The nutraceutical market in Indonesia is expanding, with projections indicating significant growth over the next few years. This growth is fuelled by rising consumer interest in health and wellness products. The shift in consumer behaviour has created significant opportunities for both local and international players in the nutraceutical industry. In this blog, we attempt to provide overview of the regulatory requirements for the registration of nutraceuticals in Indonesia.
Regulatory Agency for Neutraceuticals in Indonesia
Indonesia's regulations on nutraceuticals are primarily governed by the National Agency of Drug and Food Control (NADFC), also known as Badan Pengawas Obat dan Makanan (BPOM),was officially established on January 31, 2001. It was created as an independent agency under the President's direct supervision to manage and regulate drugs, food, cosmetics, and medical devices.
NADFC Laws and Regulations for Nutraceuticals in Indonesia
Law No. 18 of 2012 on Food: This law serves as the overarching legal framework for all food products, including nutraceuticals and functional foods. It mandates that all food products, including supplements with nutritional or health claims, must meet the safety, quality, and labeling requirements before being marketed in Indonesia.
BPOM Regulation No. 27 of 2017 on Food Supplements: This regulation specifically governs the registration, safety, labeling, and advertising of food supplements, including nutraceuticals.
BPOM Regulation No. 31 of 2018 on Processed Food Labeling: This regulation governs the labeling of all processed foods, including nutraceuticals.
BPOM Regulation No. 12 of 2020 on Processed Food Registration: This regulation sets out the specific requirements for the registration of processed foods, including nutraceuticals.
BPOM Regulation No. 31 of 2022 on Health Supplements: This regulation provides a comprehensive framework for the regulation of health supplements, including nutraceuticals.
Minister of Health Regulation No. 86 of 2019 on Importation of Drugs and Food Products: This regulation provides the legal basis for the importation of drugs and food products, including nutraceuticals.
NADFC Requirement of Local Representative for Nutraceuticals in Indonesia
The foreign companies are required to authorise a local representative for their neutraceutical products in Indonesia. The local representative serves as the liaison between the foreign company and the Indonesian National Agency of Drug and Food Control (BPOM) to ensure compliance with the country’s regulations. The key requirements of a local representative are -
Must be a legally registered entity in Indonesia. They can be a locally incorporated company or a subsidiary or authorized distributor of the foreign nutraceutical manufacturer.
Must have an import license or be authorized to register and distribute nutraceutical products on behalf of the foreign manufacturer.
The local representative must be registered with BPOM and authorized to submit product dossiers for approval.
The local representative acts as the legal applicant for the registration of nutraceutical products with BPOM.
NADFC Categorization of Nutraceuticals in Indonesia
In accordance with NADFC regulations, nutraceuticals may fall under the purview of various regulations and may fall into any of the categories. Proper classification is essential for determining the regulatory pathway, documentation, and requirements for the product. Teh categories include including:
Food Supplements: Products containing concentrated nutrients (e.g., vitamins, minerals, amino acids, herbal extracts) and meant to supplement the diet are governed under BPOM’s food supplement regulations, including BPOM Regulation No. 27 of 2017 on Food Supplements.
Functional Foods: Foods that offer health benefits beyond basic nutrition due to the presence of biologically active compounds, such as probiotics, prebiotics, or other bioactive components are regulated under BPOM Decree No. HK.00.05.52.0685 on Functional Foods).
Traditional Medicines: Products made from natural ingredients (usually derived from plants, animals, or minerals) based on traditional practices and knowledge are governed by BPOM’s regulations on traditional medicines.
Fortified Foods: Foods enriched with additional nutrients, such as vitamins, minerals, or other beneficial compounds, to enhance nutritional value must comply with both food safety and labeling regulations.
Novel Foods: Foods or food ingredients that have not been traditionally consumed in Indonesia or that contain new bioactive ingredients with potential health benefits and are governed under BPOM's guidelines on novel ingredients.
Health Supplements: Products containing one or more ingredients such as vitamins, minerals, amino acids, enzymes, or botanicals intended to support health and wellness fall under purview of BPOM Regulation No. 31 of 2022 on Health Supplements which provides specific guidelines for the registration, safety, and labeling of these products.
NADFC Registration Process for Nutraceuticals in Indonesia
Before a nutraceutical can be marketed in Indonesia, it must be registered with BPOM. This process includes the submission of a detailed product dossier containing all required documentation on safety, quality, efficacy, and labeling.
Classify the product (nutraceutical, functional food, traditional medicine).
Ensure ingredient and GMP compliance.
Prepare the dossier with all necessary documentation.
Submit the dossier to BPOM using the digital platform and pay the registration fees.
BPOM evaluates the product’s safety, efficacy, and quality.
Laboratory testing may be required to verify safety and composition.
Receive approval and a registration number from BPOM.
Post-market surveillance ensures continued compliance and safety.
Renew the registration before it expires.
NADFC Dossier Submission Requirements for Nutraceuticals in Indonesia
The dossier submitted to BPOM must include the following:
Product Composition
Full disclosure of the product’s ingredients, including active ingredients, additives, and excipients.
Quantity of each ingredient per dosage or serving.
Source of ingredients, especially for products containing herbal or natural substances.
Manufacturing Information
Details of the manufacturing process, including GMP (Good Manufacturing Practices) certification.
Location and accreditation of the manufacturing site (both domestic and international).
Quality control measures taken during production to ensure product consistency and safety.
Scientific Evidence of Efficacy and Safety
For health claims: Evidence supporting any claims made about the product’s benefits (clinical trials, scientific literature, or traditional use evidence).
For novel ingredients: Toxicological and safety data for ingredients that are not commonly used in the Indonesian market.
Stability and Shelf Life: Stability studies showing that the product remains safe and effective over its intended shelf life, including testing under various storage conditions.
NAFDC Labeling Requirements for Nutraceuticals in Indonesia
The label must include the following:
Product name and category.
List of ingredients and their amounts.
Instructions for use, including dosage, warnings, and contraindications.
Expiry date and storage conditions.
Manufacturer’s and distributor’s name and address.
Health claims must be scientifically validated and approved by BPOM. Misleading or unsubstantiated claims are prohibited.
Additional Information on Labeling: Halal labels, alcohol content, and information on the origin of certain ingredients must be mentioned on the label.
NAFDC Language Requirements of Nutraceuticals in Indonesia
Indonesian Language: All labels and promotional materials must be in the Indonesian language (Bahasa Indonesia). This includes product names, ingredients, usage instructions, health claims, and warnings.
Additional Languages: While the primary requirement is for Indonesian, additional languages can be included on the packaging, provided they do not replace or obscure the Indonesian information.
Certification of Nutraceuticals in Indonesia
Product Testing: Products may be required to undergo laboratory testing for safety and quality, including testing for contaminants (e.g., heavy metals, microbial content) and compliance with labeling claims (e.g., nutrient content). BPOM may require a Certificate of Analysis (CoA) for each batch of the product.
Import Regulations for Foreign Nutraceuticals
Import License: Foreign nutraceuticals must be registered by an authorized importer holding a valid BPOM import license.
Documentation from the Country of Origin: Foreign manufacturers must provide certificates or documentation from regulatory authorities in their country of origin to confirm the product’s approval for sale there.
Customs Clearance: Imported products are subject to customs clearance and inspection, including product testing to ensure they meet Indonesian standards.
Validity and Renewal of Nutracetical Registrations in Indonesia
Nutraceutical registrations are valid for a period of five years. Renewal applications must be submitted before the registration expires. Renewal requires an updated dossier with any new data on safety, efficacy, and stability, along with post-market surveillance data.
NAFDC Post-Market Obligations for Nutraceuticals in Indonesia
The manufacturer or local representative is responsible for monitoring the product once it is on the market. Any adverse effects or quality issues must be reported to BPOM. Random inspections or testing of the product may be conducted by BPOM to ensure compliance with regulations. The local representative must ensure that the product remains safe and compliant during its lifecycle.
License Transfer for Nutraceuticals in Indonesia
NAFDC allows transfer of Nutraceutical license. A formal request for the transfer of the license must be submitted to BPOM. BPOM will review the request to ensure the new license holder meets all regulatory requirements.
Legal Documentation:
Ownership Transfer Agreements: Both parties (the original and new license holders) need to provide legal documentation that confirms the transfer agreement. This may include contracts, acquisition agreements, or other legal proof of the change in ownership or responsibility.
Notarized Documents: Key documents related to the transfer must often be notarized, especially if the license holder is a foreign entity working with a local partner.
Product Re-registration (if required):
In some cases, the transfer of the license may trigger the need for product re-registration under the new license holder’s name, especially if there are changes in branding, packaging, or formulation. This would involve re-submitting product documentation and going through the approval process again.
Key Regulatory Considerations for Registering Nutraceutcials in Indonesia
Health Claims: Any health benefits claimed by a nutraceutical must be backed by substantial scientific evidence, and the product label must accurately reflect the approved claims.
Novel Ingredients: For new or unfamiliar ingredients, additional safety and efficacy data are required, including toxicology studies.
Harmonization with ASEAN Guidelines: Indonesia is aligning its nutraceutical regulations with ASEAN standards, making it easier to trade nutraceutical products within the region.
Key Challenges in launching Nutraceuticals in the Indonesian Market
Regulatory Compliance With Strict BPOM Regulations: All nutraceuticals must undergo rigorous registration and approval processes by the National Agency of Drug and Food Control (BPOM), which can be time-consuming and require significant documentation.
Local Partnerships and Distribution: Foreign companies need a local partner or entity to import and distribute products in Indonesia. Establishing reliable partnerships with local distributors can be challenging due to unfamiliarity with the market.
Complex Distribution Networks: Indonesia is an archipelago with thousands of islands, making logistics and distribution complex and costly, especially to reach remote areas.
Consumer Awareness and Education - Low Health Literacy in Some Segments: Although urban populations are increasingly health-conscious, many consumers in rural areas may lack awareness of nutraceutical benefits or have limited understanding of product differences.
Frequent Regulatory Updates: The regulatory environment in Indonesia is evolving, which means companies must stay updated with changes to ensure ongoing compliance.
Indonesia's nutraceutical regulations, overseen by the National Agency of Drug and Food Control (BPOM), provide a comprehensive framework to ensure the safety, efficacy, and quality of products in this growing category. The regulations reflect the country's commitment to aligning with international standards, particularly ASEAN guidelines, while addressing the unique needs of the Indonesian market.
Navigating the complex landscape of infant food regulations requires expert guidance and comprehensive understanding. Ensure your products meet the highest safety and quality standards with Atrixio's specialized regulatory consultation services. Contact Artixio today at info@artixio.com for expert consultation services.
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