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Recent in Regulatory (page 38 of 38)

Changes to US Sunscreen Regulations

The newest regulations and comments on sunscreens from the US Food and Drug Administration (FDA) were officially published in the Federal Register on June 17, 2011, and will go into effect June 17, 2012.

EU Regulatory Update: The Individual Safety Assessment–a Practical Approach towards Regulation (EC) No 1223/2009

The new Cosmetics Regulation (EC) No. 1223/2009 defined the format of the Cosmetic Product Safety Report (CPSR) in the Regulation’s Annex I. Accordingly, the information for documenting the product’s safety is to be listed in a part A of the CPSR, and this needs to include the toxicological profiles of the ingredient substances, their physical and chemical characteristics, impurities, trace components, as well as their exposure criteria in use.

NSF/ANSI 305 Expands to Include EU Organic Ingredients

NSF International’s American National Standard for Personal Care Products Containing Organic Ingredients (NSF/ANSI 305) has been expanded to allow plant-based ingredients that are certified to European Union (EU) organic regulations.

FDA Rule for Broad-spectrum Labeling: Key Substrate Findings

UVA protection is part of the mandatory testing for claiming broad-spectrum sun protection. A worldwide standardization is in development with the ISO TC217, expected for UVA testing 2012. The FDA has issued a final rule following Colipa’s proposed UVA in vitro method. While this rule establishes UVA labeling and testing, inconsistencies remain. This study compares the critical wavelength in roughness and application before and after two levels of UV doses.

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