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EU Regulation No. 1223/2009 Part 1: Product Safety
By: David Steinberg, Steinberg & Associates
Posted: July 30, 2010, from the August 2010 issue of Cosmetics & Toiletries.
The European Union (EU) has published the long-awaited Regulation No. 1223/2009 on Dec. 22, 2009. At 151 pages, it is a lengthy read and when it goes into effect on July 11, 2013, it will make the EU the most highly regulated cosmetics industry in the world. While it is sometimes referred to as the 8th Amendment to the Cosmetic Directive 76/768/EEC or the Recast, its correct designation is Regulation No. 1223/2009.1 Many people have written about Regulation No. 1223/2009 and industry associations seem to view the regulation optimistically. Truth be told, however, this regulation offers few improvements over the previous directive.
As noted, Regulation No. 1223/2009 is a regulation and no longer a directive. While a directive must be encompassed in the local regulations of Member States, a regulation supersedes all local laws. This prevents Member States from adapting regulations for their purposes, and from forcing companies to monitor and comply with regulations for 27 different countries rather than one EU directive. This eliminates the confusion that stemmed from adaptations such as: the UK defining who is qualified to be a safety assessor; France requiring Poison Control Center notifications on its forms; Belgium charging to register a formulation; and Spain requiring notification even if the product manufacturer does not have a Spanish address on the label. Now, cosmetic manufacturers need only be concerned with one registration and one Poison Control notification, both of which will be submitted electronically, and Member States cannot change or enhance these regulations. That’s the good news.
The bad news is that, in this author’s opinion, an already poor regulation was retained, albeit with a slight change in phrasing: The requirement for a cautionary statement on a product label when it contains more than 0.5% benzophenone-3. When a product met this requirement, the warning: Contains oxybenzone was required to appear on the label. While oxybenzone is the drug name for the INCI designation benzophenone-3, a consumer in the EU might look at a product label, see this warning and scan through the ingredient listing only to find no oxybenzone listed there. Regulation No. 1223/2009 changes the phrasing of this warning to now read: Contains benzophenone-3, to match the way it appears in the ingredient disclosure.
The present column focuses on a portion of Regulation No. 1223/2009 that both finished product manufacturers and ingredient suppliers will need to begin work on to prepare for 2013: the safety report. The requirements for this report will be time consuming and costly, thus companies are advised to begin evaluating their products and positions to determine if the safety report requirements will render some products cost-ineffective. Whether it does or not, companies should begin allocating both financial and human resources to prepare for the compliance timelines and requirements, as are described below.
Readers should note that this discussion of Regulation No. 1223/2009 consists of three main parts: the Preamble, which explains changes to the original Cosmetics Directive; followed by Articles and Annexes.