What is a simplified MA?
A simplified authorisation procedure aims at encouraging the use of biocidal products that are less harmful for the environment as well as for 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
- the handling of the biocidal product and its intended use do not require personal protective equipment
If all of the conditions above are met, the applicant seeking authorisation can submit an application to ECHA through R4BP, indicating which Member State competent authority will evaluate the application.
The evaluation process
The competent authority evaluates the dossier and has 90 days (starting from the approaval of the request) to authorise the biocidal product.
When a simplified authorisation is granted, the biocidal product can be made available on the market in other Member States without the need for mutual recognition.
However, the authorisation-holder, needs to notify each relevant Member State 30 days before placing the product on the latter's territory. This notification is also done via R4BP 3.
Before submitting your simplified MA dossier, you should ask the competent authority chosen for the assessment work for a written agreement. This document will later be submitted to ECHA.
To have a complete list of all the supporting documents needed for a simplified MA request, do not hesitate to visit ANSES's biocides helpdesk by clicking here.
Fees related to simplified MAs are considerably inferior to those required for more "classical" authorisations, such as Union or National ones.
Fees due to ECHA are detailed in the regulation 564/2013, available here.
Want to know more about biocidal products' regulation in Europe?
For more information on biocides, do not hesitate to contact our expert, Mr. Fang Zhou by phone at : +33 1 83 64 20 54 for Europe, or +1 (778) 234 1607 for North America or even send him an email at [email protected]
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