How to Set Microbial Limits in Food Supplements

[Jack G]

Hi Everyone,

I hope you are all well.

I am new to the forum and really hope that I am posting this in the correct area.

I have recently started in a Quality role in the UK for a company that sources and purchases raw materials (food supplements) as well as finished products from around the world (mostly China) to sell to customers. I am basically responsible for most of the Quality even though I have little experience!

My main concern is the contamination limits that we should be requesting on the product specifications and subsequent CoAs. I have already read into heavy metals and have the limits. However, I am really struggling to find the microbiological limits for food supplements. I can only seem to locate limits for meats and eggs etc. So my question is, how do I know which tests should be on the product spec/CoA (total bacterial, total yeast & mould etc.) as well as their limits (cfu/g, Negative/Positive)?

Any help would be hugely appreciated, thank you!

TLDR: How can I locate the microbial limits and requirements for food supplements in the UK/EU.

 

[Jack G]

I am still seeking some advice. Anyone?

 

[Rincewind]

Hello,

I am not a food guy but I assume you checked this document:
Commission Regulation (EC) No 2073/2005 of 15 November 2005 on microbiological criteria for foodstuffs
already?

According to the following paper (2015):
Microbiological quality of food supplements
[...] There are currently no normative documents specifying microbiological contamination limits for dietary supplements. [...]

 

[Jack G]

Hello,

I am not a food guy but I assume you checked this document:
Commission Regulation (EC) No 2073/2005 of 15 November 2005 on microbiological criteria for foodstuffs
already?

According to the following paper (2015):
Microbiologiacl quality of food supplements
[...] There are currently no normative documents specifying microbiological contamination limits for dietary supplements. [...]

Thank you for your reply.

Yes, I have read the EC No 2073/2005 which as you can see, doesn't really touch on supplements.

However, I have just been reading the European Pharmacopoeia 5.1.4 which has the limits for Non-sterile pharma substances. It appears that people use this as a guideline (the last point in the table).

Also, for botanicals, I have been advised to follow 5.1.8 which gives limits for Herbal medicinal products.

As you state, it doesn't appear that there are any regulations in place for food supplements. Hopefully that will change with time.

 

[jmreeves]

Hi Jack,

While i can't speak specifically to the UK, i believe my knowledge to be accurate and apply to your case.

You are correct that their is no "black and white" guidelines for microbials in dietary supplements. You will run into issues with safety and the FD&C however if you have pathogens in the product. It all comes down to safety.

So I typically focus on defining limits of zero for pathogens(E.coli/salmonella etc). For total aerobic mesophilic microorganisms it really just depends on what you want to set as long as it is safe. I have some limits at 100,000 cfu/g on certain raw materials and typically stay under 2000 cfu/g for finished products.