Commission Implementing Regulation (EU) 2016/2023 of 18 November 2016 concerning the authorisation of sodium benzoate, potassium sorbate, formic acid and sodium formate as feed additives for all animal species (Text with EEA relevance )

L 313/14 EN Official Journal of the European Union 19.11.2016 COMMISSION IMPLEMENTING REGULATION (EU) 2016/2023 of 18 November 2016 concerning the authorisation of sodium benzoate, potassium sorbate, formic acid and sodium formate 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(7) of Regulation (EC) No 1831/2003 in conjunction with Article 10(1) to (4) thereof sets out specific provisions for the evaluation of products used in the Union as silage additives. (2) In accordance with Article 10(1)(b) of Regulation (EC) No 1831/2003, sodium benzoate was entered in the Register of Feed Additives as existing product belonging to the functional group of silage additives, for all animal species. (3) In accordance with Article 10(2) of Regulation (EC) No 1831/2003 in conjunction with Article 7 thereof, application was submitted for the authorisation of sodium benzoate and in accordance with Article 7 of Regulation (EC) No 1831/2003 applications were submitted for the authorisations of potassium sorbate, formic acid and sodium formate. Those applications were accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003. (4) Those applications concern the authorisations of sodium benzoate, potassium sorbate, formic acid and sodium formate as feed additives for all animal species to be classified in the category ‘technological additives’. (5) The European Food Safety Authority (‘the Authority’) concluded in its opinion of 13 June 2012 (2) that, under the proposed conditions of use, sodium benzoate does not have an adverse effect on animal health, human health or the environment; however it was considered as a potential sensitizer and a risk for inhalation cannot be excluded. The Authority also concluded that the additive has a potential to improve the production of silage by reducing the pH and increasing the preservation of dry matter in easy, moderate difficult and difficult to ensile material. (6) The Authority concluded in its opinion of 18 June 2013 (3) that, under the proposed conditions of use, potassium sorbate does not have an adverse effect on animal health, human health or the environment; however it was considered irritant for skin and eyes and potential irritant to respiratory tract. The Authority also concluded that the additive has a potential to improve the aerobic stability of silage in easy and moderate difficult to ensile material. (7) The Authority concluded in its opinion of 11 September 2014 (4) that, under the proposed conditions of use, formic acid does not have an adverse effect on animal health, human health or the environment; however it was considered corrosive for skin and eyes and respiratory tract. The Authority also concluded that the additive has a potential to improve the ensiling process and the quality of the silage in aerobic stability of silage in easy, in moderate difficult and difficult to ensile material. (1) OJ L 268, 18.10.2003, p. 29. (2) EFSA Journal 2012;10(7):2779. (3) EFSA Journal 2013;11(7):3283. (4) EFSA Journal 2014;1(10):3827.19.11.2016 EN Official Journal of the European Union L 313/15 (8) The Authority concluded in its opinion of 11 March 2015 (1) that, under the proposed conditions of use, sodium formate does not have an adverse effect on animal health, human health or the environment; however the liquid form was considered corrosive for skin and eyes and to respiratory tract. The Authority also concluded that the additive has a potential to improve the preservation of nutrients by reducing the dry matter loss in easy, moderate and difficult to ensile material. (9) For sodium benzoate, potassium sorbate, formic acid and sodium formate, 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. (10) The assessments of sodium benzoate, potassium sorbate, formic acid and sodium formate show that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of those additives should be authorised as specified in the Annex to this Regulation. (11) Since safety reasons do not require the immediate application of the modifications to the conditions of authoris­ ation of sodium benzoate, it is appropriate to allow a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the authorisation. (12) 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 additives specified in the Annex, belonging to the additive category ‘technological additives’ and to the functional group ‘silage additives’, are authorised as additives in animal nutrition, subject to the conditions laid down in that Annex. Article 2 Transitional measures The sodium benzoate specified in the Annex and feed containing it, which are produced and labelled before 9 June 2017 in accordance with the rules applicable before 9 December 2016 may continue to be placed on the market and used until the existing stocks are exhausted. Article 3 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. (1) EFSA Journal 2015;13(5):4056.L 313/16 EN Official Journal of the European Union 19.11.2016 This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 18 November 2016. For the Commission The President Jean-Claude JUNCKERANNEX Minimum Maximum Identifica­ Name of content content Species or tion the holder Composition, chemical formula, Maximum End of period Additive category of Other provisions number of of authorisa­ description, analytical method age mg/kg of complete feeding­ of authorisation animal the additive tion stuff with a moisture content of 12 % Category of technological additives. Functional group: silage additives 1k301 — Sodium Additive composition All animal — 2 400 1. For users of the additive and pre­ 9 December benzoate species mixtures, feed business operators 2026 Sodium benzoate ≥ 99,5 % shall establish operational proce­ Solid form dures and organisational measures to address potential risks resulting Characterisation of the active sub­ from its use. Where those risks stance cannot be eliminated or reduced Sodium benzoate ≥ 99,5 % to a minimum by such procedures C H Na O and measures, the additive and 7 5 2 premixtures shall be used with CAS no 532-32-1 personal protective equipment, in­ Produced by chemical syn­ cluding breathing protection, thesis safety glasses and gloves. Analytical method(1) 2. The mixture of different sources of sodium benzoate shall not ex­ For the determination of so­ ceed the permitted maximum con­ dium benzoate: titrimetric tents. method (01/2008:0123 of European Pharmacopoeia). 1k202 — Potassium Additive composition All animal 300 1. For users of the additive and pre­ 9 December sorbate species mixtures, feed business operators 2026 Potassium sorbate ≥ 99 % shall establish operational proce­ Solid form dures and organisational measures to address potential risks resulting Characterisation of the active sub­ from its use. Where those risks stance cannot be eliminated or reduced Potassium sorbate ≥ 99 % to a minimum by such procedures C H KO and measures, the additive and 6 7 2 premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves. 19.11.2016 EN Official Journal of the European Union L 313/17Minimum Maximum Identifica­ Name of content content Species or tion the holder Composition, chemical formula, Maximum End of period Additive category of Other provisions number of of authorisa­ description, analytical method age mg/kg of complete feeding­ of authorisation animal the additive tion stuff with a moisture content of 12 % CAS no 24634-61-5 2. The additive shall be used in easy and moderate difficult to ensile Produced by chemical syn­ materials.(2) thesis Analytical method(1) For the determination of po­ tassium sorbate in feed addi­ tive: titration with perchloric acid (European Pharmaco­ poeia, monographs 6.0 method 01/2008:0618). For the determination of po­ tassium sorbate in premixture and feedingstuffs: ion exclu­ sion High Performance Liquid Chromatography with UV de­ tection (HPLC-UV). 1k236 — Formic acid Additive composition All animal — 10 000 1. For users of the additive and pre­ 9 December species mixtures, feed business operators 2026 Formic acid (≥ 84,5 %) shall establish operational proce­ Liquid form dures and organisational measures to address potential risks resulting Characterisation of the active sub­ from its use. Where those risks stance cannot be eliminated or reduced Formic acid ≥ 84,5 % to a minimum by such procedures H CO and measures, the additive and 2 2 premixtures shall be used with CAS no 64-18-6 personal protective equipment, including breathing protection, safety glasses and gloves L 313/18 EN Official Journal of the European Union 19.11.2016Minimum Maximum Identifica­ Name of content content Species or tion the holder Composition, chemical formula, Maximum End of period Additive category of Other provisions number of of authorisa­ description, analytical method age mg/kg of complete feeding­ of authorisation animal the additive tion stuff with a moisture content of 12 % Analytical method(1) 2. The mixture of different sources of formic acid shall not exceed the For the determination of for­ permitted maximum content in mic acid: ion chromatography complete feedingstuffs. method equipped with electrical conductivity detec­ tion (IC-ECD). 1k237 — Sodium for­ Additive composition All animal — 10 000 1. For users of the additive and pre­ 9 December mate species mixtures, feed business operators 2026 Solid form (formic shall establish operational proce­ acid equi­ Sodium formate ≥ 98 % dures and organisational measures valent) Liquid form to address potential risks resulting from its use. Where those risks Sodium formate ≥ 15 % cannot be eliminated or reduced Formic acid ≤ 75 % to a minimum by such procedures and measures, the additive and Water ≤ 25 % premixtures shall be used with Characterisation of the active sub­ personal protective equipment, in­ stance cluding breathing protection, safety glasses and gloves. Sodium formate ≥ 98 % (solid form) 2. The mixture of different sources of formic acid shall not exceed the NaHCO 2 permitted maximum contents in CAS no 141-53-7 complete feedingstuffs. formaldehyde ≤ 6,2 mg/kg acetaldehyde ≤ 5 mg/kg butylaldehyde ≤ 25 mg/kg Sodium formate ≥ 15 % (liquid form) Formic acid ≤ 75 % Produced by chemical syn­ thesis 19.11.2016 EN Official Journal of the European Union L 313/19Minimum Maximum Identifica­ Name of content content Species or tion the holder Composition, chemical formula, Maximum End of period Additive category of Other provisions number of of authorisa­ description, analytical method age mg/kg of complete feeding­ of authorisation animal the additive tion stuff with a moisture content of 12 % Analytical method(1) Determination of sodium in feed additives: EN ISO 6869: atomic absorption spectrome­ try (AAS) or EN 15510: inductively coupled plasma atomic emission spectrometry, (ICP-AES). Determination of total formate in feed additives: EN 15909 re­ verse phase HPLC with UV de­ tection (RP-HPLC-UV). Determination of total formate in premixtures and feeding­ stuffs: Ion-exclusion high per­ formance liquid chromatogra­ phy with UV or with refractive index detection (HPLC-UV/RI) or Ion chromatography method equipped with electri­ cal conductivity detection (IC-ECD). (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 (2) Easy to ensile forage: > 3 % soluble carbohydrates in fresh materials. Moderately difficult to ensile forage: 1,5-3,0 % soluble carbohydrates in fresh materials. Commission Regulation (EC) No 429/2008 (OJ L 133, 22.5.2008, p. 1). L 313/20 EN Official Journal of the European Union 19.11.2016