Supply Chain Preventive Controls Program - Mycotoxins

Good morning, everyone,
I wanted to share a question with you.

During hazard analysis if an ingredient (e.g. ground pepper used in small amounts in the formulation of a product), is known to be associated with a chemical hazard (mycotoxins) and the supplier does not provide analysis with each delivery what do you do?

Firt af all, Is it a risk to you even if used in small percentages (less than 1% in the recipe)?
If yes, Is it correct from your point of view to manage it by performing sample analyses yourself?

Thank you very much!

Lino
 

Have you asked your manufacturer how they deal with mycotoxins in their HACCP plan?  While black pepper is indeed susceptible to mycotoxins, your supplier may have a kill step applied in their processing to mitigate the risk.  If not, you'll need to run a risk analysis on black pepper as a raw ingredient in your process and determine your product's risk from it.

Hi jfrey a thanks for your reply.
Our supplier is an importer. He states that the manufacturer only does the drying and grinding of black pepper. The manufacturer does not provide COA with each delivery. In hazard analisys we considered pepper as raw material.  Pepper is added to recipes (less than 1%) for sterilized food production. What degree of hazard would you attribute to pepper at the supply stage?

Hi jfrey a thanks for your reply.
Our supplier is an importer. He states that the manufacturer only does the drying and grinding of black pepper. The manufacturer does not provide COA with each delivery. In hazard analisys we considered pepper as raw material.  Pepper is added to recipes (less than 1%) for sterilized food production. What degree of hazard would you attribute to pepper at the supply stage?

Hi Lino,

Nowadays,from a traditional haccp POV, the raw material control step is typically classified as a PRP. (FSMA might be an exception).

But, the intrinsic risk of raw materials could be evaluated through procedures such as illustrated in this BRC-related post -

http://www.ifsqn.com...al/#entry100194

PS - you have posted under "Allergen Management" but the OP seems unrelated ?

Thank you Charles,
always very kind!
What do you mean by "FSMA might be an exception"?
Our product is exported to the USA. Our risk analysis is based on RASFF (EU) and Hazard Analysis and Risk-Based Preventive Controls for Human Food: Draft Guidance for Industry (FDA). For black pepper effectively there is historical criticality for mycotoxin content. My question is to understand if the amount of pepper used in the recipe (final product) warrants a preventive control on purchase.

 

Thank you Charles,
always very kind!
What do you mean by "FSMA might be an exception"?
Our product is exported to the USA. Our risk analysis is based on RASFF (EU) and Hazard Analysis and Risk-Based Preventive Controls for Human Food: Draft Guidance for Industry (FDA). For black pepper effectively there is historical criticality for mycotoxin content. My question is to understand if the amount of pepper used in the recipe (final product) warrants a preventive control on purchase.

 

Hi Lino,

Regret that I am not a user of FSMA/HARPC but I dimly remembered that this methodology elevates relevant "Supply Chain" controls to PC (approx equivalent to CCP) status. So I will happily pass your query on to other (probably US based) members to respond to yr query.

(Offhand I would have thought that the US Regulatory limit would be the defining control characteristic (max 20ppb?) rather than "amount").

I see where you are going with the 1% of the formula argument.   However, that argument doesn't hold water with regulators like the FDA.   You cant dilute an adulterated ingredient or food into compliance.  It does seem to me like it would be difficult to have enough mycotoxin in the raw material to put your final product out of compliance.  

The mycotoxin risk isn't controlled by your supplier or probably even the manufacture.  its most likely further down the supply chain.  

If the spices are treated, the FDA appendix 1 (page 142) doesn't list mycotoxins a hazard for treated spices, only untreated.   I think it is assumed that the risk was already controlled prior to treatment.  

I think your best course of actions is to state that risk is controlled through supply chain PC.    You verify this by reviewing copies of third party audits and testing that you do upon receipt (see the supply chain control section and verification activities).    I think that is your best course of action.    you most likely have a supply chain control for black pepper anyway to control pathogens.   

Hi Kingstudruler 1,

I don't think your company can control the risk.  Obviously you don't want to store it in a manner that it would mold.   How the product was handled from growing to processing is where the risk comes from.

You are managing the risk by purchasing from an approved supplier.   The thought is that if everyone in the supply chain did their part the likelihood for mold growing and mycotoxins production is at an acceptable level.    When a hazard is controlled by supply chain control, you need to have verification procedures that the risk is controlled.  This could be testing by you or the supplier.   See chapter 12 of the PCQI manual (12-10) for all things "supply chain" related.  

  FSPCA PC Course Participant Manual_V1.2_public.pdf (d1vy0qa05cdjr5.cloudfront.net)

I hope this helps.

Thank a lot Kingstudruler1

 

Thank a lot Kingstudruler1

 

 

Might suggest you also have a look around the famous US, ASTA Spice website since this problem must be documented by now.

https://www.astaspice.org/

Thank you Charles,
valuable suggestion!