Indonesia Consults on the Amendments to Required Documents for Product Information File (PIF)

1

Administrative documents

1. Fulfillment of the criteria for safety, efficacy, quality, labeling, and claims stipulated in the Procedure for Submission of Cosmetics Notification;

2. Fulfillment of the requirements stipulated in the Regulation for Cosmetics Adverse Reaction Monitoring in terms of the monitoring results of cosmetic adverse reactions;

3. Scientific or empirical evidence’s compliance with the ingredients’ technical requirements stipulated in Technical Requirements for Cosmetics Ingredients;

4. Fulfillment of contamination requirements stipulated in Limitations for Contamination in Cosmetics.

2

Cosmetic ingredient’s quality and safety data

3

Cosmetic product’s quality data

4

Safety and efficacy data of cosmetic product

1. photocopy of the GMP certificate or the fulfillment certificate for GMP aspects

2. photocopy of the license agreement between the brand owner and the notification applicant (for the notification applicant who is appointed as the trademark licensee)

3. photocopy of valid cosmetics production license

1. photocopy of the agency appointment letter consistent with the one submitted when conducting notification

2. photocopy of the contract cooperation agreement between the notification applicant and overseas cosmetic company that is legalized by a notary public and includes the brand and/or product name and the expiration date of the agreement

3. photocopy of the Certificate of Free Sale (CFS)

4. photocopy of the GMP certificate or the statement of GMP application consistent with the one submitted when conducting notification

5. photocopy of Importer Identification Number (API)

6. photocopy of statement regarding brand

1. photocopy of cosmetics production license and GMP certificate

2. photocopy of the contract cooperation agreement between the contractor and the recipient of a production contract consistent with the one submitted when conducting notification

3. photocopy of business license in the cosmetics sector from the contractor

4. photocopy of statement regarding brand

Cosmetics ingredient’s quality and safety data

1. Cosmetics ingredient’s quality data

• The specification of each ingredient (including water if it's in the formula) and quality specification certificate (certificate of analysis);

• Analytical methods that correspond to the specification of each ingredient, including the identification of cosmetics ingredients. This document must be provide by the owner of the notification number;

• Source and/or manufacturing process of certain ingredients.

• For fragrance, the names and code numbers of the fragrance, the supplier's name and address, and a statement fulfilling the latest International Fragrance Association (IFRA) guidelines.

2. Cosmetics ingredient’s safety data

• Data from suppliers;

• Published data or reports from Scientific Committees such as ASEAN Cosmetic Scientific Body (ACSB), EU Scientific Committee on Consumer Safety (SCCS), and US Cosmetic Ingredient Review Board (CIR);

• Other scientific evidences;

• Empirical evidence.

Notes: Safety data can be stored separately from other PIF documents.

Cosmetic product’s   quality data

1. Cosmetics formula which contains

• Name and concentration of the ingredients. Ingredient names are written as the names in the International Nomenclature Cosmetic Ingredients (INCI) or other names in accordance with internationally recognized references. Ingredient concentrations are written in percentages with a total amount of 100%;

• The function of each cosmetic ingredient.

• For fragrances or aromatic ingredients must include;

1) name

2) fragrance composition code number in accordance with International Fragrance Association (IFRA) guidelines

3) supplier identity

2. Cosmetics manufacturing

• Complete and detailed data regarding names, addresses and countries of the manufacturing and packaging companies (if the primary packaging process is carried out by other companies);

• A summary of the manufacturing process;

• Additional information about the manufacturing process, quality control, and other related information must be available when being examined by the auditor/authorized officer;

• Explanation of the batch numbering system.

3. Cosmetics specifications and analytical methods:

• Cosmetic specifications, including contamination control and ingredients’ purity;

• The analytical method in accordance with the specified product specifications.

4. Cosmetics stability data

• Stability test data to support the determination of the expiration date.

Safety and efficacy data of cosmetic product

1. Safety assessment

• Cosmetics safety assessment report based on cosmetics ingredients, chemical structure and exposure level, signed by the technical responsible person or safety assessor;

• Curriculum Vitae of the technical responsible person or safety assessor.

2. Regularly updated and reported cosmetic adverse reaction monitoring results.

3. Data supporting cosmetic claims

• A complete and signed report on the efficacy evaluation based on product composition or efficacy test conducted;

• Supporting data, including a literature review on efficacy claims.

4. Cosmetics labeling and information, at least contain:

• Labeling on primary packaging and/or secondary packaging;

• Other information in the form of brochures, etc., as an integral part of the primary packaging and/or secondary packaging.

Notes: Added or amended document requirements are marked in red. Deleted document requirements are marked with a strikethrough.