California Proposition 65: Benzophenone in Sunscreen Products
SAFEGUARDS | Cosmetics, Personal Care & Household NO. 119/15
Pursuant to Proposition 65 on June 22, 2012, California identified and listed benzophenone as a chemical known to be carcinogenic. In a recent California court case (Case No. 100959) and some recently filed 60-Day Notice of Violation documents, benzophenone (CAS RN 119-61-9) has been reported to be present in sunscreen products sold in US California State without the proper warning statements.
In one Settlement Agreement, a ‘Compliant Product’ was defined as those products containing benzophenone in concentrations less than or equal to 12.5 parts per million (ppm) when analyzed pursuant to a scientifically reliable application of U.S. Environmental Protection Agency testing methodologies 3580A and 8270C or any other scientifically reliable methodology to determine level of benzophenone. The effective date of this settlement agreement was January 1, 2015.
The settlement also stated that the party shall not manufacture, or cause to be manufactured, or order for distribution or sale in California unless the products are Compliant Products or carry the Proposition warnings specified below.
The product shall bear clear and reasonable warnings for all products that do not qualify as Compliant Products, in a conspicuous, prominent, easily read and understood way. A warning such as, WARNING: This product contains benzophenone, a chemical known to the State of California to cause cancer, shall be affixed to the packaging, labeling or directly on each product provided for sale in the California State. This warning is for products with only one cancer-causing chemical, benzophenone. A similar approach is necessary if the products are sold via mail order catalog or internet to customers located in California.
Requirement of Sunscreen Product under US FDA
Unlike European countries, sunscreen product falls into the category of Over-The-Counter (OTC) drug products under US Food and Drug Administration (FDA). Only active ingredients listed under 21 CFR Part 352 are permitted for use in sunscreen products and all products shall follow the FDA’s Final Rule on sunscreen Drug Facts labeling. Functional claims on SPF value and broad spectrum, which address the protection against ultraviolet B (UVB) and ultraviolet A (UVA) radiation respectively, as well as water resistance claims, have to be verified using an international method (e.g. FDA) and to ensure the effectiveness of sunscreen products.
It is crucial for all cosmetic, personal care and household products to be safe effective and stable. SGS provides testing, inspection, auditing and consulting services to manufacturers, distributors and importers to ensure a high level of product quality in every area. Our state of the art laboratories offer custom-made solutions for chemical, biophysical, microbiological, stability and biological aspects. We also have extensive capabilities in performance testing, claim support studies and consumer panels. Our testing is conducted according to customer specific or recognised standard methods, some of which were developed by SGS. Our cosmetic safety assessors and other technical experts can support customers by making sure new products comply with regulatory requirements. Please do not hesitate to contact us for further information or visit our website.
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