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.

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The statement in the justification that cosmetic products are safe so long as all the ingredients are is curious—this is not good science. It assumes that no chemical reactions take place among ingredients during the process of manufacture and that cosmetics are simple mixtures. Further, it assumes that simply mixing ingredients together does not affect product safety. In fact, this is simple to disprove—just look at the effect a solvent has on the skin irritation of the solid dissolved in it.

Another confusing part of Regulation No. 1223/2009 is the requirement for a microbiology challenge test for all cosmetics. In this author’s opinion, the test is not necessary and is a waste of money. Cosmetics should not be challenge tested if they have a water activity below 0.7. Similarly, nail polish or products with more than 20% alcohol do not require microbiology challenge tests. Why waste money running tests that are not applicable?

The other issue with Regulation No. 1223/2009 is that all safety assessments must be re-run in order to comply with the new requirements. Previously, safety assessments only required a simple statement that the assessor had reviewed the data and expected the product to be safe based on the warnings and directions for use. Now the entire assessment must be justified. One can expect upcoming price increases for safety assessments to rise fast.

In relation, one common complaint about the old directive, which has been addressed by Regulation No. 1223/2009, concerns the qualifications of the safety assessor. The safety assessor is defined as “a person in possession of a diploma or other evidence of formal qualifications awarded on completion of a university course of theoretical and practical study in pharmacy, toxicology, medicine or a similar discipline, or a course recognized as equivalent by a Member State.” It is surprising that this regulation considers individuals who have taken a one-week course as equals to individuals with university degrees. A

t the start of this column, it was noted that both raw material suppliers and finished product manufacturers must begin accumulating the required data and running whatever additional tests or reviews are necessary to comply with this revision. This author cannot wait to see what mandatory tests the EU comes up with to prove claims made by manufacturers.