Introduction
Responsibility for warnings
New retailer obligations to provide warnings
New warning text
Safe harbour warnings
General additional considerations
On August 30 2016 the California Office of Environmental Health Hazard Assessment (OEHHA) released its final amendments to the Proposition 65 warning regulations.
The new warning standards may apply to any products sold in California or to any business operations in California. The warning rules are changing for manufacturers, distributors and retailers as, for the first time, specific rules will govern warnings for internet sales.
The new warning standards apply to products manufactured on and after August 30 2018. Between now and then, companies may still use warnings which comply with the existing 2008 regulations.
The new regulations impose primary responsibility for providing warnings on product manufacturers, producers, packagers, importers, suppliers or distributors. They must either affix warnings on the products or product labels, or provide notice and warning materials to "the authorized agent" of a retailer. Detailed terms regulate how manufacturers may ask retailers to warn.
New retailer obligations to provide warnings
A retailer can be liable for failure to warn in relation to the retailer's private label products or where:
- the retailer received warning materials from an upstream party and failed to provide the warnings;
- the retailer knowingly introduced a listed chemical to be created in or added to a product;
- the retailer modified or obscured a product's label warning;
- the retailer has "actual knowledge" of the potential consumer exposure requiring the warning (such knowledge can arise on receipt of a 60-day notice of intent to sue letter); and
- no upstream person in the product supply chain is subject to Proposition 65.
For internet sales, new rules require the internet seller to provide a warning before completion of check out. There is some flexibility on how and when the warning is provided.
The OEHHA has developed specific warnings for exposures to listed chemicals in foods, alcoholic beverages sold at retail stores, foods and alcoholic beverages sold at restaurants, prescription drugs, emergency dental and medical care, non-emergency dental services, raw wood products, furniture, diesel engines, vehicle purchases, recreational vessels, enclosed parking facilities, amusement parks, petroleum products, service station and vehicle repair facilities and designated smoking areas. The OEHHA is still developing unique text for hotels and apartment building warnings.
Most people are familiar with the safe harbour warning text deemed "clear and reasonable" under the 2008 regulations: "WARNING: This product contains a chemical known to the State of California to cause cancer and birth defects or other reproductive harm." Going forward, the OEHHA's position on what constitutes a safe harbour has changed.
On-product warnings
The new regulations do not require identification of a specific chemical. There are three versions of on-product label warnings – one for carcinogens, one for reproductive toxicants and one form of warning for both carcinogens and reproductive toxicants, as below.
 | WARNING: Cancer – www.P65Warnings.ca.gov. |
| WARNING: Reproductive Harm – www.P65Warnings.ca.gov. |
| WARNING: Cancer and Reproductive Harm – www.P65Warnings.ca.gov. |
Signs, label and internet warnings
The new regulations also impose material changes to warning text on shelf signs and certain internet warnings. These warnings can also be used on the product. One key change is that one or more listed chemicals must be identified by name. If the listed chemical identified by name is not both a carcinogen and reproductive toxicant, two chemicals must be listed by name (one for cancer and one for reproductive harm) if the warning text includes the "cancer and birth defects or other reproductive harm" language. The OEHHA abandoned the idea that only the 12 chemicals identified in earlier drafts of these regulations had to be identified by name. Below is an example for the cancer and reproductive harm warnings (which may not be suitable for use in all circumstances).
 | WARNING: This product can expose you to chemicals including [name one or more listed chemicals] which [is/are] known to the State of California to cause cancer and [name one or more listed 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. |
Care must be taken to match the warning text and the listed chemicals for which the warning is given.
General additional considerations
This notice focuses on consumer product warnings. The OEHHA has also updated the environmental exposure warning text. Environmental exposures are those that occur in an area (eg, inside a business or at a petrol station). The new regulations are complex and may sow confusion, especially during the two-year transition period when many different forms of warning are expected to appear.
For further information on this topic please contact Judith Praitis or Amy Lally at Sidley Austin LLP by telephone (+1 213 896 6000) or email ([email protected] or [email protected]). The Sidley website can be accessed at www.sidley.com.