Home Blog Permissible Contamination Limits in Health Supplement Products in Indonesia Product Registration Permissible Contamination Limits in Health Supplement Products in Indonesia InCorp Editorial Team 20 May 2025 3 minutes reading time Table of Contents Permissible Contamination Limits in Health Supplement Products in Indonesia Consultation and Product Registration in Indonesia through Cekindo Health supplement products are among the products that can be distributed and sold in Indonesia. Prior to distributing and selling the health supplements, they need to go through the product registration process and you need to get yourself familiar with the latest product registration regulations in Indonesia, such as the permissible contamination limits. In the process of product manufacturing, there will always be a possibility to have a contamination in the product. The contamination can come from raw material, during process, during bulk handling process, etc. With regard to the fact that the contamination can cause health issue to humans in the continual consumption of the product especially for health supplement, Indonesia FDA (BPOM) regulates the limits of contamination in the health supplement products to avoid health issues during product consumption. Permissible Contamination Limits in Health Supplement Products in Indonesia For products that contain Blue-Green Alga (BGS) and Aphanizomenon flos-aquae (AFA), there is a contaminant called toxin Cyanobacterial Microcystin-LR (MC-LR). Toxin Cyanobacterial Microcystin-LR (MC-LR is one of the secondary products of cyanobacteria metabolism and most harmful cyanotoxins found in water bodies). Studies have shown that MC-LR negatively affects various human organs when exposed to it. The limit for this contaminant is 0,02 μg MC-LR/kg body weight/day. For products that are derived from bees and their derivatives, they have to be free from chloramphenicol. As we know, chloramphenicol is the antibiotic that has a similar structure to antimicrobial substance in the bee-related products and its derivatives. Careless use of antibiotic can cause resistance to human body. On the other hand, during the manufacturing process, there are also possibilities to have microbial and heavy metal contaminants in the finish product. Regarding this matter, the limitation is as follows: Supplements containing herbal Microbiology: 2×104 CFU/ml, do not contain Eschericia Coli and Staphylococcu aureus per gram, and do not contain Salmonella species per 10 gram Heavy metals : Arsenic : 5 mg/kg Cadminum : 0,3 mg/kg Lead : 10 mg/kg Mercury : 0,5 mg/kg Supplements containing no herbal Microbiology: 2×102 CFU/ml and do not contain Eschericia Coli per gram With the implementation of the latest regulation, BPOM is improving the quality for marketed products in Indonesia, with expectation that products marketed in Indonesia will be less harmful and have fewer side effects, and at the same time can improve the quality of life of the society. Consultation and Product Registration in Indonesia through Cekindo Needless to say, paying attention to the safety of each health supplement product that is distributed and sold across the regions in Indonesia is extremely important. As such, as previously mentioned, you need to understand the latest regulations of health supplement products before going through the product registration process in Indonesia. If you are not sure whether you have the most updated regulations in hand, our team of experts would be happy to provide complimentary advisory. Moreover, Cekindo also provides a suite of services related to health supplement products in Indonesia, such as product registration, import license and Halal certification. Get in touch with us by filling in the form below. Read Full Bio Verified by Daris Salam COO Indonesia at InCorp Indonesia With more than 10 years of expertise in accounting and finance, Daris Salam dedicates his knowledge to consistently improving the performance of InCorp Indonesia and maintaining clients and partnerships. Frequently Asked Questions What requirements are needed if my Indonesian company registers the product? Register the product with BPOM (National Agency of Food and Drugs) and MoH (Ministry of Health). The type of testing and document requirements depend on the type of product you want to register. Also, the time frame for registration could vary between 3 to 15 months. If my company is Halal certified for Europe or Malaysia, does it mean it is also Halal certified for Indonesia? The Indonesian Halal bodies recognize some of the international halal certifications. Nevertheless, since there might be differences in the standards used by each certification body, it is still necessary to process Halal Certification in Indonesia. Can you provide pricing examples for the product registration services?v To provide you with accurate pricing information for our product registration services, we consider the complexities of your inquiries and the dynamic nature of regulations in Indonesia. As a result, the pricing for the service may vary accordingly. For detailed information, please get in touch with our consultants. Is halal registration required for all products in Indonesia? Under the latest regulations on Halal Product Assurance, the mandatory requirement for halal certification has been expanded to encompass a wide range of consumer products in Indonesia. This change, which was previously voluntary, now dictates that various items must obtain halal certification. Initially, the certification focus has been on food and beverage products, with the deadline for compliance set for October 17, 2024 Get in touch with us. 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