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