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Statutory Instruments of the Scottish Parliament
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Scottish Statutory Instruments
2022 No. 288
Agriculture
The Feed Additives (Authorisations) (Scotland) Regulations 2022
Made
27th September 2022
Laid before the Scottish Parliament
29th September 2022
Coming into force
24th November 2022
The Scottish Ministers make the following Regulations in exercise of the powers conferred by Articles 9(1), 13(6) and 18A(3) of Regulation (EC) No. 1831/2003of the European Parliament and of the Council on additives for use in animal nutrition( 1), and all other powers enabling them to do so.
There has been consultation as required by Article 9 of Regulation (EC) No. 178/2002of the European Parliament and of the Council laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety( 2).
Citation, commencement and extent
1.—(1) These Regulations may be cited as the Feed Additives (Authorisations) (Scotland) Regulations 2022 and come into force on 24 November 2022.
(2) These Regulations extend to Scotland only.
Interpretation
2.—(1) In these Regulations—
“ Regulation (EC) 1831/2003” means Regulation (EC) No. 1831/2003of the European Parliament and of the Council on additives for use in animal nutrition, and
“ Regulation (EC) 767/2009” means Regulation (EC) No. 767/2009of the European Parliament and of the Council on the placing on the market and use of feed, amending European Parliament and Council Regulation (EC) No. 1831/2003and repealing Council Directive 79/373/EEC, Commission Directive 80/511/EEC, Council Directives 82/471/EEC, 83/228/EEC, 93/74/EEC, 93/113/ECand 96/25/ECand Commission Decision 2004/217/EC( 3).
(2) Unless the contrary intention appears, any expression used both in these Regulations and in Regulation (EC) 1831/2003or Regulation (EC) 767/2009has the same meaning as it has in those Regulations.
Authorisations
3.—(1) The terms of modifications of authorisations in these Regulations are to be in the same form as authorisations under Article 9 of Regulation (EC) 1831/2003.
(2) Schedules 1 to 11 have effect.
(3) Subject to Article 14(4) (renewal of authorisation) of Regulation (EC) 1831/2003, the authorisations set out in schedules 1 to 11 cease to have effect at the end of 23 November 2032.
Amendment of Commission Implementing Regulation (EU) No. 306/2013
4.—(1) Commission Implementing Regulation (EU) No. 306/2013 concerning the authorisation of a preparation ofBacillus subtilis(ATCC PTA-6737) for weaned piglets and weaned Suidae other than Sus scrofa domesticus (holder of authorisation Kemin Europa N.V.)( 4) is amended as follows.
(2) In the Annex, in the table, in the column headed—
(a) “Additive”, for “Bacillus subtilis” substitute “Bacillus velezensis”, and
(b) “Composition, chemical formula, description, analytical method”, for “Bacillus subtilis”, in each place it occurs, substitute “Bacillus velezensis”.
Amendment of Commission Implementing Regulation (EU) No. 787/2013
5.—(1) Commission Implementing Regulation (EU) No. 787/2013 concerning the authorisation of a preparation ofBacillus subtilis(ATCC PTA-6737) as a feed additive for turkeys for fattening and turkeys reared for breeding (holder of authorisation Kemin Europa N.V.)( 5) is amended as follows.
(2) In the Annex, in the table, in the column headed—
(a) “Additive”, for “Bacillus subtilis” substitute “Bacillus velezensis”, and
(b) “Composition, chemical formula, description, analytical method”, for “Bacillus subtilis”, in each place it occurs, substitute “Bacillus velezensis”.
Amendment of Commission Implementing Regulation (EU) 2015/1020
6.—(1) Commission Implementing Regulation (EU) 2015/1020 concerning the authorisation of the preparation ofBacillus subtilis(ATCC PTA-6737) as a feed additive for laying hens and minor poultry species for laying (holder of the authorisation Kemin Europa NV)( 6) is amended as follows.
(2) In the Annex, in the table, in the column headed—
(a) “Additive”, for “Bacillus subtilis” substitute “Bacillus velezensis”, and
(b) “Composition, chemical formula, description, analytical method”, for “Bacillus subtilis”, in each place it occurs, substitute “Bacillus velezensis”.
Amendment of Commission Implementing Regulation (EU) 2017/2276
7.—(1) Commission Implementing Regulation (EU) 2017/2276 concerning the authorisation of a new use of the preparation ofBacillus subtilis(ATCC PTA-6737) as a feed additive for sows (holder of the authorisation Kemin Europa N.V.)( 7) is amended as follows.
(2) In the Annex, in the table, in the column headed—
(a) “Additive”, for “Bacillus subtilis” substitute “Bacillus velezensis”, and
(b) “Composition, chemical formula, description, analytical method”, for “Bacillus subtilis”, in each place it occurs, substitute “Bacillus velezensis”.
Transitional provision:Saccharomyces cerevisiae(identification number 4b1702)
8.—(1) The relevant feed additive, and premixtures containing it, which are produced and labelled before the end of 23 May 2023 in accordance with the conditions of the prior authorisation, may continue to be placed on the market and used until the existing stocks are exhausted.
(2) Compound feed, and feed materials containing the relevant feed additive, intended for food-producing animals, which are produced and labelled before the end of 23 November 2023 in accordance with the conditions of the prior authorisation, may continue to be placed on the market and used until the existing stocks are exhausted.
(3) In this regulation—
“ relevant feed additive” means the feed additiveSaccharomyces cerevisiaeCNCM I-4407, with the identification number 4b1702, which was previously authorised under the prior authorisation, and
“ the prior authorisation” means Commission Regulation (EU) No. 883/2010concerning the authorisation of a new use ofSaccharomyces cerevisiaeNCYC Sc 47 as a feed additive for calves for rearing (holder of the authorisation Société industrielle Lesaffre)( 8).
Transitional:Bacillus velezensis(identification number 4b1823)
9.—(1) Any substance or product labelled “Bacillus subtilis(ATCC PTA-6737)”, or as containing “Bacillus subtilis(ATCC PTA-6737)”, but otherwise produced and labelled in accordance with an authorisation contained in retained direct EU legislation mentioned in regulations 4 to 7, may continue to be placed on the market and used under that authorisation.
(2) The relevant feed additive, and premixtures containing it, which are produced and labelled before the end of 23 May 2023 in accordance with the conditions of the prior authorisation, may continue to be placed on the market and used until the existing stocks are exhausted.
(3) Compound feed, and feed materials containing the relevant feed additive, intended for food-producing animals, which are produced and labelled before the end of 23 November 2023 in accordance with the conditions of the prior authorisation, may continue to be placed on the market and used until the existing stocks are exhausted.
(4) Compound feed, and feed materials containing the relevant feed additive, intended for non-food-producing animals, which are produced and labelled before the end of 23 November 2024 in accordance with the conditions of the prior authorisation, may continue to be placed on the market and used until the existing stocks are exhausted.
(5) In this regulation—
“ relevant feed additive” means the feed additiveBacillus velezensisATCC PTA-6737 or, as formerly designated,Bacillus subtilisATCC PTA-6737, with the identification number 4b1823, which was previously authorised under the prior authorisation, and
“ the prior authorisation” means—
-
Commission Regulation (EU) No. 107/2010concerning the authorisation ofBacillus subtilisATCC PTA-6737 as a feed additive for chickens for fattening (holder of authorisation Kemin Europa NV)( 9), or
-
Commission Implementing Regulation (EU) No. 885/2011 concerning the authorisation ofBacillus subtilis(ATCC PTA-6737) as a feed additive for chickens reared for laying, ducks for fattening, quails, pheasants, partridges, guinea fowl, pigeons, geese for fattening and ostriches (holder of the authorisation Kemin Europa N.V.)( 10).
Transitional: Decoquinate (Deccox®) (identification number 51756i (formerly E756))
10.—(1) The relevant feed additive, and feed containing it, which are produced and labelled before the end of 23 May 2023 in accordance with the conditions of the prior authorisation, may continue to be placed on the market and used until the existing stocks are exhausted.
(2) In this regulation—
“ relevant feed additive” means the feed additive decoquinate (Deccox®), which was previously authorised under the prior authorisation with the identification number E756, and
“ the prior authorisation” means Regulation (EC) No. 1289/2004concerning the authorisation for 10 years of the additive Deccox® in feedingstuffs, belonging to the group of coccidiostats and other medicinal substances( 11).
Revocations
11. The retained direct EU legislation listed in schedule 12 is revoked subject to regulations 8, 9(2) to (5) and 10.
MAREE TODD
Authorised to sign by the Scottish Ministers
St Andrew’s House,
Edinburgh
27th September 2022
Regulation 3(2)
SCHEDULE 1 Authorisation of a preparation of manganese chelate of lysine and glutamic acid (identification number 3b509) as a feed additive for all animal species
Authorisation
1. The preparation specified in the table in this schedule, belonging to the additive category ‘nutritional additives’ and to the functional group ‘compounds of trace elements’, is authorised as an additive in animal nutrition, subject to the conditions set out in the table in this schedule.
Table
| Column 1 | Column 2 | |
|---|---|---|
| Additive | Manganese chelate of lysine and glutamic acid | |
| Identification number of the additive | 3b509 | |
| Authorisation holder( 12) | ||
| Additive category | Nutritional additives | |
| Functional group | Compounds of trace elements | |
| Additive composition | A preparation of chelates of manganese with lysine and chelates of manganese with glutamic acid in a ratio of 1:1 as a powder with the following components: | |
| ||
| Characterisation of the active substance(s) |
Manganese-2,6-diaminohexanoic acid, chloride and hydrogen sulphate salt (C6H19ClN2O8SMn). Manganese-2-aminopentanedioic acid, sodium and hydrogen sulphate salt (C5H10NNaO9SMn). | |
| Analytical method( 13) | 1. For quantification of total manganese in the feed additive and premixtures: | |
| ||
| 2. For quantification of total manganese in feed materials and compound feed: | ||
| ||
| 3. For quantification of lysine and glutamic acid in the feed additive: | ||
| ||
| 4. For proving the chelated structure of the feed additive: | ||
| ||
| Species or category of animal | All animal species | |
| Maximum age | Not applicable | |
| Content of Manganese chelate of lysine and glutamic acid in mg/kg of complete feed with a moisture content of 12% | Minimum content | No minimum |
| Maximum content |
Fish 100 (total) All other animal species 150 (total) | |
| Other provisions | The additive must be incorporated into the feed in the form of a premixture. | |
Regulation 3(2)
SCHEDULE 2 Authorisation of a preparation ofLactobacillus buchneriDSM 29026 (identification number 1k20759) as a feed additive for all animal species
Authorisation
1. The preparation specified in the table in this schedule, belonging to the additive category ‘technological additives’ and to the functional group ‘silage additives’, is authorised as an additive in animal nutrition, subject to the conditions set out in the table in this schedule.
Table
| Column 1 | Column 2 | |
|---|---|---|
| Additive | Lactobacillus buchneriDSM 29026 | |
| Identification number of the additive | 1k20759 | |
| Authorisation holder( 18) | ||
| Additive category | Technological additives | |
| Functional group | Silage additives | |
| Additive composition | A preparation ofLactobacillus buchneriDSM 29026 containing a minimum of 2 x 1010CFU/g additive | |
| Characterisation of the active substance(s) | Viable cells ofLactobacillus buchneriDSM 29026 | |
| Analytical methods( 19) | 1. For enumeration (colony count) of the feed additive: | |
| ||
| 2. For identification of bacterial strain: | ||
| ||
| Species or category of animal | All animal species | |
| Maximum age | Not applicable | |
| Content of Lactobacillus buchneri DSM 29026 in CFU of additive/kg of fresh material | Minimum content | Minimum content of the additive when not combined with other micro-organisms as silage additives: 5x107CFU/kg of easy and moderately difficult to ensile fresh material( 21). |
| Maximum content | No maximum | |
| Other provisions | In the directions for use of the additive and premixtures, the storage conditions must be indicated. | |
Regulation 3(2)
SCHEDULE 3 Authorisation of a preparation of serine protease produced byBacillus licheniformisDSM 19670 (identification number 4a13) as a feed additive for chickens for fattening
Authorisation
1. The preparation specified in the table in this schedule, 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 in this schedule.
Table
| Column 1 | Column 2 | |
|---|---|---|
| Additive | Serine protease | |
| Identification number of the additive | 4a13 | |
| Authorisation holder | DSM Nutritional Products Ltd in Switzerland | |
| Additive category | Zootechnical additives | |
| Functional group | Digestibility enhancers | |
| Additive composition | Solid and liquid preparation of serine protease (EC 3.4.21.-1) | |
| ||
| Characterisation of the active substance(s) |
Serine protease (EC 3.4.21.-1) produced byBacillus licheniformisDSM 19670 CAS number: 37259-58-8 (serine protease)( 23) EINECS number: 253-431-3( 24) IUB number: 3.4.21.-1( 25) | |
| Analytical methods( 26) | For quantification of serine protease activity in the feed additive, premixtures, compound feed and feed materials: | |
| ||
| Species or category of animal | Chickens for fattening | |
| Maximum age | Not applicable | |
| Content of Serine protease (units of activity/kg of complete feed with a moisture content of 12%) | Minimum content | 15,000 PROT/kg |
| Maximum content | No maximum | |
| Other provisions | In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment must be indicated. | |
Regulation 3(2)
SCHEDULE 4 Renewal of authorisation of pyridoxine hydrochloride (vitamin B6) (identification number 3a831) as a feed additive for all animal species
Authorisation
1. The additive specified in the table in this schedule, belonging to the additive category ‘nutritional additives’ and to the functional group ‘vitamins, pro-vitamins and chemically well-defined substances having similar effect’, is authorised as an additive in animal nutrition, subject to the conditions set out in the table in this schedule( 27).
Table
| Column 1 | Column 2 | ||
|---|---|---|---|
| Additive | Pyridoxine hydrochloride (vitamin B6) | ||
| Identification number of the additive | 3a831 | ||
| Authorisation holder( 28) | |||
| Additive category | Nutritional additives | ||
| Functional group | Vitamins, pro-vitamins and chemically well-defined substances having similar effect | ||
| Additive composition |
Pyridoxine hydrochloride: C8H11NO3.HCI Purity criteria not less than 98.5% | ||
| Characterisation of the active substance(s) |
Pyridoxine hydrochloride CAS no:58-56-0( 29) EINECS no:200-386-2( 30) | ||
| Analytical methods( 31) | 1. For the determination of pyridoxine hydrochloride (Vitamin B6) in the feed additive: | ||
| |||
| 2. For the determination of pyridoxine hydrochloride (Vitamin B6) in premixtures: | |||
| |||
| 3. For the determination of pyridoxine hydrochloride (Vitamin B6) in feed and water: | |||
| |||
| Species or category of animal | All animal species | ||
| Maximum age | Not applicable | ||
| Content of Pyridoxine hydrochloride (Vitamin B6) in mg/kg of complete feed with a moisture content of 12% | Minimum content | No minimum | |
| Maximum content | No maximum | ||
| Other provisions | 1. | In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment must be indicated. | |
| 2. | Pyridoxine hydrochloride (Vitamin B6) may be used via water for drinking. | ||
Regulation 3(2)
SCHEDULE 5 Renewal of authorisation (with modification) of a preparation ofSaccharomyces cerevisiaeCNCM I-4407 (ACTISAF® Sc 47) (identification number 4b1702) as a feed additive for calves for rearing
Authorisation
1. The preparation specified in the table in this schedule, 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 in this schedule( 34).
Table
| Column 1 | Column 2 | |
|---|---|---|
| Additive | Saccharomyces cerevisiaeCNCM I-4407 (ACTISAF® Sc 47) | |
| Identification number of the additive | 4b1702 | |
| Authorisation holder | S.I. Lesaffre | |
| Additive category | Zootechnical additives | |
| Functional group | Gut flora stabilisers | |
| Additive composition | Solid form preparation ofSaccharomyces cerevisiaeCNCM I-4407 containing a minimum of 5x109CFU/g | |
| Characterisation of the active substance(s) | Viable dried cellsSaccharomyces cerevisiaeCNCM I-4407 | |
| Analytical methods( 35) | 1. For enumeration (colony count): | |
| ||
| 2. For identification of yeast strain: | ||
| ||
| Species or category of animal | Calves for rearing | |
| Maximum age | Not applicable | |
| Content of Saccharomyces cerevisiae CNCM I-4407 in CFU/kg of complete feed with a moisture content of 12% | Minimum content | 1.5 x 109CFU/kg |
| Maximum content | No maximum | |
| Other provisions | In the directions of use of the additive and premixtures, the storage conditions and stability to heat treatment must be indicated. | |
Regulation 3(2)
SCHEDULE 6 Renewal of authorisation (with modification) of a preparation ofBacillus velezensis(ATCC PTA-6737) (identification number 4b1823) as a feed additive for chickens for fattening, chickens reared for laying, ducks for fattening, quails, pheasants, partridges, guinea fowl, pigeons, geese for fattening and ostriches, and its authorisation as a feed additive extending existing uses to cover all minor poultry species (except for laying), ornamental birds, sporting birds and game birds
Authorisation
1. The preparation specified in the table in this schedule, 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 in this schedule( 38).
Table
| Column 1 | Column 2 | |
|---|---|---|
| Additive | Bacillus velezensis(ATCC PTA-6737) | |
| Identification number of the additive | 4b1823 | |
| Authorisation holder | Kemin Europa N.V. | |
| Additive category | Zootechnical additives | |
| Functional group | Gut flora stabilisers | |
| Additive composition | Preparation ofBacillus velezensisATCC PTA-6737 containing a minimum of 8 x 1010CFU/g additive | |
| Characterisation of the active substance(s) | Viable spores ofBacillus velezensis(ATCC PTA-6737) | |
| Analytical methods( 39) | 1. For enumeration (colony count): | |
| ||
| 2. For identification of bacterial strain | ||
| ||
| Species or category of animal | Chickens for fattening, chickens reared for laying, minor poultry species (except for laying), ornamental, sporting and game birds | |
| Maximum age | Not applicable | |
| Content of Bacillus velezensis (ATCC PTA-6737) in CFU/kg of complete feed with a moisture content of 12% | Minimum content | 1 x 107CFU/kg |
| Maximum content | No maximum | |
| Other provisions |
1. In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment must be indicated. 2. WhereBacillus velezensis(ATCC PTA-6737) is to be used in feed containing coccidiostats, this feed additive is authorised for use with the following coccidiostats only, and in accordance with their individual authorisation criteria: | |
| ||
Regulation 3(2)
SCHEDULE 7 Authorisation of a preparation ofBacillus licheniformisDSM 28710 (identification number 4b1828) as a feed additive for laying hens, minor poultry species for laying, poultry species for breeding and ornamental birds
Authorisation
1. The preparation specified in the table in this schedule, 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 in this schedule.
Table
| Column 1 | Column 2 | |
|---|---|---|
| Additive | Bacillus licheniformisDSM 28710 | |
| Identification number of the additive | 4b1828 | |
| Authorisation holder | HuvePharma NV | |
| Additive category | Zootechnical additives | |
| Functional group | Gut flora stabilisers | |
| Additive composition | Solid form preparation ofBacillus licheniformisDSM 28710 containing a minimum of 3.2 x 109CFU/g of additive | |
| Characterisation of the active substance(s) | Viable spores ofBacillus licheniformisDSM 28710 | |
| Analytical methods( 40) | 1. For enumeration (colony count) in the additive, premixture and feed: | |
| ||
| 2. For identification of bacterial strain: | ||
| ||
| Species or category of animal | Laying hens, minor poultry species for laying, poultry species for breeding and ornamental birds | |
| Maximum age | Not applicable | |
| Content of Bacillus licheniformis DSM 28710 in CFU/kg of complete feed with a moisture content of 12% | Minimum content | 1.6 x 109CFU/kg |
| Maximum content | No maximum | |
| Other provisions |
1. In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment must be indicated. 2. WhereBacillus licheniformisDSM 28710 is to be used in feed containing coccidiostats, this feed additive is authorised for use with the following coccidiostats only, and in accordance with their individual authorisation criteria: | |
| ||
Regulation 3(2)
SCHEDULE 8 Renewal of authorisation of a preparation ofClostridium butyricum(FERM BP-2789) (identification number 4b1830) as a feed additive for chickens reared for laying, turkeys for fattening, turkeys reared for breeding, minor avian species (excluding laying birds), weaned piglets and weaned minor porcine species, and its authorisation as a feed additive for chickens for fattening, suckling pigs and suckling minor porcine species
Authorisation
1. The preparation specified in the table in this schedule, 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 in this schedule( 42).
Table
| Column 1 | Column 2 | |
|---|---|---|
| Additive | Clostridium butyricum(FERM BP-2789) | |
| Identification number of the additive | 4b1830 | |
| Authorisation holder | Miyarisan Pharmaceutical Co. Ltd | |
| Additive category | Zootechnical additives | |
| Functional group | Gut flora stabilisers | |
| Additive composition | Solid form preparation ofClostridium butyricum(FERM BP-2789) containing a minimum of 5 x 108CFU/g additive | |
| Characterisation of the active substance(s) | Viable spores ofClostridium butyricumFERM BP-2789 | |
| Analytical methods( 43) | 1. For enumeration (colony count): | |
| ||
| 2. For identification of bacterial strain: | ||
| ||
| Species or category of animal | Turkeys for fattening; turkeys reared for breeding; chickens for fattening; chickens reared for laying; minor avian species (excluding laying birds); piglets and piglets of minor porcine species | |
| Maximum age | Not applicable | |
| Content of Clostridium butyricum(FERM BP-2789)in CFU/kg of complete feed with a moisture content of 12% | Minimum content |
Turkeys: 1.25 x 108CFU/kg Chickens, minor avian species, piglets and minor porcine species: 2.5 x 108CFU/kg |
| Maximum content | All species and categories of animal as provided for above: no maximum | |
| Other provisions |
1. In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment must be indicated. 2. WhereClostridium butyricum(FERM BP-2789) is to be used in feed containing coccidiostats, this feed additive is authorised for use with the following coccidiostats only, and in accordance with their individual authorisation criteria: | |
| ||
Regulation 3(2)
SCHEDULE 9 Authorisation of a preparation of 6-phytase (EC 3.1.3.26) (identification number 4a32) as a feed additive for all poultry species, ornamental birds, piglets, pigs for fattening, sows and minor porcine species for fattening or reproduction
Authorisation
1. The preparation specified in the table in this schedule, 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 in this schedule.
Table
| Column 1 | Column 2 | |
|---|---|---|
| Additive | 6-phytase (EC 3.1.3.26) | |
| Identification number of the additive | 4a32 | |
| Authorisation holder | Huvepharma EOOD | |
| Additive category | Zootechnical additives | |
| Functional group | Digestibility enhancers | |
| Additive composition |
Preparation of 6-phytase (EC 3.1.3.26) produced byKomagataella phaffii(DSM 32854) In granular, coated and liquid forms, minimum activity 5000 FTU/g( 45) | |
| Characterisation of the active substance(s) | 6-phytase (EC 3.1.3.26) produced byKomagataella phaffii(DSM 32854) | |
| Analytical methods( 46) | 1. For quantification of phytase activity in the feed additive: | |
| ||
| 2. For quantification of phytase activity in feed materials and compound feed: | ||
| ||
| 3. For quantification of phytase activity in premixtures: | ||
| ||
| Species or category of animal | All poultry species; ornamental birds; piglets; pigs for fattening; sows; minor porcine species for fattening or reproduction | |
| Maximum age | Not applicable | |
| Content of 6-phytase (units of activity/kg of complete feed with a moisture content of 12%) | Minimum content | 250 FTU |
| Maximum content | No maximum | |
| Other provisions | In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment must be indicated. | |
Regulation 3(2)
SCHEDULE 10 Authorisation of Decoquinate (Deccox®) (identification number 51756i) as a feed additive for chickens for fattening
Authorisation
1. The substance Decoquinate specified in the table in this schedule, 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 in this schedule( 50).
Table
| Column 1 | Column 2 | |
|---|---|---|
| Additive | Decoquinate (Deccox®) | |
| Identification number of the additive | 51756i | |
| Authorisation holder | Zoetis Belgium SA | |
| Additive category | Coccidiostats and Histomonostats | |
| Functional group | None | |
| Additive composition |
| |
| Characterisation of the active substance(s) |
| |
| Analytical methods( 52) | 1. For quantification of Decoquinate in the feed additive, premixtures and feed: | |
| ||
| 2. For quantification of Decoquinate in tissues: | ||
| ||
| Species or category of animal | Chickens for fattening | |
| Maximum age | Not applicable | |
| Content of Decoquinate (Deccox®) in mg/kg of complete feed with a moisture content of 12% | Minimum content | 30 mg/kg |
| Maximum content | 40 mg/kg | |
| Other provisions |
1. In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment must be indicated. 2. The additive must be incorporated in compound feed in the form of a premixture. 3. Decoquinate must not be mixed with other coccidiostats. 4. Decoquinate must not be used in feed containing bentonite. 5. Post-market monitoring programmes must be carried out by the holder of authorisation for resistance to bacteria andEimeria sppand submitted to the Scottish Ministers by the end of 23 November 2031. | |
Regulation 3(2)
SCHEDULE 11 Authorisation of Decoquinate (Avi-Deccox® 60G) (identification number 51756ii) as a feed additive for chickens for fattening
Authorisation
1. The substance Decoquinate specified in the table in this schedule, 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 in this schedule( 54).
Table
| Column 1 | Column 2 | |
|---|---|---|
| Additive | Decoquinate (Avi-Deccox® 60G) | |
| Identification number of the additive | 51756ii | |
| Authorisation holder | Zoetis Belgium SA | |
| Additive category | Coccidiostats and Histomonostats | |
| Functional group | None | |
| Additive composition |
| |
| Characterisation of the active substance(s) | Decoquinate: (Ethyl 6-decycloxy-7-ethoxy-4-hydroxyquinoline-3-carboxylate) | |
| ||
| Related impurities: | ||
| ||
| Analytical methods( 56) | 1. For the quantification of Decoquinate in the feed additive, premixtures and feed: | |
| ||
| 2. For quantification of Decoquinate in tissues: | ||
| ||
| Species or category of animal | Chickens for fattening | |
| Maximum age | Not applicable | |
| Content of Decoquinate (Avi-Deccox®) in mg/kg of complete feed with a moisture content of 12% | Minimum content | 30 mg/kg |
| Maximum content | 40 mg/kg | |
| Other provisions |
1. In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment must be indicated. 2. The additive must be incorporated in compound feed in the form of a premixture. 3. Decoquinate must not be mixed with other coccidiostats. 4. Decoquinate must not be used in feed containing bentonite. 5. Post-market monitoring programmes must be carried out by the holder of the authorisation for resistance to bacteria andEimeria sppand submitted to the Scottish Ministers by the end of 23 November 2031. | |
Regulation 11
SCHEDULE 12 Revocation of retained direct EU legislation
1. Commission Regulation (EC) No. 1289/2004concerning the authorisation for 10 years of the additive Deccox® in feedingstuffs, belonging to the group of coccidiostats and other medicinal substances( 58).
2. Commission Regulation (EC) No. 903/2009concerning the authorisation of the preparation ofClostridium butyricum(FERM-BP 2789) as a feed additive for chickens for fattening (holder of authorisation Miyarisan Pharmaceutical Co. Ltd, represented by Huvepharma NV Belgium)( 59).
3. Commission Regulation (EU) No. 8/2010concerning the authorisation of the serine protease produced byBacillus licheniformis(DSM 19670) as a feed additive for chickens for fattening (holder of authorisation DSM Nutritional Products Ltd, represented by DSM Nutritional Products Sp.Z.o.o)( 60).
4. Commission Regulation (EU) No. 107/2010concerning the authorisation ofBacillus subtilisATCC PTA-6737 as a feed additive for chickens for fattening (holder of authorisation Kemin Europa NV)( 61).
5. Commission Regulation (EU) No. 883/2010concerning the authorisation of a new use ofSaccharomyces cerevisiaeNCYC Sc 47 as a feed additive for calves for rearing (holder of the authorisation Société industrielle Lesaffre)( 62).
6. Commission Regulation (EU) No. 168/2011amending Regulation (EU) No. 107/2010 as regards the use of the feed additiveBacillus subtilisATCC PTA-6737 in feed containing maduramycin ammonium, monensin sodium, narasin, or robenidine hydrochloride( 63).
7. Commission Implementing Regulation (EU) No. 373/2011 concerning the authorisation of the preparation ofClostridium butyricumFERM-BP 2789 as a feed additive for minor avian species except laying birds, weaned piglets and minor porcine species (weaned) and amending Regulation (EC) No. 903/2009(holder of authorisation Miyarisan Pharmaceutical Co. Ltd, represented by Huvepharma NV Belgium)( 64).
8. Commission Implementing Regulation (EU) No. 515/2011 concerning the authorisation of vitamin B6as a feed additive for all animal species( 65).
9. Commission Implementing Regulation (EU) No. 885/2011 concerning the authorisation ofBacillus subtilis(ATCC PTA-6737) as a feed additive for chickens reared for laying, ducks for fattening, quails, pheasants, partridges, guinea fowl, pigeons, geese for fattening and ostriches (holder of the authorisation Kemin Europa N.V.)( 66).
10. Commission Implementing Regulation (EU) No. 357/2013 amending Regulation (EC) No. 903/2009and Implementing Regulation (EU) No. 373/2011 as regards the minimum content of a preparation ofClostridium butyricum(FERM-BP 2789) as a feed additive for chickens for fattening and minor avian species (excluding laying birds) (holder of authorisation Miyarisan Pharmaceutical Co. Ltd represented by Miyarisan Pharmaceutical Europe S.L.U.)( 67).
11. Commission Implementing Regulation (EU) No. 374/2013 concerning the authorisation of a preparation ofClostridium butyricum(FERM-BP 2789) as a feed additive for chickens reared for laying (holder of authorisation Miyarisan Pharmaceutical Co. Ltd represented by Huvepharma NV Belgium)( 68).
12. Commission Implementing Regulation (EU) No. 291/2014 amending Regulation (EC) No. 1289/2004as regards the withdrawal time and maximum residues limits of the feed additive decoquinate( 69).
13. Commission Implementing Regulation (EU) No. 1108/2014 concerning the authorisation of a preparation ofClostridium butyricum(FERM-BP 2789) as a feed additive for turkeys for fattening and turkeys reared for breeding (holder of authorisation Miyarisan Pharmaceutical Co. Ltd represented by Huvepharma NV Belgium)( 70).
14. Commission Implementing Regulation (EU) No. 2017/1126 amending Regulation (EC) No. 903/2009and Implementing Regulations (EU) No. 373/2011, (EU) No. 374/2013 and (EU) No. 1108/2014 as regards the name of the EU representative of the holder of the authorisation of a preparation ofClostridium butyricum(FERM-BP 2789)( 71).
EXPLANATORY NOTE
(This note is not part of the Regulations)
These Regulations make provision as regards the authorisation of feed additives under Regulation (EC) 1831/2003of the European Parliament and of the Council on additives for use in animal nutrition (“Regulation (EC) 1831/2003”).
Regulation 3 and schedules 1 to 11 prescribe the authorisation of 11 feed additives, in accordance with article 9(1) of Regulation (EC) 1831/2003.
Schedule 1 is a new authorisation, for a preparation of Manganese chelate of lysine and glutamic acid (identification number 3b509).
Schedule 2 is a new authorisation, for a preparation ofLactobacillus buchneriDSM 29026 (identification number 1k20759).
Schedule 3 is a new authorisation, for a preparation of Serine protease (EC 3.4.21.-1) produced byBacillus licheniformis(DSM 19670) (identification number 4a13).
Schedule 4 is a renewal of the authorisation of Pyridoxine hydrochloride (vitamin B6) (identification number 3a831).
Schedule 5 is a renewal of the authorisation of a preparation ofSaccharomyces cerevisiaeCNCM I-4407 (ACTISAF® Sc47) (identification number 4b1702). The name of the bacterial strain is changed from “Saccharomyces cerevisiaeNCYC Sc 47” to “Saccharomyces cerevisiaeCNCM I-4407”.
Schedule 6 is a renewal of the authorisation of a preparation ofBacillus velezensis(ATCC PTA-6737) (identification number 4b1823). The authorisation has been modified as follows:-
-
the bacterial strain name from “Bacillus subtilis”to “Bacillus velezensis”,
-
the minimum content of the feed additive in the preparation is increased from 1x1010to 8x1010colony forming units per gram (CFU/g).
Schedule 7 is a new authorisation, for a preparation ofBacillus licheniformisDSM 28710 (identification number 4b1828).
Schedule 8 is a renewal of the authorisations of a preparation ofClostridium butyricum(FERM BP-2789) (identification number 4b1830), and authorises it for a new use to be used in feed for chickens for fattening, suckling piglets and minor porcine species (suckling).
Schedule 9 is a new authorisation, for a preparation of 6-phytase produced byKomagataella phaffiiDSM 32854 (identification number 4a32).
Schedule 10 authorises a new formulation of Decoquinate (Deccox®) (identification number E756) as Decoquinate (Deccox®) (identification number 51756i) following a re-evaluation requested by the holder.
Schedule 11 authorises a modified form of Decoquinate (Deccox®) (identification number E756) as Decoquinate (Avi-Deccox® 60G) (identification number 51756ii). This feed additive differs from Decoquinate (Deccox®) in physical form and in the dilutant used being calcium sulphate dehydrate.
The authorisations are valid for a period of 10 years, in accordance with Article 9(7) of Regulation (EC) 1831/2003. This is subject to Article 14(4) of that Regulation, which provides for an extension of the authorisation period in certain circumstances following the submission of an application for renewal. Relevant provision is made by regulation 3(3) of these Regulations.
Regulations 4 to 7 modify 4 retained EU Regulations that authorise the feed additiveBacillus subtilisATCC PTA-6737 for differing poultry and pig sub-groups. The name of the feed additive is updated from “Bacillus subtilis”to “Bacillus velezensis”. Regulation 9(1) is a transitional provision which allows products labelled using the name “Bacillus subtilis”to continue to be marketed and used under the relevant authorisations despite the name change.
Regulations 8, 9(2) to (5) and 10 make transitional provision to enable the continued production and labelling of products, for limited time periods, under the conditions of previous authorisations where authorisations are renewed under schedules 5, 6 and 10 respectively.
Regulation 11 and schedule 12 revoke retained direct EU legislation that contains previous authorisations for the feed additives now authorised by schedules 3, 4, 5, 6, 8 and 10.
A business and regulatory impact assessment has not been produced for this instrument as no significant impact on the private or voluntary sector is foreseen.
EUR 1831/2003 as amended by S.I. 2019/654and 2022/377. Article 9 was substituted by S.I. 2019/654and amended by S.I. 2022/377. Article 13 was substituted and article 18A was added by S.I. 2019/654. The terms “ prescribe” and “ appropriate authority” are defined in Article 2 of EUR 1831/2003.
EUR 178/2002 as amended by S.I. 2019/641. S.I. 2019/641was amended by S.I. 2020/1504.
EUR 767/2009 as amended by S.I. 2019/654. S.I. 2019/641was amended by S.I. 2020/1504.
EUR 306/2013.
EUR 787/2013.
EUR 2015/1020.
EUR 2017/2276.
EUR 883/2010. This Regulation is revoked by regulation 11 of these Regulations.
EUR 107/2010 as amended by EUR 168/2011. EUR 107/2010 is revoked by regulation 11 of these Regulations.
EUR 885/2011. This Regulation is revoked by regulation 11 of these Regulations.
EUR 1289/2004 as amended by EUR 552/2008, EUR 118/2012, EUR 1014/2013 and EUR 291/2014. EUR 1289/2004 is revoked by regulation 11 of these Regulations.
There is no requirement to include the name of the holder of this authorisation as this authorisation does not fall within the scope of Article 9(5) of Regulation (EC) 1831/2003.
Details of the analytical methods are set out in the document referenced “Ares(2018)3918699 – 24/07/2018” and the document referenced “Ares(2019)7167892 – 20/11/2019” and last updated 28 January 2020. These documents are available at the following address:https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports/fad-2018-0009?search&form-return.
ISO standards are published in Geneva by the International Organisation for Standardisation, and are available on their website (www.iso.org) or at ISO Central Secretariat, International Organization for Standardization (ISO), 1 rue de Varembé, Case postale 56, CH-1211, Geneva 20, Switzerland. Under reference BS EN ISO 6869:2001, it was published as a UK standard by the British Standards Institution on 15 March 2001 (ISBN 0 580 36933 1).
This standard was approved by the European Committee for Standardization (CEN) on 6 February 2017. Under reference BS EN 15510:2017, it was published as a UK standard by the British Standards Institution on 30 August 2017 (ISBN 978 0 580 94541 0).
This standard was approved by the European Committee for Standardization (CEN) on 6 February 2017. Under reference BS EN 15621:2017, it was published as a UK standard by the British Standards Institution on 31 August 2017 (ISBN 978 0 580 94543 4).
EUR 152/2009. There are amendments to EUR 152/2009 not relevant to these Regulations.
There is no requirement to include the name of the holder of this authorisation as this authorisation does not fall within the scope of Article 9(5) of Regulation (EC) 1831/2003.
Details of the analytical methods are set out in the document referenced “Ares(2019)4747322 – 22/07/2019” and last updated on 18 October 2019. The document is available at the following address:https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports/fad-2018-0093.
This standard was approved by the European Committee for Standardization (CEN) on 2 August 2021. Under reference BS EN 15787:2021, it was published as a UK standard by the British Standards Institution on 31 December 2021 (ISBN 978 0 580 99831 7).
Easy to ensile forage: > 3 % soluble carbohydrates in fresh material; moderately difficult to ensile forage: 1.5-3.0 % soluble carbohydrates in the fresh material in accordance with Commission Regulation (EC) No. 429/2008of 25 April 2008 on detailed rules for the implementation of Regulation (EC) No. 1831/2003of the European Parliament and of the Council as regards the preparation and the presentation of applications and the assessment and the authorisation of feed additives (EUR 2008/429, amended by S.I. 2019/654. S.I. 2019/654was amended by 2020/1504).
One PROT is the amount of serine protease that liberates one micromole/minute of para-nitroaniline (pNA) from 1 millimolar (mM) Suc-Ala-Ala-Pro-Phe-pNA substrate at pH 9 & 37°C.
This is a reference to the CAS Registry Number assigned to this preparation by the Chemical Abstracts Servicehttps://cas.org/cas-data/cas-registry.
The EINECS number is given in the European Inventory of Existing Commercial Substances, as published in O.J. No. C146A, 15.6.90, p.1.
This is the identification number allotted by the International Union of Biochemistry (IUB), which is now the International Union of Biochemistry and Molecular Biology (IUBMB)iubmb.org.
Details of the analytical methods are set out in the document referenced “Ares(2019)6802986 – 04/11/2019” and last updated 27 January 2020. The document is available at the following address:https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports/fad-2019-0010.
This authorisation is a renewal of the authorisation granted under Commission Implementing Regulation (EU) No. 515/2011. That Regulation is revoked by regulation 11 of these Regulations.
There is no requirement to include the name of the holder of this authorisation as this authorisation does not fall within the scope of Article 9(5) of Regulation (EC) 1831/2003.
This is a reference to the CAS Registry Number assigned to this additive by the Chemical Abstracts Servicehttps://cas.org/cas-data/cas-registry.
The EINECS number is given in the European Inventory of Existing Commercial Substances, as published in O.J. No. C146A, 15.6.90, p.1.
Details of the analytical methods are set out in the document referenced “JRC.DG.D.6/CvH/GB/ag/ARES(2011)356822” and last updated on 6 June 2016. The document is available at the following address:https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports/fad-2010-0139.
The Association of German Agricultural Analytical and Research Institutes (VDLUFA) Method book, Volume III, the Chemical Analysis of Feedingstuffs (ISBN 978 3 941273 14 6) is available at the following address: Method book Volume III Feedingstuffs (vdlufa.de). Copies of a translated version of Part 13.9.1 may be obtained from Food Standards Scotland, Pilgrim House, Old Ford Road, Aberdeen, AB11 5RL.
This standard was approved by the European Committee for Standardization (CEN) on 17 April 2014.
This authorisation is a renewal of the authorisation granted under Commission Regulation (EU) No. 883/2010. That Regulation is revoked by regulation 11 of these Regulations, subject to the transitional provision in regulation 8.
Details of the analytical methods are set out in the document referenced “JRC.DG.D.6/CvH/DM/mds/ARES(2010)967257” and last updated on 6 June 2016. The document is available at the following address:https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports/fad-2010-0038.
This standard was approved by the European Committee for Standardization (CEN) on 2 August 2021.
DD CEN/TS 15790:2008, published by the British Standards Institution on 31 January 2009 (ISBN 978 0 580 61806 2).
This authorisation is a renewal of the authorisations granted under Commission Regulation (EU) No. 107/2010and Commission Implementing Regulation (EU) No. 885/2011. Those Regulations are revoked by regulation 11 of these Regulations, subject to the transitional provision in regulation 9(2) to (5). This feed additive is separately authorised for use in feed for specified other species or categories of animals by Commission Implementing Regulations (EU) No. 306/2013, 787/2013, 2015/1020 and 2017/2276.
Details of the analytical methods are set out in the document referenced “D08/FSQ/CVH/SY/Ares(2009)61627” and last updated on 6 June 2016. The document is available at the following address:https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports/fad-2008-0039.
Details of the analytical methods are set out in the document referenced “Ares(2015)4524025 – 23/10/2015” and last updated on 6 June 2016. The document is available at the following address:https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports/fad-2015-0016.
This standard was approved by the European Committee for Standardization (CEN) on 2 August 2021. Under reference BS EN 15784:2021, it was published as a UK standard by the British Standards Institution on 30 November 2021 (ISBN 978 0 580 99829 4).
This authorisation is a renewal of the authorisations granted under Commission Implementing Regulations (EU) No. 373/2011, 374/2013 and 1108/2014. Those Regulations are revoked by regulation 11 of these Regulations.
Details of the analytical methods are set out in the document referenced “JRC.DG.D.6.CvH/DM/hn/ARES (2010)-355411” and last updated on 6 June 2016. The document is available at the following address:https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports/fad-2010-0005.
ISO standards are published in Geneva by the International Organisation for Standardisation, and are available on their website (www.iso.org) or at ISO Central Secretariat, International Organization for Standardization (ISO), 1 rue de Varembé, Case postale 56, CH-1211, Geneva 20, Switzerland. Under reference BS ISO 15213:2003, it was published as a UK standard by the British Standards Institution on 16 May 2003 (ISBN 0 580 41892 8).
FTU means phytase enzyme units. One FTU is the amount of enzyme that releases 1 micromole (µm) of inorganic phosphate from sodium phytate per minute under reaction conditions of pH 5.5 and 37°C.
Details of the analytical methods are set out in the document referenced “Ares(2020)762221 – 06/02/2020” and last updated on 4 May 2020. The document is available at the following address:https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports/fad-2019-0052.
The Association of German Agricultural Analytical and Research Institutes (VDLUFA) Method book, Volume III, the Chemical Analysis of Feedingstuffs (ISBN 978 3 941273 14 6) is available at the following address: Method book Volume III Feedingstuffs (vdlufa.de). Copies of a translated version of Part 27.1.4 may be obtained from Food Standards Scotland, Pilgrim House, Old Ford Road, Aberdeen, AB11 5RL.
ISO standards are published in Geneva by the International Organisation for Standardisation, and are available on their website (www.iso.org) or at ISO Central Secretariat, International Organization for Standardization (ISO), 1 rue de Varembé, Case postale 56, CH-1211, Geneva 20, Switzerland. Under reference BS EN ISO 30024:2009, it was published as a UK standard by the British Standards Institution on 30 September 2009 (ISBN 0 580 62651 7).
The Association of German Agricultural Analytical and Research Institutes (VDLUFA) Method book, Volume III, the Chemical Analysis of Feedingstuffs (ISBN 978 3 941273 14 6) is available at the following address: Method book Volume III Feedingstuffs (vdlufa.de). Copies of a translated version of Part 27.1.3 may be obtained from Food Standards Scotland, Pilgrim House, Old Ford Road, Aberdeen, AB11 5RL.
This authorisation replaces the authorisation Decoquinate (Deccox®) under Regulation (EC) No. 1289/2004. That Regulation is revoked by regulation 11 of these Regulations, subject to the transitional provision in regulation 11. See also schedule 11 of these Regulations, which contains a separate re-authorisation of Decoquinate (Deccox®), but in a modified form, Decoquinate (Avi-Deccox®60G).
This is a reference to the CAS Registry Number assigned to this substance by the Chemical Abstracts Servicehttps://cas.org/cas-data/cas-registry.
Details of the analytical methods are set out in the document referenced “Ares(2013)3639174 – 04/12/2013” and last updated on 6 June 2016. The document is available at the following address:https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports/fad-2013-0034.
This standard was approved by the European Committee for Standardization (CEN) on 4 February 2012. Under reference BS EN 16162:2012, it was published as a UK standard by the British Standards Institution on 31 March 2012 (ISBN 978 0 580 67002 2).
This authorisation is for a modified form of decoquinate (Deccox®), which was previously authorised under Regulation (EC) No. 1289/2004, and now authorised under schedule 10 of these Regulations.
This is a reference to the CAS Registry Number assigned to this substance by the Chemical Abstracts Servicehttps://cas.org/cas-data/cas-registry.
Details of the analytical methods are set out in the document referenced “Ares(2014)2704635 – 18/08/2014” and “JRC.D.5/SFB/CvH/MGH/mds/Ares” and last updated on 6 June 2016. The document is available at the following address:https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports/fad-2014-0014.
EUD 2002/657 as amended by S.I. 2020/1461.
EUR 1289/2004 as amended by EUR 291/2014.
EUR 903/2009 as amended by EUR 373/2011 and EUR 1126/2017.
EUR 8/2010.
EUR 2010/107.
EUR 883/2010.
EUR 168/2011.
EUR 2011/373 as amended by EUR 1126/2017.
EUR 2011/515.
EUR 885/2011.
EUR 2013/357.
EUR 2013/374 as amended by EUR 1126/2017.
EUR 291/2014.
EUR 2014/1108 as amended by EUR 1126/2017.
EUR 20171126.