Is this a loss of control? Allergen contamination

Have a chocolate line that used an enrober (like a chocolate waterfall), if peanuts are enrobed and the chocolate that falls off (excess) is recirculated and ultimately can be used on a non-peanut product is that a loss of control?

the facility uses an allegen statement that they think will alleviate any legal issues. the allergen statement says "manufactured on shared equipment with products containing peanuts, incidental amounts of these allergens may be present".


I need advise on how to tackle this. it would take a lot of capital to resolve the current circulation issues by segregating excess chocolate.
I am at a loss....

You might want to take a look at this document, as it even specifically mentions enrobed chocolate. I only glanced over it briefly though:

https://www.aibonlin...genLabeling.pdf

 

added Charles.C / 090814 - sadly link now appears broken

SInce I have heard discussions about not having peanuts in break rooms due to the allergen issue, I would presume that would, in fact. be a loss of control, BUT I am sure we have some chocolate manufacturers on the forum.

Ladybug,
The chocolate makes direct contact with a known allergen, "peanuts", some residual protein could be present in the chocolate " waterfall" .
Most operations have to have isolate raw material and clean-up between an allergen finished good production and a non allergen production, (with cleaning validation tests if possible) and still be required to state "manufactured on equipment with known allergens".
Thinking that a blanket statement " manufactured on shared equipment" would cover this would be a problem if a consumer had an issue ,... and showed the jury the sweet little 3 year old girl ,on a ambulance cot. The attoney would investigate your procedures and labeling and.........bla bla bla
Who would lose in this senario?
I would not take the chance , just saying.
Jeff

Dear All,

Not entirely sure from which POV the OP is querying, eg ethical / liability ?

Seems unlikely (to me) that a Regulatory (haccp) inspection would condone an “intentionally (?)” generated significant risk of allergen cross-contamination of a hitherto uncontaminated product with a harmful (albeit to a restricted consumer group) contaminant. However I’m unsure what minimum corrective actions from the typical range of options would be demanded. Mere requirement of relevant labeling in such a scenario seems improbable if “practical” options do exist. But ....?

Additionally, as per Marshenkos’s useful attachment (MA), the legal situation regarding allergen labeling also seems to be a minefield, arguably favoring the manufacturer (?)

One recent discussion (2013) I found on the liability aspect was this unofficial article –
m1 - why so many food label disclaimers.pdf   116.15KB   41 downloads

An extremely detailed, but nonetheless very readable legal survey of the (allergen) liability situation up to 2011 is attached.

m2 - Food allergen law, FDA regulated products.pdf   159.82KB   41 downloads

If m1, m2 are currently accurate, their content appears to indicate that some of the “myths” listed in the MA document are actually not so far from reality.

Rgds / Charles.C

PS – Here is another very informative 2006 FDA report (ie covering pre / post FALCPA 2004) on allergen consumer studies / inspections / utilized corrective practices / effectiveness of labeling, etc. The report included some chocolate processing operations but does not mention, I think, how many incorporated line corrective actions for unintentional cross-contamination.

m3 - FDA, 2006, report on FALCPA to Committees.pdf   1.72MB   33 downloads

Thanks everyone! I just needed back up when I go to the owner and explain that this is not a good idea and that they need to invest capital funds to fix this if that is what it is going to take. currently they have the blanket statement, but I keep having to explain that putting that on there isnt going to save them.

Just to throw out ideas here... I'm not sure how long your process allows you to keep the "recirculated" chocolate for use in a future production, but if you're keeping it in that regard can you label it as an allergen in your storage area and only use it for future allergen products?

I'm assuming there's a full cleaning between an allergen and non-allergen product on your line, so it really doesn't make sense to me to allow chocolate exposed to an allergen to be reused on non-allergen foods. I'm sure you might be able to have some sort of lab test done to confirm if the exposure is significant, but seems like its still a place for the uninformed to ask questions (uninformed like myself)

Have a chocolate line that used an enrober (like a chocolate waterfall), if peanuts are enrobed and the chocolate that falls off (excess) is recirculated and ultimately can be used on a non-peanut product is that a loss of control?

the facility uses an allegen statement that they think will alleviate any legal issues. the allergen statement says "manufactured on shared equipment with products containing peanuts, incidental amounts of these allergens may be present".


I need advise on how to tackle this. it would take a lot of capital to resolve the current circulation issues by segregating excess chocolate.
I am at a loss....

Hi,
If as you describe, it seems like a massive loss of control. I sense you're fighting an uphill battle to convince someone this is an issue. I hope the responses you get to your posting gives you some ammo to clear this up because it truly is a very dangerous condition.

Fight the good fight!

Bruce

>>>
I'm assuming there's a full cleaning between an allergen and non-allergen product on your line, so it really doesn't make sense to me to allow chocolate exposed to an allergen to be reused on non-allergen foods. I'm sure you might be able to have some sort of lab test done to confirm if the exposure is significant, but seems like its still a place for the uninformed to ask questions (uninformed like myself)

Dear john,

Yr assumption may be correct however, based on the context/words like "recirculated","ultimately", "segregating" and the overall tone of the OP I went in the opposite direction.
Only the ladybug knows of course.

Rgds / Charles.C

Hi ladybugtag,

in europe this first of all not a questions of food law, but of product liability. If something happens your company is in charge/responsibility. And if the effect is not releted to a traces (what is a trace in respect to peanut allergy?) only the questions arises whether you are applying GMP.
In Germany for example authorities checking products. If the result is positive and the number determined exceed a cerqin level they will have an inspection looking in detail on your risk assessment and cleaning schedule, i.e. looking to general GMP requirements.

Rgds
moskito

Have a chocolate line that used an enrober (like a chocolate waterfall), if peanuts are enrobed and the chocolate that falls off (excess) is recirculated and ultimately can be used on a non-peanut product is that a loss of control?

the facility uses an allegen statement that they think will alleviate any legal issues. the allergen statement says "manufactured on shared equipment with products containing peanuts, incidental amounts of these allergens may be present".


I need advise on how to tackle this. it would take a lot of capital to resolve the current circulation issues by segregating excess chocolate.
I am at a loss....

There is an obvious risk of cross contamination. You would have to scientifically validate that it is not a loss of control. I would also expect ongoing validation. You could test the chocolate to see if there are any proteins present. I wouldn't risk it though. If there is someway that the process can be modified so that the flow of materials hits the peanuts last, that would be best in my opinion.

Ladybug,

You are in the same position as a chocolate plant that makes dark and milk chocolates on the same line, you have unavoidable cross contact contamination with an allergen. In your case, for allergen control purposes you must assume that you do not produce any enrobed products that do not contain peanuts, and must label all products with an ingredient statement that lists peanuts as either the final ingredient, or make the statement after the ingredient listing- Contains: Peanuts. This informs the consumer and puts you in compliance with the allergen labeling regs. Simply stating 'shared equipment' is not sufficient notice to the consumer. You are likely in HACCP violation for every lot released that does not declare the presence of peanuts.

Dear john,

Yr assumption may be correct however, based on the context/words like "recirculated","ultimately", "segregating" and the overall tone of the OP I went in the opposite direction.
Only the ladybug knows of course.

Rgds / Charles.C

To throw another hat into the ring regarding circulation, do you test the circulated chocolate for pathogens (think cadbury's, salmonella fiasco)

Caz x