FAQ

We hope this provides answers to some of your questions.

If any question you want to see answered is missing, let us know via cropscience-transparency@bayer.com

Transparency Initiative

  • Why has Bayer decided to enable access to its safety studies?
    • Crop protection products are among the most thoroughly investigated and strictly regulated products in the world. However, our data is rarely seen in full outside of authorities, and this has developed into a barrier to building public trust. The public’s interest in information transparency continues to grow and we want to lead the way 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 to give you a chance to judge for yourself.
    • We want to level the playing field, by giving non-commercial parties access to the science behind safety regulations. In doing so, we hope to foster an open, science-based dialogue on crop protection products.
  • How has the transparency initiative been set up?
    • Much of the information found on 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. Some additional information may be requested from authorities. This process of acquiring information can be burdensome, to both the public and the authorities. Our transparency initiative is designed to reduce the bureaucracy and make information more easily accessible for non-commercial purposes.
    • We intend to provide easier and faster access to human and environmental safety study information through the gradual implementation of our new Transparency Initiative. Downloadable evaluation summaries covering a large number of active substances will be made available alongside educational and supplementary materials. These will put the regulatory science into context and ensure that it is accessible to all. From 2018 onwards, Bayer will on request offer non-commercial access to full study reports on which summaries are based.
  • What will be disclosed?
    • Safety-relevant summaries of studies will be made available on our website. In addition, Bayer enables non-commercial access to full study reports on which summaries are based.
    • 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 which are subject to third party rights have to be exempted to respect these rights.
  • What is the timeline for the transparency initiative?
    • The disclosure of safety study data will be 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. In 2017, study summaries for about 20 active substances and some representative products (formulations) will be made available online.
    • In 2018, we will enable non-commercial access on request to full study reports on which summaries are based. This will be a continuous process.
  • What will be blacked out in the documents and why?
    • We will blacken information that can compromise the privacy of Bayer’s employees or contractors.
    • We will 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 under special protection under applicable laws (like Art. 63 EU 1107/2009) and therefore called by law Confidential Business Information.
    • We will redact regulatory certificates to prevent misuse of Bayer’s know how for unauthorized regulatory purposes and protect our commercial interest.
    • Regulators receive an edition of the documents without the blacked out sections. Data which are blacked out have been disclosed and assessed properly by regulators.
  • What about those substances which are registered in non-European countries only?
    • 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.
  • What am I allowed to do with the study information available?
    • 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.
  • How can I contact Bayer experts to get further information?
    • If you would like more information about the safety of the active substances used in those Bayer products which are 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.
  • How can I get access to full study reports?
    • A lot of safety-related information, especially the summarized results of safety-studies, is freely available on cropscience-transparency.bayer.com. 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 e-mail address, you will receive an e-mail containing a code. Please follow the link in the email and enter the code.
    • You will be sent an automatic reply by e-mail, 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 blackened 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 cropscience-transparency@bayer.com.
  • Why is the edition number of the study report I ordered different from the edition number of the citation in the summary document?
    • The edition number cited in the summary document refers to the un-blackened edition submitted to the regulatory authority. Before disclosure to the public, we will blacken 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.
  • Why can it take up to several weeks for me to gain access to the study report I requested?
    • Before a study report can be made available, disclosure guidelines have to be followed. When a study report is requested, all names and non-safety-relevant certificates have to 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.
  • Why can I only request access to a limited number of active substances and products?
    • 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 have to 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 those products and substances which have successfully passed through the registration process will be available. Please contact us via cropscience-transparency@bayer.com and we will follow up with you regarding the disclosure of further studies.

Crop protection safety studies

  • What are 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 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 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, how are they 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.  Toxicity happens when the body can no longer get rid of chemicals effectively and a toxic effect happens.  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.  Because we cannot test in humans or in all wild animals or all beneficial insects, 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 published scientific criteria and international guidance documents and have to 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 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 (e.g. in Germany under § 27a ChemG).

FACTS

Plant protection products need to undergo a strict evaluation to ensure that they are safe for humans and have no irreversible adverse effects on the environment.