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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Further, the mandate for a new safety assessment will require all existing safety assessments to be conducted again. One wonders whether findings from a safety assessment performed last year will be any different from findings in 2013; perhaps manufacturers can say that a product is safer than safe. In addition, had the authors of this regulation ever actually made cosmetics, they would know better than to assume that if the ingredients in a product are safe, the final product combining them will also be safe.

In this author’s opinion, the strangest addition to EC No. 1123/2009 is the CMR escape clause; one wonders what the EU will do when alcohol is correctly classified as a carcinogen and as toxic to reproduction, since it is the major cause of birth defects and liver cancer.⁴ According to the Cosmetics Directive, alcohol would be banned. However, the EC’s escape clause explains that if a product is found naturally in foods—for example, if wine were considered a natural food—and there is no substitute, then it may be allowed. But is there no substitute? In the late 1980s, any use of alcohol was forbidden in one Muslim country, thus isopropyl alcohol was substituted for alcohol in hair sprays, fragrances, etc. It had a sharp, biting odor but was used since it served as a substitute.

The answer is that CMRs are directly linked to exposure route. Alcohol is toxic to reproduction only via ingestion by pregnant women, and is only a carcinogen by ingestion. Neither route is relevant to its use in cosmetics. The escape clause will allow the EU to get around the banning of alcohol—but how will the group deal with titanium dioxide, which is not found naturally in foods although it is used in foods worldwide? Cosmetic formulators could use other white colorants; for instance, Annex IV lists 10 other white pigments. Perhaps formulators should just revert to what was used before titanium dioxide to make white paint—lead carbonate.

Another part of this regulation that shows lack of scientific support is the EC’s definition of nanomaterials. Rather than waiting for the International Cooperation of Cosmetic Regulations (ICCR) to arrive at a definition that everyone agrees upon, here the EU has defined a nanomaterial as being an “insoluble material manufactured with one or more dimensions from 1 to 100 nm.” A sheet of paper 1 nm thick would meet this definition but it could never penetrate the skin.

Finally, the other critical questions around nanotechnology are never mentioned. The first issue is that there is a general consensus that a nanoparticle must be manufactured at nano-size; i.e., a micro-sized particle cannot be ground down to make a nanoparticle. Thus, a nanoparticle is manufactured, measured somehow, then placed into a solvent. Once in the solvent, agglomeration takes place. So the next question becomes: Is the particle still a nanoparticle? And even if the formulator or raw material supplier is able to prevent this agglomeration from happening, when the cream is placed on the consumer’s skin, agglomeration takes place before there is penetration. Are the particles in this cream still considered nano-sized? These are but a few of the critical questions that must be resolved before regulations are promulgated.