In a complex and ever-evolving chemical regulatory landscape, it is very important to ensure accurate and sustained chemical product compliance. Chemicals can contribute significant value to products; however, they require careful management to protect people, animals and the environment. New regulations for restricting harmful chemical content come into effect every year worldwide to control potential risks; existing laws are constantly evolving to keep pace with new information and scientific advancements. As a result, there are a wide variety of chemical regulations manufacturers must address. Here is an overview of compliance with California Proposition 65 in consumer products.
Failure to be in compliance can lead to law suits, heavy penalties and court-mandated reformulation.
California’s Safe Drinking Water and Toxic Enforcement Act of 1986, known generally as Proposition 65 and is intended to provide consumers with information about potential exposures to carcinogens and reproductive/developmental toxicants. This law requires manufacturers to provide a “clear and reasonable warning” on their products if they contain a listed carcinogen or reproductive or developmental toxicant. Proposition 65 is self-contained and EPA, FDA or REACH registrations do not confer exemption from the law.
Since 1986, over 800 chemicals have been placed on the Proposition 65 list by the California Office of Environmental Health Hazard Assessment (OEHHA). The list contains chemicals, additives and other ingredients present in many common household and office products including toys, clothing, shoes, jewelry, pesticides, rugs, furniture, appliances, luggage, medical devices, over-the-counter drugs and food. A product manufacturer is required to determine to the best of their ability whether their products contain a listed substance. If the listed substance is present, the manufacturer must provide a label statement warning consumers of the potential hazard or demonstrate that human exposures related the product are below “safe harbor levels” established by the state. Unfortunately, OEHHA has set safe harbor levels for less than 1/3 of the listed chemicals and, where safe harbors levels have not been established, manufacturers must either provide warnings regardless of the degree of risk or establish a safe harbor level, an often difficult task even for companies with experienced toxicologists.
California Revises Proposition 65 Warning Requirements, New Regulations Became Operative on August 30, 2018
Product manufacturers putting their products onto the market in California, must pay attention to the changes came into effect on August 30, 2018. California Proposition 65 compliance now requires adoption of a new warning label, in which one or more listed chemicals in the product must be identified.
The following is an example of the new warning label, which must be placed on the external packaging of product. The intent is to warn the individual prior to coming into contact with the listed chemical or chemicals prior to exposure.
Alternatively, a truncated warning may be used:
WARNING: Cancer (and/or Reproductive Harm) – www.P65Warnings.ca.gov.
Warning labels are required for a variety of situations including environmental exposure (i.e., fumes containing these substances), consumer exposure (i.e., handling or using consumer products), or workplace exposure (i.e., workers exposed to products that contain these chemicals). Products sold over the internet to customers within the State of California require warnings prior to completion of sale. Non-compliance may result not only in monetary or legal settlements, but also in product reformulation, redesign, or even market withdrawal.
What you may need to do:
- Reach out to your suppliers to identify if any California Proposition 65 chemicals are contained in the raw materials, components, sub-assemblies, or products they provide.
- Review your product Bill of Materials (BOM) to determine if individuals would come in contact with the chemicals during the expected normal use of the product.
- Consider options for addressing potential exposure to these chemicals.
Why is this important? Non-compliance can be costly:
- In 2015, Plaintiffs paid a total of $26.2 million dollars in total settlement payments, with a total of 583 settlements.
- In 2016, the last year official figures were published, Plaintiffs paid a total of $30.15 million dollars in total settlement payments. With a total of 760 settlements, the average cost of $40,000/per settlement.
Currently, the California Proposition 65 list of chemicals has grown to almost 1000 chemicals and will continue to expand as new chemicals are added.