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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.
page 8 of 10
Annex IX—Part A, Repealed Directive with its successive amendments; Part B, List of time for transposition into national law and applications: Annex IX, including repealed directives, is useful as it shows what old regulations will no longer be in effect.
Annex X—Correlation Table: This annex correlates the new regulations to what they replace in the Cosmetics Directive.
While some believe that EC No. 1223/2009 is a great improvement, this author finds only three positive aspects to the regulation. The first is that all Member States will have the same rules, which will make life easier. The second and third good points are the centralized electronic cosmetic and poison control notifications. These will eliminate repetitive filings of the same information; and from a regulatory control position, the Member States’ competent authorities will have a central place to find the information they need. Many of the other changes will be time-consuming for cosmetic chemists, regulatory specialists, toxicologists, raw material marketers and the EC.
Another criticism is that this would have been the perfect time to define borderline cosmetic products. EC No. 1223/2009 applies to cosmetics only; not medicinal products, medical devices or biocidal products. However, the EU unfortunately did not address this critical area3 and Member States can regulate borderline cosmetics as they see fit, which defeats the purpose of having one harmonized regulation that is applicable to all countries.
Such borderline products may include: antimicrobial products, i.e. anti-fungals for skin and nails, antibacterial cleansers and leave-on products and hand sanitizers; hair growth products; dandruff products; teeth whiteners; antiaging products; exfoliants; acne products; anticellulite products; massage products; skin whiteners; insect repellents; and aromatherapy. By not clearly establishing under what conditions these products are considered cosmetics, the EC must now deal with them individually. This disregard places cosmetic companies in jeopardy of not knowing whether their product is a cosmetic, drug or consumer product, etc.—and these different product types have different regulations.