Commission declines to renew buprofezin approval over thyroid endocrine concerns

The European Commission has decided not to renew the approval of the active substance buprofezin, an insecticide widely used in plant protection products, after the European Food Safety Authority concluded that it meets the criteria for identification as an endocrine disruptor for the thyroid in humans. The decision is contained in Commission Implementing Regulation (EU) 2026/2517 of 12 November 2026, published in the Official Journal of the European Union on 13 November 2026, and it obliges Member States to withdraw existing product authorisations.

The substance had been authorised at EU level since Commission Directive 2011/6/EU of 20 January 2011 included it in Annex I to Council Directive 91/414/EEC, and it was subsequently carried over to Part A of the Annex to Implementing Regulation (EU) No 540/2011. Its approval, repeatedly extended, was due to run until 15 March 2027 under Implementing Regulation (EU) 2026/2348 of 23 October 2026; the Commission argues that because the non-renewal decision has arrived ahead of that date, the new regulation should apply earlier.

The renewal file was handled by Italy as rapporteur Member State and Austria as co-rapporteur. Their draft renewal assessment report, submitted to the Authority and the Commission on 9 September 2021, had initially proposed renewing the approval.

Thyroid disruptor finding

In its conclusion of 16 April 2025, published in the EFSA Journal (2025;23(4):9392), the Authority held that buprofezin meets the criteria to be identified as an endocrine disruptor for the thyroid (T)-modality for humans, and that it had not been demonstrated that human exposure under realistic conditions of use is negligible. The assessment of endocrine-disrupting properties for non-target organisms other than mammals could not be carried out for lack of relevant data.

Residues, bees and aquatic life unresolved

The Commission’s text lists further gaps that prevented the risk assessment from being completed:

• Consumer risk from potential residues present in honey and in succeeding crops.
• Risks for bees and other non-target arthropods for uses in non-permanent greenhouses.
• Risk for aquatic organisms.

The applicant submitted comments on both the Authority’s conclusion and the renewal report; the Commission says these were examined but did not remove the concerns. It therefore concluded that the approval criteria of Article 4 of Regulation (EC) No 1107/2009 are not met for at least one representative use, and declined renewal under Article 20(1)(b) of that regulation.

Withdrawal deadlines and grace periods

The renewal report and the draft regulation were presented to the Standing Committee on Plants, Animals, Food and Feed on 10 December 2025, and the measures adopted are in line with its opinion. The operative provisions set out:

• Article 1: the approval of buprofezin is not renewed.
• Article 2: row 320 on buprofezin is deleted from Part A of the Annex to Implementing Regulation (EU) No 540/2011.
• Article 3: Member States must withdraw authorisations for plant protection products containing buprofezin by 3 June 2027.
• Article 4: any grace period granted under Article 46 of Regulation (EC) No 1107/2009 must expire by 3 December 2027.
• Article 5: the regulation enters into force on the twentieth day following publication, that is 3 December 2026.

The Commission classified the concerns for human health, animal health and the environment as serious but not immediate within the meaning of Article 20(2) of Regulation (EC) No 1107/2009, which is why national authorities retain room to phase out uses. The regulation, adopted in Brussels on 12 November 2026 and signed for the Commission by its President Ursula von der Leyen, is binding in its entirety and directly applicable in all Member States, with EEA relevance.

What it means

The decision removes one of the last EU-level approvals for a chemistry that several national regulators had already flagged, and it opens a two-stage calendar for the sector: authorisations fall by mid-2027 and any remaining use ends by the close of that year. For farmers, it means finding alternatives for the crops and greenhouse uses concerned, while manufacturers and distributors face the cost of reformulating or withdrawing products from a market of 27 Member States in little more than eighteen months.

Source: Official Journal of the European Union (OJ L), 2026/2517, 13 November 2026, p. 1 (official reference: Implementing Regulation (EU) 2026/2517; ELI: http://data.europa.eu/eli/reg_impl/2026/2517/oj).