F1The Feed Additives (Authorisations) (Scotland) Regulations 2022
Citation, commencement and extent1.
(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.
Interpretation2.
(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
(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.
AuthorisationsF13.
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Amendment of Commission Implementing Regulation (EU) No. 306/20134.
(1)
(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. 787/20135.
(1)
(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) 2015/10206.
(1)
(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) 2017/22767.
(1)
(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 additive Saccharomyces cerevisiae CNCM I-4407, with the identification number 4b1702, which was previously authorised under the prior authorisation, and
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 F3assimilated 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 F4an authorisation contained in—
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, orCommission 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
Revocations11.
The F6assimilated direct legislation listed in schedule 12 is revoked subject to regulations 8, 9(2) to (5) and 10.
St Andrew’s House,
Edinburgh
SCHEDULE 1Authorisation of a preparation of manganese chelate of lysine and glutamic acid (identification number 3b509) as a feed additive for all animal species
F1
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SCHEDULE 2Authorisation of a preparation of Lactobacillus buchneri DSM 29026 (identification number 1k20759) as a feed additive for all animal species
F1
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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
F1
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SCHEDULE 4Renewal of authorisation of pyridoxine hydrochloride (vitamin B6) (identification number 3a831) as a feed additive for all animal species
F1
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SCHEDULE 5Renewal of authorisation F7... of a preparation of Saccharomyces cerevisiae CNCM I-4407 F8... (identification number 4b1702) as a feed additive for calves for rearing
F1
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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
F1
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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
F1
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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 F9piglets and suckling minor porcine species
F1
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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
F1
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SCHEDULE 10Authorisation of Decoquinate (Deccox®) (identification number 51756i) as a feed additive for chickens for fattening
F1
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SCHEDULE 11Authorisation of Decoquinate (Avi-Deccox® 60G) (identification number 51756ii) as a feed additive for chickens for fattening
F1
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SCHEDULE 12Revocation of F10assimilated direct EU legislation
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14.
These Regulations make provision as regards the authorisation of feed additives under Regulation (EC) 1831/2003 of 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 of Lactobacillus buchneri DSM 29026 (identification number 1k20759).
Schedule 3 is a new authorisation, for a preparation of Serine protease (EC 3.4.21.-1) produced by Bacillus 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 of Saccharomyces cerevisiae CNCM I-4407 (ACTISAF® Sc47) (identification number 4b1702). The name of the bacterial strain is changed from “Saccharomyces cerevisiae NCYC Sc 47” to “Saccharomyces cerevisiae CNCM I-4407”.
Schedule 6 is a renewal of the authorisation of a preparation of Bacillus 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 1x1010 to 8x1010 colony forming units per gram (CFU/g).
Schedule 7 is a new authorisation, for a preparation of Bacillus licheniformis DSM 28710 (identification number 4b1828).
Schedule 8 is a renewal of the authorisations of a preparation of Clostridium 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 by Komagataella phaffii DSM 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 additive Bacillus subtilis ATCC 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.