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Home > Press > New "Nano" Product Recall Brings Safety Data and Manufacturer Accountability back on the Agenda

Abstract:
In 2006, the alleged nanotechnology sealing product Magic Nano had been recalled by the manufacturer after more than 100 intoxications. More than four years later, the Danish authorities have ordered the market withdrawal of another similar sealing agent called NanoCover. Proper risk management could have saved the company a lot of money and would have prevented the resulting reputational damage.

New "Nano" Product Recall Brings Safety Data and Manufacturer Accountability back on the Agenda

St.Gallen, Switzerland | Posted on August 9th, 2010

In July 2010, a floor sealer product called NanoCover has been ordered to be removed from the Danish market and it has been notified in the European Union's RAPEX system. The NanoCover product series encompasses various surface treatment products, which, according to the manufacturer, are "developed and manufactured using the latest and most advanced nanotechnologies".

According to the information provided under RAPEX, NanoCover poses a chemical risk because it contains a specifically modified fluorsilane which should be classified as toxic by inhalation [1]. Fluorsilanes are often used to create hydrophobic surfaces, but have nothing in common with manufactured nanoparticles. The sealant is sprayed onto a surface, and a thin (nano) film is formed by self-organization during evaporation of the solvent. However, the formation of very fine particles in the air during application of the spray is possible.

RAPEX is the EU's rapid alert system for dangerous consumer products - with the exception of food, pharmaceutical and medical devices. It facilitates the rapid exchange of information between Member States and the Commission on measures taken to prevent or restrict the marketing or use of products posing a serious risk to the health and safety of consumers. Both measures ordered by national authorities and measures taken voluntarily by producers and distributors are reported by RAPEX. Magic Nano and NanoCover remain the only "nano" products listed in the RAPEX database so far.

As in the Magic Nano case back in 2006, the now-recalled NanoCover product is provided as a pump spray application. After the Magic Nano intoxication series in 2006, the German Federal Institute for Risk Assessment (BfR) carried out investigations and tests concerning the mechanism of toxicity of aerosol spray coating applications. Studies on rats confirmed the serious pulmonary toxicity of the Magic Nano product if applied as aerosol sprays [2].

Furthermore, in the course of these investigations, semi-volatile fluorsilanes have been identified as the probable cause of the harm in the case of Magic Nano, rather than any kind of manufatured nanoparticles (as previously suspected). It has been postulated in the scientific literature that perfluorinated silanes may increase the surface tension of the lung lining fluid. This could counteract the effects of lung surfactants resulting in alveolar collapse with the consequence of serious lung damages.

On the basis of this knowledge, the market withdrawal of NanoCover seems reasonable both because it contains such fluorsilanes, and because it is provided as an aerosol application. However, in the case of NanoCover, it is unclear whether the product has already caused health damages or whether the Danish authorities have acted as a precaution.

Clearly, NanoCover differs from Magic Nano as there has been virtually no media reporting about it. There seems to be no damage to the reputation of "nanotechnologies" in general, as in the Magic Nano case. That's the good news.

However, the NanoCover case seems particularly "unnecessary", as the information would have been available to properly identify and assess the intoxication risks of such fluorsilanes for this kind of aerosol application. Proper risk management and risk monitoring would have saved the company real money, compared to the costs of a product recall and the loss of reputation it now faces.

In conclusion, the market withdrawals of both Magic Nano and NanoCover and their publication on RAPEX may lead to an increased awareness of consumers and authorities towards such claimed "nano" sealants. From the package insert, it is often impossible to identify what active ingredients such nano sealant products contain. This seems to be at least partly a result of the manufacturers trying to protect the chemical formulation of their products. These formulations should be subject to closer scrutiny and testing, and the necessary safety information must be passed along to the consumers.

Sources:
[1] Rapid Alert System for Nano-Food Products (RAPEX) (enter "nano" or "NanoCover" as search term):

ec.europa.eu/consumers/dyna/rapex/create_rapex_search.cfm

[2] BfR Protocols, Aerosols from coating spays (27./28.4.2009, German):

www.bfr.bund.de/cm/207/2_sitzung_der_bfr_kommission_bewertung_von_vergiftungen.pdf

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