1.The applicant may indicate which information submitted under Articles 9(1), 10(2) and 12(2) is to be treated as confidential on the ground that its disclosure might significantly harm its competitive position. Verifiable justification must be given in such cases.
2.Information relating to the following shall not be considered confidential:
(a)the name and address of the applicant and the chemical name of the substance;
(b)information of direct relevance to the assessment of the safety of the substance;
(c)the analytical method or methods.
3.The Commission shall determine, after consultation with the applicant, which information should be kept confidential and shall inform the applicant and the Authority of its decision.
4.The Authority shall supply the Commission and the Member States with all information in its possession on request.
5.The Commission, the Authority and the Member States 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6.If an applicant withdraws or has withdrawn an application, the Authority, the Commission and the Member States shall respect the confidentiality of commercial and industrial information provided, including research and development information as well as information on which the Commission and the applicant disagree as to its confidentiality.
1.In accordance with the conditions and the procedures laid down in Articles 39 to 39e of Regulation (EC) No 178/2002 and in this Article:
(a)the applicant may submit a request to treat certain parts of the information submitted under this Regulation as confidential, accompanied by verifiable justification; and
(b)the Authority shall assess the confidentiality request submitted by the applicant.
2.In addition to the items of information referred to in Article 39(2) of Regulation (EC) No 178/2002 and pursuant to Article 39(3) thereof, the Authority may also grant confidential treatment with respect to the following items of information, where the disclosure of such information is demonstrated by the applicant to potentially harm its interests to a significant degree:
(a)any information provided in detailed descriptions of starting substances and mixtures used to manufacture the substance subject to the authorisation, the composition of mixtures, materials or articles in which the applicant intends to use that substance, the manufacturing methods of those mixtures, materials or articles, impurities, and migration testing results, except for information which is relevant to the assessment of safety;
(b)the trademark under which the substance shall be marketed as well as the tradename of the mixtures, material or articles in which it shall be used, where applicable; and
(c)any other information deemed confidential within the specific procedural rules referred to in point (n) of Article 5(1) of this Regulation.
3.This Article is without prejudice to Article 41 of Regulation (EC) No 178/2002.