“Nano-Free” Sunscreen Claim Spurs Environmental Group Complaint

Friends of the Earth claims that materials supplier Antaria misleads its customers and consumers by billing the ZinClear-IM sunscreen ingredient as “nano-free” when third-party testing shows it contains “clusters” of nanoparticles. The issue of defining nanotechnology continues to be debated internationally.

Allegations that an Australian firm misrepresented a nanotechnology ingredient in popular sunscreen brands hinge on an ongoing dispute – how exactly a “nanomaterial” should be defined.

International environmental network Friends of the Earth accuses materials supplier Antaria Ltd. of misrepresenting its ZinClear-IM zinc-oxide UV filter to customers, and subsequently to consumers, as “nano-free.”

U.S. and Australia-based FOE groups maintain ZinClear-IM is an example of nanotechnology – or the use and manipulation of materials on the level of nanometers, or billionths of a meter – based on product testing and patent analysis performed by the Australian National Measurement Institute.

“It is deeply concerning that people trying to avoid nano-ingredients in sunscreen have been misled in this way,” Gregory Crocetti, nanotechnology campaigner for Friends of the Earth Australia, said in a July 24 release.

“Dermatologists and toxicologists have made public warnings that people with damaged skin, young children and people who use sunscreens very regularly are at greater risk of exposure to nanomaterials and should avoid using nano-sunscreens,” he added.

Painting the situation as a “sunscreen scandal,” FOE filed a complaint with the Australian Competition & Consumer Commission, the equivalent to the Federal Trade Commission in the U.S. The Australian Council of Trade Unions and the Public Health Association of Australia, among others, are backing the complaint.

According to FOE’s release, “high-profile” Australian brands that use ZinClear include Invisible Zinc and the Woolworths supermarket brand. Brands available in the U.S. that feature ZinClear-IM include Estee Lauder, Jason Natural, Desert Essence and Victoria’s Secret, the organization says.

Another U.S. skin care product firm using Antaria’s ingredient, Louisville, Colo.-based MyChelle Dermaceuticals LLC says it “has chosen to formulate with ZinClear” in its sun-protection products “to be able to offer a translucent appearance of zinc oxide without resorting to nanotechnology.”

Do Microns Add Up To Nano?

According to a product description offered by the Dow Chemical Company, which distributes ZinClear in the Americas and selected European and Asian markets, the active ingredient contains “micron-sized” zinc oxide particles.

In a July 25 letter, Antaria rejected FOE’s allegation and noted that the firm’s evaluation aligns with U.S. and Australian health care product regulators’ definition of nano-materials.

Antaria Chairman Rade Durovic wrote that “based on measurements of the diameter of the particle using internationally accepted methods, the zinc oxide in ZinClear-IM is of non-nanoparticle size. He pointed out FDA, Australia’s Therapeutic Goods Administration and other regulatory agencies “have repeatedly confirmed that” zinc oxides are safe for use in sunscreens.

Durovic added that the firm made multiple offers to meet and discuss FOE’s concerns, “but you have not taken up our offers.”

Antaria launched in 1997 to commercialize materials technology originally developed by the University of Western Australia and initially scaled-up via a 2000-2004 joint venture with Samsung Corning Co. Ltd of Korea. Antaria also manufactures industrial paints and other coating materials, including nanoZ, described as “a transparent industrial zinc oxide nanoparticle dispersion for functional coating formulations to protect wood, plastics and textiles from UV and microbial degradation, according to the firm’s website.

FOE contends that ZinClear-IM “is made up of clusters of nanoparticles,” which qualifies it as nanotechnology.

The advocacy group’s argument reflects a point FDA made in its June 2011 draft guidance on regulating nano-engineered materials. FDA says larger agglomerates and aggregates of nanoscale substances "may exhibit dimension-dependent properties or phenomena relevant to nanotechnology and distinct from those of macro-scaled materials" (Also see "FDA Nanotech Guidance Takes Small Step Forward" - Pink Sheet, 13 Jun, 2011.).

Commenting on the guidance, the Woodrow Wilson International Center for Scholars’ Project on Emerging Nanotechnologies made an argument similar to FOE’s. The guidance language suggests that firms "won't be able to hide behind agglomerates" of nanomaterials when FDA evaluates product safety, PEN said.

FDA Held Responsible

According to Ian Illuminato, health and environment campaigner at FOE U.S., purchasers of products with ZinClear “who thought they were buying nano-free sunscreens for their family were misled, and ultimate responsibility in the U.S. lies squarely with” FDA.

“If the FDA had properly regulated and labeled nano-ingredients in sunscreen, we wouldn’t be in this mess,” Illuminato said.

FOE has contacted all U.S. companies with products featuring ZinClear-IM “to alert them to the fact that Antaria’s product is in fact a nano-ingredient.”

In October 2008, Consumers Union, publisher of Consumer Reports, launched a similar exposé of sunscreen products it claimed were fraudulently marketed as being free of nanoparticles (Also see "Nano-Engineered Sunscreen Report Shows Need For Industry Education" - Pink Sheet, 10 Nov, 2008.).

Nanotech Definition Elusive

The disagreement between FOE and Antaria boils down to how nanotechnology is defined, though it may be a moot point in a global regulatory environment where authorities have yet to reach a consensus on the issue.

While nanotechnology enables novel applications and product benefits, novel behavior can also mean novel risks.

Concerns among the public and policymakers have prompted regulators to impose testing and labeling requirements on manufacturers to ensure that nanotech-enabled products are safe for use. But they have hit snags and points of contention – not least of which is the question of what exactly constitutes nanotechnology at its most unpredictable and potentially hazardous.

The National Nanotechnology Initiative – a U.S. research and development program encompassing 25 federal agencies and $2.1 billion in 2012 funding – ventured a definition at its conception that many stakeholders have adopted. NNI defines nanotechnology as “the understanding and control of matter at the nanoscale, at dimensions between approximately 1 and 100 nanometers.”

Using that broad rule as a basis, regulators have sought to refine and augment the definition to optimize oversight efforts and resources in the sectors they oversee.

FOE maintains that “major international definitions” including those of the International Organization for Standardization and the European Commission “agree that nanomaterials include agglomerates and aggregates of nano-objects.”

Under the European Cosmetics Directive, as recast in 2009, manufacturers are required to report their use of nanomaterials to the European Commission prior to going to market, disclose their use of nanomaterials on product labeling and provide the EC with relevant safety data (Also see "Parliament Passes Updated Cosmetics Directive For All 27 European States" - HBW Insight, 30 Mar, 2009.). That program defines nanotechnology as “an insoluble or biopersistent and intentionally manufactured material with one or more external dimensions, or an internal structure, on the scale from 1 to 100 nm.”

However, the requirements do not go into effect until 2013.

FOE and other environmental advocacy groups filed a lawsuit in December 2011 seeking an order that FDA amend the OTC sunscreen monograph to designate nanoparticles as ingredients that require approval through a new drug application. The groups say FDA should regulate the use of nano-sized particles, particularly in sunscreens and other personal care products, according to their lawsuit filed in U.S. District Court for the Northern District of California seeking an agency response to their 2006 citizen petition that made the same request (Also see "Nanotech Is “More Than Just Tiny,” Requires FDA Regulation – Lawsuit" - Pink Sheet, 9 Jan, 2012.).

FDA has focused less on pinning down exactly what constitutes nanotechnology and shied away from hard caps on the nano scale, instead emphasizing awareness among manufacturers that the behavior of materials can change as they approach the nano scale and may warrant modifications in firms’ safety assessment methods to ensure that products are not adulterated or misbranded. The agency said its draft guidance essentially initiated a dialogue with industry on nanotech products and was a starting point in the regulation of nano-engineered materials, already found in some foods and dietary supplements, sunscreens and cosmetics.