General Assembly Discusses Endocrine Disruptors, Nano, Animal Alternatives and More

By: Claire Thévenin

Posted: July 12, 2012

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According to the EC's Martin Seychell, PhD, regulatory bodies must adopt a responsible approach and learn from experience, i.e., biotechnologies. The Cosmetics Regulation is the first legislation to include nanotechnology, but it has an evolutionary definition.

On July 6, 2012 the EC published the "Guidance on the Safety Assessment of Nanomaterials in Cosmetics," to help industry comply with the Cosmetics Regulation. This was expected, as after Jan. 11, 2013, industrials will have to notify to the EC all cosmetic products containing nanomaterials, six months prior to placing them on the market. The document should be updated regularly.

Safety Assessment

Prof. Vera Rogiers, PhD, head of the department of toxicology, dermato-cosmetology and pharmacognosy at the Vrije Universiteit Brussel is also co-chair of the Scientific Committee on Consumer Safety (SCCS), one of the independent committees advising the EC by legal mandate. Rogiers presented the recent work of the SCCS on risk assessment of cosmetic substances. On baby products, she recalled that the margin of safety (MoS = NOAEL / SED) should, as for adults, be greater than or equal to 100. Considering that the surface/body weight ratio goes from to 2:3 at birth to 1:5 at 5 years old, there is no need for an extra margin to calculate the MoS of a cosmetic substance in case of intact skin. For the diaper area, risk factors could be different due to occlusion, the presence of urine/feces and maceration; therefore, a specific risk assessment is needed for finished cosmetic products used in this area.

Concerning the Threshold of Toxicological Concern (TTC), the SCCS’s opinion is that it should only be used when the substance “belongs to a sufficiently represented structural class in the TTC database, and when appropriate exposure data are available.”

Rogiers mentioned three nanosized UV filters submitted by the industry to the SCCS that are being reviewed for inclusion into the Annexes of the Cosmetics Regulation.