SGS SA COSMETICS, PERSONAL CARE & HOUSEHOLD | NO. 119/15 |
Compliance Standard
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.
Product Warnings
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.
For enquiries, please contact:
Queenie Tse
Cosmetics, Personal Care and Household
t: +852 2765 3672 ext 1672
© SGS Group Management SA - 2015- All rights reserved - SGS is a registered trademark of SGS Group Management SA. This is a publication of SGS, except for 3rd parties' contents submitted or licensed for use by SGS. SGS neither endorses nor disapproves said 3rd parties contents. This publication is intended to provide technical information and shall not be considered an exhaustive treatment of any subject treated. It is strictly educational and does not replace any legal requirements or applicable regulations. It is not intended to constitute consulting or professional advice. The information contained herein is provided "as is" and SGS does not warrant that it will be error-free or will meet any particular criteria of performance or quality. Do not quote or refer any information herein without SGS's prior written consent.
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