These Regulations concern the placing on the market of novel foods and novel food ingredients which have not yet been used for human consumption to a significant degree on the European market and which fall within the categories listed in article 2.1. The Regulations shall not apply to food ingredients listed in article 2.3. Article 4.1. defines general safety requirements for novel foods and food ingredients. Novel foods shall not be placed on the market in Malta if not assessed and placed on t