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Recent in Regulatory (page 40 of 40)

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

Jul 11, 2013 | Robert J.W. Hefford, Independent Cosmetic Advice Ltd

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

Use and Labeling of Nanomaterials in the EU

Jul 11, 2013 | Chris Flower, PhD, CTPA

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

Jul 8, 2013

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

Jul 2, 2013 | Robert J.W. Hefford, Independent Cosmetic Advice Ltd

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

Jul 1, 2013 | Chris Flower, PhD, CTPA

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FDA Publishes its Draft Guidance for Cosmetic GMPs

Jun 26, 2013

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.

Cosmetic Ingredients on the EU’s Dangerous Substances List

Jun 25, 2013 | David C. Steinberg, Steinberg & Associates

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: The Impact of REACH on the United States

Jun 20, 2013 | David C. Steinberg, Steinberg & Associates

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

Jun 20, 2013 | Julian Hewitt and Mindy Goldstein, PhD

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

Jun 20, 2013 | David C. Steinberg, Steinberg & Associates

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

Jun 20, 2013 | David C. Steinberg, Steinberg & Associates

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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