Prop 65 requires the State of California to maintain and update a list of chemicals known to the state to cause cancer or reproductive toxicity and has large-scale implications for products that need to carry a warning and warning symbol (an exclamation mark against a yellow background).
Safe harbor levels, which include No Significant Risk Levels (NSRLs) for cancer-causing chemicals and Maximum Allowable Dose Levels (MADLs) for chemicals causing reproductive toxicity, have been established for many of the chemicals listed under Prop 65.
A safe harbor is a provision of a statute or a regulation that specifies that certain conduct will be deemed not to violate a given rule.
Prop 65 is confined to the State of California which has one of the largest food and beverage industry in the country. A Prop 65 warning informs a consumer that they are being exposed to carcinogens or reproductive toxins that exceed certain threshold levels which is not the same as a regulatory decision that a product is “safe” or “unsafe,” according to the State of California Department of Justice.
The law places an obligation on companies to provide “clear and reasonable” warnings if they choose to sell such products into California.
The changes are likely to directly impact manufacturers, distributors, and retailers, including online vendors. Manufacturers and distributors will have the primary obligation to display an updated warning label on products.
Prop 65: The background and changes
The initial warning took effect in 1988 with most Prop 65 warnings simply stating that a chemical is present that causes cancer or reproductive harm. However, they do not identify the chemical or provide specific information about how a person may be exposed or ways to reduce or eliminate exposure to it.Prop 65: The background and changes
New Office of Environmental Health Hazard Assessment (OEHHA) regulations have now been adopted. The new regulations change the safe harbor warnings which are deemed to comply with the law in several important ways. For example, the new warnings for consumer products will say the product “can expose you to” a Prop 65 chemical rather than saying the product “contains” the chemical.
They will also include:
- The name of at least one listed chemical that prompted the warning.
- The Internet address for OEHHA’s new Prop 65 warnings website, www.P65Warnings.ca.gov, which includes additional information on the health effects of listed chemicals and ways to reduce or eliminate exposure to them.
- A triangular yellow warning symbol ⚠ on most warnings.
The new warning regulation also adds new “tailored” warnings that provide more specific information for certain kinds of exposures, products, and places, provides for website warnings for products purchased over the Internet, provides for warnings in languages other than English in some cases and clarifies the roles and responsibilities of manufacturers and retailers in providing warnings.
The new warning system has several main goals including making warnings more meaningful and useful for the public, reducing “over-warning” in which businesses provide unnecessary warnings and giving businesses clearer guidelines on how and where to provide warnings.
There are around 800 chemicals listed. Glyphosate was added to the Prop 65 list in July with a safe harbor level of 1,100 micrograms/per day. However, there is pending legal action which means that companies do not have to add a Prop 65 warning to products containing glyphosate because of a court-ordered injunction and the outcome of a lawsuit filed by Monsanto which is challenging the case for glyphosate to be added.
Campaign group Moms Across America, is calling for controversial glyphosate – the active herbicide in Monsanto’s Roundup weedkiller used in commercialized agriculture all over the world – to be banned across the US and has been working on Prop 65 issues for a long time.
“We applaud the decision by California's OEHHA to require companies which expose the public to chemicals which cause cancer or reproductive harm to specifically name which chemicals do so on the product or shelf label,” she tells. “This is a significant change. The public has a right to know. If companies are unhappy about being required to name the specific chemicals, we hope they will simply stop using them.”
Solutions to beverage development
It is largely accepted that these types of warning labels can be off-putting to consumers and so some companies are reformulating.
One company offering solutions to beverage development amid Prop 65 is Imbibe.
Three of the blacklisted chemicals under Prop 65 include Furfuryl alcohol, 4-Methylimidazole (4-MEI) and acrylamide. Furfuryl alcohol is not Prop 65 compliant in any amount, and 4-MEI and acrylamide require a Prop 65 claim above predetermined levels. These chemicals occur naturally in many brown-note flavors like caramel, coffee, cola, root beer and maple. Imbibe has developed these common flavors – along with several others – without those chemicals, therefore allowing brand owners the ability to remove warning labels on their products that would scare off consumers.
Holly McHugh, Marketing Associate, Imbibe says: “We work with our clients who do not want warning labels on their products in California to help them come up with alternative ingredients. Imbibe offers several flavors and ingredients that would typically require warning labels without blacklisted chemicals (therefore allowing brand owners the ability to remove warning labels) while also maintaining or improving the quality of their product.”
