Shelf-life is traditionally associated with food safety. Also in relation to the MOCAs (Materials and Objects Intended for Food Contact) used. (1) Moreover, an integrated approach to its management can help prevent serious risks of noncompliance that relate to weight loss of prepackaged food products.
Safety and fitness of the food for human consumption
Food safety, in the definition introduced by the General Food Law, is expressed by compliance with two essential requirements:
– Absence of risks in the short, medium, long and very long term related to the consumption of the food. Also taking into account the sensitivity of vulnerable consumer groups, chronic cumulative toxic effects and those transmissible to offspring,
– fitness for human consumption of the food ‘according to its intended use, as a result of contamination due to foreign material or other reasons, or as a result of putrefaction, spoilage or decomposition.’ (2)
The evaluation
The security assessment must consider:
– ‘the conditions of use normal of the food by the consumer at each stage of production, processing and distribution,
– information made available to the consumer, including information on the label‘. (2)
Reg. (EU) 2017/625 then distinguished the concepts of hazard (understood as ‘any agent or condition having potential harmful effects on human, animal or plant health, animal welfare or the environment‘) and risk (as ‘afunction of the probability and severity‘ of occurrence of the hazard). Thus prescribing the extension of risk analysis to factors that may affect human and animal health, animal welfare and the environment (3,4).
Shelf-life and accountability
The operator responsible for B2C and B2B( Business toConsumers and Business to Business) information bears the burden of defining the shelf-life-or durability-of the product. That is, the period within which the food can be consumed under conditions of:
– security, based on the requirements mentioned above,
– quality, understood as substantial invariance of the food’s own organoleptic characteristics as it is placed on the market.
Deadline and TMC
This responsibility is expressed by inclusion-on the label and/or in the commercial information accompanying the food, as well as on the outer packaging containing multiple units of prepackaged products-of:
– expiration date, for microbiologically rapidly perishable products,
– minimum storage term, for other foods.
Responsibilities first hinge on the operator who has ownership or management of the brand under which the food is marketed and of the importer, for products arriving from non-EU countries. In each case, the concurrent liability of the distributor is added (5,6,7).
Shelf-life and realistic storage conditions
Shelf-life predictions and tests must take into account realistic product storage conditions at the logistics and distribution stages. Without neglecting the one after purchase, as pointed out by reg. EC 178/02. (8) With special attention to thermal aspects, which have been the subject of numerous experimental studies and regulatory insights.
The Ministry of Health-in its explanatory note 2.7.13, ‘Application Clarifications on Yoghurt Storage Temperatures‘-had highlighted the need to consider discontinuities in the cold chain as an ineradicable condition. In light of EC Regulation 852/04 one must ‘demonstrate through shelf life studies that the temperature indicated on the label does not expose the consumer to any risk‘.
Voluntary standards, work in progress
ISO 20976-1:2019 in turn offers an application example on how to consider thermal alternation in shelf life assessment. (9) Referring, in the case and for the specific purposes, to the time required to reach the Listeria monocytogenes criterion of LOG 2 (100 CFU/g). Following the European Commission Communication (2016) on food safety management systems, risk assessment related to possible cold chain disruptions was included as an Action Criterion, in the program of operational pre-requisites (PRPs) (10,11). With a more flexible and realistic approach that overcomes the rigidity of its historical framing in CCPs as a Critical Limit.
ISO Technical Committee TC34, Subcommittee SC17(Food Safety Management System)-where this writer has represented the European food industry for several years-is now working, through Working Group WG11(prerequisite programs on food safety), on the definition of PRPs to be applied within distribution activities. Management of the microbial multiplication hazard will be included there, also with a view to adopting an ISO 22002 standard of unitary value from farm to fork. (12)
Shelf-life and weight loss
The risk analysis associated with shelf-life assessment, on closer inspection, should also consider the serious risk of noncompliance associated with natural decline in product weight. A particularly topical phenomenon in the summertime, with serious legal liability implications.
Net quantity is the only mandatory label information subject to a placement requirement, in the same visual field as the food name. (13) Precisely because the food name and quantity are the basic data that characterize the economic offer.
‘Indication of the net quantity is not mandatory for foods that are subject to considerable loss of their volume or mass and that are sold by the piece or weighed in front of the purchaser.’ (14)
In some cases-such as those of cured meats and deli products-the distributor can address weight loss by weighing and re-labeling products daily. On the other hand, the situation is critical when the product subject to natural weight loss, even significant, is pre-packaged in preserving liquid or otherwise in packages that cannot be opened without damaging the product and therefore does not allow for verifications by the point of sale.
The case of mozzarella cheese
Mozzarellas are subject to inevitable and significant natural weight loss, which varies in relation to endogenous (fermentations that result in continuous product evolution) and exogenous (temperature, handling, crushing) factors. Drained product can often be lower in weight than declared, even a few hours after the goods leave the production plant.
In the case of official public controls , the risk of prosecution and conviction of the responsible operators (see supra) for the crime of fraud in trade is high, in the face of established case law in this regard. On the other hand, it is absolutely forbidden to refer to ‘natural weight loss,’ its approximations or other similar wording. (14) And it is not materially possible to subject mozzarella cheese – like other foodstuffs (e.g., mozzarella canned fish ‘au naturel‘) immersed in preserving liquid-without breaking the relevant packaging.
Metrological tolerances of the rest tend to crash with reality, where the weight stated on the label must always and in any case be guaranteed to the consumer throughout the product’s life cycle. With no margin, in fact, for fault tolerances.
Validation of operational PRPs
Prof. Gianni Di Falco-in addition to coordinating in UNI WG 14(Food Safety)-represents the Italian standards body in the ISO TC34/SC17/WG11 Working Group. And it is he who confirms the criticality of the weight-loss issue. ‘This is a critical issue that does not relate to microbiological aspects but has just as much importance in evaluations and decisions on product shelf-life. With significant business and legal implications.
This phenomenon touches products in which it is easily managed with controls made at the point of sale (e.g., cured meats),
but in other cases this is not possible because the products are packaged (e.g., mozzarella, salmon). And that is why it could be considered, in the ongoing work on the draft UNI 1607481 standard on validation of operational PRPs (PRPo).
In fact, PRPo validation represents the only means of consumer assurance and protection. Particularly for products that cannot be checked during the distribution phase. Communication C/2016/4608, after all-although aimed at food safety aspects-emphasizes once again the importance of risk assessment. In terms of being able to objectively demonstrate the ability to achieve the set goals based on the control measures taken.
The point of view of the large-scale retail trade
Gianni Di Falco – who represents the distribution in UNI – goes on to point out that ”these principles should be applicable not only to food safety aspects but to all those situations that are relevant to consumer assurance and can lead to serious legal consequences. The distribution sector is therefore pushing to develop both PRPo and validation concepts.
Serious operators will then have indisputable ‘due diligence’ tools. Particularly when control tools cannot be applied at the sales stage and the distributor is solely responsible for the information provided (MDD products), supplier qualification and PRPo validation are the only serious and objective means of protection. Applying the same principles that are used to define the maturity (and TMC) of products.
We need to get out of the self-referential logic that if you work well at the origin everything else is a consequence and the problems belong to others. The distributor has the responsibility to handle the products properly, but the manufacturer must predict what the ‘realistic distribution conditions’ are.
Interim conclusions
In the face of widespread reports of non-compliance-and consequent risks to the application of criminal and administrative penalties (7)-it is considered necessary to extend the criteria adopted for defining microbiological shelf-life to weight reductions of prepacked products.
These assessments-which fall to the owner of the brand under which the food is sold, in the various cases of IDM and MDD-must always be shared with the distributor, as he in turn is responsible for the completeness and truthfulness of the information offered on the label (5,6). Also with a view to sharing know-how of collective interest, with a view to continuous improvement.
Thus, the perspective is the development of reliable protocols for shelf-life assessments with an integrated approach, prevention of non-compliance risks and mitigation of their impacts on companies and their legal representatives.
Dario Dongo
Notes
(1) TMC on PET vinegar? Lawyer Dario Dongo answers.. FARE(Food & Agriculture Requirements). 19.3.19
(2) Reg. EC 178/02, Article 14
(3) Reg. EU 2017/625, Art. 3, para. 23 and 24
(4) Dario Dongo, Giulia Torre.
Official public controls, EU Regulation 2017/625 kicks off.
. GIFT (Great Italian Food Trade). 18.12.19
(5) Dario Dongo.
The responsibilities of the large-scale retail trade.
. GIFT (Great Italian Food Trade). 17.3.18
(6) Dario Dongo, Pier Luigi Copparoni. Distributor responsibility, insights. GIFT(Great Italian Food Trade). 22.5.18
(7) Dario Dongo.
Corporate administrative responsibility in the food supply chain.
. GIFT (Great Italian Food Trade). 21.6.18
(8) Reg. EC 178/02, Article 14.3.a
(9) ISO 20976-1:2019. Microbiology of the food chain – Requirements and guidelines for conducting challenge tests of food and feed products. V. Annex E
(10) Communication from the European Commission on the implementation of food safety management systems concerning prerequisite programs (PRPs) and procedures based on HACCP principles, including facilitation/flexibility of implementation in certain food businesses (C/2016/4608, in OJEU 2016/C 278/01)
(11) ‘Operational PRPs are PRPs that are generally linked to the production process and are categorized as essential by hazard analysis for the purpose of controlling the likelihood of introduction, survival and/or proliferation of food safety hazards in products or the processing environment.’ V. Notice referred to in footnote 10, paragraph 5
(12) ISO/TS 22002-1:2009. Prerequisite programs on food safety. The standard was reviewed and confirmed in 2020. ISO has, moreover, declined the ISO/TS 22002 Technical Specification into 6 Parts, dedicated to the different sectors (1:2009 Food manufacturing, 2:2013 Catering, 3:2011 Farming, 4:2013 Food packaging manufacturing, 5:2019 Food storage, 6:2016 Feed and animal food production)
(13) Reg. EU 1169/11, Article 13.5
(14) Reg. EU 1169/11, Annex IX(Indication of net quantity), point 1.a
(15) Nominal quantity, net weight, drained weight, replied the lawyer. Dario Dongo. FARE(Food & Agriculture Requirements). 20.1.17
Dario Dongo, lawyer and journalist, PhD in international food law, founder of WIISE (FARE - GIFT - Food Times) and Égalité.
