Date: 2023-01-05Category: Not ApplicableState: Union GovernmentCountry: Europe
Commission Implementing Regulation (EU) 2023/53 of 4 January 2023 concerning the authorisation of a preparation of Pediococcus acidilactici CNCM I-4622 as a feed additive for all animal species (Text with EEA relevance)
Issued by European Commission
· Directorate-General for Health and Food Safety
Executive Summary:
This regulation authorises the use of Pediococcus acidilactici CNCM I-4622 as a feed additive for all animal species, classifying it as a technological additive within the functional groups of acidity regulators and hygiene condition enhancers. The authorisation is subject to specific conditions outlined in the Annex. The regulation came into force on January 24, 2023, and the authorisation period ends on January 24, 2033.
Key Points / Main Content:
Authorisation:
* Pediococcus acidilactici CNCM I-4622 is authorised as a feed additive for all animal species.
* It is classified as a technological additive.
* It falls under two functional groups: acidity regulators and hygiene condition enhancers.
Conditions of Use:
* The additive shall be used only in mash compound feed for preparing liquid feed on farms and/or in solid feed materials intended for liquid feed preparation on the farm.
* It may be used in feed containing specific coccidiostats: halofuginone, diclazuril, decoquinate, and nicarbazin.
* Directions for use and storage conditions shall be indicated on the additive and premixtures.
Safety Measures:
* Feed business operators must establish operational procedures and organisational measures to address potential risks from the additive's use.
* If risks cannot be eliminated or minimized, personal protective equipment, including breathing protection, must be used.
Specifications:
* Minimum content: 1 x 109 CFU/kg of complete feed (12% moisture).
* The additive contains a minimum of 1010 CFU/g.
End of Authorisation Period:
* The authorisation is valid until January 24, 2033.
Impact Analysis:
Feed Business Operators:
* Impact: Must comply with the conditions of use and safety measures outlined in the Annex.
* Action Required: Establish operational procedures and organizational measures to address potential risks and ensure proper labeling and storage instructions.
Users of the Additive and Premixtures:
* Impact: Need to follow safety protocols and use personal protective equipment if risks cannot be adequately controlled.
* Action Required: Use appropriate personal protective equipment, including breathing protection, if necessary, and follow established operational procedures.
Animal Nutrition Industry:
* Impact: Can utilize the authorized feed additive within the specified conditions to improve feed quality and animal health.
* Action Required: Incorporate the additive into feed formulations according to the regulations and ensure compliance with labeling and safety requirements.
Member States:
* Impact: Must ensure the regulation is implemented and enforced within their jurisdiction.
* Action Required: Ensure the regulation is implemented and enforced within their jurisdiction.
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 Food Safety Authority: An agency of the European Union that provides independent scientific advice and risk assessment on food and feed safety.
Pediococcus acidilactici CNCM I-4622: A strain of bacteria authorized as a feed additive for all animal species, functioning as an acidity regulator and hygiene condition enhancer.
Standing Committee on Plants, Animals, Food and Feed: A committee that provides opinions on measures related to food safety within the European Union.
Ursula VON DER LEYEN: The President of the European Commission.
Brussels: The de facto capital city of the European Union, located in Belgium.
L 3/8 EN Official Journal of the European Union 5.1.2023
COMMISSION IMPLEMENTING REGULATION (EU) 2023/53
of 4 January 2023
concerning the authorisation of a preparation of Pediococcus acidilactici CNCM I-4622 as a feed
additive 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.
(2) In accordance with Article 7(1) of Regulation (EC) No 1831/2003, an application was submitted for the
authorisation of a preparation of Pediococcus acidilactici CNCM I-4622. 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 Pediococcus acidilactici CNCM I-4622 as a feed additive
for all animal species, to be classified in the additive category ‘technological additives’ and in the functional groups
‘acidity regulators’ and ‘hygiene condition 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 Pediococcus acidilactici CNCM I-4622 does not have adverse effects on
animal health, consumer safety or the environment. It also concluded that it is considered a respiratory sensitiser, but
not irritant to eyes/skin or a skin sensitiser. The Authority further concluded that the preparation showed a potential
to reduce the pH and the growth of coliforms in liquid feeds. It 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) The assessment of the preparation of Pediococcus acidilactici CNCM I-4622 shows that the conditions for
authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of
this 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.
(6) 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
1. The preparation specified in the Annex, belonging to the additive category ‘technological additives’ and to the
functional group ‘acidity regulators’, is authorised as an additive in animal nutrition, subject to the conditions laid down in
that Annex.
2. The preparation specified in the Annex, belonging to the additive category ‘technological additives’ and to the
functional group ‘hygiene condition enhancers’, is authorised as an additive in animal nutrition, subject to the conditions
laid down in that Annex.
(1) OJ L 268, 18.10.2003, p. 29.
(2) EFSA Journal 2022;20(8):7424.5.1.2023 EN Official Journal of the European Union L 3/9
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, 4 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 CFU of additive/kg of authorisation
additive animal
complete feed with a
moisture content of 12 %
Category: technological additives. Functional group: acidity regulators.
4d1712 Pediococcus Additive composition All animal - 1 x 109 - 1. In the directions for use of the additive and pre 24.1.2033
acidilactici CNCM species mixtures, the storage conditions shall be indi
Preparation of Pediococcus
I-4622 cated.
acidilactici CNCM I-4622
2. The additive shall be used only in mash com
containing a minimum of 1 ×
pound feed intended for the preparation of liquid
1010 CFU/g
feed on the farm and/or in solid feed materials
intended for the preparation of liquid feed on
Solid form
the farm.
Characterisation of the active 3. May be used in feed containing the following per
substance mitted coccidiostats: halofuginone, diclazuril,
Viable cells of Pediococcus decoquinate and nicarbazin.
acidilactici CNCM I-4622 4. For users of the additive and premixtures, feed
business operators shall establish operational
Analytical method(1) procedures and organisational measures to ad
dress potential risks resulting from its use. Where
Enumeration: Spread plate those risks cannot be eliminated or reduced to a
method using MRS agar (EN minimum by such procedures and measures, the
15786) additive and premixtures shall be used with per
sonal protective equipment, including breathing
Identification: Pulsed Field Gel protection.
Electrophoresis (PFGE) or DNA
sequencing methods
(1) 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
3/10
EN
Official
Journal
of
the
European
Union
5.1.2023Minimum Maximum
Identification Species or content content
Composition, chemical formula, Maximum End of period of
number of the Additive category of Other provisions
description, analytical method age authorisation
additive animal CFU of additive/kg of
fresh material
Category: technological additives. Functional group: hygiene condition enhancers (reduction of the growth of coliforms).
4d1712 Pediococcus Additive composition All animal - 1 x 109 - 1. In the directions for use of the additive and pre 24.1.2033
acidilactici CNCM species mixtures, the storage conditions shall be indi
Preparation of Pediococcus
I-4622 cated.
acidilactici CNCM I-4622
2 The additive shall be used only in mash com
containing a minimum of 1 ×
pound feeds intended for the preparation of li
1010 CFU/g
quid feed on the farm and/or in solid feed materi
als intended for the preparation of liquid feed on
Solid form
the farm.
Characterisation of the active 3. May be used in feed containing the following per
substance mitted coccidiostats: halofuginone, diclazuril,
Viable cells of Pediococcus decoquinate and nicarbazin.
acidilactici CNCM I-4622 4. For users of the additive and premixtures, feed
business operators shall establish operational
Analytical method(1) procedures and organisational measures to ad
dress potential risks resulting from its use. Where
Enumeration: Spread plate those risks cannot be eliminated or reduced to a
method using MRS agar (EN minimum by such procedures and measures, the
15786) additive and premixtures shall be used with per
sonal protective equipment, including breathing
Identification: Pulsed Field Gel protection.
Electrophoresis (PFGE) or DNA
sequencing methods
(1) 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
5.1.2023
EN
Official
Journal
of
the
European
Union
L
3/11