Addressing Allergen Validation Non-Conformities

We got an NC for not having allergen-specific test kits to use in our annual allergen validation procedure. We have soy, wheat, and sesame in our products, with soy being our most common allergen found in each product and sesame our least. We're planning to purchase the Neogen Reveal 3-D kit for this.

 

Should we just purchase one for sesame (our least common allergen in each of our product) or do we need a test kit for each allergen? 

Hi GDTQA,

 

:welcome:

 

Welcome to the IFSQN forums.

 

The need for allergen-specific test kits for validation will depend on the allergen content of your products.

 

If you have soy, wheat, and sesame in all your products then the allergen content should be declared on the label and there is no need for validation that an allergen has been removed between products.

 

When you have products that contain different allergens then this is when validation is required.

 

For example if you produce a product containing soy, wheat, and sesame and then your next product only contains soy then you need to ensure that you have effectively removed wheat and sesame content before that next product is run. This can be validated using both wheat and sesame allergen-specific test kits after your clean and before you run the soy only product.

 

I would also get the first off soy only product analysed by an outside laboratory to confirm that wheat and sesame content are below threshold levels.

 

Kind regards,

 

Tony

We had the same allergens and we had a separate test kit for each allergen. Like Tony said, our products contained different allergens between them (and sometimes we ran products that contained no allergens on those lines) so we had to make sure the cleaning could effectively remove all allergens.

Hi GDTQA,

 

:welcome:

 

Welcome to the IFSQN forums.

 

The need for allergen-specific test kits for validation will depend on the allergen content of your products.

 

If you have soy, wheat, and sesame in all your products then the allergen content should be declared on the label and there is no need for validation that an allergen has been removed between products.

 

When you have products that contain different allergens then this is when validation is required.

 

For example if you produce a product containing soy, wheat, and sesame and then your next product only contains soy then you need to ensure that you have effectively removed wheat and sesame content before that next product is run. This can be validated using both wheat and sesame allergen-specific test kits after your clean and before you run the soy only product.

 

I would also get the first off soy only product analysed by an outside laboratory to confirm that wheat and sesame content are below threshold levels.

 

Kind regards,

 

Tony

 Tony, Speaking of the threshold levels for food allergens, can you please provide me the threshold levels of all food allergen types? Thank you 

https://www.food-saf...ergens-in-foods

 

 

The committee’s final recommended reference dose (RfD) for each allergenic food is as follows, in milligrams (mg) per total protein from the allergenic source:

• Celery: 1 mg
• Soy: 10 mg
• Brazil nut, Macadamia nut, and pine nut: 1 mg
• Mustard: 1 mg
• Lupin: 10 mg
• Buckwheat: 10 mg
• Oat: An oat-specific RfD is unavailable, as Immunoglobulin E (IgE) -mediated food allergy risks identified for oats stem from cross-contact with other grains in oats rather from oats themselves; therefore, an oat-specific RfD would be an inappropriate way of managing the issue.

Previously, the committee established RfDs for 11 allergenic foods, as follows, in mg per total protein from the allergenic source:

• Walnut and pecan: 1 mg
• Cashew and pistachio: 1 mg
• Almond: 1 mg
• Milk: 2 mg
• Peanut: 2 mg
• Egg: 2 mg
• Sesame: 2 mg
• Hazelnut: 3 mg
• Wheat: 5 mg
• Fish: 5 mg
• Crustaceans: 200 mg.

Hi Jason,

 

You will need to refer to local/national legislation first and also legislation in the country that your products as sold. Just a warning that the levels quoted are not absolute, opinions vary and it up to you and your organisation to decide if you wish to apply best practice and if it is practical. See the links and quotes below.

 

FAO/WHO RISK ASSESSMENT OF FOOD ALLERGENS PART 2: REVIEW AND ESTABLISH THRESHOLD LEVELS IN FOODS FOR THE PRIORITY ALLERGENS

CHAPTER 9 DEFINITION OF REFERENCE DOSES (RfDs)

9.2 SUMMARY AND CONCLUSIONS ON HAZARD CHARACTERIZATION

‘The group also reviewed the supporting data from the Remington et al. (2020) and Houben et al. (2020) manuscripts with a focus on reaction severity characteristics at ED₀₁/ED₀₅/ED10. Over 1 100 data points lent themselves to this analysis. Evidence indicated that reactions at levels of exposure up to and including the ED₀₅ could include mild anaphylaxis, but none of the reported reactions met the World Allergy Organization (WAO) definition for severe (i.e. life-threatening or refractory) anaphylaxis (although the group acknowledged that the dataset examined does not preclude the possibility of such a severe reaction). The group also found that, on the basis of the available evidence, the characteristics of objective (externally observable) reactions were no different at ED₀₁ and ED₀₅, with up to 5 percent of individuals with objective symptoms to that level of exposure developing symptoms consistent with anaphylaxis. Furthermore, the expected (very low) rate of severe anaphylaxis would not be expected to differ between ED₀₁ and ED₀₅. The group noted that (by definition) around five times more individuals would be expected to develop any objective symptoms to ED₀₅ than ED₀₁ exposure, and therefore in absolute terms, five times more people would be expected to experience mild anaphylaxis to ED₀₅ exposures as to the ED₀₁ level. However, given the very significant analytical limitations that currently exist in relation to using ED₀₁ rather than ED₀₅ as RfDs, the group suggested that the ED05 form the basis of the proposed RfDs. It was noted that while fewer individuals would experience allergic symptoms to ED₀₁ levels of exposure, the same proportion of reactors would experience anaphylaxis, and use of ED₀₁ would not “minimise the probability of any clinically relevant objective allergic response, to a point where such further refinement meaningfully reduces health impact”, particularly where the “incidental symptoms likely to be elicited in the range of envisioned RfDs are of an acceptable severity”. In contrast, use of the ED₀₁ would introduce considerable burdens and limitations for monitoring and potential unintended consequences on the application of PAL or other risk management strategies.’

 

VITAL Scientific Expert Panel 2019 Summary Recommendations – the new allergen Reference Doses for VITAL® Program Version 3.0

‘The VSEP noted a significant increase in the number of suitable data points from individuals who had undergone challenge studies for most allergens. Sufficient data were available for egg, hazelnut, lupin, milk, mustard, peanut, sesame, shrimp, soy, wheat, cashew, celery, fish and walnut and as a result ED₀₁ doses were identified for all allergens.The VSEP considered that ED01 best meets the requirements of the Allergen Bureau, including minimising the percentage of the allergic population at risk from cross contact allergens in unlabelled products, increasing the likelihood of global acceptance of VITAL and a level of risk no greater than VITAL 2.0.’

 

Also see some reference in this topic Allergen validation.

 

Kind regards,

 

Tony