EU Regulation No. 1223/2009 Part 2: Prohibited Ingredients, Definitions and More

By: David C. Steinberg, Steinberg & Associates

Posted: January 3, 2011, from the January 2011 issue of Cosmetics & Toiletries.

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EC No. 1223/2009 states the EC will review each product on a case-by-case basis to determine if it is a cosmetic. Since the EC can change annexes, it was previously easier to deem a product a cosmetic. Now that pre-approved product categories are included in an article, cosmetic companies must match their products to them. If a cosmetic product does not fit a definition, the EC will decide whether the product is allowed, which could result in delays or even put the sale of such products in jeopardy as the regulations are enforced locally.

Food vs. cosmetics advertising: The regulation states that both the physical and advertised presentation of a cosmetic product must clearly indicate it is not a food, to avoid placing consumers’ health at risk. This is interesting since there are several large retail brands, one in particular in the UK, that sell cosmetics that in this author’s opinion resemble food and are sold in what look like food stores.

Responsible person: As noted, EC No. 1223/2009 establishes the concept of a Responsible Person (RP), who manages the majority of a product’s compliance. This is a complicated part of the regulation and will be covered in full detail in a third part to this series. It should be noted, however, that the RP’s role is to trace the entire supply chain of a product. The RP also is responsible for reporting safety information on the use of nano-sized ingredients to the Scientific Committee on Consumer Safety (SCCS). Finally, the RP is responsible for reporting all serious undesirable effects to the local authorities.

Cosmetic distributors: The regulation also establishes the requirements of cosmetic distributors, who probably never dreamed of coming under such complex regulations; for instance, cosmetics are now required to be manufactured under Good Manufacturing Practices (GMPs) under the regulation.

Product safety: As discussed in the first part of this series, the Product Information Package (PIP), sometimes called a dossier, must include the Product Safety Report, and existing PIPs must be revised to comply with this regulation. The Product Safety Report must include a complete safety assessment, which is different from current requirements. In addition, the competent authorities must be notified when cosmetics are placed on the market, and poison control centers must have access to formulations, both of which will soon be completed electronically to the EC.