Indonesia BPOM approval is a mandatory regulatory requirement for introducing new food ingredients, innovative food additives, alternative proteins, functional ingredients, or novel processing technologies into the Indonesian market. According to the Indonesian Food and Drug Authority (BPOM), any ingredient not listed in the national positive lists or technical regulations requires a rigorous scientific assessment before importation, commercialization, or use in finished food products.
REACH24H provides comprehensive regulatory compliance services to help global food ingredient manufacturers, additive suppliers, brand owners, importers, and distributors navigate the BPOM assessment process and secure approval for new food ingredients in Indonesia efficiently.
Understanding Indonesia’s Regulatory Framework for New Food Ingredients
Indonesia is one of the largest food consumer markets in Southeast Asia, with growing demand for healthier, innovative, and functional food products. Increasing public health concerns, particularly related to obesity, diabetes, hypertension, and other non-communicable diseases, are also driving consumer interest toward healthier and more sustainable food choices, including plant-based products, functional ingredients, alternative proteins, and other innovative food technologies.
As food innovation continues to grow, companies introducing new food ingredients and food additives into Indonesia must navigate the country's regulatory framework and scientific assessment requirements. Unlike some jurisdictions, Indonesia does not yet have a single dedicated regulation specifically governing "novel food." Instead, regulatory oversight is embedded within the broader processed food regulatory framework administered by the National Agency of Drug and Food Control (BPOM).
Within BPOM, the Directorate of Standardization of Processed Food plays a central role in the scientific assessment and evaluation of innovative processed food products. In practice, "novel food" in Indonesia generally refers to food ingredients or additives that have not yet been approved by BPOM for use in food products. The outcome of this process is not a distribution permit for a finished product, but rather BPOM approval confirming that the ingredient or additive has been scientifically evaluated and accepted for use in food products in Indonesia in accordance with the applicable regulatory provisions.
What Is Considered a “New” Food Ingredient or Additive in Indonesia?
One of the key initial steps before introducing a food ingredient or food additive into Indonesia is determining whether the substance is considered "new" under the Indonesian regulatory framework.
Generally, an ingredient or additive may be considered "new" if:
It is not listed in existing Indonesian positive lists or technical regulations;
It has not previously been approved by BPOM;
It was previously used in Indonesia but still requires a new assessment if it is proposed for a different food category from what was previously accepted;
It involves new technologies or innovative production processes;
It originates from unconventional sources;
It introduces new functional or technological purposes in food applications.
For example, under the annexes of BPOM Regulation No. 11 of 2019 on Food Additives, only approved food additives listed in the positive lists may be used in food products. The regulation also stipulates that additives outside the approved lists require prior approval from BPOM through a scientific assessment process.
Based on the regulatory framework and approach, the assessment of whether an ingredient is considered "new" is generally conducted on a case-by-case basis. Therefore, preliminary regulatory assessment and consultation with BPOM are highly recommended before commercialization or importation activities.
New Food Ingredient Approval vs. Finished Product Registration in Indonesia
One common misunderstanding is treating new ingredient approval and finished food product registration as the same process. While they are related, they are not identical.
A BPOM approval or assessment outcome for a new food ingredient or additive does not automatically replace finished product registration. Finished products containing the approved ingredient may still be subject to applicable Indonesian requirements for processed food registration, labeling, claims, import, and distribution before commercialization.
A new food ingredient approval is a prior regulatory step, particularly required when the ingredient has not been previously used or approved for use in food products in Indonesia. This process serves as a scientific and regulatory evaluation of the ingredient itself before it can be used as part of finished product registration.
Related REACH24H Service: Indonesian Food Import Regulation: Professional Registration & Labeling Compliance
BPOM Approval Requirements
Once an ingredient or additive has been determined to be "new," companies are required to prepare supporting documentation for scientific assessment and regulatory review by BPOM. The evaluation is conducted based on the dossier requirements specified by BPOM. In general, the assessment focuses on the following key areas:
Identity of the ingredient or additive
Composition and specifications
Manufacturing process of the new food ingredient/additive and the product
Intended use and applicable food categories
Proposed usage levels
Dietary exposure considerations
Safety evaluation and toxicological information
Supporting scientific evidence
International approval or regulatory status
The approval serves as BPOM's authorization for the use of the ingredient or additive in processed food products intended for commercial distribution in Indonesia. The approved assessment results are also generally published on the official Standardization of Processed Food website managed by the Directorate of Standardization of Processed Food.
BPOM Submission Process for New Food Ingredients and Additives
The typical timeline for a new food ingredient or additive approval is 4 to 5 months after the dossier is confirmed complete. The standard regulatory workflow includes:
Regulatory Assessment & Strategy: Preliminary assessment to determine whether ingredient or additive may categorized as a "new" materials, BPOM consultation and confirmation, determination of the applicable regulatory pathways and relevant requirements.
Dossier Preparation & Gap Analysis: Compilation and review of available dossier, gap analysis and confirmation of BPOM data expectations, translationn and finalization of administrative and technical documents for BPOM assessment.
e-Standar Pangan Account Preparation: Submission of administrative document for e-Standar Pangan account activation.
Online Submission via e-Standar Pangan: Submission of the dossier through BPOM's e-Standar Pangan platform.
BPOM Review & Clarification Process: BPOM evaluation process takes up to 85 working days after the dossier has been verified and declared complete. Clarification or additional information may be requested during the review process.
Approval Outcome & Market Entry Planning: Utilize the BPOM approval to support finished product registration, importer coordination, label review, and Indonesia market entry planning.
REACH24H Indonesia New Food Ingredient Registration Services
REACH24H provides comprehensive support to navigate the complex regulatory landscape for new food ingredients and additives in Indonesia. Our expert services are designed to ensure compliance and expedite market entry.
Regulatory Assessment & Gap Analysis
Preliminary assessment of whether an ingredient or additive may be considered "new" in Indonesia
Review of regulatory applicability and compliance pathways
Gap analysis of available technical and safety data
Regulatory Strategy Consultation
Regulatory pathway determination for new food ingredients and additives
Consultation on applicable BPOM requirements and scientific assessment approach
Support for regulatory planning before commercialization or importation
Dossier Preparation & Submission Support
Assistance in preparation of administrative and technical documents
Dossier review and compilation
Support for BPOM online submission process (e-Standarpangan)
Regulatory Liaison & Follow-Up with BPOM
Regulatory updates and compliance monitoring
Frequently Asked Questions (FAQ)
A: Yes. Even if an ingredient has already been commercialized or approved overseas, it may still be considered "new" in Indonesia if it has not previously been used in Indonesia and has not yet been evaluated by BPOM.
A: No. The approval process for a new ingredient or additive is separate from finished product registration. The outcome of the submission is BPOM authorization for the use of the ingredient or additive in processed food applications. Finished food products using the approved ingredient may still require separate product registration before commercialization.
A: In practice, the submission process generally requires involvement of a local representative or Indonesian entity for administrative and regulatory purposes. Therefore, overseas companies commonly work together with local importers, distributors, or appointed representatives during the submission and evaluation process.
A: BPOM generally accepts regulatory references or international approvals issued by recognized countries or international organizations, such as the United States, European Union, Australia/New Zealand, Japan, ASEAN countries, Codex Alimentarius, and other internationally recognized authorities. For instance, EU Novel Food (NF) approval or US FDA New Dietary Ingredient (NDI) notification may serve as supporting references where the intended food application is comparable. The references should be relevant to the same food application or food category proposed in Indonesia and should clearly demonstrate that the ingredient or additive is permitted or evaluated for the intended use. Supporting documents are generally expected to be official regulations, standards, or regulatory publications in English or accompanied by an English translation.
Overseas companies do not have a local representative in Indonesia;
Difficulties for ingredient manufacturers in completing the "food application data" section;
Insufficient safety or toxicological data;
Limited history of use in food products; and
Regulatory uncertainty for novel ingredients or new product categories that are not yet clearly covered under existing Indonesian regulations.
Therefore, early regulatory assessment and proper dossier preparation are highly recommended to minimize delays and potential rejection during the evaluation process.
A: Yes. The assessment results are published through BPOM's processed food standardization platform. These published results generally include information such as:
The name and type of ingredient or additive;
Approved food categories; and
Applicable usage limitations or maximum levels.
A: In practice, other companies may refer to these published assessment results for similar food applications without submitting a completely new assessment. However, if the intended food category or application is different from the approved scope, a separate submission and evaluation may still be required.
Start Your Indonesia Food Ingredient Compliance Assessment
Before launching a new food ingredient, additive, processing aid, microbial ingredient, or functional food component in Indonesia, companies should confirm whether a BPOM assessment is required and whether the existing data package is sufficient.
REACH24H can help you:
✓Determine whether your ingredient requires BPOM approval;
✓Identify the correct regulatory pathway;
✓Review your existing dossier;
✓Prepare the submission package;
✓Coordinate with local partners;
✓Respond to BPOM questions;
✓Plan finished product registration and market entry.
