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.
Get in touch with us by filling in the form below.