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Assessment of the risk posed by biocides to non-professional users and the general public

The BfR assesses whether applications of biocidal products pose a health risk to non-professional users, to the general public or to pets and livestock. The BfR only agrees to the authorisation of a biocidal product if a corresponding risk can be excluded – if necessary, under specified conditions.

Exposure assessment

The BfR uses numerous exposure scenarios and initially conservative model parameters for its exposure assessment. The basic assumptions as well as a variety of exposure models are aligned throughout Europe and published in the guidelines of the European Chemicals Agency (ECHA) “Guidance on the Biocidal Products Regulation, Volume III, Parts B+C, Version 4.0, 2017” and “Biocides Human Health Exposure Methodology”. An important tool for exposure assessments is the ConsExpo programme, which covers numerous exposure scenarios.

The BfR assesses the exposure of non-professional users during and after use as well as the exposure of those present during or exposed after application, e.g. by entering treated rooms or via contact with treated objects.

Special consideration of children

When carrying out the exposure assessment for the general public, the BfR takes into account not only adults, but also children as their behaviour significantly differs from that of adults, especially in the first years of their life. Young children often put their fingers in their mouths or potentially swallow objects (e.g. sand, other small parts).

No further considerations are necessary if the determined exposure does not exceed the corresponding limit values. Otherwise, exposure is estimated more realistically and accurately using specific parameters. If necessary, the exposure estimate can be refined using measured data collected under the specific conditions of use.

Risk assessment

The health risk assessment is based on the toxicological assessment of the biocidal product and the exposure estimates described above. The risk is acceptable if the maximum expected exposure is below the respective toxicological limit (e.g. acceptable exposure level – AEL).

As a result, the BfR’s risk assessment includes:

• deriving a classification and labelling proposal according to CLP Regulation (EC) 1272/2008 regarding the toxicological aspects of preparations
• issuing restrictions on use or risk reduction measures to further reduce exposure
• further conditions for safely handling biocidal products

Personal protective measures, such as the use of gloves or protective clothing, are in general only considered for professional users. However, other measures, such as the use of ready-to-use biocidal products, bait boxes, child-resistant closures or water-soluble bags, are also suitable for protecting non-professional users or the general public.

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