Characteristics
Active substances should be regularly examined to take account of developments in science and technology. Therefore, an active substance is approved for a maximum of 10 years at first.
An active substance approval can be renewed, resulting in redefining the duration period of the approval. For this, an application has been filed for active substance renewal. An application of this type is especially meant to start the re-assessment procedure, to make sure the active substance will be reassessed in time. This results in a decision on the renewal of the active substance.
Duration of the approval
The approval of an active substance is renewed for a defined number of years, not exceeding 15 years and is renewable.
Substances that meet the exclusion criteria, but for which a derogation is applicable, can be approved for a maximum of five years, and is renewable.
Substances that meet the substitution criteria can be approved for maximum seven years and is also renewable.
Data requirements
For renewal of the active substance approval all data required under Article 20 of the BPR that has been generated since the initial approval or previous renewal has been granted. This is further described in ECHA’s Practical guide on BPR – Renewal of an approval of active substance.