Date: 2023-12-21Category: Not ApplicableState: Union GovernmentCountry: Europe
Commission Implementing Regulation (EU) 2023/2850 of 20 December 2023 concerning the authorisation of a preparation of endo–1,4-beta-mannanase produced by Aspergillus niger CBS 120604 as a feed additive for all poultry species for fattening (holder of authorisation: Kerry Ingredients and Flavours Ltd)
Issued by European Commission
· Directorate-General for Health and Food Safety
Executive Summary:
Commission Implementing Regulation (EU) 2023/2850 authorises the use of a preparation of endo-1,4-betamannanase produced by Aspergillus niger CBS 120604 as a zootechnical feed additive (digestibility enhancer) for all poultry species for fattening. The authorisation is valid until 10 January 2034. The regulation addresses the safety and efficacy of the additive, as well as necessary protective measures for users.
Key Points / Main Content:
* **Authorisation:** A preparation of endo-1,4-betamannanase produced by Aspergillus niger CBS 120604 is authorised as a feed additive for all poultry species for fattening.
* **Additive Category:** Zootechnical additives, functional group: digestibility enhancers.
* **Holder of Authorisation:** Kerry Ingredients and Flavours Ltd.
* **Composition:** Preparation of endo-1,4-betamannanase produced by Aspergillus niger CBS 120604 having a minimum activity of 265 U/g solid form.
* **Maximum Content:** 30 U endo-1,4-betamannanase/kg of complete feedingstuff with a moisture content of 12%.
* **End of Authorisation Period:** 10 January 2034.
* **Safety:** The additive is considered an irritant to skin and eyes, and a dermal and respiratory sensitiser.
* **Analytical Method:** Colorimetric method based on the enzymatic reaction of endo-1,4-betamannanase on the azurine crosslinked carob galactomannan substrate.
* **Operational Procedures:** Feed business operators shall establish operational procedures and organizational measures to address potential risks resulting from the use of the additive, and use personal protective equipment where those risks cannot be eliminated.
* **Labelling:** The directions for use of the additive and premixture, the storage conditions and stability to heat treatment shall be indicated.
Impact Analysis:
**Poultry Producers (Fattening):**
* Impact: Can now use the authorised feed additive to potentially enhance digestibility in feed for poultry.
* Action Required: Follow the directions for use, including dosage, storage conditions, and stability information, as indicated on the additive and premixture.
**Feed Business Operators:**
* Impact: Responsible for incorporating the additive into feed and premixtures.
* Action Required: Establish operational procedures and organizational measures to address potential risks resulting from the use of the additive, and use personal protective equipment where those risks cannot be eliminated.
**Additive and Premixture Users:**
* Impact: Potential exposure to the additive.
* Action Required: Use personal breathing, eye, and skin protective equipment when handling the additive and premixtures if risks cannot be eliminated by procedures and measures.
**Kerry Ingredients and Flavours Ltd:**
* Impact: As the authorisation holder, they are responsible for the production and supply of the additive.
* Action Required: Ensure the additive meets the specified composition and activity levels, and provide necessary information on storage, stability, and safe handling.
Key Entities Referenced
European Union: A political and economic union of member states located primarily in Europe.
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 Parliament: The parliamentary body of the European Union that, together with the Council of the European Union, forms the EU's legislative branch.
Council of the European Union: One of the legislative bodies of the European Union. It is composed of government ministers from each EU member state.
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.
Kerry Ingredients and Flavours Ltd: The holder of authorisation for the feed additive preparation of endo-1,4-betamannanase.
Aspergillus niger CBS 120604: The strain of Aspergillus niger used to produce the endo 1,4-betamannanase feed additive.
Official Journal EN
of the European Union L series
2023/2850 21.12.2023
COMMISSION IMPLEMENTING REGULATION (EU) 2023/2850
of 20 December 2023
concerning the authorisation of a preparation of endo– 1,4-beta-mannanase produced by Aspergillus
niger CBS 120604 as a feed additive for all poultry species for fattening (holder of authorisation:
Kerry Ingredients and Flavours Ltd)
(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 an 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-mannanase produced by Aspergillus niger CBS 120604 as a feed additive. 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-mannanase produced by Aspergillus
niger CBS 120604 as a feed additive for all poultry species for fattening, requesting that additive to be classified in
the category ‘zootechnical additives’ and in the functional group ‘digestibility enhancers’.
(4) The European Food Safety Authority (‘the Authority’) concluded in its opinion of 11 May 2023(2)that, under the
proposed conditions of use, the preparation of endo– 1,4-beta-mannanase produced by Aspergillus niger CBS
120604 is safe for all poultry species for fattening, consumers and the environment. It also concluded that the
preparation of endo– 1,4-beta-mannanase produced by Aspergillus niger CBS 120604 is considered an irritant to
skin and eyes, and a dermal and respiratory sensitiser. The Authority further concluded that the preparation of
endo– 1,4-beta-mannanase produced by Aspergillus niger CBS 120604 has the potential to be efficacious at the level
of inclusion of 30 U endo– 1,4-beta-mannanase/kg complete feed for all poultry species for fattening. It did not
consider that there is a need for specific requirements of post-market monitoring. The Authority also verified the
report on the methods of analysis of the feed additive in feed submitted by the Reference Laboratory set up by
Regulation (EC) No 1831/2003.
(5) In view of the above, the Commission considers that the preparation of endo– 1,4-beta-mannanase produced by
Aspergillus niger CBS 120604 satisfies the conditions for authorisation provided for in Article 5 of Regulation (EC)
No 1831/2003. Accordingly, the use of that preparation should be authorised for all poultry species for fattening.
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.
(6) 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 2023;21(6):8045.
ELI: http://data.europa.eu/eli/reg_impl/2023/2850/oj 1/3EN
OJ L, 21.12.2023
HAS ADOPTED THIS REGULATION:
Article 1
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, subject to the conditions laid down in that
Annex.
Article 2
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, 20 December 2023.
For the Commission
The President
Ursula VON DER LEYEN
2/3 ELI: http://data.europa.eu/eli/reg_impl/2023/2850/ojELI:
http://data.europa.eu/eli/reg_impl/2023/2850/oj
3/3
ANNEX
Minimum Maximum
Identifi- content content
cation Species or
Name of the holder Composition, chemical formula, Maxi- End of period of
number Additive category of Units of activity/kg of Other provisions
of authorisation description, analytical method mum age authorisation
of the animal complete feedingstuff
additive with a moisture content
of 12%
Category of zootechnical additives. Functional group: digestibility enhancers
4a42 Kerry Ingredients Endo– 1,4- Additive composition: All poultry — 30 U — 1. In the directions for use of the 10 January 2034
and Flavours Ltd beta- Preparation of species for additive and premixture, the sto
mannanase endo– 1,4-beta-mannanase fattening rage conditions and stability to
(EC 3.2.1.78) produced by Aspergillus niger CBS heat treatment shall be indicated.
120604 having a minimum
activity of 265 U(1)/g solid form
2. For users of the additive and pre
Characterisation of the active substance: mixtures, feed business operators
Endo– 1,4-beta-mannanase (EC shall establish operational proce
3.2.1.78) produced by Aspergillus dures and organisational mea
niger CBS 120604 sures to address potential risks re
sulting from its use. Where those
Analytical method(2):
risks cannot be eliminated by such
Determination of the
procedures and measures, the ad
endo– 1,4-beta-mannanase activity
ditive and premixtures shall be
in the feed additive, premixtures
used with personal breathing,
and compound feed: colorimetric
eye and skin protective equip
method based on the enzymatic
ment.
reaction of
endo– 1,4-beta-mannanase on the
azurine cross-linked-carob
galactomannan substrate
(1) One endo-1,4-beta-mannanase unit (U) is defined as the amount of enzyme required to release one micromole of mannose reducing sugar equivalents per minute at 40°C and pH 4,5.
(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
OJ
L,
21.12.2023
EN