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Exposure data for personal care products: Hairspray, spray perfume, liquid foundation, shampoo, body wash, and solid antiperspirant
Abstract
Reliable exposure information for cosmetic and other personal care products and ingredients is needed in order to conduct safety assessments. Essential information includes both the amount of product applied, and the frequency of use. To obtain current data, studies to assess consumer use practices were undertaken. Six widely used personal care product types were included in the studies. Five of the products were cosmetics (spray perfume, hairspray, liquid foundation, shampoo, body wash) and one product was a cosmetic/over-the-counter drug product (solid antiperspirant). Three hundred and sixty women, ages 19-65 years, who regularly use the products of interest, were recruited at 10 different geographical locations within the US. The number of recruits was chosen to ensure a minimum of three hundred completed responses per product type. Subjects were provided with a new container of the brand of product they normally use and kept diaries and recorded detailed daily usage information over a two week period. Products were weighed at the start and completion of the study in order to determine the total amount of product used. Statistical analyses of the data were conducted to derive summary distributions of use patterns. The geometric mean and median usage per application, respectively, for the six product types were: spray perfume, 0.33 g and 0.23 g; hairspray, 2.58 g and 1.83 g (aerosol); 3.64 g and 2.66 g (pump); liquid foundation, 0.54 g and 0.36 g; shampoo, 11.76 g and 9.56 g; body wash, 11.3g and 9.5 g; and solid antiperspirant, 0.61 g and 0.45 g. The mean and median usage per day for the six product types were: spray perfume, 0.53 g and 0.34 g; hairspray, 3.57 g and 2.71 g (aerosol); 5.18 g and 3.74 g (pump); liquid foundation, 0.67 g and 0.45 g; shampoo, 12.80 g and 10.75 g; body wash, 14.5 g and 12.9 g; and solid antiperspirant, 0.79 g and 0.59 g. The mean number of applications per day for spray perfume, hairspray, liquid foundation, shampoo, body wash, and solid antiperspirant was 1.67, 1.49 (aerosol) and 1.51 (pump), 1.24, 1.11, 1.37, and 1.3, respectively. This study provides current exposure information for commonly used products which will be useful for risk assessment purposes.
... 3) Statistical distributions of the quantities per use of each product (Tozer et al., 2004;Loretz et al., 2005Loretz et al., , 2006Loretz et al., , 2008Hall et al., 2007Hall et al., , 2011. ...
... For solid deodorants, the Cowan-Ellsberry et al. (2008) deodorant/antiperspirant data were used by the Applicant instead of those of Loretz et al. (2006) and Hall et al. (2007) because Cowan-Ellsberry et al. (2008) used measured 90th percentile exposure (amount) and surface area data and integrated them into a per diem exposure. The 90th percentile for product amount was 1.77 g/day and the 90th percentile surface area was 193.6 cm 2 . ...
... This choice is therefore conservative. However, compared to Loretz et al. (2006), the use amounts varied less: probably because in Cowan-Ellsberry et al. (2008) only one product type was used by either sex: females used a solid formulation, and males a deo roll-on. This may result in a lower P90 than for the distribution of products that are on the market, but no data are available on this. ...
SCCS Opinion on Citral (CAS No. 5392-40-5, EC No. 226-394-6) sensitisation endpoint - SCCS/1666/24 - Final Opinion
U. Bernauer, L. Bodin, Q. Chaudhry, P.J. Coenraads, J. Ezendam, E. Gaffet, C. L. Galli, E. Panteri, V. Rogiers, Ch. Rousselle, M. Stepnik, T. Vanhaecke, S. Wijnhoven, E. Benfentati, N. Cabaton, E. Corsini, A. Koutsodimou, H. Louro, W. Uter, N. von Goetz
The SCCS adopted this document by written procedure on 29 July 2024
Publication date : 26 August 2024
https://health.ec.europa.eu/publications/sccs-opinion-citral-cas-no-5392-40-5-ec-no-226-394-6-sensitisation-endpoint_en
https://health.ec.europa.eu/document/download/1d28405e-f5f9-4ee2-ac1c-465407e3b569_en?filename=sccs_o_287.pdf
... Deterministic systemic exposure dose after inhalation exposure (SEDinh) to 0.5% Benzyl Salicylate in hair spray formulationsSCCS commentThe use amount derived fromSteiling et al., 2014 goes back to Bremmer et al., 2006 and is a P75. Therefore, for propellant spray SCCS uses the P95 (9890 mg/application) ofLoretz et al., 2006 for daily use combined with a frequency of 1. This results in an exposure value of 3.86 µg/kg/d. ...
... This results in an exposure value of 3.86 µg/kg/d. For pump spray, the amount is a P50 derived fromLoretz et al., 2006. The SCCS therefore uses the P95 (15620 mg/application) fromLoretz et al., 2006 for daily use in combination with a frequency of 1. ...
... For pump spray, the amount is a P50 derived fromLoretz et al., 2006. The SCCS therefore uses the P95 (15620 mg/application) fromLoretz et al., 2006 for daily use in combination with a frequency of 1. This results in an exposure value of 0.102 µg/kg/d for pump spray. ...
OPINION on benzyl salicylate (CAS No. 118-58-1, EC No. 204-262-9)
U. Bernauer, L. Bodin, Q. Chaudhry, P.J. Coenraads, M. Dusinska, J. Ezendam, E. Gaffet, C. L. Galli, E. Panteri, V. Rogiers, Ch. Rousselle, M. Stepnik, T. Vanhaecke, S. Wijnhoven, E. Benfentati, N. Cabaton, E. Corsini, A. Koutsodimou, H. Louro, W. Uter, N. von Goetz
The SCCS adopted this document during its plenary meeting on 26th October 2023 (69 Pages)
Mise en ligne 29th July 2024
Ed. Publications Office of the European Union, Luxembourg, Luxembourg
ISSN 1831-4767
ISBN 978-92-68-19384-6
doi:10.2875/160899
Catalog Number : EW-AQ-24-001-EN-N
https://op.europa.eu/en/publication-detail/-/publication/d29f82d8-4e1a-11ef-acbc-01aa75ed71a1/language-en/format-PDF/source-337155742
... Final version Opinion on Hexyl Salicylate (CAS/EC No. 6259-76-3/228-408-6) _________________________________________________________________________________ Steiling et al. (2014) and corrected by the frequency of use; ** Loretz et al. 2006. #Bremmer/RIVM 2006 Table 4 of the 11th SCCS NoG (2021). ...
... The use amount derived from Steiling et al., 2014goes back to Bremmer et al., 2006, and is a P75. Therefore, for propellant spray SCCS has used the P95 (9890 mg/day) of Loretz et al., 2006 for daily use combined with a frequency of 1, which is more conservative than the P90 derived for French citizens (4900 mg/application). Both values do not represent the European population but are the best proxies available. ...
... The amount for pump spray used by the Applicant is close to a P50 derived from Loretz et al., 2006 (3740 mg/day). The SCCS has therefore used the P95 from Loretz et al., 2006 for daily use (15620 mg/day) in combination with a frequency of 1. This results in an exposure value of 0.061 µg/kg/d for pump spray. ...
SCIENTIFIC OPINION on Hexyl Salicylate (CAS/EC No. 6259-76-3/228-408-6) - SCCS/1658/23 - Final version
U. Bernauer, L. Bodin, Q. Chaudhry, P.J. Coenraads, J. Ezendam, E. Gaffet, C. L. Galli, E. Panteri, V. Rogiers, Ch. Rousselle, M. Stepnik, T. Vanhaecke, S. Wijnhoven, E. Benfentati, N. Cabaton, E. Corsini, A. Koutsodimou, H. Louro, W. Uter, N. von Goetz
The SCCS adopted this document during its plenary meeting on 28 February 2024 (60 pages)
Mise en ligne 11 Mars 2024
https://health.ec.europa.eu/publications/hexyl-salicylate-casec-no-6259-76-3228-408-6_en
https://health.ec.europa.eu/document/download/17f43404-596c-4b87-a74a-cd1ea68ef17a_en?filename=sccs_o_281_final.pdf
... Deterministic systemic exposure dose after inhalation exposure (SEDinh) to 0.5% Benzyl Salicylate in hair spray formulationsSCCS commentThe use amount derived fromSteiling et al., 2014 goes back to Bremmer et al., 2006 and is a P75. Therefore, for propellant spray SCCS uses the P95 (9890 mg/application) ofLoretz et al., 2006 for daily use combined with a frequency of 1. This results in an exposure value of 3.86 µg/kg/d. ...
... This results in an exposure value of 3.86 µg/kg/d. For pump spray, the amount is a P50 derived fromLoretz et al., 2006. The SCCS therefore uses the P95 (15620 mg/application) fromLoretz et al., 2006 for daily use in combination with a frequency of 1. ...
... For pump spray, the amount is a P50 derived fromLoretz et al., 2006. The SCCS therefore uses the P95 (15620 mg/application) fromLoretz et al., 2006 for daily use in combination with a frequency of 1. This results in an exposure value of 0.102 µg/kg/d for pump spray. ...
SCCS OPINION on benzyl salicylate (CAS No. 118-58-1, EC No. 204-262-9) - SCCS/1656/23– Final Opinion
... According to this backdrop, a clear understanding of consumer behavior cannot be overemphasized. The personal care products market consists of several sectors which are complementary and satisfy all consumer needs and expectations regarding personal care, including hair care, skincare, body care, oral care, and hygiene products [8]. The aim of this study is to examine the use pattern of 125 types of commonly used personal care products amongst Iranian adults and probe the relationship among various demographic factors on the use pattern, crosssectional perceptions of retail brand loyalty, purchase place, and choice of domestic or foreign products. ...
... For instance, environmental sensibility can be cultivated among individuals to active consumers regarding personal care products and create a link to their intrinsic desires, this sensibility and sensitivity towards environmental sustainability is often created by friends and family members; thus, environmentally friendly products can strongly resonate with this group of individuals [29,30]. The variability in the methods of data collection based on available databases [4,31], telephone interviews [18], diary documentation by volunteers [8,32,33], and different populations studied in the literature may explain the differences regarding in use prevalence, purchasing locations, product source preferences, and cross-sectional perceptions of retail brand loyalty. However, there are some limitations for this study to point out: first, the available literature on sociodemographic factors such as gender, age, economic status, occupational status, level of religiosity, education level was not rich enough to adequately address and explain the effects of these factors on the use pattern of personal care products. ...
Personal care products are amongst the most consistently used goods in every population. To evaluate the market trends of these products in Iran, this study considers their use frequency, use prevalence, cross-sectional perceptions of retail brand loyalty, purchase location preferences, and sources, be them domestic or foreign. Usage patterns of 125 types of personal care products were collected in over 2021 households in 8 cities of Iran by means of a checklist fill out. The strength of the study were the separation of data by socio-demographic factors such as gender, education level, economic status, occupational status, and level of religiosity. Daily shampoo, bath soap, toothpaste, and face and hand moisturizer were the most frequent products used while the use of face and eye care products was less prevalent. The most repeatedly use-pattern was once-daily for sunscreens, moisturizers, lightnings, deodorants, toothpastes, mouthwashes , eye-care, anti-acne, and anti-chap products. Men and women with a higher economic status were more likely to use eye moisturizer, intense anti-acne-peeling, nourishing antiaging, cream soap, and body lotion/oil. Moreover, in all products studied, respondents prefer domestic over foreign ones except in deodorants and anti-perspirants. In addition, 42% and 29.8% of respondents prefer to purchase their personal care products from pharmacies and beauty shops, respectively. Given the immense popularity of such products ,their impact on community health an consumers' preferences, results of this study can have far-reaching implications for manufacturing companies and health authorities in terms of developing strategies and regulations to optimize the use pattern of these products.
... Benzaldehyde is commonly found in perfume, cologne, hairspray, deodorants, moisturizers, shaving cream, shampoo, and bath soap. It has systemic effects like irritation to the mouth, throat, eyes, skin, lungs, causing nausea and gastrointestinal pain (Loretz et al. 2006). Benzyl acetate is present in perfume, shampoo, soap, hairspray, after-shave, and deodorants. ...
... It is an irritant and causes eye, nose and throat irritation. It also acts as a CNS stimulant and can cause dizziness, confusion, nausea, twitching muscles, convulsions (Loretz et al. 2006). Try to avoid the inhalation of vapors of camphor containing perfume and other cosmetic products. ...
Cosmetics are the group of products, including sun-cream, moisturizers, powders, perfumes, lipsticks, nail polishes, hair colors, shampoo, deodorants, baby products, and others. The use of cosmetic products is increasing day by day throughout the world. Both men and women are using cosmetics for their beautification and attractive looking. Cosmetic products contain a variety of chemical ingredients and some of these can create toxicity. There is a restriction to the use of toxic and non-permitted chemicals in cosmetics but, due to poor surveillance, sometime product contains unauthenticated chemicals. Thus, there is every time chance for the intoxication of cosmetics. The common effects of cosmetic toxicity are skin damage, hypersensitivity reaction and allergic dermatitis, skin rash, skin irritation, the appearance of acne, formation of dry and scaly skin, and carcinoma. The present work has focused on the main toxic chemical substances present in cosmetic products and the possible health complications related to cosmetic use. The side effects of cosmetics are now being an emerging issue of public health. Proper surveillance, authentication of the product and public awareness will be helpful to prevent cosmetic-related health problems.
... These European data have been reported in the Scientific Committee on Consumer Safety notes of guidance (The Scientific Committee on Consumer Safety, 2021) and are integrated into industry models such as the CREME-RIFM aggregate exposure model for fragrance ingredients Comiskey et al., 2015Comiskey et al., , 2017. A similar series of studies by Loretz et al. (2005Loretz et al. ( , 2006 provided consumption data for 12 types of products largely used by US consumers. Both data sets are presented in the US Environmental Protection Agency exposure factors handbooks (U. S. Environmental Protection Agency, 2011). ...
... Using six product types: body wash, conditioner, shampoo, body moisturizer, face moisturizer and hand moisturizer, a figure for daily product exposure was obtained by dividing the weekly exposure by 7. This was then used to compare with habits and practices studies carried out in other countries or regions, including Europe (Hall et al., , 2011, Korea (Park et al., 2015), Switzerland (Garcia Hidalgo et al., 2017), and the US (Loretz et al., 2005(Loretz et al., , 2006. It should be noted that not every product type was included in every study. ...
Understanding trends in habits and practices of cosmetics and personal care products is essential for the assessment of product exposure and simultaneously, the establishment of safe use levels for incorporated ingredients. To date, most exposure data is limited to European and USA populations, with data on Asian-specific habits and practices lacking. This data gap needs to be filled as evidence has shown that there is a large variation in product use behaviors between consumers, across and within populations. Moreover, there is a need to seek a more efficient approach of data collection. Conventional methods of collecting habits and practices data require extensive effort and are generally cost and time intensive. In this publication, we demonstrate the feasibility of employing a rapid and cost-effective online survey approach to gather habits and practices for Southeast Asia, specifically Singapore. We describe the methodology and display the type of habits and practices data that can be gathered through this approach. Although certain limitations exist, this approach can be used to effectively collect preliminary product use data across regions and different product categories.
... Since cosmetics alone do not exceed the upper limit, the allocation of contributions of different 23 exposure sources is a risk management issue and cannot be addressed at the level of risk 24 assessment. 25 ...
... SCCS is invited to update accordingly opinion SCCS/1576/16 on Vitamin A notably as 24 regards, as needed, the maximum concentration limits for the different categories of 25 cosmetic products indicated in that Opinion. 26 ...
... Since cosmetics alone do not exceed the upper limit, the allocation of contributions of different 23 exposure sources is a risk management issue and cannot be addressed at the level of risk 24 assessment. 25 ...
... SCCS is invited to update accordingly opinion SCCS/1576/16 on Vitamin A notably as 24 regards, as needed, the maximum concentration limits for the different categories of 25 cosmetic products indicated in that Opinion. 26 ...
SCCS REVISION of the scientific Opinion (SCCS/1576/16) on Vitamin A (Retinol, Retinyl Acetate, Retinyl Palmitate) - SCCS/1639/21- Preliminary version
U. Bernauer, L. Bodin, Q. Chaudhry, P.J. Coenraad, M. Dusinska, J. Ezendam, E. Gaffet, C. L. Galli, B. Granum, E. Panteri, V. Rogiers, Ch. Rousselle, M. Stepnik, T. Vanhaecke, S. Wijnhoven, A. Koutsodimou, W. Uter, N. von Goetz
The SCCS adopted this document by written proccedure on 10 December 2021 (41 pages)
Mise en ligne le 13 Décembre 2021
https://ec.europa.eu/health/sites/default/files/scientific_committees/consumer_safety/docs/sccs_o_261.pdf
... Under the conditions of this study, Hexyl Salicylate does not induce irritation of the eyes following its application. Based on these results, it does not need to be classified according toRegulation EC No. 1272/2008 Addendum to the Scientific Opinion on Hexyl Salicylate SCCS/1658/23 -children exposure 0-3 y.o. _________________________________________________________________________________ ________________________________________________________________________________________ 26 ...
ADDENDUM to the SCIENTIFIC OPINION on Hexyl Salicylate SCCS/1658/23 (CAS/EC No. 6259-76-3/228-408-6) - - Children exposure 0-3 years old - SCCS/1668/24 – Corrigendum
U. Bernauer, L. Bodin, Q. Chaudhry, P.J. Coenraads, J. Ezendam, E. Gaffet, C. L. Galli, E. Panteri, V. Rogiers, Ch. Rousselle, M. Stepnik, T. Vanhaecke, S. Wijnhoven, E. Benfentati, N. Cabaton, E. Corsini, A. Koutsodimou, H. Louro, W. Uter, N. von Goetz
The SCCS adopted this Opinion during the plenary meeting on 25 October 2024 (56 Pages)
CORRIGENDUM adopted by written procedure on 18 December 2024
Mise en ligne 18 December 2024
https://health.ec.europa.eu/publications/sccs-addendum-scientific-opinion-hexyl-salicylate-sccs165823-casec-no-6259-76-3228-408-6-children_en
https://health.ec.europa.eu/document/download/7aa2f176-65af-494f-883e-3cf578b46cee_en?filename=sccs_o_290.pdf
... Under the conditions of this study, Hexyl Salicylate does not induce irritation of the eyes following its application. Based on these results, it does not need to be classified according toRegulation EC No. 1272/2008 Addendum to the Scientific Opinion on Hexyl Salicylate SCCS/1658/23 -children exposure 0-3 y.o. _________________________________________________________________________________ ________________________________________________________________________________________ 26 ...
SCCS ADDENDUM to the SCIENTIFIC OPINION on Hexyl Salicylate SCCS/1658/23 (CAS/EC No. 6259-76-3/228-408-6) - - Children exposure 0-3 years old - SCCS/1668/24 – Final Opinion
U. Bernauer, L. Bodin, Q. Chaudhry, P.J. Coenraads, J. Ezendam, E. Gaffet, C. L. Galli, E. Panteri, V. Rogiers, Ch. Rousselle, M. Stepnik, T. Vanhaecke, S. Wijnhoven, E. Benfenati, N. Cabaton, E. Corsini, A. Koutsodimou, H. Louro, W. Uter, N. von Goetz
The SCCS adopted this Opinion during the plenary meeting on 25 October 2024 (55 Pages)
Mise en ligne : 25 October 2024
https://health.ec.europa.eu/publications/sccs-addendum-scientific-opinion-hexyl-salicylate-sccs165823-casec-no-6259-76-3228-408-6-children_en
https://health.ec.europa.eu/document/download/7aa2f176-65af-494f-883e-3cf578b46cee_en?filename=sccs_o_290.pdf
... (Loretz L., et al., 2005) • CTFA2 "Exposure data for personal care products: hairspray, spray perfume, liquid foundation, shampoo, body wash, and solid antiperspirant. (Loretz et al., 2006) • CTFA3 "Exposure data for cosmetic products: facial cleanser, hair conditioner, and eye shadow." (Loretz et al., 2008) The amounts for Bar Soap products were taken from the publication of Comiskey et al. (2017), who report the amounts used for showering and washing hands. ...
Opinion on the safety of aluminium in cosmetic products - Submission III
U. Bernauer, L. Bodin, Q. Chaudhry, P.J. Coenraads, M. Dusinska, J. Ezendam, E. Gaffet, C. L. Galli, E. Panteri, V. Rogiers, Ch. Rousselle, M. Stepnik, T. Vanhaecke, S. Wijnhoven, N. Cabaton, A. Koutsodimou, W. Uter, N. von Goetz
The SCCS adopted this document at its plenary meeting on 21 and 22 March 2023 (62 Pages)
Mise en ligne : 29th July 2024
Ed. Publications Office of the European Union, Luxembourg, Luxembourg
ISSN : 1831-4767
ISBN : 978-92-68-19396-9
DOI : 10.2875/404299
Catalog Number : EW-AQ-24-013-EN-N
https://op.europa.eu/en/publication-detail/-/publication/7fc4a809-4e1c-11ef-acbc-01aa75ed71a1/language-en/format-PDF/source-337151657
... We chose women as subjects because the main users of color makeup products are still female consumers and set a series of strict inclusion and exclusion criteria to obtain daily exposure scenarios 12 . The sample size of our study was 346, which was similar to the relevant studies in the United States and Japan [12][13][14][15] . With the rapid development of China's cosmetics industry, it has become the second-largest cosmetics consumer market in the world 10 . ...
Limited data exist on cosmetic exposure in China, especially for make-up cosmetic products. The objective of this study was to evaluate the daily exposure of 346 female make-up users in Shanghai to 10 make-up cosmetic products over a two-week period using an online daily questionnaire. The levels of exposure to non-powder base makeup, eye shadow and eyeliner, mascara, lip stick, and makeup remover were lower than the values currently used by the Scientific Committee on Consumer Safety (SCCS). The amount of applied per application of some categories was close to that of Japan and South Korea, but the amount of applied per day was lower. Therefore, it is urgent to establish exposure parameters for the local population in China. The exposure values obtained in this study for the Shanghai population will be useful for safety assessors and for safety agencies in order to protect both the general population and at-risk populations.
... Among them, toxic heavy metals such as Pb, Ni, As, Cr, Cd and Hg were detected in various types of cosmetics, exhibiting toxic effects on human health even at low concentrations (Al-Dayel et al., 2011;FDA's Testing of Cosmetics for Arsenic, 2022;Koller et al., 2004;Ng et al., 2015;Piccini et al., 2013). It should be noted that the application of cosmetics can be prone to cause several exposure scenarios (Loretz et al., 2005(Loretz et al., , 2006. In certain situations, cosmetics such as shampoos and toothpaste are rinsed off immediately after usage, but in some cases, cosmetic products are applied over a large surface of the body and may remain in contact for a particular amount of time, having the potential of getting much greater exposure such as body lotion, lipsticks and talcum powders. ...
... Security assessments need information on both the natural risk of the item's parts as well as openness levels. 7 Herbs are commonly used as the main element in herbal formulations. Herbal extracts are commonly utilized in these compositions. ...
erbal formulations are in high demand on the global market. The human epidermis is the most vulnerable organ in the body to infections and disease-causing microbes. It also acts as the majorly responsible body part for respiration. As a result, it needs a great deal of care and protection. Many skin issues can occur throughout puberty due to internal component imbalances and hormone imbalances. The most prevalent skin condition is acne. The most commonly afflicted areas are the face and neck. The removal of oil from the face is a preventative measure. This will need proper cleaning and washing. Antibiotic gels and anti-acne washes or masks containing synthetic medicines are presently available on the market. Unfortunately, in addition to treating illnesses and killing infections, these medicines may have adverse effects. Various studies have demonstrated the effectiveness of herbal-based compositions for cleansing and oil removal. As a result of this necessity, we came up with the notion of using herbs and various plant derived components markedly useful in the various treatments of skin-related conditions. The characteristics of various face wash and their efficacy are reviewed in the current study comprehensively. The main objective of this study is the comparison of Ingredients used in various formulations of face wash like Neem, Aloe vera, Belpatra, Curry, Haldi, Lemon, Indian madder, Sweet flag, Lodhra, Gelling agent, Preservative, Neutralizer, Humectants, Vehicle, Perfume, Chelating agent, on the basis of evaluation and effective development of emerging techniques used in the markedly available face wash which reportedly proven as an advantageous measure of treatment.
... (Loretz L., et al., 2005) • CTFA2 "Exposure data for personal care products: hairspray, spray perfume, liquid foundation, shampoo, body wash, and solid antiperspirant. (Loretz et al., 2006) • CTFA3 "Exposure data for cosmetic products: facial cleanser, hair conditioner, and eye shadow." (Loretz et al., 2008) The amounts for Bar Soap products were taken from the publication of Comiskey et al. (2017), who report the amounts used for showering and washing hands. ...
SCCS OPINION on the safety of aluminium in cosmetic products - Submission III - SCCS / 1644/22 – Final Opinion and Corrigendum
U. Bernauer, L. Bodin, Q. Chaudhry, P.J. Coenraads, M. Dusinska, J. Ezendam, E. Gaffet, C. L. Galli, E. Panteri, V. Rogiers, Ch. Rousselle, M. Stepnik, T. Vanhaecke, S. Wijnhoven, N. Cabaton, A. Koutsodimou, W. Uter, N. von Goetz
The SCCS adopted this document at its plenary meeting on 21 and 22 March 2023 (62 Pages)
Mise en ligne : 23 Mars 2023
https://health.ec.europa.eu/publications/sccs-safety-aluminium-cosmetic-products-submission-iii_en
https://health.ec.europa.eu/system/files/2023-03/sccs_o_266_0.pdf
... (Loretz L., et al., 2005) • CTFA2 "Exposure data for personal care products: hairspray, spray perfume, liquid foundation, shampoo, body wash, and solid antiperspirant. (Loretz et al., 2006) • CTFA3 "Exposure data for cosmetic products: facial cleanser, hair conditioner, and eye shadow." (Loretz et al., 2008) The amounts for Bar Soap products were taken from the publication of Comiskey et al. (2017), who report the amounts used for showering and washing hands. ...
... (Loretz L., et al., 2005) • CTFA2 "Exposure data for personal care products: hairspray, spray perfume, liquid foundation, shampoo, body wash, and solid antiperspirant. (Loretz et al., 2006) • CTFA3 "Exposure data for cosmetic products: facial cleanser, hair conditioner, and eye shadow." (Loretz et al., 2008) The amounts for Bar Soap products were taken from the publication of Comiskey et al. (2017), who report the amounts used for showering and washing hands. ...
SCCS OPINION on the safety of aluminium in cosmetic products - Submission III - SCCS / 1644/22 – Final Opinion
U. Bernauer, L. Bodin, Q. Chaudhry, P.J. Coenraads, M. Dusinska, J. Ezendam, E. Gaffet, C. L. Galli, E. Panteri, V. Rogiers, Ch. Rousselle, M. Stepnik, T. Vanhaecke, S. Wijnhoven, N. Cabaton, A. Koutsodimou, W. Uter, N. von Goetz
The SCCS adopted this document by written procedure on 1st Februray 2023 (60 Pages)
Mise en ligne : 2 February 2023
https://health.ec.europa.eu/publications/sccs-safety-aluminium-cosmetic-products-submission-iii_en
https://health.ec.europa.eu/system/files/2023-02/sccs_o_266.pdf
... More realistic exposure assessment methods need to consider patterns of use and co-use of consumer products in a population, acknowledging that not all individuals use all products and that not all brands of a product will contain the chemical, or at least not to the maximum concentration level. Information on the quantities and frequencies of use of various product groups has become available in recent decades [2][3][4][5][6][7][8][9][10][11]. To account for these aspects, person-oriented modeling is required [12][13][14]. ...
Background
To ascertain the safe use of chemicals that are used in multiple consumer products, the aggregate human exposure, arising from combined use of multiple consumer products needs to be assessed.
Objective
In this work the Probabilistic Aggregate Consumer Exposure Model (PACEM) is presented and discussed. PACEM is implemented in the publicly available web tool, PACEMweb, for aggregate consumer exposure assessment.
Methods
PACEM uses a person-oriented simulation method that is based on realistic product usage information obtained in surveys from several European countries. PACEM evaluates aggregate exposure in a population considering individual use and co-use patterns as well as variation in product composition. Product usage data is included on personal care products (PCPs) and household cleaning products (HCPs).
Results
PACEM has been implemented in a web tool that supports broad use in research as well as regulatory risk assessment. PACEM has been evaluated in a number of applications, testing and illustrating the advantage of the person-oriented modeling method. Also, PACEM assessments have been evaluated by comparing its results with biomonitoring information.
Significance
PACEM enables the assessment of realistic aggregate exposure to chemicals in consumer products. It provides detailed insight into the distribution of exposure in a population as well as products that contribute the most to exposure. This allows for better informed decision making in the risk management of chemicals.
Impact
Realistic assessment of the total, aggregate exposure of consumers to chemicals in consumer products is necessary to guarantee the safe use of chemicals in these products. PACEMweb provides, for the first time, a publicly available tool to assist in realistic aggregate exposure assessment of consumers to chemicals in consumer products.
... Refinement of exposure, based on probabilistic approaches related to the applied dose, has been developed. For instance, studies have been conducted to assess consumer use and behavior habits about various product types [12][13][14][15][16] , whereas total amounts that might be emitted to the environment have been estimated based on information pertaining to GDP and using sales and marketing data [5,17,18] . The information obtained from these studies characterizes the probability distributions associated with the amount of product used by consumers in various geographic regions. ...
Assessing chemical exposure in home and personal care products (HPCPs) represents an important data need. Key challenges to the assessment are related to limited knowledge in quantifying and characterizing the weight-fraction inclusion level and functionality of chemicals in HPCPs. Publicly available tools have been developed to address these challenges, such as the Chemical and Products database (CPDat). This study aims to evaluate the relative performance of CPDat by comparing estimates of weight-fraction inclusion level and functionality to other relevant data sources. Specifically, estimates obtained from CPDat are evaluated and compared with estimates obtained from marketing analytic data, using Euromonitor Passport for 31 commonly used chemicals found in HPCPs. The results obtained from this exercise suggest relatively good agreement between each of the methods for 10 chemicals (ρ = 0.92; P-value =0.02). When considering all 31 chemical ingredients, however, the correlation observed is generally poor (ρ = 0.46; P-value = 0.1), which is attributed to differences in how the underlying data are obtained for each method. With an emphasis on obtaining data based on mining datasheets for individual products, the application of CPDat is suggested to be useful for higher tiers of assessment, with data obtained from marketing analytics providing valuable input to exposure-based screening models. The insight gained from this study can be used to help guide the appropriate use of data obtained from different sources within a tiered exposure assessment.
... Regarding the daily amount of product use for hair spray, Steiling et al. (2014) reported 6.8 g/d for hair spray (aerosol) from Bremmer et al. (2006) and 3.6 g/d for hairspray (pump spray) from Loretz et al. (2006). In this assessment, the worst-case amount for hair spray is used for aerosol and pump sprays, which is the one corresponding to aerosol, i.e. 6.8 g/d. ...
SCCS OPINION on Methyl salicylate (methyl 2-hydroxybenzoate) - Submission I- SCCS/1633/21- Final Opinion
U. Bernauer, L. Bodin, Q. Chaudhry, P.J. Coenraad, M. Dusinska, J. Ezendam, E. Gaffet, C. L. Galli, B. Granum, E. Panteri, V. Rogiers, Ch. Rousselle, M. Stepnik, T. Vanhaecke, S. Wijnhoven, A. Koutsodimou, W. Uter, N. von Goetz
The SCCS adopted this document at its plenary meeting on 26 and 27 October 2021 (76 pages)
Published:17 August 2022
Ed. Publications Office of the European Union, Luxembourg, Luxembourg (76 pages)
ISSN : 1831-4767
ISBN : 978-92-76-54817-1
DOI : https://data.europa.eu/doi/10.2875/47640
Catalog Number : EW-AQ-22-014-EN-N
https://op.europa.eu/fr/publication-detail/-/publication/8a6f0298-21c8-11ed-8fa0-01aa75ed71a1
https://op.europa.eu/fr/publication-detail/-/publication/8a6f0298-21c8-11ed-8fa0-01aa75ed71a1/language-en/format-PDF/source-264517785
... Only in recent decades has been scientifically recognized that some topically applied substances may penetrate human skin, and their systemic exposure may cause toxicity (Loretz et al. 2006;Nohynek et al. 2010). Clay and clay minerals participate into the formulations of many cosmetics, which are mainly topically applied. ...
Clay, or more precisely, certain clay typologies, have been used traditionally by humans for therapeutic, nutritional, and skin-care purposes though they may be responsible for some relatively rare but significant health and skin-care risks. For example, clay particles could adsorb and make available for elimination or excretion any potential toxic elements or toxins being ingested or produced, but they could also adsorb and make available for incorporation, through ingestion or through dermal absorption, toxic elements, e.g. heavy metals. Geophagy has been observed in all parts of the world since Antiquity, reflecting cultural practices, religious beliefs, and physiological needs, be they nutritional (dietary supplementation) or as a remedy for disease. Some clays and clay minerals are employed widely in both the pharmaceutical and cosmetics industries as active compounds/agents and as excipients. In the biomedical field, some clay minerals such as halloysite and montmorillonite are known for their effective role as carriers for the control and sustainable delivery of active drug molecules, and in the biomaterials field some clay minerals are used for scaffold, hydrogel, foam, and film production. Constraints, both chemical and microbiological, on the use of clay-based products for therapeutic and cosmetic topical applications are generally imposed by sanitary regulations, and some solutions are proposed herein to control and reduce such restrictions. Particular emphasis is placed here on peloids and pelotherapy, as well as on manipulated and modified peloids, and specifically on tailored peloids or ‘designed and engineered’ peloids, and their derivatives, bactericidal peloids and ointments. As far as the so-called ‘killer clays’ are concerned, their pre-requisites, mechanisms of action, and disinfection role are also enhanced. Podoconiosis is an environment-related or geochemical disease that occurs in tropical highland areas, and is caused by long-term exposure of bare feet to volcanic, red-clay soil and affects some people, particularly those working in agriculture in some regions of Africa, Asia, and South America.
... Several studies have been conducted in Europe focusing on the amount of consumption of various types of cosmetic products, the results of which have been adopted by the Scientific Committee on Consumer Safety (SCCS) in its Notes of Guidance on safety assessment of cosmetics to guide risk assessment of raw ingredients in Europe [2][3][4][5] . In the United States, even though the Food and Drug Administration (USFDA) does not require the cosmetic industry to provide safety assessment data for the purpose of product registration, studies have still been carried out to reveal consumer's consumption of cosmetic products, including large scale investigations and epidemiological studies [6][7][8][9] . However, those types of studies focusing on the Chinese population remain limited. ...
The present study aimed to reveal the amount per application of facial sheet masks and its influencing factors in Chinese population to form the base for an accurate exposure assessment. A total of 175 healthy subjects aged 18 years or older were recruited and divided into two subgroups: one group of 35 subjects were asked to apply same mask for 5, 10, 15, 20, 25, and 30 min respectively, and the other 140 subjects were instructed to apply one of four types of facial sheet masks presented in the market for 15 min. Furthermore, phenoxyethanol and methylparaben were measured to reflect actual exposure to chemicals. The sharp increase in the relative exposure to phenoxyethanol (CAS NO.122-99-6) and methylparaben at 25 min and longer suggests applying facial sheet masks for longer than 20 min may drive the exposure to hazardous chemicals to increase significantly. The 90th percentile of amount per application for plant-cellulose, bamboo charcoal fiber, bio-cellulose, and binchotan charcoal fiber-based masks was 5.753, 5.371, 5.017, and 4.821 g respectively. In addition, men and subjects with sebaceous skin demonstrated lower amount per application compared to women and subjects with dry skin, respectively. Finally, our data showed that the larger the contacting area between face and mask, the more amount per application. We concluded that the appropriate time of application should be less than 20 min. And mask fabrics, gender, sebum content, and contacting area could significantly impact the risk assessment of facial sheet masks. Our data for the first time provides insights into a realistic risk assessment of facial sheet masks in Chinese population.
... Chemicals of concern in personal care products include suspected endocrine disruptors, such as phthalates (an ingredient in fragrances, nail polish, and makeup), parabens (preservatives in various types of personal care products), triclosan (an antimicrobial agent) and benzophenone-3 ((BP-3), a sunscreen agent), and carcinogens, such as 1,4-dioxane and formaldehyde [5][6][7][8][9][10][11][12][13]. Human exposure to these chemicals can occur through dermal absorption of products applied topically or through inhalation or ingestion of products during application or wear [14]. Several ingredients or unintentional products and fewer makeup items and deodorants, while White women used more sunscreen [26]. ...
Background
Personal care products may contain many chemicals, some of which are suspected endocrine disrupters. This is an important source of chemical exposure for women, but little is known about how chemical exposure differs among different races/ethnicities.
Objective
This study examines differences in personal care product use among Black, Latina, Vietnamese, Mixed Race, and White women in California.
Methods
We used a community-based participatory process to create and administer a personal care product usage survey to 321 Black, Latina, Vietnamese, Mixed Race, and White women. We used multivariate regression models with pairwise comparisons to examine the frequency of product use by race/ethnicity.
Results
We found distinct trends of personal care product use by race/ethnicity: Latina women typically used makeup most frequently; Black women used certain hair products or styles most frequently; and Vietnamese women were most likely to use facial cleansing products compared to other races/ethnicities. Latina and Vietnamese women were less likely to try to avoid certain ingredients in their products.
Significance
These findings can help estimate disparities in chemical exposure from personal care product use and complement future research on health inequities due to chemical exposures in the larger environmental and social context.
... Cyclosiloxanes can be used as an initial reagent for the preparation of siloxane homoand copolymer rubbers and liquids [1][2][3][4], as well as functional precursors for molecular design [5][6][7][8][9], cross-linking reagents [10], flame retardants [11], components of compositions for dry cleaning and detergents [12][13][14], solvents for coloring fabrics [15][16][17][18][19] and in cosmetics for various purposes, including skin and hair care products, deodorants/antiperspirants, makeup products, etc. [20][21][22][23]. ...
This paper reports a method for the synthesis of 1,1,3,3,5,5-hexamethyl-7,7-diorganocyclotetrasiloxanes by the interaction of 1,5-disodiumoxyhexamethylsiloxane with dichlorodiorganosilanes such as methyl-, methylvinyl-, methylphenyl-, diphenyl- and diethyl dichlorosilanes. Depending on the reaction conditions, the preparative yield of the target cyclotetrasiloxanes is 55–75%. Along with mixed cyclotetrasiloxanes, the proposed method leads to the formation of polymers with regular alternation of diorganosylil and dimethylsylil units. For example, in the case of dichlorodiethylsilane, 70% content of linear poly(diethyl)dimethylsiloxanes with regular alternation of units can be achieved in the reaction product. Using 7,7-diethyl-1,1,3,3,5,5-hexamethylcyclotetrasiloxane as an example, the prospects of the mixed cycle in copolymer preparation in comparison with the copolymerization of octamethyl- and octaethylcyclotetrasiloxanes are shown.
... A total of five individual applications (n = 5) were carried out for each tested product. Each application procedure (exposure scenario) was designed to simulate normal use conditions according to the relevant published data on product use (Loretz et al., 2006;Steiling et al., 2012;2018;SCCS 2018). In the absence of published data on the application amount of a product (e.g. ...
Safe, rapid, and sensitive analysis of hazardous chemical compounds in aerosol products significantly benefits both inspector and operator health and detection throughput. This study presents a novel approach for the direct mass spectrometry analysis of regulated chemical compounds in aerosol products, utilizing gas-flow-assisted transfer/nebulization and electrostatic field-induced spray ionization via a custom-made double-tee assembly. Without any pretreatment or solvent, samples are introduced into the assembly, which transfers the sample and generates microdroplets using high-pressure sheath gas. Target analyte ions are mixed with formic acid or derivatization reagent microdroplets in the cavity and then directed into an ion trap mass spectrometer through an electrostatic field for quantitative analysis. Key parameters of the double-tee assembly were systematically optimized using response surface methodology, achieving excellent analytical performance. Sample consumption was 20 μL, and the whole analytical procedure was completed within 1 min. The limits of detection and quantitation for target compounds were in the range of 10–25 μg/kg and 25–50 μg/kg, respectively. The proposed method exhibited good recoveries between 94.3 % and 101.3 %, with relative standard deviations from 2.4 % to 8.2 %. Moreover, this method has the potential to monitor chemical reaction intermediates and distinguish sample authenticity through multivariate statistical analysis. Overall, it is user-friendly for aerosol product analysis and prioritizes operator safety and health.
Understanding consumer habits and practices of cosmetics and personal care products (PCP) is essential to generate realistic product exposure data for the safety assessment of ingredients such as fragrance materials. Product usages can vary across regions due to differences in cultural norms, seasonal and climate conditions, and the availability of different product forms, yet there is limited data published on cosmetics and PCP use outside of North America and Europe. This study reports the habits and practices of cosmetics and PCP (such as frequency and amount of use) in Singapore where participants (n = 494, aged 21–64 years) recorded their product usages and had their products weighed over a two-week period. Overall, similar use patterns were observed across demographic groups within the Singapore population for most of the products surveyed, as were the expected usage amounts. Additionally, the Singaporean dataset was mapped onto the Creme-RIFM aggregate exposure model to assess exposure estimates. Preliminary comparisons with product exposures observed in the United States (US) and Europe suggest that exposures in Singapore are comparable. Findings from this study will contribute to the Creme-RIFM model, expanding its geographic scope and applicability for the global safety assessment of fragrance ingredients and fragranced products.
Cosmetics are a staple in daily beauty routines worldwide, embraced for their role in enhancing personal appearance and self-care. However, their direct application exposes the skin to a range of ingredients, including metal(loid)s, and these can have a hazardous impact on human health if they exceed the limits defined by regulatory agencies. As a result, it is important to evaluate metal(loid) levels to ensure the safety of these cosmetic products. This research aimed to analyze several cosmetic products (massage cream, cleaner, mud mask, skin polish, scrub, lipstick, foundation, lotion, face powder, and highlighter) for metalloids (Al, Cr, Mn, Fe, Co, Ni, Cu, Zn, Sr, As, Sb, Cd, Pb, Bi, and Hg) by using inductively coupled plasma-optical emission spectrometry (ICP-OES). Multivariate and bivariate statistical approaches were used to interpret the sources and association between the metal(loid)s. The concentration ranges of metals were found to be Al (1.18–4.15 mg/kg), Cr (0.13–2.19 mg/kg), Mn (1.89–28.77 mg/kg), Fe (4.09–126.02 mg/kg), Co (0.19–31.62 mg/kg), Ni (0.11–5.39 mg/kg), Cu (0.08–0.19 mg/kg), Zn (1.99–47.81 mg/kg), Sr (0.99–10.34 mg/kg), Cd (0.16–1.50 mg/kg), Pb (0.29–2.44 mg/kg), Bi (0.23–2.18 mg/kg), and Hg (0.012–0.42 mg/kg), whereas the concentration ranges of metalloids were found to be As (0.011–0.051 mg/kg) and Sb (0.042–1.66 mg/kg). Among the tested cosmetic products for the metal(loid) levels, the estimation of the margin of safety (MOS < 100), hazard quotient (HQ > 1), hazard index (HI > 1), and cumulative cancer risk (LCR ≤ 1 × 10⁻³) indicated non-carcinogenic and carcinogenic health risks associated with the use of few products. Most of the cosmetics products under investigation are safe with respect to non-carcinogenic and carcinogenic health risks. By highlighting the need to limit excessive use and adhering to sustainable safety practices, this study underscores the importance of monitoring and regulating metal(loid) content to ensure consumer safety and mitigate environmental impact.
Dear students and graduated aesthetic cosmetologists,
the teaching material we present uses data from research and websites on current topics for face and body treatment that have been used by people for centuries, all with the aim of improving appearance, improving the health of the skin, hair and nails.
Students from the Department of Cosmetology at the MIT University College, Bobana Žežova and Sibil Mustafovska helped me in the preparation of this material.
Each research offers new dimensions in our practical work. We are of the opinion that this publication will help you master your skills, to have in practice a high level of professionalism, based on scientific claims.
.
From the Author
Cyclic volatile methyl siloxanes (cVMS) are ubiquitous in hair care products (HCPs). cVMS emissions from HCPs are of concern, given the potential adverse impact of siloxanes on the environment and human health. To characterize cVMS emissions and exposures during the use of HCPs, realistic hair care experiments were conducted in a residential building. Siloxane-based HCPs were tested using common hair styling techniques, including straightening, curling, waving, and oiling. VOC concentrations were measured via proton-transfer-reaction time-of-flight mass spectrometry. HCP use drove rapid changes in the chemical composition of the indoor atmosphere. cVMS dominated VOC emissions from HCP use, and decamethylcyclopentasiloxane (D5) contributed the most to cVMS emissions. cVMS emission factors (EFs) during hair care routines ranged from 110–1500 mg/person and were influenced by HCP type, styling tools, operation temperatures, and hair length. The high temperature of styling tools and the high surface area of hair enhanced VOC emissions. Increasing the hair straightener temperature from room temperature to 210 °C increased cVMS EFs by 50–310%. Elevated indoor cVMS concentrations can result in substantial indoor-to-outdoor transport of cVMS via ventilation (0.4–6 tons D5/year in the U.S.); thus, hair care routines may augment the abundance of cVMS in the outdoor atmosphere.
SCIENTIFIC OPINION on Hexyl Salicylate (CAS/EC No. 6259-76-3/228-408-6) - SCCS/1658/23 - Preliminary version
U. Bernauer, L. Bodin, Q. Chaudhry, P.J. Coenraads, M. Dusinska, J. Ezendam, E. Gaffet, C. L. Galli, E. Panteri, V. Rogiers, Ch. Rousselle, M. Stepnik, T. Vanhaecke, S. Wijnhoven, E. Benfentati, N. Cabaton, E. Corsini, A. Koutsodimou, H. Louro, W. Uter, N. von Goetz
The SCCS adopted this document during its plenary meeting on 26 October 2023 (55 pages)
Mise en ligne : 9th November 2023
https://health.ec.europa.eu/publications/hexyl-salicylate-casec-no-6259-76-3228-408-6_en
https://health.ec.europa.eu/system/files/2023-11/sccs_o_281.pdf
SCCS REVISION of the scientific Opinion (SCCS/1576/16) on Vitamin A (Retinol, Retinyl Acetate, Retinyl Palmitate)
SCCS/1639/21- Final version
U. Bernauer, L. Bodin, Q. Chaudhry, P.J. Coenraads, M. Dusinska, J. Ezendam, E. Gaffet, C. L. Galli, E. Panteri, V. Rogiers, Ch. Rousselle, M. Stepnik, T. Vanhaecke, S. Wijnhoven, N. Cabaton, A. Koutsodimou, W. Uter, N. von Goetz
The SCCS adopted this document at its plenary meeting on 24 – 25 October 2022 (45 pages)
Mise en ligne le 30 Août 2023
Ed. Publications Office of the European Union, Luxembourg, Luxembourg
ISSN : 1831-4767
ISBN : 978-92-68-06262-3
doi:10.2875/92
Catalog Number : EW-AQ-23-007-EN-N
https://op.europa.eu/en/publication-detail/-/publication/53c49d56-46f5-11ee-bbdc-01aa75ed71a1/language-en/format-PDF/source-291550351
This work demonstrates high-throughput screening of personal care products to provide an overview of potential exposure. Sixty-seven products from five categories (body/fragrance oil, cleaning product, hair care, hand/body wash, lotion, sunscreen) were rapidly extracted and then analyzed using suspect screening by two-dimensional gas chromatography (GCxGC) high-resolution mass spectrometry (GCxGC-HRT). Initial peak finding and integration were performed using commercial software, followed by batch processing using the machine learning program Highlight. Highlight automatically performs background subtraction, chromatographic alignment, signal quality review, multidilution aggregation, peak grouping, and iterative integration. This data set resulted in 2,195 compound groups and 43,713 individual detections. Compounds of concern (101) were downselected and classified as mild irritants (29%), environmental toxicants/severe irritants (51%) and endocrine disrupting chemicals/carcinogens (20%). High risk compounds such as phthalates, parabens, and avobenzone were detected in 46 out of the 67 products (69%), and only 5 out of the 67 products (7%) listed these compounds on their ingredient labels. The Highlight results for the compounds of concern were compared to commercial software results (ChromaTOF) and 5.3% of the individual detections were discerned only by Highlight, demonstrating the strength of the iterative algorithm to effectively discover low-level signatures. Highlight provides a significant labor advantage, requiring only 2.6% of the time estimated for a largely manual workflow using commercial software. In order to address significant time needed for postprocessing assignment of identification confidence, a new machine-learning-based algorithm was developed to assess the quality of assigned library matches, and a balanced accuracy of 79% was achieved.
Historically, formaldehyde was used as a preservative in personal care products to extend product shelf-life; however, given its skin sensitization potential it has been phased out of use and replaced with formaldehyde-releasing preservatives, such as Dimethyloldimethyl hydantoin (DMDMH). A relationship has been established between positive patch test results following exposure to DMDMH and previous sensitization to formaldehyde. Upon direct contact with the skin, formaldehyde can react with skin proteins and cause an acute inflammatory reaction, which may progress to skin sensitization following repeated exposure. This quantitative risk assessment (QRA) aimed to assess the risk of skin sensitization induction following use of shampoo products containing the maximum allowable concentrations of DMDMH in formulation (1% w/v), translating to a free formaldehyde concentration of 0.02%. To determine a margin of safety (MOS) for exposure to DMDMH from use of shampoo products, consumer exposure levels (CEL) were estimated based on typical use scenarios and then benchmarked against an acceptable exposure level (AEL). The AEL was derived using a weight of evidence approach where a range of no expected sensitization induction levels (NESILs) was utilized. The MOS values for a shampoo product containing 1% DMDMH (.02% formaldehyde) was above 1 for the typical use scenario indicating a low likelihood of skin sensitization induction among healthy individuals. Thus, it can be concluded that shampoo products containing DMDMH at or below current allowable concentrations are not expected to increase the risk of skin sensitization induction.
SCCS REVISION of the scientific Opinion (SCCS/1576/16) on Vitamin A (Retinol, Retinyl Acetate, Retinyl Palmitate) - SCCS/1639/21- Final version
U. Bernauer, L. Bodin, Q. Chaudhry, P.J. Coenraad, M. Dusinska, J. Ezendam, E. Gaffet, C. L. Galli, E. Panteri, V. Rogiers, Ch. Rousselle, M. Stepnik, T. Vanhaecke, S. Wijnhoven, N. Cabaton, A. Koutsodimou, W. Uter, N. von Goetz
The SCCS adopted this document at its plenary meeting on 24 – 25 October 2022 (45 pages)
Mise en ligne le 26 Octobre 2022
https://health.ec.europa.eu/publications/revision-scientific-opinion-sccs157616-vitamin-retinol-retinyl-acetate-retinyl-palmitate_en
Natural sources such as clays, plant extracts, and raw materials containing naturally occurring radioactive material (NORM) have been used as ingredients for medicinal and cosmetic purposes since ancient times. Nowadays, a variety of commercially available cosmetics products used clay minerals containing NORMs as the main formulation, which poses unknown radiation risks to the consumer. In this study, 11 samples of clay-based cosmetic products were used to conduct dose assessments on members of the public for various usage scenarios to evaluate the external exposure dose. Gamma-ray spectroscopy was utilised to measure the activity concentrations of ²³⁸U, ²³²Th, and ⁴⁰K in the sample. Meanwhile, doses to skin and other organs from these cosmetic products were modelled using Geant4 Monte Carlo simulations and the MIRD5 mathematical phantom, incorporating dose conversion factors (DCFs). The results revealed that the activity concentration for ²³⁸U, ²³²Th, and ⁴⁰K ranged from 0.1 – 1.3, 0.06–15.6, and 0.22–6.9 Bq g⁻¹, respectively, which were lower than the reference provided by the international regulation. The analysis for heavy metals showed that sample 9 contained a high amount of Cd, which gave an immediate alert to that particular product. Furthermore, the effective doses in the skin estimated in this study with the range of 2.7–240 μSv y⁻¹, were significantly lower than the International Commission on Radiological Protection (ICRP) reference limit of 50 mSv per year for members of the general public. Based on the few μSv of effective dose exposure, it is sufficient to conclude that the dose from these products poses no radiological risk to the user. The addition of NORMs in cosmetic products should be done with caution because higher concentrations can raise the dose.
Fragrances are widely used in everyday life. However, too fast volatilization rates and poor adhesion on substrates limit their applications. In this study, reactive nano-fragrance based on cyanuric chloride (CYC)-modified chitosan (CSCYC) were prepared by a solvent evaporation method. First, CS-CYC was synthesized. Subsequently, CS and CS-CYC were utilized to prepare nano-fragrances. The results demonstrated that adding CS and CS-CYC could significantly improve the fragrance encapsulation efficiency and reduce the release rate of phenylethanol. phenylethanol Moreover, the adhesion of nano-capsules on commodities was improved with CS by forming hydrogen bonds. CYC on the surface of the nanocapsules further enhanced the conglutination of nano-fragrances on commodities by a condensation reaction with wallpaper. Additionally, the addition of both CS and CS-CYC imparted antibacterial activity for the nano-fragrances against Gram-positive and Gram-negative bacteria with excellent biosafety. Therefore, the reactive nano-fragrances with antimicrobial activity and slow-release properties could provide a comfortable and healthy living environment, making them have vast application potential.
SCCS OPINION on the safety of aluminium in cosmetic products - Submission III - SCCS / 1644/22 – Preliminary Opinion
U. Bernauer, L. Bodin, Q. Chaudhry, P.J. Coenraads, M. Dusinska, J. Ezendam, E. Gaffet, C. L. Galli, B. Granum, E. Panteri, V. Rogiers, Ch. Rousselle, M. Stepnik, T. Vanhaecke, S. Wijnhoven, N. Cabaton, A. Koutsodimou, W. Uter, N. von Goetz
The SCCS adopted this document by written procedure on 6 May 2022 (51 Pages)
Mise en ligne 30 Mai 2022
https://ec.europa.eu/health/publications/sccs-safety-aluminium-cosmetic-products-submission-iii_en
Little information is available on product use by consumers, which severely hampers exposure estimation for consumer products. This article describes actual contact with several consumer products, specifically dishwashing detergents, cleaning products, and hair styling products. How and where products are handled, as well as the duration, frequency, and amount of use were studied by means of diaries, in-home observations, and measurements. This study addressed the question, "To what extent are frequency, duration, and amount of use associated?" Findings showed that there was a large intra- as well as interindividual variation in frequency, duration, and amount of use, with the interindividual variation being considerably larger. At the same time, results showed that, for a given activity, users tended to follow their own routine. Few relations were found among frequency, duration, and amount of use. It was concluded that among persons, frequency, duration, and amount of product act in practice as independent parameters. Diaries appear to be quite suitable for gaining insight into frequently used products. Observations of usage, recorded on video, were indispensable for obtaining particular information on product use. In addition, home visits enabled the collection of specific measurements. Although diaries and home visits are time-consuming, the combination provided insight into variation as well as relations among frequency, duration, and amount of use.
Accurate exposure information for cosmetic products and ingredients is needed in order to conduct safety assessments. Essential information includes both the amount of cosmetic product applied, and the frequency of use. To obtain current data, a study to assess consumer use practices was undertaken. The study included three widely used cosmetic product types: lipstick, body lotion, and face cream. Three hundred and sixty women, ages 19-65 years, who regularly use the products of interest, were recruited at ten different geographical locations within the US. The number of recruits was chosen to ensure a minimum of 300 completes per product type. Subjects were provided with prototype test products, and kept diaries and recorded detailed daily usage information over a two week period. Products were weighed at the start and completion of the study in order to determine the total amount of product used. Statistical analysis of the data was conducted to derive summary distribution of use patterns. The mean and median usage per application, respectively, for the three products was: face cream, 1.22 g and 0.84 g; lipstick, 10 mg and 5 mg; and body lotion, 4.42 g and 3.45 g. The mean and median usage per day for the three products was: face cream, 2.05 g and 1.53 g; lipstick, 24 mg and 13 mg; and body lotion, 8.70 g and 7.63 g. The mean number of applications per day for face cream and lipstick was 1.77 and 2.35, respectively. For body lotion, the mean number of applications per day was dependent on body area, and was 2.12, 1.52, 1.11, 0.95, 0.43, 0.26, and 0.40 for hands, arms, legs, feet, neck and throat, back, and other body areas, respectively. The effect of product preference on use practices was also investigated. This study provides current cosmetic exposure information for commonly used products which will be useful for risk assessment purposes.
Statistics in Medicine. Little, Brown and Co., Massachusetts. European Centre for Ecotoxicology and Toxicology of Chemicals
- T Colton
Colton, T., 1974. Statistics in Medicine. Little, Brown and Co., Massachusetts. European Centre for Ecotoxicology and Toxicology of Chemicals [ECETOC], 1993. Monograph No. 20, Percutaneous Absorption.