COMMISSION REGULATION (EU) 2016/441

24.3.2016 | EN | Official Journal of the European Union | L 78/47 ---|---|---|--- * * * COMMISSION REGULATION (EU) 2016/441 of 23 March 2016 amending Annex II to Regulation (EC) No 1333/2008 of the European Parliament and of the Council as regards the use of Steviol glycosides (E 960) as a sweetener in mustard (Text with EEA relevance) THE EUROPEAN COMMISSION, Having regard to the Treaty on the Functioning of the European Union, Having regard to Regulation (EC) No 1333/2008 (1) of the European Parliament and of the Council of 16 December 2008 on food additives, and in particular Article 10(3) thereof, Whereas: (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) | That list may be updated in accordance with the common procedure referred to in Article 3(1) of Regulation (EC) No 1331/2008 of the European Parliament and of the Council (2) either on the initiative of the Commission or following an application. ---|--- (3) | On 23 January 2015 an application was submitted for authorisation of the use of steviol glycosides (E 960) as a sweetener in mustard. The application was subsequently made available to the Member States pursuant to Article 4 of Regulation (EC) No 1331/2008. ---|--- (4) | Steviol glycosides are non-caloric sweet-tasting constituents which may be used to replace sucrose in the production of mustard thus allowing for an extension of its shelf life and its microbiological stability (decreasing the content of sugar prevents the process of fermentation for which sugar is a substrate) whilst retaining the demanded organoleptic properties of the product. Permitting steviol glycosides in mustard will make it possible to widen the assortment of this product by means of a product containing a sweetener different than those applied hitherto and having slightly other flavour properties. ---|--- (5) | The European Food Safety Authority (‘the Authority’) evaluated the safety of steviol glycosides, extracted from the leaves of the Stevia rebaudiana Bertoni plant, as a sweetener and expressed its opinion on 14 April 2010 (3). The Authority established an Acceptable Daily Intake (ADI) for steviol glycosides, expressed as steviol equivalents, of 4 mg/kg body weight/day. ---|--- (6) | Authorising this sweetener in mustard at 120 mg/kg (as steviol equivalents) would lead to an increase in the intake of E960 within the following limits: between 0 up to 0,133 % of the ADI in the case of mean consumption and between 0 up to 1,143 % of the ADI in the case of high level consumption. This is considered to be an additional negligible exposure of the consumer and therefore is not of safety concern. ---|--- (7) | Pursuant to Article 3(2) of Regulation (EC) No 1331/2008, the Commission is to seek the opinion of ‘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 that update is not liable to have an effect on human health. Since the authorisation of use of steviol glycosides (E 960) as a sweetener in mustard constitutes an update of that list which is not liable to have an effect on human health, it is not necessary to seek the opinion of the Authority. ---|--- (8) | Therefore, it is appropriate to authorise the use of steviol glycosides (E 960) as a sweetener added to mustard (food subcategory 12.4) at maximum level of 120 mg/kg. ---|--- (9) | Therefore, Annex II to Regulation (EC) No 1333/2008 should be amended accordingly. ---|--- (10) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, ---|--- HAS ADOPTED THIS REGULATION: Article 1 Annex II to Regulation (EC) No 1333/2008 is amended in accordance with the Annex to this Regulation. Article 2 This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 23 March 2016. For the Commission The President Jean-Claude JUNCKER * * * (1) OJ L 354, 31.12.2008, p. 16. (2) Regulation (EC) No 1331/2008 of the European Parliament and of the Council of 16 December 2008 establishing a common authorisation procedure for food additives, food enzymes and food flavourings (OJ L 354, 31.12.2008, p. 1). (3) EFSA Journal 2010;8(4):1537. * * * ANNEX Part E of Annex II to Regulation (EC) No 1333/2008 is amended as follows: (1) | in food subcategory 12.4 Mustard, the following entry is inserted after the entry for E 959: | | ‘E 960 | Steviol glycosides | 120 | (60)’ | ---|---|---|---|---|--- (2) | the following footnote is added: | ‘(60): | Expressed as steviol equivalents’. ---|--- * * *