 27 January 2020. Available at: https://joint-research-centre.ec.europa.eu/publications/fad-2019-00160028_en. |
| (3) Under reference BS EN ISO 17180:2013 “Animal feeding stuffs. Determination of lysine, methionine and threonine in commercial amino acid products and premixtures”. Published by the British Standards Institution on 30 April 2013 (ISBN 978 0 580 76077 8). Available at: https://knowledge.bsigroup.com. | (3) Under reference BS EN ISO 17180:2013 “Animal feeding stuffs. Determination of lysine, methionine and threonine in commercial amino acid products and premixtures”. Published by the British Standards Institution on 30 April 2013 (ISBN 978 0 580 76077 8). Available at: https://knowledge.bsigroup.com. |
| (4) Content of L-lysine (mg/kg of complete feed with a moisture content of 12%). | (4) Content of L-lysine (mg/kg of complete feed with a moisture content of 12%). |
| Additive | L-lysine base (liquid) |
| Identification number | 3c320 |
| Authorisation holder | None |
| Additive category | Nutritional additives |
| Functional group | Amino acids, their salts and analogues |
| Additive composition | Aqueous solution with a minimum of 50% L-lysine |
| Characterisation of the active substance(s) | L-lysine base (liquid) (NH₂(CH₂)CH(NH₂)COOH) produced by fermentation with Corynebacterium glutamicum (KCCM 80183). CAS number[^f01049]: 56-87-1 |
| Analytical methods[^f01050] | For the quantification of lysine in the feed additive and premixtures containing more than 10% lysine: Ion-exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS/FLD)[^f01050] (BS EN ISO 17180:2013) |
| Analytical methods[^f01050] | For quantification of lysine in premixtures, feed materials and compound feed: Ion-exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS) (Commission Regulation (EC) No 152/2009 laying down the methods of sampling and analysis for the official control of feed - Annex 3, F) |
| Analytical methods[^f01050] | For the quantification of lysine in water: Ion exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS/FLD) (BS EN ISO 17180:2013[^f01051]), or Ion exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS) (Commission Regulation (EC) No 152/2009 - Annex 3, F) |
| Species or category of animal | All animal species |
| Maximum age | None |
| Minimum content[^f01052] | None |
| Maximum content[^f01052] | None |
| Other provisions | 1. The L-lysine content must be stated on the labelling of the additive. |
| Other provisions | 2. The additive may be used via water for drinking. |
| Other provisions | 3. The following must be stated, in English or in English and Welsh, on the labelling of the additive and premixture: In English: “The supplementation with L-lysine, in particular via water for drinking, should take into account all essential and conditionally essential amino acids in order to avoid imbalances”. In Welsh: “Dylai’r atchwanegiad ag L-lysin, yn arbennig drwy ddŵr i’w yfed, ystyried yr holl asidau amino hanfodol ac amodol hanfodol er mwyn osgoi anghydbwysedd”. |
SCHEDULE 13 — ...
The substance L-lysine monohydrochloride (technically pure) produced by fermentation with Corynebacterium glutamicum (KCCM 80183) specified in the table, belonging to the additive category “nutritional additives” and to the functional group “amino acids, their salts and analogues”, is authorised as an additive in animal nutrition subject to the conditions set out in the table.
| (1) CAS Registry Number® assigned to this preparation by the Chemical Abstracts Service https://www.cas.org/cas-data/cas-registry. | (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 are set out in the document referenced “Ares(2019)7003671 - 12/11/2019” and “JRC F.5/CvH/SB/AS/Ares”, and last updated on 27 January 2020. Available at: https://joint-research-centre.ec.europa.eu/publications/fad-2019-00160028_en. | (2) Details of the analytical methods are set out in the document referenced “Ares(2019)7003671 - 12/11/2019” and “JRC F.5/CvH/SB/AS/Ares”, and last updated on 27 January 2020. Available at: https://joint-research-centre.ec.europa.eu/publications/fad-2019-00160028_en. |
| (3) Food Chemicals Codex (FCC), 13th edition (Method: FCC L-lysine monohydrochloride monograph published). Published by the United States Pharmacopeial Convention on 1 March 2022 (ISSN 2153-1455). Available at: https://www.foodchemicalscodex.org/. | (3) Food Chemicals Codex (FCC), 13th edition (Method: FCC L-lysine monohydrochloride monograph published). Published by the United States Pharmacopeial Convention on 1 March 2022 (ISSN 2153-1455). Available at: https://www.foodchemicalscodex.org/. |
| (4) Under reference BS EN ISO 17180:2013 “Animal feeding stuffs. Determination of lysine, methionine and threonine in commercial amino acid products and premixtures”. Published by the British Standards Institution on 30 April 2013 (ISBN 978 0 580 76077 8). Available at: https://knowledge.bsigroup.com. | (4) Under reference BS EN ISO 17180:2013 “Animal feeding stuffs. Determination of lysine, methionine and threonine in commercial amino acid products and premixtures”. Published by the British Standards Institution on 30 April 2013 (ISBN 978 0 580 76077 8). Available at: https://knowledge.bsigroup.com. |
| (5) Content of L-lysine monohydrochloride (mg/kg of complete feed with a moisture content of 12%). | (5) Content of L-lysine monohydrochloride (mg/kg of complete feed with a moisture content of 12%). |
| Additive | L-lysine monohydrochloride (technically pure) |
| Identification number | 3c322ii |
| Authorisation holder | None |
| Additive category | Nutritional additives |
| Functional group | Amino acids, their salts and analogues |
| Additive composition | Powder of L-lysine monohydrochloride with a minimum of 78% L-lysine and a maximum moisture content of 1.5% |
| Characterisation of the active substance(s) | L-lysine monohydrochloride (technically pure) (NH₂(CH₂)₄CH(NH₂)COOH) produced by fermentation with Corynebacterium glutamicum (KCCM 80183) CAS number[^f01053]: 657-27-2 |
| Analytical method[^f01054] | For the identification of L-lysine monohydrochloride in the feed additive: Food Chemicals Codex[^f01055] “L-lysine monohydrochloride monograph” |
| Analytical method[^f01054] | For the quantification of lysine in the feed additive and premixtures containing more than 10% lysine: Ion-exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS/FLD) (BS EN ISO 17180:2013[^f01056]) |
| Analytical method[^f01054] | For the quantification of lysine in premixtures, feed materials and compound feed: Ion-exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS) (Commission Regulation (EC) No 152/2009 laying down the methods of sampling and analysis for the official control of feed - Annex 3, F) |
| Analytical method[^f01054] | For the quantification of lysine in water: Ion exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS/FLD) (BS EN ISO 17180:2013[^f01056]), or Ion exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS) (Commission Regulation (EC) No 152/2009 - Annex 3, F) |
| Species or category of animal | All animal species |
| Maximum age | None |
| Minimum content[^f01057] | None |
| Maximum content | None |
| Other provisions | 1. The L-lysine content must be stated on the labelling of the additive. |
| Other provisions | 2. The additive may be used via water for drinking. |
| Other provisions | 3. The following must be stated, in English or in English and Welsh, on the labelling of the additive and premixture: In English: “The supplementation with L-lysine, in particular via water for drinking, should take into account all essential and conditionally essential amino acids in order to avoid imbalances”. In Welsh: “Dylai’r atchwanegiad ag L-lysin, yn arbennig drwy ddŵr i’w yfed, ystyried yr holl asidau amino hanfodol ac amodol hanfodol er mwyn osgoi anghydbwysedd”. |
SCHEDULE 14 — ...
The substance disodium 5’-guanylate (GMP) produced by fermentation with Corynebacterium stationis (KCCM 10530) and Escherichia coli K-12 (KFCC 11067) specified in the table, belonging to the additive category “sensory additives” and to the functional group “flavouring compounds”, is authorised as an additive in animal nutrition subject to the conditions set out in the table.
| (1) CAS Registry Number® assigned to this preparation by the Chemical Abstracts Service https://www.cas.org/cas-data/cas-registry. | (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, as published in OJ No C146A, 15.6.90, p.1. | (2) European Inventory of Existing Commercial Substances, as published in OJ No C146A, 15.6.90, p.1. |
| (3) Details of the analytical methods are set out in the document referenced “Ares(2020)4619276 – 04/09/2020” and “JRC F.5/CvH/ZE/AS/Ares”, and last updated on 16 October 2020. Available at: https://joint-research-centre.ec.europa.eu/publications/fad-2019-0085_en. | (3) Details of the analytical methods are set out in the document referenced “Ares(2020)4619276 – 04/09/2020” and “JRC F.5/CvH/ZE/AS/Ares”, and last updated on 16 October 2020. Available at: https://joint-research-centre.ec.europa.eu/publications/fad-2019-0085_en. |
| (4) Food and Agriculture Organisation of the United Nations (FAO) Joint FAO/WHO Expert Committee on Food Additives (JECFA) - Combined Compendium of Food Additive Specifications, “Disodium 5’-guanylate” Monograph 1 (2006). Published by the FAO and last updated (Web version) August 2011 (ISBN 92-5-105569-6). Available at:https://www.fao.org/food/food-safety-quality/scientific-advice/jecfa/jecfa-additives/detail/en/c/255 | (4) Food and Agriculture Organisation of the United Nations (FAO) Joint FAO/WHO Expert Committee on Food Additives (JECFA) - Combined Compendium of Food Additive Specifications, “Disodium 5’-guanylate” Monograph 1 (2006). Published by the FAO and last updated (Web version) August 2011 (ISBN 92-5-105569-6). Available at:https://www.fao.org/food/food-safety-quality/scientific-advice/jecfa/jecfa-additives/detail/en/c/255 |
| (5) Content of disodium 5’-guanylate (mg/kg of complete feed with a moisture content of 12%). | (5) Content of disodium 5’-guanylate (mg/kg of complete feed with a moisture content of 12%). |
| Additive | Disodium 5’-guanylate |
| Identification number | 2b627i |
| Authorisation holder | None |
| Additive category | Sensory additives |
| Functional group | Flavouring compounds |
| Additive composition | Powder of disodium 5’-guanylate with a minimum purity criteria of 97%. |
| Characterisation of the active substance(s) | Hydrated form of disodium 5’-guanylate (GMP) produced by fermentation with Corynebacterium stationis(KCCM 10530) andEscherichia coliK-12 (KFCC 11067)(C₁₀H₁₂N₅Na₂O₈P) CAS number: 5550-12-9[^f01058] EINECS number[^f01059]: 226-914-1 |
| Analytical methods[^f01060] | For the identification of disodium 5’-guanylate (GMP) in the feed additive: FAO JECFA monograph[^f01061] “disodium 5’-guanylate” |
| Analytical methods[^f01060] | For the determination of disodium 5’-guanylate (GMP) in the feed additive, flavouring premixtures and water: High performance liquid chromatography coupled to UV detection (HPLC-UV) |
| Species or category of animal | All animal species |
| Maximum age | None |
| Minimum content[^f01062] | None |
| Maximum content[^f01062] | None |
| Other provisions | 1. The storage condition-s and stability to heat treatment must be stated in the directions for use of the feed additive and premixture. |
| Other provisions | 2. The additive must be incorporated into the feed in the form of a premixture. |
| Other provisions | 3. The following must be stated, in English or in English and Welsh, on the labelling of the additive: In English: “Recommended maximum content of the active substance when used alone or in combination with other ribonucleotides up to the same level per kg of complete feedingstuff with a moisture content of 12%: 50 mg”. In Welsh: “Yr uchafswm cynnwys a argymhellir o’r sylwedd actif pan y’i defnyddir ar ei ben ei hun neu mewn cyfuniad â riboniwcleotidau eraill hyd at yr un lefel fesul kg o fwyd anifeiliaid â chynnwys lleithder o 12%: 50 mg”. |
| Other provisions | 4. The functional group, identification number, name and added amount of the active substance must be indicated on the label of the premixture where the use level on the label of the premixture would result in the level of active substance (alone or in combination with other ribonucleotides) in complete feed exceeding 50 mg/kg. |
SCHEDULE 15 — ...
The preparation of muramidase (EC 3.2.1.17) produced by fermentation with Trichoderma reesei (DSM 32338) specified in the table, belonging to the additive category “zootechnical additives” and to the functional group “other zootechnical additives”, is authorised as an additive in animal nutrition subject to the conditions set out in the table.
| (1) 1 LSU(F) is defined as the amount of enzyme that increases the fluorescence of 12.5 µg/ml fluorescein-labelled peptidoglycan per minute at pH 6.0 and 30 ºC by a value that corresponds to the fluorescence of approximately 0.06 nmol fluorescein isothiocyanate isomer. | (1) 1 LSU(F) is defined as the amount of enzyme that increases the fluorescence of 12.5 µg/ml fluorescein-labelled peptidoglycan per minute at pH 6.0 and 30 ºC by a value that corresponds to the fluorescence of approximately 0.06 nmol fluorescein isothiocyanate isomer. |
|---|---|
| (2) CAS Registry Number® assigned to this preparation by the Chemical Abstracts Service https://www.cas.org/cas-data/cas-registry. | (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, as published in OJ No C146A, 15.6.90, p.1. | (3) European Inventory of Existing Commercial Substances, as published in OJ No C146A, 15.6.90, p.1. |
| (4) Identification number allocated by the International Union of Biochemistry and Molecular Biology (IUBMB) https://iubmb.org. | (4) Identification number allocated by the International Union of Biochemistry and Molecular Biology (IUBMB) https://iubmb.org. |
| (5) Details of the analytical methods are set out in the document referenced “Ares(2018)811287 - 12/02/2018” and “JRC F.5/CvH/SB/AS/Ares”, and last updated on 2 March 2018. Available at: https://joint-research-centre.ec.europa.eu/publications/fad-2017-0046_en. | (5) Details of the analytical methods are set out in the document referenced “Ares(2018)811287 - 12/02/2018” and “JRC F.5/CvH/SB/AS/Ares”, and last updated on 2 March 2018. Available at: https://joint-research-centre.ec.europa.eu/publications/fad-2017-0046_en. |
| (6) Content of muramidase (LSU(F)/kg of complete feed with a moisture content of 12%) | (6) Content of muramidase (LSU(F)/kg of complete feed with a moisture content of 12%) |
| Additive | Muramidase (EC 3.2.1.17) |
| Identification number | 4d16 |
| Authorisation holder | DSM Nutritional Products Ltd |
| Additive category | Zootechnical additives |
| Functional group | Other zootechnical additives |
| Additive composition | Solid and liquid preparationsofmuramidase (EC 3.2.1.17) produced by fermentation with Trichoderma reesei (DSM 32338) having a minimum enzyme activity of 60,000 LSU(F)/g[^f01063] |
| Characterisation of the active substance(s) | Muramidase (EC 3.2.1.17) produced by fermentation with Trichoderma reesei (DSM 32338) CAS number: 9001-63-2[^f01064] EINECS number: 232-620-4[^f01065] EC (IUBMB) number[^f01066]: 3.2.1.17 |
| Analytical methods[^f01067] | For the quantification of muramidase in the feed additive, premixtures and compound feed: Fluorescence-based enzyme assay method that determines the enzyme-catalysed depolymerisation of a fluorescein-labelled peptidoglycan preparation at pH 6.0 and 30 °C. |
| Species or category of animal | Weaned piglets |
| Maximum age | None |
| Minimum content[^f01068] | 50,000 LSU(F)/kg |
| Maximum content[^f01068] | 65,000 LSU(F)/kg |
| Other provisions | The storage conditions and stability to heat treatment must be stated in the directions for use of the feed additive and premixture. |
SCHEDULE 16 — ...
The preparation of phytomenadione (vitamin K₁) specified in the table, belonging to the additive category “nutritional additives” and to the functional group “vitamins, pro-vitamins and chemically well-defined substances having a similar effect”, is authorised as an additive in animal nutrition subject to the conditions set out in the table.
Reading this document does not replace reading the official text published on legislation.gov.uk. Contains public sector information licensed under the Open Government Licence v3.0. We assume no responsibility for any inaccuracies arising from the conversion of the original CLML XML to this format.
This text is published under legislation.gov.uk's own terms of reuse, not a Legalize or public-domain licence.
legislation.gov.uk
Open Government Licence v3.0 (attribution required)
© Crown and database right. Derived from content available under the Open Government Licence v3.0 from legislation.gov.uk.