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:
It is only possible to access one full safety study report with one request.
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.
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).
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).
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.
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).
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.
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.