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) Thaumatin was authorised for 10 years as a feed additive for all animal species by Commission Implementing Regulation (EU) No 869/2012 (2).

(3) In accordance with Article 14(1) of Regulation (EC) No 1831/2003, an application was submitted for the renewal of the authorisation of thaumatin as a feed additive, requesting the feed additive to be classified in the additive category ‘sensory additives’ and in the functional group ‘flavouring compounds’. The application included a proposal for amending the conditions of the original authorisation. It consisted of a modification of the specifications for nitrogen and protein in the additive, in order to align them to the specifications for thaumatin when used as a food additive (not less than 15,1 % nitrogen (N) on the dried basis and not less than 93 % protein). That application was accompanied by the particulars and documents required under Article 14(2) of Regulation (EC) No 1831/2003.

(4) The European Food Safety Authority (‘the Authority’) concluded in its opinion of 11 May 2023 (3) that thaumatin remains safe for all animal species, the consumers and the environment under the conditions of use currently authorised. In particular, it concluded that the proposed modification of the specifications of the additive would not add any hazard to those already assessed and is not considered to have an impact on the efficacy of the substance. The Authority further concluded that the exposure of users to thaumatin via inhalation is likely and that, due to its proteinaceous nature, thaumatin is considered a respiratory sensitiser. According to the Authority, thaumatin is not a skin or an eye irritant. In the absence of data, the Authority could not conclude on the dermal sensitisation potential of thaumatin.

(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 thaumatin as a feed additive in the context of the previous authorisation are valid and applicable for the current application. In accordance with Article 5(4), point (c), of Commission Regulation (EC) No 378/2005 (4), an evaluation report of the Reference Laboratory is therefore not required.

(6) In view of the above, the Commission considers that thaumatin satisfies the conditions, as provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the authorisation of that additive should be renewed. 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) Certain conditions should be provided for to allow better control. In particular, a recommended maximum content should be indicated on the label of the additive. Where such content is exceeded, certain information should be indicated on the label of premixtures.

(8) As a consequence of the renewal of the authorisation of thaumatin as a feed additive, Implementing Regulation (EU) No 869/2012 should be repealed.

(9) Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation of thaumatin for all animal species, it is appropriate to provide for a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the renewal of the authorisation.

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