Two-tier multiplier

Unlike most legislations with a ‘simple’ single registration (like REACH), BPR has two tiers which both carry their own costs. Under BPR there are:

• Two sets of study data requirements: for active substance(s) and for products.
• Two dossiers that need to be developed: one for the biocidal active substance and at least one for the biocidal product (family);
• Two regulatory fees: one for the approval evaluation of the active substance dossier and another for the evaluation for the authorisation of the biocidal product (family);

Note that the Biocidal Active Substance approval and Biocidal Product authorisation are per Product Type. So a wider use will be more costly than approval and authorisation for a single Product Type. More on the Biocidal Products in our future article. For now, let’s dive into the cost for the active substance dossier approval.

Study Data development for hazard and efficacy

Member States will only accept dossiers for evaluation if they meet a lot of content requirements. The biggest chunk of the work is the development of study data.
It requires toxicological studies, ecotoxicological studies, environmental fate (biodegradation) information, physical-chemical and physical-hazard studies to fulfill the hazard endpoint information requirements.
In addition, studies that show the efficacy against target organisms are of vital importance.

The BPR guidance has continued to develop, leading to new data requirements. Already submitted dossiers (or draft Assessment Reports) must be updated to meet the new criteria. This means continued support from subject matter experts consultants and contract labs and hence an increase of the study costs.

Cost Range Estimate for study data development: €1,000,000 – 2,500,000.

We provide a range as some (hazard) data may already have been developed for other regulatory purposes such as REACH, or for the EU Plant Protection Product Regulation (EC 1107/2009). And costs might be shared by multiple applicants. For studies developed based on vertebrate animal models, that is even a legal requirement!

Dossier development

All the study endpoints above must be summarized and reviewed to ensure that the hazard and efficacy data can be used in the relevant dossier under EU BPR.

Risk = f (Hazard x Exposure)
The hazard data endpoints must be evaluated against the human health and the environmental exposure models agreed upon by the EU Member States Competent Authorities. A risk assessment for both must be conducted to show at what level the biocidal active substance is still safe to use.

Efficacy conclusion
Next to safe use, it should be shown that the active substance renders the target organisms ‘sufficiently harmless’. An (independent) expert must review at what concentration the biocidal active substance works as intended.

In summary, it should be shown that appropriate efficacy can be reached at a dose level of the biocidal active substance that is considered safe for human health and the environment.

Cost Range Estimate dossier development & risk assessment: €300,000 – 500,000.

Regulatory fees

The applicants need to find an evaluating Member State for each active substance evaluation. This Member State will levy a fee for dossier evaluation. Be aware that each member state has its own fee. These are based on their detailed calculations of a.o. the number of experts involved, the number of meetings foreseen and possibly outsourcing of expertise.

It is important to know that the regulatory evaluation fee will (significantly!) increase if approval is sought for more than one Product Type.

Cost Range Estimate Regulatory fees: €200,000-750,000 (for the first PT!).

In the case of multiple applicants, costs can be shared by the parties (via Task Forces or other forms of collaborations). This is even mandatory for data developed using vertebrate animal models! Therefore, the below cost is again provided in a range.

Summary & Conclusions

The costs for the development of the study data and the BPR active dossier plus the evaluation of this approval dossier for the biocidal active substance amount to a total of 1,5 to almost 4 million euro. Usually, these costs are split between several applicants.

Many of the original active substance dossiers were submitted years ago. However, these investments did not yet result in approvals for many organisations. And additional data requests (as mentioned above), raised questions in many senior leadership teams: does it add value to continue investing in biocides for the European market?

 The Overview of Alternatives Query (OAQ) tool provides your organisation with an overview of the alternatives that are still allowed on the EU market. It takes into account the toxicological hazard profiles and the intended application.
An OAQ report can support you in re-assuring your leadership team that the biocides portfolio of your organisation is still worthwhile investing in. And in case any of your active substances comes under regulatory scrutiny, OAQ gives a quick, easy and complete overview to start an Analysis of Alternatives. And that at a tiny fraction of the cost of an active substance dossier.