Milk Allergen Threshold: What is Acceptable?

Hi members,

Is there a threshold for milk allergen? or should it be negative in product? we have purchased an ingredient that contains lactose, after testing milk allergen is 9 ppm. is it considered allergen now? shall we state on the label and take all cross contamination procedures into account?

Thank you in advance.

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! 

It is NOT up to you and your customer (at least not in Canada)

It is up to you and CFIA

https://www.afdo.org...1012_LowRes.pdf

https://www.canada.c...lergene-eng.pdf

https://www.canada.c...lergene-eng.pdf

Could you share if CFIA has a defined limit? 

By default, the allowable for ALL allergens in Canada is zero

Food allergens and gluten must be declared in the list of ingredients in which they are present, or in a "food allergen source, gluten source and added sulphites statement", by their prescribed source names [B.01.010.1(2), FDR].

Note: the words "contains statement" and "food allergen source, gluten source and added sulphites statement" have the same meaning and are used interchangeably in this section for ease of reference.

If a contains statement is used on the label, all allergen, gluten and added sulphite information must appear in the statement at least once, even if that information is already shown in the list of ingredients for the product [B.01.010.3(1)(b), B.01.010.3(2), FDR].

Interesting! There must be a method that measures at such low levels then in Canada.

Here in the US, "gluten free" items get <5 ppm result and marketed as gluten free. 

If your product uses an ingredient that contains lactose, you should consider that product as containing milk and act accordingly vis-a-vis allergen management.  I'm unclear on whether the ingredient tested at 9ppm of milk, or if your finished product tested to 9ppm of milk — but in terms of labeling or precautions it doesn't matter. It could matter in terms of ultimate risk to the consumer and in terms of how you design your allergen management program.  

It's also worth keeping in mind that amounts of allergen can vary sample to sample and test to test — today you got 9ppm but next week you could get more (or less). And lactose as an ingredient is tough / can be hard to detect since it "should" not have protein in it. There are plenty of rapid tests for milk on the market, with the ability to detect casein and/or beta-lactoglobulin around 1ppm.

As an aside, with gluten labeling, you can't have label a product that intentionally contains gluten as gluten-free. If an ingredient contains gluten, your product is not gluten-free, even if the final amount of gluten is undetectable.

Thanks Emily for more insight. I did not mean deliberated addition of gluten and calling it "gluten free" based on detection limit. 

Thanks Emily for more insight. I did not mean deliberated addition of gluten and calling it "gluten free" based on detection limit. 

You got it! And no, I got your meaning — but I've had a surprising number of clients over the years try to argue that if there's no detectable gluten in the finished product they don't need to think about it. It's just a little bit in the spice blend, etc. So always like to emphasize that point.

If your product uses an ingredient that contains lactose, you should consider that product as containing milk and act accordingly vis-a-vis allergen management.  I'm unclear on whether the ingredient tested at 9ppm of milk, or if your finished product tested to 9ppm of milk — but in terms of labeling or precautions it doesn't matter. It could matter in terms of ultimate risk to the consumer and in terms of how you design your allergen management program.  

 

It's also worth keeping in mind that amounts of allergen can vary sample to sample and test to test — today you got 9ppm but next week you could get more (or less). And lactose as an ingredient is tough / can be hard to detect since it "should" not have protein in it. There are plenty of rapid tests for milk on the market, with the ability to detect casein and/or beta-lactoglobulin around 1ppm.

 

As an aside, with gluten labeling, you can't have label a product that intentionally contains gluten as gluten-free. If an ingredient contains gluten, your product is not gluten-free, even if the final amount of gluten is undetectable.

Hi Emily, 

It was the ingredient that contained 9 ppm of milk allergen. i am waiting to test final product. I think it should not be detectable as the amount for this ingredient in the recipe is 0.02gr. so if it was not detectable in the final product, what shall we consider as allergen management ? Thank you in advance!

Hi Emily, 

It was the ingredient that contained 9 ppm of milk allergen. i am waiting to test final product. I think it should not be detectable as the amount for this ingredient in the recipe is 0.02gr. so if it was not detectable in the final product, what shall we consider as allergen management ? Thank you in advance!

Short question with a long answer! You've got a few helpful docs linked up above and I'm sure elsewhere in the forum. But I'd say the biggest three steps are making sure your labels are correct, figuring out how you can prove that you've successfully cleaned the equipment after the allergen runs, and ensuring that this ingredient is stored in an allergen-conscious manner.

Cleaning validation and verification could be any/all of the following, depending on the specifics of your situation: milk-specific allergen testing for surfaces and/or product and/or flush materials, testing for the presence of other allergens in the mix, general protein testing for surfaces.

As Emportllc says, the amount of allergen may vary. Your supplier could give you an ingredient that contains 20ppm, 500ppm, 5000ppm...

As long as it is labeled correctly on their end, the liability would fall on you.

I will acknowledge that the theoretical ppm in your finished product is small.

Even at a serving size of 10g, 0.02g @ 9ppm would yield ~ 0.018ppm in final product.

Milk-containing ingredient= 0.02g

Serving size= 10g

The milk-containing ingredient makes up 1/500th of the serving size.

9ppm / 500 = 0.018ppm

But now let's assume the worst-case scenario. You are supplied an ingredient that contains 0.9% lactose.

Since you are using such a small amount in your recipe, I assume a 0.9% difference in composition would be hard to detect.

0.9% = 9000ppm

9000ppm/500 = 18ppm 

A variation of less than 1% from your supplier could cause illnesses with your customers.

Regulators would look at your suppliers ingredient and say "They have listed milk listed as an allergen. Why don't you?"

"We don't use very much in our recipe" would not be an appropriate response.

Hi Emily, 

It was the ingredient that contained 9 ppm of milk allergen. i am waiting to test final product. I think it should not be detectable as the amount for this ingredient in the recipe is 0.02gr. so if it was not detectable in the final product, what shall we consider as allergen management ? Thank you in advance!

If you know an allergen was present in one of the ingredients it most likely needs to be declared.  Dilution does not make it go away -- the concentration of allergen is irrelevant for labeling in most places.

Soy sauce is a good example of this concept.  After processing there's a good chance you can't actually detect soy allergen, but it still needs to be listed; and even if you just use a small amount of soy sauce as an ingredient in another product, it still gets soy listed as an allergen even if you can't detect it in the finished goods.  Dilution does not remove the allergen or the obligation to include it as a declaration.

Hi members,

Is there a threshold for milk allergen? or should it be negative in product? we have purchased an ingredient that contains lactose, after testing milk allergen is 9 ppm. is it considered allergen now? shall we state on the label and take all cross contamination procedures into account?

Thank you in advance.

Hi shookimogh,

You will need to refer to local/national legislation first and also legislation in the country that your products are sold (if different)

I would have a look at this topic where you will find useful information Addressing Allergen Validation Non-Conformities

Your Lactose appears to contain milk protein. Whilst a ppm is useful this needs to be measured in terms of mg milk protein and the dose, so the amount of milk protein in mg that someone will consume when having a normal ‘portion’ of your food.

Reference Dose – The milligram protein level (total protein from an allergenic food) below which only the most sensitive (5% for VITAL 4.0) of individuals in the allergic population are likely to experience an objective allergic reaction.

The new VITAL recommended Reference Doses are: Milk (0.1 to 0.2 mg milk protein)

Kind regards,

Tony

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

It is NOT up to you and your customer (at least not in Canada)

 

It is up to you and CFIA

From the UK’s Food Standards Agency:

Precautionary Allergen Labelling and Allergen Thresholds

4. Guidance and enforcement

4.1 In the UK the use of PAL is voluntary, with a guidance-based approach.  This is currently the same in most countries (including the EU, US and Australia) that use it in some way.  However, as noted above, if it is not applied and someone with a food hypersensitivity experiences an adverse reaction there could be a breach of food law, because the food may be unsafe.

Kind regards,

Tony