LegalizeCommission Implementing Regulation (EU) 2020/149 of 4 February 2020 concerning the renewal of the authorisation of Saccharomyces cerevisiae CNCM I-1077 as a feed additive for lambs and horses and repealing Regulations (EC) No 1293/2008 and (EC) No 910/2009 (holder of authorisation Danstar Ferment AG represented in the Union by Lallemand SAS) (Text with EEA relevance)
Article 1
The authorisation of the additive specified in the Annex, belonging to the additive category ‘zootechnical additives’ and to the functional groups ‘gut flora stabilisers’ for lambs and ‘digestibility enhancers’ for horses, is renewed subject to the conditions laid down in that Annex.
Article 2
Regulations (EC) No 1293/2008 and (EC) No 910/2009 are repealed.
Article 3
Saccharomyces cerevisiae CNCM I-1077, as set out in Regulation (EC) No 910/2009, premixtures and compound feed containing that substance, which are produced and labelled before 25 February 2020 in accordance with the rules applicable before 25 February 2020 may continue to be placed on the market and used until the existing stock are exhausted.
Article 4
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.
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 |
|---|---|---|---|---|---|---|---|---|---|
| CFU/kg of complete feedingstuff with a moisture content of 12 % | |||||||||
| Category of zootechnical additives. Functional group: digestibility enhancers | |||||||||
| 4b1711 | Danstar Ferment AG represented by Lallemand SAS | Saccharomyces cerevisiae CNCM I-1077 | Additive composition: Preparation of Saccharomyces cerevisiae CNCM I-1077 containing a minimum of: — 1 × 1010 CFU/g of additive (coated form); — 2 × 1010 CFU/g of additive (not-coated form); Characterisation of the active substance Viable cells of Saccharomyces cerevisiae CNCM I-1077 Analytical method (1) Enumeration: pour plate method using chloramphenicol dextrose yeast extract agar (EN15789:2009) Identification: polymerase chain reaction (PCR) method (CEN/TS 15790:2008) | Horses | - | 3,0 × 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 or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including eye protection. | 25.2.2030 |
| 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 containing a minimum of: — 1 × 1010 CFU/g of additive (coated form); — 2 × 1010 CFU/g of additive (not-coated form); Characterisation of the active substance Viable cells of Saccharomyces cerevisiae CNCM I-1077 Analytical method (1) Enumeration: pour plate method using chloramphenicol dextrose yeast extract agar (EN15789:2009) Identification: polymerase chain reaction (PCR) method (CEN/TS 15790:2008) | Lambs | - | 1 × 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 or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including eye protection. | 25.2.2030 | |
| (1) Details of the analytical methods are available at the following address of the Reference Laboratory: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports |
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