California’s Office of Environmental Health Hazard Assessment (OEHHA) announced that nickel (soluble compounds) would be added to the Pro 65 list effective October 26, 2018 as a result of the finding that soluble nickel compounds were shown to cause reproductive toxicity. As such, affected products will be subject to warning requirements as of October 26, 2019 unless an exception applies.
Nickel (soluble compounds) was listed based on a determination by OEHHA’s Developmental and Reproductive Toxicant Identification Committee (DARTIC) in its capacity as the “state’s qualified experts.” A hazard identification document outlining the evidence of reproductive toxicity (in developmental and male reproductive endpoints) as a result of exposure to nickel compounds was made available for public review in July 2018.
Some nickel producers agreed that soluble compounds warranted inclusion on the Prop 65 list based on studies on reproductive toxicants in rats, but that insoluble compounds should not be subject to listing. Insoluble compounds include nickel alloys found in coil and rods. The Nickel Institute endorsed the decision to list only soluble nickel compounds as substances that are known to cause reproductive toxicity. This determination was supported by various industries that manufacture materials containing nickel (such as stainless steel) and companies that use these materials for consumer products. The basis for this finding was that scientific studies did not support a conclusion that exposure to nickel from metal alloys cause reproductive toxicity per the Proposition 65 regulations for listing chemicals.
Metallic nickel and some nickel compounds are already designated as carcinogenic substances under Proposition 65. Nickel alloys are specifically excluded as a carcinogen under OEHHA’s designation. As a result, stainless steel and other nickel alloys are not subject to Proposition 65 warning requirements when they are manufactured in products that come into direct contact with the user, such as body piercings and implants. In addition, nickel carbonyl is listed as a chemical known to cause developmental and reproductive toxicity. Now nickel soluble compounds will join this designation although it is unclear which compounds will be required to comply with warning requirements. OEHHA has yet to determine the scope of the listing for soluble nickel compounds.
Grimaldi Law Offices has been advising clients for over 20 years on chemical and product law. For knowledgeable advice and in-depth analysis on your Prop 65 compliance obligations, contact Grimaldi Law Offices at (415) 463-5186 or email us at [email protected].