Industry bodies in Europe and US defend stands on phthalates

Related tags Personal care products Cosmetics Us

Both the CTFA and Colipa have defended their different stands on
the use of phthalates in cosmetics and personal care products in
the light of a new study linking the family of chemicals to birth
defects in baby boys, reports Simon Pitman.

In reaction to the study, conducted by a team at the University of Rochester in New York and published by Environmental Health Perspectives online, the CTFA​ said that while it was committed to having the data fully evaluated, it was still convinced about the safety of phthalates for use in cosmetic and personal care products sold on the US market because of overwhelming evidence from scientific studies.

The phthalates chemical family is commonly used as a solvent in a variety of personal care products, including shampoos, nail varnish, hair spray and perfumes. In Europe regulation has dictated that only one phthalate - DEP - has been deemed safe for use in cosmetics, but in the US there is no specific regulation in place meaning that any type of phthalate can be used in cosmetics formulations.

The University of Rochester study found that exposure to a range of the phthalates was linked to a higher risk of baby boys having undescended testes and smaller penises. An anogenital index was used to determine the statistics for the study, which tested for phthalate derivatives including DEHP, DBP and DIBP.

In response to the findings, the CTFA has now conducted a preliminary review of the study with its expert reproductive toxicologist. Accordingly the organisation says that there appears to be 'potential technical uncertainties' regarding the way the study was conducted and the conclusions it drew.

"To draw the broad conclusions being reported in the media from such preliminary findings is totally unsupportable from a scientific viewpoint,"​ the CFTA said in an official statement.

The organisation also added: "The sensational and alarming conclusions being drawn from this single study are completely speculative and scientifically unwarranted. There is virtually no data on normal values for anogenital distance (AGD) in humans. This study of less than 100 boys, who spanned a fairly wide age range, is the only study in the literature for humans using the 'anogenital index.'"

Meanwhile in Europe, although Colipa​ refused to comment directly on the reports findings, Dr. Gerald Renner, the body's director of Science and Research, said that European regulators would be sticking to their tougher stand on phthalates.

"According to our information there is only one phthalate that has consistently proved negative in safety testing,"​ he told CosmeticsDesign.com​. "This is why the European Union will continue to approve this one phthalate and not the rest of the chemical family."

In an official statement on the matter Colipa said that DEP has been tested for adverse effects on the reproductive system and has been ruled as safe on the basis of the findings. The tests were carried out in 2002 and 2003 and concluded that 'the safety profile of diethyl phthalate supports its use in cosmetics products at current levels'.

Whether or not the findings from the University of Rochester are validated by the industry, the question it poses indicates that further safety studies on phthalates use in cosmetic products seem inevitable.

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