Abstract
The ‘Precautionary Principle’ provides a somewhat ill-defined guide, often of uncertain normative status, for those exercising administrative decision-making power in circumstances where that may create potential risks to human health or the environment. This paper seeks to explore to what extent the precautionary principle should have been and was in fact utilised by the Australian Therapeutic Goods Administration (TGA) in its decision to approve the marketing of sunscreens containing titanium dioxide (TiO2) and zinc oxide (ZnO) in nanoparticulate form. In particular, this article assesses to what extent better application of that principle might have altered the TGA’s decision that TiO2 and ZnO ENPs in sunscreens do not require new safety testing, because they are considered to be functionally equivalent to their bulk counterparts.
Similar content being viewed by others
Notes
See for instance, s391 Environment Protection and Biodiversity Conservation Act (1999) (Cth); s30(1)(c) Fisheries Management Act (1994) (NSW).
The distinction was articulated in Friends of Hinchinbrook Society Inc v Minister for Environment and Others (1997) 142 ALR 632, 677–678.
[1993] NSWLEC 191.
Janet Fletcher v The Corporation of the City of Kingston (2004) 240 DLR (4th) 734, 754 para 86.
EC Measures concerning Meat and Meat Products (Hormones), WTO Doc WT/DS26/AB/R, WT/DS48/AB/R (16 January 1998), paras187, 194.
References
Advanced Nanotechnology Limited (2005) ZinClear—the choice is clear for cosmetic clarity and broad spectrum UV blocking. Advanced Nanotechnology, Perth
Cameron J (1999) The precautionary principle: core meaning, constitutional framework and procedures for implementation. In: Harding R, Fisher E (eds) Perspectives on the precautionary principle. Federation Press, Sydney, pp 29–58
Cartagena Protocol on Biosafety to the Convention on Biological Diversity (2000) Int Leg Mater 39:1027
Commission of the European Communities (2000) Communication from the commission on the precautionary principle. Brussels, 2 February 2000), available at <http://europa.eu.int/comm/dgs/health_consumer/library/pub/pub07_en.pdf> (last visited 1 October 2004)
Commonwealth of Australia (1989) Therapeutic Goods Act
Commonwealth of Australia (2000) Gene Technology Act (169)
Cross FB (1996) Paradoxical perils of the precautionary principle. Wash Lee Law Rev 53:851–925
Department of Health and Aging (2001) Environmental health risk assessment guidelines for assessing human health risks from environmental hazards. Department of Health and Aging
Dussert AS, Gooris E (1997) Characterisation of the mineral content of a physical sunscreen emulsion and its distribution onto human stratum corneum. Int J Cosmet Sci 19:119–129
European Community (1992) The Maastricht Treaty
European Community (2001) Treaty Establishing the European Community, (EUR-lex)
Faunce T (2008) Toxicological and public good considerations for the regulation of nanomaterial-containing medical products. Expert Opin Drug Saf 7(2):103–106
Fisher E, Jones J, von Schomberg R (2006) Chapter 1: Implementing the precautionary principle: perspectives and prospects. In: Fisher E, Jones J, von Schomberg R (eds) Implementing the precautionary principle: perspectives and prospects. Edward Elgar, UK, pp 1–16
Flinders Consulting Group (2006) A review of the potential occupational health and safety implications of nanotechnology. Department of Employment and Workplace Relations: Office of the Australian Safety and Compensation Council
Food and Drug Administration (2007) Nanotechnology—a report of the U.S. food and drug administration nanotechnology task force. FDA, Washington DC
Graham JD (2001) Decision-analytic refinements of the precautionary principle. J Risk Res 4:127–141
Gurr JR et al (2005) Ultrafine titanium dioxide particles in the absence of photoactivation can induce oxidative damage to human bronchial epithelial cells. Toxicology 213:66–73
Heads of Government of the Commonwealth, States and Territories of Australia, and representatives of Local Government in Australia (1992) Intergovernmental agreement on the environment. Commonwealth Department of the Environment and Water Resources
Holm S, Harris J (1999) Precautionary principle stifles discovery. Nature 400:398
International Centre for Technology Assessment et al (2006) Citizen petition to the United States Food and Drug Administration. CTA, Washington DC
Jordan A, O’Riordan T (1998) The precautionary principle in contemporary environmental policy and politics. Paper given at Wingspread Conference on ‘Implementing the Precautionary Principle’, Racine, Wisconsin, 23–25 January
Kertesz ZS, Sikszai Z, Kiss AZ (2003–2004) Quality of skin as a barrier to ultra-fine particles. Nanoderm EU 5-Project in 2003–2004
Kimbrell GA (2006) Nanomaterial consumer products and FDA regulation: regulatory challenges and necessary amendments. Nanotech L & Bus 3(3):329–338
Lademann J et al (2001) Investigation of follicular penetration of topically applied substances. Skin Pharmacol Appl Skin Physiol 14:17–22
Lademann J et al (1999) Penetration of titanium dioxide microparticles in a sunscreen formulation into the horny layer and the follicular orifice. Skin Pharmacol Appl Skin Physiol 12:247–256
Lademann J et al (2006) Nanoparticles—an efficient carrier for drug delivery into the hair follicles. Eur J Pharm Biopharm. doi:10.1016/j.ejpb.2006.10.019
Lansdown ABG, Taylor A (1997) Zinc and titanium oxides: promising UV-absorbers but what influence do they have on the intact skin. Int J Cosmet Sci 19:167–172
Lawson A (2005) The Therapeutic Goods Administration will investigate the safety of a new sunscreen technology due to concerns it could damage skin cells. The Sydney Morning Herald, sec. Health and Fitness, 18 December
Maier T, Korting HC (2005) Sunscreens—which and what for. Skin Pharmacol Physiol 18(6):253–262
Majone G (2006) The internationalisation of regulation. In: Minogue M, Carino L (eds) Regulatory governance in developing countries. Edward Elgar, London, p 51
Marchant GE, Mossman KL (2004) Arbitrary and capricious: the precautionary principle in the European Union Courts. AEI Press, Washington
Marchant GE, Sylvester DJ (2006) Transnational models for regulation of nanotechnology. J Law Med Ethics 34:714–725
Miller G (2006) Nanomaterials, sunscreens and cosmetics: small ingredients big risks. Friends of the Earth
Nohynek GJ, Lademann J, Ribaud C, Roberts MS (2007) Grey goo on the ski? Nanotechnology, cosmetic and suncreeen safety. Crit Rev Toxicol 37:251–277
NIOSH (2005a) NIOSH Pocket Guide to Chemical Hazards: Zinc Oxide. Centers for Disease Control and Prevention, Department of Health and Human Services
NIOSH (2005b) NIOSH Current Intelligence Bulletin: Evaluation of Health Hazard and Recommendations for Occupational exposure to Titanium Dioxide. NIOSH
Nollkaemper A (1996) “What you risk reveals what you value”, and other dilemmas encountered in the legal assaults on risks. In: Freestone D, Hey E (eds) The precautionary principle and international law: the challenge of implementation. Kluwer Law International, The Hague, pp 73–94
Peel J (2006) Precautionary only in name? Tensions between precaution and risk assessment in the Australian GMO regulatory framework. In: Fisher E, Jones J, von Schomberg R (eds) Implementing the precautionary principle perspectives and prospects. Edward Elgar, London, pp 203–220
Pflucker F et al (1999) The outermost stratum corneum layer is an effective barrier against dermal uptake of topically applied micronized titanium dioxide. Int J Cosmet Sci 21(6):399–411
Randall A (2008) Taking the precautionary principle seriously, Seminar presented at the Crawford School of Economics and Governance, The Australian National University, Canberra, 15 April 2008, the audio recording available via <http://www.crawford.anu.edu.au/events/ev_sem.php> (last visited 23 April 2008)
Rip A (2006) The tension between fiction and precaution in nanotechnology. In: Fisher E, Jones J, von Schomberg R (eds) Implementing the precautionary principle: perspectives and prospects. Edward Elgar, London
Rouse JG et al (2007) Effects of mechanical flexion on the penetration of fullerene amino acid-derivatized peptide nanoparticles through skin. Nano Lett 7(1):155–160
Ryman-Rasmussen JP, Riviere JE, Monteiro-Riviere NA (2006) Penetration of intact skin by quantum dots with diverse physiochemical properties. Tox Sci 91:159–165
Sandin P (1999) Dimensions of the precautionary principle. HumEcol Risk Assess 5:889–907
Schulz J et al (2002) Distribution of sunscreens on skin. Adv Drug Deliv Rev 54(1):157–163
Scientific Committee on Consumer Products (2005) Scientific Committee on Consumer Products—request for a scientific option: safety of nanomaterials in cosmetic products. Health and Consumer Protection Directorate-General, European Commission, Brussels, http://ec.europa.eu/health/ph_risk/committees/04_sccp/docs/sccp_nano_en.pdf
Scientific Committee on Consumer Products (2007) Opinion on safety of nanomaterials in cosmetic products. Brussels: Health and Consumer Protection Directorate-General, European Commission
Sunstein CR (2005) Laws of fear: beyond the precautionary principle. Cambridge University Press, Cambridge
Tan MH et al (1996) A pilot study on the percutaneous absorption of microfine titanium dioxide from sunscreens. Australas J Dermatol 37:185–187
The Hon. Justice Paul L Stein AM (1999) Are decision-makers too cautious with the precautionary principle? Paper given at Land and Environment Court of New South Wales Annual Conference, Peppers Hydro Majestic, Medlow Bath, Blue Mountains
The United Nations Conference on Environment and Development (1992) Rio Declaration on Environment and Development. United Nations Environment Programme
Therapeutic Goods Administration (2003) Australian regulatory guidelines for OTC medicines. Department of Health and Aging
Therapeutic Goods Administration (2004) Medicines Regulation and the TGA. Department of Health and Aging, Commonwealth of Australia
Therapeutic Goods Administration (2006a) Regulation of therapeutic goods in Australia, <http://www.tga.gov.au/docs/html/tga/tgaginfo.htm>, accessed 24/09/2006
Therapeutic Goods Administration (2006b) Safety of sunscreens containing nanoparticles of zinc oxide or titanium dioxide. Department of Health and Aging, Canberra
Tinkle SS et al (2003) Skin as a route of exposure and sensitization in chronic beryllium disease. Environ Health Perspect 111(9):1202–1208
Tsuji JS et al (2006) Research strategies for safety evaluation of nanomaterials, part IV: risk assessment of nanoparticles. Toxicol Sci 89(1):42–45
Trouwborst A (2002) Evolution and status of the precautionary principle in international law. Kluwer Law International, The Hague
Vogt A et al (2006) 40 nm, but not 750 or 1,500 nm, nanoparticles enter epidermal CD1a+ cells after transcutaneous application on human skin. J Invest Dermatol 126:1316–1322
Author information
Authors and Affiliations
Corresponding author
Rights and permissions
About this article
Cite this article
Faunce, T., Murray, K., Nasu, H. et al. Sunscreen Safety: The Precautionary Principle, The Australian Therapeutic Goods Administration and Nanoparticles in Sunscreens. Nanoethics 2, 231–240 (2008). https://doi.org/10.1007/s11569-008-0041-z
Received:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1007/s11569-008-0041-z