With Element’s Prop 65 testing services, manufacturers and distributors can ensure compliance to California’s Proposition 65 right-to-know law, under which they are primarily responsible to provide a clear and reasonable warning prior to intentionally exposing individuals to levels of over 900 chemicals detailed within the legislation that may exceed established safety thresholds.
Although primary responsibility is assigned to manufacturers and distributors to determine whether a warning label is required per California’s Safe Drinking Water and Toxic Enforcement Act, also known as CA Prop 65, broader responsibility to comply with the regulations is required of all manufacturers, producers, packagers, importers, suppliers and distributors. The goal of the 1986 legislation is to protect consumers from exposure to chemicals and other toxic substances linked to cancer, birth defects, or other reproductive harm. If any consumer product contains one or more of the chemicals that have been deemed hazardous in levels that may exceed safe harbor limits, the product must be labeled as such.
The state of California makes updates to the Proposition 65 list of chemicals periodically, and the safe harbor levels associated with them, if adopted, are also published. After a new chemical is added to the list of substances, businesses are provided a 12-month period to comply with labeling and warning requirements. The risk non-compliant organizations face is litigation and legal action, which may be carried out by California’s enforcement community.
California Prop 65 testing and compliance services
- Compositional assessment for listed chemicals in products
- Detailed exposure assessments, including a determination of warning obligations
- Determination of safe harbor status
The Element advantage
Protect the health and safety of consumers and the environment while ensuring your business remains compliant with California state regulations with the support of Element’s regulatory and scientific experts who are well-versed in Prop 65 testing and regulations. Our comprehensive service offerings include compositional assessments, evaluations of detailed exposure and corresponding warning label requirements, and the determination of safe harbor status.
To evaluate your products for compliance to California Proposition 65 requirements, learn more about our comprehensive Prop 65 testing services, or to speak with one of our experts, contact us today.
Who does the list of CA Prop 65 regulated chemicals apply to?
Any California manufacturer or distributor with 10 or more employees or whose products are sold or distributed within the state of California are subject to Proposition 65 regulations. The proper labeling of products containing Prop 65 chemicals is not the responsibility of retailers.
What classes of chemicals are listed in Prop 65 regulations?
The CA Prop 65 list of over 900 chemicals known to cause cancer, birth defects, or other reproductive harm contains solvents and chemicals ranging from naturally occurring compounds to man-made or synthetic chemicals. These compounds and chemicals can be found in a variety of goods including drugs, foods, household products, agricultural products, and construction materials. Chemicals used for manufacturing processes as well any byproducts associated with those processes are also included.
How do I know if a warning is required for my product based on the Proposition 65 list of chemicals?
The state of California has published a searchable list of chemicals that are associated with the legislation. The chemicals used in the formulation, manufacturing, and packaging of your product can be searched within the online database. If, when your product is used as intended, a harmful chemical regulated by the law is produced as a result, a warning label may be required. Warning labels refer to the exposure level and associated risk of the chemical(s) to consumers.
Do short form warnings satisfy Prop 65 labeling requirements?
Short form warnings are placed directly on products and do not list the specific chemical compound(s) of concern. They are typically found on products that are small and cannot accommodate larger, more detailed labels. Some companies are relying on short form warnings to satisfy their obligations; however, there is still some debate as to the validity of the less restricted Prop 65 short form warning format.
How does Prop 65 safe harbor status impact labeling requirements?
Safe harbor levels dictate the level at which a chemical of concern can be present where it no longer poses no significant risk of reproductive harm, birth defects, or cancer. Businesses are exempt, i.e., having “safe harbor” status from warning requirements or discharge prohibitions for the more than 300 chemicals the state of California has published that are associated with safe harbor levels. However, if the chemical used by your business does not appear on the list of safe harbor levels, by default, a warning label must be applied to the product, unless an exemption is granted, as detailed below.
Are any other exemptions available for specific chemicals, aside from the Prop 65 safe harbor status?
Some businesses may qualify for Proposition 65 exemptions from the Office of Environmental Health Hazard Assessment (OEHHA) if the level of exposure for chemicals present 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.
The chemicals used by my business do not pose a significant risk. How can I establish this and comply with CA Prop 65?
Per the California Code of Regulations Title 27, Articles 7 and 8, it is the responsibility of the business to demonstrate the safety of a chemical. This can be accomplished by partnering with a qualified laboratory that has experience in material characterization, identification, classification, and toxicity evaluation of major and minor components. 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.
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