These Regulations apply to any food additive that a) falls within one or more categories of food additives specified in the first Annex; b) is used or is intended for use as a component in the preparation of any foodstuff and remains in the final product even if in altered form. The provisions of the Regulations do not apply to those substances defined in Annex II. Regardless of the provisions of article 22 of the Law, the sale of any food additive is prohibited, unless contained in packages bea