Regulatory

Recent in Regulatory (page 13 of 40)

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.

When Ingredient Alarm Leads to the Courtroom

The personal care industry has experienced growing consumer interest in the ingredients its products contain. This interest has resulted in better responsibility and safety among cosmetic manufacturers; however, it also has produced elevated concerns over potentially harmful ingredients.

The Future of Hair Dyes Under the New EU Regulation: A Discussion

The “recast” of the 1976 Cosmetics Directive was intended to make things simpler, but does it? This article reviews and comments on the EU’s regulatory position on hair dyes, as of the first half of 2013.

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.”

Kanebo Recalls Brightening Products Containing Rhododenol

Kanebo Cosmetics Inc. and its affiliates Lissage Ltd. and E’quipe, Ltd. have recalled brightening products from the Japanese market containing the quasi-drug ingredient rhododenol (4-(4-hydroxyphenyl)-2-butanol).

The Future of Hair Dyes Under the New EU Regulation: A Discussion

The “recast” of the 1976 Cosmetics Directive was intended to make things simpler, but does it? This article reviews and comments on the EU’s regulatory position on hair dyes, as of the first half of 2013.

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.

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C&T Summit

C&T Summit is a new two-day event for cosmetic scientists focused on both theory and application. Coming June 26 & 27, 2014 to University of Pennsylvania. Learn more about the conference and join the mailing list to learn more today.

Coloring the Cosmetic World

Coloring the Cosmetic World book cover

Finally! A practical resource on cosmetic pigments in one book. Edwin B. Faulkner offers a comprehensive look at what goes into selecting colors for decorative cosmetic products. Order your copy today.