Proposition 65 Compliance for Cosmetics Products
Our board-certified toxicologists and regulatory experts help cosmetics companies understand and comply with the Proposition 65 requirements to successfully place their products on the California market.
The Safe Drinking Water and Toxic Enforcement Act, commonly known as Proposition 65 (“Prop 65”), has been in effect in California since 1986. Under Prop 65, the State of California maintains and updates a list of 900+ substances known to be carcinogenic or known to cause reproductive/developmental toxicity.
Who is Impacted?
Companies intending to bring a product to market in California must report the presence of Prop 65–listed substances in their product by affixing a "warning label" on the product. The Prop 65 warning label informs Californians about exposures to these substances in consumer products, including cosmetic products, distributed on the local market.
A warning label is needed if the consumer can be exposed to a Prop 65 substance at a level exceeding the Safe Harbor Level (SHL). The California Office of Environmental Health Hazard Assessment (OEHHA) defines SHLs (i.e., no significant risk levels/maximum allowable dose levels) for the substances on the Prop 65 list.
What are the Challenges?
All cosmetics products sold in the State of California are subject to the Prop 65 regulation. This can be challenging for companies if they do not know the substances that could be problematic in their product or if they are unaware of the SHLs associated with the substances in their product. These challenges make it difficult for companies to determine whether a Prop 65 warning label is required on a product. Failure to comply with the Prop 65 requirements can result in fines, civil lawsuits, reformulations, and/or the addition of warning labels.
The Intertek Advantage
Our team of experts has in-depth knowledge of the complexities of Prop 65 compliance issues and can provide guidance on how to address these issues.
We incorporate a 3-step process in our Prop 65 compliance strategy to help cosmetics companies, selling in California, determine whether their product should be labeled with Prop 65 warnings.
- Step 1 - Full Formulation Review:
Intertek will review a product’s full chemical composition and will determine the chemicals of concern based on the Prop 65 list. This is accomplished through a full review of raw material information on both the formulation and the packaging. Intertek will:
- Liaise with suppliers to gather additional information on formulation and Safety Data Sheets (SDS)
- Analyze the Bill of Materials (BoM)
- Perform screening/audits for chemicals of concern
- Step 2 - Chemical Testing:
Intertek will determine the potential Prop 65 substances of concern based on the applicable exposure route (if any). Intertek will:
- Conduct product screening (X-ray, fluorescence, wipe test)
- Perform migration testing
- Step 3 - Exposure Assessment:
Based on the above information and the intended use of a product, Intertek will determine the quantity of chemicals a consumer could be exposed to per day and will compare this to the SHL set by the State of California. If a SHL has not been determined by the State, Intertek will calculate one based on OEHHA guidance and supporting data.