In this guide

Statement on the EFSA Opinion on the risks to human health related to the presence of perfluoroalkyl substances in food

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

Last updated: 16 November 2022

In this guide

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.

Region, country

Year of sampling

Number of samples

Mean LB-UB (SEMa, SDb or 95% CIc) (ng/L)

Median (ng/L)

Range (ng/L)

LODa LOQb (ng/L)

Detection frequency (%)

Reference

Barcelona, Spain

2009

20

120#

84#

< LOQ-870

3.5a
11.7b

95#
(>LOQ)

Llorca et al., 2010

France

2010

30

78

74

24-170

2a

100

Kadar et al., 2011

Belgium

2009- 2010

40 (P & M)

130
(90 - 130)c

100

70 - 220 (P10 - P90)

10b

100 (>LOQ)

Croes et al., 2012

Bologna, Italy

2010

21 (P)

57 (13a)

NR

<LOQ - 290

15b

90
(>LOQ)

Barbarossa et al., 2013

Bologna, Italy

2010

16 (M)

36 (7a)

NR

<LOQ - 120

15b

63
(>LOQ)

Barbarossa et al., 2014

France

2010-2013

61

40*

<LOQ

<LOD - 380

NRa
40b

82 (>LOD)

Cariou et al., 2015

Czech Republic

2010

50

53
(sum of linear and branched means 33 and 20, respectively)

30
(linear)

7-110

5b

100 (>LOQ)

Lankova et al., 2013

Czech Republic

2010

50

54
(sum of linear and branched means 33 and 20, respectively)

17 (branched)

<LOQ - 63

10b

72 (>LOQ)

Lankova et al., 2014

Seine-Saint Denis, Ardèche, Isère, Loire and Savoie (France)

2007

48 (P)

92

79

<LOD - 330

50a

90
(>LOD)

Antignac et al., 2013

Ireland

Not identified in paper

16 (P) pooled samples

38

20

<20 - 120

20b

62
(>LOQ)

Abdallah et al., 2020

Stockholm, Sweden

2012

20

51#

45#

16 - 96

0.5a

100 (linear)
92.5 (branched)
(>LOD)

Nyburg et al., 2018

Gothenburg, Sweden

2012

16

44#

38#

13 - 100

0.5a

100 (linear)
91 (branched)
(>LOD)

Nyburg et al., 2019

Stockholm, Sweden

2016

10

46#

45#

24 - 72

0.5a

100 (linear)
70 (branched)
(>LOD)

Nyburg et al., 2020

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.

Region, country

Year of sampling

No. of samples

Mean LB-UB (SEMa, SDb or 95% CIc) (ng/L)

Median (ng/L)

Range (ng/L)

LODa LOQb (ng/L)

Detection frequency (%)

Reference

Barcelona, Spain

2008

20

150-151#

<LOQ#

< LOQ-907

4.5a
15.2b

45
(>LOQ)

Llorca et al., 2010

France

2010

30

59

57

18-102

3a

100

Kadar et al., 2011

Belgium

2009- 2010

40 (P & M)

80
(60 - 90)c

70

60 - 150 (P10 - P90)

10b

100 (>LOQ)

Croes et al., 2012

Bologna, Italy

2010

21 (P)

76 (14)a

NR

24 - 241

24b

81
(LOQ)

Barbarossa et al., 2013

Bologna, Italy

2010

16 (M)

43 (6)a

NR

24 - 100

24b

69
(>LOQ)

Barbarossa et al., 2013

France

2010-2013

61

41*

<LOQ

<LOD - 308

NRa
50b

77 (>LOD)

Cariou et al., 2015

Czech Republic

2010

50

50

44

12 - 128

6b

100 (>LOQ)

Lankova et al., 2013

Murcia, Spain

2014

67 (P & M)

54 (54)b

26

<LOQ - 211

10b

60
(>LOQ)

Guzman et al., 2016

Seine-Saint Denis, Ardèche, Isère, Loire and Savoie (France)

2007

48

82

75

<LOD - 224

50a

98
(>LOD)

Antignac et al., 2013

Ireland

Not identified in paper

16 (P) pooled samples

130

100

16 - 350

20b

100
(>LOQ)

Abdallah et al., 2020

Stockholm, Sweden

2012

20

53#

45#

23 - 102

2a

100
(>LOD)

Nyburg et al., 2018

Gothenburg, Sweden

2012

16

53#

49#

21 - 104

2a

100
(>LOD)

Nyburg et al., 2019

Stockholm, Sweden

2016

10

44#

42#

3 - 83

2a

100
(>LOD)

Nyburg et al., 2020

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

Region, country

Year of sampling

No. of samples

Mean LB-UB (SEMa, SDb or 95% CIc) (ng/L)

Median (ng/L)

Range (ng/L)

LODa LOQb (ng/L)

Detection frequency (%)

Reference

Belgium

2009- 2010

40 (P & M)

NC

<LOQ

<LOQ - 20 (P10 - P90)

10b

20 (>LOQ)

Croes et al., 2012

France

2010-2013

61

26*

<LOD

<LOD-217

10 - 30a
30b

15 (>LOD)

Cariou et al., 2015

Czech Republic

2010

50

NC

NC

<6 - 12

6b

8 (>LOQ)

Lankova et al., 2013

Seine-Saint Denis, Ardèche, Isère, Loire and Savoie (France)

2007

48

49

50

40 - 66

NRa,b

100
(>LOD)

Antignac et al., 2013

Ireland

Not identified in paper

16 (P) pooled samples

<40

<40

<40 - 87

40b

31
(>LOQ)

Abdallah et al., 2020

Stockholm, Sweden

2012

20

8.38

7.55

0.8 - 25.4

0.8a

95 (linear)
0 (branched)
(>LOD)

Nyburg et al., 2018

Gothenburg, Sweden

2012

16

5.60625

4.1

1.4 - 14.4

0.8a

94 (linear)
6 (branched)
(>LOD)

Nyburg et al., 2019

Stockholm, Sweden

2016

10

7.63

8.2

0.8 - 13.4

0.8a

80 (linear)
30 (branched)
(>LOD)

Nyburg et al., 2020

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.

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

Region, country

Year of sampling

No. of samples

Mean LB-UB (SEMa, SDb or 95% CIc) (ng/L)

Median (ng/L)

Range (ng/L)

LODa LOQb (ng/L)

Detection frequency (%)

Reference

Belgium

2009- 2010

40 (P & M)

NC

<LOQ

<LOQ - 20 (P10 - P90)

10b

43 (>LOQ)

Croes et al., 2012

France

2010-2013

0/61 quantified

11*

<LOD

<LOD-<LOD

NRa
50b

0 (>LOD)

Cariou et al., 2015

Czech Republic

2010

50

NC

NC

<6 - 15

6b

48 (>LOQ)

Lankova et al., 2013

Murcia, Spain

2014

67 (P & M)

41 (29)b

40

15 - 70

10b

6
(>LOQ)

Guzman et al., 2016

Seine-Saint Denis, Ardèche, Isère, Loire and Savoie (France)

2007

Detected 1/48

NC

NC

<LOD - 64

50a

2
(>LOD)

Antignac et al., 2013

Ireland

Not identified in paper

16 (P) pooled samples

26

14

<10 - 100

10b

69
(>LOQ)

Abdallah et al., 2020

Stockholm, Sweden

2012

20

15

15

3 - 30

2a

100
(>LOD)

Nyburg et al., 2018

Gothenburg, Sweden

2012

16

17

16

5 - 38

2a

100
(>LOD)

Nyburg et al., 2019

Stockholm, Sweden

2016

10

9.3

10

1 - 18

2a

70
(>LOD)

Nyburg et al., 2020

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.

Chemical

Average of reported median values (ng/L)

References

PFOS

53

Llorca et al., 2010; Kadar et al., 2011; Croes et al., 2012; Lankova et al., 2013; Antignac et al., 2013; Abdallah et al., 2020; and Nyburg et al., 2018

PFOA

56

Kadar et al., 2011; Croes et al., 2012; Lankova et al., 2013; Guzman et al., 2016; Antignac et al., 2013; Abdallah et al., 2020; and Nyburg et al., 2018

PFHxS

17

Antignac et al., 2013; and Nyburg et al., 2018

PFNA

19

Guzman et al., 2016; Abdallah et al., 2020; and Nyburg et al., 2018

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

Chemical

Average of reported maximum values

(ng/L)

References

PFOS

170*

Llorca et al., 2010; Kadar et al., 2011; Croes et al., 2012; Barbarossa et al., 2013; Cariou et al., 2015; Lankova et al., 2013; Antignac et al., 2013; Abdallah et al., 2020; and Nyburg et al., 2018

PFOA

180

Llorca et al., 2010; Kadar et al., 2011; Croes et al., 2012; Barbarossa et al., 2013; Cariou et al., 2015; Lankova et al., 2013; Guzman et al., 2016; Antignac et al., 2013; Abdallah et al., 2020; and Nyburg et al., 2018

PFHxS

30

Antignac et al., 2013; and Nyburg et al., 2018

PFNA

51

Guzman et al., 2016; Abdallah et al., 2020; and Nyburg et al., 2018

*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

PFOS concentration ng/L

0 to <4 months

(800 mL)

0 to <4 months

(1,200 mL)

4 to <6 months

(800 mL)

4 to <6 months

(1,200 mL)

PFOS concentration 53 ng/L

50

75

38

57

PFOS concentration 170 ng/L

160

240

120

180

PFOA concentration 56 ng/L

53

80

40

60

PFOA concentration 180 ng/L

170

260

130

190

PFHxS concentration 17 ng/L

16

24

12

18

PFHxS concentration 30 ng/L

28

43

22

32

PFNA concentration 19 ng/L

18

27

14

20

PFNA concentration 51 ng/L

48

73

37

55

Exposure values 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

References

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Antignac J-P, Veyrand B, Kadar H, Marchand P, Oleko A, Le Bizec B, and Vandentorren S. (2013). Occurrence of perfluorinated alkylated substances in breast milk of French women and relation with socio-demographical and clinical parameters: Results of the ELFE pilot study. Chemosphere. 91: 802-808.

Barbarossa A, Masetti R, Gazzotti T, Zama D, Astolfi A, Veyrand B, Pession A, Pagliuca G. (2013). Perfluoroalkyl substances in human milk: a first survey in Italy. Environment International. 51:27-30.
Available at:
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Cariou R, Veyrand B, Yamada A, Berrebi A, Zalko D, Durand S, Pollono C, Marchand P, Leblanc JC, Antignac JP, Le Bizec B. (2015). Perfluoroalkyl acid (PFAA) levels and profiles in breast milk, maternal and cord serum of French women and their newborns. Environment International. 84:71-81.
Available at:
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Croes K, Colles A, Koppen G, Govarts E, Bruckers L, Van de Mieroop E, Nelen V, Covaci A, Dirtu AC, Thomsen C, Haug LS, Becher G, Mampaey M, Schoeters G, Van Larebeke N, Baeyens W. (2012). Persistent organic pollutants (POPs) in human milk: a biomonitoring study in rural areas of Flanders (Belgium). Chemosphere. 89(8):988-94.
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Kadar H, Veyrand B, Barbarossa A, Pagliuca G, Legrand A, Bosher C, Boquien CY, Durand S, Monteau F, Antignac JP, Le Bizec B. (2011). Development of an analytical strategy based on liquid chromatography–high resolution mass spectrometry for measuring perfluorinated compounds in human breast milk: Application to the generation of preliminary data regarding perinatal exposure in France. Chemosphere. 85(3):473-80.
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Lankova D, Lacina O, Pulkrabova J, Hajslova J. (2013). The determination of perfluoroalkyl substances, brominated flame retardants and their metabolites in human breast milk and infant formula. Talanta. 117:318-25.
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Guzmàn M, Clementini C, Pérez-Cárceles MD, Jiménez Rejón S, Cascone A, Martellini T, Guerranti C, Cincinelli A. (2016). Perfluorinated carboxylic acids in human breast milk from Spain and estimation of infant's daily intake. The Science of the Total Environment. 544:595-600.
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Nyberg E, Awad R, Bignert A, Ek C, Sallsten G and Benskin JP. (2018). Inter-individual, inter-city, and temporal trends of per- and polyfluoroalkyl substances in human milk from Swedish mothers between 1972 and 2016. Environmental Science: Processes and Impacts. 20: 1136.