CalEPA Office of Environmental Health Hazard Assessment 5
Proposition 65 Clear and Reasonable Warnings
Questions and Answers for Businesses Revised – May 2019
product and/or the retailer to ensure that the warning is appropriately transmitted to the
retailer and end consumer [Section 25600.2(i)].
Q10: If a company manufactures component parts or ingredients that are sold in
bulk to other manufacturers or formulators, how can it comply with the
requirement to provide a warning, especially if the need for a warning depends on
the concentration or the manner of use of the listed chemical in the final product?
A10: A company that manufactures component parts or ingredients that include listed
chemicals can comply with the obligation to warn persons who can be occupationally
exposed to the bulk product by providing warnings consistent with Section 25606. The
company would only have responsibility for a consumer warning if it has knowledge that
the end use of the component part or ingredient can expose a consumer to a listed
chemical (See FSOR, p. 138). For example, if a manufacturer of a food ingredient
knows that the ingredient is typically used in certain types of prepared foods and could
thereby result in an exposure under the Act, then the ingredient manufacturer should
provide the warning or notice to the product manufacturer [Section 25600.2]. The
product manufacturer is then responsible for determining whether the product they are
manufacturing causes an exposure to the chemical at a level that requires a warning. If
so, the product manufacturer is responsible for passing the information along to its
customers or the product retailer [Section 25600.2]. In such a situation, the ingredient
manufacturer may also choose to work with the product manufacturer to evaluate
whether the product should have a warning and may enter into a contract with product
manufacturers to ensure that the warning is transmitted to the retailer and ultimately the
consumer [Section 25600.2(i)].
Subarticle 2. Safe Harbor Methods and Content
Q11: What are the type size requirements for safe harbor warnings?
A11: Type size requirements depend on the category of exposure covered by the safe
harbor warning. Consumer product exposure warnings must generally be prominently
displayed on a label, labeling, or sign, and must be displayed with such
conspicuousness as compared with other words, statements, designs or devices on the
label, labeling, or sign, as to render the warning likely to be seen, read and understood
by an ordinary individual under customary conditions of purchase or use [Section
25601(c)]. Some safe harbor warnings, such as short-form warnings for consumer
products [Section 25602], environmental exposure warnings [Sections 25604, 25605],
and several “tailored warnings” [Section 25607.1, et seq.], have specific minimum
type-size requirements. You should refer to the safe harbor methods and content
corresponding to the exposure category for which you are providing a warning to
determine if there are any applicable type size requirements.