Confidentiality

The applicant shall at the same time submit the complete list of studies and a list of test and study reports for which any claims for data protection pursuant to Article 59 are requested. Upon a request for access to information the Member State examining the application shall decide what information is to be kept confidential (PPPR (EC) 1107/2009 art. 33(4-6)).

PPPE (EC) 1107/2009, art. 63 states that confidential treatment may be granted only 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.

Article 63 Confidentiality

1.  An applicant may submit a request to treat certain parts of the information submitted under this Regulation as confidential, accompanied by verifiable justification.

2. Confidential treatment may be granted only 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) information referred to in Article 39(2) of Regulation (EC) No 178/2002;

(b) the specification of impurity of the active substance and the related methods of analysis for impurities in the active substance as manufactured, except for the impurities that are considered to be toxicologically, ecotoxicologically or environmentally relevant and the related methods of analysis for such impurities;

(c) results of production batches of the active substance including impurities; and

(d) information on the complete composition of a plant protection product.

2a.   Where the Authority assesses confidentiality requests under this Regulation, the conditions and the procedures laid down in Articles 39 to 39e of Regulation (EC) No 178/2002 and paragraph 2 of this Article shall apply.

2b.   Where Member States assess confidentiality requests under this Regulation, the following requirements and procedures apply:

(a) confidentiality treatment may only be granted with respect to information listed in paragraph 2;

(b) where the Member State has decided which information is to be treated as confidential, it shall inform the applicant of its decision;

(c) Member States, the Commission and the Authority shall take the necessary measures so that information for which confidential treatment has been granted is not made public;

(d) Article 39e of Regulation (EC) No 178/2002 shall apply mutatis mutandis;

(e) notwithstanding paragraph 2 and points (c) and (d) of this paragraph:

(i) where urgent action is essential to protect human health, animal health or the environment, such as in emergency situations, the Member State may disclose the information referred to in paragraph 2;

(ii) information which forms part of the conclusions of the scientific outputs delivered by the Authority 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;

(f) if the applicant withdraws or has withdrawn an application, Member States, the Commission and the Authority shall respect the confidentiality as granted in accordance with this Article. Where the withdrawal of the application takes place before the Member State has decided on the relevant confidentiality request, Member States, the Commission and the Authority shall not make public the information for which confidentiality has been requested.

3.   This Article is without prejudice to Directive 2003/4/EC ( 4 ) and Regulations (EC) No 1049/2001 ( 5 ) and (EC) No 1367/2006 ( 6 ) of the European Parliament and of the Council.