(1)

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

(2)

Commission Regulation (EU) No 231/2012 (2) lays down specifications for food additives that are listed in Annexes II and III to Regulation (EC) No 1333/2008.

(3)

Cochineal, Carminic acid, Carmines (E 120) is a substance authorised as a colour in a variety of foods in accordance with Annex II to Regulation (EC) No 1333/2008.

(4)

Article 32(1) of Regulation (EC) No 1333/2008 provides that all food additives that were already permitted in the Union before 20 January 2009 are subject to a new risk assessment by the European Food Safety Authority (‘the Authority’).

(5)

For that purpose, a program for the re-evaluation of food additives is laid down in Commission Regulation (EU) No 257/2010 (3), according to which the re-evaluation of colours had to be completed by 31 December 2015.

(6)

On 18 November 2015 the Authority delivered a Scientific Opinion on the re-evaluation of cochineal, carminic acid, carmines (E 120) as a food additive (4). The Authority concluded that the present dataset did not give reasons to revise the Acceptable Daily Intake (ADI) value for E 120 and that the refined exposure estimates were below the ADI for all population groups. However, the Authority recommended to revise the current title ‘Cochineal, Carminic acid, Carmines’, so that it would more accurately reflect the material used as a food additive and to update the specifications as regards the percentage of material not accounted for, the maximum limits for toxic elements and the presence of proteinaceous compounds.

(7)

Pursuant to Article 10(3) of Regulation (EC) No 1333/2008, the Union list of approved food additives shall be amended in accordance with the procedure referred to in Regulation (EC) No 1331/2008 of the European Parliament and of the Council (5).

(8)

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

(9)

It is therefore appropriate to amend Annex II to Regulation (EC) No 1333/2008 and the Annex to Regulation (EU) No 231/2012.

(10)

A reasonable period should be allowed to elapse before the amendments become applicable in order to permit food business operators to meet the new requirements laid down in this Regulation.

(11)

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