We hope this provides answers to some of your questions. If any question you want to see answered is missing, let us know via email@example.com.
FAQ about the Transparency Initiative
Crop protection products are among the most thoroughly investigated and strictly regulated products in the world. However, often our data is only shared in full with regulatory authorities. The public’s interest in the transparency of information is continuing to grow, and we want to lead the way in providing for better access to safety-related information.
We want to show our commitment to transparency and to meeting the highest international standards when assessing the safety of our products. After all, we share the same values when it comes to the safety of our families, our food and our environment.
We believe in transparency so that everyone has the chance to judge for themselves.
We want to level the playing field by giving non-commercial parties access to the science behind the safety of our products. In doing so, we hope to foster an open, science-based dialog on crop protection products.
Much of the information found in the active substance registration documents, submitted by Bayer as part of the European Union (EU) approval process, is publicly available on the European Food Safety Authority’s website. This includes summaries of human and environmental safety studies. Additional information may also be requested from authorities; however, this process of acquiring information can be burdensome for both the public and the authorities. Our transparency initiative is designed to make information more easily accessible for non-commercially interested parties – from an interested citizen to a member of the scientific community.
Since we are talking about access to tens of thousands of documents, we intend to provide easier and faster access to human and environmental safety study information through the gradual implementation of our new Transparency Initiative. As a first step from December 2017, downloadable evaluation summaries covering a large number of active substances were made available, in addition to the bee –related studies for imidacloprid, alongside educational and supplementary materials. The latter help put the regulatory science into context and ensure that it is accessible to all. Since the beginning of 2018, Bayer has been (on request) offering non-commercial access to full study reports upon which the summaries are based.
Safety-relevant summaries of studies are being made available on our website. In addition, Bayer enables non-commercial access to the full study reports.
Only documents which have been submitted to and evaluated by a regulatory authority and where products are available on the market will be disclosed.
Documents that are subject to third-party rights must be exempted to respect these rights.
- We are firmly committed to our transparency initiative announced in 2016. We apply the same principles to all our substances, which will also include molecules acquired from Monsanto. Our principles can be found in this FAQ.
- For substances submitted by a task force (e.g. glyphosate), or containing other data not fully owned by Bayer, we first must analyze potential legal restrictions imposed on us requiring us to respect third party rights.
- As of December 7, 2018, we have disclosed glyphosate study summaries on our transparency platform. As of March 28, 2019, we enabled access to all 107 Bayer-owned glyphosate safety study reports that were submitted to the European Food Safety Authority (EFSA) as part of the substance authorization process in the European Union (EU). For more information on this, please see the Glyphosate Safety Summaries section of this FAQ.
- The disclosure of safety study data is a continuous process, starting with active substances registered in the EU and some other countries. The documents submitted as part of the EU registration process cover more than 90% of the studies performed on active substances globally. Since 2017, study summaries for many active substances and many representative products (formulations) have been made available online.
- In early 2018, we started to enable non-commercial access to full study reports upon request. This will be a continuous process.
- On December 7, 2018, we added glyphosate safety study summaries to the platform. As of March 28, 2019, we enabled access to all 107 Bayer-owned glyphosate safety study reports that were submitted to the European Food Safety Authority (EFSA) as part of the substance authorization process in the European Union (EU).
- In case you are interested in safety studies for active substances or products which are on the market but not yet available on our Transparency platform, please send your request to firstname.lastname@example.org. We will respond as soon as possible.
- We do not redact the information needed to assess the safety of our products.
- We redact information that can compromise the privacy of Bayer’s employees or third parties.
- We redact information relating to sensitive trade secrets such as manufacturing processes, formulations, or other details that could be commercially misused. This type of information is under special protection under applicable laws (like Art. 63 EU 1107/2009) and therefore called by law Confidential Business Information.
- We redact regulatory certificates to prevent misuse of Bayer’s knowhow for unauthorized regulatory purposes and to protect our commercial interest.
- Regulators receive an edition of the documents without the blacked-out sections. Data that are blacked out have been disclosed and assessed properly by regulators.
- You can always request a study report currently not available. Please send an email to email@example.com if you would like to get access to safety study information which is currently not available on our platform. We will respond to you as soon as possible.
- The disclosure of safety study information will be an ongoing process. Over time, we will disclose information pertaining to more substances and products. Refer to the “News” section of this website for information on the future availability of safety-related information submitted outside the EU.
You will be granted a license to use one copy of the respective document. Any distribution, reproduction or publication requires the consent of Bayer AG (or its respective affiliate). Any use of the document or its content for regulatory or any other commercial purpose is prohibited and constitutes a violation of the underlying license agreement. For further details please see the Terms and Conditions for Access to Crop Protection Study Documents.
If you would like more information about the safety of our marketed products or the active substances used in Bayer products which are currently on the market, please email firstname.lastname@example.org. We will respond to you as soon as possible.
Bayer actively seeks scientific collaboration and encourages you to get in touch with us. Bayer is interested in collaborating with scientists to advance research in the fields of agronomics and public health.
- A lot of safety-related information, especially the summarized results of safety studies, is freely available here. These summary documents are based on study reports. For those substances marked with an asterisk (*), full study reports are already available on demand for non-commercial use. These can be requested by opening the relevant summary document and clicking on the link referencing the study report. You will be re-directed to an order form.
- List your name and email address on the order form. To verify your email address, you will receive an email containing a code. Please follow the link in the email and enter the code.
- You will be sent an automatic reply by email, confirming that your request has been received.
- A download link will be sent to you after the safety study report has been prepared.
- If this is the first time that the study report has been requested, it may take a while for it to become available. This is because names, locations and non-safety relevant certificates have to be blacked-out to protect the privacy of individuals and contractors and minimize potential misuse of the report in a regulatory context.
- Once used, this download link will remain valid for 24 hours.
- If you would like to get access to a large number of study reports, please contact us via email@example.com.
- Due to legal restrictions and to respect third party rights, we are only allowed to provide documents that are fully owned by Bayer. Therefore, public literature and studies performed in cooperation with other companies are excluded from our disclosure process.
- Documents that are not safety studies and could be commercially misused are also excluded. These documents have been submitted to and evaluated by regulators but can’t be ordered via our transparency platform. The links to the order form are therefore not activated for the document IDs in the summary documents. Please send an email to firstname.lastname@example.org if you would like to discuss the content of these study reports. We will respond to you as soon as possible.
The edition number cited in the summary document refers to the non-redacted edition which was submitted to the regulatory authority. Before disclosure to the public, we will black out all names and locations of testing facilities and non-safety-relevant (laboratory) certificates, as well as confidential business information. This document will receive another edition number. The edition number is the last digit of the document ID (M-xxxxxx-vv-e).
- The documents are updated over time. The newest version is the latest one submitted to the authorities. Between the versions, there is absolutely no difference concerning the results of the study. In most cases, only typos are corrected, or information is added for better understanding.
- Only the latest version of a study will be provided to you, even if you requested an older one.
- The version number is displayed as the two digits in the document ID (M-xxxxxx-vv-e).
Before a study report can be made available, disclosure guidelines must be followed. When a study report is requested, all names and non-safety-relevant certificates must be redacted manually. Study reports can be as long as 800 pages. They also differ in structure and format (e.g. scanned paper documents) which can require further preparation.
- Given the extensive number of steps required to prepare the documents for release, the list of available reports will be expanded on a continuous basis. Prior to disclosure, between 300 and 700 reports must be reviewed (e.g. for data privacy reasons) and formatted for each active ingredient. A single study report can have up to 800 pages.
- Only information pertaining to the products and substances which have successfully passed through the registration process will be available. Please contact us via email@example.com and we will follow up with you regarding the disclosure of further studies.
FAQ about Crop Protection 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, animals, microorganisms, and plants that are not pests) or the environment (e.g. soil, water, and air 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 150 per chemical) that are required by law to be performed by companies that want to register a crop protection product. The studies are designed to test chemical 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 tests look at the toxicity to organisms that live in soil, sediment, and water, as well as beneficial insects, birds, wild mammals, and plants.
Regulators use the results from all these studies to understand the safety profile of the chemical. They evaluate the toxic effects of the plant protection product and they determine potential exposure levels, which are safe for humans and the environment. They always apply a safety margin of at least 100 between the no effect-concentration in the studies and the potential exposure to the chemical under the specified conditions of use. Only then is the product considered to be safe for use.
Regulatory tests are performed according to published scientific criteria and international guidance documents and must be conducted following GLP (Good Laboratory Practice). The compliance with guidelines and GLP regulations is monitored by internal Quality Assurance Units as well as externally by authority inspections to guarantee that the conduct of studies and data 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 following 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 are also reflected in the fact that study directors or other people falsifying, using falsified or fraudulently issuing inaccurate GLP certificates may be subject to criminal prosecution (e.g. in Germany under § 27a ChemG).
FAQ about Glyphosate Safety Studies
- On December 7, 2018, we disclosed more than 300 glyphosate safety study summaries on our dedicated transparency platform. As of March 28, 2019, we enabled access to all 107 Bayer-owned glyphosate safety study reports that were submitted to the European Food Safety Authority (EFSA) as part of the substance authorization process in the European Union (EU).
- As with the other substances included under our Transparency Initiative, we are focusing on safety studies submitted under the European Union (EU) substance authorization process for plant protection products.
- Bayer cannot publish the studies owned by the other companies that form part of the Glyphosate Task Force. However, Bayer is committed to improving transparency around crop protection safety studies and would encourage its industry peers to follow suit.
- Since December 7, 2018, we have made available all 318 glyphosate safety study summaries which are part of the EU dossier. This includes studies on residues and metabolism (18), environmental fate (32), toxicology (180), and ecotoxicology (88) on the active substance as well as representative formulations.
- As of March 28, 2019, we enabled access to all 107 Bayer-owned glyphosate safety study reports that were submitted to the European Food Safety Authority (EFSA) as part of the substance authorization process in the European Union (EU).
The European Glyphosate Task Force (GTF) is a consortium of companies joining resources and efforts to renew the European glyphosate registration with a joint submission. This consortium is not to be considered a legal entity.
Safety studies on glyphosate conducted by the GTF, and the data contained within these studies, are not wholly owned by Bayer. As a result, we are not automatically at liberty to disclose this information.
We cannot speak on behalf of other companies. However, Bayer is committed to improving transparency around crop protection safety studies and would encourage its industry peers to follow suit.
- Glyphosate products have been used safely and successfully for over four decades worldwide and are a valuable tool to help farmers deliver crops to markets and practice sustainable farming by reducing soil tillage, soil erosion, and carbon emissions.
- Regulatory authorities around the world consider glyphosate-based herbicides as safe when used as directed.
- There is an extensive body of research on glyphosate and glyphosate-based herbicides that confirms that these products are safe when used as directed.