Allergen Detection and Level Limits

Hello! I work for a company which produces a range of cookies and bakery goods. I recently conducted an internal and external allergen swab of our cookie line after producing a product that contained peanut and completing a full clean and sanitation. We used Neogen Reveal 3-D for Peanut for our internal allergen swab which has a detection level of 2 ug/100cm^2 or greater. We sent our external allergen swab to an outside accredited lab which has a detection level of 0.5 ug/100cm^2 or greater. The internal allergen swab came back negative for peanut but, the external allergen swab came back positive for peanut (0.92 ug/100cm^2). My question to you is what is acceptable for the detection limit? Right now our program is set up that the only acceptable value is negative for any level of allergen but, is there any safe acceptable limit it can go up to? Thanks!

per FDA the detection limit is zero presence of allergen. 

Hello!

 

I work for a company which produces a range of cookies and bakery goods.

I recently conducted an internal and external allergen swab of our cookie line after producing a product that contained peanut and completing a full clean and sanitation. 

 

We used Neogen Reveal 3-D for Peanut for our internal allergen swab which has a detection level of 2 ug/100cm^2 or greater.

We sent our external allergen swab to an outside accredited lab which has a detection level of 0.5 ug/100cm^2 or greater.

 

The internal allergen swab came back negative for peanut but, the external allergen swab came back positive for peanut (0.92 ug/100cm^2). 

 

My question to you is what is acceptable for the detection limit? Right now our program is set up that the only acceptable value is negative for any level of allergen but, is there any safe acceptable limit it can go up to?

 

Thanks!

The answer might be different if the consumer was in Australia or a few other locations. Otherwise > zero-tolerant defect.

In Canada, it is zero or none detected

For peanuts in particular, folks who are allergic, tend to be VERY (e.g anaphylaxis) type allergic , which could result in death/

I will give you an example-------I am allergic to sulpha based medications--------whenever I'm asked, I tell them. Only found out while in hospital as a child and penicillin based antibiotics weren't cutting it. Had I been at home when taking the meds , the time to hospital may not have been short enough for sufficient interventions.  The same type of reaction happens for some with severe allergies. THIS IS NOT A RECOVERABLE PLAN. The business would never recover financially if a customer ended up in hospital because the product contained undeclared allergens of any type.

I am harping here a bit, but it is important that people understand the implications of "pushing boundaries". 

Unless you're declaring a "may contain" statement on your packaging, no amount detectable is "safe"

I'm also going out a limb, and am guessing you are feeling pressured by the ops department to release the equipment faster...............tell them to modify the work schedule order of products OR get a dedicated line.

You should read and follow the "suggestions" in this link, and understand that allergens need to be treated like any other chemical hazard in your facility

https://inspection.c...3/1528203218321

Production scheduling

When possible, use dedicated production lines. If this is not feasible, the preparation of foods containing allergens, gluten or added sulphites should be scheduled so that the equipment can be thoroughly cleaned prior to the preparation of a food that should not contain them.

Verifying the effectiveness of the control measures

The effectiveness of the control measures applied can be verified by determining whether residues of ingredients that can cause food sensitivities remain in the processing environment - or end up in foods that should not contain them.

The most frequently used methods to detect for the presence of food allergens and gluten can be classified into protein-based and DNA-based methods.

Note: The analytical methods used should be capable of detecting the ingredient under consideration in the low mg/kg range.

• Protein-based methods: Enzyme-linked immunosorbent assays (ELISAs)
  • Detect the allergenic protein or a marker protein using an antibody such as:
    • well and lateral flow devices (LFDs)/dipsticks
    • sandwich and competitive
    • multiplex LFDs
  • Can be used on:
    • push through materials after cleaning (for example, salt, sugar or the next product prepared)
    • the first product prepared after cleaning (prepared off line or finished products)
    • Clean In Place (CIP) rinse-water
    • food-contact surfaces after cleaning
• DNA-based methods: Polymerase chain reaction (PCR)
  • Targets specific DNA sequences
    • offers the best option for the sensitive detection of food allergens
    • is negatively affected by thermal treatments (with the effect being most pronounced under acidic conditions)
• Non-specific methods
  • Adenosine Triphosphate (ATP) Swabs: measures the ATP residues present from biological sources
    Note:
    • ATP residues may not come from an allergen.
    • Total protein measures the protein residues present (the protein measured may not come from an allergen)

Hello,

For FDA it is acceptable to label your product as gluten free if the tested product comes at <20 ppm (ELISA Neogen Veratox). See link:

https://www.fda.gov/...ns-what-it-says

Hope it helps!

Hello,

 

For FDA it is acceptable to label your product as gluten free if the tested product comes at <20 ppm (ELISA Neogen Veratox). See link:

 

https://www.fda.gov/...ns-what-it-says

 

Hope it helps!

Unfortunately that 20ppm threshold is only for gluten and not for allergens.

While there is some research into acceptable amounts of cross-contact (see Allergen Bureau's VITAL program), there is no legal cut-off or 'allowable' amount of allergens in Canada or the USA.

Note that the OP was requesting information related to peanut allergen.