BAKGRUNN (fra kommisjonsforordningen)

(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 and renewing such an authorisation. 

(2) Sodium bisulphate was authorised for a period of 10 years as a feed additive for all animal species in the additive category ‘technological additives’, functional group ‘preservatives’, and for all animal species other than cats, mink, pet and other nonfood producing animals in the additive category ‘technological additives’, functional group ‘acidity regulators’, by Commission Implementing Regulation (EU) No 2015/1416. 

(3) In accordance with Article 14(1) of Regulation (EC) No 1831/2003, an application was submitted for the renewal of the authorisation of sodium bisulphate as a feed additive for all terrestrial animal species, requesting that additive to be classified in the category ‘technological additives’ and in the functional group ‘preservatives’, and for all terrestrial animal species other than cats, mink, pets and other non-food-producing animals, requesting that additive to be classified in the additive category ‘technological additives’ and in the functional group ‘acidity regulators’. That application was accompanied by the particulars and documents required under Article 14(2) of Regulation (EC) No 1831/2003. In accordance with Articles 4(1) and 7 of Regulation (EC) No 1831/2003, the applicant also requested the authorisation of new uses of sodium bisulphate as a feed additive for all pets and other non-food-producing animals except aquatic animals, asking for the substance to be classified in the category ‘technological additives’, functional group ‘acidity regulators’, and in the category ‘sensory additives’, functional group ‘flavouring compounds’. The application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

(4) The European Food Safety Authority (‘the Authority’) concluded in its opinion of 1 February 2024 that, under the current conditions of authorisation, sodium bisulphate remains safe for all terrestrial animal species, consumers of products from animals fed the additive and the environment and that the new uses of the additive as an acidity regulator and sensory additive in pets and other non-food-producing animals except aquatic animals would not introduce risks not already considered in the previous assessment and therefore the same conclusions on all terrestrial animal species, consumers of products from animals fed the additive and the environment would apply. The Authority also concluded that sodium bisulphate is irritant to skin, eyes and respiratory tract, and should be considered as skin and respiratory sensitiser. It also indicated that there is no need for assessing the efficacy of the additive in the context of the renewal of its authorisation as the application does not include a proposal for amending or supplementing the conditions of the original authorisation which would have an impact on the efficacy of the additive. The Authority added that the efficacy data assessed in its previous opinion of 13 October 2011 concerning sodium bisulphate are considered valid and can cover the new use of the additive as an acidity regulator and a sensory additive (flavouring compound) in feed for pets and non-foodproducing animals except aquatic animals. Therefore, it considered that sodium bisulphate has the potential to be efficacious in feed for these species and categories. 

(5) The Reference Laboratory set up by Regulation (EC) No 1831/2003 considered that the conclusions and recommendations reached in the assessment carried out regarding the method of analysis of sodium bisulphate as a feed additive in the context of the previous authorisation are valid and applicable for the current applications. In accordance with Article 5(4), points (a) and (c), of Commission Regulation (EC) No 378/2005, an evaluation report of the Reference Laboratory is therefore not required. 

(6) In view of the above, the Commission considers that the sodium bisulphate satisfies the conditions, as provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the authorisation of that additive for use in feed for all animal species other than aquatic animals in the category ‘technological additives’, functional group ‘preservatives’, and for all terrestrial animal species other than cats, mink, pets and other non-food-producing animals in the additive category ‘technological additives’, functional group ‘acidity regulators’ should be renewed, and the new use as feed additive in the category ‘technological additives’, functional group ‘acidity regulators’, and in the category ‘sensory additives’, functional group ‘flavouring compounds’ for all pets and other non-food-producing animals except aquatic animals, should be authorised. In addition, the Commission considers that appropriate protective measures should be taken to prevent adverse effects on the health of the users of the additive. Those protective measures should be without prejudice to other workers’ safety requirements under Union law. 

(7) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,