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Lychee Nut Management as an Allergen

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Posted 25 March 2024 - 04:22 PM

I am hoping someone could provide some guidance. I am trying to help a European manufacturer determine how to include lychee/lychee nut as part of their allergen management program.


To the best of our knowledge, it is not considered a tree nut allergen in the EU; however, according to the FDA it is considered a tree nut in the USA. Some of their products will be intended for use in the US. As of right now, all of their products have a CIP between each product change and they do test for existing allergens (gluten, etc.)


I cannot seem to find any allergen swabs, tests, kits, etc. that would test for lychee as a tree nut. Does anyone have any input on what sort of testing could be done? Or, if there are no means of testing, how could they address this in their allergen management program?







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Posted 25 March 2024 - 04:44 PM

Your question got me wondering, because I've never seen the FDA address this directly.  So, I went on a search and found this site - may be of interest to you in determining the type of tests you may need to run ----



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Ryan M.

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Posted 25 March 2024 - 09:36 PM

If you want a test to "prove" your residue removal I suggest a total protein test.


If I were you I would reach out to FARRP and get their input.  They have a wealth (really unlimited) knowledge and can provide you with guidance.




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Posted 29 March 2024 - 09:19 AM

It would be worth them reaching out to RSSL.  They will give some great "official" advice on this.


Of course there is nothing stopping a manufacturing site from assigning additional materials as allergens if they are seen as allergens of concern by the market they are supplying.


BUT what it's important to remember is you don't have to test for every allergen when validating or verifying cleaning programmes.  What causes most allergen issues in consumers isn't a trace amount left after cleaning, it's wrong packaging, wrong recipe or wrong ingredient.  That doesn't mean that it's not worth validating the cleaning efficacy of some equipment but it does mean that you should do a bit of a mindset shift on what you're trying to achieve.  The point of allergen validation is to check that the method is capable of removing allergenic residues.


So once you've designed your cleaning process, you then choose which allergen to test for.  That choice is going to be governed by several things:


  • Cleanability of the allergen off the surface (milk and egg are often the most difficult)
  • Concentration of the allergen in the recipe
  • How many recipes you use with that allergen in
  • Level of allergen sensitivity in the population
  • Availability of tests
  • Sensitivity of tests


So for each you're going to want to choose the MOST difficult to clean, highest concentration, most susceptible population risk and the best most sensitive, most available tests.


To re-emphasise the point that doesn't mean testing every allergen in all of your formulations!


So for example, say your site processes milk and that's 50% of one formulation, milk is present in 20 recipes and lychee is 10% of one recipe only formulation, I would only test the milk.


Then once validation is achieved, you can choose what your ongoing verification and monitoring is.  That can be as simple as visual inspection, it does not have to include rapid swabs.

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