Nano- cosmetics, sunscreen and personal care

The Nanoparticle toxicology debate appeares to have started with sunscreen. The nanoformulated titanium dioxide available in sunscreens captured the attention of NGO’s and led to a number of significant questions being raised:

• Was nanoformulated titanium dioxide was ever tested for medical health and environmental safety?

• Has the Food and Drug Administration (USA) asked for data related to nanoformulated materials which would be relevant to this question

• Has new data has to been provided for nanoformulated materials that would allow comparisons in cases where data exist for the non-nanoformulated counterpart.

Nanoscale materials are present in a wide range of consumer products, including cosmetics and personal care formulations. “Nanomaterials first began to be applied in consumer products such as cosmetics and sunscreens about ten years ago” according to the Associated Press article by Linda A. Johnson. She points out that “Nano-based products starting to have consumer impact” from November 8, 2004. The questions being raised were, therefore, valid and timely.

The answers to the above questions were negative. No toxicology data with regard to nanoscale materials had to be provided to the FDA. The industries initial response was predictable. They claimed that nanoscale materials behave like their micro and macro counterparts. This statement was rejected by NGO’s and some scientists. In the age of the internet it is easier to disseminate knowledge and the NGO’s used these new network capabilities to make available to the public facts that countered the industries claims.

The no-need-for-testing-front quickly broke down and nanotoxicology is now an established arm of the toxicology field. More and more scientists work in this field. The insurance industry is especially anxious that nanoscale materials be tested for their medical health and environmental safety. For some this might sound surprising because it did not appear that the insurance industry had already bad experience with nanoscale particles. However one has to use a different term if one wants to find evidence of that history.

Nano versus ultrafine particle

When the debate around Nanoparticle started after 2000, one gained the impression that this was a totally new class of materials. However this couldn’t be further from the truth. Nanoparticle had for some time been side products or desired products of industrial and other production processes. However the discussions that dealt with these compounds used a different term -- namely the term ultrafine particle.

To quote a review article about ultrafine particle “In an effort to better understand particulate matter (commonly referred to as dust), it is important to understand some of the features that classify and distinguish the pollutant. Atmospheric particles are described by their morphology and composition. The categories of particulate matter with a diameter less the 10 micrometers but greater than 2.5 micrometers are known as Particulate Matter 10 micron fraction (PM10), particulate matter with a diameter less than 2.5 but greater than 0.1 micrometers is known as Particulate Matter 2.5 micron fraction (PM 2.5), and particles with a diameter of less than .1 micrometers are considered as the ultrafine particle fraction (UFP) (Ibald-Mulli et al., 2002)”.

According to the review toxicology data related to ultrafine particle started to show up around 1994 (see some titles in the resource section at the end of this column).

The review article stated “Ultrafine particles (UFP) were overlooked by the majority of investigators as a significant factor in respiratory tract health and health of other organs until 1994 when Oberdorster and Utell, (2002), introduced the hypothesis that UFP could cause toxicity to the human respiratory tract.”

Indeed if one searches google, google scholar or pub med the library of the National Institute of Health (USA) for the combination of terms “toxicology” and “ultrafine particle” one finds numerous references, including articles in which the toxicology of ultrafine versions of titanium dioxide is reported

Given the history of ultrafine particle toxicology, the increased public visibility of “ultrafine particles” as “Nanoparticles” and the increased production and diversity of these compounds – especially in cosmetics -- it is understandable that the insurance industry was concered. They wanted to avoid another disaster such as they experienced with asbestos, another ultrafine particle.

The nano market in cosmetics, sunscreens and personal care products

A recent research report from BCC Research has estimated that the global market for cosmetics using nanotechnology is currently valued at $62m and is forecast to grow annually by 16.6 percent reaching $155.8m by 2012. The market research company listed sunscreens as one of three applications in the biomedical, pharmaceutical and cosmetics industry that are expected to account for 95 percent of the market in 2012. The report "Beneath the Skin: Hidden Liabilities, Market Risk and Drivers of Change in the Cosmetics and Personal Care Products Industry" was published in 2006 by the Investor Environmental Health Network, (IEHN), which represents 20 investment organizations with $22 billion in assets under management according to nanowerk and the Rose Foundation. This report provides evidence for a variety of risks and health concerns, and documents the lack of scrutiny by the FDA.

The report lists the following examples of new nanotechnology applications in personal care products

• Penetration enhancer - Encapsulating or suspending key ingredients in so-called nanospheres or nanoemulsions, increases their penetration into the skin:

• L’Oreal (which ranks No. 6 in nanotechnology patent holders in the U.S.) has used polymer nanocapsules to deliver active ingredients, e.g. retinol or Vitamin A, into the deeper layers of skin.

• In 1998 the company unveiled Plentitude Revitalift, an anti-wrinkle cream using nanoparticles.

• Freeze 24/7, a new anti-wrinkle skincare line is planning to incorporate nanotechnology in future products.

• La Prairie’s product, the Dollars 500 Skin Caviar Intensive Ampoule Treatment, claims to minimize the look of uneven skin pigmentation, lines and wrinkles in six weeks using nanotechnology. La Prairie’s vice president of retail marketing and training, Holly Genovese, says the nanoemulsions in the product “optimize the delivery of functional ingredients into the skin and allow these materials to get to the site of action quicker”.

• Procter & Gamble’s Olay brand was designed with nanoemulsion technology in 2005.

• Other companies using nanotech in their skin products as of 2005 include: Mary Kay and Clinique from Lauder; Neutrogena, from Johnson & Johnson; Avon; and the Estee Lauder brand • Hair products – using nanoemulsions to encapsulate active ingredients and carry them deeper into hair shafts.

• PureOlogy began experimenting with nanoemulsions in 2000 when the company’s founder set out to create a product line especially developed for color treated hair.

• Sunscreens – the zinc and titanium in sunscreens are “micronized”, making them transparent, less greasy, less smelly and more absorbable into the skin.

• DDF planned more nanotech-enhanced anti-aging products as of 2004.

• Colorescience markets a product named Sunforgettable, a powder which contains titanium dioxide nanoparticles.

• Paris-based Caudalie launched its Vinosun Anti-Aging Suncare, a sunscreen and anti-aging treatment that relies on “nanomized” UV filters and antioxidants, in the US in 2003.

The UK company Malvern has supplied researchers at Particle Sciences in Pennsylvania, US, with a nano particle characterisation system as part of efforts to improve the formulation of its recently developed encapsulated form of retinol. In May 2006, a report by Friend of the Earth identified at least 116 personal products with nano-ingredients currently on the market and set up a database.

Regulations

As yet legislation on the use of nanoscale products in personal care products is minimal to non existent. Manufacturers are not obliged to state whether nanoparticles are included in their products. Both regulatory agencies and the industries resist the calls for the regulation of the use of nanotechnology in cosmetics and personal care products. However it is questionable whether the non regulation of nanoparticles will be tenable in the future. The growing number of nanoparticle-containing products is likely to lead to further calls to regulate the use of the technology in consumer products in 2008.

A variety of groups sent a legal petition to the FDA in 2006. The Citizens' Coalition on Nanotechnology (CCoN) formed as a result of a Consensus conference on Nanotechnology organized at the University of Wisconsin - Madison in the spring of 2005 included nanocosmetics among its concerns. In June 2007 the Environmental Working Group (EWG) published a report on the safety of over 700 sunscreen products, many of which contain nanoparticles. In August 2007 Friends of the Earth published a report, about nano in sun care products. Friends of the Earth and other groups ask for the labeling of nanoparticle-containing products and called for a moratorium on their commercial release.
In contrast however the FDA's nanotechnology Task Force report which was released in July 2007 did not call for labelling of Nanoparticle a move which was questioned by many. However there are indications of a shift since then which might signal that regulations will appear eventually. The U.S. Food and Drug Administration proposed in August 2007 a new regulation that sets standards for formulating, testing and labeling over-the-counter (OTC) sunscreen drug products with ultraviolet A (UVA) and ultraviolet B (UVB) protection. Labelling of Nanoparticle is not required by the new rules. However the FDA asked for comments in regards to Nanoparticle. In explaining this request for comments the FDA stated “because of the potential risk of nanoparticle ingredients penetrating consumers’ skin, FDA is soliciting public comment on the safety and effectiveness of sunscreen ingredients formulated in particle sizes as small as a few nanometers.”  In this statement, the FDA seems to acknowledge that safety might be an issue. The actual language soliciting information on nano-sunscreens from the proposed rule is here at 72 FR at 49110.