Allergen - precautionary labeling

hi everyone

 

im having a hard time assessing the control measure for allergen hazard.

 

im christian r&d from the philippines

our plant is FSSC CERTIFIED, currently our control measure for cross contact from an allergen materal (coconut) is only  "precautionary labeling" which is our OPRP also. this was accepted during initial to 2nd surveillance audit. the problem is, during the FSSC 3rd and last surveillance audit there is obviously a new set of auditor, and this time they asked for a validation of Precautionary labeling. it is given because as required by the standard, (pls correct me if im wrong) ccp and oprp shall have validation. 

 

problem is as of now our plant cannot afford to purchase swab kits which costs 4,500 US Dollars as quoted by a potential supplier. thus I just wanted to ask if there are other ways to validate the said OPRP and how. this finding/non conformance is still open and needs to be closed as soon as possible.

 

suggestions/recommendations will be highly appreciated. thank you.

 

 

Under our systems, coconuts are specifically designated not nuts. Are you sure you need this?

 

All products supplied and manufacturing sites used to produce these products must be entirely free of all nuts, including:

Jack Nuts

Queensland Nuts

All cold-pressed nut oils

Ginkgo Nuts

Heart Nuts

Hickory

Almonds

Tallow Nuts

Acorns

Peanuts (Groundnuts)

Paradise Nuts

Oyster Nuts

Persian Walnuts

Pecan Nuts

Beechnuts

Pili Nuts

Betal Nuts

Brazil Nuts

Quandong Nuts

Breadnuts/Breadfruit

Pistachio Nuts

Chestnuts

Cashew Nuts

Chinquapins (Baby Chestnuts)

Cola Nuts

Tahiti Nuts

Chilean Wild Nuts

Filberts/Hazelnuts

Walnuts

Tiger Nuts

Cob Nuts

Squari Nuts

Tropical Nuts

 

Nutmeg, Water Chestnuts, Coconut and Nut oils or blends refined to appropriate standards are not considered nuts.

 

Of course I may be wrong. What does everyone else think?

 

Jim

Hi BrummyJim,

 

For "coconut"  it appears that EU  / USA have different allergen classifications. I daresay the Phillippines follows USA.

 

eg -

 

http://www.fda.gov/F...n/ucm064880.htm

 BRC guidance_on_allergen_labelling_2013.pdf   2.81MB   65 downloads

 

refined nut oils may also  be regarded differently to the source nuts from an allergenic POV. Opinions seem to vary with location.

I did say I may be wrong! What's the position in The Philippines - US, EU or local?

Hi xtian,

 

Please confirm that coconut is regarded as an allergen in yr local haccp treatment (or perhaps depending on an export destination).

 

Assuming yes, the appropriate control measure depends on the Product/Process/ Hazard/Risk Assessment.

 

A cross-contact allergen hazard is usually controlled by an allergen management  program based on cleaning/testing.

 

From memory, allergen (sanitation-based) management programs are typically PRPs as per ISO 2002-1 for FSSC22000.

afaik, PRPs in FSSC22000 do not require validation but still require (cleaning program effectiveness) verification. This is likely to need a specific allergen test kit.

 

And yes, CCPs / OPRPs require validation / verification.

If (somehow) an OPRP I  would have thought the validation aspect would primarily relate to demonstrating the capability of a cleaning program, plus the labeling precaution. Followed by verification. Test kits needed for both.

 

It all depends on what you are doing.

 

PS - I'm not a user of allergen test kits but the amount you quote seems rather astronomic ? But perhaps depending on the number of tests available.?

 

@ BrummyJim - not criticising, only too gratetful for yr help.  i didn't know (or didn't remember) of the classification differences until today . The precise nature of coconut allergenicity seems to be contentious, some (infrequent) bad results have been documented but not necessarily correlated to tree nut sensitivities. In fact the majority opinion seems to be that biologically it isn't a tree nut. But no doubt FDA have their reasons.

I'm guessing from an earlier metal detector thread that locally the Philippines follow US guidelines but perhaps with their own adaptions.

Charles,

 

I'm with you here. We source from around the world (fruit juices and similar), but generally only sell in Europe. We (I) have to ensure that our processors conform to EU regs, especially when they differ from the local ones. My colleague travels extensively to ensure they understand our requirements. As such, I can become a little EU centric (and BRC) on these issues.

 

Wouldn't it be good if the G in GFSI stood for global, and we technos were able to apply the same standards and requirements world wide?

 

Xtian, I'm sure that it should cost much less than $4500 to test though. How many suppliers have you contacted? If you search the web you'll see them at CAD$275 for 10 strips.

 

Jim

Charles,

 

I'm with you here. We source from around the world (fruit juices and similar), but generally only sell in Europe. We (I) have to ensure that our processors conform to EU regs, especially when they differ from the local ones. My colleague travels extensively to ensure they understand our requirements. As such, I can become a little EU centric (and BRC) on these issues.

 

Wouldn't it be good if the G in GFSI stood for global, and we technos were able to apply the same standards and requirements world wide?

 

Xtian, I'm sure that it should cost much less than $4500 to test though. How many suppliers have you contacted? If you search the web you'll see them at CAD$275 for 10 strips.

 

Jim

 

 

hi jim,

 

4500USD including the instrument that analyze the traces.... 160USD if strips only...

Hi xtian,
 
Please confirm that coconut is regarded as an allergen in yr local haccp treatment (or perhaps depending on an export destination).
 
Assuming yes, the appropriate control measure depends on the Product/Process/ Hazard/Risk Assessment.
 
A cross-contact allergen hazard is usually controlled by an allergen management  program based on cleaning/testing.
 
From memory, allergen (sanitation-based) management programs are typically PRPs as per ISO 2002-1 for FSSC22000.
afaik, PRPs in FSSC22000 do not require validation but still require (cleaning program effectiveness) verification. This is likely to need a specific allergen test kit.
 
And yes, CCPs / OPRPs require validation / verification.
If (somehow) an OPRP I  would have thought the validation aspect would primarily relate to demonstrating the capability of a cleaning program, plus the labeling precaution. Followed by verification. Test kits needed for both.
 
It all depends on what you are doing.
 
PS - I'm not a user of allergen test kits but the amount you quote seems rather astronomic ? But perhaps depending on the number of tests available.?
 
@ BrummyJim - not criticising, only too gratetful for yr help.  i didn't know (or didn't remember) of the classification differences until today . The precise nature of coconut allergenicity seems to be contentious, some (infrequent) bad results have been documented but not necessarily correlated to tree nut sensitivities. In fact the majority opinion seems to be that biologically it isn't a tree nut. But no doubt FDA have their reasons.
I'm guessing from an earlier metal detector thread that locally the Philippines follow US guidelines but perhaps with their own adaptions.

 
noted.
will re-assess if the allergen hazard from cross contact should really be controlled by an OPRP/CCP or PRP is enough.
as a follow up question attached herewith is our decision tree,kindly give inputs if this is adequate enough to justify my OPRP and CCP. your feedbacks will be highly appreciated.
 
thank you guys for the enlightenment.

Hello Christian,

 

Precautionary labeling in my opinion could never be considered as an OPRP for the risk of an allergen that might be present in your product. It is not an operational control measure in your own process and therefore validation is also not possible/required. You have no validated control measures in your process to mimimize the risk of potential allergen coconut in the process. Therefore communication to the customer/consumer is necessary. When you add this possibility into your decision tree, I think the problem might be solved.

 

Kind regards,

 

PKFC

 
as a follow up question attached herewith is our decision tree,kindly give inputs if this is adequate enough to justify my OPRP and CCP. your feedbacks will be highly appreciated.
 
thank you guys for the enlightenment.

 

Hi xtian,

 

Thks for the attachment.

 

Regarding CCP/OPRP Tree, a few comments –

 

(1) Tree is similar to that in this post  –

 

http://www.ifsqn.com...ion/#entry34560

 

(2) The box labeled PRP should probably be OPRP ?

 

(3) The text might preferably  refer to “control measure” rather than “step”

 

Just as an addendum - the stated capability of the control measure (or combination of control measures) must  be validatable .

 

IMO, the basic layout is OK.