Risk Assessment of Biocide Residues in Food
The BfR is assessing whether residues in or on foods resulting from biocidal applications pose a risk to consumers. Residue levels in foods must be so low that they cannot damage human health when consumed either daily over the course of a lifetime or only once in large quantities.
The BfR evaluates whether this prerequisite is satisfied for every single use prior to authorisation of a biocidal product. The BfR also assesses the risk of biocide residues in food detected within the context of food monitoring.
How are residues transferred into food?
With insecticides and disinfectants in particular, and to a lesser extent with wood preservatives and other products, applications which can lead to a contamination of foods and feeds are of significance. Examples of these are:
- The disinfection of animal housing where transfer of residues from feed or treated surfaces to foods of animal origin is possible
- The treatment of wooden crates with a wood preservative and subsequent use thereof for the storage or transport of food
- Disinfection in kitchen areas where the biocidal product comes in contact with food or
- The treatment of food storage areas with insecticides
Guidelines for exposure estimation
Specific guidelines for the estimation and assessment of biocide residues in foods of animal and plant origin are currently available for:
- Applications concerning the exposure of food-producing animals (Guidance on the Biocidal Products Regulation, Vol III Parts B+C, section 6, Guidance on Estimating Livestock Exposure to Active Substances used in Biocidal Products
https://echa.europa.eu/documents/10162/23036412/biocides_guidance_human_health_ra_iii_part_bc_en.pdf/30d53d7d-9723-7db4-357a-ca68739f5094
- Use of biocidal products in private households by non-professional users (Guidance on BPR: Volume III, Part B+C, Human Health – Assessment & Evaluation, Section 5, Guidance on Estimating Dietary Risk from Transfer of Biocidal Active Substances into Foods – Non-professional Uses
https://echa.europa.eu/documents/10162/23036412/biocides_guidance_human_health_ra_iii_part_bc_en.pdf/30d53d7d-9723-7db4-357a-ca68739f5094
To date there are no harmonised guidelines covering the application of biocidal products by professional users (excluding uses in livestock farming). A residue assessment must nevertheless be presented by the applicant for these applications too. It should be based on the principles contained in the above-mentioned guidelines.
Regarding applications comparable to plant protection (e.g. the treatment of stored foods), the BfR currently refers to guidelines that were developed for the assessment of plant protection product residues. Apart from this, it is decided case by case which data are required for the assessment of consumer exposure.
EU working group ARTFood
The development of suitable approaches for the assessment of biocide residues in foods is one of the tasks of the EU working group ARTFood, i.e. the ad hoc working group “Assessment of Residue Transfer into Food“ of the ECHA Biocidal Product Committee (formerly DRAWG, Dietary Risk Assessment Working Group). ARTFood consists of experts from several EU member states, including representatives of the BfR.
The above-mentioned guidelines were established in the working group’s first two projects: (1) to estimate the exposure of food-producing animals and (2) to estimate consumer exposure to biocide residues in food (from the use of biocides in private households by non-professional users). In a third project, a guideline is now being prepared for the residue assessment of biocidal applications by professional users excluding uses in livestock farming.
BfR risk assessment
The BfR is assessing the risk for consumers by comparing the quantity of residue consumers ingest with their food (exposure) with its toxicity. To assess life-long consumer exposure, uptake of residues is calculated based on mean food consumption and mean residue levels and the result is compared to the toxicological reference value ADI. To assess a singular food consumption event, exposure is calculated from a large amount of food and the highest residue level that can be expected or measured and compared with the toxicological reference value ARfD. When establishing toxicological reference values, the BfR works on the basis of international standards.