Plan ahead for EU BPR ethanol dossiers

With ethanol receiving a positive opinion from the Biocidal Product Committee (BPC) on its approval for all uses (consumer and professional) as a biocidal product for PTs 1, 2, and 4, companies face important decisions about which disinfectant products to take forward under the EU Biocidal Products Regulation (BPR). Experience shows that those who plan early – and focus on the most important formulations and claims – are best placed to secure authorisation efficiently and reduce commercial and regulatory risk.

Below, we outline the practical considerations that most often determine the cost, scope and success of EU BPR disinfectant product family applications.

Rationalise EU BPR disinfectant portfolios

Rationalising a product portfolio requires balancing commercial priorities with the realities of data generation costs and evolving regulatory guidance. Now is an ideal time to assess your portfolio and determine which products to retain, enhance, or discontinue to ensure it remains focused, compliant, and sustainable. Ingredients such as fragrances and dyes can introduce hidden challenges for product families, particularly in relation to efficacy and risk assessments, often adding disproportionate regulatory complexity. In our experience, streamlining the portfolio to focus on the bestselling formulation variants helps reduce unnecessary variability and complexity, significantly smoothing the path through the BPR evaluation process.

Prioritise product claims that drive value

A clear understanding of which product claims are truly essential – and which are merely desirable – can significantly strengthen your portfolio strategy. Taking a deeper look at the claims your company considers critical helps streamline product offerings and avoids unnecessary complexity. By focusing only on the claims that deliver real market value, you can reduce the need for product‑specific data generation and minimise the regulatory burden associated with supporting optional or low‑value claims.

Strategize product-specific data generation

After rationalising your product family and identifying the essential product claims, the next step is to establish a coherent and defensible data‑generation strategy. This is particularly critical for product families where worst‑case formulations must be clearly defined, and where robust read‑across justifications for physical‑chemical properties and efficacy are essential to support the overall dossier. The need for a strong evidence base is even more pronounced for products – such as disinfectants – that historically have not been assessed to the depth now expected under the EU BPR. In these cases, efficacy testing may need to demonstrate the specific impact of co‑formulants, and failing to address these considerations early can leave insufficient time for formulation adjustments later in the process.

Compounding these challenges is the limited capacity within contract research laboratories, which is expected to tighten further as regulatory submission deadlines approach. Securing testing slots early and ensuring clarity on test designs and worst‑case justification can help mitigate delays and keep the evaluation process on track.

Expert support for EU BPR ethanol disinfectant product authorisation

With a proven track record of securing product authorisations for alcohol‑based disinfectants under the EU BPR, for both Union and national routes, Sagentia Regulatory supports businesses navigating the regulatory, technical and commercial complexity of ethanol‑based biocidal products.

Our biocides team can support you at every stage of the authorisation process, helping you make defensible decisions early and avoid unnecessary cost, delay and re‑work.

We can support you with:

Strategic advice for FMCGs containing ethanol, either as an active substance or as a co-formulant
Impact assessment of proposed ethanol classification
Checking the classifications of your product portfolio
Building Biocidal Product Families
Identifying data gaps and developing testing strategy for physical chemistry and efficacy to support your product’s claims
Complying with other regulations/requirements: National registrations, Harmonised Poison Centre Notifications
Preparing and submitting your product authorisation dossiers, including production of detailed risk assessments of human health and environmental exposure