product registration indonesia - health supplements

Permissible Contamination Limits in Health Supplement Products in Indonesia

  • InCorp Editorial Team
  • 30 December 2019
  • 3 minute reading time

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.

Pandu Biasramadhan

Senior Consulting Manager at InCorp Indonesia

An expert for more than 10 years, Pandu Biasramadhan, has an extensive background in providing top-quality and comprehensive business solutions for enterprises in Indonesia and managing regional partnership channels across Southeast Asia.

Get in touch with us.

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Disclaimer: The information is provided by PT. Cekindo Business International (“InCorp Indonesia/ we”) for general purpose only and we make no representations or warranties of any kind.

We do not act as an authorized government or non-government provider for official documents and services, which is issued by the Government of the Republic of Indonesia or its appointed officials.

We do not promote any official government document or services of the Government of the Republic of Indonesia, including but not limited to, business identifiers, health and welfare assistance programs and benefits, unclaimed tax rebate, electronic travel visa and authorization, passports in this website.

Frequent Asked Questions

You can transfer the license as long as your current local distributor agrees to change the product license holder. The procedure will be different for each product category. We can only recommend you try to prevent these issues by setting cooperation with a trustworthy partner from the beginning

Before you can distribute your products in Indonesia, you will have to register your product with the BPOM (National Agency of Food and Drugs) and MoH (Ministry of Health). Only an Indonesian legal entity can register the product. If you decide to distribute your product via a local distributor, they will register the product under their entity in Indonesia and become the product license holder. Cekindo can act as your local distributor and register the product under its name.