On July 19, 2016, the European Commission approved UV-treated milk as a novel food under Regulation (EC) No 258/97 of the European Parliament and of the Council ("Novel Food Regulation"). Under the Novel Food Regulation, any food that has not been consumed to a significant degree by humans in the EU prior to 1997 is considered a "Novel Food" and is subject to a prior authorization before it can be sold in Europe. Novel Foods will be approved for use in the EU only if they do not present a risk to public health, are not nutritionally disadvantageous when replacing a similar food, and are not misleading to the consumer. In addition, novel foods must undergo a scientific assessment prior to authorization to ensure their safety.

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