Extensive literature search and provision of summaries of studies related to the oral toxicity of perfluoroalkylated substances (PFASs), their precursors and potential replacements in experimental animals and humans. Area 1: Data on toxicokinetics (absorption, distribution, metabolism, excretion) in in vitro studies, experimental animals and humans. Area 2: Data on toxicity in experimental animals. Area 3: Data on observations in humans

The European Commission asked EFSA for a scientific evaluation on the risks to human health related to the presence of perfluoroalkyl substances ( PFAS s) in food. Based on several similar effects in animals, toxicokinetics and observed concentrations in human blood, the CONTAM Panel decided to perform the assessment for the sum of four PFAS s: PFOA , PFNA , PFH xS and PFOS . These made up half of the lower bound ( LB ) exposure to those PFAS s with available occurrence data, the remaining contribution being primarily from PFAS s with short half‐lives. Equal potencies were assumed for the four PFAS s included in the assessment. The mean LB exposure in adolescents and adult age groups ranged from 3 to 22, the 95th percentile from 9 to 70 ng/kg body weight (bw) per week. Toddlers and ‘other children’ showed a twofold higher exposure. Upper bound exposure was 4‐ to 49‐fold higher than LB levels, but the latter were considered more reliable. ‘Fish meat’, ‘Fruit and fruit products’ and ‘Eggs and egg products’ contributed most to the exposure. Based on available studies in animals and humans, effects on the immune system were considered the most critical for the risk assessment. From a human study, a lowest BMDL 10 of 17.5 ng/ mL for the sum of the four PFAS s in serum was identified for 1‐year‐old children. Using PBPK modelling, this serum level of 17.5 ng/ mL in children was estimated to correspond to long‐term maternal exposure of 0.63 ng/kg bw per day. Since accumulation over time is important, a tolerable weekly intake ( TWI ) of 4.4 ng/kg bw per week was established. This TWI also protects against other potential adverse effects observed in humans. Based on the estimated LB exposure, but also reported serum levels, the CONTAM Panel concluded that parts of the European population exceed this TWI , which is of concern.

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“…The search was performed in March 2013. The methodology and the results are detailed in Bull et al (2014).…”

Section: Literature Search and Appraisal Of Studiesmentioning

confidence: 99%

Risk to human health related to the presence of perfluoroalkyl substances in food

Schrenk¹,

Bignami²,

Bodin³

et al. 2020

EFS2

304

265

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“…The search was performed in March 2013, covering the period 2008-2013, for PFOS and PFOA. The methodology and the results are detailed in Bull et al (2014).…”

Section: Literature Search and Appraisal Of Studiesmentioning

confidence: 99%

Risk to human health related to the presence of perfluorooctane sulfonic acid and perfluorooctanoic acid in food

Knutsen¹,

Alexander²,

Barregård³

et al. 2018

EFS2

180

199

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The European Commission asked EFSA for a scientific evaluation on the risks to human health related to the presence of perfluorooctane sulfonic acid (PFOS) and perfluorooctanoic acid (PFOA) in food. Regarding PFOS and PFOA occurrence, the final data set available for dietary exposure assessment contained a total of 20,019 analytical results (PFOS n = 10,191 and PFOA n = 9,828). There were large differences between upper and lower bound exposure due to analytical methods with insufficient sensitivity. The CONTAM Panel considered the lower bound estimates to be closer to true exposure levels. Important contributors to the lower bound mean chronic exposure were 'Fish and other seafood', 'Meat and meat products' and 'Eggs and egg products', for PFOS, and 'Milk and dairy products', 'Drinking water' and 'Fish and other seafood' for PFOA. PFOS and PFOA are readily absorbed in the gastrointestinal tract, excreted in urine and faeces, and do not undergo metabolism. Estimated human half-lives for PFOS and PFOA are about 5 years and 2-4 years, respectively. The derivation of a health-based guidance value was based on human epidemiological studies. For PFOS, the increase in serum total cholesterol in adults, and the decrease in antibody response at vaccination in children were identified as the critical effects. For PFOA, the increase in serum total cholesterol was the critical effect. Also reduced birth weight (for both compounds) and increased prevalence of high serum levels of the liver enzyme alanine aminotransferase (ALT) (for PFOA) were considered. After benchmark modelling of serum levels of PFOS and PFOA, and estimating the corresponding daily intakes, the CONTAM Panel established a tolerable weekly intake (TWI) of 13 ng/kg body weight (bw) per week for PFOS and 6 ng/kg bw per week for PFOA. For both compounds, exposure of a considerable proportion of the population exceeds the proposed TWIs.

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“…Perfluoroalkane sulfonic acids (PFSAs) and perfluoroalkyl carboxylic acids (PFCAs) are highly persistent chemicals with a toxicological characterization continuously in progress (Joensen et al, 2009;Stahl et al, 2009;Lindström et al, 2011;Bull et al, 2014). Perfluorooctane sulfonate (PFOS), perfluorooctanoic acid (PFOA), and other long-chained PFSAs (with 6 or more perfluorinated carbons) and PFCAs (with 7 or more perfluorinated carbons) bioaccumulate and biomagnify despite their water solubility (Martin et al, 2004;Conder et al, 2008).…”

Section: Introductionmentioning

confidence: 99%

Pathways and factors for food safety and food security at PFOS contaminated sites within a problem based learning approach

Brambilla

D’Hollander

Oliaei³

et al. 2015

Chemosphere

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Cited by 14 publications

References 105 publications

Risk to human health related to the presence of perfluoroalkyl substances in food

Risk to human health related to the presence of perfluoroalkyl substances in food

Risk to human health related to the presence of perfluorooctane sulfonic acid and perfluorooctanoic acid in food

Pathways and factors for food safety and food security at PFOS contaminated sites within a problem based learning approach

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