General information about regulatory data transparency
- CropLife International and its member companies like BASF have launched a transparency commitment in March 2018. Its goal: a global, voluntary and non-binding commitment to make more safety-related data of crop protection products publicly available.
- Through this commitment we recognize that we play an important role in making crop protection safety data more easily accessible to the public to provide greater transparency.
- We believe that enhanced transparency of regulatory crop protection safety data can help maintain public confidence in the regulatory review process and thereby address the questions consumers may have about crop protection products.
- To register a crop protection product, regulatory authorities require more than 200 safety studies following strict procedures and protocols. All relevant health and environmental safety information is already made public through various channels, such as the product label, product brochures or company websites, peer reviewed scientific literature and regulatory summaries by competent authorities.
- In the EU, for example, the regulatory risk assessment and study summaries for all active ingredients, and sometimes also for the crop protection products, is online with links to review reports and decisions. Further, the active substance registration reports (done by a rapporteur member state and containing the study summaries and risk assessment, as well as summaries on scientific literature) are published on the EFSA website. EFSA also peer-reviews the registration reports and publishes their peer review.
- There are similar portals in the US, Canada, Japan and elsewhere, and more information around pesticides can be found in "The Pesticide Manual".
On this website, BASF makes safety data directly available by publishing those EU active substance study summaries submitted by us in the EU regulatory approval process as also available in the Register of Questions of the European Food Safety Authority. We show our EU study summaries for those active substances that are currently approved for use in crop protection products we sell in the EU (except if subject to third party rights). Additionally, we offer upon request but only for non-commercial purposes access to full study reports that contain safety data and on which the summaries are based, provided that no EU regulatory review process is currently pending for the active substance. Such access upon request is subject to acceptance of our Terms and Conditions for Access to and Use of Crop Protection Safety Data.
In addition to safety data, the full study reports also contain non-safety related data such as efficacy data. They will not be disclosed. Further, we blacken all our Confidential Business Information (CBI). Disclosing data which qualifies as CBI could significantly harm innovation by reducing competition and undermining the policy balance between the public’s interest in relevant health and environmental safety information, and competitive commercial interests achieved through the protection of regulatory data. In order to protect the privacy and safety of researchers, no names, addresses or personal information of scientists will be disclosed. These parts will be redacted in the documents. In any case, we can only make study information available to the extent we have the sole rights therein or, if not, the permission to make it available via this website.
The crop protection industry is research intensive - investing around $3 billion every year in innovation to ensure sustainable products are continuously being created. Confidential business information (CBI) is information that, if disclosed, could cause harm to the developer’s commercial interests. Regulatory data are submitted to regulatory authorities with the understanding that CBI will be protected by confidentiality rules and will not be disclosed at any time. If disclosed without permission, it could be detrimental to a developer’s business interests or to the safety and privacy of researchers. Similar to the violation of patents and trademarks, disclosure of CBI can lead to the significant loss of potential revenue, and failure to adequately protect CBI discourages the research and development of innovative plant protection products. Protection of CBI is therefore a crucial incentive for innovators to create new technologies.
BASF invites any individual member of the general public to submit a request for access to a specific safety data study test report except to such persons that plan to use the safety data for any commercial purposes. We consider regulatory purposes to include commercial purposes. Any grant of access is conditioned on the express acceptance of and agreement with our Terms and Conditions for Access to and Use of Crop Protection Safety Data. For the avoidance of doubt, employees from other crop protection companies that develop, register or place onto the market crop protection products shall be deemed to have the intent to use the safety data for commercial purposes and, therefore, would not be granted access.
The conditions of use are set forth in the Terms and Conditions for Access to and Use of Crop Protection Safety Data which in particular stipulate the following:
Following a valid request for access to the safety data, the submission of the safety data will be governed by a license granted by BASF to the requestor. The license shall be royalty-free, non-exclusive, non-transferable and non-assignable, and subject to the following conditions:
- The scope of the license is limited to one copy of the safety data requested.
- The copy is made available by BASF for the personal use of the requestor. The requestor is not entitled to copy or otherwise reprocess, transmit to a third party, circulate or make publicly available, in hard copy or electronically, the safety data, except for scientists who wish to quote (extracts from) the safety data as evidence in a scientific study, provided that the source is acknowledged and BASF is duly marked as copyright holder (whenever applicable).
- In no event may the requestor use or have used the safety data for any commercial/regulatory purposes, nor may he directly or indirectly act on behalf of or to the advantage of any third parties that may use or have used the safety data for any commercial/ regulatory purposes.
- BASF has the right to revoke any license at any time without stating any reason(s), at which point the requestor shall then immediately return to BASF the safety data received and either return or delete any copy/material associated thereto and provide BASF with affirmative evidence thereof.
It is only possible to access one full safety study report with one request.