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Section: Regulations > Regional

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.

The poster exhibition at the Sun Protection Conference 2013

Sun Protection Conference Addresses the Future of Sun Care

The conference opened the summer season for sun care scientists, and the topics included SPF and UVA standard tests, new sunscreen actives, greater product efficacy and improved product textures.

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.

Bright-petri-dishes-850

The Importance of Formaldehyde-Donor Preservatives in Personal Care Products

Preservatives are critical ingredients in personal care products and cosmetics, where they help to ensure consumer safety as well as product performance and stability. Among these materials, formaldehyde-donor (FD) preservatives have demonstrated a long history of safe and effective use for controlling microbial growth.

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.”

The Importance of Formaldehyde-Donor Preservatives in Personal Care Products

Preservatives are critical ingredients in personal care products and cosmetics, where they help to ensure consumer safety as well as product performance and stability. Among these materials, formaldehyde-donor (FD) preservatives have demonstrated a long history of safe and effective use for controlling microbial growth.

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.

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.

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.

The Consequences of Poor Regulations

The U.S. government is not alone in passing legislation that can and sometimes does lead to disasters, even if it has been warned about the consequences of its actions. The EU announced on March 11, 2013, that it has banned the sale of cosmetics containing ingredients that have been tested on animals.

NYSCC Holds First U.S./China Cosmetic Regulatory Symposium

The New York chapter of the Society of Cosmetic Chemists (NYSCC) collaborated with the Chinese-American Cosmetic Professional Association (CACPA) to host the U.S.-China Cosmetic Regulatory Symposium on May 16, 2013, following Suppliers' Day 2013.

PASS Coalition and Congressman Sam Farr Press FDA for UV Filter Approval

The PASS Coalition expresses its gratitude to subcommittee ranking member Sam Farr (D-CA) for pressing the FDA about the approval of pending sunscreen ingredients but notes that some UV filters have been pending with the FDA for over a decade.

PASS Coalition and Congressman Sam Farr Press FDA for UV Filter Approval

The PASS Coalition expresses its gratitude to subcommittee ranking member Sam Farr (D-CA) for pressing the FDA about the approval of pending sunscreen ingredients but notes that some UV filters have been pending with the FDA for over a decade.

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