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Allergen Packaging and Labelling

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Posted 02 March 2022 - 04:13 PM



Our facility is trying to repack allergens (all major 9 allergens). Allergens will be repacked in a segregated area and separate lines than other products that doesn't include allergen? 


Does Allergen Labelling requirements necessities us to add "Products are processed or repacked at where allergens is repacked/processed" for other products (except allergens) that is being produced in same facility? 


Thank you! 


Please share your experience. 


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Posted 02 March 2022 - 04:27 PM

You did not specify where this work in located.  If you are in the US, allergen advisory statements are not required.  They must be truthful and not misleading, but there is no regulatory language involved.  However, again if you are in the US, you are probably subject to the requirements in 21CFR117, the GMP and preventive controls regulation.  In summary, this requires that you have an allergen control plan.  The process for developing and implementing one is too complex to describe here.  If you are covered you should have a Preventive Controls Qualified Individual who can oversee that development or work with an outside consultant to do so.  You can contact me for more information if needed.  

Carolina Motto

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Posted 03 March 2022 - 03:25 PM

Completely in agreement with the previous comment, only reinforcing the idea that precautionary labeling is always the last resource to be used, once, as a result of the risk assessment and the exploration of all available control measures, it is not possible to guarantee the absence of allergens foreign to the formulation.
In the case you mention, if products with allergens are made and packaged in a separate area from products without allergens, the risk of unintentional presence of allergens through cross-contact is significantly reduced. In any case, it is necessary to evaluate the hazards at each stage of the process of making allergen-free products.

To delve into the subject, I suggest you subscribe to my free newsletter where I publish weekly tools to improve the management of allergens in the plant

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Edited by Charles.C, 03 March 2022 - 07:31 PM.
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Posted 03 March 2022 - 07:39 PM

I'm afraid that truth or otherwise is often not a primary factor where implementation of precautionary labelling is involved. It's more likely a mixture of a (possibly perceived) defence mechanism to "cushion" against subsequent hassles plus a, claimed, attempt to maximally protect allergenic customers.

Kind Regards,



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