The European Commission is using a dangerous concept to renew the authorisation of a very harmful pesticide that can damage the unborn child. For the very first time, it plans to use an exceptional clause of the Regulation called ‘negligible exposure’. It basically says: “Yes, it’s very toxic, but don’t worry, nobody will be exposed to it.” However, there is no robust scientific evidence for this claim that would allow the continued use of the ‘Toxic 12’ fungicide 8-hydroxyquinoline.
The Commission proposes the renewal of the ‘reprotoxic’ fungicide 8-hydroxyquinoline, based on the claim of "negligible exposure” to humans. This exceptional clause of negligible exposure allows for the approval of highly hazardous pesticides if it can be convincingly proven that there will be no contact with humans according to the Pesticide Regulation. Worryingly, such a robust demonstration was not provided for 8-hydroxyquinoline. PAN Europe is calling upon Member States to reject the Commission’s proposal and ban 8-hydroxyquinoline to protect human health.
Classified as toxic for reproduction category 1B since 2015, 8-hydroxyquinoline is presumed to "damage the unborn child." Under the EU Pesticide Regulation, substances that present such hazards cannot be approved. An exception is possible if negligible exposure to humans can be convincingly demonstrated. Negligible exposure should be strictly understood as conditions of use excluding contact with humans and resulting in no residues of the pesticide in food.
Member States and the Commission have not reached a consensus yet on a guidance document to assess and define negligible exposure in the course of pesticide risk assessment. As a result, this clause of negligible exposure has never resulted in the approval of a hazardous pesticide since the Pesticide Regulation came into force in 2011.
This situation could change as the Commission is now proposing to renew 8-hydroxyquinoline for drip irrigation building on the negligible exposure clause. Worryingly, the data presented by the applicant and summarised in EFSA's peer review conclusions fall short of the rigorous scientific standards required to justify the renewal of this hazardous substance.
For substances known or presumed to be genotoxic or endocrine disruptors, no threshold is considered safe, particularly for pregnant women, newborns and children. For this precise reason, the use of the ‘negligible exposure’ would completely twist the purpose of the Regulation, which is to remove harmful substances from the EU market rather than to try to mitigate the related risks.
Unreliable study is the cornerstone for far-reaching proposal
One major issue lies in the assessment of non-dietary exposure for workers and operators. The field study submitted to support the claim of negligible exposure was plagued by technical deficiencies, rendering it unreliable for quantitative risk assessment. Despite this, it formed the cornerstone of the argument that exposure levels are acceptable. The risks are equally alarming for bystanders’ and residents’ children. The assessment of their non-dietary exposure is incomplete due to data gaps. As a result, the conclusion that they may not be exposed to 8-hydroxyquinoline via drip irrigation use is mostly based on assumptions.
Discussion with EU Member States on 2 and 3 October
The Commission’s proposal will be discussed with Member States on 2 and 3 October. More discussions and possibly a vote will take place in late 2024 or the beginning of 2025. Meanwhile, the current approval period of the substance will be extended. Since 2021, 8-hydroxyquinoline is on PAN Europe's list of Toxic12 pesticides to be banned immediately.
PAN Europe urges Member States to reject the renewal of 8-hydroxyquinoline and to advocate for the immediate withdrawal of products containing this substance from the EU market. This is not just a regulatory matter; it is a critical public health issue that demands decisive action.
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