Date: 2021-05-03Category: Not ApplicableState: Union GovernmentCountry: Europe
Commission Implementing Regulation (EU) 2021/719 of 30 April 2021 concerning the authorisation of L-valine produced by Corynebacterium glutamicum CGMCC 7.358 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:
This regulation authorises L-valine produced by Corynebacterium glutamicum CGMCC 7.358 as a feed additive for all animal species. It classifies L-valine as a nutritional additive (amino acid group). The regulation addresses safety concerns for users and sets conditions for its use, taking effect twenty days after its publication in the Official Journal of the European Union on May 3, 2021.
Key Points / Main Content:
* **Authorisation:**
* L-valine produced by Corynebacterium glutamicum CGMCC 7.358 is authorised as a feed additive for all animal species.
* It is classified as a nutritional additive, specifically within the functional group of amino acids, their salts, and analogues.
* The additive is identified by the number 3c371i.
* **Composition and Characteristics:**
* L-valine must have a minimum content of 98% on a dry matter basis.
* Maximum water content is 1.5%.
* The additive consists of a preparation of L-valine in powder form.
* L-valine’s chemical formula is C5H11NO2, and its CAS number is 72-18-4.
* **Conditions of Use:**
* L-valine can be placed on the market and used as an additive consisting of a preparation.
* It may be used via drinking water.
* Storage conditions, heat treatment stability, and stability in drinking water must be indicated in the instructions.
* The label must state that L-valine supplementation, especially via drinking water, should consider all essential and conditionally essential amino acids to avoid imbalances.
* **Safety Measures:**
* Feed business operators must establish operational procedures and organisational measures to address potential risks of inhalation, eye, or dermal contact for users.
* If risks cannot be minimised, appropriate personal protective equipment (breathing protection, safety glasses, and gloves) must be used.
* **Analytical Methods:**
* Specific analytical methods are defined for identifying and quantifying L-valine in the feed additive, premixtures, feed materials, compound feed, and water. Details are available at the provided Reference Laboratory address.
* **Expiration:**
* Authorisation expires on May 23, 2031.
Impact Analysis:
* **Feed Manufacturers:**
* Impact: Can now legally use L-valine produced by Corynebacterium glutamicum CGMCC 7.358 as a feed additive, provided they adhere to the specified conditions.
* Action Required: Ensure L-valine meets purity and content specifications, implement safety measures for handling, and provide accurate labelling and usage instructions.
* **Animal Feed Additive Users:**
* Impact: Access to L-valine as a feed additive to improve animal nutrition.
* Action Required: Follow safety protocols, use appropriate personal protective equipment, and ensure proper supplementation levels, considering other amino acids.
* **European Food Safety Authority (EFSA):**
* Impact: Their assessment forms the basis for this regulation.
* Action Required: No specific action is required as the regulation is based on their prior assessment.
* **European Commission:**
* Impact: Responsible for implementing and enforcing the regulation.
* Action Required: Ensure the regulation is correctly applied and monitored across member states.
Key Entities Referenced
Lvaline: An amino acid authorized as a feed additive for all animal species.
Corynebacterium glutamicum CGMCC 7.358: The strain of bacteria used to produce Lvaline.
European Food Safety Authority: The Authority that provided an opinion on the safety and efficacy of Lvaline.
Regulation EC No 1831/2003: Regulation of the European Parliament and of the Council on additives for use in animal nutrition.
European Union: Political and economic union of member states located primarily in Europe.
Standing Committee on Plants, Animals, Food and Feed: Committee that provided an opinion in accordance to which the measures were provided.
Ursula VON DER LEYEN: The President of the European Commission.
Brussels: The city where the Commission Implementing Regulation EU 2021/719 was adopted.
L 151/12 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 Union 3.5.2021
COMMISSION IMPLEMENTING REGULATION (EU) 2021/719
of 30 April 2021
concerning the authorisation of L-valine produced by Corynebacterium glutamicum CGMCC 7.358 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 2003on
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, an application was submitted for the authorisation
of L-valine. The application was accompanied by the particulars and documents required under Article 7(3) of that
Regulation.
(3) The application concerns the authorisation of L-valine produced by Corynebacterium glutamicum CGMCC 7.358 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’.
(4) The European Food Safety Authority (‘the Authority’) concluded in its opinion of 30 September 2020(2)that, under
the proposed conditions of use, L-valine produced by Corynebacterium glutamicum CGMCC 7.358, when
supplemented to diets in appropriate amounts, does not have an adverse effect on animal health, consumer health
or the environment. With respect to the safety of the user of L-valine produced by Corynebacterium glutamicum
CGMCC 7.358, the Authority could neither exclude a risk by inhalation, nor that the substance it is irritant to skin
or eyes, or a dermal sensitiser. Therefore, appropriate protective measures should be taken for this additive to
prevent adverse effects on human health, in particular as regards the users of the additive. Furthermore, the
Authority concluded that the substance is considered an efficacious source of the essential amino acid L-valine for
animal nutrition and that, in order to be efficacious in ruminants, it 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 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.
(5) The assessment of L-valine produced by Corynebacterium glutamicum CGMCC 7.358 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 substance 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 a feed additive, subject to the conditions laid down in that Annex.
(1) OJ L 268, 18.10.2003, p. 29.
(2) EFSA Journal 2020; 18(11):6286.3.5.2021 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 Union L 151/13
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, 30 April 2021.
For the Commission
The President
Ursula VON DER LEYENANNEX
Minimum Maximum
Identification Name of the content content
Composition, chemical formula, Species or category End of period of
number of the holder of Additive Maximum age Other provisions
description, analytical method. of animal authorisation
additive authorisation mg additive/kg of complete feed
with a moisture content of 12 %
Category of nutritional additives. Functional group: amino acids, their salts and analogues.
3c371i - L-valine Additive composition: All species - - - 1. L-valine may be placed on 23.5.2031
Powder with a minimum the market and used as an
content of L-valine of 98 % (on additive consisting of a
a dry matter basis) and a preparation.
maximum content of 1,5 % 2. The additive may be used
water via water for drinking.
3. In the directions for use of
the additive and premix
ture, the storage condi
Characterisation of the tions, the stability to heat
active substance: treatment and the stability
L-valine ((2S)-2-amino-3- in water for drinking shall
methylbutanoic acid) be indicated.
produced by Corynebacterium 4. The label of the additive
glutamicum CGMCC 7.358 and premixture shall indi
Chemical formula: C H NO cate the following: ‘The
5 11 2
CAS number: 72-18-4 supplementation with
L-valine, in particular via
water for drinking, should
take into account all essen
Analytical method(1): tial and conditionally es
For the identification of sential amino acids in or
L-valine in the feed additive: der to avoid imbalances.’
— Food Chemical Codex 5. For users of the additive
"L-valine monograph" and premixtures, feed
business operators shall
establish operational pro
cedures and organisational
measures to address the
L
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3.5.2021For the quantification of valine potential risks by inhala
in the feed additive: tion, eye or dermal con
— ion exchange chromato tact. Where those risks
graphy coupled with post- cannot be eliminated or re
column derivatisation and duced to a minimum by
photometric detection such procedures and mea
(IEC-VIS) sures, the additive and pre
For the quantification of valine mixtures shall be used with
in premixtures, feed materials appropriate personal pro
and compound feed: tective equipment, includ
— ion exchange chromato ing breathing protection,
graphy coupled with post- safety glasses and gloves.
column derivatisation and
photometric detection
(IEC-VIS) – Commission
Regulation (EC)
No 152/2009 (Annex III, F)
For the quantification of valine
in water:
— ion exchange chromato
graphy coupled with post-
column derivatisation and
optical detection
(IEC-VIS/FD)
(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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