18 replies to this topic

[monette maniago]

Good day!

This is my first time to post inquiries to this group.

 

We manufactured baked products specifically ice cream cones.

We have ongoing revision of our existing HACCP Plan.

 

This is my inquiry:

Is precautionary labelling connected to allergen (Wheat and Soya) a CCP or OPRP?

 

Thank you.

 

Monette

 

[tiarautami]

Hello!

This is my first time also for posting here.

 

We manufacture cassava chips & crackers and we put labelling process as CCP. On our previous BRC audit, an auditor suggest that labelling process should be CCP. We produce both allergen and non-allergen products with the same equipments and the risk of mislabelling is quite high. Also, there are recall cases due to undeclared allergen in the packaging and we'd like to prevent that to happen.

 

hope it helps.

[monette maniago]

Thank you for the information provided tiarautami. 

[teodymayojr]

if the product intentionally contain an allergen - it does need to be labeled - and therefore regulatory.

 

The only thing that will lead to product recall is if you have products with allergen sold as no-allergen, (leading to product recall).

 

It does not always fall as CCP, it depends on the risk. If it is cross-contact allergen (running on same line with allergens), it should be your PRP, in my opinion. 

 

I work with coconuts, which may or may not be sulfited, the risk of having it sold unlabeled is likely (as there is no bar code and allergen is manually ticked in the packaging). This we considered as CCP. 

Edited by teody, 08 April 2020 - 02:41 AM.

[Charles.C]

Good day!

This is my first time to post inquiries to this group.

 

We manufactured baked products specifically ice cream cones.

We have ongoing revision of our existing HACCP Plan.

 

This is my inquiry:

Is precautionary labelling connected to allergen (Wheat and Soya) a CCP or OPRP?

 

Thank you.

 

Monette

 

Hi Monette,

 

You omitted to mention if any particular Standard was involved.

 

However  BRC, SQF, FSSC22000 afaik handle allergen controls within an allergen management program. Typically set as a PRP program..

 

@tiarautami - I suggest to refer to  BRC8 Clause 2.2. although I agree that this is not a mandatory requirement.

[MDG]

It can be consider as a OPRP and not CCP, As process /SOP will be in-place (including line clearance, Training).

[Charles.C]

It can be consider as a OPRP and not CCP, As process /SOP will be in-place (including line clearance, Training).

 

Hi MDG,

 

afaik OPRP would relate to the use of iso22000 or fssc22000.

 

The latter requires (for food) the  implementation of iso22002-1 which includes a PRP designated, Allergen Management Program. The former is less definitive but recommends iso22002-1.

[Leila Burin]

Hello, definitively, it is a OPRP; as described in the GUIDANCE DOCUMENT: ISO 22000 INTERPRETATION (Dis 2019):

 

“one of the characteristics of a CCP is the good feasibility of measurements to detect and correct failure. However, in the practice of producing safe food, there are situations in which, despite of a high likelihood x severity of hazards and of failure, the feasibility of measurement to detect and correct failure is rather low. A typical example of low feasibility to Guidance document: ISO 22000 Interpretation FSSC 22000 Version 5 | December 2019 8 of 14 detect failure can be the measurement of control measures like the manual cleaning of equipment and the separation of raw materials and processes to control allergens. Basically, in cases like these, low feasibility of measurement to detect and correct failure means that control of the hazard cannot be guaranteed. A well accepted practice in these cases is that products are labelled as potentially unsafe with disclaimers like “may contain traces of peanuts”

And

“To assure the communication of correct allergen information on the product label, a combination of monitoring procedures is needed. Let’s focus on ‘applying the correct label on the consumer product at the packing line’ as an example and take the assessment criteria in ISO 22000:2018 – 8.5.2.4 into account: • The likelihood of failure is high. • The severity of the consequences in case of failure is high (there are no subsequent monitoring procedures). • The feasibility of critical limits and a monitoring procedure is high. • The feasibility of timely correction is high. Although ‘labelling of the consumer product at the packing line’ does not meet the definition of a CCP, it is likely that the required monitoring and corrections shall be performed similar to a CCP.”

Hope this helps
Leila

[Charles.C]

Hello, definitively, it is a OPRP; as described in the GUIDANCE DOCUMENT: ISO 22000 INTERPRETATION (Dis 2019):

 

“one of the characteristics of a CCP is the good feasibility of measurements to detect and correct failure. However, in the practice of producing safe food, there are situations in which, despite of a high likelihood x severity of hazards and of failure, the feasibility of measurement to detect and correct failure is rather low. A typical example of low feasibility to Guidance document: ISO 22000 Interpretation FSSC 22000 Version 5 | December 2019 8 of 14 detect failure can be the measurement of control measures like the manual cleaning of equipment and the separation of raw materials and processes to control allergens. Basically, in cases like these, low feasibility of measurement to detect and correct failure means that control of the hazard cannot be guaranteed. A well accepted practice in these cases is that products are labelled as potentially unsafe with disclaimers like “may contain traces of peanuts”

And

“To assure the communication of correct allergen information on the product label, a combination of monitoring procedures is needed. Let’s focus on ‘applying the correct label on the consumer product at the packing line’ as an example and take the assessment criteria in ISO 22000:2018 – 8.5.2.4 into account:

• The likelihood of failure is high

. • The severity of the consequences in case of failure is high (there are no subsequent monitoring procedures).

• The feasibility of critical limits and a monitoring procedure is high.

• The feasibility of timely correction is high.

Although ‘labelling of the consumer product at the packing line’ does not meet the definition of a CCP, it is likely that the required monitoring and corrections shall be performed similar to a CCP.”

Hope this helps
Leila

 

Hi Leila,

 

IMO,  the Guidance is incorrect (or debatable) in respect to various textual elements, eg -

 

(1) Its interpretation of Prerequisite programs as only controlling non-significant(important) hazards, cf.  hazards become non-significant due to their control by PRPs.. This is a well-known, unending, debate.

Referring to the Guidance included decision tree, this concept is (IMO critically) embedded in the opening stages.

Note that the Guidance tree is non-compliant with the revised Codex tree as proposed by Campden. The former also seems to be effectively  ignoring the iso22002-1 Standard inasmuch as PRPs are typically defined prior to a hazard analysis.

I note that the Tree Guidance section is prefaced by this (caveat?) -

 

The appendix to this document presents a decision tree (spread over two pages) that can be used to conduct a hazard analysis within the framework of ISO 22000. Potential users should be aware that this decision tree is a result of an interpretation and that other tools can be used.

 

(2)  The statement  that the use of "may contain" is "well-accepted" is inaccurate. In fact this Procedure as frequently implemented  is widely debated. eg -

 

 MayContainAllergenStatements,2017.pdf   987.09KB   55 downloads

 

(3) ISO22002-1 enables Allergen management to be categorized as a PRP and states  -

 

10.3 Allergen management  
Allergens present in the product, either by design or by potential manufacturing cross-contact, shall be declared. The declaration shall be on the label for consumer products, and on the label or the accompanying documentation for products intended for further processing.

 

 

Accordingly, in my understanding of PRPs,  the hazard due to incorrect allergen labelling is  non-significant (ie LOW Likelihood).

 

(4) ^^^^^(green)(purple) - Referring to the (green) analysis in yr quote preceding the (purple) conclusion.

If allergen control were not pre-set as a PRP by FSSC's own Standard iso22002-1 (!!), I would agree that the (green) pattern could support  a justification for the existence of a significant hazard to be controlled as a CCP. So I am simply baffled by the (purple) conclusion seemingly stating the opposite. ??

(also see (1) above).

 

 

JFI -  I also find this analysis in the Guidance extremely puzzling  -

 

The assessment of the likelihood x severity of failure in ISO 22000 is the basic to the understanding of OPRPs: a control measure, managed as an OPRP controls a significant hazard but failure of on [an] OPRP does not necessarily lead to unsafe product. This is reflected in clause 8.5.2.4.1. In this clause control measures can be categorized as to be managed as OPRPs when a) the likelihood of failure is low and/or b) the severity of the consequence of failure is low.

 

 

^^^(red) - Based on (a,b), I cannot see how the hazard could  initially be determined as Significant ?

 

 

PS - IMHO the latest version of iso22000 has improved the interpretive handling of OPRP but the overall treatment of CCP/OPRP remains a confused Mess.

 

PPS - JFI I include the Guidance document being discussed -

 

 FSSC22000 Guidance ver.5.pdf   666.91KB   57 downloads

Edited by Charles.C, 11 April 2020 - 09:10 AM.
expanded

[monette maniago]

if the product intentionally contain an allergen - it does need to be labeled - and therefore regulatory.

 

The only thing that will lead to product recall is if you have products with allergen sold as no-allergen, (leading to product recall).

 

It does not always fall as CCP, it depends on the risk. If it is cross-contact allergen (running on same line with allergens), it should be your PRP, in my opinion. 

 

I work with coconuts, which may or may not be sulfited, the risk of having it sold unlabeled is likely (as there is no bar code and allergen is manually ticked in the packaging). This we considered as CCP. 

Thank you for your reply.

 

The Wheat and Soya are common allergen to all Production Lines. 

 

Thank you and God bless.

[monette maniago]

Hi Monette,

 

You omitted to mention if any particular Standard was involved.

 

However  BRC, SQF, FSSC22000 afaik handle allergen controls within an allergen management program. Typically set as a PRP program..

 

@tiarautami - I suggest to refer to  BRC8 Clause 2.2. although I agree that this is not a mandatory requirement.

Thank you for your reply @Charles.

 

Our Allergen Management Program focused on Personnel Awareness through training and Finished Product Labelling (Allergen Declaration).

We followed FSSC22000 standard, the auditor required us to have annual allergen testing.

 

Thank you.

[GMO]

I'd doubt it as a CCP.  oPRP or PRP is debatable. 

 

If it was a CCP, unless you have continuous inspection of labelling (which is possible), I'm not sure you could justify you're monitoring it adequately.  But I'd also say that most factories use line clear downs and intermittent checking to ensure accuracy without having it as a CCP.

[Charles.C]

Thank you for your reply @Charles.

 

Our Allergen Management Program focused on Personnel Awareness through training and Finished Product Labelling (Allergen Declaration).

We followed FSSC22000 standard, the auditor required us to have annual allergen testing.

 

Thank you.

 

Hopefully yr auditor referred you to iso22002-1 / "allergens"

[monette maniago]

Thank you GMO.

I'd doubt it as a CCP.  oPRP or PRP is debatable. 

 

If it was a CCP, unless you have continuous inspection of labelling (which is possible), I'm not sure you could justify you're monitoring it adequately.  But I'd also say that most factories use line clear downs and intermittent checking to ensure accuracy without having it as a CCP.

[Charles.C]

Thank you GMO.

 

See post 13.

 

IMO yr auditor was likely ignorant.

[El Molino]

in discussion of allergens and "may contain" - refer also to your regulatory agency for allergen labeling - Allergens in Canada fall under the regulatory compliance and label standards - we also have based allergen control under the FSEP 2014 Prerequisite Program where the oPRPs are part of the PRP - allergens, labeling, foreign material detection etc.

[Charles.C]

in discussion of allergens and "may contain" - refer also to your regulatory agency for allergen labeling - Allergens in Canada fall under the regulatory compliance and label standards - we also have based allergen control under the FSEP 2014 Prerequisite Program where the oPRPs are part of the PRP - allergens, labeling, foreign material detection etc.

 

Thanks but the query related to Philippines  and fssc22000?

[El Molino]

Same answer - FSSC 22000 cannot trump the regulatory requirements (for Canada) - recommend the poster inquire with their regulatory standards first regarding precautionary labeling usage - then classify according to the correct analysis for hazard - labeling will more likely be managed as an SOP/ oPRP 

[Charles.C]

Same answer - FSSC 22000 cannot trump the regulatory requirements (for Canada) - recommend the poster inquire with their regulatory standards first regarding precautionary labeling usage - then classify according to the correct analysis for hazard - labeling will more likely be managed as an SOP/ oPRP 

 

I agree but the query afaik did not relate to Canada.

 

afaik the "Operational Prerequisite Program" as implemented  in Canada is literally unique. Maybe that is, afaik, why the (ISO) acronym OPRP is not used..

Edited by Charles.C, 06 May 2020 - 09:03 PM.
edited