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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 and repealing Directives 80/590/EEC and 89/109/EEC

article  5

CELEX:  02004R1935-20210327

Specific measures for groups of materials and articles
1. 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. Those specific measures may include:
(a) a list of substances authorised for use in the manufacturing of materials and articles;
(b) list(s) of authorised substances incorporated in active or intelligent food contact materials and articles, or list(s) of active or intelligent materials and articles and, when necessary, special conditions of use for these substances and/or the materials and articles in which they are incorporated;
(c) purity standards for substances referred to in (a);
(d) special conditions of use for substances referred to in (a) and/or the materials and articles in which they are used;
(e) specific limits on the migration of certain constituents or groups of constituents into or on to food, taking due account of other possible sources of exposure to those constituents;
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 and repealing Directives 80/590/EEC and 89/109/EEC

article  5

CELEX:  02004R1935-20210327

(f) an overall limit on the migration of constituents into or on to food;
(g) provisions aimed at protecting human health against hazards arising from oral contact with materials and articles;
(h) other rules to ensure compliance with Articles 3 and 4;
(i) basic rules for checking compliance with points (a) to (h);
(j) rules concerning the collection of samples and the methods of analysis to check compliance with points (a) to (h);
(k) specific provisions for ensuring the traceability of materials and articles including provisions regarding the duration for retention of records or provisions to allow, if necessary, for derogations from the requirements of Article 17;
(l) additional provisions of labelling for active and intelligent materials and articles;
(m) provisions requiring the Commission to establish and maintain a publicly available Community Register (Register) of authorised substances, processes, or materials or articles;
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 and repealing Directives 80/590/EEC and 89/109/EEC

article  5

CELEX:  02004R1935-20210327

(n) specific procedural rules adapting, as necessary, the procedure referred to in Articles 8 to 12, or making it appropriate for the authorisation of certain types of materials and articles and/or processes used in their manufacture, including, where necessary, a procedure for an individual authorisation of a substance, process, or material or article through a decision addressed to an applicant. 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).
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 and repealing Directives 80/590/EEC and 89/109/EEC

article  5

CELEX:  02004R1935-20210327

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).