BIOCIDES COMPLIANCE IN EUROPE

For biocidal products containing an active substance under evaluation at the European level, it is necessary to follow the national requirements of each Member State in order to be able to place them on the market under transitional measures. EcoMundo supports you in the creation and submission of dossiers according to these transitional measures, in all European countries. All your regulatory procedures are thus centralised and optimised. Once the date of approval of the active substance is published, it will then be necessary to anticipate and prepare a permanent Authorisation dossier (see focus disinfectants below).

FOCUS ON DISINFECTANTS

A disinfectant formulated with an active substance under evaluation (in a transitional regime), such as ethanol, can access the European market more easily. The complexity lies in the need for a specific regulatory approach in each country. However, EcoMundo's expertise in this field facilitates this procedure and allows you to benefit from short deadlines.

Our specialists will guide you from the creation to the submission of your Marketing Authorisation (MA) dossier :

• 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
• with the evaluating Member State in order to validate the submission authorization and to manage exchanges in case of additional information requests
  

• Use of our software tool, SDS Factory, to calculate the CLP hazard classification of your Biocidal Products
• • Interacción directa con las autoridades nacionales competentes
• Guaranteed anonymity until the application is submitted, thereby simplifying interactions and ensuring the success of negotiations
• 100% of the MA dossiers submitted by our experts have been validated!