The Feed Additives (Authorisations) and Uses of Feed Intended for Particular Nutritional Purposes (Miscellaneous Amendment) (Scotland) Regulations 2024

Prospective

SCHEDULES

Regulation 3(1)

SCHEDULE 1 S Authorisation of a preparation of chromium chelate of DL-methionine (identification number GB4d0001) as a feed additive for dairy cows

Authorisation S

1.  The preparation specified in the table, belonging to the additive category “zootechnical additives” and to the functional group “other zootechnical”, is authorised as an additive in animal nutrition, subject to the conditions set out in the table.

Additive		Chromium chelate of DL-methionine
Identification number		GB4d0001
Authorisation holder		Zinpro Animal Nutrition (Europe), Inc
Additive category		Zootechnical additives
Functional group		Other zootechnical
Additive composition		Solid preparation of chelates of chromium (Cr) with DL-methionine with the below components: Calcium carbonate: 95.6% Chromium-DL-Methionine: 3.4% Vegetable oil: 1.0%
Characterisation of the active substance(s)		Chromium chelate of DL-methionine ([CH3S(CH 2)2CH(NH2)COO]3 Cr)
Analytical methods(1)		For quantification of chromium in the feed additive: Inductively coupled plasma-mass spectrometry (ICP-MS) in accordance with BS EN 17053:2018(2)
		For quantification of methionine in the feed additive: Ion-exchange chromatography coupled to post-column derivatisation and photometric detection (IEC-VIS) in accordance with BS EN ISO 13903:2005(3)
		For proving the chelated structure of the feed additive: Mid-infrared (IR) spectrometry together with the determination of the content of chromium and methionine in the feed additive
Species or category of animal		Dairy cows
Maximum age		No maximum
Content of chromium in complete feed with a moisture content of 12%	Minimum content	0.2 mg/kg
	Maximum content	0.5 mg/kg
Other provisions		The storage conditions and stability to heat treatment must be stated in the directions for use of the feed additive and premixture

Commencement Information

I1 Sch. 1 para. 1 in force at 20.12.2024, see reg. 1(1)

Regulation 3(1)

SCHEDULE 2 S Renewal of authorisation of a preparation of Saccharomyces cerevisiae (MUCL 39885) (identification number 4b1710) as a feed additive for weaned piglets, and its authorisation as a feed additive extending existing uses to cover all Suidae other than sows and suckling piglets, and cats and dogs

Authorisation S

1.  The preparation specified in the table, 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(4).

Additive		Saccharomyces cerevisiae (MUCL 39885)
Identification number		4b1710
Authorisation holder		Prosol S.p.A
Additive category		Zootechnical additives
Functional group		Gut flora stabilisers
Additive composition		Solid preparation of Saccharomyces cerevisiae (MUCL 39885) containing a minimum of 1 × 10 9 colony forming units (CFU)/g
Characterisation of the active substance(s)		Viable cells of Saccharomyces cerevisiae (MUCL 39885)
Analytical methods(5)		For enumeration: Pour plate method CGYE (chloramphenicol, glucose, yeast extract) agar in accordance with BS EN 15789:2021(6)
		For identification of the yeast strain: Polymerase chain reaction (PCR) method (DD CEN/TS 15790:2008(7))
Species or category of animal		All Suidae other than sows and suckling piglets Cats Dogs
Maximum age		No maximum
Colony forming units of additive/ kg complete feed with a moisture content of 12%	Minimum content	For all Suidae other than sows and suckling piglets, and Suidae for reproduction purposes: 3 × 109 CFU/kg
		For all Suidae for reproduction purposes, other than sows: 6.4 × 109 CFU/kg
		For cats and dogs: 7 × 1010 CFU/kg
	Maximum content	No maximum
Other provisions		The storage conditions must be indicated in the directions for use of the feed additive and premixture

Commencement Information

I2 Sch. 2 para. 1 in force at 20.12.2024, see reg. 1(1)

Regulation 3(1)

SCHEDULE 3 S Authorisation of a preparation of Pediococcus acidilactici (CNCM I-4622) (identification number 4d1712) as a feed additive for all animal species

Authorisation S

1.  The preparation specified in the table, belonging to the additive category “technological additives” and to the functional groups “acidity regulators” and “hygiene condition enhancers”, is authorised as an additive in animal nutrition, subject to the conditions set out in the table.

Additive		Pediococcus acidilactici (CNCM I-4622)
Identification number		4d1712
Authorisation holder(8)		None
Additive category		Technological additives
Functional groups		Acidity regulators Hygiene condition enhancers
Additive composition		Solid preparation of Pediococcus acidilactici (CNCM I-4622) containing a minimum of 1×10 10 colony forming units (CFU)/g
Characterisation of the active substance(s)		Viable cells of Pediococcus acidilactici (CNCM I-4622)
Analytical methods(9)		For enumeration (colony count) of the feed additive: Spread plate method using MRS agar in accordance with BS EN 15786:2021(10)
		For identification of the bacterial strain: Pulsed-Field Gel Electrophoresis (PFGE)
Species or category of animal		All animal species
Maximum age		No maximum
Colony forming units of additive/ kg complete feed with a moisture content of 12%	Minimum content	1 × 109 CFU/kg
	Maximum content	No maximum
Other provisions		1. The storage conditions and stability to heat treatment must be stated in the directions for use of the feed additive and premixture
		2. To be used only in mash compound feed intended for preparation of liquid feed on farm, or solid feed materials intended for preparation of liquid feed on farm
		3. If Pediococcus acidilactici (CNCM I-4622) 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 Halofuginone Nicarbazin Robenidine hydrocholoride

Commencement Information

I3 Sch. 3 para. 1 in force at 20.12.2024, see reg. 1(1)

Regulation 3(1)

SCHEDULE 4 S Renewal of authorisation (with modification) of a preparation of monensin sodium (produced from Streptomyces cinnamonensis 28682 (NBIMCC 3419)) (carrier: perlite, calcium carbonate) (identification number 51701) as a feed additive for chickens for fattening, chickens reared for laying, and turkeys for fattening, and its authorisation as a feed additive extending existing uses to cover turkeys reared for breeding

Authorisation S

1.  The preparation specified in the table, 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(11).

Additive		Monensin sodium
Identification number		51701
Authorisation holder		Huvepharma NV
Additive category		Coccidiostats and histomonostats
Functional group		None
Additive composition		Preparation of monensin sodium produced by fermentation with Streptomyces cinnamonensis (NBIMCC 3419) in powder form with the below components: Monensin sodium technical substance: 250 g/kg containing: Monensin A: 90% minimum Monensin A + B: 95% minimum Monensin C: 0.2% – 0.3% Perlite: 150 – 200 g/kg Calcium carbonate: 550 – 600 g/kg
Characterisation of the active substance(s)		Monensin sodium technical substance produced by fermentation with Streptomyces cinnamonensis (NBIMCC 3419): Monensin sodium A (C36H61NaO11) Monensin sodium B (C35H59NaO11) Monensin sodium C (C37H63NaO11) CAS number: 22373-78-0(12)
Analytical methods(13)		For quantification of monensin in the feed additive, premixtures and compound feed: Reversed phase high performance liquid chromatography using post-column derivatisation coupled to spectrophotometric detection (RP-HPLC-PCD-UV-Vis) in accordance with BS EN ISO 14183:2008(14)
		For quantification of monensin sodium in chicken and turkey tissues: Reversed phase high performance liquid chromatography coupled to a triple quadrupole mass spectrometer (RP-HPLC-MS/MS) or any equivalent methods
Species or category of animal		Chickens for fattening Chickens reared for laying Turkeys for fattening Turkeys reared for breeding
Maximum age		For chickens for fattening: No maximum
		For chickens reared for laying; turkeys for fattening; turkeys reared for breeding: 16 weeks
Content of monensin (mg/kg of complete feed with a moisture content of 12%)	Minimum content	For chickens for fattening; chickens reared for laying: 100 mg/kg
		For turkeys for fattening; turkeys reared for breeding: 60 mg/kg
	Maximum content	For chickens for fattening; chickens reared for laying: 125 mg/kg
		For turkeys for fattening; turkeys reared for breeding: 100 mg/kg
Maximum residue limits (MRLs) of monensin sodium in food of animal origin		For wet skin and fat: 25 µg/kg
		For wet liver; wet kidney; wet muscle: 8 µg/kg
Other provisions		1. The storage conditions and stability to heat treatment must be stated in the directions for use of the feed additive and premixture
		2. The feed additive must be incorporated into compound feed in the form of a premixture
		3. Monensin sodium must not be mixed with other coccidiostats
		4. The following must be stated in the directions for use: “Dangerous for equines. This feed contains an ionophore. Avoid simultaneous administration with tiamulin and monitor for possible adverse reactions when used concurrently with other medicinal substances.”
		5. A post-market monitoring programme must be carried out by the holder of the authorisation for resistance to bacteria and Eimeria spp. A report containing the outcome of that programme must be submitted to the Scottish Ministers before the end of 19 December 2033

Commencement Information

I4 Sch. 4 para. 1 in force at 20.12.2024, see reg. 1(1)

Regulation 3(1)

SCHEDULE 5 S Renewal of authorisation (with modification) of a preparation of monensin sodium (produced from Streptomyces cinnamonensis 28682 (NBIMCC 3419)) (carrier: perlite, wheat bran) (identification number 51701) as a feed additive for chickens for fattening, and turkeys for fattening, and its authorisation as a feed additive extending existing uses to cover chickens reared for laying, and turkeys reared for breeding

Authorisation S

1.  The preparation specified in the table, 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(15).

Additive		Monensin sodium
Identification number		51701
Authorisation holder		Huvepharma NV
Additive category		Coccidiostats and histomonostats
Functional group		No functional group
Additive composition		Preparation of monensin sodium produced by fermentation with Streptomyces cinnamonensis (NBIMCC 3419) in powder form with the below components: Monensin sodium technical substance: 250g/kg containing: Monensin A: 90% minimum Monensin A + B: 95% minimum Monensin C: 0.2 – 0.3% Perlite: 150 – 200 g/kg Wheat bran: 550 – 600 g/kg
Characterisation of the active substance(s)		Monensin sodium technical substance produced by fermentation with Streptomyces cinnamonensis (NBIMCC 3419): Monensin sodium A (C36H61NaO11) Monensin sodium B (C35H59NaO11) Monensin sodium C (C37H63NaO11) CAS number: 22373-78-0(16)
Analytical methods(17)		For quantification of monensin in the feed additive, premixtures and compound feed: Reversed phase high performance liquid chromatography using post-column derivatisation coupled to spectrophotometric detection (RP-HPLC-PCD-UV-Vis) in accordance with BS EN ISO 14183:2008(18)
		For quantification of monensin sodium in chicken and turkey tissues: Reversed phase high performance liquid chromatography coupled to a triple quadrupole mass spectrometer (RP-HPLC-MS/MS) or any equivalent methods
Species or category of animal		Chickens for fattening Chickens reared for laying Turkeys for fattening Turkeys reared for breeding
Maximum age		For chickens for fattening: No maximum
		For chickens reared for laying; turkeys for fattening; turkeys reared for breeding: 16 weeks
Content of monensin (mg/kg of complete feed with a moisture content of 12%)	Minimum content	For chickens for fattening; chickens reared for laying: 100 mg/kg
		For turkeys for fattening; turkeys reared for breeding: 60 mg/kg
	Maximum content	For chickens for fattening; chickens reared for laying: 125 mg/kg
		For turkeys for fattening; turkeys reared for breeding: 100 mg/kg
Maximum residue limits (MRLs) of monensin sodium in food of animal origin		For wet skin and fat: 25 µg/kg
		For wet liver; wet kidney; wet muscle: 8 µg/kg
Other provisions		1. The storage conditions and stability to heat treatment must be stated in the directions for use of the feed additive and premixture
		2. The feed additive must be incorporated into compound feed in the form of a premixture
		3. Monensin sodium must not be mixed with other coccidiostats
		4. The following must be stated in the directions for use: “Dangerous for equines. This feed contains an ionophore. Avoid simultaneous administration with tiamulin and monitor for possible adverse reactions when used concurrently with other medicinal substances.”
		5. A post-market monitoring programme must be carried out by the holder of the authorisation for resistance to bacteria and Eimeria spp. A report containing the outcome of that programme must be submitted to the Scottish Ministers before the end of 19 December 2033

Commencement Information

I5 Sch. 5 para. 1 in force at 20.12.2024, see reg. 1(1)

Regulation 3(1)

SCHEDULE 6 S Renewal of authorisation (with modification) of a preparation of 6-phytase (EC 3.1.3.26) produced from Komagataella phaffii (formerly Komagataella pastoris) (DSM 23036) (identification number 4a16) as a feed additive for chickens for fattening, chickens reared for laying, laying hens, turkeys for fattening, turkeys reared for breeding, other avian species for fattening and laying, sows, pigs for fattening and weaned piglets, and its authorisation as a feed additive extending existing uses to cover all avian species and all porcine species

Authorisation S

1.  The preparation specified in the table, 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(19).

Additive		6-phytase (EC 3.1.3.26)
Identification number		4a16
Authorisation holder		Huvepharma NV
Additive category		Zootechnical additives
Functional group		Digestibility enhancers
Additive composition		Preparation of 6–phytase (EC 3.1.3.26) produced by fermentation with Komagataella phaffii (DSM 23036) having a minimum enzyme activity of: 4,000 OTU/g(20) in solid form 8,000 OTU/g in liquid form
Characterisation of the active substance(s)		6-phytase (EC 3.1.3.26) produced by fermentation with Komagataella phaffii (DSM 23036): CAS number: 9001-89-2(21) EC (IUBMB) number(22): 3.1.3.26
Analytical methods(23)		For the quantification of phytase activity in the feed additive, premixtures and compound feed: Colorimetric method based on the quantification of the inorganic phosphate released by the enzyme from the sodium phytate
Species or category of animal		All avian species All Suidae species
Maximum age		No maximum
Content of 6-phytase (EC 3.1.3.26) (units of activity (OUT/kg) of complete feed with a moisture content of 12%)	Minimum content	For all avian species other than turkeys, and all Suidae species other than piglets: 125 OTU/kg
		For turkeys and piglets: 250 OTU/kg
	Maximum content	No maximum
Other provisions		The storage conditions and stability to heat treatment must be stated in the directions for use of the feed additive and premixture

Commencement Information

I6 Sch. 6 para. 1 in force at 20.12.2024, see reg. 1(1)

Regulation 3(1)

SCHEDULE 7 S Renewal of authorisation (with modification) of a preparation of Bacillus velezensis (formerly Bacillus subtilis) (DSM 15544) (identification number 4b1820) as a feed additive for weaned piglets, chickens reared for laying, turkeys, minor avian species, ornamental birds and game birds and its authorisation as a feed additive extending and consolidating existing authorised uses to cover all avian species

Authorisation S

1.  The preparation specified in the table, 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(24).

Additive		Bacillus velezensis (DSM 15544)
Identification number		4b1820
Authorisation holder		Asahi Biocycle Co., Ltd
Additive category		Zootechnical additives
Functional group		Gut flora stabilisers
Additive composition		Solid preparation of Bacillus velezensis (DSM 15544) containing a minimum of 1 × 10 10 colony forming units (CFU)/g
Characterisation of the active substance(s)		Viable spores of Bacillus velezensis (DSM 15544)
Analytical methods(25)		For enumeration (colony count) of the feed additive: Spread plate method using tryptone soya agar in all target matrices in accordance with BS EN 15784:2021(26)
		For identification of the feed additive: Pulsed-field gel electrophoresis (PFGE)
Species or category of animal		Weaned piglets All avian species
Maximum age		No maximum
Colony forming units of additive/ kg complete feed with a moisture content of 12%	Minimum content	3 × 108 CFU/kg
	Maximum content	No maximum
Other provisions		The storage conditions and stability to heat treatment must be stated in the directions for use of the feed additive and premixture

Commencement Information

I7 Sch. 7 para. 1 in force at 20.12.2024, see reg. 1(1)

Regulation 3(1)

SCHEDULE 8 S Authorisation of a preparation of L-histidine monohydrochloride monohydrate (produced from Escherichia coli K-12 (KCCM 80212)) (identification number 3c352i) as a feed additive for all animal species

Authorisation S

1.  The preparation specified in the table, belonging to the additive category “nutritional additives” and to the functional group “amino acids, their salts and analogues”, is authorised as an additive in animal nutrition, subject to the conditions set out in the table.

Additive		L-histidine monohydrochloride monohydrate
Identification number		3c352i
Authorisation holder(27)		None
Additive category		Nutritional additives
Functional group		Amino acids, their salts and analogues
Additive composition		L-histidine monohydrochloride monohydrate with a purity criteria not less than 98% as a powder with the following components: Moisture: 1% maximum Histidine: 72% minimum Histamine: 100ppm maximum
Characterisation of the active substance(s)		L-histidine monohydrochloride monohydrate produced by fermentation with Escherichia coli K-12 (KCCM 80212) (C6H12ClN3O3): CAS number: 5934-29-2(28) EINECS number: 611-821-4(29)
Analytical methods(30)		For quantification of histidine in the feed additive: High performance liquid chromatography coupled with photometric detection (HPLC-UV) in accordance with BS EN ISO 13903:2005(31), or Ion-exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS/FLD)
		For quantification of histidine in premixtures, feed materials and compound feed: Ion-exchange chromatography coupled to post-column derivatisation and photometric detection (IEC-VIS) in accordance with Commission Regulation (EC) No 152/2009 laying down the methods of sampling and analysis for the official control of feed (Annex 3-F)(32)
		For quantification of histamine in the feed additive: High performance liquid chromatography coupled with photometric detection (HPLC-UV) in accordance with BS EN ISO 13903:2005
Species or category of animal		All animal species
Maximum age		No maximum
Content of L-histidine monohydrochloride monohydrate (mg/kg of complete feed with a moisture content of 12%)	Minimum content	No minimum
	Maximum content	No maximum
Other provisions		1. The storage conditions and stability to heat treatment must be stated in the directions for use of the feed additive and premixture
		2. L-histidine monohydrochloride monohydrate may be placed on the market and used as an additive consisting of a preparation
		3. The histidine content must be indicated on the label of the additive and must contain the following declaration on the label of the additive and premixture:
			“The supplementation with L-histidine monohydrochloride monohydrate shall be limited to the nutritional requirements of the target animal, which depends on the environmental conditions, the species, physiological state, performance level of the animal and level of other amino acids and essential trace elements such as copper and zinc.”
		4. The endotoxin content of the additive and its dusting potential must ensure a maximal endotoxin exposure of 1600 IU endotoxins/m3air (33)

Commencement Information

I8 Sch. 8 para. 1 in force at 20.12.2024, see reg. 1(1)

Regulation 3(1)

SCHEDULE 9 S Authorisation of a preparation of L-tryptophan (produced from Escherichia coli (KCCM 80210)) (identification number 3c440i) as a feed additive for all animal species

Authorisation S

1.  The preparation specified in the table, belonging to the additive category “nutritional additives” and to the functional group “amino acids, their salts and analogues”, is authorised as an additive in animal nutrition, subject to the conditions set out in the table.

Additive		L-tryptophan
Identification number		3c440i
Authorisation holder(34)		None
Additive category		Nutritional additives
Functional group		Amino acids, their salts and analogues
Additive composition		L-tryptophan with a purity criteria on a dry matter basis not less than 98% as a powder with the following components: Moisture content: 1% maximum 1,1’-ethylidene-bis-L-tryptophan: 10 mg/kg maximum
Characterisation of the active substance(s)		L-tryptophan produced by fermentation with Escherichia coli (KCCM 80210) (C11H12N2O2): CAS number: 73-22-3(35) EINECS number: 200-795-6(36)
Analytical methods(37)		For identification of L-tryptophan in the feed additive: Food Chemical Codex “L-tryptophan monograph”(38)
		For determination of tryptophan in the feed additive and premixtures: High performance liquid chromatography with fluorescence detection (HPLC-FLD) in accordance with BS EN ISO 13904:2016(39)
		For determination of tryptophan in feed materials and compound feed: High performance liquid chromatography with fluorescence detection (HPLC-FLD) in accordance with Commission Regulation (EC) No 152/2009 laying down the methods of sampling and analysis for the official control of feed (Annex 3-G)
Species or category of animal		All animal species
Maximum age		No maximum
Content of L-tryptophan (mg/kg of complete feed with a moisture content of 12%)	Minimum content	No minimum
	Maximum content	No maximum
Other provisions		1. L-tryptophan must be rumen protected when administered to ruminants
		2. Declaration to be made on the label of the additive and premixture: “The supplementation with L-tryptophan must take into account all essential and conditionally essential amino acids in order to avoid imbalances.”
		3. The endotoxin content of the additive and its dusting potential must ensure a maximal endotoxin exposure of 1600 IU endotoxins/m3air (40)

Commencement Information

I9 Sch. 9 para. 1 in force at 20.12.2024, see reg. 1(1)

Regulation 3(1)

SCHEDULE 10 S Authorisation of a preparation of L-lysine sulphate (produced from Corynebacterium glutamicum (KCCM 80227)) (identification number 3c324i) as a feed additive for all animal species

Authorisation S

1.  The preparation specified in the table, belonging to the additive category “nutritional additives” and to the functional group “amino acids, their salts and analogues”, is authorised as an additive in animal nutrition, subject to the conditions set out in the table.

Additive		L-lysine sulphate
Identification number		3c324i
Authorisation holder(41)		None
Additive category		Nutritional additives
Functional group		Amino acids, their salts and analogues
Additive composition		Granulated preparation of L-lysine sulphate with a minimum of 52% L-lysine, a maximum of 24% sulphate and a maximum moisture content of 4%
Characterisation of the active substance(s)		L-lysine sulphate produced by fermentation with Corynebacterium glutamicum (KCCM 80227) (C12H28N4O4·H2SO4): CAS Number: 60343-69-3(42)
Analytical methods(43)		For quantification of lysine in the feed additive and premixtures containing more than 10% lysine: Ion-exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS/FLD) in accordance with BS EN ISO 17180:2013(44)
		For identification of sulphate in the feed additive: European Pharmacopoeia Monograph 20301(45)
		For quantification of lysine in premixtures, feed materials and compound feed: Ion-exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS in accordance with Commission Regulation (EC) No 152/2009 laying down the methods of sampling and analysis for the official control of feed (Annex 3-F)
		For quantification of lysine in water: Ion exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS/FLD) in accordance with BS EN ISO 17180:2013
Species or category of animal		All animal species
Maximum age		No maximum
Content of L-lysine sulphate (mg/kg of complete feed with a moisture content of 12%)	Minimum content	No minimum
	Maximum content	10,000 mg/kg
Other provisions		1. The storage conditions and stability to heat treatment must be stated in the directions for use of the feed additive and premixture
		2. The L-lysine content must be stated on the labelling of the additive
		3. The following must be stated on the labelling of the additive and premixture: “The supplementation with L-lysine should take into account all essential and conditionally essential amino acids in order to avoid imbalances.”

Commencement Information

I10 Sch. 10 para. 1 in force at 20.12.2024, see reg. 1(1)

Regulation 3(1)

SCHEDULE 11 S Authorisation of the substance butylated hydroxyanisole (identification number 1b320) as a feed additive for cats

Authorisation S

1.  The substance specified in the table, belonging to the additive category “technological additives” and to the functional group “antioxidants”, is authorised as an additive in animal nutrition, subject to the conditions set out in the table.

Additive		Butylated hydroxyanisole (BHA)
Identification number		1b320
Authorisation holder(46)		None
Additive category		Technological additives
Functional group		Antioxidants
Additive composition		Butylated hydroxyanisole (BHA) with a minimum content of 98.5% in a waxy solid form
Characterisation of the active substance(s)		Butylated hydroxyanisole containing a mixture of 2-tert-butyl-4-hydroxyanisole and a minimum of 85% 3-tert-butyl-4-hydroxyanisole (C11H16O2): CAS number: 25013-16-5(47)
Analytical methods(48)		For quantification of butylated hydroxyanisole (BHA) in feed additives: Gas chromatography coupled to flame ionization detection (GC-FID) Food Chemical Codex 7th edition method(49)
		For quantification of butylated hydroxyanisole (BHA) in premixtures and compound feed: Reversed phase high performance liquid chromatography coupled to ultraviolet-diode-array detection (RP-HPLC-UV-DAD, 285 nm)
Species or category of animal		Cats
Maximum age		No maximum
Content of butylated hydroxyanisole (mg/kg of complete feed with a moisture content of 12%)	Minimum content	No minimum
	Maximum content	150 mg/kg
Other provisions		1. The storage conditions and stability to heat treatment must be stated in the directions for use of the feed additive and premixture
		2. Butylated hydroxyanisole (BHA) is authorised to be used in combination with butylated hydroxytoluene (BHT) only up to a maximum combined content of 150 mg/kg of complete feed

Commencement Information

I11 Sch. 11 para. 1 in force at 20.12.2024, see reg. 1(1)

Regulation 3(1)

SCHEDULE 12 S Authorisation of a preparation of L-lysine base (liquid) (produced from Corynebacterium glutamicum (KCCM 80183)) (identification number 3c320) as a feed additive for all animal species

Authorisation S

1.  The preparation specified in the table, belonging to the additive category “nutritional additives” and to the functional group “amino acids, their salts and analogues”, is authorised as an additive in animal nutrition, subject to the conditions set out in the table.

Additive		L-lysine base (liquid)
Identification number		3c320
Authorisation holder(50)		None
Additive category		Nutritional additives
Functional group		Amino acids, their salts and analogues
Additive composition		Aqueous solution with a minimum of 50% L-lysine
Characterisation of the active substance(s)		L-lysine base (liquid) (NH2(CH2)CH(NH2)COOH) produced by fermentation with Corynebacterium glutamicum (KCCM 80183): CAS no: 56-87-1(51)
Analytical methods(52)		For quantification of lysine in the feed additive and premixtures containing more than 10% lysine: Ion-exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS/FLD) in accordance with BS EN ISO 17180:2013(53)
		For quantification of lysine in premixtures, feed materials and compound feed: Ion-exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS) in accordance with Commission Regulation (EC) No 152/2009 laying down the methods of sampling and analysis for the official control of feed (Annex 3, F)
		For quantification of lysine in water: Ion exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS/FLD) in accordance with BS EN ISO 17180:2013, or Ion exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS) in accordance with Commission Regulation (EC) No 152/2009 laying down the methods of sampling and analysis for the official control of feed (Annex 3-F)
Species or category of animal		All animal species
Maximum age		No maximum
Content of L-lysine (mg/kg of complete feed with a moisture content of 12%)	Minimum content	No minimum
	Maximum content	No maximum
Other provisions		1. The L-lysine content must be stated on the labelling of the additive
		2. The additive may be used via water for drinking
		3. The following must be stated on the labelling of the additive and premixture: “The supplementation with L-lysine, in particular via water for drinking, should take into account all essential and conditionally essential amino acids in order to avoid imbalances.”

Commencement Information

I12 Sch. 12 para. 1 in force at 20.12.2024, see reg. 1(1)

Regulation 3(1)

SCHEDULE 13 S Authorisation of the substance L-lysine monohydrochloride (technically pure) (produced from Corynebacterium glutamicum (KCCM 80183)) (identification number 3c322ii) as a feed additive for all animal species

Authorisation S

1.  The substance specified in the table, belonging to the additive category “nutritional additives” and to the functional group “amino acids, their salts and analogues”, is authorised as an additive in animal nutrition, subject to the conditions set out in the table.

Additive		L-lysine monohydrochloride (technically pure)
Identification number		3c322ii
Authorisation holder(54)		None
Additive category		Nutritional additives
Functional group		Amino acids, their salts and analogues
Additive composition		Powder of L-lysine monohydrochloride with a minimum of 78% L-lysine and a maximum moisture content of 1.5%
Characterisation of the active substance(s)		L-lysine monohydrochloride (technically pure) (NH2(CH2)4CH(NH2)COOH) produced by fermentation with Corynebacterium glutamicum (KCCM 80183): CAS number: 657-27-2(55)
Analytical methods(56)		For identification of L-lysine monohydrochloride in the feed additive: Food Chemicals Codex “L-lysine monohydrochloride monograph”(57)
		For quantification of lysine in the feed additive and premixtures containing more than 10% lysine: Ion-exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS/FLD) in accordance with BS EN ISO 17180:2013(58)
		For quantification of lysine in premixtures, feed materials and compound feed: Ion-exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS) in accordance with Commission Regulation (EC) No 152/2009 laying down the methods of sampling and analysis for the official control of feed (Annex 3, F)
		For quantification of lysine in water: Ion exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS/FLD) in accordance with BS EN ISO 17180:2013, or Ion exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS) in accordance with Commission Regulation (EC) No 152/2009 laying down the methods of sampling and analysis for the official control of feed (Annex 3, F)
Species or category of animal		All animal species
Maximum age		No maximum
Content of L-lysine monohydrochloride (mg/kg of complete feed with a moisture content of 12%)	Minimum content	No minimum
	Maximum content	No maximum
Other provisions		1. The L-lysine content must be stated on the labelling of the additive
		2. The additive may be used via water for drinking
		3. The following must be stated on the labelling of the additive and premixture: “The supplementation with L-lysine, in particular via water for drinking, should take into account all essential and conditionally essential amino acids in order to avoid imbalances.”

Commencement Information

I13 Sch. 13 para. 1 in force at 20.12.2024, see reg. 1(1)

Regulation 3(1)

SCHEDULE 14 S Authorisation of the substance disodium 5’-guanylate (GMP) (produced from Corynebacterium stationis (KCCM 10530) and Escherichia coli K-12 (KFCC 11067)) (identification number 2b627i) as a feed additive for all animal species

Authorisation S

1.  The substance specified in the table, belonging to the additive category “sensory additives” and to the functional group “flavouring compounds”, is authorised as an additive in animal nutrition, subject to the conditions set out in the table.

Additive		Disodium 5’-guanylate
Identification number		2b627i
Authorisation holder(59)		None
Additive category		Sensory additives
Functional group		Flavouring compounds
Additive composition		Powder of disodium 5’-guanylate with a minimum purity criteria of 97%
Characterisation of the active substance(s)		Hydrated form of disodium 5’-guanylate (GMP) produced by fermentation with Corynebacterium stationis (KCCM 10530) and Escherichia  coli K-12 (KFCC 11067) (C10H12N5Na2O8P): CAS number: 5550-12-9(60) EINECS number: 226-914-1(61)
Analytical methods(62)		For identification of disodium 5’-guanylate (GMP) in the feed additive: FAO JECFA monograph “disodium 5’-guanylate”(63)
		For determination of disodium 5’-guanylate (GMP) in the feed additive, flavouring premixtures and water: High performance liquid chromatography coupled to UV detection (HPLC-UV)
Species or category of animal		All animal species
Maximum age		No maximum
Content of disodium 5’-guanylate (mg/kg of complete feed with a moisture content of 12%)	Minimum content	No minimum
	Maximum content	No maximum
Other provisions		1. The storage conditions and stability to heat treatment must be stated in the directions for use of the feed additive and premixture
		2. The additive must be incorporated into the feed in the form of a premixture
		3. The following must be stated on the labelling of the additive: “Recommended maximum content of the active substance when used alone or in combination with other ribonucleotides up to the same level per kg (mg/kg of complete feed with a moisture content of 12%): 50 mg.”
		4. The functional group, identification number, name and added amount of the active substance must be indicated on the label of the premixture where the use level on the label of the premixture would result in the level of active substance (alone or in combination with other ribonucleotides) in complete feed exceeding 50 mg/kg

Commencement Information

I14 Sch. 14 para. 1 in force at 20.12.2024, see reg. 1(1)

Regulation 3(1)

SCHEDULE 15 S Authorisation of a preparation of muramidase (produced by fermentation with Trichoderma reesei (DSM 32338)) (identification number 4d16) as a feed additive for weaned piglets

Authorisation S

1.  The preparation specified in the table, belonging to the additive category “zootechnical additives” and to the functional group “other zootechnical additives”, is authorised as an additive in animal nutrition, subject to the conditions set out in the table.

Additive		Muramidase (EC 3.2.1.17)
Identification number		4d16
Authorisation holder		DSM Nutritional Products Ltd
Additive category		Zootechnical additives
Functional group		Other zootechnical additives
Additive composition		Solid and liquid preparations of muramidase (EC 3.2.1.17) produced by fermentation with Trichoderma reesei  (DSM 32338) having a minimum enzyme activity of 60,000 LSU(F)/g(64)
Characterisation of the active substance(s)		Muramidase (EC 3.2.1.17) produced by fermentation with Trichoderma reesei (DSM 32338): CAS number: 9001-63-2(65) EINECS number: 232-620-4(66) EC (IUBMB) number: 3.2.1.17(67)
Analytical methods(68)		For quantification of muramidase in the feed additive, premixtures and compound feed: Fluorescence-based enzyme assay method that determines the enzyme-catalysed depolymerisation of a fluorescein-labelled peptidoglycan preparation at pH 6.0 and 30 °C.
Species or category of animal		Weaned piglets
Maximum age		No maximum
Content of muramidase (LSU(F)/kg of complete feed with a moisture content of 12%)	Minimum content	50,000 LSU(F)/kg
	Maximum content	65,000 LSU(F)/kg
Other provisions		The storage conditions and stability to heat treatment must be stated in the directions for use of the feed additive and premixture

Commencement Information

I15 Sch. 15 para. 1 in force at 20.12.2024, see reg. 1(1)

Regulation 3(1)

SCHEDULE 16 S Authorisation of the substance vitamin K₁ or Phytomenadione (identification number 3a712) as a feed additive for horses

Authorisation S

1.  The substance specified in the table, belonging to the additive category “nutritional additives” and to the functional group “vitamins, pro-vitamins and chemically well-defined substances having a similar effect”, is authorised as an additive in animal nutrition, subject to the conditions set out in the table.

Additive		Vitamin K1 or Phytomenadione
Identification number		3a712
Authorisation holder(69)		None
Additive category		Nutritional additives
Functional group		Vitamins, pro-vitamins and chemically well-defined substances having similar effect
Additive composition		Produced by chemical synthesis: Solid preparation containing a minimum of 4.2% of phytomenadione (vitamin K1)
Characterisation of the active substance(s)		2-methyl-3-[(E-7R,11R)-3,7,11,15-tetramethylhexadec-2- enyl] naphthalene-1,4-dione (phytomenadione) (C31H46O2): CAS number: 84-80-0(70) EINECS number: 201-564-2(71) with the following components: E-phytomenadione: 75% minimum E-epoxyphytomenadione: 4% maximum Total purity of E-phytomenadione, E-epoxyphytomenadione and Z-phytomenadione isomers: 97% minimum
Analytical methods(72)		For determination of phytomenadione (vitamin K1) in the feed additive: High performance liquid chromatography (HPLC) in accordance with the European Pharmacopoeia monograph(73)
		For determination of phytomenadione in the additive preparation and in complimentary feed: High performance liquid chromatography with fluorescence detection (HPLC-FLD) in accordance with BS EN 14148:2003(74)
Species or category of animal		Horses
Maximum age		No maximum
Content of phytomenadione (vitamin K1) (mg/kg of complete feed with a moisture content of 12%)	Minimum content	No minimum
	Maximum content	No maximum
Other provisions		The storage conditions and stability to heat treatment must be stated in the directions for use of the feed additive and premixture

Commencement Information

I16 Sch. 16 para. 1 in force at 20.12.2024, see reg. 1(1)

Regulation 3(1)

SCHEDULE 17 S Renewal of authorisation (with modification) of a preparation of copper chelate of hydroxy analogue of methionine (identification number 3b410i (formerly 3b4.10)) as a feed additive for all animal species

Authorisation S

1.  The preparation specified in the table, 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(75).

Additive		Copper chelate of hydroxy analogue of methionine
Identification number		3b410i
Authorisation holder(76)		None
Additive category		Nutritional additives
Functional group		Compounds of trace elements
Additive composition		Copper chelate of hydroxy analogue of methionine in solid form containing a minimum of 16% copper and the following components: (2-hydroxy-4-methylthio) butanoic acid: 78% minimum Nickel: 20 ppm maximum
Characterisation of the active substance(s)		Copper chelate of hydroxy analogue of methionine (Cu(CH3S(CH2)2-CH(OH)-COO)2): CAS number: 292140-30-8(77)
Analytical methods(78)		For quantification of the hydroxy analogue of methionine content in the feed additive: Titrimetry, potentiometric titration after oxidation reduction reaction
		For quantification of total copper in the feed additive: Inductively coupled plasma atomic emission spectrometry (ICP-AES) in accordance with BS EN 15510:2017(79) or BS EN 15621:2017(80)); or
		Atomic absorption spectrometry (AAS) in accordance with BS EN ISO 6869:2001(81)
		For quantification of total copper in premixtures: Inductively coupled plasma atomic emission spectrometry (ICP-AES) in accordance with BS EN 15510:2017 or BS EN 15621:2017; Atomic absorption spectrometry (AAS) in accordance with BS EN ISO 6869:2001; or Inductively coupled plasma mass spectrometry (ICP-MS) in accordance with BS EN 17053:2018(82)
		For quantification of total copper in feed materials and compound feed: Inductively coupled plasma atomic emission spectrometry (ICP-AES) in accordance with BS EN 15510:2017 or BS EN 15621:2017; Atomic absorption spectrometry (AAS) in accordance with Commission Regulation (EC) No 152/2009 (Annex 4-C) or BS EN ISO 6869:2001; or Inductively coupled plasma mass spectrometry (ICP-MS) in accordance with BS EN 17053:2018
Species or category of animal		All animal species
Maximum age		No maximum
Content of copper (Cu) (mg/kg of complete feed with a moisture content of 12%)	Minimum content	No minimum
	Maximum content	For bovines: before the start of rumination - 15 mg/kg (total) other - 30 mg/kg (total)
		For ovines: 15 mg/kg (total)
		For caprines: 35 mg /kg
		For piglets: suckling and weaned up 4 weeks after weaning – 150 mg/kg (total) from 5th week up to 8 weeks after weaning – 100 mg/kg (total)
		For crustaceans: 50 mg/kg (total)
		For all other animal species: 25 mg/kg (total)
Other provisions		1. The additive must be incorporated into feed in the form of a premixture
		2. For feed for sheep, where the level of copper in the feed exceeds 10 mg/kg, the following must be stated on the labelling of the feed: “The level of copper in this feed may cause poisoning in certain breeds of sheep.”
		3. For feed for bovines after the start of rumination, where the level of copper in the feed is less than 20 mg/kg, the following must be stated on the labelling of the feed: “The level of copper in this feed may cause copper deficiencies in cattle grazing pastures with high contents of molybdenum or sulphur.”

Commencement Information

I17 Sch. 17 para. 1 in force at 20.12.2024, see reg. 1(1)

Regulation 3(1)

SCHEDULE 18 S Renewal of authorisation (with modification) of a preparation of manganese chelate of hydroxy analogue of methionine (identification number 3b510 (formerly 3b5.10)) as a feed additive for all animal species

Authorisation S

1.  The preparation specified in the table, 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(83).

Additive		Manganese chelate of hydroxy analogue of methionine
Identification number		3b510
Authorisation holder(84)		None
Additive category		Nutritional
Functional group		Compounds of trace elements
Additive composition		Manganese chelate of hydroxy analogue of methionine in solid form containing a minimum of 14% manganese and the following components: (2-hydroxy-4-methylthio) butanoic acid: 76% minimum Nickel: 170 ppm maximum
Characterisation of the active substance(s)		Manganese chelate of hydroxy analogue of methionine (Mn(CH3S(CH2)2-CH(OH)-COO)2): CAS number: 292140-29-5(85)
Analytical methods(86)		For quantification of the hydroxy analogue of methionine content in the feed additive: Titrimetry, potentiometric titration after oxidation reduction reaction
		For quantification of total manganese in the feed additive and premixtures: Atomic absorption spectrometry, (AAS) in accordance with BS EN ISO 6869:2001, Inductively coupled plasma atomic emission spectrometry (ICP-AES) in accordance with BS EN 15510:2017(87), or Inductively coupled plasma atomic absorption spectrometry (AAS) after pressure digestion, (ICP-AES) in accordance with BS EN 15621:2017
		For quantification of total manganese in feed materials and compound feed: Atomic absorption spectrometry (AAS) in accordance with Commission Regulation (EC) No 152/2009 (Annex 4-C), Atomic absorption spectrometry (ASS) in accordance with BS EN ISO 6869:2001, Inductively coupled plasma – atomic emission spectrometry, (ICP-AES) in accordance with BS EN 15510:2017, or Inductively coupled plasma – atomic emission spectrometry after pressure digestion, (ICP-AES) in accordance with BS EN 15621:2017
Species or category of animal		All animal species
Maximum age		No maximum
Content of manganese (Mn) (mg/kg of complete feed with a moisture content of 12%)	Minimum content	No minimum
	Maximum content	For fish: 100 mg/kg (total)
		For all other animal species: 150 mg/kg (total)
Other provisions		1. The additive must be incorporated into feed in the form of a premixture
		2. Manganese chelate of hydroxy analogue of methionine may be placed on the market and used as an additive consisting of a preparation

Commencement Information

I18 Sch. 18 para. 1 in force at 20.12.2024, see reg. 1(1)

Regulation 3(1)

SCHEDULE 19 S Renewal of authorisation (with modification) of a preparation of zinc chelate of hydroxy analogue of methionine (identification number 3b610 (formerly 3b6.10)) as a feed additive for all animal species

Authorisation S

1.  The preparation specified in the table, 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(88).

Additive		Zinc chelate of hydroxy analogue of methionine
Identification number		3b610
Authorisation holder(89)		None
Additive category		Nutritional
Functional group		Compounds of trace elements
Additive composition		Zinc chelate of hydroxy analogue of methionine in solid form containing a minimum of 17% zinc and the following components: (2-hydroxy-4-methylthio) butanoic acid: 79% minimum Nickel: 1.7 ppm maximum
Characterisation of the active substance(s)		Zinc chelate of hydroxy analogue of methionine (Zn(CH3S(CH2)2-CH(OH)-COO)2): CAS number: 292140-29-5(90)
Analytical methods(91)		For quantification of the hydroxy analogue of methionine content in the feed additive: Titrimetry, potentiometric titration after oxidation reduction reaction
		For quantification of total zinc in the feed additive: Inductively coupled plasma atomic emission spectrometry (ICP-AES) in accordance with BS EN 15510:2017(92) or BS EN 15621:2017(93), or
		Atomic absorption spectrometry (AAS) in accordance with BS EN ISO 6869:2001(94)
		For quantification of total zinc in premixtures: Inductively coupled plasma atomic emission spectrometry (ICP-AES) in accordance with BS EN 15510:2017 or BS EN 15621:2017, Atomic absorption spectrometry (AAS) in accordance with BS EN ISO 6869:2001, or Inductively coupled plasma mass spectrometry (ICP-MS) in accordance with BS EN 17053:2018(95)
		For quantification of total zinc in feed materials and compound feed: Inductively coupled plasma atomic emission spectrometry (ICP-AES) in accordance with BS EN 15510:2017 or BS EN 15621:2017, Atomic absorption spectrometry (AAS) in accordance with Commission Regulation (EC) No 152/2009 (Annex 4-C) or BS EN ISO 6869:2001, or Inductively coupled plasma mass spectrometry (ICP-MS) in accordance with BS EN 17053:2018
Species or category of animal		All animal species
Maximum age		No maximum
Content of zinc (Zn) (mg/kg of complete feed with a moisture content of 12%)	Minimum content	No minimum
	Maximum content	For cats: 200 mg/kg (total)
		For dogs: 200mg/kg (total)
		For fish: Salmonids – 180 mg/kg (total) Other – 150 mg/kg (total)
		For milk replacers for calves: 180 mg/kg (total)
		For rabbits: 150 mg/kg (total)
		For Suidae: Piglets, sows – 150 mg/kg (total) Other – 120 mg/kg (total)
		For all other animal species: 120 mg/kg (total)
Other provisions		1. The additive must be incorporated into feed in the form of a premixture
		2. Zinc chelate of hydroxy analogue of methionine may be placed on the market and used as an additive consisting of a preparation

Commencement Information

I19 Sch. 19 para. 1 in force at 20.12.2024, see reg. 1(1)

Regulation 3(1)

SCHEDULE 20 S Authorisation of a preparation of fumonisin esterase (EC 3.1.1.87) produced by fermentation with Komagataella phaffi (DSM 32159) (identification number 1m03i) as a feed additive for all animal species, for use only in maize-based silages

Authorisation S

1.  The preparation specified in the table, belonging to the additive category “technological additives” and to the functional group “substances for reduction of the contamination of feed by mycotoxins”, is authorised as an additive in animal nutrition, subject to the conditions set out in the table.

Additive		Fumonisin esterase (EC 3.1.1.87)
Identification number		1m03i
Authorisation holder(96)		None
Additive category		Technological additives
Functional group		Substances for reduction of the contamination of feed by mycotoxins
Additive composition		Preparation of fumonisin esterase (EC 3.1.1.87) produced by fermentation with Komagataella phaffii (DSM 32159) having a minimum enzyme activity of 3000 U/g(97)
Characterisation of the active substance(s)		Fumonisin esterase (EC 3.1.1.87) produced by Komagataella phaffii (DSM 32159): EC (IUBMB) Number: 3.1.1.87(98)
Analytical methods(99)		For determination of fumonisin esterase activity: High performance liquid chromatography coupled with a tandem mass spectrometry (HPLC-MS/MS) method based on the quantification of the tricarballylic acid released from the action of the enzyme on fumonisin B1 at pH 8.0 and 30 ºC
Species or category of animal		All animal species
Maximum age		No maximum
Units of activity/kg of fresh material	Minimum content	40 U/kg
	Maximum content	No maximum
Other provisions		1. The storage conditions and stability to heat treatment must be stated in the directions for use of the feed additive and premixture
		2. The additive is authorised for use only in maize-based silages

Commencement Information

I20 Sch. 20 para. 1 in force at 20.12.2024, see reg. 1(1)

Regulation 22

SCHEDULE 21 S Revocations

1.  Commission Regulation (EC) No 109/2007 concerning the authorisation of monensin sodium (Coxidin) as a feed additive(100). S

Commencement Information

I21 Sch. 21 para. 1 in force at 20.12.2024, see reg. 1(1)

2.  Commission Regulation (EU) No 333/2010 concerning the authorisation of a new use of Bacillus subtilis C-3102 (DSM 15544) as a feed additive for weaned piglets (holder of authorisation Asahi Calpis Wellness Co. Ltd, represented in the European Union by Pen & Tec Consulting S.L.U.)(101). S

Commencement Information

I22 Sch. 21 para. 2 in force at 20.12.2024, see reg. 1(1)

3.  Commission Regulation (EU) No 335/2010 concerning the authorisation of zinc chelate of hydroxy analogue of methionine as a feed additive for all animal species(102). S

Commencement Information

I23 Sch. 21 para. 3 in force at 20.12.2024, see reg. 1(1)

4.  Commission Regulation (EU) No 349/2010 concerning the authorisation of copper chelate of hydroxy analogue of methionine as a feed additive for all animal species(103). S

Commencement Information

I24 Sch. 21 para. 4 in force at 20.12.2024, see reg. 1(1)

5.  Commission Regulation (EU) No 350/2010 concerning the authorisation of manganese chelate of hydroxy analogue of methionine as a feed additive for all animal species(104). S

Commencement Information

I25 Sch. 21 para. 5 in force at 20.12.2024, see reg. 1(1)

6.  Commission Regulation (EU) No 170/2011 concerning the authorisation of Saccharomyces cerevisiae MUCL 39885 as a feed additive for piglets (weaned) and amending Regulation (EC) No 1200/2005 (holder of authorisation Prosol SpA)(105). S

Commencement Information

I26 Sch. 21 para. 6 in force at 20.12.2024, see reg. 1(1)

7.  Commission Regulation (EU) No 184/2011 concerning the authorisation of Bacillus subtilis C-3102 (DSM 15544) as a feed additive for chickens reared for laying, turkeys, minor avian species and other ornamental and game birds (holder of authorisation Asahi Calpis Wellness Co. Ltd, represented in the European Union by Pen & Tec Consulting S.L.U.)(106). S

Commencement Information

I27 Sch. 21 para. 7 in force at 20.12.2024, see reg. 1(1)

8.  Commission Implementing Regulation (EU) No98/2012 concerning the authorisation of 6-phytase (EC 3.1.3.26) produced by Pichia pastoris (DSM 23036) as a feed additive for chickens and turkeys for fattening, chickens reared for laying, turkeys reared for breeding, laying hens, other avian species for fattening and laying, weaned piglets, pigs for fattening and sows (holder of authorisation Huvepharma AD)(107). S

Commencement Information

I28 Sch. 21 para. 8 in force at 20.12.2024, see reg. 1(1)

9.  Commission Implementing Regulation (EU) No140/2012 concerning the authorisation of monensin sodium as a feed additive for chickens reared for laying (holder of authorisation Huvepharma NV Belgium)(108). S

Commencement Information

I29 Sch. 21 para. 9 in force at 20.12.2024, see reg. 1(1)

10.  Commission Implementing Regulation (EU) 2019/893 concerning the renewal of the authorisation of Bacillus subtilis DSM 15544 as a feed additive for chickens for fattening and repealing Regulation (EC) No 1444/2006 (holder of authorisation Asahi Calpis Wellness Co. Ltd, represented in the European Union by Pen & Tec Consulting S.L.U.)(109). S

Commencement Information

I30 Sch. 21 para. 10 in force at 20.12.2024, see reg. 1(1)

11.  Commission Implementing Regulation (EU) 2020/146 amending Regulation (EU) No333/2010, Implementing Regulation (EU) 2017/2312, Implementing Regulation (EU) 2018/1081, Implementing Regulation (EU) 2016/897, Implementing Regulation (EU) 2019/893 and Regulation (EU) No184/2011 concerning the authorisations of the preparation of Bacillus subtilis C-3102 (DSM 15544) as a feed additive(110). S

Commencement Information

I31 Sch. 21 para. 11 in force at 20.12.2024, see reg. 1(1)

(1)

Details of the analytical methods are set out in the document referenced “JRC F.5/CvH/ZE/AS/Ares” and last updated on 18 October 2019 are available at: https://joint-research-centre.ec.europa.eu/publications/fad-2018-0021_en.

(2)

BS EN 17053: 2018 “Animal feeding stuffs: Methods of sampling and analysis. Determination of trace elements, heavy metals and other elements in feed by ICP-MS”. Published by the British Standards Institution on 28 February 2018 (ISBN 978 0 580 94471 0). Available from the British Standards Institution https://knowledge.bsigroup.com.

(3)

BS EN ISO 13903: 2005 “Animal feeding stuffs – Determination of amino acids content”. Published by the British Standards Institution on 24 October 2005 (ISBN 0 580 46218 8). Available from the British Standards Institution https://knowledge.bsigroup.com.

(4)

This authorisation is a renewal (with modifications) of the authorisation granted under Commission Regulation (EU) No 170/2011 (EUR 2011/170). That Regulation is revoked by regulation 22 and schedule 21 of these Regulations. The explanatory note to these Regulations sets out the modifications made to that authorisation.

(5)

Details of the analytical methods are set out in the document referenced “D06/FSQ/CVH/CMP/mdr/ARES (2010)58412”, and last updated on 6 June 2016. Available at: https://joint-research-centre.ec.europa.eu/publications/fad-2009-0028_en.

(6)

BS EN 15789:2021 “Animal feeding stuffs: Methods of sampling and analysis. Detection and enumeration of Saccharomyces cerevisiae used as feed additive”. Published by the British Standards Institution on 30 November 2021 (ISBN 978 0 580 99832 4). Available at: https://knowledge.bsigroup.com.

(7)

DD CEN/TS 15790:2008 “Animal feeding stuffs. PCR typing of probiotic strains of Saccharomyces cerevisiae (yeast)”. Published by the British Standards Institution on 31 January 2009 (ISBN 978 0 580 61806 2). Available at: https://knowledge.bsigroup.com.

(8)

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.

(9)

Details of the analytical methods are set out in the document referenced “Ares(2014)1202206 - 16/04/2014” and “JRC.D.5/SFB/CvH/JO/mds/Ares”, and last updated on 6 June 2016. Available at: https://joint-research-centre.ec.europa.eu/publications/fad-2013-0031_en.

(10)

BS EN 15786:2021 “Animal feeding stuffs: Methods of sampling and analysis. Detection and enumeration of Pediococcus spp. used as feed additive”. Published by the British Standards Institution on 30 November 2021 (ISBN 978 0 580 99830). Available at: https://knowledge.bsigroup.com.

(11)

This authorisation contains a renewal (with modification) of the authorisation granted under Commission Regulation (EC) No 109/2007 (EUR 2007/109). Those Regulations are revoked by regulation 22 and schedule 21 of these Regulations. The explanatory note to these Regulations sets out the modifications and new use made to that authorisation.

(12)

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

(13)

Details of the analytical methods are set out in the document referenced “Ares(2017)1087313 - 01/03/2017” and “JRC F.5/CvH/MGH /mds/Ares”, and last updated on 27 April 2017. Available at: https://joint-research-centre.ec.europa.eu/publications/fad-2016-0009_en.

(14)

BS EN ISO 14183:2008 “animal feeding stuffs. Determination of monensin, narasin and salinomycin contents. Liquid chromatographic method using post-column derivatization”. Published by the British Standards Institution on 24 January 2006 (ISBN 978 0 580 62955 6). Available at: https://knowledge.bsigroup.com.

(15)

This authorisation contains a renewal (with modification) of the authorisation granted under Commission Regulation (EC) No 109/2007 (EUR 2007/109). That Regulation is revoked by regulation 22 and schedule 21 of these Regulations. The explanatory note to these Regulations sets out the modifications and new use made to that authorisation.

(16)

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

(17)

Details of the analytical methods are set out in the document referenced “Ares(2017)1087313 - 01/03/2017” and “JRC F.5/CvH/MGH /mds/Ares”, and last updated on 27 April 2017. Available at: https://joint-research-centre.ec.europa.eu/publications/fad-2016-0009_en.

(18)

BS EN ISO 14183:2008 “Animal feeding stuffs. Determination of monensin, narasin and salinomycin contents. Liquid chromatographic method using post-column derivatization”. Published by the British Standards Institution on 24 January 2006 (ISBN 978 0 580 62955 6). Available at: https://knowledge.bsigroup.com.

(19)

This authorisation contains a renewal (with modification) of the authorisation granted under Commission Implementing Regulation (EC) No 98/2012 (EUR 2012/98). That Regulation is revoked by regulation 22 and schedule 21 of these Regulations. The explanatory note to these Regulations sets out the modifications and new use made to that authorisation.

(20)

OptiPhos technical units (phytase activity) : 1 OTU is the amount of enzyme that catalyses the release of 1 µmol of inorganic phosphate per minute from 5.1 mM sodium phytate in pH 5.5 citrate buffer at 37ºC, measured as the blue P-molybdate complex colour at 820 nm.

(21)

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

(22)

Identification number allocated by the International Union of Biochemistry and Molecular Biology (IUBMB) https://iubmb.org.

(23)

Details of the analytical methods are set out in the document referenced “Ares(2016)5971303 - 17/10/2016” and “JRC F.5/CvH/MGH /mds/Ares”, and last updated on 17 November 2016. Available at: https://joint-research-centre.ec.europa.eu/publications/fad-2016-0019_en.

(24)

This authorisation contains a renewal (with modification) of the authorisation granted under Commission Regulation (EU) No 333/2010 (EUR 2010/333). That Regulation is revoked by regulation 22 and schedule 21 of these Regulations. The explanatory note to these Regulations sets out the modifications and new use made to that authorisation.

(25)

Details of the analytical methods are set out in the document referenced “D08/FSQ/CVH/CMP/mds/ARES (2009)347415” and last updated on 6 June 2016. Available at: https://joint-research-centre.ec.europa.eu/publications/fad-2009-0013_en.

(26)

Under reference BS EN 15784:2021 “Animal feeding stuffs: Methods of sampling and analysis. Detection and enumeration of Bacillus spp. used as feed additive”. Published by the British Standards Institution on 30 November 2021 (ISBN 978 0 580 99829 4). Available at: https://knowledge.bsigroup.com.

(27)

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.

(28)

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

(29)

European Inventory of Existing Commercial Substances, as published in OJ No C146A, 15.6.90, p.1.

(30)

Details of the analytical methods are set out in the document referenced “Ares(2020)3718494 – 14/07/2020” and “JRC F.5/CvH/ZE/AS/Ares”, and last updated on 16 October 2020. Available at: https://joint-research-centre.ec.europa.eu/publications/fad-2020-0016_en.

(31)

BS EN ISO 13903:2005 “Animal feeding stuffs. Determination of amino acids content”. Published by the British Standards Institution on 24 October 2005 (ISBN 0 580 46218 8).Available at: https://knowledge.bsigroup.com.

(32)

EUR 2009/152, to which there amendments not relevant to these Regulations.

(33)

Exposure calculated based on the endotoxin level and the dusting potential of the additive according to the method used by EFSA (EFSA Journal 2015;13(2):4015); analytical method: European Pharmacopoeia 2.6.14. (bacterial endotoxins).

(34)

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.

(35)

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

(36)

European Inventory of Existing Commercial Substances, as published in OJ No C146A, 15.6.90, p.1.

(37)

Details of the analytical methods are set out in the document referenced “Ares(2020)7146784 – 27/11/2020” and “JRC F.5/CvH/ZE/AS/Ares”, and last updated on 19 December 2020. Available at: https://joint-research-centre.ec.europa.eu/publications/fad-2020-0038_en.

(38)

Food Chemicals Codex (FCC), 13th edition (Method: FCC L-tryptophan monograph published). Published by the United States Pharmacopeial Convention on 1 March 2022 (ISSN 2153-1455). Available at: https://www.foodchemicalscodex.org.

(39)

BS EN ISO 13904:2016 “Animal feeding stuffs. Determination of tryptophan content”. Published by the British Standards Institution on 31 March 2016 (ISBN 978 0 580 84452 2). Available at: https://knowledge.bsigroup.com.

(40)

Exposure calculated based on the endotoxin level and the dusting potential of the additive according to the method used by EFSA (EFSA Journal 2015;13(2):4015); analytical method: European Pharmacopoeia 2.6.14. (bacterial endotoxins).

(41)

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.

(42)

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

(43)

Details of the analytical methods are set out in the document referenced “Ares(2021)2533252 – 14/04/2021” and “JRC F.5/CvH/ZE/AS/Ares”, and last updated on 2 July 2021. Available at: https://joint-research-centre.ec.europa.eu/publications/fad-2020-00820085_en.

(44)

BS EN ISO 17180:2013 “Animal feeding stuffs. Determination of lysine, methionine and threonine in commercial amino acid products and premixtures”. Published by the British Standards Institution on 30 April 2013 (ISBN 978 0 580 76077 8). Available at: https://knowledge.bsigroup.com.

(45)

European Pharmacopoeia Monograph – Ph. Eur. 6.0, 01/2008: 20301: “Identification reactions of ions and functional groups – sulphates”. Published online by the European Directorate for the Quality of Medicines and Healthcare. Available at https://pheur.edqm.eu/home.

(46)

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.

(47)

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

(48)

Details of the analytical methods are set out in the document referenced “JRC.D.5/CvH/SB/ag/ARES(2012)40826”, and last updated on 6 June 2016. Available at: https://joint-research-centre.ec.europa.eu/publications/fad-2010-0132_en.

(49)

Food Chemicals Codex (FCC), 7th edition (Method: BHA-FCC V1 monograph _ published). Published by the United States Pharmacopeial Convention on 1st March 2010. Available at: https://www.foodchemicalscodex.org

(50)

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.

(51)

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

(52)

Details of the analytical methods are set out in the document referenced “Ares(2019)7003671 - 12/11/2019” and “JRC F.5/CvH/SB/AS/Ares”, and last updated on 27 January 2020. Available at: https://joint-research-centre.ec.europa.eu/publications/fad-2019-00160028_en.

(53)

BS EN ISO 17180:2013 “Animal feeding stuffs. Determination of lysine, methionine and threonine in commercial amino acid products and premixtures”. Published by the British Standards Institution on 30 April 2013 (ISBN 978 0 580 76077 8). Available at: https://knowledge.bsigroup.com.

(54)

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.

(55)

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

(56)

Details of the analytical methods are set out in the document referenced “Ares(2019)7003671 - 12/11/2019” and “JRC F.5/CvH/SB/AS/Ares”, and last updated on 27 January 2020. Available at: https://joint-research-centre.ec.europa.eu/publications/fad-2019-00160028_en.

(57)

Food Chemicals Codex (FCC), 13th edition (Method: FCC L-lysine monohydrochloride monograph published). Published by the United States Pharmacopeial Convention on 1 March 2022 (ISSN 2153-1455). Available at: https://www.foodchemicalscodex.org/.

(58)

BS EN ISO 17180:2013 “Animal feeding stuffs. Determination of lysine, methionine and threonine in commercial amino acid products and premixtures”. Published by the British Standards Institution on 30 April 2013 (ISBN 978 0 580 76077 8). Available at: https://knowledge.bsigroup.com.

(59)

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.

(60)

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

(61)

European Inventory of Existing Commercial Substances, as published in OJ No C146A, 15.6.90, p.1.

(62)

Details of the analytical methods are set out in the document referenced “Ares(2020)4619276 – 04/09/2020” and “JRC F.5/CvH/ZE/AS/Ares”, and last updated on 16 October 2020. Available at: https://joint-research-centre.ec.europa.eu/publications/fad-2019-0085_en.

(63)

Food and Agriculture Organisation of the United Nations (FAO) Joint FAO/WHO Expert Committee on Food Additives (JECFA) - Combined Compendium of Food Additive Specifications, “Disodium 5’-guanylate”. Published by the FAO and last updated (Web version) August 2011 (ISBN 92-5-105569-6). Available at: http://www.fao.org.

(64)

1 LSU(F) is defined as the amount of enzyme that increases the fluorescence of 12.5 µg/ml fluorescein-labelled peptidoglycan per minute at pH 6.0 and 30 ºC by a value that corresponds to the fluorescence of approximately 0.06 nmol fluorescein isothiocyanate isomer.

(65)

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

(66)

European Inventory of Existing Commercial Substances, as published in OJ No C146A, 15.6.90, p.1.

(67)

Identification number allocated by the International Union of Biochemistry and Molecular Biology (IUBMB) https://iubmb.org.

(68)

Details of the analytical methods are set out in the document referenced “Ares(2018)811287 - 12/02/2018” and “JRC F.5/CvH/SB/AS/Ares”, and last updated on 2 March 2018. Available at: https://joint-research-centre.ec.europa.eu/publications/fad-2017-0046_en.

(69)

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.

(70)

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

(71)

European Inventory of Existing Commercial Substances, as published in OJ No C146A, 15.6.90, p.1.

(72)

Details of the analytical methods are set out in the document referenced “Ares(2021)145311 – 07/01/2021” and “JRC F.5/CvH/SB/AS/Ares”, and last updated on 17 February 2021. Available at https://joint-research-centre.ec.europa.eu/publications/fad-2020-0006_en.

(73)

European Pharmacopoeia monograph – Ph. Eur. 8.0, 01/2014:1036. Published online by the European Directorate for the Quality of Medicines and Healthcare on 1st January 2024. Available at: https://pheur.edqm.eu/home.

(74)

BS EN 14148:2003 “Foodstuffs. Determination of vitamin K1 by HPLC”. Published by the British Standards Institution on 25 July 2003 (ISBN 0 580 42317 4). Available at: https://knowledge.bsigroup.com.

(75)

This authorisation contains a renewal (with modifications) of the authorisation granted under Commission Regulation (EU) No 349/2010 (EUR 2010/349). That Regulation is revoked by regulation 22 and schedule 21 of these Regulations. The explanatory note to these Regulations sets out the modifications made to that authorisation.

(76)

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.

(77)

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

(78)

Details of the analytical methods are set out in the document referenced “D08-FSQ(2007)D/29104”, and last updated on 6 June 2016. Available at: https://joint-research-centre.ec.europa.eu/publications/fad-2007-0012_en.

(79)

BS EN 15510:2017 “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”. Published by the British Standards Institution on 31 August 2017 (ISBN 978 0 580 94541 0). Available at: https://knowledge.bsigroup.com.

(80)

BS EN 15621:2017 “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”. Published by the British Standards Institution on 31 August 2017 (ISBN 978 0 580 94543 4). Available at: https://knowledge.bsigroup.com.

(81)

BS EN ISO 6869:2001 “Animal feeding stuffs. Determination of the contents of calcium, copper, iron, magnesium, manganese, potassium, sodium and zinc. Method using atomic absorption spectrometry”. Published by the British Standards Institution on 15 March 2001 (ISBN 0 580 36933 1). Available at: https://knowledge.bsigroup.com.

(82)

BS EN 17053:2018 “Animal feeding stuffs: Methods of sampling and analysis. Determination of trace elements, heavy metals and other elements in feed by ICP-MS (multi-method)”. Published by the British Standards Institution on 28 February 2018 (ISBN 978 0 580 94471 0). Available at: https://knowledge.bsigroup.com.

(83)

This authorisation contains a renewal (with modification) of the authorisation granted under Commission Regulation (EU) No 350/2010 (EUR 2010/350). That Regulation is revoked by regulation 22 and schedule 21 of these Regulations. The explanatory note to these Regulations sets out the modifications made to that authorisation.

(84)

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.

(85)

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

(86)

Details of the analytical methods are set out in the document referenced “D08-FSQ(2007)D/29224”, and last updated on 6 June 2016. Available at: https://joint-research-centre.ec.europa.eu/publications/fad-2007-0011_en.

(87)

BS EN 15510:2017 “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”. Published by the British Standards Institution on 31 August 2017 (ISBN 978 0 580 94541 0). Available at: https://knowledge.bsigroup.com.

(88)

This authorisation contains a renewal (with modification) of the authorisation granted under Commission Regulation (EU) No 350/2010 (EUR 2010/350). That Regulation is revoked by regulation 22 and schedule 21 of these Regulations. The explanatory note to these Regulations sets out the modifications made to that authorisation.

(89)

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.

(90)

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

(91)

Details of the analytical methods are set out in the document referenced “D08-FSQ(2007)D/29110”, and last updated on 6 June 2016. Available at: https://joint-research-centre.ec.europa.eu/publications/fad-2007-0010_en.

(92)

BS EN 15510:2017 “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”. Published by the British Standards Institution on 31 August 2017 (ISBN 978 0 580 94541 0). Available at: https://knowledge.bsigroup.com.

(93)

BS EN 15621:2017 “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”. Published by the British Standards Institution on 31 August 2017 (ISBN 978 0 580 94543 4). Available at: https://knowledge.bsigroup.com.

(94)

BS EN ISO 6869:2001 “Animal feeding stuffs. Determination of the contents of calcium, copper, iron, magnesium, manganese, potassium, sodium and zinc. Method using atomic absorption spectrometry”. Published by the British Standards Institution on 15 March 2001 (ISBN 0 580 36933 1). Available at: https://knowledge.bsigroup.com.

(95)

BS EN 17053:2018 “Animal feeding stuffs: Methods of sampling and analysis. Determination of trace elements, heavy metals and other elements in feed by ICP-MS (multi-method)”. Published by the British Standards Institution on 28 February 2018 (ISBN 978 0 580 94471 0). Available at: https://knowledge.bsigroup.com.

(96)

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.

(97)

1 U is the enzymatic activity that releases 1 µmol tricarballylic acid per minute from 100 µM fumonisin B1 in 20 mM Tris-Cl buffer pH 8.0 with 0.1 mg/ml bovine serum albumin at 30 ºC.

(98)

Identification number allocated by the International Union of Biochemistry and Molecular Biology (IUBMB) https://iubmb.org.

(99)

Details of the analytical methods are set out in the document referenced “Ares(2017)2516958 - 17/05/2017” and “JRC F.5/CvH/MGH /mds/Ares”, and last updated on 18 May 2017. Available at: https://joint-research-centre.ec.europa.eu/publications/fad-2017-0005_en.

(100)

EUR 2007/109.

(101)

EUR 2010/333.

(102)

EUR 2010/335.

(103)

EUR 2010/349.

(104)

EUR 2010/350.

(105)

EUR 2011/170.

(106)

EUR 2011/184.

(107)

EUR 2012/98.

(108)

EUR 2012/140.

(109)

EUR 2019/893.

(110)

EUR 2020/146.