Food allergens – reference doses, action levels and precautionary labelling
Anton Alldrick and Helen Arrowsmith discuss aspects of allergen reference doses and action levels, and how they can they can be used to determine whether there a need or justification for precautionary labelling of products.
Helen Arrowsmith is currently a Principal Food Law Adviser and Allergen Specialist in the Regulatory Affairs Department at Campden BRI. Helen uses her knowledge, gained over more than 17 years working with the food and drink industry, to provide advice on relevant UK and harmonised EU legislation, to present on training courses, and to contribute to publications such as Food Law Alert. Read more...
Anton joined Campden BRI in 1990 and held a number of management positions before being appointed Special Projects Manager. He provides consultancy and project management services - particularly in the areas of chemical food safety and scientific regulatory affairs. Read more...
You may also be interested in
Interviewer: I'm at Campden BRI talking to Helen Arrowsmith and Anton Alldrick about their latest developments with food allergens. So there's a lot of talk at the moment about action levels, reference doses and precautionary labelling. So can I start by asking you Anton, what is a reference dose?
Anton: A reference dose is an index of safe exposure and there are essentially two types. One separates what is safe from unsafe. While another type which is going to be used in the action level calculations actually defines how many people are at risk or not at risk from having an adverse reaction.
Interviewer: So what about those that are at risk?
Anton: Well the calculations assume that either 95 percent or 99 percent of the food allergic population are protected. Unfortunately the clinical nature of food allergy is such that it's not possible to guarantee the safety of 100 percent of the food allergic population. So the reference doses that are being calculated for precautionary labelling purposes consider populations of either 95 or 99 percent population who would not be affected. So between one and five percent would still be affected.
Interviewer: So what about those one to five percent that are potentially still at risk?
Anton: Well the scientists who have developed the reference doses for these purposes believe that those individuals, although they might suffer an adverse effect, the severity of that effect would be far less.
Interviewer: So how does that relate to an action level?
Anton: Action levels can be used in determining whether or not you need to precautionary label a product for the presence of an allergen. And they're based on a reference dose which indicates what would be safe consumption for between 95 and 99 percent of the food allergic population.
Interviewer: So Helen, where would I find these reference doses?
Helen: The reference doses currently that are commonly used are available from the allergen bureau over in Australia. They've come up with a system called VITAL 2.0. Vital stands for voluntary incidental trace allergen labelling. And they have a tool which is web based where you can calculate an action level from a reference dose.
Interviewer: So I've got reference doses and I've got action levels. How do I go about using them?
Anton: You go about using them in terms of precautionary labelling and it must be emphasized that they can only be used for that purpose currently. And Campden BRI has recently produced a guideline document which includes a flow diagram which shows when and when not you can use them.
Interviewer: So could you give me an example of when it could be used?
Anton: So for example, it could be used in a case where you've got homogenous distribution of a cross contaminating food allergen in a ready meal, for example.
Interviewer: And could you give me an instance were it wouldn't be appropriate to use them?
Anton: Well one classic example would be where you've got a particulate contaminant for example, nuts, because action levels assume homogenous distribution. And nuts are obviously heterogeneously distributed because of their particulate nature.
Interviewer: So Helen, what are the consequences of this for testing food and drink products for allergens?
Helen: The consequences for testing are sort of far ranging and actually impact the choice of test before you even do anything. And also how you deal with the results once you've got them. One thing to say is that testing should really be used in combination with other aspects of managing food allergens, such as paper traceability. You can't solely base decisions on testing results.
Interviewer: So I'm thinking of getting some product tested for allergen. Where would I start?
Helen: The very first thing you need to do is speak to the analytical laboratory. It's very important that you get the right tests conducted on your product. In terms of specificity, so picking out which is the correct allergen or the allergen test to be using. An example of that might be a product which contains milk for example. The most relevant test here would be one for casein. Whereas if you were looking at a product containing whey power for example, the most relevant test would be for beta-lactoglobulin. So it's very important to get the correct test for the allergen that you're looking for.
Another thing to consider is looking at the need for a quantitative test. So the need to actually get a figure in terms of the results, there are a lot of tests on the market such as dip tests and a lot of the PCR or DNA based tests which can't provide you with a quantitative result. And there is a need in this circumstance to have that quantitative result.
Interviewer: So you got a test result from the analysis of a product and you've got an action level. So what do you actually do with these?
Helen: First remember that analysis is only part of the information that's required in making the decision on whether to precautionary label. You should also be looking at other information that's been gathered and calculations that have been conducted to inform that decision. We also need to remember that at this point the assumption is that good manufacturing practices are already in place. So you've already looked at your process and your raw materials and that you're cleaning to prevent any contamination. So then once you've got your analysis result you compare that with the action level. And if the action level is exceeded that triggers the need for the precautionary labelling.
Interviewer: So where's all this fit in with established systems for assuring product safety?
Anton: Well one of the important things in food allergen safety management is to ensure that what takes place in the factory is accurately reflected on the label. So the use of action levels will allow food manufacturers to give more careful consideration as to whether or not they need to apply precautionary labelling in certain cases.
Interviewer: We've covered a lot of information there much of which is presented in much more detail in the Campden BRI guideline 71, Food Allergens, Practical Risk Analysis Testing and Action Levels. And if anyone wants to talk in more detail then they can talk to you, Anton, about food allergen management and risk analysis and to you, Helen, about aspects of testing food and drink for allergens. Anton Alldrick, Helen Arrowsmith, thank you both very much indeed.