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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 9 CELEX: 02004R1935-20210327 Application for authorisation of a new substance |
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 9 CELEX: 02004R1935-20210327 1. To obtain the authorisation referred to in Article 8(1), the following procedure shall apply: (a) an application shall be submitted to the competent authority of a Member State accompanied by the following: (i) the name and address of the applicant; (ii) a technical dossier containing the information specified in the guidelines for the safety assessment of a substance to be published by the Authority; (iii) a summary of the technical dossier; (b) the competent authority referred to in (a) shall: (i) acknowledge receipt of the application in writing to the applicant within 14 days of its receipt. The acknowledgement shall state the date of receipt of the application; (ii) inform the Authority without delay; and (iii) make the application and any supplementary information supplied by the applicant available to the Authority; (c) the Authority shall without delay: (i) inform the Commission and the other Member States of the application and shall make the application and any supplementary information supplied by the applicant available to them; and (ii) make public the application, relevant supporting information and any supplementary information supplied by the applicant, in accordance with Articles 19 and 20. |
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 9 CELEX: 02004R1935-20210327 2. The Authority shall publish detailed guidelines, following the agreement with the Commission, concerning the preparation and the submission of the application, taking into account standard data formats, where they exist in accordance with Article 39f of Regulation (EC) No 178/2002, which shall apply mutatis mutandis. |