The placing on the market of a biocidal product requires compliance with national and European regulations. We help you comply with these regulations, including Directive No. 98/8/EC (BPD) or its amendment (BPR) Reg (EU) 528/2012.

EquiTox team members have implemented and supported the creation of Biocide dossiers for active substances and biocidal products.

1- Broad overview of Biocide regulation
You manufacture or import, and market a new active substance in Europe
The provision of a new biocidal active substance on European territory is subject to approval by the European authorities. EquiTox supports you in this process with:

  • 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).
You formulate/market in Europe biocidal products
The Biocide Regulation offers many possibilities as regards the authorisation procedures of one or several products of a biocide portfolio: union or national authorisation, simplified authorisation, mutual recognition, notification, biocidal product families, SAME … EquiTox helps you in these steps:

  • 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
Portfolio analysis, identification of your obligations.
The choice of a biocidal active substance, a mode of application, a formulation must ultimately meet regulatory requirements. We help you in defining a strategy that takes into account the technical and regulatory levers to build an action plan, and in integrating your commercial constraints for the sustainability and development of your products.
Deposit strategy of regulatory dossiers
EquiTox helps you in developing your most effective / profitable dossier deposit strategy to make available your product portfolio on the european biocidal market:

  • 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;
Preliminary assessment of the health/environment risk
The authorisation of a biocidal product is in particular conditioned by the demonstration of the control of the risks for human health and the environment, under the claimed conditions of use.
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.
Regulatory dossier constitution
The authorisation dossier constitution is based on the requirements of Annex III of the biocidal regulation (EU / 528/2012) but also on technical elements relating to the active substance (CA-report, BPC Opinion ) or to the product or product family (claim, form, mode of application …).

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 …
Defense of the dossier before to the authorities
Obtaining authorisation for a biocidal product can be a long and tortuous path. It is likely to involve not only the national evaluation authority, but also other Member States, ECHA and even the European Commission; this through different processes and committees.

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
Authorisation of Biocidal Products: Increase the Chance of Success by Reducing the Uncertainties
Different levels of uncertainties characterise the way to the granting of an authorisation for biocidal products under the BPR (Reg (EU) No 528/2012). Uncertainties come from, amongst others, the understanding of the active substance properties, the identification of substances of concern, the application of non-harmonised processes, if any, for efficacy testing and Human/Animal/Environmental risk assessment, the quality of the relation with the evaluating Member-State.

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.

The Biocide Regulation: how to anticipate the future
The new biocidal regulation (BPR, 528/2012) presents a wider field of application compared to the former one (BPD, 98/8/EC). As an example, active substances generated in situ have to be approved with a closed list of precursors.
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…
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