Date: 2023-01-06Category: Not ApplicableState: Union GovernmentCountry: Europe
Commission Implementing Regulation (EU) 2023/61 of 5 January 2023 concerning the authorisation of a preparation of endo-1,4-beta-glucanase from Aspergillus niger CBS 120604, a preparation of endo-1,3(4)-beta-glucanase from Aspergillus neoniger MUCL 39199, a preparation of endo-1,4-beta-xylanase from Trichoderma citrinoviride MUCL 39203 and a preparation of endo-1,4-beta-xylanase from Trichoderma citrinoviride CBS 614.94 as feed additives for all animal species (Text with EEA relevance)
Issued by European Commission
· Directorate-General for Health and Food Safety
Executive Summary:
This regulation authorises specific preparations of endo-1,4-beta-glucanase and endo-1,4-beta-xylanase as feed additives for all animal species. These additives belong to the technological additives category and the functional group of silage additives. The authorisation is subject to specific conditions outlined in the annex, and transitional measures are in place regarding the placing on the market and use of products produced and labelled before specified dates in 2023, extending into 2024 and 2025 depending on the animal type. The regulation takes effect on the twentieth day following its publication in the Official Journal of the European Union.
Key Points / Main Content:
* **Authorisation of Feed Additives:**
* Authorises endo-1,4-beta-glucanase from Aspergillus niger CBS 120604.
* Authorises endo-1,34-beta-glucanase from Aspergillus neoniger MUCL 39199.
* Authorises endo-1,4-beta-xylanase from Trichoderma citrinoviride MUCL 39203.
* Authorises endo-1,4-beta-xylanase from Trichoderma citrinoviride CBS 614.94.
* These are authorised for all animal species.
* The additives are classified as technological additives, functional group silage additives.
* **Conditions of Use:**
* Directions for use must include storage conditions.
* Minimum content of additive must be ensured when used without other enzymes/microorganisms.
* Users of additives/premixtures must establish procedures to address potential risks.
* Personal protective equipment (skin, eye, breathing protection) must be used if risks cannot be minimised.
* **Transitional Measures:**
* Preparations and premixtures produced and labelled before 26 July 2023, under previous rules, can be placed on the market/used until stocks are exhausted.
* Compound feed/feed materials for food-producing animals, produced/labelled before 26 January 2024, under previous rules, can be placed on the market/used until stocks are exhausted.
* Compound feed/feed materials for non-food-producing animals, produced/labelled before 26 January 2025, under previous rules, can be placed on the market/used until stocks are exhausted.
Impact Analysis:
* **Feed Business Operators:**
* *Impact:* Must adhere to new authorisation conditions for the specified feed additives.
* *Action Required:* Establish operational procedures and organisational measures to address potential risks to users of the additives and premixtures, including the use of personal protective equipment where risks cannot be minimised.
* **Additive and Premixture Producers:**
* *Impact:* Affected by the conditions of authorisation, including labelling and storage requirements.
* *Action Required:* Adjust production and labelling processes to comply with the new regulations by 26 July 2023, or benefit from transitional arrangements for existing stock.
* **Users of the Additives:**
* *Impact:* Potential exposure to respiratory sensitisers, requiring appropriate protective measures.
* *Action Required:* Use personal protective equipment, including skin, eye, and breathing protection, where risks cannot be eliminated or minimised through operational procedures.
* **European Food Safety Authority (EFSA):**
* *Impact:* Its scientific opinions formed the basis for the regulation.
* *Action Required:* Continue to provide scientific advice and risk assessments related to feed additives.
* **Member States:**
* *Impact:* Required to ensure the regulation is implemented and enforced within their jurisdiction.
* *Action Required:* Incorporate the regulation into national law and monitor compliance.
Key Entities Referenced
European Union: A political and economic union of member states located primarily in Europe.
European Commission: An executive branch of the European Union responsible for proposing legislation, implementing decisions, and managing the EU's day-to-day affairs.
Aspergillus niger CBS 120604: A strain of fungus used in the production of endo-1,4-beta-glucanase feed additive.
Aspergillus neoniger MUCL 39199: A strain of fungus used in the production of endo-1,3(4)-beta-glucanase feed additive.
Trichoderma citrinoviride MUCL 39203: A strain of fungus used in the production of endo-1,4-beta-xylanase feed additive.
Trichoderma citrinoviride CBS 614.94: A strain of fungus used in the production of endo-1,4-beta-xylanase feed additive.
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.
L 5/24 EN Official Journal of the European Union 6.1.2023
COMMISSION IMPLEMENTING REGULATION (EU) 2023/61
of 5 January 2023
concerning the authorisation of a preparation of endo-1,4-beta-glucanase from Aspergillus niger CBS
120604, a preparation of endo-1,3(4)-beta-glucanase from Aspergillus neoniger MUCL 39199, a
preparation of endo-1,4-beta-xylanase from Trichoderma citrinoviride MUCL 39203 and a preparation
of endo-1,4-beta-xylanase from Trichoderma citrinoviride CBS 614.94 as feed additives for all animal
species
(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. Article 10(2) of that Regulation provides for the
re-evaluation of additives authorised pursuant to Council Directive 70/524/EEC(2). Article 10(7) of Regulation (EC)
No 1831/2003 sets out specific provisions for the placing on the market and use of products used in the Union as
silage additives.
(2) The preparations of endo-1,4-beta-glucanase from Aspergillus niger CBS 120604, endo-1,3(4)-beta-glucanase from
Aspergillus neoniger MUCL 39199, endo-1,4-beta-xylanase from Trichoderma citrinoviride MUCL 39203 and
endo-1,4-beta-xylanase from Trichoderma citrinoviride CBS 614.94 were entered in the Register of feed additives as
existing products(3)for all animal species belonging to the functional group of silage additives, in accordance with
Article 10(1), point (b), of Regulation (EC) No 1831/2003.
(3) In accordance with Article 10(7) of Regulation (EC) No 1831/2003 in conjunction with Article 10(2) and Article 7
thereof, an application was submitted for the authorisation of the preparations of endo-1,4-beta-glucanase from
Aspergillus niger CBS 120604, endo-1,3(4)-beta-glucanase from Aspergillus neoniger MUCL 39199, endo-1,4-beta-
xylanase from Trichoderma citrinoviride MUCL 39203 and endo-1,4-beta-xylanase from Trichoderma citrinoviride CBS
614.94 as feed additives for all animal species. The applicant requested the preparations to be classified in the
additive category ‘technological additives’ and the functional group ‘silage additives’. The application was
accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.
(4) The European Food Safety Authority (‘the Authority’) concluded in its opinions of 7 March 2018(4) and 29 June
2022(5), that, under the proposed conditions of use, the preparations concerned do not have adverse effects on
animal health, consumer health or the environment. The Authority also concluded that in the absence of data, no
conclusion could be drawn on the skin and eye irritancy of the additives and on their skin sensitisation potential.
Owing to the proteinaceous nature of the active substances, these preparations should be considered to be potential
(1) OJ L 268, 18.10.2003, p. 29.
(2) Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs (OJ L 270, 14.12.1970, p. 1).
(3) In the Register of feed additives: endo-1,4-beta-glucanase from Aspergillus niger CBS 120604 was identified as cellulase from Aspergillus
niger CBS 120604; endo-1,3(4)-beta-glucanase from Aspergillus neoniger MUCL 39199 was identified as beta-glucanase from Aspergillus
niger MUCL 39199 or Aspergillus tubingensis MUCL 39199; endo-1,4-beta-xylanase from Trichoderma citrinoviride MUCL 39203 was
identified as xylanase from Trichoderma longibrachiatum MUCL 39203 or Trichoderma koningii MUCL 39203; endo-1,4-beta-xylanase
from Trichoderma citrinoviride CBS 614.94 was identified as xylanase from Trichoderma longibrachiatum CBS 614.94.
(4) EFSA Journal 2018;16(4):5224.
(5) EFSA Journal 2022;20(7):7425.6.1.2023 EN Official Journal of the European Union L 5/25
respiratory sensitisers. The Authority further concluded in its opinion of 29 June 2022 that the preparations
concerned have the potential to improve the production of silage from easy, moderate and difficult to ensile forage
materials. It also verified the report on the methods of analysis of the feed additives in feed submitted by the
Reference Laboratory set up by Regulation (EC) No 1831/2003.
(5) The assessment of the preparations of endo-1,4-beta-glucanase from Aspergillus niger CBS 120604, endo-1,3(4)-beta-
glucanase from Aspergillus neoniger MUCL 39199, endo-1,4-beta-xylanase from Trichoderma citrinoviride MUCL
39203 and endo-1,4-beta-xylanase from Trichoderma citrinoviride CBS 614.94 shows that the conditions for
authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of
those preparations 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.
(6) Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation
of the preparations concerned, it is appropriate to provide for a transitional period for interested parties to prepare
themselves to meet the new requirements resulting from the authorisation.
(7) 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
Authorisation
The preparations specified in the Annex, belonging to the additive category ‘technological additives’ and to the functional
group ‘silage additives’, are authorised as additives in animal nutrition, subject to the conditions laid down in that Annex.
Article 2
Transitional measures
1. The preparations specified in the Annex and premixtures containing these preparations, which are produced and
labelled before 26 July 2023in accordance with the rules applicable before 26 January 2023may continue to be placed on
the market and used until the existing stocks are exhausted.
2. Compound feed and feed materials containing the preparations specified in the Annex which are produced and
labelled before 26 January 2024 in accordance with the rules applicable before 26 January 2023 may continue to be
placed on the market and used until the existing stocks are exhausted if they are intended for food-producing animals.
3. Compound feed and feed materials containing the preparations specified in the Annex which are produced and
labelled before 26 January 2025 in accordance with the rules applicable before 26 January 2023 may continue to be
placed on the market and used until the existing stocks are exhausted if they are intended for non-food producing animals.
Article 3
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.L 5/26 EN Official Journal of the European Union 6.1.2023
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 5 January 2023.
For the Commission
The President
Ursula VON DER LEYENANNEX
Minimum Maximum
content content
Identification Species or
Composition, chemical formula, Maximum End of period of
number of the Additive category of Other provisions
description, analytical method age Units of activity of authorisation
additive animal
additive/kg of fresh
material
Category: technological additives. Functional group: silage additives.
1k105 Endo-1,4-beta- Additive composition All animal - - - 1. In the directions for use of the additive and pre 26 January
glucanase (EC Preparation of endo-1,4-beta- species mixtures, the storage conditions shall be indi 2033
3.2.1.4) glucanase produced by: cated.
2. Minimum content of the additive when used
Aspergillus niger CBS 120604,
without combination with other enzymes or mi
having a minimum activity of
cro-organisms as silage additives: 3 DNS/kg of
25 650DNS(1)/g additive
fresh material.
Solid form 3. For users of the additive and premixtures, feed
business operators shall establish operational
Characterisation of the active
procedures and organisational measures to ad
substance
dress potential risks resulting from its use. Where
Endo-1,4-beta-glucanase (EC those risks cannot be eliminated or reduced to a
3.2.1.4) produced by Aspergillus minimum by such procedures and measures, the
niger CBS 120604 additive and premixtures shall be used with per
sonal protective equipment, including skin, eye,
Analytical method(2)
and breathing protection.
For the determination of
endo-1,4-beta-glucanase in the
feed additive:
— colorimetric (DNS) method
based on the enzymatic
hydrolysis of the carboxy
methyl cellulose (CMC) at
pH 4,5 and 37 °C
(1) 1 DNS (3,5-dinitrosalicylic acid) unit is the amount of reducing sugar released as glucose equivalents in μmol per g per min at pH 4,5 and 37 °C from starch.
(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
6.1.2023
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Official
Journal
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the
European
Union
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5/27Minimum Maximum
content content
Identification Species or
Composition, chemical formula, Maximum End of period of
number of the Additive category of Other provisions
description, analytical method age Units of activity of authorisation
additive animal
additive/kg of fresh
material
Category: technological additives. Functional group: silage additives.
1k106 Endo-1,3(4)-beta- Additive composition All animal - - - 1. In the directions for use of the additive and pre 26 January
glucanase species mixtures, the storage conditions shall be indi 2033
Preparation of endo-1,3(4)-β-
(EC 3.2.1.6) cated.
glucanase produced by:
2. Minimum content of the additive when used
Aspergillus neoniger MUCL without combination with other enzymes or mi
39199, having a minimum cro-organisms as silage additives: 3,4 DNS/kg of
activity of 10 000DNS(1)/g fresh material.
additive 3. For users of the additive and premixtures, feed
business operators shall establish operational
Solid form procedures and organisational measures to ad
Characterisation of the active dress potential risks resulting from its use. Where
substance those risks cannot be eliminated or reduced to a
minimum by such procedures and measures, the
Endo-1,3(4)-beta-glucanase (EC
additive and premixtures shall be used with per
3.2.1.6) produced by Aspergillus
sonal protective equipment, including skin, eye
neoniger MUCL 39199
and breathing protection.
Analytical method(2)
For the determination of
endo-1,3(4)-beta-glucanase in
the feed additive:
— colorimetric (DNS) method
based on the enzymatic
hydrolysis of the carboxy
methyl cellulose (CMC) at
pH 4,5 and 37 °C
(1) 1 DNS (3,5-dinitrosalicylic acid) unit is the amount of reducing sugar released as glucose equivalents in μmol per g per min at pH 4,5 and 37 °C from starch.
(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
L
5/28
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Official
Journal
of
the
European
Union
6.1.2023Minimum Maximum
content content
Identification Species or
Composition, chemical formula, Maximum End of period of
number of the Additive category of Other provisions
description, analytical method age Units of activity of authorisation
additive animal
additive/kg of fresh
material
Category: technological additives. Functional group: silage additives.
1k107 Endo-1,4-beta- Additive composition All animal - - - 1. In the directions for use of the additive and pre 26 January
xylanase species mixtures, the storage conditions shall be indi 2033
Preparation of endo-1,4-beta-
(EC 3.2.1.8) cated.
xylanase produced by:
2. Minimum content of the additive when used
Trichoderma citrinoviride MUCL without combination with other enzymes or mi
cro-organisms as silage additives: 3,2 DNS/kg of
39203, having a minimum
fresh material.
activity of 51 600DNS(1)/g
3. For users of the additive and premixtures, feed
additive
business operators shall establish operational
Solid form procedures and organisational measures to ad
dress potential risks resulting from its use. Where
Characterisation of the active
those risks cannot be eliminated or reduced to a
substance minimum by such procedures and measures, the
Endo-1,4-beta-xylanase (EC additive and premixtures shall be used with per
3.2.1.8) produced by Trichoderma sonal protective equipment, including skin, eye
citrinoviride MUCL 39203 and breathing protection.
Analytical method(2)
For the determination of
endo-1,4-beta-xylanase in the
feed additive:
— colorimetric (DNS) method
based on the enzymatic
hydrolysis of the xylan at
pH 4,5 and 37 °C
(1) 1 DNS (3,5-dinitrosalicylic acid) unit is the amount of reducing sugar released as xylose equivalents in μmol per g per min at pH 4,5 and 37 °C from birchwood xylan.
(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
6.1.2023
EN
Official
Journal
of
the
European
Union
L
5/29Minimum Maximum
content content
Identification Species or
Composition, chemical formula, Maximum End of period of
number of the Additive category of Other provisions
description, analytical method age Units of activity of authorisation
additive animal
additive/kg of fresh
material
Category: technological additives. Functional group: silage additives.
1k108 Endo-1,4-beta- Additive composition All animal - - - 1. In the directions for use of the additive and pre 26 January
xylanase species mixtures, the storage conditions shall be indi 2033
Preparation of endo-1,4-beta-
(EC 3.2.1.8) cated.
xylanase produced by:
2. Minimum content of the additive when used
Trichoderma citrinoviride CBS without combination with other enzymes or mi
614.94, having a minimum cro-organisms as silage additives: 15 DNS/kg of
activity of 70 000DNS(1)/g fresh material.
additive 3. For users of the additive and premixtures, feed
Solid form business operators shall establish operational
procedures and organisational measures to ad
Characterisation of the active
dress potential risks resulting from its use. Where
substance
those risks cannot be eliminated or reduced to a
Endo-1,4-beta-xylanase (EC minimum by such procedures and measures, the
3.2.1.8) produced by Trichoderma additive and premixtures shall be used with per
citrinoviride CBS 614.94 sonal protective equipment, including skin, eye
and breathing protection.
Analytical method(2)
For the determination of
endo-1,4-beta-xylanase in the
feed additive:
— colorimetric (DNS) method
based on the enzymatic
hydrolysis of the xylan at
pH 4,5 and 37 °C
(1) 1 DNS (3,5-dinitrosalicylic acid) unit is the amount of reducing sugar released as xylose equivalents in μmol per g per min at pH 4,5 and 37 °C from birchwood xylan.
(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
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