Commission Implementing Regulation (EU) 2024/1058 of 10 April 2024 concerning the renewal of the authorisation of a preparation of endo–1,4-beta-xylanase produced by Aspergillus oryzae DSM 33700 as a feed additive for poultry for fattening, weaned piglets, pigs for fattening, lactating sows and laying hens, the change of the terms of the authorisation and authorisation of new uses of that preparation as a feed additive for all poultry species and all Suidae (holder of authorisation: DSM Nutritional Products Ltd, represented by DSM Nutritional Products Sp. z o.o.) and repealing Implementing Regulations (EU) No 1206/2012, (EU) No 2020/995 and (EU) 2020/1034
Date: 2024-04-10
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: animal feedingstuffs, enzyme, fattening, food additive, market approval, poultry, swine




L_202401058EN.000101.fmx.xml












Official Journal of the European Union


EN
L series













2024/1058


11.4.2024







            COMMISSION IMPLEMENTING REGULATION (EU) 2024/1058
of 10 April 2024
         
concerning the renewal of the authorisation of a preparation of endo–1,4-beta-xylanase produced by Aspergillus oryzae DSM 33700 as a feed additive for poultry for fattening, weaned piglets, pigs for fattening, lactating sows and laying hens, the change of the terms of the authorisation and authorisation of new uses of that preparation as a feed additive for all poultry species and all Suidae (holder of authorisation: DSM Nutritional Products Ltd, represented by DSM Nutritional Products Sp. z o.o.) and repealing Implementing Regulations (EU) No 1206/2012, (EU) No 2020/995 and (EU) 2020/1034
(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 2003 on additives for use in animal nutrition (1), and in particular Article 9(2) and Article 13(3) 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, modifying and renewing such an authorisation.












(2)


A preparation of endo–1,4-beta-xylanase produced by Aspergillus oryzae DSM 26372 was authorised for a period of 10 years as a feed additive for poultry for fattening, weaned piglets and pigs for fattening by Commission Implementing Regulation (EU) No 1206/2012 (2), for lactating sows by Commission Implementing Regulation (EU) 2020/995 (3) and for laying hens by Commission Implementing Regulation (EU) 2020/1034 (4).












(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 endo–1,4-beta-xylanase produced by Aspergillus oryzae DSM 26372 as a feed additive for poultry for fattening, weaned piglets, pigs for fattening, lactating sows and laying hens, requesting that additive to be classified in the additive category ‘zootechnical additives’ and in the functional group ‘digestibility enhancers’. In the context of that application, the holder of the authorisation also proposed changing the terms of the authorisation of the preparation concerned by requesting for a change in the production strain, from Aspergillus oryzae DSM 26372 to Aspergillus oryzae DSM 33700 in accordance with Article 13(3) of Regulation (EC)No 1831/2003. The application was accompanied by the particulars and documents required under Article 14(2) and by the relevant data supporting the request for the change.












(4)


In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of new uses of the preparation endo–1,4-beta-xylanase produced by Aspergillus oryzae DSM 33700. The application concerns the authorisation of that preparation as a feed additive for all poultry species and all Suidae, requesting that additive to be classified in the category ‘zootechnical additives’ and in the functional group ‘digestibility enhancers’. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.












(5)


The European Food Safety Authority (‘the Authority’) concluded in its opinion of 26 September 2023 (5) that the preparation of endo–1,4-beta-xylanase produced by Aspergillus oryzae DSM 33700 remains safe for poultry for fattening, weaned piglets, pigs for fattening, lactating sows and laying hens, the consumers and the environment under the conditions of use currently authorised. It also concluded that the additive is safe for all poultry and all Suidae, the consumers and the environment, under the recommended conditions of use. The Authority further stated that both formulations of the additive (liquid and solid) were not irritant to skin. Liquid formulation is not an eye irritant, however, no conclusions can be drawn on the potential of solid formulation to be an eye irritant. Due to the lack of data, the Authority was not able to conclude on the potential of both formulations of the additive to be dermal sensitisers. Due to the proteinaceous nature of the active substance (xylanase), the additive is considered a respiratory sensitiser. As regards the proposed new uses for the additional target species, the Authority concluded that the additive has the potential to be efficacious in all poultry species and in all Suidae at the proposed conditions of use. The Authority further concluded that the preparation of endo–1,4-beta-xylanase produced by Aspergillus oryzae DSM 33700 remains efficacious for poultry for fattening, weaned piglets, pigs for fattening, lactating sows and laying hens. The Authority did not consider that there is a need for specific requirements of post-market monitoring.












(6)


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 endo–1,4-beta-xylanase produced by Aspergillus oryzae DSM 33700 as a feed additive in the context of the previous authorisation are valid and applicable for the current application. In accordance with Article 5(4), point (c), of Commission Regulation (EC) No 378/2005 (6), an evaluation report of the Reference Laboratory is therefore not required.












(7)


In view of the above, the Commission considers that the preparation of endo–1,4-beta-xylanase produced by Aspergillus oryzae DSM 33700 satisfies the conditions provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the authorisation of that additive should be renewed for poultry for fattening, weaned piglets, pigs for fattening, lactating sows and laying hens, and the use of that preparation should be authorised for all poultry species other than poultry for fattening and laying hens, and all Suidae other than weaned piglets, pigs for fattening and lactating sows. 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.












(8)


As a consequence of the renewal of the authorisation of the preparation of endo–1,4-beta-xylanase produced by Aspergillus oryzae DSM 33700 as a feed additive for poultry for fattening, weaned piglets, pigs for fattening, lactating sows and laying hens, Implementing Regulations (EU) No 1206/2012, (EU) No 2020/995 and (EU) 2020/1034 should be repealed.












(9)


Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation of the preparation of endo–1,4-beta-xylanase produced by Aspergillus oryzae DSM 33700 for poultry for fattening, weaned piglets, pigs for fattening, lactating sows and laying hens, 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.












(10)


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 for poultry for fattening, weaned piglets, pigs for fattening, lactating sows and laying hens, subject to the conditions laid down in that Annex.


Article 2

Authorisation

The preparation specified in the Annex, belonging to the additive category ‘zootechnical additives’ and to the functional group ‘digestibility enhancers’, is authorised as an additive in animal nutrition for all poultry species other than poultry for fattening and laying hens, and all Suidae other than weaned piglets, pigs for fattening and lactating sows, subject to the conditions laid down in that Annex.


Article 3

Repeals

Implementing Regulations (EU) No 1206/2012, (EU) No 2020/995 and (EU) 2020/1034 are repealed.


Article 4

Transitional measures


1.   The preparation specified in the Annex and premixtures containing that preparation, which are intended for poultry for fattening, weaned piglets, pigs for fattening, lactating sows and laying hens, and which are produced and labelled 1 November 2024 in accordance with the rules applicable before 1 May 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 intended for poultry for fattening, weaned piglets, pigs for fattening, lactating sows and laying hens, and which are produced and labelled before 1 May 2025 in accordance with the rules applicable before 1 May 2024 may continue to be placed on the market and used until the existing stocks are exhausted.



Article 5


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, 10 April 2024.


For the Commission


The President

Ursula VON DER LEYEN
            





(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 1206/2012 of 14 December 2012 concerning the authorisation of a preparation of endo–1,4-beta-xylanase produced by Aspergillus oryzae (DSM 10287) as a feed additive for poultry for fattening, weaned piglets and pigs for fattening and amending Regulations (EC) No 1332/2004 and (EC) No 2036/2005 (holder of the authorisation DSM Nutritional Products) (OJ L 347, 15.12.2012, p. 12, ELI: http://data.europa.eu/eli/reg_impl/2012/1206/oj).

(3)  Commission Implementing Regulation (EU) 2020/995 of 9 July 2020 concerning the authorisation of a preparation of endo–1,4-beta-xylanase produced by Aspergillus oryzae (DSM 26372) as a feed additive for lactating sows (holder of authorisation DSM Nutritional Products Ltd represented by DSM Nutritional Products Sp. Z o.o) (OJ L 221, 10.7.2020, p. 84, ELI: http://data.europa.eu/eli/reg_impl/2020/995/oj).

(4)  Commission Implementing Regulation (EU) 2020/1034 of 15 July 2020 concerning the authorisation of a preparation of endo–1,4-beta-xylanase produced by Aspergillus oryzae (DSM 26372) as a feed additive for laying hens (holder of authorisation DSM Nutritional Products Ltd represented by DSM Nutritional Products Sp. Z o.o) (OJ L 227, 16.7.2020, p. 34, ELI: http://data.europa.eu/eli/reg_impl/2020/1034/oj).

(5)  
            EFSA Journal 2023;21(10):8339.

(6)  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).




ANNEX














Identification number of the feed additive


Name of the holder of authorisation


Additive


Composition, chemical formula, description, analytical method


Species or category of animal


Maximum age


Minimum content


Maximum content


Other provisions


End of period of authorisation




Units of activity/kg of complete feedingstuff with a moisture content of 12 %





Category: zootechnical additives. Functional group: digestibility enhancers.





4a1607ii


DSM Nutritional Products Ltd, represented by DSM Nutritional Products Sp. z o.o.


Endo–1,4-beta-xylanase (EC 3.2.1.8)



Additive composition

Preparation of endo–1,4-beta-xylanase (EC 3.2.1.8) produced by Aspergillus oryzae DSM 33700 having a minimum activity of: Solid form: 1 000 FXU (1)/g
Liquid form: 650 FXU/ml

Characterisation of the active substance

Endo–1,4-beta-xylanase (EC 3.2.1.8) produced by Aspergillus oryzae DSM 33700.

Analytical method
 (2)

For the quantification of endo–1,4-beta-xylanase in the feed additive:






—


colorimetric method measuring coloured compound produced by the dinitro salicylic acid (DNSA) and the xylosylic moieties released by the action of xylanase on arabinoxylan.




For the quantification of endo–1,4 -beta-xylanase in premixtures and compound feed:






—


colorimetric method measuring water soluble dye released by action of xylanase from dye-labelled oat spelt azo-xylan.






All poultry species


—


100 FXU


—








1.


In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated.










2.


For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from its use.




Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, eye protection and skin protection.


1 May 2034




All Suidae


200 FXU






(1)  One xylanase unit (FXU) is the amount of enzyme which liberates 7,8 micromoles of reducing sugars (xylose equivalents) from azo-wheat arabinoxylan per minute at pH 6,0 and 50 °C.

(2)  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




ELI: http://data.europa.eu/eli/reg_impl/2024/1058/oj
ISSN 1977-0677 (electronic edition)