Return on Investment (ROI)

The business decision to (continue to) place a biocidal product (family) on the market in Europe relies on cost estimates and market assumptions (i.e. supply chain stability, sales forecasts, market growth) to calculate the required investment and the return on this investment.

Therefore the investment related to BPR product (family) authorisation dossier development is of crucial importance for senior leaders in making such a commercial decision.

Two tiered legislation

The European Biocidal Products Regulation has two distinct steps. For more information about this and a cost estimate of ‘step 1’ please visit one of our earlier blogs: Cost of BPR Compliance: The Active Substance dossier.

Different options

EU Biocidal product dossiers come in various shapes and sizes. There are single biocidal product dossiers and biocidal product families. On top of this, each biocidal product (family) dossier can be authorised via National Authorisation or via Union Authorisation.

Below we will dive into:

1. The generic costs of biocidal product (family) dossier development;
2. The costs specific for a National Authorisation (sometimes followed by Mutual Recognition) of a single biocidal product (bp) dossier and a Biocidal Product Families (BPF);
3. Costs specific for the Union Authorisation of a single bp dossier and a BPF dossier.

In case of more than 1 applicant, costs might be shared by multiple applicants (via a Task Force, alliance or any other form of collaboration). Therefore, the costs in the chapters below are provided in a range.

Generic costs

The active substance hazard data package
The biocidal actives substance(s) that your biocidal product is based on is/are in many cases the most hazardous ingredient(s) of your product formulation(s). Therefore you will need to include hazard data on the active substance(s) in your biocidal product (family) dossier to be able to perform the safety risk assessment for your product.
This data can usually be obtained in the form of a Letter of Access from the Article 95 supplier.
Usually these costs are calculated into the raw material commercial price of the active substance. If a product manufacturer would buy a raw material from a non-listed supplier, the cost and resources for Article 95 listing would have to be carried by the product manufacturer.

Estimated costs range of Active Substance hazard data: €500,000 – 2,000,000 (per a.s.).

The biocidal product (family) data package
To ensure that the characteristics of the biocidal product are not adding any risk for users compared to the risk of the active substance, you will need to develop and/or purchase additional data. This includes data on physical-chemical properties, physical-hazards, efficacy and potentially Substance of Concern data.

For biocidal product families you can select one product that is most representative (i.e. the worst case) for hazard testing and another one that is most relevant for the efficacy testing.

Estimated costs range of biocidal product (family) study data: €150,000 – 500,000.

Costs for National Authorisation (with Mutual Recognition)

Each Member State will levy a fee for the evaluation of single product and product family dossiers. These costs range from 100,000-200,000 euro.
Generally speaking it is worthwhile to create a product family for 3-5 different products provided they are similar. Similar in the sense of the same active substance(s), BPR product type and hazard profile of the total product.

As you will understand, the cost will (significantly!) increase in case Mutual Recognition is sought in multiple additional EU Member States. As a rule of thumb, if Mutual Recognition is expected to span 7 additional Member States or more, it is advisable to compare the total cost estimate for a Union Authorisation with the total costs of National Authorisation including the costs of Mutual Recognition in the relevant Member States.

In addition, there are costs that must be made for the preparation of the product dossier and the risk assessment (for human health and the environment). Usually this work is outsourced to a specialised consultancy firm. Depending on the complexity of the biocidal product (family) dossier costs are in the range of 100,000-300,000 euro.

Total Cost Range Estimate for national authorisation of biocidal product (family) dossiers: €200,000 – 2,000,000.

Costs for Union Authorisation

The fees for the evaluation of Union Authorisation dossiers are usually higher than for a single or a few National authorisations, but cheaper than for a significant part of the . Again, the evaluation fees will differ Member State. Also the evaluation of single product dossiers will be lower than for the evaluation of product family dossiers.

On top of the Member State evaluation fees, there is also a fee levied by ECHA to process the Union Authorisation dossier. The latest (draft) overview can be found here.
The estimated costs for regulatory evaluation fees range from 300,000-400,000 euro

Also for the Union Authorisation dossier, there are costs that must be made for the preparation of the product dossier and the risk assessment (for human health and the environment). And also in this case, this work is usually outsourced to a specialised consultancy firm. As the Union Authorisation dossier requires more preparation (e.g. pre-meetings with authorities, additional meetings with experts), the costs for outsourcing of the development of the Union Authorisation dossier is slightly higher than for single product dossiers.
Depending on the complexity of the biocidal product (family) dossier costs are in the range of 150,000-300,000 euro.

Total Cost Range Estimate for Union Authorisation of biocidal product (family) dossiers: €950,000 – 2,000,000.

Summary & Conclusion

Clearly, the decision to (continue to) place a biocidal product on the market in Europe requires a signification investment under BPR.

For senior leadership it is of crucial importance that investment decisions like these
1) are in line with corporate strategy and
2) that the assumptions (regarding sales forecasts, market uptake, supply chain stability) that support these decisions are correct.

This requires an active substance regulatory scan that allows regulatory leaders to advice their senior management to make the most future-proof business decision as this will create a stable market for investors and customers.

As things can change rapidly under BPR, your regulatory team also must be able to quickly assess the regulatory status of the active substance(s) used for your biocidal product (family) to ensure that all necessary measures can be taken to defend your products, based on robust scientific arguments, to keep them as long as possible on the market in Europe. Please feel free to reach out if you would like us to support you in this.