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Exposure estimation for biocides

Exposure of consumers when using biocidal products

Consumers are exposed to biocidal products in many different ways. People are exposed when using biocidal products by themselves, as well as when they are present during the application or when they get in contact with residues on treated objects, in the air or in foods. To guarantee the protection of consumers, exposure assessment is based on conservative assumptions. The basic assumptions and many different exposure models are harmonised throughout Europe and published in the Guidance on the Biocidal Products Regulation (Vol III, Parts B+C) and the Biocides Human Health Exposure Methodology.

Consumer exposure is estimated for the different uptake paths (dermal, inhalative, oral), for the relevant exposure situation (e.g. use of the biocide or contact with treated objects) and the exposed person groups (adults, children). These individual estimations are then combinedto give the overall contamination that is compared with the toxicologically derived tolerable values.

Please note: When estimating exposure it is generally not assumed that consumers wear protective gloves or protective clothing. However, product-integrated risk reduction measures, such as childproof closures or small packaging units, are taken into account,.

The exposure of professional users of biocidal products (e.g. pest controllers, cleaning personnel, tradesmen or livestock farmers) is assessed by the Federal Institution for Occupational Safety and Health. The Federal Environment Agency is responsible for environmental exposure.

Program for calculating consumer exposure via food

The use of biocidal products in private households may result in biocidal residues in food. On the one hand the biocidal active substance can come into direct contact with food, on the other hand residues from contaminated surfaces can be transferred onto the food.

A guideline on the risk assessment of the transfer of biocidal active substances to foods through non-professional applications was prepared on European level which covers various scenarios (ECHA Guidance on the Biocidal Products Regulation, Volume III, Parts B+C, Version 4.0, 2017, Section 5). In order to facilitate the respective exposure estimates the BfR hereby provides an Excel-based courtesy tool based on the respective guidance document.

The calculation program and guideline are aimed at evaluation authorities and applicants who estimate consumer exposure through the transfer of biocidal product residues to foods in private households.

The calculation program and related information can be found here:

• https://www.bfr.bund.de/cm/343/bfr-calculator-for-estimating-transfer-of-biocide-residues-into-foods-non-professional-uses.xlsx (128.1 KB)
• https://www.bfr.bund.de/cm/349/bfr-calculator-for-estimating-consumer-exposure-to-biocide-residues-in-food.pdf (37.4 KB)

BfR calculator for estimating the external exposure of livestock to biocidal active substances

The use of biocides in animal husbandry can lead to the exposure of livestock. This may lead to the formation of residues in foods of animal origin. A guideline has been prepared on European level to estimate the exposure of agricultural livestock to biocidal active substances (ECHA Guidance on the Biocidal Products Regulation, Volume III, Parts B+C, Version 4.0, 2017, Section 6). In order to facilitate the respective exposure estimates the BfR hereby provides an Excel-based courtesy tool based on the respective guidance document.

The updated version of the BfR calculator (v2, 2021) now also allows for calculating consumer exposure based on prior exposure of livestock (see also EMA guideline: EMA/CVMP/90250/2010). The respective model uses food consumption data for food of animal origin from the EFSA calculation model PRIMo and the EMA „Food Basket“ (Commission Regulation (EU) 2018/782).

The updated version of the Excel-based calculation program (v2, 2021) and related information can be found here:

• https://www.bfr.bund.de/cm/343/bfr-calculator-for-estimating-livestock-exposure-to-active-substances-used-in-biocidal-products.xlsm (309.5 KB)
• https://www.bfr.bund.de/cm/349/bfr-calculator-for-estimating-external-exposure-of-livestock-animals-to-biocidal-active-substances.pdf (309.5 KB)

As a further update, the BfR has developed a web application that now allows estimating livestock exposure and the resulting consumer exposure even more specifically and user friendly.

The web application guides the user step-by-step through the tiered assessment approach as described in the ECHA and EMA guidance documents. Input information and choices regarding parameters and assumptions are explained step-by-step and are tailored to the previously specified applications of the biocidal product. Finally, a report in Excel-format may be downloaded providing calculation results (livestock exposure, residues in food of animal origin, consumer dietary exposure) including the applied parameters, assumptions and refinements.

For web application klick here:

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