1. The specific provisions applicable to the groups of foodstuffs for particular nutritional uses appearing in Annex I shall be laid down by means of specific Directives. Such specific Directives may cover in particular:
essential requirements as to the nature or composition of the products;
provisions regarding the quality of raw materials;
hygiene requirements;
permitted changes within the meaning of Article 3(2);
a list of additives;
provisions regarding labelling, presentation and advertising;
sampling procedures and methods of analysis necessary for checking compliance with the requirements of the specific Directives.
Such specific Directives shall be adopted:
— | in the case of point (e), in accordance with the procedure laid down in Article 95 of the Treaty, |
— | in the case of the other points, by the Commission. Those measures, designed to amend non-essential elements of this Directive by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 15(3). |
Provisions likely to have an effect on public health shall be adopted after consultation of the European Food Safety Authority.
2. To enable foodstuffs intended for particular nutritional uses and resulting from scientific and technological progress to be placed on the market rapidly, the Commission may, after consulting the European Food Safety Authority, authorise for a two-year period the placing on the market of foodstuffs which do not comply with the rules as to composition laid down by the specific Directives for groups of foodstuffs for particular nutritional uses referred to in Annex I. Those measures, designed to amend non-essential elements of this Directive by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 15(3). If necessary, the Commission may add in the authorisation decision labelling rules relating to the change in composition.
3. The Commission shall adopt a list of substances with specific nutritional purposes such as vitamins, mineral salts, amino acids and of other substances intended to be added to foodstuffs intended for particular nutritional uses, together with the purity criteria applicable to them, and, where appropriate, the conditions under which they should be used. Those measures, designed to amend non-essential elements of this Directive by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 15(3). On imperative grounds of urgency, the Commission may have recourse to the urgency procedure referred to in Article 15(4).