Allergen management for food manufacture is a complex, rapidly changing field. Ensuring an allergen management plan is fit for purpose in a landscape of diverse and malleable regulations can be daunting. Many allergen management plans feature analysis as part of their validation and verification. Testing of ingredients, production surfaces, and final product are frequently parts of ensuring products do not contain unexpected allergens.
The world of allergen analysis is often foreign to manufacturers as it is based on knowledge of analytical chemistry techniques that are distinct to the skill set required for manufacturing. To add to this complexity, detection methods are often situational. Which analysis to use is often dependent on not only the allergen to be tested for, but also the material in which it is present.
It is not, however, all bad news for food manufacturers that want to ensure their products meet regulatory requirements and that want to provide their customers with confidence in the foods they eat. Most allergen analyses take place in a commercial lab, with manufacturers sending samples for analysis on a fee-per-analysis basis. Most of these labs perform enzyme-linked immunosorbent assay detection. Ideally, competent analytical labs will provide more than basic analysis. The best labs are often a rich source of helpful advice, guidance, and interpretation.
Choosing an Analytical Laboratory
The selection of an analytical laboratory is a decision that will impact implementation of your allergen management plan, and one that will (hopefully) positively impact your service for some time. You should, therefore, consider your decision carefully, much as you would any other business partnership.
The first criterion is the experience of the lab in testing foods for allergen residues. Many commercial labs focus on other types of analyses and have limited experience with allergens. Another obvious criterion for choosing your analytical partner is whether they offer analyses that are suitable for you. You should know which allergens are present in your facility, and have identified which ones you need to analyze. Your ideal laboratory should be able to test for the presence of these allergens, perhaps using more than one type of assay.
They should also be aware of how the detection methods they use perform in a range of different foods and ingredients, preferably the ones your facility uses or manufactures. Your lab should have allergen methods under the scope of a quality assurance framework (such as ISO 17025). Remember that ISO 17025 is not a general laboratory certification, but certification that the laboratory can perform certain specified methods to ISO 17025 requirements. Look for which methods are under the scope of an ISO 17025 accreditation.
Many manufacturers will know the allergens for which they need to test but will not feel that they have sufficient knowledge to select an analytical method themselves. In this case, try asking analytical laboratories which methods they would recommend. Do they present you with clear choices and recommendations with adequate justification? Do they clearly point out strengths and weaknesses of competing methods?
When comparing the analytical criteria of methods, be careful to look at the units presented. A lower number is not always better. For example, kits that report in quantities of β-lactoglobulin (BLG) may appear to be more sensitive than those that give their results in amounts of nonfat dry milk (NFDM). But are they really? A detection limit of 0.1 ppm BLG converts to around 2.85 ppm NFDM. Is your chosen lab aware of these unit differences and will they help you convert one unit to another? Do they answer your questions in a timely fashion? If you can answer positively to these questions, it is more likely that this laboratory will serve your needs well into the future.