EcoMundo is an expert in assessing the risk of biocidal products, and will assist you in creating and submitting Marketing Authorisation applications for biocidal products, whether you are a formulator or a distributor of biocidal products.

1

REGULATORY DIAGNOSIS

Before putting your dossier together, EcoMundo carries out an accurate regulatory diagnosis in order to draw up an action plan with a view to ensuring the compliance of your biocidal product (BP).

This diagnosis includes :

Analysis of active substances (have they been approved, do they already exist?) contained in your biocidal products,

Identification of the most suitable type of MA dossier for your biocidal products out of the three main authorization groups (long-term, transitional and provisional) described in the EU Biocides Regulation 528/2012

 
Bonus :
  • • You will be guided step-by-step through the entire process of ensuring the compliance of your BP.
  • • Possible creation of BP groups (cost optimisation)
2

CREATING AND SUBMITTING MARKETING AUTHORISATION APPLICATIONS

Our specialists will guide you from the creation to the submission of your Marketing Authorization (MA) application

  • Determine the size of your business, and validation by ECHA
  • Complete the toxicological and ecotoxicological “data gap” that must be provided (read-accross strategy, QSAR, etc.)
  • Help with the collection of relevant data: analytics, efficiency, toxicology, ecotoxicology, residue analysis, etc.
  • Draw up the scientific argument
  • Create the dossier in IUCLID 6 format
  • Submit the dossier via R4BP

EcoMundo will represent you and look after your interests :

  • before ECHA and the BPC (Biocidal Product Committee)
  • within task forces
  • before data owners to negotiate LoA costs
  • before the assessing Member State to confirm authorization of the application and manage interactions in the event that additional information is requested.
 
Bonus :
  • • Use of advanced software tools (SDS Factory) to calculate the CLP hazard classification of your Biocidal Products
  • • Direct interaction with the national competent authorities (eCA)
  • • Guaranteed anonymity until the application is submitted, thereby simplifying interactions and ensuring the success of negotiations
  • • 100% of the MA applications submitted by our experts have been validated !
3

CREATION OF A BIOCIDE CONSORTIUM

Creating or joining a biocide consortium involves submitting a Marketing Authorization application to various authorities. There are considerable advantages to this approach :

  • Reduction of the costs associated with submitting the application to the competent authorities,
  • Optimization of resources involved in carrying out tests,
  • Sharing of technical and regulatory work involved in putting the dossier together.
 
Bonus :
  • • EcoMundo handles all the activities related to the creation and/or management of a biocide consortium
  • • Our experts manage the interface with other members of the consortium
  • • The confidentiality of your information is guaranteed