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Declaring Allergens in the USA

allergen big 8 FDA dairy milk Merle

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#1 Mr. Incognito

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Posted 14 June 2013 - 11:44 AM

Hello,

 

I'm fairly new to the food safety field and had a question after seeing a few things lately.

 

A thread I saw recently in the SQF section, along with a recent recall posting by the FDA, has used the term Dairy when it comes to allergens:

 

"While the products are labeled with a precautionary statement “Made in a facility that processes peanuts, tree nuts, sesame, dairy, and soy”, Vega will be revising our packaging to expand the current precautionary allergen labeling information to include “May Contain Dairy…”."

 

I am aware of the Big 8: http://www.fda.gov/f...s/ucm079311.htm however nowhere I have seen on the FDA website says anything about labeling for Dairy.

 

Unless I'm woefully uneducated I thought that milk was dairy and that typically when someone things of a dairy they think milk products (milk, cheese, etc).

 

So what is up with this "Dairy" allergen label?  Anyone know better than me?  Is it a throwback to previous labeling laws or practices or is something else going on?

 

Thanks,

 

Merle


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#2 Charles.C

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Posted 14 June 2013 - 03:09 PM

Hello,

 

I'm fairly new to the food safety field and had a question after seeing a few things lately.

 

A thread I saw recently in the SQF section, along with a recent recall posting by the FDA, has used the term Dairy when it comes to allergens:

 

"While the products are labeled with a precautionary statement “Made in a facility that processes peanuts, tree nuts, sesame, dairy, and soy”, Vega will be revising our packaging to expand the current precautionary allergen labeling information to include “May Contain Dairy…”."

 

I am aware of the Big 8: http://www.fda.gov/f...s/ucm079311.htm however nowhere I have seen on the FDA website says anything about labeling for Dairy.

 

Unless I'm woefully uneducated I thought that milk was dairy and that typically when someone things of a dairy they think milk products (milk, cheese, etc).

 

So what is up with this "Dairy" allergen label?  Anyone know better than me?  Is it a throwback to previous labeling laws or practices or is something else going on?

 

Thanks,

 

Merle

 

Dear Merle,

 

I’m not in USA so am quite happy to be corrected by other posters.

 

As you suggested, a typical definition is –

 

Dairy products are generally defined as food produced from the milk of mammals (the Food Standards Agency of the United Kingdom defines dairy as "foodstuffs made from mammalian milk")

http://en.wikipedia....i/Dairy_product

 

(logically, “dairy allergens” refers to allergens associated with “dairy products”.)

 

“Dairy products” are also defined in this US FDA standard of identity (SI)  –

 

http://milkfacts.inf...of Identity.htm

 

For example, the FDA, SI for milk specifically refers to the source as a cow. (the UK/FSA interpretation above seems wider scope).

 

So the above quite well supports yr current understanding IMO.

 

I presume the labeling mentioned in yr OP is a “convenience”  for the product group within SI above although this appears highly non-specific (?).  I could not track any specific US labeling law which permits such a shorthand format, or defines a  permitted scope.  Maybe it is automatically linked to the  SI ?. (although I noted an absence of “egg” in yr OP list and see the “egg” comments later on in this post).

 

A more detailed US answer might be (if I understood it all) –

 

The terminology “dairy allergens” typically includes casein proteins which account for approximately 80 percent of proteins in common dairy products such as milks and cheeses. This terminology also typically includes the following dairy products and their by-products: artificial butter flavor, butter fat, butter oil, cheese flavoring, curds, ghee, hydrolysates of casein, milk protein, whey and whey protein, lactalbumin, lactalbumin phosphate, lactoglobulin, lactoferrin, lactulose, nougat, rennet, Recaldent®, Simplesse®, and the like.

 

.

http://www.google.co...s/US20100291265

 

But, despite all the above, it is only too easy to find variations in usage, some examples  –

 

(1) The technical definition of a dairy allergy is a person that is hypersensitive to egg protein or milk products.

http://www.todays-wo...-allergies.html

-------------------------------------------------------------------------------------------

(2) Q: Rachel - I was wondering if goat and sheep products, such as milk, cheese and yogurt, were considered dairy? Are they ok to eat or not?

A: Alisa – This is one of our most frequently asked questions on Go Dairy Free. In general, all mammal milks (sheep, goat, camel, etc.) and their related products (cheese, sour cream, etc.) are classified as dairy. In fact, if you look up goat milk and sheep milk online, you will probably come across the American Dairy Goat Association and the Wisconsin Sheep Dairy Cooperative.

http://www.godairyfr...p-milk-products

------------------------------------------------------------------

Dairy Allergies - Definition

Food allergy or hypersensitivity refers to an abnormal immunologic reaction in which the body's immune system produces an allergic antibody, called immunoglobulin E (IgE) antibody, to usually harmless foods, such as milk or egg protein, resulting in allergy symptoms such as wheezing, diarrhea or vomiting.

http://www.healthcen...ia/408/502.html

------------------------------------------------------------

 

Even more legal confusion (inc. the usual Federal / State variations) seems to exist around meaning of non-dairy, nondairy, dairy-free on labels. :smile:

 

No doubt further input to follow.

 

Rgds / Charles.C


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Charles.C


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#3 Mr. Incognito

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Posted 14 June 2013 - 04:27 PM

Thanks Charles,

 

That's a lot of digging you did there.  I didn't really consider egg as "dairy" but only because there is a separate listing in the Big 8 between egg and milk and when I think dairy I think cow.

 

Just seems a little odd to me.

 

I understand why they are changing their label... bad practices.  Really, in the end, if milk isn't an ingredient and your getting milk in your food then you haven't done something right.  Cleaning, cross contamination, storage, transportation routes, etc.  But to use the term Dairy when it's not an actual listed allergen just confuses me.

 

This is on the FDA's website: http://www.fda.gov/F...s/ucm106890.htm about allergens the labeling law introduced in 2004 that was created to protect consumers from products that had labeling that consumers may not understand.  It came about, from what I've heard, because someone (or people) who were allergic to milk didn't know that a product had milk in it because it was listed as contains: Casein.

 

"FALCPA was designed to improve food labeling information so that consumers who suffer from food allergies - especially children and their caregivers - will be able to recognize the presence of an ingredient that they must avoid. For example, if a product contains the milk-derived protein casein, the product's label would have to use the term "milk" in addition to the term "casein" so that those with milk allergies would clearly understand the presence of an allergen they need to avoid."

 

A line from the FDA page explaining that exact type of situation.


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#4 esquef

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Posted 14 June 2013 - 04:49 PM

Mearle,

 

In general, all mammal milks (sheep, goat, camel, etc.) and their related products (cheese, sour cream, etc.) are classified as dairy in the U.S. This includes any products made from mammalian milk (butter, cheese, yogurt, etc.). I think that there's a lot more confusion with dairy allergens due to the fact that the issue involves sensitivity to both whey proteins and the casein fraction (curds), and some people are allergic to one or the other. This is further complicated by the following cut & paste:

 

BACKGROUND:  

Cow's milk (CM) allergy is the most frequent cause of food allergy in infants. Most children who are allergic to CM are also sensitized to whey proteins and/or to the casein fraction and many of them cannot tolerate goat's or sheep's milk (GSM) either. Conversely, the GSM allergies that are not associated with allergic cross-reactivity to CM are rare.

METHODS:  

Twenty-eight children who had severe allergic reactions, including anaphylaxis, after consumption of GSM products but tolerated CM products were recruited in a retrospective study. Whole casein and whey proteins were fractionated from CM and GSM. beta-Lactoglobulin and the different caseins were isolated, purified and used to perform enzyme allergosorbent tests (EAST) and EAST inhibition studies with the sera of the allergic children.

RESULTS:  

Clinical observations, skin prick testing and immunoglobulin (Ig)E-binding studies confirmed the diagnosis of GSM allergy without associated CM allergy. EAST determinations demonstrated that GSM allergy involves the casein fraction and not whey proteins. Cow's milk caseins were not at all or poorly recognized by the patient's IgE, while alphaS(1)-, alphaS(2)- and beta-caseins from GSM were recognized with a high specificity and affinity. In all cases, increasing concentrations of CM caseins failed to inhibit the binding of patient's IgE to sheep or goat milk caseins, whereas this binding was completely inhibited by GSM caseins.

CONCLUSIONS:  

The characteristics of GSM allergy differ from those of the CM allergy because it affects older children and appears later. CM products do not elicit any clinical manifestation in GSM allergic patients, whereas CM allergic patients, usually cross-react to GSM. In all the GSM allergic children, the IgE antibodies recognized the caseins but not the whey proteins. Moreover, IgE specificity and affinity was high to GSM and lower to CM caseins despite their marked sequence homology. Doctors and allergic individuals should be aware that GSM allergy requires a strict avoidance of GSM and milk-derived products because reactions could be severe after ingestion of minimal doses of the offending food.

 

http://www.ncbi.nlm....pubmed/17002714

 

 

 

 

I think in general if you have any king of dairy products in your product it's wise to include the "Includes Dairy" statement on your labels.

 

Regards,

esquef


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#5 Mr. Incognito

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Posted 14 June 2013 - 05:28 PM

Well that explains it a bit.  Thank you for that.  

 

I'm not sure that'll be the whole story by the end of the thread, maybe it will be, but it is a good piece to read.


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#6 john123

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Posted 14 June 2013 - 06:04 PM

In my limited experience, I see the "May contain dairy" on items where you wouldn't normally expect dairy to be a factor.  Can't think of anything specific at the moment though...  First time I noticed it after entering the food industry, it made me wonder if it's a CP identified through a HACCP program, as I know folks who package allergens include the labeling in their HACCP plans.

 

Could be that they throw it on as a sort of "catch all".  If you have a processing line that one day handles non-dairy and then one day handles dairy, I can see an auditor asking "What if your cleaning isn't 100% effective one day?"  So the warning becomes a way to satisfy the auditor.

 

Last thought is the use of dairy powders as part of seasoning packets.  Cheese powder, milk powder, etc.  If it runs through machines and the dust pickup systems fail, could pose a cross contamination risk.  I think the FDA allows a certain PPM before it becomes a significant concern, so that could be again a reason to list "Processed in a facility that handles dairy."  I use some powdered protein for meal replacement shakes that are derrived from milk and are labeled "Contains: Milk".  Some of the powders made by the same brand are labeled "Contains:  Milk, soy and whey."  Now, I sit here and think to myself if some are made with all 3 products and the ones I prefer are made with milk powder only, how exactly do they guarantee no soy got into my powder?  Shouldn't the milk one say "Made in a facility that processes soy."?  Sheesh, now I'm rambling but these are thoughts I've had related to the subject.


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#7 Charles.C

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Posted 15 June 2013 - 07:53 AM

Hi Merle,

 

It is possible that  the legal labeling interpretation of “dairy products” may/may not be  matched to the general definitions previously mentioned. For example this extract from the NMPF website –

 

9. What about milk from goats, sheep, etc.?

If you see “milk” being sold, this refers to cow’s milk (see FAQ #5), based on the standard of identity for “milk”.

When milk from other mammals is sold, the term “milk” cannot be used alone – it must be qualified by including the animal (“goat’s milk”, “sheep’s milk”, etc.).

In fact, there are standards of identity for products made from the milk of other mammals (goats, sheep, and water buffalo), like cheeses (21 CFR 133) and ice cream (21 CFR 135).

 

http://www.foodaller...ns/milk-allergy

 

But I also noticed this Ohio regulation –

 

(F) "Milk" means the lacteal secretion, substantially free from colostrum, obtained by the complete milking of one or more healthy cows, goats, sheep, or other animals and intended for either of the following purposes:

(1) To be sold for human consumption or for use in dairy products;

(2) To be used for human consumption or for use in dairy products on the premises of a governmental agency or institution.

http://codes.ohio.gov/orc/917

 

 

The first quote  above relates to commercialised "primary" dairy items. But does it also relate to the case where a dairy ingredient is involved, ie must append the (allergenic) source if not from a cow ?

 

So maybe it depends where you are drinking / eating in USA ?. Your guess is as good as mine (probably better) :smile: .

The “milk” terminology in the Big 8 seems to have no "origin" complications but maybe also the case ?.

 

Based on inability to find any official conformational info. (and “commonsense”) I  think it is mandatory  to include the specific identities of “dairy products” in the ingredients list unless they (or the product) are exempted for some reason (eg amount perhaps). Similarly, I think it is not generally acceptable to use “Dairy Products” as a blanket replacement for one or more individual items in a typical ingredients list. (No doubt someone will be able to find a counter-example after I post this :smile: ?).

 

However there are other possibilities, maybe as mentioned JohnL - 

 

It is apparently not legally objectionable if a label is “over” informative, eg –

 

Because of regulations or lawsuit-related ass covering, in the US a lot of food products that obviously have a product in them (Peanut M&Ms have peanuts!) have this trope in action on their packaging. Like milk or cheese labeled "Contains Dairy product."

  • Although it is somewhat valuable to people with serious food allergies, in that some products don't actually contain what you think they obviously should. For example 'honey nut' Cheerios don't contain nuts and in various times in their production history did not contain honey.

 

 

http://tvtropes.org/...dancyDepartment

(quite amusing to read though not primarily food content)

 

The famous  (“may” contain….)  above is also well-known in the  producer defensive sense of course. And apparently this terminology is currently completely uncontrolled (hence further inc. popularity I guess)  –

 

As of this time, the use of advisory labels (such as “May Contain”) on packaged foods is voluntary, and there are no guidelines for their use. However, the FDA has begun to develop a long-term strategy to help manufacturers use these statements in a clear and consistent manner, so that consumers with food allergies and their caregivers can be informed as to the potential presence of the eight major allergens.

 

http://www.foodaller...ns/milk-allergy

 

The last example was perhaps the case in the OP.

 

Rgds / Charles.C


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Charles.C






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