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Indonesia Cosmetic Regulation

  •   18 Sep 2017
  •    Jo Zhou
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     Indonesia Cosmetics Regulation

    Overarching Regulation
    Regulation Concerning Cosmetic Notification
    Competent Authority
    BADAN POM
    Main Supporting Rules 
    Sep 13 2017Guidelines for Product Information File
    Jan 1 2011Criteria and Procedure for Submission of Cosmetics Notification 
    Dec 29 2015Technical Requirement of Cosmetic
    Aug 22 2019Technical Requirement of Cosmetic Ingredients

    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.

    Contents

    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 Categories and Types of Cosmetics Allowed for Production by Manufacturers with Class B Production Licenses2012-01-05
    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
    ImportationRegulation Concerning Importer Identification Number2018-07-20
    Regulation for Supervision on the Entry of Drug and Food into the Territory of Indonesia2017-12-21
    Regulation for Supervision on the Entry of Drug and Food Ingredients into the Territory of Indonesia2017-12-21
    NotificationRegulation Concerning Cosmetic Notification2011-01-01
    Criteria and Procedure for Submission of Cosmetics Notification 2011-01-01
    Amendments to Criteria and Procedure for Submission of Cosmetics Notification 2013-06-05
    Criteria and Procedure for Submission of Cosmetics Notification (Draft)Draft
    PIFGuidelines for Product Information File2017-09-13
    AdvertisementTechnical Guidelines for Cosmetics Advertising2016-02-05
    Amendments to Technical Guidelines for Cosmetics Advertising2016-08-04
    IngredientsTechnical Requirements for Cosmetic Ingredients 20192019-08-22
    Limitations for Contamination in Cosmetics2019-07-04
    Cosmetic Analysis Methods2011-09-21
    Post-market surveillanceCriteria and Procedure of Recall and Destruction of Cosmetics2017-06-20
    Regulation for Cosmetics Adverse Reaction Monitoring2019-09-06
    Label/claimTechnical Requirements for Cosmetics 2015 2015-12-29
    Technical Requirements for Cosmetics Labeling (Draft)Draft
    OthersRegulation for Electronic Business Licensing of Drug and Food2018-08-23

     

    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 Institute for Food and Drug Assessment of Indonesian Council of Ulama (LPPOM MUI) 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 mouth mucous membranes, primarily to cleanse, 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 following kinds of cosmetics without conditions, and prohibit manufacturing 1) children cosmetics; 2) cosmetics contain antiseptic, anti-dandruff, skin lightening and sunscreen ingredients.

    No.Cosmetic FormCosmetic Types
    1LiquidEau de Cologne
    Body mist
    Hair Oil
    Facial skin cleanser
    Facial skin freshener
    astringent
    Skin freshener
    2Viscous liquidBath soap
    Bath oil
    Foot care
    Shampoo
    Hair conditioner
    Hair oil
    Hair and body wash
    Facial skin cleanser
    Scrub
    Oil for massage (Massage oil) including spices
    Skin care for body and hands
    3CreamScrub
    Massage cream
    Hair creambath
    4Half SolidPomade
    5SolidBath soap
    bath salt
    Other bath preparations (spices)
    Scrub
    Mangir
    Cool powder
    6PowderBath powder
    Scrub
    Mangir
    Body powder
    Deodorant-antiperspirant
    7SuspensionScrub
    Powder (Liquid powder)
    Mangir

    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 dossiers required are as follows:

    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

    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 or they are for maket test with an aim of business development or investment.

    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 Post Border

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