Commission Implementing Regulation (EU) 2024/781 of 5 March 2024 concerning the renewal of the authorisation of a preparation of alpha-galactosidase produced by Saccharomyces cerevisiae CBS 615.94 and endo-1,4-beta-glucanase produced by Aspergillus niger CBS 120604 as a feed additive for chickens for fattening, minor poultry species for fattening and chickens reared for laying (holder of authorisation: Kerry Ingredients & Flavours Ltd.) and repealing Implementing Regulations (EU) No 237/2012 and (EU) No 1365/2013

Official Journal EN of the European Union L series 2024/781 6.3.2024 COMMISSION IMPLEMENTING REGULATION (EU) 2024/781 of 5 March 2024 concerning the renewal of the authorisation of a preparation of alpha-galactosidase produced by Saccharomyces cerevisiae CBS 615.94 and endo-1,4-beta-glucanase produced by Aspergillus niger CBS 120604 as a feed additive for chickens for fattening, minor poultry species for fattening and chickens reared for laying (holder of authorisation: Kerry Ingredients & Flavours Ltd.) and repealing Implementing Regulations (EU) No 237/2012 and (EU) No 1365/2013 (Text with EEA relevance) THE EUROPEAN COMMISSION, Having regard to the Treaty on the Functioning of the European Union, Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003on additives for use in animal nutrition(1), and in particular Article 9(2) thereof,

Whereas:

(1) Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting and renewing such an authorisation.

(2) A preparation of alpha-galactosidase produced by Saccharomyces cerevisiae CBS 615.94 and endo-1,4-beta-glucanase produced by Aspergillus niger CBS 120604, was authorised for 10 years as a feed additive for chickens for fattening by Commission Implementing Regulation (EU) No 237/2012(2), and for minor poultry species for fattening and chickens reared for laying by Commission Implementing Regulation (EU) No 1365/2013(3).

(3) In accordance with Article 14(1) of Regulation (EC) No 1831/2003, an application was submitted for the renewal of the authorisation of the preparation of alpha-galactosidase produced by Saccharomyces cerevisiae CBS 615.94 and endo-1,4-beta-glucanase produced by Aspergillus niger CBS 120604, as a feed additive for chickens for fattening, minor poultry species for fattening and chickens reared for laying, requesting the additive to be classified in the additive category ‘zootechnical additives’ and in the functional group ‘digestibility enhancers’. That application was accompanied by the particulars and documents required under Article 14(2) of Regulation (EC) No 1831/2003.

(4) The European Food Safety Authority (‘the Authority’) concluded in its opinion of 6 July 2023(4)that the preparation of alpha-galactosidase produced by Saccharomyces cerevisiae CBS 615.94 and endo-1,4-beta-glucanase produced by Aspergillus niger CBS 120604 remains safe for chickens for fattening, minor poultry species for fattening and chickens reared for laying, the consumers and the environment under the conditions of use currently authorised. It also concluded that the preparation of alpha-galactosidase produced by Saccharomyces cerevisiae CBS 615.94 and endo-1,4-beta-glucanase produced by Aspergillus niger CBS 120604, is a skin and eye irritant and a dermal sensitiser, and that it should be considered a respiratory sensitiser. It also indicated that there is no need for assessing the efficacy of the preparation of alpha-galactosidase produced by Saccharomyces cerevisiae CBS 615.94 and endo-1,4-beta-glucanase produced by Aspergillus niger CBS 120604 as the application for renewal of the

(1) OJ L 268, 18.10.2003, p. 29, ELI: http://data.europa.eu/eli/reg/2003/1831/oj.

(2) Commission Implementing Regulation (EU) No 237/2012 of 19 March 2012 concerning the authorisation of alpha-galactosidase (EC

3.2.1.22) produced by Saccharomyces cerevisiae (CBS 615.94) and endo-1,4-beta-glucanase (EC 3.2.1.4) produced by Aspergillus niger (CBS 120604) as a feed additive for chickens for fattening (holder of authorisation Kerry Ingredients and Flavours) (OJ L 80,

20.3.2012, p. 1, ELI: http://data.europa.eu/eli/reg_impl/2012/237/oj).

(3) Commission Implementing Regulation (EU) No 1365/2013 of 18 December 2013 concerning the authorisation of a preparation of alpha-galactosidase produced by Saccharomyces cerevisiae (CBS615.94) and endo-1,4-beta-glucanase produced by Aspergillus niger (CBS

120604) as a feed additive for minor poultry species for fattening and for chickens reared for laying (holder of authorisation Kerry Ingredients and Flavours) (OJ L 343, 19.12.2013, p. 31, ELI: http://data.europa.eu/eli/reg_impl/2013/1365/oj).

(4) EFSA Journal 2023;21(8):8175.

ELI: http://data.europa.eu/eli/reg_impl/2024/781/oj 1/6EN OJ L, 6.3.2024 authorisation does not include a proposal for amending or supplementing the conditions of the original authorisations which would have an impact on the efficacy of the additive. The Authority did not consider that there is a need for specific requirements of post-market monitoring.

(5) The Reference Laboratory set up by Regulation (EC) No 1831/2003 considered that the conclusions and recommendations reached in the assessment carried out regarding the method of analysis of the preparation of alpha-galactosidase produced by Saccharomyces cerevisiae CBS 615.94 and endo-1,4-beta-glucanase produced by Aspergillus niger CBS 120604 as a feed additive in the context of the previous authorisations are valid and applicable for the current application. In accordance with Article 5(4), point (c), of Commission Regulation (EC) No 378/2005(5), an evaluation report of the Reference Laboratory is therefore not required.

(6) In view of the above, the Commission considers that the preparation of alpha-galactosidase produced by Saccharomyces cerevisiae CBS 615.94 and endo-1,4-beta-glucanase produced by Aspergillus niger CBS 120604, satisfies the conditions, as provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the authorisation of that additive should be renewed. In addition, the Commission considers that appropriate protective measures should be taken to prevent adverse effects on the health of the users of the additive. Those protective measures should be without prejudice to other workers’ safety requirements under Union law.

(7) As a consequence of the renewal of the authorisation of the preparation of alpha-galactosidase produced by Saccharomyces cerevisiae CBS 615.94 and endo-1,4-beta-glucanase produced by Aspergillus niger CBS 120604, as a feed additive, Implementing Regulations (EU) No 237/2012 and (EU) No 1365/2013 should be repealed.

(8) Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation of the preparation of alpha-galactosidase produced by Saccharomyces cerevisiae CBS 615.94 and endo-1,4-beta- glucanase produced by Aspergillus niger CBS 120604, it is appropriate to provide for a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the renewal of the authorisation.

(9) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

HAS ADOPTED THIS REGULATION:

Article 1 Renewal of authorisation The authorisation of the preparation specified in the Annex, belonging to the additive category ‘zootechnical additives’ and to the functional group ‘digestibility enhancers’, is renewed subject to the conditions laid down in that Annex.

Article 2 Repeals Implementing Regulations (EU) No 237/2012 and (EU) No 1365/2013 are repealed.

(5) Commission Regulation (EC) No 378/2005 of 4 March 2005 on detailed rules for the implementation of Regulation (EC) No 1831/2003 of the European Parliament and of the Council as regards the duties and tasks of the Community Reference Laboratory concerning applications for authorisations of feed additives (OJ L 59, 5.3.2005, p. 8, ELI: http://data.europa.eu/eli/reg/ 2005/378/oj).

2/6 ELI: http://data.europa.eu/eli/reg_impl/2024/781/ojEN OJ L, 6.3.2024 Article 3 Transitional measures

1. The preparation specified in the Annex and premixtures containing that preparation, which are produced and labelled before 26 September 2024 in accordance with the rules applicable before 26 March 2024 may continue to be placed on the market and used until the existing stocks are exhausted.

2. Compound feed and feed materials containing the preparation specified in the Annex, which are produced and labelled before 26 March 2025in accordance with the rules applicable before 26 March 2024may continue to be placed on the market and used until the existing stocks are exhausted.

Article 4 Entry into force This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 5 March 2024.

For the Commission The President Ursula VON DER LEYEN

ELI: http://data.europa.eu/eli/reg_impl/2024/781/oj 3/64/6

ELI:

http://data.europa.eu/eli/reg_impl/2024/781/oj ANNEX Maximum Minimum content Identifica- content tion Name of the holder Composition, chemical formula, Species or category Maximum End of period of Additive Other provisions number of of authorisation description, analytical method of animal age Units of activity/kg of complete authorisation the additive feedingstuff with a moisture content of 12 % Category of zootechnical additives. Functional group: digestibility enhancers 4a17 Kerry Ingredients Alpha- Additive composition Chickens for — 50 U alpha- — 1. In the directions for use of 26 March 2034 and Flavours Ltd. galactosidase Preparation of alpha- fattening galactosidase the additive and premix­ (EC 3.2.1.22) galactosidase produced by ture, the storage condi­ Endo-1,4- Saccharomyces cerevisiae CBS Minor poultry 285 U tions and stability to heat beta- 615.94 and endo-1,4-beta- species for endo-1,4-beta- treatment shall be indi­ glucanase (EC glucanase produced by fattening glucanase cated.

3.2.1.4) Aspergillus niger CBS 120604 2. Indicate in the directions Chickens reared

having a minimum activity of: for use: for laying — 1 000 U (1) alpha-galactosi ‘Maximum recommended dase/g, dose: — 5 700U(2)endo-1,4-beta-glu — 100 U alpha-galactosi­ canase/g. dase/kg complete feed Solid form. — 570 U endo-1,4-beta-gluca­ nase/kg complete feed’ Characterisation of the active

3. For users of the additive substance and premixtures, feed Alpha-galactosidase (EC business operators shall

3.2.1.22) produced by establish operational pro­ Saccharomyces cerevisiae CBS cedures and organisational

615.94 and endo-1,4-beta- measures to address the glucanase (EC 3.2.1.4) produced potential risks resulting by Aspergillus niger CBS 120604. from their use. Where Analytical method (3) those risks cannot be For the determination of alpha- eliminated by such proce­

galactosidase: in the feed additive, dures and measures, the

premixtures and compound feed: additive and premixtures colorimetric method measuring shall be used with personal p-nitrophenol released by action breathing, eye and skin protective equipment.

EN OJ L,

6.3.2024ELI:

http://data.europa.eu/eli/reg_impl/2024/781/oj 5/6 of alpha-galactosidase from p-nitrophenyl-alpha- galactopyranoside substrate.

For the determination of endo-1,4-beta-glucanase in the feed additive, premixtures and

compound feed: colorimetric method measuring water soluble dye released by action of endo-1,4-beta-glucanase from azurine-crosslinked barley glucan substrate.

Category of zootechnical additives. Functional group: digestibility enhancers 4a17 Kerry Ingredients Alpha- Additive composition Chickens for — 50 U alpha- — 1. In the directions for use of 26 March 2034 and Flavours Ltd. galactosidase Preparation of alpha- fattening galactosidase the additive and premix­ (EC 3.2.1.22) galactosidase produced by ture, the storage condi­ Endo-1,4- Saccharomyces cerevisiae CBS 285 U tions and stability to heat beta- 615.94 and endo-1,4-beta- endo-1,4-beta- treatment shall be indi­ glucanase (EC glucanase produced by glucanase cated.

3.2.1.4) Aspergillus niger CBS 120604 2. Indicate in the directions

having a minimum activity of: for use: — 500 U alpha-galactosidase/g, ‘Maximum recommended — 2 850U dose: endo-1,4-beta-glucanase/g. — 100 U alpha-galactosi­ Liquid form. dase/kg complete feed — 570 U Characterisation of the active endo-1,4-beta-gluca­ substance nase/kg complete feed’ Alpha-galactosidase (EC 3. For users of the additive

3.2.1.22) produced by and premixtures, feed Saccharomyces cerevisiae CBS business operators shall

615.94 and endo-1,4-beta- establish operational pro­ glucanase (EC 3.2.1.4) produced cedures and organisational by Aspergillus niger CBS 120604. measures to address the potential risks resulting from their use. Where those risks cannot be OJ L,

6.3.2024 EN6/6

ELI:

http://data.europa.eu/eli/reg_impl/2024/781/oj Analytical method eliminated by such proce­ For the determination of alpha- dures and measures, the

galactosidase: in the feed additive, additive and premixtures

premixtures and compound feed: shall be used with personal colorimetric method measuring breathing, eye and skin p-nitrophenol released by action protective equipment. of alpha- galactosidase from p-nitrophenyl-alpha- galactopyranoside substrate.

For the determination of endo-1,4-beta-glucanase in the feed additive, premixtures and

compound feed: colorimetric method measuring water soluble dye released by action of endo-1,4-beta-glucanase from azurine-crosslinked barley glucan substrate.

(1) One alpha-galactosidase unit (U) is the amount of enzyme that will produce one micromole of para-nitrophenol per minute from p-nitrophenyl-alpha-galactopyranoside (pNPG) under the specified conditions (pH = 5,0; temperature 37 °C).

(2) One endo-1,4-beta-glucanase unit (U) is the amount of enzyme that will produce one milligram of reducing sugar (glucose equivalent) per minute from hydrolyses of beta-D-glucans under the specified conditions (pH = 5,0; temperature 50 °C).

(3) Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation- reports_en EN OJ L,

6.3.2024