LegalizeThe Feed Additives (Authorisations) and Uses of Feed Intended for Particular Nutritional Purposes (Amendment of Commission Regulation (EU) 2020/354) (England) Regulations 2024
Made: 4th November 2024
Laid before Parliament: 5th November 2024
Coming into force: 20th December 2024
The Secretary of State makes these Regulations in exercise of the powers conferred by Articles 9(1), 10(5) and 18A(3) of Regulation (EC) No 1831/2003 of the European Parliament and of the Council on additives for use in animal nutrition[^f00001] and sections 74A(1)(a) and (b) of the Agriculture Act 1970[^f00002].
There has been open and transparent public consultation during the preparation and evaluation of 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[^f00003].
Part 1 — Introductory
Citation, commencement, extent and application
1
- (1) These Regulations may be cited as the Feed Additives (Authorisations) and Uses of Feed Intended for Particular Nutritional Purposes (Amendment of Commission Regulation (EU) 2020/354) (England) Regulations 2024 and come into force on 20th December 2024.
- (2) These Regulations extend to England and Wales but apply in relation to England only.
Interpretation
2
- (1) In these Regulations —
- “Regulation (EC) 152/2009” means Commission Regulation (EC) No 152/2009 laying down the methods of sampling and analysis for the official control of feed.
- (2) Any expression used both 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, etc. has the same meaning as it has in those Regulations.
- (3) In Schedules 1 to 20, in the tables, in the row relating to “Species or category of animal”, expressions used that are also used in Annex 4 of Commission Regulation (EC) No 429/2008 on detailed rules for the implementation of Regulation (EC) 1831/2003 of the European Parliament and of the Council as regards the preparation and the presentation of applications and the assessment and the authorisation of feed additives (categories and definitions of target animals etc.) have the same meaning as in that Annex.
Part 2 — Feed additive authorisations
Authorisation of various feed additives
3
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Part 3 — 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
4
In Commission Regulation (EU) 2020/354 establishing a list of intended uses of feed intended for particular nutritional purposes, etc.[^f00006], in the Annex, in Part B (list of intended uses), 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 4 — Amendment of assimilated direct legislation
Modification of authorisation: a preparation of Bacillus velezensis (DSM 15544), (identification number 4b1820)
5
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Modification of authorisation: selenised yeast Saccharomyces cerevisiae (CNCM I-3060), inactivated (identification number 3b810)
6
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Changes of authorisation holder: amendment of Commission Implementing Regulation (EU) No887/2011 and Commission Implementing Regulations (EU) 2017/961 and 2020/1395
7
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Amendment of Commission Implementing Regulation (EU) 2016/1095
8
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Amendment of Commission Implementing Regulation (EU) 2018/1039
9
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Part 5 — Transitional Provisions
Transitional provision: a preparation of Bacillus velezensis (DSM 15544) (identification number 4b1820)
10
- (1) Any substance or product labelled “Bacillus subtilis C-3102 (DSM 15544)” or as containing “Bacillus subtilis C-3102 (DSM 15544)”, but otherwise produced and labelled in accordance with an authorisation contained in an instrument mentioned in regulation 5, may continue to be placed on the market and used under that authorisation.
- (2) Stocks of the relevant feed additive, and premixtures containing it, which are produced and labelled before the end of 19th June 2025 in accordance with the conditions of the prior authorisation and the labelling requirements applicable immediately before 20th December 2024, may continue to be placed on the market and used until they are exhausted.
- (3) Stocks of feed materials and compound feed containing the relevant feed additive, intended for food-producing animals, which are produced and labelled before the end of 19th December 2025 in accordance with the conditions of the prior authorisation and the labelling requirements applicable immediately before 20th December 2024, may continue to be placed on the market and used until they are exhausted.
- (4) Stocks of feed materials and compound feed containing the relevant feed additive, intended for non-food-producing animals, which are produced and labelled before the end of 19th December 2026 in accordance with the conditions of the prior authorisation and the labelling requirements applicable immediately before 20th December 2024, may continue to be placed on the market and used until they are exhausted.
- (5) In this regulation—
- “relevant feed additive” means the feed additive of a preparation of Bacillus velezensis(DSM 15544), with the identification number 4b1820 authorised under the prior authorisation;
- “prior authorisation” means the authorisations contained in Commission Implementing Regulation (EU) 2016/897 concerning the authorisation of a preparation of Bacillus subtilis(C-3102) (DSM 1544) as a feed additive for laying hens and ornamental fish, etc., Commission Implementing Regulation (EU) 2017/2312 concerning the authorisation of a new use of the preparation of Bacillus subtilis C-3102 (DSM 15544) as a feed additive for sows, suckling piglets and dogs, etc., and Commission Implementing Regulation (EU) 2018/1081 concerning the authorisation of the preparation of Bacillus subtilis C-3102 (DSM 15544) as a feed additive for pigs for fattening, etc.[^f00016], as the Regulations had effect immediately before 20th December 2024.
Transitional provision: selenised yeast Saccharomyces cerevisiae (CNCM I-3060), inactivated (identification number 3b810)
11
- (1) Stocks of the relevant feed additive, and premixtures containing it, which are produced and labelled before the end of 19th June 2025 in accordance with the conditions of the prior authorisation and the labelling requirements applicable immediately before 20th December 2024, may continue to be placed on the market and used until they are exhausted.
- (2) Stocks of feed materials and compound feed containing the relevant feed additive, intended for food-producing animals, which are produced and labelled before the end of 19th December 2025 in accordance with the conditions of the prior authorisation and the labelling requirements applicable immediately before 20th December 2024, may continue to be placed on the market and used until they are exhausted.
- (3) Stocks of feed materials and compound feed containing the relevant feed additive, intended for non-food-producing animals, which are produced and labelled before the end of 19th December 2026 in accordance with the conditions of the prior authorisation and the labelling requirements applicable immediately before 20th December 2024, may continue to be placed on the market and used until they are exhausted.
- (4) In this regulation—
- “relevant feed additive” means the feed additive selenised yeast Saccharomyces cerevisiae (CNCM I-3060), inactivated, with the identification number 3b810 authorised under the prior authorisation;
- “prior authorisation” means the authorisation contained in Commission Implementing Regulation (EU) 2019/804 concerning the renewal of the authorisation of organic form selenium produced by Saccharomyces cerevisiae CNCM I-3060 and of selenomethionine produced by Saccharomyces cerevisiae NCYC R397 as feed additives for all animal species[^f00017].
Transitional provision: butylated hydroxyanisole (identification number 1b320)
12
- (1) Butylated hydroxyanisole (E 320) is authorised to be placed on the market, processed or used as a feed additive for cats only to the extent that it is covered by and meets the conditions of the authorisation contained in Schedule 11 to these Regulations[^f00018], and in consequence of that authorisation butylated hydroxyanisole (E 320) shall no longer be treated as an existing product under, and for the purposes of, Article 10 of Regulation (EC) No 1831/2003.
- (2) Stocks of butylated hydroxyanisole as a feed additive for cats, and premixtures containing it, which are produced and labelled before the end of 19th June 2025 in compliance with the conditions of the authorisation and the labelling requirements applicable before 20th December 2024, may continue to be placed on the market and used until they are exhausted.
- (3) Stocks of feed materials and compound feed containing butylated hydroxyanisole, intended for cats, which are produced and labelled before the end of 19th December 2026 in compliance with the conditions of the authorisation and the labelling requirements applicable immediately before 20th December 2024, may continue to be placed on the market and used until they are exhausted.
Transitional provision: 6-phytase (EC 3.1.3.26) (identification number 4a16)
13
- (1) Stocks of the relevant feed additive, and premixtures containing it, which are produced and labelled before the end of 19th June 2025 in accordance with the conditions of the prior authorisation and the labelling requirements applicable immediately before 20th December 2024, may continue to be placed on the market and used until they are exhausted.
- (2) Stocks of feed materials and compound feed containing the relevant feed additive, intended for food-producing animals, which are produced and labelled before the end of 19th June 2025 in accordance with the conditions of the prior authorisation and the labelling requirements applicable immediately before 20th December 2024, may continue to be placed on the market and used until they are exhausted.
- (3) In this regulation—
- “relevant feed additive” means the feed additive 6-phytase (EC 3.1.3.26), with the identification number 4a16 authorised under the prior authorisation;
- “prior authorisation” means the authorisation contained in Commission Implementing Regulation (EU) No98/2012[^f00019], as it had effect immediately before 20th December 2024, 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 (holder of authorisation Huvepharma AD)[^f00020].
Transitional provision: copper chelate of hydroxy analogue of methionine (identification number 3b410i)
14
- (1) Stocks of the relevant feed additive, and premixtures containing it, which are produced and labelled before the end of 19th June 2025 in accordance with the conditions of the prior authorisation and the labelling requirements applicable immediately before 20th December 2024, may continue to be placed on the market and used until they are exhausted.
- (2) Stocks of feed materials and compound feed containing the relevant feed additive, intended for food-producing animals, which are produced and labelled before the end of 19th December 2025 in accordance with the conditions of the prior authorisation and the labelling requirements applicable immediately before 20th December 2024, may continue to be placed on the market and used until they are exhausted.
- (3) Stocks of feed materials and compound feed containing the relevant feed additive, intended for non-food-producing animals, which are produced and labelled before the end of 19th December 2026 in accordance with the conditions of the prior authorisation and the labelling requirements applicable immediately before 20th December 2024, may continue to be placed on the market and used until they are exhausted.
- (4) In this regulation—
- “relevant feed additive” means copper chelate of hydroxy analogue of methionine, with the identification number 3b410i authorised under the prior authorisation;
- “prior authorisation” means the authorisation contained in Commission Regulation (EU) No 349/2010[^f00021], as it had effect immediately before 20th December 2024, concerning the authorisation of copper chelate of hydroxy analogue of methionine as a feed additive for all animal species[^f00022].
Transitional provision: manganese chelate of hydroxy analogue of methionine (identification number 3b510)
15
- (1) Stocks of the relevant feed additive, and premixtures containing it, which are produced and labelled before the end of 19th June 2025 in accordance with the conditions of the prior authorisation and the labelling requirements applicable immediately before 20th December 2024, may continue to be placed on the market and used until they are exhausted.
- (2) Stocks of feed materials and compound feed containing the relevant feed additive, intended for food-producing animals, which are produced and labelled before the end of 19th December 2025 in accordance with the conditions of the prior authorisation and the labelling requirements applicable immediately before 20th December 2024, may continue to be placed on the market and used until they are exhausted.
- (3) Stocks of feed materials and compound feed containing the relevant feed additive, intended for non-food-producing animals, which are produced and labelled before the end of 19th December 2026 in accordance with the conditions of the prior authorisation and the labelling requirements applicable immediately before 20th December 2024, may continue to be placed on the market and used until they are exhausted.
- (4) In this regulation—
- “relevant feed additive” means manganese chelate of hydroxy analogue of methionine, with the identification number 3b510 authorised under the prior authorisation;
- “prior authorisation” means the authorisation contained in Commission Regulation (EU) No 350/2010[^f00023], as it had effect immediately before 20th December 2024, concerning the authorisation of manganese chelate of hydroxy analogue of methionine as a feed additive for all animal species[^f00024].
Transitional provision: zinc chelate of hydroxy analogue of methionine (identification number 3b610)
16
- (1) Stocks of the relevant feed additive, and premixtures containing it, which are produced and labelled before the end of 19th June 2025 in accordance with the conditions of the prior authorisation and the labelling requirements applicable immediately before 20th December 2024, may continue to be placed on the market and used until they are exhausted.
- (2) Stocks of feed materials and compound feed containing the relevant feed additive, intended for food-producing animals, which are produced and labelled before the end of 19th December 2025 in accordance with the conditions of the prior authorisation and the labelling requirements applicable immediately before 20th December 2024, may continue to be placed on the market and used until they are exhausted.
- (3) Stocks of feed materials and compound feed containing the relevant feed additive, intended for non-food-producing animals, which are produced and labelled before the end of 19th December 2026 in accordance with the conditions of the prior authorisation and the labelling requirements applicable immediately before 20th December 2024, may continue to be placed on the market and used until they are exhausted.
- (4) In this regulation—
- “relevant feed additive” means zinc chelate of hydroxy analogue of methionine, with the identification number 3b610 authorised under the prior authorisation;
- “prior authorisation” means the authorisation contained in Commission Regulation (EU) No 335/2010[^f00025], as it had effect immediately before 20th December 2024, concerning the authorisation of zinc chelate of hydroxy analogue of methionine as a feed additive for all animal species[^f00026].
Part 6 — Revocation of assimilated direct legislation
Revocation of assimilated direct legislation
17
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Schedule 1 — Authorisation of a preparation of chromium chelate of DL-methionine (identification number GB4d0001) as a feed additive for dairy cows
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
| Additive | Additive | Chromium chelate of DL-methionine |
|---|---|---|
| Identification number | Identification number | GB4d0001 |
| Authorisation holder | Authorisation holder | Zinpro Animal Nutrition (Europe), Inc |
| Additive category | Additive category | Zootechnical additives |
| Functional group | Functional group | Other zootechnical |
| Additive composition | 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 | Characterisation of the active substance | Chromium chelate of DL-methionine ([CH₃S(CH₂)₂CH(NH₂)COO]₃ Cr) |
| Analytical method[^f00027] | Analytical method[^f00027] | For the quantification of chromium in the feed additive: inductively coupled plasma mass spectrometry (ICP-MS) in accordance with European standard BS EN 17053:2018[^f00028] For the quantification of methionine in the feed additive: ion-exchange chromatography coupled to post-column derivatisation and photometric detection (IEC-VIS) in accordance with BS EN ISO 13903:2005[^f00029] 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 | Species or category of animal | Dairy cows |
| Maximum age | Maximum age | Not applicable |
| Content of chromium in complete feed with a moisture content of 12% | Minimum content | 0.2 mg/kg |
| Content of chromium in complete feed with a moisture content of 12% | Maximum content | 0.5 mg/kg |
| Other provisions | 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 — Renewal of authorisation of a preparation of Saccharomyces cerevisiae (MUCL 39885) (identification number 4b1710) as a feed additive for weaned piglets, and its authorisation extending to the use for cats, dogs and all Suidae other than sows and suckling piglets
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
| Additive | Additive | Saccharomyces cerevisiae(MUCL 39885) |
|---|---|---|
| Identification number | Identification number | 4b1710 |
| Authorisation holder | Authorisation holder | Prosol S.p.A. |
| Additive category | Additive category | Zootechnical additives |
| Functional group | Functional group | Gut flora stabilisers |
| Additive composition | Additive composition | Solid preparation of Saccharomyces cerevisiae (MUCL 39885) containing a minimum of 1 x 10⁹ Colony Forming Units (CFU)/g |
| Characterisation of the active substance | Characterisation of the active substance | Viable cells of Saccharomyces cerevisiae (MUCL 39885) |
| Analytical method[^f00031] | Analytical method[^f00031] | For enumeration: Pour plate method CGYE (chloramphenicol, glucose, yeast extract) agar in accordance with BS EN 15789:2021[^f00032] For identification of the yeast strain: Polymerase chain reaction (PCR) method in accordance with DD CEN/TS15790:2008[^f00033] |
| Species or category of animal | Species or category of animal | All Suidae other than suckling piglets or sows Cats Dogs |
| Maximum age | Maximum age | Not applicable |
| Colony Forming Units (CFU) of additive/kg complete feed with a moisture content of 12% | Minimum content | For all Suidae (other than suckling piglets, sows and Suidae for reproduction) 3 x 10⁹ CFU/kg For all Suidae for reproduction purposes other than sows: 6.4 x 10⁹ CFU/kg For cats and dogs: 7 x 10¹⁰ CFU/kg |
| Colony Forming Units (CFU) of additive/kg complete feed with a moisture content of 12% | Maximum content | No maximum |
| Other provisions | Other provisions | In the directions for use of the additive and premixtures, the storage conditions must be indicated. |
Schedule 3 — Authorisation of a preparation of Pediococcus acidilactici(CNCM I-4622) (identification number 4d1712) as a feed additive for all animal species
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
| Additive | Additive | Pediococcus acidilactici (CNCM I-4622) |
|---|---|---|
| Identification number | Identification number | 4d1712 |
| Authorisation holder[^f00034] | Authorisation holder[^f00034] | None |
| Additive category | Additive category | Technological |
| Functional groups | Functional groups | Acidity regulator and hygiene condition enhancer |
| Additive composition | Additive composition | Solid preparation of Pediococcus acidilactici(CNCM I-4622) containing a minimum of 1x10¹⁰ Colony Forming Units (CFU)/g |
| Characterisation of the active substance(s) | Characterisation of the active substance(s) | Viable cells of Pediococcus acidilactici (CNCM I-4622) |
| Analytical method[^f00035] | Analytical method[^f00035] | For enumeration (colony count) of the feed additive: Spread plate method using MRS agar in accordance with BS EN 15786:2021[^f00036] For identification of the bacterial strain: Pulsed-Field Gel Electrophoresis (PFGE) |
| Species or category of animal | Species or category of animal | All animal species |
| Maximum age | Maximum age | Not applicable |
| Colony Forming Units (CFU) of additive/kg of complete feed with a moisture content of 12% | Minimum content | 1x10⁹ CFU/kg |
| Colony Forming Units (CFU) of additive/kg of complete feed with a moisture content of 12% | Maximum content | No maximum |
| Other provisions | 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. 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. 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 hydrochloride |
Schedule 4 — Renewal of authorisation (with modification) of a preparation of monensin sodium produced by fermentation with Streptomyces cinnamonensis 28682 (NBIMCC 3419) (carrier: perlite, calcium carbonate) (identification number 51701) as a feed additive for chickens for fattening, chickens reared for laying and turkeys for fattening, and its authorisation extending to the use for turkeys reared for breeding
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
| Additive | Additive | Monensin sodium |
|---|---|---|
| Identification number | Identification number | 51701 |
| Authorisation holder | Authorisation holder | Huvepharma NV |
| Additive category | Additive category | Coccidiostats and histomonostats |
| Functional group | Functional group | No separate functional groups |
| Additive composition | 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) | 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 no: 22373-78-0[^f00038] |
| Analytical method[^f00039] | Analytical method[^f00039] | 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) in accordance with BS EN ISO 14183:2008[^f00040] 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 | Species or category of animal | Chickens for fattening Chickens reared for laying Turkeys for fattening Turkeys reared for breeding |
| Maximum age | Maximum age | Chickens for fattening: none Chickens reared for laying, turkeys for fattening and turkeys reared for breeding: 16 weeks |
| Content of monensin (mg/kg of complete feed with a moisture content of 12%) | Minimum content | Chickens for fattening and chickens reared for laying: 100 mg/kg Turkeys for fattening and turkeys reared for breeding: 60 mg/kg |
| Content of monensin (mg/kg of complete feed with a moisture content of 12%) | Maximum content | Chickens for fattening and chickens reared for laying: 125 mg/kg Turkeys for fattening and turkeys reared for breeding: 100 mg/kg |
| Maximum residue limits (MRLs) of monensin sodium in food of animal origin | Maximum residue limits (MRLs) of monensin sodium in food of animal origin | Wet skin and fat: 25 µg/kg Wet liver, wet kidney, and wet muscle: 8 µg/kg |
| Other provisions | 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. 2 The additive must be incorporated in compound feed in the form of a premixture. 3 Monensin sodium must not be mixed with other coccidiostats. 4 Declaration to be made in the directions for use: “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”. 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 the post-market monitoring programme must be submitted to the appropriate authority[^f00041] by 19th December 2033. |
Schedule 5 — Renewal of authorisation (with modification) of a preparation of monensin sodium produced by fermentation with Streptomyces cinnamonensis 28682 (NBIMCC 3419) (carrier: perlite, wheat bran) (identification number 51701) as a feed additive for chickens for fattening, turkeys for fattening and its authorisation extending to the use for chickens reared for laying and turkeys reared for breeding
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
| Additive | Additive | Monensin sodium |
|---|---|---|
| Identification number | Identification number | 51701 |
| Authorisation holder | Authorisation holder | Huvepharma NV |
| Additive category | Additive category | Coccidiostats and histomonostats |
| Functional group | Functional group | No separate functional groups |
| Additive composition | 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 Wheat bran: 550 – 600 g/kg |
| Characterisation of the active substance(s) | 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 no: 22373-78-0[^f00043] |
| Analytical method[^f00044] | Analytical method[^f00044] | 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) in accordance with BS EN ISO 14183:2008[^f00045] 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 | Species or category of animal | Chickens for fattening Chickens reared for laying Turkeys for fattening Turkeys reared for breeding |
| Maximum age | Maximum age | Chickens for fattening: None Chickens reared for laying, turkeys for fattening and turkeys reared for breeding: 16 weeks |
| Content of monensin (mg/kg of complete feed with a moisture content of 12%) | Minimum content | Chickens for fattening and chickens reared for laying: 100 mg/kg Turkeys for fattening and turkeys reared for breeding: 60 mg/kg |
| Content of monensin (mg/kg of complete feed with a moisture content of 12%) | Maximum content | Chickens for fattening and chickens reared for laying: 125 mg/kg Turkeys for fattening and turkeys reared for breeding: 100 mg/kg |
| Maximum residue limits (MRLs) of monensin sodium in food of animal origin | Maximum residue limits (MRLs) of monensin sodium in food of animal origin | Wet skin and fat: 25 µg/kg Wet liver, wet kidney, and wet muscle: 8 µg/kg |
| Other provisions | 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. 2 The additive must be incorporated in compound feed in the form of a premixture. 3 Monensin sodium must not be mixed with other coccidiostats. 4 Declaration to be made in the directions for use: “Dangerous for equines. This feed contains an ionophore. Avoid simultaneous administration with tiamulin and monitor for possible adverse reactions when use concurrently with other medicinal substances”. 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 the post-market monitoring programme must be submitted to the appropriate authority by 19th December 2033. |
Schedule 6 — Renewal of authorisation (with modification) of a preparation of 6-phytase (EC 3.1.3.26) produced by fermentation with Komagataella phaffii (formerly Komagataella pastoris) (DSM 23036) (identification number 4a16) as a feed additive for chickens for fattening, chickens reared for laying, laying hens, turkeys for fattening, turkeys reared for breeding, other avian species for fattening and laying, sows, pigs for fattening and weaned piglets, and its authorisation extending to the use for all avian species and all Suidae
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
| Additive | Additive | 6-phytase (EC 3.1.3.26) |
|---|---|---|
| Identification number | Identification number | 4a16 |
| Authorisation holder | Authorisation holder | Huvepharma NV |
| Additive category | Additive category | Zootechnical additives |
| Functional group | Functional group | Digestibility enhancers |
| Additive composition | 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 in solid form and 8,000 OTU/g in liquid form[^f00047] |
| Characterisation of the active substance(s) | Characterisation of the active substance(s) | 6-phytase (EC 3.1.3.26) produced by fermentation with Komagataella phaffii (DSM 23036) CAS no: 9001-89-2[^f00048] EC (IUBMB) no: 3.1.3.26[^f00049] |
| Analytical method[^f00050] | Analytical method[^f00050] | 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 | Species or category of animal | All avian species All Suidae |
| Maximum age | Maximum age | Not applicable |
| Content of 6-phytase (EC 3.1.3.26) (units of activity (OTU)/kg of complete feed with a moisture content of 12%) | Minimum content | All avian species other than turkeys and all Suidae other than piglets: 125 OTU/kg Turkeys and piglets: 250 OTU/kg |
| Content of 6-phytase (EC 3.1.3.26) (units of activity (OTU)/kg of complete feed with a moisture content of 12%) | Maximum content | No maximum level |
| Other provisions | 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 — Renewal of authorisation (with modification) of a preparation of Bacillus velezensis (formerly Bacillus subtilis) (DSM 15544) (identification number 4b1820) as a feed additive for weaned piglets, chickens reared for laying, turkeys, minor avian species, ornamental birds and game birds; consolidation of existing authorised uses for laying hens and chickens for fattening; and its authorisation as a feed additive extending existing authorised uses to cover all other avian species
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
| Additive | Additive | Bacillus velezensis (DSM 15544) |
|---|---|---|
| Identification number | Identification number | 4b1820 |
| Authorisation holder | Authorisation holder | Asahi Biocycle Co., Ltd |
| Additive category | Additive category | Zootechnical additives |
| Functional group | Functional group | Gut flora stabilisers |
| Additive composition | Additive composition | Solid preparation of Bacillus velezensis (DSM 15544) containing a minimum of 1x10¹⁰ Colony Forming Units (CFU)/g |
| Characterisation of the active substance(s) | Characterisation of the active substance(s) | Viable spores of Bacillus velezensis (DSM 15544) |
| Analytical method[^f00052] | Analytical method[^f00052] | For enumeration (colony count) of the feed additive: Spread plate method using tryptone soya agar in all target matrices in accordance with BS EN 15784:2021[^f00053] For identification of the feed additive: Pulsed-field gel electrophoresis (PFGE) |
| Species or category of animal | Species or category of animal | Weaned piglets All avian species |
| Maximum age | Maximum age | Not applicable |
| Colony Forming Units (CFU)/kg of complete feed with a moisture content of 12% | Minimum content | 3x10 ⁸ CFU/kg |
| Colony Forming Units (CFU)/kg of complete feed with a moisture content of 12% | Maximum content | No maximum level |
| Other provisions | 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 — Authorisation of a preparation of L-histidine monohydrochloride monohydrate produced by fermentation withEscherichia coli K-12 (KCCM 80212) (identification number 3c352i) as a feed additive for all animal species
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
| Additive | Additive | L-histidine monohydrochloride monohydrate |
|---|---|---|
| Identification number | Identification number | 3c352i |
| Authorisation holder[^f00054] | Authorisation holder[^f00054] | None |
| Additive category | Additive category | Nutritional additives |
| Functional group | Functional group | Amino acids, their salts and analogues |
| Additive composition | 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) | Characterisation of the active substance(s) | L-histidine monohydrochloride monohydrate produced by fermentation with Escherichia coli K-12 (KCCM 80212) (C₆H₁₂ClN₃O₃) CAS no: 5934-29-2[^f00055] EINECS no: 611-821-4[^f00056] |
| Analytical method[^f00057] | Analytical method[^f00057] | For the quantification of histidine in the feed additive: High performance liquid chromatography coupled with photometric detection (HPLC-UV) in accordance with BS EN ISO 13903:2005[^f00058]; or Ion-exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS/FLD) 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) 152/2009 (Annex III, F) For the quantification of histamine in the feed additive: High performance liquid chromatography coupled with photometric detection (HPLC-UV) in accordance with BS EN ISO 13903:2005 |
| Species or category of animal | Species or category of animal | All animal species |
| Maximum age | Maximum age | Not applicable |
| Content of L-histidine monohydrochloride monohydrate (mg/kg of complete feed with a moisture content of 12%) | Minimum content | No minimum |
| Content of L-histidine monohydrochloride monohydrate (mg/kg of complete feed with a moisture content of 12%) | Maximum content | No maximum |
| Other provisions | 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. 2 L-histidine monohydrochloride monohydrate may be placed on the market and used as an additive consisting of a preparation. 3 The histidine content must be indicated on the label of the additive and premixture and must contain the following declaration on the label of the additive and the premixture: “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”. 4 The endotoxin content of the additive and its dusting potential must ensure a maximal endotoxin exposure of 1600 IU endotoxins/m³ air[^f00059]. |
Schedule 9 — Authorisation of a preparation of L-tryptophan produced by fermentation with Escherichia coli (KCCM 80210) (identification number 3c440i) as a feed additive for all animal species
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
| Additive | Additive | L-tryptophan |
|---|---|---|
| Identification number | Identification number | 3c440i |
| Authorisation holder[^f00060] | Authorisation holder[^f00060] | None |
| Additive category | Additive category | Nutritional additives |
| Functional group | Functional group | Amino acids, their salts and analogues |
| Additive composition | 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 active substance(s) | Characterisation of active substance(s) | L-tryptophan produced by fermentation with Escherichia coli (KCCM 80210) (C₁₁H₁₂N₂O₂) CAS no: 73-22-3[^f00061] EINECS no: 200-795-6[^f00062] |
| Analytical method[^f00063] | Analytical method[^f00063] | For the identification of L-tryptophan in the feed additive: • Food Chemical Codex “L-tryptophan monograph”[^f00064] For the determination of tryptophan in the feed additive and premixtures: High performance liquid chromatography with fluorescence detection (HPLC-FLD) in accordance with BS EN ISO 13904:2016[^f00065] For the determination of tryptophan in feed materials and compound feed: High performance liquid chromatography with fluorescence detection (HPLC-FLD) in accordance with Commission Regulation (EC) 152/2009 (Annex III, G) |
| Species or category of animal | Species or category of animal | All animal species |
| Maximum age | Maximum age | Not applicable |
| Content of L-tryptophan (mg/kg of complete feed with a moisture content of 12%) | Minimum content | No minimum |
| Content of L-tryptophan (mg/kg of complete feed with a moisture content of 12%) | Maximum content | No maximum |
| Other provisions | Other provisions | 1 L-tryptophan must be rumen protected when administered to ruminants. 2 Declaration to be made on the label of the additive and premixture: “The supplementation with L-tryptophan shall take into account all essential and conditionally essential amino acids in order to avoid imbalances”. 3 The endotoxin content of the additive and its dusting potential must ensure a maximal endotoxin exposure of 1600 IU endotoxins/m³ air[^f00066]. |
Schedule 10 — Authorisation of a preparation of L-lysine sulphate produced by fermentation with Corynebacterium glutamicum (KCCM 80227) (identification number 3c324i) as a feed additive for all animal species
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
| Additive | Additive | L-lysine sulphate |
|---|---|---|
| Identification number | Identification number | 3c324i |
| Authorisation holder[^f00067] | Authorisation holder[^f00067] | None |
| Additive category | Additive category | Nutritional additives |
| Functional group | Functional group | Amino acids, their salts and analogues |
| Additive composition | 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) | Characterisation of the active substance(s) | L-lysine sulphate produced by fermentation with Corynebacterium glutamicum (KCCM 80227) (C₁₂H₂₈N₄O₄· H₂SO₄) CAS no: 60343-69-3[^f00068] |
| Analytical method[^f00069] | Analytical method[^f00069] | For the quantification of lysine in the feed additive and premixtures containing more than 10% lysine: •on exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS/FLD) in accordance with BS EN ISO 17180:2013[^f00070] For the identification of sulphate in the feed additive: European Pharmacopoeia Monograph 20301[^f00071] For quantification of lysine in premixtures, feed materials and compound feed: •on-exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS) in accordance with Commission Regulation (EC) 152/2009 (Annex III, F) For the quantification of lysine in water: Ion exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS/FLD) in accordance with BS EN ISO 17180:2013 |
| Species or category of animal | Species or category of animal | All animal species |
| Maximum age | Maximum age | Not applicable |
| Content of L-lysine sulphate (mg/kg of complete feed with a moisture content of 12%) | Minimum content | No minimum |
| Content of L-lysine sulphate (mg/kg of complete feed with a moisture content of 12%) | Maximum content | 10,000 mg/kg |
| Other provisions | 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. 2 The L-lysine content must be stated on the labelling of the additive. 3 Declaration to be made on the label of the additive and premixture: “The supplementation with L-lysine should take into account all essential and conditionally essential amino acids in order to avoid imbalances”. |
Schedule 11 — Authorisation of the substance butylated hydroxyanisole (identification number 1b320) as a feed additive for cats
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
| Additive | Additive | Butylated hydroxyanisole |
|---|---|---|
| Identification number | Identification number | 1b320 |
| Authorisation holder[^f00073] | Authorisation holder[^f00073] | None |
| Additive category | Additive category | Technological |
| Functional group | Functional group | Antioxidants |
| Additive composition | Additive composition | Butylated hydroxyanisole with a minimum content of 98.5% in a waxy solid form |
| Characterisation of the active substance(s) | 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 no: 25013-16-5[^f00074] |
| Analytical method[^f00075] | Analytical method[^f00075] | For the quantification of butylated hydroxyanisole in feed additives: Gas chromatography coupled to flame ionization detection (GC-FID) (Food Chemical Codex 7th edition method)[^f00076] 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 | Species or category of animal | Cats |
| Maximum age | Maximum age | Not applicable |
| Content of butylated hydroxyanisole (mg/kg of complete feed with a moisture content of 12%) | Minimum content | No minimum |
| Content of butylated hydroxyanisole (mg/kg of complete feed with a moisture content of 12%) | Maximum content | 150 mg/kg |
| Other provisions | 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. 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 — Authorisation of a preparation of L-lysine base (liquid) produced by fermentation with Corynebacterium glutamicum (KCCM 80183) (identification number 3c320) as a feed additive for all animal species
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
| Additive | Additive | L-lysine base (liquid) |
|---|---|---|
| Identification number | Identification number | 3c320 |
| Authorisation holder[^f00077] | Authorisation holder[^f00077] | None |
| Additive category | Additive category | Nutritional additives |
| Functional group | Functional group | Amino acids, their salts and analogues |
| Additive composition | Additive composition | Aqueous solution with a minimum of 50% L-lysine |
| Characterisation of the active substance(s) | Characterisation of the active substance(s) | L-lysine base (liquid) (NH₂(CH₂)CH(NH₂)COOH) produced by fermentation with Corynebacterium glutamicum (KCCM 80183) CAS no: 56-87-1[^f00078] |
| Analytical method[^f00079] | Analytical method[^f00079] | 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) in accordance with BS EN ISO 17180:2013[^f00080] For quantification of lysine in premixtures, feed materials and compound feed: Ion-exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS) in accordance with Commission Regulation (EC) 152/2009 (Annex III, F) For the quantification of lysine in water: Ion exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS/FLD) in accordance with BS EN ISO 17180:2013; or Ion exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS) in accordance with Commission Regulation (EC) 152/2009 (Annex III, F) |
| Species or category of animal | Species or category of animal | All animal species |
| Maximum age | Maximum age | Not applicable |
| Content of L-lysine (mg/kg of complete feed with a moisture content of 12%) | Minimum content | No minimum |
| Content of L-lysine (mg/kg of complete feed with a moisture content of 12%) | Maximum content | No maximum |
| Other provisions | Other provisions | 1 The L-lysine content must be stated on the labelling of the additive. 2 The additive may be used via water for drinking. 3 Declaration to be made on the label of the additive and premixture: “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”. |
Schedule 13 — Authorisation of the substance L-lysine monohydrochloride (technically pure) produced by fermentation with Corynebacterium glutamicum (KCCM 80183) (identification number 3c322ii) as a feed additive for all animal species
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
| Additive | Additive | L-lysine monohydrochloride (technically pure) |
|---|---|---|
| Identification number | Identification number | 3c322ii |
| Authorisation holder[^f00081] | Authorisation holder[^f00081] | None |
| Additive category | Additive category | Nutritional additives |
| Functional group | Functional group | Amino acids, theirs salts and analogues |
| Additive composition | 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) | 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 no: 657-27-2[^f00082] |
| Analytical method[^f00083] | Analytical method[^f00083] | For the identification of L-lysine monohydrochloride in the feed additive: Food Chemicals Codex “L-lysine monohydrochloride monograph”[^f00084] 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) in accordance with BS EN ISO 17180:2013[^f00085] 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) in accordance with Commission Regulation (EC) 152/2009 (Annex III, F) For the quantification of lysine in water: Ion exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS/FLD) in accordance with BS EN ISO 17180:2013; or Ion exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS) in accordance with Commission Regulation (EC) 152/2009 (Annex III, F) |
| Species or category of animal | Species or category of animal | All animal species |
| Maximum age | Maximum age | Not applicable |
| Content of L-lysine monohydrochloride (mg/kg of complete feed with a moisture content of 12%) | Minimum content | No minimum |
| Content of L-lysine monohydrochloride (mg/kg of complete feed with a moisture content of 12%) | Maximum content | No maximum |
| Other provisions | Other provisions | 1 The L-lysine content must be stated on the labelling of the additive. 2 The additive may be used via water for drinking. 3 Declaration to be made on the label of the additive and the premixture: “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.” |
Schedule 14 — Authorisation of the substance disodium 5’ -guanylate (GMP) produced by fermentation with Corynebacterium stationis (KCCM 10530) and Escherichia coliK-12 (KFCC 11067) (identification number 2b627i) as a feed additive for all animal species
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
| Additive | Additive | Disodium 5’ -guanylate |
|---|---|---|
| Identification number | Identification number | 2b627i |
| Authorisation holder[^f00086] | Authorisation holder[^f00086] | None |
| Additive category | Additive category | Sensory |
| Functional group | Functional group | Flavouring compounds |
| Additive composition | Additive composition | Powder of disodium 5’ -guanylate with a minimum purity criteria of 97% |
| Characterisation of the active substance(s) | Characterisation of the active substance(s) | Hydrated form of disodium 5’ -guanylate (GMP) produced by fermentation with Corynebacterium stationis (KCCM 10530) and Escherichia coli K-12 (KFCC 11067) (C₁₀H₁₂N₅Na₂O₈P) CAS no: 5550-12-9[^f00087] EINECS no: 226-914-1[^f00088] |
| Analytical method[^f00089] | Analytical method[^f00089] | For the identification of disodium 5’ -guanylate (GMP) in the feed additive: FAO JECFA monograph “disodium 5’-guanylate”[^f00090] 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 | Species or category of animal | All animal species |
| Maximum age | Maximum age | Not applicable |
| Content of disodium 5’ -guanylate (mg/kg of complete feed with a moisture content of 12%) | Minimum content | No minimum |
| Content of disodium 5’ -guanylate (mg/kg of complete feed with a moisture content of 12%) | Maximum content | No maximum |
| Other provisions | 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. 2 The additive must be incorporated into the feed in the form of a premixture. 3 On the label of the additive the following must be indicated: ‘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%: 50mg’. 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 the active substance (alone or in combination with other ribonucleotides) in complete feed exceeding 50mg/kg. |
Schedule 15 — Authorisation of a preparation of muramidase (EC 3.2.1.17) produced by fermentation with Trichoderma reesei (DSM 32338) (identification number 4d16) as a feed additive for weaned piglets
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
| Additive | Additive | Muramidase (EC 3.2.1.17) |
|---|---|---|
| Identification number | Identification number | 4d16 |
| Authorisation holder | Authorisation holder | DSM Nutritional Products Ltd |
| Additive category | Additive category | Zootechnical |
| Functional group | Functional group | Other zootechnical |
| Additive composition | Additive composition | Solid and liquid preparations of muramidase (EC 3.2.1.17) produced by fermentation with Trichoderma reesei (DSM 32338) having a minimum enzyme activity of 60,000 LSU(F)/g[^f00091] |
| Characterisation of the active substance(s) | Characterisation of the active substance(s) | Muramidase (EC 3.2.1.17) produced by fermentation with Trichoderma reesei (DSM 32338): CAS no: 9001-63-2[^f00092] EINECS no: 232-620-4[^f00093] EC (IUBMB) no: 3.2.1.17 |
| Analytical method[^f00094] | Analytical method[^f00094] | 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 | Species or category of animal | Weaned piglets |
| Maximum age | Maximum age | Not applicable |
| Content of muramidase (units of activity/kg of complete feed with a moisture content of 12%) | Minimum content | 50,000 LSU(F)/kg |
| Content of muramidase (units of activity/kg of complete feed with a moisture content of 12%) | Maximum content | 65,000 LSU(F)/kg |
| Other provisions | 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 — Authorisation of the substance of phytomenadione (Vitamin K₁) (identification number 3a712) as a feed additive for horses
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
| Additive | Additive | Vitamin K ₁ or phytomenadione |
|---|---|---|
| Identification number | Identification number | 3a712 |
| Authorisation holder[^f00095] | Authorisation holder[^f00095] | None |
| Additive category | Additive category | Nutritional additives |
| Functional group | Functional group | Vitamins, pro-vitamins and chemically well-defined substances having similar effect |
| Additive composition | Additive composition | Produced by chemical synthesis Solid preparation containing a minimum of 4.2% of phytomenadione (Vitamin K₁) |
| Characterisation of the active substance(s) | Characterisation of the active substance(s) | 2-methyl-3-[(E-7R,11R)-3,7,11,15-tetramethylhexadec-2-enyl] naphthalene-1, 4-dione (phytomenadione) (C₃₁H₄₆O₂) CAS no: 84-80-0[^f00096] EINECS no: 201-564-2[^f00097] with the following components: E-phytomenadione: 75% minimum E-epoxyphytomenadione: 4% maximum Total purity of E-phytomenadione, E-epoxyphytomenadione and Z-phytomenadione isomers: 97% minimum |
| Analytical method[^f00098] | Analytical method[^f00098] | For the determination of phytomenadione (Vitamin K₁) in the feed additive: High performance liquid chromatography (HPLC) in accordance with the European Pharmacopoeia[^f00099] For the determination of phytomenadione in the additive preparation and in complimentary feed: High performance liquid chromatography with fluorescence detection (HPLC-FLD) in accordance with BS EN 14148:2003[^f00100] |
| Species or category of animal | Species or category of animal | Horses |
| Maximum age | Maximum age | Not applicable |
| Content of phytomenadione (Vitamin K₁) (mg/kg of complete feed with a moisture content of 12%) | Minimum content | No minimum |
| Content of phytomenadione (Vitamin K₁) (mg/kg of complete feed with a moisture content of 12%) | Maximum content | No maximum |
| Other provisions | 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 17 — Renewal of authorisation (with modification) of a preparation of copper chelate of hydroxy analogue of methionine (identification number 3b410i (formerly 3b4.10)) as a feed additive for all animal species
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
| Additive | Additive | Copper chelate of hydroxy analogue of methionine |
|---|---|---|
| Identification number | Identification number | 3b410i |
| Authorisation holder[^f00102] | Authorisation holder[^f00102] | None |
| Additive category | Additive category | Nutritional additives |
| Function group | Function group | Compounds of trace elements |
| Additive composition | Additive composition | Copper chelate of hydroxy analogue of methionine in solid form containing a minimum of 16% copper and the following components: (2-hydroxy-4-methylthio) butanoic acid: 78% minimum Nickel: 20 ppm maximum |
| Characterisation of the active substance(s) | Characterisation of the active substance(s) | Copper chelate of hydroxy analogue of methionine (Cu(CH₃S(CH₂)₂-CH(OH)-COO)₂) CAS no: 292140-30-8[^f00103] |
| Analytical method[^f00104] | Analytical method[^f00104] | For the quantification of the hydroxy analogue of methionine content in the feed additive: Titrimetry, potentiometric titration after oxidation reduction reaction For the quantification of total copper in the feed additive: Inductively coupled plasma atomic emission spectrometry, ICP-AES (BS EN 15510:2017[^f00105] or BS EN 15621:2017[^f00106]); or Atomic absorption spectrometry, AAS (BS EN ISO 6869:2001[^f00107]) For the quantification of total copper in premixtures: Inductively coupled plasma atomic emission spectrometry, ICP-AES (BS EN 15510:2017 or BS EN 15621:2017); or Atomic absorption spectrometry, AAS (BS EN ISO 6869:2001); or Inductively coupled plasma mass spectrometry, ICP-MS (BS EN 17053:2018[^f00108]) For the quantification of total copper in feed materials and compound feed: Inductively coupled plasma atomic emission spectrometry, ICP-AES (BS EN 15510:2017 or BS EN 15621:2017); or Atomic absorption spectrometry, AAS (in accordance with Commission Regulation (EC) 152/2009 (Annex IV, C) or BS EN ISO 6869:2001); or Inductively coupled plasma mass spectrometry, ICP-MS (BS EN 17053:2018) |
| Species or category of animal | Species or category of animal | All animal species |
| Maximum age | Maximum age | Not applicable |
| Content of copper (Cu) (mg/kg of complete feed with a moisture content of 12%) | Minimum content | No minimum |
| Content of copper (Cu) (mg/kg of complete feed with a moisture content of 12%) | Maximum content | Bovines before the start of rumination and ovines: 15 mg/kg (total) Other bovines: 30 mg/kg (total) Caprines: 35 mg/kg (total) Piglets Suckling and weaned up to 4 weeks after weaning: 150 mg/kg (total) From 5th week up to 8 weeks after weaning: 100 mg/kg (total) Crustaceans: 50 mg/kg (total) Other animal species: 25 mg/kg (total) |
| Other provisions | Other provisions | 1 The additive must be incorporated into feed in the form of a premixture. 2 The following words must be included in the labelling: for feed for sheep if the level of copper in the feed exceeds 10 mg/kg: ‘The level of copper in this feed may cause poisoning in certain breeds of sheep.’ for feed in bovines after the start of rumination if the level of copper in the feed is less than 20 mg/kg: ‘The level of copper in this feed may cause copper deficiencies in cattle grazing pastures with high contents of molybdenum or sulphur.’ |
Schedule 18 — Renewal of authorisation (with modification) of a preparation of manganese chelate of hydroxy analogue of methionine (identification number 3b510 (formerly 3b5.10)) as a feed additive for all animal species
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
| Additive | Additive | Manganese chelate of hydroxy analogue of methionine |
|---|---|---|
| Identification number | Identification number | 3b510 |
| Authorisation holder[^f00110] | Authorisation holder[^f00110] | None |
| Additive category | Additive category | Nutritional additives |
| Functional group | Functional group | Compounds of trace elements |
| Additive composition | Additive composition | Manganese chelate of hydroxy analogue of methionine in solid form containing a minimum of 14% manganese and the following components: (2-hydroxy-4-methylthio) butanoic acid: 76% minimum Nickel: 170 ppm maximum |
| Characterisation of the active substance(s) | Characterisation of the active substance(s) | Manganese chelate of hydroxy analogue of methionine (Mn(CH₃S(CH₂)₂-CH(OH)-COO)₂) CAS no: 292140-29-5[^f00111] |
| Analytical method[^f00112] | Analytical method[^f00112] | For the quantification of the hydroxy analogue of methionine content in the feed additive: Titrimetry, potentiometric titration after oxidation reduction reaction For the quantification of total manganese in the feed additive and premixtures: Atomic absorption spectrometry, AAS (BS EN ISO 6869:2001[^f00113]); or Inductively coupled plasma atomic emission spectrometry, ICP-AES (BS EN 15510:2017[^f00114]); or Inductively coupled plasma atomic emission spectrometry after pressure digestion, ICO-AES (BS EN 15621:2017[^f00115]) For the quantification of total manganese in feed materials and compound feed: Atomic absorption spectrometry, AAS (in accordance with Commission Regulation (EC) 152/2009 (Annex IV, C) or BS EN ISO 6869:2001); or Inductively coupled plasma atomic emission spectrometry, ICP-AES (BS EN 15510:2017); or Inductively coupled plasma atomic emission spectrometry after pressure digestion, ICP-AES (BS EN 15621:2017) |
| Species or category of animal | Species or category of animal | All animal species |
| Maximum age | Maximum age | Not applicable |
| Content of manganese (Mn) (mg/kg of complete feed with a moisture content of 12%) | Minimum content | No minimum |
| Content of manganese (Mn) (mg/kg of complete feed with a moisture content of 12%) | Maximum content | Fish: 100 mg/kg (total) Other animal species: 150 mg/kg (total) |
| Other provisions | Other provisions | 1 The additive must be incorporated into feed in the form of a premixture. 2 Manganese chelate of hydroxy analogue of methionine may be placed on the market and used as an additive consisting of a preparation. |
Schedule 19 — Renewal of authorisation (with modification) of a preparation of zinc chelate of hydroxy analogue of methionine (identification number 3b610 (formerly 3b6.10)) as a feed additive for all animal species
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
| Additive | Additive | Zinc chelate of hydroxy analogue of methionine |
|---|---|---|
| Identification number | Identification number | 3b610 |
| Authorisation holder[^f00117] | Authorisation holder[^f00117] | None |
| Additive category | Additive category | Nutritional additives |
| Functional group | Functional group | Compounds of trace elements |
| Additive composition | Additive composition | Zinc chelate of hydroxy analogue of methionine in solid form containing a minimum of 17% zinc and the following components: (2-hydroxy-4-methylthio) butanoic acid: 79% minimum Nickel: 1.7 ppm maximum |
| Characterisation of the active substance(s) | Characterisation of the active substance(s) | Zinc chelate of hydroxy analogue of methionine (Zn(CH₃S(CH₂)₂-CH(OH)-COO)₂) CAS no: 292140-29-5[^f00118] |
| Analytical method[^f00119] | Analytical method[^f00119] | For the quantification of the hydroxy analogue of methionine content in the feed additive: Titrimetry, potentiometric titration after oxidation reduction reaction For the quantification of total zinc in the feed additive: Inductively coupled plasma atomic emission spectrometry, ICP-AES (BS EN 15510:2017[^f00120] or BS EN 15621:2017[^f00121]); or Atomic absorption spectrometry, AAS (BS EN ISO 6869:2001[^f00122]) For the quantification of total zinc in premixtures: Inductively coupled plasma atomic emission spectrometry, ICP-AES (BS EN 15510:2017 or BS EN 15621:2017); or Atomic absorption spectrometry, AAS (BS EN ISO 6869:2001); or Inductively coupled plasma mass spectrometry, ICP-MS (BS EN 17053:2018[^f00123]) For the quantification of total zinc in feed materials and compound feed: Inductively coupled plasma atomic emission spectrometry, ICP-AES (BS EN 15510:2017 or BS EN 15621:2017); or Atomic absorption spectrometry, AAS (in accordance with Commission Regulation (EC) 152/2009 (Annex IV, C) or BS EN ISO 6869:2001); or Inductively coupled plasma mass spectrometry, ICP-MS (BS EN 17053:2018) |
| Species or category of animal | Species or category of animal | All animal species |
| Maximum age | Maximum age | Not applicable |
| Content of zinc (Zn) (mg/kg of complete feed with a moisture content of 12%) | Minimum content | No minimum |
| Content of zinc (Zn) (mg/kg of complete feed with a moisture content of 12%) | Maximum content | Dogs and cats: 200 mg/kg (total) Salmonids and milk replacers for calves: 180 mg/kg (total) Piglets, sows, rabbits and all fish other than salmonids: 150 mg/kg (total) Other animal species: 120 mg/kg (total) |
| Other provisions | Other provisions | 1 The additive must be incorporated into feed in the form of a premixture. 2 Zinc chelate of hydroxy analogue of methionine may be placed on the market and used as an additive consisting of a preparation. |
Schedule 20 — Authorisation of a preparation of fumonisin esterase (EC 3.1.1.87) produced by fermentation with Komagataella phaffii (DSM 32159) (identification number 1m03i) as a feed additive for all animal species, for use only in maize-based silages
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.