2.1.5. HBM4EU

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 in the absence of sufficient quantitative data, the biological limit value is calculated on the basis of another effect; the BLV* is then called a "pragmatic BLV*”. This latter value does not guarantee the absence of health effects, but aims to limit exposure to these substances in the workplace.

ANSES also recommends biological reference values (BRVs*), which correspond to concentrations found in a general population whose characteristics are similar to those of the French population. These BRV*s cannot be considered to offer protection from the onset of health effects, but allow a comparison with the concentrations of biomarkers assayed in exposed workers). More information about derivation methods can be found in (ANSES, 2014, 2017)

2.1.5. HBM4EU*

HBM4EU* is a joint effort of 30 countries, the European Environment Agency and the European Commission, co-funded under Horizon 2020 (HBM4EU website, 2021), Within the framework of the HBM4EU five years project (from 2017 to 2021), human biomonitoring guidance values HBM-GV*for the general population and for workers have been derived. It should be noted that these values are recommendations from a research project and do not have any regulatory status. Values are published for Cadmium (Lamkarkach et al., 2021), Bisphenol A (Ougier et al., 2021), Phthalates and DINCH (Lange et al., 2021) and the Pyrrolidones NMP and NEP (David et al., 2021). Further information and values are available in the Deliverables D 5.2, D 5.6 and D 5.9 and D 5.12 on the HBM4EU website.

The methodology of HBM-GVs derivation is based on existing derivation schemes as used by the German Human Biomonitoring Commission (German HBM Commission 1996, 2007, 2014) regarding the general population and the French Agency for Food, Environmental and Occupational Health & Safety (ANSES (2014)) regarding the occupational field. The data collection on the substances of concern is based as a priority on recently published reports, if available. These reports can be issued from established EU bodies, such as SCOEL*, EFSA*, EU* (risk assessment reports (RAR)), international organisations (e.g., WHO*, IARC), and relevant national scientific committees (e.g., DECOS, MAK*, US-EPA, ATSDR, US NIOSH, German HBM Commission, ANSES*). REACH registration dossiers and the recent peer- reviewed literature are also be considered for additional and/or new data, but an exhaustive review of the scientific literature is not performed (Apel et al., 2020).

Options for deriving HBM-GVs*

Three options are available (for both HBM-GV*GenPop and HBM-GV*Workers). The 1st and 2nd options correspond to options already described above by SCOEL* and ANSES*. However, there is a 3rd possible option, on the basis of the HBM-I value and BEPOD* approach. This approach consists of extrapolating a critical dose (POD*) identified in a key animal study into a human internal concentration of a selected biomarker. After applying assessment factors to convert the POD* to a ‘toxicity reference value (TRV*)-like’ value, the next step is to calculate the internal concentration of the substance/its biomarker(s) corresponding to the ‘TRV-like’ value (via PBK* modelling or a simple urinary mass balance approach) (for further details see Apel et al., 2020).

A global level of confidence (LoC) (high, medium or low) is attributed to each derived HBM-GV reflecting the uncertainties underlying its derivation. The LoC* is attributed regarding the selected option of derivation, nature and quality of toxicological and toxicokinetic data; choice of the critical effect and the mode of action; the selection of critical dose; and the selection of the key study. More information about derivation methods can be found in (Apel et al., 2020). Examples on the allocation of confidence levels are given in annex A).

OCCUPATIONAL BIOMONITORING GUIDANCE DOCUMENT © OECD 2022