11 replies to this topic

[Riggio]

Greetings All,

I am looking for some guidance concerning receiving a non-allergen product from a allergen producing co-packer for inclusion in a kit we are producing for a customer.

The product we would be receiving for the kit is a flavored cranberry packed in a machine sealed film pouch.

The "master cartons" of packaged film sealed pouches have a label from the manufacturer stating the following: *This product is manufactured in a facility that processes peanuts, tree nuts, soybean, milk, egg, wheat (gluten), and fish products". This statement does not however appear on the individual pouches we will be including in the assembled kit.

Do we need to include any allergen warning statements on the assembled kits that contain this product?

Our facility does produce, process or store any of the 8 major allergens.

In summary. The product packaged for us is not an allergen, but is packed in a facility that does produce allergens and sent to us in a master carton that states "allergens are produced in their facility". What is the bottom line for us as far as the need for "any" labeling requirements?

Thanks in advance!

[Mr. Incognito]

Greetings All,

I am looking for some guidance concerning receiving a non-allergen product from a allergen producing co-packer for inclusion in a kit we are producing for a customer.

The product we would be receiving for the kit is a flavored cranberry packed in a machine sealed film pouch.

The "master cartons" of packaged film sealed pouches have a label from the manufacturer stating the following: *This product is manufactured in a facility that processes peanuts, tree nuts, soybean, milk, egg, wheat (gluten), and fish products". This statement does not however appear on the individual pouches we will be including in the assembled kit.

Do we need to include any allergen warning statements on the assembled kits that contain this product?

Our facility does produce, process or store any of the 8 major allergens.

In summary. The product packaged for us is not an allergen, but is packed in a facility that does produce allergens and sent to us in a master carton that states "allergens are produced in their facility". What is the bottom line for us as far as the need for "any" labeling requirements?

Thanks in advance!

 

Hello,

 

Did you mean: Our facility does NOT produce, process or store any of the 8 major allergens.  ?

 

I would ask them about their allergen program.  

Do they have a run matrix to run non allergen products before allergen products?  

Do they swab test the line to ensure that all allergenic protein has been removed before switching products.  

How many customer complaints / recalls / withdrawals they have had due to allergen problems.

 

After you get the relevant information have your food safety team do a risk assessment.

[Riggio]

Oops...sorry. We "do not" produce, process or store any of the 8 major allergens!

[Mr. Incognito]

Also in your RA you should look at what bodies they are audited by.  AIB, GFSI, Etc.

[Charles.C]

Hi Riggio,

 

Not too sure what you mean by a “kit” (multi-component?) but, ignoring dilution factors (zero tolerance), the risk of the assembled item will presumably match the inputs.

 

I get the impression from the Literature that the Food Industry default (rightly or wrongly)  is to minimize allergenic  responsibilities wherever labeling offers a legally valid mechanism. Even for a believed optimized process from an allergenic risk POV. Commercial necessity trumps Science. Just my opinion.

[Mr. Incognito]

Charles,

 

In the United States "May Contain" and "Produced in a facility that (handles, makes, packages, etc)" do not create protection from suits other than customers not buying it.

 

Using those misleading statements really just says "Hey we don't clean our lines properly or handle allergens properly" and shouldn't be used unless you don't trust your process or your supplier.

 

There have been cases also where the FDA has investigated companies that just label "May contain" all of the allergens when none of the allergens were labeled on their product.

 

Intelligence and proper work practices could, maybe someday, end this cycle of attempted backside coverage.

[Charles.C]

Hi Mr.Inc,

 

This is UK -

 

http://www.foodnavig...e-allergen-free

 

(Note the "best practice")

[3esa]

With the recent cumin recalls earlier this year, I remember reading a discussion the American Spice Trade Association had with people from the FDA.  One of the things the FDA mentioned was that manufacturer's tend to overuse "may contain allergen...", but it was up to the company to decide if they were to use advisory statements. 

[Mr. Incognito]

Charles this is an issue a poster has in the United States not the UK and he hasn't indicated that he is shipping this product overseas.  If you saw something I didn't, and still don't, please feel free to copy and paste it.

 

3esa: The FDA has stated that you can use advisory statements however there is no protection along with them.  If you label a product does have something and someone with that allergy uses it then that is their own fault.  However may contain statements do not provide the same protection.  Really all they do is scare customers away.  Also there are multiple instances where companies have lost large contracts with places like school districts because of may contain statements. 

[Charles.C]

Hi Mr.Inc,

 

I was afraid that you felt i was finger-pointing. That's all.

[Mr. Incognito]

Charles,

 

My point is sometimes what people have made "best practices" are actually "bad practices".  There are programs that should be in place to control cross contamination of allergens.  Asking appropriate questions of the supplier and gathering information, maybe visiting, will give the information the OP needs to perform a through risk assessment which is what their plant needs to do to decide if they should label or not.  However using that sort of label has a negative side and they could lose sales because of it.

 

Rather than succumbing to being one of the many companies that just decide to label advisory statements rather than doing a complete RA I was giving an option to look at other ways of avoiding it.

 

In the end it's their choice to label or not.

[Charles.C]

Hi Mr. Inc./ Riggio

 

This is a USA comment ex FARRP –

 

Precautionary labelling

Examples of precautionary labels. The term in brackets [ ] may differ depending on the food concerned.

"May contain [fish]"

"Manufactured in a facility that uses [egg] ingredients"

"Manufactured in a facility which processes [egg]"

"Processed in a facility that uses [milk]"

"Manufactured on equipment that processes products containing [peanuts]"

"Manufactured on equipment that uses [milk]"

"Manufactured in a facility that processes [tree nuts], but not on the same equipment"

"Manufactured on shared equipment…may contain [peanuts, tree nuts, wheat, soy, milk…]"

 

This is the type of labelling that uses terms such as 'may contain'. This type of labelling (also termed advisory labelling or defensive labelling) is strictly voluntary and not required by federal regulation. Consequently, situations when precautionary labelling may be used vary among food companies, as does the wording of the statements used (see Table for some examples but note this list is not exhaustive!!). FDA specifies that such labelling cannot be used as a substitute for good manufacturing practices such as allergen identification and control, cleaning of shared equipment, and segregation during processing. Some consumers believe manufacturers use precautionary labels as a way to protect themselves from legal action in case a food causes a reaction. This is not typically the case since this type of label should only be used by food manufacturers when there actually is a possibility (however small) that the food may contain an allergen which is not an ingredient but may be present as a result of the manufacturing process.

We know this type of labelling is not liked by consumers but currently it is the only way for food manufacturers to inform consumers if there is a possibility that an allergen which is not part of the final product may be present in the food. In the future, some restrictions may be placed on the use of precautionary labels but that is not yet the case.

 

https://farrp.unl.edu/FoodLabeling

 

The following  comments are  OT since not USA but possibly relate to the thought process being requested by the OP from a legal POV.

 

This is abstract of attachment below containing an analysis of  liability issues as related to EC (voluntary) advisory/precautionary labelling –

 

This article answers two questions concerning the liability aspects of the use of “may contain” labelling on food packages, such as “This product may contain traces of nuts.” This type of voluntary labelling refers to the unintentional presence of an allergenic foodstuff, the inclusion of which can occur during the production process. Firstly, it is probable that courts consider a food product without a “may contain” warning defective under the Directive, even though this can create unintended consequences. This question is approached in terms of a defect both in design and in warning, since food manufacturers are able to reduce the risk by means of redesigning the production process or by providing a warning. With regard to the second liability question concerning the adequacy of “may contain” warnings, it is not likely that courts will consider the product warning defective in view of the difficulty of providing a better alternative.

 

 May contain issues.pdf   303.19KB   71 downloads

 

How, if at all, the logic used would transfer to a US legal system,  no idea.