Application for changes to product authorisation
Authorised biocidal products, on request of the authorisation holder, can be changed to reflect updates to the authorised product based on Regulation (EU) No 354/2013.
Three types of changes can be distinguished:
- Minor changes, which should not affect the conclusion with regard to the fulfilment of the conditions for authorisation; and
- Major changes, when a need for re-assessment of the risk and the efficacy can be expected to fulfil the conditions for authorisation.
The application shall be submitted to the European Chemicals Agency (ECHA) via the Register for Biocidal Products (R4BP).
If an intended change is not listed in one of the tables in the Annex to Regulation No 354/2013, the authorisation holder may request an opinion from ECHA on the classification of that change.