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Probiotics Registration

Requirements for probiotics product registration as a health supplement (NPRA) and for probiotics in food

PROBIOTIC STRAIN NAME

It is mandatory to declare the probiotic species name and strain for probiotic product registration under NPRA.

Here is an example of probiotic strain declaration:

 

Bifidobacterium bifidum AB123​

AB123 is the strain name.​

The COA of ingredient must include the probiotic strain name.

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ANTIBIOTIC RESISTANCE DATA

For products containing probiotics, the product holder is required to provide strain specific antibiotic resistance data for each probiotic strain. The data must state the value and be not more than the limit set by EFSA (click on the button below to know EFSA's limits)

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CFU COUNT - LABEL CLAIM

You have to provide CFU count data to the Authority for approval. After approval, you may declare the CFU count on your product label. Please send an enquiry to learn more on CFU count data approval.

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PROBIOTIC STRAIN LIST FOR FOOD

This is the list of probiotic strains allowed in food. This list is part of the food regulations of Malaysia.

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