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Regulation (EC) No 1935/2004 of the European Parliament and of the CouncilDangos y teitl llawn

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

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Article 10U.K.Opinion of the [F1Food Safety Authority]

1.The [F2Food Safety 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 [F2Food Safety 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 F3....

2.The [F4Food Safety Authority] may, where appropriate, request the applicant to supplement the particulars accompanying the application within a time limit specified by the [F4Food Safety Authority]. Where the [F4Food Safety 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.

3.In order to prepare its opinion, the [F5Food Safety 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 F6... 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 [F7Food Safety Authority] shall forward its opinion to the [F8appropriate authority] and the applicant.

6.The [F9Food Safety Authority] shall make its opinion public, after deletion of any information identified as confidential, in accordance with Article 20.

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