Flavors - Risk Analysis

Hello,

My company deals with a lot of flavors from different flavor houses. I am revising our HACCP plan and was wondering what sort of hazards might be associated with them. I don't see anything else relevant other than Allergens. Would there be any other chemical hazards that I am missing?

Thanks!

Hello,

 

My company deals with a lot of flavors from different flavor houses. I am revising our HACCP plan and was wondering what sort of hazards might be associated with them. I don't see anything else relevant other than Allergens. Would there be any other chemical hazards that I am missing?

 

Thanks!

Hi yogirl,

Are the flavours classified as food additives ?

If yes  i presume they have to be FDA approved for food use ?

If approved I guess they can be assumed to not "present" a significant hazard.

If you want to know what hazards "might" be associated with them, maybe study the details of the Product Specification.

Hi yogirl,

How are your flavours supplied; dehydrated, water or alcohol? If they are in alcohol you must consider the flammability/explosive nature of the vapour.

Thanks for the answers. They are all food grade, some are liquids and others are dried. The liquid ones are all water soluble/dispersal, some of the common carriers are propylene glycol and alcohol. 

Use the preventive controls guidance appendix 1 and search for "flavors". FDA has them all broken down by type and what hazards they expect you to address in your food safety plan.

https://www.fda.gov/...A/UCM517402.pdf

Use the preventive controls guidance appendix 1 and search for "flavors". FDA has them all broken down by type and what hazards they expect you to address in your food safety plan.

 

https://www.fda.gov/...A/UCM517402.pdf

Hi 3F,

I tend to forget this potentially valuable source.

The document seems destined to be infinitely draft and is undated.I daresay date/refs are in the main document [also draft presumably?]. Perhaps draft = discontinued, ie Final as per document title. Odd.

I hv extracted a flavor portion -

flavors.png   180KB   17 downloads

FSMA apparently requires the addressing of (depending on type of flavor) one of nil, Salmonella, Salmonella +L.mono.

I wonder why the differences ? Process related ? Is there any FSMA draft (statistical?)  Validation material existing to support these entries ? Or are they currently just  "draft' opinions ?

I noticed that this draft contains some, IMO, rather bizarre entries on potential hazards, for example try searching for "bottled water".(i assume = drinking).

PS - I deduce that FSMA would definitely not like the hazard/control measure format as per my yoghurt excel in this model plan. Tough.

http://www.ifsqn.com...ge-4#entry50651

Hi 3F,

 

I tend to forget this potentially valuable source.

 

The document seems destined to be infinitely draft and is undated.I daresay date/refs are in the main document [also draft presumably?]. Perhaps draft = discontinued, ie Final as per document title. Odd.

 

I hv extracted a flavor portion -

 

flavors.png

 

FSMA apparently requires the addressing of (depending on type of flavor) one of nil, Salmonella, Salmonella +L.mono.

 

I wonder why the differences ? Process related ? Is there any FSMA draft (statistical?)  Validation material existing to support these entries ? Or are they currently just  "draft' opinions ?

 

I noticed that this draft contains some, IMO, rather bizarre entries on potential hazards, for example try searching for "bottled water".(i assume = drinking).

 

PS - I deduce that FSMA would definitely not like the hazard/control measure format as per my yoghurt excel in this model plan. Tough.

 

http://www.ifsqn.com...ge-4#entry50651

If you're looking for FDA to provide a scientific justification for their risk assessment, good luck.

All FDA guidance is "guidance" when they disagree, and "law" when they agree. In general it's best to try and follow the guidance rather than spend audit "goodwill" explain why you disagreed with it. It's also a way to make auditors stop using their "gut" to evaluate your controls since you have a federal reference.

Remember there are three sections of identified hazards, not just the ones for pathogens that you pulled out above (e.g the unapproved additives etc. in the other sections).

Why do you think the bottled water one is weird may I ask? Everything identified is pretty much included as required controls in the bottled water GMP's.

If you're looking for FDA to provide a scientific justification for their risk assessment, good luck.

 

All FDA guidance is "guidance" when they disagree, and "law" when they agree. In general it's best to try and follow the guidance rather than spend audit "goodwill" explain why you disagreed with it. It's also a way to make auditors stop using their "gut" to evaluate your controls since you have a federal reference.

 

Remember there are three sections of identified hazards, not just the ones for pathogens that you pulled out above (e.g the unapproved additives etc. in the other sections).

 

Why do you think the bottled water one is weird may I ask? Everything identified is pretty much included as required controls in the bottled water GMP's.

Hi 3F,

I assumed "bottled water" production = Drinking water.

I assumed such production in USA is Regulated/certified by FDA.

i assume, as IMO implied in Pg2, that the tabled "Potentials" are considered to be "reasonably likely to occur".

So -

"Drug residues" are a potential hazard. Really ? Why ?

Pathogenic E.Coli is the (only) potential micro. hazard. Really ? Why ?

I'm afraid that Validation rules IMO.

Hi 3F,

 

I assumed "bottled water" production = Drinking water.

I assumed such production in USA is Regulated/certified by FDA.

 

i assume, as IMO implied in Pg2, that the tabled "Potentials" are considered to be "reasonably likely to occur".

 

So -

 

"Drug residues" are a potential hazard. Really ? Why ?

Pathogenic E.Coli is the (only) potential micro. hazard. Really ? Why ?

 

I'm afraid that Validation rules IMO.

"Drug residues": dichloromethane is identified as a contaminant in the bottled water GMP's that requires testing that can be considered a drug residue. 

The bottled water GMP's also identify required testing for coliforms and e. coli, with a zero tolerance level set for e. coli. It's an old standard that's been in place forever and relies on e. coli as an indicator of fecal contamination, which we know is an obsolute "absolute" but none-the-less remains in place. It is odd that actual common water-borne pathogens aren't included.

Basically........they already have a set of hazards they identified for this product (bottled water) as needing to be addressed, so they're in the list because then in theory you would have needed a preventive control in place to address them. For those examples I have a "supplier preventive control" where I verify that our water provider remains an active/approved provider by EPA and that their most recent test results have been satisfactory, and verification occurs once per year when I sample our source water and send it out.

My new favorite definition of "preventive control" now is "something where if it didn't happen you would be expected to recall". Which helps me swallow the pill that sanitation and suppliers providing unadulterated product is a "preventive control" rather than a PRP. I treat the table as things FDA has decided need to be in my hazard analysis, and they're all considered "likely" enough that a preventive control is expected to be in place.

Hi 3F,

I was unable to find any mention of "drug residues" in the CFR bottled water regulations. I guess it is possible that the draft hazards main document has re-defined "drug residues" for this compilation, eg = any chemical listed in the CFR document (there are many of course). A nice voluminous target for the OP's QA documentation (the EC directive has even more listed chemicals IIRC from which, IMEX, factories routinely select an annual, "representative" handful for testing).

There is (CFR) mention of Total Coliform / E.coli. The latter is presumably generic E.coli but probably encouraged the FDA's  inclusion of the pathogenic entities in the Table as a possible hazard. Sort of justifiable from a CFR POV. I could not find any statistics of actual pathogenic E.coli detections in bottled water.

I agree with you that auditors are likely to be perfectly happy with anything officially labelled as "Guidance", whether a draft or not. Unless it conflicts with their accumulated experiences from other audits.