(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. Scansmoke SEF 7525 (SF-004) was included in that list with expiry date of the authorisation 1 January 2024.

(3)

On 30 June 2022, the company Azelis Denmark A/S submitted an application for the renewal of the authorisation of Scansmoke SEF 7525 (SF-004) as a smoke flavouring primary product.

(4)

On 28 September 2023, the European Food Safety Authority (‘the Authority’) adopted its scientific opinion on the safety of Scansmoke SEF 7525 (SF-004) (3).

(5)

In its scientific opinion, the Authority noted that Scansmoke SEF 7525 (SF-004) contains styrene and benzofuran that raise a potential concern for genotoxicity. In line with the Authority’s statement on the genotoxicity assessment of chemical mixtures (4) and considering that the exposure estimates for styrene and benzofuran are above the threshold of toxicological concern (TTC) value of 0.0025 μg/kg bw per day for DNA-reactive mutagens and/or carcinogens and that further data are needed to clarify their potential genotoxicity, the Authority concluded that the potential safety concern for genotoxicity of Scansmoke SEF 7525 (SF-004) cannot be ruled out. Furthermore, the Authority concluded that also the unidentified part of Scansmoke SEF 7525 (SF-004) raises a potential concern for genotoxicity.

(6)

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 Scansmoke SEF 7525 (SF-004) as a smoke flavouring primary product.

(7)

However, in order to allow food business operators to use Scansmoke SEF 7525 (SF-004) 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), Scansmoke SEF 7525 (SF-004) should be allowed to be placed on the market until that date.

(8)

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