California Proposition 65

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California Proposition 65

California Proposition 65, the Safe Drinking Water and Toxic Enforcement Act of 1986, often is used as reference for carcinogenic compounds also on other fields than water safety, e.g. in CDPH Section 01350 regarding emissions from products into indoor air.

California Proposition 65 and consumer products

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 exposure level is assumed to cause 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 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.

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.

Eurofins services

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
• Determine the release of such chemicals from your product
• 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.

Further information

• List of chemicals known to the state to cause cancer or reproductive toxicity - updated Nov 04, 2011
  - or the same list as EXCEL file.
• FAQ about Proposition 65
• "Safe Harbor Levels": No Significant Risk Levels (NSRLs) and Maximum Allowable Dose Levels (MADLs), present list - updated Nov 12, 2010
• More information in Wikipedia

For further information please contact our national organisations or our specialists for making use of the experience of Eurofins, the world market leader for VOC emissions chamber testing.

Your direct contacts:

Direct contact to Eurofins Product Testing A/S, the world market leader for VOC emissions chamber testing:

• Sales: Reinhard Oppl, email voc@eurofins.com
• Certification: Dr. Roland Augustin, email ccs@eurofins.com
• Testing laboratory: Thomas Neuhaus, email voc@eurofins.com