gaining deeper insights into the grey zone of beauty

© Mibelle Biochemistry, Switzerland 2019

Gaining deeper insights into the

grey zone of Beauty Claims

made on Food Supplements

in the EU market

Ioanna Bousoula (Ir.) Regulatory Affairs Specialist

Mibelle AG Biochemistry, Switzerland

Nutricosmetics Summit


Novel concepts

Are Beauty Supplements

The Future Of Skin Care? Beauty From Within

Hair, Skin & Nails Vitamin Supplements Nutricosmetics


New relationships

Nutrition

Personal care Pharmaceuticals

Nutricosmetics

Cosmeceuticals

Nutraceuticals


What are beauty supplements for?

Food supplements to promote and enhance

wellbeing & beauty from within

Hair Skin

Nails


• Collagen, Hyaluronic acid etc.

• Vitamins & minerals mixtures

• Botanical combinations

…in any form:

• Soft- & hardgels

• Tablets

• Chewable tablets

• Gummies

• Liquid (syrup)

Beauty supplements


Beauty supplements

EU Regulation

• No specific legislation addressing nutricosmetics.

• Directive 2002/46/EC (food supplements)


Beauty supplements

EU Regulation

• Rules on Vitamins and Minerals:

o Regulation (EC) 1925/2006

(addition of vitamins, minerals and of certain other substances to foods)

o Regulation (EC) 1170/2009

(amending Dir. 2002/46/EC and Reg. (EC) 1925/2006 as regards the lists of vitamin and

minerals and their forms that can be added to foods, including food supplements)

o Regulation (EC) 1161/2011 (lists of mineral substances that can be added to foods)

o Others on specific nutrients

E.g. glucosamine salt, organic silicon


Beauty claims

≠

Health claims

Not regulated

Reg. (EC) 1924/2006 (nutrition & health claims on foods)

Claims

EU Regulation


Why beauty claims are not health claims?

• Regulation (EC) 1924/2006 :


Authorised health claims in relation to beauty

• Regulation (EU) 432/2012

• Biotin, Copper, Iodine, Niacin, Zinc & Vitamins (A, B2, C)

o Alone or in combination with other ingredients

• In relation to skin, hair, nails

• Specific conditions for use

• EFSA evaluation, Opinions available


Authorised health claims in relation to beauty (1)

Nutrient substance, food or food category

Claim

Biotin

Biotin contributes to the maintenance of normal hair

Biotin contributes to the maintenance of normal mucous membranes

Biotin contributes to the maintenance of normal skin

Copper

Copper contributes to normal hair pigmentation

Copper contributes to normal skin pigmentation

Iodine Iodine contributes to the maintenance of normal skin

Niacin

Niacin contributes to the maintenance of normal mucous membranes

Niacin contributes to the maintenance of normal skin


Nutrient substance, food or food category

Claim

Riboflavin (Vitamin B2)

Riboflavin contributes to the maintenance of normal mucous membranes

Riboflavin contributes to the maintenance of normal skin

Selenium

Selenium contributes to the maintenance of normal hair

Selenium contributes to the maintenance of normal nails

Vitamin A

Vitamin A contributes to the maintenance of normal mucous membranes

Vitamin A contributes to the maintenance of normal skin

Vitamin C Vitamin C contributes to normal collagen formation for the normal function of skin

Zinc

Zinc contributes to the maintenance of normal hair

Zinc contributes to the maintenance of normal nails

Zinc contributes to the maintenance of normal skin

Authorised health claims in relation to beauty (2)


EFSA Opinion on Health Claims on Zinc


EU health claims on labels


Examples: Rejected Health Claim

Applications with Reg. 1924/2006

Nutrient substance, food or food category Claim

Brewer`s Yeast Improves skin, hair and nail condition

Natural mineral water Contributes to visible improvement of the skin

surface structure.

Hyaluronic Acid Helps to keep young look of skin

‘Non-compliance with the Regulation because (…) this claimed effect has not been

linked to a function of the body (…).’

Beauty Claim

Justification:

Beauty link

Appearance only

No relationship with health


• Brewer`s Yeast

“Improves skin, hair and nail condition”

EFSA Opinion Reference 2011;9(6):2228

Examples: Rejected Health Claim

Applications with Reg. 1924/2006


Beauty claims

Hair

Substance X maintains thick and shiny hair

…improves hair elasticity

…increases hair sheen


Health claims

Hair

Substance X contributes to/ promotes normal hair growth

…leads to reduced hair loss

Rejected health claims (claimed effect has not been substantiated):

Substance Claim

Quinoa (Chenopodium quinoa) Stimulation of the hair bulb, favouring the growth of the hair

Vitamine B3 Activates the scalp microcirculation


Beauty claims

Skin

Substance X improves skin elasticity/ skin suppleness

… maintains skin surface structure

… increases skin firmness/ hydration


Health claims

Skin

Substance X contributes to the maintenance (i.e. reduced loss) of the

barrier functions of the skin

…decreases DNA damage after UV radiation exposure

… promotes healthy skin

Rejected health claims (claimed effect has not been substantiated):

Substance Claim

L-carnosine Against skin ageing. Protects cells from ageing.

Lycopene Contributes to the maintenance of healthy skin when exposed to sun

light. (Avoid sunburns by using an effective sun screen. Lycopene is

not a replacement for sun screens).


Beauty claims

Nails

Substance X maintains glossy nails

…improves nail thickness

…helps maintain nails in optimum condition


Health claims

Nails

Substance X promotes normal nail growth

…preserves healthy nails

Rejected health claim (claimed effect has not been substantiated):

Substance Claim

Dimetilsolfone Source of bioavailable sulphur useful for the physiological synthesis of

keratin the main constituent of nails


Correctly used beauty claims on labels


Beauty claim substantiation in EU


Efficacy studies for Beauty claims (1)

• Clinical trials on representative target population

o by specific inclusion/ exclusion criteria (i.e. gender, age, status of beauty concern)

• Determination of population size

• Studies advised to comply with Good Clinical Practices and should respect ethics

• Clearly define the main objective

• Study design & Methodology based on study objective

o double blind randomized placebo controlled or observational study in real conditions of

use, etc.

o feasible to combine several approaches (i.e. instrumental approach, assessment by

professional experts)

o tests conducted by qualified personnel in controlled lab conditions


Efficacy studies for Beauty claims (2)

• Validation

o use of appropriate statistical method, defined before study starts in the study protocol or

in a separate document

o 5% appropriate level of significance

• In vitro studies

o Tests can be performed on cell culture (keratinocytes, fibroblasts…) or on more complex

models

o In fact, these study designs are solely indicative, since they do not include metabolism of

ingredients after digestion


Conclusion remarks

• Beauty claims can be made on food supplements

• They are NOT health claims, so they are not governed by the respective EU

Regulation

• They should be focused on appearance and not to beneficial nutritional or

physiological effects on body

• Advisable for food business operators to keep a dossier proving the beauty claim

– Via existing evidence (books)

– Scientific publications

– New efficacy / proprietary data


Questions?

Thank you!

Vielen Dank!

Merci beaucoup!

Ευχαριστώ πολύ!

Grazie mille!

Mibelle Group Biochemistry, Bolimattstrasse 1, 5033 Buchs, Switzerland

E [email protected]

W www.mibellebiochemistry.com

T +41 62 836 17 31

gaining deeper insights into the grey zone of beauty

Documents