Statement on the active substance acetamiprid

Abstract

Acetamiprid is a pesticide active substance with insecticidal action currently under the third renewal (AIR3) of the Commission implementing regulation (EU) No 844/2012. Following concerns that this substance may pose high risks to humans and the environment, the French authorities asked the Commission to restrict its uses under Article 69 of Regulation (EC) No 1107/2009. To support this request, competent Authorities from France cited a series of literature papers investigating its hazards and/or exposure to humans and the environment. Consequently, the EFSA PPR Panel was mandated to advise on the likelihood that body of evidence would constitute proof of serious risks to humans or the environment. Therefore, the EFSA PPR Panel evaluated the likelihood of these studies indicating new or higher hazards and exposure to humans and the environment compared to previous EU assessments.A stepwise methodology was designed, including: (i) the initial screening; (ii) the data extraction and critical appraisal based on the principles of OHAT/NTP; (iii) the weight of evidence, including consideration of the previous EU assessments; (iv) the uncertainty analysis, followed, whenever relevant, by an expert knowledge elicitation process. For human health, no conclusive evidence of higher hazards compared to previous assessment was found for genotoxicity, developmental toxicity, neurotoxicity including developmental neurotoxicity and immunotoxicity. However, due to the lack of adequate assessment of the current data set, the PPR Panel recommends conducting an assessment of endocrine disrupting properties for acetamiprid in line with EFSA/ECHA guidance document for the identification of endocrine disruptors. For environment, no conclusive, robust evidence of higher hazards compared to the previous assessment was found for birds, aquatic organisms, bees and soil organisms. However, the potential of high inter-species sensitivity of birds and bees towards acetamiprid requires further consideration.

Those That Remain: Sorption/Desorption Behaviour and Kinetics of the Neonicotinoids Still in Use

“…Imidacloprid, thiamethoxam and clothianidin were first banned in 2013 for use on agricultural crops attractive to bees, but with the possibility of application on other crops; in 2018 they were banned for use in the EU except in greenhouses, but with were still available to use by invoking emergency authorisations [ 14 ]; finally, in January 2023, the EU’s highest court prohibited member states from issuing such authorisations [ 15 ]. This derogation loophole was thus closed for three out of five neonics; thiacloprid was not included in the ruling, while acetamiprid was and still is regularly approved in all EU states [ 16 ]. Both are also still in use around the globe [ 17 , 18 , 19 , 20 , 21 , 22 , 23 , 24 , 25 ].…”

Revised guidance on the risk assessment of plant protection products on bees (Apis mellifera, Bombus spp. and solitary bees)

“…power of the experimental design). However, in other cases, this is assessed separately (EFSA, 2020 ; EFSA PPR Panel, 2022a , b ). Either way, this aspect should be considered.…”

“…Strength can be viewed as the degree to which the line of evidence allows achieving a conclusion for the assessment question. Overall reliability, relevance and consistency, all contribute to the strength of the line of evidence (EFSA PPR Panel, 2022a , b ).…”

“…Ideally, considerations about uncertainty should already be included when assessing reliability and relevance of the individual lines of evidence. However, it is even more important to clearly report the uncertainty associated with each line of evidence (See for example EFSA PPR Panel ( 2022a , b )). Uncertainty can also be evaluated at the very end of the assessment process, just before reaching a conclusion (see for example EFSA ( 2018b , c , d ).…”

“…Different methods may also be applied to different steps of the same WoE. EFSA PPR Panel ( 2022a , b ) are examples of WoE integrating aspects of the category ‘rating’ (for the evidence appraisal), ‘quantification’ (for determining consistency within and between lines of evidence) and ‘best professional judgment’ (for integrating the lines of evidence, assessing uncertainty and reaching a conclusion).…”