- Crop Protection
Bringing Crop Protection Products to the Market
Find out about the regulatory rigor, which ensures that crop protection products put on the market are proven to be safe if applied according to the use instructions.
How are plant protection products approved?
Step 1 Before we are allowed to sell plant protection products, they need to undergo strict evaluation by authorities for each country to ensure that they are safe for humans and have no unacceptable effects on the environment. | |
Step 2 For this purpose, we need to submit hundreds of residue, toxicological, eco-toxicological, environmental, physical-chemical, and efficacy studies. All this scientific information is compiled in a registration dossier, containing individual study reports, summaries and risk assessments, including proposals for risk mitigation. | |
Step 3 These dossiers are submitted to regulatory authorities around the world who review the submitted data and risk assessments, and grant or deny approval of active substances and products based on their specific regulations and conclusions. |
This is important to us:
We are not only scientists but also consumers just like you. We take our responsibility for comprehensive, accurate and high-quality safety studies very seriously.
| To identify one potentially marketable chemical, an agrochemical company screens an average of 160,000 molecules. | |
| Pests, fungi, and weeds develop resistance, this is one reason why there is a constant need for new innovative crop protection products and proper stewardship of the product. | |
| In addition to legally required studies, we perform and submit further studies that go beyond the requirements to thoroughly understand our molecules and prove the compatibility of our products with the environment. We are also obligated to observe additional requirements, such as record keeping, product integrity and informing various regulatory agencies should new information become available. |
When and why do we perform these studies?
Study reports have to be submitted in dossiers to register new active substances and their formulations. The same applies to the renewal of already registered substances and their formulations in many countries. For example, in Europe substance authorizations expire after a maximum of 15 years, which triggers a new application according to latest rules and scientific standards. In the U.S. the authorities regularly review substance authorizations and request new data to reflect regulatory and scientific developments.
The registration process of crop protection products has to follow country- or region-specific guidelines.
The design, performance, and reporting of the studies follow internationally agreed guidance developed by organizations/authorities such as e.g. OECD, EPA, CODEX, EFSA, and others. In general, safety studies are conducted according to international scientific standards, known as Good Laboratory Practice (GLP), that ensure data quality, integrity, and traceability.
Which people in Bayer are involved in the registration process and what are their challenges?
How many years does it take from discovering a new compound to being able to sell a developed and authorized product?
In 2019, the average time was 12.3 years. The increase of the required time is to a large extent driven by increasing requirements with regard to safety studies and risk assessments.
Crop Protection AI Discovery and Development Lead Time
Number of years between the first synthesis and the first sale of the product containing AI. *Source: AgbioInvestor (2024)
Did you know?
The number of molecules that had to be investigated to find one fit for developing into a product for market has increased from 52,500 in 1995 to 159,574 in 2014. This increase is mainly driven by stricter safety criteria.
Number of molecules screened leading to a successful product launch
Did you know?
Due to the high development cost and regulatory requirements, the number of substances developed has decreased from an average of 4 per year in 1995 to an average of 1.5 in 2014.
Number of substances developed per year leading to a successful product launch
What to protect?
To decide whether a crop protection product is safe when used according to the label, we look at several areas.
Dietary Safety
Dietary safety evaluates the exposure to the human population, including sensitive populations such as infants and children, from potential residues of chemicals in food and drinking water to ensure the levels are safe.
Toxicology
Toxicology studies the adverse effects of chemicals in mammals to assess potential effects in humans.
Environmental fate
Environmental fate investigates the behavior, metabolism and distribution of substances in the environment (soil, water, groundwater, air).
Environmental Effects
Environmental effects assess the potential effects of chemical or biological agents to non-target organisms in the environment.
Occupational exposure
Occupational exposure evaluates exposure to workers resulting from the manufacture and use of chemicals and determines required personal protection equipment to ensure safety.
Product chemistry
Product chemistry determines the physical chemical properties of a chemical (e.g. solubility, volatility, chemical reactivity) that are important to ensure safe storage, transport, use and disposal of a chemical.
Agronomic development
Agronomic development evaluates how a product should be used in the field to ensure maximum efficiency and crop safety.
About Animal Testing
Animal testing is required under many regulations worldwide to ensure that pesticides and other chemicals (e.g. pharmaceuticals) are safe for humans with no unacceptable risks for the environment when used according to the label.
But everyone should know
Bayer works hard to minimize animal testing with intelligent testing strategies including in-vitro studies, modeling, avoiding double studies and sharing studies with other stakeholders.
Entities in the Bayer family of companies located outside of the United States conduct the production, sale, marketing, and distribution of Roundup and glyphosate products outside of the United States. These entities are responsible for the content on this webpage; this webpage relates only to these entities and their activities outside the United States. Inside the United States, the production, marketing, sale, and distribution of Roundup and glyphosate products are conducted by a separate company, Ruveon.