Certification and Registration
California Proposition 65
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California Prop 65
In August 2020, California reported its first case involving penalties against a company for selling leather products containing hexavalent chromium (Chromium VI). The leather products involved violated California Proposition 65 requirements and resulted in litigation (Case Number: HG20064308). The products involved were leather gloves. The company was prohibited from supplying or selling any related products that had not been improved unless such products carried warning labels. In addition, the company was required to pay US$33,000.
What Is Proposition 65?
In 1986, California voters approved Proposition 65, an initiative aimed at addressing increasing concerns regarding exposure to toxic chemicals. The initiative is officially known as the Safe Drinking Water and Toxic Enforcement Act of 1986. The law requires the State of California to publish a list of chemicals known to cause cancer or reproductive toxicity and requires businesses to provide warnings when they knowingly and intentionally expose individuals to listed chemicals.
This list currently (as of March 2021) includes approximately 900 chemicals. Proposition 65 does not prohibit or restrict the sale of chemicals included on the list. Instead, these warnings are intended to help Californians make informed decisions about products they use and places they visit where exposure to these chemicals may occur.
The Office of Environmental Health Hazard Assessment (OEHHA) is responsible for managing the Proposition 65 program.
Chemicals Listed Under Proposition 65
The Proposition 65 list covers a wide range of natural and synthetic chemicals, including pesticides, common household products, food-related substances, pharmaceuticals, and additives or ingredients used in dyes and solvents. Listed chemicals may also be used in manufacturing and construction, or generated as by-products of chemical processes, such as vehicle exhaust emissions.
California Proposition 65 applies to nearly all products, including jewelry, toys, electrical appliances, electrical wires, beauty products, ceramic tableware, household furniture, motor vehicles, alcoholic beverages, canned and bottled foods and beverages, fresh fruits and vegetables, and many other products. The list is updated at least once a year.
Proposition 65 Requirements
When a chemical is added to the Proposition 65 list, 12 months later, companies are prohibited from knowingly and intentionally exposing individuals to that chemical without first providing a clear and reasonable warning.
When a chemical is added to the Proposition 65 list, 20 months later, companies are prohibited from knowingly discharging listed chemicals into sources of drinking water.
Common High-Risk Substances
Currently, the Proposition 65 list contains nearly one thousand substances, making it impractical to test for all listed chemicals. Supply chain assessments are an effective approach for risk management. If a supply chain assessment is not feasible, companies are advised to review relevant legal cases applicable to their products, evaluate whether hazardous substances are present, and determine whether their products comply with applicable limits established in those cases. If substance levels exceed the thresholds identified in relevant cases, companies should apply appropriate warning labels. In the absence of applicable precedents, it is recommended to prioritize managing risks associated with substances that have a higher likelihood of litigation, including:
◉ Lead (Pb)
◉ Cadmium (Cd)
◉ Phthalates
◉ Flame retardants
◉ Arsenic (As)
◉ Formaldehyde
◉ Bisphenol A (BPA)
Proposition 65 Warning Labels
Since the original warning requirement came into effect in 1988, most Proposition 65 warnings only stated that chemicals capable of causing cancer or reproductive harm were present. However, these warnings did not identify the specific chemical involved or provide clear guidance regarding potential exposure routes or methods to reduce exposure.
Content of the previous version of the warning text ( Example )
The California Office of Environmental Health Hazard Assessment (OEHHA) approved revisions to Proposition 65 on August 30, 2016, providing updated requirements for “clear and reasonable” California Proposition 65 warnings. The revised warning requirements became effective on August 30, 2018. Retailers and manufacturers must take appropriate measures to ensure that their products comply with the updated California Proposition 65 warning requirements.
New Version of Warning Text
The updated warning label introduces several key changes, including replacing the previous wording “Contains chemicals” with “May expose you to…” followed by the listed Proposition 65 chemical. In addition, the revised warning label must identify at least one listed chemical responsible for triggering the warning, display a triangular yellow warning symbol, and include the Proposition 65 warning website URL and related information.
New Version of Warning Text (Example)
Responsibilities of Manufacturers and Retailers
Manufacturers have the primary responsibility for providing Proposition 65 warnings. Manufacturers may choose to attach warning labels or markings directly to their products, or provide notices to distributors, importers, or retailers indicating that the product may expose users to listed chemicals requiring a warning, together with appropriate warning labels or other warning materials.
Manufacturers may also establish written agreements with retailers to modify the allocation of responsibility, provided that consumers receive clear and reasonable warnings before exposure to chemicals listed under Proposition 65.
Internet Warning
For consumer products purchased online, a warning must be displayed on the product listing page, or a hyperlink clearly labeled with the word “Warning” must be provided on the product listing page to communicate the required warning information.
Translation of Warning Labels
When consumer information on product markings, labels, or shelf tags requiring a warning is provided in a language other than English, warnings must also be provided in that language in addition to English. Consumer information includes warnings, instructions for use, ingredient lists, and nutritional information, but does not include trademarks, product names, company names, manufacturing locations, or product advertisements.Facilities displaying signage in languages other than English must also provide required warnings in those languages in addition to English.
Spanish Warning Text
SATISFY provides customers with comprehensive and proactive California Proposition 65 compliance solutions, assisting companies in determining whether their products contain chemicals listed under Proposition 65, as well as providing services such as warning label design and multilingual translation.
SATISFY California Proposition 65 Services Include:
BPA warning label compliance services
Supply chain analysis and data collection
Establishment and certification of compliance assurance processes
Chemical testing, analysis, and product screening (XRF), including acrylamide analysis
Identification of risk areas related to Proposition 65 listed substances and provision of compliance strategies
Preparation of Proposition 65 position statements for companies (including arguments for objecting to the listing of chemicals or requesting removal of chemicals from the Proposition 65 list)
When no safe harbor level has been established by OEHHA, establishment of a “No Significant Risk Level” (NSRL) and “Maximum Allowable Dose Level” (MADL)
Conducting exposure assessments to determine whether products comply with applicable requirements and whether warning labels are required
Assistance in obtaining OEHHA decisions regarding the safe use of products
For more information, please contact SATISFY customer service for additional information regarding California Proposition 65.
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