Recent in Regulatory (page 16 of 21)

Use and Labeling of Nanomaterials in the EU

Although originally presented as a consolidation and simplification of the Cosmetics Directive and its complex amendments, the recasting of the directive into a regulation for cosmetic products was used as an opportunity to extend the scope in several areas. One of these concerned the use of nanomaterial in cosmetic products, now defined in Article 2(k) of the regulation. It states, “‘Nanomaterial’ means an insoluble or biopersistent and intentionally manufactured material with one or more external dimensions, or an internal structure, on the scale from 1 to 100 nm.”

FDA Publishes its Draft Guidance for Cosmetic GMPs

The U.S. Food and Drug Administration (FDA) has published its Draft Guidance for Cosmetic Good Manufacturing Practices (GMPs), an update to its Cosmetic Good Manufacturing Guidelines/Inspection Checklist, mostly to include ISO 227 16:2007 as part of an effort to harmonize GMPs internationally.

Regulatory Review: The Impact of REACH on the United States

While this column will not focus on REACH legislation, it does report on several critical areas related to REACH that were discussed at REACH in the Pre-registration Window and Beyond.

Nanomaterials in Personal Care: Opportunities and Safety Considerations

So what exactly is nanotechnology and what are its applications in cosmetics and personal care? Nanotechnology is one of those terms that most think they understand—in the scientific community, at least—but for which most would struggle to provide a precise definition.

Net Contents of a Cosmetic: The ‘E’ Mark and Units of Measure

Recently, some European Union member states have expressed concern over the misuse of the Estimated Symbol (℮), often referred to as the “e” mark, on product labels. In addition, some regulators have argued that the International System of Units, known as the metric system, should be used on all product labels to indicate the net contents of a finished product. Both of these concerns have fueled the present column in which the author debates how product labels should indicate the net contents of a cosmetic product. In closing, he comments on the jurisdiction of the CPSC in the United States.

Cosmetics Registration in California and the FDA's Electronic-only Drug Registration

The stars where poorly aligned on June 15, 2009, when California finally issued its registration procedure and forms for the California Safe Cosmetics Act of 2005. At the same time, the US Food and Drug Administration (FDA) moved to an electronic-only filing system for drug registrations. These two changes have created significantly more work for the personal care industry—and with questionable benefits.

Labeling Claims

Little is more confusing to marketers and cosmetic formulators than product claims regulations. Questions regarding the rules commonly arise.

Recent ATPs and Their Effect in the EU and Abroad

The recast of the directive, known as the 8th Amendment, has been proposed. This amendment currently is in review by the European Parliament and Council of Ministers. If an agreement is reached, the personal care industry will see many sweeping changes, as reported in the June 2008 edition of this column.

Organic and Natural: Caveat Emptor

Previous columns have discussed Canadian Natural Health Products regulations but have steered clear of the natural and organic debate, although this author previously published an article that debates animal versus vegetable ingredients, in which he explains that a chemical is a chemical regardless of its origin; a molecule of glycerin is just that, whether from natural sources like animal or vegetable fat, or from petroleum or biodiesel sources.

Recent Changes in US Regulations

Two recent changes to regulations will significantly impact the industry in 2009. These include changes to over-the-counter (OTC) labels, and the latest amendment to the Lacey Act.

Cosmetic Ingredients on the EU’s Dangerous Substances List

The Cosmetics Directive 76/768/EEC was recast as Regulation (EC) No 1223/2009 on Nov. 30, 2009, and this recast will totally repeal the original legislation on July 11, 2013. While the recast still contains a Dangerous Substances List, elements of the list have changed. This column distills some 1,355 pages of regulation down to review the cosmetic ingredients listed.

Regulatory Review—Labeling Alcohol, Alcohol Denat. and Booze

Alcohol is a complex regulatory issue that confuses many chemists and marketers, as well as regulatory experts, as to the permitted grades, required uses and proper labeling—which vary by country. This confusion can lead to use of the wrong denaturants and levels, custom holds on imports and exports, and consumer misuse. The regulation of alcohol rarely changes but these problems remain.

Can't find what you're looking for? Try searching, or looking through past issues.