8 replies to this topic

[PGabarra]

Hi all, I understand that lactose is considered a milk allergen, being that it is derived from it, by Codex.  In many EU and US, Canada lists lactose is part of the milk derivatives list, to make that point.  Does anyone know where-o-where the FDA lists lactose as milk allergen in this context?  I have found all other references expect for an FDA one.  Thanks in advance!

[smgendel]

I am afraid that this is a common misconception - lactose is not a major food allergen in the US.  Milk is an allergen, as defined by the Food Allergen Labeling and Protection Act.  Ingredients derived from milk that include milk proteins are considered to be "milk" for the purposes of allergen labeling and control.  Purified lactose that is protein-free is not an allergen by this standard.  Companies that opt to label it as an allergen are probably concerned that their ingredient is not pure; that it contains milk protein.  

 

It is important to realize that lactose itself is a problem for many people with lactose sensitivity.  However, that is a different issue.  

[kfromNE]

The best source of information in the US on food allergens for the food industry other than the FDA website- https://farrp.unl.edu/

 

Pretty good about answering questions as well. Inspector's consider this a trusted source. 

Edited by kfromNE, 07 February 2022 - 04:55 PM.

[Scampi]

And there is this article from May of 2021

As of now, the FDA has not established thresholds for any major food allergen. However, this does not mean that we do not consider information related to allergen thresholds in our regulatory work. For example, the FDA may consider allergen threshold data in assessing the safety of ingredients exempted from FALCPA allergen labeling requirements. We continue to monitor and evaluate new science that has emerged in the past decade on population threshold dose response to a variety of food allergens.

https://www.fda.gov/...ergen-landscape

 

And this

https://www.sheetlab...e-free-products

[shookimogh]

I am afraid that this is a common misconception - lactose is not a major food allergen in the US.  Milk is an allergen, as defined by the Food Allergen Labeling and Protection Act.  Ingredients derived from milk that include milk proteins are considered to be "milk" for the purposes of allergen labeling and control.  Purified lactose that is protein-free is not an allergen by this standard.  Companies that opt to label it as an allergen are probably concerned that their ingredient is not pure; that it contains milk protein.  

 

It is important to realize that lactose itself is a problem for many people with lactose sensitivity.  However, that is a different issue.  

Is there a threshold for milk allergen? or should it be negative? we have purchased an ingredient that contains lactose, after testing milk allergen is 9 ppm. is it considered allergen now?

[kconf]

9 ppm is generally safe. 

[shookimogh]

9 ppm is generally safe. 

Do you have a source for that?

[Setanta]

Unfortunately there isn't a declared minimum for milk from the FDA. 

I did find this from 2003

 

https://pubmed.ncbi.... milk proteins 

 

Minimal reactive quantities show that, in order to guarantee a 95% safety for patients who are allergic to egg, peanut and milk, and on the basis of consumption of 100 g of food, the detection tests should ensure a sensitivity of 10 p.p.m. for egg, 24 p.p.m. for peanut and 30 p.p.m. for milk proteins

[kconf]

The FDA has no established threshold. It is up to you and your customers what limits are tolerable. 

 

I would also reach out to the lab to know which assay/method was used to analyze this test, and how they interpret this result. If >5 ppm qualitative is positive then you might wanna think twice.

 

Good luck!