Neonicotinoids

Some facts about neonicotinoids

Neonicotinoids are active substances used in plant protection products to control harmful insects, which means they are insecticides
The name literally means "new nicotine-like insecticides". They are chemically similar to nicotine
The name neonicotinoids is sometimes shortened to "neonics" or "NNIs"
The first neonic was approved in the EU in 2005
Neonics are systemic pesticides. Unlike contact pesticides, which remain on the surface of the treated parts of plants (e.g. leaves), systemic pesticides are taken up by the plant and transported throughout the plant (leaves, flowers, roots and stems, as well as pollen and nectar)
Neonics are much more toxic to invertebrates, like insects, than they are to mammals, birds and other higher organisms
Neonics affect the central nervous system of insects, leading to eventual paralysis and death
They are also common in veterinary applications such as tick control and flea collars for pets

Current status of the neonicotinoids in the EU

In 2013, five neonicotinoid insecticides were approved as active substances in the EU for the use in plant protection products, namely clothianidin, imidacloprid, thiamethoxam, acetamiprid and thiacloprid.

The Commission closely monitors the possible relations between bee health and pesticides and is determined to take the most cautious approach possible to protect bees.

In 2013, the Commission severely restricted the use of plant protection products and treated seeds containing three of these neonicotinoids (clothianidin, imidacloprid and thiamethoxam) to protect honeybees (see Regulation (EU) No 485/2013).

The measure was based on a risk assessment of the European Food Safety Authority (EFSA) in 2012. It prohibits the use of these three neonicotinoids in bee-attractive crops (including maize, oilseed rape and sunflower) with the exception of uses in greenhouses, of treatment of some crops after flowering and of winter cereals.

At the same time, the applicants of the three substances were obliged to provide further data (so-called "confirmatory information") for each of their substances in order to confirm the safety of the uses still allowed.

Following the assessment of this confirmatory information by EFSA of clothianidin, imidacloprid and thiamethoxam, the remaining outdoor uses could no longer be considered safe due to the identified risks to bees. Therefore, the Commission services prepared in 2017 three proposals to completely ban the outdoor uses of the three active substances.

EFSA has evaluated data collected in an open call for the review of the 2013 restrictions for the above-mentioned neonicotinoids as foreseen in Regulation (EU) No 485/2013. The deadline for this evaluation was postponed to February 2018 due to the amount of data to be assessed, the complexity of the request and to give Member States experts sufficient opportunity to comment on EFSA's draft conclusions.

The EFSA Conclusions on the risk assessment for the active substances clothianidin, imidacloprid and thiamethoxam were published on the EFSA website on 28 February 2018. The Commission and the Member States have examined these conclusions thoroughly and concluded that they confirm the already identified risks for outdoor uses.

Therefore, the Commission services maintained the proposals to completely ban the outdoor uses of the three active substances and these were supported by a qualified majority of Member States in the Regulatory Committee on 27 April 2018.

The Commission Implementing Regulations amending the conditions of approval of the active substances imidacloprid, clothianidin and thiamethoxam have been published in the Official Journal of the European Union on 30 May 2018. As a result, all outdoor uses of the three substances are banned and only the use in permanent greenhouses remains possible.

In the light of these restrictions, the applicants for the renewal of approval of clothianidin, thiamethoxam and imidacloprid withdrew their applications. Consequently, the approval of these substances expired on 31 January 2019, 30 April 2019 and 1 December 2020, respectively. For another neonicotinoid, acetamiprid, EFSA established a low risk to bees. A ban or further restrictions of this substance is therefore neither scientifically nor legally appropriate. A draft Regulation proposing a renewal of approval has been presented to the Member States on 5-6 October 2017.

The proposal was further discussed and presented to the Member States for opinion in the Regulatory Committee on 12 and 13 December 2017. The Committee gave a favourable opinion on the draft Regulation with a qualified majority of Member States. The Regulation renewing the approval until 28 February 2033 has been published in the Official Journal of the European Union.

The approval of a fifth neonicotinoid, thiacloprid was withdrawn on 3 February 2020.

Based on the EFSA conclusion which was published at the beginning of 2019 on the outcome of the peer review of the risk assessment conducted in view of a potential renewal, the Commission had proposed to the Member States in the Regulatory Committee not to renew the approval. On 22 October 2019, the Committee gave a favourable opinion on the draft Regulation, with a qualified majority of Member States. The Commission adopted the Regulation on 13 January 2020.

Emergency authorisations in the Member States

Following the restrictions on the three neonics in 2013, several Member States have repeatedly granted emergency authorisations for some of the restricted uses.

The Commission monitors closely this issue and had, in accordance with Article 53(2) of the legislation, mandated EFSA to examine the emergency authorisations granted in 2017 by those EU countries who repeatedly granted them before. EFSA assessed whether the repeated use of these emergency authorisations was indeed justified because of a danger which could not be contained by any other reasonable means.

EFSA found that for about one third of the products for which emergency authorisations were granted, alternatives would have been available. The Commission requested the Member States concerned to commit not to repeat the granting of the emergency authorisations in question.

In the light of the outcome of the assessment by EFSA and the reaction of the EU countries concerned, the Commission proposed decisions requiring Romania and Lithuania not to grant emergency authorisation in accordance with Article 53(3) for the uses of these neonicotinoids for future seasons to the Member States in the Regulatory Committee.

Following inconclusive votes (no qualified majority) in the Standing (October 2019) and Appeal (November 2019) Committees, the Commission adopted the measures on 3 February 2020.

Following the prohibition of all outdoor uses of the three neonicotinoids imidacloprid, thiamethoxam and clothianidin in May 2018 and the non-renewal of approval of thiacloprid on 3 February 2020, 10 EU countries have repeatedly granted emergency authorisations for their use in sugar beets. Notifications from the Member States of these emergency authorisations are publicly available.

The Commission therefore sent on 26 October 2020 a second mandate to EFSA in accordance with Article 53(2) of Regulation (EC) No 1107/2009 to assess whether the emergency authorisations granted for imidacloprid, thiamethoxam, clothianidin and thiacloprid for the 2020 sugar beet growing season by these 10 Member States fulfil the conditions set out in Article 53(1) of the Regulation.

The Commission updated this mandate with a request to assess additionally the emergency authorisations granted by France and Germany for the use of these neonicotinoids for the 2021 sugar beet growing season.

In particular, EFSA was asked to assess the justifications provided by Member States that the authorisations are necessary due to a danger, which cannot be contained by any reasonable means and to verify if a research programme is in place to find alternative solutions.

Besides using the available information in the notifications provided by the Member States, EFSA was asked to also request access from the concerned Member States to the original applications for these emergency authorisations and the full evaluation conducted by the Member States of these application(s).

EFSA published its evaluations on 18 November 2021 and concluded that all emergency authorisations were justified. Ten Member States for which the emergency authorisations were assessed in 2021 meanwhile granted again one or more emergency authorisations for the use of imidacloprid, thiamethoxam, clothianidin on sugar beet for the 2022 growing season and 3 additional Member States also granted such emergency authorisations.

The Commission therefore sent on 19 December 2022 a further mandate to EFSA to assess the justifications for emergency authorisations for the use of certain neonicotinoids in sugar beet during the 2022 growing season. This mandate includes as well a request to develop new fit-for-purpose protocols to assess such justifications.

Following the ruling by the European Court of Justice of 19 January 2023 in Case C-162/21, the Commission will withdraw its request to EFSA for the assessment of the justifications for emergency authorisations for the use of neonicotinoids in sugar beet during the 2022 growing season as Member States cannot grant these emergency authorisations anymore.

The Commission and the Member States are analysing and discussing possible wider implications of the ruling – in this context an informal technical meeting between the Commission and Member States was held on 13 February 2023. Please see the Summary Report.

Maximum Residue Levels for the neonicotinoid substances clothianidin and thiamethoxam

Further information on Commission Regulation (EU) 2023/334 amending Annexes II and V to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for clothianidin and thiamethoxam can be found here.