Biocidal product authorisation: human health and environment factors

The arduous nature of dossier preparation for biocidal product authorisation can result in some aspects only receiving attention towards the end of the process. This is often the case for the human health and environmental risk assessments. However, many regulatory obligations associated with these critical areas have changed or become more stringent in the past decade. Based on our experience in dossier preparation, we advise ascertaining data requirements at the earliest opportunity.

Biocidal Product Regulation

A central aim of the EU BPR is “to improve the functioning of the biocidal products market in the EU, while ensuring a high level of protection for humans and the environment.” It is often necessary to source or generate new data surrounding safe and effective use of biocidal products, in line with the EU Biocidal Products Regulation (BPR) and/or its GB equivalent.

With this in mind, we suggest that human health and environment risk assessments should dovetail with efficacy testing. In fact, we advocate three steps for the front end of the dossier preparation process:

1. Build a core foundation of product information upfront. Know the product formulation, including active substance/s and co-formulants. This is vital, as any discrepancies or changes in the formulation may impact the validity of efficacy and safety studies.
2. Conduct efficacy data gap analysis and testing. A key outcome of this process is determining the minimum amount of active substance required to achieve the desired outcome for the intended use/s. If you know this ahead of safety studies, they can be conducted using as little of the product as possible.
3. Carry out preliminary risk assessments in relation to human health and the environment to ensure that safe use can be demonstrated. Ascertain any data gaps that need to be addressed to satisfy BPR requirements while efficacy testing is ongoing. This allows third party data to be sourced, or new safety studies to be commissioned quickly once efficacy tests are complete. Conducting a preliminary risk assessment can be considered particularly beneficial for biocidal Product Types (PTs) where demonstrating acceptable risk may be more challenging, for example (e.g. insecticides (PT 18), repellents and attractants (PT 19), preservatives for liquid-cooling and processing systems (PT 11)).

We’ve previously written about the need to build a core foundation of information about a biocidal product ahead of dossier preparation. And we’ve also looked at how requirements related to efficacy have changed, making data gap analysis an essential step. So, what about satisfying BPR requirements in relation to human health and environment factors?

Human health and environment risk assessments

The first step is to extrapolate data related to the product’s active substance/s from European Chemicals Agency (ECHA) biocide information published online. Historic data from previous product authorisations should also be assessed, if applicable. This provides the foundation for both environmental and human health risk assessments, since (eco)toxicology and environmental fate endpoints will have been set during active substance approval or renewal of authorisation.

Co-formulants also need to be assessed to determine whether there is any need for them to be defined as substances of concern (SoCs). In particular, the product should be screened for substances that are endocrine disruptors. This may require access to the EU or UK Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) databases.

Environment

In terms of assessing environmental risk, the intended use of the biocidal product must first be determined (i.e where and how the biocidal product will be used). It is then possible to identify the relevant environmental emission scenario(s) from which to calculate emissions to the environment that occur from the use of the biocidal product. For instance, under PT 18, different emission scenarios exist for indoor and outdoor uses, as well as how the product is applied (e.g. via spraying, gel, diffuser, etc.). Where quantitative risk assessment is appropriate, Predicted Environmental Concentrations (PECs) can then be derived from the resulting calculated emissions, and the environmental risk assessed against Predicted No Effect Concentrations (PNECs). The default assumptions of the environmental emission scenarios provide a worst-case, and for some scenarios it is typical that additional data are required in order to refine the assessment and demonstrate acceptable risk (e.g. leaching data are often required for biocidal products that may leach from treated wood). Conducting a preliminary environmental risk assessment can therefore be invaluable towards establishing potential challenges demonstrating acceptable risk, whilst giving sufficient time for suitable refinements to be made if necessary (e.g. reducing active substance or SoC levels and/or generating additional data).

Human health

A preliminary risk assessment considers a ‘worst case’ scenario to establish whether the use of the biocidal product results in acceptable levels of exposure. Performing this step early allows sufficient time to refine the risk assessment if necessary (e.g. by reducing the level of active substance/s or SoC/s in the product and/or generating additional data).

Keep ahead of the shifting BPR landscape

Official guidance and requirements related to human health and environmental risks are changing constantly. Any biocidal product undergoing authorisation is likely to require risk analysis, either because previous obligations have become stricter or additional conditions have been introduced. For instance, a new and important area of guidance is the potential for livestock and dietary exposure.

In this shifting landscape, nothing can be taken for granted. Understanding how product data aligns with the current requirements for human health and environmental risk assessments is essential. Refining data, or generating new data, takes time. Identifying and addressing data gaps at an early stage avoids issues that could delay, or lead to denial of, authorisation.

This is the final part of a series on the authorisation of biocidal products in the EU and GB. We’ve previously looked at How to get a head-start on biocidal product renewal of authorisation and Substantiating biocidal product efficacy.

Good planning and preparation help reduce the burden of dossier preparation for biocidal product authorisation. Here at TSG, we have the knowledge and experience to ensure the process is seamless and cost-effective. Contact us at [email protected] to find out more.