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. )

23.2.2018 EN Official Journal of the European Union L 53/1 II (Non-legislative acts) REGULATIONS 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) 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. Article 10 of that Regulation provides for the re-evaluation of additives authorised pursuant to Council Directive 70/524/EEC (2). (2) Disodium 5′-ribonucleotides, disodium 5′-guanylate and disodium 5′-inosinate (‘substances concerned’) were authorised without a time limit by Directive 70/524/EEC as feed additives for all animal species. Those products were subsequently entered in the Register of feed additives as existing products, in accordance with Article 10(1) of Regulation (EC) No 1831/2003. (3) In accordance with Article 10(2) of Regulation (EC) No 1831/2003 in conjunction with Article 7 thereof, an application was submitted for the re-evaluation of the substances concerned as feed additives for all animal species. The applicant requested those additives be classified in the additive category ‘sensory additives’. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003. Lately the applicant withdrew the application for water for drinking. (4) The European Food Safety Authority (‘the Authority’) concluded in its opinion of 4 March 2014 (3) that, under the proposed conditions of use the substances concerned do not have adverse effects on animal health, human health or the environment. The Authority further concluded that the function of the substances concerned in feed is similar to that in food. The Authority has already concluded that for food the substances concerned are efficacious, as they increase the food smell or palatability. Therefore, that conclusion can be extrapolated for feed. The applicant withdrew the application for water for drinking. However, the substances concerned can be used within compound feeds which are subsequently administered via water. (5) Restrictions and conditions should be provided for to allow better control. Since safety reasons do not require the setting of a maximum content and taking into account the re-evaluation performed by the Authority, recommended contents should be indicated on the label of the additive. Where such contents are exceeded, certain information should be indicated on the label of premixtures and on the labelling of compound feeds and feed materials. (1) OJ L 268, 18.10.2003, p. 29. (2) Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs (OJ L 270, 14.12.1970, p. 1). (3) EFSA Journal 2014;12(3):3606.L 53/2 EN Official Journal of the European Union 23.2.2018 (6) The Authority also concluded that in the absence of data the substances concerned should be considered as potentially hazardous to workers by skin, eyes and mucous membranes or inhalation exposure. Consequently, appropriate protective measures should be taken The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the method of analysis of the feed additives in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003. (7) The assessment of the substances concerned shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied except for the substances concerned produced by fermentation. The applicant asked for the authorisation of the substances concerned produced by fermentation and RNA hydrolysis. The lack of information on the production strains does not allow to assess the safety of the substances concerned produced by fermentation despite they are ‘per se’ safe. Accordingly, the use of the substances concerned should be authorised as specified in the Annex to this Regulation and the authorisation of those additives produced by fermentation should be denied. (8) Since safety reasons do not require the immediate application of the modifications to the conditions of authori­ sation of the substances concerned, it is appropriate to allow a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the authorisation. (9) 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 Authorisation 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. Article 2 Denial The authorisation of disodium 5′-ribonucleotides, disodium 5′-guanylate and disodium 5′-inosinate produced by fermentation is denied. Article 3 Transitional measures 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.23.2.2018 EN Official Journal of the European Union L 53/3 Article 4 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, 15 February 2018. For the Commission The President Jean-Claude JUNCKERANNEX Minimum Maximum content content Identifi­ Name of End of Species or cation the holder Composition, chemical formula, Maximum period of Additive category of mg of active substance/kg Other provisions number of of authori­ description, analytical method age authori­ animal of complete feedingstuff the additive sation sation with a moisture content of 12 % Category: Sensory additives. Functional group: Flavouring compounds 2b635 — Disodium Additive composition All animal — — — 1. The additive shall be incorporated 15.3.2028 5′-ribonucleo­ species into the feed in the form of a pre­ Disodium 5′-ribonucleotides tide mixture. Characterisation of the active sub­ 2. In the directions for use of the addi­ stance tive and premixtures, the storage Disodium 5′-ribonucleotides: a and stability conditions shall be in­ mixture of disodium 5′-guanylate dicated. (GMP) and disodium 5′-inosinate 3. The recommended maximum con­ (IMP). tent of the active substance or the Produced by RNA hydrolysis combination of disodium 5′-ribonu­ cleotide (2b635), disodium 5′-gua­ Purity: min.: 97 % assay nylate (2b627) and disodium Chemical formula: 5′-inosinate (2b631) shall be: — C H N O P · nH O 50 mg/kg of complete feedingstuff 10 11 4 8 2 — C H N Na O P · nH O with a moisture content of 12 %. 10 12 5 2 8 2 4. On the label of the additive the fol­ Method of analysis(1) lowing shall be indicated: For the identification of GMP and ‘Recommended maximum content IMP in the feed additive: of the active substance or the com­ JECFA monograph, Specifications bination of disodium 5′-ribonucleo­ for food additives: Disodium tide, disodium 5′-guanylate and di­ 5′-Ribonucleotides. sodium 5′-inosinate of complete For the determination of GMP feedingstuff with a moisture content and IMP in the feed additive and of 12 %: 50 mg/kg’. premixtures of flavourings: High performance Liquid Chroma­ tography coupled to UV detection (HPLC-UV). L 53/4 EN Official Journal of the European Union 23.2.2018Minimum Maximum content content Identifi­ Name of End of Species or cation the holder Composition, chemical formula, Maximum period of Additive category of mg of active substance/kg Other provisions number of of authori­ description, analytical method age authori­ animal of complete feedingstuff the additive sation sation with a moisture content of 12 % 5. The functional group, the identifica­ tion number, the name and the added amount of the active sub­ stance shall be indicated on the label of premixtures and on the la­ belling of feed materials and com­ pound feedingstuffs, if the following content of the active substance or the combination of disodium 5′-ribonucleotide, disodium 5′-gua­ nylate and disodium 5′-inosinate in complete feedingstuff with a mois­ ture content of 12 % is exceeded: 50 mg/kg. 6. For users of the additive and pre­ mixtures, feed business operators shall establish operational proce­ dures and organisational measures to address potential risks by inhala­ tion, dermal contact or eyes contact. Where those risks cannot be elimi­ nated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equip­ ment, including breathing protec­ tion, safety glasses and gloves. 2b627 — Disodium Additive composition All animal — — — 1. The additive shall be incorporated 15.3.2028 5′-guanylate species into the feed in the form of a pre­ Disodium 5′-guanylate (GMP) mixture. Characterisation of the active sub­ 2. In the directions for use of the addi­ stance tive and premixtures, the storage Disodium 5′-guanylate and stability conditions shall be in­ dicated. Produced by RNA hydrolysis 23.2.2018 EN Official Journal of the European Union L 53/5Minimum Maximum content content Identifi­ Name of End of Species or cation the holder Composition, chemical formula, Maximum period of Additive category of mg of active substance/kg Other provisions number of of authori­ description, analytical method age authori­ animal of complete feedingstuff the additive sation sation with a moisture content of 12 % Purity: min.: 97 % assay 3. The recommended maximum con­ tent of the active substance or the combination of disodium 5′-ribonu­ Chemical formula: cleotide (2b635), disodium 5′-gua­ C H N Na O P · n H O 10 12 5 2 8 2 nylate (2b627) and disodium 5′-inosinate (2b631) shall be: CAS number: 5550-12-9 50 mg/kg of complete feedingstuff Method of analysis(1) with a moisture content of 12 %. For the identification of GMP in 4. On the label of the additive the fol­ the feed additive: lowing shall be indicated: JECFA monograph, Specifications ‘Recommended maximum content for food additives: Disodium of the active substance or the com­ 5′-Ribonucleotides. bination of disodium 5′-ribonucleo­ tide, disodium 5′-guanylate and di­ sodium 5′-inosinate of complete For the determination of GMP in feedingstuff with a moisture content the feed additive and premixtures of 12 %: 50 mg/kg’. of flavourings: 5. The functional group, the identifica­ High performance Liquid Chroma­ tion number, the name and the tography coupled to UV detection added amount of the active sub­ (HPLC-UV). stance shall be indicated on the label of premixtures and on the la­ belling of feed materials and com­ pound feedingstuffs, if the following content of the active substance or the combination of disodium 5′-ribonucleotide disodium 5′-gua­ nylate and disodium 5′-inosinate in complete feedingstuff with a mois­ ture content of 12 % is exceeded: 50 mg/kg. L 53/6 EN Official Journal of the European Union 23.2.2018Minimum Maximum content content Identifi­ Name of End of Species or cation the holder Composition, chemical formula, Maximum period of Additive category of mg of active substance/kg Other provisions number of of authori­ description, analytical method age authori­ animal of complete feedingstuff the additive sation sation with a moisture content of 12 % 6. For users of the additive and pre­ mixtures, feed business operators shall establish operational proce­ dures and organisational measures to address potential risks by inhala­ tion, dermal contact or eyes contact. Where those risks cannot be elimi­ nated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equip­ ment, including breathing protec­ tion, safety glasses and gloves. 2b631 — Disodium Additive composition All animal — — — 1. The additive shall be incorporated 15.3.2028 5′-inosinate species into the feed in the form of a pre­ Disodium 5′-inosinate (IMP) mixture. Characterisation of the active sub­ 2. In the directions for use of the addi­ stance tive and premixtures, the storage Disodium 5′-inosinate and stability conditions shall be in­ dicated. Produced by RNA hydrolysis 3. The recommended maximum con­ Purity: min. 97 % assay tent of the active substance or the Chemical formula: C H N O P · combination of disodium 5′-ribonu­ 10 11 4 8 nH O cleotide (2b635), disodium 5′-gua­ 2 CAS number 4691-65-0 nylate (2b627) and disodium 5′-inosinate (2b631) shall be: Method of analysis(1) 50 mg/kg of complete feedingstuff For the identification of IMP in with a moisture content of 12 %. the feed additive: JECFA monograph, Specifications for food additives: Disodium 5′-Ribonucleotides. 23.2.2018 EN Official Journal of the European Union L 53/7Minimum Maximum content content Identifi­ Name of End of Species or cation the holder Composition, chemical formula, Maximum period of Additive category of mg of active substance/kg Other provisions number of of authori­ description, analytical method age authori­ animal of complete feedingstuff the additive sation sation with a moisture content of 12 % For the determination of IMP in 4. On the label of the additive the fol­ the feed additive and premixtures lowing shall be indicated: of flavourings: ‘Recommended maximum content High performance Liquid Chroma­ of the active substance or the com­ tography coupled to UV detection bination of disodium 5′-ribonucleo­ (HPLC-UV). tide, disodium 5′-guanylate and di­ sodium 5′-inosinate of complete feedingstuff with a moisture content of 12 %: 50 mg/kg’. 5. The functional group, the identifica­ tion number, the name and the added amount of the active sub­ stance shall be indicated on the label of premixtures and on the la­ belling of feed materials and com­ pound feedingstuffs, if the following content of the active substance or the combination of disodium 5′-ribonucleotide, disodium 5′-gua­ nylate and disodium 5′-inosinate in complete feedingstuff with a mois­ ture content of 12 % is exceeded: 50 mg/kg. 6. For users of the additive and pre­ mixtures, feed business operators shall establish operational proce­ dures and organisational measures to address potential risks by inhala­ tion, dermal contact or eyes contact. Where those risks cannot be elimi­ nated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equip­ ment, including breathing protec­ tion, safety glasses and gloves. (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 L 53/8 EN Official Journal of the European Union 23.2.2018