A simplified authorisation procedure aims to encourage the use of biocidal products that are less harmful for the environment, human and animal health.
To be eligible for the simplified authorisation procedure a biocidal product must comply with all of the following conditions:
- all the active substances contained in the biocidal product appear in Annex I of the BPR and comply with the specified restrictions
- the biocidal product does not contain any substance of concern
- the biocidal product does not contain any nanomaterials
- the biocidal product is sufficiently effective.See Guide to efficacy studies
- the handling of the biocidal product and its intended use do not require personal protective equipment
If all of these conditions are met, the applicant seeking authorisation should submit an application to ECHA through R4BP 3 indicating which Member State competent authority will evaluate the application.
Where a simplified authorisation is granted, the biocidal product may be made available on the market in other Member States without the need for mutual recognition. The authorisation holder, however, needs to notify each relevant Member State 30 days before placing the product on its territory. This notification is done in R4BP 3.
Applicants seeking the authorisation of a biocidal product under the simplified authorisation procedure must inform ECHA of the name of the authority processing the application and provide written confirmation that authority agrees to do so.
Please note that the application submitted must include the original studies of efficacy and the so-called maximum residue limits (MRL).
ECHA has published a manual in which you will be guided through the application process