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Commission Implementing Regulation (EU) 2020/1397Show full title
Commission Implementing Regulation (EU) 2020/1397 of 5 October 2020 concerning the renewal of the authorisation of L-isoleucine produced by Escherichia coli FERM ABP-10641 as a nutritional additive, its extension of use and the authorisation of L-isoleucine produced by Corynebacterium glutamicum KCCM 80189 as a feed additive for all animal species, and repealing Regulation (EU) No 348/2010 (Text with EEA relevance)
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ANNEXU.K.
| a 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 | |||||||||
| b Commission Regulation (EC) No 152/2009 of 27 January 2009 laying down the methods of sampling and analysis for the official control of feed (OJ L 54, 26.2.2009, p. 1). | |||||||||
| c Exposure calculated based on the endotoxin level and the dusting potential of the additive according to the method used by EFSA (EFSA Journal 2020;18(2):6022); analytical method: European Pharmacopoeia 2.6.14. (bacterial endotoxins). | |||||||||
| 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 |
|---|---|---|---|---|---|---|---|---|---|
| mg/kg of complete feed with a moisture content of 12 % | |||||||||
| Category: nutritional additives. Functional group: amino acids, their salts and analogues. | |||||||||
| 3c381 | - | L-isoleucine | Additive composition Powder with a minimum content of L-isoleucine of 93,4 % (on a dry matter basis) | All animal species | - | - | - | 1. L-isoleucine may be placed on the market and used as an additive consisting of a preparation. 2. In the directions for use of the additive and premixture, the storage conditions, the stability to heat treatment and in water shall be indicated. 3. The additive may be used via water for drinking. 4. Declaration to be made on the label of the additive and premixture:
5. The endotoxin content of the additive and its dusting potential shall ensure a maximal endotoxin exposure of 1 600 IU endotoxins/m3 air c. 6. For users of the additive and premixture, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixture shall be used with personal protective equipment. | 26 October 2030 |
| Characterisation of the active substance L-isoleucine produced by fermentation with Escherichia coli FERM ABP-10641 IUPAC name: (2S,3S)-2-amino-3-methylpentanoic acid Chemical formula: C6H13NO2 CAS number: 73-32-5 | |||||||||
| Analytical method a For the identification of L-isoleucine in the feed additive:
For the quantification of isoleucine in the feed additive:
For the quantification of isoleucine in premixtures:
For the quantification of isoleucine in compound feed and feed materials:
For the quantification of isoleucine in water:
| |||||||||
| 3c383 | - | L-isoleucine | Additive composition Powder with a minimum content of L-isoleucine of 90 % | All animal species | - | - | - | 1. L-isoleucine may be placed on the market and used as an additive consisting of a preparation. 2. In the directions for use of the additive and premixture, the storage conditions, the stability to heat treatment and in water shall be indicated. 3. The additive may be used via water for drinking. 4. Declaration to be made on the label of the additive and premixture:
| 26 October 2030 |
| Characterisation of the active substance L-isoleucine produced by fermentation with Corynebacterium glutamicum KCCM 80189 IUPAC name: (2S,3S)-2-amino-3-methylpentanoic acid Chemical formula: C6H13NO2 CAS number: 73-32-5 | |||||||||
| Analytical method a For the identification of L-isoleucine in the feed additive:
For the quantification of isoleucine in the feed additive:
For the quantification of isoleucine in premixtures:
For the quantification of isoleucine in compound feed and feed materials:
For the quantification of isoleucine in water:
| |||||||||
| Category: Sensory additives. Functional group: Flavouring compounds | |||||||||
| 3c381 | - | L-isoleucine | Additive composition Powder with a minimum content of L-isoleucine of 93,4 % (on a dry matter basis) | All animal species | - | - | 1. L-isoleucine may be placed on the market and used as an additive consisting of a preparation. 2. The additive shall be incorporated into the feed in the form of a premixture. 3. In the directions for use of the additive and premixture, the storage conditions and the stability to heat treatment shall be indicated. 4. On the label of the additive the following shall be indicated: ‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 25 mg/kg.’ 5. The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded: 25 mg/kg. 6. The endotoxin content of the additive and its dusting potential shall ensure a maximal endotoxin exposure of 1 600 IU endotoxins/m3 airc. 7. For users of the additive and premixture, feed business operators shall establish operational procedures and organisational measures to address potential by inhalation. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixture shall be used with personal protective equipment. | 26 October 2030 | |
| Characterisation of the active substance L-isoleucine) produced by fermentation with Escherichia coli FERM ABP-10641 IUPAC name: (2S,3S)-2-amino-3-methylpentanoic acid Chemical formula: C6H13NO2 CAS number: 73-32-5 | |||||||||
| Analytical method a For the identification of L-isoleucine in the feed additive:
For the quantification of isoleucine in the feed additive:
For the quantification of isoleucine in premixtures:
| |||||||||
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