Although the title of the Inaugural SCS Symposium 2008 was Emerging technologies and challenges for the next decade and beyond, the underlying theme was what a cosmetic is, how safe it is and how it can deliver its promises without becoming a medicine? John Woodruff and Clare Henderson report from the Chepstow event (28-29 April)
People have certainly been using cosmetics for a long time for a variety of reasons, as Bob Hefford reminded delegates in Cosmetic technologies of yesteryear. Over many centuries people have used cosmetics because they like being colourful, to smell nice, to stop being smelly and itchy, to feel better, to stop their teeth falling out, to look nice, to be more attractive to other people and to be socially acceptable. While some older formulations bear many similarities to today’s products, a lot of the materials used in the past (eg lead) are now of course banned.
However, not only are cosmetics under constant scrutiny by the Medicines and Healthcare Products Regulatory Agency (MHRA, formerly MCA) they are under continual attack by certain sections of the media encouraged by those in niche markets, such as ‘organic’, a problem neatly encapsulated by Dr Emma Meredith of the CTPA in the title of her presentation Science – No challenge for a good scare story.
Article 2 of the Cosmetic Products (Safety) Regulations 2004 (SI No2152) clearly states that a cosmetic product put on the market within the community must not cause damage to human health when applied under normal or reasonably foreseeable conditions of use. Manufacturers and companies that market cosmetic products must be able to demonstrate that their products are safe and be able to provide adequate information to prove this to the consumer and competent authorities. However, despite the overriding consideration of safety enshrined in the European Cosmetic Regulations, the media publish titles like Poisoned in the womb, Being pampered to death and Is that scent poison?
These headlines blaming cosmetic products for untold damage to human life are based on myths that usually start on the internet and are often supported by those with a vested interest, ie their products do not contain any of the so-called damaging ingredients. Part of the work of the CTPA is to discount these myths, said Meredith, who then showed some of the more outrageous and proceeded to demolish the claims with science. The idea that 60% of everything put on you skin is absorbed and women absorb 5lbs of chemicals from cosmetics every year are two particularly silly myths. Most women do not apply 5lbs of cosmetics a year and the skin is a very effective barrier that resists percutaneous absorption yet these figures are continually repeated without question.
The CTPA aims to be the authoritative public voice of a responsible and vibrant UK cosmetic industry and in order to put such myths in perspective it has published several monographs including Making sense of risk and Risk in perspective, which may be downloaded from its website, which also has authoritive replies to some of the other media myths that beset the industry. In summary, the CTPA’s position statements are there as foundations to build upon when a scientifically sound response to scare stories in the media is needed.
THE CASE FOR NANO
Nanotechnology and its application to cosmetics is an area subjected to ill-informed comment and the CTPA website [http://www.ctpa.org.uk] carries details of what nanotechnology is and the safety criteria that ingredients, nano- or otherwise, have to pass before being incorporated in cosmetic products. It was also the subject of two presentations at Chepstow. Eric Antignac of L’Oréal discussed nanotechnology, cosmetic and sunscreen safety, and talked through the extensive testing that L’Oréal has undertaken to assess the safety or otherwise of the nanoparticles titanium dioxide and zinc oxide, and Professor Johann Wiechers of J W Solutions posed the question Nanoparticles delivery and cosmetics: a perfect fit or a formulation recipe for disaster?
Antignac started his presentation with Lesson 1 in toxicology: risk = hazard x exposure. Exposure is the influence of nano-formulations on skin penetration and the hazard is whether the toxicity of nanoparticles is any greater than the toxicity of microparticles of the same substances, in particular that of titanium dioxide and zinc oxide. After putting the size of nanoparticles into perspective Antignac explained that the cosmetics industry already uses nanotechnology in the form of liposomes or nanosomes and that numerous reviews on the skin penetration of micrometer or nanometer-sized vesicles concluded that liposomes or nanosomes do not penetrate through the intact stratum corneum (SC).
Intact capsules were only found on the surface of the SC and lipids from hard capsules were found only in the superficial layers of the SC and although lipids from soft capsules may penetrate into the deeper layers of the SC they were absent from the living skin. All the evidence produced so far suggests that TiO2 nanoparticles do not penetrate into living skin. Relative toxicity between nano-sized particles and microparticles was also investigated and it was concluded that particle size did not influence toxicity.
Following a request from EU authorities, an industry consortium of TiO2 producers and cosmetics companies investigated the cytotoxicity, genotoxicity and photo-genotoxicity of the most commonly used TiO2 materials including micrometer and nanometer-sized grades of both rutile and anatase crystalline forms and of both coated and non-coated particles. It was concluded that all TiO2 sunscreens showed minimal cytotoxicity in both the absence and presence of UV; that all materials tested negative in the Ames, photo-Ames, CHO, and photo-CHO tests; and that UV radiation, particle size, crystalline form or coating had no effect on cytoxic or photo-genotoxic potential of these materials. The final report by the EU authorities (SCCP, 2000) concluded that fine particle TiO2 is not expected to present a genotoxic or photo-genotoxic risk for humans under normal conditions of use.
Wiechers is a well known expert on skin delivery systems and he commenced his presentation with the 4Rs of delivery, which is to deliver the right chemical to the right site at the right concentration for the right period of time. There are numerous delivery systems used in the cosmetics industry but he proposed that they be classified by how they protect the active, target the delivery site, enhance delivery and prolong delivery.
Encapsulation in cyclodextrin or within liposomes protects actives but has little effect on enhancing skin penetration. Nano-sized particles of less than 10nm may penetrate the sebaceous gland and if less than 3nm they may penetrate skin. After discussing enhanced delivery and prolonging delivery systems and various safety studies on nanoparticles Wiechers concluded that overall, the current weight of evidence suggests that nano-materials such as nano-sized vesicles or TiO2 and ZnO nanoparticles currently used in cosmetic preparations or sunscreens pose no risk to human skin or human health. Other nanoparticles may have properties that warrant safety evaluation on a case-by-case basis before human use.
The future of sun care products was discussed by Mike Brown (The Boots Co) who began his presentation with a short history of the subject that saw SPF as a measure of protection being introduced in the 1980s and UVA protection in the 1990s. Our knowledge of the effects of sunlight is improving and in the future we should know about the specific cellular damage arising from UV exposure and each of the biological responses. This knowledge should include the relative ability of each UV wavelength in sunlight to elicit each and every undesired biological response and whether components of solar radiation other than UV are damaging. We also need to know the threshold level for damage and hence the safe exposure levels for each undesired biological response; initially by grouped wavelengths but eventually by individual wavelength and which wavelengths are really beneficial so that we can balance benefit versus risk for each wavelength.
This will enable the development of products tailored to protect against the most damaging wavelengths whilst selectively transmitting beneficial wavelengths, said Brown. Legislation has a strong influence over the future of sunscreens; current European legislation requires SPF testing according to International SPF Test Method or equivalent degree of protection obtained by any in-vitro method and UVA protection to be determined as a protection factor according to the PPD human volunteer method or an equivalent degree of protection as determined by any in-vitro method. Brown expects that in-vivo testing will be replaced entirely by in-vitro tests. He also thinks that the current use of SPF numbers will be discontinued in favour of just three categories: Low Protection (SPF 15), Medium Protection (SPF 30) and High Protection (SPF50+), with UVA protection being at least two thirds of SPF.
Brown examined the protection profiles of commonly used sunscreen actives and found that a combination was necessary to provide adequate levels of protection across the whole UV spectrum and wondered if the ideal material to achieve this would ever be discovered. To complicate this ideal it may also be necessary to allow a narrow waveband of UV light to penetrate the system for the benefit of the user. In summary Brown said that sun protection products have continuously evolved and improved and this will continue into the future with different appearances, enhanced performance as well as protecting against more than sunburn.
Werner Voss of Dermatest discussed the application of our knowledge of genetics and related areas to skin care, looking specifically at telomeres, dentritic cells (the gatekeepers of the immune response), Reactive Oxygen Species (ROS) producing mechanisms, immunological cells, signal proteins and nutrients. While we have seen successful engineering in some fields, a cosmetic that is able to influence the genetic mechanisms of the skin is still a dream, said Voss, and so far there is no progress concerning growth and regeneration of the skin. “I wonder why,” he said. “All those scientists at L’Oréal... I wonder what they’re doing.” He gave a few examples of brands looking at genetic technologies, including Beiersdorf’s DNAge influencing the DNA in the cell core, Dior’s vector molecules and bionectines feeding the skin’s stem cells and Lauder’s molecule of youth that activates SIRT1, the gene of longevity. “They’re nice fairytales but they have nothing to do with the actual science or reality,” he said. If we’re to move on, Voss said he was convinced we need to redefine cosmetics in terms of where the borderline lies.
This borderline can certainly cause problems, and Tony Dweck (Dweck Data) pointed out that the MHRA, ASA, Clearcast, FDA and the Trading Standards Office can all have you taken out of the marketplace if you don’t play by the rules. Providing clear definitions for cosmetics and drugs, Dweck also added a quick test: if it cleans, perfumes, protects or colours the skin it’s a cosmetic, but if it heals/cures, mentions a disease or has a physiological action it’s a drug. “If in doubt, ask the MHRA,” said Dweck “They’d rather prevent than sue.” And if you come out with an unlicensed medical product you’re likely to be reported by companies with licensed ones. You need to be very careful with words. “If you do nothing else get hold of Guidance Leaflet 8 (formerly MAL 8) – it’s free – and commit it to memory.”
Among the hot topics in cosmetics at the moment are nutricosmetics and prebiotics, covered here by Anja Dahten (Analyze & Realize) and Heather Carolan (Givaudan) respectively.
Dahten said nutricosmetics can no longer be seen as a gimmick, with consumers certainly increasingly open to the idea, and that the launch of such products from a beauty platform offered excellent prospects for growth in the functional foods sector. There is support for dietary bioactives such as vitamins, carotenoids, polyphenols and trace elements contributing to the maintenance and improvement of skin integrity, physiology and prevention of deleterious effects induced by ageing and environmental stress. However, claims are often based on traditional uses and do need to be substantiated.
Key product areas at the moment include fortified soft drinks, juices and dairy products, with key active ingredients including aloe vera, collagen, coenzyme Q10 and ceramide. Applications include daily skin protection, sun protection and anti-cellulite, with Innéov probably the best substantiated brand on the market and sun protection the best substantiated claim. Future opportunities were said to include further development of anti-ageing foods, increased gender and age specific targeting (particularly 60+) and the chocolate market, thanks to the high polyphenol content of cocoa extracts, which is set to experience radical growth by 2010 as a convenient oral delivery format for health and beauty.
Carolan presented the prebiotic concept as a novel approach to skin health. Prebiotics are the neutral, harmless bacteria that contribute towards skin health and that probiotics thrive on. “The rationale is to provide a substrate that preferentially favours the growth of friendly organisms over some of the less friendly bacteria, reducing the chance of harmful species proliferating,” said Carolan. It’s about skin health and prevention rather than killing pathogens, which would be the job of a medicine. Suggested was a yogurt and inulin (chicory derivative) blend said to support the growth of neutral organisms but not pathogenic ones. It’s therefore something that needs to be approached carefully and is something that’s quite hard to market. Suggested uses include baby care, kitchen and bathroom handwashing products, and non-aggressive antibacterial formulations for sensitive skin and for skin prone to conditions like acne (for full report see this issue, p40-45).
High performance skin care - from concept to consumer, re-subtitled The marriage of psychology, biology and technology, was the title of the presentation given by Dr Paul Matts of Procter & Gamble. Matts said that by wedding an energising understanding of the psychology of visual perception to the biology responsible for appearance and letting this guide technology development his team have had some amazing results. Research showed that perceived age was very much affected by skin tone. A total of 95% of transmitted light passes through the stratum corneum before being scattered and diffused by the epidermis and reflected back by the collagen layer and there is some absorption by melanin and haemoglobin. Matts said that human appearance was driven overwhelmingly by interaction with visible light and this was affected by skin surface topography and melanin concentration.
By undertaking chromophore mapping the concentration and spatial distribution of melanin, haemoglobin and collagen in subjects of different ages he showed that even distribution in the young became uneven with age. This is caused primarily by exposure to sunlight and uneven distribution of melanin was the main indicator of age. Matts described how the mapping was transferred from human faces to flat computer screens and suggested that a combination of n-acetyl glucosamine and niacinamide moderated melanogenesis and reduced visible signs of ageing.
Claims & physiology
Chris Gummer, Cider Solutions, talked about the challenges and emerging trends in product claim substantiation. A claim is any statement made about a product or the consumers who use it but it must be a fact that can be proven with data. Gummer was primarily interested in claims made in television advertising and on shopping channels and described the activities of the various bodies that monitor such claims. There are many pitfalls along the way but there is also help and, as Gummer said, “it’s better to find there is a problem before advertising a product rather than face a possible withdrawal”.
That said, he is disappointed that many of the claims made today have changed little from the 50s, they’re just couched in more creative advertising. The conundrum is that you are required to prove a significant effect without changing function. But if you can increase or enhance rather than change this ought still to be considered cosmetic. “An imaginary line has been drawn,” said Gummer. “The boundary of the epidermal/dermal junction is a myth that is propagated by a lack of understanding and an absence of data. Let’s challenge the authorities. Let’s get good products out there and make bold claims. Put the data on the table and I’m convinced you’ll get the claims. Otherwise we’re stuck with more of the same for the next 20 years.”
Cosmetic Physiology, an oxymoron or an opportunity? was the title of the talk by Steve Barton, Oriflame. Physiology is the branch of science concerned with the functioning of organisms. Organisms are sophisticated mechanisms designed to respond to local environments in a way that is beneficial to survival. Highly evolved organisms develop mechanisms to control their environments in a number of ways. The cosmetics industry is a consequence of a particular need to control human responses to certain environments that pose a threat to external tissues.
Barton discussed the problems of cosmetics being confused with medicines and illustrated the differences with accepted definitions. In summary he said that it was essential to have dialogue between dermatologists and cosmetologists, that regulatory borders constrain markets but not information sharing and that innovation in areas outside cosmetics acts both as threat and opportunity. Also the capability to measure physiological factors with greater precision fuels the debate between what is normal and what is diseased. In conclusion Barton said accept cosmetic physiology and focus on changing the appearance but keep claims realistic. In addition ensure robust levels of proof for physiological modes of action and work with industry bodies and regulators to improve common understanding of cosmetic science and the terms used.
While the majority of presentations focused on products, regulations and ingredients, Johann Schroder, Symex, focused on a new mixer. Under the heading Homogenizing technology for the next generation, he described the action of this new mixing device. Essentially this new piece of kit reduces the particle size of a typical w/o emulsion to less than 5 microns with one pass through the system and droplet size is further reduced with more mixing time.
Of course no conference these days seems complete without a look at the marketplace itself, provided on this occasion by Euromonitor’s Alexander Kirillov who gave an overview of the global cosmetics market, including current and future trends. The market has consolidated considerably. In 2001, the top ten companies accounted for 43% of the market but this had risen to 52.2% by 2007. But it is an increasingly competitive environment, with rivals appearing from more dynamic emerging markets and a proliferation of niche brands. In addition to emerging markets key trends to watch are premiumisation, globalisation, cosmeceuticals, private label and of course naturals and organics. The next five years will see increasing regulation globally, consumer intimacy becoming central to brand success, segmentation by lifestyle brands replacing demographic profiles and local BRIC (Brazil, Russia, India, China) companies going global. Looking further ahead, beyond 2012, we can probably expect an economic slowdown in the BRICs, a decrease in natural resources and possibly increased use of surgery over cosmetics.
Some companies are moving faster than others and Shona Bear explained how Marks & Spencer is taking on the environmental challenge, reporting on how the company is doing one year into Plan A, a five-year, 100-point plan to tackle some of the biggest challenges facing this business and the world. Bear said the company is working with its employees, customers and suppliers to combat climate change, reduce waste, safeguard natural resources, trade ethically and build a healthier nation. The first challenge is climate change and Bear said that all M&S operations will be carbon neutral by 2012.
In beauty, suppliers are being introduced to the M&S model green factory where lighting has been reduced by 50%, CO2 emissions have been cut by 40% and water harvesting has been introduced, saving 20% water. The company is also investigating low energy formulations and is continuing to manage Critical Path to ensure products are not air freighted. Meanwhile, packaging is being reduced (-25% by 2012) and sourced only from recycled or sustainable sources that are recyclable or compostable; PVC remains one of the biggest problems.
In terms of ethical trading, by the end of 2008 M&S will sell only Fairtrade cotton wool. Also, all factories are Sedex (Supplier Ethical Data Exchange) registered and by the end of the year all existing factories will be independently ethically audited and any new ones will be ethically audited prior to approval. So far in raw materials the company has a fixed cut off date of 1 January 2006 for animal testing on all products and now has BUAV approval for all beauty, household and home fragranced products. Sustainability of raw materials may form part of the next stage. “It’s about managing resources,” said Bear. “It all takes time and is not solved overnight but Stuart Rose [M&S chief executive] has said the plan shouldn’t cost any more to the company or the consumer.”