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Indonesian Regulatory Consulting for the Nutrition Industry
Artixio provides personalised consulting services to help companies grow their business in Indonesia’s food industry, combining global reach with local experience.
Artixio - Key Regulatory Partner for Nutritional Success in Indonesia
In Indonesia, the National Agency of Drug and Food Control (NADFC), also known as Badan Pengawas Obat dan Makanan (BPOM), or the Indonesian FDA, is a government agency is responsible for the supervision of therapeutic products, narcotics, psychotropic and additive substances, traditional medicines, cosmetics, health supplements, and food safety.
Health supplements are regulated by the National Agency of Food and Drug Control (BPOM). Only registered Indonesian entities are permitted to import and distribute supplements in accordance with Indonesia’s health supplement regulations. Before products may be sold in Indonesia, they must pass BPOM’s certification procedure.
In Indonesia, registering for food supplements can be done online or offline. In order to make sure the products meet all safety and standard distribution standards, this procedure involves inspections.
According to NADFC rules, nutraceuticals can be classified into any of the following categories and be subject to a number of different regulations. Determining the regulatory procedure, documentation, and requirements for the product depends on its proper classification. Among the categories are the following:
Food Supplements
Functional Foods
Traditional Medicines
Fortified Foods
Novel Foods
Health Supplements
For the food supplement registration services to be completed successfully in Indonesia, it is advisable to hire a professional. Artixio can help to simplify the process and ensure adherence to Indonesia’s complicated regulatory requirements and documentation procedures.
Halal Certification – Companies have to establish and maintain a Halal Assurance System and get a Product Halal Consistency Certificate in order to ensure ongoing compliance. This certification will be granted by the Halal Product Assurance System (SJPH) through a series of evaluations conducted every four years. The certification is a strong social and economic force in Indonesia, where the great majority of people practise Islam. It also acts as a branding tool.
Artixio Services for the Nutrition Market of Indonesia
- Product Classification
- Formula Review/Ingredients Assessment
- Label and Claims Review
- Dossier Compilation and Gap Analysis
- Submission of Dossier to the Health Authority.
- Legal Representation (LR).
- Translation Support.
- Regulatory Intelligence (RI) Report.
- Post Approval Life Cycle Management.
Why Artixio
Excellent health authority relationships – with BPOM.
Proven track record- Successful Approvals for 100+ Nutritional Products.
End to end Regulatory consultation from concept to commercialization.
Expert Regulatory team with 25+ years of expertise across all food categories in Indonesia.
Economical and structured approach.
FAQs
1. Can Artixio assist with navigating Indonesia’s Halal certification process for nutrition products?
For many nutrition products in Indonesia, Halal certification is required, and Artixio can navigate that journey with you! This involves collaborating with the Indonesian Ulema Council (MUI) for certification and taking steps to ensure that your product adheres to halal standards, from sourcing raw materials to the manufacturing process.
2. How can I make sure my dietary supplement conforms with Indonesia's laws on contaminants (such as pesticides and heavy metals)?
Regarding the permissible quantities of contaminants in food and nutrition products, Indonesia has stringent laws. BPOM sets these criteria, which include levels for microbiological contamination, pesticide residues, and heavy metals (such as lead and mercury). Companies must demonstrate that their product satisfies these requirements in order to comply, usually by laboratory testing and a Certificate of Analysis (COA).
3. How does Indonesia regulate the use of new ingredients in food supplements?
The safety of novel or otherwise uncommonly used ingredients in food supplements must be assessed by BPOM. Companies must submit extensive documentation on the ingredient’s safety profile, including clinical trials, toxicological studies, or other relevant research. Before authorising the ingredient’s usage in food supplements, BPOM will determine if it is safe for human consumption. Artixio can guide in preparing the required documentation and ensuring that the ingredient meets BPOM’s safety standards.
4. Are food supplements required to undergo clinical trials in Indonesia?
Not all food supplement products need to undergo clinical trials, but those that fall under the specified categories of BPOM and conditions are required to do so. Artixio can guide you on the necessity of clinical trials and offer assistance in trial design if applicable.
Regulatory Expertise Across
Multiple Countries
India
Vietnam
Mexico
Vietnam
United States
Brazil
Europe
Malaysia
Taiwan
China
Thailand
Philippines
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