Why non-GRG members need to access glyphosate studies
In order to place a glyphosate plant protection product (PPP) on the market, non-GRG members may need to access glyphosate studies that were commissioned (and are jointly owned) by GRG members for the 2020 Scientific Dossier or are owned by members of the Glyphosate Task Force for the 2012 Scientific Dossier. Access to certain of these studies and use of their data will be necessary to support an authorisation of the non-GRG member’s glyphosate PPP by the competent authority in a Member State.
Data protection for studies submitted for the authorisation of glyphosate
Certain of the glyphosate studies submitted for the authorisation of glyphosate benefit from data protection under the provisions of Regulation (EC) No 1107/2009. The data protection period for studies that were necessary for the renewal of glyphosate will be until 30 months have elapsed after the date of first re-authorization of a glyphosate PPP, at Member State level. During the course of this period, a third party cannot use protected data in support of an application for authorisation of their product, without the permission of the data owner.
The only way for a non-GRG member to cite these data for authorisation of its PPP is to request a letter of access from the GRG member(s) that own the study. In the letter of access, the data owner must explicitly confirm that the applicant can rely on the data for its own authorisation request.
GRG members have claimed data protection over all studies jointly owned by them and submitted as part of the 2020 Scientific Dossier. Therefore, a letter of access request would need to be made by non-GRG members in order to rely on these studies.
Once these studies are out of data protection, they can be used by a third party, without gaining permission to do so from the data owner and therefore no letter of access is required. Data protection has not been claimed over the submitted Stewardship studies as these are not classified as regulatory studies under Regulation (EC) No 1107/2009.
Certain of the glyphosate studies commissioned by members of the Glyphosate Task Force for the 2012 Scientific Dossier may be out of protection, if the 30-month data protection period for studies necessary for glyphosate renewal has expired. In addition, for Member State product authorisations, the data protection period for new studies is 10 years, so it may be that a specific study is still protected in a given Member State. For these studies, a letter of access request would still need to be made to an owner of the study.
Process for accessing studies by non-GRG members
Scientific studies submitted for the authorisation of glyphosate are either jointly owned by the individual companies who are members of the GRG or owned by members of the Glyphosate Task Force. The GRG, as a group of companies, does not own any of the studies submitted for the purposes of authorisation and is unable to provide access to these studies pursuant to the requirements of Regulation (EC) No 1107/2009.
Non-GRG members interested in obtaining a letter of access for a study may submit a request for a letter of access to any one or more individual GRG member(s).
Pursuant to Regulation (EC) No 1107/2009, when studies are shared by the individual GRG members, they are shared in a fair, transparent and non-discriminatory way.
The non-GRG member may negotiate with the individual GRG member the terms of access and payment, where appropriate, for this letter of access. Any fee imposed for granting access to the studies shall be determined in a fair, transparent and non-discriminatory way and shall be reasonable.
The non-GRG member may find the owner(s) of the studies submitted for the 2020 and 2012 Scientific Dossiers in the ‘Reference Lists for glyphosate study ordering’ that can be downloaded under ‘Our owned studies’ page. It should be noted that the Reference List for the 2020 Scientific Dossier also includes studies submitted for the authorisation of Bayer’s proprietary glyphosate PPP as the reference formulation.
These studies are provided by Bayer in order to support the 2020 Scientific Dossier. Any third party interested in relying on the data of these studies for the authorisation of its glyphosate PPP must request a letter of access from Bayer.