LegalizeCommission Implementing Regulation (EU) 2019/857 of 27 May 2019 concerning the renewal of the authorisation of Saccharomyces cerevisiae CNCM I-1077 as a feed additive for dairy sheep and dairy goats and repealing Regulation (EC) No 226/2007 (holder of authorisation Danstar Ferment AG represented by Lallemand SAS) (Text with EEA relevance.)
This is the act as published. Later amendments are not folded into the text below: each one is a separate act in this repository and an entry in this law's history.
| 28.5.2019 | EN | Official Journal of the European Union | L 140/18 |
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 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 and renewing such authorisation.
- (2) Saccharomyces cerevisiae CNCM I-1077 was authorised for 10 years as a feed additive for dairy goats and dairy sheep by Commission Regulation (EC) No 226/2007 2.
- (3) In accordance with Article 14 of Regulation (EC) No 1831/2003, an application was submitted by the holder of that authorisation for the renewal of the authorisation of Saccharomyces cerevisiae CNCM I-1077 as a feed additive for dairy goats and dairy sheep, requesting that additive to be classified in the additive category ‘zootechnical additives’. That application was accompanied by the particulars and documents required under Article 14(2) of Regulation (EC) No 1831/2003.
- (4) The European Food Safety Authority (‘the Authority’) concluded in its opinion of 5 July 2018 3 that the applicant has provided data demonstrating that the additive complies with the conditions of authorisation.
- (5) The assessment of Saccharomyces cerevisiae CNCM I-1077 shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the authorisation of that additive should be renewed as specified in the Annex to this Regulation.
- (6) As a consequence of the renewal of the authorisation of Saccharomyces cerevisiae CNCM I-1077 as a feed additive under the conditions laid down in the Annex to this Regulation, Regulation (EC) No 226/2007 should be repealed.
- (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
The authorisation of the additive specified in the Annex, belonging to the additive category ‘zootechnical additives’ and to the functional group ‘gut flora stabilisers’, is renewed subject to the conditions laid down in that Annex.
Article 2
Regulation (EC) No 226/2007 is repealed.
Article 3
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, 27 May 2019.
For the Commission
The President
Jean-Claude JUNCKER
Commission Regulation (EC) No 226/2007 of 1 March 2007 concerning the authorisation of Saccharomyces cerevisiae CNCM I-1077 (Levucell SC20 and Levucell SC10 ME) as a feed additive (OJ L 64, 2.3.2007, p. 26).
EFSA Journal 2018;16(7):5385.
ANNEX
| 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 |
|---|---|---|---|---|---|---|---|---|---|
| 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 | CFU /kg of complete feedingstuff with a moisture content of 12 % | CFU /kg of complete feedingstuff with a moisture content of 12 % | Other provisions | End of period of authorisation |
| Category of zootechnical additives. Functional group: gut flora stabilisers | Category of zootechnical additives. Functional group: gut flora stabilisers | Category of zootechnical additives. Functional group: gut flora stabilisers | Category of zootechnical additives. Functional group: gut flora stabilisers | Category of zootechnical additives. Functional group: gut flora stabilisers | Category of zootechnical additives. Functional group: gut flora stabilisers | Category of zootechnical additives. Functional group: gut flora stabilisers | Category of zootechnical additives. Functional group: gut flora stabilisers | Category of zootechnical additives. Functional group: gut flora stabilisers | Category of zootechnical additives. Functional group: gut flora stabilisers |
| 4b1711 | Danstar Ferment AG represented by Lallemand SAS | Saccharomyces cerevisiae CNCM I-1077 | Additive composition Preparation of Saccharomyces cerevisiae CNCM I-1077 with a minimum concentration of: — 1 × 1010 CFU/g of additive (coated form); — 2 × 1010 CFU/g of additive (not-coated form); Characterisation of the active substance Viable dried cells of Saccharomyces cerevisiae CNCM I-1077 Analytical method 4 Enumeration: pour plate method using chloramphenicol dextrose yeast extract agar (EN15789:2009) Identification: polymerase chain reaction (PCR) method CEN/TS 15790:2008 | Dairy goats | — | 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. In the label of feed additive the following shall be indicated: ‘Recommended dose for dairy goats and dairy sheep: 4 × 109 CFU/head/day’ 3. 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 or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including eye and breathing protection. | 17 June 2029 |
| 4b1711 | Danstar Ferment AG represented by Lallemand SAS | Saccharomyces cerevisiae CNCM I-1077 | Additive composition Preparation of Saccharomyces cerevisiae CNCM I-1077 with a minimum concentration of: — 1 × 1010 CFU/g of additive (coated form); — 2 × 1010 CFU/g of additive (not-coated form); Characterisation of the active substance Viable dried cells of Saccharomyces cerevisiae CNCM I-1077 Analytical method 4 Enumeration: pour plate method using chloramphenicol dextrose yeast extract agar (EN15789:2009) Identification: polymerase chain reaction (PCR) method CEN/TS 15790:2008 | Dairy sheep | — | 1,2 × 109 | — | 1. In the directions for use of the additive and premixture, the storage conditions and stability to heat treatment shall be indicated. 2. In the label of feed additive the following shall be indicated: ‘Recommended dose for dairy goats and dairy sheep: 4 × 109 CFU/head/day’ 3. 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 or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including eye and breathing protection. | 17 June 2029 |
Details of the analytical methods are available at the following address of the European Union Reference Laboratory for Feed Additives: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports
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