6 replies to this topic

[amorel]

We are a dry manufacturing facility with Soy Lecithin as the only allergen that we declare. We adhere to the labeling and storage requirements. What I have struggled with is there is no test capable of detecting protein in soy lecithin. 

If we swab the ingredients directly it will not show soy proteins.

 

I have an expert opinion from University of Nebraska stating that they dont believe special cleaning procedures are needed for shared equipment with ingredients that do contain soy lecithin and those that dont. 

 

How would I implement a comprehensive thought out Allergen program in this scenario. I believe a hazard analysis would drive the requirements for internal controls. But how do i do this if Soy is a known allergen but likelihood of the hazard is low but severity (at least for soy is high)? 

 

Soy lecithin seems to be in the grey area for the FDA and creates ambiguity. 

 

Iam uncertain how to validate that operators running one line with Soy Lecithin at the same time they operate another line without soy Lecithin, shared draining vacuum equipment, and utensils dont need to be controlled for. 

[Ayman Zaki]

I would establish a validation study that incorporates:

- Testing program of:

    * Swabbing product contact surfaces.

    * Finished non-allergen product testing for soy residues.

 

- History of non-conformance and customer complaints (shows clear records of allergen problem - if true).

 

In general, the idea is to find methods that verify based on process records that your allergen controls are working properly.

 

 

Thanks,

 

Ayman

[Charles.C]

We are a dry manufacturing facility with Soy Lecithin as the only allergen that we declare. We adhere to the labeling and storage requirements. What I have struggled with is there is no test capable of detecting protein in soy lecithin. 

If we swab the ingredients directly it will not show soy proteins.

 

I have an expert opinion from University of Nebraska stating that they dont believe special cleaning procedures are needed for shared equipment with ingredients that do contain soy lecithin and those that dont. 

 

How would I implement a comprehensive thought out Allergen program in this scenario. I believe a hazard analysis would drive the requirements for internal controls. But how do i do this if Soy is a known allergen but likelihood of the hazard is low but severity (at least for soy is high)? 

 

Soy lecithin seems to be in the grey area for the FDA and creates ambiguity. 

 

Iam uncertain how to validate that operators running one line with Soy Lecithin at the same time they operate another line without soy Lecithin, shared draining vacuum equipment, and utensils dont need to be controlled for. 

 

Hi amorel,

 

Assuming no subsequent changes, based on the first link below (2015), it might be wise to assume that FDA may not agree with the non-requirement of any special cleaning as suggested by FARRP in the second link below (undated). And similarly for the allergen control program.

 

FDA are presumably the prime information source on details of the current Regulatory situation from an allergen POV.

 

http://www.qualityas...exemption-food/

http://farrp.unl.edu/soy-lecithin

 

Presumably you can always use “preventive labeling” on other non-soy containing products..

 

PS - Yr initial OP comment regarding detection might perhaps better read something like "likely no sufficiently sensitive test ....... " (presumably would need specific validation).

[QAGB]

We are a dry manufacturing facility with Soy Lecithin as the only allergen that we declare. We adhere to the labeling and storage requirements. What I have struggled with is there is no test capable of detecting protein in soy lecithin. 

If we swab the ingredients directly it will not show soy proteins.

 

I have an expert opinion from University of Nebraska stating that they dont believe special cleaning procedures are needed for shared equipment with ingredients that do contain soy lecithin and those that dont. 

 

How would I implement a comprehensive thought out Allergen program in this scenario. I believe a hazard analysis would drive the requirements for internal controls. But how do i do this if Soy is a known allergen but likelihood of the hazard is low but severity (at least for soy is high)? 

 

Soy lecithin seems to be in the grey area for the FDA and creates ambiguity. 

 

Iam uncertain how to validate that operators running one line with Soy Lecithin at the same time they operate another line without soy Lecithin, shared draining vacuum equipment, and utensils dont need to be controlled for. 

 

 

Hi amorel,

 

 

We've been pondering the same sort of questions too. I was under the impression that there are test kits out there that capable of detecting presence of soy  lecithin in products, but that soy lecithin has such a small amount of protein in it, it's under the threshold (which wouldn't be a bad thing) for soy proteins.

 

We have the issue of running a product containing soy lecithin (as an ingredient; not a processing aid), and also running a non-allergen product on the same line too. We do ATP swabbing and also allergen swabbing for soy to be on the safe side.

 

I feel like this is an area that really needs more research and FDA insight -- to be honest. I'd be a tad nervous about trying not to do special cleaning, or having physical segregation of products considering the stance on allergens.

 

QAGB

[Charles.C]

Hi All,

 

(slightly OT)

 

It only adds a fragment to the present thread but this recent FSIS allergen publication is, i think, not previously posted here and seemed quite interesting so, JFI  - 

 

 FSIS Compliance Guidelines,2015 - Allergens-Ingredients.pdf   903.22KB   64 downloads

[Ryan M.]

Hi All,

 

(slightly OT)

 

It only adds a fragment to the present thread but this recent FSIS allergen publication is, i think, not previously posted here and seemed quite interesting so, JFI  - 

 

FSIS Compliance Guidelines,2015 - Allergens-Ingredients.pdf

 

Take no chances...here's what's in the FSIS Compliance Guide on soy lecithin:

 

"soy lecithin*

* With the exception of a few specific products, FDA does not exempt soy lecithin from allergen labeling as it generally contains residual protein. The use of soy lecithin in non-stick sprays and coatings (i.e. releasing agents) has led to recalls of FSIS-regulated product when the soy was not properly declared."

 

Just because your test doesn't pick it up doesn't mean you don't put it on the label or follow proper allergen preventive controls to keep it out of other products.  QAGB mentioned a number of good practices you can use in your operation as well.  I would start by seeing what may be there after you run the soy lecithin containing product to see what kind of levels you get and find the most sensitive testing.  Use FARRP for assistance with this.  From there you can look at using ATP swabbing to see what kind of baseline results you get and also to verify your cleaning procedures.  This can be difficult with a dry operation though.  I think for your dry operation you are really best off using separate equipment if possible, but if not testing finished products with the most sensitive test available.  I would add the statement "Processed on Same Equipment as Soy Lecithin" if you can't use separate equipment just to be on the safer side.  It doesn't absolve you from the proper allergen controls though.

[amorel]

Thanks all, Really appreciate the feedback