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Allergens limits in product - mg/kg

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Dorothy87

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Posted 05 February 2018 - 02:21 PM

Hi There,

 

Is about allergens validation (cleaning), as long as I have limits for swab analysis ELISA uq/swabs by RSSL I have no clue about mg/kg in product.

I can`t find what is the limits for lets say Sesame seeds in positive sample control.. basically; our sesame seeds baps are produced on the plain baps line and I know that is very difficult to clean particles and unfortunately line must be in use between other non sesame seeds products. I have done swabs before cleaning (uq/swabs) (limits - 0.025 - 0.4 where I receive >0.40 which understandable), after cleaning (uq/swabs) ( limits - 0.025 - 0.4 where I receive 0.11 which is fine)  and now I end up with positive sample control (plain bap after line cleaning) of <6.3mg/kg but I have no idea where I can find limits..

 

Thank you !

 

Dot

ELISA (
Quantitative)ELISA
ELISA (
Quantitative)
Quantitative)
ELISA (
Quantitative)


GMO

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Posted 06 February 2018 - 08:27 AM

The simple answer is there are none in the UK and the same applies for swabs.  Currently there is insufficient research to be able to say xx ppm is safe.  VITAL in Australia has made a stab at this but I'm unsure whether I agree.  It's a difficult topic because, for example, my son has a nut allergy and it will take approximately 5g for him to react (at the moment).  A friend of mine will react and have anaphylaxis to a trace of nuts.  

Ultimately the only control you can have now is no detection at the limit of detection for the most sensitive method.  If you think about it, it makes sense in any case.  If you decided that 10ppm was fine and your result came back with 9ppm, how do you know your cleaning is not going to be as little as 20% worse next time taking you over that limit?  How do you know your sampling is accurate and representative?  

In reality we all know there must be a threshold whereby most people would not react and RSSL were doing a lot of work on this but it's not law.  At the moment, if you have presence then you're shooting yourself in the foot come legal action if someone did have anaphylaxis in response to your product as in legal terms you've proven the sesame persists even after cleaning.  Definitely a case for alibi labelling but in reality I'm never sure how much that would actively protect you in terms of due diligence.  I suppose what is good though is that you can actively prove you are trying to clean it to the best of your abilities and trying to improve.



Dorothy87

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Posted 06 February 2018 - 08:50 PM

Hi, Thank you !

 

That`s why I have placed this as may contain on the label, but this is only what I can do to validate as my verification is done by the rapid test.. and as you know is not a quantitative test.. 



GMO

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Posted 07 February 2018 - 09:45 AM

Hi, Thank you !

 

That`s way I have placed this as may contain on the label, but this is only what I can do do validate as my verification is done by the rapid test.. and as you know is not a quantitative test.. 

 

Sorry I am a bit confused by your comment.  Yep a rapid test isn't quantitative but ELISA is so you could validate using ELISA and verify using your rapid test.  I still think you need to aim for absence at the limit of detection though and it's worth checking your detection limits in your rapid swabs vs. ELISA.



smgendel

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Posted 13 February 2018 - 05:56 PM

An additional consideration - I don't think that swabs are good for verifying cleaning of particulates.  It is easy to mix a stray seed or two, which are unlikely to be picked up on a swab in any case.  In this situation it is important to be able to clearly examine every surface of the equipment involved.  If you are getting intermittent positives in a subsequent product that indicates that seeds are hanging up somewhere in the system and coming loose at random times.  





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