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Coffee in Hazard Anlaysis

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Posted 10 March 2023 - 12:55 PM

The FDA guidance for Potential Hazards lists coffee and has a chemical hazard of mytotoxins. We don't get a COA from the vendor, but I do have a COI & LOG. Can I do a risk analysis to justify use? How is everyone handling this?




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Posted 10 March 2023 - 02:45 PM

If you're not getting a COA from the vendor, I would say the safest thing to do is test for mycotoxins yourself, either with an in-house lab and a validated method or contracting out to an external lab. I'm not sure a LOG would be enough. 21 CFR 117 Subpart G will tell you everything required for supply-chain applied controls. Section 117.430 states that you need to audit the facility (either you or a third party) before using raw materials from the vendor to ensure that the hazard is being controlled. Hope this helps.


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Posted 10 March 2023 - 03:35 PM

Depending on the type of mycotoxin, you can either get mildly ill or die (or anything in between) if you ingest them.


A letter of guarantee is merely a promise to deliver product that is in compliance with the law, but the number of RASFF alerts proves a promise alone isn't enough. You need evidence. What is on the COI?


I would test the coffee myself and follow the European legislation so you can sell internationally without additional work (What requirements must coffee comply with to be allowed on the European market? | CBI)


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Posted 15 March 2023 - 10:01 PM

Here is a great article you should read regarding mycotoxins.




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Posted 16 March 2023 - 04:32 PM

Does the vendor's product spec address mycotixins?  Would your vendor push back against providing a COA showing tests for mycotoxins?  I think testing after receiving is a workable solution for your program, but if a load tests at an unacceptable level you're going to be potentially stuck without usable product to run in production, and you'll have to argue with the supplier to get a credit, just becomes a big mess.  But if they're providing the COA upfront, your raw material testing then becomes just a periodic check for supplier quality.

Sayed M Naim Khalid

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Posted 16 March 2023 - 04:57 PM

Reputable vendor or certified vendor may reduce the burden for your business.


However, mycotoxin are produced when coffee or any food product is not kept in dry place. So even if you have a certificate from a reputable vendor but during transport or within your facility humidity is not controlled, you will have mycotoxin. 


If you have inhouse technical capacity to quantify mycotoxin, it is a good idea. But I would recommend sending it to a lab so they can help you. I would also consider the most stringent standards because your product would be safe and you can do business in different places. 


Just to detect mycotoxin is easy but you will have in a lot of food products. Thus, mere detection might not be enough. 


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Posted 17 March 2023 - 01:13 AM

is your question regarding preventive controls or FSVP. 



Either way in general I wouldn't trust a COA, LOG, etc.   Test yourself (its not too expensive) or third party lab.   or both with some frequency.     


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