Freedom From Allergen Risk

In addition to these basic training requirements, instruction should ensure that employees working in areas where color-coded systems are used to segregate equipment are able to identify color differences (e.g., training should include checks for color blindness).

Raw Materials and Supply Chain

The stringent policies adopted to exclude allergens need to extend to the entire supply chain. For a food manufacturer switching from non-dedicated to dedicated free-from production, this usually requires some fairly exhaustive preliminary work. Ingredient suppliers should expect their own practices to be thoroughly scrutinized by their customers and should carry out extensive checks on their own suppliers and distributors.

Manufacturers should demand that their ingredient suppliers complete an extensive allergen questionnaire to qualify the risk of contamination in their ingredients or facilities. Those candidates identified as able to supply allergen-free ingredients should then be subject to a third-party audit, using the questionnaire as the basis for the audit standard.

Ingredient suppliers should make similar audits of their own suppliers; once the supply base is established, the allergen-free policy can be reinforced using binding contracts, which should extend to the purchase order system.

Analytical Testing of Ingredients

Before manufacture, an initial comprehensive ingredient screening regime is needed to validate the findings from the supplier risk questionnaire/audit. Testing will form the basis of this screening, and the frequency of sampling will be dictated by the inherent risk of contamination associated with a given ingredient. The actual route of likely contamination will also need to be taken into consideration when devising specific sampling plans: for example, nut fragments (hot spots) versus residual surface cross contact (homogeneous).

An independent, accredited laboratory using the most sensitive, validated methods available should conduct the testing. It is worth remembering that no test can show the absence of an allergen; it can only prove that a given allergen is not present at levels that exceed the limit of detection. So, although a negative result cannot be taken as a 100% guarantee that an allergen-free ingredient has been produced, a positive result definitely reveals that allergen-free production has not been achieved.

It is also worth remembering that any analytical technique needs to be fully validated for use on a particular food matrix. For example, there are many commercially available assays for nut allergens, but it is preferable that contract labs use enzyme-linked immunosorbent assay kits approved by internationally recognized organizations such as AOAC. The lab itself should also have external accreditation (e.g., International Organization for Standardization or the United Kingdom Accreditation Service).

The results from the initial screen can be used to construct a matrix based on analytical results and audit findings. Only suppliers that meet both prerequisites should be sanctioned for use in allergen-free manufacture, and this level of screening must be maintained until the manufacturer has complete confidence in the allergen-free status of ingredients. This screening process should also be mandatory for all new production batches. Once the manufacturer is confident about the ingredient, the sampling frequency can be reviewed accordingly.

The detection of a positive result above the action limit—a quantifiable result—should automatically trigger the rejection of an ingredient and the reinstatement of the supplier/ingredient to the original sampling frequency. This situation should persist until it can be reliably demonstrated that the contamination issue has been resolved. Of course, the ingredient supplier needs to have an effective traceability system in place so that any recalls that are necessary can be carried out effectively. This system can be tested, as can the decision-making process leading up to a recall.

Reading Scientific Services Ltd. (RSSL; Reading, U.K.) recently ran an incident management scenario for members of its emergency response service in which participants were progressively introduced to a scenario of escalating crisis built around contamination of product with peanut protein. The event successfully challenged participants to work out just when and how the decision to recall might be reached. Any training of this kind is useful in helping a business deal calmly with a potential crisis.

Sanitation

Plant sanitation matters most where equipment is used both for allergen-free production and standard production. Of course, it is preferable to have dedicated or strictly segregated production, and, in this instance, intensive allergen sanitation is a prerequisite following plant or zone dedication. In theory, the only other case in which intensive allergen sanitation would be required would follow the detection of a contaminant.