Cosmetic Compliance
Intelligence & Solutions
Indonesia Cosmetic Regulation
Aug 11, 2022
Jo Zhou
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CONTENTS

In Indonesia, both domestically manufactured and imported cosmetics shall be notified before circulated on the market. To apply for notification the applicant shall register with BPOM firstly and then fill out and submit a form of notification template online. Prior to notification, cosmetic manufacturers must obtain a production license while importers must have an importer identification number (API). SKI Post Border is also necessary for imported cosmetics to enter into the Indonesian territory after getting the approval of notification.

Halal cosmetics are also a feature of the Indonesian market, because this country is a primarily Muslim country. Sale of halal cosmetics requires a Halal certificate. There is a complicated procedure to apply for this certificate.

Part 1 Regulatory Framework and Competent Authority

1 Existing Main Cosmetic Regulations in Indonesia

TypeRegulationsImplementation Date
ProductionRegulation about Cosmetics Production Licenses2010-08-20
Amendments to Regulation about Cosmetics Production Licenses2013-11-12
List of Forms and Types of Cosmetics Allowed for Production by Manufacturers with Class B Production Licenses2021-02-26
Guidelines for Implementation of Hygiene Sanitation and Documentation for Cosmetic Manufacturers Class B2016-06-10
GMPGuideline for Cosmetic Good Manufacturing Practice 20192019-09-06
Operational Instructions of Guideline for Cosmetic Good Manufacturing Practice 20032010-06-21
Operational Instructions of Guideline for Cosmetic Good Manufacturing Practice (Draft) Draft
Certification Procedures of Cosmetic Good Manufacturing Practice (Draft)Draft
ImportationRegulation Concerning Importer Identification Number2018-07-20
Regulation for Supervision on the Entry of Drug and Food into the Territory of Indonesia2022-12-15
Amendments to Regulation for Supervision on the Entry of Drugs and Food into the Territory of Indonesia2023-12-08
List of Drugs and Food Restricted from Entering Indonesia2023-12-03
Regulation for Supervision on the Entry of Drug and Food Ingredients into the Territory of Indonesia2022-12-15
List of Drugs and Food Ingredients Restricted from Entering Indonesia2022-12-15
NotificationRegulation Concerning Cosmetic Notification2011-01-01
Procedure for Submission of Cosmetics Notification2022-10-05
PIFGuidelines for Product Information File2023-08-02
IngredientsTechnical Requirements for Cosmetics Ingredient 20192019-08-22
Amendment to Technical Requirements for Cosmetics Ingredients2022-07-28
Regulation concerning Permitted Ingredients Changes in Cosmetics2023-12-07
Limitations for Contamination in Cosmetics2019-07-04
Cosmetic Analysis Methods2011-09-21
Post-market surveillanceRegulation for Supervision on Manufacture and Circulation of Cosmetics2023-03-28
Criteria and Procedure of Recall and Destruction of Cosmetics2017-06-20
Regulation for Cosmetics Adverse Reaction Monitoring2019-09-06
Label/Claim/AdvertisementTechnical Requirements for Cosmetic Labeling2020-12-28
Technical Requirements for Cosmetics Claims2022-01-07
Technical Guidelines for Cosmetics Advertising2021-12-13
Halal certification
Law of the Republic of Indonesia Number 33 Year 2014 concerning Halal Product Assurance2019-10-17
Amendments to Law of the Republic of Indonesia Number 33 Year 2014 concerning Halal Product Assurance2020-11-02
Decree of the Head of BPJPH Number 40 of 2022 concerning the Determination of the Halal Label2022-03-01
Decree on Materials Excluded From Halal Certification Obligation2021-12-27
OthersRegulation for Electronic Business Licensing of Drug and Food2018-08-23
Application of 2D Barcode in the Control of Drugs and Food2022-10-05

2 Competent Authority

The Agency for Drug and Food Control (BADAN POM) is the competent authority in Indonesia to regulate cosmetics, it is the agency to issue cosmetic regulations and grant cosmetic production license and cosmetic notification before market entry.

The Halal Product Guarantee Agency (BPJPH) is the authority which regulates HALAL cosmetics and issue HALAL Certificate enterprise looking to enter the HALAL market in Indonesia.

Part 2 Cosmetic Products

1 Definition

In Indonesia, cosmetics are products that are intended for use on the outside of the human body (epidermis, hair, nails, lips and external genital organs), teeth and oral mucous membranes, primarily to cleanse, fragrance, alter the appearance and/or improve body odor or protect or maintain the body in good condition. (click to see all types of cosmetic products)

2 Manufacturer Obligation

2.1 Production Licenses

In Indonesia, the manufacturer must obtain a "production license" before manufacturing cosmetics. Production License is a permit which must be owned by cosmetics factories to perform cosmetic manufacturing activities. The production license is valid for 5 years, and may be extended as long as they comply with regulations.

Production license is divided into two categories by cosmetic categories and types:

Class A Production License grants rights to manufacture all forms and types of cosmetics

Class B Production License grants restricted rights confined to manufacture cosmetics listed in the following table without conditions, and prohibit manufacturing 1) Cosmetics used for babies; 2) Cosmetics used around the eyes, oral cavity, and / or other mucous membranes; 3) Cosmetics contain functional ingredients such as anti-acne, skin whitening, sunscreen, chemical peeling, hair dyeing agents; 4) Cosmetics that require complicated technologies during the manufacturing process, such as aerosols and compact powders.

No.Cosmetic FormsCosmetic TypesCosmetic Categories
1Liquids

a. Liquid

b. Viscous liquid

c. Suspension
  • Body mist

  • Eau de cologne

  • Eau de toilette

  • Eau de parfum

  • Perfume

  • Hair oil

  • Facial cleanser

  • Facial skin freshener

  • Astringent

  • Skin freshener

  • Bath soap

  • Bath oil

  • Bath foam

  • Foot care

  • Shampoo

  • Hair conditioner

  • Hair and body wash

  • Hair dressing

  • Hair creambath

  • Scrub

  • Massage oil including spices

  • Skin, body and / or hand care

  • Liquid powder

  • Mangir

  • Day cream

  • Night cream

  • Moisturizer

  • Make up base

  • Foundation

  • Deodorant

  • Other bath preparations (hand soap)

  • Skin conditioner

  • Massage preparations

  • Other fragrance preparations

2Half solid

a. Cream

b. Gel

c. Pomade
  • Scrub

  • Massage cream

  • Hair creambath

  • Day cream

  • Night cream

  • Moisturizer

  • Skin, body and / or hand care

  • Facial mask

  • Peeling

  • Hair styling

  • Hair dressing

  • Hair conditioner

  • Hair creambath

  • Shampoo

  • Facial cleanser

  • Bath soap

  • Deodorant

  • Massage gel

  • Other bath preparations (hand soap)

3Powder

a. Powder

b. Scrub

c. Mangir

d. Bath salts
  • Bath powder

  • Facial mask

  • Body powder

  • Cold powder

  • Facial powder

  • Antiperspirant, deodorant

  • Foot care powder

  • Bath salts

4Solid

a. Bar soap

b. Shampoo bars

c. Deodorant stick

d. Spices

e. Cold powder
  • Bath salts

  • Scrub

  • Mangir

  • Deodorant

  • Other bath preparations (spices, hand soap)

  • Bath foam

  • Hair & body wash

  • Facial cleanser

  • Moisturizer

  • Body fragrance

If cosmetic manufacturers with class B license wants to manufacture cosmetics which are neither prohibited for class B and are not listed on the above positive list, the manufacturers should submit a safety assessment of the cosmetic before manufacture.

To obtain Class A production License, a cosmetic manufacturer should fulfil the following requirements:

  1. Have a pharmacist as the responsible party;

  2. Have production facilities for products to be manufactured;

  3. Have laboratory facilities;

  4. Have GMP qualification

To obtain Class B production license, a cosmetic manufacturer should fulfil the following requirements:

  1. Have at least one pharmaceutical technical personnel in charge;

  2. Have production facilities with simple technology for products to be manufactured;

  3. Able to provide appropriate hygiene and sanitation documentation in accordance with GMP.

2.2 GMP (Cara Pembuatan Kosmetika yang Baik in Indonesian, CPKB)

Manufacturers of Class A must ensure their compliance with the Guideline for Cosmetic Good Manufacturing Practice 2019 (GMP) and manufacturers of Class B must comply with the hygiene and sanitation requirements in accordance with the GMP. The competent authority will conduct corresponding inspections on the compliance status within 7 working days after receiving the application of a production license. 

Manufacturers who implement the GMP are able to apply for a certificate online. The GMP certificate is valid for 5 years. The procedures are as follows:

1. Business actors apply GMP certificate and upload required documents through BPOM integrated with the OSS system

1) Administrative documents

  • Application letter

  • Cosmetic product license

  • Proof of payment of non-tax revenue

2) Technical documents in the form of appropriate quality system documents in accordance with GMP

2. BPOM conducts audits and evaluations of documents within 35 working days. Based on evaluation results, BPOM issues GMP certificate if the business actors comply with the requirements and submit GMP certificate through the OSS system no later than 1 working day.

If the business actors do not meet the requirements, rejection decision will be conveyed though the OSS system no later than 1 working day.

procedures-of-gmp-certification.pngSource: Regulation for Electronic Business Licensing of Drug and Food

3 Importer Obligation

3.1 Importer Identification Number (Angka Pengenal Importir in Indonesian, API)

API is an identification as an importer. Individuals or enterprises are permitted to conduct import activities in Indonesia only after obtaining the API. There are two types of API:

  • General API (API Umum in Indonesian, API-U)

  • Manufacturer API (API Produsen, API-P)

API-U is granted to companies that import goods for trading purpose while API-P is for companies that import goods for their own internal use, e.g. raw materials, production machinery or other materials to be further processed or used for the production. API-P can import finished cosmetics only when they serve as complementary goods.

Each importer can only have 1 type of API. The API applies to every import activity in Indonesia and is valid as long as the importer is still import goods

3.2 SKI Border and SKI Post Border

Importers of cosmetic ingredients are required to obtain an import certificate (SKI Post Border) either before or within seven days after the goods are released from the customs area. Importers of cosmetic products must obtain an import certificate (SKI Border) prior to the release of goods from the customs area. Furthermore, imported cosmetics must have a remaining shelf life of at least 1/3 when entering Indonesia.

To apply for the SKI Border or SKI Post Border, the applicant shall register with BPOM with the following documents to obtain a username and password:

  • Original application letter signed by the director or the proxy of board of directors

  • Duly stamped, original statement of the person in charge

  • Original NIB

  • Original Import Power of Attorney

  • HS Code list of commodities to be imported

  • Original of Resident Identity Card (KTP) of the person in charge

  • Front view and back view photos of the warehouse and office

  • Warehouse address where the product is stored

With the username and password, the applicant can apply for SKI Border and SKI Post Border online. The documents required to be uploaded are as follows:

TypesDocuments
Cosmetic Products
  • Notification approval

  • Certificate of Analysis (CoA) including product names, testing parameters, testing results, testing methods, batch number/production code, production date and/or expiration date and manufacturer name and address (if the CoA issuer is not the manufacturer, then the CoA can only be issued by an accredited laboratory)

  • Invoice

  • Sampling/Laboratory testing (if necessary)

  • Other supporting documents required by the competent authority


Note:

  • The product name, packaging, and packing size listed on the invoice must correspond to those listed on the notification certificate;

  • In the event that the product name does not match the name listed in the notification certificate, the reference letter from the manufacturer must be submitted;

  • In the event that the validity period of the notification is less than three months, the application receipt for notification renewal must be submitted.

Cosmetic Ingredients
  • Certificate of Analysis (COA) including ingredient names, testing parameters, testing results, testing methods, batch number/production code, production date and/or expiration date, and manufacturer name and address (if the CoA issuer is not the manufacturer, then the CoA can only be issued by an accredited laboratory)

  • Safety data sheets and/or ingredient specification

  • A duly stamped statement letter of the designation/distribution purposes

  • Invoice

  • Sampling/Laboratory testing (if necessary)

  • Other supporting documents required by the competent authority

 

Fragrance must also attach:

  • A statement letter issued by the fragrance manufacturer, stating that the fragrance is manufactured in accordance with guidelines of International Fragrance Association (IFRA) for Cosmetic Substances in the form of fragrance ingredients;

  • Reporting on the distribution of previously imported fragrance ingredients.

Approval of the application of SKI Border and SKI Post Border will be issued in electronic no later than 1 working day after the submission of documents if there is no incompliance.

application-of-ski-1.pngSource: Regulation for Electronic Business Licensing of Drug and Food

4 Business Registration Number (Nomor Induk Berusaha in Indonesian, NIB)

NIB, in the form of 13 (thirteen) random digits accompanied by an Electronic Signature, is the identity of the business actor issued by the OSS Institution after the business actor has registered. With the NIB, the business actor does not need to obtain some required licenses such as Trading Business License (SIUP), Company Registration Certificate (TDP), Import Identification Number (API), etc.

Business actors can follow the following steps to obtain a NIB:

  • Log in to the OSS system

  • Fill in the data needed, namely company data, shareholders, capital ownership, investment value and planned use of labor including foreign workers

  • Fill in business information that corresponds to the 5 digit Indonesian Business Field Standard Classification (KBLI)

  • Give a checklist and a disclaimer regarding the truth and validity of the data submitted

  • The OSS system will issue a NIB for business actors

NIB is valid as long as the business actor runs his business and/or activities in accordance with statutory provisions.

5 Notification

Both domestically manufactured and imported cosmetics should be notified with the Agency for Drug and Food Control before circulated on the market (those products only used for research or samples for exhibitions in limited quantities and not for trade are exempted).

5.1 Applicant Registration

Three types of stakeholders are qualified to apply for the notification:

  1. Cosmetic industry located in the territory of Indonesia which has a production license;

  2. Importers who have Import Identification Numbers (API) and obtain the letter of authorization for agency from manufacturer of country of origin;

  3. Individual businesses/ business entities that contract with a domestic cosmetic industry which has obtained a production license.

These qualified applicants must first register with the Head of the Agency. The registration shall be done by filling out an electronic data form and uploading electronic data via BPOM cosmetics notification service official page (http://notifkos.pom.go.id/new). If the data submitted are verified, the applicant will get the User ID and Password to apply for notification.

For an importer or business individual/business entity that undertakes a production contract, it must obtain a recommendation as a notification applicant. The recommendation shall be obtained by submitting an application for facilities inspection to the Head of the local UPT BPOM.

registration-of-notification-applicant-indonesia.pngNotification Applicant Registration Procedures

Source: Regulation for Electronic Business Licensing of Drug and Food

5.2 Notification Procedure

  1. Registered applicant apply for notification by filling out and uploading data on another electronic form of Template on the BPOM cosmetics notification service official page (* Template consists of information needed for this application, which will be detailed below or refer to our coslist).

  2. The applicant who has successfully submitted the Template will receive an electronic Pay Order. The applicant should make a payment through an electronic payment system as non-tax state revenue within seven working days. The system issues a product ID number automatically as a receipt for the notification application (If the applicant makes the payment exceeding seven working days, the notification application will be considered null and void automatically deleted from the system).

  3. The notification applicant will receive the cosmetic notification dossiers verification result in any of the following conditions within fourteen working days from the issue of the product ID number (for perfume products, three working days).

1. Received. The Head of the Agency will issue a notification letter stating the notification number.

2. Rejected. Fees that have been paid are irrevocable.

3. Clarification request. This result will be issued in terms of cosmetics contain ingredients with uncertain safety and usefulness or cosmetics with unclear data related to the product name, status, categories, and/or brand ownership. Clarification documents shall be supplemented within 14 working days. Clarification is carried out at most three times.

4. Once the product got notified, it must be produced or imported and circulated within 6 months.

cosmetics-notification-procedure-indonesia-1.pngNotification Procedures

Source: Regulation for Electronic Business Licensing of Drug and Food

Note: During the application processing, the Head of Agency may require the notification applicant to give an example of cosmetics when needed.

Notification is valid for a period of 3 years, and the cosmetic industry, cosmetic importer or individual business/business entity should be responsible for the cosmetic quality and safety.

Cosmetics with expired notification are prohibited from being produced or imported and/or distributed in Indonesian. But in cases where the notification has expired, cosmetics that have been distributed can be circulated for a maximum of 6 months under the following conditions:

Still in the process of submitting notification renewal
Still in the process of submitting new notification
Has receieved a new notification

If changes were made to the following aspects, notification of change must be made:

  • Name of the industry/importer/business entity that carries out notification without changing the rights to circulate or ownership status

  • Address of the industry/importer/business entity that carries out notification without changing the rights to circulate or ownership status

  • Packaging size and type

As for other changes, industry/importer/business entity must renew the notification.

5.3 Examples of Notification Template

1. Product Status (Choose one)

  • Import

  • Contract

  • Domestic/Local

2. Manufacturer

  • Manufacturer

  • Other Manufacturers (leave “other manufacturers”blank if your product is manufactured only by 1 factory)

3. Packaging

  • Primary packaging

  • Secondary packaging

4. Product data

  • Brand

  • Product name

  • Stock color

5. Product type

  • Stock

  • Category

  • Usage

  • Product type

  • Non-tax state revenue (PNBP) rates

6. Product packaging list

  • Primary packaging

  • Secondary packaging

  • Net contents

  • Unit

7. List of cosmetic ingredients

  • Ingredient name

  • Function

  • Percentage

  • Group

  • Total percentage of ingredient

8. CFS data

  • Has the product been officially traded overseas?

  • Please provide the name of the country to be circulated

  • CFS file from the original country

  • CFS validity period

5.4 Priority Services for Notification

Priority services are provided to notification applicants who meet the following criteria. The notification dossiers verification results shall be issued within three working days under priority service.

Type of products and categories of cosmetics which can be designed in priority services

No.

Product Type

Detailed Category

1

Creams, emulsions, lotions, gels

and oils for skin (hands, face, feet,

etc.)

Massage products

2

Tinted bases (liquids, pastes,

powders)

Make up Base/Foundation

3

Make-up powders, after-bath

powder, hygienic powders, etc.

Face powder

Liquid powder

Cold powder

4

Toilet soaps, deodorant soaps, etc.

Bath soap, solid

5

Hair care products

Hair styling

Shampoo

Hair and body wash

Hair dressing

Hair conditioner

6

Shaving product (creams, foams,

lotions, etc.)

Pre-shaving products

Shaving products

7

Products for making-up and

removing make-up from the face

and the eyes

Compact powder

Blush on

8

Products for nail care and make-up

Top coat

Base coat

Nail dryer

Nail extender/Nail elongator

Nail color

Nail polish remover

9

Bath and shower preparations

(salts, foams, oils. gels, etc.)

Liquid bath soap

Bath foam

Bath oils

Bath salt

Bath powder

Scurb/Mangir

Criterias shall be met:

Cosmetics industry that has been registered with BPOM and has a cosmetics notification number for sub-accounts submitted

Have never been involved in a criminal offense in the field of cosmetics

Administrative documents submitted are well-formed and in good order

Have a safety assessor / technical person in charge

Not use a service bureau in handling notification/distribution permit

Never received a warning letter related to violations and/or listed in a public warning related to prohibited ingredients and illegal cosmetics during the last two years

Never received a stern warning letter during the last two years

Conduct and report the results of cosmetics adverse reaction monitoring

Never received the rejected results of notification dossiers verification on the grounds of not meeting administrative, safety and quality requirements for the past three years

Have audited PIF and/or inspection of production facilities and/or GMP with the results of complete documents (CAPA closed)

Not use the brand together

Never involved a case related to the brand

5.5 Product Information File (Dokumen Informasi Produk, DIP)

PIF shall be prepared by manufacturers or importers before cosmetics are notified and provided when the POM agency conducts an examination. The PIF must be kept in the form of electronic and/or written documents (hard-copy) and stored properly for a minimum of 1 years after the expiration date of the last cosmetics produced or imported and updates once there are any changes.

PIF can either be in English or Indonesian and has to include the following information:

Administrative documents

Indonesian   cosmetics

Imported cosmetics

Contract cosmetics

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

1. photocopy of 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

Cosmetic   ingredients 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.

 

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.

Cosmetics   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.

 

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 cosmetics

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.

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

6 Ingredients Standard

Cosmetic ingredients in Indonesia shall comply with Limitations for Contamination in Cosmetics and the Technical Requirements for Cosmetic Ingredients 2019 which includes appendices:

  • Appendix I: permitted ingredients with limitations and terms of use

  • Appendix II: permitted colorants with limitations and terms of use

  • Appendix III: permitted preservatives with limitations and terms of use

  • Appendix IV: permitted sunscreens with limitations and terms of use

  • Appendix V: prohibited ingredients

6.1 The Scope of Prohibited Cosmetic Ingredients

  • Ingredients listed in Appendix I that do not comply with the allowable limit and conditions of use;

  • Ingredients listed in Appendix II, III and IV that do not comply with the specified requirements;

  • Ingredients listed in Appendix II, III and IV that are not used as the colorant, preservative and sunscreen agent, and do not comply with the requirements in Appendix II, III and IV;

  • Colorants not listed in Appendix II (except for colorants specifically used for hair dyeing);

  • Preservatives and sunscreen agents not listed in Appendix III and IV;

  • Prohibited ingredients listed in Appendix V.

Note:

  • Other cosmetic ingredients not listed in Appendix I can be used as long as it meets the safety, efficacy and quality requirements. Relevant scientific or empirical evidence proving compliance with safety, usefulness and quality requirements is required to provide and include in PIF.

  • When natural ingredients not listed in Appendix II, III and IV are used as colorants, preservatives or sunscreens in cosmetics, relevant scientific or empirical evidence is required to provide and include in PIF, and an approval from Directorate of Standardization of Traditional Medicines, Health Supplements and Cosmetics is required.

6.2 Additional Requirements for Cosmetics Containing Specific Ingredients

  • In the case of imported cosmetics containing isopropylparaben, isobutylparaben, or benzylparaben, cosmetics can be notified in Indonesia but must fulfill the following conditions:

1) isopropylparaben, isobutylparaben, and benzylparaben are permitted as cosmetic ingredients in the country of origin;
2) does not conflict with the requirements as listed in Appendix III
  • In the case of cosmetics containing alpha arbutin or beta arbutin,

1) in the PIF must be attached in the form of test results of hydroquinone content in:
a. Certificate of cosmetic analysis
b. Cosmetic stability test
2) cosmetics storage conditions shall be labeled on the packaging

6.3 Limitations for Contamination in Cosmetics

a) Limitation Standards on Microbial Contamination


1. Cosmetics for children under 3 years old
2. Cosmetics used around the eyes
3. Cosmetics used in the area contacting with mucous membranes
Cosmetics except for:
1. cosmetics for children under 3 years old
2. used around the eyes
3. used in the area contacting with mucous membranes
Total plate count≤ 5x102 colony/g or colony/mL≤ 103 colony/g or colony/mL
Mold and Yeast≤ 5x102 colony/g or colony/mL≤ 10colony/g or colony/mL
Pseudomonas aeruginosaNegative per 0.1 g or 0.1 mL sample (test sample)Negative per 0.1 g or 0.1 mL sample (test sample)
Staphylococcus aureusNegative per 0.1g or 0.1 mL sample (test sample)Negative per 0.1 g or 0.1 mL sample (test sample)
Candida albicansNegative per 0.1 g or 0.1 mL sample (test sample)Negative per 0.1 g or 0.1 mL sample (test sample)

b) Limitation Standards on Heavy Metal Contamination

Heavy MetalLimitation
Mercury (Hg)≤ 1mg/kg or 1mg/L (1ppm)
Lead (Pb)≤ 20 mg/kg or 20 mg/L
(20 ppm)
Arsenic (As)≤ 5 mg/kg or 5 mg/L (5 ppm)
Cadmium (Cd)≤ 5 mg/kg or 5 mg/L (5 ppm)

c) Limitation Standards on Chemical Contamination

ContaminationLimitation
1,4-Dioxane (*)≤ 25 mg/kg or 25 mg/L
(25 ppm)

Note: (*) refer to cosmetics containing ingredients made through ethoxylation processes such as Sodium Laureth Sulphate or Polyethylene Glycol.

7 Label

The cosmetic label in Indonesia must list all required information in accordance with the existing reality honestly and accurately, and should be presented in a way that is not easily removed or separated from the packaging and not easily faded or damaged.

The label should contain the following information:            

  • Cosmetic name

  • Functions

  • Instructions

  • List of ingredients

  • Name and country of producer

  • Name and full address of the notification applicant

  • Batch number

  • Size, content or net weight

  • Expiration date

  • Notification number

  • 2D Barcode

  • Warning/Attention

The following information must be written in Indonesian language:

  • Functions

  • Instructions

  • Warning/Attention

Other information listed above may be written in Indonesian language or Latin letters and/or Arabic numerals.

Special warning must be labeled for certain products:

ProductsWarning
AerosolsAttention! Do not contact with eyes and do not breathe in. Watch out! High pressure content, can explode at temperatures above 50℃. Do not stab, do not store in heated place or near open flame, and do not dispose of using an incinerator.
Mouthwash containing fluorideDo not apply to children under 6 years old.
Cosmetics containing ingredients derived from porkContaining Pork
Cosmetics whose manufacturing process is in contact with ingredients derived from porkIn the manufacturing process it intersects with pork sourced ingredients

8 Claim

Unlike the notification system the authority doesn’t conduct a strict premarket evaluation on product claims. Therefore, cosmetic industry/importers/business entities are required to conduct self-assessment and ensure the objectivity and authenticity of claims on labels and advertisements.

Cosmetic claims must meet the following criteria:

  • Legal compliance;

  • Truth;

  • Honesty;

  • Justice;

  • Verifiable;

  • Clear and easy to understand;

  • May not pretend to be a medicine or aim to prevent a disease.

To fulfill the above criteria, cosmetic claims must pay attention to the following matters:

1. Claim evaluation should be the compliance evaluation of the entire sentence.

2. Claims must be true and can be proven, such as:

  • If cosmetics claim to contain certain ingredients, the ingredients must be included in the formula;

  • The ingredient efficacy claims are supported by scientific references or on the basis of use that has been passed down from generation to generation;

  • Cosmetics claims must be proven by relevant data within the scope of cosmetics or supported by testing using a currently valid and ethical methodology. E.g., dermatologically tested, dermatologist tested, hypoallergenic, and clinically tested.

3. Claims must be objective, not derogatory to the company, organization, industry, or competitor's products.

4. Claims must not promise immediate efficacies if:

  • The product must be used regularly and continuously;

  • A series of products must be used to achieve efficacy.

5. Claims must not use sentences that aim to treat, pretend to be a medicine, or aim to prevent a disease or contain medical terms. E.g. gingivitis (inflammation of the gums), halitosis.

6. Claims must not include statements issued by a particular organization or institution unless accompanied by justifiable evidence. E.g., cruelty-free and organic.

7. Claims must not use exaggerated words such as "safe" without being accompanied by objective, adequate and reliable evidence.

8. Claims do not describe or give the impression of any advice, recommendations, or information about the use of cosmetics from a laboratory, research institute, government agency, health/beauty professional organization or health personnel.

9. Claims do not contain name, logo/symbol or identity from ministries, institutions, laboratories or agencies that conduct analysis or issue cosmetic certificates.

10. Claims must not use exaggerated words such as "harmless," "no side effects," "potent," or words/sentences with the same meaning.

11. Claims must not use superlative words such as "most," "number one," "top," or words starting with "ter," or words/sentences that have the same meaning unless accompanied by verifiable evidence.

12. Claims must not use words "100%," "pure," "original," or words with the same meaning unless accompanied by a reliable explanation, in which case the product is the only one.

13. Claims must not use words "only" or words with the same meaning unless accompanied by verfiable evidence.

14. Claims must not include a statement that does not contain ingredients allowed in cosmetics, except for ingredients related to culture, religion and fragrance which are proven to cause allergies. E.g., Free of alcohol, free of ammonia, free of soap, free of detergents, and free of fragrances.

15. Claims must not include a statement that it does not contain prohibited ingredients in cosmetics.

16. Claims must not contain usage methods outside the cosmetic definitions.

Here are some examples of permitted and prohibited claims:

1) Permitted Claims

No.

Cosmetic Types

Permitted Claims

1

Creams, emulsions, lotions, gels, and oils for skin (hands, face, feet, etc.)

  • Cleanse and keep baby's skin in good condition

  • Reduce sweat odor on feet

  • Cool the skin

2

Face masks (with the exception of chemical peeling products)

  • Smooth the skin

  • Remove dead skin cells

  • Brighten face

3

Tinted bases (liquids, pastes, powders)

  • Cover blemishes on the face

  • Coat facial skin so that make-up is easily applied and removed

  • Cover/disguise fine wrinkles

  • ...

4

Make-up powders, after-bath powder, hygienic powders, etc.

  • Brighten skin tone

  • Absorb sweat

  • Provide a cool sensation on the skin

5

Toilet soaps, deodorant soaps, etc.

  • Cleanse the body

  • Refresh the body

6

Perfumes, toilet waters, and eau de cologne

  • Give fragrance and freshness to the body

2) Prohibited Claims

1. Relieve irritation/redness due to prickly heat

2. Prevent prickly heat

3. Reduce itching due to mosquito bites

4. Treat diaper rash

5. Free from rashes and irritation

6. Eliminate nail fungus

7. Anti-fungal

8. Do not cause skin allergies and irritation

9. Anti-irritation

10. Minimize skin irritation

9 Advertisement

In Indonesia Cosmetics can be advertised after obtaining an approval of notification. Notification number holders are responsible for the compliance of advertisements. The advertisements must be:

  • Objective, namely providing information in accordance with the existing reality and must not deviate from the nature of the efficacy, usage, and safety of cosmetics;

  • Not misleading, namely providing honest, accurate, and responsible information, and not taking advantage of public concerns;

  • Does not pretend to be a medicine or aim to prevent a disease.

Click here to see more requirements for advertisements.

Part 3 HALAL Cosmetic

Indonesia is the fourth biggest country in the world with about 260 million people, of whom more than 86% are Islamic, meaning HALAL products are extremely important. For the same kind of products, Muslim consumers will give priority to products with halal certification labels.

To give consumers a guarantee of whether products are halal, on Oct. 17, 2014, Indonesia issued Law Number 33 Year 2014 concerning Halal Product Assurance (HPA Law), which was effective on Oct. 17, 2019. Article 4 of the HPA Law stipulated that all halal products which are imported, distributed and traded in Indonesia or services related to cosmetics, foods, beverages, medicines, chemical products, biologic products and genetically modified products must be certified halal from Oct. 17, 2019. Halal-certified products must label “Halal” on the outer packaging, or non-halal information for which is not certified as halal, indicating that it is a non-halal product.

1 Competent Authorities

1.1 MUI and LPPOM MUI

MUI (Majelis Ulama Indonesia) is the authoritative and credible Islamic organization in Indonesia. Before the establishment of BPJPH, MUI served as the only halal certifier and has been controlling the entire halal certification process for over 2 decades.

Under the MUI, there set an LPPOM MUI (Institute for Food and Drug Assessment of Indonesian Council of Ulama), responsible for halal certification examination for cosmetics, food and medicines before the establishment of BPJPH.

Under the HPA Law, MUI will be responsible for issuing the Halal Fatwa after holding the Halal Fatwa Assembly, which guarantees that the products are in accordance with the Islamic Syariat and also the basis for obtaining BPJPH endorsed halal certification.

1.2 BPJPH

BPJPH (Badan Penanggulangan Jaminan Produk Halal) was newly founded in 2017 to gradually take charge of halal certification. It took over the mandate previously held by MUI’s Food, Drug and Cosmetics Assessment Body (LPPOM MUI) on Oct 17, 2019. MUI need to cooperate with BPJPH, but the responsibility division between them was unclear in the past several years.

The Omnibus Law implemented on Nov. 2, 2020, partially resolves this ambiguity. MUI is authorized for the product halal status determination through a Halal Fatwa. BPJPH will coordinate with MUI about the product halal status determination.

2 Halal Certification Procedures

2.1 Former Procedures

Previously if enterprises wanted to obtain a halal certificate, they can apply to LPPOM MUI voluntarily after all the dossiers are ready. After LPPOM MUI conducts a formal audit, it will submit the results to MUI. If MUI approves the application, a halal certificate will be issued. The entire process takes an average of 75 days. But the timeline does not include the document preparation before the submission and it will be longer under certain conditions, we expect it to take an average of 6 months.

2.2 Current Procedures

After the implementation of HPA Law and the Omnibus Law, the halal certification procedures are divided into the following steps.

1) Business operators apply for halal certification to the BPJPH in written. The BPJPH must confirm the application documents’ completeness within 1 working day after submission.

2) BPJPH appointed an LPH to perform examination and/or testing of the product halal status based on the application of the business operator. The appointment of an LPH should be performed within 1 working day after receiving the halal certification application.

3) LPH appointed halal auditors to conduct the product halalness examination. Halal auditors should check and examine the halal status of the product within 15 working days. LPH is allowed to submit a written proposal to BPJPH for extra examination time.

Product halalness examination is performed on business location during the production process. In case during the product examination there is an ingredient in which the halalness is doubtful, testing in a laboratory shall be conducted.

4) Halal auditors submit the product halalness examination results to LPH. LPH submit the results to MUI with a copy sent to BPJPH.

If the examination results fail to meet BPJPH standards, BPJPH shall convey the consideration to MUI.

5) Determination of Product Halalness is conducted by MUI and performed in Halal Fatwa Assembly. Halal Fatwa Assembly should decide the product halalness with 3 working days after the MUI receives the examination results.

Decree of the Determination of Halal Product (Halal Fatwa) is submitted by MUI to BPJPH as the basis for issuing the Halal Certificate.

6) In case the Halal Fatwa Assembly determined the Product being applied for by the Business Operator as halal, BPJPH shall issue the Halal Certificate within 1 working day.

In case the Halal Fatwa Assembly determined the Product not halal, BPJPH returns the Halal Certificate application to the Business Operator along with the reason within 1 working day.

1e1a38fe-332f-4412-a5f3-2252fce9d01b.pngDesigned by ChemLinked

2.3 What Business Operators need to do

If you want to obtain a halal certificate for your product, you should fulfill the following approval requirements:

1. Understanding halal certification requirements and following Halal Assurance System (HAS) Training

Companies must understand the halal certification requirements listed in HAS 23000. In addition, the company must also attend HAS training, either in the form of regular training or online training (e-training).

2. Implementing Halal Assurance System

Companies must implement HAS before applying and registering for halal certification process. The Halal assurance system is based on halal policies, establishing Halal Management Team, preparing HAS Manual, conducting training, preparing related HAS procedures, implementing internal audit, and reviewing management properly.

3. Preparing Halal Certification Document

The Company must prepare all necessary documents for the halal certification process. The documents required include: a list of products, a list of materials and documents of the material, a list of butchers (particularly for Slaughterhouse), matrix of products, HAS Manual, flow chart of the process, a list of production facilities addresses, evidence on halal policy dissemination, evidence on internal training and evidence on internal audit.

4. Registering the halal certificate (upload data)

Applying and Registering for halal certification is performed online.

5. Monitoring pre-audit and payment of contract for halal certification process

After uploading certification data, the company must conduct a pre audit monitoring and finalize payment of the contract. This pre audit monitoring is recommended to be conducted every day to uncover any discrepancies in the results of pre audit. Payment of contract for certification process is performed by downloading the certification contract, paying the cost of the contract and signing the contract, and then making payments.

6. Performing audit

Audits can be performed if the company has already passed the pre-audit process and the contract has also been approved. Audits are conducted at all facilities related with products to be certified.

7. Performing post-audit monitoring

After uploading the data certification, the company must conduct post-audit monitoring. This post-audit monitoring is recommended to be performed every day to find out any discrepancies in the results of the audit, and if there is any discrepancy, then it must be corrected properly.

8. Receiving halal certificate

Halal certificate is valid for four (4) years.

2.4 For Foreign Companies

Products certified halal by foreign institutions that cooperate with the BPJPH do not need BPJPH halal certification but must still be registered with the BPJPH before they can be distributed in Indonesia. The full list of international partners is forthcoming; however, the following terms have been defined:

  • If the agency is recognized by the BPJPH, foreign businesses can then register with the BPJPH with a list and detailed description of their products along with the Halal certification from the local foreign halal agency (FHA) partner;

Dossiers Necessary
Copy of product’s Foreign Halal Certificate, that has been authorized by Indonesia’s representative in the country of origin
List of products to be imported to Indonesia, completed with the HS code number
Statement letter declaring that submitted documents are true and legal
  • The BPJPH will then issue a registration number that must be placed on all packaging; and

  • The product is then ready to be exported to Indonesia.

3 Business Operators Obligations

1) Business operators that submit application of halal certificate must:

  • provide information that is correct, clear, and truthful;

  • separate the location, place, and equipment for processing, storing, packaging, distributing, selling, and presenting between halal and non-halal Product;

  • have halal supervisor;

  • report change of material composition to BPJPH.

2) Business operators that obtain halal certificate must:

  • attach the halal label on the product that receive halal certificate;

  • maintain the “halalness” of the product that has obtain halal certificate;

  • separate the location, place and equipment for processing, storing, packaging, distributing, selling, and presenting between halal and non-halal product;

  • renew the halal certificate if the validity period of the halal certificate has expired;

  • report change of material composition to BPJPH.

3) Business operators that produce product from material that originate from haram material is excluded from submitting Halal certificate application.

4 Halal Logo

Halal-certified products must label “Halal” on the outer packaging. Business operators that have obtained Halal Certificate must include the Halal Logo on:

  • Product packaging;

  • Specific part of the product;

  • Specific place of the product.

Inclusion of Halal logo must be easy to see and read as well as not easily erase, detach, and damage.

The new format of halal logo is determined by the BPJPH in Regulation 40/2022. The new halal logo has been applied nationally and must be shown on the product packaging as a sign of product halalness from March 1, 2022.

To offer convenience for business operators to cope with the transition, for those who have halal-certificated products in stock that were manufactured and packaged with the former halal logo before the implementation of the new logo, they are still allowed to sell the stock first. After that, they must immediately adjust halal label on their products in accordance with the provisions in Regulation 40/2022.

halal-logo.pngThe former halal logo (left) and the new halal logo (right)

5 Latest Updates

1) Implementation Timeline

Halal Certification became mandatory for enterprises entering Indonesian market on Oct.17, 2019. The head of BPJPH said that the authorities will not require all the products to be halal-certified immediately, but to implement the HPA Law step by step, likely meaning there will be some form of grace period offered. Businesses are able to obtain the halal certification progressively or gradually with the period specified below:

  • Food and beverages: October 17, 2019 – October 17, 2024

  • Food and beverages packaging: depending on the type of food and beverages

  • Traditional medicines and health supplements: October 17, 2021 – October 17, 2026

  • Clothing, headwear and accessories: October 17, 2021 – October 17, 2026

  • Chemical products, cosmetic products, and genetically engineered products: October 17, 2021 – October 17, 2026

  • Risk A class medical devices: October 17, 2021 – October 17, 2026

  • Household appliances, household healthcare supplies, stationery and office equipment, Muslim prayer equipment: October 17, 2021 – October 17, 2026

  • Risk B class medical devices: October 17, 2021 – October 17, 2029

  • Over-the-counter (OTC) drugs and limited OTC drugs: October 17, 2021 – October 17, 2029

  • Risk C class medical devices: October 17, 2021 – October 17, 2034

  • Prescription drugs (except psychotropics): October 17, 2021 – October 17, 2034

  • Services relating to OTC drugs, limited OTC drugs, prescription drugs (except psychotropics), chemical products, cosmetics and genetically engineered products: depending on the type of product

  • Biological products, drug products, medical devices with its materials or production processes not determined as halal yet: according to related laws and regulations

Products that had not had their halal certificates before October 17, 2019 can still be imported and traded in Indonesia according to the periods as stated above. Except for food and beverages, it' s not allowed for businesses to submit their halal certification application before the commencement of the stated periods above.

Halal certificates issued by MUI before HPA Law takes effect are still effective until they expire, but upon expiry renewal submissions would need to be submitted to BPJPH. The renewal of the halal certificate must be applied no later than 3 months before expiry date of the halal certificate.

2) Halal Certification Process Changes Following the Pass of the Omnibus Law

IndonesianOmnibus Law was approved by Indonesian House of Representatives (DPR) and signed by thr President Jokowi on Nov. 2, 2020. It amended 76 existing laws including the HPA Law. The following are the main amendments.

1) Significantly reduce the time required for halal certification

The Omnibus Law set or reduced the time limit for each link of halal certification. The time required from application to certificate issuance has been shortened to around 21 working days.

2) Reduce the burden on enterprises

The biggest challenge of halal certification for micro and small business is the high cost. The Omnibus Law exempts the halal certification fees for micro and small business.

Another notable point among the amendments is that BPJPH can renew the halal certificate directly if the ingredients are not changed. The enterprises do not need to undergo the halal review or examination for certificate renewal.

3) Clarify the responsibility division between BPJPH and MUI

Before the establishment of BPJPH, there was no government agency for halal certification in Indonesia. MUI served as the only halal certifier and has been controlling the entire halal certification process for over 2 decades.

Established in 2017 and officially started operating in 2019, BPJPH took over from MUI as the sole and national halal certification government agency in Indonesia. MUI need to cooperate with BPJPH, but the responsibility division between them was unclear.

The Omnibus Law partially resolves this ambiguity. MUI is authorized for the product halal status determination through a halal fatwa. BPJPH will coordinate with MUI about the product halal status determination.

The details regarding halal supervisors, LPH, halal auditors, the halal certificate renewal process, fees, public involvement and sanctions shall be further regulated in a Government Regulation that is to be issued.

For more information about halal certification, please refer to CL News and related Webinars.

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