Allergen risk management: Cost-effectiveness

1. Introduction

Undeclared allergens in food products are as a result of cross contamination (allergenic foods accidently mixed up non-allergenic foods) and pose a serious risk for food allergic consumers. During the production of foodstuffs, allergen cross contact can occur at different stages but particularly during preparation, processing and packing (Bucchini et al., 2016). 

Unintended allergen presence (UAP) (i.e. “possible and unintentional presence in food of substances or products causing allergies or intolerances” as defined in Article 36 of Regulation (EU) No. 1169/2011) occurs mainly in products from factories where multiple foods or ingredients are processed, and when allergenic foods/ ingredients are processed on the same production line (Jackson et al., 2008). Consumers are informed of potential UAP via precautionary allergen labelling (PAL or "may contain" warnings).

In the European Union, food safety requirements are laid out in article 14 of Regulation (EC) No. 178/2002, which stipulates that, “food shall not be placed on the market if it is unsafe, and this includes food which is injurious to health”. To determine if a food is injurious to health, health sensitivities of specific groups of consumers, where the food is intended for those individuals, should be considered along with labelling, such as PAL. As food allergen labelling concerns foods intended for all consumers, generally, food that contains undeclared UAP above certain levels are injurious to health.

Given the potential risk to human health, it is important to control UAP through risk management measures. When applying the iFAAM allergen tracking tool, or other guidelines based on hazard analysis and critical control points (HACCP) principles, insight into the (most) vulnerable areas of manufacture can help identify what measures are necessary as well as where they are needed. Costs associated with improving precautions, and or their introduction, are also a consideration.

For any food business, the process starts with UAP identification in the context of HACCP, followed by assessment of vulnerabilities in processing and allergen mapping; the iFAAM allergen tracking tool is designed specifically for this purpose. This assessment can be complemented by early consideration of risk management (i.e., have we implemented applicable risk management options?) and assessment of the food chain, using the chain vulnerability assessment tool.

Once this assessment is complete, and the measures in place meet best practice and food safety requirements, Tier 1 risk assessment can be used to determine whether food safety requirements are also met and there is an acceptable residual risk from UAPs. Included in Tier 1 is a method estimation of UAP in conjunction with analytical data or, as a preliminary approach, before starting an analytical programme. This tool also drives reduction of expected UAP (e.g., reducing allergenic ingredient use or carry over between production runs). The tool has been tested with SMEs and the results showed good correlation between analytical data and managers’ estimates.

If Tier 1 does not provide an acceptable risk, Tier 2 can be applied for a more detailed assessment, with support from TNO (NL).

If food safety requirements are not met at any level, risk management options, as described in the risk management options tool, can be used to identify ways to reduce UAP. This tool can also be used to exceed food safety requirements and, potentially, achieve non-detectable levels or support “free-from” claims, although particular care is required for the latter.

The tools can also be used to plan investment, once goals and specific costs have been added.

Users of the tools are expected mainly to be quality managers in food businesses. However, other users include auditors and regulators responsible for enforcing food law. The risk management options tool could be used, in partnership with existing guidance or IFS or BRC certification criteria, for assessing current practices and advising on improvements. For example, labelling control practices, from design to control, is a major factor in managing allergen risk, given its role in food allergen recalls.

In the case of recalls, authorities that find acceptable levels have been exceeded may require food businesses to consider risk management options for improvement or better monitoring of their supply chain. The supply chain is known to have a key role in determining risks such as presence of soy in wheat due to milling or transportation.

2. Procedures and measures of cost effectiveness

3. Examples

4. Conclusions


Use of the tools requires training/ support and, from 1st March 2017, EuroFIR AISBL and the MoniQA Association will facilitate such user support through referral. For more information, contact Sian Astley ( who - for the time being - will pass on enquiries. Ultimately, this will be replaced with a contact form, but the site is currently under construction