This framework introduces a number of new requirements for halal slaughterhouses (Rumah Potong Hewan ? ?RPH?), mandating specific timeframes for stunning, slaughtering and hot-water dipping. The Decree goes on to set out a number of tiered certification requirements for compliance personnel based on their business sizes and also allows for automated machine slaughtering, compelling RPH operators to significantly overhaul their processing lines and logistics in order to maintain market access.
This Regulation introduces a more comprehensive food packaging framework that establishes certain specific requirements that will now apply to reusable and recycled food packaging. The new framework also addresses enhanced migration testing and safety assessments, as well as a 12-month transition period. In addition, the new Regulation strengthens technical standards through a set of updated heavy metal migration limits, revised testing protocols and clearer restrictions on food contact substances.
This Regulation introduces a unified Restructuring program for the agro-industry sector that expands eligible industries and maintains reimbursement incentives for machinery and/or equipment purchases. Applicants must complete mandatory INDI 4.0 self-assessments through the SIINas system, while companies that have secured TKDN and/or green industry certification will receive priority treatment, with reimbursements of up to 35% available for machinery with TKDN levels of at least 25%. The new Regulation also standardizes the minimum purchase threshold at Rp. 300 million and requires KBLI updates to be introduced through the OSS system.
This new framework represents a paradigm shift in the classification of hospitals, specifically a move from bed-count quotas to service capability tiers (i.e. comprehensive, main, middle and basic tiers). This Regulation also significantly relaxes foreign investment barriers by allowing for the creation of 50-bed facilities, provided that they offer comprehensive-tier services, while tightening overall enforcement through new fines and accreditation sanctions. A two-year transition period can also be used by existing hospitals in order to bring their operations and compliance structures into line with the new framework.
This Regulation introduces a mandatory nutri-level labeling system for ready-to-drink beverages, powder drinks, and liquid or solid concentrates based on their sugar, salt (in the form of sodium) and fat content, to be displayed alongside the Nutritional Value Information (Informasi Nilai Gizi ? ?ING?) table and fully implemented by June 2028. This Regulation also revises ING requirements, including mandatory disclosure of total sugar and updated exemption categories. Additionally, micro-scale enterprises may use BPOM standards or ingredient-based calculations to determine nutritional values.
If ultimately enforced, then this Draft Regulation will introduce a unified recall and destruction framework for natural medicines, quasi-drugs, health supplements and cosmetics, while expanding oversight to advertisements and certain raw materials. The framework also broadens the various obligations of distribution permit holders and Special Access Scheme (SAS) importers, establishes new recall classifications and reporting timelines, mandates electronic reporting and mandates the imposition of harmonized administrative sanctions for non-compliance, which include suspensions of business activities and the revocation of distribution permits.
If it is ultimately enforced, then this new Draft Regulation will update the various import supervision requirements that apply to food and drug products by revising territorial coverage, reducing the shelf-life threshold for biological products from nine to seven months and tightening application procedures for Import Certificates (Surat Keterangan Impor/SKI). This Draft Regulation also introduces a number of additional documentation requirements that will specifically apply to imports of drug and cosmetic products, while also expanding the available administrative sanctions to electronic access restrictions that will apply to all products that are registered by non-compliant applicants.
The Halal Product Assurance Organizing Agency (Badan Penyelenggara Jaminan Produk Halal - ?BPJPH?) has introduced a stringent administrative sanctions framework for violations within the halal ecosystem. This new regulation enforces strict penalties, including product recalls, fines, and certificate revocations, for non-compliant business actors, halal inspection agencies, and auditors. Companies must immediately ensure absolute compliance with halal separation and reporting mandates to avoid operational suspensions or mandatory market withdrawals.
If it is ultimately enforced, then this new Draft Regulation will strengthen the processed food manufacturing compliance framework by expanding Risk Management Program (Program Manajemen Risiko/PMR) obligations, enhancing oversight through foreign facility inspections and imposing stricter licensing remediation requirements. The Draft Regulation also introduces phased compliance pathways for micro- and small-scale enterprises, while expanding administrative sanctions for non-compliance, which will now include permit suspensions and a three-year prohibition on future permit applications.
This new Regulation represents a comprehensive reform of Indonesia?s health supplies framework through the consolidation and replacement of a number of previous Regulations under a single unified regime. This new framework will now affect pharmaceutical wholesalers, manufacturers, importers, healthcare service facilities, pharmacies and retailers. The new unified regime expands pharmaceutical distribution and dispensing mechanisms through broader retail access for certain products and enhanced real-time monitoring obligations through the National Health Information System (SIKN). In addition, the new framework also strengthens domestic sourcing priorities, revises pharmaceutical pricing controls and imposes stricter administrative sanctions.