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New version applies from 01/07/2013. 133 provisions change. Later versions: 30/06/2014, 28/08/2017, 10/11/2018, 15/07/2019, 14/12/2019, 27/03/2021, 21/11/2022, 16/06/2026. Article 63 changes in this version: compare with the current text.

Article 63 - Confidentiality

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 19.

  1. 19 OJ L 41, 14.2.2003, p. 26 . ↩
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