10 replies to this topic

[AurW]

hi all, 

 

we are a manufacturer of food ingredient, mainly for food supplement (mineral blending on carrier - all powders)

we've made a blend a tested it and it was found OOS for lead 4.1ppm, limit max 3ppm. the product is OOS and non-conformance has been raised. investigation has been started and it's not an issue with the testing, the blend is OOS. we think we know where it might have come from so this will not happen (hopefully) in the future.

I had in my head that I wasn't allowed to mix unsafe & safe products together to make a safe product, here mixing in the same quantity a batch with has 1 ppm of lead with a batch witch has 4ppm of lead, the blend will have 2.5ppm of lead on average. I've tried to look into ISO22000 and pre-requisite program for food manufacturing and cannot find anything.

I then thought it was in (EC) No 178/2002 but no.

Did I invent my rule or is it somewhere? if so, please guide me to the text - I used to work in pharmaceutical maybe it comes from there?

thank you for your help.

 

Aurélie 

[SQFconsultant]

I am not aware of any regulation that allows tainted and "safe" to be mixed to produce "safe."

Edited by SQFconsultant, 28 September 2020 - 01:37 PM.

[olenazh]

ISO 22000:2018 doesn't contain any requirements regarding that. However, using common sense it's obvious that a manufacturer is responsible for products they are producing in terms of safety, quality and legality - and how can you be sure you're producing safe product if part of this product is not safe?

[AurW]

Thank you Glenn for your swift response, that's what I thought too but i can't find anything that confirm or infirm this.

ISO22000 section 8.9.4 Handling of potentially unsafe products just specifies that unsafe products shall be controlled and that product can be reprocessed if needed (8.9.4.3). PRP section 14 rework states that control shall be in place when doing a rework but no mention of what not to do. 

the more i think about it, the more I feel that you cannot mix unsafe and safe to make a safe products (even if I can't find any docs or regs that says so): if my issue was with micro contamination, i wouldn't have thought twice about it and destroyed the lot. the type of hazards should not affect the decision on what to do.

will go with my gut on this and will destroy the OOS product.

thanks again

 

Aurélie 

[pHruit]

hi all, 

 

we are a manufacturer of food ingredient, mainly for food supplement (mineral blending on carrier - all powders)

we've made a blend a tested it and it was found OOS for lead 4.1ppm, limit max 3ppm. the product is OOS and non-conformance has been raised. investigation has been started and it's not an issue with the testing, the blend is OOS. we think we know where it might have come from so this will not happen (hopefully) in the future.

I had in my head that I wasn't allowed to mix unsafe & safe products together to make a safe product, here mixing in the same quantity a batch with has 1 ppm of lead with a batch witch has 4ppm of lead, the blend will have 2.5ppm of lead on average. I've tried to look into ISO22000 and pre-requisite program for food manufacturing and cannot find anything.

I then thought it was in (EC) No 178/2002 but no.

Did I invent my rule or is it somewhere? if so, please guide me to the text - I used to work in pharmaceutical maybe it comes from there?

thank you for your help.

 

Aurélie 

If the Pb limit is one defined under Regulation (EC) 1881/2006 then the rule you are looking for is Article 3(2) of that regulation: Foodstuffs complying with the maximum levels set out in the Annex shall not be mixed with foodstuffs which exceed these maximum levels.

[Slab]

Adding for US Food Code:

 

Sec. 117.110 Defect action levels.

(a) The manufacturer, processor, packer, and holder of food must at all times utilize quality control operations that reduce natural or unavoidable defects to the lowest level currently feasible.

(b) The mixing of a food containing defects at levels that render that food adulterated with another lot of food is not permitted and renders the final food adulterated, regardless of the defect level of the final food. For examples of defect action levels that may render food adulterated, see the Defect Levels Handbook, which is accessible athttp://www.fda.gov/pchfrule and athttp://www.fda.gov .

 

 

 

[AurW]

thank you all for your input, product has been discarded this morning.

Aurélie 

[Ryan M.]

This always reminds me of what a former professor in college told me..."The solution to pollution is dilution."  Ha....

[TimG]

I am familiar with this code because we do reprocess material that doesn't meet quality spec. Check my logic in these scenarios though to make sure I am not out of compliance:

• Product is out of spec for a quality parameter, such as assay
  • Fine to reprocess as long as it is tested again for full analysis and all parameters pass
• Product is out of spec for a heavy metal, such as iron, arsenic, etc.
  • Product must be discarded

I guess another question I have, what if there are systems specifically designed to remove the heavy metal in question (certain carbon packs in conjunction with chelants) and we can show the iron removed after reprocessing through this step?

 

This one has always been kind of a gray area for me (which I hate) because food chemicals are quite a bit different then food.

[Ryan M.]

I think this goes back to food code that says something about food that is adultered cannot be "unadultered".

 

I am familiar with this code because we do reprocess material that doesn't meet quality spec. Check my logic in these scenarios though to make sure I am not out of compliance:

• Product is out of spec for a quality parameter, such as assay
  • Fine to reprocess as long as it is tested again for full analysis and all parameters pass
• Product is out of spec for a heavy metal, such as iron, arsenic, etc.
  • Product must be discarded

I guess another question I have, what if there are systems specifically designed to remove the heavy metal in question (certain carbon packs in conjunction with chelants) and we can show the iron removed after reprocessing through this step?

 

This one has always been kind of a gray area for me (which I hate) because food chemicals are quite a bit different then food.

Edited by Ryan M., 29 September 2020 - 08:24 PM.

[moskito]

Hi,

 

as already mentioned: In the EU dilution of contaminants is not the solution and not permitted.

 

Rgds

moskito