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The EU's Proposed 8th Amendment

Just as the industry began to comply with the 7th Amendment to the Cosmetic Directive, the European Union (EU) Commission proposed the new 8th Amendment. After confusion surrounding the old rules, the commission attempted to correct matters, only making them worse.

REACH and In Vitro Alternatives: Phototoxicity Testing

This is the third column in a continuing discussion regarding the new REACH regulations and their impact on chemical testing. The first appeared in December 2007 and discussed dermal corrosive potential testing; the second, in February 2008, covered dermal irritancy potential testing.

Harmonizing Cosmetics Standards: ISO

The importance of harmonization continues to grow. Past and present standard-setting work by ISO, such as in microbiology and sun protection, is laying the foundation for future bridges across regulatory gaps.

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.

Regulations in ASEAN Countries

The Association of Southeast Asian Nations (ASEAN) has agreed to harmonize its cosmetic regulatory scheme.

Testing Tactics: REACH and In vitro Alternatives: Skin Irritation Testing

Welcome back to a continuing discussion regarding the new Registration, Evaluation and Authorization of Chemicals (REACH) regulation and its impact on chemical testing. It is the purpose of this series of articles to provide an overview of these existing validated in vitro methods, as well as new methods that are being considered for validation.

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.

Regulatory Review: The Proposed Amendment for Sunscreen Products in the United States

The US Food and Drug Administration (FDA) published the long-awaited Proposed Rules (PR) for sunscreens in the Federal Register. This column reviews some of the changes included in the amendment, citing pages of this document to provide additional details.

Testing Tactics—REACH and In vitro Alternatives: Corrosive Potential Testing

The authors of the REACH directive had the foresight to recognize the impact of such a large amount of testing on animal use and mandated that in vitro testing methods should be used as animal testing alternatives whenever possible.

Regulatory Review: Regulations in Chemicals, Sunscreen Labeling and Nanotechnology

There have been several changes in regulations that will impact global formulations. The most important one concerns chemicals in the European Union (EU). In addition, steps towards evaluating the safety of nanomaterials have been made by US regulatory bodies.

(Re) formulating within REACh with Formulating from First Principles

With new legislation in action like REACH in Europe, most formulations will contain at least one ingredient that will need to be eliminated and hence these formulations need to be reformulated. The authors describe a fundamental approach to formulation science allowing reformulation within the shortest timeframe possible, at minimal cost, while optimizing desired skin sensory attributes, skin delivery and physical stability.

Regulatory Review: European Union and US OTC Drug Updates

The European Union (EU) issued the latest Adaptations to Technical Progress (ATP) on April 17, 2007. This ATP prohibited several ingredients and severely restricted an important preservative.

Regulatory Review: European Update

The European Union (EU) recently issued two important documents. The first document covered units of measure while the second discussed public consultation on the simplification of the Cosmetic Directive. In addition, several new opinions were given by the Scientific Committee on Consumer Products (SCCP). Finally the latest Adaptations to Technical Progress (ATP) were released.

Regulatory Review: Canada's Personal Care Natural Health Product Regulations

The only things that are “natural,” are earth, wind and fire. Marketers know that, with the exception of animal skin, natural sells, be it food, cosmetics or clothing. But what happens if a government declares a product to be a “natural health product?"

Regulatory Review: EU Update: Animal Origin Materials and Other SCCP Opinions

This column outlines recent advancements in EU regulation. It discusses regulation of animal origin ingredients in addition to SCCP opinions on coumarin, parabens, toluene, triclosan, HC Red No. 1 and 4-methylbenzylidene camphor.

Tech Edge--Getting Ready for REACH

C&T magazine welcomes this new column, Tech Edge, to the regular 2007 lineup. Mindy Goldstein, PhD, of Estée Lauder will explore various topics of concern to the cosmetics and personal care industry, beginning with the REACH legislation in Europe.

Regulatory Review--United States Update

California’s Safe Cosmetic Act Well, he did it. In October Governor Arnold Schwarzenegger signed into law the California Safe Cosmetic Act of 2005. As reported in my last column, this new law will not make cosmetics safer than they are now, but will increase costs for cosmetic companies and the taxpayers of the State of California while accomplishing absolutely nothing.

Regulatory Review--United States and Canada: Update Online

Methods of registering cosmetic formulations are changing. This column will desribe the online registration processes for the United States and Canada.