Call for data for finalising the risk assessment for bees linked to outdoor uses of thiacloprid

Published:

17 veebruar 2026

Deadline:

20 aprill 2026 - 23:59 (CEST)

Ongoing

Background

In 2019, EFSA finalised the peer review for the renewal of thiacloprid under Regulation (EC) No 1107/2009. Critical concerns were identified for representative uses, and the assessment of the risk to bees could not be concluded due to lack of data. As the approval criteria were not met, thiacloprid was not renewed in the EU, and all authorisations were subsequently withdrawn.

Following the non renewal, the Commission requested EFSA to perform a targeted risk assessment of MRLs based on Codex MRLs and import tolerances. Although no acute consumer risk was identified, this assessment relied on toxicological reference values established before the adoption of current criteria for endocrine disruptors. On this basis, Commission Regulation (EU) 2024/2711 provisionally lowered all MRLs to the limits of determination (LOD).

In line with the SPS Agreement, following the adoption of provisional measures, it is necessary to seek to obtain additional information to enable their reassessment. Therefore, in addition to revising the toxicological reference values for thiacloprid and updating the consumer risk assessment, it is necessary to complete the evaluation of the risk to bees, which remained outstanding since the 2019 peer review conclusion and must now be conducted using the most recent data for all uses concerned.

As additional data may have become available since 2019, it is necessary to launch a Call for Data open to all stakeholders (including all relevant interested parties).

Overall objective

The objective of this call for data is to gather documented information—published, unpublished, or newly generated—relevant to the risk assessment of chronic effects on bee larvae resulting from exposure to thiacloprid. EFSA invites contributions from all interested parties (including business operators, national food authorities, research institutions and academia, NGOs, advocacy groups, and any other stakeholders) with relevant data.

Previous risk assessment for bees

For the peer review for the renewal of the approval of thiacloprid (EFSA, 2019), the available dataset included acute toxicity data for honey bees, chronic toxicity data for adult honey bees, acute toxicity data for honey bee larvae, and some limited information for adult bumble bees. Quantitative risk assessments were conducted only for acute effects. For other areas, qualitative assessments were available, but these were associated with considerable uncertainty. Therefore, the risk assessments for the chronic effects could not be finalised.

Specific objective

Since a relevant chronic study for adult honey bees and thiacloprid is already available, the only missing toxicity endpoint required for quantitative chronic risk assessment is a chronic laboratory study on bee larvae.

EFSA therefore seeks laboratory toxicity study(ies) on bee larvae with a chronic exposure regime, conducted according to, or in a manner equivalent to, OECD Guidance Document No. 239. These studies should generate toxicity endpoints (e.g., EDx, NOED) related to brood development and emergence to adult, expressed as mass of test substance per larva per developmental period, which is the appropriate metric for risk assessment.

Data on honey bees (Apis mellifera) are particularly valuable; however, studies on other bee species—including non-European species—may also be considered relevant.

Deadline for submission of data

Interested parties and stakeholders should submit data by 20/04/2026 complying with the information described in this call.

Confidentiality

In order to comply with its requirements for proactive transparency, EFSA must, inter alia, make public the information on which its scientific outputs are based, as outlined in Article 38(1)(d) of Regulation (EC) No 178/2002, the “General Food Law” (GFL) and Article 6(1)(i) of EFSA’s Practical Arrangements concerning transparency and confidentiality (“EFSA’s Practical Arrangements”). Information/data received in the context of the present call are subject to the afore-mentioned proactive transparency requirements insofar as they will constitute information on which scientific outputs, including scientific opinions, are based.

However, in accordance with Articles 39-39e of the GFL confidential status may be awarded to information the disclosure of which might potentially harm the information owner to a significant degree. Provided that the conditions set out in Articles 39-39e and further detailed in EFSA’s Practical Arrangements are satisfied, EFSA must not make public any information/data for which confidential treatment has been requested and duly justified pending its confidentiality assessment where urgent action is essential to protect human health, animal health or the environment.

As mentioned above, EFSA’s proactive transparency obligations require publication of any data used in EFSA’s Scientific Outputs. To ensure compliance with EFSA’s transparency requirements and avoid possible disclosure of confidential information interested parties may claim:

1. Confidentiality Requests for Personal Data and CBI

If your submission includes Personal Data (e.g. name and surname, email address) or Confidential Business Information (CBI) (e.g. commercial links to producers, information revealing sourcing, market shares or business strategy, the manufacturing/production process), please:

Submit via Portalino both a confidential version (in which confidential information has been earmarked but remains visible) and a non-confidential version (in which confidential information has been irreversibly redacted) of the completed form.
Submit via Portalino a separate confidentiality request for each part of your data that you want to claim confidential, using applicable legal grounds listed below.

You may claim confidentiality provided that:

i.    the information falls within the scope of the closed list of information items listed in the Annex to EFSA’s Practical Arrangements and
ii.    the confidentiality request is accompanied by a verifiable justification that demonstrates how the public disclosure of the information/data for which confidential status is requested would harm your interests to a significant degree.
iii.    When claiming confidentiality for some of the information/data, both a non-confidential (public dissemination) and a confidential version of the information/data must be submitted as indicated here. A separate confidentiality request must be submitted for each document and for each legal ground under which information is claimed confidential. A precise description of the information/data claimed confidential must be provided to enable a clear identification and the information/data claimed confidential must be earmarked in the confidential version and redacted in the non-confidential version.

For submissions which do not contain any confidential information, only a non-confidential (public dissemination) version has to be uploaded to Portalino. Additional information can be found in the User Guide on Confidentiality.

2. Portalino Registration Process
To submit data via Portalino, follow these steps:
1.    Register in Connect.EFSA using this form
2.    Create a profile in Portalino by sending an email to servicedesk [at] efsa.europa.eu with the following info:
a.    scope: Call for data on Bee Exposure to Thiacloprid
b.    full name, business/personal email
c.    in the heading of the email please insert: Call for data on Bee Exposure to Thiacloprid

Note: Registration may take a few days, so we encourage you to start the process immediately to meet the deadline. When accessing Portalino, you will use the email and log-in info created by EFSA during the steps above (e.g. ending with “@net.efsa.europa.eu”).

Submission of information/data

Interested business operators and/or parties should submit the information/data in electronic format exclusively via the tool Submission Builder “Portalino”.

Submission of data in any other form (email, third party e-submission platforms, etc) will not be accepted.
Interested business operators and/or interested parties should submit the following information to EFSA via Portalino, clearly stating:
• in the Subject of the submission: Call for data on Bee Exposure to Thiacloprid
• The contact details (name of contact person, name of company/organisation, e-mail address and telephone number) of the person responsible for the data submission and, if applicable, the list of interested business operators and/or interested parties represented and their contact details.

Information on how to use Portalino is available here.

Please note that EFSA may, where legally possible, use or re-use relevant information or data (e.g., technical, toxicological data) for the assessment of the same or another substance/topic under the same or a different legal or regulatory framework from the one mentioned above.

Correspondence

Please address any enquiries to RAL [at] efsa.europa.eu.