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Proposed Amendments to California’s Proposition 65 Warning Regulations

  • In response to stakeholder comments, California’s Office of Environmental Health Hazard Assessment (OEHHA) has proposed amendments to clarify ambiguities in Article 6 of its Proposition 65 (Prop 65) warning regulations.  Prop 65 is a right-to-know law that requires individuals to receive a clear and reasonable warning before being exposed to certain chemicals that California deems to be carcinogens or reproductive toxicants.  As summarized here, OEHHA’s final rule amending Article 6 of the regulations implementing Prop 65 became effective in 2018 and imposed requirements on content and methods of transmission, including new Prop 65 warning language.

  • Among other clarifications, the amendments proposed by OEHHA on January 31, 2020 would make it explicit that:

    •  Sales through mobile devices are covered by current Article 6 regulations that require warnings for “internet sales;”

    • The option of providing warnings via an electronic device or a process that automatically provides the warning to the purchaser prior to or during the purchase of a product is only for a “physical retail location;”

    • Product-specific safe harbor warning provisions apply to all products that are subject to specific safe harbor warnings under Prop 65;

    • Product-specific warnings must be provided for online or catalog sales of those products;

    • Foreign language translations of product-specific warnings will be required; and

    • Product-specific warnings (e.g., for food, furniture, etc.) may be provided under the existing regulation on catalog warnings.

There are also several new proposed amendments that apply specifically to alcoholic beverages.  A full analysis is available here, of OEHHA’s proposed amendments to its Article 6 regulations on Prop 65 warnings.  OEHHA is accepting comments on the proposed amendments through March 16, 2020.

© 2020 Keller and Heckman LLPNational Law Review, Volume X, Number 41

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About this Author

Keller and Heckman offers global food and drug services to its clients. Our comprehensive and extensive food and drug practice is one of the largest in the world. We promote, protect, and defend products made by the spectrum of industries regulated by the U.S. Food and Drug Administration (FDA), the European Commission and Member States authorities in the European Union (EU) and similar authorities throughout the world. The products we help get to market include foods, pharmaceuticals, medical devices, veterinary products, dietary supplements, and cosmetics. In addition...

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