Keeping Crop Protection Safe

DNT studies: Public statement on media reports

On June 1, 2023, an article by Mie and Rudén was published in the journal Environmental Health, in which crop protection product manufacturers are accused of having withheld studies on developmental neurotoxicity from the EU approval process and thus having hindered the evaluation of various active substances. Bayer is mentioned in connection with three active ingredients.

Regarding the three active ingredients and the mentioned studies linked to Bayer, there was no safety concern, neither for farmers, nor for consumers. The EU risk assessments were carried out reliably in each case. The results of the mentioned studies would not have changed these risk assessments. They did not provide any relevant additional safety information compared to the data already submitted. 

Bayer has always acted in full compliance with the relevant EU law and made the complete data package available to the competent EU authorities – according to the applicable EU regulations. 

Bayer is committed to scientifically based safety assessments of our active substances that take into account the risks of a product under realistic conditions of use. Before crop protection products can be approved, they undergo rigorous assessment to ensure a high level of protection for human health and environment. The official approval is regulated by numerous international and national laws and regulations. The approval process in the EU is among the most stringent and robust in the world. Consumers and civil society at large can have confidence in the EU system for regulating substances. As a company, we also have trust in – and adhere to – this rigorous process established by EU policymakers. 

Our chemical and biological crop protection products are thoroughly screened and investigated in the development phase regarding their mode of action, their toxicological properties and the extent of possible residues in plants and in the environment, so that we only develop products with the best safety profiles. The Organization for Economic Cooperation and Development (OECD) sets strict international guidelines for the approval of crop protection products, which we follow. We evaluate the possible health and environmental risks of a product along its entire life cycle.

We stand for transparency and were the first company in the industry to make safety-relevant data on crop protection products publicly available already in 2019. Summaries of scientific studies submitted to the European Food Safety Authority as part of the approval procedures for our active ingredients are available on our transparency online platform. These reports include information on toxicological and ecotoxicological studies as well as investigations regarding the degradation behavior of plant protection products.

As we support a transparent and open communication regarding our Crop Science products, please find below some specific details on the three active ingredients that were mentioned by Mie and Rudén in Environmental Health:

Ethoprophos:
Bayer made a submission to the EU authorities in April 2002, in accordance with EU law governing the approval of pesticidal substances (Directive 91/414/EEC) at the time. In addition to a large number of studies on toxicity, studies on developmental neurotoxicity were also submitted. The EU authorities were informed that a further study required by the US authorities was planned. It was not yet completed at the time of the EU evaluation of the data package. The study would not have changed the outcome of the EU authorities’ risk assessment as it did not provide any relevant additional safety information compared to the data already submitted and was therefore not required to be submitted. All studies were passed on to AMVAC when the active ingredient was divested in 2010.

Fenamiphos:
Bayer, along with other companies, made a submission to EU authorities in 2002 in accordance with EU law governing the approval of pesticidal substances (Directive 91/414/EEC) at the time. A DNT study required by US authorities was started in parallel and completed only in 2004. It was not yet completed at the time of the start of the EU evaluation of the data package. The study would not have changed the outcome of the EU authorities’ risk assessment as it did not provide any relevant additional safety information compared to the data already submitted and was therefore not required to be submitted. This was confirmed in a later review by EU authorities. All studies were passed on to AMVAC when the active ingredient was divested in 2010.

Fenamidone:
Bayer’s last submission for reapproval to EU authorities was made in 2013 in accordance with EU law governing the approval of pesticidal substances (Regulation EU 1107/2009) at the time. Based on the toxicological profile of the active substance, a DNT study was not required under the applicable requirements. This was confirmed by EFSA. A DNT study was performed and submitted to US authorities upon request. The study would not have changed the outcome of the EU authorities’ risk assessment as it did not provide any relevant additional safety information compared to the data already submitted and was therefore not required to be submitted. All studies were passed on to Gowan when the active ingredient was divested in 2019.