January 22 2019
In October 2018, the Danish Environmental Protection Agency published the project report: Survey of chemical substances in consumer products No. 169 with the title: Risk assessment of fluorinated substances in cosmetic products.
The authors were Anna Brinch and Frans Cristensen from COWI A/S, together with Allan Astrup Jensen from NIPSECT. The chemical analyses were performed by Eurofins A/S.
The purpose of the project was to build knowledge of polyfluoroalkylated substances (PFAS) in cosmetic products on the Danish market and to clarify, whether using cosmetic products containing PFAS posed a risk to consumers. It is well-known that many PFAS, especially perfluoroalkyl carboxylic acids (e.g. PFOA) and perfluoroalkyl sulfonic acids (e.g. PFOS) and their derivatives are considered to be problematic, as they are very persistent (vP) in the environment, some may accumulate in humans or the environment (bioaccumulative (B) or very bioaccumulative (vB) and because some of the substances are known to be toxic (T).
The project consisted of the following phases:
- Survey of PFAS in cosmetic products
A worldwide survey of the occurrence of fluorinated substances in cosmetic products such as foundation, moisturizer, eye shadow, powder, lipstick and shaving cream etc. was undertaken based on data from international literature, data obtained from the Danish Consumer Council and data from relevant Internet databases.
The results from the survey showed that a variety of fluorinated substances were present in a wide range of cosmetic products with emphasis on foundations, creams, lotions and powders. PFAS occurred in cosmetic products both as desired ingredients and as unintentional degradation products and/or impurities from the production. Polytetrafluoroethylene (PTFE) was found in most product types, followed by C9-15 polyfluoroalcohol phosphates.
Based on the results of the survey, 22 cosmetic products on the Danish market containing fluorinated substances, as well as two control products, were initially selected for chemical analysis.
2. Chemical analyses
However, only 17 of these selected cosmetic products were actually analysed for a number of single PFAS, for which analytical standards were available, and for total organic fluorine (TOF).
In two of the foundations perfluorooctanoic acid (PFOA) was determined in concentrations above the EU limit value of 25 ng/g. In six of the products, the proposed REACH EU limit value for the sum of C9–14 perfluoroalkyl carboxylic acids (PFCAs) was also exceeded. Organic fluorine was determined in all but one product.
3. Potential health hazards and risk assessment
Based on the results from the chemical analyses, five PFAS (PFCAs) were selected for the hazard and risk assessments. These were: Perfluorooctanoic acid (PFOA), perfluorobutanoic acid (PFBA), perfluoropentanoic acid (PFPeA), perfluorohexanoic acid (PFHxA) and perfluoroheptanoic acid (PFHpA).
Exposure scenarios were prepared for three leave-on product types: Body lotion, CC cream/foundation and concealer.
The hazard assessment was based primarily on previous assessments of the selected PFCAs by the EU, other countries and previous publications by the Danish Environmental Agency as well as IARC’s recent assessment of PFOA. In addition, the hazard assessment included new data from the literature as well as information on physicochemical properties from different databases.
Among the five PFCAs, far most data on toxicology, toxicokinetics, toxicodynamics and population studies exists for PFOA, thus PFOA was used as a reference substances for comparisons with the other PFAS.
Of the selected PFCAs:
- PFOA had in all cases had the lowest “No Observed Adverse Effect Level (NOAEL)” of 0.06 mg/kg bw/day.
- PFOA was the only, which had an estrogenic effect in animal experiments and in vitro test systems, was carcinogenic, and having an adverse effect on the mammary gland.
- PFOA had with 8.5 years in humans the longest serum/plasma half-life.
- PFOA was detected in the highest concentrations in bone and bone marrow in humans. The substance is also detected in high concentrations in human blood, lungs and liver.
- PFOA was the most effective endocrine disruptor and had the greatest effect on the thyroid gland
- PFOA had the strongest binding to albumin in the blood.
Exposure scenarios were prepared in accordance with the principles from the “Guidance for safety assessment of chemical substances in cosmetic products” from the Scientific Committee for Consumer Safety (SCCS), for the product types: Body lotion, CC cream/foundation and Concealer.
Dermal absorptions of PFAS as salts and acids were estimated to 2% and 70%, respectively, and the highest estimated daily total PFAS exposures were calculated.
The risk assessment was based on calculation of worst-case “Margin of Safety’s (MoS)” expressing the relationship between three differently determined “No Observed Adverse Effect levels (NOAELs)” for PFOA and the estimated internal total PFAS exposures assumed to be PFOA.
It was concluded, that exposure to PFAS alone from use of one cosmetic product did not pose a risk to consumers, however, the worst-case scenario with the simultaneous use of more cosmetic products with PFAS (and other simultaneous PFAS exposures?) a risk cannot be ruled out.