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Type: Article

Section: Regulations > Claims/Labeling

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.”

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.

Labeling Claims

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

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.

Certifying Hair Product Claims

Certifying Hair Product Claims

Claims for hair products generally are not associated with clear cut outcomes. Therefore, consumers have no standard by which to compare product efficacy. In relation, the North American Hair Research Society (NAHRS) has proposed standards for hair product claims, outlined here, which relate to characteristics including frizz, color fastness and curl retention, among others.

Function vs. Size: Patenting Nano-scale Cosmetic Inventions

Nanometer-scale components are increasingly appearing in cosmetic formulations and a corresponding increase in related patents has occurred. To assist inventors and formulators in protecting nano-scale inventions, this article describes approaches to claimed inventions and illustrates key variables that formulators can monitor and record to give a patent the best chance of later being found valid and infringed.

Translating Data into Claims and Interpreting Regulations: Science vs. Marketing

Substantial evidence, which the FDA requires to support claims for drugs, is applicable to personal care, especially considering the pharmaceutical direction products have taken. The present article considers whether the industry is benefiting from marketing without assuming the responsibility for potential effects. In addition, it considers the limitations of in vitro and in vivo test models.

Regulatory Review—Titanium Dioxide

This column will discuss titanium dioxide (TiO2). TiO2 is the most frequently used ingredient in cosmetics after water (aqua), fragrance (parfum), methylparaben, propylparaben, glycerin and propylene glycol, according to the U.S. Food and Drug Administration’s (FDA) Voluntary Cosmetic Registration Program.

EU Update—Changes with Implementation of 1223/2009

The implementation of Regulation 1223/2009 is of prime importance to the cosmetics industry. Although many requirements remain the same as in the directive, there are changes that will have an impact on companies, with compliance required by July 11, 2013.

Communicating Anti-aging Skin Care Benefits to the Consumer: Part I

This dialogue, the first of a two-part series, is based on a presentation given by Katerina Steventon, PhD, at the Anti-Ageing Skin Care Conference on June 12, 2012, in London. It establishes a conversation with Steve Barton, a skin biologist, to discuss concerns and perceptions of British consumers related to skin care. Barton has extensive experience working with marketing teams to improve communication of skin care benefits to consumers, to initiate a dialogue between the consumer and the formulator.

Regulatory Review—US and Canada Updates: Canadian Cosmetic Harmonization and the FDA's Claim Crackdown

Several major regulatory changes are coming in cosmetics from Canada, while in the United States, the U.S. Food and Drug Administration (FDA) has been active in sending out warning letters to cosmetic companies making unapproved drug claims. This column provides an overview of them.

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C&T's Regulatory Webinar Garners Great Response

On Nov. 28, 2012, Cosmetics & Toiletries hosted a live Webinar titled, "Regulations—What You Forgot to Ask," featuring a call-in with industry regulatory expert David Steinberg.

Asia-Pacific Update: ASEAN Updates to Nano, Sun Care, Trace Limits and More

Changes to the European Union’s Cosmetic Directive 76/768/EEC were a main topic of discussion at the meeting of the ASEAN Cosmetic Scientific Body (ACSB) and the ASEAN Cosmetic Council (ACC), which took place in Cambodia on July 11-12, 2012.

General Assembly Discusses Endocrine Disruptors, Nano, Animal Alternatives and More

Cosmetics Europe—The Personal Care Association, formerly Colipa, held its annual General Assembly in Brussels, Belgium in June 2012. The scientific forum discussed topics of interest in EU legislation such as The Cosmetics Regulation, which was set to replace the Cosmetics Directive on July 11, 2013.

The EU Fragrance Allergens

On March 11, 2003, the European Union (EU) published the 7th Amendment to its Cosmetic Directive 76/768/EEC. Among the changes was the addition of the 26 popular fragrance ingredients to the Annex III “List of Substances Which Cosmetic Products Must Not Contain Except Subject to the Restrictions Laid Down.” These are now commonly referred to as the EU Fragrance Allergens.

Indulgence, Claims and Innovation Trends at In-Cosmetics

The Marketing Trends presentations at In-Cosmetics Barcelona, which takes place on April 17–19, 2012, provide an opportunity to discover the latest trends and issues affecting the global cosmetics industry. This article will take a look at some of the key trends that will be analyzed in more depth in the presentations.

Establishing the Dividing Line: Is Your Product a Drug?

To avoid regulatory penalties, a company developing an OTC product must institute properly administered shelf-life testing programs as an integral part of its product development and marketing efforts.

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