Commission Regulation (EU) 2023/447 of 1 March 2023 amending Annex II to Regulation (EC) No 1333/2008 of the European Parliament and of the Council and the Annex to Commission Regulation (EU) No 231/2012 as regards the use of glucosylated steviol glycosides as sweetener (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 of the European Parliament and of the Council of 16 December 2008 on food additives (1), and in particular Article 10(3) and Article 14 thereof,

Having regard to 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 (2), and in particular Article 7(5) thereof,

Whereas:

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

(3) Those lists 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.

(4) In January 2019, an application was submitted for the authorisation of glucosylated steviol glycosides as a new food additive for use as a sweetener. The application was made available to the Member States pursuant to Article 4 of Regulation (EC) No 1331/2008.

(5) Glucosylated steviol glycosides are produced via enzymatic bioconversion using a cyclomaltodextrin glucanotransferase that catalyses the transfer of glucose from starch to mixtures enriched in one or more individual steviol glycosides from purified Stevia Rebaudiana leaf extracts. They consist of a mixture of glucosylated steviol glycosides, containing 1–20 additional glucose units bound to the parent steviol glycosides. They have an improved sweetness profile as compared to the other authorised sweeteners including steviol glycosides from Stevia (E 960a).

(6) The European Food Safety Authority (‘the Authority’) evaluated the safety of glucosylated steviol glycosides and expressed its opinion on 15 December 2021 (4). The Authority considered that the metabolism of glucosylated steviol glycosides is sufficiently similar to the already authorised steviol glycosides, and thus the toxicological data previously assessed by the Authority for steviol glycosides (E 960a) were considered to support their safety as a food additive. The enzyme cyclomaltodextrin glucanotransferase (EC 2.4.1.19) derived from a non-genetically modified strain of Anoxybacillus caldiproteolyticus and intended to be used in the manufacture of modified steviol glycosides does not give rise to safety concerns under the intended conditions of use based on the data provided to the Authority (5). The Authority concluded that there is no safety concern for the use of glucosylated steviol glycosides as a food additive for the same proposed uses and use levels as steviol glycosides (E 960a–960c) used as sweeteners.

(7) Therefore, it is appropriate to authorise the food additive ‘glucosylated steviol glycosides’ (E 960d) as a sweetener in the food categories where steviol glycosides (E 960a–960c) are currently authorised and at the same the maximum levels.

(8) The specifications for the food additive glucosylated steviol glycosides should be included in Regulation (EU) No 231/2012 as it is included in the Union list of food additives laid down in Annex II to Regulation (EC) No 1333/2008 for the first time.

(9) Regulations (EC) No 1333/2008 and (EU) No 231/2012 should therefore be amended accordingly.

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

HAS ADOPTED THIS REGULATION:

Article 1

The Annex II to Regulation (EC) No 1333/2008 is amended in accordance with Annex I to this Regulation.

Article 2

The Annex to Regulation (EU) No 231/2012 is amended in accordance with Annex II to this Regulation.

Article 3

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, 1 March 2023.

For the Commission The President Ursula VON DER LEYEN

(1) OJ L 354, 31.12.2008, p. 16.

(2) OJ L 354, 31.12.2008, p. 1.

(3) Commission Regulation (EU) No 231/2012 of 9 March 2012 laying down specifications for food additives listed in Annexes II and III to Regulation (EC) No 1333/2008 of the European Parliament and of the Council (OJ L 83, 22.3.2012, p. 1).

(4) EFSA Journal 2022;20(2):7066.

(5) EFSA Journal 2022;20(1):7004.