EcoMundo is an expert in the assessment of risks related to biocidal products, and will assist you in the creation and submission of your biocidal Active Substance approval applications, and facilitate your registration in the official list of approved suppliers.
Before putting the dossier together, EcoMundo carries out an accurate regulatory diagnosis and draws up an action plan with a view to ensuring the compliance of your biocidal Active Substances (SA).
This diagnosis includes the analysis of active substances (have they been approved, do they already exist?) before identifying which procedure will best meet your requirements: technical equivalence or approval application for a new Active Substance. Our experts will guide you and identify their strategic recommendations (optimization of costs, simplification of regulatory approaches, etc.).
- Prior risk assessment: EcoMundo's specialists anticipate the acceptance of the product’s intended use even if the Active Substance is under examination.
DOSSIER FOR A NEW BIOCIDAL ACTIVE SUBSTANCE
Dossiers for a new Active Substance (AS) are put together for each biocidal product type (PT) in question. They include physico-chemical, toxicological and ecotoxicological data and the effectiveness of the AS. They also undergo an assessment of the risk to human health and the environment.
EcoMundo assists you in creating your new AS dossiers before sending your dossier to a national competent authority (eCA) which then submits the application to ECHA. The agency gives an initial opinion concerning the approval of the AS in the European Union. The European Commission then makes the final decision on whether or not to approve the AS for the given PT.
EcoMundo also puts together your dossiers for renewing approval of the SA
- • Comprehensive monitoring of your dossiers and optimization of costs related to tests (data gap)
- • Personalized support: our experts deal directly with the eCA. This facilitates the process and ensures your regulatory compliance.
REGISTRATION ON THE LIST OF APPROVED SUPPLIERS
According to Article 95 of the EU Biocides Regulation, every manufacturer of an existing Active Substance (whether it has already been approved or is under examination) for a given type of product must be registered on the list of approved suppliers in order to comply with the Regulation
Our specialists are on hand to help you when purchasing the Letter of Access (LoA) and submitting your application to register on the list of approved suppliers