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Statutory Instruments of the Scottish Parliament |
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You are here: BAILII >> Databases >> Statutory Instruments of the Scottish Parliament >> The Feed Additives (Authorisations) (Scotland) Regulations 2023 No. 339 URL: http://www.bailii.org/scot/legis/num_reg/2023/ssi_2023339_en_1.html |
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This is the original version (as it was originally made). This item of legislation is currently only available in its original format.
Scottish Statutory Instruments
Agriculture
Made
8th November 2023
Laid before the Scottish Parliament
10th November 2023
Coming into force
22nd December 2023
The Scottish Ministers make the following Regulations in exercise of the powers conferred by Articles 9(1) and 18A(3) of Regulation (EC) No 1831/2003of 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 178/2002of 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).
1.—(1) These Regulations may be cited as the Feed Additives (Authorisations) (Scotland) Regulations 2023 and come into force on 22 December 2023.
(2) These Regulations extend to Scotland only.
2.—(1) In these Regulations—
“ Regulation 1831/2003” means Regulation (EC) No 1831/2003of the European Parliament and of the Council on additives for use in animal nutrition,
“ Regulation 429/2008” means Commission Regulation (EC) No 429/2008on detailed rules for the implementation of Regulation (EC) No 1831/2003of 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( 3),
“ Regulation 152/2009” means Commission Regulation (EC) No 152/2009laying down the methods of sampling and analysis for the official control of feed( 4),
“ Regulation 767/2009” means Regulation (EC) No 767/2009of 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 1831/2003and repealing Council Directive 79/373/EEC, Commission Directive 80/511/EEC, Council Directives 82/471/EEC, 83/228/EEC, 93/74/EEC, 93/113/ECand 96/25/ECand Commission Decision 2004/217/EC( 5).
(2) Unless the contrary intention appears, any expression used both in these Regulations and in Regulation 1831/2003 or Regulation 767/2009 has the same meaning as it has in those Regulations, respectively.
(3) In schedules 1 to 13—
(a) expressions used to refer to species or categories of animals that are also used in Annex 4 (categories and definitions of target animals and indication of the minimum duration of efficacy studies) of Regulation 429/2008 have the same meaning as in that Annex,
(b) any reference to a minor species is to be read in accordance with the definition of “minor species” in Article 1 (definitions) of Regulation 429/2008.
3.—(1) Schedules 1 to 13 have effect.
(2) Subject to Article 14(4) (renewal of authorisation) of Regulation 1831/2003, the authorisations set out in schedules 1 to 13 cease to have effect at the end of 21 December 2033.
4.—(1) The relevant feed additive, and premixtures containing it, which are produced and labelled before the end of 21 June 2024 in compliance with the conditions of the prior authorisation and the labelling requirements applicable before 22 December 2023, may continue to be placed on the market and used until stocks are exhausted.
(2) Compound feed, and feed materials containing the relevant feed additive, and intended for food-producing animals, which are produced and labelled before the end of 21 December 2024 in compliance with the conditions of the prior authorisation and the labelling requirements applicable before 22 December 2023, may continue to be placed on the market and used until stocks are exhausted.
(3) In this regulation—
“ relevant feed additive” means the feed additive endo-1,4-beta-xylanase (EC 3.2.1.8), with the identification number 4a8, authorised under the prior authorisation,
“ prior authorisation” means the authorisation contained in Commission Regulation (EC) No 902/2009concerning the authorisation of an enzyme preparation of endo-1,4-beta-xylanase produced byTrichoderma reesei(CBS 114044) as a feed additive for weaned piglets, chickens for fattening, chickens reared for laying, turkeys for fattening and turkeys reared for breeding (holder of authorisation Roal Oy)( 6).
5.—(1) Commission Implementing Regulation (EU) No601/2013concerning the authorisation of cobalt(II) acetate tetrahydrate, cobalt(II) carbonate, cobalt(II) carbonate hydroxide (2:3) monohydrate, cobalt(II) sulphate heptahydrate and coated granulated cobalt(II) carbonate hydroxide (2:3) monohydrate as feed additives( 7) is amended as follows.
(2) In the Annex, in the table, omit the entries for—
(a) cobalt(II) acetate tetrahydrate (identification number 3b301),
(b) cobalt(II) carbonate (identification number 3b302),
(c) cobalt(II) carbonate hydroxide (2:3) monohydrate (identification number 3b303),
(d) cobalt(II) sulphate heptahydrate (identification number 3b305).
6.—(1) Commission Implementing Regulation (EU) 2019/221amending Regulations (EC) No 785/2007, (EC) No 379/2009, (EC) No 1087/2009, (EU) No 9/2010, (EU) No 337/2011 and Implementing Regulations (EU) No 389/2011, (EU) No 528/2011, (EU) No 840/2012, (EU) No 1021/2012, (EU) 2016/899, (EU) 2016/997, (EU) 2017/440 and (EU) 2017/896 as regards the name of the holder of the authorisation and the representative of the holder of the authorisation for certain feed additives( 8) is amended as follows.
(2) The following Articles are omitted—
(a) Article 4 (Amendment to Commission Regulation (EU) No 9/2010),
(b) Article 7 (Amendment to Commission Implementing Regulation (EU) No528/2011),
(c) Article 9 (Amendment to Commission Implementing Regulation (EU) No1021/2012).
7.—(1) The instrument listed in paragraph 1 of schedule 14 is revoked subject to regulation 4.
(2) The instruments listed in paragraphs 2 to 10 of schedule 14 are revoked.
JENNI MINTO
Authorised to sign by the Scottish Ministers
St Andrew’s House,
Edinburgh
8th November 2023
Regulation 3(1)
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( 9).
| Column 1 | Column 2 | |
|---|---|---|
| Additive | Endo-1,4-beta-xylanase (EC 3.2.1.8) | |
| Identification number | 4a11 | |
| Authorisation holder | Danisco (UK) Ltd | |
| Additive category | Zootechnical additives | |
| Functional group | Digestibility enhancers | |
| Additive composition | Preparation of endo-1,4-beta-xylanase (EC 3.2.1.8) produced by fermentation withTrichoderma reesei(CBS 143953) with a minimum enzyme activity of 40 000 U/g( 10) | |
| Characterisation of the active substance(s) | Endo-1,4-beta-xylanase (EC 3.2.1.8) produced by fermentation withTrichoderma reesei(CBS 143953) | |
| Analytical method( 14) | For quantification of endo-1,4-beta-xylanase enzyme activity in the feed additive, premixtures, feed materials and compound feed: | |
| ||
| Species or category of animal |
| |
| Maximum age | No maximum | |
| Content of endo-1,4-beta-xylanase (EC 3.2.1.8) (units of activity/kg of complete feed with a moisture content of 12%) | Minimum content |
|
| 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 | |
Regulation 3(1)
1. The preparation specified in the table, 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.
| Column 1 | Column 2 | |
|---|---|---|
| Additive | Lacticaseibacillus rhamnosus(IMI 507023) | |
| Identification number | 1k21701 | |
| Authorisation holder( 15) | None | |
| Additive category | Technological additives | |
| Functional group | Silage( 16) additives | |
| Additive composition | Solid preparation ofLacticaseibacillus rhamnosus(IMI 507023) containing a minimum of 1 x 1010CFU/g additive | |
| Characterisation of the active substance(s) | Viable cells ofLacticaseibacillus rhamnosus(IMI 507023) | |
| Analytical methods( 17) | 1. For enumeration (colony count) of the feed additive: | |
| ||
| 2. For identification of bacterial strain: | ||
| ||
| Species or category of animal | All animal species | |
| Maximum age | No maximum | |
| Colony forming units of additive/kg of fresh material | Minimum content | Minimum content of the additive when not combined with other micro-organisms as silage additives: 1 x 109CFU/kg |
| Maximum content | No maximum | |
| Other provisions |
1. The storage conditions must be stated in the directions for use of the feed additive and premixture 2. The additive is authorised for use only in easy to ensile or moderately difficult to ensile fresh material | |
Regulation 3(1)
1. The preparation specified in the table, 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.
| Column 1 | Column 2 | |
|---|---|---|
| Additive | Pediococcus pentosaceus(IMI 507024) | |
| Identification number | 1k21016 | |
| Authorisation holder( 19) | None | |
| Additive category | Technological additives | |
| Functional group | Silage( 20) additives | |
| Additive composition | Solid preparation ofPediococcus pentosaceus(IMI 507024) containing a minimum of 1 x 1010CFU/g additive | |
| Characterisation of the active substance(s) | Viable cells ofPediococcus pentosaceus(IMI 507024) | |
| Analytical methods( 21) | For enumeration (colony count) of the feed additive: | |
| ||
| For identification of bacterial strain: | ||
| ||
| Species or category of animal | All animal species | |
| Maximum age | No maximum | |
| Colony forming units of additive/kg of fresh material | Minimum content | Minimum content of the additive when not combined with other micro-organisms as silage additives: 1 x 109CFU/kg |
| Maximum content | No maximum | |
| Other provisions |
1. The storage conditions must be stated in the directions for use of the feed additive and premixture 2. The additive is authorised for use only in easy to ensile or moderately difficult to ensile fresh material | |
Regulation 3(1)
1. The preparation specified in the table, 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.
| Column 1 | Column 2 | |
|---|---|---|
| Additive | Pediococcus pentosaceus(IMI 507025) | |
| Identification number | 1k21017 | |
| Authorisation holder( 23) | None | |
| Additive category | Technological additives | |
| Functional group | Silage( 24) additives | |
| Additive composition | Solid preparation ofPediococcus pentosaceus(IMI 507025) containing a minimum of 1 x 1010CFU/g additive | |
| Characterisation of the active substance(s) | Viable cells ofPediococcus pentosaceus(IMI 507025) | |
| Analytical methods( 25) | 1. For enumeration (colony count) of the feed additive: | |
| ||
| 2. For identification of bacterial strain: | ||
| ||
| Species or category of animal | All animal species | |
| Maximum age | No maximum | |
| Colony forming units of the additive/kg of fresh material | Minimum content | Minimum content of the additive when not combined with other micro-organisms as silage additives: 1 x 109CFU/kg |
| Maximum content | No maximum | |
| Other provisions |
1. The storage conditions must be stated in the directions for use of the feed additive and premixture 2. The additive is authorised for use only in easy to ensile or moderately difficult to ensile fresh material | |
Regulation 3(1)
1. The preparation specified in the table, 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.
| Column 1 | Column 2 | |
|---|---|---|
| Additive | Lactiplantibacillus plantarum(IMI 507026) | |
| Identification number | 1k21601 | |
| Authorisation holder( 27) | None | |
| Additive category | Technological additives | |
| Functional group | Silage( 28) additives | |
| Additive composition | Solid preparation ofLactiplantibacillus plantarum(IMI 507026) containing a minimum of 1 x 1010CFU/g additive | |
| Characterisation of the active substance(s) | Viable cells ofLactiplantibacillus plantarum(IMI 507026) | |
| Analytical methods( 29) | 1. For enumeration (colony count) of the feed additive: | |
| ||
| 2. For identification of bacterial strain: | ||
| ||
| Species or category of animal | All animal species | |
| Maximum age | No maximum | |
| Colony forming units of the additive/kg of fresh material | Minimum content | Minimum content of the additive when not combined with other micro-organisms as silage additives: 1 x 109CFU/kg |
| Maximum content | No maximum | |
| Other provisions |
1. The storage conditions must be stated in the directions for use of the feed additive and premixture 2. The additive is authorised for use only in easy to ensile or moderately difficult to ensile fresh material | |
Regulation 3(1)
1. The preparation specified in the table, 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.
| Column 1 | Column 2 | |
|---|---|---|
| Additive | Lactiplantibacillus plantarum(IMI 507027) | |
| Identification number | 1k21602 | |
| Authorisation holder( 31) | None | |
| Additive category | Technological additives | |
| Functional group | Silage( 32) additives | |
| Additive composition | Solid preparation ofLactiplantibacillus plantarum(IMI 507027) containing a minimum of 1 x 1010CFU/g additive | |
| Characterisation of the active substance(s) | Viable cells ofLactiplantibacillus plantarum(IMI 507027) | |
| Analytical methods( 33) | 1. For enumeration (colony count) of the feed additive: | |
| ||
| 2. For identification of bacterial strain: | ||
| ||
| Species or category of animal | All animal species | |
| Maximum age | No maximum | |
| Colony forming units of the additive/kg of fresh material | Minimum content | Minimum content of the additive when not combined with other micro-organisms as silage additives: 1 x 109CFU/kg |
| Maximum content | No maximum | |
| Other provisions |
1. The storage conditions must be stated in the directions for use of the feed additive and premixture 2. The additive is authorised for use only in easy to ensile or moderately difficult to ensile fresh material | |
Regulation 3(1)
1. The preparation specified in the table, 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.
| Column 1 | Column 2 | |
|---|---|---|
| Additive | Lactiplantibacillus plantarum(IMI 507028) | |
| Identification number | 1k21603 | |
| Authorisation holder( 35) | None | |
| Additive category | Technological additives | |
| Functional group | Silage( 36) additives | |
| Additive composition | Solid preparation ofLactiplantibacillus plantarum(IMI 507028) containing a minimum of 1 x 1010CFU/g additive | |
| Characterisation of the active substance(s) | Viable cells ofLactiplantibacillus plantarum(IMI 507028) | |
| Analytical methods( 37) | 1. For enumeration (colony count) of the feed additive: | |
| ||
| 2. For identification of bacterial strain: | ||
| ||
| Species or category of animal | All animal species | |
| Maximum age | No maximum | |
| Colony forming units of the additive/kg of fresh material | Minimum content | Minimum content of the additive when not combined with other micro-organisms as silage additives: 1 x 109CFU/kg |
| Maximum content | No maximum | |
| Other provisions |
1. The storage conditions must be stated in the directions for use of the feed additive and premixture 2. The additive is authorised for use only in easy to ensile or moderately difficult to ensile fresh material | |
Regulation 3(1)
1. The preparation specified in the table, 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.
| Column 1 | Column 2 | |
|---|---|---|
| Additive | Lactiplantibacillus plantarum(DSM 26571) | |
| Identification number | 1k1604 | |
| Authorisation holder( 39) | None | |
| Additive category | Technological additives | |
| Functional group | Silage( 40) additives | |
| Additive composition | Solid preparation ofLactiplantibacillus plantarum(DSM 26571) containing a minimum of 1 x 1011CFU/g additive | |
| Characterisation of the active substance(s) | Viable cells ofLactiplantibacillus plantarum(DSM 26571) | |
| Analytical methods( 41) | 1. For enumeration (colony count) of the feed additive: | |
| ||
| 2. For identification of bacterial strain: | ||
| ||
| Species or category of animal | All animal species | |
| Maximum age | No maximum | |
| Colony forming units of the additive/kg of fresh material | Minimum content | Minimum content of the additive when not combined with other micro-organisms as silage additives: 1 x 108CFU/kg |
| Maximum content | No maximum | |
| Other provisions |
1. The storage conditions must be stated in the directions for use of the feed additive and premixture 2. The additive is authorised for use in easy to ensile, moderately difficult to ensile, and difficult to ensile fresh material | |
Regulation 3(1)
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( 43).
| Column 1 | Column 2 | |
|---|---|---|
| Additive | Endo-1,4-beta-xylanase (EC 3.2.1.8) | |
| Identification number | 4a8i | |
| Authorisation holder | Roal Oy | |
| Additive category | Zootechnical additives | |
| Functional group | Digestibility enhancers | |
| Additive composition | Preparation of endo-1,4-beta-xylanase (EC 3.2.1.8) produced by fermentation withTrichoderma reesei(CBS 114044) having a minimum enzyme activity of 160 000 BXU/g for both solid and liquid forms( 44) | |
| Characterisation of the active substance(s) | Endo-1,4-beta-xylanase (EC 3.2.1.8) produced by fermentation withTrichoderma reesei(CBS 114044) | |
| Analytical methods( 48) | 1. For the quantification of endo-1,4-beta-xylanase (EC 3.2.1.8) in the feed additive and premixtures: | |
| ||
| 2. For the quantification of endo-1,4-beta-xylanase (EC 3.2.1.8) in feed materials and compound feed: | ||
| ||
| Species or category of animal |
| |
| Maximum age | No maximum | |
| Content of endo-1,4-beta-xylanase (EC 3.2.1.8) (units of activity (BXU/kg) of complete feed with a moisture content of 12%) | Minimum content |
|
| 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 | |
Regulation 3(1)
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( 49).
| Column 1 | Column 2 | ||
|---|---|---|---|
| Additive | 6-phytase (EC 3.1.3.26) | ||
| Identification number | 4a12 | ||
| Authorisation holder | Roal Oy | ||
| Additive category | Zootechnical additives | ||
| Functional group | Digestibility enhancers | ||
| Additive composition | Preparation of 6-phytase (EC 3.1.3.26) produced by fermentation withTrichoderma reesei(CBS 122001) having a minimum enzyme activity of 40 000 PPU( 50)/g for the solid form and 5000 PPU/g for the liquid form | ||
| Characterisation of the active substance(s) | 6-phytase (EC 3.1.3.26) produced by fermentation withTrich oderma reesei(CBS 122001) | ||
| Analytical methods( 54) | For the quantification of phytase activity in the feed additive, premixtures, feed materials and compound feed: | ||
| |||
| Species or category of animal |
| ||
| Maximum age | No maximum | ||
| Content of 6-phytase (units of activity (PPU/kg) of complete feed with a moisture content of 12%) | Minimum content |
Pigs Poultry for breeding Poultry for fattening |
250 PPU/kg |
| Poultry for laying | 125 PPU/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 | ||
Regulation 3(1)
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.
| Column 1 | Column 2 | |
|---|---|---|
| Additive | L-lysine base (liquid) | |
| Identification number | 3c326 | |
| Authorisation holder( 55) | 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) produced by fermentation withCorynebacterium glutamicum(KCCM 80216 or KCTC 12307BP) | |
| L-lysine (C6H14N2O2) | ||
| Analytical methods( 58) | 1. For the quantification of lysine in the feed additive and premixtures containing more than 10% lysine: | |
| ||
| 2. For the quantification of lysine in premixtures, feed materials and compound feed: | ||
| ||
| 3. For the quantification of lysine in water: | ||
| ||
| 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 lysine content must be stated on the labelling of the additive 2. L-lysine base (liquid) may be placed on the market and used as an additive consisting of a preparation | |
Regulation 3(1)
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.
| Column 1 | Column 2 | |
|---|---|---|
| Additive | L-lysine monohydrochloride (technically pure) | |
| Identification number | 3c327 | |
| Authorisation holder( 60) | 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) produced by fermentation withCorynebacterium glutamicum(KCCM 80216 or KCTC 12307BP) | |
| L-lysine monohydrochloride (C6H15ClN2O2) | ||
| Analytical methods( 63) | 1. For the identification of L-lysine monohydrochloride in the feed additive: | |
| ||
| 2. For the quantification of lysine in the feed additive and premixtures containing more than 10% lysine: | ||
| ||
| 3. For the quantification of lysine in premixtures, feed materials and compound feed: | ||
| ||
| 4. For the quantification of lysine in water: | ||
| ||
| 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 lysine content must be stated on the labelling of the additive 2. L-lysine monohydrochloride (technically pure) may be placed on the market and used as an additive consisting of a preparation | |
Regulation 3(1)
1. The preparation specified in the table, belonging to the additive category ‘zootechnical additives’ and to the functional group ‘substances which favourably affect the environment’ is authorised as an additive in animal nutrition, subject to the conditions set out in the table.
| Column 1 | Column 2 | |
|---|---|---|
| Additive | 3-nitrooxypropanol | |
| Identification number | 4c1 | |
| Authorisation holder | DSM Nutritional Products Ltd., Switzerland | |
| Additive category | Zootechnical additives | |
| Functional group | Substances which favourably affect the environment | |
| Additive composition |
Preparation of 3-nitrooxypropanol containing a minimum of 10% additive Granular powder, consisting of particles with a diameter < 50µm: 0.4% | |
| Characterisation of the active substance(s) | 3-nitrooxypropanol (C3H7NO4) | |
| ||
| Analytical methods( 67) | For quantification of 3-nitrooxypropanol in the feed additive, premixtures, feed materials and compound feed: | |
| ||
| Species or category of animal |
| |
| Maximum age | No maximum | |
| Content of 3-nitrooxypropanol (mg/kg of complete feed with a moisture content of 12%) | Minimum content | 53 mg/kg |
| Maximum content | 88 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 additive must be incorporated into feed in the form of a premixture | |
Regulation 7
1. Commission Regulation (EC) No 902/2009concerning the authorisation of an enzyme preparation of endo-1,4-beta-xylanase produced byTrichoderma reesei(CBS 114044) as a feed additive for weaned piglets, chickens for fattening, chickens reared for laying, turkeys for fattening and turkeys reared for breeding (holder of authorisation Roal Oy)( 68).
2. Commission Regulation (EU) No 9/2010concerning the authorisation of the endo-1,4-beta-xylanase produced byTrichoderma reesei(ATCC PTA 5588) as a feed additive for chickens for fattening, laying hens, ducks and turkeys for fattening (holder of authorisation Danisco (UK) Ltd, trading as Danisco Animal Nutrition and represented by Genencor International B.V.)( 69).
3. Commission Regulation (EU) No 277/2010concerning the authorisation of 6-phytase as a feed additive for poultry for fattening and breeding other than turkeys for fattening, for poultry for laying and for pigs other than sows (holder of authorisation Roal Oy)( 70).
4. Commission Regulation (EU) No 891/2010concerning the authorisation of a new use of 6-phytase as a feed additive for turkeys (holder of authorisation Roal Oy)( 71).
5. Commission Implementing Regulation (EU) No528/2011concerning the authorisation of endo-1,4-β-xylanase produced by Trichoderma reesei (ATCC PTA 5588) as a feed additive for weaned piglets and pigs for fattening (holder of authorisation Danisco (UK) Ltd, trading as Danisco Animal Nutrition and represented by Genencor International B.V.)( 72).
6. Commission Implementing Regulation (EU) No886/2011concerning the authorisation of 6-phytase (EC 3.1.3.26) produced byTrichoderma reesei(CBS 122001) as a feed additive for sows (holder of authorisation Roal Oy)( 73).
7. Commission Implementing Regulation (EU) No1110/2011concerning the authorisation of an enzyme preparation of endo-1,4-beta-xylanase produced byTrichoderma reesei(CBS 114044) as a feed additive for laying hens, minor poultry species and pigs for fattening (holder of authorisation Roal Oy)( 74).
8. Commission Implementing Regulation (EU) No1021/2012concerning the authorisation of endo-1,4-beta-xylanase produced byTrichoderma reesei(ATCC PTA 5588) as a feed additive for minor poultry species other than ducks (holder of authorisation Danisco (UK) Ltd, trading as Danisco Animal Nutrition and represented by Genencor International B.V.)( 75).
9. Commission Implementing Regulation (EU) No1196/2012amending Regulation (EU) No9/2010as regards the minimum content of a preparation of endo-1,4-beta-xylanase produced byTrichoderma reesei(ATCC PTA 5588) as a feed additive in feed for laying hens (holder of authorisation Danisco Animal Nutrition)( 76).
10. Commission Implementing Regulation (EU) 2018/1569amending Commission Implementing Regulation (EU) No1110/2011concerning the authorisation of an enzyme preparation of endo-1,4-beta-xylanase produced byTrichoderma reesei(CBS 114044) as a feed additive for laying hens, minor poultry species and pigs for fattening (holder of authorisation Roal Oy)( 77).
(This note is not part of the Regulations)
These Regulations make provision regarding the authorisation of feed additives under Regulation (EC) No 1831/2003of the European Parliament and of the Council on additives for use in animal nutrition (“Regulation (EC) 1831/2003”) in Scotland.
Regulation 3(1) and schedules 1 to 13 provide for the authorisation of 13 feed additives.
Schedule 1 contains a renewal of the authorisation of a preparation of endo-1,4-beta-xylanase (EC 3.2.1.8) produced fromTrichoderma reesei(CBS 143953) (identification number 4a11). The authorisation has been modified as follows:—
the strain identification number forTrichoderma reeseiis updated from “ATCC PTA 5588” to “CBS 142953”,
the minimum content of the feed additive for turkeys for fattening is reduced from 1,250 to 625 units of activity per kilogram of complete feed (U/kg), to provide that the minimum content is 625 U/kg for all poultry species.
Schedule 2 contains a new authorisation, for a preparation ofLacticaseibacillus rhamnosus(formerlyLactobacillus rhamnosus) (IMI 507023) (identification number 1k21701).
Schedule 3 contains a new authorisation, for a preparation ofPediococcus pentosaceus(IMI 507024) (identification number 1k21016).
Schedule 4 contains a new authorisation, for a preparation ofPediococcus pentosaceus(IMI 507025) (identification number 1k21017).
Schedule 5 contains a new authorisation, for a preparation ofLactiplantibacillus plantarum(formerlyLactobacillus plantarum) (IMI 507026) IMI 507026) (identification number 1k21601).
Schedule 6 contains a new authorisation, for a preparation ofLactiplantibacillus plantarum(formerlyLactobacillus plantarum) (IMI 507027) (identification number 1k21602).
Schedule 7 contains a new authorisation, for a preparation ofLactiplantibacillus plantarum(formerlyLactobacillus plantarum) (IMI 507028) (identification number 1k21603).
Schedule 8 contains a new authorisation, for a preparation ofLactiplantibacillus plantarum(formerlyLactobacillus plantarum) (DSM 26571) (identification number 1k1604).
Schedule 9 contains a renewal of the authorisation of a preparation of endo-1,4-beta-xylanase (EC 3.2.1.8) produced fromTrichoderma reesei(CBS 114044) (identification number 4a8i). The authorisation has been modified as follows:—
the identification number of the feed additive is changed from “4a8” to “4a8i”,
the minimum level of stock enzyme activity is reduced from 4,000,000 BXU/g in the solid form and 400,000 BXU/g in the liquid form to 160,000 BXU/g in both solid and liquid forms.
Schedule 10 contains a renewal of the authorisation of a preparation of 6-phytase (EC 3.1.3.26) produced fromTrichoderma reesei(CBS 122001) (identification number 4a12). The authorisation has been modified as follows:—
the minimum level of stock enzyme activity is reduced from 10,000 BXU/g to 5,000 BXU/g in the liquid form.
Schedule 11 contains a new authorisation, for L-lysine (liquid) produced fromCorynebacterium glutamicum(KCCM 80216 or KCTC 12307BP) (identification number 3c326).
Schedule 12 contains a new authorisation, for L-lysine monohydrochloride produced fromCorynebacterium glutamicum(KCCM 80216 or KCTC 12307BP) (identification number 3c327).
Schedule 13 contains a new authorisation, for a preparation of 3-nitrooxypropanol (identification number 4c1).
Regulation 3(2) provides that 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.
Regulation 4 makes transitional provision in relation to the feed additive endo-1,4-beta-xylanase (EC 3.2.1.8) the authorisation of which is renewed under schedule 9. Under the renewal of the authorisation the identification number of the feed additive is changed. Regulation 4 allows the continued production and labelling of products, for the specified limited time periods, under the conditions of the prior authorisation and the labelling requirements applicable immediately before the coming into force of these Regulations. Products produced within the transitional periods may be marketed and used until stocks are exhausted.
Regulation 5 amends Commission Implementing Regulation (EU) No601/2013by removing from the Annex the authorisations for cobalt (II) acetate tetrahydrate, cobalt (II) carbonate, cobalt (II) carbonate hydroxide (2:3) monohydrate and cobalt (II) sulphate heptahydrate. This is consequential to the Feed Additives (Form of Provisional Authorisations) (Cobalt (II) Compounds) (Scotland) Regulations 2023 ( S.S.I. 2023/170) which provisionally authorised these feed additives.
Regulation 6 amends Commission Implementing Regulation (EU) 2019/221by revoking articles which amend Commission Regulation (EU) No 9/2010and Commission Implementing Regulations (EU) No 528/2011 and 1021/2012. Those Regulations are revoked by regulation 7 and schedule 14.
Regulation 7 and schedule 14 revoke retained direct EU legislation that contains previous authorisations for the feed additives now authorised by schedules 1, 9 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.
EUR 2003/1831; relevant amending instruments are S.I. 2019/654, S.I. 2022/377and 1351. S.I. 2019/654was amended by S.I. 2020/1504. See Article 2 for the definitions of “prescribe” and “appropriate authority”. Article 9(1) applies in relation to renewals in accordance with Article 14.
EUR 2002/178, amended by S.I. 2019/641. S.I. 2019/641was amended by S.I. 2020/1504.
EUR 2008/429; relevant amending instruments are S.I. 2019/654and S.I. 2022/1351. S.I. 2019/654was amended by S.I. 2020/1504.
EUR 2009/152; relevant amending instruments are S.I. 2019/654and S.I. 2022/1351.
EUR 2009/767, amended by S.I. 2019/654and S.I. 2022/1351.
EUR 2009/902, to which there are amendments not relevant to this instrument.
EUR 2013/601, amended by EUR 2014/131.
EUR 2019/221.
This authorisation is a renewal (with modifications) of the authorisations granted under Commission Regulation (EU) No 9/2010, Commission Implementing Regulation (EU) No528/2011and Commission Implementing Regulation (EU) No1021/2012. Those Regulations are revoked by regulation 7, and schedule 14, of these Regulations. The explanatory note to these Regulations sets out the modifications made to those authorisations.
Enzyme activity: one unit is the amount of enzyme which releases 0.48 micromoles (μmol) of reducing sugar (xylose equivalent) per minute from wheat arabino xylan at pH 4.2 and 50°C.
This is a reference to the CAS Registry Number® assigned to this preparation by the Chemical Abstracts Servicehttps://cas.org/cas-data/cas-registry.
This is the identification number assigned by the International Union of Biochemistry and Molecular Biology (IUBMB)https://iubmb.org.
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.
Details of the analytical methods are set out in the document referenced “JRC.D.5/FSQ/CvH/DM/ag/ARES(2012)353089” and last updated 6 June 2016. Available at:https://joint-research-centre.ec.europa.eu/publications/fad-2011-0030_en.
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.
The categories of silage are easy to ensile forage: >3% soluble carbohydrates in fresh material (e.g.whole plant maize, ryegrass, brome grass or sugar beet pulp) and moderately difficult to ensile forage: 1.5–3% soluble carbohydrates in the fresh material (e.g. meadow grass, fescue or wilted alfalfa) (see paragraph 1.4 of Annex III of Regulation 429/2008).
Details of the analytical methods are set out in the document referenced “Ares(2021)1687524-08/03/2021” and “JRC F.5/CvH/ZE/AS/Ares” and last updated on 21 April 2021. The document is available at the following address:https://joint-research-centre.ec.europa.eu/publications/fad-2020-0075007800790080_en. The relevant dossier reference number is “FAD-2020-0075”.
BS EN 15787: 2021 “Animal feeding stuffs: Methods of sampling and analysis. Detection and enumeration of Lactobacillus spp. used as feed additive”. Published by the British Standards Institution on 31 December 2021 (ISBN 978 0 580 99831 7). Available from the British Standards Institutionhttps://knowledge.bsigroup.com.
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.
The categories of silage are easy to ensile forage: >3% soluble carbohydrates in fresh material (e.g. whole plant maize, ryegrass, brome grass or sugar beet pulp) and moderately difficult to ensile forage: 1.5–3% soluble carbohydrates in the fresh material (e.g. meadow grass, fescue or wilted alfalfa) (see paragraph 1.4 of Annex III of Regulation 429/2008).
Details of the analytical methods are set out in the document referenced “Ares(2021)1902366-16/03/2021” and “JRC F.5/CvH/MGH/AS/Ares” and last updated on 21 April 2021. The document is available at the following address:https://joint-research-centre.ec.europa.eu/publications/fad-2020-00760077_en. The relevant dossier reference number is “FAD-2020-0076”.
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 0). Available from the British Standards Institutionhttps://knowledge.bsigroup.com.
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.
The categories of silage are easy to ensile forage: >3% soluble carbohydrates in fresh material (e.g. whole plant maize, ryegrass, brome grass or sugar beet pulp) and moderately difficult to ensile forage: 1.5–3% soluble carbohydrates in the fresh material (e.g. meadow grass, fescue or wilted alfalfa) (see paragraph 1.4 of Annex III of Regulation 429/2008).
Details of the analytical methods are set out in the document referenced “Ares(2021)1902366-16/03/2021” and “JRC F.5/CvH/MGH/AS/Ares” and last updated on 21 April 2021. The document is available at the following address:https://joint-research-centre.ec.europa.eu/publications/fad-2020-00760077_en. The relevant dossier reference number is “FAD-2020-0077”.
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 0). Available from the British Standards Institutionhttps://knowledge.bsigroup.com.
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.
The categories of silage are easy to ensile forage: >3% soluble carbohydrates in fresh material (e.g.whole plant maize, ryegrass, brome grass or sugar beet pulp) and moderately difficult to ensile forage: 1.5–3% soluble carbohydrates in the fresh material (e.g. meadow grass, fescue or wilted alfalfa) (see paragraph 1.4 of Annex III of Regulation 429/2008).
Details of the analytical methods are set out in the document referenced “Ares(2021)1687524-08/03/2021” and “JRC F.5/CvH/ZE/AS/Ares” and last updated on 21 April 2021. The document is available at the following address:. The relevant dossier reference number is “FAD-2020-0078”.
BS EN 15787: 2021 “Animal feeding stuffs: Methods of sampling and analysis. Detection and enumeration of Lactobacillus spp. used as feed additive”. Published by the British Standards Institution on 31 December 2021 (ISBN 978 0 580 99831 7). Available from the British Standards Institutionhttps://knowledge.bsigroup.com.
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.
The categories of silage are easy to ensile forage: >3% soluble carbohydrates in fresh material (e.g. whole plant maize, ryegrass, brome grass or sugar beet pulp) and moderately difficult to ensile forage: 1.5–3% soluble carbohydrates in the fresh material (e.g. meadow grass, fescue or wilted alfalfa) (see paragraph 1.4 of Annex III of Regulation 429/2008).
Details of the analytical methods are set out in the document referenced “Ares(2021)1687524-08/03/2021” and “JRC F.5/CvH/ZE/AS/Ares” and last updated on 21 April 2021. The document is available at the following address:https://joint-research-centre.ec.europa.eu/publications/fad-2020-0075007800790080_en. The relevant dossier reference number is “FAD-2020-0079”.
BS EN 15787: 2021 “Animal feeding stuffs: Methods of sampling and analysis. Detection and enumeration of Lactobacillus spp. used as feed additive”. Published by the British Standards Institution on 31 December 2021 (ISBN 978 0 580 99831 7). Available from the British Standards Institutionhttps://knowledge.bsigroup.com.
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.
The categories of silage are easy to ensile forage: >3% soluble carbohydrates in fresh material (e.g. whole plant maize, ryegrass, brome grass or sugar beet pulp) and moderately difficult to ensile forage: 1.5–3% soluble carbohydrates in the fresh material (e.g. meadow grass, fescue or wilted alfalfa) (see paragraph 1.4 of Annex III of Regulation 429/2008).
Details of the analytical methods are set out in the document referenced “Ares(2021)1687524-08/03/2021” and “JRC F.5/CvH/ZE/AS/Ares” and last updated on 21 April 2021. The document is available at the following address:https://joint-research-centre.ec.europa.eu/publications/fad-2020-0075007800790080_en. The relevant dossier reference number is “FAD-2020-0080”.
BS EN 15787: 2021 “Animal feeding stuffs: Methods of sampling and analysis. Detection and enumeration of Lactobacillus spp. used as feed additive”. Published by the British Standards Institution on 31 December 2021 (ISBN 978 0 580 99831 7). Available from the British Standards Institutionhttps://knowledge.bsigroup.com.
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.
The categories of silage are easy to ensile forage: >3% soluble carbohydrates in fresh material (e.g. whole plant maize, ryegrass, brome grass or sugar beet pulp), moderately difficult to ensile forage: 1.5–3% soluble carbohydrates in the fresh material (e.g. meadow grass, fescue or wilted alfalfa) and difficult to ensile forage: <1.5% soluble carbohydrates in the fresh material (e.g orchard grass or leguminous plants) (see paragraph 1.4 of Annex III of Regulation 429/2008).
Details of the analytical methods are set out in the document referenced “Ares(2020)5563084-15/10/2020” and “JRC.F.5/CvH/ZE/AS/Ares” and last updated on 16 October 2020. The document is available at the following address:https://joint-research-centre.ec.europa.eu/publications/fad-2019-0091_en.
BS EN 15787: 2021 “Animal feeding stuffs: Methods of sampling and analysis. Detection and enumeration of Lactobacillus spp. used as feed additive”. Published by the British Standards Institution on 31 December 2021 (ISBN 978 0 580 99831 7). Available from the British Standards Institutionhttps://knowledge.bsigroup.com.
This authorisation is a renewal (with modifications) of the authorisation granted under Commission Regulation (EC) No 902/2009. That Regulation is revoked by regulation 7, and schedule 14, of these Regulations. The explanatory note to these Regulations sets out the modifications made to that authorisation.
Enzyme activity expressed in birch xylan units (BXU), where one BXU is the amount of enzyme which liberates 1 nanomole of reducing sugars as xylose from birch xylan per second at pH 5.3 and 50°C.
This is a reference to the CAS Registry Number® assigned to this preparation by the Chemical Abstracts Servicehttps://cas.org/cas-data/cas-registry.
This is the identification number assigned by the International Union of Biochemistry and Molecular Biology (IUBMB)https://iubmb.org.
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.
Details of the analytical methods are set out in the document referenced “Ares(2019)3101222-10/05/2019” and “JRC F.5/CvH/MGH/AS/Ares” and last updated on 2 July 2019. The document is available at the following address:https://joint-research-centre.ec.europa.eu/publications/fad-2018-0071_en.
This authorisation is a renewal (with modification) of the authorisations granted under Commission Regulation (EU) No 277/2010, Commission Regulation (EU) No 891/2010and Commission Implementing Regulation (EU) No886/2011. Those Regulations are revoked by regulation 7, and schedule 14, of these Regulations. The explanatory note to these Regulations sets out the modification made to those authorisations.
Enzyme activity is expressed in PPU units, where one PPU is the amount of enzyme which liberates 1 micromole (μmol) of inorganic phosphate from sodium phytate per minute at pH 5.0 and 37°C.
This is a reference to the CAS Registry Number® assigned to this preparation by the Chemical Abstracts Servicehttps://cas.org/cas-data/cas-registry.
This is the identification number assigned by the International Union of Biochemistry and Molecular Biology (IUBMB)https://iubmb.org.
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.
Details of the analytical methods are set out in the document referenced “D08/FSQ/CVH/SY/D/Ares(2009)173372” and last updated on 6 June 2016. The document is available at the following address:https://joint-research-centre.ec.europa.eu/publications/fad-2008-0040_en.
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.
This is a reference to the CAS Registry Number® assigned to this substance by the Chemical Abstracts Servicehttps://cas.org/cas-data/cas-registry.
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.
Details of the analytical methods are set out in the document referenced “Ares(2020)4503369-31/08/2020” and “JRC F.5/CvH/MGH/AS/Ares” and last updated on 16 October 2020. The document is available at the following address:https://joint-research-centre.ec.europa.eu/publications/fad-2020-0008_en.
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 from the British Standards Institutionhttps://knowledge.bsigroup.com.
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.
This is a reference to the CAS Registry Number® assigned to this substance by the Chemical Abstracts Servicehttps://cas.org/cas-data/cas-registry.
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.
Details of the analytical methods are set out in the document referenced “Ares(2020)4503369-31/08/2020” and “JRC F.5/CvH/MGH/AS/Ares” and last updated on 16 October 2020. The document is available at the following address:https://joint-research-centre.ec.europa.eu/publications/fad-2020-0008_en.
Food Chemicals Codex, United Stated Pharmacopeial Convention, 13th edition (online). Published by US Pharmacopeia (USP) on 1 March 2022 (ISSN 2153-1455). Available at:https://www.foodchemicalscodex.org
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 from the British Standards Institutionhttps://knowledge.bsigroup.com.
This is a reference to the CAS Registry Number® assigned to this preparation by the Chemical Abstracts Servicehttps://cas.org/cas-data/cas-registry.
Details of the analytical methods are set out in the document referenced “Ares(2020)981992-15/02/2020” and “JRC F.5/CvH/ZE/AS/Ares” and last updated on 4 May 2020. The document is available at the following address:https://joint-research-centre.ec.europa.eu/publications/fad-2019-0057_en.
EUR 2009/902.
EUR 2010/9.
EUR 2010/277.
EUR 2010/891.
EUR 2011/528.
EUR 2011/886.
EUR 2011/1110.
EUR 2012/1021.
EUR 2012/1196.
EUR 2018/1569.
