Neonicotinoids

In recent years, neonicotinoids have come under the spotlight. They have been linked to the death of bees, they are subject to restrictions, and some people believe that they should all be banned. What are neonicotinoids, which restrictions are they subject to, and what is the future of these substances? We try to answer these and other questions below. The following are the questions we will address:

  1. What are neonicotinoids?
  2. Which neonicotinoids are approved in the EU?
  3. Which restrictions are imposed on neonicotinoids to protect bees in the EU?
  4. Why did Belgium not vote for the latest proposal of the European Commission?
  5. Why were the same restrictions not imposed on all neonicotinoids?
  6. Will the approvals granted to neonicotinoids be renewed?
  7. What about the so-called 120-day authorisations (emergency authorisations) for neonicotinoids?
  8. Is the EFSA guidance document used to assess the effects on bees?

1. What are neonicotinoids?

Neonicotinoids are a group of insecticides within the same chemical "family", which designates chemicals with a similar molecular structure. They block the transmission of nerve impulses by acting on a specific receptor in the nervous system of insects, the "nicotinic receptor". Their chemical structure is similar to that of nicotine. Depending on their molecular structure, we can identify the following three subgroups of neonicotinoids:

  • Nitroguanidine neonicotinoids:
    • Clothianidin
    • Dinotefuran
    • Imidacloprid
    • Imidaclothiz
    • Thiamethoxam
  • Nitromethylene neonicotinoids:
    • Nitenpyram
    • Nithiazine
  • Pyridyl methylamine neonicotinoids:
    • Acetamiprid
    • Cycloxaprid
    • Imidacloprid
    • Nitenpyram
    • Paichongding
    • Thiacloprid

As we can see, certain neonicotinoids belong to two subgroups. The Imidacloprid molecule, for example, contains both the nitroguanidine and pyridyl methylamine parts.

Neonicotinoids are sometimes referred to as a new group of insecticides, but the earliest neonicotinoids have in fact been on the market for a long time. In Belgium, Imidacloprid has already been authorised since the early 1990s.

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2. Which neonicotinoids are approved in the EU?

In the EU, plant protection products are subject to a dual procedure:

  • The active substances they contain must be approved at EU level;
  • The plant protection products themselves must be authorised at Member State level.

Our web page "Authorisation of a plant protection product" provides more information on this subject.

The following neonicotinoids are approved in the EU:

  • Imidacloprid
  • Clothianidin
  • Thiamethoxam
  • Acetamiprid
  • Thiacloprid

EU approval may include various conditions and restrictions that must be observed by Member States for the authorisation of products based on these substances. For the restrictions imposed during the approval of neonicotinoids: see question 3.

Plant protection products based on these substances are authorised in Belgium. These products can easily be found on our website (in French or Dutch), with all the details relating to the conditions of use (crops, doses, measures to limit risks, etc.).

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3. What restrictions does the EU impose on neonicotinoids in order to protect bees?

Scientific studies have shown that certain neonicotinoids can be highly dangerous for bees and other pollinators. As such, in April 2012, the European Commission commissioned the European Food Safety Authority (EFSA) to produce a risk assessment of the three most dangerous neonicotinoids (Imidacloprid, Clothianidin, and Thiamethoxam), in the form of seed treatment and in the form of granules, on bees and other pollinators. The application of treated seeds and granules can lead to the formation of dust, to which bees may be exposed.

At the start of 2013, the EFSA published its reports:

In these conclusions, the EFSA observed that in certain situations, unacceptable effects on bees cannot be ruled out.

Based on these conclusions, the European Commission, in consultation with the Member States, adopted Regulation 485/2013 in May 2013. The conditions for the approval of Imidacloprid, Clothianidin and Thiamethoxam have been strengthened.  In summary, this Regulation prescribes the following:

  • Use by private individuals has been banned, seed treatment has been restricted, the foliar treatment of most cereals has been banned, and for a whole range of crops listed, use has been restricted (only in greenhouses or after flowering). Member States had to adapt their national authorisations by 30/09/2013.
  • By the end of 2014, producers had to provide additional information which would make it possible to eliminate a range of uncertainties identified by the EFSA in the risk assessment.
  • New scientific information relevant for the risk assessment of these three substances to bees and other pollinators needed to be reviewed within two years. Often, the press incorrectly refers to a two-year "moratorium" (by which it means that the limitation is apparently provisional), whereas for the above-mentioned restrictions, no validity deadline has been set in the legislation.

In the meantime, the European Commission had also requested the EFSA to carry out a risk assessment for applications of the three neonicotinoids mentioned above, other than as seed treatment and granules. In August 2015, the EFSA published its conclusions on this subject:

In general, the uncertainties and risks identified in 2013 were confirmed. The European Commission saw no reason to change the approval conditions once again.

One of the requirements of Regulation 485/2013 was that producers needed to file additional information by the end of 2014. This information was first assessed by a Rapporteur Member State before the EFSA published its conclusions in November 2016, for imidacloprid and clothianidin at any rate, as insufficient information was provided for thiamethoxam by the deadline:

Finally, as regards the stated review within 2 years, the work proceeded as follows: the Commission requested the EFSA to organise a data call-in where everyone - Member States, producers, NGOs - had the opportunity to submit all the information they deemed relevant for the risk assessment for bees and other pollinators. The EFSA then evaluated all these data and published a new set of conclusions in February 2018:

Based on these successive sets of EFSA conclusions, the European Commission further strengthened the conditions for approval. To this end, the Commission adopted Regulations 2018/783 (Imidacloprid), 2018/784 (Clothianidin) and 2018/785 (Thiamethoxam), which prescribe that plant protection products containing one (or more) of the three neonicotinoids may only be applied to crops which, during their entire life cycle, remain in a permanent greenhouse, or on seeds that are exclusively intended for use in permanent greenhouses (the plant obtained remains in this greenhouse throughout its life cycle). Member States needed to adjust their authorisations accordingly by 19/09/2018; by 19/12/2018, farmers needed to comply with the newly introduced restrictions.

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4. Why did Belgium not vote for the latest proposal of the European Commission?

A Regulation on the approval (or non-approval) of an active substance is adopted according to the following procedure:

  • The European Commission drafts a proposal for a regulation.
  • This proposal is discussed in the Standing Committee on Plants, Animals, Food and Feed, where all Member States are represented.
  • Following discussion, the European Commission submits the proposal to the Standing Committee for a vote.
  • If a qualified majority of the Member States supports the Commission's proposal, the Commission may adopt its proposal. To obtain a qualified majority, two conditions must be met:
    • At least 16 of the 28 Member States must vote in favour; and
    • Member States that vote 'for' must represent at least 65% of the EU population (Belgium represents 2.22%).

Regulations 2018/783, 2018/784 in 2018/785, in which the European Commission imposed additional restrictions on the neonicotinoids imidacloprid, clothianidin and thiamethoxam, were submitted by the Commission, as a proposal, to the Standing Committee for a vote on 27 April 2018. The proposals obtained a small qualified majority.

Belgium abstained from this vote. By abstaining, we indicated that the proposal is not fully supported, but that our country was not opposed to the proposal per se (otherwise, we would have voted against it). Our country still unreservedly supports measures to protect the environment, and bees in particular, against the impact of plant protection products. But we believe that the European Commission's measures are falling short in their objective, and that they can ultimately have a negative impact on bee populations. In particular, seed treatment for sugar beets should remain possible. This is a plant that does not flower during the growing cycle, and does not pose any problems with guttation (the formation of droplets by the plant that can be absorbed by bees). In addition, when treating sugar beet seeds, the plant protection product is not simply applied to the seed, but integrated into a hard layer around the seed (the seed is said to be "pelleted"). This technique significantly reduces the release of the plant protection product in the form of dust during sowing. As such, the crop itself is not a source of exposure for bees. The main problem relates to crop rotation. In effect, neonicotinoids do not break down rapidly in the soil and any residue present could lead to an unacceptable level of exposure, due to absorption by a subsequent crop that is attractive to bees. In practice, sugar beets are generally followed by cereals, a crop that is not very attractive to bees. Subject to certain crop rotation conditions, it is possible to rule out an unacceptable risk.

If sugar beet growers cannot use seeds treated with neonicotinoids, they will need to apply foliar treatments with other. It is questionable whether insecticides authorised for this purpose which, unlike neonicotinoids, have not yet been assessed by the application of the EFSA guidance document on the risk assessment of plant protection products on bees (Apis mellifera, Bombus spp. and solitary bees) (see also question 8), will not, after a risk assessment in accordance with this guidance document, be more harmful to bees than seed treatments with neonicotinoids. It does not seem unlikely that this is the case. Hence our concern that the restrictions adopted by the Commission may, in some cases, have a negative impact on bee populations.

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5. Why were the same restrictions not imposed on all neonicotinoids?

In the EU, 5 active substances from the neonicotinoid group have been approved, but only 3 of these 5 substances have been the subject of restrictions to protect bees (see question 2 and question 3). Following a number of scientific publications on the toxicity of imidacloprid, clothianidin and thiamethoxam to bees and bumblebees, in 2012 the European Commission requested the EFSA to study the risks to bees relating to the use of these three substances. For acetamiprid and thiacloprid, the scientific community has not given very clear signals. Taking into account the limited resources available to the EFSA, it was therefore justified to restrict the evaluation to the most critical substances, bearing in mind that the other substances would also be re-evaluated in any event in the context of a possible application for renewal of the approval (see also question 6).

Neonicotinoids cannot be grouped together easily: their properties can vary considerably one to the next. For example, if we compare the toxicity of clothianidin to bees with that of acetamiprid:

Active substance

Clothianidin1

Acetamiprid2

LD50 acute contact toxicity

0.0258 µg/bee

9.26 µg/bee

LD50 acute oral toxicity

0.00379 µg/bee

8.85 µg/bee

Chronic toxicity (10 days)

LDD50: 0.00095 µg/bee/day

LDD50: 11.7 µg/bee/day

1Data from the EFSA Conclusion on the peer review of the pesticide risk assessment for bees for the active substance clothianidin considering the uses as seed treatments and granules

2Data from the EFSA Conclusion on the peer review of the pesticide risk assessment of the active substance acetamiprid

LD50 indicates the amount of substance in a test that leads to 50% mortality after exposure to a dose (= acute toxicity), either by contact or oral ingestion. As such, the lower the value indicated in the table, the more toxic the substance. It is clear that clothianidin is much more toxic to bees than acetamiprid, about 359 times more toxic by contact (9.26: 0.0258 = 359) and 2,335 times more toxic by oral ingestion (8.85: 0.00379).

In order to determine chronic toxicity, the substance is administered for 10 days. The conclusion is the same: clothianidin is much more toxic to bees, even with chronic administration.

In addition, both substances are used in agricultural practice with similar doses. The lower toxicity of acetamiprid is consequently not offset by a higher application dose.

Each substance must be assessed in the same way. The chemical group to which an active substance belongs is irrelevant for the assessment, since within a chemical group, the properties of individual substances can vary considerably. There is no scientific basis for assessing an entire chemical group of substances.

In this context, discussions on whether or not to include certain new active substances in the neonicotinoid group are ultimately irrelevant. Each substance must be assessed objectively and in the same way, without prejudice to the chemical group to which it belongs.

Such a debate on chemical classification has already been held, for example, for the insecticide sulfoxaflor. The acute toxicity of this substance to bees lies somewhere between that of clothianidin and that of acetamiprid. An application for authorisation of a plant protection product based on this substance has been submitted in Belgium for use in open fields and in greenhouses. The application was assessed by the Belgian authorities and an authorisation was granted, but only for treatments in greenhouses. This restriction was imposed because it was not convincingly demonstrated that the exposure of bees and other pollinators in fields is low enough to conclude that the risk is acceptable.

Fipronil is also sometimes mentioned in the same breath as neonicotinoids, as it was subject to the same restrictions as certain neonicotinoids at EU level in 2013. However, Fipronil is not a neonicotinoid; it is a phenylpyrazole insecticide. This substance is currently no longer approved in the EU.

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6. Will the approvals granted to neonicotinoids be renewed?

Active substances are approved at EU level for a certain period of time, after which the approval may be renewed following a re-assessment; this period is generally 10 years for an initial approval and 15 years in the event of a renewal of an approval. Regular re-assessment makes it possible to take new developments into account:

  • The legal requirements pertaining to data (i.e. the studies that the applicant must include in their application) were adapted in 2013 and the application is now different from what it was 10 years ago;
  • New guidance documents have been elaborated since the previous assessment; these guidance documents are based on the most recent scientific knowledge and allow for a more accurate risk assessment;
  • The scientific literature published since the last assessment is taken into account.

In summary, the renewal procedure is as follows:

  • The producer submits an application to a Member State designated by the European Commission as Rapporteur Member State (RMS);
  • The RMS prepares a draft renewal assessment report (dRAR);
  • The EFSA organises a peer review of the dRAR (all Member States and stakeholders are invited to comment on the dRAR, usually followed by one or more expert meetings);
  • The EFSA drafts a conclusion.

Since the initial approval, the approval of one of the neonicotinoids has already been renewed, namely acetamiprid. The approval of this substance was extended to 28/02/2033 by Regulation 2018/113. Member States are now required to re-assess all plant protection products containing this substance. In so doing, they need to pay particular attention to a number of aspects of the application of Regulation 2018/113, including the risk to bees. However, it was not considered necessary to impose a restriction to protect bees (see also question 5).

As regards thiacloprid, the EFSA's assessment of the request for renewal of approval is still ongoing. The current approval is valid until 30/04/2019. If, for reasons beyond the applicant's control, an approval is likely to expire before a renewal decision has been taken, the European Commission will provisionally extend the approval for a long-enough period to take the decision (Article 17 of Regulation 1107/2009 concerning the placing of plant protection products on the market). It appears that such an extension will be necessary for thiacloprid. One of the most problematic aspects of this substance is its classification as a reproductive toxicant, category 1B (Known or presumed human reproductive toxicant), under Regulation 1272/2008 on classification, labelling and packaging of substances and mixtures. A substance with such a classification can only be approved in accordance with Regulation 1107/2009 if human exposure, under realistic conditions of use, is negligible or if it is demonstrated that the substance is necessary to control a plant health hazard that cannot be controlled by other means. The dRAR is already available for this substance.

As regards the other three approved neonicotinoids:

  • Imidacloprid is still approved until 31/07/2022;
  • Clothianidin is approved until 31/01/2019; the EFSA has received the dRAR from the RMS, but it has not yet been published; it seems likely that a provisional extension of the approval under Article 17 of Regulation 1107/2009 will be necessary;
  • Thiamethoxam is approved until 30/04/2019; the situation is comparable to that of clothianidin.

At present, it is impossible to predict what the final decision will be after the assessment of these substances. The decision may be to no longer approve the substance, or to lift the restrictions currently in place.

It should be noted that the approval of a substance may be reviewed at any time in the light of new scientific and technical knowledge (Article 21 of Regulation 1107/2009). As such, the fact that a substance has been approved for a period of 10 or 15 years does not mean that action can't be taken during this period. In addition, it was under this Article 21 that the European Commission requested the EFSA to carry out the assessments that led to the restrictions.

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7. What about the so-called 120-day authorisations (emergency authorisations) for neonicotinoids?

Member States of the European Union are authorised to grant emergency authorisations for plant protection products which have not been subject to the normal authorisation procedure. These are valid for a period of 120 days and therefore only offer a temporary solution. However, this is only possible if there is no other reasonable method to protect plant production, i.e. to protect agriculture from pests or weeds, against which no authorised plant protection products are available. A complete list of all Belgian emergency authorisations can be found here.

As explained in question 4, sugar beet production is threatened by the loss of neonicotinoids and there is no exposure to bees if the subsequent crops do not flower or are not visited by bees. Since the ban will lead to the use of other plant protection products, there is a concern that this could have a negative effect on bees. This also applies to the treatment of lettuce and carrot seeds. Lettuce is sown indoors and planted in pressed clods. Carrot seeds are robustly pelleted. As such, there will be little or no dust formation during sowing. In addition, these cultures produce very little liquid by guttation.

An emergency authorisation will only be granted by Belgium after an assessment of all available data. As many measures as are necessary will be imposed to limit the identified risks. In this case, the risks therefore only relate to the exposure of bees, since all other possible risks (e.g. for birds or consumers) have already been assessed when authorising the plant protection products in question.

Given these circumstances, the 'Committee for the approval of pesticides for agricultural use' has given an agreement for an emergency authorisation for sugar beet (thiamethoxam or clothianidin), carrots (thiamethoxam) and lettuce (thiamethoxam), provided that guarantees can be given regarding the absence of subsequent crops or - between crops - green fertiliser that flowers and is attractive to bees. As such, only cereals (except maize) and any crops harvested before flowering are acceptable as a subsequent crop. After two years, when the concentrations of neonicotinoids in the soil have decreased significantly, crops that flower but are unattractive to bees - such as potatoes and corn - are acceptable. The regional authorities are able to provide the necessary guarantees to this end.

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8. Is the EFSA guidance document used to assess the effects on bees?

Scientific or technical guidance documents are often used to evaluate studies carried out with plant protection products and their active substances. In effect, studies can be highly complex, and evaluating them is no simple task. It is also important that all Member States evaluate the studies in the same way. That is why guidance documents are drawn up, which explain in detail how applications should be prepared by applicants and how studies should be evaluated by Member States.

A guidance document is normally only used for the risk assessment of active substances and plant protection products after the Standing Committee on Plants, Animals, Food and Feed has taken note of it. On this occasion, it is determined from which date applications will be assessed with the application of the guidance note. This is important for reasons of predictability and harmonisation, and to allow manufacturers to produce and submit the necessary data.

In 2013, the EFSA published a Guidance Document on the Risk Assessment of Plant Protection Products on Bees (Apis mellifera, Bombus spp. and solitary bees). When the European Commission proposed that the Standing Committee took note of this guidance document, a relatively large number of Member States were opposed. They believed that this guidance document sets the bar at an unrealistic level, and that consequently, substances that are not of concern to bees would be wrongly identified as posing a risk to bees, by applying the guidance document. More than five years after the publication of the EFSA guidance document, the Standing Committee has still not taken note of it. The Commission is currently seeking a solution by proposing a gradual application of the guidance document.

When the Commission asked the EFSA in 2012 to carry out an in-depth risk assessment of the three neonicotinoids on bees (see question 3), the EFSA's guidance document was not yet available. However, the main lines of the guidance document had already been set out in preparatory document produced by the EFSA (Scientific Opinion of the Panel on Plant Protection Products and their Residues on a request from the European Commission on the science behind the development of a risk assessment of plant protection products on bees (Apis mellifera, Bombus spp. and solitary bees)). In 2012, the Commission asked the EFSA to use this document as a basis for risk assessment. For subsequent sets of conclusions, the European Commission explicitly requested the EFSA to use its guidance document which had been published in the meantime.

Until the EFSA guidance document from 2013 is taken note of, the Guidance Document on terrestrial ecotoxicology will in principle remain applicable for the evaluation of bee studies. This document dates from 2002 and was prepared by the European Commission in cooperation with the Member States. Less than three pages were devoted to a risk assessment for apiculture (the EFSA guidance document has 268 pages...). It is impossible to adequately evaluate all the studies that need to be provided under the current data requirements. Chronic toxicity, for example, is not addressed. It is therefore understandable that the Commission has requested the EFSA to apply its guidance document to assess neonicotinoids, although the Standing Committee has not yet taken note of it.

On the other hand, it should be acknowledged that the application of the EFSA guidance document requires the availability of a whole range of studies, including field studies. Producing these studies requires a lot of time. Many of these studies were not available when the Commission requested the EFSA to apply the 'Scientific Opinion of the Panel on Plant Protection Products and their Residues on a request from the European Commission on the science behind the development of a risk assessment of plant protection products on bees (Apis mellifera, Bombus spp. and solitary bees)' in 2012. Indeed, at the time, the legal requirements regarding the data to be provided did not prescribe all these studies. These circumstances led the EFSA to conclude in its 2013 conclusions that, due to a lack of adequate studies, risk could not be ruled out in many situations. For the subsequent sets of conclusions, even if a more significant number of studies were available, the EFSA observed once again that the risk assessment could not be finalised for certain situations, as there was still a lack of studies. It is possible that producers did not have enough time to carry out all the studies, or that the research organisations that could conduct such studies had insufficient capacity. In any event, the restrictions imposed on neonicotinoids by the European Commission in 2018 (see question 3) are partly due to the uncertainty resulting from the absence of certain studies, and not always from the identification of a proven risk.

The Belgian authorities believe that it is necessary to apply at least part of the EFSA guidance document in the national authorisation procedure for plant protection products. A document explains how we address this question.

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