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On July 25, 2024, Indonesian Trade Minister Zulkifli Hasan, along with the import task force, uncovered a significant illegal import operation involving clothing, toys, and electronics worth more than Rp40 billion. The items were found in a warehouse suspected to be used by foreign nationals for packaging and online sales.Following up on this discovery, on August 6, 2024, Minister Hasan led another inspection at the Cikarang Customs Bonded Warehouse, Bekasi. The task force seized illegal imported goods worth Rp46.18 billion, including used clothing, electronics, textiles, cosmetics, and various types of ready-to-wear garments.In addition to the Ministry of Trade, the Indonesian National Police's Criminal Investigation Unit (Bareskrim) and Customs and Excise also participated in the operation. Bareskrim seized 1,883 bales of used clothing, Tanjung Priok Customs seized 3,044 bales of used clothing, and Cikarang Customs seized various finished products, textiles, cosmetics, footwear, and electronics."From the results of the action, the total estimated value of the goods is IDR 46,188,205,400, all the goods submitted earlier did not meet the import compliance according to applicable laws," said Zulhas at the location, Tuesday (6/8/2024).Minister Hasan emphasized that all seized goods did not comply with import regulations. After providing a briefing, he inspected the seized items, including used clothing and electronics, revealing that many of the used items were actually old, unsold products.The task force has secured the seized goods, which will be destroyed as they do not meet import requirements."As a follow-up to the supervision, the Task Force has secured goods suspected of being illegal goods," he added.Reference:https://finance.detik.com/berita-ekonomi-bisnis/d-7475638/lagi-zulhas-dan-satgas-bongkar-barang-impor-ilegal-rp-46-miliarhttps://www.kemendag.go.id/berita/siaran-pers/mendag-zulkifli-hasan-pimpin-ekspose-penindakan-produk-impor-ilegal-temuan-satgas-senilai-rp4619-miliar

Before the Job Creation Law, businesses in Indonesia were required to register and obtain a Business Registration Certificate (TDP). However, with the implementation of the Job Creation Law, the TDP has been replaced by the Business Identification Number (NIB). What is a NIB?Business Identification Number or NIB is an official identification for Business Actors issued as proof of registration or enrollment to conduct business activities. NIB also serves as a unique identifier for Business Actors in carrying out their business activities. Every Business Actor in Indonesia is required to have one NIB, which is issued by the Online Single Submission (OSS) Institution. The NIB consists of a random number with security features and an electronic signature, making it an official identity for conducting business activities. The issuance of NIB is regulated by Government Regulation of the Republic of Indonesia Number 5 of 2021 concerning the Implementation of Risk-Based Business Licensing.The NIB includes various important information, such as:Business Actor Profile: Basic information about the Business Actor.Business Capital: Details of the capital used in the business.Taxpayer Identification Number (NPWP): Tax identity for the Business Actor.Indonesian Standard Industrial Classification (KBLI) Code: Code indicating the type of business activity.Business Location: Address of the business location.The OSS Institution issues the NIB through the OSS System by considering several factors:Risk Level: Assessing the risks associated with the business field.Examination of Business Field Provisions: Ensuring compliance with applicable regulations.Minimum Investment Provisions: Checking the minimum investment required.Capital Provisions: Assessing the business capital structure.Reference:Government Regulation of the Republic of Indonesia Number 5 of 2021https://peraturan.bpk.go.id/Details/161835/pp-no-5-tahun-2021

A Production Certificate is a primary requirement for manufacturing Medical Devices, In Vitro Diagnostic Medical Devices, and Household Health Supplies (PKRT). According to the Indonesian Ministry of Health Regulation No. 1189/Menkes/Per/VIII/2010 on the production of medical devices and household health supplies, only companies that have a production certificate/standard certificate are allowed to manufacture these products, meaning that production must comply with the Good Manufacturing Practice (GMP) for Medical Devices.The classification of the Production Certificate is based on the results of factory inspections for compliance with the GMP for Medical Devices or PKRT as stipulated by law. Depending on the manufacturing eligibility and the risks posed by the medical devices, production certificates for medical devices are classified into three categories: Class A, B, and C, as follows:Class A Medical Device Production Certificate: Granted to factories that have fully implemented GMP for Medical Devices, allowing them to produce Class I, Class IIa, Class IIb, and Class III medical devices.Class B Medical Device Production Certificate: Granted to factories eligible to produce Class I, Class IIa, and Class IIb medical devices according to GMP for Medical Devices.Class C Medical Device Production Certificate: Granted to factories eligible to produce certain Class I and Class IIa medical devices according to GMP for Medical Devices.Similarly, PKRT production certificates are classified into three categories:Class A PKRT Production Certificate: Granted to factories that have fully implemented GMP for PKRT, allowing them to produce Class I, Class II, and Class III PKRT.Class B PKRT Production Certificate: Granted to factories eligible to produce Class I and Class II PKRT according to GMP for PKRT.Class C PKRT Production Certificate: Granted to factories eligible to produce certain Class I and Class II PKRT according to GMP for PKRT.Reference:Regulation of the Minister of Health Number 1189/MENKES/PER/VIII/2010 of 2010 concerning the Production of Medical Devices and Household Health Supplieshttps://regulasi.bkpk.kemkes.go.id/detail/860cba8b-cb6e-4e5c-bedc-b008737a91a6/unduh/

Substances prohibited from use in cosmetics as stipulated in the Regulation of the Food and Drug Supervisory Agency Number 17 of 2022, concerning Amendments to the Regulation of the Food and Drug Supervisory Agency Number 23 of 2019 regarding Technical Requirements for Cosmetic Ingredients. Here are some examples of ingredients that are not allowed in cosmetics:1. Mercury (Hg)In cosmetic creams, mercury compounds inhibit melanin production, making the skin appear brighter at a relatively low cost. Side effects include allergic dermatitis, skin redness, nail discoloration, and grayish skin.2. HydroquinoneHydroquinone is permitted for use in Indonesia in certain concentrations in medications prescribed by doctors to treat conditions. However, its use is prohibited in cosmetic preparations.  In cosmetics, it can cause irritant dermatitis, ochronosis, nail discoloration, and conjunctival melanosis.3.Tretinoin (Retinoic Acid)Tretinoin is a topical medication often prescribed to treat acne and other skin conditions like psoriasis and photoaging. Its use must be under a doctor's prescription due to potentially serious side effects. Prohibited in cosmetics due to serious side effects like burning, peeling, sun sensitivity, and skin discoloration.4. ResorcinolResorcinol is a chemical used in various industrial and medical applications, including as an antiseptic and disinfectant. In cosmetics, resorcinol is sometimes used to treat acne and psoriasis and as a skin-whitening agent. However, its use in cosmetics is highly restricted due to risks of skin irritation and allergic dermatitis.5. Diethylene Glycol (DEG)DEG is a toxic substance that can be found in cosmetics like toothpaste. DEG is toxic to humans and can cause severe poisoning if absorbed through the skin or accidentally ingested. DEG poisoning can lead to kidney failure, metabolic acidosis, and even death. DEG can also affect the nervous system, causing symptoms such as headaches, fatigue, and coordination disorders.6. Lead (Pb)Lead is a heavy metal often found in lipstick and other cosmetic products. Long-term lead exposure can cause organ damage and is carcinogenic at high doses. The maximum limit in cosmetics is 20 mg/kg according to BPOM regulations. Harmful to fetuses and babies.7. Red Coloring AgentsRed coloring agents CI 15585, Red K.10 (Rhodamine B), and Orange K.1 (CI 12075) are often misused in lipstick or other decorative products (eyeshadow, blush on) due to their bright colors. These coloring agents are synthetic dyes generally used in paper, textile, or ink dyes. These dyes are carcinogenic. High concentrations of Rhodamine B can cause liver damage.For details, check BPOM Regulation Number 17 of 2022 on Annex V regarding the List of Substances Prohibited in Cosmetics: https://jdih.pom.go.id/download/product/1395/17/2022Reference:Learning Module: Smart Choices in Selecting and Using Safe Cosmeticshttps://sikerjaduper.pom.go.id/uploads/modul/handbook_modul_cerdas_memilih_kosmetik_yang_aman.pdf

Certificate of Free Sale, hereinafter abbreviated to CFS, means a certificate issued by the appropriate agency of a country that certifies that the Medical Devices, In Vitro Diagnostic Medical Devices and PKRT have obtained Product License and have been free sale in the country. Based on the Minister of Health Regulation of the Republic of Indonesia Number 62 Year 2017 concerning the Distribution License of Medical Devices, In Vitro Diagnostic Medical Devices, and Household Health Supplies, the requirements for a Certificate of Free Sale are as follows:Trade name/brand name, issued by the authorized entity in the country of originStatement of the registered product typeName and address of the manufacturer in the country of originValidity period as stated on the health certificate/free sale certificate. If not specified in the appointment letter, the validity period shall not exceed 1 year from the date of issuanceCertificate of Free Sale for Domestic Products The Certificate of Free Sale (CFS) for domestic products is a document stating that a domestic Medical Device, In Vitro Diagnostic Medical Device, or Household Health Supplies (PKRT) has obtained market authorization and is freely sold in Indonesia. The application for the Certificate of Free Sale (CFS) for domestic products is submitted by the license holder. The Certificate of Free Sale is valid for 2 (two) years from the date of issuance.Certificate of Free Sale for Imported Products The Certificate of Free Sale (CFS) for imported products is a document stating that an imported Medical Device, In Vitro Diagnostic Medical Device, or Household Health Supplies (PKRT) has obtained market authorization and is freely sold in Indonesia. The application for the Certificate of Free Sale (CFS) for imported products is submitted by the distributor who holds the market authorization. The Certificate of Free Sale is valid for 2 (two) years from the date of issuance.For manufacturers aiming to enter foreign markets, obtaining a CFS is typically obligatory. It assures importing countries that the products meet comparable safety and regulatory standards, facilitating smoother market entry and preventing potential delays and harm to their reputation.Reference:Minister of Health Regulation of the Republic of Indonesia Number 62 Year 2017https://regalkes.kemkes.go.id/informasi_alkes/PMK_No_62.pdfGuidelines for Export and Import Regulations of Medical Devices, In Vitro Diagnostic Medical Devices, and Household Health Supplieshttps://regalkes.kemkes.go.id/informasi_alkes/Pedoman%20Ekspor%20Impor.pdf

Cosmetics distributed in Indonesia must meet the requirements for safety, efficacy, quality, and labeling. Cosmetics that do not meet these requirements must be recalled. Recall is the process or action to withdraw cosmetics that do not meet the requirements from circulation. Every cosmetics industry, cosmetics importer, or individual business/business entity that enters into a production contract is required to recall cosmetics that do not meet the standards and/or requirements.Criteria for Cosmetics that Must be RecalledBased on the Head of the National Agency for Food and Drug Control Regulation Number 11 of 2017 concerning Criteria and Procedures for Cosmetic Product Recall and Destruction, the criteria for cosmetics that must be recalled include:Containing prohibited materialsDoes not meet the requirements for microbial contaminationDoes not meet the requirements for heavy metal contaminationContains materials exceeding the permitted levelsExpiredIncludes labeling that is not objective, misleading and/or contains information as if it were a drug.Implementation of Cosmetic RecallThe recall is carried out by the Notification Number Owner on the orders of the Head of the Agency. The implementation of this recall is carried out based on:Findings from inspection results at production facilities, importers/individual businesses or business entities that have production contracts, and/or distributionSampling and testing resultsTagging evaluation resultsPost Market Alert System (PMAS) receipt resultsProduct Information Document (DIP) audit resultsFollow-up on evaluation results of public complaints/complaintsResults of monitoring side effects of cosmeticsAdditionally, recalls can also be initiated by the Notification Number Holder based on the results of monitoring retained samples and/or internal audits. Recalls are conducted for:The entire batch distributed for cosmetics that contain prohibited substances or display misleading, deceptive, and/or drug-like labeling.One batch before, the non-compliant batch, and one batch after for cosmetics that do not meet pathogenic microbial contamination requirements.Non-compliant batches for cosmetics that exceed the microbial contamination limits of Total Plate Count (TPC) or Yeast Mold Count (YMC), contain substances exceeding permitted levels, or are expired.Reference:BPOM Regulation No. 11 of 2017https://peraturan.bpk.go.id/Details/220305/perka-bpom-no-11-tahun-2017

One of the breakthroughs of BPOM in ensuring the safety, benefits, and quality of traditional medicine products, quasi-medicines, health supplements, and cosmetics in circulation is by utilizing information technology in conducting supervision through the application of 2D Barcodes. This system is a graphical representation of digital data in a two-dimensional format with high decoding capacity which is used for identification, tracking, and tracing. Regulations related to the use of 2D Barcodes are regulated in BPOM Regulation No. 22 of 2022 concerning the Application of 2D Barcodes in Drug and Food Supervision, which is a revision of BPOM Regulation No. 33 of 2018. Based on BPOM Regulation No. 22 of 2022, 2D Barcode uses the main methods, namely the authentication method and the identification method.2D Barcode Authentication, a method to track and verify the legality, batch number, expiration date, and/or serial number of Drug and Food products. The 2D Barcode Authentication generated by the BPOM Track and Trace Application according to the Business Actor's request is in the form of information that can then be converted into a 2D Barcode. The minimum information on the 2D Barcode is as follows:(90)XXXXXXXXXXXX(10)WWWWWW(17)VVVVVV(21)YYYYYYYYYYYY YYYY or(01)XXXXXXXXXXXX(10)WWWWWW(17)VVVVVV(21)YYYYYYYYYYYY YYYY Description:CodeInformationCharacter CountData Format(90)XXXXXXXXXXXX(90) followed by Product Distribution Permit Number. Maximum 16 (alphanumeric)According to product NIE.(10)WWWWWW (10) followed by the batch or lot number.1-20 (alphanumeric)According to the product's bet/lot number(17)VVVVVV (17) followed by the end of the product's expiry date.Maximum 6 (numeric)YYMMDD (Year-Month-Date)(21)YYYYYYYYYYYY YYYY(21) followed by the product serialization number.1-20 (alphanumeric)1) If the 2D Barcode is generated by the POM Agency Track and Trace application: serialization will be generated by the POM Agency application. 2) If the 2D Barcode is generated by the Business Actor independently, then serialization follows the policy set by the Business Actor.01)XXXXXXXXXXXX (01) followed by the international product identity, namely the Global Trade Item Number (GTIN).14 (numeric)Generated by a third party through membership.2D Barcode Identification, a method to verify the legality of Drugs and Food based on Distribution Permits. In the electronic Distribution Permit, a 2D Barcode will be issued consisting of the following information:(90)XXXXXXXXXXXX Description:CodeInformationCharacter CountData Format(90)XXXXXXXXXXXX (90) followed by Product Distribution Permit Number. Maximum 16 (alphanumeric)According to product NIE.The 2D Barcode listed on the packaging must match the 2D Barcode listed on the Distribution Permit electronically and can be scanned using the BPOM Mobile application.Reference:PerBPOM No.22 Tahun 2022https://jdih.pom.go.id/download/product/1423/22/2022

To ensure that cosmetics distributed within Indonesia meet the criteria, business operators must distribute cosmetics that have obtained a distribution permit in the form of a notification. Cosmetics that have been notified will receive a cosmetic notification number, which is indicated on the notification letter. This notification number signifies that the cosmetic product has met the quality, safety, and efficacy requirements set by BPOM. The cosmetic notification number is valid for a period of 3 (three) years.The marking of the cosmetic notification number is done by placing the notification number on the approved cosmetic product. This marking is carried out on the label or packaging of the cosmetic product. The notification number consists of 2 letters and 11 digits, in the format NX12345678901, where:X = A/B/C/D/ECosmetic Kit Notification NumberNotified cosmetic kits will receive a cosmetic kit notification number, which is indicated on the notification letter for combination/kit products. The cosmetic kit notification number consists of 4 letters and 9 digits, in the format NKIT123456789. Cosmetics in Primary Packaging:Consisting of more than 1 (one) cosmetic with the same or different categories and having more than 1 (one) notification number.Consisting of more than 1 (one) cosmetic with different categories where each cosmetic has its own notification number.For primary packaging cosmetic kits, the following must be included:Cosmetic kit notification numberImage and/or description explaining the position of each cosmetic in the kit.Cosmetics in Secondary PackagingConsisting of more than 1 (one) cosmetic with the same or different categories and having more than 1 (one) notification number.For secondary packaging, the cosmetic kit notification number must be included.Reference:PerBPOM No.30 Tahun 2020https://jdih.pom.go.id/download/product/1202/30/2020