General information about regulatory data transparency
Why does BASF make safety data more easily accessible?
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.
What information is already available?
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".
What information will BASF make available?
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.
What information will not be available as part of the disclosed studies?
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.
What is confidential business information and why is this important?
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.
Who can request access?
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.
What am I allowed to do with the study information available?
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.
How many full study reports can be accessed via the request?
It is only possible to access one full safety study report with one request.
If I need further information, how can I contact BASF?
A lot of 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. Certain summarized results of safety-studies are freely available on BASF’s regulatory data transparency website, offering the interested public already a lot of safety-related information. You can find on this website those EU active substance study summaries generated and submitted by us in the EU regulatory approval process as also searchable 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).
The summary documents are based on study reports. For those studies that contain safety data; full study reports can be requested for non-commercial purposes via our request form, provided that no EU review process is currently pending for the active substance. It is only possible to request one full study report with the request form.
In the request form, we ask you to identify the full report of a safety study you are interested in by the so-called BASF Doc-ID number. The BASF Doc-ID can be found in the relevant summary document as shown here.
In addition, please enter the name of the active substance and the subject matter of the safety study.
If you submitted a valid request but this is the first time that the study has been requested, it may take up to several weeks before you receive it.
After the safety study report has been prepared for the purpose of being made available to interested parties, a download link will be sent to you. This download link will remain valid for 7 calendar days.
Why can it take some time before I receive access to the full report that I requested?
Before we can give access to a full study report containing safety data, disclosure guidelines have to be followed. When a study report is requested, confidential business information (CBI), all names, addresses or personal information as well as the text of the GLP certificates have to be blackened manually. We do this in order to protect our data against misuse. Depending on the structure and format of the document, further preparation work can be required.
General questions around safety studies
What are safety data / safety studies?
Safety studies are specially designed experiments that allow regulatory scientists to assess the potential of a crop protection product to adversely affect humans, animals, non-target organisms (insects and plants that are not pests) or the environment (e.g. soil and water and the organisms that live in them).
How are safety studies conducted?
Regulatory agencies from around the world have designed and validated a whole package of safety studies (more than 200 per chemical) that are required by law to be performed by companies that want to register a crop protection product. Regulatory tests are performed according to internationally agreed guidance documents and have to be conducted following Good Laboratory Practice (GLP) guidelines. The studies are designed to test exposures over different lengths of time and at different concentrations. There are studies that test a large single dose to assess what happens in an accidental exposure or spill. The studies also test all routes of exposure: by mouth, on the skin and by inhalation. Other studies test low and high doses over longer periods of time (days to months to years) to assess exposure to workers and consumers, as well as to the environment (e.g. beneficial insects, birds, mammals, fish, earthworms, soil microorganisms and plants).
What do safety studies tell us?
Safety studies tell us a lot about a chemical. These studies show us how the chemical interacts with the environment and in the body. How does it enter a plant, bug, animal or human; where does it go; how much goes to different organs or parts of a plant; is it toxic and at what dose; how long does it stay; how is it broken down; is it still toxic when it is broken down; how much stays in the environment (soil, water, and air). For humans and animals, these studies test if the chemical is toxic to the immune system, reproduction and development of fetuses and young animals; all organ systems (liver, kidney, heart, brain, reproductive organs, eyes, nervous system, blood, spleen, bones, muscles, thyroid); and whether it is genotoxic (toxic to genetic material) or can cause cancer. For the environment, these test look at the toxicity to organisms that live in soil, sediment and water, as well as beneficial insects, birds, wild mammals and plants.
Many of the safety studies show toxic effects, why are products considered safe?
Every chemical can be toxic including water, oxygen, salt and sugar. Our bodies are designed to take in chemicals, use what we need to be healthy and then get rid of everything we don’t need. A toxic effect happens when the body can no longer get rid of chemicals effectively. For example, when you drink alcohol faster than your body can break it down and eliminate it, the alcohol builds up in your body and causes toxicity (e.g. incoordination, dehydration, decreased body temperature, decreased breathing and heart rate, nausea, vomiting and death in extreme cases).
Many crop protection products are designed to be toxic to pests, others to combat weeds or diseases. Safety studies are specifically designed to show toxicity. As representative species are used in safety testing, there is always uncertainty if humans or other non-target organisms might be more sensitive to the toxic effect of a chemical than the test species. Therefore, safety studies require a range of doses. The lowest dose should cause no observable adverse effect (called a NOAEL; like a small sip of beer). Higher doses are tested until a toxic effect is observed (called a lowest observable adverse effect level (LOAEL); like 2-3 bottles of beer for a non-drinker). The highest dose in the study should cause significant adverse effects (similar to passing out due to too much alcohol). By testing the full range of toxicity, regulators have better certainty that if the maximum exposure a human may have is still 100 times or more lower than the NOAEL in the safety studies, then the product is safe to use according to the approved label (e.g. NOAEL = 10 mg/kg/day and the maximum human exposure is 0,1 mg/kg/day, the product is considered safe).
How do regulators use safety studies to assess crop protection products?
Regulators use the results from all of these studies to understand the safety profile of the chemical. They look at the toxic effects and the dose levels. Then they estimate how much exposure is likely to happen based on how the product will be used. If the exposure is well below (at least 100 times lower) doses that cause no adverse effects in the studies, the product is considered to be safe for use.
Safety studies are funded by industry – can the results therefore be trusted?
Regulatory tests are performed according to internationally agreed guidance documents and have to be conducted following Good Laboratory Practice (GLP) guidelines. They are also an integral part of the 1981 European Council Decision on the Mutual Acceptance of Data in the Assessment of Chemicals. The compliance with guidelines and GLP regulations is monitored internally, as well as externally by authority inspections and audits to guarantee that the conduct of studies and data generation is accurate and valid. Monitoring activities include audits of the facilities, ongoing work in the facilities (i.e. the observation of personnel in the laboratory to assure they are working in compliance with GLP and follow test guidelines), the inspection of documents (e.g. review of the study plan that outlines the work to be conducted, review of the report for accuracy of data generated) and also include regular authority visits. Raw data of studies are archived for at least 15 years. The high standards and importance which is attached to GLP-Studies is also reflected in the fact that study directors or other people falsifying, using falsified or fraudulently issuing inaccurate GLP-certificates may be potentially subject to criminal prosecution.
If you have a question about the regulatory process, already public available data or food safety, please contact us.