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)).

PPPR (EC) 1107/2009, art. 63 states that a person requesting that information 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.

Confidential information which disclosure shall normally be deemed to undermine the protection of the commercial interests or of privacy and the integrity of the individuals concerns:

• the method of manufacture;
• the specification of impurity of the active substance except for the impurities that are considered to be toxicologically, ecotoxicologically or environmentally relevant;
• results of production batches of the active substance including impurities;
• 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;
• links between a producer or importer and the applicant or the authorisation holder;
• information on the complete composition of a plant protection product;
• names and addresses of persons involved in testing on vertebrate animals.

This arrangement on confidential information does not exclude the provisions of Directive 2003/4/EC of the European Parliament and of the Council of 28 January 2003 on public access to environmental information.

Contrary to the protection of confidential information related to commercial  interests, or privacy and the integrity of the individual, PPPR(EC) 1107/2009, art. 57 states that a specified set of authorisation data shall be publicly available.

Member States shall keep information electronically available to the public on plant protection products authorised or withdrawn in accordance with this Regulation, containing at least:

• the name or business name of the holder of the authorisation and the authorisation number;
• the trade name of the product;
• the type of preparation;
• the name and amount of each active substance, safener or synergist which it contains;
• the classification, risk and safety phrases in accordance to Directive 1999/45/EC and to the Regulation referred to in Article 65
• the use or uses for which it is authorised;
• the reasons for withdrawal of an authorisation if they are related to safety concerns;
• the list of minor uses referred to in Article 51(8).

Also information on parallel trade permits shall be made publicly available.