California's Office of Environmental Health Hazard Assessment (OEHHA) is considering a Proposition 65 change that could affect food, dietary supplement, botanical, and other natural product companies that use extracted or concentrated ingredients. As part of its eight-part Omnibus 2026 pre-rulemaking package, OEHHA proposes to clarify that extraction or concentration of a Proposition 65-listed chemical from a natural source may constitute "human activity" even when the process does not change the chemical's Chemical Abstracts Service (CAS) Registry Number. The Omnibus package also addresses internet warnings, retailer responsibilities, QR codes, and other Proposition 65 issues. The materials are discussion drafts only and have no current legal effect.
The natural-source proposal raises a threshold question for companies that rely on Section 25501's "naturally occurring" treatment: When does ordinary processing of a natural ingredient cause a listed chemical that was naturally present in the source material to be treated as resulting from "human activity"? If adopted, the proposed language could narrow the circumstances in which the naturally occurring provision applies to processed natural-source ingredients.
The Proposed Change to "Naturally Occurring" Chemicals
Section 25501 currently provides that human consumption of a food does not constitute an "exposure" to a listed chemical, to the extent the person responsible for the exposure can show that the chemical is naturally occurring in the food. A chemical is naturally occurring only to the extent it did not result from known human activity. The regulation already distinguishes naturally occurring levels from amounts added as a result of human activity and separately addresses avoidable contaminants.
OEHHA would add a sentence to Section 25501(a)(3) stating, in substance, that a listed chemical extracted or concentrated from any source, such as a plant, may be present in a product as a result of human activity even if the extraction or concentration does not change the chemical's CAS Registry Number.
OEHHA's choice of "may," rather than "shall," is important here. OEHHA's workshop presentation likewise states that whether a chemical is present as a result of human activity will continue to depend on the specific facts. The language therefore does not appear to propose a categorical rule that any extraction or concentration of a natural ingredient would automatically exclude a naturally present chemical from Prop 65's "naturally occurring" treatment. It would make clear, however, that an unchanged chemical identity or CAS number is not enough, by itself, to resolve the issue in the company's favor.
Why This Matters for Botanical and Natural-Source Ingredients
Extraction and concentration are common manufacturing steps for botanical ingredients and other natural-source materials. A plant extract may be produced to increase the level of selected constituents, reduce bulk, improve consistency, or create a standardized ingredient. Under the proposed language, companies may need to evaluate more carefully whether processing has extracted or concentrated a listed chemical that was naturally present in the source material and, if so, whether the resulting amount can still be treated as naturally occurring.
The issue is not limited to conventional foods. Section 25501(b) also addresses non-food consumer products made using food-derived materials, so the proposal could have downstream implications for cosmetics, personal care products, and other consumer products that use plant- or food-derived inputs containing listed chemicals. The practical impact will depend on the listed chemical, the source material, the manufacturing process, the degree of concentration, and the exposure presented by the finished product, although the weight of these factors is an open question worthy of comment.
Because this is only a pre-rulemaking proposal, the immediate focus for affected companies is comment preparation rather than operational change. Companies considering comments may want to develop concrete examples showing how listed chemicals behave during common extraction, concentration, standardization, fractionation, or purification processes; whether a listed chemical is intentionally or only incidentally concentrated; and what information is realistically available to distinguish naturally occurring levels from amounts attributable to processing. Those fact patterns may help OEHHA evaluate whether the proposed language is sufficiently clear and workable.
Other Omnibus Proposals to Watch:
OEHHA also proposes changes addressing short-form warning language, internet and app-based purchases, retailer responsibility for upstream warnings, and the use of QR codes to provide product-specific Proposition 65 warnings.
Potential Issues for Comment
For companies potentially affected by the natural-source proposal, the near-term opportunity is to help OEHHA understand how the proposed language would apply to real-world ingredients and manufacturing processes. Issues for comment include the following:
- Whether and when extraction or concentration should constitute "human activity," including whether the analysis should differ when a listed chemical is only incidentally concentrated rather than the target of the process
- Whether OEHHA should identify factors or thresholds—such as concentration ratio, purpose of the process, or change from natural background levels—to guide the fact-specific analysis
- How a business should distinguish or allocate the portion of a listed chemical that remains naturally occurring from any portion attributable to processing after extraction or concentration
- What evidence should be relevant or sufficient, particularly where ingredient suppliers control the extraction or concentration process and finished-product manufacturers may have limited process information
- How the proposal should apply to complex botanical extracts, standardized ingredients, and downstream non-food consumer products that use food- or plant-derived materials
OEHHA is accepting written comments on the Omnibus 2026 draft through September 7, 2026.
Venable's Food & Drug Law team stands ready to assist companies with questions about how the Omnibus proposals may affect their products, ingredient sourcing, manufacturing processes, labeling, or Proposition 65 compliance strategy.