Commission Regulation (EU) amending Annex I to Regulation (EC) No 1334/2008 of the European Parliament and of the Council as regards certain flavouring substances (Text with EEA relevance)
The Union list of flavourings and source materials is laid down in Annex I to Regulation (EC) No 1334/3008. The Union list was established by Commission Implementing Regulation (EU) No 872/2012. This list will be amended by the notified measure.
This amendment concerns the modification of the conditions of use of the twenty flavouring substances mentioned in the annex of the measure.
The European Food Safety Authority (EFSA) evaluated the genotoxicity of these substances taking into account the data on the following two substances selected as representative of the group, hexa-2(trans),4(trans)-dienal (FL-no: 05.057), and deca-2(trans),4(trans)-dienal (FL-no: 05.140) in its scientific opinion of 26 March 2014. Overall, EFSA concluded that the safety concern regarding genotoxicity cannot be ruled out for both representative substances of the group and that this conclusion is likewise applicable to the other substances of this FGE group 203.
The current measure concerns a modification of the conditions of use of the abovementioned substances of group FGE.203 to prevent the further extension of their uses to other food categories where currently there is no use and to more closely reflect the current real uses in the food categories specified by establishing maximum levels for the food categories where they are used in order to contain the consumer exposure to these substances.
The measure takes into account the current uses reported by industry and therefore it is unlikely that international trade in foods containing these flavourings, flavourings or mixtures of flavourings containing these flavourings will be affected. Nevertheless, transitional measures will apply for products en route to the European Union and here will be a period of 20 days after the publication before entry into force.
EFSA will evaluate further data on the genotoxicity of these substances. However, it is anticipated that the complete evaluation of first the genotoxicity and subsequently, if appropriate, the complete evaluation of each of the twenty substances will take well beyond a year. Therefore, it is appropriate to adopt this measure at this stage.
The provisions of Article 15 g of Regulation 1334/2008 on flavourings will also be applicable to these flavourings as it is the case for all flavourings with maximum levels in foods.
The draft measure has been the object of a public request for comments under the Better Regulation approach established by the Commission. The operators have had therefore additional time to consider any adjustment in their practices if necessary before the measure enters into force.
Any follow-up measure regarding these substances will also be notified under this mechanism.