Art. 63

texts differ too much for an inline diff; shown separately

before (02009R1107-20191214)

Article 63
Confidentiality
1. A person requesting that information submitted under this Regulation is to be treated as confidential shall provide verifiable evidence to show that the disclosure of the information might undermine his commercial interests, or the protection of privacy and the integrity of the individual.
2. Disclosure of the following information shall normally be deemed to undermine the protection of the commercial interests or of privacy and the integrity of the individuals concerned:
(a) the method of manufacture;
(b) the specification of impurity of the active substance except for the impurities that are considered to be toxicologically, ecotoxicologically or environmentally relevant;
(c) results of production batches of the active substance including impurities;
(d) methods of analysis for impurities in the active substance as manufactured except for methods for impurities that are considered to be toxicologically, ecotoxicologically or environmentally relevant;
(e) links between a producer or importer and the applicant or the authorisation holder;
(f) information on the complete composition of a plant protection product;
(g) names and addresses of persons involved in testing on vertebrate animals.
3. This Article is without prejudice to Directive 2003/4/EC of the European Parliament and of the Council of 28 January 2003 on public access to environmental information
OJ L 41, 14.2.2003, p. 26..

after (02009R1107-20210327)

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
Directive 2003/4/EC of the European Parliament and of the Council of 28 January 2003 on public access to environmental information and repealing Council Directive 90/313/EEC (OJ L 41, 14.2.2003, p. 26). and Regulations (EC) No 1049/2001
Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents (OJ L 145, 31.5.2001, p. 43). and (EC) No 1367/2006
Regulation (EC) No 1367/2006 of the European Parliament and of the Council of 6 September 2006 on the application of the provisions of the Aarhus Convention on Access to Information, Public Participation in Decision-making and Access to Justice in Environmental Matters to Community institutions and bodies (OJ L 264, 25.9.2006, p. 13). of the European Parliament and of the Council.