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.
Finding a lab that can conduct your full range of required analyses is tempting. It is worth remembering, however, that allergen analysis and data interpretation can be very different compared to other types of testing for food safety. It’s best to find an allergen analytical service that has a good understanding of food allergens, testing, and regulations. The advice such laboratories can offer in developing and carrying out an allergen management plan is potentially of more value than the convenience of using one supplier for all analytical needs. This being said, if a laboratory can offer both comprehensive food testing and expert guidance and interpretation, this should be a preferred option.
Sending a limited number of samples to an analytical lab can be a useful “road test” of a future relationship. Turnaround time is, for some food safety applications, a crucial factor. The laboratory may give a maximum turnaround time from receipt of samples, but how fast is shipping to their location? How your analytical data is presented to you is also extremely important. The quality and detail of result reporting can be surprisingly varied. Does the lab report contain all of the data you need for your allergen management plan and to satisfy potential auditors? ISO 17025 reporting requirements are a good reference for what constitutes a complete report. The method used and the units in which this method reports are essential information. It is important that the company help explain or further interpret data contained in the report.
Working with Your Analytical Laboratory on Allergen Management
After selecting a laboratory a good first step is to establish a point of contact. Being able to deal with the same knowledgeable person within a lab can smooth the process of getting the information you are after. This person will also have a good oversight of different analytical methods and validation data.
Get into the habit of contacting your partner laboratory before sending samples that are different from samples you would usually send. This might include differences in the material composition of the samples, which can cause issues for labs in terms of something as simple as grinding, or mean that results may be affected in ways in which the lab can help to predict. As noted previously, the food matrix on which an analytical method is used can greatly affect the results and their interpretation. Many heavily processed materials may give lower than expected analytical results. In some cases, methods may give false positive results when used with certain food matrices. Interpretation of analysis of materials that have been fermented or distilled can be particularly problematic. A good laboratory will be able to advise you ahead of time regarding the applicability of methods to your situation. Your partner lab will also appreciate advanced notice that you will be sending large numbers of samples so that it can plan for a heavy workload and pre-order necessary supplies.
In some cases, food manufacturers may be loath to disclose compositional details for confidentiality concerns. Such reluctance is often unjustified, as the terms of service of most analytical labs include guarantees of confidentiality. It is always worth checking these to assure yourself that you may speak freely to the analytical lab regarding details of your samples. The ability to fully describe the sample you are analyzing can often be crucial to selection and performance of methods as well as interpreting what results may mean.
Regardless of whether or not product compositional information is disclosed, it can also be beneficial to provide positive and negative controls to an analytical lab, particularly when analyzing a new ingredient, product, or formulation. You should also keep replicate samples of those sent for analysis. Not all analytical labs retain portions of analyzed samples, so if the lab needs to a repeat an analysis you may need to provide another sample. If possible, build sample replication into your analytical strategy. Taking replicate samples of ingredients or finished product may be relatively simple, but taking replicate swabs may be more challenging. When faced with unexpected analytical results, however, you will not regret the effort.
What to Expect from Your Lab
The benefits of maintaining a good relationship with a well-run, knowledgeable analytical laboratory will become evident over time. However, many clients do not request help beyond the analysis itself, thereby denying themselves a potentially invaluable source of information.
As expert users of detection methods, people who work in allergen analysis laboratories, particularly those in management positions, are often uniquely qualified to interpret results and advise on the suitability of different methods. Provision of such additional information is most often part of providing an analytical service, so do not be afraid to ask questions. More complex, time-consuming advisory services are sometimes dealt with through consultancy arrangements that (typically larger) analytical laboratories may provide. However, many relatively simple questions should be fully addressed by the lab as part of an analytical service.
You should be satisfied as to what an analytical report means, and what its implications are. Reports can appear complex and full of jargon to the uninitiated. Your lab should be able to tell you, in clear and plain language, what any problematic terms mean and what the implications might be. Much of the language may be standardized, and appear on most reports of the same type, regardless of which laboratory performs them. In some cases, different lab practices may result in terminology that you are not familiar with. For example, labs may subsample materials you send for analysis. A lab code for this subsample may be used in reporting. You should understand if this has occurred, and how such subsample names are derived.
Labs should be able to provide guidance on analytical methods that you perform yourself. Frequently, an allergen management plan may feature both in-house and lab-provided analyses. Lateral-flow devices, for example, are most often designed so that analysis may be performed entirely within a manufacturing facility. A good analytical lab should be able to inform you which in-house analyses to use within your allergen management plan, and how to perform them properly.
You should be confident that your analytical method is detecting the allergen it is meant to detect, and have some idea as to how sensitive it is. In theory, this should be simple. An egg detection method should detect egg, and measures of sensitivity (e.g., limit of detection and quantitation) should be available from the manufacturer of the method. However, methods differ widely in how they detect allergens in different types of food, or after processing (usually heating). Your lab may be able to provide information as to how your selected allergen detection method is likely to work in your individual circumstances.
A good first choice in finding this information is in validation reports from the kit manufacturer. It may be that the method was tested under conditions that are similar to those that you are testing under. If not, the analytical lab may have tested under similar conditions and be able to inform you of how well the method is likely to function.
If you are testing a “difficult” food matrix, or an extensively processed material, and no information on test performance already exists, it may wise to validate the method for your particular conditions. This will typically involve a “spike and recovery” type experiment where the method’s ability to detect a known amount of allergen in your food matrix is determined. Validation is more useful if you will be analyzing the same material many times using the same method, and you have reason to believe that the method is not functioning well. Your laboratory should be able to help you decide whether such a validation is necessary, and, if so, to design and conduct this type of validation with your input.
Allergen analysis may be more prone to interference and subject to interpretation than comparable chemical analyses. For the most part, this is due to the regulatory necessity of having to analyze for the presence of whole food, such as peanut or egg, rather than well-defined chemicals. It is also problematic that regulators do not stipulate levels at which allergens are deemed to be safe. The nuances of allergen detection make the relationship between food manufacturer and analyst more important than is the case for other food analyses. As with any relationship, communication is the key to success.
Johnson is an associate professor of food science and technology at the University of Nebraska-Lincoln. Reach him at [email protected]. Downs is an assistant professor of food science and technology at the University of Nebraska-Lincoln. Reach her at [email protected].
ACCESS THE FULL VERSION OF THIS ARTICLE
To view this article and gain unlimited access to premium content on the FQ&S website, register for your FREE account. Build your profile and create a personalized experience today! Sign up is easy!
GET STARTED
Already have an account? LOGIN