5.17. Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food OJ L 338, 13.11.2004, p. 4.

As regards Regulation (EC) No 1935/2004, the Commission should be empowered in particular to adopt specific measures for groups of materials and articles, Community authorisation of a substance, and the modification, suspension or revocation of such authorisation. Since those measures are of general scope and are designed to amend non-essential elements of Regulation (EC) No 1935/2004, inter alia, by supplementing it 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. In order to strengthen the competitiveness and innovation of the European industry, materials and articles intended to come into contact with food should be marketed as soon as possible once their safety has been established. On grounds of efficiency, the normal time-limits for the regulatory procedure with scrutiny should be curtailed for the adoption of a list of substances authorised for use in the manufacturing of materials and articles; list(s) of authorised substances incorporated in active or intelligent food contact materials and articles, list(s) of active or intelligent materials and articles and, when necessary, special conditions of use for those substances and/or the materials and articles in which they are incorporated; purity standards; special conditions of use for certain substances and/or the materials and articles in which they are used; specific limits on the migration of certain constituents or groups of constituents into or on to food; amendments of existing specific directives on materials and articles; Community authorisations and the modification, suspension or revocation thereof. When, on imperative grounds of urgency, the normal time-limits for the regulatory procedure with scrutiny cannot be complied with, the Commission should be able to have recourse to the urgency procedure provided for in Article 5a(6) of Decision 1999/468/EC for the adoption of specific measures regarding the modification, suspension or revocation of Community authorisations. Accordingly, Regulation (EC) No 1935/2004 is hereby amended as follows: Article 5 shall be amended as follows: the first subparagraph of paragraph 1 shall be replaced by the following: ‘For the groups of materials and articles listed in Annex I and, where appropriate, combinations of those materials and articles or recycled materials and articles used in the manufacture of those materials and articles, specific measures may be adopted or amended by the Commission.’; the following subparagraphs shall be added to paragraph 1: ‘The specific measures referred to in point (m) shall be adopted by the Commission in accordance with the regulatory procedure referred to in Article 23(2). The specific measures referred to in points (f), (g), (h), (i), (j), (k), (l) and (n), designed to amend non-essential elements of this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 23(3). The specific measures referred to in points (a) to (e), designed to amend non-essential elements of this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 23(4).’; paragraph 2 shall be replaced by the following: ‘2. The Commission may amend the existing specific directives on materials and articles. Those measures, designed to amend the non-essential elements of this Regulation by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 23(4).’; Article 11(3) shall be replaced by the following: ‘3. Community authorisation in the form of specific measure, as referred to in paragraph 1, shall be adopted by the Commission. That measure, 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 23(4).’; Article 12(6) shall be replaced by the following: ‘6. A final specific measure on the modification, suspension or revocation of the authorisation shall be adopted by the Commission. That measure, 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 23(4). On imperative grounds of urgency, the Commission may have recourse to the urgency procedure referred to in Article 23(5).’; Article 22 shall be replaced by the following: ‘Article 22 Amendments to Annexes I and II shall be adopted by the Commission. Those measures, designed to amend non-essential elements of this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 23(3).’; Article 23 shall be amended as follows: paragraph 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.’; the following paragraphs shall be added: ‘4. Where reference is made to this paragraph, Article 5a(1) to (4) and (5)(b) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. The time-limits laid down in Article 5a(3)(c), (4)(b) and (4(e) of Decision 1999/468/EC shall be set at two months, one month and two months respectively. 5. Where reference is made to this paragraph, Article 5a(1), (2), (4) and (6) 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.