The Feed Additives (Authorisations) (Scotland) Regulations 2022

There has been consultation as required by Article 9 of Regulation (EC) No. 178/2002 of the European Parliament and of the Council laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety[^f00002].

Citation, commencement and extent

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• (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

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• (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/EC[^f00003].

• (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.

Authorisations

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Amendment of Commission Implementing Regulation (EU) No. 306/2013

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• (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.)[^f00004] 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

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• (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.)[^f00005] 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

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• (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)[^f00006] 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

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• (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.)[^f00007] 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)

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• (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 an authorisation contained in 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)[^f00008].

Transitional: Bacillus velezensis (identification number 4b1823)

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• (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 assimilated 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 an 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)[^f00009], orCommission 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.)[^f00010].

Transitional: Decoquinate (Deccox®) (identification number 51756i (formerly E756))

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• (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 an 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 substances[^f00011].

Revocations

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The assimilated direct legislation listed in schedule 12 is revoked subject to regulations 8, 9(2) to (5) and 10.

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

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SCHEDULE 2 — Authorisation of a preparation of Lactobacillus buchneri DSM 29026 (identification number 1k20759) as a feed additive for all animal species

Authorisation

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SCHEDULE 3 — Authorisation of a preparation of serine protease produced by Bacillus licheniformis DSM 19670 (identification number 4a13) as a feed additive for chickens for fattening

Authorisation

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SCHEDULE 4 — Renewal of authorisation of pyridoxine hydrochloride (vitamin B₆) (identification number 3a831) as a feed additive for all animal species

Authorisation

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SCHEDULE 5 — Renewal of authorisation ... of a preparation of Saccharomyces cerevisiae CNCM I-4407 ... (identification number 4b1702) as a feed additive for calves for rearing

Authorisation

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SCHEDULE 6 — Renewal 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

Authorisation

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SCHEDULE 7 — Authorisation 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

Authorisation

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SCHEDULE 8 — Renewal 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 piglets and suckling minor porcine species

Authorisation

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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

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SCHEDULE 10 — Authorisation of Decoquinate (Deccox®) (identification number 51756i) as a feed additive for chickens for fattening

Authorisation

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SCHEDULE 11 — Authorisation of Decoquinate (Avi-Deccox® 60G) (identification number 51756ii) as a feed additive for chickens for fattening

Authorisation

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SCHEDULE 12 — Revocation of assimilated direct EU legislation

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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 substances[^f00058].

2

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)[^f00059].

3

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)[^f00060].

4

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)[^f00061].

5

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)[^f00062].

6

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 hydrochloride[^f00063].

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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)[^f00064].

8

Commission Implementing Regulation (EU) No. 515/2011 concerning the authorisation of vitamin B₆ as a feed additive for all animal species[^f00065].

9

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.)[^f00066].

10

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.)[^f00067].

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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)[^f00068].

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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 decoquinate[^f00069].

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