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CTFA files comments with FDA on nanoparticles

By Simon Pitman , 21-Sep-2006

The Cosmetic, Toiletry, and Fragrance Association (CTFA) has filed a comprehensive dossier with the FDA outlining the science and regulation of nanoparticles in personal care products.

The CFTA says that the aim of the petition file, which was presented to the FDA earlier this year, is to address issues relating to the incorporation of the technology into a range of personal care products, particularly sunscreen products.

"Nanoparticles in sunscreens are very small particles that have been reviewed and approved by FDA. They have been used safely and effectively by consumers for decades to protect from harmful UV rays and to prevent skin cancer," said John Bailey, executive vice president for science at CTFA and former FDA official.

 

"These ingredients have properties that provide a greater degree of protection from the sun, are transparent when applied and aesthetically pleasing, and therefore encourage greater consumer acceptance."

 

Nanoparticles exist naturally in a variety of substances and compounds, however, the technology to develop them for personal care applications is much more recent. For sunscreens that technology has been used for decades now to develop titanium dioxide and zinc oxide formulations that are said to greatly increase efficacy.

 

Further to this, the FDA ruled in 1996 that there is no evidence to prove that smaller micronized particles in titanium dioxide are unsafe. Indeed the CFTA points out that nano-sized titanium dioxides and zinc oxides form a transparent coating when applied in a sunscreen formulation, as opposed to the thick white one found in normal-sized formulations.

 

Ultimately this means that consumers have greater acceptance of such nano-sized formulations, leading them to use more of a sunscreen that has proven to be more effective at blocking both UVA and UVB rays.

 

"Nanoparticle ingredients in personal care products sit on top of the skin, are used in small amounts, and are not absorbed into the body. The general scientific consensus is that there is no risk to human health. But we don't rest on this knowledge alone," Bailey said.

 

"We take the science of safety very seriously, and that is why we review the latest and most comprehensive scientific research, including nanotech research, before bringing a product to market."

 

Scientists point out that whereas nanoparticles have always existed in natural compounds, particularly in smoke, the ability to process them using scientific technology dates back to the 19th century - signifying that human exposure has been ubiquitous for a long, long time.

 

Consumer lobby groups have said that they are concerned over the potential risks of both the level to which nanoparticles in personal care products can penetrate the skin, as well as what they claim is inconclusive evidence pertaining to the chemical volatility of processed nano-particles.

 

However scientists working in the area state that these claims are largely unsubstantiated, and that nanoparticle ingredients such as titanium dioxide and zinc oxide have proven to be stable and do not pose any more of a risk to skin penetration than normal-sized ingredients.

 

The CTFA says that there are a number of national and international bodies that have thoroughly reviewed nano-based titanium dioxides and zinc oxides and found them to be safe. Those bodies include the FDA, The Scientific Committee for Cosmetic Products in the European Union and in Germany the BfR, Federal Agency for Risk Assessment.

 

All of these bodies have carried out extensive work in the area, testing thousands of formulations and ingredients, generally concluding that such nano-based formulations do not behave any differently than their natural counterparts.

 

Emphasizing that all nano-based sunscreens and related cosmetic products on sale in the US have gone through extensive pre-market safety and efficacy testing, the FDA says it can assure consumers that these types of products are safe.

 

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