You are using an outdated browser and your browsing experience will not be optimal. Please update to the latest version of Microsoft Edge, Google Chrome or Mozilla Firefox. Install Microsoft Edge

September 9, 2026

Indonesia’s Updated Regulation on Food Packaging

On June 30, 2026, Indonesia’s National Agency of Drug and Food Control (BPOM) issued BPOM Regulation No. 11 of 2026 on Food Packaging, which expands the list of approved food-contact substances and recognizes a broader range of permissible functions for those substances. The new regulation, which revokes BPOM Regulation No. 20 of 2019, reflects developments in packaging technology and materials science.

Although the new regulation provides more advantages to business actors by adding more food contact substances to the approved list for use in food packaging, there are more stringent rules and restrictions for testing. One of the most significant changes is a comprehensive migration-testing framework that sets out requirements for packaging materials, testing conditions, food simulants, and specific migration limits.

Overall and Specific Migration

Under BPOM Regulation No. 20 of 2019, migration requirements were primarily set out within the lists of approved food-contact substances and packaging materials. BPOM Regulation No. 11 of 2026 instead expressly requires packaging materials that come into direct contact with food to meet both overall and specific migration limits. These are defined as follows:

  • Overall migration: The total quantity of all substances that migrate from the packaging, regardless of whether the substances are hazardous or nonhazardous to health.
  • Specific migration: The quantity of a particular identified substance known to be hazardous to health that migrates from the packaging.

Stricter Limits on Heavy Metals

The overall migration limit for plastic packaging remains unchanged under both regulations at 60 mg/kg or 10 mg/dm². However, the new regulation introduces significant changes to the regulation of heavy metals. Under the 2019 regulation, four heavy metals—lead, cadmium, chromium VI, and mercury—were subject to a single combined limit of 1 mg/kg. The 2026 regulation, however, requires each heavy metal to meet its own individual specific migration limit, adds arsenic as a newly regulated substance, and broadens the scope of chromium testing from chromium VI (Cr(VI)) to total chromium (Cr). The specific migration limits under the 2026 Regulation are set out below:

  • Arsenic (As): Not detected (LOD 0.01 mg/kg)
  • Cadmium (Cd): Not detected (LOD 0.002 mg/kg)
  • Total Chromium (Cr): Not detected (LOD 0.01 mg/kg)
  • Lead (Pb): 0.05 mg/kg
  • Mercury (Hg): Not detected (LOD 0.01 mg/kg)

Updated Rules on Food Simulants

A food simulant is a medium used to mimic the characteristics of a particular food to simulate the migration of components from the food packaging into the food. The 2026 regulation identifies five types of food simulants for use in overall migration testing, as follows:

  • Simulant A: Ethanol 10% (v/v)
  • Simulant B: Acetic acid 3% (w/v)
  • Simulant C: Ethanol 20% (v/v)
  • Simulant D1: Ethanol 50% (v/v)
  • Simulant D2: Vegetable oil containing less than 1% unsaponifiable matter; if food simulant D2 cannot be used, 95% alcohol or isooctane may be used as an alternative food simulant
  • Simulant E: Poly (2,6-diphenyl-p-phenylene oxide), particle size 60–80 mesh, pore size 200 nm

Under the 2019 regulation, simulant D2 was defined as vegetable oil, with no specific compositional requirements. The 2026 regulation narrows this definition and provides an alternative for situations where simulant D2 cannot be used.

New Requirements for Food Product Composition

The 2026 regulation introduces new disclosure requirements for the composition of food products that may come into contact with their packaging material. The name, percentage, and function of each component must be declared, and the sum of all declared percentages must equal 100%.

New Testing Requirements for Reusable Plastic Packaging

The 2026 regulation introduces additional requirements for reusable food packaging. Reusable plastic packaging must meet both the overall and specific migration limits through the testing protocol prescribed in Annex V.

For overall migration, compliance may be demonstrated in a single test. If the first result meets the applicable limit, no further testing is required. If it does not, up to two additional tests are permitted, provided that the results show a decreasing trend, with the second result lower than the first, and the third lower than the second.

Specific migration, by contrast, requires three tests in order to simulate the repeated contact that occurs over the packaging’s service life. Each result must meet the applicable specific migration limit, and the levels must not increase across the cycles; the second result may not exceed the first, and the third may not exceed the second. Compliance depends on these results, as well as on the stability of the packaging material throughout the three testing cycles. A material is considered unstable if detectable migration increases from the first test to the third, even when the migration values remain below the applicable regulatory limit.

Because contact under single-use conditions represents the worst-case scenario for migration, test data generated under those conditions is generally understood to support compliance for repeated-use applications as well.

Transition Period

BPOM Regulation No. 11 of 2026 provides a 12-month transition period from its promulgation date to allow food packaging products already circulating in the market to comply with the new requirements. Food packaging that was already in circulation before the regulation entered into force must be brought into compliance with the new regulation by June 30, 2027.

Business Impact

BPOM Regulation No. 11 of 2026 updates Indonesia’s food packing rules to better respond to developments in food packaging technology and materials science. Food packaging manufacturers, importers, and brand owners in Indonesia should review existing compliance practices and test reports to confirm that packaging intended for direct food contact meets the new overall and specific migration requirements.

RELATED INSIGHTS​ 

September 20, 2023
Thailand is preparing to open its first renewal period for drug marketing authorizations (MAs) since the passage of the Drug Act (No. 6) B.E. 2562 (2019). Before 2019, MAs for pharmaceuticals and vaccines in Thailand had lifelong validity. The 2019 Drug Act stipulated that all new MAs would be valid for seven years and could be renewed. The 2019 law also set out expiration dates for existing pharmaceutical products registered and approved prior to the implementation of the law (i.e., before October 13, 2019): Drug MAs issued before January 1, 1997, expire on October 13, 2024. Drug MAs approved between January 1, 1997, and December 31, 2007, expire on October 13, 2026. Drug MAs approved between January 1, 2008, and October 13, 2019, expire on October 13, 2028. Based on these dates, the first renewal period for drug MAs will commence in the fourth quarter of 2023. To facilitate the renewal process, the Thai Food and Drug Administration (FDA) has publicized draft regulations and notifications on the required application form and documents, the rules and conditions, and the process for renewing an MA. In May 2023, the Thai FDA issued Ministerial Regulation Re: Renewal of Drug MA Licenses B.E. 2566 (2023) to prescribe the essential requirements for filing a renewal application: To renew a drug MA, holders must submit their renewal application to the Thai FDA within the one-year period before the MA’s expiration date. Renewal applications can only be submitted online via the Thai FDA’s electronic system. The Thai FDA will grant approval for an MA renewal if the following conditions are satisfied: The documents in relation to efficacy and safety are up-to-date, accurate, and in accordance with academic principles. The specification and analytical method comply with the official pharmacopeias as prescribed in the Drug Act, as amended.
September 15, 2023
In May 2023, Thailand issued a regulation on conditional approval for emergency use of medicinal products, replacing a series of similar notifications that had been issued to aid mitigation efforts during the COVID-19 pandemic. During the pandemic, regulatory authorities worldwide—including the Thai Food and Drug Administration (FDA)—reshaped the approval pathway for emergency drugs intended for the treatment of COVID-19. The Thai FDA published five Notifications Re: Conditional Approval for the Emergency Use of Medicinal Products to outline the registration requirements and channels of distribution for drugs intended for the diagnosis, treatment, or prevention of COVID-19. As the threat from COVID-19 was receding, the Thai FDA saw fit to prepare for the potential emergence of other serious communicable diseases by enabling the supply of timely medications for disease diagnosis, treatment, and prevention. The Thai FDA therefore cancelled the five COVID-19-related emergency use notifications, which were published in 2020 and 2022, and replaced them with the Notification Re: Conditional Approval for Emergency Use of Medicinal Products published in May 2023. Under the May 2023 FDA notification on emergency use, conditional approval can be applied to drugs supported by empirical scientific evidence demonstrating their capacity to diagnose, treat, alleviate, cure, or prevent a serious communicable disease. The drugs eligible for approval under this new emergency pathway include novel drugs that are not yet approved in Thailand, as well as existing drugs approved in Thailand but recently discovered to have additional potential indications for the diagnosis, treatment, alleviation, cure, or prevention of a serious communicable disease. Distribution The 2023 FDA notification also clearly defines permissible distribution channels based on the dosage form of drug products: Vaccines can be distributed to governmental organizations that have a duty to prevent or treat diseases, such as the Thai Red Cross Society (TRCS), the Government Pharmaceutical Organization
September 7, 2023
Thailand is a member state of the ASEAN Economic Community, and next year, it is expected that the ASEAN Harmonization of Traditional Medicines and Health Supplements will be signed by the economic minister of each ASEAN country. Following ratification, the ASEAN Guidelines on Claims and Claims Substantiation for Traditional Medicines and Health Supplements will become the standard guidelines in the region, and various implementation efforts and instruments will follow. These guidelines cover a wide range of medicines and supplements; however, it is not possible to cover all herbal products. There are three types of health supplement claims: nutritional claims, functional claims, and disease risk reduction claims. Examples of the three types of claims include the following: Nutritional claims: supplements nutrition, nourishes the body, supports healthy growth and development, etc. Functional claims: maintains healthy joints, supports immunity, maintains liver function, etc. Disease risk reduction claims: helps to reduce risk of dyslipidemia, helps to reduce risk of osteoporosis, etc. The degree of evidence required for substantiating disease risk reduction claims is higher than for functional claims and nutritional claims. Functional claims and disease risk reduction claims must be substantiated by efficacy studies and the relevant toxicity data. It is the responsibility of the health supplement company to provide the required evidence in order to comply with the criteria for making such claims. Tips on Health Claims for Health Supplements 1. Nutritional Claims For essential nutrients such as vitamins and minerals, as listed by the Thai Food and Drug Administration (FDA), the amount included in a supplement must be between 15% and 100% of the Thai Recommended Daily Intake (RDI) values. Rules for specific kinds of nutritional claims are provided in the Notification of the Thai FDA RE: Nutrient Function Claims. For example, the nutrients that can be claimed as boosting the
August 29, 2023
Laos’ Ministry of Health (MOH) has promulgated a regulation detailing registration and notification protocols for medical devices. Decision on the Registration and Notification of Medical Devices No. 1470/MOH will come into force 60 days after both the signing of the regulation (which already occurred in July) and publication in the Official Gazette, which has not yet been specified by the government. Registration of medical devices in Laos is mentioned in the country’s Law on Drugs and Medical Products No. 07/NA, dated December 21, 2011, but a registration procedure has not been put in place. There was only a separate requirement to furnish certain required documents when importing medical devices. Now, the decision outlines the registration and notification process for medical devices through the Ministry of Health’s Food and Drug Department (FDD), in line with the regulatory principles in the ASEAN Medical Device Directive of 2015, which Laos has ratified. Medical Devices in Laos The decision defines medical devices as any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material, or other similar or related article intended for any of the following uses in humans: Diagnosis, prevention, monitoring, recovery from, or alleviation or treatment of a disease; Diagnosis, monitoring, recovery from, or alleviation of or compensation for an injury; Replacement, modification, or support of anatomy or a physiological process; Supporting and sustaining life; Controlling or assisting in conception; or Disinfection and sterilization of tools and medical devices. Medical devices in Laos are given one of four classifications based on their level of risk: Class A – Low risk (e.g., rubber belts, cotton for medical purposes, nonwoven swabs, adhesive bandages) Class B – Low-moderate risk (e.g., neonatal suction equipment, surgical gloves, gastro-catheters) Class C – Moderate-high risk (e.g., endoscopic surgical equipment, anesthesia equipment, peritoneal dialysis equipment) Class