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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 10 CELEX: 02004R1935-20210327 Opinion of the Authority
1. The Authority shall give an opinion within six months of the receipt of a valid application, as to whether, under the intended conditions of use of the material or article in which it is used, the substance complies with the safety criteria laid down in Article 3 and, where they apply, Article 4.
The Authority may extend the said period by a maximum period of a further six months. In such a case it shall provide an explanation for the delay to the applicant, the Commission and the Member States. 2. The Authority may, where appropriate, request the applicant to supplement the particulars accompanying the application within a time limit specified by the Authority. Where the Authority requests supplementary information, the time limit laid down in paragraph 1 shall be suspended until that information has been provided. Similarly, the time limit shall be suspended for the time allowed the applicant to prepare oral or written explanations. |
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 10 CELEX: 02004R1935-20210327 3. In order to prepare its opinion, the Authority shall: (a) verify that the information and documents submitted by the applicant are in accordance with Article 9(1)(a), in which case the application shall be regarded as valid, and examine whether the substance complies with the safety criteria laid down in Article 3 and, where they apply, Article 4; (b) inform the applicant, the Commission and the Member States if an application is not valid. 4. In the event of an opinion in favour of authorising the evaluated substance, the opinion shall include: (a) the designation of the substance including its specifications; and (b) where appropriate, recommendations for any conditions or restrictions of use for the evaluated substance and/or the material or article in which it is used; and (c) an assessment as to whether the analytical method proposed is appropriate for the intended control purposes. 5. The Authority shall forward its opinion to the Commission, the Member States and the applicant. 6. The Authority shall make its opinion public, after deletion of any information identified as confidential, in accordance with Article 20. |