Regulation (EC) No 2065/2003 of the European Parliament and of the CouncilShow full title

Regulation (EC) No 2065/2003 of the European Parliament and of the Council of 10 November 2003 on smoke flavourings used or intended for use in or on foods

Article 15U.K.Confidentiality

1.The applicant may indicate which information submitted under Article 7 should be treated as confidential because disclosure may significantly harm his or her competitive position. Verifiable justification must be given in such cases.

2.Without prejudice to paragraph 3, the [F1Authority] shall determine, after consultation with the applicant, which information should be kept confidential and shall inform the applicant F2... of its decision.

3.Without prejudice to Article 39(3) of Regulation (EC) No 178/2002, information relating to the following shall not be considered confidential:

(a)the name and address of the applicant and the name of the product;

(b)in the case of an opinion in favour of authorising the evaluated product, the particulars mentioned in Article 6(2);

(c)information of direct relevance to the assessment of the safety of the product;

(d)the analytical method referred to in point 4 of Annex II.

4.Notwithstanding paragraph 2, the Authority shall on request supply the [F3appropriate authority] with all information in its possession.

5. The [F4appropriate authority and the Authority] shall take the necessary measures to ensure appropriate confidentiality of the information received by them under this Regulation except for information which must be made public if circumstances so require in order to protect human health.

6.If an applicant withdraws or has withdrawn an application, the Authority, [F5and the appropriate authority] shall respect the confidentiality of the commercial and industrial information provided, including research and development information as well as information on which the [F6Authority] and the applicant disagree as to its confidentiality.

Textual Amendments