(1)

Annex II to Regulation (EC) No 1333/2008 lays down a Union list of food additives approved for use in foods and their conditions of use.

(2)

Pursuant to Article 3(1) of Regulation (EC) No 1331/2008, the Union list of food additives may be updated either on the initiative of the Commission or following an application.

(3)

Commission Regulation (EU) No 231/2012 (3) lays down specifications for food additives that are listed in Annex II to Regulation (EC) No 1333/2008.

(4)

Stearyl tartrate (E 483) is a substance authorised in certain foods in accordance with Annex II to Regulation (EC) No 1333/2008.

(5)

On 11 March 2020, the European Food Safety Authority (‘the Authority’) issued a scientific opinion on the re-evaluation of stearyl tartrate (E 483) as a food additive (4). The opinion stated that there was a lack of adequate toxicological data on stearyl tartrate. In addition, adequate data that could allow read-across from data on other substances were lacking. Consequently, the Authority was not able to confirm the safety of stearyl tartrate as a food additive and concluded that the acceptable daily intake (ADI) for this substance could not be confirmed.

(6)

On 19 January 2021, the Commission launched a public call for technical and scientific data on the permitted food additive stearyl tartrate (E 483), targeting the data needs identified by the Authority. However, no business operator committed to provide the requested toxicological data for stearyl tartrate (E 483). Without those data, the Authority cannot complete the re-evaluation of the safety of stearyl tartrate as a food additive. Therefore, it cannot be determined whether this substance still fulfils the conditions pursuant to Article 6(1) of Regulation (EC) No 1333/2008 for inclusion in the Union list of approved food additives.

(7)

It is therefore appropriate to remove stearyl tartrate (E 483) from the Union list of approved food additives.

(8)

Due to the absence of appropriate toxicological data to confirm the safety of stearyl tartrate (E 483) as a food additive, its inclusion in the list of authorised food additives can no longer be justified and stearyl tartrate (E 483) should be deleted from the Union list of authorised food additives. Annex II to Regulation (EC) No 1333/2008 and the Annex to Regulation (EU) No 231/2012 should be amended accordingly.

(9)

In order to enable food business operators to find alternatives to stearyl tartrate (E 483), this Regulation should start to apply 6 months after the date of its entry into force.

(10)

It is also appropriate to provide for a transitional period during which foods containing stearyl tartrate (E 483) that have been lawfully placed on the market before the date of application of this Regulation may continue to be marketed.

(11)

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