Annex A - Statement for use of the EFSA 2020 Opinion on the risks to human health related to the presence of perfluoroalkyl substances in food in UK risk assessments

Breast milk exposures

1.              A literature search was carried out for concentrations of PFAS in human breast milk. There were no UK data. Only data from countries in the EU with breast milk samples taken after 2008 were considered. Only those that had median and/or maximum values were included in the exposure calculations. Tables 1 to 4 show the studies and breast milk concentrations for PFOS, PFOA, PFHxS and PFNA, respectively.

Table 1. Concentrations of PFOS in breast milk in EU studies where breast milk samples were taken after 2008.

Values are given to 2 significant figures. P – primiparous; M – multiparous; SEM – standard error of the mean; LB - lower bound assigns the value of zero to non-quantified data; UB - upper bound assigns the value of the LOD/LOQ to non-quantified data; SD – standard deviation; 95% CI – 95th percent confidence interval; NR – not reported; LOD – limit of detection; LOQ – limit of quantification P10 – P90 – 10th to 90th percentiles. *identified by year; #calculated from individual data in the published paper.

Table 2. Concentrations of PFOA in breast milk in recent EU studies where breast milk samples were taken after 2008.

Values are given to 2 significant figures. P – primiparous; M – multiparous; SEM – standard error of the mean; LB - lower bound assigns the value of zero to non-quantified data; UB - upper bound assigns the value of the LOD/LOQ to non-quantified data; SD – standard deviation; 95% CI – 95^th percent confidence interval; NR – not reported; LOD – limit of detection; LOQ – limit of quantification P10 – P90 – 10^th to 90^th percentiles. *identified by year; ^#calculated from individual data in the published paper.

Table 3. Concentrations of PFHxS in breast milk in recent EU studies where breast milk samples were taken after 2008.

Values are given to 2 significant figures. P – primiparous; M – multiparous; SEM – standard error of the mean; LB - lower bound assigns the value of zero to non-quantified data; UB - upper bound assigns the value of the LOD/LOQ to non-quantified data; SD – standard deviation; 95% CI – 95^th percent confidence interval; NC not calculated; NR – not reported; LOD – limit of detection; LOQ – limit of quantification P10 – P90 – 10^th to 90^th percentiles. *identified by year; ^#calculated from individual data in the published paper.

Table 4. Concentrations of PFNA in breast milk in recent EU studies where breast milk samples were taken after 2008.

Values are given to 2 significant figures. P – primiparous; M – multiparous; SEM – standard error of the mean; LB - lower bound assigns the value of zero to non-quantified data; UB - upper bound assigns the value of the LOD/LOQ to non-quantified data; SD – standard deviation; 95% CI – 95th percent confidence interval; NC not calculated; NR – not reported; LOD – limit of detection; LOQ – limit of quantification P10 – P90 – 10th to 90th percentiles. *identified by year; #calculated from individual data in the published paper.

2.  In the absence of a suitable UK study of PFAS in breast milk, data from EU studies for which all samples were taken after 2008 have been used to calculate exposures to PFAS from breast milk in this paper.  The exposure estimates are based on concentrations derived as an average of the median (Table 5) or maximum (Table 6) values reported in the literature.

Table 5. Concentrations (ng/L) derived as an average of the median values reported in the literature.

Table 6. Concentrations (ng/L) derived as an average of the maximum values reported in the literature.

*The maximum PFOS value in the Llorca et al., (2010) study was from an individual and was approximately 5 – 30-fold higher than all other measure values. Therefore, the second highest value from this study was used.

3.                 No consumption data were available for exclusive breastfeeding in infants aged 0 to 6 months. Therefore, the default consumption values used by the COT in other evaluations of the infant diet of average (800 mL) and high-level (1200 mL) consumption have been used to estimate exposures to PFOS and PFOA from breast milk. Bodyweights of 5.9 and 7.8 kg were used for infants aged 0 - <4 and 4 - <6 months, respectively.

4.                 For the average median PFASs concentrations in breast milk the following ranges of exposures were calculated which included average and high consumers:

• PFOS: 38 – 75 ng/kg bw per week
• PFOA: 40 – 80 ng/kg bw per week
• PFHxS: 12 – 24 ng/kg bw per week
• PFNA: 14 – 27 ng/kg bw per week

5.                 For the average maximum PFASs concentrations in breast milk the following ranges of exposures were calculated which included average and high consumers:

• PFOS: 120 - 240 ng/kg bw per week
• PFOA: 130 - 260 ng/kg bw per week
• PFHxS: 22 - 43 ng/kg bw per week
• PFNA: 37 - 73 ng/kg bw per week

Table 7. Estimated PFOS, PFOA, PFHxS and PFNA exposure (ng/kg bw per week) in 0 to 6-month-old infants and from breast milk

Exposurevalues were calculated based on default consumption values of 800 and 1200 mL for average and high-level exclusive consumption of breast milk and expressed on a bodyweight (5.9 kg for infants aged 0-4 months and 7.8 kg for infants aged 4 to < 6 months) basis.

COT
October 2022
Statement Number 04/22

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