20 replies to this topic

[QANewHopeMills]

Allergen: I'm an SQF Practitioner in the middle of validating our Allergen Control and Cleaning and Sanitation pre-requisites for a dry mix manufacturer. Due to our dry manufacturing environment and dry finished product (well below aw<0.80) we are primarilly a "dry clean" facility. We avoid the un-necessary introduction of moisture into our facility/finished products so as to minimize harmful microbial growth. Therefore, we recently developed more stringent equipment dry clean procedures for alleregn control. After conducting our "dry allergen cleans" we took 1 lb samples from the proceeding batch (which did not contain the allergen being tested for) and sent them out to a certified lab for analysis. The test results came back negative for Walnuts/Pecans but the other results revealed the following levels as present...
Egg-6.0 ppm, Casein- >13.5 ppm, and Soy-18 ppm.
My question is what levels of these allergens, egg, milk,soy will cause a reaction that is considered a threat to public health?
Also, does anyone have scientific information (peer reviewed journals) as to what levels of egg, milk and soy will generally cause allergic reactions in humans?

Trace

[DavidGB]

Tracy -on second thoughts your Soy results would possibly be OK.
David

[GMO]

I've searched for this before and drawn a blank. Here's some info I did find:

http://www.freefromf...from_means.html
http://www.europreva...paper_Final.pdf

I think the problem is that if they did some trials, not only is it dangerous to the patients but also some people are hyper sensitive and may react where another person does not.

[DavidGB]

Trace

See

http://www.allergenb...es_12_06_07.pdf

The levels of Soy are probably Ok but the others not.

regards

David

[MQA]

Good one, David.

A small trace of food can cause a life-threatening reaction. Some extremely sensitive individuals can react to even the smell of a food.


Also check out these references:

Allergen Bureau
www.allergenbureau.net

ASCIA | Australasian Society of Clinical Immunology & Allergy
www.allergy.org.au


Anaphylaxis Australia
www.allergyfacts.org.au

NIAID | National Institute of Allergy & Infectious Diseases
www.niaid.nih.gov

[cosmo]

Therefore, we recently developed more stringent equipment dry clean procedures for alleregn control. After conducting our "dry allergen cleans" we took 1 lb samples from the proceeding batch (which did not contain the allergen being tested for) and sent them out to a certified lab for analysis. The test results came back negative for Walnuts/Pecans but the other results revealed the following levels as present...
Egg-6.0 ppm, Casein- >13.5 ppm, and Soy-18 ppm.
My question is what levels of these allergens, egg, milk,soy will cause a reaction that is considered a threat to public health?
Also, does anyone have scientific information (peer reviewed journals) as to what levels of egg, milk and soy will generally cause allergic reactions in humans?

Trace

Trace
What levels of allergen causes a reaction? is a question manufacturers of allergen free foods have been asking foor some time.
First consideration is if you have any free from claims you need to comply with the food standard maximum levels for that market.
Secondly the societies (celeac, anaphylaxis etc) have access to their members who know the trigger level for their allergy. A good place to start
The test results you mention indicate either cross contamination or an ineffective clean (or effective depending on the level of allergen you decide acceptable).
Scientific studies have indicated different population groups (nationalities) have different allergenic susceptability and levels of allergen they react to, so use data based on your target population. One way is to compare the major food standards and determine target levels for the free from claims (benchmark from these) then work towards those levels.
There are a number of manufacturers of (rapid) protein detection kits for most allergens as it is the proteins that trigger the majority of allergies. I would suggest sensativities to smell and odours (phenolics and flavanoids) is another issue.
To put it in perspective, the contamination levels we are looking at for 5ppm is; one teaspoon in 1000kg (2200lb)
Cosmo

[Charles.C]

Dear All,

I note the original poster is in USA.

Some interesting stuff in this thread however i wud suggest one note of caution. I recall investigating/posting the situation mainly (from memory) with respect to UK in another thread here and finding that geographical variations were of significance for legislatory requirements.

Rgds / Charles.C

[faisal rafique]

Try to avoid, although in some literature minimum levels are defined but allergens (proteins) can trigger reaction below minimum range. scientists are still working on it to solve this mystery of proteins.

Faisal Rafique

[Dr Ajay Shah]

I am in total agreement with the comments made by Faisal Rafique. People react differently to the levels of allergens dpending on their hypersensitivity.

[Charles.C]

I am in total agreement with the comments made by Faisal Rafique. People react differently to the levels of allergens dpending on their hypersensitivity.

Indeed, this seems to be a medical inevitability.

So a labelling "May contain allergens" is the only way to go ?

Reminiscent of (legislatory) Salmonella although not on the labels.

Rgds / Charles.C

[Dr Ajay Shah]

Hi Charles. C

One has to conduct an allergen risk assessment and then determine what needs to be stated on the label.

JAKMQA has already listed the website that one can consult:
Allergen Bureau
www.allergenbureau.net

One needs to look at the Vital tool on the website.

Rgds

Ajay

[Charles.C]

Dear Ajay Shah,

Yes, i do understand the principle of risk analysis but the preceding posts seemed to imply that it was difficult in practice to attach a probability to the value of life particularly in view of the random characteristic of allergenic reactions.

I recall the builders of nuclear plants were a long time ago faced with the same dilemma (hence ALARP etc?.

Rgds / Charles.C

[Ken]

Trace

There are 2 separate issues, one is associated with legal declaration of allergens and any legal limits - this will vary depending on country. In practice, legal limits for most allergens doen't exist or are in practice the limit of detection. Certainly in the EU, if it is detectable, it is declarable! (Except the limits we have for SO2 <10 & and gluten <20 - only need to be declared if above these thresholds) The legal framework will decide for you whether a product has to be labelled.

To get back to your original question 'What levels of allergen causes a reaction?', research to date suggests this varies between individuals in a specific country and can vary from country to country. There isn't common agreement but lots of research. I found the following link a good starting point to at least being to understand what is a very complex issue. See http://www.eu-vital.org/en/home.html. The Australia link has already been posted but it is good to see that this work is spreading to other parts of the world.

This research has no legal status for the EU but at least it is starting to pull together, some information in a logical format. I think we have to let the expert groups do the thinking for us and until the work such as VITAL has some 'official' recognition, I would exercise caution and say if it is detectable, label it, unless a legal threshold exists in the country where you will be selling the products.

I had to do a similar exercise for dry products in the UK and we did get the cleaning right. We managed allergens within Haccp and effectively created CCP's for allergen control which were validated in the same way you describe.


Ken

[Bob Bottel]

The attached two files do give the ranges of allergen threshhold levels in succeptable individuals. I agree with others, you must also be sensitive to regulatory and customer requirements. One other note: the threshhold levels are normally given in mg; you will need to convert your ppm readings to a total mg dosage by considering the serving size.

 Allergen Threshold Levels.pdf   60.92KB   335 downloads  Allergen Threshold Levels - Taylor and Hefle 2002.pdf   148.59KB   381 downloads  Allergen Threshold Levels - Taylor and Hefle 2002.pdf   148.59KB   381 downloads

Bob

[Charles.C]

Dear Bob Bottel,

i think 1st ref is identical to post#4 (ie Australian based 2007)
2nd and 3rd refs appear identical to each other ? (American, but perhaps a bit old [2002] ?)

Thks anyway.

Rgds / Charles.C

[Carlos Leoncini]

Hi. I agree with the post saying that different populations (and also different regulations) will look at the issue from different points of view. Even scientific community disagrees on the threshold levels. Example: celery is not an allergen in South America.

To get independent from thresholds, will be wise to think about cleaning validation. A quite good criteria to consider will be visual absence in solid matter systems (like bakery for example).

An additional issue to consider is sampling. Some systems like liquid piping systems could be easy to obtain a representative sample but others very difficult.

Best regards.

Carlos

[cosmo]

Hi. I agree with the post saying that different populations (and also different regulations) will look at the issue from different points of view. Even scientific community disagrees on the threshold levels. Example: celery is not an allergen in South America.

To get independent from thresholds, will be wise to think about cleaning validation. A quite good criteria to consider will be visual absence in solid matter systems (like bakery for example).

An additional issue to consider is sampling. Some systems like liquid piping systems could be easy to obtain a representative sample but others very difficult.

Best regards.

Carlos

The different populations will look at allergens differently because they have slightly varying genetics based on their racial origins.
By this I mean that in the UK wheat allergy is more prominent than say in Japan, where rice allergies are more prevalent. Western Europe has celery and an individual with Buckwheat allergies can also be hypersensative to proteins from latex, rice and poppy seed.
With the level of migration the world has seen in the past 50 years any population group in 1st and 2nd world countries is going to have a large mix of allergenic sensativities, which is what we are now experiencing if the level of discussion in these forums are any measure.
Each person will have an individual reaction threshold, but within a normal distribution curve for their population and it is the lower limit that threshold levels are based on.
Agreed that some areas of the world have vastly differing standards (Gluten: Australia <5ppm, USA and Europe <20ppm), however I would suggest that these limits are set by scientific analysis by the relevant food standards authority based on their populations.
With cleaning validations, if an allergen swabbed for and found to be detected, I would suggest the surface is not clean, regardless of how visually clean it is. As I have posted before, if you have determined an acceptable level of allergen, then the test used must either react (detected/Not detected) at a known concentration or a quantitative test needs to be used (gives result in ppm of contaminant).
Cosmo

[fstRicky]

Not sure this has been answered.?!

You do a clean, post allergen containing product production, then test line for allergens, find a positive - ie allergens present.

Meanwhile you have run product with no allergen in it thru the system,

What would on with the product? Test product for allergens?

Ricky

[cosmo]

Not sure this has been answered.?!

You do a clean, post allergen containing product production, then test line for allergens, find a positive - ie allergens present.

Meanwhile you have run product with no allergen in it thru the system,

What would on with the product? Test product for allergens?

Ricky

Ricky
If I understand correctly you are saying;
You cleaned after running an allergen product
You then ran a non allergenic product
You then swabbed the line and tested allergens present.

I would;
Hold all non allergenic product, including any already dispatched.
Heavily sample starting with the first product produced
Allergen test to determine if allergen is in the product.
What you do next is based on the level of risk the business is prepared to take.

To minimise cross contamination like this, a flush is passed through the process. This could be the first 200kg? of product that is diverted to waste or simply classed as containing the allergen/s. This is validated by a lot of trials and testing.
Best practice though is to wait for the rapid swab test result before running the next product through the process.
Yes manufacturing will claim this is causing downtime. The response is 5 minutes lost production time is cheaper than a recall.

Cosmo

[ScottN_AMQA]

I agree with Charles C. on the labeling, listing "may contain or was processed on the same equipment as ".
Also the testing of samples from a single batch or production run only provides enough data and proof your process worked that time.

[garrygh]

Trace
What levels of allergen causes a reaction? is a question manufacturers of allergen free foods have been asking foor some time.
First consideration is if you have any free from claims you need to comply with the food standard maximum levels for that market.
Secondly the societies (celeac, anaphylaxis etc) have access to their members who know the trigger level for their allergy. A good place to start
The test results you mention indicate either cross contamination or an ineffective clean (or effective depending on the level of allergen you decide acceptable).
Scientific studies have indicated different population groups (nationalities) have different allergenic susceptability and levels of allergen they react to, so use data based on your target population. One way is to compare the major food standards and determine target levels for the free from claims (benchmark from these) then work towards those levels.
There are a number of manufacturers of (rapid) protein detection kits for most allergens as it is the proteins that trigger the majority of allergies. I would suggest sensativities to smell and odours (phenolics and flavanoids) is another issue.
To put it in perspective, the contamination levels we are looking at for 5ppm is; one teaspoon in 1000kg (2200lb)
Cosmo

Valuable information. Thank you.