EFSA assesses potential link between two neonicotinoids and developmental neurotoxicity

EFSA has delivered its scientific opinion Opinions include risk assessments on general scientific issues, evaluations of an application for the authorisation of a product, substance or claim, or an evaluation of a risk assessment. at the request of the European Commission by considering recent research by Kimura-Kuroda[1] and existing data on the potential of acetamiprid and imidacloprid to damage the developing human nervous system - in particular the brain.

The PPR Panel found that acetamiprid and imidacloprid may adversely affect the development of neurons and brain structures associated with functions such as learning and memory. It concluded that some current guidance levels for acceptable exposure Concentration or amount of a particular substance that is taken in by an individual, population or ecosystem in a specific frequency over a certain amount of time. to acetamiprid and imidacloprid may not be protective enough to safeguard against developmental neurotoxicity Any adverse effect on the nervous system (e.g. paralysis or loss of function) that results from exposure to potentially toxic substances. and should be reduced.  These so-called toxicological reference values provide clear guidance on the level of a substance that consumers can be exposed to in the short- and long-term without an appreciable health risk. Examples include the acute reference dose The total amount of a substance (e.g. a chemical or nutrient) given to, consumed or absorbed by an individual organism, population or ecosystem. (ARfD), the acceptable daily intake An estimate of the amount of a substance in food or drinking water that can be consumed daily over a lifetime without presenting an appreciable risk to health. It is usually expressed as milligrams of the substance per kilogram of body weight per day and applies to chemical substances such as food additives, pesticide residues and veterinary drugs. ( ADI An estimate of the amount of a substance in food or drinking water that can be consumed daily over a lifetime without presenting an appreciable risk to health. It is usually expressed as milligrams of the substance per kilogram of body weight per day and applies to chemical substances such as food additives, pesticide residues and veterinary drugs.) and the acceptable operator exposure level (AOEL). (See Notes to editors for more detail on how these reference values are designed to protect consumers and operators.)

Based on its review, EFSA proposes changes to the following toxicological reference values for acetamiprid and imidacloprid:

• For acetamiprid – the current ADI The acceptable daily intake (ADI) is an estimate of the amount of a substance in food or drinking water that can be consumed daily over a lifetime without presenting an appreciable risk to health. It is usually expressed as milligrams of the substance per kilogram of body weight and applies to chemical substances such as food additives, pesticide residues and veterinary drugs. and AOEL of 0.07 mg/kg bw/per day and the ARfD of 0.1 mg/kg bw should be lowered to 0.025 mg/kg bw (per day);
• For imidacloprid, the current AOEL and ARfD of 0.08mg/kg/bw/day should be lowered to 0.06 mg/kg bw/per day. The current ADI for imidacloprid is considered to provide adequate protection against potential developmental neurotoxic effects.

EFSA recognises the available evidence has limitations and recommends further research be carried out to provide more robust data. However, the PPR Panel said health concerns raised in the review of the existing data are legitimate. EFSA therefore supports the establishment of clear and consistent criteria to trigger the mandatory submission of DNT studies as part of the authorisation process in the EU. This could include the development of an integrated DNT testing strategy consisting of a stepped approach that uses laboratory tests on cells (so-called in vitro Research method which involves testing cells or tissues extracted from living organisms.) in the first instance and progresses to tests on animals ( in vivo Research method which involves testing individual live animals or populations of live animals.) if the initial results raise concerns over the DNT-potential of a substance. The PPR Panel advises that all neonicotinoid substances be evaluated as part of this testing strategy.

• Scientific Opinion on the developmental neurotoxicity potential of acetamiprid and imidacloprid