Answer given by Mr Borg on behalf of the Commission
24.4.2014
Regulation (EC) No 1107/2009[1] provides for the most restrictive risk assessment for active substances to be used in plant protection products worldwide. Applicants have to provide a substantial amount of information.
The system is based on scientific rigorousness and does not distinguish a priori between studies financed by the applicant itself, or studies coming from other sources, e.g. from public literature.
There is a high standard set by the OECD/EU test guidelines in determining the way information is generated by industry and when academic studies do not adhere to this standard this should be transparent in the information provided in order to allow a transparent judgment of the open literature by the public, EFSA, and all stakeholders.
Studies published in open literature unfortunately do often not contain the raw data, but only secondary information. This jeopardises the reproducibility of the results and an independent and transparent scientific evaluation of such data is not possible.
The EFSA guidance document[2] clearly sets out the requirements for a quality assessment which makes sure that all information submitted is subject to the same scientific rigor.
The Commission would welcome if more studies financed by third parties could be taken into account in the risk assessment.
It is the role of EFSA to provide independent scientific advice to the Commission.
- [1] Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC. OJ L 209, 24.11.2009, p. 50.
- [2] Submission of scientific peer-reviewed open literature for the approval of pesticide active substances under Regulation (EC) No 1107/2009. EFSA Journal 2011;9(2):2092 [49 pp.]. doi:10.2903/j.efsa.2011.2092.
OJ C 355, 08/10/2014