7 Oct 2016
California Amends Proposition 65 Warning Language
The California Office of Environmental Health Hazard Assessment has amended in various ways the Proposition 65 warning requirements of Article 6 of Title 27 of the California Code of Regulations. As we have extensively reported, Proposition 65 requires businesses to inform consumers in the state about significant amounts of listed chemicals in consumer products, food, drugs and other goods, and this requirement is generally fulfilled by labelling products with a “clear and reasonable” warning. For more than two years, California authorities worked on a proposal (which has now been finalised) aimed at reducing unnecessary litigation and providing more useful information to the public on what they are being exposed to and how they can protect themselves. The new requirements will enter into force on 30 August 2018. In the meantime, businesses may comply with either the current or the new requirements.
Under the existing regulations, a warning is “clear” if it clearly communicates that the chemical in question is known to the state of California to cause cancer, birth defects or other reproductive harm. A warning is “reasonable” if the method employed to transmit the message is reasonably calculated to make the warning message available to the individual prior to exposure. However, the existing safe harbour warnings lack the specificity necessary to ensure that the public receives useful information about potential exposures. In addition, the existing regulations were adopted more than 25 years ago and communication technology has progressed considerably during that time. Accordingly, OEHHA found it necessary to update the regulations to take advantage of current and future approaches to providing important health-related information to the public.
An OEHHA statement of reasons indicates that the new regulations will require more detailed information in Proposition 65 safe harbour warnings, including a clear statement that a person can be exposed to a listed chemical, the names of one or more listed chemicals that are the subject of the warning, and a link to a website maintained by OEHHA containing supplemental information. The agency believes this information will further the “right-to-know” purposes of the statute and provide more specificity for the content of safe harbour warnings for a variety of exposure situations, as well as corresponding methods for providing those warnings. In addition, a new mandatory regulation has been established to address the relative responsibility of product manufacturers and others in the distribution chain versus the product retailer. Businesses will continue to be assured that compliance with the safe harbour regulations will help them avoid litigation because the content and methods provided in the regulation are deemed “clear and reasonable” for purposes of complying with the law.
According to the new regulations, a warning meets the applicable requirements if the name of one or more of the listed chemicals in the consumer product or affected area for which the warning is being provided is included in the text of the warning. Where a warning is being provided for more than one endpoint (cancer and reproductive toxicity), it must include the name of one or more chemicals for each endpoint unless the named chemical is listed as known to cause both cancer and reproductive toxicity and has been so identified in the warning.
The regulations require consumer product exposure warnings to be prominently displayed on a label, labelling or sign. Specifically, they must be displayed with such conspicuousness as compared with other words, statements, designs or devices on the label, labelling or sign as to render the warning likely to be read and understood by an ordinary individual under customary conditions of purchase or use. The warning content may contain information that is supplemental to the required content only to the extent that it identifies the source of the exposure or provides information on how to avoid or reduce exposure to the identified chemical or chemicals.
According to the new regulations, a warning meets the relevant requirements if it contains the elements laid out below and is provided using (i) a product-specific warning provided on a posted sign, shelf tag or shelf sign for the consumer product at each point of display of the product; (ii) a product-specific warning provided via any electronic device or process that automatically provides the warning to the purchaser prior to or during the purchase of the consumer product, without requiring the purchaser to seek out the warning; (iii) a label that complies with the content requirements laid out below; or (iv) an on-product warning that complies with the content requirements laid out below (the entire warning must be at least 6-point type and no smaller than the largest type size used for other consumer information on the product). Where a consumer product sign, label or shelf tag used to provide a warning includes consumer information in a language other than English, the warning must also be provided in that language in addition to English.
The required elements for product exposure warnings include the following.
- use of the word “WARNING” in all capital letters and bold print
- inclusion of a warning symbol consisting of a black exclamation point in a yellow equilateral triangle with a bold black outline, although such symbol may be printed in black and white in instances where the sign, label or shelf tag for the product is not printed using the colour yellow (this symbol must be placed to the left of the text of the warning, in a size no smaller than the height of the word “WARNING”)
- for exposures to listed carcinogens, the words “This product can expose you to chemicals including [name of one or more chemicals], which is [are] known to the State of California to cause cancer. For more information go to www.P65Warnings.ca.gov.”
- for exposures to listed reproductive toxicants, the words “This product can expose you to chemicals including [name of one or more chemicals], which is [are] known to the State of California to cause birth defects or other reproductive harm. For more information go to www.P65Warnings.ca.gov.”
- for exposures to both listed carcinogens and reproductive toxicants, the words “This product can expose you to chemicals including [name of one or more chemicals], which is [are] known to the State of California to cause cancer, and [name of one or more chemicals], which is [are] known to the State of California to cause birth defects or other reproductive harm. For more information go to www.P65Warnings.ca.gov.”
- for exposures to a chemical that is listed as both a carcinogen and a reproductive toxicant, the words “This product can expose you to chemicals including [name of one or more chemicals], which is [are] known to the State of California to cause cancer and birth defects or other reproductive harm. For more information go to www.P65Warnings.ca.gov.”
- where a warning is being provided for an exposure to a single chemical, the words “chemicals including” may be deleted from the warning content
An on-product warning may be provided using all of the following elements.
- the word “WARNING” in all capital letters and bold print
- the symbol described above
- for consumer products that cause exposures to a listed carcinogen, the words “Cancer - www.P65Warnings.ca.gov.”
- for consumer products that cause exposures to a listed reproductive toxicant, the words “Reproductive Harm - www.P65Warnings.ca.gov.”
- for consumer products that cause exposures to both a listed carcinogen and a reproductive toxicant, the words, “Cancer and Reproductive Harm - www.P65Warnings.ca.gov”
A person providing an on-product warning is not required to include within the text of the warning the name or names of a listed chemical.
For internet purchases, a warning that complies with the content requirements must be provided by including either the warning or a clearly marked hyperlink using the word “WARNING” on the product display page or by otherwise prominently displaying the warning to the purchaser prior to completing the purchase. If an on-product warning is provided, the warning provided on the website may use the same content as the on-product warning. A warning is not prominently displayed if the purchaser must search for it in the general content of the website. For catalogue purchases, the warning must be provided in the catalogue in a manner that clearly associates it with the item being purchased.
The regulations also set forth specific warning methods and content for specific types of exposures, including exposures from food (including dietary supplements), alcoholic beverages, prescription drugs, raw wood products, furniture, diesel engines (except passenger vehicle engines), vehicles, recreational vessels, and canned and bottled foods and beverages containing bisphenol A. In the case of furniture, a warning meets the applicable requirements if it is provided using the following process:
- a warning is affixed to the furniture product in the same manner as other consumer information or warning materials that are provided on the product; and
- a notice or sign no smaller than 8.5 by 11 inches is displayed either at each public entrance or point of display and printed in no smaller than 28-point type, or a notice is printed or stamped in no smaller than 12-point type on each receipt.
An on-product warning label for furniture must include the word “WARNING” in all capital letters and bold print, the symbol described above, and the words “This product can expose you to chemicals including [name of one or more chemicals known to cause cancer, name of one or more chemicals known to cause reproductive toxicity, or name of one or more chemicals known to cause both cancer and birth defects or other reproductive harm], which is [are] known to the State of California to cause cancer or birth defects or other reproductive harm. For more information go to www.P65Warnings.ca.gov/furniture.” A notice for furniture displayed or stamped on a receipt as explained above must contain the word “NOTICE” in all capital letters and bold print as well as the words “Some furniture products can expose you to chemicals known to the State of California to cause cancer or birth defects or other reproductive harm. Please check on-product label for warning information.”
With regard to the responsibility to provide consumer product exposure warnings, the regulations state that the manufacturer, producer, packager, importer, supplier or distributor of a product may fulfil its responsibility either by affixing a label to the product bearing a warning that satisfies the applicable requirements or by providing a written notice directly to the authorised agent for a retail seller (i) stating that the product may result in an exposure to one or more listed chemicals; (ii) including the exact name or description of the product or specific identifying information for the product such as a Universal Product code or other identifying designation; and (iii) including all necessary warning materials such as labels, labelling, shelf signs or tags and warning language for products sold on the Internet. Once the notice is sent to the retail seller, the manufacturer, producer, packager, importer, supplier or distributor must obtain confirmation either electronically or in writing of receipt of the notice.
If the manufacturer, producer, packager, importer, supplier or distributor of a product provides a written notice directly to the authorised agent, the notice must be renewed and receipt of the renewed notice confirmed electronically or in writing by the retail seller’s authorised agent within six months during the first year after the effective date and then annually thereafter during the period in which the product is sold in California by the retail seller. An additional notice is required within 90 days when a different or additional chemical name or endpoint (cancer or reproductive toxicity) is included in the warning. The retail seller is responsible for the placement and maintenance of warning materials, including warnings for products sold over the Internet.
The retail seller is responsible for providing the required warning for a consumer product exposure only when it:
- is selling the product under a brand or trademark that is owned or licenced by the retail seller or an affiliated entity;
- has knowingly introduced a listed chemical into the product or knowingly caused a listed chemical to be created in the product;
- has covered, obscured or altered a warning label that has been affixed to the product;
- has received a notice and warning materials for the exposure and sold the product without conspicuously posting or displaying the warning; or
- has actual knowledge of the potential consumer product exposure requiring the warning and there is no manufacturer, producer, packager, importer, supplier or distributor of the product who is a “person in the course of doing business” under Section 25249.11(b) of the Act and has designated an agent for service of process in California or has a place of business in California.
Moreover, the retail seller of a consumer product that may cause an exposure must promptly provide, on written request and to the extent the information is reasonably available, the name and contact information for the manufacturer, producer, packager, importer, supplier and distributor of the product to the appropriate California authorities or to any person who has served notice under Section 25249.7(d)(1) of the Act alleging that the consumer product causes an exposure that requires a warning under the Act.