CODEX and How Your Allergen Labelling Might Change: 5 Things You Need to Know

Changes in the CODEX standard for allergen labeling are coming, but how will they impact the way I label my products? While it may take some time before these changes are implemented as regional and local regulations, food producers need to know what’s coming so they can prepare. Here, we take a look at some of the proposed changes and the questions that they can raise.

1. What are the proposed CODEX changes about?

We can summarize the changes proposed by the committee of experts as follows:
- The removal of some “classic” allergens from the global priority allergen list: soybean, Brazil nuts, macadamia nuts, pine nuts and oats, all of which would be included in a “secondary” priority list in the future. Different countries can decide whether to include them depending on their regional prevalence;
- The inclusion of sesame as a global priority allergen;
- The active monitoring of some allergens that could gain more importance when more data is available (kiwi, insect protein, etc.) to assess their future inclusion;
- The establishment of reference doses for allergens on the global priority list. These reference doses correspond to the amount of allergen that 95% of allergic persons can consume without showing severe reactions. These doses are meant to be applied to allergen management programs as part of risk evaluation and to inform decisions such as whether to use precautionary allergen labeling (PAL);
- The establishment of a regulatory framework for PAL that defines when it is permissible to apply it and how to do it. 

2. Do the changes mean that I need to stop labeling for soybeans and start doing it for sesame?

When it comes to soybeans, the quick answer is… it depends. Although soybean has been removed from the list of global priority allergens, there are still regional differences and the standard sanctions, including extra allergens in local regulations to reflect these differences. Normally, it is much easier to tighten a regulation than to loosen it. Some countries will decide to keep the soybean labelling requirement in spite of the standard recommendation as the regulation is already in place there. A similar case can be made for Brazil nuts, macadamia and pine nuts.

The case of sesame is much more straightforward, and this allergen will likely be incorporated into the current list of allergens that require labelling in all countries that are members of the World Trade Organization (WTO). Why? For the same reason mentioned above: making regulations stricter is usually easier than weakening them.

3. Do I need to include PAL on my labels now?

The easiest answer for this one is, “no, not yet!” While the committee of experts has recommended that a regulatory framework for the application of PAL be created, their work could spur the creation of another task force specifically devoted to PAL instead of the immediate application of any recommendations. Indeed, the committee has proposed not only the creation of the framework; they have also recommended how and when to implement PAL.

By now, it is common knowledge that PAL in its current form is used in a heterogenous way and in many cases, its application is arbitrary and is not based on appropriate risk evaluation. Furthermore, not many countries have a regulation that contemplates the use of PAL on pre-packed products, let alone how to do it.

The expert committee has taken an approach similar to the one already proposed by the Allergen Bureau in the VITAL^® Program, i.e., that the use of PAL should be based on the application of an exhaustive risk assessment-based allergen management program that includes the contrast of allergen content in the final product with reference doses. Furthermore, the use of PAL would be subject to prior implementation of such programs and may be otherwise prohibited. In the case of the expert committee, they have used a slightly different approach on how to establish the reference doses. Nevertheless, the general application of these is the same: the reference doses would be used to establish action levels for the end-product; these would in turn be used to inform the decision on whether PAL should be applied.
 

4. If reference doses are established with  protecting 95% of the population in mind, couldn’t I better protect my business if I apply PAL, even if the action level has not been reached?

No. Indeed, the proposal includes the recommendation that PAL must not be implemented if the presence level does not exceed the action. This measure clearly addresses the issue of the abuse of PAL by some manufacturers. The recommendations go even further and suggest a clearly visible logo that indicates that an appropriate allergen risk evaluation has been implemented in producing the food, regardless of whether PAL is used.

There’s more: the 95% cut-off value chosen considers not only the occurrence of allergic reactions but also the severity of these reactions. This way, the expert committee considers that any reaction reported for the consumption at and below the determined reference doses would be mild. This would avoid both overprotecting customers in a way that doesn’t bring them any extra benefit as well as the need to create excessively sensitive methods of detection for some products.

5. Will I be able to label my food as “allergen-free” if any allergenic content is below the recommended reference doses?

No. Just note that the threshold levels are meant to be implemented as a tool to help decide whether PAL is necessary. They are not to be applied as a criterion for deciding whether a product can be labeled as “free-from”. “Free-from” foods are largely undefined and their labeling is not regulated. Hence, the committee expressly discourages this. To include any “free-from” label, the producer must rely on appropriately selected standards that can ensure the safety of their food and the reliability of such a claim. Nevertheless, this goes beyond the scope of this discussion and of the recommendations of the expert committee.

Conclusion: Time to get ready for CODEX

These proposals are still waiting for the approval of their respective CODEX commissions. While the publication of the new standards as well as their further adoption by all signatory countries is not something that can be done overnight, one thing is clear: food operators still have time to evaluate and adapt if necessary. But by failing to prepare, you are preparing to fail, and although standards do not have legal provisions, their current revision represents a giant step in the right direction for better and more appropriate food allergen management.