Kommisjonsforordning (EU) 2022/1922 av 10. oktober 2022 om endring av vedlegg til forordning (EU) nr. 231/2012 om spesifikasjoner for tilsetningsstoffer oppført i vedlegg II og III i europaparlaments- og rådsforordning (EF) nr. 1333/2008 med hensyn til rebaudiosider M, D og AM framstilt ved enzymmodifisering av rensede steviabladekstrakter og rebaudiosid M framstilt ved enzymmodifisering av steviolglykosider fra Stevia (E 960c(i))
Commission Regulation (EU) 2022/1922 of 10 October 2022 amending the Annex to Regulation (EU) No 231/2012 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 as regards specifications for rebaudiosides M, D and AM produced via enzymatic conversion of puriﬁed stevia leaf extracts and the specifications for rebaudioside M produced via enzyme modification of steviol glycosides from Stevia (E 960c(i))
Kommisjonsforordning publisert i EU-tidende 11.10.2022
BAKGRUNN (fra kommisjonsforordningen, engelsk utgave)
(1) Commission Regulation (EU) No 231/2012 lays down specifications for food additives listed in Annexes II and III to Regulation (EC) No 1333/2008.
(2) The specifications for 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) The currently authorised food additive ‘enzymatically produced steviol glycosides’ (E 960c) are included in the group ‘steviol glycosides (E960a-E960c)’ in Part C of Annex II to Regulation (EC) No 1333/2008.
(4) Regulation (EU) No 231/2012 provides that ‘rebaudioside M produced via enzyme modification of steviol glycosides from Stevia’ (E 960c(i)) is obtained via enzymatic bioconversion of purified steviol glycoside leaf extracts of the Stevia rebaudiana Bertoni plant, using UDP-glucosyltransferase and sucrose synthase enzymes produced by the genetically modified yeasts K. phaffi UGT-a and K. phaffi UGT-b.
(5) On 18 February 2019, an application was submitted to the Commission for the amendment of the specifications concerning the food additive steviol glycosides (E 960). The Commission made the application available to the Member States pursuant to Article 4 of Regulation (EC) No 1331/2008.
(6) On June 2021, the applicant revised its application and requested enzymatic conversion of highly purified rebaudioside A or stevioside from Stevia leaf extracts to, respectively, rebaudiosides M and D and rebaudioside AM, using enzymes produced by genetically modified microorganisms derived from strains of E. coli K-12, to be used as an alternative production process for E 960c.
(7) This newly suggested production process involves the enzymatic conversion of purified rebaudioside A or stevioside stevia leaf extract (≥95% steviol glycosides) through a multistep enzymatic process with enzymes prepared at the first stage of the process. According to the different duration of the enzymatic reaction on the purified rebaudioside A and stevioside stevia leaf extract, three main mixtures with a high content of rebaudioside M, D and AM can be obtained. The resulting mixtures undergo a series of puriﬁcation and isolation steps to produce the ﬁnal rebaudioside M, D or AM (≥ 95% steviol glycosides).
(8) The European Food Safety Authority (‘the Authority’) evaluated the safety of ‘steviol glycosides preparations obtained by enzymatic bioconversion of highly purified rebaudioside A or stevioside stevia leaf extracts’ and adopted its opinion on 22 June 2021 . The Authority considered that there is no safety concern for steviol glycosides with a high content of rebaudioside M, rebaudioside D and rebaudioside AM, when obtained by the process in question, to be used as food additives. The Authority considered that exposure to rebaudioside AM (expressed as steviol equivalent) will not be higher than the exposure to steviol glycosides (E 960a), if those would be replaced by rebaudioside AM. The Authority further concluded that the ADI of 4 mg/kg bw per day that applies to the 60 steviol glycosides listed in Appendix A to the opinion adopted on 24 March 2020 , expressed as steviol equivalent, also applies to the rebaudioside M, D and AM obtained by the enzymatic bioconversion in question.
(9) Therefore, specifications for rebaudioside M, D and AM produced via enzymatic conversion of purified rebaudioside A or stevioside stevia leaf extract should be set out in the Annex to Regulation (EU) No 231/2012.
(10) Furthermore, in order to ensure clarity, it is appropriate to align the current definition of the additive ‘Rebaudioside M produced via enzyme modification of steviol glycosides from stevia’ in the entry E 960c(i) of the Annex to Regulation (EU) No 231/2012 with the wording of the conclusion of the Authority on the safety of its manufacturing process as regards the absence of viable cells and of residual DNA of the yeasts K. phafﬁi UGT-a and K. phafﬁi UGT-b in the food additive.
(11) Regulation (EU) No 231/2012 should therefore be amended accordingly.
(12) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,
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