Commission Implementing Regulation (EU) 2021/2093 of 29 November 2021 concerning the authorisation of disodium 5'-guanylate as a feed additive for all animal species (Text with EEA relevance)
Date: 2021-11-29
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: animal feedingstuffs, flavouring, market approval








L_2021427EN.01016901.xml










30.11.2021   


EN


Official Journal of the European Union


L 427/169








            COMMISSION IMPLEMENTING REGULATION (EU) 2021/2093
of 29 November 2021
         
concerning the authorisation of disodium 5'-guanylate 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 an application was submitted for the authorisation of disodium 5'-guanylate. 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 disodium 5'-guanylate as a feed additive for all animal species, to be classified in the category ‘sensory additives’ and in the functional group ‘flavouring compounds’.












(4)


The applicant requested disodium 5'-guanylate to be authorised also for use 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 disodium 5'-guanylate in water for drinking should not be allowed.












(5)


The European Food Safety Authority (‘the Authority’) concluded in its opinion of 5 May 2021 (2) that, under the proposed conditions of use, disodium 5'-guanylate does not have adverse effects on animal health, human health or the environment.












(6)


The Authority further concluded, that disodium 5'-guanylate is efficacious to contribute to the flavour of feed. The Authority 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.












(7)


The assessment of disodium 5'-guanylate shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of that substance should be authorised as specified in the Annex to this Regulation.












(8)


Certain conditions should be provided for to allow better control. In particular, a recommended content should be indicated on the label of the feed additives. Where such content is exceeded, certain information should be indicated on the label of premixtures.












(9)


The fact that disodium 5'-guanylate is not authorised for use as a flavouring in water for drinking, does not preclude its use in compound feed which is administered via water.












(10)


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 ‘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
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, 29 November 2021.


For the Commission


The President

Ursula VON DER LEYEN
            





(1)  
            OJ L 268, 18.10.2003, p. 29.

(2)  EFSA Journal 2021;19(6):6619.




ANNEX














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




mg active substance/kg of complete feed with a moisture content of 12 %





Category: Sensory additives


Functional group: Flavouring compounds





2b627i


-


Disodium 5'-guanylate



Additive composition

Disodium 5'-guanylate (GMP).
Powder form

Characterisation of the active substance

Disodium 5'-guanylate (hydrated form) produced with Corynebacterium stationis KCCM 10530 and Escherichia coli K-12 KFCC 11067.
Produced by fermentation
Purity: min.: 97 %
Chemical formula:
C10H12N5Na2O8P
CAS number: 5550-12-9
Einecs number: 226-914-1

Analytical method
 (1)

For the identification of disodium 5'-guanylate (GMP) in the feed additive:






—


FAO JECFA monograph ‘disodium 5'-guanylate’




For the determination of disodium 5'-guanylate (GMP) in the feed additive, flavouring premixtures and water:






—


High performance liquid chromatography coupled to UV detection (HPLC-UV)






All animal species


-


-


-








1.


The additive shall be incorporated into the feed in the form of a premixture.










2.


In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated.










3.


On the label of the additive the following shall be indicated:
‘Recommended maximum content of the active substance when used alone or in combination with other ribonucleotides up to the same level per kg of complete feedingstuff with a moisture content of 12 %: 50 mg’.










4.


The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level on the label of the premixture would result in exceeding the level of active substance in complete feedingstuff referred to in point 3.






20 December 2031






(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