In this insight piece we look at how to lay the groundwork for a smoother authorisation experience in the European Union (EU) and Great Britain (GB) under their separate BPR regimes.

Data gap analysis for biocidal products

The regulatory landscape for biocidal products has changed significantly since the EU Biocidal Product Directive 98/8, now replaced with the EU’s Biocidal Product Regulation (BPR, Regulation (EU) 528/2012), came into force. The BPR involves a two-step process: the evaluation and approval of biocidal active substances followed by the authorisation of biocidal products containing the approved substances. There are also rules for treated articles. Active substances and biocidal products are generally re-evaluated on a ten-yearly basis.

Following its exit from the EU, the UK introduced its own GB BPR for the Great Britain market (England, Scotland, Wales) while Northern Ireland still falls under the EU BPR. At present, the GB BPR largely mirrors the EU BPR, but divergence is expected over time as GB will assess the active substances and biocidal products independently of the EU.

Until all the active substances contained in a product are approved for the relevant Product Type (PT) (use), a biocidal product can be made available on the market under the existing national rules in place. This is known as transitional measures (Article 89).

Many biocidal products that are either only notified in some countries or authorised under existing schemes (for example the Control of Pesticides Regulation (COPR) in the UK) face different and more stringent requirements under BPR. Companies rarely hold all the information needed for a BPR dossier, so conducting data gap analysis at an early stage ensures any missing information can be sourced in good time. However, sometimes the requirements are so different or even new that it’s hard to know where to start. Building a core product foundation with key information about the biocidal product helps shape the process.

Getting ahead: know your biocidal product

Critical knowledge for a well-informed and focused data gap analysis includes:

• Formulation – you need to know exactly what’s in the product, and in what quantities. Sometimes a product has a slightly different composition from one country to the other. Ensure you have full details of the active substances it contains, as well as all co-formulants. Any ingredients classified as ‘substances of concern’ will face higher levels of scrutiny and all active substances must be sourced from an Article 95 listed supplier.
• Packaging – rules for the packaging and labelling of biocidal products are set out both in the BPR (Article 69) and in the EU’s classification, labelling and packaging of substances and mixtures (CLP) regulation No 1272/2008, and its GB equivalent. Sometimes additional regulations such as the Detergent Regulation No 648/2004 also apply for labelling. Important information for the core dataset includes pack sizing and product users, as this will impact the overall product classification and labelling.
• Application method – the product’s formulation type (e.g. powder or soluble concentrate) and the way it is applied (e.g. spraying or mopping) has implications for data requirements. Consider how it is dispensed, whether it requires dilution and how easy it is to measure and control the amount used.
• Intended use – the way the product is used (for human or veterinary hygiene; for disinfection of food and feed areas; without application to humans and animals etc.) dictates its biocidal type (PT). The environment it’s used in (e.g. indoors or outdoors) also impacts the data that needs to be provided for exposure assessment.
• Performance claims – efficacy is the main area of focus here. Any claims made about product performance must be properly substantiated with robust data generated in recorded test conditions. Detailed knowledge of the claims included on packaging or in product descriptions is needed to facilitate this.

When this depth and breadth of information is available upfront it provides a solid foundation for data gap analysis and accelerates the process. Knowledge of the product’s intended use and application methods also enables preliminary risk assessments to be conducted, as long as the endpoints for active substances have been established. Again, this paves the way for a more streamlined authorisation.

Talk to your active substance suppliers

With BPR taking a hard line on the traceability of active substances, it pays to build good relationships with Article 95 listed suppliers. This may also allow you to benefit from insights during an active substance’s evaluation phase. In the EU, there is typically a two-year window between the opinion from the Biocidal Product Committee (BPC) on the approval of an active substance and the date of approval of such active, triggering any biocidal products that contain it (that are already on the market) to apply for authorisation. If you know the likely endpoints of evaluation before the BPC opinion, you can get ahead of the game planning new testing strategies or sourcing relevant data at an earlier stage.

This is especially useful for biocidal products requiring field tests which may be influenced by seasonal variations, such as insect repellents. In any event, with the current backlog of laboratory antimicrobial testing caused by Covid-19, it’s useful to schedule tests well ahead of dossier submission deadlines.

When’s the best time to start?

With biocidal products’ authorisation dictated by the active substance approval date, manufacturers have a rough idea of timescales well in advance. As a rule of thumb, it’s a good idea to start collecting the necessary data at least two years before the submission date. So, it follows that data gap analysis should happen immediately after the BPC opinion on approval of the active substance becomes available.

However, it’s never too early to build the core dataset for a biocidal product. In fact, the sooner this can happen the better. In our experience, very few organisations initiating data gap analysis have the level of information needed to shape the process, so gathering it can take up valuable time. Our advice for any biocidal product owner is to invest time building and maintaining knowledge of your biocidal product and getting to know your active substance suppliers.

A well-orchestrated data gap analysis eases the burden of dossier work and budget planning by increasing efficiency and avoiding wasted effort. Here at TSG our regulatory specialists and scientists are experienced in all aspects of BPR dossier planning and preparation for active substances and biocidal products. Contact us at [email protected] to find out more.

This is the first in a series of insight pieces on authorisation for biocidal products in the EU and UK. Future articles will look at efficacy testing, environmental considerations and human health risk assessments.