The Feed Additives (Authorisations) (Scotland) Regulations 2022

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. 1831/2003 of 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. 178/2002 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(2).

Citation, commencement and extent S

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.

Commencement Information

I1 Reg. 1 in force at 24.11.2022, see reg. 1(1)

Interpretation S

2.—(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(3).

(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.

Commencement Information

I2 Reg. 2 in force at 24.11.2022, see reg. 1(1)

Authorisations S

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.

Commencement Information

I3 Reg. 3 in force at 24.11.2022, see reg. 1(1)

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

4.—(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”.

Commencement Information

I4 Reg. 4 in force at 24.11.2022, see reg. 1(1)

Amendment of Commission Implementing Regulation (EU) No. 787/2013 S

5.—(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”.

Commencement Information

I5 Reg. 5 in force at 24.11.2022, see reg. 1(1)

Amendment of Commission Implementing Regulation (EU) 2015/1020 S

6.—(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”.

Commencement Information

I6 Reg. 6 in force at 24.11.2022, see reg. 1(1)

Amendment of Commission Implementing Regulation (EU) 2017/2276 S

7.—(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”.

Commencement Information

I7 Reg. 7 in force at 24.11.2022, see reg. 1(1)

Transitional provision: Saccharomyces cerevisiae (identification number 4b1702) S

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

“the prior authorisation” means [F1 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)(8).

Textual Amendments

F1 Words in reg. 8(3) inserted (9.2.2023) by The Food and Feed (Miscellaneous Amendments) (Scotland) Regulations 2022 (S.S.I. 2022/373), regs. 1(1), 5(2)

Commencement Information

I8 Reg. 8 in force at 24.11.2022, see reg. 1(1)

Transitional: Bacillus velezensis (identification number 4b1823) S

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 [F2 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 [F3 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)(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).

Textual Amendments

F2 Words in reg. 9(1) 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(2)

F3 Words in reg. 9(5) inserted (9.2.2023) by The Food and Feed (Miscellaneous Amendments) (Scotland) Regulations 2022 (S.S.I. 2022/373), regs. 1(1), 5(3)

Commencement Information

I9 Reg. 9 in force at 24.11.2022, see reg. 1(1)

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

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 [F4 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(11).

Textual Amendments

F4 Words in reg. 10(2) inserted (9.2.2023) by The Food and Feed (Miscellaneous Amendments) (Scotland) Regulations 2022 (S.S.I. 2022/373), regs. 1(1), 5(4)

Commencement Information

I10 Reg. 10 in force at 24.11.2022, see reg. 1(1)

Revocations S

11.  The [F5 assimilated direct] legislation listed in schedule 12 is revoked subject to regulations 8, 9(2) to (5) and 10.

Textual Amendments

F5 Words in reg. 11 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(3)

Commencement Information

I11 Reg. 11 in force at 24.11.2022, see reg. 1(1)

MAREE TODD

Authorised to sign by the Scottish Ministers

St Andrew’s House,

Edinburgh

27th September 2022

Regulation 3(2)

SCHEDULE 1 S Authorisation of a preparation of manganese chelate of lysine and glutamic acid (identification number 3b509) as a feed additive for all animal species

Authorisation S

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:
		Manganese 15-17% Lysine 20-21.5% Glutamic acid 22-24% Moisture 3.5% maximum Nickel 4 ppm maximum
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:
		Atomic Absorption Spectrometry (AAS) in accordance with international standard BS EN ISO [F6 6869:2001] entitled “Animal feeding stuffs. Determination of the contents of calcium, copper, iron, magnesium, manganese, potassium, sodium and zinc. Method using atomic absorption spectrometry”(14); Inductively Coupled Plasma-Atomic Emission Spectrometry, (ICP-AES) in accordance with European standard EN 15510:2017 entitled “Animal feeding stuffs. Methods of sampling and analysis. Determination of calcium, sodium, phosphorus, magnesium, potassium, iron, zinc, copper, manganese, cobalt, molybdenum and lead by ICP-AES”(15) (for premixtures and feed only); F7 ... Inductively Coupled Plasma-Atomic Emission Spectrometry after pressure digestion (ICP-AES) in accordance with European standard EN 15621:2017 entitled “Animal feeding stuffs: Methods of sampling and analysis – Determination of calcium, sodium, phosphorus, magnesium, potassium, sulphur, iron, zinc, copper, manganese and cobalt after pressure digestion by ICP-AES”(16)F8 ...[F9 ; or Inductively Coupled Plasma-Mass Spectrometry (ICP-MS) in accordance with international standard BS EN 17053: 2018 entitled “Animal feeding stuffs: Methods of sampling and analysis. Determination of trace elements, heavy metals and other elements in feed by ICP-MS (multi-method)”.]
		2. For quantification of total manganese in feed materials and compound feed:
		Atomic Absorption Spectrometry (AAS) – Commission Regulation (EC) No. 152/2009 laying down the methods of sampling and analysis for the official control of feed (Annex 4-C)(17); Atomic Absorption Spectrometry, AAS in accordance with international standard BS EN ISO 6869:2001; Inductively Coupled Plasma-Atomic Emission Spectrometry, (ICP-AES) in accordance with European standard EN 15510:2017 entitled “Animal feeding stuffs. Methods of sampling and analysis. Determination of calcium, sodium, phosphorus, magnesium, potassium, iron, zinc, copper, manganese, cobalt, molybdenum and lead by ICP-AES” (for premixtures and feed only); F10 ... Inductively Coupled Plasma – Atomic Emission Spectrometry after pressure digestion, ICP-AES (EN 15621 [F11 : 2017] )F12 ...[F13 ; or Inductively Coupled Plasma-Mass Spectrometry (ICP-MS) in accordance with international standard BS EN 17053: 2018.]
		3. For quantification of lysine and glutamic acid in the feed additive:
		Ion exchange chromatography coupled with post-column derivatisation and photometric detection (IEC-VIS) [F14 in accordance with BS EN ISO 13903:2005 entitled “Animal feeding stuffs. Determination of amino acids content].
		4. [F15 For determination of the chelated form] of the feed additive:
		Mid-infrared (IR) spectrometry together with the determination of the content of trace element and lysine and glutamic acid in the feed additive.
Species or category of animal		All animal species
Maximum age		Not applicable
Content of [F16 element (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.

Textual Amendments

F6 Word in sch. 1 table substituted (9.2.2023) by The Food and Feed (Miscellaneous Amendments) (Scotland) Regulations 2022 (S.S.I. 2022/373), regs. 1(1), 5(5)(a)(i)(aa)

F7 Word in sch. 1 table 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(5)(a)(i)(bb)

F8 Sch. 1 table full stop 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(5)(a)(i)(cc)

F9 Words in sch. 1 table inserted (9.2.2023) by The Food and Feed (Miscellaneous Amendments) (Scotland) Regulations 2022 (S.S.I. 2022/373), regs. 1(1), 5(5)(a)(i)(dd)

F10 Word in sch. 1 table 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(5)(a)(ii)(aa)

F11 Word in sch. 1 table inserted (9.2.2023) by The Food and Feed (Miscellaneous Amendments) (Scotland) Regulations 2022 (S.S.I. 2022/373), regs. 1(1), 5(5)(a)(ii)(bb)

F12 Sch. 1 table full stop 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(5)(a)(ii)(cc)

F13 Words in sch. 1 table inserted (9.2.2023) by The Food and Feed (Miscellaneous Amendments) (Scotland) Regulations 2022 (S.S.I. 2022/373), regs. 1(1), 5(5)(a)(ii)(dd)

F14 Words in sch. 1 table inserted (9.2.2023) by The Food and Feed (Miscellaneous Amendments) (Scotland) Regulations 2022 (S.S.I. 2022/373), regs. 1(1), 5(5)(a)(iii)

F15 Words in sch. 1 table substituted (9.2.2023) by The Food and Feed (Miscellaneous Amendments) (Scotland) Regulations 2022 (S.S.I. 2022/373), regs. 1(1), 5(5)(a)(iv)

F16 Words in sch. 1 table substituted (9.2.2023) by The Food and Feed (Miscellaneous Amendments) (Scotland) Regulations 2022 (S.S.I. 2022/373), regs. 1(1), 5(5)(b)

Commencement Information

I12 Sch. 1 para. 1 in force at 24.11.2022, see reg. 1(1)

Regulation 3(2)

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

Authorisation S

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 buchneri DSM 29026
Identification number of the additive		1k20759
Authorisation holder(18)
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 methods(19)		1. For enumeration (colony count) of the feed additive:
		Spread plate method on MRS agar in accordance with European standard EN 15787:2021 entitled “Animal feeding stuffs: Methods of sampling and analysis – Detection and enumeration of Lactobacillus spp. used as feed additive”(20)
		2. For identification of bacterial strain:
		Pulsed Field Gel Electrophoresis (PFGE)
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 material(21).
	Maximum content	No maximum
Other provisions		In the directions for use of the additive and premixtures, the storage conditions must be indicated.

Commencement Information

I13 Sch. 2 para. 1 in force at 24.11.2022, see reg. 1(1)

Regulation 3(2)

SCHEDULE 3 S 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 S

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 [F17 (EC 3.4.21-)]
Identification number of the additive		4a13
Authorisation holder		DSM Nutritional Products Ltd [F18 (Switzerland)]
Additive category		Zootechnical additives
Functional group		Digestibility enhancers
Additive composition		Solid and liquid preparation of serine protease (EC [F19 3.4.21.-] )
		Produced by Bacillus licheniformis DSM 19670 Having a minimum activity of 75,000 PROT/g(22)
Characterisation of the active substance(s)		Serine protease (EC [F19 3.4.21.-] ) produced by Bacillus licheniformis DSM 19670 CAS number: 37259-58-8 (serine protease)(23) EINECS number: 253-431-3(24) IUB number: [F19 3.4.21.-] (25)
Analytical methods(26)		For quantification of serine protease activity in the feed additive, premixtures, compound feed and feed materials:
		Colourimetric method based on the enzymatic reaction of serine protease on the Suc-Ala-Ala-Pro-Phe-pNA substrate
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.

Textual Amendments

F17 Words in sch. 3 table inserted (9.2.2023) by The Food and Feed (Miscellaneous Amendments) (Scotland) Regulations 2022 (S.S.I. 2022/373), regs. 1(1), 5(6)(a)

F18 Words in sch. 3 table substituted (9.2.2023) by The Food and Feed (Miscellaneous Amendments) (Scotland) Regulations 2022 (S.S.I. 2022/373), regs. 1(1), 5(6)(b)

F19 Word in sch. 3 table substituted (9.2.2023) by The Food and Feed (Miscellaneous Amendments) (Scotland) Regulations 2022 (S.S.I. 2022/373), regs. 1(1), 5(6)(c)

Commencement Information

I14 Sch. 3 para. 1 in force at 24.11.2022, see reg. 1(1)

Regulation 3(2)

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

Authorisation S

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: [F20 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:
		Titration with perchloric acid (Ph.Eur. 10th edition, monograph 0245)
		2. For the determination of pyridoxine hydrochloride (Vitamin B6) in premixtures:
		Reversed phase High Performance Liquid Chromatography coupled to UV detector (RP-HPLC-UV) in accordance with the VDLUFA Method Book, Volume III, 13.9.1(32)
		3. For the determination of pyridoxine hydrochloride (Vitamin B6) in feed and water:
		Reversed phase High Performance Liquid Chromatography coupled to fluorescence detector (RP-HPLC-FLD) – method based in accordance with European standard EN 14164:2014 entitled “ Foodstuffs – Determination of vitamin B6 by high performance chromatography”(33)
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.

Textual Amendments

F20 Word in sch. 4 table substituted (9.2.2023) by The Food and Feed (Miscellaneous Amendments) (Scotland) Regulations 2022 (S.S.I. 2022/373), regs. 1(1), 5(7)

Commencement Information

I15 Sch. 4 para. 1 in force at 24.11.2022, see reg. 1(1)

Regulation 3(2)

SCHEDULE 5 S Renewal of authorisation F21 ... of a preparation of Saccharomyces cerevisiae CNCM I-4407 F22 ... (identification number 4b1702) as a feed additive for calves for rearing

Textual Amendments

F21 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)

F22 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)

Authorisation S

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 cerevisiae CNCM I-4407 F23 ...
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 methods(35)		1. For enumeration (colony count):
		Pour plate method using CGYE (yeast extract glucose chloramphenicol) agar in accordance with European standard EN 15789:2021 entitled “ Animal feeding stuffs: Methods of sampling and analysis – Detection and enumeration of Saccharomyces cerevisiae used as feed additive”(36)
		2. For identification of yeast strain:
		Polymerase chain reaction (PCR) method in accordance with DD CEN/TS 15790:2008 entitled “Animal Feeding Stuffs – PCR typing of probiotic strains of Sacccharomyces cerevisiae (yeast)”(37)
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.

Textual Amendments

F23 Words in sch. 5 table 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)(b)

Commencement Information

I16 Sch. 5 para. 1 in force at 24.11.2022, see reg. 1(1)

Regulation 3(2)

SCHEDULE 6 S 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 S

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 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 methods(39)		1. For enumeration (colony count) [F24 in the feed additive, premixtures, feed materials and compound feed] :
		Spread plate method using tryptone soya agar with pre-heat treatment of [F25 feed samples]
		2. For identification of bacterial strain
		Pulsed-field gel electrophoresis (PFGE)
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:
		Decoquinate, Diclazuril, Lasalocid [F26 A sodium], [F27 Maduramicin ammonium], Monensin [F28 sodium], Narasin, Narasine/Nicarbazin (as combined use only), Robenidine [F29 hydrochloride], Salinomycin [F30 sodium].

Textual Amendments

F24 Words in sch. 6 table inserted (9.2.2023) by The Food and Feed (Miscellaneous Amendments) (Scotland) Regulations 2022 (S.S.I. 2022/373), regs. 1(1), 5(9)(a)(i)

F25 Words in sch. 6 table substituted (9.2.2023) by The Food and Feed (Miscellaneous Amendments) (Scotland) Regulations 2022 (S.S.I. 2022/373), regs. 1(1), 5(9)(a)(ii)

F26 Words in sch. 6 table inserted (9.2.2023) by The Food and Feed (Miscellaneous Amendments) (Scotland) Regulations 2022 (S.S.I. 2022/373), regs. 1(1), 5(9)(b)(i)

F27 Words in sch. 6 table substituted (9.2.2023) by The Food and Feed (Miscellaneous Amendments) (Scotland) Regulations 2022 (S.S.I. 2022/373), regs. 1(1), 5(9)(b)(ii)

F28 Word in sch. 6 table inserted (9.2.2023) by The Food and Feed (Miscellaneous Amendments) (Scotland) Regulations 2022 (S.S.I. 2022/373), regs. 1(1), 5(9)(b)(iii)

F29 Word in sch. 6 table inserted (9.2.2023) by The Food and Feed (Miscellaneous Amendments) (Scotland) Regulations 2022 (S.S.I. 2022/373), regs. 1(1), 5(9)(b)(iv)

F30 Word in sch. 6 table inserted (9.2.2023) by The Food and Feed (Miscellaneous Amendments) (Scotland) Regulations 2022 (S.S.I. 2022/373), regs. 1(1), 5(9)(b)(v)

Commencement Information

I17 Sch. 6 para. 1 in force at 24.11.2022, see reg. 1(1)

Regulation 3(2)

SCHEDULE 7 S 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 S

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 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 methods(40)		1. For enumeration (colony count) in the [F31 feed additive, premixtures, feed materials and compound feed]:
		Spread plate method in accordance with European standard EN 15784:2021 entitled “Animal feeding stuffs: Methods of sampling and analysis – Detection and enumeration of Bacillus spp. used as feed additive”(41)
		2. For identification of bacterial strain:
		Pulsed field gel electrophoresis (PFGE)
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:
		Diclazuril Lasalocid A sodium

Textual Amendments

F31 Words in sch. 7 table substituted (9.2.2023) by The Food and Feed (Miscellaneous Amendments) (Scotland) Regulations 2022 (S.S.I. 2022/373), regs. 1(1), 5(10)

Commencement Information

I18 Sch. 7 para. 1 in force at 24.11.2022, see reg. 1(1)

Regulation 3(2)

SCHEDULE 8 S 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 [F32 piglets] and suckling minor porcine species

Textual Amendments

F32 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)

Authorisation S

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 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 methods(43)		1. For enumeration (colony count) [F33 in the feed additive, premixtures, feed materials and compound feed]:
		Pour plate method in accordance with international standard BS ISO 15213:2003 entitled “Microbiology of food and animal feeding stuffs. Horizontal method for the enumeration of sulphite-reducing bacteria growing under anaerobic conditions”(44)
		2. For identification of bacterial strain:
		Pulsed-field gel electrophoresis (PFGE)
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); [F34 piglets (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:
		Decoquinate, Diclazuril, Lasalocid [F35 A sodium], Maduramicin ammonium, Monensin sodium, Narasin, Narasin/Nicarbazin (as combined use only), Robenidine [F36 hydrochloride,] Salinomycin sodium, Semduramicin sodium.

Textual Amendments

F33 Words in sch. 8 table inserted (9.2.2023) by The Food and Feed (Miscellaneous Amendments) (Scotland) Regulations 2022 (S.S.I. 2022/373), regs. 1(1), 5(11)(b)(i)

F34 Words in sch. 8 table substituted (9.2.2023) by The Food and Feed (Miscellaneous Amendments) (Scotland) Regulations 2022 (S.S.I. 2022/373), regs. 1(1), 5(11)(b)(ii)

F35 Words in sch. 8 table inserted (9.2.2023) by The Food and Feed (Miscellaneous Amendments) (Scotland) Regulations 2022 (S.S.I. 2022/373), regs. 1(1), 5(11)(b)(iii)(aa)

F36 Word in sch. 8 table inserted (9.2.2023) by The Food and Feed (Miscellaneous Amendments) (Scotland) Regulations 2022 (S.S.I. 2022/373), regs. 1(1), 5(11)(b)(iii)(bb)

Commencement Information

I19 Sch. 8 para. 1 in force at 24.11.2022, see reg. 1(1)

Regulation 3(2)

SCHEDULE 9 S 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 S

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 by [F37 fermentation with] Komagataella 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 by Komagataella phaffii (DSM 32854)
Analytical methods(46)		1. For quantification of phytase activity in the feed additive:
		Colorimetric method based on the enzymatic reaction of phytase on the phytate in accordance with the VDLUFA Method Book, Volume III, Part 27.1.4(47)
		2. For quantification of phytase activity in feed materials and compound feed:
		Colorimetric method based on the enzymatic reaction of phytase on the phytate in accordance with international standard BS EN ISO 30024:2009 entitled “Animal feeding stuffs. Determination of phytase activity”(48)
		3. For quantification of phytase activity in premixtures:
		Colorimetric method based on the enzymatic reaction of phytase on the phytate in accordance with the VDLUFA Method Book, Volume III, Part 27.1.3(49)
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.

Textual Amendments

F37 Words in sch. 9 table inserted (9.2.2023) by The Food and Feed (Miscellaneous Amendments) (Scotland) Regulations 2022 (S.S.I. 2022/373), regs. 1(1), 5(12)

Commencement Information

I20 Sch. 9 para. 1 in force at 24.11.2022, see reg. 1(1)

Regulation 3(2)

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

Authorisation S

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		Decoquinate: 60.0g/kg Refined deodorised soya oil: 28.5g/kg Colloidal silica: 0.6g/kg Wheat middlings: q.s. 1kg
Characterisation of the active substance(s)		Decoquinate: (Ethyl 6-decycloxy-7-ethoxy-4-hydroxyquinoline-3-carboxylate) Chemical formula: C24H35NO5 CAS No: 18507-89-6(51) Related impurities: Methyl-6-decycloxy-7-ethoxy-4-hydroxyquinoline-3-carboxylate:<1.0% 6-decycloxy-7-ethoxy-4-hydroxyquinoline-3-carboxylic acid:<0.5% Diethyl-4-decycloxy-3-ethoxyanilinomethylenemalonate: <0.5%
Analytical methods(52)		1. For quantification of Decoquinate in the feed additive, premixtures [F38 , feed materials and compound feed]:
		Reversed-Phase High Performance Liquid Chromatography with fluorescence detection (RP-HPLC-FL) in accordance with European standard EN 16162:2012 entitled “Animal feeding stuffs – Determination of decoquinate by HPLC with fluorescence detection”(53)
		2. For quantification of Decoquinate in tissues:
		Reversed-Phase High Performance Liquid Chromatography coupled to a triple quadrupole mass spectrometer [F39 (RP-HPLC-MS/MS]
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 [F40 feed] additive and premixtures, the storage conditions and stability to heat treatment must be indicated. 2. The [F40 feed] 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.

Textual Amendments

F38 Words in sch. 10 table substituted (9.2.2023) by The Food and Feed (Miscellaneous Amendments) (Scotland) Regulations 2022 (S.S.I. 2022/373), regs. 1(1), 5(13)(a)(i)

F39 Word in sch. 10 table substituted (9.2.2023) by The Food and Feed (Miscellaneous Amendments) (Scotland) Regulations 2022 (S.S.I. 2022/373), regs. 1(1), 5(13)(a)(ii)

F40 Word in sch. 10 table inserted (9.2.2023) by The Food and Feed (Miscellaneous Amendments) (Scotland) Regulations 2022 (S.S.I. 2022/373), regs. 1(1), 5(13)(b)

Commencement Information

I21 Sch. 10 para. 1 in force at 24.11.2022, see reg. 1(1)

Regulation 3(2)

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

Authorisation S

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		Decoquinate: 60.0 g/kg Colloidal silica: 0.6 g/kg Silicon dioxide: 4.0 g/kg Carboxymethylcellulose sodium: 30.0 g/kg Calcium sulphate dihydrate: q.s. ad 1,000 g
Characterisation of the active substance(s)		Decoquinate: (Ethyl 6-decycloxy-7-ethoxy-4-hydroxyquinoline-3-carboxylate)
		Chemical Formula: C24H35NO5 [F41 CAS No: 18507-89-6]
		Related impurities:
		Methyl-6-decycloxy-7-ethoxy-4-hydroxyquinoline-3-carboxylate:<1.0% 6-decycloxy-7-ethoxy-4-hydroxyquinoline-3-carboxylic acid: <0.5% Diethyl-4-decycloxy-3-ethoxyanilinomethylenemalonate:<0.5%
Analytical methods(55)		1. For the quantification of Decoquinate in the feed additive, premixtures [F42 , feed materials and compound feed] :
		Reversed-Phase High Performance Liquid Chromatography with fluorescence detection (RP-HPLC-FL) in accordance with European standard EN 16162:2012 entitled “Animal feeding stuffs – Determination of decoquinate by HPLC with fluorescence detection”
		2. For quantification of Decoquinate in tissues:
		Reversed-Phase High Performance Liquid Chromatography coupled to a triple quadrupole mass spectrometer (RP-HPLC-MS/MS) or any other analytical method complying with the requirements set by F43 ... EU Decision 2002/657/EC(56)
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 [F44 feed] additive and premixtures, the storage conditions and stability to heat treatment must be indicated. 2. The [F44 feed] 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.

Textual Amendments

F41 Words in sch. 11 table substituted (9.2.2023) by The Food and Feed (Miscellaneous Amendments) (Scotland) Regulations 2022 (S.S.I. 2022/373), regs. 1(1), 5(14)(a)

F42 Words in sch. 11 table substituted (9.2.2023) by The Food and Feed (Miscellaneous Amendments) (Scotland) Regulations 2022 (S.S.I. 2022/373), regs. 1(1), 5(14)(b)

F43 Word in sch. 11 table omitted (1.1.2024) by virtue of 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(4)

F44 Word in sch. 11 table inserted (9.2.2023) by The Food and Feed (Miscellaneous Amendments) (Scotland) Regulations 2022 (S.S.I. 2022/373), regs. 1(1), 5(14)(c)

Commencement Information

I22 Sch. 11 para. 1 in force at 24.11.2022, see reg. 1(1)

Regulation 11

SCHEDULE 12 S Revocation of [F45 assimilated direct] EU legislation

Textual Amendments

F45 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)

1.  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(57). S

Commencement Information

I23 Sch. 12 para. 1 in force at 24.11.2022, see reg. 1(1)

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)(58). S

Commencement Information

I24 Sch. 12 para. 2 in force at 24.11.2022, see reg. 1(1)

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)(59). S

Commencement Information

I25 Sch. 12 para. 3 in force at 24.11.2022, see reg. 1(1)

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)(60). S

Commencement Information

I26 Sch. 12 para. 4 in force at 24.11.2022, see reg. 1(1)

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)(61). S

Commencement Information

I27 Sch. 12 para. 5 in force at 24.11.2022, see reg. 1(1)

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(62). S

Commencement Information

I28 Sch. 12 para. 6 in force at 24.11.2022, see reg. 1(1)

7.  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)(63). S

Commencement Information

I29 Sch. 12 para. 7 in force at 24.11.2022, see reg. 1(1)

8.  Commission Implementing Regulation (EU) No. 515/2011 concerning the authorisation of vitamin B₆ as a feed additive for all animal species(64). S

Commencement Information

I30 Sch. 12 para. 8 in force at 24.11.2022, see reg. 1(1)

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.)(65). S

Commencement Information

I31 Sch. 12 para. 9 in force at 24.11.2022, see reg. 1(1)

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.)(66). S

Commencement Information

I32 Sch. 12 para. 10 in force at 24.11.2022, see reg. 1(1)

11.  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)(67). S

Commencement Information

I33 Sch. 12 para. 11 in force at 24.11.2022, see reg. 1(1)

12.  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(68). S

Commencement Information

I34 Sch. 12 para. 12 in force at 24.11.2022, see reg. 1(1)

13.  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)(69). S

Commencement Information

I35 Sch. 12 para. 13 in force at 24.11.2022, see reg. 1(1)

14.  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)(70). S

Commencement Information

I36 Sch. 12 para. 14 in force at 24.11.2022, see reg. 1(1)

EXPLANATORY NOTE

(This note is not part of the Regulations)

These Regulations make provision as regards the authorisation of feed additives under Regulation (EC) 1831/2003 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.

(1)

EUR 1831/2003 as amended by S.I. 2019/654 and 2022/377. Article 9 was substituted by S.I. 2019/654 and 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.

(2)

EUR 178/2002 as amended by S.I. 2019/641. S.I. 2019/641 was amended by S.I. 2020/1504.

(3)

EUR 767/2009 as amended by S.I. 2019/654. S.I. 2019/641 was amended by S.I. 2020/1504.

(4)

EUR 306/2013.

(5)

EUR 787/2013.

(6)

EUR 2015/1020.

(7)

EUR 2017/2276.

(8)

EUR 883/2010. This Regulation is revoked by regulation 11 of these Regulations.

(9)

EUR 107/2010 as amended by EUR 168/2011. EUR 107/2010 is revoked by regulation 11 of these Regulations.

(10)

EUR 885/2011. This Regulation is revoked by regulation 11 of these Regulations.

(11)

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.

(12)

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.

(13)

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.

(14)

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).

(15)

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).

(16)

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).

(17)

EUR 152/2009. There are amendments to EUR 152/2009 not relevant to these Regulations.

(18)

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.

(19)

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.

(20)

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).

(21)

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. 429/2008 of 25 April 2008 on detailed rules for the implementation of Regulation (EC) No. 1831/2003 of the European Parliament and of the Council as regards the preparation and the presentation of applications and the assessment and the authorisation of feed additives (EUR 2008/429, amended by S.I. 2019/654. S.I. 2019/654 was amended by 2020/1504).

(22)

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.

(23)

This is a reference to the CAS Registry Number assigned to this preparation by the Chemical Abstracts Service https://cas.org/cas-data/cas-registry.

(24)

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.

(25)

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.

(26)

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.

(27)

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.

(28)

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.

(29)

This is a reference to the CAS Registry Number assigned to this additive by the Chemical Abstracts Service https://cas.org/cas-data/cas-registry.

(30)

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.

(31)

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.

(32)

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.

(33)

This standard was approved by the European Committee for Standardization (CEN) on 17 April 2014.

(34)

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.

(35)

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.

(36)

This standard was approved by the European Committee for Standardization (CEN) on 2 August 2021.

(37)

DD CEN/TS 15790:2008, published by the British Standards Institution on 31 January 2009 (ISBN 978 0 580 61806 2).

(38)

This authorisation is a renewal of the authorisations granted under Commission Regulation (EU) No. 107/2010 and 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.

(39)

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.

(40)

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.

(41)

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).

(42)

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.

(43)

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.

(44)

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).

(45)

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.

(46)

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.

(47)

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.

(48)

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).

(49)

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.

(50)

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).

(51)

This is a reference to the CAS Registry Number assigned to this substance by the Chemical Abstracts Service https://cas.org/cas-data/cas-registry.

(52)

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.

(53)

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).

(54)

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.

(55)

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.

(56)

EUD 2002/657 as amended by S.I. 2020/1461.

(57)

EUR 1289/2004 as amended by EUR 291/2014.

(58)

EUR 903/2009 as amended by EUR 373/2011 and EUR 1126/2017.

(59)

EUR 8/2010.

(60)

EUR 2010/107.

(61)

EUR 883/2010.

(62)

EUR 168/2011.

(63)

EUR 2011/373 as amended by EUR 1126/2017.

(64)

EUR 2011/515.

(65)

EUR 885/2011.

(66)

EUR 2013/357.

(67)

EUR 2013/374 as amended by EUR 1126/2017.

(68)

EUR 291/2014.

(69)

EUR 2014/1108 as amended by EUR 1126/2017.

(70)

EUR 20171126.