Date: 2023-03-23Category: Not ApplicableState: Union GovernmentCountry: Europe
Commission Implementing Regulation (EU) 2023/668 of 22 March 2023 concerning the authorisation of a preparation of endo-1,4-beta-xylanase produced by Komagataella phaffii ATCC PTA-127053 as a feed additive for all laying poultry (holder of authorisation: Kemin Europa N.V.) (Text with EEA relevance)
Issued by European Commission
· Directorate-General for Health and Food Safety
Executive Summary:
Commission Implementing Regulation (EU) 2023/668 authorises the use of endo-1,4-beta-xylanase produced by Komagataella phaffii ATCC PTA127053 as a zootechnical feed additive (digestibility enhancer) for all laying poultry. The authorisation, granted to Kemin Europa N.V., is valid until 13 April 2033. Specific conditions for use, including safety measures for users, are detailed in the Annex.
Key Points / Main Content:
* **Authorisation:**
* A preparation of endo-1,4-beta-xylanase produced by Komagataella phaffii ATCC PTA127053 is authorised as a feed additive for all laying poultry.
* Additive category: Zootechnical additives.
* Functional group: Digestibility enhancers.
* **Holder of Authorisation:** Kemin Europa N.V.
* **Composition and Activity:**
* The additive must have a minimum endo-1,4-beta-xylanase activity of 3,000,000 U/g.
* The maximum content in complete feeding stuff is 45,000 U/kg.
* **Conditions of Use:**
* The directions for use of the additive and premixes must specify storage conditions and stability to heat treatment.
* Feed business operators must establish procedures and organisational measures to address potential risks to users of the additive and premixes.
* If risks cannot be eliminated or minimised, appropriate personal protective equipment (breathing and skin protection) must be used.
* **Duration of Authorisation:** The authorisation is valid until 13 April 2033.
* **Analytical Methods:**
* Specific colorimetric methods for determining endo-1,4-beta-xylanase in the feed additive, premixtures, and compound feed are referenced.
* Details are available at the EU Reference Laboratory.
Impact Analysis:
Feed Business Operators/Users of the Additive and Premixes:
* Impact: They are authorised to use the specified enzyme preparation as a feed additive for laying poultry, enhancing digestibility.
* Action Required: They must implement operational procedures and organisational measures to address potential risks to workers. If risks are not eliminated or minimised, they need to ensure appropriate personal protective equipment is used. They must follow directions for the use of the additive and premixes, including correct storage conditions.
Kemin Europa N.V. (Holder of Authorisation):
* Impact: They are authorised to market the specified enzyme preparation as a feed additive.
* Action Required: They must ensure that the directions for use of the additive and premixes include storage conditions and stability to heat treatment.
European Food Safety Authority (EFSA):
* Impact: Their positive scientific opinion paved the way for the authorization.
* Action Required: No action specified.
EU Reference Laboratory:
* Impact: Responsible for providing the analytical methods to determine the content of xylanase.
* Action Required: Maintain the website with the details of the analytical methods.
Key Entities Referenced
European Union: The political and economic union of European member states.
European Commission: The executive branch of the European Union responsible for proposing legislation, implementing decisions, and managing the EU's day-to-day operations.
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: An agency of the European Union that provides independent scientific advice and communicates on existing and emerging risks associated with the food chain.
Komagataella phaffii ATCC PTA127053: A strain of yeast used to produce the enzyme endo-1,4-beta-xylanase.
endo-1,4-beta-xylanase: An enzyme produced by Komagataella phaffii ATCC PTA127053, used as a feed additive for laying poultry to enhance digestibility.
Kemin Europa N.V.: The holder of the authorization for the feed additive preparation of endo-1,4-beta-xylanase.
Brussels: The city where the regulation was adopted.
23.3.2023 EN Official Journal of the European Union L 84/7
COMMISSION IMPLEMENTING REGULATION (EU) 2023/668
of 22 March 2023
concerning the authorisation of a preparation of endo-1,4-beta-xylanase produced by Komagataella
phaffii ATCC PTA-127053 as a feed additive for all laying poultry (holder of authorisation: Kemin
Europa N.V.)
(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 ATCC PTA-127053. That application
was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.
(3) The application concerns the authorisation of a preparation of endo-1,4-beta-xylanase produced by Komagataella
phaffii ATCC PTA-127053 as a feed additive for all laying poultry, 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 ATCC PTA-
127053 did not have an adverse effect on consumer safety or the environment. As regards the target species, the
Authority concluded that the additive is safe and has the potential to be efficacious for laying hens when added to
feed at 45 000U/kg and that the conclusions on laying hens can be extrapolated to all laying poultry species.
(5) The Authority concluded that that additive was not irritant to eyes and skin but was considered a dermal and
respiratory sensitiser.
(6) The Authority considered that there was no 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.
(7) The assessment of the preparation of endo-1,4-beta-xylanase produced by Komagataella phaffii ATCC PTA-127053
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. The Commission considers that appropriate
protective measures should be taken to prevent adverse effects on human health, in particular as regards the users of
the additive.
(8) 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):7439.L 84/8 EN Official Journal of the European Union 23.3.2023
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
Minimum Maximum
Identifi- content content
cation Species or
Name of the holder of Composition, chemical formula, description, Maximum End of period of
number Additive category of Units of activity/kg of Other provisions
authorisation analytical method age authorisation
of the animal complete feedingstuff
additive with a moisture content
of 12 %
Category of zootechnical additives. Functional group: digestibility enhancers
4a36 Kemin Europa N.V. Endo-1,4-beta- Additive composition All laying — 45 000U — 1. In the directions for use of 13.4.2033
xylanase (EC Preparation of endo-1,4-beta-xylanase poultry the additive and premix
3.2.1.8) (EC 3.2.1.8) produced by Komagataella tures, the storage condi
phaffii ATCC PTA-127053 with a tions and stability to heat
minimum activity of: treatment shall be indi
3 000 000U(1)/g cated.
Solid form 2. For users of the additive
Characterisation of the active substance and premixtures, feed
Endo-1,4-beta-xylanase (EC 3.2.1.8) business operators shall
produced by Komagataella phaffii ATCC establish operational pro
PTA-127053 cedures and organisa
Analytical method(2) tional measures to ad
For the determination of endo-1,4-beta- dress potential risks
xylanase in the feed additive: resulting from their use.
— colorimetric method based on the Where those risks cannot
enzymatic hydrolysis of be eliminated or reduced
endo-1,4-beta-xylanase on the beech to a minimum by such
wood xylan substrate. procedures and measures,
For the determination of endo-1,4-beta- the additive and premix
xylanase in premixtures and compound tures shall be used with
feed: appropriate personal pro
— colorimetric method based the enzy tective equipment, in
matic reaction of endo-1,4-beta-xyla cluding breathing and
nase on the azurine cross-linked skin protection.
wheat arabinoxylan substrate.
(1) One U unit is the amount of enzyme that releases 0,0067 μmol of reducing sugar (xylose equivalent) per minute and per gram of enzyme product at 50 °C and pH 5,3.
(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
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