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PCPC Experts Offers Insights Into U.S.; EU Regulations

By: Jeff Falk
Posted: April 5, 2012

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While some may point to the fact that the EU regulation (Annex II) bans more cosmetic ingredients than does the U.S. FDA, we do not believe that this difference has any impact on product safety. For example, an examination of Annex II of the EU Cosmetics Directive, a list of approximately 1,300 banned ingredients, reveals that over 75% of those chemicals are not used or never have been used in cosmetics in the U.S. or Europe. For example, the EU list includes substances such as jet aircraft fuel, various petroleum refinery byproducts and carbon monoxide.

Another difference between the EU and U.S. systems of regulating cosmetics is that the EU allows the marketing of cosmetic products with certain medicinal effects while the United States has required extra regulatory hurdles because they are classified as drugs. Some of the substances include sunscreens, anticaries toothpaste [those that fight tooth decay] and lip balms. Even though color additives are not classified as over-the-counter (OTC) drug actives, they are also subject to more regulatory scrutiny in the U.S. than they are in Europe.

But again, overall, we believe that both systems are fairly similar in their outlook and safe outcomes.

Q: What are the implications of the different regulatory environments for brands selling in both European and US markets?

Lamoriello: As the U.S. and EU regulatory systems are so similar, there are very few implications for marketing the same products in both markets. Of course, as previously mentioned, it is possible that new ingredients and innovative products may be more quickly offered in Europe if these are considered OTC in the U.S. and therefore must go through a “new drug application,” which can be very costly and time consuming. In addition, there are different labeling requirements, for example, for certain commonly known ingredients that pose added costs and complexities to inventory controls. We are hoping to work with FDA and other regulators to seek more comprehensive harmonization of labeling requirements.