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”
“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 – 126.96.36.199 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
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 -
(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 188.8.131.52.1. 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
Edited by Charles.C, 11 April 2020 - 09:10 AM.