5.4. Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients OJ L 43, 14.2.1997, p. 1.
As regards Regulation (EC) No 258/97, the Commission should be empowered in particular to adopt data protection arrangements. Since those measures are of general scope and are designed to supplement Regulation (EC) No 258/97 with new non-essential elements, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC. Accordingly, Regulation (EC) No 258/97 is hereby amended as follows: in Article 1(3), the words ‘Article 13’ shall be replaced by the words ‘Article 13(2)’; in the second subparagraph of Article 3(4), the words ‘Article 13’ shall be replaced by the words ‘Article 13(2)’; in Article 4(5), the words ‘Article 13’ shall be replaced by the words ‘Article 13(2)’; in Article 7(1), the words ‘Article 13’ shall be replaced by the words ‘Article 13(2)’; in Article 8(3), the words ‘Article 13’ shall be replaced by the words ‘Article 13(2)’; Article 10 shall be replaced by the following: ‘Article 10 Detailed rules for the protection of the information provided by the applicant shall be adopted by the Commission. Those measures, designed to amend non-essential elements of this Regulation by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 13(3).’; Article 12(2) shall be replaced by the following: ‘2. The Commission shall examine the grounds referred to in paragraph 1 as soon as possible within the Standing Committee for Foodstuffs. It shall take the appropriate measures aimed at confirming, amending or repealing the national measure in accordance with the regulatory procedure laid down in Article 13(2). The Member State which took the decision referred to in paragraph 1 may maintain it until the measures have entered into force.’; Article 13(3) shall be replaced by the following: ‘3. Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.’.
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Source: EUR-Lex (Cellar) · retrieved 2026-10-21 · Text as adopted (Official Journal); later amendments are not incorporated in this text.