Intro to the issue
Our industry is one of the most heavily regulated industries in the world. A substantial set of safety studies is required and evaluated by authorities applying a rigorous system of independent scrutiny before any product can enter the market.
It’s because a fundamental principle lies behind the EU pesticide, biopesticide legislation and GMO legislation: protection of human and animal health, wildlife and the environment comes first. Our industry is committed to continue creating innovation that upholds the highest safety standards in Europe.
Why this is a priority for us?
Our members work together to invest into systematic research to improve risk assessments.
Firstly, we believe that, the more open scientific data there is, the less uncertainty remains. This helps evaluating authorities as well as companies to conclude on the safety of any marketed solution be it a chemical pesticide, a biopesticide derived from natural materials or a genetically modified plant.
Secondly, it is our clear conviction to support this scientific process using all relevant data. This will allow to exhaustively evaluate if products are safe at the level where humans and animals are exposed to them.
What are we doing about it
Many of the scientists within our membership are engaged in exciting research with academia, NGOs and other stakeholders to further advance the scientific understanding of both safety of our innovations as well as risk assessment frameworks that govern their approval.
To identify just one potentially marketable discovery a company screens hundreds of thousands of solutions. Once identified, tests cover chemistry, biology, toxicology, ecotoxicology to ensure that correct use of the product will not lead to health concerns.
Evolving requirements, new guidance documents, or extra questions asked by regulators can certainly identify new data needs – and we remain committed to supplying them to the best of our ability.
For example, only recently a question has been identified by EFSA in the area of exposure of workers in vineyards – we have engaged in the BROV [Bystander Resident Orchard Vineyard] re-entry project aiming at answering this question, by generating new field data for regulatory use in re-entry exposure assessments for relevant activities in vineyards.
CropLife Europe shares any generated data and knowledge with regulating authorities. They then can make a decision where more data is needed, and where there is sufficient security to protect health through pragmatic risk assessment practice.
As from 2021, the content of technical dossiers for pesticides, biopesticide and genetically modified plants will be made publicly available at the beginning of the evaluation process. This will gradually give access to the general public, but more importantly to the scientific and regulatory communities, to a vast amount of safety related data. We believe such transparency will benefit the evaluation process and enhance the risk assessment approaches.