Anti-ageing and Skincare Claims - Summit Events 10... · 15/06/2016 1 Anti-ageing and Skincare...
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Transcript of Anti-ageing and Skincare Claims - Summit Events 10... · 15/06/2016 1 Anti-ageing and Skincare...
15/06/2016
1
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 Sagging skin
Dark circles Pigmented spots
Fragility Thinner skin Dryness
Discolouration 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
• Restrictions: – Ingredients
– Evaluation of safety
– Efficacy tests (whitening, SPF, anti-wrinkle)
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Korea
• Three categories:
– General cosmetics
– Functional cosmetics
– Quasi drugs
• Functional cosmetics include those that:
– brighten skin
– improving wrinkles in skin
– protection against UV
Korea
• General cosmetics – Registration through MFDS
– Subject to post market supervision
• Functional cosmetics – Required to undergo a pre market evaluation of safety
and efficacy
• Functional ingredients – Certain claims such as ‘whitening’ can only be made
based on certain levels of approver functional ingredients
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Japan
• Two categories – Cosmetics
– Quasi Drugs
• Cosmetics include: – Sunscreen (special-purpose cosmetics)
• 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
• Should consider relevant guidelines
• Use scientifically valid methodology and best practice
• Evaluation criteria should be well defined
• Results should be statistically relevant
• Examples: – SPF
– Biodegradability
– Flammability
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Consumer Perception
• Sample should be ethically representative
• Should use scientifically valid methodology
• Trials should clearly link to the product
• Questions should be clear and understandable – Answer options well balanced
– Questions directly related
– Reporting of answers not misleading
• 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