8 replies to this topic

[pghosh]

We are presently under the FDA Preventive Control Surveillance audit. A question came up on a May contain statement on one of our suppliers ingredients that states May Contain Peanuts. None of the finished product we make contains Peanut. 

 

We identify only those allergens identified on the ingredients received, in the Ingredient Hazard Analysis. We have never considered identifying allergens under the May Contain statement as a hazard whose risks need to be assessed in our food safety plan. 

 

Would like to know how you handle a May Contain Allergen statement in your Food Safety Plan? Would you assess the risk if any and accordingly make adjustments to your facility allergen program? 

 

Piki

 

 

[SQFconsultant]

We are presently under the FDA Preventive Control Surveillance audit. A question came up on a May contain statement on one of our suppliers ingredients that states May Contain Peanuts. None of the finished product we make contains Peanut.

We identify only those allergens identified on the ingredients received, in the Ingredient Hazard Analysis. We have never considered identifying allergens under the May Contain statement as a hazard whose risks need to be assessed in our food safety plan.

Would like to know how you handle a May Contain Allergen statement in your Food Safety Plan? Would you assess the risk if any and accordingly make adjustments to your facility allergen program?

Piki

Opens up a whole big ball of wax by having a supplier indicate that it may contain peanuts.

Client of ours had a similar issue for an allergen free facility and product and a supplier made a statement about how their item may contain soy and peanuts.

If they accepted that it would have had to go into the allergen plan, haccp, etc etc and then they faced the issue with having to change their labeling to have a may contain statement and based on their customer base that spelled loss of sales to them.

Instead they made the supplier conduct allergen testing on all product and the item shipped was then sent for allergen testing again.

These procedures were documented and included in the alkergen plan and fsp.

Interestly enough not one test since then has turned up soy nor peanuts.

[BostonCream]

Opens up a whole big ball of wax by having a supplier indicate that it may contain peanuts.

Client of ours had a similar issue for an allergen free facility and product and a supplier made a statement about how their item may contain soy and peanuts.

If they accepted that it would have had to go into the allergen plan, haccp, etc etc and then they faced the issue with having to change their labeling to have a may contain statement and based on their customer base that spelled loss of sales to them.

Instead they made the supplier conduct allergen testing on all product and the item shipped was then sent for allergen testing again.

These procedures were documented and included in the alkergen plan and fsp.

Interestly enough not one test since then has turned up soy nor peanuts.

 

Good point, thank you. My question then is how often do they need to do this allergen test? For every shipment from that supplier, or a once-a-year validation would be enough?

 

Thanks.

[pHruit]

If your supplier has so little confidence in their allergen controls and/or are limited by practicalities that necessitate the "may contain" statement, then IMO I'd want to see analysis of each shipment.

When you're not under the pressure of a live FDA audit I'd also be inclined to discuss in more detail with the supplier about why they feel the "may contain" is necessary, and understand more about what they are / aren't doing in terms of cross-contamination controls.

Edited by pHruit, 25 February 2020 - 08:29 PM.

[Charles.C]

Extracted from some Canadian comments -
 

 

While it has generally been accepted practice for precautionary labelling on ingredients to be carried forward to the label of the end products made with those ingredients, there is no regulatory requirement for a manufacturer to do so. For example, if a food manufacturer believes that a retail product containing flour that displayed a precautionary statement for mustard does not pose a risk to a mustard allergic consumer, there is no need for a precautionary statement about mustard to appear on the product's label. Deciding not to carry forward a precautionary statement from an ingredient onto a retail food product is not, in and of itself, a violation of any current labelling regulation, policy or guideline. The decision not to carry forward a precautionary statement should be informed by the manufacturer's knowledge of their overall manufacturing process and in consideration of whether or not the end product poses a potential health risk to an allergic consumer.

https://www.canada.c...rd-allergy.html

 

 

 

Precautionary labelling of food ingredients

Health Canada has published "information for Canadians with mustard allergy" that clarifies that it is not a requirement to carry over precautionary labelling on ingredient labels to the label of end food products made with those ingredients. This is a manufacturer or importer's decision, made in consideration of whether the end product poses a potential health risk to an allergic consumer. While the Health Canada information above was developed for mustard which may be inadvertently present in cereal grain flours, the same principles may be used to assess whether other precautionary allergen statements should be carried over to the end food product.

Regulated parties are responsible for the safety of their products, including addressing potential risks associated with the presence of allergens. Options to achieve this may include (but are not limited to):

• Putting production system or process controls in place,
• Performing sampling of end product for allergen presence,
• Working with suppliers on ingredient specifications, and
• Carrying over precautionary labelling to final products intended to be sold at retail.

During inspections, CFIA inspectors may request information from manufacturers or importers to demonstrate how potential health risks to allergic consumers are being addressed.
 

https://www.inspecti...52326591?chap=4

[pghosh]

Thank you for sharing your experiences and thoughts. The ingredient under question is manufactured in multiple facilities; in few facilities this item is made on equipment shared with peanuts, and in other facilities, the equipment is dedicated to the allergen. To maintain consistency on the label for consumers, doesn't matter which facility this was made at, the packaging declares the precautionary statement. 

 

And luckily the location from where this ingredient is shipped to us, is the facility with dedicated equipment thus no risk of cross contamination.

 

We have decided to identify the May Contain allergens in our Food Safety Plan and justify how the risk if any is mitigated, without making any changes to our Allergen Program. 

[Brendan Triplett]

The FALCPA of 2004 does not require this type of labeling.  You can see the FDA guidance on this, question and answer 13

 

https://www.fda.gov/...and-answers#q13

 

Should help give you some ammunition.

 

Cheers!

[Charles.C]

The FALCPA of 2004 does not require this type of labeling.  You can see the FDA guidance on this, question and answer 13

 

https://www.fda.gov/...and-answers#q13

 

Should help give you some ammunition.

 

Cheers!

 

Hi Brendan,

 

I think the driving force has mostly been much more oriented to legal protection than Food Safety per se. Despite avowals to the contrary.

[Brendan Triplett]

legal protection than Food Safety

“Government Regulatory vs Company Legalese” ... my old nemesis, we meet again.

Edited by Brendan Triplett, 26 February 2020 - 11:50 PM.