You are on page 1of 11

All Rights Reserved 2007 Health Sciences Authority | 1

Introduction to ASEAN Technical


Guidelines for Cosmetic Products
Cosmetics Control Unit
Centre for Drug Administration
Health Products Regulation Group
Health Sciences Authority
ASEAN Cosmetic Directive (ACD)
Workshop
1 2 August 2007
All Rights Reserved 2007 Health Sciences Authority | 2
ACD Technical Guidelines
References under ACD Appendices:
1. ASEAN Cosmetic Labeling Requirements
Guidelines (Appendix II)
2. ASEAN Cosmetic Claim Guideline (Appendix III)
3. ASEAN Cosmetic Good Manufacturing Practice
(GMP) Guidelines (Appendix VI)
All Rights Reserved 2007 Health Sciences Authority | 3
ACD Technical Guidelines
Other guidelines:
1. Adverse Event Reporting of Cosmetic Products
A Guide Manual for the Industry (dated J un 05)
2. Guidelines for the Safety Assessment of a
Cosmetic Product (adopted Dec 06)
3. ASEAN Cosmetic Directive Guidelines for
Product Information File (PIF) (dated 13 J un 07)
4. ASEAN Microbiological Test Limits (dated 12 J un
07)
All Rights Reserved 2007 Health Sciences Authority | 4
Cosmetic Claim Guidelines
General Rule
1. Must only make cosmetic claimed benefits
Not medicinal or therapeutic claimed benefits
2. J ustified either by technical data and/or
cosmetic formulation or preparation
Manufacturers allowed to use their own
scientifically accepted and justifiable protocols/
design
3. Claimed benefits aligned with what is
accepted internationally
All Rights Reserved 2007 Health Sciences Authority | 5
Cosmetic Claim Guidelines
Evaluation of cosmetic claim takes into
consideration whether a product is cosmetic or
not, determined on 5 main factors below
1. Composition
2. Target site of application
3. Intended main function
4. Product presentation
5. Physiological effects
All Rights Reserved 2007 Health Sciences Authority | 6
Cosmetic Claim Guidelines
1. Composition
Cosmetic ingredients & not banned
2. Target site of application
Placed in contact with external parts of human
body or with the teeth and mucous membranes
of the oral cavity
3. Intended main function
Exclusively or mainly to clean, perfume, change
appearance and/or correct body odours and/or
protect or keep defined parts of human body in
good condition
All Rights Reserved 2007 Health Sciences Authority | 7
Cosmetic Claim Guidelines
4. Product presentation
Product should not be presented as treating
or preventing disease in human beings
labeling, packaging, promotional literature,
product form (e.g. injection not allowed)
5. Physiological effects
Every product generally has an effect on body
function. The effects of cosmetic products
typically are not permanent and have to be used
regularly to maintain their effects
All Rights Reserved 2007 Health Sciences Authority | 8
Cosmetic Claim Guidelines
Document provides some examples of
unacceptable claims, not a final nor an exhaustive
list, some examples:
1. Hair care products
Eliminates dandruff permanently
Restores hair cells
Hair loss can be arrested or reversed
Stimulates hair growth
2. Depilatories
Stops/ retards/ prevents hair growth
All Rights Reserved 2007 Health Sciences Authority | 9
Cosmetic Claim Guidelines
(unacceptable claims continue..)
3. Skin products
Prevents, reduces or reverses the physiological
changes & degeneration conditions brought
about by aging
Removes scars
Prevents, heals, treats or stops acne
Treatment of cellulite
Removes/ burns fat
Fungicidal/ virucidal action
All Rights Reserved 2007 Health Sciences Authority | 10
ASEAN Microbiological Test Limits
J une 12, 2007
ASEAN Microbiological Test Limits
J une 12, 2007
ASEAN
Products for children under 3
years, eye area and mucous
membranes
Other products
Total Microbial
Count (Bacteria,
Yeast & Molds) =< 500 cfu/g =< 1000 cfu/g
P. aeruginosa -ve per 0.1g or 0.1ml test sample -ve per 0.1g or 0.1ml test sample
S. aureus -ve per 0.1g or 0.1ml test sample -ve per 0.1g or 0.1ml test sample
C. albicans -ve per 0.1g or 0.1ml test sample -ve per 0.1g or 0.1ml test sample
All Rights Reserved 2007 Health Sciences Authority | 11
Thank You
Thank You