(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)

That list may be updated in accordance with the common procedure referred to in Article 3(1) of Regulation (EC) No 1331/2008, either on the initiative of the Commission or following an application.

(3)

In accordance with Annex II to Regulation (EC) No 1333/2008, polyvinylpyrrolidone (E1201) is authorised for use as a food additive in table-top sweeteners in tablets and in food supplements supplied in a solid form, excluding food supplements for infants and young children.

(4)

On 29 October 2018, an application was submitted for authorisation of the use of polyvinylpyrrolidone (E1201) as a food additive in food for special medical purposes, in tablet and coated tablet forms, as a tablet binder. The application was made available to the Member States pursuant to Article 4(1), second subparagraph, of Regulation (EC) No 1331/2008.

(5)

Polyvinylpyrrolidone (E 1201) was evaluated by the Scientific Committee for Food in 1990 (3). In its 1 July 2020 scientific opinion (4), the European Food Safety Authority (‘the Authority’) re-evaluated the safety of polyvinylpyrrolidone (E1201) as a food additive and considered the extension of its use in food for special medical purposes in tablet and coated tablet forms. In that opinion, the Authority concluded that such an extension of use, at the proposed maximum permitted level and recommended consumption level, is not expected to be of a safety concern.

(6)

There is a technological need for the addition of polyvinylpyrrolidone (E1201) during the production of the tablets for special medical purposes to strongly bind the ingredients, ensure their cohesion and slow down their disintegration. It is therefore appropriate to authorise the use of this additive as a stabiliser of food for special medical purposes in tablet and coated tablet forms.

(7)

The authorisation of the use of polyvinylpyrrolidone (E1201) as a food additive in category 13.2 ‘Dietary foods for special medical purposes defined in Directive 1999/21/EC (excluding products from food category 13.1.5)’ of Part E of Annex II to Regulation (EC) No 1333/2008 does not entail the classification of a product processed with that food additive as a food for special medical purposes under Regulation (EU) No 609/2013 of the European Parliament and of the Council (5).

(8)

Regulation (EC) No 1333/2008 should therefore be amended accordingly.

(9)

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