Risk assessment for prepacked foodstuffs

A rigorous, stringent and comprehensive risk assessment of the product, its ingredients and production is an essential pre-requisite for proposing to apply a “free-from” label to any product. It should cover all elements from raw materials to packing, assessing the probability of contamination by the allergen from various sources. It must be proportionate to the increased probability of harming consumers, at whom those products are specifically targeted. If an allergenic ingredient is present (e.g. used in other product lines), then the risk of cross-contamination from the specified allergen must be strictly controlled with GMP or as part of the site's HACCP system.

The scope of the risk assessment should consider the following factors for prepacked foods:

  1. Supplier quality assurance, raw material approval controls & supply agreements
    1. Can the supplier consistently demonstrate that all raw materials are “free-from” the specified allergen and is this covered in the terms of supply agreement?
    2. Has the raw material supplier been initially approved and regularly audited to assess their ability to reliably maintain the “free-from” status of the supplied raw materials?
  2. Facility design
    1. Is the production facility dedicated to exclude the allergen for which the “free-from” claim is made?
    2. If the production facility is not wholly dedicated, is it sufficiently physically or time segregated to eliminate the risk of cross-contamination (change of work clothing, storage, production scheduling, warehousing, material flows etc.)?
  3. Production controls
    1. Are defined control measures in place at the manufacturing facility and have these controls been validated?
    2. Are these controls periodically verified and continuously monitored?
    3. If those controls include cleaning and sanitation, have these been demonstrated reliably to remove the allergen(s) of concern to the required extent?
  4. Product testing
    1. Testing for the specified allergen in the product can be an effective way to verify allergen management controls. It is never a substitute for good allergen management. The necessity to test and how to implement a robust programme depends on a number of considerations. These include the way the product is produced, the type of product and the type and form of the allergen being tested for. Have you considered the role and purpose of testing and whether it would effectively verify allergen management controls?
    2. Where testing is considered appropriate and necessary, have you considered:
      • What will be tested?
      • Where in the production process will the samples be taken?
      • What test method is most appropriate?
      • Based on risk, how frequently should samples be tested?
      • How much a sample should be and whether this is representative?
      • What action will be taken following results? Have you considered positive release procedures to assure the “free-from” status of the product?
  5. Distribution & transport practices
    1. Have distribution and transport practices been assessed in the risk assessment (considering off-site storage or third party hauliers)?

For information on allergen management see:


Next page: Risk assessment for non-prepacked food-stuffs and catering


Last reviewed: 12 Nov 2015