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.
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
- • 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)
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.
- • 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 !
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.
- • 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