ACD Guidelines .pdf

Introduction to ASEAN Technical Guidelines for Cosmetic Products  ASEAN Cosmetic Directive (ACD) Workshop 1 – 2 August 2007 Cosmetics Control Unit Centre for Drug Administration Health Products Regulation Group Health Sciences Authority

 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)

 ACD Technical Guidelines Other guidelines: 1. Adverse Event Reporting of Cosmetic Products  A Guide Manual for the Industry (dated Jun 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 Jun 07) 4. ASEAN Microbiological Test Limits (dated 12 Jun 07)

Cosmetic Claim Guidelines General Rule 1. Must only make cosmetic claimed benefits •

Not medicinal or therapeutic claimed benefits

2. Justified 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

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

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

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

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

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

 ASEAN Microbiological Test Limits June 12, 2007  ASEAN Products for children under 3 years, eye area and mucous membranes

Other products

=< 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

Total Microbial Count (Bacteria, Yeast & Molds)

Thank You