ANSES opinion on the plant protection substances identified as giving rise to concern in the December 2017 mission report on the use of plant protection products

As part of France’s national action plan to reduce the use of plant protection substances, ANSES is publishing its expert appraisal on the substances requiring particular attention, based on their hazard level and on phytopharmacovigilance data. ANSES is recommending a reassessment of several active substances at European level as a priority. At the same time, the Agency is undertaking its own immediate reassessment of products already on the market, based on the latest European standards.

In December 2017, as part of a plan put in place by the French government to reduce the use of pesticides in farming, a CGAAER-CGEDD-IGAS[1] inspection mission listed some of the active plant protection substances most frequently identified or mentioned in monitoring reports, which it described as giving cause for concern.

Based on the findings of this mission report, and taking account of the banning of some substances and the subsequent withdrawal of a number of products, ANSES conducted an expert appraisal of the substances requiring particular attention. For some substances, it is recommending the non-renewal of approval, or an immediate reassessment at European level. At the same time, it is undertaking its own risk assessment for several authorised products and assessing one substance for its endocrine-disrupting potential, without waiting for renewed approval of the active substances included in these products.

An approach building on all regulations and available data

ANSES points out that all authorised active substances and plant protection products undergo a risk assessment – strictly regulated and harmonised at European level – before their first marketing authorisation and on each renewal.

In its expert appraisal, the Agency identified a number of currently approved substances recently listed by ECHA as category 1 carcinogens or reproductive toxicants, and which therefore meet the exclusion criteria set out in European Regulation 1107/2009. Meeting these exclusion criteria implies de facto non-renewal of approval, unless a case is put forward for strict exemption measures in compliance with the regulation. ANSES has also taken into consideration the possible endocrine-disrupting potential of some substances, as discussed in an impact assessment conducted by the European Commission.

Last, ANSES has taken account of the applications for renewal and reassessments of active substances and plant protection products that are currently underway.

From a scientific standpoint, the Agency relied on:

  • the scientific assessments currently available on these substances;
  • a calculation of risk indicators for safety in the workplace, consumer safety, non-target organisms and groundwater;
  • data from the French phytopharmacovigilance scheme coordinated by ANSES, whose role is to monitor and warn of real-life contamination levels and health effects.

ANSES's recommendations

Based on these studies, ANSES is calling for a rapid decision by the European Commission – which has already decided not to renew the approval of chlorpyrifos-ethyl and chlorpyrifos-methyl – on the non-renewal of two other active substances:

  • mancozeb, considered by ECHA as a category 1B reproductive toxicant;
  • thiophanate-methyl, currently the only active substance classed as a category 2 mutagen used in products authorised in France.

Without waiting for Europe to re-examine approval of the active substances, ANSES is also undertaking the following for the 2020-2021 period:

  • a re-assessment of the risks posed by products containing the substances below, with a view to possibly changing current marketing authorisations:
    • 8-hydroxyquinoline, ipconazole, flurochloridone, spirodiclofen and halosulfuron-methyl, all recently listed by ECHA as category 1B carcinogens or reproductive toxicants.  Given the hazard level, ANSES believes that a rapid update of the risk assessment is necessary in order to better protect operators, workers, bystanders and residents;
    • prosulfocarb, for which authorised treatment of some crops also contaminated nearby non-target crops, leading to a change in its conditions of use. As a result, the risk assessment of products including this substance will be updated for bystanders and residents.
  • an assessment of the endocrine-disrupting effects of prochloraz, based on the European guidance document issued in 2018 to assess the endocrine-disrupting effects of plant protection products. This assessment will be conducted without waiting for a possible renewal application to be submitted for this substance.

[1] CGAAER: General Council for Food, Agriculture and Rural Areas, CGEDD: General Council for the Environment and Sustainable Development, IGAS: General Inspectorate of Social Affairs