2022 No. 288
The Feed Additives (Authorisations) (Scotland) Regulations 2022
Made
Laid before the Scottish Parliament
Coming into force
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. 1831/2003 of the European Parliament and of the Council on additives for use in animal nutrition1, and all other powers enabling them to do so.
There has been consultation as required by Article 9 of Regulation (EC) No. 178/2002 of the European Parliament and of the Council laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety2.
Citation, commencement and extentI11
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.
InterpretationI22
1
In these Regulations—
“Regulation (EC) 1831/2003” means Regulation (EC) No. 1831/2003 of the European Parliament and of the Council on additives for use in animal nutrition, and
“Regulation (EC) 767/2009” means Regulation (EC) No. 767/2009 of 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. 1831/2003 and repealing Council Directive 79/373/EEC, Commission Directive 80/511/EEC, Council Directives 82/471/EEC, 83/228/EEC, 93/74/EEC, 93/113/EC and 96/25/EC and Commission Decision 2004/217/EC3.
2
Unless the contrary intention appears, any expression used both in these Regulations and in Regulation (EC) 1831/2003 or Regulation (EC) 767/2009 has the same meaning as it has in those Regulations.
AuthorisationsI33
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. 306/2013I44
1
Commission Implementing Regulation (EU) No. 306/2013 concerning the authorisation of a preparation of Bacillus 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. 787/2013I55
1
Commission Implementing Regulation (EU) No. 787/2013 concerning the authorisation of a preparation of Bacillus 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) 2015/1020I66
1
Commission Implementing Regulation (EU) 2015/1020 concerning the authorisation of the preparation of Bacillus 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) 2017/2276I77
1
Commission Implementing Regulation (EU) 2017/2276 concerning the authorisation of a new use of the preparation of Bacillus 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)I88
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 additive Saccharomyces cerevisiae CNCM I-4407, with the identification number 4b1702, which was previously authorised under the prior authorisation, and
“the prior authorisation” means F30an authorisation contained inCommission Regulation (EU) No. 883/2010 concerning the authorisation of a new use of Saccharomyces cerevisiae NCYC Sc 47 as a feed additive for calves for rearing (holder of the authorisation Société industrielle Lesaffre)8.
Transitional: Bacillus velezensis (identification number 4b1823)I99
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 F44assimilated direct 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 additive Bacillus velezensis ATCC PTA-6737 or, as formerly designated, Bacillus subtilis ATCC PTA-6737, with the identification number 4b1823, which was previously authorised under the prior authorisation, and
“the prior authorisation” means F31an authorisation contained in—
Commission Regulation (EU) No. 107/2010 concerning the authorisation of Bacillus subtilis ATCC PTA-6737 as a feed additive for chickens for fattening (holder of authorisation Kemin Europa NV)9, or
Commission Implementing Regulation (EU) No. 885/2011 concerning the authorisation of Bacillus subtilis (ATCC PTA-6737) as a feed additive for chickens reared for laying, ducks for fattening, quails, pheasants, partridges, guinea fowl, pigeons, geese for fattening and ostriches (holder of the authorisation Kemin Europa N.V.)10.
Transitional: Decoquinate (Deccox®) (identification number 51756i (formerly E756))I1010
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 F32an authorisation contained in Regulation (EC) No. 1289/2004 concerning the authorisation for 10 years of the additive Deccox® in feedingstuffs, belonging to the group of coccidiostats and other medicinal substances11.
RevocationsI1111
The F45assimilated direct legislation listed in schedule 12 is revoked subject to regulations 8, 9(2) to (5) and 10.
SCHEDULE 1Authorisation of a preparation of manganese chelate of lysine and glutamic acid (identification number 3b509) as a feed additive for all animal species
AuthorisationI121
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.
Column 1 | Column 2 | |
|---|---|---|
Additive | Manganese chelate of lysine and glutamic acid | |
Identification number of the additive | 3b509 | |
Authorisation holder12 | ||
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 method13 | 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. F10For determination of the chelated form of the feed additive: | ||
| ||
Species or category of animal | All animal species | |
Maximum age | Not applicable | |
Content of F11element (Mn) 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. | |
SCHEDULE 2Authorisation of a preparation of Lactobacillus buchneri DSM 29026 (identification number 1k20759) as a feed additive for all animal species
AuthorisationI131
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.
Column 1 | Column 2 | |
|---|---|---|
Additive | Lactobacillus buchneri DSM 29026 | |
Identification number of the additive | 1k20759 | |
Authorisation holder18 | ||
Additive category | Technological additives | |
Functional group | Silage additives | |
Additive composition | A preparation of Lactobacillus buchneri DSM 29026 containing a minimum of 2 x 1010 CFU/g additive | |
Characterisation of the active substance(s) | Viable cells of Lactobacillus buchneri DSM 29026 | |
Analytical methods19 | 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: 5x107 CFU/kg of easy and moderately difficult to ensile fresh material21. |
Maximum content | No maximum | |
Other provisions | In the directions for use of the additive and premixtures, the storage conditions must be indicated. | |
SCHEDULE 3Authorisation of a preparation of serine protease produced by Bacillus licheniformis DSM 19670 (identification number 4a13) as a feed additive for chickens for fattening
AuthorisationI141
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.
Column 1 | Column 2 | |
|---|---|---|
Additive | Serine protease F12(EC 3.4.21-) | |
Identification number of the additive | 4a13 | |
Authorisation holder | DSM Nutritional Products Ltd F13(Switzerland) | |
Additive category | Zootechnical additives | |
Functional group | Digestibility enhancers | |
Additive composition | Solid and liquid preparation of serine protease (EC F143.4.21.- ) | |
| ||
Characterisation of the active substance(s) | Serine protease (EC F143.4.21.- ) produced by Bacillus licheniformis DSM 19670 CAS number: 37259-58-8 (serine protease)23 EINECS number: 253-431-324 | |
Analytical methods26 | 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. | |
SCHEDULE 4Renewal of authorisation of pyridoxine hydrochloride (vitamin B6) (identification number 3a831) as a feed additive for all animal species
AuthorisationI151
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 schedule27.
Column 1 | Column 2 | ||
|---|---|---|---|
Additive | Pyridoxine hydrochloride (vitamin B6) | ||
Identification number of the additive | 3a831 | ||
Authorisation holder28 | |||
Additive category | Nutritional additives | ||
Functional group | Vitamins, pro-vitamins and chemically well-defined substances having similar effect | ||
Additive composition | Pyridoxine hydrochloride: F39C8H11NO3.HCI Purity criteria not less than 98.5% | ||
Characterisation of the active substance(s) | Pyridoxine hydrochloride CAS no:58-56-029 EINECS no:200-386-230 | ||
Analytical methods31 | 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 B 6) may be used via water for drinking. | ||
SCHEDULE 5Renewal of authorisation F22... of a preparation of Saccharomyces cerevisiae CNCM I-4407 F23... (identification number 4b1702) as a feed additive for calves for rearing
Words in sch. 5 heading omitted (9.2.2023) by virtue of The Food and Feed (Miscellaneous Amendments) (Scotland) Regulations 2022 (S.S.I. 2022/373), regs. 1(1), 5(8)(a)(ii)
AuthorisationI161
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 schedule34.
Column 1 | Column 2 | |
|---|---|---|
Additive | Saccharomyces cerevisiae CNCM I-4407 F24... | |
Identification number of the additive | 4b1702 | |
Authorisation holder | S.I. Lesaffre | |
Additive category | Zootechnical additives | |
Functional group | Gut flora stabilisers | |
Additive composition | Solid form preparation of Saccharomyces cerevisiae CNCM I-4407 containing a minimum of 5x109 CFU/g | |
Characterisation of the active substance(s) | Viable dried cells Saccharomyces cerevisiae CNCM I-4407 | |
Analytical methods35 | 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 109 CFU/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. | |
SCHEDULE 6Renewal of authorisation (with modification) of a preparation of Bacillus 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
AuthorisationI171
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 schedule38.
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 of Bacillus velezensis ATCC PTA-6737 containing a minimum of 8 x 1010 CFU/g additive | |
Characterisation of the active substance(s) | Viable spores of Bacillus velezensis (ATCC PTA-6737) | |
Analytical methods39 | 1. For enumeration (colony count) F15in the feed additive, premixtures, feed materials and compound feed : | |
| ||
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 107 CFU/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. Where Bacillus velezensis (ATCC PTA-6737) is to be used in feed containing coccidiostats, this feed additive is authorised for use with the following coccidiostats only, and in accordance with their individual authorisation criteria: | |
SCHEDULE 7Authorisation of a preparation of Bacillus licheniformis DSM 28710 (identification number 4b1828) as a feed additive for laying hens, minor poultry species for laying, poultry species for breeding and ornamental birds
AuthorisationI181
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.
Column 1 | Column 2 | |
|---|---|---|
Additive | Bacillus licheniformis DSM 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 of Bacillus licheniformis DSM 28710 containing a minimum of 3.2 x 109 CFU/g of additive | |
Characterisation of the active substance(s) | Viable spores of Bacillus licheniformis DSM 28710 | |
Analytical methods40 | 1. For enumeration (colony count) in the F41feed additive, premixtures, feed materials and compound 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 109 CFU/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. Where Bacillus licheniformis DSM 28710 is to be used in feed containing coccidiostats, this feed additive is authorised for use with the following coccidiostats only, and in accordance with their individual authorisation criteria: | |
| ||
SCHEDULE 8Renewal of authorisation of a preparation of Clostridium 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 F25piglets and suckling minor porcine species
Word in sch. 8 heading substituted (9.2.2023) by The Food and Feed (Miscellaneous Amendments) (Scotland) Regulations 2022 (S.S.I. 2022/373), regs. 1(1), 5(11)(a)
AuthorisationI191
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 schedule42.
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 of Clostridium butyricum (FERM BP-2789) containing a minimum of 5 x 108 CFU/g additive | |
Characterisation of the active substance(s) | Viable spores of Clostridium butyricum FERM BP-2789 | |
Analytical methods43 | 1. For enumeration (colony count) F26in the feed additive, premixtures, feed materials and compound feed: | |
| ||
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); F27piglets (suckling and weaned) and minor porcine species (suckling and weaned) | |
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 108 CFU/kg Chickens, minor avian species, piglets and minor porcine species: 2.5 x 108 CFU/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. Where Clostridium butyricum (FERM BP-2789) is to be used in feed containing coccidiostats, this feed additive is authorised for use with the following coccidiostats only, and in accordance with their individual authorisation criteria: | |
SCHEDULE 9Authorisation 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
AuthorisationI201
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.
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 by F40fermentation withKomagataella phaffii (DSM 32854) In granular, coated and liquid forms, minimum activity 5000 FTU/g45 | |
Characterisation of the active substance(s) | 6-phytase (EC 3.1.3.26) produced by Komagataella phaffii (DSM 32854) | |
Analytical methods46 | 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. | |
SCHEDULE 10Authorisation of Decoquinate (Deccox®) (identification number 51756i) as a feed additive for chickens for fattening
AuthorisationI211
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 schedule50.
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 methods52 | 1. For quantification of Decoquinate in the feed additive, premixtures F33, feed materials and compound 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 F35feed additive and premixtures, the storage conditions and stability to heat treatment must be indicated. 2. The F35feed 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 and Eimeria spp and submitted to the Scottish Ministers by the end of 23 November 2031. | |
SCHEDULE 11Authorisation of Decoquinate (Avi-Deccox® 60G) (identification number 51756ii) as a feed additive for chickens for fattening
AuthorisationI221
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 schedule54.
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 methods56 | 1. For the quantification of Decoquinate in the feed additive, premixtures F37, feed materials and compound 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 F38feed additive and premixtures, the storage conditions and stability to heat treatment must be indicated. 2. The F38feed 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 and Eimeria spp and submitted to the Scottish Ministers by the end of 23 November 2031. | |
SCHEDULE 12Revocation of F43assimilated direct EU legislation
Words in sch. 12 heading substituted (1.1.2024) by The Retained EU Law (Revocation and Reform) Act 2023 (Consequential Amendments) (Scotland) Regulations 2023 (S.S.I. 2023/374), reg. 1(1), sch. 2 para. 41(5)
I231
Commission Regulation (EC) No. 1289/2004 concerning the authorisation for 10 years of the additive Deccox® in feedingstuffs, belonging to the group of coccidiostats and other medicinal substances58.
I242
Commission Regulation (EC) No. 903/2009 concerning the authorisation of the preparation of Clostridium butyricum (FERM-BP 2789) as a feed additive for chickens for fattening (holder of authorisation Miyarisan Pharmaceutical Co. Ltd, represented by Huvepharma NV Belgium)59.
I253
Commission Regulation (EU) No. 8/2010 concerning the authorisation of the serine protease produced by Bacillus licheniformis (DSM 19670) as a feed additive for chickens for fattening (holder of authorisation DSM Nutritional Products Ltd, represented by DSM Nutritional Products Sp.Z.o.o)60.
I264
Commission Regulation (EU) No. 107/2010 concerning the authorisation of Bacillus subtilis ATCC PTA-6737 as a feed additive for chickens for fattening (holder of authorisation Kemin Europa NV)61.
I275
Commission Regulation (EU) No. 883/2010 concerning the authorisation of a new use of Saccharomyces cerevisiae NCYC Sc 47 as a feed additive for calves for rearing (holder of the authorisation Société industrielle Lesaffre)62.
I286
Commission Regulation (EU) No. 168/2011 amending Regulation (EU) No. 107/2010 as regards the use of the feed additive Bacillus subtilis ATCC PTA-6737 in feed containing maduramycin ammonium, monensin sodium, narasin, or robenidine hydrochloride63.
I297
Commission Implementing Regulation (EU) No. 373/2011 concerning the authorisation of the preparation of Clostridium butyricum FERM-BP 2789 as a feed additive for minor avian species except laying birds, weaned piglets and minor porcine species (weaned) and amending Regulation (EC) No. 903/2009 (holder of authorisation Miyarisan Pharmaceutical Co. Ltd, represented by Huvepharma NV Belgium)64.
I308
Commission Implementing Regulation (EU) No. 515/2011 concerning the authorisation of vitamin B6 as a feed additive for all animal species65.
I319
Commission Implementing Regulation (EU) No. 885/2011 concerning the authorisation of Bacillus subtilis (ATCC PTA-6737) as a feed additive for chickens reared for laying, ducks for fattening, quails, pheasants, partridges, guinea fowl, pigeons, geese for fattening and ostriches (holder of the authorisation Kemin Europa N.V.)66.
I3210
Commission Implementing Regulation (EU) No. 357/2013 amending Regulation (EC) No. 903/2009 and Implementing Regulation (EU) No. 373/2011 as regards the minimum content of a preparation of Clostridium butyricum (FERM-BP 2789) as a feed additive for chickens for fattening and minor avian species (excluding laying birds) (holder of authorisation Miyarisan Pharmaceutical Co. Ltd represented by Miyarisan Pharmaceutical Europe S.L.U.)67.
I3311
Commission Implementing Regulation (EU) No. 374/2013 concerning the authorisation of a preparation of Clostridium butyricum (FERM-BP 2789) as a feed additive for chickens reared for laying (holder of authorisation Miyarisan Pharmaceutical Co. Ltd represented by Huvepharma NV Belgium)68.
I3412
Commission Implementing Regulation (EU) No. 291/2014 amending Regulation (EC) No. 1289/2004 as regards the withdrawal time and maximum residues limits of the feed additive decoquinate69.
I3513
Commission Implementing Regulation (EU) No. 1108/2014 concerning the authorisation of a preparation of Clostridium butyricum (FERM-BP 2789) as a feed additive for turkeys for fattening and turkeys reared for breeding (holder of authorisation Miyarisan Pharmaceutical Co. Ltd represented by Huvepharma NV Belgium)70.
I3614
Commission Implementing Regulation (EU) No. 2017/1126 amending Regulation (EC) No. 903/2009 and Implementing Regulations (EU) No. 373/2011, (EU) No. 374/2013 and (EU) No. 1108/2014 as regards the name of the EU representative of the holder of the authorisation of a preparation of Clostridium butyricum (FERM-BP 2789)71.
(This note is not part of the Regulations)
Words in sch. 5 heading omitted (9.2.2023) by virtue of The Food and Feed (Miscellaneous Amendments) (Scotland) Regulations 2022 (S.S.I. 2022/373), regs. 1(1), 5(8)(a)(i)