The current EU policy to test if a pesticide is an endocrine disruptor (altering the function of human and animal hormonal system) is far from being implemented. Endocrine disruption is a serious health concern that could lead to reproductive effects, cancer, brain damage and a range of other diseases. PAN Europe’s survey on the approval decisions of 33 pesticide active substances in Europe revealed that in 31 cases no relevant testing -specific to assess endocrine disruption- was requested from industry. While OECD-tests are available and agreed since 2012, the most sensitive tests were never requested from industry and even the tests to just determine endocrine activity were requested only in very few cases (4 of the 33 decisions studied). Additionally, in 4 other cases where Food Authority EFSA advised requesting OECD-tests, the European Commission refused to oblige industry to do so, ultimately saving costs for industry.
The EFSA/ECHA Guideline from 2018 on the identification of endocrine disrupting pesticides (EDPs)1 is very clear on testing requirements and mentions on page 32 a range of OECDtests that “need to be available” to decide on EDPs. Overall, Commission’s testing policy is very inconsistent, but -most importantly- fails to oblige industry to do OECD-tests as prescribed by the 2018-Guideline on endocrine disruptors. Commission thus relies in the majority of the cases on the available old, outdated and non-ED sensitive animal testing data. EFSA, in several cases (the pesticides Dimethenamid, Pendimethalin), acknowledges that “sensitive endpoints” in the related industry studies are lacking, and still draws the conclusion “unlikely to be an EDP”. However, without the correct data, EDPs will never be identified.
For about half of the cases surveyed by PAN Europe, DG SANTE only requested “information” (12 cases) or an “updated assessment” ( in 4 more recent cases). The information for the 12 cases has to be provided only after a new approval period for the pesticide is granted. In 10 out of these 12 cases, industry didn’t even submit the requested “information” at all, and the Rapporteur Member State in charge of the assessment accepted this. This clearly futile procedure puts the control of the identification process into the hands of the industry, allowing them to repeat claims that their pesticide is not an endocrine disrupting pesticide (EDP), and grants them another 10 years of market access. Many years of authorisation (approval) are added with a failing protection of the public.
Furthermore, many potential endocrine disrupting effects observed in animal studies are downplayed by EFSA and the Commission with views as “indirect effect” (Fluopyram), “only at high dose” (2,4-D, Flurochloridon, Trifloxystrobine), “likely other mechanisms” (Propyzamide), “non-treatment related” (Florpyrauxifen), “within historical control data range” (Flutianil), which are all speculations based on little experimental evidence. In the best cases, the assessment concludes that “endocrine effect couldn’t be excluded” and “information is needed to confirm absence of ED-activity”. It seems as if regulators do not try to identify EDPs but try to do their best to dismiss effects that could be related to endocrine disruption and consequently give the green light for the pesticide to remain on the market. Even the 7 pesticides out of the 33 surveyed by PAN Europe that were already identified as an EDP by EU-JRC (Joint Research Center, Ispra), were either dismissed by Commission from being EDPs (the pesticides Pendimethalin, Propyzamide, L-cyhalothrin), or approved for another 10 years with the futile request for additional “information” (the pesticides Epoxiconazole, Prochloraz, 2,4-D, Tetraconazole). This demonstrates the weakness of the safety assessment of pesticides and the random outcome of “expert judgement” (the opinions and feelings of those experts that happen to do the assessment).
Very disturbing is the fact that EFSA and the Commission apply the concept of “potency”, that was found unfit for decision making and therefore was excluded from the scientific criteria in 2016. This is the case for the pesticides 2,4-D, Trifloxystrobin, Epoxiconazole and Flutianil. Effects were dismissed when they were above the NOAEL for a non-ED adverse effect.
Furthermore, the Pesticide Regulation is underpinned by the precationary principle to ensure that pesticides do not adversely affect human and animal health or the environment. Since in most of the cases examined, adverse effects were observed in animal studies following exposure to the active susbtance, simply guessing that these are not endocrine-related without providing robust evidence, is against EU law and therefore should be considered illegal.
In conclusion, Commission’s policy is effectively blocking the identification of endocrine disrupting pesticides and it very much looks like another loophole (a vicious circle) is put in the way by regulators to stop the policy on endocrine disruption. An obstruction that is ongoing now for more than 9 years2 3.