Anti-ageing and Skincare Claims - Summit Events 10... · 15/06/2016 1 Anti-ageing and Skincare Claims An Asian and EU perspective Dr James Wakefield What is Anti Ageing? The term

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?

15/06/2016

2

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.

15/06/2016

3

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

15/06/2016

4

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

15/06/2016

5

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

15/06/2016

6

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

15/06/2016

7

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

15/06/2016

8

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

15/06/2016

9

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

15/06/2016

10

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

15/06/2016

11

Claims Substantiation

• Ultimately the level and quality of claims

substantiation is the decision of the

Responsible Person

An Asian Perspective

15/06/2016

12

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

15/06/2016

13

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

15/06/2016

14

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)

15/06/2016

15

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

15/06/2016

16

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

15/06/2016

17

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

15/06/2016

18

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

15/06/2016

19

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

15/06/2016

20

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

15/06/2016

21

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

15/06/2016

22

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

15/06/2016

23

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

15/06/2016

24

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

15/06/2016

25

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