Indonesia Cosmetics Regulation

General provisions stipulate definition of cosmetics as products that treat the outer part of the human body or teeth and oral mucosa for cleansing, changing appearance and/or to deodorize body odor, for protection and care of the human body in good condition.

Cosmetic products are classified into two main categories. First categories are those that are controlled, namely products intended for babies, around eyes and other mucosa or oral cavity with ingredients within designated limits of the certifications and usage of ingredients with unknown functional safety benefits. Second category are all those that are not listed under the first category.

Requirements for Manufacturers

Manufacturers are categorized: under license, under contract and imported cosmetics. Manufacturing to be in accordance with Good Manufacturing Practices must have manufacturing/circulation permit from the Food and Drug Supervisory Agency.  Industries complying with methods on how to produce good cosmetics shall be given a certificate by Head of POM who has a lot of discretionary powers.

Registered distribution permits are only issued by FDA to manufacturers with valid industrial business permits and appointed authorized marketing and/or the corporate head offices. Applications for rights to distribute products are to be in writing to the FDA by completing registration form using the established electronic registration system. Evaluations are in two stages, a pre-evaluation on completion of registration questionnaire, legality documentations and the formal evaluation on documents and its complementary information.

Evaluation of distribution permits examines data and/or information relating to quality, safety and product benefits. An evaluation committee under the National Evaluation Committee headed by the FDA shall be evaluating the permits and its applicability of its applicant. Once approved, the permits are valid for five years. In the event of products failing to comply with their applicable quality, safety, benefits set forth in Article 15; permits shall be immediately withdrawn and sanction imposed as set forth in accordance to Article 38.

Ingredients

Ingredients can either be classified as natural or synthetic. The ingredients used for the manufacturing and/or distributed cosmetics products must comply with the usage conditions, quality standard, and other necessary conditions required. All ingredients shall comply with the quality standards set forth under Article 2 Indonesian Cosmetics Codex and other applicable standards. Ingredients that are not listed under Appendixes would need the approval from FDA. Ingredients which have controlled limits and conditions need to be in accordance with those specified in Appendix 1; dyes in Appendix 2, preservatives listed in Appendix 3 and UV protectors in Appendix 9. Prohibited ingredients are listed in Appendix 5.

Packaging, Wrapping, Labeling and Advertising

Packaging is in direct contact of products and wrapping are secondary packaging. Certification translates to adequate information on its defined benefit, safety, methods of use, and other information contained in the label and/or brochure or other forms affixed to the cosmetics products.

Cosmetic packaging and wrapping must be able to protect its content from external impact, guarantee quality and its originality content. Packaging and wrapping are to comply with standards of safety for its intended users and made with non-hazardous materials which may endanger human lives. Packaging and wrapping certifications are to be obtained and approved by FDA based on comprehensive data with non-misleading information and in accordance with the registration data.

Labelling and statements on products much be clearly readable with information on usage and other applicable information pertaining to the cosmetics product. Such information must be in the Indonesian language. Mandatory labeling information for products is:

  • Name of product;
  • Name and address of manufacturer or importer/distributor;
  • Size, content or net weight;
  • Composition and names of materials according to the Indonesian Cosmetics Codex or other applicable nomenclatures;
  • Number of circulation permit;
  • Batch number/code of production:
  • Use and methods of use, except for products which methods of use are   understandable;
  • Month and year of expiration for products with stability period of less than 30 months;
  • Other certifications related to safety and/or quality.

For smaller packaging or wrapping, the above context can appear on hangtag or brochure attached to the cosmetics products.

Advertising of a cosmetics product cannot be made prior to approval of distribution permit. In accordance to Article 30, the advertising objective must be non-misleading and in accordance with the approved registered data.

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