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Allergy Today: What do ‘May Contain’ Statements Actually Mean?

Posts to Allergy NZ’s Facebook page have again highlighted the confusion over ‘may contain’ allergen statements on food labels. The main thing to know is that the statements are not regulated. iStock-1213725710-337

Food manufacturers are only required to warn about food allergens on the label if they are intentionally in the food; e.g. put there as an ingredient or a processing aid. Listing them on the ingredients list is sufficient. Anything else on the label about allergens, including a separate ‘Contains xxx’ and/or ‘May contain’ statement, are put there voluntarily by the manufacturer, and there are no rules on their use.

This has led to a lot of confusion for everyone – not only consumers, but manufacturers, regulators and health professionals. For consumers with food allergies though, it is known to increase anxiety and impair quality of life. This is due to the difficulty in assessing your/your child’s individual risk in relation to products that may – or may not – be safe. In some cases, this also means not having any safe options for particular foods or ingredients.

While it seems logical that precautionary allergen labelling (PAL) - as it is referred to internationally – should be regulated, there are a number of issues that have to be resolved first.

Anyone living with food allergy knows the main risk in food preparation is cross-contamination with the food you/your child is allergic to. These same risks also arise in food manufacturing. There are many opportunities for food to be contaminated in the production process, literally from the paddock to the plate, including where and how it is grown, stored, transported, and processed. Food can be comprised of ingredients from more than one manufacturer, and with the global nature of the industry, these manufacturing processes can be in any number of countries before being imported into New Zealand and processed into the final product. The more ingredients in a product, the more processing is likely to have happened, resulting in a higher risk of cross-contamination.

Food allergens are proteins in certain foods. They are also known to be very ‘stable’ and don’t change structure significantly with heating and other processes. Some, such as nuts, can be oily and sticky so are very hard to clean off surfaces. It should also be noted there are complex issues around testing food products for food allergens, so this isn’t yet a way to solve the problem.

Food manufacturers and food retailers (e.g. a supermarket that has its own bakery) in New Zealand are required to have an allergen management plan to minimise the risk of cross-contamination. However, for many manufacturers, they cannot entirely eliminate the risk, particularly with ingredients that have been imported, and/or where manufacturing takes place in facilities where a range of food, including allergens, is stored and processed.

A PAL statement is normally decided after an assessment of the risk of a food allergen unintentionally being in a product. Although some consumers may consider PAL statements to be a way of food businesses ‘covering themselves’, most food operators are more concerned about inadvertently causing someone to have a severe reaction. The cost of a food recall, if they get it wrong, can also be prohibitive, including the damage to reputation and brand.

PAL is therefore a dilemma for manufacturers, who try to convey as much information as they can about the risk. This can often lead to variations in the wording of PAL, such as:

‘May contain x’; ‘May be present: x’; ‘Not suitable for x allergy sufferers’; ‘Manufactured on the same equipment as products containing x’; ‘May contain traces of x’, etc.

Surveys have found that consumers, as well as health professionals, interpret some of these statements as conveying a lower level of risk than others. Unfortunately, there is currently no agreed scientific basis on which a level of risk can be based in relation to any of these statements.

Given that PAL is commonly based on the assessment of risk of cross-contamination rather than an actual measure of how much is in the final product, it is possible that some products with PAL are quite safe, however, the consumer has no way of knowing this, and therefore, their food choices may be restricted unnecessarily.  

So, what is being done to resolve these issues?

Although allergen management is currently required under New Zealand’s food safety regulations, the standards for this are not defined. There are, however, industry guidelines. VITAL (Voluntary Incidental Trace Allergen Labelling) was established by the Australia New Zealand Allergen Bureau (http://www.allergenbureau.net/) several years ago and is now recognised internationally. VITAL, through its robust allergen risk assessment process, both identifies and quantifies potential cross-contamination for all ingredients right from source. The process requires the manufacturer to, if possible, eliminate an identified risk. Where this is not possible, the decision-making tool developed as part of VITAL is used to quantify the amount of each allergen that could be unintentionally in the final product.

The decision then to add a PAL statement to the final product (VITAL uses ‘May be present: XX’) is based on the concept of ‘reference doses’. This has been defined as ‘the amount of protein from an allergenic source judged to pose an acceptable risk of a reaction’. Of course, for consumers, any risk of reaction is not acceptable. However, the statistical modelling that has been done means that the risk is extremely low. For example, reference doses are based firstly on clinical data internationally, defining ‘ED01’. This is the allergen dose which ‘elicits’ a mild reaction in only 1% of the overall population of people allergic to that allergen; while the remaining 99% have no reaction at that level. Reference doses are then modelled to take other factors into consideration, such as exercise or illness which may lower an individual’s threshold level from the norm.  

An expert international scientific and clinical panel convened by the Allergen Bureau has reviewed and updated the reference doses used by VITAL and deemed them to be low risk. Allergy New Zealand and Allergy and Anaphylaxis Australia have also been consulted on these. Several countries are now considering them for regulatory purposes.

In the last step of the process, VITAL uses the reference doses to define ‘Action Levels’ for determining whether a PAL is required. If the amount of unintended allergen in the product is assessed as being lower than the reference dose, then the risk to the consumer is low and a PAL is not needed. If it is ‘at’ or ‘above’ then there is a risk of a reaction, and the ‘May be present xx’ statement is used.

While the use of VITAL in New Zealand and Australia is voluntary, the international Food Allergy and Anaphylaxis Alliance (of which Allergy New Zealand is a founding member) with more than 30 countries represented, have contributed to proposals made to CODEX (the world food standards-setting body under the United Nations). The proposals are to:

a) Adopt a code of practice on food allergen management for food business operators (largely based on VITAL); and

b) Adopt guidelines for precautionary allergen labelling based on a quantitative assessment to determine the level of potential exposure to the allergen concerned.

These proposals have been led by the Australian government and are supported by government representatives from many other countries, including New Zealand.

Assuming these changes to CODEX are successful, they will enable national food standards bodies internationally to regulate the code of practice on food allergen management, and the use of PAL based on agreed reference doses. It will also mean that, regardless of whether manufactured food is made locally or imported, the same standards will apply.

However, the steps to achieving this will take time to put in place. A number of scientific assessments and surveys need to be completed, and consensus needs to be achieved across many countries and stakeholders.

If successful, the education of consumers with food allergy, and healthcare professionals, will also be critical in enabling consumers to more effectively assess individual risk, have more trust in food allergen labelling, and more choice.

In the meantime, we recommend:

i) Always read every label, every time. If there is something you don’t understand, contact the manufacturer or food business concerned, to ask about their ingredients and manufacturing practices. Ask if they use VITAL.

ii) Don’t ignore PAL. You may eat a product numerous times without having a reaction but the next time you may not be so lucky. Cross-contamination can be intermittent.

iii) Assume all versions of PAL mean the same – that is, ‘there is a possibility of some of this allergen unintentionally in this product’. Contact the manufacturer or food business concerned if you are unsure if it is safe for you.

iv) As part of your assessment of risk in whether or not to eat a product with a PAL for the food you are allergic to, take into account whether you/your child is unwell, and/or whether you have your EpiPen® on hand.

v) Be careful with imported products. Food labelling regulations vary by country. Imported items are supposed to comply with New Zealand’s food regulations but occasionally they may not, and it may be difficult to get information on the ingredients and manufacturing practices used.

Penny Jorgensen, Allergy Advisor, Allergy New Zealand.