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New version applies from 27/03/2021. 38 provisions change. Article 20 changes in this version: compare with the current text.

Article 20 - Confidentiality

Article 20
Confidentiality

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6.If an applicant withdraws or has withdrawn an application, the Authority, the Commission and the Member States shall respect the confidentiality of commercial and industrial information provided,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.

Official text · consolidated version 07/08/2009 (no longer in force) Open full page ↗
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