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Nanotechnology: Small Talk

_{Nanotechnology makes it possible for sunscreens to be clear, instead of white.}

Nanoparticles have already made their way into a variety of cosmetic and personal care products. But more testing will be required to overcome safety and regulatory concerns.

_{By Daniel Schatzman, Former Editor, Nutritional Outlook}

If good things come in small packages, some really good things might come out of nanotechnology. The science of manipulating matter on an extremely small scale, nanotechnology enables the creation of materials with a wide range of useful physical properties.

In the case of beauty products, these materials include ultraviolet (UV) light filters, emulsion aids, and texturizers, as well as flow agents that make raw materials easier to handle on production lines.

Zinc oxide and titanium dioxide nanoparticles, for example, are commonly used in sunscreens that block harmful UV rays. The nanosized forms of these minerals tend to be transparent and nonallergenic, making them useful for cosmetic and personal care applications, says Ray Matulka, PhD, assistant director of toxicology for the Burdock Group (Orlando, FL).

While the use of nanomaterials in cosmetics holds great promise, there is also great uncertainty. Some experts, as well as public interest groups such as the Consumers Union (Yonkers, NY), are worried about the safety of the materials, particularly when they are added to cosmetics and personal care products (see the top sidebar on the page at right). Moreover, in December, several major chemical suppliers supported the findings of a National Research Council (Washington, DC) report that blasted the U.S. government’s current risk-assessment approach for nanotechnology as inadequate. Meanwhile, many product manufacturers are wary about embracing the technology until FDA offers regulatory guidance.

Safety Concerns

Determining if a nanoparticle is safe to use as a cosmetic or personal care ingredient poses several challenges. First, scientists need to estimate how much of the material is exposed to the human body once the customer uses the product. That can be difficult when a single unit of the material in question can be as small as 1 billionth of a meter. It takes about 100,000 nanometers to span the width of a human hair.

Second, scientists need to understand how the material migrates within the human body. Nanoparticles could build up in high concentrations within vulnerable organs, and materials that are benign in one region of the body may be toxic in another.

Third, and perhaps most importantly, scientists still need to build consensus about how to assess the potential risks of nanomaterials in the first place.

“Research has indicated that some materials exhibit significantly different physical properties when manufactured at a nanoparticle size compared with the typical macroparticle size,” Matulka says. “There are even different types of nanoparticles of the same material. However, the changes in physical properties may result in significant changes in the safety of these materials. Nanoparticles cannot be determined safe as part of a general class, but must be evaluated on a case-by-case basis.”

The bottom line, Matulka says, is that all nanoparticles should be tested, even if the same substances are safe at bulk levels.

“Despite what some would like to believe, nanoparticles do penetrate skin, especially damaged skin,” Matulka says. “Damaged skin includes damage produced by the sun, as well as cuts and scratches, all of which provide convenient entryways for nanoparticles. Also, nanoparticles in creams and lip gloss get swallowed, and nanosized particles in sunblock aerosols or nanosized powders get inhaled.”

Regulatory Uncertainty

Further complicating matters is the fact that nanotechnology emerged long after the Federal Food, Drug, and Cosmetic Act was written, and FDA has offered very little guidance on it. Many manufacturers would like to hear more from the agency about its views on nanotechnology and on what constitutes an unsafe ingredient. Under the act, FDA considers cosmetics to be adulterated if they contain materials that may be harmful when the product is used according to the directions on its labeling.

“If the nanotechnology substances used in a cosmetic product could be considered not to be safe under the conditions of use, then the product would be adulterated and therefore subject to regulatory action,” Matulka says.

“A solid assessment of the safety-in-use of the product that contains a nanotech ingredient is critical,” Matulka says.

The Future

Cosmetic and personal care manufacturers so far have expressed a combination of both interest and trepidation in nanotechnology, given the lack of data and guidance. Those manufacturers that do use it to make their products should revise their own QA/QC programs accordingly, as it is up to them, rather than FDA, to verify that their products are safe.

“Not everything has to be tested exhaustively, but in order for manufacturers to maintain their self-policing status and avoid restrictive regulations, they cannot afford to allow a toxic effect to become manifested as the result of an untested nanotechnological ingredient,” says Matulka.

In 2007, the global market for goods produced using nanotechnology was nearly $150 billion, according to Lux Research (Boston). Lux estimates that the market could be worth as much as $3.1 trillion by 2015. How manufacturers deal with today’s challenges could have a major impact on the success of the category in the future.

“The advantages provided by the use of nanotechnology are very seductive, but companies know that nanotechnology brings its own problems,” Matulka says.

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