(1)

Regulation (EC) No 2065/2003 provides that only smoke flavourings included in the Union list of authorised smoke flavouring primary products (‘the Union list’) may be placed on the market within the Union.

(2)

Commission Implementing Regulation (EU) No 1321/2013 (2) established the Union list. SmokEz Enviro-23 (SF-006) was included in that list with expiry date of the authorisation 1 January 2024.

(3)

By letter dated 27 June 2022, Kerry Inc. informed the Commission that it had acquired the assets of Red Arrow Products Company LLC and that it now owns the rights for SmokEz Enviro-23 (SF-006).

(4)

On 30 June 2022, the company Kerry Inc submitted an application for the renewal of the authorisation of SmokEz Enviro-23 (SF-006) as a smoke flavouring primary product.

(5)

On 28 September 2023, the European Food Safety Authority (‘the Authority’) adopted its scientific opinion on the safety of SmokEz Enviro-23 (SF-006) (3).

(6)

In its scientific opinion, the Authority noted that SmokEz Enviro-23 (SF-006) contains the substances furan-2(5H)-one and benzene–1,2-diol and concluded that a concern for genotoxicity for those substances was identified in vivo upon oral administration. In line with the Authority’s statement on the genotoxicity assessment of chemical mixtures (4) and considering that the exposure estimates for those two components are above the threshold of toxicological concern (TTC) of 0,0025 μg/kg bw per day for DNA-reactive mutagens and/or carcinogens, the Authority concluded that SmokEz Enviro-23 (SF-006) raises concern with respect to genotoxicity. Furthermore, the Authority concluded that other four components in SmokEz Enviro-23 (SF-006) and the unidentified part thereof raise a potential concern for genotoxicity.

(7)

Pursuant to Article 4 of Regulation (EC) No 2065/2003, only smoke flavourings that do not present risks to human health may be authorised and placed on the market. It is therefore appropriate to refuse the renewal of the authorisation of SmokEz Enviro-23 (SF-006) as a smoke flavouring primary product.

(8)

However, in order to allow food business operators to use SmokEz Enviro-23 (SF-006) as a smoke flavouring primary product for the production of foods to be placed on the market until 1 July 2029, as provided for in Commission Implementing Regulation (EU) 2024/2067 (5), SmokEz Enviro-23 (SF-006) should be allowed to be placed on the market until that date.

(9)

The measures provided for in this Decision are in accordance with the opinion of the standing Committee on Plants, Animals, Food and Feed,