California Proposition 65
California Proposition 65, the Safe Drinking Water and Toxic Enforcement Act of 1986, constitutes the basis for a legislation on transparency of exposure for consumers before they purchase a product - not limited at all to water safety as the titel might pretend. Prop 65 often is used as reference for specifying carcinogenic compounds in other regulations and specifications as well, e.g. in CDPH Section 01350 regarding emissions from products into indoor air.
Any consumer product, if manufactured, handled or sold in California by a business with more than 9 employees, is covered by this regulation. Example products are toys, furniture, paints, cosmetics, glass, ceramics, textiles, electrical devices, and many more.
Chemicals involved are those that can cause cancer or reproductive harm such as birth defects (CMR). Examples of listed compounds comprise formaldehyde, benzene, lead, crystalline silica, some heavy metals, Bisphenol A etc.
A warning must be placed on the product if any CMR chemical is contained in the product and can lead to health risk by exposure during its use. This is the case if the exposure level is assumed to cause a risk of 1 additional case of any such harm per 100.000 people.
Exposure can be calculated from composition with the worst-case assumption that the whole amount of the chemical is released. Another option is to determine average release rates, such as emission into indoor air or migration into drinking water or food. Exposure is calculated over 70 years life duration.
Risk is estimated from exposure pathways and quantity in comparison with limit values (if available). As an example, release of particles from painted wall can occur in very small quantities and the particles can be dispersed in indoor air. If e.g. lead is contained in that paint then this small release can already make a Proposition 65 warning necessary.
Prop 65 Warning - is it needed?
If a manufacturer wants to identify the need for placing a warning then the following steps need to be followed:
- Identify whether any chemical in your product is on the Prop65 list of chemicals. Beware of possible updates not yet reflected here with this link.
Involve your suppliers for the components that they deliver.
- If any chemical in your product is present, then you either place the warning, or you identify whether consumer exposure is lower than the respective Safe Harbor Level - taking into account all routes of exposure during whole lifetime. Beware of possible updates not yet reflected here with this link.
- If the exposure assessment confirms the risk, place the warning; else you can do without.
There are no specifications available of the formal path for showing compliance. At the end of the day, in case of a litigation suit against a non-labeled product a court will decide whether a delivered documentation of no risk is regarded convincing.
As many lawyers are very active on this field, many businesses prefer to place a Proposition 65 warning even if there is severe doubt that their products really may show human exposure that causes any health risk. This over-cautious attitude may protect the individual business, but it counteracts the intention of Prop 65 regulation if all products carry a warning, and nobody can distinguish between real and non-real hazards.
Prop 65 warnings
If a Prop 65 warning is necessary, then it must have one of these text examples, as appropriate:
- WARNING: This product contains a chemical known to the State of California to cause cancer.
- WARNING: This product contains a chemical known to the State of California to cause birth defects or other reproductive harm.
- WARNING: This product contains a chemical known to the State of California to cause cancer and birth defects or other reproductive harm.
The warning must be placed such, that a consumer easily recognizes it before purchase, e.g. on product packaging, in marketing material, in advertisements, on homepages etc.
Eurofins can provide you with
- Survey whether your product and its formulation are concerned by Proposition 65 limit values
- Perform a literature and experience study on similar products if you do not know the chemical composition of your specific product
- Analyze the content of such chemicals in your product, e.g.
- content of phthalates, lead, mercury, arsenic, formaldehyde
- release of such chemicals from your product, e.g. VOCs, formaldehyde
- Specify and use an exposure model for concluding with a good risk estimate
In any case it is strongly recommended to search legal advice before any final conclusions.
Contact to Eurofins Support and Laboratories
Eurofins proposes consulting and testing for solving your Prop 65 issues. Please contact our specialists.