Allergen acceptable threshold level
I hope this isn't a dumb question...If we do our qualitative allergen test and the sample comes back less than 2.5 ppm allergens, is that result considered by the FDA as the industry standard for allergen free?
Or is this just an unofficial standard? Is there an industry standard?
Perhaps someone in the US can clarify but I believe it's only Australia who have defined an acceptable level so any detection in other countries is unacceptable but if the result is "less than the minimal detectable level" you can't get a result better than that.
In the US, it makes a big difference as to whether you are labeling your product as "allergen free" or are determining whether you have cross-contact. It is not clear what you are testing with your qualitative test. Is it a swab test or a food sample?
If you are making an "allergen free" claim, a test like this can be used as part of your justification, but you should be sure that you also have an excellent allergen control system in place. The FDA is very strict about "free from" labels. Testing alone may not be sufficient if there are other reasons to think that allergen protein may be present in a food.
You are using a <LOD result from an equipment swab to verify cleaning if you have data to show that the swab is actually performing at this level in your hands with your foods. A thorough visual inspection for residues can be important. Similarly, a quick test such as an LFD using a food extract can be used to verify control if you have data to justify the assessment of performance.
In any testing case, be sure that you are taking enough samples. A single swab or a single food sample do not characterize all the equipment or all the food (unless the food is a well stirred liquid, and even then it is worth doing a replicate).
I just went through this and took me forever to find some quantitative answers. However, I did find some information on the Allergen Bureau's website. I used the following formula to determine acceptable levels:
Action Level Transition Point * ppm = Reference Dose (mg) x (1000/Reference Amount (g))
so you would insert your reference dose which is the amount of allergen that will cause the general public with an allergy to react to a substance according to the Allergen Bureau's chart
http://allergenburea...rt-Oct-2011.pdf
The VITAL program was created for use in multiple countries including US and for us, being a smaller company, it was not worth paying for it so I just used their formulas and calculated it myself.
Hope this helps!
I hope this isn't a dumb question...If we do our qualitative allergen test and the sample comes back less than 2.5 ppm allergens, is that result considered by the FDA as the industry standard for allergen free?
Or is this just an unofficial standard? Is there an industry standard?
Hi halfpops,
It's not dumb however this query is certainly a popular one. Many US answers are provided by FARRP.
Afaik the official US standard other than for a few exceptions is conceptually "zero tolerance". Operationally one is faced with LOD/LOQ. Labelling is another matter, eg "may contain" etc.
The FDA page linked below was last "updated" in 2017. It contains this comment -
Will FDA establish a threshold level for any allergen?
FDA may consider a threshold level for one or more food allergens.
https://www.fda.gov/...cm106890.htm#q9
I daresay gluten / sulphites are 2 published examples of "may". Possibly the only US examples ?
Be very very careful about using the VITAL numbers. They are not regulatory levels, and do not apply in many important situations (such as with particulate allergens). It is important to realize that the application of the levels depends on some critical assumptions about consumption levels. They were developed with an eye to addressing the question of when to use advisory labels, they were never intended to address the base question of allergen control and ingredient labeling.
I daresay gluten / sulphites are 2 published examples of "may". Possibly the only US examples ?
The only examples I'm aware of where a threshold has been set.
Currently "absence", no tolerance level. The absence is based on the testing with the lowest detection possible. There isn't a hard lined definition on which testing to use, what is valid, or if the lowest detection limit is a hard number.
Not sure if someone knows otherwise for US regulatory?
Gluten and sulphite are considered "sensitive agents", NOT ALLERGENS.
Currently "absence", no tolerance level. The absence is based on the testing with the lowest detection possible. There isn't a hard lined definition on which testing to use, what is valid, or if the lowest detection limit is a hard number.
Not sure if someone knows otherwise for US regulatory?
Gluten and sulphite are considered "sensitive agents", NOT ALLERGENS.
Beware of this, may be the case in the US but not elsewhere and I know someone with a life threatening allergy to gluten (not an intolerance.)
Beware of this, may be the case in the US but not elsewhere and I know someone with a life threatening allergy to gluten (not an intolerance.)
What you speak of is Celiac disease. Gluten is funny because most people are sensitive to it, while few have actual Celiac disease where it CAN BE life threatening.
Of course with anything....one must follow the law of the land where they may export their goods. True.
Currently "absence", no tolerance level. The absence is based on the testing with the lowest detection possible. There isn't a hard lined definition on which testing to use, what is valid, or if the lowest detection limit is a hard number.
Not sure if someone knows otherwise for US regulatory?
afaik, Post 5 is US Regulatory (except my error, see below). So presumably all US operational allergen thresholds are "nominally" zero.
Gluten and sulphite are considered "sensitive agents", NOT ALLERGENS.
Yes, my error. The EU would officially disagree of course.
Hi Ryan,
Thks for the correction.
What you speak of is Celiac disease. Gluten is funny because most people are sensitive to it, while few have actual Celiac disease where it CAN BE life threatening.
Of course with anything....one must follow the law of the land where they may export their goods. True.
Actually no I'm not. Coeliac disease is very different. My friend has a life threatening anaphylaxis reaction to wheat and gluten.
Actually no I'm not. Coeliac disease is very different. My friend has a life threatening anaphylaxis reaction to wheat and gluten.
Ah ok that makes sense. You friend is allergic to wheat. It is confusing how in america when people start talking about gluten specifically when one is actually allergic to wheat, yes it contains gluten of course. The reason is due to other sources of gluten that are not wheat which aren’t part of our big 8 allergens.
People who are sensitive to gluten can consume wheat products, just in small amounts. This type of person is very rare. It is really more of a fad thing over here in the states “gluten free”.
Ah ok that makes sense. You friend is allergic to wheat. It is confusing how in america when people start talking about gluten specifically when one is actually allergic to wheat, yes it contains gluten of course. The reason is due to other sources of gluten that are not wheat which aren’t part of our big 8 allergens.
People who are sensitive to gluten can consume wheat products, just in small amounts. This type of person is very rare. It is really more of a fad thing over here in the states “gluten free”.
Yes but gluten is the protein in wheat he's allergic to. He can't eat other sources of gluten either. My point was it is dangerous to think of all reactions to wheat or gluten being mild.
I think all of us here as food professionals are aware of the extreme over self diagnosis of wheat or gluten allergy or intolerance while knowing it is also possible to have more severe, and readily medically diagnosed allergies in both the forms of coeliac disease and anaphylaxis. I was concerned a comment on here seemed to dismiss it as an allergen.
Regulatory guidance on thresholds for allergenic foods is needed to improve the quality of life for food-allergic consumers.