ISES 2015, Henderson, Nevada
French consumer probabilistic exposure to cosmetic products: A national survey Ficheux AS, Wesolek N, Chevillotte G, Bernard A, Roudot AC. Laboratory of risk assessment for consumer
SCIENCES TECHNOLOGIES SANTÉ
Background
European regulation (EC) No 1223/2009 A cosmetic product must be safe for human health be evaluated for its safety prior to marketing Toxicological data Exposure data
Exposure equation: Exposure to cosmetic product (mg/kg bw/day)
Frequency of use (day-1)
=
X
Amount per use (mg/use)
X
Retention factor
Body weight (kg bw) 2
Background
European exposure data al., 2007)
12 cosmetic products Adult population
(Hall et al., 2007 et 2011 ; McNamara et
Data used by the Scientific Committee on Consumer Safety (SCCS)
Aim of the study: to create a French database of exposure 140 products Adults – Children – babies ♀, pregnant ♀ and ♂ January 2013 – June 2016
3
140 cosmetic products
Hands and Feet
Hair
Cream, exfoliating scrub, deodorant, polish…
Shampoo (liquid, dry), mask, lacquer, wax, dying products …
Face
Body Shower gel, wipes, deodorants, moisturizers, massage, hair bleach, sunscreens…
Soap, micellar water, exfoliating scrub, moisturizers, make-up, toothpaste, mouthwash, after shave …
Baby Wipes, milk, lotion, cream, eau de toilette, massage… 4
Methods
Supplementary data (wipes, dye)
Validation of the frequency enquiry
24 hours recall enquiry Frequency enquiry Web 7.100 people Quotas: nationally representative panel 140 products Sept. 2013
Phone 11.000 personnes Quotas 100 products Oct. 2013 – Sept. 2014
Percentage of users, Frequency of use, Body weight
Web enquiry 1.500 people Quotas Oct. 2014
Face to face enquiry 1.200 people 4 cities Adults ♀et ♂ Girls 13-17 ans Babies 100 products Amount per use
5
Supplementary data (wipes, dye)
Methods Validation of the frequency enquiry o
24 hours recall enquiry Phone
Frequency enquiry
11.000 personnes Quotas
Web 7.131 people Quotas: nationally representative panel
100 products Oct. 2013 – Sept. 2014
140 products
Percentage of users, Frequency of use, Body weight
Sept. 2013
Probabilistic exposure assessment (Monte carlo method)
Frequency
x
Amount
Body weight
x
P50
P90
Web enquiry 1.500 people Quotas Oct. 2014
Face to face enquiry 1.200 people 4 cities Adults ♀et ♂ Girls 13-17 ans Babies 100 products Amount per use
Retention factor
= Exposure (mg/kg bw/d)
6
Preliminary results Exposure assessment
(in function of sex and age) Example with hair cosmetics Probabilistic exposure assessment
Frequency
x
x Amount
Body weight
P50
P90
Retention factor
= Exposure (mg/kg bw/d) 7
Exposure of the French population to liquid shampoo
Liquid shampoo exposure (mg/kg bw/day) Age groups (years old)
Pregnant women
Girls / Women
Boys / Men
4-9
10-14
15-39
40-59
≥ 60
≥ 15
4-9
15-59
≥ 60
Mean
1,17
1,16
1,21
0,90
0,48
0,90
1,00
0,54
0,41
Median (P50)
0,82
0,72
0,77
0,55
0,31
0,56
0,71
0,34
0,26
P90
2,49
2,55
2,58
1,97
1,03
1,93
2,10
1,21
0,95
P95
3,23
3,64
3,73
2,86
1,47
2,91
2,55
1,73
1,31
Comparison of P90 values: ♂ ≥ 60 ans : the lowest exposure value to liquid shampoo ♀ 15-39 years old : the highest exposure value to liquid shampoo Factor 2.7 8
Exposure of French population to liquid shampoo and conditioner Comparison with SCCS data
Exposure assessment (mg/kg bw/day) SCCS (P90)
This study (P90)
Ratio This study / SCCS
Liquid shampoo
1,51
Conditioner
0,6
0,95 (Men ≥ 60 years old) 1,03 (Women ≥ 60 years old) 1,21 (Men 15-59 years old) 1,93 (Pregnant women ≥ 15 years old) 1,97 (Women 40-59 years old) 2,10 (Boys 4-9 years old) 2,49 (Girls 4-9 years old) 2,55 (Girls 10-14 years old) 2,58 (Women 15-39 years old) 0,59 (Women ≥ 60 years old) 0,78 (Men ≥ 15 years old) 1,34 (Pregnant women ≥ 15 years old) 1,38 (Women 15-59 years old) 1,78 (Girls 10-14 years old)
0,6 0,7 0,8 1,3 1,3 1,4 1,6 1,7 1,7 1 1,3 2,2 2,3 3
Percentile value equal to SCCS P90 P97 P95 P93 P85 P85 P78 P78 P78 P77 P90 P83 P71 P69 P55
9
shampoo
1,03 (Women ≥ 60 years old) 1,21to(Men 15-59 products years old) Exposure of French population hair styling Comparison with SCCS data 1,93 (Pregnant women ≥ 15 years old) 1,97 (Women 40-59 years old) 2,10 (Boys 4-9 years old) 2,49 (Girls 4-9 years old) 2,55 (Girls 10-14 years old) 2,58 (Women 15-39 years old) Conditioner 0,6 0,59 (Women ≥ 60 years old) (Men ≥ 15(mg/kg years old) Exposure0,78 assessment bw/day) 1,34 (Pregnant women ≥ 15 years old) 1,38 15-59 years old) SCCS (P90) This(Women study (P90) 1,78 (Girls 10-14 years old) Liquid 1,51 0,95 (Pregnant (Men ≥ 60women years old) Lacquer 5,74 3,53 ≥ 15 years old) shampoo 1,03 (Men (Women 60 years 4,48 ≥ 15≥ years old)old) 1,21 (Women (Men 15-59 years old)old) 4,50 15-39 years 1,93 (Women (Pregnant≥women ≥ old) 15 years old) 5,31 40 years 1,97 (Girls (Women 40-59 years 7,18 10-14 years old)old) 2,10 (Men (Boys ≥4-9 Gel 5,74 3,78 60years yearsold) old) 2,49 (Pregnant (Girls 4-9 years old) 3,92 women ≥ 15 years old) 2,55 (Women (Girls 10-14 years old) 4,64 ≥ 15 years old) 2,58 (Men (Women 15-39 years 5,62 25-59 years old)old) Conditioner 0,6 0,59 (Men (Women ≥ 60 years old) 7,10 15-24 years old) 0,78 (Women (Men ≥ 15≥ years old)old) Foam 5,74 8,80 40 years 1,34 (Pregnant 18,73 (Pregnantwomen women≥≥1515years yearsold) old) 1,38 (Women 20,71 (Women15-59 15-39years yearsold) old) 1,78 (Girls 10-14 years old) Wax 5,74 1,22 (Pregnant women ≥ 15 years old) Lacquer 5,74 3,53 (Women (Pregnant≥women ≥ old) 15 years old) 1,41 15 years 4,48 (Men ≥ 15 years old) 3,33 4,50 (Pregnant (Women 15-39 years Spray 5,74 1,83 women ≥ 15old) years old) 5,31 (Women ≥ 40 years old) 2,10 15 7,18 (Girls 10-14 years old)
0,7 0,8 1,3 1,3 1,4 1,6 1,7 1,7 1 1,3 2,2 2,3 Ratio This study / SCCS 3 0,6 0,7 0,8 0,8 1,3 0,9 1,3 1,4 0,7 1,6 0,7 1,7 0,8 1,7 1,0 11,2 1,3 1,5 2,2 3,3 2,3 3,6 30,2 0,6 0,2 0,8 0,6 0,8 0,3 0,9 0,4 1,3
P95 P93 P85 P85 P78 P78 P78 P77 P90 P83 Percentile value equal P71 to P69SCCS P90 P55 P97 P96 P95 P94 P93 P85 P91 P85 P80 P78 P95 P78 P95 P78 P93 P77 P90 P90 P86 P83 P82 P71 P69 P69 P67 P55 P100 P96 P100 P94 P97 P93 P98 P91 P98 P80 10
shampoo
1,03 (Women ≥ 60 years old) 1,21to(Men 15-59 products years old) Exposure of French population hair styling Comparison with SCCS data 1,93 (Pregnant women ≥ 15 years old) 1,97 (Women 40-59 years old) 2,10 (Boys 4-9 years old) 2,49 (Girls 4-9 years old) 2,55 (Girls 10-14 years old) 2,58 (Women 15-39 years old) Conditioner 0,6 0,59 (Women ≥ 60 years old) (Men ≥ 15(mg/kg years old) Exposure0,78 assessment bw/day) 1,34 (Pregnant women ≥ 15 years old) 1,38 15-59 years old) SCCS (P90) This(Women study (P90) 1,78 (Girls 10-14 years old) Liquid 1,51 0,95 (Pregnant (Men ≥ 60women years old) Lacquer 5,74 3,53 ≥ 15 years old) shampoo 1,03 (Men (Women 60 years 4,48 ≥ 15≥ years old)old) 1,21 (Women (Men 15-59 years old)old) 4,50 15-39 years 1,93 (Women (Pregnant≥women ≥ old) 15 years old) 5,31 40 years 1,97 (Girls (Women 40-59 years 7,18 10-14 years old)old) 2,10 (Men (Boys ≥4-9 Gel 5,74 3,78 60years yearsold) old) 2,49 (Pregnant (Girls 4-9 years old) 3,92 women ≥ 15 years old) 2,55 (Women (Girls 10-14 years old) 4,64 ≥ 15 years old) 2,58 (Men (Women 15-39 years 5,62 25-59 years old)old) Conditioner 0,6 0,59 (Men (Women ≥ 60 years old) 7,10 15-24 years old) 0,78 (Women (Men ≥ 15≥ years old)old) Foam 5,74 8,80 40 years 1,34 (Pregnant 18,73 (Pregnantwomen women≥≥1515years yearsold) old) 1,38 (Women 20,71 (Women15-59 15-39years yearsold) old) 1,78 (Girls 10-14 years old) Wax 5,74 1,22 (Pregnant women ≥ 15 years old) Lacquer 5,74 3,53 (Women (Pregnant≥women ≥ old) 15 years old) 1,41 15 years 4,48 (Men ≥ 15 years old) 3,33 4,50 (Pregnant (Women 15-39 years Spray 5,74 1,83 women ≥ 15old) years old) 5,31 (Women ≥ 40 years old) 2,10 15 7,18 (Girls 10-14 years old)
0,7 0,8 1,3 1,3 1,4 1,6 1,7 1,7 1 1,3 2,2 2,3 Ratio This study / SCCS 3 0,6 0,7 0,8 0,8 1,3 0,9 1,3 1,4 0,7 1,6 0,7 1,7 0,8 1,7 1,0 11,2 1,3 1,5 2,2 3,3 2,3 3,6 30,2 0,6 0,2 0,8 0,6 0,8 0,3 0,9 0,4 1,3
P95 P93 P85 P85 P78 P78 P78 P77 P90 P83 Percentile value equal P71 to P69SCCS P90 P55 P97 P96 P95 P94 P93 P85 P91 P85 P80 P78 P95 P78 P95 P78 P93 P77 P90 P90 P86 P83 P82 P71 P69 P69 P67 P55 P100 P96 P100 P94 P97 P93 P98 P91 P98 P80 11
Preliminary results Exposure assessment Babies data (0-3 years old) Liquid shampoo %of users
87
Exposure (mg/kgbw/d) Mean 1,61 P50 0,85 P90 3,32
Toothpaste Milk (face)
Shower gel
2 in 1 (hair and body)
Eau de toilette
Wipes (whole body)
62
25
77
39
47
77
32,82 17,36 68,95
230,19 130,69 476,34
2,94 1,81 6,53
3,10 1,81 7,20
24,53 13,02 57,80
500,36 361,14 1114,95
SCCSexposure data (mg/kgbw/d) P90 1,51 2,16
2,79
Baby exposure data >> SCCS exposure data 12
Conclusion
French consumption data by sex and age Exposure data by sex and age
Final results in June 2016
13
Publications
Bernard A et al., 2016. Consumption of hair dye products by the French women population: usage pattern and exposure assessment. Food Chem Toxicol. Accepted for modifications Chevillotte G et al., 2014. Exposure method development for risk assessment to cosmetic products using a standard composition. Food Chem Toxicol. 68, 108-116. Ficheux AS et al., 2014. Probabilistic assessment of exposure to nail cosmetics in French consumers. Food Chem Toxicol. 66, 36-43. Ficheux AS et al., 2015. Consumption of cosmetic products by the French population. First part: Frequency data. Food Chem Toxicol. 78, 159–169. Ficheux AS et al., Consumption of cosmetic products by the French population Second part: Amount data. Food Chem Toxicol, Submitted Ficheux AS et al., Probabilistic exposure assessment to hair products by the French population. Food Chem Toxicol, Submitted Ramirez-Martinez A et al., 2015. Exposure of hairdressers to the main cosmetics used in hairdressing salons from France by means of a preliminary study. Arch Environ. Occup. H. Under presse
Posters
Chevillotte G et al., How to assess the dermal systemic exposure to compounds present in a cosmetic product? Methodology. Congrès de l’ISES, Cincinnati, Oct 2014. Ficheux AS et al., Usage patterns of cosmetic products in France and exposure assessment: Methodology. Congrès Eurotox, Porto, Sept 2015. Ficheux AS et al., Probabilistic assessment of cutaneous exposure to baby wipes in French children between 0 and 3 years old. Congrès de l’ISES (International Society of Exposure Science), Cincinnati, Oct 2014. Ficheux AS et al., Probabilistic exposure assessment to nail cosmetics by French consumers. Congrès Eurotox, Interlaken, Sept 2013.
Ledoux C et al., Occupational exposure in beauty salons and customers exposure in the French population by the Monte Carlo method. Congrès de l’ISES, Henderson, Oct 2015. Morsch J et al., Aggregate exposure of phenoxyethanol and parabens from nine cosmetic products. Congrès Eurotox, Porto, Sept 2015.
Thank you for your attention ! Thanks to the contributors of the study Audrey Bernard, Grégoire Chevillotte, Nathalie Wesolek, Typhaine Morisset, Nicolas Dornic, Ziad Dahmoul, Alice Bertho, Lorraine Leroy, Astrid Romanet, Anne-Camille Mercat, Thomas Creusot, Ewan Simon, master 1 students and Alain-Claude Roudot
Many thanks to the 20 000 volunteers of this study
For additional questions:
[email protected]
Preliminary results Frequency enquiry
Comparaison of frequency values with the SCCS values
Conditioner
SCCS < French values Under-estimation of exposure
Other products
Values in the same order of magnitude Validation of French data
Difference between women and pregnant women
6
6
Ficheux AS et al., 2015. Food Chem. Toxicol. 78, 159-169
0.55 0.51
0.36 1.65
Difference between women and pregnant women
6
6
Ficheux AS et al., 2015. Food Chem. Toxicol. 78, 159-169
0.55 0.51
0.36 1.65
Preliminary results Face to face enquiry (Amount per use data)
Face to face enquiry: Amount per use data Face to face interview: 45 minutes (♀), 20 minutes (♂)
Example: Distribution of liquid shampoo for women ≥ 15 years old
Brest Toulouse Paris Nancy
4 french cities: Brest, Paris, Toulouse et Nancy
No inter-regional variation
Application of data obtained in the 4 cities for the French population
Face to face enquiry: Amount per use data Example of liquid shampoo Amount (g/use)
Age class
Age (years old) Girls / Women Mean P50 (median) P95 N Age (years old) Boys / Men Mean P50 (median) P95 N
Age class
4-9
10-14
15-24
25-39
40-59
60
15-59
4,6 5,1 7,2 8 4-9 4,6 4,2 6,8 6
8,5 6,8 13,8 25 10-14 0
11,5 9,5 27,8 130 a 15-24 5,2 5,1 10,7 29 a
11,8 9,0 25,6 129 a 25-39 5,5 4,9 10,8 56 a
10,1 7,7 24,5 186 a 40-59 6,7 5,3 18,1 57 a
7,6 6,3 18,2 93 b 60 5,8 5,4 11,4 38 a
11,0 8,6 26,8 445 a ≥ 15 5,9 5,1 13,9 180 a
