Date: 2020-02-21Category: Not ApplicableState: Union GovernmentCountry: Europe
Commission Implementing Regulation (EU) 2020/238 of 20 February 2020 concerning the authorisation of L-threonine as a feed additive for all animal species (Text with EEA relevance)
Issued by European Commission
· Directorate-General for Health and Food Safety
Executive Summary:
Commission Implementing Regulation (EU) 2020/238 authorises L-threonine, produced by Corynebacterium glutamicum KCCM 80117 or KCCM 80118, as a feed additive for all animal species. It classifies L-threonine as a nutritional additive. The authorisation is valid until 12 March 2030. The regulation entered into force on 11 March 2020, twentieth day following its publication.
Key Points / Main Content:
Authorisation of L-Threonine:
* L-threonine, produced by Corynebacterium glutamicum KCCM 80117 or KCCM 80118, is authorised as a feed additive for all animal species.
* It falls under the additive category of nutritional additives, functional group amino acids, their salts, and analogues (3c410).
Conditions of Use:
* L-threonine must have a minimum content of 98% on a dry matter basis.
* L-threonine can be marketed and used as a preparation.
* L-threonine may be used via drinking water.
* Supplementation with L-threonine, particularly via drinking water, should consider all essential and conditional essential amino acids to avoid imbalances.
Labelling Requirements:
* The additive's label must indicate its moisture content.
* The label of the additive and premixtures must state that supplementation with L-threonine, especially via water, should consider all essential and conditional essential amino acids.
Analytical Methods:
* Specific analytical methods for determining L-threonine in the feed additive, premixtures, compound feed, feed materials, and water are referenced, with details available at the European Union Reference Laboratory.
Validity Period:
* The authorisation is valid until 12 March 2030.
Impact Analysis:
Feed Additive Manufacturers/Producers:
* Impact: Authorised to produce and market L-threonine as a feed additive under the specified conditions.
* Action Required: Ensure the L-threonine meets the minimum content requirements, adhere to labelling requirements, and follow the specified analytical methods for quality control.
Feed Industry (Compound Feed and Premixtures):
* Impact: Can use L-threonine in feed formulations for all animal species.
* Action Required: Ensure proper labelling of products containing L-threonine and consider amino acid balance when supplementing with L-threonine, especially through drinking water.
Animal Feed Businesses/Farmers:
* Impact: Access to an authorised source of L-threonine for animal nutrition.
* Action Required: Be aware of the appropriate use and limitations of L-threonine supplementation, particularly in relation to amino acid balance.
EU Member States:
* Impact: Must ensure the regulation is directly applicable within their jurisdiction.
* Action Required: Enforce the regulation and monitor compliance of feed additive manufacturers and the feed industry.
Key Entities Referenced
European Union: A political and economic union of member states located primarily in Europe.
European Commission: An institution of the European Union responsible for proposing legislation, implementing decisions, upholding the EU treaties and managing the day-to-day business of the EU.
Regulation EC No 1831/2003: A regulation of the European Parliament and of the Council on additives for use in animal nutrition.
L-threonine: An essential amino acid authorized as a feed additive for all animal species.
Corynebacterium glutamicum KCCM 80117: A strain of bacteria used in the production of L-threonine.
Corynebacterium glutamicum KCCM 80118: A strain of bacteria used in the production of L-threonine.
European Food Safety Authority: An agency of the European Union that provides independent scientific advice and communicates on risks associated with the food chain.
Ursula VON DER LEYEN: The President of the European Commission.
21.2.2020 E N O f f i c i a l J o u r n a l o f t h e E u r o p e a n U nion L 48/3
COMMISSION IMPLEMENTING REGULATION (EU) 2020/238
of 20 February 2020
concerning the authorisation of L-threonine 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 of Regulation (EC) No 1831/2003, applications were submitted for the authorisation of
L-threonine produced by Corynebacterium glutamicum KCCM 80117 or by Corynebacterium glutamicum KCCM 80118
as a feed additive for use in feed for all animal species. These applications were accompanied by the particulars and
documents required under Article 7(3) of that Regulation.
(3) Those applications concern the authorisation of L-threonine produced by Corynebacterium glutamicum KCCM 80117
or by Corynebacterium glutamicum KCCM 80118 as a feed additive for all animal species to be classified in the additive
category ‘nutritional additives’.
(4) The European Food Safety Authority (‘the Authority’) concluded in its opinions of 22 January 2019(2)(3) that, under
the proposed conditions of use, L-threonine produced by Corynebacterium glutamicum KCCM 80117 or
Corynebacterium glutamicum KCCM 80118 does not have an adverse effect on animal health, human health or the
environment. 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.
(5) The assessment of L-threonine produced by Corynebacterium glutamicum KCCM 80117 and by Corynebacterium
glutamicum KCCM 80118 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.
(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.
(1) OJ L 268, 18.10.2003, p. 29.
(2) EFSA Journal 2019;17(2):5602.
(3) EFSA Journal 2019;17(3):5603.L 48/4 E N O f f i c i a l J o u r n a l o f t h e E u r o p e an Union 21.2.2020
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, 20 February 2020.
For the Commission
The President
Ursula VON DER LEYENANNEX
Minimum Maximum
Identifica-
Name of the Species or content content End of period
tion Composition, chemical formula, description, analytical Maximum
holder of Additive category of Other provisions of
number of method. age
authorisation animal mg/kg of complete feed with a authorisation
the additive
moisture content of 12 %
Category of nutritional additives. Functional group: amino acids, their salts and analogues.
3c410 — L-threonine Additive composition All species — — — 1. L-threonine may be 12.3.2030
Powder with a minimum of 98 % placed on the market
L-threonine (on a dry matter basis). and used as an addi
tive consisting of a
Characterisation of the active substance preparation.
L-threonine produced by fermentation with Corynebac 2. L-threonine may be
terium glutamicum KCCM 80117 or used via water for
Corynebacterium glutamicum KCCM 80118 drinking.
Chemical formula: C 4H 9NO 3 3. The labelling of the CAS Number: 72-19-5. additive shall indi
cate the moisture
Analytical methods (1) content.
For the determination of L-threonine in the feed addi 4. The labelling of the
tive:
additive and premix
— Food Chemical Codex ‘L-threonine monograph’, and
tures shall indicate
— Ion exchange chromatography coupled with post- the following:
column derivatisation and optical detection (IEC-
‘The supplementa
VIS/FLD) – EN ISO 17180.
tion with L-threo
For the determination of threonine in premixtures:
nine, in particular
— ion exchange chromatography coupled with post-
via water for drink
column derivatisation and optical detection (IEC-
ing, should take into
VIS/FLD) – EN ISO 17180, and
account all essential
— ion exchange chromatography coupled with post-
and conditional es
column derivatisation and photometric detection
sential amino acids
(IEC-VIS), Commission Regulation (EC) No
in order to avoid im
152/2009 (Annex III, F).
balances.’
For the determination of threonine in compound feed
and feed materials:
— Ion exchange chromatography coupled with post-
column derivatisation and photometric detection
(IEC-VIS): Commission Regulation (EC) No
152/2009 (Annex III, F).
For the determination of threonine in water:
— ion exchange chromatography coupled with post-
column derivatisation and optical detection (IEC-
VIS/FLD).
(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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