Risks running standard and lactose free dairy products?
Hi! I was wondering if you could help me with the below....
Is it legal/ could there be any legal repercussion on producing a lactose-free product in a line that's also used to manufacture dairy products that are not lactose-free? is a dedicated lactose-free line or facility needed?
if not legal repercussion, maybe a risk? even if we ensure that the content of lactose is below 0,01g/100ml before batches are released?
I'm under the impression that some manufacturers don't do this (even if they can sustain the claim with the lactose being below 0,01g/100ml) but tbh I don't understand why...
thanks any advice will be greatly appreciated!
Paula
Hi Paula
No I don't believe you need a dedicated line - the reaction to lactose is an intolerance not an allergy. Lactose intolerance can cause sickness but I have never heard of a fatality associated with lactose ingestion in a lactose intolerant individual.
However if a claim is made re "lactose free" you would need to be pretty confident that your product is just that & consistently too.
To defend against any potential claim there are a number of things that you should do - robust production scheduling & through validated cleaning being two of the controls, as well as end point testing. Relying solely on end point testing is not advisable as, in theory, if your clean is not thorough you could have 'pockets' of contamination which end point testing would not necessarily pick up.
If you can get hold of the M&S 5 point plan to control allergens this is a great resource to walk through the risks & controls associated with an allergen (even if you don't produce for them) and could be used to show that your controls of lactose carryover are thorough.
There is obviously the FDF/BRC guidance notes too - although I don't know how up to date this is - copy attached.
Whilst lactose, being a sugar, not a protein is most definitely not an allergen, if you follow the same controls as you would for an allergen you would have sufficient supporting evidence for a due diligence defence.
BRC-FDF Guidance on Free-From Allergen Claims.pdf 351.17KB 15 downloads
Attached Files
Hi Paula
No I don't believe you need a dedicated line - the reaction to lactose is an intolerance not an allergy. Lactose intolerance can cause sickness but I have never heard of a fatality associated with lactose ingestion in a lactose intolerant individual.
However if a claim is made re "lactose free" you would need to be pretty confident that your product is just that & consistently too.
To defend against any potential claim there are a number of things that you should do - robust production scheduling & through validated cleaning being two of the controls, as well as end point testing. Relying solely on end point testing is not advisable as, in theory, if your clean is not thorough you could have 'pockets' of contamination which end point testing would not necessarily pick up.
If you can get hold of the M&S 5 point plan to control allergens this is a great resource to walk through the risks & controls associated with an allergen (even if you don't produce for them) and could be used to show that your controls of lactose carryover are thorough.
There is obviously the FDF/BRC guidance notes too - although I don't know how up to date this is - copy attached.
Whilst lactose, being a sugar, not a protein is most definitely not an allergen, if you follow the same controls as you would for an allergen you would have sufficient supporting evidence for a due diligence defence.
great advice and clarification, thanks so much Lesley !
No problem Paula - I have recently been through a similar exercise.
Attempting to explain to difference between an intolerance & an allergen (and the associated risks) to non technical people made me want to shove my head in a blender!
Attempting to explain to difference between an intolerance & an allergen (and the associated risks) to non technical people made me want to shove my head in a blender!
Of course some of the regulation on this doesn't help - sulphites definitely aren't a protein either...
In this respect it's worth noting that Annex II of Regulation (EU) 1169/2011 does actually state: Milk (including Lactose)
As such, whilst "lactose free" isn't an allergen claim in a biological sense, it probably is in a legal sense. Lesley's advice to treat it as such is therefore very much correct.
It's also interesting to note that there seems to be some confusion amongst consumers with dairy allergy and lactose intolerance as to which specific claims are / aren't suitable for them: https://www.food.gov...e-or-dairy-free
As a result of this you may want to consider the scope of your validation, and potentially include both lactose and e.g. β-Lactoglobulin.