Biocidal products are mixtures containing active substances for domestic or professional use. These products include household disinfectants, insecticides and other products used to eliminate, destroy or repel organisms considered harmful (fungi, bacteria, viruses, rodents, insects, etc.). Due to the diversity of target organisms, areas of application and claimed biocidal use, biocidal products have a multitude of applications, all of which must be EU-approved for active substances and require a national or EU authorisation for biocidal products.
Whether you are a manufacturer of biocidal active substances or a formulator/distributor of biocidal products, Equitox helps you comply with the Biocidal Products regulation.
How to determine whether my product is a biocidal product/treated article?
- Determines the status of your product: treated article/biocidal product? Borderline cases biocidal product and medicinal product for human use, veterinary medicinal product, plant protection product, or cosmetic product.
I wish to sell a new active substance or biocidal product in the EU…
… And I would like to know if my project is viable
- Establishes a prior diagnosis and assesses this data with regard to the information requirements set out in annexes II and III of the Biocidal Products regulation, taking into account the specific characteristics of the active substance in relation to claims.
- Carries out a preliminary risk assessment: identification of the strengths and weaknesses of the claims and estimate of the risk taken if the application is submitted as is. If the conditions of use do not guarantee risk control, potential optimisations are suggested to finalise the missing data analysis and the budgets for the compilation of the dossier.
… And I would like assistance in the preparation of the application for product authorisation or active substance approval
- Assesses your situation: active substance/biocidal product? Treated article? Exclusion/substitution criteria? Composition? Presence of co-formulant of concern? Targets and claims envisaged?
- Determines the best strategy: product dossier or product family, national authorisation with/without mutual recognition, EU authorisation, dossier SAME, request for minor/major amendments, choice of Member State in charge of evaluating the dossier?
- Prepares the regulatory dossier and provides you with everything you need for the final submission of the dossier to the authorities…
… I would also like support when arguing the case for my dossier during its evaluation by the authorities until the approval/authorisation is obtained
- Monitors the entire European comitology process,
- Argues the case for your dossier before the various bodies involved in its evaluation.
What if I only need occasional support?
.. Official list of approved suppliers (article 95): should I or my supplier be included?
- Assesses your situation and determines whether registration is necessary, as well as who within the supply chain should be registered.
… Compliance of commercial documents (SDS, labels, website)
- Analyses the content of commercial documents with regard to claims, authorisations granted and requirements under the Biocidal Products regulation,
- Helps you comply with European and national requirements.
… My supplier/customer suggests/wants a new biocidal treatment
- Analyses the regulatory status of the proposed product,
- Determines the actions to be undertaken and associated costs to ensure compliance,
- Proposes, where appropriate, alternatives based on relevant products/treatments already authorised at national or European level.