What is the Union MA?
The process of Union authorisation enables companies to place their biocidal products (families or unique product) on the European market as a whole, without needing a specific national authorisation.
Thus, a Union authorisation grants the same rights and obligations in all the member states.
This procedure is applicable to biocidal products containing new active substances (ASs) or already existing ones. To see all the deadlines for Union authorisations requests, visit ECHA’s page on the subject.
Careful: Union authorisation are not applicable to biocidal products containing active substances answering to exclusion criteria or product type (PT) 14, 15, 17, 20 and 21.
The dossier submission
The first step for the applicant consists in creating a dossier with the entirety of the supporting documents, possibly in collaboration with their regulatory consultant. The submissions are then sent using R4BP, in the format of a IUCLID file.
For more information regarding the authorisation dossier submission, do not hesitate to consult the manual for help in the submission of biocidal products dossiers, dedicated to the Union MA: “BSM Application instructions: Union authorisations” written by ECHA and available, here.
The evaluation process
The process of evaluation for a Union MA request is a long one in which multiple actors intervene.
Evaluating Competent Authority (eCA)
Its goal is to conduct the evaluation of the dossiers submitted by the applicants. It has 365 days to do so and can, if need be, request complementary information from the applicant. The latter will then be given 180 days to communicate it.
NB: In this situation, the period allocated to the applicant to provide complementary information extends the total time of evaluation (which is, initially, of 365 days).
Biocidal Products' Committee
The Biocidal Products’ Committee (BPC) issues an opinion on the biocidal product’s authorisation within 180 days.
It completes the BPC’s work by providing a technical and scientific assistance. Thirty days after the submission of BCP’s opinion, ECHA gives the summary of biocidal product’s characteristics to the Commission in all the official languages of the EU.
The European Commission
It has the final say.
Assisted by the permanent committee of biocidal products (composed of member states’ representatives), it takes into account the opinion given by the BPC and decides on whether to grant a Union authorisation.
When submitting an authorisation request on R4BP, you have to provide the following elements, in English:
- IUCLID technical dossier (gathering all studies as well as the risk evaluation)
- SPCs (Summary of Product Characteristics)
- The LoA (Letter of Access)
- Technical equivalence, if need be
For a more complete list of the supporting documents needed for your request for Union MA, do not hesitate to visit ANSES’ biocides helpdesk.
All ECHA taxes related to Union authorisation requests are specified on Annex II of the regulation (EU) n°564/2013 of the Commission.
Nonetheless, SMEs can benefit from discounts in the payment of their fees:
- Micro company: 30%
- Small company: 20%
- Medium-sized company: 10%
Careful: Fees linked to Union authorisation requests payable to eCA can vary too, according to the competent authorities.
Want to know more about biocidal products' regulation in Europe?
For more information on biocidal products, do not hesitate to contact our expert M. Fang Zhou by phone : +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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