Government Decision No. HG442/2023 amending Governmental Decree No. HG538/2009 validating Sanitary Regulation on food additives.

New definition shall be given to food additive considered a food product intended to supplement normal diet and which is a concentrated source of nutrients or one or a combination of nutrients or other substances with food or physiological effect and distributed in dosage form, that is, in form, for example, of capsules, tablets, lozenges, pills and other similar forms, dosed powders, ampoules with liquids, vials with drops and other similar forms of liquids and powders intended to be taken in measured quantities. Exclusion from the State Register of Food Additives and notification/registration of food additives is carried out by the National Agency for Public Health in the following cases: (a) if a food additive is found to be insufficiently safe; (b) at the request of the food sector operator; and (c) if false information is identified in the submitted documentation.