7 replies to this topic

[Laura982]

We have a risk assessment in place for production and allergens handled, but a lot of our specs state may contain, should this information be transferred to our label?

 

I have been looking at our suppliers, updated the database to state what their spec says eg may contain milk, and contacted them for information regarding the controls in place, depening on their answer do I need to list the allergen on the label?

[Scampi]

Yes

 

the may contain statement is not sufficient and the regulator will see it as a lack of GMPs in your facility

[Laura982]

Thanks, we have the controls in place on our site but don't handle the  allergen eg celery as an ingredient but the supplier does and states may contain on their spec so we should then have may contain celery if they are declaring it 

[MDaleDDF]

I second what Scampi said.   May Contain statements are dubious at best, and certainly aren't legally covering you should the worst happen.   Companies use them all the time, but I never would.....

I got a spec from a perspective vendor once, and every allergen in every major country was listed on their 'may contain' statement.   Needless to say I passed on their product....

We have 4 allergens in my building.   If any ingredient has something other than those 4, even on a may contain basis, I will not use it.

[GMO]

Depending on their answer.  Where there is a genuine risk.  

 

Which country are you in?  The FSA have some good advice on this but it's only for the UK market obviously.

 

Precautionary allergen labelling | Food Standards Agency

[AZuzack]

I feel like I just sat through a free webinar that addressed this.  It may have been one of these: 

https://tracegains.c...ives_chemicals/

or

https://easconsultin...source=hs_email

 

FDA is going to hold a Virtual Public Meeting in November on Allergen thresholds:

https://www.fda.gov/...their-potential

[Dehydrated]

May contains statements are very unhelpful for consumers with food allergies. Used and abused to cover manufacturer's buts.

They also end up ruling out products for these customers, who will avoid risk by not buying them in the first place.

 

Have you heard of the VITAL tool? (Voluntary Incidental Trace Allergen Labelling). A scientific risk based assessment for allergen cross contact.

 

I'm not sure where you are based, but here in ANZ this tool is quite commonly used as a way to help assess risk and determine if a PAL statement should be included on pack. PAL isn't regulated here, our regulations only cover labelling of allergens inherently present in the ingredient or components , including processing aids. If you feel there is cross contact risk, VITAL can help to assess. And then you voluntarily include the relevant details in your product specs/labels.

 

https://vital.allergenbureau.net/.

Edited by Dehydrated, 03 September 2025 - 10:30 PM.

[GMO]

We have a risk assessment in place for production and allergens handled, but a lot of our specs state may contain, should this information be transferred to our label?

 

I have been looking at our suppliers, updated the database to state what their spec says eg may contain milk, and contacted them for information regarding the controls in place, depening on their answer do I need to list the allergen on the label?

 

Which country are you in?  The VITAL tool is a good one but you need to use something valid for your country.

 

First step is honestly to go back to the supplier and ask questions.  You'd need it anyway if you're going to do any kind of risk assessment.  What I've found when I've challenged is probably as many as 80% have no justifiable reason for the PAL / alibi labelling.  As in there is no foreseeable risk of cross contact.  None!  

 

The things you want to look out for are where they're using the same machinery to process different allergens.  Where that happens, ask for information about the machinery, cleaning processes and any validation they've done.  If it's likely to be difficult to clean, I'd carry over that PAL.  If it's likely to be easy to clean and reproducible, with decent verification in place, I'd talk to the supplier about whether there is genuinely a risk.  If they stick to their guns it's a judgement call.

For example, a couple of years ago there was a major issue with potential mustard contamination with Italian wheat.  One company I consult with decided not to put a "may contains" statement onto their pack and, looking at the evidence, I agree with them.  There was poor evidence it was even mustard to start with (likely to be cross reactivity with oil seed rape) and, even if present, it was a vastly diluted risk within a diluted risk (the product had a low wheat quantity).  That was backed up with some opinion statements from millers and some due diligence testing before use.  But as you will see if you look into the issue, lots of Italian companies went for shelf edge warnings.  So there's not always a "right" answer to these questions, especially as it has no legal protection to the brand per se to put a PAL on pack.  So to me the real questions are:

 

• Is it really there?
• If it is, how can we prevent or remove it so it's not a contaminant going forward?

 

Because my view is PAL is used too much as an excuse for poor standards or failing to truly risk assess.

 

But want to know the real secret?  Most allergenic consumers (unless with a severe allergy) will ignore it anyway.  For example, if you have an allergy to a specific tree nut, current medical advice if you go to a specialist is not "avoid all nuts" anymore, that advice will be told that it's important to eat other nuts and peanuts to avoid contracting an allergy to those.  How easy is it to even find whole tree nuts without a "may contain" PAL?  It's pretty much impossible and forget processed foods. 

 

"But we warned them!"

 

Tough.  HACCP requires you to consider consumer use and reasonably expected misuse.  This is the latter.  Sorry because it's 100% reasonably expected because consumers MUST eat these products to avoid further allergy....

 

So if you start with the mindset "PAL is pointless, how can I avoid it?" but err as much to the side of caution as much as possible using really clear and strong wording where the risk is genuine and unavoidable "produced on the same equipment as..." or "not suitable for xxx allergy sufferers", I think you'll be about right.