Last week, the European Commission decided not to renew the approval of the neonicotinoid active substance thiacloprid.

The insecticide, which is manufactured by Bayer, is used for aphid control on some field vegetable crops, as well as in orchards. The active is found in products such as Calypso and Biscaya, but overall sales volumes of these products in Ireland are low.

Dates for the final use of products containing the active were announced this week and are as follows:

  • Last date of sale by the authorisation holder (Bayer) is 3 August 2020.
  • Last date of sale by those other than the authorisation holder is 3 November 2020.
  • Last date of use is 3 February 2021.

    • Thiacloprid is an ingredient of and insecticide to control rosy apple aphid in apples.

    Neonicotinoids, commonly referred to as neonics or NNIs are active substances used in plant protection products to control harmful insects. This group of actives has drawn much criticism over the past decade due to their endocrine disruption properties and the potential risk to bees.

    Useful facts about neonicotinoids

    Below are some useful facts about the actives:

  • Neonicotinoid literally means "new nicotine-like insecticides". They are chemically similar to nicotine.
  • The first neonic was approved in the EU in 2005.
  • Neonics are systemic pesticides. They differ significantly from contact pesticides, which remain on the surface of the treated parts of plants, ie the 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 such as insects, than they are to mammals, birds and other larger organisms.
  • They affect the central nervous system of insects, leading to eventual paralysis and death.
  • Neonics are also common in veterinary applications, such as tick control and flea collars for pets.

    • A focus on bees

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

    Bee populations have been under pressure in recent years.

    As readers will know, the EU has one of the strictest regulatory systems in the world in relation to the approval of pesticides. All pesticides on the market must go through thorough assessment to ensure a high level of protection of both human and animal health and the environment.

    By their very nature, insecticides are toxic to bees. However, the European Commission states that their use should still be possible if exposure does not occur or is minimised to levels which do not generate harmful effects.

    Within the EU, regulation (EC) No 1107/2009 provides clear criteria for the approval of active substances, including criteria in relation to honey bees. It requires a fact-based approach and appropriate risk assessment of any active substance. They can be approved only if their use:

  • Will result in a negligible exposure of honeybees, or
  • Has no unacceptable acute or chronic effects on colony survival and development.

    • When this framework was adopted, the Commission laid down new "data requirements" for pesticide dossiers.

    The dossiers for active substances and plant protection products have to comply with these minimum data requirements. This significantly strengthened the authorisation process for plant protection products, including several new requirements regarding bees.

    Neonicotinoids under scrutiny in the EU

    In 2012, new scientific findings indicated that some insecticides showed high risks for bees. These were Fipronil (this pesticide was reviewed by European Food Safety Authority and was subsequently subject to restrictions) and neonics.

    As a result, in 2013, the Commission severely restricted the use of plant protection products and treated seeds containing three of these neonics (clothianidin, imidacloprid and thiamethoxam) to protect honeybees. Clothianidin was a key ingredient in the seed dressing Redigo Deter.

    The seed dressing Redigo Deter was an important tool for aphid and BYDV control for Irish growers.

    This measure was based on the European Food Safety Authority’s (EFSA) risk assessment in 2012. It prohibited the use of these three neonics 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.

    Maize was deemed to be a 'bee-attractive' crop.

    At the same time, the applicants of the three actives were obliged to provide further data (so-called "confirmatory information") for each actives 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.

    Outdoor ban

    Therefore, in 2017 the Commission prepared proposals to completely ban the outdoor use of these three active substances.

    In the meantime, the EFSA evaluated data collected in an open call for the review of the 2013 restrictions for the three neonics.

    In actual fact, the deadline for this evaluation was postponed until 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 EU Commission maintained their proposals to completely ban the outdoor uses of the three active substances based on the EFSA conclusion.

    The EFSA conclusions on the risk assessment for the three active substances concluded that they confirm the already identified risks for their outdoor use.

    Therefore, the Commission maintained their proposals to completely ban the outdoor use of the three active substances and these were subsequently supported by a qualified majority of member states on 27 April 2018.

    As a result, all outdoor use of the three substances are banned and only the use in permanent greenhouses remains possible.

    Renewal of approval

    In the light of these restrictions, the applicants for the renewal of approval of clothianidin and thiamethoxam withdrew their applications. The approval of these substances then expired on 31 January 2019 and 30 April 2019 respectively.

    The deadline for submission of the renewal dossier for imidacloprid is 31 January 2020 and the expiry date for imidacloprid is 31 July 2022.

    Not all bad news

    The neonic acetamiprid was deemed by the EFSA to be a low risk to bees. The active is used mainly in household garden products.

    Acetamiprid is used mainly in household garden products.

    A ban or further restrictions of this substance was deemed to be neither scientifically nor legally appropriate.

    A draft regulation proposing a renewal of approval until February 2033 was presented to the member states in October 2017. The committee gave a favourable opinion on the draft regulation with a qualified majority of member states.

    Fifth neonicotinoid gone

    The fifth neonicotinoid registered in 2013, thiacloprid, was a candidate for substitution, based on its endocrine disrupting properties.

    Candidates for substitution are pesticides for which national authorities need to carry out an assessment to establish whether more favourable alternatives to using the active exist, including non-chemical methods.

    Thiacloprid is a neonicotinoid insecticide to control aphids in broccoli and a number of other field vegetables.

    The approval for thiacloprid is due to expire on 30 April 2020. Based on the EFSA conclusion, which was published at the beginning of 2019, the commission had proposed to the member states in the regulatory committee not to renew the approval.

    On 22 October, the committee gave to this proposal a favourable opinion with a qualified majority of member states. The commission adopted the regulation on 13 January 2020.

    Emergency authorisation

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

    In particular, Romania, Bulgaria, Lithuania, Hungary, Finland, Latvia and Estonia applied for multiple derogations on major crops since the entry into force of the restrictions of use.

    The Commission had been closely monitoring this issue and mandated the EFSA to examine the emergency authorisations granted in 2017 by the member states who repeatedly granted them before.

    The EFSA assessed whether the repeated use of these emergency authorisations was justified because of a danger which could not be contained by any other reasonable means.

    The EFSA found that for about one third of the products for which emergency authorisations were granted, alternatives would have been available.

    Several Member States repeatedly granted emergency authorisations for some of the restricted uses of the three neonics in 2013.

    The Commission requested the member states involved to commit not to repeat the granting of the emergency authorisations in question, which two of the four accepted.

    In the light of the outcome of the assessment by EFSA and the reaction of the member states concerned, the Commission proposed decisions requiring Romania and Lithuania not to grant emergency authorisation for the uses of these neonicotinoids for future seasons to the member states in the regulatory committee.

    The votes on the draft on 22 October 2019 resulted in no opinion, meaning that there was insufficient support from the member states for the adoption of the decisions.

    Votes in the appeal committee on 25 November 2019 also resulted in no opinion. The Commission is currently reflecting on the next steps.

    Redigo Deter was a vital seed dressing for Irish growers.

    In June of 2019, the IFA lodged an application for emergency authorisation of Redigo Deter (containing clothianidin) seed dressing. The emergency authorisation was not granted.

    Information obtained from the European Commission plant website.

    Read more

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    Emergency authorisation request for Redigo Deter seed dressing rejected

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