Proposition 65 Warning Label Requirements More Strict in 2018
Written by: Brittiny Harris & Joe Mangiardi, NES, Inc.
Beginning August 30, 2018, Proposition 65 will require warning labels to more clearly convey chemical dangers to California consumers.
California Warning Labels Law Becoming More Stringent
Proposition 65, the law requiring all products sold in California to have labels providing “clear and reasonable warnings” of any harmful chemicals those products might contain, is slated to become more stringent in 2018. Any businesses that manufacture, distribute, and/or sell products in California are advised to become familiar with these changes to ensure their products’ labels maintain compliance.
Proposition 65, or the Safe Drinking Water and Toxic Enforcement Act, was first put on the ballot in California on November 1986. A guiding element of the law is the requirement for labels on products sold in California to provide a warning if they contain one of the over 800 Proposition 65-listed harmful chemicals. Chemicals known to cause cancer, birth defects, or other reproductive harm are required to be put on the warning label, and the list of harmful chemicals is required to be kept up to date.
Proposition 65: Clear and Reasonable Warnings
The specific language used in the law instructs companies to provide “clear and reasonable warnings” before knowingly exposing consumers to a listed chemical, though this has often been challenging to confidently interpret. The best way to achieve compliance is to follow wording guidelines provided by the regulations (these guidelines are summarized in the K&L Gates article WARNING: Proposition 65 Warning Requirements Have Changed).
Further, a product is exempt if none of its constituent chemicals poses a significant cancer risk—itself a vague criterion. According to the American Cancer Society article Cancer Warning Labels Based on California’s Proposition 65, the law defines “no significant risk” as a level of chemical exposure to the user that will cause cancer in no greater than 1 user out of every 100,000 people over a 70-year lifetime. Similar criteria apply to rates of birth defects and reproductive harm.
Changes to Proposition 65
On August 30, 2018, the new regulations about warning labels will go into effect. Old and possibly unaccounted for inventory bearing outdated warning labels (or none at all) can cause compliance issues for businesses. To ensure being fully prepared and protected from potential litigation, companies should start making the required changes now.
This video provides an overview of Proposition 65 including information on the 2018 updates (beginning at the 11:00 mark).
Prior to 2018, warning labels have needed simply to state that a listed chemical is present in a product, but they were not required to disclose what the chemical is, where to find it, how consumers will be exposed to it, how to reduce exposure, or what the level of risk is. The language added to Proposition 65 for 2018 will address many of these questions and concerns in requiring labels to clearly inform consumers that there is a harmful chemical found in the product, the name of at least one of those chemicals, and in what ways the chemical(s) may be hazardous to consumers’ health.
Some specific groups that are going to be directly affected include manufacturers, distributors, and retailers—and particularly internet vendors. Manufacturers and distributors still have the initial obligation to put a warning label on their products, but the responsibility will not be placed solely on their shoulders. Retailers will have to pay attention to the specific duties they are now assigned according to the updated regulations. Previously, internet sales were not directly included in Proposition 65; now internet sales have regulations guiding the arrangement of warnings on webpages listing products. Language governing facilities such as amusement parks, parking facilities, designated smoking areas, etc., has been added to the new regulations as well. The California Office of Environmental Health Hazard Assessment (OEHHA) is even working on safer regulations for hotels.
Warning labels in 2018 will need to include three main elements:
- The name of at least one chemical that caused the warning to be written must be listed.
- A link to a website containing Proposition 65 information, which will have more details on health effects and ways to reduce and/or eliminate exposure, must be prominently displayed.
- A yellow and black triangle warning symbol must always be located on the label (as pictured below).
Other information that will now be required on the warning label includes specific exposures, website warnings for the products, and warnings in more languages than English. Additionally, labels have to be written in six-point or larger font.
Proposition 65 List and How to Add
The Proposition 65 List consists of naturally occurring and synthetic chemicals that are associated with causing cancer, reproductive harm, and/or birth defects. The chemicals that are included in this list consist of ingredients in pesticides, household products, foods, drugs, dyes, and solvents.
As written in the OEHHA publication How chemicals are added to the Proposition 65 list, at a minimum, each process to add or delete from the harmful chemical list includes, “Public notice that a chemical is under consideration for listing, a public comment period, review of comments received, and notice of the final decision.” The publication outlines four ways that a chemical can be added to the list:
The chemical has to be compliant with reference Labor Code section 6382(b)(1), which would have to be a chemical that the World Health Organization’s International Agency for Research on Cancer (IARC) deems a cancer causing chemical in humans or laboratory animals.
State’s Qualified Experts
Two self-sufficient committees (the Carcinogen Identification Committee and the Developmental and Reproductive Toxicant Committee), made up of scientists and health experts, work separately. If, through their research and study of the chemicals, one of the committees finds a chemical that has been proven to cause cancer, birth defects, or other reproductive harm, that chemical may be listed.
Authoritative bodies are designated organizations (by the Carcinogen Identification Committee and the Developmental and Reproductive Toxicant Committee) such as U.S. Environmental Protection Agency (EPA), U.S. Food and Drug Administration (FDA), etc. If one of these designated organizations identifies a chemical that has been proven to cause cancer, birth defects, or other reproductive harm, it will be added to the list.
Formally Required to be Labeled
If a state agency or federal government requires that a chemical needs to be listed because it is proven to cause cancer, birth defects, or other reproductive harm, it will be added to the list.
Complications Due to Proposition 65 Changes
Historically, Proposition 65 has been problematic. The list of harmful chemicals continues to grow, and often companies do not realize their products contain a listed chemical until it is too late. “Bounty hunters,” in the form of those seeking to benefit financially from catching companies in violation, are always in search of improper/incorrect warning labels.
Proposition 65 violation bounty hunters are not actually similar to the stereotype depicted in the above image; they are primarily lawyers looking for a payday.
With constant changes to contend with, businesses are going to have to be very careful in order to avoid the potential downpour of lawsuits from citizen groups wanting to enforce the new Proposition 65. For manufacturers and distributors, putting warning labels on products will be more complicated because different products may fall under different categories in the regulations. For example, labels for furniture, food, and clothing, etc., will vary in this respect. The key is to make a due diligence effort in determining the best warning label design to both serve business interests and be compliant with the law.
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Original Proposition 65 Regulations: Proposition 65
K&L Gates Article: WARNING: Proposition 65 Warning Requirements Have Changed
American Cancer Society Article: Cancer Warning Labels Based on California’s Proposition 65
OEHHA Publication: The Proposition 65 List
Assent Compliance YouTube Video: https://www.youtube.com/watch?v=AuH7Rf9EID0
OEHHA Publication: How chemicals are added to the Proposition 65 list
Downey Brand Article: New Proposition 65 Clear and Reasonable Warning Regulations Are Effective in 2018
Exponent Article: Are You Ready for Proposition 65 Changes in 2018?
OEHHA Publication: Notice of Adoption Article 6: Clear and Reasonable Warnings