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Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC - Commission Declaration

article  25

CELEX:  02001L0018-20210327

Confidentiality
1. The notifier may submit a request to the competent authority to treat certain parts of the information submitted under this Directive as confidential, accompanied by verifiable justification, in accordance with paragraphs 3 and 6.
2. The competent authority shall assess the confidentiality request submitted by the notifier.
3. Upon request of a notifier, the competent authority may grant confidential treatment only with respect to the following items of information, upon verifiable justification, where the disclosure of such information is demonstrated by the notifier to potentially harm its interests to a significant degree:
(a) items of information referred to in points (a), (b) and (c) of Article 39(2) of Regulation (EC) No 178/2002;
(b) DNA sequence information, except for sequences used for the purpose of detection, identification and quantification of the transformation event; and (c) breeding patterns and strategies.
4. The competent authority shall, after consultation with the notifier, decide which information is to be treated as confidential and shall inform the notifier of its decision.
Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC - Commission Declaration

article  25

CELEX:  02001L0018-20210327

5. Member States, the Commission and the relevant Scientific Committee(s) shall take the necessary measures to ensure that confidential information notified or exchanged under this Directive is not made public.
6. The relevant provisions of Articles 39e and 41 of Regulation (EC) No 178/2002 shall apply mutatis mutandis.
7. Notwithstanding paragraphs 3, 5 and 6 of this Article:
(a) where urgent action is essential to protect human health, animal health or the environment, such as in emergency situations, the competent authority may disclose the information referred to in paragraph 3; and (b) information which forms part of the conclusions of the scientific outputs delivered by the relevant Scientific Committee(s) or the conclusions of the assessment reports and which relate to foreseeable effects on human health, animal health or the environment shall nevertheless be made public. In that case, Article 39c of Regulation (EC) No 178/2002 shall apply.
Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC - Commission Declaration

article  25

CELEX:  02001L0018-20210327

8. In the event of a withdrawal of the notification by the notifier, Member States, the Commission and the relevant Scientific Committee(s) shall respect the confidentiality as granted by the competent authority in accordance with this Article. Where the withdrawal of the notification takes place before the competent authority has decided on the relevant confidentiality request, Member States, the Commission and the relevant Scientific Committee(s) shall not make public the information for which confidentiality has been requested.