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Regulatory: Updates to Independent EU Cosmetic Directive

By: David C. Steinberg, Steinberg & Associates
Posted: July 7, 2009

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The US Food and Drug Administration (FDA) does not define natural in the Food, Drug and Cosmetic Act or any other FDA regulation; the closest definition2 for natural personal care products was established in Canada as a regulated category called Natural Health Products. This regulation, which went into effect on Jan. 1, 2004, defines natural health products (NHPs) as: vitamins and minerals, herbal remedies, homeopathic medicines, traditional medicine such as traditional Chinese medicine, probiotics, and other products like amino acids and essential fatty acids.

While these materials are found in nature, Canada took it a step further to describe acceptable substances as being synthetic duplicates of those materials listed above. Synthetic duplicates are substances that share identical chemical structures and pharmacological properties with their natural counterparts; an example of such is vitamin E.

A semi-synthetic substance may also be acceptable as an NHP, provided that it shares identical chemical structures and pharmacological properties with its natural counterpart. Semi-synthetic substances are produced by processes that chemically change a related starting material that has been extracted or isolated from a plant or a plant material, an alga, a fungus or a non-human animal material. An example of such is ginsenosides, which are produced from the starting compound betulafolienetriol.

In the end, whatever marketing deems natural is natural; the critical inference is that consumers believe products marketed as natural are safer than products that are not marketed as natural. This has given rise to an increase in use of the word organic within the cosmetic industry.

Recalling studies from his youth, the author notes that the term organic originally referred to the chemistry of the carbon atom. Then in 1973, an organization called the California Certified Organic Farmer was formed to promote organic farming in California, instilling in the public a new sense of the word organic. This group became one of the first to certify products with an organic seal of approval on the label. In 1979, the state made the organic labeling of foods a law subject to their controls.