Revised EU Data Rules Set to Reshape Active Substance Approvals for Plant Protection Products
The EU is updating data requirements for active substances in plant protection products, raising safety standards and regulatory expectations.
Plant Protection Products Regulation authorisations in Northern Ireland are required to align with the relevant EU MRLs, as per the European Union's regulatory frameworks. The EU's MRL review program frequently updates these levels, which can affect the compliance status of certain PPPs. The current bulletin provides an overview of the status of ongoing and upcoming reviews of these MRLs.
February 2024 SCoPAFF Meeting: Key MRL Amendments
During the February 2024 meeting of the EU Standing Committee on Plants, Animals, Food and Feed (SCoPAFF), amendments to MRLs were agreed upon for several active substances under Regulation (EC) No 396/2005. The substances affected include:
- Deltamethrin
- Metalaxyl/metalaxyl-M
- Thiabendazole
- Trifloxystrobin
- Dithianon
The new MRLs for dithianon are expected to be implemented on 5 December 2024, with the other substances' MRLs coming into force on 11 December 2024.
April 2024 SCoPAFF Meeting: Additional MRL Revisions
In April 2024, SCoPAFF further discussed amendments to MRLs for several other active substances. Should these changes pass the scrutiny of the European Parliament and Council, the corresponding EU Implementing Regulations will be published in the next 4-6 months. The affected substances include:
- Benomyl
- Carbendazim
- Thiophanate-methyl
- Cyproconazole
- Spirodiclofen
- Napropamide
- Pyridaben
- Tebufenpyrad
These new MRLs are anticipated to be enforced by early to mid-2025.
Implications and Guidance for NI PPP Authorisation Holders
HSE will review NI PPP authorisations to determine which ones may require amendments or withdrawals due to the new EU MRLs and will notify the affected authorisation holders. PPP holders in Northern Ireland are advised to check their authorisations against the updated EU MRLs to ensure compliance. It is also recommended that they consult the European Food Safety Authority’s opinions for any missing data or information necessary to maintain MRLs following the EU reviews.
Next Steps
Authorisation holders should review the EU MRL database to confirm their products meet the latest standards. If discrepancies are found, it is crucial to contact HSE promptly. Those wishing to retain their MRLs should submit the required data to an EU Member State by the specified deadlines.
For additional guidance on submitting data to confirm EU MRLs, PPP authorisation holders are encouraged to refer to the resources provided by HSE and the EU.
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