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Allergen Risk Assessment and Management


Best Answer , 20 June 2019 - 12:56 PM

JFI, a little intro -

 

The purpose of an allergen risk assessment is to determine the risks due to unintentional presence of allergens. Based on the result of the risk assessment you can decide whether or not allergen advisory labelling is appropriate.

Important factors to cover in the risk assessment are:

  • Which allergenic foods or ingredients that unintentionally could get into contact with your food products
  • The amount of the allergenic food generally needed to provoke a reaction in allergic people
  • How common adverse reactions are to a particular food
  • Whether subgroups of the population have an increased risk
  • The relative allergenicity of your ingredient and whether processing changes the allergenicity. In general there is no effective way to process out allergens.But clearly if no or very little protein is present as could be the case for e.g. refined nut oils, the risk of an allergic reaction is very low.
  • The physical form of the ingredient e.g. whether air-borne cross-contact is a possibility
  • How cross-contact could happen and how likely it is to happen

In practice it is difficult to assess the risk with our current knowledge. Recent research has concluded that there exist lower limits under which food allergens will not cause any symptoms (called a threshold). Researchers use data from the diagnostic method double blind placebo controlled food challenge (DBPCFC) to obtain knowledge on thresholds for individuals. However, current available data do not permit estimation of population thresholds with adequate certainty. The amount of food allergen that may trigger allergic reactions visible for others range from a tenth of milligram in rare cases up to grams, and sometimes tens of grams, with considerable variability between individuals as well as between allergens. The data also indicate that, at the level of the allergic population, the lower the dose of food, the less severe symptoms, and the lower the proportion of allergic people with symptoms. However, in diagnostic challenges with milk, egg, peanut, soy and wheat patients who experienced more severe reactions tended to react to a lower dose than those experiencing milder reactions. A review of diagnostic DBPCFCs conducted since the 1970s found that the majority of food-allergic individuals tested needed to eat more than 500 mg of the offending food to provoke allergic reactions, but a significant minority responded to lower doses.

To date, the most reliable data on individual threshold levels come from studies performed in peanut allergic patients. Sufficient DBPCFC data do likely exist for cows’ milk, eggs and peanuts to be able to make a statistical evaluation to predict a dose of those foods that it will be safe for the majority of allergic individuals to eat. However, it is only recently that scientists and regulatory authorities have started discussions on what is the best way to make statistical evaluations of the individual data. So it still remains a matter of debate how to use the individual threshold data to predict the amount of food safe to eat for most allergic patients. The Australian Food and Grocery Council is to our knowledge the first organisation to develop and recommend the use of an allergen risk assessment tool to harmonise the application of allergen precautionary labelling.

Even though the risk is difficult to assess you can decrease it if you decrease how likely it is for allergen cross-contact to happen on your premises. That is one of the major objectives of allergen risk management.
http://www.foodaller...fac/Assess.html

 

 I was impressed by the detail in link in Post 5 but almost equally disappointed for one major reason - A lot of practical suggestions but zero practical examples.

 

@ CPR - To answer query in yr OP, afaik there is no uniform methodology for risk assessment with respect to allergens.

 

I suggest that yr overall chosen (Risk-related) Procedure may depend on (a) Regulatory/labelling factors at the consumer's geographical location, (b) the Private FS Standard related to yr OP (if any).

 

Generally yr options include -

 

(i) qualitative haccp-type RAs which (implicitly or explicitly) regard (almost) all "relevant" allergens as zero-tolerant hazards, ie Severity = HIGH.  Risk then becomes effectively prioritized by "likelihood".

(ii) quantitative/semi-quantitative risk assessments utilizing threshold et al data to additionally estimate severity of "relevant" allergens.

 

afaik only a few countries, eg Australia, have Regulatory approved the use of methods based on (ii).

 

I have attached a few examples below of (i, ii)

 

Numerous previous threads here have discussed related aspects, eg -

 

https://www.ifsqn.co...ers/#entry68867

https://www.ifsqn.co...ate/#entry29169

https://www.ifsqn.co...te/#entry123889

 

examples

(i)

 

(ii)

)


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Olive

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Posted 18 June 2019 - 04:04 PM

Hi All,

 

I'm currently assigned to lead Allergen Working group. One of the requirements to be satisfied is to create a procedure that will assess the risk for allergen cross contact in the manufacturing facility and create a plan to manage the risks.

I tried to search for a risk assessment template like HACCP that uses likelihood and severity but I cannot find one. I have found some procedure but it is more on finding risks through GMP checks and addressing/managing risks through GMP Principle applications.

 

May I know if there is a globally recognized format for allergen risk assessment?

Below is our current version of risk assessment procedure (based on many references like BSI, Allergen Risk Review (Allergen Bureau) etc).  Would like to know if we are on the right track and would like to benchmark best practices from other food companies especially on how you monitor and verify CM.

 

1) Assemble an Allergen Management Team

2) List all Raw Materials and the allergen status of each ingredient, processing and work in process and rework products

3) List the ingredients and suppliers

4) Create a finished product allergen matrix

5) Obtain the most current process flow diagram

6) Conduct the Allergen Risk Assessment - using flow diagram and risk assessment questionnaire

7) Create an Allergen Mapping - containing info from risk assessment and potential allergen cross contact and current declaration of the products

8) Apply the information from the allergen risk assessment and mapping process

9) Validate the effectiveness of the identified control measures

10) Monitor and Review the implementation of Allergen Management Plan

11) Verify the effectiveness of the Control Measures

12) Management of Allergens (Product Labelling)

 

Thank you,

Olive

 

 



Dr.Khan

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    AM available as consultant in Quality Assurance, Product & process development/ optimisation, staff training and trouble shooting in complex manufacturing Environment

    Cal me on +61411588329 to discuss your requirements.

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Posted 19 June 2019 - 09:47 AM

Hi CPR

 

Your list is very comprehensive and will require considerable time and efforts to manage it. In my opinion just you the VITAL's  approach to manage risks associated with allergen.I have attached the VITAL guide it contains action level , calculator etc for developing allergen risk assessment matrix.

 

Kind regards

Dr Humaid Khan

Managing Director

Halal International Services 
Australia

+61411588329



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Dr.Khan

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    AM available as consultant in Quality Assurance, Product & process development/ optimisation, staff training and trouble shooting in complex manufacturing Environment

    Cal me on +61411588329 to discuss your requirements.

    Am available for International Assignments

Posted 19 June 2019 - 09:49 AM

Hi Olive

Sorry I did  not attached the document referred in my reply. Here it is



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Olive

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Posted 19 June 2019 - 10:21 AM

Hi Dr. Khan,

 

Thank you but it seems like attachment is not available/posted.

 

Regards,

Olive



The Food Scientist

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Posted 19 June 2019 - 01:23 PM

You can use this as a guidance:

 

https://www.fsis.usd...pdf?MOD=AJPERES


Everything in food is science. The only subjective part is when you eat it. - Alton Brown.


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Posted 20 June 2019 - 05:24 AM

The Food Scientist,

 

Thank you very much!

That was a good reference.

 

Regards,

Olive



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Posted 20 June 2019 - 06:32 AM

Hi Olive, I think you have most of it covered, I would like to emphasise the need to control new product development/introduction. Also if you do rework then this can be a high risk and need close control.

 

Thank you to The Food Scientist, I quite like that guidance.

 

Kind regards,

 

Tony



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Olive

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Posted 20 June 2019 - 06:53 AM

Hi Tony,

 

Noted. I already included the New product development and rework process in my Allergen Management Plan.

 

Warm regards,

Olive



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Posted 20 June 2019 - 12:56 PM   Best Answer

JFI, a little intro -

 

The purpose of an allergen risk assessment is to determine the risks due to unintentional presence of allergens. Based on the result of the risk assessment you can decide whether or not allergen advisory labelling is appropriate.

Important factors to cover in the risk assessment are:

  • Which allergenic foods or ingredients that unintentionally could get into contact with your food products
  • The amount of the allergenic food generally needed to provoke a reaction in allergic people
  • How common adverse reactions are to a particular food
  • Whether subgroups of the population have an increased risk
  • The relative allergenicity of your ingredient and whether processing changes the allergenicity. In general there is no effective way to process out allergens.But clearly if no or very little protein is present as could be the case for e.g. refined nut oils, the risk of an allergic reaction is very low.
  • The physical form of the ingredient e.g. whether air-borne cross-contact is a possibility
  • How cross-contact could happen and how likely it is to happen

In practice it is difficult to assess the risk with our current knowledge. Recent research has concluded that there exist lower limits under which food allergens will not cause any symptoms (called a threshold). Researchers use data from the diagnostic method double blind placebo controlled food challenge (DBPCFC) to obtain knowledge on thresholds for individuals. However, current available data do not permit estimation of population thresholds with adequate certainty. The amount of food allergen that may trigger allergic reactions visible for others range from a tenth of milligram in rare cases up to grams, and sometimes tens of grams, with considerable variability between individuals as well as between allergens. The data also indicate that, at the level of the allergic population, the lower the dose of food, the less severe symptoms, and the lower the proportion of allergic people with symptoms. However, in diagnostic challenges with milk, egg, peanut, soy and wheat patients who experienced more severe reactions tended to react to a lower dose than those experiencing milder reactions. A review of diagnostic DBPCFCs conducted since the 1970s found that the majority of food-allergic individuals tested needed to eat more than 500 mg of the offending food to provoke allergic reactions, but a significant minority responded to lower doses.

To date, the most reliable data on individual threshold levels come from studies performed in peanut allergic patients. Sufficient DBPCFC data do likely exist for cows’ milk, eggs and peanuts to be able to make a statistical evaluation to predict a dose of those foods that it will be safe for the majority of allergic individuals to eat. However, it is only recently that scientists and regulatory authorities have started discussions on what is the best way to make statistical evaluations of the individual data. So it still remains a matter of debate how to use the individual threshold data to predict the amount of food safe to eat for most allergic patients. The Australian Food and Grocery Council is to our knowledge the first organisation to develop and recommend the use of an allergen risk assessment tool to harmonise the application of allergen precautionary labelling.

Even though the risk is difficult to assess you can decrease it if you decrease how likely it is for allergen cross-contact to happen on your premises. That is one of the major objectives of allergen risk management.
http://www.foodaller...fac/Assess.html

 

 I was impressed by the detail in link in Post 5 but almost equally disappointed for one major reason - A lot of practical suggestions but zero practical examples.

 

@ CPR - To answer query in yr OP, afaik there is no uniform methodology for risk assessment with respect to allergens.

 

I suggest that yr overall chosen (Risk-related) Procedure may depend on (a) Regulatory/labelling factors at the consumer's geographical location, (b) the Private FS Standard related to yr OP (if any).

 

Generally yr options include -

 

(i) qualitative haccp-type RAs which (implicitly or explicitly) regard (almost) all "relevant" allergens as zero-tolerant hazards, ie Severity = HIGH.  Risk then becomes effectively prioritized by "likelihood".

(ii) quantitative/semi-quantitative risk assessments utilizing threshold et al data to additionally estimate severity of "relevant" allergens.

 

afaik only a few countries, eg Australia, have Regulatory approved the use of methods based on (ii).

 

I have attached a few examples below of (i, ii)

 

Numerous previous threads here have discussed related aspects, eg -

 

https://www.ifsqn.co...ers/#entry68867

https://www.ifsqn.co...ate/#entry29169

https://www.ifsqn.co...te/#entry123889

 

examples

(i)

Attached File  Kraft allergen management.pdf   2.77MB   529 downloads

Attached File  BSI Allergen risk assessment.pdf   694.2KB   484 downloads

Attached File  FDA-FSPCA forms for allergen controls.pdf   170.66KB   374 downloads

 

(ii)

Attached File  VITAL(quantitative-decision tree) allergen risk assessmernt.pdf   670.49KB   387 downloads

Attached File  Woolworths allergen management.pdf   1.1MB   374 downloads)

Attached File  rssl (semi-quantitative) allergen risk assessment.pdf   987.3KB   394 downloads


Edited by Charles.C, 20 June 2019 - 02:03 PM.
added intro, expanded

Kind Regards,

 

Charles.C


Olive

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Posted 21 June 2019 - 04:07 AM

Hi Charles,

 

Thank you for your inputs and the reading materials about allergen management.

I can now compare my templates, plans and procedure with the references that you've provided.

 

Warm regards,

Olive






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