April 25, 2016


Notice Regarding Emergency Action on Proposition 65 Warnings for Exposures to Bisphenol A
 
California's Office of Environmental Health Hazard Assessment (OEHHA) issued a notice of emergency action on Monday April 18 that will affect Proposition 65 warnings required for foods that present an exposure to bisphenol A (BPA).
 
Background
On May 11, 2015, BPA was added to the Proposition 65 list of chemicals known to the state to cause reproductive toxicity based on the female reproductive endpoint. BPA is approved by the U.S. Food and Drug Administration (FDA) for use in food-contact applications (except baby formula) and is commonly used in linings of metal cans and lids of glass jars and bottles containing food and beverages. It is also found in other food packaging materials and has been detected in unpackaged foods, presumably due to BPA's use in harvest, transport, and processing equipment.
 
As with all Proposition 65 listed chemicals, mandated warnings must be provided within one year of the listing date. Therefore, starting May 11, 2016, warnings are required for exposures to BPA (except for companies with fewer than 10 employees) unless the person causing the exposure can show that the exposure when multiplied by 1,000 times has no observable effect. OEHHA has not established a maximum allowable dose level (MADL) for oral exposure to BPA, so businesses must make their own determination as to whether any BPA exposures from their products require the warning.
 
Emergency Rulemaking
In the April 18th notice of emergency action OEHHA described its implementation of an emergency regulation regarding Proposition 65 warnings for exposures to BPA that allows for temporary use of a point-of-sale warning for exposure from canned and bottled foods and beverages.
 
Under the emergency regulation, canned and bottled foods and beverages offered for retail sale in California on or after May 11, 2016 that cause exposures to BPA are deemed to comply with the warning requirements of Section 25249.6 if the following provisions are met:

(A) 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 Section 25249.6 of the Act, or

(B) Provides written notice directly or through an authorized agent or trade association to the retailer or its authorized agent. The written notice must:
(i) State that the canned or bottled food or beverage may result in an exposure to bisphenol A; and
(ii) Include the name or description of the canned or bottled foods or beverages for which a warning is being provided, such as a Universal Product Code or other identifying designation; and
(iii) Provide, or offer to provide, to the retail seller, at no cost, a sufficient number of point-of-sale warning signs that satisfy the requirements of subsection 25603.3(g).
 
A retail seller that receives a notice of a BPA warning from a manufacturer, producer, packager, importer or distributor of a canned or bottled food or beverage must post the warning sign at each point-of-sale in the retail facility. The placement and maintenance of warning signs is the responsibility of the retail seller of the affected products.  For internet sales to California, warnings must be provided before checkout.
 
Product Review Needed
If you are a manufacturer, producer, packager, importer or distributor of canned or bottled food or beverages in commerce in California that cause exposures to BPA, you have until May 11, 2016 to determine if Proposition 65 warnings are needed and to comply with the requirements of the emergency regulation if needed.
 
Compliance assistance
IASC strongly recommends that aloe product companies that may need to provide this warning consult an experienced Proposition 65 compliance professional to determine if the warning is needed and ensure compliance as applicable. For assistance finding an experienced compliance professional please contact Jane Wilson (jwilson@iasc.org), IASC Executive Director.
 
Products sold via retail outlets:  
Companies with products that require the BPA warning need to either label their products with the required warning or distribute a notification to retailers that sell the products along with a list of affected products to comply with the emergency action.
 
Products sold via the internet:
Companies selling products in California through their own website or one or more distributor websites must ensure that the point of sale warning is provided for the relevant products prior to checkout on their website and must notify any distributors of the need to post the warning prior to checkout on the distributor's website. 
 
More information on the OEHHA rulemaking is available here
 
Please contact Jane Wilson (jwilson@iasc.org), if you would like to discuss this issue further.