SAFEGUARDS | Cosmetics, Personal Care & HouseholdNO. 019/20
Legislators at both the state and federal level throughout the United States remain focused on reforming and advancing regulations surrounding cosmetic and personal care products. Most of the recent discussions have focused around major trends surrounding sunscreens, ingredient disclosure and cosmetics reform. Many of these proposed bills contain bipartisan support and could lead to significant regulatory changes in these markets.
The long anticipated final rule on over the counter (OTC) sunscreen products (SG No. 058/19) has been delayed, in part as a result of Senate Bill 2740 having passed through the first House of Congress. As part of this proposed legislation, OTC sunscreen drugs would be subject to all requirements specified in 21 CFR 352 (published May 1999; 64 FR 27687), with the exception that requirements for effectiveness and labeling will remain regulated according to 21 CFR 201.327.
As part of the bill, the Secretary of Health and Human Services will be required to amend and revise the administrative order surrounding OTC sunscreen products and issue a revised sunscreen order within 18 months of enactment of the proposed OTC Reform Act, with an effective date of one year thereafter. The revised proposal must include provisions related to the effectiveness of SPF levels and address all dosage forms, otherwise a rationale for exclusion along with a new plan and timeline be submitted to compile the information necessary to reach a conclusion on these endpoints.
Unless included in the proposal by the Secretary of Health and Human Services, the provisions of this Act would delay and/or invalidate the provisions set forth by the FDA Proposed Rule. This includes any new criteria for UVA determination, updated labelling requirements, and other provisions surrounding efficacy testing of sunscreen products.
The bill has now been referred to the House Committee on Energy and Commerce for review.
In the interim, labeling and effectiveness data will continue to be governed by the 2011 sunscreen final rule as outlined in 21 CFR 201.327(i). This leaves in place the claim substantiation procedures for Broad Spectrum and SPF claims when marketing sunscreen. Under the current regulation, Broad Spectrum claims are only required when marketed as having Broad Spectrum protection and permitted if the product displays a total absorbance of at least 90% by 370 nm. Similarly, SPF claims will continue to be validated according to the 2011 sunscreen final rule.
This also allows for the continued use of OTC sunscreen drug products which contain the 12 ingredients initially left without a GRASE determination in the current proposed rulemaking, including oxybenzone and octinoxate. These two UV filters have undergone intense scrutiny in recent years for allegedly leading to coral bleaching and the degradation of coral reefs. While these ingredients may continue to be marketed in sunscreen products, individual states and territories have begun to prohibit their use within their jurisdictions (Hawaii, Florida, US Virgin Islands…).
Additionally, in line with the interest in ingredient disclosure in the United States, there is a new bill (H.R. 4296 Safe Cosmetics and Personal Care Products Act of 2019) which would require ingredients to be reviewed and placed on one of three lists to be classified as:
- Prohibited and restricted ingredients
- Ingredients safe without limits, or
- An insufficient data list
The bill identifies twelve ingredients to be included on prohibited list, including the previously mentioned oxybenzone and octinoxate.
If passed, this standard would define the acceptable margin of safety for a toxicological risk assessment needed to market a cosmetic and then a sunscreen in the US.
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 recognized 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.
Pending legislation will continue through its normal rulemaking process but current standards and requirements will continue to govern product compliance.
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