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

On June 17, 2026, Indonesia’s National Agency of Drug and Food Control (BPOM) issued BPOM Regulation No. 10 of 2026 on Nutritional Information on Processed Food Labels. The new regulation, which revokes three previous nutrition labeling regulations, introduces several notable changes affecting food and beverage manufacturers, importers, and distributors. These changes range from updated nutrient reference values and serving-size requirements to the introduction of the Nutri-Level front-of-pack labeling system for certain beverage products. Businesses operating in Indonesia should carefully review these developments and assess their products’ compliance with the new requirements during the transition period. Implementation of the Nutri-Level Labeling System To implement the recently issued decree on Nutri-Level labeling, BPOM Regulation No. 10 of 2026 stipulates the requirements to implement the Nutri-Level labeling system on the front-of-pack. Under the new framework, ready-to-drink beverages, powdered beverages, and liquid or solid concentrates are required to display Nutri-Level labeling on the front label of their packaging. The Nutri-Level labeling system classifies products into color-coded levels A through D based on their sugar, sodium, and total fat content. The applicable Nutri-Level is determined based on the lowest level measured in the assessment of sugar, sodium, and total fat content. For products classified as level C or D, the Nutri-Level label must be accompanied by information on the relevant sugar, sodium, and total fat content per 100 ml of the ready-to-consume product. Products classified as level A or B may either display only the Nutri-Level designation or display the Nutri-Level together with the relevant nutritional information per 100 ml. Minimum Vitamin and Mineral Content Required for Declaration BPOM Regulation No. 10 of 2026 introduces a stricter threshold for the declaration of vitamins and minerals in the nutritional value information section (ING). Vitamins or minerals may only be declared if they are present at a

The Indonesian Food and Drug Administration (BPOM) has introduced more stringent oversight of health supplements containing probiotics with new guidelines that require clinical trials for certain products and expanded documentation standards. BPOM Regulation No. 17 of 2025 replaces the previous 2021 regulation and establishes a comprehensive framework for evaluating probiotic strains used in health supplements. Assessment Requirements The new regulation expands the scope of assessment to include not only categorization and documentation but also technical procedures, strain classification, and clinical trial requirements. Unlike the previous regulation, which provided general guidance, the updated framework creates a comprehensive system for evaluating both registered probiotic strains and new or combined strains. Manufacturers must now submit supporting documentation covering strain identification and functional characterization, safety, efficacy, and product quality. The previous regulation required documentation only on safety, efficacy, and quality. Clinical Trials One of the most significant changes is the requirement for clinical trials conducted in Indonesia for applications that include benefit claims other than maintaining digestive health, or where there are modifications to benefit claims. The regulation specifies that phase 1 trials must demonstrate safety, while phase 2 trials must validate efficacy using statistically valid methods such as double-blind, randomized, placebo-controlled studies). In addition, phase 3 and phase 4 trials may be required, and postmarket surveillance data must be submitted. Technical Assessment Framework Annex 4, a newly introduced section, establishes technical procedures for assessing health supplements containing probiotics in Indonesia. This comprehensive framework outlines criteria for evaluating new probiotic strains, including strain identification, functional characterization, safety, efficacy, and product quality. The annex introduces a clear classification of claims for health supplement products containing probiotics: General claims(e.g., maintaining digestive health). Functional claims(e.g., normal biological function or activity in the body). Risk reduction claims(e.g., lowering disease risk). The regulation restricts use of the term

On October 28, 2024, Indonesia officially amended its existing Patent Law when the president ratified Law Number 65 of 2024. This comprehensive update—the third such amendment in the history of Indonesia’s Patent Law—introduces several key changes that will significantly impact patent protection and application processes in Indonesia. Key highlights and changes are outlined below. Definition of Invention The new law broadens the definition of “invention” to explicitly include systems, methods, and uses. Additionally, the law introduces formal definitions for traditional knowledge and genetic resources. Patentability Criteria Notable changes include: Computer programs are now excluded, with an exception for computer-implemented inventions. Theories and methods in science and mathematics are added to the list of excluded inventions. Previous restrictions on new uses of existing products are removed. Grace Periods The grace periods for some patent-related actions have been adjusted: The grace period for disclosures has been extended to 12 months (from 6 months previously), providing inventors with more flexibility in filing patent applications after initial disclosure. A newly introduced item is the grace period for a conventional patent application claiming priority rights, which is 4 months after the 12-month filing deadline under the Paris Convention. The grace period for annuity payments is 6 months (from 12 months previously) with a fine for late payments of 100% of the annual fee payable. Patent Holder Rights and Obligations Patent holders can now grant permissions to enforce patents. There is a new requirement for patent holders to submit annual statements on patent implementation in Indonesia. Compulsory Licensing Significant changes to compulsory licensing include: Establishment of licenses based on the principle of expediency. Limitations on license scope and transferability. Prioritization of domestic market needs. New provisions for technical improvements and economic significance. Government Patent Exploitation The new law contains specific provisions for the government’s implementation