Flawless or Fallible? A Review of the Applicability of the European Union's Cosmetics Directive in Relation to Nano-Cosmetics

Consumer demand for new products within the cosmetics and toiletries industry has encouraged the industry increasingly to incorporate and experiment with new products and processes, including nanotechnologies. A number of cosmetic products which claim to incorporate engineered nano-materials have already entered the market and include, for instance, anti-ageing creams, make up, hair care products, cleansers and moisturisers. While the use of engineered nano-materials within cosmetics offers a range of benefits, including increased transparency and solubility, there has been increasing debate over the potential risks associated with a number of the nano-materials already found in these products. While such concerns are not unique to the cosmetics sector, due to the direct application of these products onto the human skin, concern has been expressed over the potential health effects of nanotechnology-based cosmetics. This is despite the fact that cosmetic products are subject to regulatory controls within every jurisdiction in which they are sold. With debate over the safety of cosmetics containing nano-materials likely to escalate in line with the number of products entering the marketplace, this article examines the adequacy of the current regulatory framework for cosmetics containing nanoscale materials within one of the world’s largest cosmetic's market, the European Union. Two case studies are presented, and the effectiveness of the Cosmetics Directive is examined by reference to these two products. By drawing on this analysis, the article articulates the strengths and weaknesses of the current regulatory regime, and discusses how these may be addressed under the proposed new regulatory framework.

[1]  A. R. Kulkarni,et al.  Biodegradable polymeric nanoparticles as drug delivery devices. , 2001, Journal of controlled release : official journal of the Controlled Release Society.

[2]  R H Guy,et al.  Skin penetration and distribution of polymeric nanoparticles. , 2004, Journal of controlled release : official journal of the Controlled Release Society.

[3]  U. Osterwalder,et al.  Novel emerging sunscreen technologies. , 2006, Dermatologic clinics.

[4]  E. Perrier,et al.  Synthesis and characterization of polyurethane and poly(ether urethane) nanocapsules using a new technique of interfacial polycondensation combined to spontaneous emulsification. , 2004, International journal of pharmaceutics.

[5]  J. Hadgraft Skin, the final frontier. , 2001, International journal of pharmaceutics.

[6]  J. James,et al.  Research strategies for safety evaluation of nanomaterials, part IV: risk assessment of nanoparticles. , 2006, Toxicological sciences : an official journal of the Society of Toxicology.

[7]  M. Schäfer-Korting,et al.  Vitamin A loaded solid lipid nanoparticles for topical use: occlusive properties and drug targeting to the upper skin. , 2000, European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V.

[8]  M. Kandlikar,et al.  Health risk assessment for nanoparticles: A case for using expert judgment , 2006 .

[9]  D. Lasič Recent developments in medical applications of liposomes: sterically stabilized liposomes in cancer therapy and gene delivery in vivo , 1997 .

[10]  Julie W. Fitzpatrick,et al.  Principles for characterizing the potential human health effects from exposure to nanomaterials: elements of a screening strategy , 2005, Particle and Fibre Toxicology.

[11]  M. Lupo Antioxidants and vitamins in cosmetics. , 2001, Clinics in dermatology.

[12]  N. Weiner,et al.  Liposomes: a novel topical delivery system for pharmaceutical and cosmetic applications. , 1994, Journal of drug targeting.

[13]  T. Tadros Future developments in cosmetic formulations , 1992, International journal of cosmetic science.

[14]  D. Lasič Novel applications of liposomes. , 1998, Trends in biotechnology.

[15]  T. Faunce,et al.  Sunscreen Safety: The Precautionary Principle, The Australian Therapeutic Goods Administration and Nanoparticles in Sunscreens , 2008 .

[16]  Anthony Seaton,et al.  Nanoscience, nanotoxicology, and the need to think small , 2005, The Lancet.

[17]  G. Barratt,et al.  Therapeutic applications of colloidal drug carriers. , 2000, Pharmaceutical science & technology today.

[18]  I. Kaur,et al.  Nanotechnology: a new paradigm in cosmeceuticals. , 2007, Recent patents on drug delivery & formulation.

[19]  R. Guy,et al.  Biodegradable polymer nanocapsules containing a sunscreen agent: preparation and photoprotection. , 2001, European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V.

[20]  M. Foldvari,et al.  Non-invasive administration of drugs through the skin: challenges in delivery system design. , 2000, Pharmaceutical science & technology today.

[21]  S. Guterres,et al.  Polymeric Nanoparticles, Nanospheres and Nanocapsules, for Cutaneous Applications , 2007, Drug target insights.

[22]  Graeme Hodge,et al.  A Small Matter of Regulation: An International Review of Nanotechnology Regulation , 2006 .

[23]  A. Michaels,et al.  Drug permeation through human skin: Theory and invitro experimental measurement , 1975 .

[24]  R. Müller,et al.  Solid lipid nanoparticles (SLN) for controlled drug delivery - a review of the state of the art. , 2000, European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V.

[25]  R Wolf,et al.  Percutaneous absorption and delivery systems. , 2001, Clinics in dermatology.

[26]  Karluss Thomas,et al.  Research strategies for safety evaluation of nanomaterials, part VII: evaluating consumer exposure to nanoscale materials. , 2006, Toxicological sciences : an official journal of the Society of Toxicology.

[27]  Michael R. Taylor Regulating the Products of Nanotechnology , 2006 .

[28]  G. Ostojic,et al.  Carbon Nanotubes , 2010, Methods in Molecular Biology.

[29]  Amarnath Sharma,et al.  Liposomes in drug delivery: Progress and limitations , 1997 .

[30]  A. Maynard,et al.  Airborne Nanostructured Particles and Occupational Health , 2005 .

[31]  P. Hoet,et al.  Nanoparticles – known and unknown health risks , 2004, Journal of nanobiotechnology.

[32]  Elias Fattal,et al.  Nanocapsule technology: a review. , 2002, Critical reviews in therapeutic drug carrier systems.

[33]  T. Hamilton,et al.  Improvement of naturally aged skin with vitamin A (retinol). , 2007, Archives of dermatology.

[34]  M. Roberts,et al.  Human Skin Penetration of Sunscreen Nanoparticles: In-vitro Assessment of a Novel Micronized Zinc Oxide Formulation , 2007, Skin Pharmacology and Physiology.

[35]  C. Mowad A practical approach to patch testing for cosmetic allergens , 2001 .

[36]  Vera Rogiers,et al.  Safety evaluation of cosmetics in the EU. Reality and challenges for the toxicologist. , 2004, Toxicology letters.

[37]  Andrew D Maynard,et al.  Nanotechnology: the next big thing, or much ado about nothing? , 2007, The Annals of occupational hygiene.