Draft Commission Regulation amending Annexes II and III 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 Annatto, Bixin, Norbixin (E 160b) (Text with EEA relevance). Language(s): English. Number of pages: 32
The Regulation aims at updating the current authorisation of the food additive Annatto, Bixin, Norbixin (E 160b) in the European Union, in line with the conclusions of the re-evaluation of the safety of this food additive by the European Food Safety Authority (EFSA), which included the assessment of an application for the authorisation of five new annatto-based extracts and some extensions of use. EFSA concluded that the main pigments in annatto extracts, namely bixin and norbixin, have different toxicological properties and therefore a different Acceptable Daily Intake (ADI). Consequently, the text removes food additive Annatto, Bixin, Norbixin (E 160b) from the Union list of permitted food additives in Regulation (EC) No. 1333/2008 and inserts instead in that list two new separate food additives, namely Annatto bixin (E 160b(i)) and Annatto norbixin (E 160b(ii)). As a consequence, the text removes the authorised uses and conditions of use for the food additive Annatto, Bixin, Norbixin (E 160b) from the list of authorised conditions of use in food in to Regulation (EC) No. 1333/2008, and lays down the authorised uses and use levels for the two new food additives Annatto bixin (E 160b(i)) and Annatto norbixin (E 160b(ii)). The Annex to Regulation (EU) No. 231/2012 (specifications for food additives) is amended accordingly.