Date: 2023-03-23Category: Not ApplicableState: Union GovernmentCountry: Europe
Commission Implementing Regulation (EU) 2023/669 of 22 March 2023 concerning the authorisation of a preparation of endo-1,4-beta-xylanase produced by Komagataella phaffii DSM 33574 as a feed additive for all poultry species for fattening and all poultry species reared for laying and reared for breeding (holder of authorisation: BioResource, international, Inc. represented in the Union by Pen & Tec Consulting, S.L.U.) (Text with EEA relevance)
Issued by European Commission
· Directorate-General for Health and Food Safety
Executive Summary:
Commission Implementing Regulation (EU) 2023/669 authorises the use of endo-1,4-beta-xylanase produced by Komagataella phaffii DSM 33574 as a zootechnical feed additive (digestibility enhancer) for all poultry species for fattening, laying and breeding. The authorisation, held by BioResource, international, Inc., is valid until April 13, 2033. The regulation outlines conditions of use, including protective measures for users and proper indication of storage conditions and stability to heat treatment in the directions for use.
Key Points / Main Content:
Authorisation:
* Authorises endo-1,4-beta-xylanase produced by Komagataella phaffii DSM 33574 as a feed additive for all poultry species for fattening, laying and breeding.
* The additive is classified as a zootechnical additive (category) and digestibility enhancer (functional group).
* The holder of authorisation is BioResource, international, Inc.
Conditions of Use:
* The additive shall not be used in premixtures.
* Directions for use must include storage conditions and stability to heat treatment.
* Users must establish operational procedures and organisational measures to address potential risks.
* Personal protective equipment (breathing, skin, and eye protection) must be used if risks cannot be eliminated or minimised.
* Maximum content in feedingstuff with a moisture content of 12 % is 10 000 XU/kg.
Analytical Methods:
* Specifies colorimetric DNS method for determining endo-1,4-beta-xylanase activity in the feed additive.
* Specifies colorimetric method based on the enzymatic reaction of endo-1,4-beta-xylanase on the Xy1X6 substrate for compound feed.
Validity:
* The authorisation is valid until April 13, 2033.
Impact Analysis:
BioResource, international, Inc. (Holder of Authorisation):
* Impact: Authorised to market the specified endo-1,4-beta-xylanase preparation as a feed additive.
* Action Required: Comply with the conditions of use outlined in the Annex, including providing appropriate directions for use.
Feed Business Operators:
* Impact: Can use the authorised feed additive in poultry feed, provided they adhere to the specified conditions.
* Action Required: Establish operational procedures and organisational measures to address potential risks to users and ensure the additive is used safely, including the use of personal protective equipment where necessary.
Poultry Farmers:
* Impact: Can use feed containing the authorised additive for their poultry.
* Action Required: Follow the directions for use provided by the feed business operators and adhere to safety measures.
Users of the Additive:
* Impact: Potential exposure to the preparation, which is a respiratory sensitiser and potential eye irritant.
* Action Required: Use appropriate personal protective equipment (breathing, skin, and eye protection) when handling the additive.
Key Entities Referenced
European Union: The political and economic union to which the regulation applies.
European Commission: The executive branch of the European Union responsible for proposing and implementing legislation.
Regulation (EC) No 1831/2003: A regulation of the European Parliament and of the Council on additives for use in animal nutrition.
European Food Safety Authority: The Authority that provided an opinion on the safety and efficacy of the feed additive.
Komagataella phaffii DSM 33574: The microorganism used to produce the endo-1,4-beta-xylanase enzyme.
BioResource International, Inc.: The holder of the authorisation for the feed additive.
Pen Tec Consulting, S.L.U.: The company representing BioResource International, Inc. in the European Union.
Standing Committee on Plants, Animals, Food and Feed: The committee that provided an opinion on the measures provided for in the regulation.
L 84/10 EN Official Journal of the European Union 23.3.2023
COMMISSION IMPLEMENTING REGULATION (EU) 2023/669
of 22 March 2023
concerning the authorisation of a preparation of endo-1,4-beta-xylanase produced by Komagataella
phaffii DSM 33574 as a feed additive for all poultry species for fattening and all poultry species
reared for laying and reared for breeding (holder of authorisation: BioResource, international, Inc.
represented in the Union by Pen & Tec Consulting, S.L.U.)
(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 such authorisation.
(2) In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation
of a preparation of endo-1,4-beta-xylanase produced by Komagataella phaffii DSM 33574. The application was
accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.
(3) That application concerns the authorisation of a preparation of endo-1,4-beta-xylanase produced by Komagataella
phaffii DSM 33574 as a feed additive for all poultry species for fattening and all poultry species reared for laying and
reared for breeding, to be classified in the additive category ‘zootechnical additives’ and in the functional group
‘digestibility enhancers’.
(4) The European Food Safety Authority (‘the Authority’) concluded in its opinion of 29 June 2022(2)that, under the
proposed conditions of use, the preparation of endo-1,4-beta-xylanase produced by Komagataella phaffii DSM
33574 does not have an adverse effect on animal health as regards the target species, on consumer safety or on the
environment. In addition, the Authority concluded that the exposure of users to the preparation by inhalation is
very likely, that the preparation is a respiratory sensitiser and that it has a potential to be eye irritant. No
conclusions could be drawn on the potential of the preparation to cause skin sensitisation.
(5) The Authority further concluded that the preparation has the potential to be efficacious for all poultry species for
fattening and all poultry species reared for laying and reared for breeding. The Authority does not consider that
there is a need for specific requirements of post-market monitoring. It also verified the report on the method of
analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.
(6) The assessment of the preparation of endo-1,4-beta-xylanase produced by Komagataella phaffii DSM 33574 shows
that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied.
Accordingly, the use of that preparation should be authorised as specified in the Annex to this Regulation. The
Commission considers that appropriate protective measures should be taken to prevent adverse effects on human
health, in particular as regards the users of that preparation.
(7) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on
Plants, Animals, Food and Feed,
(1) OJ L 268, 18.10.2003, p. 29.
(2) EFSA Journal 2022;20(7):7428.23.3.2023 EN Official Journal of the European Union L 84/11
HAS ADOPTED THIS REGULATION:
Article 1
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, subject to the conditions laid down in that
Annex.
Article 2
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, 22 March 2023.
For the Commission
The President
Ursula VON DER LEYENANNEX
Maximum
Identifi- Minimum content
content
cation
Name of the holder of Composition, chemical formula, Species or category Maximum End of period of
number Additive Other provisions
authorisation description, analytical method of animal age Units of activity/kg of complete authorisation
of the
feedingstuff with a moisture
additive
content of 12 %
Category of zootechnical additives. Functional group: digestibility enhancers
4a35 BioResource Endo-1,4-beta- Additive composition All poultry spe — 10 000XU — 1. The additive shall not be 13.4.2033
International, Inc. xylanase (EC Preparation of endo-1,4-beta- cies for fattening used in premixtures.
represented in the 3.2.1.8) xylanase (EC 3.2.1.8) produced All poultry spe 2. In the directions for use of
Union by Pen & by Komagataella phaffii DSM cies reared for the additive, the storage
Tec Consulting, S.L.U. 33574 with a minimum laying or reared conditions and stability
activity of: for breeding pur to heat treatment shall
150 000XU(1)/g poses be indicated.
3. For users of the additive,
Solid form
feed business operators
Characterisation of the active shall establish operational
substance procedures and organisa
Endo-1,4-beta-xylanase (EC tional measures to ad
3.2.1.8) produced by dress potential risks re
Komagataella phaffii (DSM sulting from its use.
33574) Where those risks cannot
be eliminated or reduced
Analytical method(2)
to a minimum by such
For the determination of procedures and measures,
endo-1,4-beta-xylanase the additive shall be used
activity in the feed additive: with personal protective
colorimetric (DNS) method equipment, including
based on the enzymatic breathing, skin and eyes
hydrolysis of the beechwood protection.
xylan substrate.
L
84/12
EN
Official
Journal
of
the
European
Union
23.3.2023For the determination of
endo-1,4-beta-xylanase
activity in compound feed:
colorimetric method based on
the enzymatic reaction of
endo-1,4-beta-xylanase on the
Xy1X6 substrate.
(1) One XU unit is the amount of enzyme which releases 1 nano-mol of reducing sugar (xylose equivalent) per second from xylan of beechwood at 50 °C and pH 6,0.
(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
23.3.2023
EN
Official
Journal
of
the
European
Union
L
84/13