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 and GM crop products are among the most thoroughly investigated and strictly regulated products in the world. The public’s interest in transparency of information is continuing to grow, and we want to lead the way in providing for better access to safety-related information.
At Bayer, we meet and often exceed the highest international standards for 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 we have provided the data that we and global regulatory authorities use to evaluate product safety so that everyone has the chance to judge for themselves.
We also 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 dialogue.
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.
Similarly, the United States Department of Agriculture (USDA) submissions for GM crops are publicly available from the USDA website.
For both active substances and GM crops, additional information may also be requested from authorities; however, this process of acquiring information can be complicated 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 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.
Since the beginning of 2018, Bayer has been offering non-commercial access to full study reports for crop protection products on request.
Since June 2020, we are providing non-commercial access to the USDA and FDA regulatory submission documents and product safety summaries concerning our commercialized GM crops. Bayer will begin offering non-commercial access to GM crop study reports on request at a later date.
Summaries of our safety relevant studies which have been submitted to the European Food Safety Authority (EFSA) are being made available for our crop protection active substances on our website.
US regulatory submission documents and safety summaries are being made available for our GM crop products.
Upon request and for non-commercial use, we are also sharing full study reports of crop protection safety studies that have been submitted to and evaluated by regulatory authorities for commercially available products. Safety studies that are still being reviewed by regulators may not be available for disclosure until their review is complete.
Documents which are subject to third-party rights must be exempted to respect these rights. For example, for substances submitted by a task force, or containing other data not fully owned by Bayer, we will appropriately respect third party rights and agreements thereof.
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 the full study reports that the summaries are based on upon request.
Since June 2020, we are disclosing and enabling non-commercial access to U.S. submission documents and safety summaries concerning our commercialized GM crop products and the associated safety studies. At a later date we will enable non-commercial access to the full safety study reports upon request and subject to agreement.
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.
In compliance with our obligations under GDPR, we protect information that could compromise the privacy of Bayer’s employees or third parties.
We do not obscure information needed to assess the safety of our products.
We also redact information relating to sensitive trade secrets such as manufacturing processes, formulations, or other details which could be commercially misused. This type of information is protected under applicable laws (like Art. 63 EU 1107/2009) and therefore called by law Confidential Business Information (CBI).
You can always file a request for a Crop Protection study report currently not available on the website for non-commercial use. Please send an email to email@example.com We will assess such requests and respond to you as soon as possible.
You will be granted a license to use one copy of the respective document under our Terms and Conditions for Access to Crop Protection and/or GM seeds and traits Study Documents. Any use of the document or its content for regulatory and commercial purpose is prohibited and constitutes a violation of the underlying license agreement.
If you would like more information about the safety of our marketed products or the active substances or biotechnology traits 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 great deal of safety-related information, especially the summarized results of safety studies, is available on cropscience-transparency.bayer.com. These summary documents are based on study reports which, in the case of crop protection active substances, have been submitted to the European Food Safety Authority (EFSA) or, in case of GM Crops, submitted to US regulatory agencies.
For those Crop Protection 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 and submit your request. Make sure that the email address you entered is valid.
You will be sent an automatic reply by email, confirming that your request has been received.
The study report will be sent to you as soon as possible. If this is the first time that a study report has been requested, delivery may be delayed. This is because the first time a report is shared, all personal data have to be redacted to protect the privacy of individuals in compliance with the General Data Protection Regulation (GDPR) and to minimize potential misuse of the report in a regulatory context.
Due to legal restrictions and to respect third party rights, we are only allowed to provide documents which are fully owned by Bayer. Therefore, public literature and studies performed in cooperation with other companies are excluded from our transparency platform.
Documents regarding substances and products which are not available on the market and documents which have not been submitted to all evaluating authorities for which they are planned are not in scope of this transparency platform.
Documents which 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 distributed by our transparency platform in order to protect Bayer’s intellectual property rights. We will always be willing to explain why a report can’t be shared, and to assess to what extend we can discuss the content of these study reports. Please send an email to email@example.com and we will respond to you as soon as possible.
Before a study report can be made available, disclosure guidelines must be followed.
When a study report is requested, all personal data 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.
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 (e.g., 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 (i.e., 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 (i.e., 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 is 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).
With our new OpenLabs program, you can apply for an exclusive behind-the-scenes visit to see our science in action. OpenLabs lets you connect with our scientists and watch them carry out a safety study live in our labs and in the field. In small groups, you’ll experience what it means to strictly follow OECD test guidelines and GLP – and we’ll show you the procedures that make our safety study results reliable, verifiable, and reproducible.
FAQ about Lab Visits (OpenLabs Program)
OpenLabs is a unique opportunity for those who wish to learn about the details of Good Laboratory Practice (GLP) and how we conduct GLP studies to ensure the integrity of our results. Visitors will observe Bayer scientists conducting a laboratory study to generate data that may be used in a regulatory substance review process. Regular laboratory visit programs are normally shorter and provide a wide range of information about various studies conducted in the laboratory.
Depending on the composition of the group, we can offer events in German or English. You can specify your preference when registering. If you are comfortable in both languages, you have a better chance of getting a place.
Participants must be at least 18 years old.
Due to the depth of detail of the information, we assume a high level of interest in the topic and a high level of attentiveness on the part of the participants; depending on the registrations, we will arrange the groups in such a way that the participants fit together as well as possible due to their stated interests and background.
Please note that due to spatial conditions in the labs and on the field, OpenLabs visits are unfortunately not accessible for people with disabilities.
Pregnant women are not allowed to be in the laboratory area and therefore unfortunately cannot participate in the program.
The OpenLabs visits are two days long and are held at our Monheim premises. If you do not live nearby, we recommend that you book a hotel near the location (e.g. in Monheim itself).
FAQ about GM Crops
These terms are often used synonymously to refer to a process that allows plant breeders to take a desirable trait found in nature and transfer from a plant or other organism to the plant they want to improve. Some examples of desirable traits commonly transferred include resistance to insects and disease and tolerance to herbicides that allow farmers to better control weeds. GMOs are not limited to just plants; many microbes used to produce medicines or enzymes used in food are GMOs.
GM Crops are imported, cultivated, and/or field-tested in more than 75 countries. There are currently 13 crops with GM events commercially available around the world:
- Alfalfa, Apple, Canola, Corn (Maize), Cotton, Brinjal (Eggplant), Papaya, Pineapple, Potato, Soybeans, Squash, Sugar Beets, Sugarcane
Currently Bayer commercializes GM traits in canola, corn (maize), cotton, soybeans, and squash. Not all varieties are commercialized in every region of the world due to different agricultural practices or diverging climates. However, the status of all global approvals for GM crops can be found in this database maintained by Crop Life International.
Regulators assess the possible risks from GM crop products to human and animal health, and the environment. As an example, in the United States GM crops are regulated by three agencies:
- The Food and Drug Administration (FDA) is responsible for assuring the safety of all foods and feeds and products derived thereof on the market, regardless of the techniques used to develop the crop. The agency works cooperatively with GM crop developers to help them ensure foods made from their new varieties are as safe as conventional counterparts—nontoxic, nonallergenic, etc.
- The United States Department of Agriculture (USDA) confirms that a GM crop product will not have an impact on agriculture and is safe to grow. They assess whether the GM crop poses a plant pest risk including any potential for enhanced weediness or becoming invasive, impacts to beneficial non-target organisms, and disease and pest susceptibility.
- The Environmental Protection Agency (EPA) evaluates the introduced components in GM crops that give them resistance to pests like insects or viruses to ensure that the GM crop will not pose unreasonable risks of harm to humans or the environment.
Additionally, more than 40 government bodies representing more than 70 countries (e.g., Australia, the European Union, and Canada) review GM crops and affirm their safety prior to that product being cultivated and/or imported in that country. Since 1992, these countries have made more than 4400 separate decisions that GM crops are as safe as conventional crops for food, feed and the environment by granting regulatory approval for research, cultivation and/or import. To gain these approvals, country-specific safety and data requirements must be met. These requirements are established by individual authorities like the U.S. Environmental Protection Agency (EPA), European Food and Safety Authority (EFSA) and Health Canada.￼
If you would like more information about the safety of Bayer GM Crops which are currently on the market, please email firstname.lastname@example.org. We will respond to you as soon as possible.
Data to support every GM Crop product that Bayer has commercialized, in any country, has been submitted to the relevant US agencies. The submissions to U.S. regulators are often the basis for submissions to other countries and contain the key safety studies that have been performed on the products and submitted to regulatory authorities around the world.
You may have noticed that we have not included the EPA submission documents. The primary reasons are:
- EPA submissions only cover products that are resistant to insects and disease therefore, not all products have an EPA submission.
- All key safety studies are included in both the USDA and FDA submission documents. The EPA submission is formatted to reference detailed study reports which will be available for request at a later date.
The regulatory processes and oversight for crop protection products and GM crop products are different because the products themselves are different. The laws and regulations that agencies rely upon to regulate certain products were enacted to cover different types of products. The submission documents for GM products that have been posted to the website are the ones that most completely showcase the testing that has been performed on our GM crop products.
An "event" can refer either to the specific insertion of a DNA segment into the genome of a GM crop or to the GM crop itself that contains the specific DNA insertion. An event may have one or more genes, which each confer specific traits, or characteristics, to the crop. Each event is assigned a unique designation, or MON number. Examples of events are MON87751, which confers protection against certain soybean insect pests or MON87411, which confers resistance to corn root pests and tolerance to the herbicide glyphosate.
Stacked traits, also known as “breeding stacks” (combined events products or stacked traits products), are GM crop products produced through conventional breeding between plants carrying independent biotechnology-derived events. The breeding stacks therefore express the traits of the individual events. The combination or "stacking" of events allows the farmer to have the value of multiple traits in the same crop (e.g., insect protection and herbicide tolerant traits) such as in our Trecepta® Corn, VT Double PRO®, VT Triple PRO® corn products.
Submissions (also referred to as dossiers, petitions, applications, registration requests, notifications) to regulatory agencies are submitted to meet the requirements set out in each agency’s regulations or guidance. Those regulations and/or guidance documents describe data that must be presented for the agency to conduct its evaluation of the product. Agencies also often give varying degrees of specificity on how that data and supporting narrative text should be presented. For example, some agencies specify the order in which material/data is presented, the level of detail, formatting of text, table and data and administrative requirements.
For more information: USDA Petition Guidance and Resources
Safety studies are specially designed experiments that allow regulatory scientists to assess the safety of GM crop products, specifically that these products do not adversely affect humans and animals (e.g., proteins are tested for allergenicity and toxicity) and do not impact the environment by ensuring no unintended consequences to other plants or species.
International regulatory bodies and leading scientific experts (e.g., the Codex Alimentarius Commission, the Organization for Economic Development) have designed and validated what types of studies and relevant data to collect and evaluate the potential impact of food/feed/environmental safety of GM crops. Depending on the regulatory agency, these studies are required “by law or regulation” when submitting a GM crop for approval/authorization to global regulators. For the evaluation of food safety, those standards were set forth by the Codex Alimentarius Commission, which is a joint intergovernmental body of the Food and Agriculture Organization (FAO) and World Health Organization (WHO) made up of 189 member countries/regions. Similarly the Organization for Economic Development (OECD), made up of 35 member countries, has provided guidelines on GM crop safety assessment best practices since 1982.
At Bayer, we ensure the quality and integrity of our data by following principles that outline how safety studies are planned, performed, monitored, recorded, archived and reported that support regulated products. These are known as Good Laboratory Practices (GLPs). GLPs are the foundation of our safety studies submitted for global regulatory approval.
GM crop safety studies assess the safety of these products and the results of safety studies establish these products are as safe as conventional crops and foods. To ensure that food and feed from GM crops are as safe and nutritious as those from conventional varieties, Bayer scientists analyze protein, carbohydrates, fat, amino acids, fiber fractions, vitamins, and other components. In addition to demonstrating that each new GM crop is nutritionally equivalent to its conventional counterpart, we generate additional assurances through field testing to verify that the plant is fundamentally unchanged from its conventional counterpart (with the exception of the introduced trait) and will not have adverse environmental effects.
In general, overarching international safety frameworks, supported by scientific principles, define testing standards followed by industry for generating safety study data and conducting safety studies. These are set by organization such as Codex Alimentarius Commission and the Organization for Economic Development (OECD). Also, to gain product authorization, country-specific safety and data requirements must be met. These are established by authorities like the US Environmental Protection Agency (EPA), European Food and Safety Authority (EFSA) and Health Canada.
Additional quality systems are in place (both internal and external) to act as checks and balances to ensure data is of high quality and integrity as well as to minimize errors. For example, internal Quality Assurance (QA) Units as well as inspections by external authorities (e.g., the EPA) ensure 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 Good Laboratory Practices 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. Quality systems protect the scientific rigor of planning and executing safety studies to ensure data is reproducible, reliable, traceable and credible; and all raw data of studies are archived for the life of the product to meet these requirements.
FAQ about Emergency Authorizations in the European Union
The European Commission’s Emergency Authorizations Database provides details about the emergency authorizations granted by EU countries, as notified through the Plant Protection Products Application Management System (PPPAMS). Each EU country is responsible for the information provided. Any request for information or clarification should be addressed to the relevant authority for the specific EU country.
As recognized by the European Commission in its guidance document on emergency authorizations, emergency situations can arise which pose a danger to crop production; these emergencies therefore require quick and effective responses that cannot await the outcome of the normal plant protection authorization process. Emergency authorizations help farmers to swiftly protect their crops against otherwise unavoidable losses in situations where there are no reasonable alternative means. As a result, this mechanism supports agricultural productivity and contributes to global food security, as well as helping to protect the farmers livelihood and rural employment.
The EU process to authorize a new active substance for use in crop protection products takes between 2.5 and 3.5 years. This timeframe is not compatible with cases where there is an immediate and significant threat to a farmer’s crops which is not controllable by any other means. In addition, a recent European Commission audit shows that many timelines stipulated in the regulation are not met by EU Member States. The EU’s legal framework therefore allows for emergency authorizations to be granted in these exceptional situations – provided that a full and clear reasoning is given and that the authorized use of the product is very specific with a narrow scope.
No. Emergency authorizations are only granted in exceptional situations where farmers have no other viable alternative to mitigate an otherwise unavoidable threat to their crops. Full and clear justifications must be provided in support of such authorizations. For example, the following may be reasons why an EU country grants an emergency authorization:
- The product is only authorized for use on certain crops, so a separate authorization is required to use that product on a different crop;
- The product contains a newly approved active substance at EU level, but the specific EU country has not yet approved products containing that active substance;
- The problem is caused by a new, invasive species that is not native to that particular geographic area, so no products are currently approved for use against it;
- The only effective solution is to use a product containing a non-approved active substance (which may be a “new” substance which is not yet approved, or a substance that was previously approved but has been withdrawn, or a substance that had been denied approval altogether).
Yes, many countries around the world have legislation in place which allows them to grant temporary, emergency authorizations of otherwise unauthorized substances when a severe agricultural pest or disease threat has been identified. For example:
- Brazil: the Ministry of Agriculture can declare a state of emergency and grant an emergency authorization of up to 1 year accordingly – but before doing so, they must take into account: the severity of the threat; the available response capacity; and the effects on the agricultural economy.
- Canada: applicants must send a request to the Pest Management Regulatory Agency, who will assess the proposed use pattern. If they agree there is a need, the PMRA can grant an emergency authorization for up to 1 year.
- Australia: the Australian Pesticides and Veterinary Medicines Agency can issue emergency permits for a specified, limited period, tailored to the emergency at hand. If the threat involves exotic pests, advice will be taken from Plant Health Australia or Animal Health Australia, who often set up related response plans.
If you have a question about the procedures in a specific jurisdiction, please email us and we will do our best to provide you with the relevant information.