Low-risk active substances: pesticides
When an active substance is evaluated for approval, if it’s found to present a much lower risk than other active substances, it may be approved as a low-risk active substance.
To be approved as a low-risk active substance, the active substance must satisfy the criteria for approval in Articles 4, 22 of retained Regulation (EC) 1107/2009.
A new low-risk active substance can be approved for a maximum period of 15 years, compared to 10 years for standard active substance approvals.
Low-risk substances in products
When all the active substances contained in a plant protection product are low-risk, as in Article 22, the product can be authorised as a low-risk plant protection product under Article 47 of retained Regulation (EC) 1107/2009.
This is provided no specific risk mitigation measures are needed following a risk assessment.
The application process for a product based on a low-risk active substance is the same as for other products but assessment is quicker.
The maximum authorisation period for products based on low-risk substances is 15 years.
Data protection can be granted for up to 15 years.
Plant protection products authorised as low-risk are allowed to use the low-risk phrase in advertisements as in Article 66 of the retained regulation (EC) 1107/2009.