To Label or Not to Label? Understanding the Proposed Changes to the CODEX Standard for Allergen Labe by romer-labs

Issue 16

A Romer Labs® Publication

To Label or Not to Label? Understanding the Proposed Changes to the CODEX Standard for Allergen Labelling

Why CODEX Alimentarius Updates Matter to Consumers: 5 reasons A New Approach to Hazard Prioritization for Food Allergens

Contents

4-9 To Label or Not to Label? Understanding the Proposed Changes to the CODEX Standard for Allergen Labelling It’s been more than 25 years since the first CODEX priority food allergen list was unveiled. Allergen management experts Benjamin Remington and René Crevel give their insight into the latest recommendations on updates to the list and how food producers might need to change how they label for allergens.

By Benjamin Remington, Remington Consulting Group B.V.; and René Crevel, René Crevel Consulting Limited

Spot On is a publication of Romer Labs Division Holding GmbH, distributed free-of-charge. ISSN: 2414-2042 Editor: Joshua Davis

Graphics: GraphX DSM Austria Research: Luis Fidalgo

Publisher: Romer Labs Division Holding GmbH Erber Campus 1 3131 Getzersdorf, Austria Tel: +43 2782 803 0 www.romerlabs.com

Photo: d3sign

Contributors: Martin Candia, René Crevel, Benjamin Remington

10-11

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 how products are labelled? Martin Candia takes a look at some of the proposed changes and the questions that they can raise. By Martin Candia, Product Manager, Romer Labs

All photos herein are the property of Romer Labs or used with license.

Spot On Issue 16

Editorial Progressing towards better allergen management Regulations about the labelling of allergens in food products vary across the globe, and substantial differences can be found in the requirements of different regions. And yet these differences do not always reflect the true risk that allergens may pose for the regional population; most regulations focus only on intentionally added allergens without addressing how precautionary allergen labelling (PAL) should be used in the case of unintentionally added allergens, also known as cross-contact allergens. Efforts to address this issue through appropriate risk-based allergen management programs have led to the establishment of maximum limits of cross-contact allergen that must be present in food before PAL is recommended. These thresholds are product-specific, since they are calculated directly from allergen reference doses and an estimate of the amount of product that is likely to be ingested by a consumer over defined timeframes. To further complicate the matter, the methods of analysis necessary to validate and confirm these levels are not always suited to the matrices. With so many of these issues unresolved, a review of the CODEX standard on labeling and allergen risk analysis as part of food safety management plans is a more than welcome development. In this issue of Spot On, Benjamin Remington and René Crevel bring their unique perspective to the changes to the CODEX standard proposed by the FAO/WHO Expert Consultation Committee, focusing on updates to the priority allergen list, threshold levels of these allergens, and implications for PAL practices. Our product manager for allergen testing solutions, Martin Candia, discusses 5 key ways that these CODEX updates could impact methods of allergen management and labelling practices in particular. One thing all the new attention from CODEX tells us is that we’re always learning new things about allergen management and analysis. It’s our hope that this issue of Spot On can shed some light on these complex issues.

Christy Swoboda Technical Services Director Romer Labs

A Romer Labs® Publication

Spot On Issue 16

To Label or Not to Label?

Understanding the Proposed Changes to the CODEX Standard for Allergen Labelling The labelling of food allergens in pre-packaged foods plays a key role in protecting food allergic individuals, as no practical preventative clinical treatment is currently available. The list of major foods and ingredients known to cause hypersensitivity was first included in the Codex General Standard for the Labelling of Pre-packaged Foods (GSLPF) in 1999 (section 4.2.1.4), which mandated their declaration on labels whenever present.

By Benjamin Remington, Remington Consulting Group B.V.; and René Crevel, René Crevel Consulting Limited

ince the GSLPF was initially drafted, our understanding of food allergens and their management has advanced significantly. In response to a new request from Codex for scientific advice, including current evidence of consumer understanding of allergens, the FAO and the WHO convened a series of three expert meetings from late 2020 to early 2022 to provide scientific advice on three different subjects:

1. Review and validate (or update) the Codex priority allergen list 2. Review and establish threshold levels of the priority allergens in foods 3. Review and establish precautionary labelling (PAL) of the priority allergens in foods In this article, we consider and discuss the issues that confronted the participants of each meeting and the principal recommendations that resulted. These recommendations reflect more than 20 years of advances both in our understanding of the science of food allergens and in practical responses to the risks posed by food allergens.

Main takeaways from all three FAO and WHO expert meetings: Meeting 1: Recommended changes to the global priority allergen list: Addition of sesame and removal of soybean and oats Meeting 2: Reference Doses (RfD) for priority allergens should be derived from the ED05, i.e., the dose predicted to result in objective reactions in no more than 5% of the population allergic to each of those priority allergens.

Meeting 3: The decision about whether or not to use a PAL statement should form part of a regulatory framework. A Romer Labs® Publication

These recommendations reflect more than 20 years of advances both in our understanding of the science of food allergens and in practical responses to the risks posed by food allergens.

Meeting / Report 1: Review and Validation of Codex Alimentarius Priority Allergen List through Risk Assessment In the first meeting, the Expert Committee stressed that the list should consist only of substances known to provoke well-characterized immune-mediated reactions, i.e., IgE-mediated reactions and coeliac disease. Not only did they further elaborate the criteria for identifying priority allergens, including prevalence of allergy to them, potency, and the severity of observed reactions, they also stressed the importance that those criteria be observed globally. They undertook a hazard prioritization exercise using a multi-criteria analysis approach, which enabled them to synthesize the different types of data into a single score reflecting the global public health importance of each allergenic food. Additionally, the review process at the core of this prioritization provided transparency and repeatability, not only facilitating scientific review but also providing an approach that could be readily used to rank a putative allergen in terms of public health impact at a global or more local level. Based on the outcome of the hazard prioritization exercise and the subsequent discussion, the following update to GSLPF section 4.2.1.4 was recommended: Current section 4.2.1.4 in GSLPF (in relation to IgE-mediated food allergies and coeliac disease)

It is important to remember that these recommendations are still being discussed within Codex committees and it can take time before they are accepted or rejected. Additionally, even if they are taken up at the Codex level, it may take some time before changes are seen in local legislation. Finally, we should emphasize the soundness of the results of the original FAO Technical Consultation on Food Allergies (Rome, 1995) that identified the foods that were eventually included in GSLPF section 4.2.1.4 as adopted in 1999. It is impressive that the list of priority allergens recommended in 1995 is still largely recognizable in the list nearly 30 years later and shows only a few recommended refinements.

Meeting 2: Review and establish threshold levels in foods of the priority allergens At Meeting 2, the Expert Committee addressed the remit provided by Codex regarding the establishment of thresholds, reviewing the available clinical data Figure 1: Overview of the hazard prioritization exercise to help guide

1st step:

Information from multiple sources is monitored and collected.

- Cereals containing gluten; i.e., wheat, rye, barley, oats, spelt or their hybridized strains and products of these; - Crustacea and products of these; - Eggs and egg products; - Fish and fish products; - Peanuts, soybeans and products of these; - Milk and milk products (lactose included); - Tree nuts and nut products; and After recommended update

- Cereals containing gluten (i.e. wheat and other Triticum species, rye and other Secale species, barley and other Hordeum species, and their hybridized strains) - Crustacean - Egg - Fish - Peanut - Milk - Tree nuts (Hazelnut, cashew, walnut, pistachio, pecan, almond) - Sesame

Changes in bold. Oats and soybeans have been struck through to highlight their recommended removal from the global priority allergen list. Spot On Issue 16

and recommending Reference Doses (RfDs) for the foods on the global priority allergen list established in Meeting 1. The Expert Committee considered both the proportion of people with a relevant allergy who will be affected by exposure to any given amount of allergen (ED01 vs ED05) and the characteristics of any reaction that may occur, summarized as “severity.” The Expert Committee identified and reviewed previously published eliciting dose (ED) values (Remington et al., 2020; Houben et al., 2020) and was also able to review newly available clinical data regarding severity of allergic reactions at low doses (Patel et al., 2021; Turner et al., 2022). The Expert Committee agreed as a general principle that the RfD values should be contextualized (including potential analytical limitations in verifying them), taking into account the wider and unintended consequences (e.g. PAL appearing on every product due to too stringent recommendations). Importantly, the Expert Committee concluded that

a guiding principle should be the consideration of whether selecting a more stringent (lower) ED value would materially improve the impact on public health. This, combined with the completed review of clinical data, severity characterization, and analytical considerations, led the Committee to agree that the safety objective would be met by deriving the RfD from the ED05, or the dose predicted to result in objective reactions in no more than 5% of the allergic population (with rounding) (see RfD recommendation table). These RfDs could be used either in a risk assessment framework to determine whether to apply precautionary allergy labelling (PAL) or in a risk management decision-making process for allergen-related incidents. Adoption of these RfDs across geographic regions provides a realistic, achievable target that would help to harmonize risk assessment and risk management for food allergens and could potentially make life simpler for stakeholders (consumers, producers, regulators, healthcare practitioners, etc.).

discussion regarding the priority allergen list. Collected information is assessed and analyzed against certain pre-determined criteria.

The following general steps comprised the hazard prioritization exercise: Step 1. ldentification of the foods to be evaluated.

Step 2. ldentification and definition of the criteria (prevalence, potency, severity) by which each selected food would be quantified. Step 3. Assignment of criterion-based values to the foods.

Step 4. Normalization of these values to make them comparable between criteria. Step 5. Weighting of the criteria to reflect relative inportance.

Step 6. Combining the weighted normalized values for each food to produce a score, and repeating of the process for all weighting options.

prioritization provided transparency and repeatability.

Adapted from Report 1 (FAO/WHO, 2022).

3rd step:

Information deemed relevant is communicated.

Possible Regional Allergen List

Step 7. Plotting of the scores to help guide discussion of which foods should be listed as global priority allergens.

at the core of this

Global Priority Allergen List

2nd step:

The review process

A Romer Labs® Publication

Reference doses

RfD Recommendation (mg total protein from the allergenic source)

could be used either in a risk assessment framework to determine whether to apply precautionary allergen labelling or in a risk management decision-making process for allergenrelated incidents.

Walnut (and pecan), cashew (and pistachio)

1.0

Almond*

1.0

Egg, milk, peanut, sesame

2.0

Hazelnut

3.0

Fish, wheat

5.0

Shrimp

200

Provisional

What about food allergen analysis? The recommended RfDs are a step forward for allergen risk assessment and risk management. However, the analytical community will need to actively support enhancement of method performance and the Expert Committee noted that: - An RfD [based on the ED05] can be implemented and monitored to some degree with current analytical capabilities but significant limitations in method performance remain.

- They strongly recommended that expression of analytical results be standardized as mg total protein from the allergenic food per kg food product analyzed in order to facilitate result interpretation and comparison with an RfD and action level by users of analytical services.

- To address deficiencies in analytical methodology, they recommended the development of method performance criteria as well as more extensive provision of accessible reference materials for priority allergens.

Meeting 3: Review and establish precautionary labelling (PAL) of priority allergens in foods

Meeting 3 reviewed the current status of PAL and proposed a framework to improve upon its application. The following summarizes their findings: Current status - The use of PAL is voluntary and often misunderstood by consumers and the industry. - The decision to apply PAL (or not) is not part of a standardized risk assessment process. - Consumers find the information currently provided by PAL to be incomplete, confusing and ambiguous concerning the characteristics of the risk and the action expected of the allergic consumer.

Proposed framework - The Expert Committee recommended that the decision about whether to use a PAL statement should form part of a regulatory framework. This would require food business operators (FBOs) to use PAL only when an unintended allergen presence (UAP) exceeds the relevant RfD. - Consumers with food allergies should be able to identify on-pack if a qualified risk assessment has been completed, irrespective of whether PAL is used or not. - A consistent and harmonized approach is the most effective use of PAL for communicating to consumers with food allergy about the risk from UAP. See Figure 2 for the PAL framework proposed by the Expert Committee. Again, the adoption of such a framework is intended to harmonize the risk analysis process for food allergens and make life simpler for all stakeholders.

Concluding remarks The recent FAO/WHO Expert Consultation represents the largest Codex-driven activity on the topic of food allergies since the inception of the original Codex priority allergen list in 2000. It represents over 120 hours of virtual meetings by up to 25 scientists from across the world with expertise spanning fields as diverse as protein and analytical chemistry, food science, risk assessment and clinical allergology. In addition, countless hours were spent reviewing and preparing syntheses of pertinent data outside those meetings as well as writing the reports. The work built on and integrated the outcomes of considerable amounts of research undertaken over the last two decades, involving many of the participants in the FAO/ WHO consultation in the context of large multinational projects (e.g. Europrevall, iFAAM, the VITAL™ program). Of course, as with all scientific endeavors, the work does not end, but the outcomes of the Consultation form a major milestone in the development of allergen risk assessment, and thereby in protecting all who suffer from food allergies. All stakeholders will need to be involved in delivering the full value of the work undertaken over the coming years as the recommendations are still being discussed within the Codex Committee on Food Labelling (CCFL) – this can take time and does not mean that the recommendations will be adopted either in full or partially. Even if they are adopted at the Codex level, it may take some time before changes are seen in local legislation. Until that time comes, all stakeholders need to continue to be vigilant to protect those suffering from food allergies and continue to push for resolutions to the current ambiguities related to allergen risk management and labelling. Spot On Issue 16

The outcomes of the

Figure 2: Proposed framework for PAL. Reproduced from: Meeting 3 (FAO/WHO 2021)

Consultation form

Appropriate quality control, hygiene and risk mitigation practices RA lndicates:

Appropriate RA

NO PAL [use wording in section 4.2 of CX/FL 21/46/8 14 Appendix III); Consumer should know RA has been applied, with an indication (e.g. symbol) on-pack or at point of sale for non-prepacked foods.

Possible UAP ≤ AL based on RfD Yes

RA indicates: Possible UAP > AL based on RfD

Can UAP be managed at or below AL based on RfD with additional risk mitigation practices?

Acronyms RA: Risk Assessment UAP: Unintended Allergen Presence AL: Action Level RfD: Reference Dose

a major milestone

RA still indicates: Possible UAP > AL based on RfD; Risk not excluded

Simple, clear and unambiguous warning readily understood by the consumer: [See full report];

in the development of allergen risk assessment, and thereby in protecting all who suffer from food allergies.

Consumer should know RA has been applied, with an indication on-pack or at point of sale for non-prepacked foods.

References Ad hoc Joint FAO/WHO Expert Consultation on Risk Assessment of Food Allergens, 2021. Part 2: Review and establish threshold levels in foods of the priority allergens (Summary and Conclusions). https://doi.org/https://cdn.who.int/media/ docs/default-source/food-safety/jemra/2nd-allergen-summary-report-20aug2021.pdf?sfvrsn=915a8417_8 Ad hoc Joint FAO/WHO Expert Consultation on Risk Assessment of Food Allergens, 2022. Part 2: Review and establish threshold levels in foods of the priority allergens (Milk and Sesame follow-up Summary and Conclusions) [WWW Document]. URL https://cdn.who.int/media/docs/default-source/food-safety/jemra/2nd-allergen-summary-report-milk-and-sesame-apr2022.pdf?sfvrsn=35130ec2_7 (accessed 4.4.22). Ad hoc Joint FAO/WHO Expert Consultation on Risk Assessment of Food Allergens, 2021. Part 3: Review and establish precautionary labelling in foods of the priority allergens (Summary and Conclusions) [WWW Document]. URL https://cdn. who.int/media/docs/default-source/food-safety/jemra/3rd-allergen-summary-report-13dec2021.pdf?sfvrsn=5415608_7 (accessed 4.25.22). FAO/WHO, 2022. Risk Assessment of Food Allergens. Part 1: Review and validation of Codex Alimentarius priority allergen list through risk assessment. FAO, Rome. https://doi.org/10.4060/cb9070en Patel, N., Adelman, D.C., Anagnostou, K., Baumert, J.L., Blom, W.M., Campbell, D.E., Chinthrajah, R.S., Mills, E.N.C., Javed, B., Purington, N., Remington, B.C., Sampson, H.A., Smith, A.D., Yarham, R.A.R., Turner, P.J., 2021. Using data from food challenges to inform management of food-allergic consumers: a systematic review with individual participant data meta-analysis. J. Allergy Clin. Immunol. https://doi.org/10.1016/j.jaci.2021.01.025 Turner, P.J., Patel, N., Ballmer-Weber, B.K., Baumert, J.L., Blom, W.M., Brooke-Taylor, S., Brough, H., Campbell, D.E., Chen, H., Chinthrajah, R.S., Crevel, R.W.R., Dubois, A.E.J., Ebisawa, M., Elizur, A., Gerdts, J.D., Gowland, M.H., Houben, G.F., Hourihane, J.O.B., Knulst, A.C., La Vieille, S., López, M.C., Mills, E.N.C., Polenta, G.A., Purington, N., Said, M., Sampson, H.A., Schnadt, S., Södergren, E., Taylor, S.L., Remington, B.C., 2022. Peanut Can Be Used as a Reference Allergen for Hazard Characterization in Food Allergen Risk Management: A Rapid Evidence Assessment and Meta-Analysis. J. Allergy Clin. Immunol. Pract. 10, 59–70. https://doi. org/10.1016/j.jaip.2021.08.008 Houben, G.F., Baumert, J.L., Blom, W.M., Kruizinga, A.G., Meima, M.Y., Remington, B.C., Wheeler, M.W., Westerhout, J., Taylor, S.L., 2020. Full range of population Eliciting Dose values for 14 priority allergenic foods and recommendations for use in risk characterization. Food Chem. Toxicol. 146, 111831. https://doi.org/10.1016/j.fct.2020.111831 Remington, B.C., Westerhout, J., Meima, M.Y., Blom, W.M., Kruizinga, A.G., Wheeler, M.W., Taylor, S.L., Houben, G.F., Baumert, J.L., 2020. Updated population minimal eliciting dose distributions for use in risk assessment of 14 priority food allergens. Food Chem. Toxicol. 139, 111259. https://doi.org/10.1016/j.fct.2020.111259 A Romer Labs® Publication

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. By Martin Candia, Product Manager, Romer Labs

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.

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.

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.

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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 A Romer Labs® Publication

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.

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.

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 “freefrom”. “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.

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