BAKGRUNN (fra kommisjonsforordningen)

(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) The Union list of food additives 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 from a Member State or an interested party. 

(3) Pursuant to Annex II to Regulation (EC) No 1333/2008, powdered cellulose (E 460(ii)) and glucono-delta-lactone (E 575) are authorised for use as food additives in a wide variety of foods. 

(4) On 28 July 2022, two applications were submitted to the Commission for the authorisation of the use of powdered cellulose (E 460(ii)) and glucono-delta-lactone (E 575) in unripened soft spreadable cheese products, under food category 01.7.6 ‘Cheese products (excluding products falling in category 16)’. The applications were subsequently made available to the Member States pursuant to Article 4 of Regulation (EC) No 1331/2008. 

(5) Powdered cellulose (E 460(ii)) and glucono-delta-lactone (E 575) are intended for use in the production of unripened soft spreadable cheese products. Glucono-delta-lactone (E 575) acidifies milk mixture and coagulates casein in short time by a controlled pH reduction without using lactic acid bacteria. Powdered cellulose (E 460(ii)) binds whey and prevents its separation from curd, ensuring a stable product over its shelflife. The intended use of powdered cellulose (E 460(ii)) and glucono-delta-lactone (E 575) thus results in more efficient production process requiring less raw material, energy and time. 

(6) Pursuant to Article 3(2) of Regulation (EC) No 1331/2008, the Commission has to seek the opinion of the European Food Safety Authority (‘the Authority’) in order to update the Union list of food additives set out in Annex II to Regulation (EC) No 1333/2008, except where the update in question is not liable to have an effect on human health. 

(7) On 16 January 2018, the Authority published a scientific opinion re-evaluating among others the safety of powdered cellulose (E 460(ii)) as a food additive3 . The Authority concluded that there was no need for a numerical ‘acceptable daily intake’ (ADI) and that there would be no safety concern at the reported uses and use levels for the unmodified and modified celluloses (E 460(i), E 460(ii), E 461–466, E 468 and E 469). Such conclusion is reached for substances of a very low safety concern and only if there is reliable information for both exposure and toxicity and there is a low probability of adverse health effects in humans at doses that do not induce nutritional imbalance in animals. 

(8) The safety of glucono-delta-lactone (E 575) was evaluated in 1990 by the Scientific Committee for Food, which established its ADI as ‘not specified’. The term ‘not specified’ means that, on the basis of the available toxicological, biochemical and clinical data, the total daily intake of the substance, arising from its natural occurrence and its present use or uses in food at the levels necessary to achieve the desired technological effect, does not present a hazard to health. In Commission Regulation (EU) No 257/2010, the Commission considered that glucono-delta-lactone (E 575) was of low concern and that its re-evaluation was not a high priority given the lack of new substantive evidence questioning the evaluation and in light of the Report from the Commission on Dietary Food Additive Intake in the EU of 2001 and of the report ‘Food additives in Europe 2000’ submitted by the Nordic Council of Ministers to the Commission, providing additional information for the prioritisation of additives for reevaluation. For the same reasons and pending the re-evaluation of glucono-deltalactone (E 575) under that programme, the Commission considers that the conclusion reached by the Scientific Committee for Food still remains valid. 

(9) Since the use of powdered cellulose (E 460(ii)) as a stabiliser and of glucono-deltalactone (E 575) as an acidity regulator in unripened soft spreadable cheese products is not liable to have an effect on human health, it is not necessary to seek the opinion of the Authority. 

(10) Therefore, Annex II to Regulation (EC) No 1333/2008 should be amended accordingly. 

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