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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.

Schakowsky Amends Safe Cosmetics Act; Reintroduces It to the House

On June 24, 2011, Rep. Jan Schakowsky (D-IL) and 10 co-sponsors introduced the Safe Cosmetics Act of 2011 (H.R. 2359) to the US House of Representatives, which aims to amend title VI of the Federal Food, Drug and Cosmetic Act.

FDA Releases a Final Sunscreen Rule

After nearly a four-year wait for an action on sunscreens, the US Food and Drug Administration (FDA) has issued a Final Sunscreen Rule, which addresses the testing and labeling of OTC sunscreen products.

Breslawec Named PCPC Chief Scientist, Replacing Bailey

The Personal Care Products Council (PCPC) announced that Halyna Breslawec, PhD, has been named the organization’s chief scientist, replacing John Bailey, PhD, who will officially retire on July 29, 2011, after nine years of service.

FDA Releases Draft Guidance Toward Nanotech Regulation

The US Food and Drug Administration (FDA) has released a draft guidance outlining its view on how to identify whether regulated products contain nanomaterials or apply such technologies.

Industry Debate: US FDA vs. Sunscreens

During last month’s NYSCC Suppliers' Day, several attendees expressed frustration regarding the delay of the US Food and Drug Administration’s Final Sunscreen Monograph. Cosmetics & Toiletries asked its LinkedIn members to comment. Here’s what the market had to say.

Organizations Support CIR Review of Formaldehyde/Methylene Glycol Safety

ICMAD has joined the Personal Care Products Council, the FDA, OSHA and consumer groups to support the safety review by the CIR for the use of formaldehyde/methylene glycol in professional hair straightening products.

'Green' Standard Launched to Certify Cosmetic Product Life Cycle

Non-profit organization Green Seal Inc. has created GS-50, reportedly the first US certification standard for cosmetic and personal care products that covers the whole product life cycle.

EU Regulation No. 1223/2009, Part III: The Responsible Person

This column is the last in a three- part series on the European Union’s (EU) Regulation No. 1223/2009,1 which was published on Dec. 22, 2009.