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The Feed Additives (Authorisations) (Scotland) Regulations 2022

S.S.I. 2022/288 · Made 27 September 2022 · Extends to Scotland

Up to date with all changes known to legislation.gov.uk, revised to 1 April 2025.

Agriculture

Made 27th September 2022

Laid before the Scottish Parliament 29th September 2022

Coming into force 24th November 2022

The Scottish Ministers make the following Regulations in exercise of the powers conferred by Articles 9(1), 13(6) and 18A(3) of Regulation (EC) No. 1831/2003 of the European Parliament and of the Council on additives for use in animal nutritionf1, and all other powers enabling them to do so.

There has been consultation as required by Article 9 of Regulation (EC) No. 178/2002 of the European Parliament and of the Council laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safetyf2.

Annotations to the whole text

Textual amendments

F1

Regulations revoked (except for regs. 8-10 and regs. 1, 2, 4-7, 11, Sch. 12 so far as they relate to regs. 8-10) (1.4.2025) by The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 (S.I. 2025/361), reg. 1(2), Sch. 1 (with reg. 23)

Footnotes

f1

EUR 1831/2003 as amended by S.I. 2019/654 and 2022/377. Article 9 was substituted by S.I. 2019/654 and amended by S.I. 2022/377. Article 13 was substituted and article 18A was added by S.I. 2019/654. The terms “prescribe” and “appropriate authority” are defined in Article 2 of EUR 1831/2003.

f2

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

Contents

  1. 1Citation, commencement and extent
  2. 2Interpretation
  3. 3Authorisations Repealed
  4. 4Amendment of Commission Implementing Regulation (EU) No. 306/2013
  5. 5Amendment of Commission Implementing Regulation (EU) No. 787/2013
  6. 6Amendment of Commission Implementing Regulation (EU) 2015/1020
  7. 7Amendment of Commission Implementing Regulation (EU) 2017/2276
  8. 8Transitional provision: Saccharomyces cerevisiae (identification number 4b1702)
  9. 9Transitional: Bacillus velezensis (identification number 4b1823)
  10. 10Transitional: Decoquinate (Deccox®) (identification number 51756i (formerly E756))
  11. 11Revocations
  12. Signature
  13. Schedule 1: Authorisation of a preparation of manganese chelate of lysine and glutamic acid (identification number 3b509) as a feed additive for all animal species
  14. Paragraph Repealed
  15. Schedule 2: Authorisation of a preparation of Lactobacillus buchneri DSM 29026 (identification number 1k20759) as a feed additive for all animal species
  16. Paragraph Repealed
  17. Schedule 3: Authorisation of a preparation of serine protease produced by Bacillus licheniformis DSM 19670 (identification number 4a13) as a feed additive for chickens for fattening
  18. Paragraph Repealed
  19. Schedule 4: Renewal of authorisation of pyridoxine hydrochloride (vitamin B6) (identification number 3a831) as a feed additive for all animal species
  20. Paragraph Repealed
  21. Schedule 5: Renewal of authorisation ... of a preparation of Saccharomyces cerevisiae CNCM I-4407 ... (identification number 4b1702) as a feed additive for calves for rearing
  22. Paragraph Repealed
  23. Schedule 6: Renewal of authorisation (with modification) of a preparation of Bacillus velezensis (ATCC PTA-6737) (identification number 4b1823) as a feed additive for chickens for fattening, chickens reared for laying, ducks for fattening, quails, pheasants, partridges, guinea fowl, pigeons, geese for fattening and ostriches, and its authorisation as a feed additive extending existing uses to cover all minor poultry species (except for laying), ornamental birds, sporting birds and game birds
  24. Paragraph Repealed
  25. Schedule 7: Authorisation of a preparation of Bacillus licheniformis DSM 28710 (identification number 4b1828) as a feed additive for laying hens, minor poultry species for laying, poultry species for breeding and ornamental birds
  26. Paragraph Repealed
  27. Schedule 8: Renewal of authorisation of a preparation of Clostridium butyricum (FERM BP-2789) (identification number 4b1830) as a feed additive for chickens reared for laying, turkeys for fattening, turkeys reared for breeding, minor avian species (excluding laying birds), weaned piglets and weaned minor porcine species, and its authorisation as a feed additive for chickens for fattening, suckling piglets and suckling minor porcine species
  28. Paragraph Repealed
  29. Schedule 9: Authorisation of a preparation of 6-phytase (EC 3.1.3.26) (identification number 4a32) as a feed additive for all poultry species, ornamental birds, piglets, pigs for fattening, sows and minor porcine species for fattening or reproduction
  30. Paragraph Repealed
  31. Schedule 10: Authorisation of Decoquinate (Deccox®) (identification number 51756i) as a feed additive for chickens for fattening
  32. Paragraph Repealed
  33. Schedule 11: Authorisation of Decoquinate (Avi-Deccox® 60G) (identification number 51756ii) as a feed additive for chickens for fattening
  34. Paragraph Repealed
  35. Schedule 12: Revocation of assimilated direct EU legislation
  36. 1Paragraph 1
  37. 2Paragraph 2
  38. 3Paragraph 3
  39. 4Paragraph 4
  40. 5Paragraph 5
  41. 6Paragraph 6
  42. 7Paragraph 7
  43. 8Paragraph 8
  44. 9Paragraph 9
  45. 10Paragraph 10
  46. 11Paragraph 11
  47. 12Paragraph 12
  48. 13Paragraph 13
  49. 14Paragraph 14
  50. Explanatory note

1Citation, commencement and extentF1I1

(1)

These Regulations may be cited as the Feed Additives (Authorisations) (Scotland) Regulations 2022 and come into force on 24 November 2022.

(2)

These Regulations extend to Scotland only.

2InterpretationF1I1

(1)

In these Regulations—

(2)

Unless the contrary intention appears, any expression used both in these Regulations and in Regulation (EC) 1831/2003 or Regulation (EC) 767/2009 has the same meaning as it has in those Regulations.

3AuthorisationsF1

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4Amendment of Commission Implementing Regulation (EU) No. 306/2013F1I1

(1)

Commission Implementing Regulation (EU) No. 306/2013 concerning the authorisation of a preparation of Bacillus subtilis (ATCC PTA-6737) for weaned piglets and weaned Suidae other than Sus scrofa domesticus (holder of authorisation Kemin Europa N.V.)f1 is amended as follows.

(2)

In the Annex, in the table, in the column headed—

(a)

“Additive”, for “Bacillus subtilis” substitute “Bacillus velezensis”, and

(b)

“Composition, chemical formula, description, analytical method”, for “Bacillus subtilis”, in each place it occurs, substitute “Bacillus velezensis”.

5Amendment of Commission Implementing Regulation (EU) No. 787/2013F1I1

(1)

Commission Implementing Regulation (EU) No. 787/2013 concerning the authorisation of a preparation of Bacillus subtilis (ATCC PTA-6737) as a feed additive for turkeys for fattening and turkeys reared for breeding (holder of authorisation Kemin Europa N.V.)f1 is amended as follows.

(2)

In the Annex, in the table, in the column headed—

(a)

“Additive”, for “Bacillus subtilis” substitute “Bacillus velezensis”, and

(b)

“Composition, chemical formula, description, analytical method”, for “Bacillus subtilis”, in each place it occurs, substitute “Bacillus velezensis”.

6Amendment of Commission Implementing Regulation (EU) 2015/1020F1I1

(1)

Commission Implementing Regulation (EU) 2015/1020 concerning the authorisation of the preparation of Bacillus subtilis (ATCC PTA-6737) as a feed additive for laying hens and minor poultry species for laying (holder of the authorisation Kemin Europa NV)f1 is amended as follows.

(2)

In the Annex, in the table, in the column headed—

(a)

“Additive”, for “Bacillus subtilis” substitute “Bacillus velezensis”, and

(b)

“Composition, chemical formula, description, analytical method”, for “Bacillus subtilis”, in each place it occurs, substitute “Bacillus velezensis”.

7Amendment of Commission Implementing Regulation (EU) 2017/2276F1I1

(1)

Commission Implementing Regulation (EU) 2017/2276 concerning the authorisation of a new use of the preparation of Bacillus subtilis (ATCC PTA-6737) as a feed additive for sows (holder of the authorisation Kemin Europa N.V.)f1 is amended as follows.

(2)

In the Annex, in the table, in the column headed—

(a)

“Additive”, for “ Bacillus subtilis” substitute “Bacillus velezensis”, and

(b)

“Composition, chemical formula, description, analytical method”, for “Bacillus subtilis”, in each place it occurs, substitute “Bacillus velezensis”.

8Transitional provision: Saccharomyces cerevisiae (identification number 4b1702)F1I1

(1)

The relevant feed additive, and premixtures containing it, which are produced and labelled before the end of 23 May 2023 in accordance with the conditions of the prior authorisation, may continue to be placed on the market and used until the existing stocks are exhausted.

(2)

Compound feed, and feed materials containing the relevant feed additive, intended for food-producing animals, which are produced and labelled before the end of 23 November 2023 in accordance with the conditions of the prior authorisation, may continue to be placed on the market and used until the existing stocks are exhausted.

(3)

In this regulation—

  • “relevant feed additive” means the feed additive Saccharomyces cerevisiae CNCM I-4407, with the identification number 4b1702, which was previously authorised under the prior authorisation, and

  • “the prior authorisation” means F2an authorisation contained in Commission Regulation (EU) No. 883/2010 concerning the authorisation of a new use of Saccharomyces cerevisiae NCYC Sc 47 as a feed additive for calves for rearing (holder of the authorisation Société industrielle Lesaffre)f1.

9Transitional: Bacillus velezensis (identification number 4b1823)F1I1

(1)

Any substance or product labelled “Bacillus subtilis (ATCC PTA-6737)”, or as containing “Bacillus subtilis (ATCC PTA-6737)”, but otherwise produced and labelled in accordance with an authorisation contained in F2assimilated direct legislation mentioned in regulations 4 to 7, may continue to be placed on the market and used under that authorisation.

(2)

The relevant feed additive, and premixtures containing it, which are produced and labelled before the end of 23 May 2023 in accordance with the conditions of the prior authorisation, may continue to be placed on the market and used until the existing stocks are exhausted.

(3)

Compound feed, and feed materials containing the relevant feed additive, intended for food-producing animals, which are produced and labelled before the end of 23 November 2023 in accordance with the conditions of the prior authorisation, may continue to be placed on the market and used until the existing stocks are exhausted.

(4)

Compound feed, and feed materials containing the relevant feed additive, intended for non-food-producing animals, which are produced and labelled before the end of 23 November 2024 in accordance with the conditions of the prior authorisation, may continue to be placed on the market and used until the existing stocks are exhausted.

(5)

In this regulation—

  • “relevant feed additive” means the feed additive Bacillus velezensis ATCC PTA-6737 or, as formerly designated, Bacillus subtilis ATCC PTA-6737, with the identification number 4b1823, which was previously authorised under the prior authorisation, and

  • “the prior authorisation” means F3an authorisation contained in—

    • Commission Regulation (EU) No. 107/2010 concerning the authorisation of Bacillus subtilis ATCC PTA-6737 as a feed additive for chickens for fattening (holder of authorisation Kemin Europa NV)f1, or

    • Commission Implementing Regulation (EU) No. 885/2011 concerning the authorisation of Bacillus subtilis (ATCC PTA-6737) as a feed additive for chickens reared for laying, ducks for fattening, quails, pheasants, partridges, guinea fowl, pigeons, geese for fattening and ostriches (holder of the authorisation Kemin Europa N.V.)f2.

10Transitional: Decoquinate (Deccox®) (identification number 51756i (formerly E756))F1I1

(1)

The relevant feed additive, and feed containing it, which are produced and labelled before the end of 23 May 2023 in accordance with the conditions of the prior authorisation, may continue to be placed on the market and used until the existing stocks are exhausted.

(2)

In this regulation—

  • “relevant feed additive” means the feed additive decoquinate (Deccox®), which was previously authorised under the prior authorisation with the identification number E756, and

  • “the prior authorisation” means F2an authorisation contained in Regulation (EC) No. 1289/2004 concerning the authorisation for 10 years of the additive Deccox® in feedingstuffs, belonging to the group of coccidiostats and other medicinal substancesf1.

11RevocationsF1I1

The F2assimilated direct legislation listed in schedule 12 is revoked subject to regulations 8, 9(2) to (5) and 10.

Signature

F1MAREE TODD

Authorised to sign by the Scottish Ministers

St Andrew’s House,

Edinburgh

27th September 2022

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1I1F1

Commission Regulation (EC) No. 1289/2004 concerning the authorisation for 10 years of the additive Deccox® in feedingstuffs, belonging to the group of coccidiostats and other medicinal substancesf1.

2I1F1

Commission Regulation (EC) No. 903/2009 concerning the authorisation of the preparation of Clostridium butyricum (FERM-BP 2789) as a feed additive for chickens for fattening (holder of authorisation Miyarisan Pharmaceutical Co. Ltd, represented by Huvepharma NV Belgium)f1.

3I1F1

Commission Regulation (EU) No. 8/2010 concerning the authorisation of the serine protease produced by Bacillus licheniformis (DSM 19670) as a feed additive for chickens for fattening (holder of authorisation DSM Nutritional Products Ltd, represented by DSM Nutritional Products Sp.Z.o.o)f1.

4I1F1

Commission Regulation (EU) No. 107/2010 concerning the authorisation of Bacillus subtilis ATCC PTA-6737 as a feed additive for chickens for fattening (holder of authorisation Kemin Europa NV)f1.

5I1F1

Commission Regulation (EU) No. 883/2010 concerning the authorisation of a new use of Saccharomyces cerevisiae NCYC Sc 47 as a feed additive for calves for rearing (holder of the authorisation Société industrielle Lesaffre)f1.

6I1F1

Commission Regulation (EU) No. 168/2011 amending Regulation (EU) No. 107/2010 as regards the use of the feed additive Bacillus subtilis ATCC PTA-6737 in feed containing maduramycin ammonium, monensin sodium, narasin, or robenidine hydrochloridef1.

7I1F1

Commission Implementing Regulation (EU) No. 373/2011 concerning the authorisation of the preparation of Clostridium butyricum FERM-BP 2789 as a feed additive for minor avian species except laying birds, weaned piglets and minor porcine species (weaned) and amending Regulation (EC) No. 903/2009 (holder of authorisation Miyarisan Pharmaceutical Co. Ltd, represented by Huvepharma NV Belgium)f1.

8I1F1

Commission Implementing Regulation (EU) No. 515/2011 concerning the authorisation of vitamin B6 as a feed additive for all animal speciesf1.

9I1F1

Commission Implementing Regulation (EU) No. 885/2011 concerning the authorisation of Bacillus subtilis (ATCC PTA-6737) as a feed additive for chickens reared for laying, ducks for fattening, quails, pheasants, partridges, guinea fowl, pigeons, geese for fattening and ostriches (holder of the authorisation Kemin Europa N.V.)f1.

10I1F1

Commission Implementing Regulation (EU) No. 357/2013 amending Regulation (EC) No. 903/2009 and Implementing Regulation (EU) No. 373/2011 as regards the minimum content of a preparation of Clostridium butyricum (FERM-BP 2789) as a feed additive for chickens for fattening and minor avian species (excluding laying birds) (holder of authorisation Miyarisan Pharmaceutical Co. Ltd represented by Miyarisan Pharmaceutical Europe S.L.U.)f1.

11I1F1

Commission Implementing Regulation (EU) No. 374/2013 concerning the authorisation of a preparation of Clostridium butyricum (FERM-BP 2789) as a feed additive for chickens reared for laying (holder of authorisation Miyarisan Pharmaceutical Co. Ltd represented by Huvepharma NV Belgium)f1.

12I1F1

Commission Implementing Regulation (EU) No. 291/2014 amending Regulation (EC) No. 1289/2004 as regards the withdrawal time and maximum residues limits of the feed additive decoquinatef1.

13I1F1

Commission Implementing Regulation (EU) No. 1108/2014 concerning the authorisation of a preparation of Clostridium butyricum (FERM-BP 2789) as a feed additive for turkeys for fattening and turkeys reared for breeding (holder of authorisation Miyarisan Pharmaceutical Co. Ltd represented by Huvepharma NV Belgium)f1.

14I1F1

Commission Implementing Regulation (EU) No. 2017/1126 amending Regulation (EC) No. 903/2009 and Implementing Regulations (EU) No. 373/2011, (EU) No. 374/2013 and (EU) No. 1108/2014 as regards the name of the EU representative of the holder of the authorisation of a preparation of Clostridium butyricum (FERM-BP 2789)f1.

Explanatory note

(This note is not part of the Regulations)

These Regulations make provision as regards the authorisation of feed additives under Regulation (EC) 1831/2003 of the European Parliament and of the Council on additives for use in animal nutrition (“Regulation (EC) 1831/2003”).

Regulation 3 and schedules 1 to 11 prescribe the authorisation of 11 feed additives, in accordance with article 9(1) of Regulation (EC) 1831/2003.

Schedule 1 is a new authorisation, for a preparation of Manganese chelate of lysine and glutamic acid (identification number 3b509).

Schedule 2 is a new authorisation, for a preparation of Lactobacillus buchneri DSM 29026 (identification number 1k20759).

Schedule 3 is a new authorisation, for a preparation of Serine protease (EC 3.4.21.-1) produced by Bacillus licheniformis (DSM 19670) (identification number 4a13).

Schedule 4 is a renewal of the authorisation of Pyridoxine hydrochloride (vitamin B6) (identification number 3a831).

Schedule 5 is a renewal of the authorisation of a preparation of Saccharomyces cerevisiae CNCM I-4407 (ACTISAF® Sc47) (identification number 4b1702). The name of the bacterial strain is changed from “Saccharomyces cerevisiae NCYC Sc 47” to “Saccharomyces cerevisiae CNCM I-4407”.

Schedule 6 is a renewal of the authorisation of a preparation of Bacillus velezensis (ATCC PTA-6737) (identification number 4b1823). The authorisation has been modified as follows:-

  • the bacterial strain name from “Bacillus subtilis” to “Bacillus velezensis”,

  • the minimum content of the feed additive in the preparation is increased from 1x1010 to 8x1010 colony forming units per gram (CFU/g).

Schedule 7 is a new authorisation, for a preparation of Bacillus licheniformis DSM 28710 (identification number 4b1828).

Schedule 8 is a renewal of the authorisations of a preparation of Clostridium butyricum (FERM BP-2789) (identification number 4b1830), and authorises it for a new use to be used in feed for chickens for fattening, suckling piglets and minor porcine species (suckling).

Schedule 9 is a new authorisation, for a preparation of 6-phytase produced by Komagataella phaffii DSM 32854 (identification number 4a32).

Schedule 10 authorises a new formulation of Decoquinate (Deccox®) (identification number E756) as Decoquinate (Deccox®) (identification number 51756i) following a re-evaluation requested by the holder.

Schedule 11 authorises a modified form of Decoquinate (Deccox®) (identification number E756) as Decoquinate (Avi-Deccox® 60G) (identification number 51756ii). This feed additive differs from Decoquinate (Deccox®) in physical form and in the dilutant used being calcium sulphate dehydrate.

The authorisations are valid for a period of 10 years, in accordance with Article 9(7) of Regulation (EC) 1831/2003. This is subject to Article 14(4) of that Regulation, which provides for an extension of the authorisation period in certain circumstances following the submission of an application for renewal. Relevant provision is made by regulation 3(3) of these Regulations.

Regulations 4 to 7 modify 4 retained EU Regulations that authorise the feed additive Bacillus subtilis ATCC PTA-6737 for differing poultry and pig sub-groups. The name of the feed additive is updated from “ Bacillus subtilis” to “Bacillus velezensis”. Regulation 9(1) is a transitional provision which allows products labelled using the name “Bacillus subtilis” to continue to be marketed and used under the relevant authorisations despite the name change.

Regulations 8, 9(2) to (5) and 10 make transitional provision to enable the continued production and labelling of products, for limited time periods, under the conditions of previous authorisations where authorisations are renewed under schedules 5, 6 and 10 respectively.

Regulation 11 and schedule 12 revoke retained direct EU legislation that contains previous authorisations for the feed additives now authorised by schedules 3, 4, 5, 6, 8 and 10.

A business and regulatory impact assessment has not been produced for this instrument as no significant impact on the private or voluntary sector is foreseen.