New Proposition 65 Warning Requirements Take Effect on August 30, 2018
This alert highlights some of the more important changes and explains how those changes apply to manufacturers, distributors, and retailers.
On August 30, 2018, new regulations under California’s Safe Drinking Water and Toxic Enforcement Act, better known as Proposition 65 (“Prop. 65”) will take effect. The new regulations concern what constitutes a clear and reasonable warning. This is a significant overhaul to current regulations and applies to businesses with 10 or more employees. Prop. 65 regulations affect many industries including food, beverage, prescription drug, dental care, consumer product, cosmetic, agricultural products, furniture products, diesel engines, vehicles, recreational vessels, medical device manufacturers, workplaces and commercial businesses.
Businesses operating in California or selling products or components in California have been required to provide a “clear and reasonable warning” before “knowingly and intentionally” exposing any person to “a chemical known to the state to cause cancer or reproductive toxicity.” The failure to comply with Prop. 65 subjects manufacturers, distributors and retailers to potential liability, including penalties of up to $2,500 per day, per violation, as well as injunctive relief (for example, a court order requiring a product to be reformulated to remove the listed chemical) and attorney fees.
These new regulations mandate that businesses operating in or supplying or manufacturing products or components that are sold in California assess and if necessary, overhaul their Prop. 65 compliance programs by August 30, 2018.
Current/Pre-August 30, 2018 Rules
Under current Prop. 65 regulations, businesses with 10 or more employees are required to provide a “clear and reasonable” warning before exposing individuals in California to any chemical listed by the state for its potential to cause cancer or reproductive toxicity. Products manufactured prior to August 30, 2018, can continue to be sold in California using the pre-August 30, 2018 Proposition 65 warning requirements; however, the new requirements must be reflected on all products manufactured after August 30, 2018.
The New Regulations
The new regulations significantly alter the safe harbor warning rules for Prop. 65 by changing the form and content required for the “safe harbor” warning provided to California consumers. The new warning requirements apply to “consumer products”, which includes any article, or component part thereof, including food, that is produced, distributed, or sold for the personal use, consumption or enjoyment of a consumer where a “consumer product exposure” is reasonably contemplated. Additionally, warnings are required in certain situations where “environmental exposure” or “occupational exposure” may occur.
The new regulations clarify that manufacturers have the primary responsibility for providing Prop. 65 warnings. Manufacturers can chose whether to put warning labels on their products or to provide notices to their distributors, importers or retail sales outlets that a product may cause an exposure to a listed chemical that requires a warning, provide warning signs, or other warning materials. Additionally, the new regulations require that retailers that receive warning signs or other warning material from a manufacturer, producer, packager, importer, supplier, or distributor must confirm in writing that they received the notice and must use the warning signs or other materials provided by the manufacturer. This expressly includes products offered for sale over the internet.
(1) New Safe Harbor Clear and Reasonable Warning Requirements
Products containing Prop. 65 listed chemicals can be sold in California and generally do not need to be reformulated if they contain a proper Prop. 65 safe harbor warning. However, as of August 30, 2018, the new Prop. 65 regulations change the appearance, form and content for the safe harbor warnings. Some of the more significant changes in the labeling requirements include:
- The word “WARNING” which must appear in bold print and in all capital letters.
- The warning must include a pictogram comprised of a black exclamation point in a yellow equilateral triangle with a black outline if the sign, label or shelf tag for the product uses the color yellow. The equilateral triangle must be placed to the left of the warning and in a size no smaller than the height of the word “WARNING”
- Language must be changed from "This product contains…" to "This product can expose you to…."
- The warning must include the full chemical name of at least one chemical found in the product that is known to cause cancer or birth defects or other reproductive harm. If the product contains a chemical on both lists, at least one chemical from each list must be identified. Additionally, there is a shortened on-product safe harbor warning that allows the person providing the on-product warning to not include within the text of the warning the name or names of listed chemicals known to cause cancer or birth defects or other reproductive harm.
- The entire warning must appear in at least 6 point font size and be in a font size that is no smaller than the largest font size used for other consumer information affixed to the product.
- Additionally, if a consumer product sign, label or shelf tag includes consumer information in a language other than English, the warning must also be provided in that language, in addition to English.
(2) Internet and Catalog Sales
The new regulations make the warning requirements applicable to all Internet purchases. The Internet warning on the product display page must be prominently displayed, have the word “WARNING” hyperlinked or the warning can be prominently displayed to the purchaser prior to completing the purchase. An Internet warning is not considered prominently displayed if the purchaser must search for it in the general content of the website. If the product has an on-product warning then the website may use the same content. The warning must also appear in languages other than English if consumer information on the website is in a language other than English.
For catalog purchases, the warning must be in the catalog in a manner that clearly associates it with the item being purchased. If the product has an on-product warning then the website may use the same content. The warning must also appear in languages other than English if consumer information in the catalogue is in a language other than English.
(3) Specific Warning Methods And Content For Certain Products And Exposure Types
In addition, the new Prop. 65 regulations require specific warning methods and content for certain products (including food, dietary supplements, alcoholic beverages, furniture) and types of exposures (including restaurants, dental care, wood dust, diesel engine, enclosed parking facility, amusement parks, service stations, hotels). For example, a new regulation has been added to require specific warning methods and content for a product commonly used in construction, such as raw wood.
While Prop. 65 regulations continue to require a warning label to be placed on any consumer product containing a chemical(s) that cause cancer or reproductive harm as identified by the Office of Environmental Health Hazard Assessment, the safe harbor language has been changed to allow for a short form warning on products or a long form warning requiring the identification of at least one offending chemical contained in the product. Additionally, the warning requirements are now applicable to internet and catalogue purchases. Lastly, tailored warnings are required for specific products, industries and areas, including food, alcohol, restaurants, prescription drugs, dental care, raw wood, furniture, diesel engines, vehicles, recreational vessels, enclosed parking facilities, service stations, vehicle repair facilities and smoking areas.
 25600.1(e) defines “consumer product exposure” to mean an exposure that results from a person’s acquisition, purchase, storage, consumption, or any reasonably foreseeable use of a consumer product, including consumption of a food.
 25600.1(f) defines “environmental exposure” to mean an exposure that occurs as the result of contact with an environmental source, such as ambient air, indoor air, drinking water, standing water, running water, soil, vegetation, or manmade or natural substances or objects, through inhalation, ingestion, or skin or other contact with the body. All exposures that are not consumer product exposures or occupational exposures are environmental exposures.
 25600.1(k) defines “occupational exposure” to mean an exposure to any employee at his or her place of employment.