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Document 32020R0378
Commission Implementing Regulation (EU) 2020/378 of 5 March 2020 concerning the authorisation of L-leucine as a feed additive for all animal species (Text with EEA relevance)
Commission Implementing Regulation (EU) 2020/378 of 5 March 2020 concerning the authorisation of L-leucine as a feed additive for all animal species (Text with EEA relevance)
Commission Implementing Regulation (EU) 2020/378 of 5 March 2020 concerning the authorisation of L-leucine as a feed additive for all animal species (Text with EEA relevance)
C/2020/1217
OJ L 69, 6.3.2020, p. 9–12
(BG, ES, CS, DA, DE, ET, EL, EN, FR, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)
In force
6.3.2020 |
EN |
Official Journal of the European Union |
L 69/9 |
COMMISSION IMPLEMENTING REGULATION (EU) 2020/378
of 5 March 2020
concerning the authorisation of L-leucine 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 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 such authorisation. |
(2) |
In accordance with Article 7(1) of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of L-leucine produced by Escherichia coli NITE BP-02351 as a nutritional feed additive for use in feed and in water for drinking and as sensory feed additive for use in feed for all animal species. This application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003. |
(3) |
This application concerns the authorisation of L-leucine produced by Escherichia coli NITE BP-02351 as a feed additive for all animal species to be classified in the additive category ‘nutritional additives’ (functional group ‘amino acids, their salts and analogues’) and in the additive category ‘sensory additives’ (functional group ‘flavouring compounds’). |
(4) |
The European Food Safety Authority (‘the Authority’) concluded in its opinion of 2 April 2019 (2) that, under the proposed conditions of use, L-leucine produced by Escherichia coli NITE BP-02351 does not have an adverse effect on animal health, consumer health or the environment. It also stated that L-leucine produced by Escherichia coli NITE BP-02351 could pose an inhalation risk for the users of the additive. Therefore, appropriate protective measures should be taken to prevent adverse effects on human health, in particular as regards the users of the additive. |
(5) |
The Authority concluded that it is an effective source of the amino acid L-leucine for all animal species. For the supplemental L-leucine to be fully efficacious in ruminants, it should be protected against degradation in the rumen. The Authority expressed in a previous statement a concern over potential nutritional imbalances for amino acids, when they are administered via water for drinking. However, the Authority did not propose a maximum content for L-leucine. Thus, it is appropriate to indicate on the label of the additive, and premixtures containing it, an alert to take into account the dietary supply with all the essential and conditionally essential amino acids, particularly in the case of supplementation with L-leucine as amino acid via water for drinking. |
(6) |
As regards the use of L-leucine as a flavouring, the Authority states that no further demonstration of efficacy is necessary when the substance is used at the recommended dose level. The use of L-leucine as a flavouring compound is not authorised in water for drinking. At the recommended dose, L-leucine as flavouring compound is not likely to pose any concern for the dietary supply with all the essential and conditionally essential amino acids. |
(7) |
The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the reports on the method of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003. |
(8) |
The assessment of L-leucine 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 additive should be authorised as specified in the Annex to this Regulation. |
(9) |
The fact that the use of the L-leucine is not authorised for use as a flavouring in water for drinking, does not preclude its use in compound feed, which is administered via water. |
(10) |
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
L-leucine produced by Escherichia coli NITE BP-02351, specified in the Annex, is authorised as a feed additive in animal nutrition in the additive category ‘nutritional additives’, functional group ‘amino acids, their salts and analogues’, and in the additive category ‘sensory additives’, functional group ‘flavouring compounds’, subject to the conditions laid down in that Annex.
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, 5 March 2020.
For the Commission
The President
Ursula VON DER LEYEN
(1) OJ L 268, 18.10.2003, p. 29.
(2) EFSA Journal 2019;17(5):5689.
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 |
||||||||||||||
mg/kg of complete feed with a moisture content of 12 % |
|||||||||||||||||||||||
Category of nutritional additives. Functional group: amino acids, their salts and analogues. |
|||||||||||||||||||||||
3c382 |
- |
L-leucine |
Additive composition: Powder with a minimum content of L-leucine of 98 % (on a dry matter basis) and a maximum content of 1,5 % water |
All animal species |
|
|
|
|
26.3.2030 |
||||||||||||||
Characterisation of the active substance: L-leucine produced by fermentation with Escherichia coli NITE BP-02351. Chemical formula: C6H13NO2 CAS number: 61-90-5 |
|||||||||||||||||||||||
Analytical method (1): For the identification of L-leucine in the feed additive:
For the quantification of leucine in the feed additive:
For the quantification of leucine in premixtures:
For the quantification of leucine in compound feed and feed materials:
For the quantification of leucine in water:
|
|||||||||||||||||||||||
Category: Sensory additives. Functional group: Flavouring compounds |
|||||||||||||||||||||||
3c382 |
- |
L-leucine |
Additive composition: Powder with a minimum content of L-leucine of 98 % (on a dry matter basis) and a maximum content of 1,5 % water |
All animal species |
- |
- |
- |
|
26.3.2030 |
||||||||||||||
Characterisation of the active substance: L-leucine produced by fermentation with Escherichia coli NITE BP-02351 Chemical formula: C6H13NO2 CAS number: 61-90-5 FLAVIS No 17.012 Method of analysis (1): For the identification of L-leucine in the feed additive:
For the quantification of leucine in the feed additive:
For the quantification of leucine in premixtures:
|
(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
(2) Exposure calculated based on the endotoxin level and the dusting potential of the additive according to the method used by EFSA (EFSA Journal 2019;17(5):5689); analytical method: European Pharmacopoeia 2.6.14 (bacterial endotoxins).