Spot On 10 - Precautionary Allergen Labeling: Informing Your Consumers or Just Covering Your Assets? by BIOMIN

Issue 10

A Romer Labs® Publication

Precautionary Allergen Labeling: Informing Consumers or Just Covering Your Assets?

The VITAL® Program 10 “Musts” of Allergen Management

This product is packaged in a facility that processes other products that may contain soy, dairy products, wheat, nuts, shellfish, fish, peanuts, eggs and may contain traces of the above. ALLERGEN INFORMATION: Consumers with food allergies or other sensitivities should review the

Contents

4-7 Informing the Consumer or Just Covering Your Assets? A Science-Based Approach to Precautionary Allergen Labelling What is actually behind all those “may contain” labels you see in grocery stores? Romer Labs Senior Research Scientist Adrian Rogers discusses trends in precautionary labelling and introduces the VITAL® Program as a tool to providing realistic risk assessment for food producers. By Adrian Rogers, Senior Research Scientist, Romer Labs®

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

Editors: Joshua Davis, Cristian Ilea

Contributors: Jasmine Lacis-Lee, Adrian Rogers, Martin Candia

Photo: Westend61_lyzs

Graphic: GraphX ERBER AG Research: Kurt Brunner

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

All photos herein are the property of Romer Labs or used with license. Romer Labs is part of ERBER Group

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Beyond Due Diligence: 10 “Musts” of Allergen Management Identify, measure, minimize, control, eliminate: food allergen management isn’t easy, but it has to be done, all without interrupting production. Martin Candia of Romer Labs summarizes 10 essential aspects of food allergen management that no program can do without. By Martin Candia, Product Manager, Romer Labs®

Spot On Issue 10

Editorial Making Allergen Information Work for the Consumer Relevant, consistent and easy-to-understand information on food allergens is essential for consumers. Helping the food industry provide such information is central to the mission of the Allergen Bureau, on whose board I serve. Since 2002, legislation in Australia and New Zealand, where the Allergen Bureau is most active, has required food manufacturers to label for mandatory allergens, thus bringing different approaches to precautionary labelling for cross-contact allergens to the fore. In our experience, many organizations still struggle with how to approach the implementation of allergen management while obtaining the business commitment required in their facilities. This is compounded by the increasing cost of manufacturing, a more pronounced lack of technical expertise in the quality and product development departments, and other financial constraints. We consistently see businesses around the globe using blanket precautionary statements to alert the allergic consumer that there “may” be a potential crosscontact issue. However, in many cases, this is not based on a scientific risk assessment process. To address this issue, the Allergen Bureau developed the Voluntary Incidental Trace Allergen Labelling (VITAL®) Program, a standardized allergen risk assessment process, which has been in use in the food industry not only in Australia and New Zealand, but also more and more frequently in companies around the world. To further support allergic consumers, the Allergen Bureau is now working towards the development of the VITAL® certification scheme, designed to communicate to consumers the safety of a product. In this issue of Spot On, Romer Labs Senior Research Scientist Adrian Rogers discusses in further detail the Allergen Bureau’s VITAL® Program and the science behind it. Martin Candia provides a short guide to the key areas for consideration when establishing an allergen management plan. The Allergen Bureau welcomes the continued collaboration with Romer Labs to increase further the awareness of the resources and support that the Allergen Bureau provides the food industry globally as we move toward an educated, more allergen-conscious food industry, providing safe products for all consumers.

Jasmine Lacis-Lee Honorary Secretary & Company Secretary, The Allergen Bureau

A R moam g ae zr i n L ea bosf® RPoumbel irc a L taibosn®

Precautionary Allergen Labeling: Informing Consumers or Just Covering Your Assets? If you’ve been to a grocery store lately, you’ve seen the labels: “May contain [allergenic food]” or “Produced in facilities where [allergenic food] has been processed”. But what’s behind a “may contain” label? Is it an honest, science-based assessment of risk designed to inform the consumer, or is it a legalistic overreaction designed to immunize a food producer from possible lawsuits. Here, Romer Labs Senior Research Scientist Adrian Rogers introduces the VITAL® Program, an initiative of the Australia and New Zealand-based Allergen Bureau and its approach to providing realistic risk assessment that food producers can use to help their consumers make scientifically informed decisions. By Adrian Rogers, Senior Research Scientist, Romer Labs®

RUMP ROAST 2 lbs. 5 oz. (1.13kg) Keep refrigerated INGREDIENTS: 100% beef. Nut-free. Gluten-free. Soy-free. Fish-free. MAY CONTAIN: nuts, gluten, egg, peanut, soy, milk, celery, mustard, sesame, fish, mollusks. NOT SUITABLE FOR CUSTOMERS WITH AN ALLERGY TO: cereals containing gluten (wheat, rye, barley, oats, spelt, kamut), crustaceans, egg, fish, peanut, soy, milk, nuts, celery, mustard, sesame, mollusks. This product is packaged in a facility that processes other products that may contain soy, dairy products, wheat, nuts, shellfish, fish, peanuts, eggs and may contain traces of the above. ALLERGEN INFORMATION: Consumers with food allergies or other sensitivities should review the ingredients carefully.

Spot On Issue 10

ll of us who buy and consume pre-packed food cannot help but notice what seems to be a proliferation of “may contain” statements on ingredients labels these days. Such precautionary allergen labelling (PAL) is voluntary on the part of the food manufactures and grocery stores and aims to guide an allergenic consumer as to the risk of potential contamination of the food from one or more food allergens during production and handling. A growing concern among the allergy community is that “may contain” statements are descending into mere alibi labelling, whereby food producers and retailers are listing all allergens to protect themselves against any possible litigation. This is an issue of real consequence: millions of consumers around the world suffer both from the risk of allergic reactions to certain foods (including anaphylactic shock) and the limits that this risk imposes on their choice of food at the store and in a restaurant. Such precautionary labelling can severely – and unnecessarily – limit the choices of food safe to eat for an allergic consumer. So what can be done to make the use of precautionary allergen labelling a scientific, risk-based assessment rather then something that seems only to protect manufacturers and retailers? This is the quandary that the Australian and New Zealand-based Allergen Bureau faced. The Allergen Bureau was established in 2005 as a non-profit industry organisation in partnership with national and multinational food manufacturing and marketing companies, suppliers, importers, exporters, retailers and consumer groups. The overall aim of the Allergen Bureau is to share information and experience within the food industry on the management of food allergens to ensure that consumers receive relevant, consistent and comprehensible information on food allergens.

Towards more precise risk assessment with the VITAL Program In consultation with multiple experts, the Allergen Bureau manages the Voluntary Incidental Trace Allergen Labelling (VITAL®) Program. While continuing to invest in VITAL® and other allergen management resources, the Allergen Bureau engages in a range of food allergen management initiatives on behalf of its stakeholders. The aim of the VITAL® Program is to make sure that manufactured food is safe to eat for the vast majority of food allergic consumers by providing consistent precautionary labelling criteria to allow allergic consumers and those who care for them to avoid buying foods that that may present a risk to the individual. In this way, they work to preserve the value A Romer Labs® Publication

of precautionary labelling as a risk management tool. VITAL® provides a common approach to due diligence for identification, reduction and control of cross-contact allergens and the process that can determine the appropriate use of precautionary allergen labelling. Prior to any implementation of VITAL®, a robust allergen management plan must already be in place. VITAL® is designed to complement existing food safety systems such as those based on the Hazard Analysis Critical Control Point (HACCP) food safety program. The VITAL® Program determines the allergen status of incoming ingredients, including the presence of any allergens that may be accidently added through the supply chain by means of shared harvesting, storage and processing facilities. VITAL® stipulates that the allergen status be assessed product-by-product rather than by factory or line. Each ingredient and processing line is assessed for potential cross-contact allergens so that such cross-contact can be reduced to a minimum level. A key capability of the VITAL® Program is the calculation of the concentration of allergenic protein from cross-contact allergens in the food product. The protein concentration is compared with scientifically determined levels that decide whether a “may be present” statement is recommended. This is intended as a precautionary statement advising the consumer with an allergy or intolerance to avoid the food; it is intended to be used only as a result of appropriate risk-based assessments. In cases in which cross-contact allergens cannot be eliminated, VITAL® provides a consistent

Precautionary labelling can severely – and unnecessarily – limit the choices of food safe to eat for an allergic consumer.

A risk assessment according to the VITAL® Program consists of these core elements: • Determination of the relevant allergens to be considered (as indicated in the regulations)

• Identification of intentionally added allergens

• Identification and quantification of cross-contact allergens due to ingredients • Identification and quantification of cross-contact allergens due to processing

• Calculation of the total cross-contact allergen in the finished product • Determination of action levels

• Review of labeling recommendations and sources of cross-contact • Recording of assumptions

• Validation of the VITAL® assessment • Ongoing monitoring

VITAL® provides a

Table 1. Summary of VITAL Scientific Expert Panel recommendations Allergen

common approach

Peanut

to due diligence

Milk

for identification,

contact allergens.

ED01

Wheat

1.0

ED05 95% lcie

0.1

2.0 (provisional)

Sesame

0.2

Shrimp

Celery Fish

ED05 95% lcid

0.05 10

Good

Sufficient

Marginally sufficient

ED05 95% lci

Marginally sufficient

ED05 95% lci NAf

Excellent

ED05 95% lci

4.0

Other tree nuts (walnut, pecan, almond, pistachio, Brazil nut, macadamia nut, and pine nut)

c d e f

ED01 and ED05 95% lci

1.0

Cashew

Lupin

Excellent

0.1

ED01 and ED05b 95% lcib,c

Mustard

Database quality

ED01a

0.03

Soy

control of cross-

Quantitative risk

0.2

Egg

Hazelnut

reduction and

Protein level, mg

ED05 95% lci

Sufficient Sufficient

Marginally sufficient lnsufficient

lnsufficient lnsufficient

ED01 = Eliciting dose at which 1 % of the allergic population would be likely to react. ED05 = Eliciting dose at which 5% of the allergic population would be likely to react. lci = Lower confidence interval. This level may not completely protect certain individuals sensitive to soy milk. Wheat allergic consumers would be largely protected by foods containing <20 ppm gluten. NA= Not applicable.

Source: The Allergen Bureau

process and method of communication concerning cross-contact risk. When applied correctly, the VITAL® Program, can decrease the need for PAL and, in turn, increase the choice of food available to the allergic consumer.

Creating food allergen reference doses In recognition of the need for VITAL® to be based on sound and robust science, in 2011 the Allergen Bureau invited scientists from around the world specialising in allergen management, food allergy and risk assessment to form the VITAL® Scientific Expert Panel (VSEP). The objective of the panel was to review the underpinning science around food allergen thresholds. The VSEP reviewed the data from clinical (low-dose oral) food challenges from both published and unpublished studies. The papers were sourced from Australia, the United States and the European Union, and over 1800 clinical data points were collated. The data included in the review were required to meet defined quality criteria using a dose-distribution modelling approach so that the results were predictive for the entire population; this ensures that the resulting allergen thresholds were statistically sound. The derived dose-response curves

enable the identification of an eliciting dose (ED) of an allergen at which a proportion of the allergic population would be likely to react (see Table 1). It is important to note, however, that this modelling does not identify a dose below which no allergic individual would react. As a result of the work of the VSEP, the key concept of reference doses was developed. A reference dose is expressed as milligrams of total protein from the allergenic food below which only the most sensitive individual (between 1% and 5% of the allergic population, depending on the quality of the data) is likely to experience an adverse reaction. Data from large numbers of subjects were available for peanut, milk, egg, and hazelnut. Smaller amounts of individual threshold data were found for soybean, wheat, cashew, mustard, lupin, sesame seed and shrimp. There were insufficient data points available for celery, and no data points available for molluscs, therefore no reference dose for celery or molluscs have been included in the VITAL® Program to date. As there was insufficient data around (fin) fish, the Allergen Bureau adopted the original data from the US FDA Threshold Working Group. It establishes a Lowest Observed Adverse Effect Level (LOAL) of 1 mg protein and applies a 10-fold safety factor, which, when Spot On Issue 10

used in combination with the reference amount, allows for the determination of an action level.

Conclusion: the role of allergen analysis in the VITAL® process. Allergen analysis plays a significant role in the application of VITAL®. However, it is only one part of the overall process of risk assessment. It is intended to provide additional information to help inform the assessment rather than to be used as a stand-alone tool. Analysis can assist in several crucial areas: verifying ingredient allergen statements, verifying the allergen profile of raw materials and potential raw material cross-contact, targeting the analysis to assess cleaning efficacy and cleaning validations, confirming assumptions made during the risk assessment process, monitoring the effect of critical changes, and validating the VITAL® risk assessment. Analysis is complex and thus needs to be matrix- and allergen-specific. It is important to consider the nature of the food or surface under analysis and the processes to which it has been exposed to ensure that the method applied is appropriate. When comparing analytical test results with concentrations calculated from a VITAL® risk assessment, it is important to ensure that the units of measurement are comparable. The VITAL® action levels grid uses the concentration (ppm) of total protein. However, analytical results may be expressed in a range of units and calibrators. Methods used should be robust, reliable, reproducible, sensitive, and specific; an appropriate sampling plan is crucial. The quantitative assessment of cross-contact allergens needs to take the sporadic nature of cross-contact allergens into account by applying a comprehensive testing regime. Allergen analysis can be used to validate

Key VITAL® Terms • Reference Dose – The protein level below which only the most sensitive individuals in the allergic population are likely to experience an adverse reaction.

• Reference Amount – The maximum amount of food eaten on a typical eating occasion. This can be the same as the stated serving size or the whole product as presented to the consumer. The reference amount should never be less than the serving size.

• ACTION LEVEL 1 - Low concentration of the relevant allergen under evaluation, low chance of adverse reaction and no precautionary statement required

• ACTION LEVEL 2 – Significant concentration of relevant allergen under evaluation, significant chance of adverse reaction and a precautionary statement is required.

Rather than benefiting the manufacturers and retailers, PAL should become a trusted method that empowers allergic consumers to make safer food choices.

the assumptions used for the allergen management plan as well as results found using physical assessment. It is important that the science behind VITAL® remains current, transparent and relevant to all stakeholders. To enable this, the Allergen Bureau continues to engage with the VSEP, the industry and research groups and is constantly reviewing allergen threshold data. To this end, an updated iteration of the VITAL® Program, VITAL® 3.0 will be launching very soon. Through the continued adoption of the VITAL® Program and the use of other science-based allergen risk assessment processes by the food industry, one can hope that the misunderstanding and confusion currently surrounding precautionary allergen labelling can begin to be resolved. Rather than benefiting the manufacturers and retailers, PAL should become a trusted method that empowers allergic consumers to make safer food choices to stop preventable fatalities while not artificially limiting their choices as consumers.

References Approaches to Establish Thresholds for Major Food Allergens and for Gluten in Food, March 2006. Taylor et al. (2014) Establishment of reference doses for residues of allergenic foods: report of the vital expert panel, food and chemical toxicology. Food Chem Toxicol 63: 9–17. Allen et al. (2014) Allergen Reference Doses for precautionary labeling (VITAL 2.0): clinical implications J Allergy Clin Immunol. 2014 Jan 133(1):156-64. Allergen Bureau, summary of the VITAL scientific expert panel recommendations 2011 Allergen Bureau, VITAL® Science - http://allergenbureau.net/vital/vital-science/ - date sourced 08 JUL 2019 Allergen Bureau, The VITAL® Program - http://allergenbureau.net/vital/ - date sourced 08 JUL 2019 Allergen Bureau, VITAL® Online - http://allergenbureau.net/vital/vital-online/ - date sourced 08 JUL 2019 Taylor et al. (2017) The Allergen Bureau VITAL program, Journal of AOAC International. 2017 101(1): 77-82. Zurzolo et al. (2013). Peanut Allergen Threshold Study (PATS): validation of eliciting doses using a novel single-dose challenge protocol. In: Allergy, Asthma & Clinical Immunology 9. A Romer Labs® Publication

Spot On Issue 10

Beyond Due Diligence:

10 “Musts” of Allergen Management

Identify, measure, minimize, control, eliminate: food allergen management isn’t easy, but it has to be done, all without interrupting production. Martin Candia of Romer Labs summarizes 10 essential aspects of food allergen management that no program can do without. By Martin Candia, Product Manager, Romer Labs®

ince the declaration of allergen content in food products became mandatory in the food industry, consumers have witnessed a proliferation of allergen statements, formulations and formats that often cause effects opposite to those intended. Product labels turn out to be either so confusing that the consumption by any allergic people is discouraged, or so all-encompassing that it is clear that no real check was conducted on the products. In both cases, a detrimental effect is achieved: the consumers lose confidence in the information on the label. Ideally, the information conveyed in the label should be the result of an exhaustive evaluation of the real risk of the presence of an allergen in the product. This evaluation should take into account a comprehensive risk assessment of the presence of allergens (comprising the whole production chain) and an appropriate allergen management plan. Food allergen management is the name given to the collection of all documented measures and policies taken by a company to identify, minimize, control, or, if possible, eliminate the presence of allergens in all the levels and areas of a company involved in the supply chain. This includes the training of personnel and the internal and external communications of the risk and presence of said allergens. There are guidance documents and many food safety certification programs that provide general guidelines on the aspects to take into account when putting a food allergen management plan in place. Though there may be some local variation, all of them share these 10 recommendations to food producers: A Romer Labs® Publication

 Understand how your suppliers determine allergen status It is essential to determine or verify the allergen status of the material suppliers provide and to understand their allergen risk and their allergen management practices. There are different ways to accomplish this. The first and simplest is to require that providers provide information about the measures they have taken to get the allergen status they declare. This inspection can include the testing of the material with allergen-specific analysis methods like ELISA. But that is just a starting point. Preferably, one should take more exhaustive measures that include requiring audits or certifying compliance via a food safety standard scheme. All information must be properly recorded and protocols that handle changes or substitutions must be in place.

The main focus should be on clear identification and the avoidance of cross-contact.

 Know how to handle and store raw materials and intermediate products Pay special attention to how raw materials and intermediate products are accepted, handled and stored. The main focus should be on clear identification and the avoidance of cross-contact, since this is the main risk that arises from handling such materials and products. Upon reception, the material should be sampled to verify its allergen status; this should be conducted in a controlled way to avoid dispersion with thoroughly cleaned (or disposable) sampling tools. Allergenic ma-

It is of utmost importance regularly to verify the effectiveness of the management plan by checking final products for the presence of allergens.

terials should be kept sealed whenever possible, and must be clearly marked at all stages, for example, by the use of clear color-coded labels or containers. Furthermore, materials should be isolated in clearly demarcated areas. Where this is not possible, other measures to minimize cross-contact should be taken. For example, some can store allergenic materials on the floor to prevent them from spilling onto other materials. Another very important consideration is the nature of the materials: liquid, powder, granulate, etc. Measures should always be appropriate to the kind of material in use.

 Use dedicated premises and equipment Whenever possible, use dedicated premises for the storage, processing and production of goods with a defined allergen profile. Alternatively, you can have dedicated production lines. Both options are seldom practical, so an effective segregation program should be in place along with a validated cleaning program. Whenever possible, equipment should be exclusively employed for specific materials (this also includes minor equipment like scales and scoops). Moreover, the design and layout of the premises and equipment, as well as the way in which they are employed, also have critical risk associated with them from an allergen management perspective. Open production lines are, for example, more prone to cross-contamination through spillage.

 Check your recipe This one is so simple that it’s often overlooked: all ingredients to be processed must be the same ones listed in the recipe. This requires some kind of check that verifies that the correct materials are used before manufacturing begins. Automated label verification systems are a good option. This complements measures from other points: correct and appropriate labeling at all times and segregating allergenic materials. Spatial segregation may not be enough! Temporal segregation can ensure that allergen-free materials enter production prior to materials with known allergen profiles.

 Check your packaging and reworking processes One of the major causes for food product recalls is incorrect packaging. This reflects the need for appropriate checks during and verification after packaging. The storage of packing materials and packed products

is also important. Here again, temporal segregation is important. If they become contaminated at this point, all the earlier measures taken to avoid cross-contact are rendered useless. Ideally, you would rework food only on the same product from which it originated. If this is not feasible, then the rework should be used only in products with the same allergen profile. Finally, it is of utmost importance regularly to verify the effectiveness of the management plan by checking final products for the presence of allergens. Note that this is necessary but not sufficient to make “free-from” claims: single assays do not supplant a whole food safety scheme.

 Evalutate and declare any changes If you need to change your product, then be sure to evaluate the new materials and communicate relevant information to the consumer! If a change of material or formulation requires that new allergens be introduced, the allergen risk needs to be re-evaluated according to the management plan. Any change to the allergen profile should be addressed by appropriate measures to control the allergen. Just as important: make sure you communicate these changes to the consumer through multiple channels. Some guides promote such communication through allergic consumer organizations. Since customers do not usually read the list of ingredients of products they are already familiar with, make sure you declare changes in the allergen profile in a clearly visible fashion on the package with labels such as “now contains…” or “new recipe”. Finally, any old packing material should be removed and destroyed to avoid using it by mistake.

 Clean thoroughly and often Your allergen management system rises or falls depending on the quality of your cleaning regimen. Validate and regularly test the cleaning of your facilities, equipment and production lines to confirm the effectiveness of your methods. Ideally, you would use an analytical method specific to the allergens that represent a risk. If this is not possible, a surrogate allergen based on the allergen load of the materials might be effective. But when it comes to the cleaning process itself, there are other things worth considering: use single-purpose cleaning materials, adapt the layout of the plan to facilitate cleaning, and employ equipment whose design prevents the build-up of raw material and allows for easy access to all the parts that need cleaning. Wet cleaning, when possible, is preferable; with dry cleaning, avoid any method such as compressed air that Spot On Issue 10

 Inform your consumers with accurate, science-based labeling The product label can be a either a powerful tool or a complete hindrance, depending on the information it contains and how it is conveyed. The main problems come from voluntary allergen labelling, as in the infamous “may contain” statements. Labelling should not be misleading, ambiguous or confusing and should be based on relevant scientific data (see for example Art. 36.3, REG EU 1169/2011). Appropriate and informative labelling serves to establish your brand as trustworthy and informs the consumer about his or her options honestly. Labels that state every possible allergen are usually perceived as useless and protect the company more than the consumer.

Validate and regularly test the cleaning of your facilities, equipment and production lines to confirm the effectiveness of your methods.

 Get commitment from your entire team could cause the unintentional spread of material that would increase the risk of cross-contamination.

 Every record in its right place There’s an old adage: “If it’s not documented, it didn’t happen”. It’s impossible to overestimate the importance of documentation in an allergen management plan. Every protocol and measure derived from the risk assessment to control the presence of allergens must be documented. Also, you’ll need to keep records of the processes in place, such as checklists and records of cleaning, inspection, receipt and release of materials. Ideally, keep the risk assessment report with the documentation of the plan so that you can offer proof about how you are managing risks if necessary. Regular audits will also ensure compliance with all protocols and procedures.

Finally, the human factor: everyone involved should be aware of the risk represented by food allergens and should be trained according to their responsibilities. Don’t forget that many employees could be allergic themselves! Your team members should be aware that cross-contamination could come from their own activities. Therefore, appropriate hygiene and GMP should be observed. Dedicated work clothes restricted to allergen-handling restricted areas should be provided. Ensure that all protocols are followed by giving your team the tools they need to do so with frequent training courses. Ensuring food safety is the collective responsibility of everyone in the organization. One component is crucial to setting the wheels in motion: the commitment of management. it’s up to them to ensure the development of a comprehensive risk-based allergen management plan, its effective application and its continuous evaluation and improvement.

References • European Parliament and Council – Regulation REG EU 1169/2011 • AFGC (Australian Food and Grocery Council) – Food Industry guide to allergen management and labeling. 2007 • BRC (British Retail Consortium) – Global standard. Food safety. 2018 • Joint FAO/WHO Codex Alimentarius Commision - CODEX Alimentarius CX/FH 18/50/7 • FDA – A food labeling guide. Guidance for industry. 2013 • FoodDrinkEurope – Guidance on food allergen management for food manufacturers. 2013 • FSA (Food Standards Agency) – Guidance on allergen management and consumer information. 2006 • IFS (Internation Featured Standards) – IFS Food. Standard for auditing quality and food safety of food products. 2012 • SQF (Safe Quality Food) – SQFI Guidance. Allergen cleaning and sanitation practices. 2012 • The Allergen Bureau – Food industry guide to the VITAL Program. 2012 A Romer Labs® Publication

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