4. Cost-effectiveness: Discussion and conclusions
It is well known that testing for allergens is expensive, making process validation an onerous as well as difficult task for food manufacturers. Food allergens management practices were variable among the SMEs visited, but improvements in allergen management were possible at all sites. Although contaminated ingredients could explain the analytical results, detectable levels of different allergen and products suggest that UAP are arising from processing/ manufacture.
Cost estimates presented in this study could help SMEs identify new measures and procedures to reduce the use of PAL, once food safety and labelling requirements are met. The proposed estimates are an average, as costs may be higher or lower depending on the size and organisation of a firm. In some cases, costs may be low, as similar procedures are in place for other reasons. However, many changes incur high cost and rely on availability of resources.
In the case of the biscuit producer, implementation of VITAL has resulted in good risk management of allergens, and low – though detectable – UAP. The use of PAL is based on further risk assessment and food safety requirements are likely to be met. Further improvements require either high-costs with the aim of removing PAL or applying “free from” with confidence. Refinements are possible, particularly medium-cost measures with medium-effectiveness. Cleaning is a particular target for improvement, as indicated by site visits, and although in principle medium-cost, are in fact likely to be of limited cost. The food supplement producer also had good allergen management procedures. Medium-cost medium-effectiveness appeared possible (further cleaning refinements, review of possible improvements), but there is little incentive for high-cost options as food safety requirements are likely to be met and PAL is not in place. In fact, although the incremental improvements are likely to be low-cost, they require consistent monitoring, which is costly.
The bakery was probably not meeting food safety requirements, although the specific legal situation is different given the nature of the foods and national provisions/ interpretation of food law. However, it would need to implement high-cost options to meet food safety requirements (specifically, management of rework), while also implementing a number of medium-cost medium-effectiveness actions as well as achieving a shift in culture with respect to allergen risk. PAL may also be a necessity, but application of the Tier 1 tool without the allergen tracking tool or a site visit, could underestimate risks significantly. As this bakery is probably representative of most mini- or micro-SMEs across the EU, it highlights the scale of the challenge in the EU, especially since measures such as scheduling, widely used in larger businesses, are not feasible.
As for the dry mix producers, implementation of best practices does not result in allergen levels less than LOD; application of Tier 1 risk assessment might be conclusive for food safety and use of PAL, although consistency in results should be demonstrated via analytical testing. Further improvements in the medium-effectiveness medium-cost category may be possible; only high-cost options might eventually bring levels below the LOD.
From a practical point of view, it should be noted that only site visits can identify that cleaning, for example, although in place and planned in accordance with the higher standard of VITAL, could be further improved before other more expensive measures are considered or manual cleaning whilst conductive to good results is more variable than automated cleaning. Thus, the allergen tracking and Tier risk assessment, and cost-effectiveness tools should be applied alongside site inspection.
The cost-effectiveness tool is more helpful than a checklist, as it guides personnel through options, taking into account the legal requirements, use of PAL, and goals of the business as well as financial constraints. As such, iFAAM recommends use as follows:
- Cost-effectiveness should be determine based on expected UAP, analytical results and measures in place using the food allergen tracking tool and potential mitigation measures whether the site is likely to meet food safety requirements (no detectable allergens, or levels below Tier 1 Risk assessment), taking into account PAL. It should be expect that some apparently-attractive options are not be feasible for smaller SMEs and training (cultural shift) may be required.
- If food safety requirements are not met, mitigation should be to improve practices and use PAL before repeating the assessment (1). This may require high-cost high-effectiveness measures (e.g. new equipment) to be implemented.
- If food safety requirements are met, consider the relevance of high cost high effectiveness measures in light of company goals (removal of PAL, etc.); only implement those measures that are relevant to control costs. If not relevant (i.e. PAL not in place or acceptable levels/ low risk), continued monitoring is essential because manufacturing practice changes.