United Kingdom has withdrawn approval of the active substance mepanipyrim, ending its use in pesticide and plant protection products across all categories.
UK Withdraws Approval for Mepanipyrim Pesticides
Sales must stop by Jan 2027 and use by Jan 2028.
What changed
Approval withdrawn for all mepanipyrim-based pesticides, herbicides, and fungicides.
Sales and supply banned after 31 January 2027.
Use and disposal banned after 31 January 2028.
Who it affects
Importers and distributors of products under HS codes 380820 and 380892 must stop sales by Jan 2027.
Farmers and agricultural users must finish using existing stocks by Jan 2028.
Key dates
Compliance Answer: Withdrawal of Mepanipyrim Approval in Great Britain
The Health and Safety Executive (HSE) has decided to withdraw the approval of mepanipyrim as an active substance in plant protection products (PPPs) in Great Britain (GB). This decision is grounded in assimilated Regulation (EC) No 1107/2009 ("the Regulation") and follows a review triggered by new scientific evidence, particularly concerning endocrine-disrupting (ED) properties in humans. Below is a structured breakdown of the regulatory process, reasons for withdrawal, and compliance obligations.
1. Legal Basis and Approval Criteria
Mepanipyrim is regulated under assimilated Regulation (EC) No 1107/2009, which requires active substances in PPPs to meet Article 4 approval criteria. These include:
- No unacceptable risks to human/animal health or the environment1.
- Endocrine disruption (ED) exclusion criterion: Substances meeting ED criteria for humans or non-target organisms (e.g., wild mammals) via oestrogen, androgen, or steroidogenesis (EAS) modalities are prohibited1.
- Representative use: At least one authorised use must be demonstrated1.
The HSE’s review concluded that mepanipyrim fails to meet these criteria due to its ED properties and high long-term risks to mammals1.
2. Reasons for Withdrawal
The HSE’s decision is based on:
- Endocrine Disruption in Humans
- Mepanipyrim meets the ED criteria for EAS modalities (oestrogen, androgen, steroidogenesis) in humans1.
- Adverse effects were observed in three species (rats, dogs, rabbits) at doses below the maximum tolerated dose (MTD), with a plausible link to endocrine activity.
- The HSE aligned its conclusion with the EU’s 2024 non-renewal decision (Regulation (EU) 2024/1217), which identified the same risks1.
- High Long-Term Risk to Wild Mammals
- The EU assessment highlighted a high long-term dietary risk to mammals, though the HSE deemed further assessment unnecessary given the ED concerns1.
- Lack of Mitigation Evidence
- The producer (Certis Belchim B.V.) did not submit comments or evidence to counter the risks during the review.
3. Regulatory Process and Timeline
Key Steps
- EU Non-Renewal (20 May 2024)
- HSE Review (Initiated May 2025)
- The HSE proposed withdrawal to Defra and Devolved Governments, who consented to the decision.
- The review focused on ED properties in humans and concluded that approval criteria were not met.
- Decision (Date:1)
- HSE formally withdrew mepanipyrim’s approval in GB.
- The GB Approvals Register will be updated to reflect this.
Grace Periods for Compliance
Under Article 21(7) of the Regulation, existing authorisations must be phased out with the following deadlines (to be confirmed in the final decision):
| Activity | Deadline | Regulation Reference |
|---|---|---|
| Sale/distribution of PPPs | 1 | Article 21(7) |
| Disposal/storage/use | 1 | Article 21(7) |
Note: Exact dates will be published by the HSE.
4. Compliance Obligations
For Authorisation Holders
- Withdrawal of Authorisations: All PPPs containing mepanipyrim must be withdrawn from the GB market.
- Grace Period Adherence: Stocks may be sold/distributed until the first deadline and used/disposed of until the second deadline.
- No New Authorisations: No new PPPs containing mepanipyrim can be authorised in GB.
For Users (Farmers/Growers)
- Cessation of Use: Mepanipyrim-based products must not be used after the final grace period deadline.
- Stock Management: Existing stocks must be disposed of or stored in compliance with the grace period.
5. Summary Table: Key Requirements
| Regulation | Key Requirement | Deadline/Threshold | Authority |
|---|---|---|---|
| Assimilated Regulation (EC) No 1107/2009 | Active substances must meet Article 4 approval criteria (no ED properties, no unacceptable risks)1. | N/A | HSE |
| Article 4(3)(c) | Substances meeting ED criteria for humans (EAS modalities) are prohibited1. | Immediate withdrawal | HSE |
| Article 21(1) | HSE may review and withdraw approvals if new evidence emerges1. | Review initiated May 2025 | HSE/Defra |
| Article 21(7) | Grace periods for sale/distribution and disposal/use of existing stocks. | 1 (TBC) | HSE |
Summary Answer
The HSE has withdrawn approval for mepanipyrim in GB under assimilated Regulation (EC) No 1107/2009, citing its endocrine-disrupting properties in humans (EAS modalities) and failure to meet Article 4 approval criteria1. The decision aligns with the EU’s 2024 non-renewal (Regulation (EU) 2024/1217)1. Existing authorisations must be withdrawn, with grace periods for sale/distribution and disposal/use to be confirmed by the HSE. No new PPPs containing mepanipyrim can be authorised in GB. The withdrawal reflects a precautionary approach to human health risks, as further assessment of mammalian risks was deemed unnecessary. All stakeholders must comply with the grace period deadlines once published.
Sources
- ↩ WTO TBT notification 26-02482 — United Kingdom https://members.wto.org/crnattachments/2026/TBT/GBR/26_02482_00_e.pdf