The draft act establishing the Union list of novel foods in accordance with the new Novel Food Regulation (Regulation 2015/2283) has been published and is open for feedback to all interested parties. The establishment of the Union list of novel foods is highly anticipated as the exclusivity of novel food authorizations will cease.
Under the former Novel Food Regulation (Regulation 258/97), an authorization by Commission Decision was exclusively directed to the applicant. An extension to other manufacturers or distributors for the same novel food or novel food ingredient had to be obtained by notification on the basis of substantial equivalence. That way only authorized providers were allowed to supply the particular novel food or novel food ingredient. The diverging procedures also made that authorizations and notifications of substantial equivalence were fragmented over different acts. Although a novel food catalogue and lists of notified novel foods had been established, the existing scheme was impractical and incomplete.
With the new Novel Food Regulation a single positive Â´Union listÂ´ of novel foods is introduced. The list creates a general authorization for the included novel foods provided the applicable conditions of use and labelling requirements are complied with. This feature extends to novel foods which have been authorized or notified in accordance with the former Novel Food Regulation. Future providers may benefit from the Union list upon its publication expected on 1 January 2018.
In anticipation of the actual adoption, the Commission has published a draft of the implementing act establishing the Union list including all former authorized novel foods (link).