Reduced efficacy requirements for low-risk plant protection products

The European Plant Protection Organisation (EPPO) standard ‘Principles of efficacy evaluation for low-risk plant protection products’ (1/296) allows for reduced efficacy data packages to be submitted for products containing approved low-risk actives.

An active substance can be approved as a low-risk in Great Britain (GB) where it may be expected that plant protection products, containing that substance, will pose only a low-risk to human and animal health and the environment as provided for in Article 47(1) of assimilated Regulation 1107/2009. Specific criteria were later provided via Commission Regulation (EU) 2017/1432.

More on low-risk active substances.

HSE will now accept a reduced data package for the efficacy assessment before approval of low-risk status for an active substance is granted in GB.

This approach also allows submission of relevant existing reduced data packages submitted previously to other countries and may prevent an unnecessary number of trials being conducted.

Download standard 1/296 from the EPPO database.

There may be cases where, following the HSE assessment, an application for low-risk status for an active substance fails for GB. In this case, the applicant will be informed during the product evaluation that HSE will potentially need additional efficacy data to support the relevant use in line with requirements for a full data package. It is important to be aware of this possibility when choosing to submit reduced data packages ahead of any final decision on low-risk status of the active substance in GB.

The approach taken by HSE for the efficacy assessments is to encourage the entry of low-risk products into GB.