Indonesia Amends Required Documents for Product Information File (PIF)

1

Administrative documents

1. Scientific or empirical evidence’s fulfillment of the ingredients’ technical requirements stipulated in Technical Requirements for Cosmetics Ingredients;

2. Fulfillment of contamination requirements stipulated in Limitations for Contamination in Cosmetics;

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

4. Fulfillment of the requirements stipulated in the Technical Requirements for Cosmetic Labeling in terms of cosmetic labeling;

5. Fulfillment of the requirements stipulated in the Technical Requirements for Cosmetics Claims in terms of cosmetic claims.

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 business registration number

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

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

4. photocopy of the statement regarding brand which is consistent with the one submitted when conducting notification

5. photocopy of the statement letter with stamp duty which proves    directors and/or leaders are not involved in criminal acts in the field of cosmetics

6. photocopy of valid cosmetics production license

1. photocopy of the agency’s appointment letter which is 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) which is consistent with the one submitted when conducting notification

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

5. photocopy of the statement regarding brand which is consistent with the one submitted when conducting notification

6. photocopy of the statement letter with stamp duty which proves directors and/or leaders are not involved in criminal acts in the field of cosmetics

7. photocopy of Importer Identification Number (API)

1. photocopy of cosmetics production license and the GMP certificate

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

3. photocopy of the statement regarding brand which is consistent with the one submitted when conducting notification

4. photocopy of the statement letter with stamp duty which proves directors and/or leaders are not involved in criminal acts in the field of cosmetics

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

Cosmetics ingredient’s quality and safety data

1. Cosmetics ingredient’s quality data

• The specification of each ingredient (including water and fragrance if they are 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 provided 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 shall be written as the names in the International Nomenclature Cosmetic Ingredients (INCI) or other names in accordance with internationally recognized references. Ingredient concentrations shall be 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 and quality control, and other related information, which 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 the contamination control and ingredients’ purity, as well as the fulfillment of the safety and quality requirements of cosmetic specifications as stipulated in related regulations;

• 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 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 that support 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 other information, at least contain:

• Labeling on the primary packaging and/or the secondary packaging;

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

Notes:

• In general, the data in PIF is sufficient to assess the safety, quality and efficacy of cosmetics in circulation. For certain cases, additional data is required to support PIF (e.g. product history, challenge tests for microbes, additional analytical methods for confirmation, and production records);

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