22 April 2016
California Relaxes Proposition 65 Requirements on BPA Warnings for Canned and Bottled Foods
California’s Office of Environmental Health Hazard Assessment has decided to provide additional flexibility to manufacturers and retailers as they struggle to implement a requirement to place warnings regarding potential consumer exposures to bisphenol A (BPA) on canned and bottled foods. The requirement was adopted last year under the authority of the Safe Drinking Water and Toxic Enforcement Act (commonly known as Proposition 65), which requires the state of California to publish a list of chemicals known to cause cancer or reproductive harm such as birth defects and update this list every year. The list was originally published in 1987 and has grown to include more than 900 naturally occurring and synthetic chemicals ranging from acrylamide and formaldehyde gas to arsenic, lead, cadmium, mercury and certain phthalates.
Commonly used in certain linings of metal cans and lids of glass bottles containing food and beverages, BPA was added to the Proposition 65 list on 11 May 2015 following a determination that it causes reproductive toxicity on the female reproductive end-point. Beginning on 11 May 2016, warnings are required for all exposures to BPA unless the person causing the exposure can show that the exposure, when multiplied by 1,000 times, has no observable effect. OEHHA indicates that a product does not require a warning simply because it contains BPA or any other chemical listed under Proposition 65, but rather when a business knowingly and intentionally causes an exposure to a listed chemical.
Because Proposition 65 requires businesses, rather than OEHHA, to determine when warnings are required, some businesses may make their own determination that the BPA exposures they are causing are too low to require a warning even though such exposures may be comparable to, or even greater than, exposures from other products that carry warnings. OEHHA generally tries to avoid such situations by establishing maximum allowed dose levels. Businesses over the years have relied on these levels and related guidance in determining when they need to provide warnings. The agency notes, however, that there is currently no maximum allowed dose level for oral exposure from food and beverages to BPA. OEHHA is waiting for research sponsored by the federal government that may resolve complicated scientific questions that would enable the agency to establish a maximum allowed dose level for BPA oral exposures. However, that research is not expected to be completed until late 2017 or early 2018.
OEHHA recognises that the listing of BPA under Proposition 65 will have widespread impacts on food and beverages sold across the state because many canned and bottled foods and beverages can cause exposures to varying amounts of this chemical. The agency is aware that some canned food and beverage manufacturers plan to reduce or eliminate the use of BPA or have recently done so and that the need for warnings for these products will likely decrease over time. Any changes made by manufacturers will not immediately affect existing retail inventories, however, because many canned foods and beverages have a shelf life of up to three years. Thus, although businesses have had a year to remove or reduce BPA from their products, many products produced prior to or immediately after the May 2015 listing of BPA are still in the stream of commerce and will require warnings beginning in May 2016.
OEHHA is concerned that businesses will take inconsistent approaches to compliance, particularly in the time period immediately following 11 May when the warning requirement begins. In the absence of a maximum allowed dose level for BPA, businesses must decide on their own whether the BPA exposures their products cause are high enough to trigger the warning requirement. OEHHA acknowledges that this is a complex decision by individual businesses that involves not only scientific interpretation of the health effects of BPA but also the use of the businesses’ own information on the frequency with which consumers use their products and how much they consume.
Some businesses may decide that products causing relatively high exposures to BPA do not require warnings, while others may decide to place warnings on products causing lower exposures to BPA. The agency believes that consumers will have no immediate way of distinguishing between them and that some may incorrectly assume that a product with no warning has no BPA. OEHHA is also concerned about consumer confusion stemming from the sudden appearance of a large number of warning signs referring to a multitude of food and beverage products, with some consumers likely to become overly alarmed while others could dismiss the warnings as uninformative. In addition, the fact that Proposition 65 warnings do not have to include the name of the chemical of concern or the health effect associated with it could exacerbate confusion.
In light of this situation, OEHHA has decided to issue an emergency action to provide additional flexibility for businesses to comply with the BPA warning requirement (as of 15 April the emergency action was still being considered by California’s Office of Administrative Law). Specifically, a business would be deemed to comply with this requirement after 11 May if the manufacturer, producer, packager, importer or distributor of the canned and bottled food or beverage either:
- affixes a label to the product bearing a warning that satisfies the Proposition 65 requirements; or
- provides written notice directly or through an authorised agent or trade association to the retailer or its authorised agent (i) stating that the canned or bottled food or beverage may result in an exposure to BPA, (ii) including the name or description of the canned or bottled food or beverage for which a warning is being provided, such as a Universal Product Code or other identifying designation, and (iii) providing or offering to provide to the retail seller at no cost a sufficient number of point-of-sale warning signs that satisfy the requirements of Proposition 65.
If the retail seller receives the notice mentioned above, it would be required to post the warning sign at each point-of-sale in the retail facility. The placement and maintenance of warning signs would be the responsibility of the retail seller of the affected products. The term point-of-sale would be defined as the area within a retail facility where customers pay for foods and beverages, such as the cash register or check-out line where the warning sign is likely to be seen and understood prior to the consumer purchasing the canned or bottled food or beverage. Point-of-sale also includes electronic check-out functions on Internet websites.
Warning signs provided at the point-of-sale would have to be no smaller than five by five inches and be displayed with such conspicuousness, as compared with other words, statements, designs or devices at the point-of-sale, as to render the sign likely to be read and understood by an ordinary individual prior to purchase of the affected products. For products sold over the Internet, the warning would have to be provided either on the product display page or otherwise be prominently displayed to the purchaser prior to completing the purchase. The warning sign would be required to contain the word “WARNING” in all capital letters and bold print as well as the following statement: “Many food and beverage cans have linings containing bisphenol A (BPA), a chemical known to the State of California to cause harm to the female reproductive system. Jar lids and bottle caps may also contain BPA. You can be exposed to BPA when you consume foods or beverages packaged in these containers. For more information go to: www.P65Warnings.ca.gov/BPA.”