Frequently Asked Questions

FAQs about the Transparency Initiative

FAQs about Crop Protection Safety Studies

FAQs about Crop Protection Safety Standards

FAQs about OpenLabs 360º

FAQs about GM crops

FAQs about Emergency Authorizations in the European Union

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 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 the 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. Non-commercial access to GM crop study reports can be requested.

As of March 2021, we have added information on our crop protection safety standards.

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 and GM crop 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 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.

Information on Bayer’s safety standards for our crop protection products has also been made available.

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.  As of February 2021, we are enabling 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 get in touch with us by filling this request form. 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 the 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 study report currently not available on the website for non-commercial use ;by using this request form. 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/or 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 currently on the market, please email cropscience-transparency@bayer.com. 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 this website. 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.

If you would like to access full safety study reports submitted to and evaluated by regulatory authorities or are interested in further information about the safety of our crop protection or seed products, please get in touch with us by completing this request form and by accepting our Terms and Conditions for Access to Crop Protection Active Substances, Crop Protection Products and GM seeds and traits Study Documents.

Enter a study report identification and/or your special interest, 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 if all disclosure criteria are fulfilled (including the acceptance of our terms and conditions by you). Please visit the below chapters to learn more about what we are disclosing as a part of our transparency platform.

• What is being disclosed?

• Why are some documents excluded from disclosure?

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 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 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 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 extent we can discuss the content of these study reports. Please send an email to cropscience-transparency@bayer.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.

Safety standards are the evaluation criteria we use to ensure that our crop protection products do not pose a risk to human health or an unacceptable risk to the environment when used according to label instructions. This includes the data, the models, and the methods we use to assess the safety and evaluate the risk of our crop protection products, as well as to define risk management measures to ensure their safe use.

We apply many safety standards, including:

• Safety standards for the users of the crop protection product, known as operators
• Safety standards for consumers, i.e. those who consume food treated with our crop protection products
• Safety standards for the environment.

The first safety standard we are sharing is the standard on operator safety. In the future we will share our standards on environmental and dietary safety.

Our internal crop protection safety standards reflect the guidelines and standards of international organizations like the Food and Agriculture Organization (FAO), the World Health Organization (WHO) and the Organization of Economic Cooperation and Development (OECD), as well as those of regulatory authorities around the world, to ensure a globally consistent baseline for product safety. These safety standards continuously evolve based on the latest scientific knowledge.

At Bayer, safety is our top priority. Our safety standards are the basis for the ongoing discussion on pesticide safety with regulators and other stakeholders around the world. By disclosing information on our safety standards, we aim to share the scientific principles and criteria we apply, and the comprehensive measures we define to ensure our crop protection products do not pose a risk to human health or an unacceptable risk to the environment if used according to label instructions. We hope that transparency on our crop protection safety standards supports an open and constructive dialogue with all interested stakeholders on the safety of pesticides and how they are regulated.

The first safety standard we are sharing is the standard on operator safety. In the future, we will share our standards on environmental and dietary safety.

Find more information in our paper: “The Safety of our Pesticides”.

You can find our commitments regarding the safety of our crop protection product via this link.

Our safety standards encompass hazard definition, exposure assessment, risk assessment and risk management, respectively. Based on the outcome of the risk assessment, we determine where and how our product should be used, including the safety measures users of our crop protection products need to take while handling our products on the farm and on the field. We also contribute to operators receiving any necessary training to enable safe use of our products.

We are proactively establishing training programs also in countries where farmers are not legally required to undertake any training or receive accreditation before handling crop protection products. Both independently and in collaboration with other stakeholders, we run initiatives to promote practices that ensure the safe and responsible use of crop protection products.

In 2020, we independently trained around 1.7 million farmers in the safe use of our products – and, as a member of CropLife International, we helped to train almost four million more farmers across 82 countries in 2019.

We also launched the Bayer Safe Use Ambassador Program in 2017. Through partnerships with universities across Asia, we train students in the safe use of crop protection products, with a focus on user and environmental safety. The students then share their knowledge with farmers during internships. In 2020, we have reached 36 universities in eight Asian countries.

Operators are users handling crop protection products.

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.

Bayer only has commercial sublicensing rights for Roundup Ready^® Alfalfa. We are not the sole owner of this technology.

However, for Roundup Ready^® Sugar Beets, Bayer does own the trait technology, but we do not commercialize any product containing this technology. Instead, we have commercial agreements in place that support the sale of sugar beet seed using our trait technology by 3rd party companies.

In both cases, Bayer is not responsible for the commercial licensing or renewals for these products, therefore we have not included the safety information as we do not own it.

Finally, Bayer does not include products that are discontinued or are in the discontinuation process (e.g. Squash).

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 its potential for enhanced weediness or becoming invasive, impacts to beneficial non-target organisms, and changes in 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 4,400 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: cropscience-transparency@bayer.com. 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 required by regulatory authorities around the world.

You may have noticed that the EPA submission documents are quite different. The primary reasons are:

• EPA submissions only cover the substances produced in certain GM crop products (called plant incorporated protectants or PIPs) that make those crops resistant to pests like insects or disease. Therefore, not all GM crop products require an EPA submission and registration.

• The data and results from all key safety studies are included in both the USDA and FDA submission documents. The EPA submission is formatted to contain a list of detailed study reports compiled in an EPA form, called the “Data Matrix”. For GM crop products submitted to EPA we have provided a copy of that study index.

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.