Low-risk plant protection products

The Plant Protection Products Regulation distinguishes 4 types of active substances:

  • Active substances that are eligible for replacement
  • “Normal” active substances
  • Low-risk active substances
  • Basic substance

Low-risk substances and basic substances are substances with a lower basic risk profile. Products based on these substances are often called low-risk plant protection products.

Low-risk substances are active substances which have been evaluated as having a low risk. For the approval of these substances, the normal assessment procedure applies. The assessment process determines whether a substance has a low-risk profile. Consequently, there is no separate application or assessment procedure for low-risk substances. Neither is there a separate application procedure for products based on these active substances: a 'normal' authorisation is still required for these products.

An active substance can be approved as a low-risk substance if it meets the regular approval criteria and in addition meets the low-risk criteria as specified in Annex II, point 5 of Regulation (EC) 1107/2009. There are specific criteria for chemical substances and for micro-organisms.
A major benefit for applicants is that the active substance will be included in the Annex for 15 years instead of the normal 10 years. As a result, the maximum authorisation period for products based on these substances will also be longer: up to 15 years.

Basic substances are substances that are not generally used as plant protection products, but can still be useful for protecting crops. This concerns substances that are not placed on the market as plant protection products. Applications for basic substances must be submitted to the European Commission, and an authorisation is issued for the entire EU for an indefinite period. Since March 2014 the first basic substances are authorised at the European level.