EquiTox team members have implemented and supported the creation of Biocide dossiers for active substances and biocidal products.
1- Broad overview of Biocide regulation
- Constitution of the dossier according to the regulatory requirements;
- Selection of the evaluating Member State (eMS);
- Deposit of the dossier to ECHA;
- Follow-up throughout the European comitology process, and defense of the dossier with the various bodies involved in the assessment (eMS; ECHA’s Working Groups and Biocidal Products Committee).
- Identification of your obligations regarding your portfolio according to the schedule of active substance approvals;
- development of a deposit strategy for a biocidal product (family);
- submission and defense of the dossiers to the various bodies involved in its evaluation (Member States, ECHA dedicated working group and committee, the European Commission coordination group);
- post-authorisation follow-up (i.e. request for minor / major changes).
2- The biocidal regulation in detail
- Choice of the procedure/type of deposited dossier:
- Single product or product family dossier;
- National authorisation with / without mutual recognition;
- Union or national authorisation;
- SAME, and request for minor / major changes …
- Choice of the Member State in charge of the dossier evaluation;
Performed in anticipation of the dossier deposition, this preliminary risk assessment enables you to identify the strengths and weaknesses of the claims. If, after a first tier assessment, the claimed conditions of use do not guarantee safe use for human health and the environement in first approximation, optimisation levers are proposed. This makes it possible to finalise the datagap anlysis and budgetisation to edit the dossier.
EquiTox’s experts help you to take ownership of these requirements and constraints to produce a dossier which best matches the expectations of the authorities.
The tasks performed by EquiTox are for example:
- Analysis of the quality and relevance of the available data;
- Identification of missing data and proposal of a strategy to acquire this data (physical chemistry, stability, efficacy, toxicology, ecotoxicology);
- Compilation of all the information in IUCLID format;
- Writing of the Product Evaluation Report (PAR), and the Summary of Product Characteristics (SPC);
- Submission of the finalised dossier via R4BP …
EquiTox accompanies you in this comitology process that mixes technical and political aspects by bringing you its expertise to defend your application.
3- Case studies
These uncertainties have a major impact on the chance of success and the total cost of such projects.
When EQUITOX takes over a dossier, we put all our energy into reducing these uncertainties as much as possible. Experts from EQUITOX constantly update their knowledge about BPR by watching not only the regulation and its related guidance documents, but also the minutes from the different groups and committees (Coordination Group, Working Groups, Biocidal Product Committee…), and national/union authorisations of biocidal products. In addition, strong relationships are built with some Member States to reach a common objective: provide a high quality dossier and reduce the workload and the cost during the evaluation phase (post-submission).
This way forward has been successful on many occasions.
An international company specialised in the production of minerals for the food, manufacturing and chemical industries, was aware of a non-conventional application of their chemicals, as precursors of active substances generated in situ. They asked EQUITOX to help them to understand the biocidal regulations, and to define a strategy to be in compliance with the applicable regulations (national, European).
EQUITOX frequently provides them with an up-to-date overview of the current discussions at the EU level on this evolving subject.
In addition we guide them in the different tasks to deal with:
- being in compliance with national regulations until the couple precursor/active substance is approved,
- communicating with the leaders of the active substance dossier submitted to the rapporteur member state,
- forming a consortium with the other mineral producers to be in a good position to negociate a letter of access…