15/06/2016
Anti-ageing and Skincare Claims An Asian and EU perspective Dr James Wakefield
What is Anti Ageing? The term “Anti-Ageing” is used to des...
Anti-ageing and Skincare Claims An Asian and EU perspective Dr James Wakefield
What is Anti Ageing? The term “Anti-Ageing” is used to describe products or techniques that are designed to prevent the appearance of getting older. What effects do we consider to occur when we’re older?
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Effects of Ageing Wrinkles
Elasticity
Dark circles Fragility
Sagging skin
Pigmented spots
Thinner skin
Discolouration
Dryness Bruising
So an anti-ageing product will resolve all these effects?
Anti Ageing Solutions • Different products target different effects of ageing – – – – –
Reducing wrinkles Firming skin Reducing spots and dark circles Sun protection Improved skin barriers
• May target a combination of effects.
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Consumer Perception What does the consumer want? • • • •
Super effective natural ingredients? Technological advances? A product with multiple benefits? Affordable?
Or perhaps consumers want to positively embrace ageing?
Cultural Differences How does culture impact ageing? • • • • • • • •
Exposure to the sun Average temperature differences Build of people Affluence Pollution levels Varying diets Occupation Social pressure
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New Market – Anti-Pollution
Physiological Differences • 4 main signs of skin ageing – Wrinkles / Texture – Lack of Firmness – Vascular Disorders – Pigmentation Difference / En-even Tone
• All signs occur independent of ethnicity, but at different rates
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Physiological Differences • Aged skin appears different – Caucasian – wrinkles / loss of elasticity – Asian - dark spots / uneven skin tone
• Why is there a difference? – Asian skin vs Caucasian skin • Thicker and more compact Dermis • More stratum corneum layers and higher lipid content – Reduced incidence of wrinkles
Physiological Differences • Sun (UV) exposure affects the skin physiology – Most important external factor in skin ageing – Coloured skin is less susceptible to UV-induced damage
• A study of age-matched Chinese and Caucasian Women with no difference in lifetime sun exposure – Wrinkle onset delayed by ~10 years – Pigmented spot intensity more prevalent Nouveau-Richard, Yang, Mac-Mary et al. J Dermatol Sci 2005;40(3) 187-193
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Anti-Ageing • So we have: – Products targeting various effects of ageing – Differences between consumer perception – Vast cultural diversity
How does this impact cosmetic claims being made?
Claims • You are making a claim when you are suggesting a cosmetic product can have a specific effect Multiple factors relating to Anti Ageing
Numerous and varying claims
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An EU Perspective
Trends in the EU • Factors impacting anti ageing products marketed include: – Social role models getting younger – Drive for a youthful look
– Busy working lives – Need to look good and improve skin – More emphasis on male and female products – Increased population numbers and therefore an ageing population
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EU Anti Ageing products • Focus on: – Skin conditioning • • • •
Firming Hydrating Improving Elasticity Tightening
– Reducing the appearance of wrinkles – Having multiple benefits
EU Anti Ageing Products • Popular types of product sold include: – Exfoliators – Skin creams – Face Masks
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What are the Regulations • “The commission shall, in cooperation with Member States, establish an action plan regarding claims used and fix priorities for determining common criteria justifying the use of the claim” • Common Criteria – 655/2013 – Justification of claims used in cosmetics products • Published in 2013 • Specific to on pack claims
Common Criteria 655/2013 • Sets out guidance under various levels – Legal compliance • Cannot claim that the product has been approved • Cannot claim when it is mere compliance and should apply to all products
– Truthfulness • If the presence of an ingredient is claims, that ingredient should be deliberately present
• Claims referring to the properties of an ingredient shall now imply that the finished product has the same property
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Common Criteria 655/2013 – Evidential Support • Claims should be supported by adequate evidence • Studies should be relevant • The level of evidence should be consistent with the claim
– Honesty • Claims about performance shall not go beyond supporting evidence • If the attribute of a product only applies under specific conditions, these should be stated.
Common Criteria 655/2013 – Fairness • Claims shall be objective and not denigrate competitors • Claims shall not create confusion with a competitor product
– Informed Decision Making • Claims shall be clear an understandable to the average end user
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Claims Substantiation • Ultimately the level and quality of claims substantiation is the decision of the Responsible Person
An Asian Perspective
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Trends in Asia • Factors impacting anti ageing products marketed include: – Concern over skin welfare – Exposure to the sun – Busy working lives – Need to look good and improve skin
Asian Anti Ageing Products • Focus on: – Sun Protection – Skin Lightening – Reducing pigmentation – Anti pollution serums – Hydration
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Asian Anti Ageing Products • Popular types of product sold include: – SPF moisturising creams – Hydration creams – Blemish balms – Skin whiteners – Dark spot correctors
Impact of Regulations • Unlike EU, each Asian country has different regulations • Definition and classification of a cosmetic is key. • Different views on claims that can be made
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China • Two categories – Non-special use cosmetics – Special use cosmetics
• Special use cosmetics refer to: – Whitening products – Freckle removing products – Sunscreens
China • Must get approval from CFDA • Imported products require pre market administrative license • Increasing emphasis on verification of cosmetic claims – Draft Guidelines for Verification on Cosmetic Efficacy Claims
• Quasi Drugs include: – Whitening products (medicated cosmetic) – General Anti Ageing products (medicated cosmetic)
Japan • Pre approval considers the efficacy of claims – Sunscreens – Whitening – Anti acne
• Labelling with false or misleading claims is prohibited. • Claims must be substantiated
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Hong Kong • There are no regulations! • For customs purposes products are required to meet the regulations of one of the developed countries
Thailand • Three categories – General cosmetics – Controlled cosmetics – Specially controlled cosmetics according to the ingredients
• Controlled cosmetics include: – Sunscreens
• All other “anti ageing” cosmetics would likely fall under general cosmetics
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Thailand • Claims must not – Indicate pharmaceutical characteristics – Imply altering physiological structure – Indicate a capability of the product for which it does not have – Mislead
Singapore • Follow the ASEAN Cosmetics Directive (similar to EU) • No classifications of cosmetics • Supporting data for claimed benefits • An assessment of the efficacy must be provided within the Product Information File
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Types of Substantiation
Experimental Studies •
In-silico, in-vitro, in-vivo
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Should consider relevant guidelines
•
Use scientifically valid methodology and best practice
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Evaluation criteria should be well defined
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Results should be statistically relevant
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Examples: – SPF – Biodegradability – Flammability
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Consumer Perception •
Sample should be ethically representative
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Should use scientifically valid methodology
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Trials should clearly link to the product
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Questions should be clear and understandable – Answer options well balanced – Questions directly related – Reporting of answers not misleading
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Examples – User trials – Surveys – Questionnaires
Published Literature • Scientific Ingredient Data – Preferably peer reviewed – Relevant to the product type – Relevant at a suitable concentration
• Market Data – Representative of the market
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Substantiation Applied Universally • Sun Protection – ISO 24443:2012 – ISO 24444:2010
• Biodegradability – ISO 14855:2005
• Hydration – Ingredients have to demonstrate appropriate effects
Substantiation with potential Criteria Differences • Whitening – Korea: specific whitening ingredients – Korea: specific ingredient concentrations
• Elasticity – EU: skin less elastic – Asia: skin more elastic – Criteria levels may differ
• Wrinkles – EU: Greater number of wrinkles – Asia: Fewer number of wrinkles – Criteria levels may differ
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Substantiation with potential Criteria Differences • Spot reduction – EU concerned mainly with facial skin spots – Asia concerned with skin spots due to the sun
• Skin firming – EU: Less firm skin on average – Asia: Firmer skin on average – Criteria levels may differ
• Skin lightening – Skin colouration different throughout EU and Asia – Determining skin lightening/brightening difficult
Challenges Facing Cosmetics Companies
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Challenges • Classification of a cosmetic in different countries – Time consuming process
– Potentially expensive – Varied compliance processes • Pre-market authorisation vs post market surveillance
– Expectation levels of information dependant on the country
Challenges • Substantiation – Differences in the amount required – Variation in quality of substantiation – External assessment vs internal decisions • • • •
EU, Thailand and Singapore – Internal Korea – Authorisation by the MFDS Japan – Approval by MHWL China – Approval by CFDA
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Challenges • Changes in consumer demand – Advances in technology – Emphasis on being ‘Green’ – Social impacts • Increased use of social media • New roles models with new styles
– Increased health awareness • Staying out of the sun • Maintaining hydration • Avoiding pigmentation
Common Goals
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Responsibilities • Whether in the EU or Asia – All claims have to be substantiated – You cannot mislead the consumer – Claims must be fair
• Common Goals – To ensure the safety and compliance of products – To allow the consumer to make a fair choice
