6th April 2016
As part of the approval process for active substances, industry is obliged to generate data which is then evaluated alongside other sources of information such as open (published) studies. The admissibility of industry studies is dependent on adherence to rigorous standards, such as OECD guidelines on Good Laboratory Practice (GLP). As it stands, the legislation aims to strike a balance between satisfying the demands of the regulatory system and respecting the investment and proprietary nature of data generated by companies. We are concerned that the confidentiality of the basic raw data from studies submitted in confidence and reviewed according to the applicable regulatory framework can be used by some to question the whole basis for the evaluation of plant protection products as set out in EU legislation. However, in order to help to address public concerns regarding the safety of glyphosate products, and without, in any way setting a precedent for other studies and substances, members of the GTF have offered to the Commissioner their willingness to voluntarily provide, through a physical reading room (or rooms), controlled access to copies of all 14 carcinogenicity studies submitted by the GTF including all the studies referred to by Commissioner Andriukaitis’ in his letter of April 4th 2016 on an exceptional basis.
More information about the reply can be found at the Glyphosate Task Force website.
Follow-up: On 24 Aug. 2016, the GTF announced it had opened a reading room for anyone interested in the relevant studies. More information: http://www.glyphosate.eu/gtf-statements/glyphosate-task-force-opens-reading-room-public-access-studies.