Date: 2023-11-28Category: Not ApplicableState: Union GovernmentCountry: Europe
Commission Implementing Regulation (EU) 2023/2632 of 27 November 2023 concerning the authorisation of disodium 5′-inosinate produced by fermentation with Corynebacterium stationis KCCM 80235 as a feed additive for all animal species
Issued by European Commission
· Directorate-General for Health and Food Safety
Executive Summary:
Commission Implementing Regulation (EU) 2023/2632 authorises disodium 5'-inosinate, produced by fermentation with *Corynebacterium stationis* KCCM 80235, as a sensory feed additive (flavouring compound) for all animal species. The regulation takes effect twenty days after its publication in the Official Journal of the European Union. The authorisation is valid until 18 December 2033.
Key Points / Main Content:
* **Authorisation:**
* Disodium 5'-inosinate produced by fermentation with *Corynebacterium stationis* KCCM 80235 is authorised as a feed additive for all animal species.
* It is classified as a sensory additive within the functional group of flavouring compounds.
* Use in drinking water is not permitted.
* **Conditions of Use:**
* The additive must be incorporated into feed as a premixture.
* Storage conditions and stability to heat treatment must be indicated in the directions for use of the additive and premixtures.
* **Labelling Requirements:**
* The label of the additive must include the recommended maximum content of the active substance, alone or in combination with other authorised disodium 5'-ribonucleotides (50 mg/kg of complete feedingstuff with a moisture content of 12%).
* The functional group, identification number, name, and added amount of the active substance must be indicated on the label of the premixture if the use level would exceed the limit.
* **Specifications:**
* Purity: minimum 97% on dry matter basis.
* **Analytical Method:**
* Specific analytical methods are referenced for identification and determination of disodium 5'-inosinate.
* **Duration:**
* Authorisation expires on 18 December 2033.
Impact Analysis:
**Animal Feed Producers:**
* Impact: Can now use disodium 5'-inosinate produced by fermentation with *Corynebacterium stationis* KCCM 80235 as a flavouring feed additive for all animal species, provided they adhere to the specified conditions and labelling requirements.
* Action Required: Ensure compliance with the conditions of use, including proper incorporation into premixtures, correct labelling, and adherence to the maximum content limits.
**European Food Safety Authority (EFSA):**
* Impact: Their positive safety assessment paved the way for authorisation.
* Action Required: No specific action required, but their findings serve as the scientific basis for the regulation.
**Reference Laboratory:**
* Impact: Responsible for providing the analytical methods.
* Action Required: Maintain and update the analytical methods for disodium 5'-inosinate in feed.
**European Commission:**
* Impact: Responsible for implementing and enforcing the regulation.
* Action Required: Ensure the regulation is properly implemented and enforced across all Member States.
**Member States:**
* Impact: Must ensure the regulation is directly applicable within their jurisdiction.
* Action Required: Implement the regulation and ensure compliance by feed producers within their territories.
Key Entities Referenced
European Union: A political and economic union of member states located primarily in Europe.
European Commission: An executive branch of the European Union responsible for proposing legislation, implementing decisions, and managing the day-to-day business of the EU.
Treaty on the Functioning of the European Union: One of the primary treaties of the European Union, outlining its scope and governance.
Regulation EC No 1831/2003: A regulation of the European Parliament and of the Council concerning additives for use in animal nutrition.
European Parliament: The directly elected parliamentary body of the European Union.
Council of the European Union: A body composed of government ministers from each EU member state.
European Food Safety Authority: An agency of the European Union that provides independent scientific advice on food-related risks.
Corynebacterium stationis KCCM 80235: A strain of bacteria used in the fermentation process to produce disodium 5'-inosinate.
Official Journal EN
of the European Union L series
2023/2632 28.11.2023
COMMISSION IMPLEMENTING REGULATION (EU) 2023/2632
of 27 November 2023
concerning the authorisation of disodium 5′-inosinate produced by fermentation with
Corynebacterium stationis KCCM 80235 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 disodium 5′-inosinate produced by fermentation with Corynebacterium stationis KCCM 80235 for all animal
species. The application was accompanied by the particulars and documents required under Article 7(3) of
Regulation (EC) No 1831/2003.
(3) That application concerns the authorisation of disodium 5′-inosinate produced by fermentation with
Corynebacterium stationis KCCM 80235 as a feed additive for all animal species, requesting that additive to be
classified in the additive category ‘sensory additives’ and in the functional group ‘flavouring compounds’. The
applicant requested the 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 this additive in water for drinking should not be allowed.
(4) The European Food Safety Authority (‘the Authority’) concluded in its opinions of 26 January 2022(2)and 21 March
2023(3) that, under the proposed conditions of use, disodium 5′-inosinate produced by fermentation with
Corynebacterium stationis KCCM 80235 is safe for all animal species, for consumers and for the environment. It
concluded that disodium 5′-inosinate produced by fermentation with Corynebacterium stationis KCCM 80235 should
be considered not toxic by inhalation, not irritant to skin or eyes and not a dermal sensitiser. The Authority further
concluded that since disodium 5′-inosinate produced by fermentation with Corynebacterium stationis KCCM 80235 is
recognised to flavour food and since its function in feed would be essentially the same as that in food, no further
demonstration of efficacy is considered necessary. The Authority 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) In view of the above, the Commission considers that disodium 5′-inosinate produced by fermentation with
Corynebacterium stationis KCCM 80235 satisfies the conditions for authorisation, as provided for in Article 5 of
Regulation (EC) No 1831/2003. Accordingly, the use of that substance should be authorised.
(6) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on
Plants, Animals, Food and Feed,
(1) OJ L 268, 18.10.2003, p. 29.
(2) EFSA Journal 2022;20(3):7153.
(3) EFSA Journal 2023;21(4):7958.
ELI: http://data.europa.eu/eli/reg_impl/2023/2632/oj 1/3EN
OJ L, 28.11.2023
HAS ADOPTED THIS REGULATION:
Article 1
Authorisation
The substance specified in the Annex, belonging to the additive category ‘sensory additives’ and to the functional group
‘flavouring compounds’, is authorised as an additive in animal nutrition, subject to the conditions laid down in that Annex.
Article 2
Entry into force
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, 27 November 2023.
For the Commission
The President
Ursula VON DER LEYEN
2/3 ELI: http://data.europa.eu/eli/reg_impl/2023/2632/ojELI:
http://data.europa.eu/eli/reg_impl/2023/2632/oj
3/3
ANNEX
Minimum Maximum
content content
Identifica-
Species or
tion Composition, chemical formula, description, Maximum mg of active End of period of
Additive category of Other provisions
number of analytical method age substance/kg of authorisation
animal
the additive complete feedingstuff
with a moisture content
of 12 %
Category: Sensory additives. Functional group: Flavouring compounds
2b631i Disodium 5′- Additive composition: All animal — — — 1. The additive shall be incorporated into 18 December 2033
inosinate species the feed in the form of a premixture.
Disodium 5′-inosinate
Solid form 2. In the directions for use of the additive
and premixtures, the storage conditions
Characterisation of active substance:
and stability to heat treatment shall be
indicated.
Disodium 5′-inosinate produced by
fermentation with Corynebacterium stationis
3. On the label of the additive the following
KCCM 80235
shall be indicated: ‘Recommended max
Purity: min. 97 % on dry matter basis.
imum content of the active substance
Chemical formula:
alone or in combination with other
C H O N Na P·7,5H O
10 11 8 4 2 2 authorised disodium 5′-ribonucleotides:
CAS number: 4691-65-0
50 mg/kg of complete feedingstuff with a
moisture content of 12 %’.
Analytical method(1):
4. The functional group, the identification
For the identification of disodium 5'-
number, the name and the added amount
inosinate (IMP) in the feed additive: FAO
of the active substance shall be indicated
JECFA monograph ‘disodium 5'-inosinate’
on the label of the premixture where the
For the determination of disodium 5'-
use level on the label of the premixture
inosinate (IMP) in the feed additive,
would result in exceeding the level re
flavouring premixtures and water: – High
ferred to in point 3.
performance liquid chromatography
coupled to UV detection (HPLC-UV)
(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-feedadditives/eurl-fa-authorisation/eurl-fa-evaluation-
reports_en
OJ
L,
28.11.2023
EN