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Document 32019R0894
Commission Implementing Regulation (EU) 2019/894 of 28 May 2019 concerning the authorisation of L-threonine produced by Escherichia coli CGMCC 7.232 as a feed additive for all animal species (Text with EEA relevance.)
Commission Implementing Regulation (EU) 2019/894 of 28 May 2019 concerning the authorisation of L-threonine produced by Escherichia coli CGMCC 7.232 as a feed additive for all animal species (Text with EEA relevance.)
Commission Implementing Regulation (EU) 2019/894 of 28 May 2019 concerning the authorisation of L-threonine produced by Escherichia coli CGMCC 7.232 as a feed additive for all animal species (Text with EEA relevance.)
C/2019/3861
IO L 142, 29.5.2019, p. 63–66
(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
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29.5.2019 |
EN |
Official Journal of the European Union |
L 142/63 |
COMMISSION IMPLEMENTING REGULATION (EU) 2019/894
of 28 May 2019
concerning the authorisation of L-threonine produced by Escherichia coli CGMCC 7.232 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:
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(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. |
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(2) |
In accordance with Article 7 of Regulation (EC) No 1831/2003 an application was submitted for the authorisation of L-threonine produced by Escherichia coli CGMCC 7.232 as a feed additive for use in feed for all animal species. That application was accompanied by the particulars and documents required under Article 7(3) of that Regulation (EC). |
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(3) |
That application concerns the authorisation of L-threonine produced by Escherichia coli CGMCC 7.232 as a feed additive for all animal species to be classified in the additive category ‘nutritional additives’. |
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(4) |
The European Food Safety Authority (‘the Authority’) concluded in its opinion of 2 October 2018 (2) that, under the proposed conditions of use, L-threonine produced by Escherichia coli CGMCC 7.232 does not have an adverse effect on animal health, consumer safety or the environment. It also concluded that the additive is considered as a potential skin sensitiser and an eye and skin irritant and stated a risk for the users of the additive upon inhalation. Therefore, the Commission considers that appropriate protective measures should be taken to prevent adverse effects on human health, in particular as regards the users of the additive. The Authority also concluded that the additive is an efficacious source of the amino-acid L-threonine for all animal species and that in order to be as efficacious in ruminants as in non-ruminant species, the additive should be protected against degradation in the rumen. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the method of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003. |
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(5) |
The assessment of L-threonine produced by Escherichia coli CGMCC 7.232 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. |
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(6) |
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 substance specified in the Annex, belonging to the additive category ‘nutritional additives’ and to the functional group ‘amino acids, their salts and analogues’, is authorised as an additive in animal nutrition, 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, 28 May 2019.
For the Commission
The President
Jean-Claude JUNCKER
(1) OJ L 268, 18.10.2003, p. 29.
(2) EFSA Journal 2018;16(10):5458.
ANNEX
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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 |
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mg/kg of complete feed with a moisture content of 12 % |
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Category of nutritional additives. Functional group: amino acids, their salts and analogues. |
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3c410 |
— |
L-threonine |
Additive composition: Powder with a minimum of 98 % L-threonine (on a dry matter basis). Characterisation of the active substance: L-threonine produced by fermentation with
Analytical methods (1): For the determination of L-threonine in the feed additive:
For the determination of threonine in premixtures:
For the determination of threonine in compound feed and feed materials:
For the determination of threonine in water:
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All species |
— |
— |
— |
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18 June 2029 |
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(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 2018;16(10):5458); analytical method: European Pharmacopoeia 2.6.14. (bacterial endotoxins).