Date: 2022-08-23Category: Not ApplicableState: Union GovernmentCountry: Europe
Commission Implementing Regulation (EU) 2022/1420 of 22 August 2022 concerning the authorisation of L-glutamic acid and monosodium glutamate produced by Corynebacterium glutamicum NITE BP-01681 as feed additives 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) 2022/1420 authorises L-glutamic acid and monosodium glutamate, produced by Corynebacterium glutamicum NITE BP01681, as feed additives for all animal species. The additives are classified as nutritional and sensory additives. The regulation specifies conditions for use, labeling requirements, and protective measures for users. The regulation took effect on September 12, 2022.
Key Points / Main Content:
Authorisation:
* L-glutamic acid and monosodium glutamate produced by Corynebacterium glutamicum NITE BP01681 are authorised as feed additives for all animal species.
* The additives are classified under nutritional additives (amino acids, their salts and analogues) and sensory additives (flavouring compounds).
* The authorisation is valid until 12 September 2032.
Conditions of Use:
* For nutritional additives, the additive may be used via water for drinking.
* For sensory additives, the additive shall be incorporated into the feed in the form of a premixture.
* For sensory additives, a recommended maximum content of 25 mg/kg of complete feed (with 12% moisture) for the active substance must be indicated on the label.
Labelling Requirements:
* The supplementation with L-glutamic acid or monosodium glutamate, particularly via drinking water, should consider all essential and conditionally essential amino acids to avoid imbalances.
* For sensory additives, if the use level on the label of the premixture would result in exceeding the recommended maximum content in complete feed, the functional group, identification number, name, and added amount of the active substance must be indicated on the label of the premixture.
* The storage conditions and stability to heat treatment must be indicated in the directions for use of the additive and premixture.
Protective Measures:
* Feed business operators must establish operational procedures and organisational measures to address potential risks by inhalation or dermal contact.
* If risks cannot be eliminated or minimised, appropriate personal protective equipment, including breathing protection, must be used.
Analytical Methods:
* Specific analytical methods for identification and quantification are referenced, with details available at the provided Reference Laboratory address.
Impact Analysis:
Feed Business Operators:
* Impact: Required to comply with the conditions of use, labelling requirements, and protective measures outlined in the regulation.
* Action Required: Update labels to include required information, implement safety procedures to minimise inhalation/dermal contact risks, and ensure proper storage and stability information is provided.
Users of the Additive and Premixtures:
* Impact: Need to follow established safety procedures and use appropriate personal protective equipment to avoid potential health risks.
* Action Required: Adhere to operational procedures, use personal protective equipment as necessary, and consider amino acid balances when supplementing feed.
Animal Nutrition Industry:
* Impact: Can utilise the authorised additives under the specified conditions to enhance the nutritional value and palatability of animal feed.
* Action Required: Incorporate the additives into feed formulations according to the regulation and ensure compliance with labelling requirements.
Key Entities Referenced
European Union: A political and economic union of member states located primarily in Europe.
European Commission: The executive branch of the European Union responsible for proposing legislation, implementing decisions, and managing the EU's day-to-day affairs.
L-glutamic acid: An amino acid authorized as an additive in animal nutrition.
Monosodium glutamate: A flavor enhancer authorized as an additive in animal nutrition.
Corynebacterium glutamicum NITE BP01681: The strain of bacteria used to produce L-glutamic acid and monosodium glutamate.
Regulation (EC) No 1831/2003: A regulation of the European Parliament and of the Council on additives for use in animal nutrition.
European Food Safety Authority: An agency of the European Union that provides independent scientific advice on food-related risks.
Brussels: The location where the regulation was adopted.
23.8.2022 EN Official Journal of the European Union L 218/17
COMMISSION IMPLEMENTING REGULATION (EU) 2022/1420
of 22 August 2022
concerning the authorisation of L-glutamic acid and monosodium glutamate produced by
Corynebacterium glutamicum NITE BP-01681 as feed additives 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 an authorisation.
(2) In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation
of L-glutamic acid and monosodium glutamate produced by Corynebacterium glutamicum NITE BP-01681. That
application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC)
No 1831/2003.
(3) The application concerns the authorisation of L-glutamic acid and monosodium glutamate produced by
Corynebacterium glutamicum NITE BP-01681 as feed additives for all animal species, to be classified in the categories
‘nutritional additives’ and ‘sensory additives’.
(4) The applicant requested the feed additive to be authorised for use also in water for drinking. However, Regulation
(EC) No 1831/2003 does not allow the authorisation of ‘flavouring compounds’ for use in water for drinking.
Therefore, the use of monosodium glutamate produced by Corynebacterium glutamicum KCCM 80188 in water for
drinking should not be allowed. The fact that the additive is not authorised for use as a flavouring in water for
drinking does not preclude its use in compound feed administered via water.
(5) The European Food Safety Authority (‘the Authority’) concluded in its opinion of 26 January 2022(2)that, under the
proposed conditions of use, L-glutamic acid and monosodium glutamate produced by Corynebacterium glutamicum
NITE BP-01681 do not have adverse effects on animal health, consumer safety or the environment. It also
concluded that these substances are neither considered irritant to skin or eyes, nor dermal sensitisers, but are
considered a risk by 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 these substances have the potential to be efficacious as nutritional additives and as flavouring
compounds in feedingstuffs. The Authority does not consider that there is a need for specific requirements of post-
market monitoring. It also verified the report on the methods of analysis of the feed additive in feed submitted by
the Reference Laboratory set up by Regulation (EC) No 1831/2003.
(6) The assessment of L-glutamic acid and monosodium glutamate produced by Corynebacterium glutamicum NITE
BP-01681 shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC)
No 1831/2003, are satisfied. Accordingly, the use of these substances should be authorised as specified in the
Annex to this Regulation.
(1) OJ L 268, 18.10.2003, p. 29.
(2) EFSA Journal 2022;20(3):7156.L 218/18 EN Official Journal of the European Union 23.8.2022
(7) Restrictions and conditions should be provided for to allow better control. In particular, a recommended content
should be indicated on the label of the feed additive. Where such content is exceeded, certain information should be
indicated on the label of premixtures.
(8) 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
1. The substances specified in the Annex, belonging to the additive category ‘nutritional additives’ and to the functional
group ‘amino acids, their salts and analogues’, are authorised as additives in animal nutrition, subject to the conditions laid
down in that Annex.
2. The substances specified in the Annex, belonging to the additive category ‘sensory additives’ and to the functional
group ‘flavouring compounds’, are authorised as additives 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, 22 August 2022.
For the Commission
The President
Ursula VON DER LEYENANNEX
Mini-
Maximum
mum
content
Identifi- content
cation Species or Maxi-
Composition, chemical formula, description, End of period of
number Additive category of mum mg active Other provisions
analytical method. authorisation
of the animal age substance/kg of
additive complete feed with a
moisture content of
12 %
Category: nutritional additives.
Functional group: amino acids, their salts and analogues
2b620i L-Glutamic acid Additive composition All animal - - - 1. In the directions for use of the additive and 12 September 2032
species premixture, the storage conditions and the
L-Glutamic acid stability to heat treatment shall be indicated.
2. The additive may be used via water for drink
Characterisation of the active substance
ing.
3. For users of the additive and premixtures,
L-Glutamic acid produced by Corynebacterium
feed business operators shall establish opera glutamicum NITE BP-01681
tional procedures and organisational mea
Purity: ≥ 98 % sures to address the potential risks by inhala
tion or dermal contact. Where those risks
Chemical formula: C H O N cannot be eliminated or reduced to a mini 5 9 4
mum by such procedures and measures, the
CAS number: 56-86-0 additive and premixtures shall be used with
Einecs number: 200-293-7 appropriate personal protective equipment,
including breathing protection.
Analytical method(1)
4. Declarations to be made on the labelling of
the additive and premixtures: ‘The supple
For the identification of L-glutamic acid in the
mentation with L-glutamic acid, in particular
feed additive:
via water for drinking, should take into ac
— Food Chemical Codex monographs:
count all essential and conditionally essential
‘L-Glutamic acid’
amino acids in order to avoid imbalances.’
For the quantification of glutamic acid in the
feed additive:
— Ion-exchange chromatography coupled
with post-column derivatisation and visi
ble or fluorescence detection
(IEC-VIS/FLD) or
23.8.2022
EN
Official
Journal
of
the
European
Union
L
218/19— Ion-exchange chromatography coupled
with post-column derivatisation and
photometric detection (IEC-VIS)
For the quantification of glutamic acid in
premixtures:
— Ion-exchange chromatography coupled
with post-column derivatisation and visi
ble or fluorescence detection
(IEC-VIS/FLD) or
— Ion-exchange chromatography coupled
with post-column derivatisation and
photometric detection (IEC-VIS), Com
mission Regulation (EC) No 152/2009
(Annex III, F)
For the quantification of glutamic acid in
feedingstuffs:
— Ion exchange chromatography coupled
to post-column derivatisation and photo
metric detection (IEC-VIS), Commission
Regulation (EC) No 152/2009 (Annex III,
F)
(1) Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation-
reports_en
L
218/20
EN
Official
Journal
of
the
European
Union
23.8.2022Mini-
Maximum
mum
content
Identifi- content
cation Species or Maxi-
Composition, chemical formula, description, End of period of
number Additive category of mum mg active Other provisions
analytical method. authorisation
of the animal age substance/kg of
additive complete feed with a
moisture content of
12 %
Category: Sensory additives.
Functional group: Flavouring compounds
2b620i L-Glutamic acid Additive composition All animal - - - 1. The additive shall be incorporated into the 12 September 2032
L-Glutamic acid species feed in the form of a premixture.
Characterisation of the active substance 2. In the directions for use of the additive and
L-Glutamic acid produced by Corynebacterium premixture, the storage conditions and the
glutamicum NITE BP-01681 stability to heat treatment shall be indicated.
Purity: ≥ 98 % 3. On the label of the additive the following
Chemical formula: C H O N shall be indicated: ‘Recommended maxi
5 9 4
CAS number: 56-86-0 mum content of the active substance of
Einecs number: 200-293-7 complete feed with a moisture content of
Analytical method(1) 12 %: 25 mg/kg.’
For the identification of L-glutamic acid in the 4. The functional group, the identification
feed additive: number, the name and the added amount
— Food Chemical Codex monographs: of the active substance shall be indicated on
‘L-Glutamic acid’ the label of the premixture, where the use
For the quantification of glutamic acid in the level on the label of the premixture would
feed additive: result in exceeding the level of active sub
— Ion-exchange chromatography coupled stance in complete feed referred to in point 3.
with post-column derivatisation and visi 5. For users of the additive and premixtures,
ble or fluorescence detection feed business operators shall establish opera
(IEC-VIS/FLD) or tional procedures and organisational mea
— Ion-exchange chromatography coupled sures to address the potential risks by inhala
with post-column derivatisation and tion or dermal contact. Where those risks
photometric detection (IEC-VIS) cannot be eliminated or reduced to a mini
mum by such procedures and measures, the
23.8.2022
EN
Official
Journal
of
the
European
Union
L
218/21For the quantification of glutamic acid in additive and premixtures shall be used with
premixtures: appropriate personal protective equipment,
— Ion-exchange chromatography coupled including breathing protection.
with post-column derivatisation and visi
ble or fluorescence detection
(IEC-VIS/FLD) or
— Ion-exchange chromatography coupled
with post-column derivatisation and
photometric detection (IEC-VIS), Com
mission Regulation (EC) No 152/2009
(Annex III, F)
(1) Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation-
reports_en
L
218/22
EN
Official
Journal
of
the
European
Union
23.8.2022Mini-
Maximum
mum
content
Identifi- content
cation Species or Maxi-
Composition, chemical formula, description, End of period of
number Additive category of mum mg active Other provisions
analytical method. authorisation
of the animal age substance/kg of
additive complete feed with a
moisture content of
12 %
Category: nutritional additives.
Functional group: amino acids, their salts and analogues
2b621ii Monosodium Additive composition All animal - - - 1. In the directions for use of the additive and 12 September 2032
glutamate Monosodium glutamate species premixture, the storage conditions and the
Characterisation of the active substance stability to heat treatment shall be indicated.
Monosodium glutamate produced by 2. The additive may be used via water for drink
Corynebacterium glutamicum NITE BP-01681 ing.
Purity: ≥ 99 % 3. For users of the additive and premixtures,
Chemical formula: C H NaNO H O feed business operators shall establish opera
5 8 4· 2
CAS number: 6106-04-3 tional procedures and organisational mea
Einecs number: 205-538-1 sures to address the potential risks by inhala
Analytical method(1) tion or dermal contact. Where those risks
For the identification of monosodium cannot be eliminated or reduced to a mini
L-glutamate monohydrate in the feed mum by such procedures and measures, the
additive: additive and premixtures shall be used with
— Food Chemical Codex monographs: appropriate personal protective equipment,
‘Monosodium L-glutamate’ including breathing protection.
For the quantification of monosodium 4. Declarations to be made on the labelling of
glutamate in the feed additive: the additive and premixtures: ‘The supple
— Ion-exchange chromatography coupled mentation with monosodium glutamate, in
with post-column derivatisation and visi particular via water for drinking, should take
ble or fluorescence detection into account all essential and conditionally
(IEC-VIS/FLD) or essential amino acids in order to avoid im
— Ion-exchange chromatography coupled balances.’
with post-column derivatisation and
photometric detection (IEC-VIS)
23.8.2022
EN
Official
Journal
of
the
European
Union
L
218/23For the quantification of monosodium
glutamate in premixtures:
— Ion-exchange chromatography coupled
with post-column derivatisation and visi
ble or fluorescence detection
(IEC-VIS/FLD) or
— Ion-exchange chromatography coupled
with post-column derivatisation and
photometric detection (IEC-VIS), Com
mission Regulation (EC) No 152/2009
(Annex III, F)
For the quantification of monosodium
glutamate in feedingstuffs:
— Ion exchange chromatography coupled
to post-column derivatisation and photo
metric detection (IEC-VIS), Commission
Regulation (EC) No 152/2009 (Annex III,
F)
(1) Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation-
reports_en
L
218/24
EN
Official
Journal
of
the
European
Union
23.8.2022Mini-
Maximum
mum
content
Identifi- content
cation Species or Maxi-
Composition, chemical formula, description, End of period of
number Additive category of mum mg active Other provisions
analytical method. authorisation
of the animal age substance/kg of
additive complete feed with a
moisture content of
12 %
Category: Sensory additives. Functional group:
Flavouring compounds
2b621ii Monosodium Additive composition All animal - - - 1. The additive shall be incorporated into the 12 September 2032
glutamate Monosodium glutamate species feed in the form of a premixture.
Characterisation of the active substance 2. In the directions for use of the additive and
Monosodium glutamate produced by premixture, the storage conditions and the
Corynebacterium glutamicum NITE BP-01681 stability to heat treatment shall be indicated.
Purity: ≥ 99 % 3. On the label of the additive the following
Chemical formula: C H NaNO H O shall be indicated: ‘Recommended maxi
5 8 4· 2
CAS number: 6106-04-3 mum content of the active substance of
Einecs number: 205-538-1 complete feed with a moisture content of
Analytical method(1) 12 %: 25 mg/kg.’
For the identification of monosodium 4. The functional group, the identification num
L-glutamate monohydrate in the feed ber, the name and the added amount of the
additive: active substance shall be indicated on the label
— Food Chemical Codex monographs: of the premixture, where the use level on the
‘Monosodium L-glutamate’ label of the premixture would result in exceed
For the quantification of monosodium ing the level of active substance in complete
glutamate in the feed additive: feed referred to in point 3.
— Ion-exchange chromatography coupled 5. For users of the additive and premixtures,
with post-column derivatisation and visi feed business operators shall establish opera
ble or fluorescence detection tional procedures and organisational mea
(IEC-VIS/FLD) or sures to address the potential risks by inhala
— Ion-exchange chromatography coupled tion or dermal contact. Where those risks
with post-column derivatisation and cannot be eliminated or reduced to a mini
photometric detection (IEC-VIS) mum by such procedures and measures, the
additive and premixtures shall be used with
appropriate personal protective equipment,
including breathing protection.
23.8.2022
EN
Official
Journal
of
the
European
Union
L
218/25For the quantification of monosodium
glutamate in premixtures:
— Ion-exchange chromatography coupled
with post-column derivatisation and visi
ble or fluorescence detection
(IEC-VIS/FLD) or
— Ion-exchange chromatography coupled
with post-column derivatisation and
photometric detection (IEC-VIS), Com
mission Regulation (EC) No 152/2009
(Annex III, F)
(1) Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation-
reports_en
L
218/26
EN
Official
Journal
of
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Union
23.8.2022