CA Prop 65 Compliance and Chemical Evaluation
California’s labeling law, CA Prop 65, puts the primary responsibility on manufacturers and distributors to determine if a warning label is needed, but broad responsibility for compliance is required of all manufacturers, producers, packagers, importers, suppliers, and distributors of any product that contains one or more listed chemicals. At Avomeen, we work to evaluate your products for compliance with California’s requirements through comprehensive Prop 65 testing.
What is Proposition 65?
California Proposition 65 is a “right to know” law passed in the mid‐1980s to address growing concerns about exposure to chemicals that may be present in consumer products. The law requires California to publish a list of chemicals known to cause cancer, birth defects or other reproductive harm. The list includes over 900 chemicals, and businesses are required to provide a “clear and reasonable” warning before intentionally exposing individuals to levels that may exceed established safety thresholds (otherwise known as safe harbor limits).
Prop 65 Compliance
Businesses are given 12 months to comply with warning requirements after a new chemical is added to the list or they may be subject to risk of litigation from California’s enforcement community.
Avomeen provides Prop 65 testing for companies to attain compliance in three steps:
- Compositional assessment for listed chemicals in products.
- Detailed exposure assessment, determining warning obligations.
- Safe harbor limit determination, when needed.
Have more questions? Check out our FAQ below!
Companies doing business in California need to be aware of and comply with Prop 65 Regulations passed via the Safe Drinking Water and Toxic Enforcement Act of 1986. Businesses must confirm whether any chemicals currently known to cause cancer are in their consumer products. The list1 has been extended to list additional chemicals, which has placed the burden on manufacturers and distributors, rather than retailers and others, involved in the product supply chain to provide “clear and reasonable warnings” about chemicals used.
1. Who should be concerned with the CA Prop 65 list of regulated chemicals?
Proposition 65, also known as the Safe Water and Toxic Enforcement Act, is a California law that is applicable to any California manufacturer or distributor with 10 or more employees whose products are sold or distributed within the state of California. Retailers are not responsible for proper labeling of products containing Prop 65 chemicals.
2. What Kinds of Chemicals Are Listed?
The CA Prop 65 List contains a list of over 900 chemicals known to cause cancer, birth defects or other reproductive harm. The list contains chemicals and solvents that range from naturally occurring compounds to man-made or synthetic chemicals. These chemicals can be found in a variety of goods like drugs, foods, household products, agricultural products (like synthetic fertilizers & pesticides), construction materials, and solvents. Additionally, the list also includes chemicals used for manufacturing processes as well any byproducts associated with those processes.
3. How do I know if my products contain listed chemicals?
The most expedient way to find out if a warning is required on your products is to review the searchable list of Proposition 65 listed chemicals against those used in the formulation, manufacture, and packaging of your products, or if the use of your products produces a harmful chemical. The warning pertains to the exposure level and associated risk of the chemical(s) to consumers.
4. What is a Prop 65 short form warning?
Some companies are using a short form warning to satisfy the requirement. The short form warning is simply a warning placed on products without listing the particular chemical, such as on small products with label size limitations.2 The validity of the less restricted Prop 65 short form warning is still in debate.
5. What is Prop 65 safe harbor?
Prop 65 safe harbor outlines over 300 safe harbor levels for chemicals listed to date which deem a business exempt, i.e., having “safe harbor” status from warning requirements or discharge prohibitions. Some businesses may qualify for Proposition 65 exemptions from the Office of Environmental Health Hazard Assessment (OEHHA), if the level of exposure for chemicals used in their products are lower than their “safe harbor” level, which is typically up to 1,000 times lower than levels set by regulatory agencies.3 A safe harbor level is indicative of a level is present in a low enough level that it has no significant risk of reproductive harm, birth defects or cancer.2 If the chemical used by your business is not on the list of more than 300 safe harbor levels, by default you must list a warning.
6. How can I establish that the chemicals used by my business pose no significant risk?
It is the responsibility of the business to prove that a chemical is safe according to the California Code of Regulations Title 27, Articles 7 and 8. This can be accomplished through testing by a qualified laboratory with experience in material characterization, identification, classification, and evaluation of toxicity for the major and minor components in a substance. Determining the chemical composition and related risk is a complex, precise process that requires an established, experienced analytical assessment. The State of California recommends businesses work with an analytical lab and scientists with experience in Prop 65 risk assessment to avoid violating the established law.3
How to Ensure Compliance with Prop 65 Regulations
Avomeen can partner with companies to help them become compliant in these three easy steps by performing:
- Compositional Assessment
- Detailed Exposure and Corresponding Warning Label Requirements
- Determination of Safe Harbor Status
Avomeen has a wide range of organic and inorganic materials testing capabilities, as well as product research and development services. We can work as an extension of your team, facilitating a seamless partnership and responsive communication surrounding your challenges and needs. Our testing laboratory is staffed with only the best and brightest chemists who are experienced in prop 65 testing requirements. Our staff will help you solve your chemical analysis needs, so you stay compliant.
We would be happy to consult with you and answer any questions you may have about the Proposition 65 warning label and what you can do.
Contact us if you have additional questions or if you’re ready to start your Proposition 65 chemical analysis.
- “Chemicals Known to the State to Cause Cancer or Reproductive Toxicity.” State of California Environmental Protection Agency Office of Environmental Health Hazard Assessment Safe Drinking Water and Toxic Enforcement Act of 1986, January 3, 2020. Retrieved from https://oehha.ca.gov/media/downloads/proposition-65//p65list010320.pdf
- “Proposition 65 Clear and Reasonable Warnings Questions and Answers for Businesses.” Office of Environmental Health Hazard Assessment California Environmental Protection Agency, May 2019, https://www.p65warnings.ca.gov/sites/default/files/art_6_business_qa.pdf
- “Frequently Asked Questions.” State of California – Department of Justice – Office of the Attorney General, 10 May 2018, https://oag.ca.gov/prop65/faqs-view-all