Update from the Chair of the Southern Zone Steering Committee
At Kerona’s Dublin Plant Protection Product Symposium in November 2023, we welcomed Dr Danae Pitarokili, Chair of the Southern Member States (SMS) Steering Committee, and Head of the Department of Plant Protection Products of the Hellenic Ministry of Rural Development and Food in Athens.
In 2023, the SMS issued an updated guidance for PPP applications which gathers important information for involved stakeholders. Spain co-ordinated this project, and the updated parts are Appendix II (Contact Points) and Appendix IV (National requirements of the SMS). The national requirements were already in force before the updated guidance, but now they are also collected in a single document for easier accessibility. The guidance document can be found on the CIRCABC website:
Danae focused on Art. 34 applications, as the SEU has not managed to reach a harmonisation in this area. She listed the most important items to remember when submitting an Art. 34 application:
- A single PPP must be used as a reference product, which must have been authorised according to Uniform Principles and the Registration Report (RR) should be available. This reference product should not be part of an ongoing Art. 43 evaluation.
- The active substance(s), any safeners or synergists contained in the PPP should not have been affected by the publication of new legislation or EFSA / ECHA opinions regarding their toxicological reference values or classification after the authorisation of the reference product.
- Guidance Document SANCO 12638/2011, 20 November 2012 rev.2, can be used for the comparison of the composition of the applicant’s formulation with the reference product.
- France, Spain, Malta, and Italy do not allow the authorisation of PPP under Art. 34 when there are significant differences, while Bulgaria, Greece, and Croatia, could potentially allow the authorisation if additional phys-chem, and efficacy data are submitted for the evaluated PPP, which prove comparability.
Efforts for harmonisation are also being made in relation to the data requirements and risk assessments on honeybees for the transitional period (until most recent EFSA Guidance on the risk assessment of PPP on bees is fully applicable). Even though the SMS have agreed to use the SANCO guidance for the Acute Risk Assessment to bees, there are still ongoing discussions about the Chronic Risk Assessment. For the latter, most SMS have accepted the EPPO Scheme (2010) and the EFSA Guidance of 2013, but the final update on the matter is still pending.
For further details, a copy of the full presentation is available from the publications page at https://kerona.ie/product/dublin-ppp-symposium-2023-speakers-presentations/
If you need regulatory support with PPPs in the EU or in the UK, please contact the experts in Kerona Scientific at firstname.lastname@example.org