Indonesia Revises Cosmetic Safety, Quality, and Efficacy Assessment Application Dossiers

Safety of cosmetic ingredients

Plant ingredients

Supporting data must include:

i. Ingredient manufacturer

a. Manufacturer name

b. Manufacturer address (including country)

ii. Ingredient information

a. Ingredient name (INCI name)

b. CAS No.

c. Dosage form

d. Intended use

e. Concentration used as rinse and/or non-rinse

f. Use frequency and method of products containing the ingredient

g. Target population

h. Other necessary documents

iii. Characterization of ingredients

a. Source of plant ingredients

b. Physical characteristics

c. Preparation method

d. Chemical characterization (if applicable)

e. Contamination

iv. Safety data

a. History of traditional use

b. Potential internal exposure routes (dermal, inhalation, oral) based on product use

c. Dermal absorption data

d. Acute toxicity studies (oral, dermal, inhalation)

e. Subchromic/chronic toxicity studies (oral, dermal, inhalation), including NOAEL values

f. Irritation studies (skin, ocular/mucous membranes)

g. Skin sensitization studies

h. Carcinogenicity studies

i. Mutagenicity and genotoxicity studies (in vitro, in vivo)

j. Reproductive toxicity studies; Reproductive and fertility toxicity; developmental toxicity/teratogenicity

k. Phototoxicity studies (required for ingredients used in products exposed to sunlight)

v. Efficacy data/research (only applicable for natural cosmetic ingredients in Indonesia, specifically as colorants, preservatives, or sunscreen agents for cosmetics manufactured in Indonesia)

vi. Other data

a. Regulatory status and usage data in various countries (minimum 4 countries)

b. Data on cosmetics containing the proposed ingredients, which have been distributed in other countries along with reports of side effects

vii. Results of Independent Material Safety Studies (made by the applicant)

Non-plant cosmetic ingredients

Supporting data must include:

i. Ingredient manufacturer

a. Manufacturer name

b. Manufacturer address (including country)

ii. Ingredient information

a. Ingredient name (INCI name)

b. CAS No.

c. Dosage form

d. Intended use

e. Concentration used as rinse and/or non-rinse

f. Use frequency and method of products containing the ingredient

g. Target population

h. Other necessary documents

iii. Characterization of ingredients

a. Chemical structure

b. Molecular weight

c. Purity and isomer composition (if the ingredient is a mixture of isomers)

d. Solubility

e. Partition coefficient (Log Pow)

f. Homogeneity

g. Stability

h. Organoleptic data

i. Melting point

j. Boiling point, relative density, pKa, density, viscosity (for liquid preparations (liquid, thick liquid, suspension) cream, lotion and gel)

k. Shape, melting point, pKa (For solid powder preparations)

l. Density (For solid powder preparations, aerosol)

m. UV light absorption spectrum (For UV filter or UV absorbent)

n. For cosmetic ingredient in the form of nanomaterials, in addition to the requirements above, must be accompanied by particle size distribution data and material absorption data

iv. Safety data

a. History of traditional use

b. Potential internal exposure routes (dermal, inhalation, oral) based on product use

c. Dermal absorption data

d. Acute toxicity studies (oral, dermal, inhalation)

e. Subchromic/chronic toxicity studies (oral, dermal, inhalation), including NOAEL values

f. Irritation studies (skin, ocular/mucous membranes)

g. Skin sensitization studies

h. Carcinogenicity studies

i. Mutagenicity and genotoxicity studies (in vitro, in vivo)

j. Reproductive toxicity studies; Reproductive and fertility toxicity; developmental toxicity/teratogenicity

k. Phototoxicity studies (required for ingredients used in products exposed to sunlight)

v. Efficacy data/research (only applicable for natural cosmetic ingredients in Indonesia, specifically as colorants, preservatives, or sunscreen agents for cosmetics manufactured in Indonesia)

vi. Other data

a. Regulatory status and usage data in various countries (minimum 4 countries)

b. Data on cosmetics containing the proposed ingredients, which have been distributed in other countries along with reports of side effects

vii. Results of Independent Material Safety Studies (made by the applicant)

Forms and types of preparations that can be produced by the class B cosmetic production enterprise

The required dossiers remain unchanged.

i. Cosmetic formula;

ii. Manufacturing method;

iii. Dosage form;

iv. Product usage;

v. BPOM-approved production facilities;

vi. Product photos (if available);

vii. Other necessary dossiers.

Cosmetic sales at cosmetic refill facilities

The required dossiers remain unchanged.

i. Proposal for the application to sell cosmetics at cosmetic refill facilities in accordance with applicable regulations;

ii. Notification number of the cosmetics to be refilled;

iii. Cosmetic refill facilities to be used;

iv. Cooperation agreement document for the sale of cosmetics at refill facilities, if the sales are conducted by a business entity other than the holder of the notification number.