Dublin PP Symposium 2024 – EU updates for co-formulants in plant protection products
Dublin PP Symposium 2024 – EU updates for co-formulants in plant protection products
During the 2024 Dublin Plant Protection Symposium, Dr Maristella Rubbiani, Policy Officer at the Directorate-General for Health and Food Safety of the European Commission (EC) provided insightful information about the EU updates for co-formulants in plant protection products (PPPs).
Dr Maristella explained why an assessment of co-formulants in PPPs are under increased scrutiny as NGOs and other organisations have expressed concerns regarding the long-term effects of PPPs. Dr Maristella referred to the Blaise judgement (C-616/17) which states that the assessment of a PPP must be undertaken as part of the EU assessment and all aspects of the product needs to be examined and safety demonstrated. Discussions to address the assessment of co-formulants have already started and several workshops and meetings have already taken place.
Dr Maristella pointed out two pieces of legislation in relation to unacceptable co-formulants. Regulation 383/2021 lists 144 unacceptable substances under Annex III whilst the more recent Regulation 574/2023 sets up a process to amend Annex III by setting criteria to identify unacceptable co-formulants. Most criteria relate to classification of a substance as CMR, POP, PBT, vPvB, ED. Additionally, EFSA has collected data on co-formulants, producing a technical report based on existing data, whilst there is a mandate to find additional unacceptable substances. The EC is working on improving the assessment of PPPs in collaboration with EFSA and Member State (MS) competent authorities. (see here ).
Dr Maristella identified the most prominent challenge as being the need for a harmonised, transparent and resource-efficient assessment. The EC aims to develop guidance to harmonise the assessment of PPPs and establish an EU database of co-formulants, starting with a local database that would need to be integrated under the ‘One substance – one assessment’ initiative. Dr Maristella explained that if a co-formulant is found unacceptable, there is a need to find an alternative co-formulant.
New substances have been notified by MS’ or identified by EFSA in representative formulations. Dr Maristella explained that the list of unacceptable co-formulants is still under development and will be published on COM website when finalised. The list should be updated regularly, especially when a new CLP is published and when the new CLP hazard classes come into force classifying more substances.
Dr Maristella concluded the presentation by explaining that the new CLP hazard classes should make the identification process for unacceptable co-formulant easier, and she shared the applicability dates for the new CLP hazard classes.
If you missed the Dublin Plant Protection Symposium, please contact Kerona if you wish to purchase a copy of the presentations. For assistance with the Regulation of PPP in the EU and UK the Kerona Regulatory team can be contacted at info@kerona.ie