Commission Implementing Regulation (EU) 2018/238 of 15 February 2018 concerning the authorisation of disodium 5′-ribonucleotides, disodium 5′-guanylate and disodium 5′-inosinate as feed additives for all animal species (Text with EEA relevance. )

Authorisation

Article 1

The substances specified in the Annex, belonging to the additive category ‘sensory additives’ and to the functional group ‘flavouring compounds’, are authorised as feed additives in animal nutrition subject to the conditions laid down in that Annex.

Denial

Article 2

The authorisation of disodium 5′-ribonucleotides, disodium 5′-guanylate and disodium 5′-inosinate produced by fermentation is denied.

Transitional measures

Article 3

1.   The substances specified in the Annex and the substances mentioned in Article 2, and premixtures containing those substances and which are produced and labelled before 15 December 2018 in accordance with the rules applicable before 15 March 2018 may continue to be placed on the market and used until the existing stocks are exhausted. 2.   Compound feed and feed materials containing the substances as specified in the Annex and the substances mentioned in Article 2 which are produced and labelled before 15 September 2019 in accordance with the rules applicable before 15 March 2018 may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for food-producing animals. 3.   Compound feed and feed materials containing the substances as specified in the Annex and the substances mentioned in Article 2 which are produced and labelled before 15 September 2020 in accordance with the rules applicable before 15 March 2018 may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for non-food-producing animals.

Entry into force

Article 4

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .

ANNEXSupplementary provisions

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 of active substance/kg of complete feedingstuff with a moisture content of 12 % Category: Sensory additives. Functional group: Flavouring compounds 2b635 — Disodium 5′-ribonucleotide Additive composition Disodium 5′-ribonucleotides Characterisation of the active substance Disodium 5′-ribonucleotides: a mixture of disodium 5′-guanylate (GMP) and disodium 5′-inosinate (IMP). Produced by RNA hydrolysis Purity: min.: 97 % assay Chemical formula: — C 10 H 11 N 4 O 8 P · nH 2 O — C 10 H 12 N 5 Na 2 O 8 P · nH 2 O Method of analysis  ( 1 ) For the identification of GMP and IMP in the feed additive: JECFA monograph, Specifications for food additives: Disodium 5′-Ribonucleotides. For the determination of GMP and IMP in the feed additive and premixtures of flavourings: 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 and stability conditions shall be indicated. 3. The recommended maximum content of the active substance or the combination of disodium 5′-ribonucleotide (2b635), disodium 5′-guanylate (2b627) and disodium 5′-inosinate (2b631) shall be: 50 mg/kg of complete feedingstuff with a moisture content of 12 %. 4. On the label of the additive the following shall be indicated: ‘Recommended maximum content of the active substance or the combination of disodium 5′-ribonucleotide, disodium 5′-guanylate and disodium 5′-inosinate of complete feedingstuff with a moisture content of 12 %: 50 mg/kg’. 5. The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of premixtures and on the labelling of feed materials and compound feedingstuffs, if the following content of the active substance or the combination of disodium 5′-ribonucleotide, disodium 5′-guanylate and disodium 5′-inosinate in complete feedingstuff with a moisture content of 12 % is exceeded: 50 mg/kg. 6. For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves. 15.3.2028 2b627 — Disodium 5′-guanylate Additive composition Disodium 5′-guanylate (GMP) Characterisation of the active substance Disodium 5′-guanylate Produced by RNA hydrolysis Purity: min.: 97 % assay Chemical formula: C 10 H 12 N 5 Na 2 O 8 P · n H 2 O CAS number: 5550-12-9 Method of analysis  ( 1 ) For the identification of GMP in the feed additive: JECFA monograph, Specifications for food additives: Disodium 5′-Ribonucleotides. For the determination of GMP in the feed additive and premixtures of flavourings: 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 and stability conditions shall be indicated. 3. The recommended maximum content of the active substance or the combination of disodium 5′-ribonucleotide (2b635), disodium 5′-guanylate (2b627) and disodium 5′-inosinate (2b631) shall be: 50 mg/kg of complete feedingstuff with a moisture content of 12 %. 4. On the label of the additive the following shall be indicated: ‘Recommended maximum content of the active substance or the combination of disodium 5′-ribonucleotide, disodium 5′-guanylate and disodium 5′-inosinate of complete feedingstuff with a moisture content of 12 %: 50 mg/kg’. 5. The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of premixtures and on the labelling of feed materials and compound feedingstuffs, if the following content of the active substance or the combination of disodium 5′-ribonucleotide disodium 5′-guanylate and disodium 5′-inosinate in complete feedingstuff with a moisture content of 12 % is exceeded: 50 mg/kg. 6. For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves. 15.3.2028 2b631 — Disodium 5′-inosinate Additive composition Disodium 5′-inosinate (IMP) Characterisation of the active substance Disodium 5′-inosinate Produced by RNA hydrolysis Purity: min. 97 % assay Chemical formula: C 10 H 11 N 4 O 8 P · nH 2 O CAS number 4691-65-0 Method of analysis  ( 1 ) For the identification of IMP in the feed additive: JECFA monograph, Specifications for food additives: Disodium 5′-Ribonucleotides. For the determination of IMP in the feed additive and premixtures of flavourings: 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 and stability conditions shall be indicated. 3. The recommended maximum content of the active substance or the combination of disodium 5′-ribonucleotide (2b635), disodium 5′-guanylate (2b627) and disodium 5′-inosinate (2b631) shall be: 50 mg/kg of complete feedingstuff with a moisture content of 12 %. 4. On the label of the additive the following shall be indicated: ‘Recommended maximum content of the active substance or the combination of disodium 5′-ribonucleotide, disodium 5′-guanylate and disodium 5′-inosinate of complete feedingstuff with a moisture content of 12 %: 50 mg/kg’. 5. The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of premixtures and on the labelling of feed materials and compound feedingstuffs, if the following content of the active substance or the combination of disodium 5′-ribonucleotide, disodium 5′-guanylate and disodium 5′-inosinate in complete feedingstuff with a moisture content of 12 % is exceeded: 50 mg/kg. 6. For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves. 15.3.2028 ( 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