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Approval of active substances, safeners and synergists
The EU’s policy on the approval of active substances, safeners and synergists is the foundation of its plant protection products regime. Before any of these components can be used in a pesticide placed on the market, they must meet the approval criteria set out in Regulation (EC) No 1107/2009. In practice, this means they are assessed for safety in relation to human health, animal health, residues in food, and environmental effects before they can be approved for use in plant protection products.
The system works through a shared EU assessment process involving a Rapporteur Member State, the European Food Safety Authority (EFSA), the European Commission, and the Member States. Applicants submit a dossier, the Rapporteur Member State prepares a draft assessment, EFSA carries out the peer review and public consultation, and the Commission then proposes approval or non-approval for a vote in the Standing Committee on Plants, Animals, Food and Feed (SCoPAFF). If approved, the substance is authorised at EU level for a limited period and may be subject to conditions or restrictions.
The policy also distinguishes between the different types of substances used in pesticides. Active substances are the components that act against pests or plant diseases. Safeners are added to reduce harmful effects of the product on certain plants, while synergists enhance the activity of the active substance even if they have little or no pesticidal effect on their own. Once approved, these substances can then be used by companies when seeking national authorisation for plant protection products in Member States. Approved substances are listed in Implementing Regulation (EU) No 540/2011 and are searchable in the EU Pesticides Database.
A further key element is that approvals are not permanent. They are granted only for a limited period and must be renewed after re-evaluation, with at least one safe use demonstrated again. The renewal procedure is governed by Implementing Regulation (EU) 2020/1740, which replaced the earlier procedure under Implementing Regulation (EU) No 844/2012. The Commission notes that, although the legal timeline for a first approval is roughly 2.5 to 3.5 years, in practice the process has averaged around 4 years.
The page also highlights recent new rules for safeners and synergists under Commission Regulation (EU) 2024/1487, applicable from 19 June 2024. This framework introduced a specific review system, including a non-exhaustive list of existing safeners and synergists, deadlines for notifications and inclusion requests, and a gradual review work programme later adopted through Commission Regulation (EU) 2025/2274. Overall, the EU policy is designed to ensure that the building blocks of pesticides are subject to centralised scientific scrutiny, periodic review, and strict conditions before products containing them can be authorised nationally.
The system works through a shared EU assessment process involving a Rapporteur Member State, the European Food Safety Authority (EFSA), the European Commission, and the Member States. Applicants submit a dossier, the Rapporteur Member State prepares a draft assessment, EFSA carries out the peer review and public consultation, and the Commission then proposes approval or non-approval for a vote in the Standing Committee on Plants, Animals, Food and Feed (SCoPAFF). If approved, the substance is authorised at EU level for a limited period and may be subject to conditions or restrictions.
The policy also distinguishes between the different types of substances used in pesticides. Active substances are the components that act against pests or plant diseases. Safeners are added to reduce harmful effects of the product on certain plants, while synergists enhance the activity of the active substance even if they have little or no pesticidal effect on their own. Once approved, these substances can then be used by companies when seeking national authorisation for plant protection products in Member States. Approved substances are listed in Implementing Regulation (EU) No 540/2011 and are searchable in the EU Pesticides Database.
A further key element is that approvals are not permanent. They are granted only for a limited period and must be renewed after re-evaluation, with at least one safe use demonstrated again. The renewal procedure is governed by Implementing Regulation (EU) 2020/1740, which replaced the earlier procedure under Implementing Regulation (EU) No 844/2012. The Commission notes that, although the legal timeline for a first approval is roughly 2.5 to 3.5 years, in practice the process has averaged around 4 years.
The page also highlights recent new rules for safeners and synergists under Commission Regulation (EU) 2024/1487, applicable from 19 June 2024. This framework introduced a specific review system, including a non-exhaustive list of existing safeners and synergists, deadlines for notifications and inclusion requests, and a gradual review work programme later adopted through Commission Regulation (EU) 2025/2274. Overall, the EU policy is designed to ensure that the building blocks of pesticides are subject to centralised scientific scrutiny, periodic review, and strict conditions before products containing them can be authorised nationally.
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