Contents
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 2003 on additives for use in animal nutritionnote, and in particular Article 9(2) and Article 13(3) 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)A preparation of Saccharomyces cerevisiae CNCM I-1077 was authorised for a period of 10 years as a feed additive for lambs and horses by Commission Implementing Regulation (EU) 2020/149note.
(3)In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of a preparation of Saccharomyces cerevisiae CNCM I-1077. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.
(4)The application concerns the authorisation of the preparation of Saccharomyces cerevisiae CNCM I-1077 as a feed additive for ruminants (other than lambs) and camelids reared for milk production or reared for reproduction, young ruminants for fattening other than calves and lambs, camelid calves for fattening, and Equidae other than horses, requesting that additive to be classified in the category ‘zootechnical additives’ and in the functional groups ‘digestibility enhancers’ and ‘gut flora stabilisers’.
(5)In accordance with Article 13(3) of Regulation (EC) No 1831/2003, an application was submitted for the modification of the terms of the authorisation of the preparation of Saccharomyces cerevisiae CNCM I-1077 as laid down in Implementing Regulation (EU) 2020/149 as regards the use for lambs. That application concerned a request to lower the minimum inclusion level in feed for lambs from 3 × 109 to 1 × 109 CFU/kg of complete feed with a moisture content of 12 %.
(6)The European Food Safety Authority (‘the Authority’) concluded in its opinion of 15 October 2024note that, under the proposed conditions of use, the preparation of Saccharomyces cerevisiae CNCM I-1077 is safe for the target species, consumers and the environment. The Authority also concluded that the preparation of Saccharomyces cerevisiae CNCM I-1077, in both formulations, should be considered a skin and respiratory sensitiser and any exposure through skin and respiratory tract is considered a risk. The not-coated form of the additive is not irritant to skin or eyes. No conclusion can be drawn on the eye irritation potential of the coated form of the additive due to the lack of data. The Authority further concluded that the preparation of Saccharomyces cerevisiae CNCM I-1077 has the potential to be efficacious in all ruminants and camelids reared for milk production or suckling or reproduction at a minimum proposed use level of 5 × 108 CFU/kg of complete feed, all minor (young) ruminant species and camelids for fattening and lambs at 1 × 109 CFU/kg of complete feed, and in all Equidae species other than horses at 3 × 109 CFU/kg of complete feed. It did not consider that there is a need for specific requirements of post-market monitoring.
(7)In accordance with Article 5(4), point (a), of Commission Regulation (EC) No 378/2005note, the Reference Laboratory set up by Regulation (EC) No 1831/2003 considered that the conclusions and recommendations reached in a previous assessment concerning the same additive are valid and applicable for the current application.
(8)In view of the above, the Commission considers that the preparation of Saccharomyces cerevisiae CNCM I-1077 satisfies the conditions provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the use of that preparation should be authorised for ruminants (other than lambs) and camelids reared for milk production or reared for reproduction, young ruminants for fattening other than calves and lambs, camelid calves for fattening, and Equidae other than horses. 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.
(9)In addition, in view of the above, the Commission considers that the authorisation of the preparation of Saccharomyces cerevisiae CNCM I-1077 still meets the conditions provided for in Article 5 of Regulation (EC) No 1831/2003 when modifying the terms thereof as regards the use for lambs, by decreasing the minimum content of the additive to 1 × 109 CFU/kg of complete feed. Implementing Regulation (EU) 2020/149 should therefore be amended accordingly.
(10)Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation of the preparation of Saccharomyces cerevisiae CNCM I-1077 for lambs, it is appropriate to provide for a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the modification of the authorisation concerned.
(11)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 1Authorisation#
The preparation specified in the Annex, belonging to the additive category ‘zootechnical additives’ and to the functional groups ‘digestibility enhancers’ and ‘gut flora stabilisers’, is authorised as an additive in animal nutrition, subject to the conditions laid down in that Annex.
Article 2Amendment to Implementing Regulation (EU) 2020/149#
In the Annex to Implementing Regulation (EU) 2020/149 in the column ‘minimum content’ regarding lambs the value is replaced by ‘1 × 109’.
Article 3Transitional measures#
1.The feed additive Saccharomyces cerevisiae CNCM I-1077, as authorised by Implementing Regulation (EU) 2020/149 and premixtures containing that additive, which are intended for lambs, and which are produced and labelled before 7 February 2026 in accordance with the rules applicable before 7 August 2025 may continue to be placed on the market and used until the stocks concerned are exhausted.
2.Compound feed and feed materials containing the feed additive referred to in paragraph 1, which are intended for lambs, and which are produced and labelled before 7 August 2026 in accordance with the rules applicable before 7 August 2025 may continue to be placed on the market and used until the stocks concerned are exhausted.
Article 4Entry 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.
| Identification number of the additive | Name of the holder of authorisation | Additive | Composition, chemical formula, description, analytical method | Species or category of animal | Maximum age | Minimum content | Maximum content | Other provisions | End of period of authorisation |
|---|---|---|---|---|---|---|---|---|---|
| CFU/kg of complete feedingstuff with a moisture content of 12 % | |||||||||
| Category: zootechnical additives. Functional group: gut flora stabilisers | |||||||||
| 4b1711 | Lallemand SAS | Saccharomyces cerevisiae CNCM I-1077 | Additive compositionPreparation of Saccharomyces cerevisiaeCNCM I-1077 with aminimum concentration of:1 × 1010 CFU/g of additive (coated form)2 × 1010 CFU/g of additive (not-coated form).Characterisation of the active substanceViable cells of Saccharomyces cerevisiae CNCM I-1077Analytical methodnoteEnumeration in the feed additive, premixtures and compound feed: pour or spread plate method using chloramphenicol dextrose yeast extract agar (EN 15789)Identification: polymerase chain reaction (PCR) method (CEN/TS 15790) | Ruminants (other than lambs) and camelids reared for milk production or reared for reproduction | - | 5 × 108 | - | 1. In the directions for use of the additive and premixture, the storage conditions and stability to heat treatment shall be indicated.2. For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal breathing, eye (only for the coated formulation) and skin protective equipment. | 7 August 2035 |
| Youngnoteruminants for fattening other than calves and lambsCamelid calves for fattening | 1 × 109 | ||||||||
| Category: zootechnical additives. Functional group: digestibility enhancers | |||||||||
| 4b1711 | Lallemand SAS | Saccharomyces cerevisiae CNCM I-1077 | Additive compositionPreparation of Saccharomyces cerevisiaeCNCM I-1077 with aminimum concentration of:1 × 1010 CFU/g of additive (coated form)2 × 1010 CFU/g of additive (not-coated form).Characterisation of the active substanceViable cells of Saccharomyces cerevisiae CNCM I-1077Analytical methodnoteEnumeration in the feed additive, premixtures and compound feed: pour or spread plate method using chloramphenicol dextroseyeast extract agar (EN 15789)Identification: polymerase chain reaction (PCR) method (CEN/TS 15790) | Equidae other than horses | - | 3 × 109 | - | 1. In the directions for use of the additive and premixture, the storage conditions and stability to heat treatment shall be indicated.2. For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal breathing, eye (only for the coated formulation) and skin protective equipment. | 7 August 2035 |
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