NANOTECHNOLOGY: A EUROPEAN INDUSTRIAL PERSPECTIVE

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1 NANOTECHNOLOGY: A EUROPEAN INDUSTRIAL PERSPECTIVE Francis QUINN L Oréal Research Leixlip, 24 January 2006

2 L OREAL & NANOTECHNOLOGY Responsible management of innovation L OREAL S COMMITTEMENT To develop and manage our innovations raw materials, processes, methods of characterisation, products in accordance with the principles of sustainable development. L OREAL & NANOTECHNOLOGY CRITERIA OF SUSTAINABILITY Ensure the safety of collaborators and consumers Ensure the protection of the environment Protect the planet s biodiversity Take into consideration the problems associated with patenting living organisms and with fair trade Take into consideration the social and societal impact of our innovations And all of this over the full life cycle of our products. Within the context of sustainable development, our know-how in the area of nanotechnology, and its use in our products, represents a major challenge for L Oréal.

3 WHAT IS NANOTECHNOLOGY & NANOSCIENCE? DEFINITION Nanotechnology and nanoscience are generic terms for techniques used to observe and construct objects, on the nanometre scale. The nano objects are called nanoparticles or nanomaterials. There is currently no accepted system of nomenclature or metrology for nanoparticles. Nanoparticles is a generic term used to lump together materials with different chemical compositions and of different size, albeit in the nanometre range: C60 fullerene TiO 2 CdSe Polystyrene latex CONTEXT FOR L OREAL L Oréal has a large patent portfolio on nanotechnology and its applications more than 150 patents. Methods of observation and characterisation developed for nanotechnology are also state-of-the-art techniques for characterising skin and hair. Some of our product innovations are based on nanomaterials.

4 1m 1mm 1µm 1nm 1Å (0.1 nm)

5 L OREAL & NANOTECHNOLOGY Characterising skin and hair CHARACTERISATION METHODS State-of-the-art techniques, such as SAXS, SIMS, AFM, ESEM and Raman microscopy are used today to characterize the fine structure of skin and hair with unprecedented precision 1. These methods are also used to demonstrate the efficacy and tolerance of products. 1. SAXS = Small angle x-ray scattering, SIMS = Secondary Ion Mass Spectroscopy, AFM = Atomic Force Microscopy, ESEM = Environmental Scanning Electron Microscope, TEM = Transmission electron Microscopy, SANS = Small Angle Neutron Scattering, QELS = Quasi Elastic Light Scattering,

6 SURFACE FINE STRUCTURE OF HAIR (AFM) 5 nm

7 ISOLATED SINGLE SKIN CELL (AFM) Dry corneocyte Hydrated corneocyte Friction profile Friction profile

8 HOW ARE NANOMATERIALS MADE? Molecule < Nanozone < 1µm Molecular assembly Process There are 2 general approaches to making nanomaterials: Assemble molecules (smaller than a nanometre) to make bigger particles (e.g. Titanium dioxide nanopigments) Pulverise matter to reduce the particle size down to the nanometre range (e.g. Nanoemulsions)

9 L OREAL & NANOTECHNOLOGY Nanotechnology-based innovations Innovation Product Benefit of nanotechnology Nanoemulsion Hair conditioner Unique texture, transparency Nanocapsule Skin care Protects & transports active ingredient Nanopigment Sunscreen Filters UV rays Nanopigment Make up Homogeneous colour

10 L OREAL & NANOTECHNOLOGY Examples of nanomaterials Liposome & Niosomes nm (Kojic acid, caffeine) Lipid Water Nanocapsule nm (Vitamin A, E) Polymer Oil Nanoemulsion 50 nm (Texture, transparency) Oleosomes nm (Mexoryl XL)

11 L OREAL & NANOTECHNOLOGY NANOPIGMENTS Titanium dioxide is a mineral UV filter composed of micron-sized aggregates. The aggregates themselves are composed of grains that are nano-sized. The aggregates are coated with a layer of silica : Image of Eusolex T- AVO TiO2 UV filter from Merck.

12 WHERE S THE PROBLEM? SAFETY OF NANOPARTICLES Nanoparticles are very tiny objects. Questions are being asked about what becomes of them once they enter the human body and/or the environment after being handled formulator, operator and used by consumers. The preliminary studies carried out so far to assess the impact of nanoparticles on health and the environment have suggested that for certain kinds of nanoparticles there are genuine concerns. ENVIRONNEMENTAL GROUPS A high profile media campaign on the dangers of nanotechnology is being led by environmental organisations, such as ETC and Greenpeace. Although small in size, the ETC group is highly successful at generating impact. ETC s call in March 2002 for a worldwide ban on research in nanotechnology was covered by all major newspapers around the globe. In June 2003, ETC organised a meeting at the European parliament at Brussels where their call for a ban on nanotechnology research was backed by the Green parties in the EU parliament.

13 RESPONSIBLE DEVELOPMENT OF NANOTECHNOLOGY THE SOCIETAL DIMENSION According to some observers high profile press reporting of respiratory toxicology studies, and the media campaigns of environmental pressure groups, mean that public perception of nanotechnology is heading for a crisis of confidence of the type already seen for genetically modified (GM) food 1. Certain NGOs want to inflict on nanotechnology the same sort as GM food 2. The question is: How do we avoid rejection by the public of nanotechnology? Part of the answer lies in being transparent and credible in how nanotechnology is used: including regulation of nanotechnology, and taking into considering its environmental and societal impact. 1) Brumfiel G.: A little knowledge Nature 2003, 424: ) Arnaud Apoteker de Greenpeace France à Sciences et Démocratie. Grenoble, Juin 2005.

14 WHAT ARE THE ACCUSATIONS? NANOTECHNOLOGY IN GENERAL Companies introduce products into the market containing nanoparticles without knowing what becomes of the nanoparticles (in the body, environment) after use. Nanorobots introduced into the body (or the environment) could proliferate wildly, since molecular machines can replicate. The problem posed here is an ethical one similar to that posed by GM crops. Civil liberty could be endangered by "nanocracy" generalised control of citizens, tagging the human herd. Video surveillance using tiny nanoscopes. The race for intellectual property rights in a field as young as nanotechnology, and recent disagreements between nations on IP issues, could trigger an economic war or unwarranted (unfair, unethical) patenting. Intelligent weapons of mass destruction would be more difficult to control than traditional chemical or biological weapons, and probably more lethal. Progress in nanotechnology takes place principally in rich countries and could increase the north south technology gap.

15 WHAT ARE THE REACTIONS TO THE ACCUSATIONS? DIFFERENT WAYS IN WHICH COMPANIES REACT Product launch abandoned, despite favourable risk assessment Development pipeline halted Products renamed to remove the "nano" prefix or inference Marketing and communication strategy adapted / revised / rethought Blanket denial: "there s nothing to see here folks, please move on now Launch without full understanding of risks / consequences

16 REGULATORY PERSPECTIVE Currently the US Food & Drug Administration (FDA) and the Environmental Protection Agency (EPA) considers that the toxicological properties of a material are not influenced by size. The toxicological properties of a material in macroscopic form are presumed to be equivalent to those of the micronised or nanometre sized form of the same material. EPA has suggested a voluntary reporting programme for nanomaterials would facilitate its understanding of and experience with these materials. In 2004 the European Union organised a workshop to discuss the toxicological and ecotoxicological risks of nanomaterials. The aim was to broadly evaluate the problems in preparation for more focused efforts later. Principal conclusions from the EU workshop: A system of nomenclature for nanomaterials should be developed quickly: Enable EU to require that companies detail their existing use of nanomaterials Facilitate labelling of consumer products as containing nanomaterials Exposure assessment is the first priority. Tests should be performed sequentially to evaluate the risk posed by new nanomaterials Precautionary principle in which materials are judged hazardous until they are proven to be safe

17 Possible EU toxicological and ecotoxicological tests for nanomaterials

18 COSMETICS INDUSTRY PERSPECTIVE TOLERANCE AND NON-PENETRATION Applied on skin nanoemulsions breakdown into the ingredients water and oil used to formulate the product. A series of studies on titanium dioxide in sunscreen products examined whether the pigment crossed the skin barrier following after being applied to skin. The studies concluded that titanium dioxide did not penetrate into the living part of the skin 1. Studies conducted by several manufacturers and end-users came to the same conclusion 2-4. A study by academic scientists entitled Nanoderm, financed by the EU, began in 2005 to determine whether nanoparticles can cross the skin barrier. The study leader is Tilmann Butz (University of Leipzig). Preliminary results presented by Butz concluded that there was no penetration into the living part of the skin 5. In addition, the SCCNFP confirmed their approval of the use of titanium dioxide in sunscreen products, irrespective of the size of the pigment particles or the type of coating used 6. 1) Lademann J., et al.: Penetration of titanium dioxide microparticles in a sunscreen formulation into the horny layer and the follicular orifice. Skin Pharmacol. Appl. Skin Pyysiol. 1999, 12: ) Dussert A., et al.: Characterization of the mineral content of a physical sunscreen and its distribution onto human stratum corneum. Int. J. Cosm. Sci , 19: ) Pflucker F., et al.: The outermost stratum corneum layer is an effective barrier against dermal uptake of topically applied micronized titanium dioxide. Int. J. Cosm. Sci. 1999, 21: ) Gamer A., et al.: The in vitro absorption of microfine zinc oxide and titanium dioxide through porcine skin. Toxicology in Vitro en presse. 5) Butz T et al.: No evidence for nanoparticle penetration into living skin. Preliminary data presented at ECETOC, Barcelona, ) SCCNFP is the European Union Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers, 2000.

19 NON PENETRATION OF VESICLES INTO SKIN In a comprehensive review of topical delivery of drugs using liposomes in 1995, the authors concluded that It has yet to be conclusively shown that liposomes can cross the human stratum corneum or localize drugs in the viable layers of human skin. 1 Joke Bouwstra (University of Leiden) specializes in studies on transdermal penetration of vesicles. She has published more than 30 articles on the subject. Bouwstra and her team assessed the distribution profiles of vesicles in human skin in vivo. A deuterium-labelled phospholipid was incorporated into these vesicles to serve as a marker for the vesicle material. Their studies conclude that vesicles do not penetrate beyond the most superficial layers of the stratum corneum 2,3. The best scientific knowledge available today says that nanoparticles applied topically in cosmetic formulations do not penetrate into the living part of skin. The results of new studies will be systematically considered and if warranted this position will be reviewed. 1. Imbert D and Wickett R: Topical delivery with liposomes. Cosmetics and Toiletries magazine. 1995; 111: Honeywell-Nguyen P et al.: Quantitative assessment of the transport of elastic and rigid vesicle components and a model drug from these vesicle formulations into human skin in vivo. Journal of Investigative Dermatology. 2004; 123(5): Van den Bergh B et al.: Interactions of elastic and rigid vesicles with human skin in vitro: electron microscopy and two-photon excitation microscopy. Biochimica and Biophysica Acta. 1999; 1461:

20 NANOTECHNOLOGY GUIDELINES [1] Stakeholder perception of nanotechnology Find out what stakeholders mean when they use terms like nanoscience and nanotechnology. Consider the complete range of aspects upon which stakeholders base their views, including: safety, health, environment, animal welfare, impact on community life, international development, cost, and ethics. Identify those areas where there are knowledge gaps, present and future. [2] Evaluate the social, societal and environmental impacts of nanotechnology Determine whether its better to do it alone or in collaboration with partners (competitors, suppliers, clients, regulators, NGO, consumer association ). Study the social, societal and environmental impacts of nanotechnology. Study future uses of nanotechnology. Encourage / engage in dialogue with stakeholders, using the best available scientific knowledge as support material.

21 NANOTECHNOLOGY GUIDELINES [3] Research programmes Carry out full life cycle analysis of nanomaterials and the products that contain them. Follow the evolution of consumer attitudes towards nanotechnology in collaboration with stakeholders. Reduce uncertainties about the toxicity and the risk of exposure to nanomaterials. [4] Identify those areas where new regulations may be warranted Establish a clear view of current regulations, both at home and abroad, and try to anticipate future modifications. Participate in the process of drawing up new regulations and directives. Set up transversal partnerships with other companies / professional associations / universities and centres of excellence / NGO /consumer associations

22 CONCLUDING REMARKS Where there is no data available on the health & safety aspects or environmental impact of a material, the precautionary principal should be used. However, where data is available, the risk assessment should supersede the precautionary principal. It is up to you to improve the acceptability of your message to stakeholders and consumers alike: Nanotechnology yes, if there is a benefit for the consumer, but with no compromise on risk.