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

Cosmetics Europe—The Personal Care Association, formerly Colipa, held its annual General Assembly in Brussels, Belgium in June 2012. The scientific forum discussed topics of interest  in EU legislation such as The Cosmetics Regulation, which was set to replace the Cosmetics Directive on July 11, 2013.

Endocrine Disruptors

Paolo Castello, PhD, of the Joint Research Center (JRC), the science service of the European Commission, presented the EU strategy on endocrine disruptors (ED). The aim is twofold: to identify the problems of ED, the causes and consequences; and to identify the appropriate policy action based on the precautionary principle. Castello listed four needs: further research, international cooperation, communication with the public and policy action for the control and regulation of ED.

The cosmetic sector is impacted by REACH, via the authorization process and Annex XIV and the Cosmetics Regulation, which will be reviewed at the latest in January 2015.

The present problem is the lack of detailed criteria for assessment and decision on ED. A draft is expected by the end of 2013, designed for plant protection and biocides, but with an ambition to give a set of criteria horizontally applicable for all legislations. Still, many questions remain on the definition of ED, adverse effects, mode of action and testing.


An expert in nanotechnology, Prof. Marcel Van de Voorde, PhD, from the University of Technology in Delft, gave an enthusiastic presentation on nanos at large. He noted that nanoparticles have a strong evolutionary character and are "the future," despite many challenges: safety issues, societal acceptance, legal framework, toxicology, etc. He called for the creation of European “synergy centers” to merge science, technology, economy and society, and he warned regulatory bodies about a potential excess of rules leading to delocalization of R&D and production, citing the steel and the textile industries.

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.

Last but not least, inhalation exposure of sprays has to be evaluated, as it can be significant. Measurement after spraying and exposure calculation via math models are necessary, especially for propellant-driven aerosol sprays.

Animal Testing Alternatives

Due to the 7th Amendment of the Cosmetics Directive, animal testing will be banned starting March 2013. This means that industry must work on the third of the “3 Rs,” which is “replacement” methods. Research on alternative methods started 20 years ago, but some end-points are still challenging.

Horst Wenck, PhD, chair of Cosmetics Europe's Strategic Project Team on Alternatives to Animal Testing, gave highlights on the recent progress in R&D and validation. For eye irritation, the validation study is completed and the data evaluation is in progress. Regarding genotoxicity, there are novel assays with drastically reduced false positive results and sufficient sensitivity. On skin sensitization, a comprehensive evaluation of hazard identification assays is in progress. And for systemic toxicity, the most difficult end-point , the Safety Evaluation Ultimately Replacing Animal Testing (SEURAT) program is now in its second year. In 2011, industry had engaged in this major joint research effort with the EC, each bringing €25 million, and this initiative will last five years and involve 70 research institutions.

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