Recent in Regulatory (page 15 of 21)

'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.

Regulatory Review: Australian Regulations Update

Australia issued its new Cosmetics Standard 2007. The following is a breakdown of products originally considered as therapeutic drugs if they made SPF claims, and that will now be regulated as secondary sunscreens.

Labeling for Legitimacy: Certifications for Natural and Organic Personal Care

Standards for organic or natural products are largely the same, although some pertain to “natural” while others do “organic.” Each program and seal is intended for a given region, which should be taken into account when targeting specified markets. Here, the author reviews the most recognized natural and organic certifiers and seals around the globe.

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.

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