BENZALKONIUM CHLORIDE ON CUTICLE TINT Cosmetic vs Drug Regulation - - PowerPoint PPT Presentation

BENZALKONIUM CHLORIDE ON CUTICLE TINT

Cosmetic vs Drug Regulation

CUTICLE TINT

Cuticle tints are used to:

• Give color to nails
• Clean, sanitize and disinfect nails after nail cleaning

DEFINITION OF DRUGS

Drugs refer to:

(1) articles recognized in official pharmacopeias and formularies, including official homeopathic pharmacopeias, or any documentary supplement to any of them, which are recognized and adopted by the FDA; (2) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals (3) articles (other than food) intended to affect the structure of any function of the body of humans or animals; or (4) articles intended for use as a component of any articles specified in clauses (1), (2), or (3) but do not include devices or their components, parts or accessories

DRUG REGULATION

Current Drug Regulation

• Used as an active ingredient in products classified as household

remedy (HR)

• Used

as an antimicrobial preservative in pharmaceutical formulations

REGISTERED HR PRODUCTS

DR No. Generic Name Brand Strenth Form DRHR-1156 Benzalkonium Chloride

• 0.0125

Solution DRHR-1289 Benzalkonium Chloride

• 0.14%

Tincture DRHR-222 Benzalkonium Chloride

• 0.0125

Solution DRHR-480 Benzalkonium Chloride

• 0.013

Tincture HRP-124 Benzalkonium Chloride

• 0.13g/ 100mL

(0.13%) Tincture DRHR-1189 Benzalkonium Chloride

• 0.2% w/v

Solution DRHR-1788 Benzalkonium Chloride

• 0.125g/100mL

Topical Solution

DEFINITION OF COSMETICS

Cosmetic refers to:

• any substance or preparation intended to be placed in contact

with the various external parts of the human body (epidermis, hair system, nails, lips, and external genital organs) or with the teeth and mucous membranes of the oral cavity with a view exclusively

• r

mainly to cleaning them, perfuming them, changing their appearance and/or correcting body

• dors

and/or, protecting them or keeping them in good condition

COSMETIC REGULATION ASEAN Cosmetic Directive

ACD Ingredient Annexes

• Used as a preservative up to a concentration of 0.1% (ACD

Annex VI)

• Allowed to be used other than as a preservative up to a

concentration of:

– 3.0% for rinse-off hair care products (ACD Annex III), and – 0.1% for other cosmetic products (ACD Annex III) – Antimicrobial, Antistatic, Deodorant, Surfactant

COSMETIC REGULATION ASEAN Cosmetic Directive

ACD Appendix III – ASEAN Cosmetic Claim Guidelines

• cosmetic products may also have a secondary, minor function that

is outside the above scope (i.e. anti-dandruff, anti-bacterial, bust contouring, anti-acne)

ACSB DECISION ON BORDERLINE PRODUCTS

Benzalkonium chloride

Notified Cosmetic Products

Brand Product Name % Function

• Cuticle Tint

0.20 Antiseptic

• Cuticle Tint with Benzalkonium Chloride

0.20 Antiseptic

• Cuticle Tint

0.20 Antiseptic

• Professional Cuticle Sanitizer

0.10 Antiseptic and Nail Tint

• Benzalkonium Chloride

0.10 Nail Tint

• Cuticle Sanitizer with Benzalkonium Chloride

0.10 Nail Tint

• Cuticle Tint

0.10 Disinfectant

• Moisturizing Cuticle Tint

0.05 Disinfectant

• Cuticle Tint

0.01 Preservative

• Cuticle Sanitizer

0.05 Preservative

• Cuticle Tint with Sanitizer

0.10 Sanitizer

• Cuticle Sanitizer

0.10 Sanitizing Agent

• ail Care – Cuticle Sanitizer

0.02 Antiseptic

Regulation on Benzalkonium Chloride

Drug Cosmetic

HARMONIZING THE COSMETIC AND DRUG REGULATION

DRUGS COSMETICS

• 1. Benzalkonium chloride as active

ingredient (antiseptic, antibacterial, disinfectant)

• 2. Benzalkonium chloride as preservative

in pharmaceutical preparations

• 1. Benzalkonium chloride as preservative

in cosmetic preparations

• 2. Benzalkonium chloride as surfactant in

rinse-off hair care products

TRANSITION PERIOD

Proposed Transition Period for Notified Products

• 1. Companies holding valid notifications shall be given two (2) years as transition

period (until 31 December 2019) to apply for the appropriate LTO and CPR from CDRR

• 2. Labels of notified products not compliant with ACD regulations shall be allowed

to be exhausted provided that the MAH shall provide FDA with the complete inventory of the following:

• Manufactured/imported products with non-compliant label
• Existing inventory of unused packaging materials.

3. MAH shall also be required to submit target exhaustion period and monthly status report on the exhaustion.

THANK YOU.