Regulatory context
The state of California has specific regulations for cosmetics products, one of which is Proposition 65. To sell products in California, cosmetics brands must comply with national regulations as well as with state-specific regulations.
California’s Safe Drinking Water and Toxic Enforcement Act (also named Proposition 65) was published for the first time in 1986.
Proposition 65 regulates products intended to be sold in the state of California, including regular cosmetics and OTC’s.
The goal of this legislation is to identify whether a specific product presents any carcinogenic risk according to state limitations. If it does, appropriate warnings must be displayed.
The California Office of Environmental Health Hazard Assessment (OEHHA) updates the Proposition 65 list on a yearly basis, adding substances considered harmful, i.e., suspected of causing cancer. This list currently contains more than 900 chemicals to consider prior to selling cosmetic products in California.
A product containing one of these substances must have “easily understandable, readable and prominently placed” warnings applied on its labeling materials along with a warning symbol.
All persons involved in the cosmetics supply chain must comply with Proposition 65 in order to do business in California.
BIORIUS reviews the production composition and advises which warning(s) should be added to the labels when necessary.
How does it work?
Two scenarios can occur when reviewing cosmetic products:
1. The product contains ingredients listed in Proposition 65, for which limitations are provided by law.
The process is then divided in two phases:
- Identification of the Ingredients: BIORIUS analyzes the cosmetic product formula in order to determine which ingredients are affected by this regulation.
- Conclusion & Warnings: BIORIUS determines the appropriate warnings based on the limitations provided by Proposition 65.
Corrective actions and comments are provided for updating the formula when necessary.
2. The product contains ingredients listed in Proposition 65 but for which no safe harbor levels are provided.
The process is then divided in three phases:
- Identification of the Ingredients: BIORIUS analyses the cosmetic product formula in order to determine which ingredients are affected by this regulation.
- Calculation of Safe Harbor Levels: BIORIUS conducts a toxicological study to calculate the limits for each ingredient listed. This is done by evaluating published toxicological data and using OEHHA methodology. For cancer, cancer potency and the NSRL (allowable risk of 1:100000) is identified using mathematical models and methodologies accepted by the EPA and OEHHA. For reproductive and developmental toxicity, toxicological data from reliable studies are used to derive an MADL (the maximum dose level having no observable effect divided by one thousand [1,000] to arrive at the maximum allowable dose level).
- Conclusion & Warnings: BIORIUS determines the appropriate warnings based on the conclusion of the toxicological study. Depending on exposure to the ingredient and its respective safe harbor level, the need for a warning can then be determined. Obviously, having accurate exposures and derived safe harbor levels is extremely important when determining whether warnings are needed or not.
Corrective actions and comments are provided for updating the formula when necessary.
To conduct a Proposition 65 assessment, BIORIUS’ experts analyze the product composition and each raw material in the product along with the product category and all specificities.
When the product is deemed as compliant with Proposition 65, a compliance certificate is issued, which highlights the following:
- Applicable legislation
- Concentration of ingredients
- Expert conclusions and any warnings to be displayed
Additional toxicological studies must be performed in addition to the above process. In this case, BIORIUS delivers a complete report which includes the toxicological studies in order to justify the presence or absence of warnings on the labeling materials.