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)
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Address https://gelex.eu/eli/EU/regulation/2016/2023@2016-11-18/en
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, 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 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 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 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.
(8) The Authority concluded in its opinion of 11 March 2015 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 authorisation 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.
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 Juncker
ANNEX
ANNEX 1.2.1.2.1.2.1.2.
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/kg of complete feedingstuff with a moisture content of 12 % Category of technological additives. Functional group: silage additives 1k301 — Sodium benzoate All animal species — 2400 For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from its use. 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. The mixture of different sources of sodium benzoate shall not exceed the permitted maximum contents. 9 December 2026 1k202 — Potassium sorbate All animal species 300 For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from its use. 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. The additive shall be used in easy and moderate difficult to ensile materials. 9 December 2026 1k236 — Formic acid All animal species — 10000 For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from its use. 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 The mixture of different sources of formic acid shall not exceed the permitted maximum content in complete feedingstuffs. 9 December 2026 1k237 — Sodium formate All animal species — 10000 (formic acid equivalent) For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from its use. 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. The mixture of different sources of formic acid shall not exceed the permitted maximum contents in complete feedingstuffs. 9 December 2026
ANNEX Additive composition
Sodium benzoate ≥ 99,5 % Solid form
Characterisation of the active substance
Sodium benzoate ≥ 99,5 % C7 H5 Na O2 CAS no 532-32-1 Produced by chemical synthesis
Analytical method
For the determination of sodium benzoate: titrimetric method (01/2008:0123 of European Pharmacopoeia).
ANNEX 1.2. Additive composition
Potassium sorbate ≥ 99 % Solid form
Characterisation of the active substance
Potassium sorbate ≥ 99 % C6 H7 KO2 CAS no 24634-61-5 Produced by chemical synthesis
Analytical method
For the determination of potassium sorbate in feed additive: titration with perchloric acid (European Pharmacopoeia, monographs 6.0 method 01/2008:0618). For the determination of potassium sorbate in premixture and feedingstuffs: ion exclusion High Performance Liquid Chromatography with UV detection (HPLC-UV).
ANNEX 1.2.1.2. Additive composition
Formic acid (≥ 84,5 %) Liquid form
Characterisation of the active substance
Formic acid ≥ 84,5 % H2CO2 CAS no 64-18-6
Analytical method
For the determination of formic acid: ion chromatography method equipped with electrical conductivity detection (IC-ECD).
ANNEX 1.2.1.2.1.2. Additive composition
Solid form Sodium formate ≥ 98 % Liquid form Sodium formate ≥ 15 % Formic acid ≤ 75 % Water ≤ 25 %
Characterisation of the active substance
Sodium formate ≥ 98 % (solid form) NaHCO2 CAS no 141-53-7 formaldehyde ≤ 6,2 mg/kg acetaldehyde ≤ 5 mg/kg butylaldehyde ≤ 25 mg/kg Sodium formate ≥ 15 % (liquid form) Formic acid ≤ 75 % Produced by chemical synthesis
Analytical method
Determination of sodium in feed additives: EN ISO 6869: atomic absorption spectrometry (AAS) or EN 15510: inductively coupled plasma atomic emission spectrometry, (ICP-AES). Determination of total formate in feed additives: EN 15909 reverse phase HPLC with UV detection (RP-HPLC-UV). Determination of total formate in premixtures and feedingstuffs: Ion-exclusion high performance liquid chromatography with UV or with refractive index detection (HPLC-UV/RI) or Ion chromatography method equipped with electrical conductivity detection (IC-ECD).