Recent in Regulatory (page 25 of 31)

Updates Encouraged for Health Canada's In-Commerce List

Suppliers that export chemicals directly into Canada or that supply ingredients for finished products that are sold in Canada and, therefore, regulated under the Food and Drugs Act (F&DA) in Canada need to ensure that these substances are nominated to the revised In-Commerce List (ICL) in Canada.

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.

Mercury Warning in Mexico-made Skin Cream

The Texas Department of State Health Services (DSHS) and South Texas Poison Control are warning consumers that Mexico-made skin cream Crema Aguamary may contain high levels of mercury.

Colipa Welcomes EC's Animal Alternatives Report

Colipa, the European Cosmetics Association, welcomes the publication of the European Commission’s (EC) annual progress report on the development of alternative methods to animal testing for cosmetic purposes.

FDA Warns Brazilian Blowout for Methylene Glycol Formulation

The US Food and Drug Administration (FDA) has sent a warning letter to Brazilian Blowout for its Açai Professional Smoothing Solution. The FDA finds the product to be misbranded by stating on its label that it does not contain formaldehyde and is adulterated by containing methylene glycol, a liquid form of formaldehyde.

'May Contain' Ingredient Disclosures

The US Code of Federal Regulations lists1 the rules for displaying ingredients, and besides outlining the content that must be included and its order of appearance, the regulation describes use of the “may contain” clause, which while legally only applies to pigments, has been abused and is thus the main topic of this column.

EU Regulatory Update: Cosmetic Ingredients Under EU Scrutiny

In the EU, numerous mandates for new scientific opinions have been posted in 2011, with a specification of the assessment criteria and goals. The application areas mostly focus on the new and ongoing ingredient assessments of hair dyes, preservatives and UV filters.

FDA Releases Regulatory Science Plan

The US Food and Drug Administration (FDA) has released Strategic Plan for Regulatory Science, its initiative to modernize the tools and methods that the agency uses to evaluate whether the products it regulates are safe for consumers.

US Sustainable Palm Oil Members Increase

Three global companies headquartered in the United States—Walmart, The Hershey Company and Citigroup—have become members of the Roundtable on Sustainable Palm Oil (RSPO), an organization that aims to promote the growth and use of sustainable palm oil in the world.

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