Risks of PFAS for human health in Europe (Signal)

Key messages: Teenagers in Europe face health risks from exposure to toxic per- and polyfluoroalkyl substances (PFAS) according to a series of studies conducted between 2014 and 2021. Of the teenagers who participated in the studies, an average of 14.3% had blood levels above the health-based guidance value (HBGV), with two countries exceeding 20%. Given the large number of PFAS and their widespread use, these results highlight the need for further upstream restrictions of these substances as a group, to limit human exposure to other PFAS substances not yet regulated.

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Chemicals are prioritised for human biomonitoring based on their health risks and EU policy relevance. PFAS is one such prioritised group of synthetic chemicals, toxic to both human health and the environment. Found in everyday items such as clothes, cosmetics and even food wrappers, PFAS are also called ‘forever chemicals’ as some do not break down in the environment and therefore accumulate over time.

Nine studies carried out in eight EU countries and Norway calculated the PFAS risk as the ratio between the exposure levels measured in the general European teenager population (12- to 18-year-olds) for four different types of PFAS and the European Food Safety Authority’s established health-based guidance value (HBGV) for these substances. A ratio greater than 1 implies that health risks from PFAS cannot be excluded.

For the 2014-2021 period covered by the studies, the risk of adverse health effects from the four PFAS could not be excluded, on average, for 14.3% of the tested teenagers. The exceedances of HBGV levels ranged from 1.34 % in Spain to up to 23.78% in France. The measured PFAS are currently regulated in the EU.

The studies show geographical differences in exposure to the four PFAS and their sum, with higher median values observed in northern and western Europe. The main source of PFAS exposure for the general population (as compared to occupational exposure) have been shown to be through diet but some exposure also occurs through the skin via cosmetics and clothing.

Only a series of PFAS is currently regulated by EU legislation, including the Persistent Organic Pollutants (POPs) Regulation,the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Regulation, and the Drinking Water Directive. A broad REACH restriction proposal was submitted to the European Chemicals Agency (ECHA) in 2023 by five national authorities to phase out the use of all persistent PFAS (around 10,000 substances) with time limited derogations. The breadth of this proposed restriction follows the grouping approach for preventing regrettable substitution of chemicals, as promoted under the Chemicals Strategy for Sustainability (CSS). Addressing all substances of similar structures would ensure that chemicals are not replaced with substances that have comparable hazardous properties and thereby help reduce the risk to both human health and the environment.

In combination with environmental monitoring, future human biomonitoring will be essential to track long-term trends of previously- and currently-used chemicals like PFAS while detecting emerging chemicals of concern in, for example, cases of regrettable substitutions. The EU Partnership for the Assessment of Risk from Chemicals (PARC) will help deliver on this.

The HBM4EU Aligned Studies survey — from the EU-funded HBM4EU project (2016-2022) — is used to generate baseline levels of internal concentrations of the four PFAS under consideration.

The survey aimed to collect human biomonitoring samples and data that were as harmonised as possible from (national) studies. The goal was to derive current internal exposure data representative for the European population across a geographic spread.

The monitored PFAS are perfluorooctanoic acid (PFOA), perfluorononanoic acid (PFNA), perfluorohexanesulfonic acid (PFHxS) and perfluorooctanesulfonic acid (PFOS). Although these PFAS substances are already restricted in the EU, they are the four most commonly-detected PFAS in human blood and are among the PFAS the European population is exposed to due to their persistence. The exposure values used to estimate exceedance are from the higher end of the exposure distribution, i.e. the 95^th percentiles.

PFAS concentration in the Norwegian NEB II study and the German GerES V study were determined using blood plasma samples taken from participating teenagers, while the seven other studies measured PFAS in blood serum samples. The data are comparable in terms of study population, matrix, sampling period, analytical method and laboratory performance.

EFSA has set the safety threshold for intake as sum values of the four PFAS of 4.4 ng/kg body weight per week, which corresponds to an internal blood level of 6.9 μg/L. This is also the guidance value used by the HBM4EU project consortium to calculate risk.

Disclaimer: Differences in the sampling designs and analytical methods, uncertainties around HBGVs and the limited temporal range and resolution of human biomonitoring data argue for caution in the interpretation of the reported values.

More information on the chemical analyses can be found in Esteban López et al. (2021), HBM4EU (2021) and on the HBM4EU indicators in Buekers et al. (2018) and Lobo Vicente et al. (2022a; 2022b).

More information on HBM4EU project can be found on its website.

References and footnotes

Apel, P., et al., 2020, ‘Human biomonitoring initiative (HBM4EU) - Strategy to derive human biomonitoring guidance values (HBM-GVs) for health risk assessment’, International Journal of Hygiene and Environmental Health 230, p. 113622.
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Ingelido, A. M., et al., 2018, ‘Biomonitoring of perfluorinated compounds in adults exposed to contaminated drinking water in the Veneto Region, Italy’, Environment International 110, pp. 149-159.
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Numata, J., et al., 2014, ‘Toxicokinetics of seven perfluoroalkyl sulfonic and carboxylic acids in pigs fed a contaminated diet’, Journal of Agricultural and Food Chemistry 62(28), pp. 6861-6870.
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EU, 2019, Regulation (EU) 2019/1021 of the European Parliament and of the Council of 20 June 2019 on persistent organic pollutants (recast) (Text with EEA relevance.) (OJ L 169, 25.6.2019, pp. 45-77).
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EU, 2006, Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, pp. 1-849).
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EU, 2020, Directive (EU) 2020/2184 of the European Parliament and of the Council of 16 December 2020 on the quality of water intended for human consumption (recast) (OJ L 435, 23.12.2020, pp. 1-62).
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EC, 2020, COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE COUNCIL, THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE AND THE COMMITTEE OF THE REGIONS Chemicals Strategy for Sustainability Towards a Toxic-Free Environment (COM(2020) 667 final of 14 October 2020) (https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:52020DC0667) accessed 26 April 2023.
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Ehresman, D. J., et al., 2007, ‘Comparison of human whole blood, plasma, and serum matrices for the determination of perfluorooctanesulfonate (PFOS), perfluorooctanoate (PFOA), and other fluorochemicals’, Environmental Research 103(2), pp. 176-184.
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Gilles, L., et al., 2021, ‘HBM4EU combines and harmonises human biomonitoring data across the EU, building on existing capacity – The HBM4EU survey’, International Journal of Hygiene and Environmental Health 237, p. 113809.
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Gilles, L., et al., 2022, ‘Harmonization of Human Biomonitoring Studies in Europe: Characteristics of the HBM4EU-Aligned Studies Participants’, International Journal of Environmental Research and Public Health 19(11), p. 6787.
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Esteban López, M., et al., 2021, ‘The European human biomonitoring platform - Design and implementation of a laboratory quality assurance/quality control (QA/QC) programme for selected priority chemicals’, International Journal of Hygiene and Environmental Health 234, p. 113740.
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HBM4EU, 2021, ‘HBM European Network’, HBM4EU (https://www.hbm4eu.eu/what-we-do/european-hbm-platform/hbm-european-network/) accessed 10 July 2022.
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Buekers, J., et al., 2018, ‘Development of Policy Relevant Human Biomonitoring Indicators for Chemical Exposure in the European Population’, International Journal of Environmental Research and Public Health 15(10), p. 2085.
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Lobo Vicente, j., et al., 2022, ‘AD5.6 Policy implications of the indicators’, HBM4EU (https://www.hbm4eu.eu/result/deliverables/) accessed 18 August 2022.
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Lobo Vicente, J., et al., 2022, ‘AD5.3 Case-study report on HBM-indicators’, HBM4EU (https://www.hbm4eu.eu/result/deliverables/) accessed 18 August 2022.
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Risks of PFAS for human health in Europe (Signal)

Share of teenagers in Europe exposed to PFAS levels exceeding the EFSA health-based guidance value (HBGV), 2014-2021

Relevant objectives under the Chemicals Strategy for Sustainability

Other relevant indicators and signals

References and footnotes