Public Statement on Developmental Neurotoxicity Studies
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 allegedly 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, Bayer has always been fully compliant. At all times during the EU regulatory process, we complied with the letter of the regulation. We made the complete data package available to the competent EU authorities, according to EU regulations in place at the time. Moreover, Bayer fulfilled any requirements about informing the EU authorities about additional information which could have an impact on the assessment. Safety is, and always has been, our main priority - we will never compromise on safety.
In each case cited by Mie and Rudén, EU regulators were able to carry out a complete risk assessment for which the new studies did not provide any additional information which could have an impact on the assessment. The data included at the submission stage or thereafter already included developmental and reprotoxicity studies that allowed EFSA to assess developmental neurotoxic effects. Therefore, developmental neurotoxicity (‘DNT’) was already covered under the studies submitted. At no point was there any safety concern for farmers or consumers.
Bayer stands for transparency, and recognizes how important this is in building trust. We therefore welcomed the opportunity to address questions from members of the European Parliament at a public hearing held on July 18.
Please find the opening statement given at the hearing by Cristina Alonso, Senior Vice President and Global Head of Sustainability, Safety, Health and Environment, here:
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 the 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 testing 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. In line with our Bayer Social Engagement principles (BASE), which govern how we interact worldwide, summaries of scientific studies submitted to the European Food Safety Authority as part of the approval procedures for our active ingredients are available on this website, 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.
Overall, these details show that Bayer made any information available to the EU authorities even beyond what is required by the wording of the law. The EU authorities had all information to conduct a solid and comprehensive risk assessment. Bayer was only responsible for the regulatory processes prior to the divestments. The data submitted met always the regulatory data requirements. All DNT-study-data available at submission date were provided or their existence was made transparent. Data which became available after dossier submission was handled according to the legal requirements. The current and also earlier EU pesticide regulations require that after the approval decision any information which “suggests” that the approval criteria are not met any longer, i.e. potential harmful effects on human (“adverse data”), has to be notified immediately and do not impose requirements to provide unnecessary information not meeting these criteria. Comparable provisions for the period between dossier submission and approval decision do not exist. It is and was always without doubt for Bayer, however, that the same standard must apply also during this period to safeguard an appropriately efficient but under all circumstances robust safety evaluation process. Bayer has fully complied with these standards.
Ethoprophos:
Bayer made a submission for ethoprophos 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 initially and at a later stage in the approval process. A further study required by the US authorities was planned, but not yet completed at the time of the EU evaluation of the data package. The results of this study were consistent with the effects observed in an already submitted study, thus it did not provide additional information which could have an impact on the assessment. Consequently, based on the studies already available, EU regulators were able to carry out a complete risk assessment, including developmental neurotoxicity. All studies were passed on to AMVAC when the active ingredient was divested in 2010.
Please find more information with regards to timelines as well actions and decision taken by Bayer for the respective active ingredient here:
Please find the abstract of the respective neurotoxicity study and request form to access the full study reports here.
Fenamiphos:
Bayer, along with other companies, made a submission for fenamiphos 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, after the start of the EU evaluation process.
Effects seen in this study only occurred at higher doses compared with the low thresholds set by EU regulators for the amount of fenamiphos that e.g. consumers, operators and the environment could be safely exposed to. Thus, it did not provide additional information which could have an impact on the assessment. Consequently, based on the studies already available, EU regulators were able to carry out a complete risk assessment, including developmental neurotoxicity.
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.
Please find more information with regards to timelines as well actions and decision taken by Bayer for the respective active ingredient here:
Please find the abstract of the respective neurotoxicity study and request form to access the full study reports here.
Fenamidone:
Bayer’s last submission for reapproval of fenamidone to EU authorities was made in 2014 in accordance with EU law governing the approval of pesticidal substances (Regulation (EC) No 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 their request and Bayer informed the EU authorities of the existence of this study.
All studies were passed on to Gowan when the active ingredient was divested in 2019.
Please find more information with regards to timelines as well actions and decision taken by Bayer for the respective active ingredient here:
Please find the abstracts of the respective neurotoxicity study, a related statement for US authorities and the request form to access the full reports here.
Bayer will continue on this path to act responsibly as a corporate citizen - committing to the highest product safety standards, and striving to further advance transparency around our activities.