Cross-contamination of allergens : a focus on how to judge and communicate

Cross-contamination of allergens: a focus on how to

judge and communicate

Elise Molthof & Tinka Groot

2015232

Cross-contamination of allergens: a focus on how to

judge and communicate

Authors

Name: Elise Molthof

Study profile: New Product Management

Adress: Blauwvoetstraat 16HS

1061BV Amsterdam

E-mail adress: elise.molthof@hva.nl

Telephone number: 0640966162

Name: Tinka Groot

Study profile: New Product Management

Adress: Tramplein 8C

1441 GP Purmerend

E-mail adress: tinka.groot@hva.nl

Telephone number: 0642288771

Company + supervisor

Name company: Tradin Organic Agriculture B.V.

Supervisor: Joanne Dronkers-Bos

Function: Department:

Quality Coördinator Quality

HvA

Lecturer: Lisette Elsinga

List of definitions

Action Levels

Action Levels are the concentration which defines the labeling outcomes for each concentration of cross contact allergen. Action levels are determined by using the serving size and reference dose. Allergen

Any substances that causes an allergic reaction. Cross Contact Allergen

A residue or trace amount of an allergic food that is unintentionally incorporated into another food. In VITAL program: cross contact sources can be from raw material of processing. Cross contact from raw materials refers to allergens which may be incorporated during the supply chain of ingredients. Cross contact due to processing is the unintentional corporation of allergens during production of the product (manufacturing lines, tools, equipment, staff).

Cross-contamination

A process in which a food that does not contain a particular allergen is contaminated with that allergen during storage, producing, cooking or serving.

GMP

Good Manufacturing Practices. These are guidelines that control the manufacturing and sale of food products. This guideline requires that a food product are of high quality and aren’t a risk to the consumer.

Haptens

A hapten is a small molecule that stimulates the production of antibody molecules and causes an auto-immune response when attached to a carrier like a protein.

Product specification

A document that provides critical defining information about a product; a list of rules, bans and standards that apply to the item. An example of a product specification of Tradin is available in the appendix.

Word of Gratitude

This thesis is written as a final assignment for the Bachelor of Applied Sciences in Nutrition and New Product Management. The past months we studied the judgement and communication of cross-contamination of allergens. The assignment was given from Tradin Organic located in Amsterdam, The Netherlands.

We would like to thank Joanne Dronkers-Bos for her helpfulness and assistance during the past 20 weeks. Her view on certain parts of the thesis was of great value. We couldn’t have done this without her. We also like to thank our lecturer Lisette Elsinga for her feedback and time she put in our

graduation assignment.

Abstract

Background: Allergens are ‘hot topic’ at the moment and a lot of companies are searching for a clear way to label allergens on their products. There’s also a lot of discussion about the right and clear way to declare these allergens. Food producers often place allergens on their ingredient declaration, even when the allergens aren’t present in the product. This causes a lot of confusion to the consumer. Tradin only wants to communicate the relevant risks to the customers in a clear way to prevent valid and invalid claims as much as possible.

Aim: How should Tradin judge the information about cross-contamination of allergens and in what way can Tradin communicate this information to her customers so that claims can be avoided? Methods: This thesis consists of a literature study and a survey. For the literature study relevant scientific articles were used to search for background information about allergens and what common effects on health are. Also, articles about the communication of cross-contamination of allergens in the international trade and how this is judged by the consumer were used. Information about the cross-contamination of allergens that are applicable for Tradin was found in the database of Tradin. This information is summarized in multiple tables. The survey was sent to 16 of Tradin’s customers to find out how they think of the current communication of cross-contamination of allergens. Out of the 16 customers, six replied.

Results: A lot of food-allergic people depend on food labels for their information about allergens, but according to research consumers stay skeptical about the exactness of the information that’s put on the label. Research also indicates that the label ‘may contain’ is overused and shows a poor

correlation with the actual presence of the food allergen due to cross-contamination. Also, some food-allergic consumers are taking risks intentionally by ignoring precautionary labeling in particular. This could cause serious health problems for allergic consumers. Because a lot of advisory labels (like ‘may contain’) are on consumer level, a more business-to business method to communicate cross-contamination is put forward for Tradin. This method is unique and fully applicable to Tradin. One of the results of the survey was that most of the respondents would like to be informed by a more comprehensive and more informative declaration of cross-contamination of allergens on the products specification. This result is consistent with the invented business-to-business way of declaring, instead of one of the traditional labels, like ‘may contain’.

To judge the information about cross-contamination, all the relevant information from Tradin’s data base is collected and analysed. Multiple factors were taken into account, such as supplier’s

information, country of origin, subcontractors, storage, transport, incoming inspections, processing and characteristics of the raw material. The result was a self-designed risk based decision tool and a statement that can be send to the customer in case of complaints or claims.

Conclusion:

Tradin should judge the information about cross-contamination of allergens by using the self designed risk based decision tool. This tool will help by deciding whether a cross-contamination should be declared on the product specification or not. When it should be declared, Tradin will indicate where in the process the cross-contamination has occurred. Does it occur on the production line (this includes site and storage as well), then it will be declared with ‘P’. Does the

cross-contamination occur on the field, it will be declared with ‘F’. This way of declaring is more business-to-business, unique and fully applicable for Tradin. This would be a more informative and innovative way to declare cross-contamination compared to other traditional labels. In case of complains Tradin can send the statement with explanation to the customer.

Index

List of definitions ... 3

Word of Gratitude ... 4

Abstract ... 5

1.

Introduction ... 7

1.3 Aim of this study ... 8

1.4 Reading guide... 9

2.

Methods ... 10

3. Results ... 11

3.2 Key results survey ... 18

3.3 Decision tool ... 19

3.4 Statement cross-contamination labeling ... 20

4. Discussion ... 21

5. Conclusion ... 23

6. Advice ... 24

5. References ... 26

Appendix I Current product specification ... 29

Appendix II Suppliers and cross-contamination declaration ... 31

Appendix III Frequencies of allergens ... 34

Appendix IV Product specific cross-contamination ... 35

Appendix V Updated product specification ... 36

Appendix VI Mind-mapping result ... 37

Appendix VII Survey ... 38

1. Introduction

The opportunity to work on this thesis was submitted by Tradin Organic. Tradin Organic sources organic food ingredients for the international food industry. In addition, Tradin also develops own sourcing initiatives and processing operations worldwide. For these projects they get involved in the entire supply chain from cultivation to processing to export, directly sourcing more than 150

products from more than 60 origins. Tradin Organic’s extensive worldwide network of suppliers, processors and partners make Tradin a major partner in the organic food industry today. Tradin is the link to global manufacturers for a lot of organic farmers. For manufacturers, Tradin is the experienced partner for their entry into the growing organic market. (1)

Tradin depends on it’s suppliers for their raw materials. These suppliers are located in more than 60 different countries. In most cases the raw materials are shipped to a warehouse located in Barneveld, the Netherlands. From there, the raw materials will be shipped to the customers of Tradin. In this thesis the wording ‘customers’ is used to describe the customers of Tradin. Customers process the raw materials into a final product. The final products are being sold to consumers. Tradin only has contact with suppliers, subcontractors and customers, but not directly with consumers. Below is a global display of Tradin’s framework. The consumer is not a direct part of the framework. However, the consumer is some how important for Tradin, because eventually the products will end up at the consumer.

Fig. 1: Global view of Tradin’s field of interest

Tradin depends on their suppliers regarding the information about allergens. Suppliers fill in a ‘questionnaire’ where they can indicate the allergens and contamination. If there is any cross-contamination, the supplier indicates where in the process this risk takes place (production line, production site, on the land or during storage). The cross-contamination that is registered in the Tradin specifications is based on the information that suppliers provide to Tradin. These product specifications are being used to provide information to the customer about the product they’re buying. In appendix I there is an example of a product specification. Below is an example of a current allergen declaration in the product specification

.

Fig 2: Allergen declaration on a current product specification

Suppliers Tradin Organic Customers Consumers

At the moment Tradin marks possible cross-contamination with a ‘?’ in the product specifications. The Quality Department of Tradin regularly receives questions concerning this way of reporting. For the customer it is not always clear if an allergen is really present in the product or that it is only an assumption. This unclear information can lead to complaints and claims.

Tradin is searching for a clear vision on cross-contamination and at what point cross-contamination needs to be declared. That is why the ‘?’ needs to be changed into a more informative declaration. If there are any questions or complaints from customers, Tradin wants to have a risk-based statement that can be send to the customer to explain why the cross-contamination is declared.

1.1 Research question

How should Tradin judge the information about cross-contamination of allergens and what is the best way for Tradin to communicate this information to their customers so that claims can be avoided?

1.2 Sub questions

1. What is cross-contamination of allergens and what are the common effects on health? 2. How is cross-contamination of allergens…

A… judged by consumers

B… communicated in the international trade?

3 What different cross-contaminations of allergens are applicable for Tradin?

4. How do the customers of Tradin think of the current communication of cross-contamination of allergens?

5. What is VITAL 2.0 and is this applicable for Tradin? 1.3 Aim of this study

Allergens are ‘hot topic’ at the moment and a lot of companies are searching for a clear way to label (cross-contamination of) allergens on their products. Food producers often place allergens on their ingredient declaration, even when the allergens aren’t present in the product. (2) This causes a lot of confusion to the consumer. More and more companies are aware of this and working to reduce unnecessary labeling and to provide clear advice to the allergic public. (3) Tradin only wants to communicate the relevant risks to the customers in a clear way to prevent valid and invalid claims as much as possible.

The aim of this thesis can be divided into two parts: the judging and communication of allergens. Judging information about cross-contamination:

Tradin communicates possible cross-contamination with a ‘?’, as said before. This is actually not a clear way to communicate to the customers. Tradin regularly receives questions about this. With the aid of consumer research (survey) and literature study an alternative solution for the ‘?’ is applied. For this end a decision tool is made. The decision tool creates the opportunity to perform a risk-based assessment to judge the risk of contamination and to help deciding whether a cross-contamination should be declared or not.

Communication of cross-contamination:

The eventual aim of this project is to communicate the risk based judgment of allergens to the customer. The communication is divided into two different communication streams.

All customers receive a product specification with their contract.The specifications need to be updated with more specific allergen information. (The ‘?’ needs to be changed).

2. Not standard communication  Customer questions or complaints about allergens. This is done with the help of a statement which explains were the declaration is based on. Because Tradin doesn’t supply to the consumer directly, it’s important that information about allergens provided by Tradin is risk based and accurate as much as possible, so that customers can communicate this information to their consumers in the correct way to avoid possible claims in the future.

1.4 Reading guide

The research question and sub questions are described in the chapter ‘introduction’. Also a background of the problem is given and additional information about cross-contamination and the communication thereof. In the chapter ‘methods’, the results are presented and also the sub questions are answered. In the chapters ‘discussion’, ‘conclusion’ and ‘advice’ the results of the research are critically viewed, the research question is answered and an advice is given regarding the communication of cross-contamination.

2. Methods

2.1 Research design

This study consists of a combination of desk and field research. To answer the research question, a qualitative research was done. The following methods are used:

- Literature study - Survey

2.2 Literature study

The literature used in this research was found in different databases like PubMed, Science Direct, Google Scholar and Cochrane. These databases were found through bib.hva.nl. For articles based on health studies, Cochrane and PubMed were used. For articles based on trade and industry, Science Direct was used. The target group of this study was mostly the customer of Tradin within Europe. Some criteria for the search of scientific literature:

 Used articles and books should have a scientific character. This should be based on author, content and publisher.

 Used articles, books and websites should be written in English or Dutch. The used search methods and keywords on this literature study were:

 Question 1: Research on scientific articles about the effects of allergens and

cross-contamination. Keywords for this research were: ‘allergens’, ‘amount’, ‘limit’, ‘threshold’, ‘risks’ and ‘effects’.

 Question 2: Research on scientific articles about how cross-communication is communicated in the international trade and how this is implemented by the consumer. Research on how consumers think of different ways of communicating allergens on products.

Keywords for this research were: ‘perception’, ‘labeling of allergens’, ‘cross-contamination’, ‘consumers’.

 Question 3: Information about cross-contamination provided by the suppliers is collected and shown in a table. This information is collected from the questionnaires which are already present in the database of Tradin. Also, a diagram of the current product specifications and the reported cross-contamination to find out which cross-contamination is applicable for Tradin is made. This information is important input for the decision tool.

 Question 4: A survey has been prepared, see 2.3 for more information.

 Question 5: Research on scientific articles about the VITAL 2.0 programme and the

possibilities for Tradin. Also, the Dutch company ‘Allergenen Consultancy’ was contacted to receive more information about VITAL 2.0 and its applicability.

Keywords for this research were: ‘VITAL 2.0’, ‘action levels’, ‘allergens’. 2.3 Survey

The aim of the survey was to indicate the opinion and perception of the customers about the current communication concerning cross-contamination of allergens. For this reason the survey was

unstructured. The survey was sent to 16 customers spread across six different countries within Europe. The selection concerns only customers who buy products with a ‘?’ in the allergen

declaration in the product specification. The survey was sent by email with a deadline of two weeks. In case of no response a reminder was sent. The survey consisted of seven questions. The answers were analysed per question and checked for coherence.

3.

Results

3.1 Literature study Cross-contamination

Allergens can be present in the product unintentionally as a result of cross-contamination. Cross-contamination of allergens occurs when food comes in contact with allergens. This can happen on different locations like on the land, during storage or on the production line. Cleaning, packaging and processing of products are also potential sources of allergen cross-contamination during food processing. (4) Since Tradin is a trading company and not a producer, they depend on the suppliers and subcontractors to handle the products with good care so cross-contamination can be prevented. In Tradin’s case cross-contamination can take place on four different occasions: during storage, on site, on the production line or on the field. Organic crops that grow on the field need to be replaced by a different kind of organic crop after one year to protect the crops and to prevent soil depletion. This is authorised by organizations (for example SKAL) that control organic agricultures. (5) Because of crop rotations, there is a risk of contamination from the previous crop. Cross-contamination can lead to a variety of allergic reactions or food intolerance.

Heating and fermentation processes don’t have any influence on the effects of allergens because the proteins that cause the allergic reactions are very heat resistant.(6) So for Tradin it wouldn’t be an option (to advise) to heat a product (for example nuts) to eliminate allergens.

Food allergy and food intolerance

There is a difference between food allergy and food intolerance. In case of food allergy, the body’s immune system responses to small parts of proteins present in the food. Mostly these allergens are proteins, but they can also be haptens. These proteins and haptens (allergens) are recognised by allergen-specific immune cells that cause specific symptoms and cause an allergic reaction. (7) When a person is allergic, the body makes antibodies against the allergen. If a product is eaten that contains a protein that is seen by the body as an ‘intruder’, there will be a physical (allergic) reaction. The immune system wants to protect the body against this threat and will cause a reaction against the food. When a person is allergic to a certain kind of food, they may also have an allergic reaction to foods related to the triggering food. For example, when a person is allergic to a type of fish like lobster they can also have a reaction to other types of shellfish. (8)

In case of food intolerance, the body misses a type of enzyme to digest the protein. Examples of food intolerances are lactose intolerance, gluten intolerance and also sulphites can cause intolerance. (9) Allergic reactions

The intensity of the allergic reaction can vary from mild to life-threatening. A few examples of physical symptoms are: redness of the skin, eczema, itching eyes, oedema (face, glottis), itching, sneezing, dry cough, swelling of the tongue, nausea, heartburn, low blood pressure. (7) Food

allergens can also cause allergic reactions in the lungs, in this way they trigger asthma attacks. Almost half of the people that have food allergy also have asthma. Foods like milk, peanuts, soy can cause an asthma attack when they come in contact with a person that has a food allergy. (10) Factors like age, rapidity of absorption (this can be influenced by the way the food is eaten; on an empty stomach or before exercising) but also asthma and atopic dermatitis may affect the severity of the allergic reaction. (11)

There is a range of severity in allergic reactions, some are worse than others. The most severe allergic reaction is anaphylaxis. This can be caused by fish, peanuts, tree nuts, sesame, eggs and dairy

Important food allergens in European Union and USA

There are more than 170 different types of foods that can cause allergic reactions but only a small part is responsible for the greater part of allergic reactions. These are: milk, tree nuts, peanuts, fish,

egg, wheat, soy and crustacean shellfish.

There is a wide diversity between countries with regards to the control and regulation of cross-contamination. (13) The allergens that need to be declared on the packaging of a food product also differ from country to country. Tradin Organic has an office in the Netherlands but also in the U.S.A. Since the results from this thesis will also be used in the American office, the European Union and the American legislations are taken in consideration.

For Europe 14 major allergens are legislated in de LeDa list: cereals containing gluten, crustaceans,

eggs, fish, peanuts, soy, milk, tree nuts, celery, mustard, sesame seeds, sulphite, lupin and molluscs. In

the European Union the EU regulation 1169/2011 is applied. The major allergens need to be declared on the packaging of a product when the ingredients are used in the preparation of the product. These allergens are listed in the LeDa list, consisted of 14 major allergens and 10 complementary allergens. The allergens need to be declared on the label in a different letter type (for example bold) then the rest of the label. The labeling of cross-contamination isn’t obligated in the European Union, but is voluntarily. (14, 15)

The FALCPA (Food Allergy Labeling and Consumer Protection Act) is an organization active in the U.S.A. This organization identifies eight major food allergens in de U.S.A: milk, egg, fish, Crustacean

shellfish, tree nuts, wheat, peanuts, and soybeans. (16) Currently, there are no laws in the U.S.A

concerning labeling of cross-contamination. The labeling of cross-contamination is voluntary. (17) Different cross-contaminations applicable for Tradin

Now that the information about allergens and cross-contamination is known, the focus is about what allergens are important for Tradin. All the details from Tradin suppliers regarding to

cross-contamination were collected. This was done in three steps: first, the supplier questionnaires were analysed. Second, the allergens that are given in the questionnaire were counted. And third, the current product specifications of Tradin were analysed. This information is important to determine what different cross-contaminations are applicable for Tradin.

Supplier Questionnaires

All suppliers fill in a questionnaire in which they declare the raw materials they deliver and the risk of cross-contamination. They declare if the risk is present on the production line, on the production site (this includes farming, production, laboratory shipping, receiving), on the land (field) or at storage areas. In some cases the supplier indicated ‘growth’. This means the risk is present on the land where the crop is growing. The result was that cross-contamination is most common on site and at storage conditions. Another result was a list of all suppliers who indicated cross-contamination in the questionnaire.

Frequencies of allergens

All the relevant allergens and the number of times the allergen is present were collected. It depends on the product which allergen is most common, but soy is frequently indicated as a

cross-contamination by several suppliers (22x), as well as sesame (15x) and wheat/gluten (13x) Product Specification

Of all the product specifications, only those with reported cross-contaminations were collected. Cross-contamination is found, inter alia, in the following products: Organic Flax seeds, Organic

Sunflower Kernels, Organic Pumpkin Kernels and Organic Lentils. See appendix II for the complete list of products with cross-contamination.

With these results a clear review is created which indicates where in the process cross-contamination occurs (storage, site or field), which cross-contaminations are most common and in which raw materials they occur. This is important information for the contents of the product specifications. Also, a comparison between the supplier’s information and the current product specification can be made. This is important to check whether the information given by the supplier matches the

information on the product specifications of Tradin. Another important comparison that can be made is the comparison between different suppliers of the same raw material. For example: Tradin has five suppliers of poppy seeds. One indicates sesame as a cross-contamination in contrast to the other four suppliers. Taking into account the reason for this, it may derive the question whether Tradin should declare sesame as a cross-contamination on the product specification or not. In the appendix all the collected information is show in tables.

It is important that all food products are labelled properly. Incorrect information on the product specification could lead to claims. Tradin’s customers could place the claim back to Tradin demanding large amounts of money. For Tradin it is important to have a clear communication toward customers. Therefore, it is important to know which options are available for Tradin to communicate cross-contaminations of allergens.

Different ways to communicate cross-contamination of allergens

As written in the introduction, the focus of this thesis isn’t directly on the consumer. However, the opinion and vision of consumers about labeling is nevertheless important for Tradin, because eventually the products will end up at the consumer. Tradin needs to know how to judge the

information about cross-contamination of allergens and how to communicate this to their customers in the most suitable way. This information will be used by the customer to put it on their final

products or packages. This means Tradin’s customers need to have reliable information to inform the consumer. Therefore, the focus in this chapter is more on consumer level.

A lot of food-allergic people depend on food labels for their information about allergens, so it’s important that these labels are written in an understandable way and most of all the information on the label needs to be clear.

The EFA (European Federation of Allergy and Airways Diseases Patients’ Associations) pursues that:

 Ingredients known for causing allergic reactions must be written down in a clear way, without exception.

 All ingredients causing allergic reactions should be in an updated list and the base for this list should be scientific evidence.

 There should be restrictions for labeling food and ingredients that only are a small part of the end product. (18)

As said before, declaring allergens on the label is obligated by law, but precautionary labeling (in case of cross-contamination) are put on the label voluntary by food producers. The labeling of products with a precautionary label such as ‘may contain traces of…’ shows a poor correlation with the actual presence or absence of food allergens due to cross-contamination. The information value of the warning for the food allergic people has reduced and leads to possible health risks. (19)

According to the Food Safety Authority of Ireland (FSAI) almost 94% of foods with precautionary allergen labeling (PAL) did not contain that particular allergen on the label. According to the FSAI this

indicates a high level of unnecessary precautionary labels being placed on the products by the producers.(20)

Several studies from different countries show that currently about 25 different terms are being used to warn for possible cross-contamination, such as ‘may contain’ or ‘produced in a factory that handles….’ All these different terms say exact the same thing: Cross-contamination is possible. (21) The table below shows several examples of advisory warnings (=precautionary labeling) found on food labels.

Table 1: Examples of advisory warnings found on food labels (1)

According to the director of the Dutch company ‘Allergenen Consultancy’ the term ‘may be present’ (see table) is derived from the VITAL 2.0 systematic (which will be explained in the next chapter) and is intended as a visible distinction on the label for the consumer. With this wording, the consumer knows that the warning is based on a risk assessment. This wording is used by Australian companies that use the VITAL system. (22)

The availability of such warnings is seen as a good way to inform consumers, but consumers stay skeptical about the exactness of the information that’s put on the label. (23)

Because the traditional ‘may contain’ (or a similar wording) is more focused on the customer than on business-to-business, other (invented) possibilities have also been considered. In order to meet a more informative declaration, it could be an option to indicate where in the process the cross-contamination has occurred. Does it occur on the production line (this includes site and storage as well), then it will be declared with ‘P’. Does the cross-contamination occur on the field, then it will be declared with ‘F’. This way of declaring is unique and fully applicable for Tradin, because this

information will be based on the supplier’s information and the decision tool. This would be a more informative and innovative way to declare cross-contamination compared to the traditional

precautionary allergen labels. This could be a possible solution for the ‘?’ on the product specifications. A copy of an example of this kind of declaring is available in appendix V. Traditional precautionary allergen warnings evaluated by consumers

The communication about allergens through the label or packaging is obligated by law. Customers often think precautionary labeling is also obligated but this is not true. Precautionary warnings are put on the label voluntary by food producers. A study assessed the value of the words ‘may contain’ by a survey and reported that 54% of allergic consumers found the statement ‘may contain’ overused

warnings to cover themselves legally to avoid liability, instead of using these labels to control the real risk. (24) This is why some consumers take precautionary labeling text less seriously, because they don’t always believe that what the label says is true. They think the product doesn’t contain a real risk. This could cause serious problems for food-allergic patients when consuming the product. Also, it means that the information provided on the labels isn’t in all cases valuable for the consumer. (25) Research also indicates that some food-allergic consumers are taking risks intentionally by ignoring precautionary labeling in particular. They choose to ignore the warning by carrying out unfairly risk assessment on the basis of the wording. The phrase ‘may contain traces’ is considered to be lower-risk than ‘may contain x’. The phrase ‘produced in a company where x is also processed’ is considered as the lowest risk. (26) In fact, none of these warnings should be read as being more or less serious than another phrase. (3)

The so called ‘risk-takers’ (people that read the information on the label, but still risk the chance of getting an allergic reaction by eating the product) want more information about cross-contamination of allergens, so they are able to make a more confident judgement when buying products.

People that completely avoid allergens (the so-called ‘total avoiders’) stated they want either a negative (product can’t be used by people with a food allergy), or positive (product can be used by people with food allergy) statement on the packaging. (27)

The Food and Drug Administration (FDA) did research on what the consumer prefer to see on the label. The FDA asked two different groups (allergic individuals + caregivers of allergic individuals and individuals who don’t have food allergies nor providing care to a person with food allergies) to indicate their preferences for food labeling. The following four advisory statements were tested:

A. ‘Allergy Information: May Contain Peanuts.’ B. ‘May contain peanuts.’

C. ‘Manufactured on the same equipment as foods that contain peanut.’

D. ‘Produced in a facility with an allergy control plan. The possibility of contact with allergenic ingredients has been minimized. May still contain trace amounts of peanut.’

The result of this research was: ‘Allergy Information: May contain peanuts’ was preferred first. ‘Manufactured on the same equipment as foods that contain peanut.’ was ranked second, ‘May

Contain Peanuts’ was preferred third and the statement ‘Produced in a facility with an allergen control plan’ was preferred least. (17)

International business and stakeholders are working together to make universal guidelines based on science based action limits to insure that the information put on the label is right. One of these guidelines is VITAL 2.0. (28)

By reducing unnecessary precautionary labeling, and pursue a proper risk control and monitoring, many foods will still be available for many allergic consumers.

VITAL 2.0

The VITAL (Voluntary Incidental Trace Allergen Labeling) system is an initiative of the Allergen Bureau and is developed to provide a risk based methodology for food producers to estimate the impact of cross-contamination of allergens and provide appropriate information for precautionary allergen labeling. The first version of VITAL was launched in June 2007 in Australia and New Zealand. In 2010 the Allergen Bureau started a review on VITAL, building on a commitment to continue to invest in VITAL to make sure that it remains a relevant instrument for food industry. The system consists of a calculator which promotes consistent labeling across industry by prescribing when a precautionary label statement is to be applied or avoided. VITAL only approach ‘may be present’ for labeling, so the consumer knows that the warning is based on a risk assessment.

The table below shows the reference dose (amount of protein in a product) which are based on the thresholds (which protects 99% of allergic consumers) and allergic reactions. This information is provided by TNO (Nederlandse Organisatie voor toegepast-natuurwetenschappelijk onderzoek). VITAL operates with these reference doses which are transferred into action levels according to the serving size (the maximum amount of food eaten in a typical eating occasion). (29)

Table 2: VITAL Scientific Expert panel Recommendations and Proposed Action Level (30)

Allergen Reference dose (mg protein) 5 g serving size: action level 1 (ppm) 5 g serving size: action level 2 (ppm) 50 g serving size: action level 1 (ppm) 50 g serving size: action level 2 (ppm) Peanut 0.20 ≤40 ≥40 ≤4 ≥4 Milk 0.10 ≤20 ≥20 ≤2 ≥2 Egg 0.03 ≤6 ≥6 ≤0.6 ≥0.6 Hazelnut 0.10 ≤20 ≥20 ≤2 ≥2 Soy 1.00 ≤200 ≥200 ≤2 ≥2 Wheat 1.00 ≤200 ≥200 ≤20 ≥20 Cashew 2.00 ≤400 ≥400 ≤40 ≥40 Mustard 0.05 ≤10 ≥10 ≤1 ≥1 Lupine 4.00 ≤800 ≥800 ≤80 ≥80 Sesame 0.20 ≤40 ≥40 ≤4 ≥4 Shrimp 10.00 ≤2000 ≥2000 ≤200 ≥200

Celery Insufficient data - -

-

-

Fish Insufficient data - -

-

-

The table shows the reference dose and action levels. For instance: the reference dose for peanuts is 0.20, this number needs to be put into the VITAL 2.0 calculator. The calculator will give action levels which are described as the amounts which decide how cross-contaminations should be declared. The VITAL programme exists of two action levels. Action level 1 stands for a low amount of allergens, slight chance of an adverse reaction, so there is no need for precautionary labeling. Action level 2 stands for a significant amount of allergen protein, meaningful change of an adverse reaction and precautionary labeling is necessary. When a concentration is even or higher then action level 2, precautionary labeling in the form of ‘may be present’ is recommended.

So when there is a high level of cross contact allergen, there is a labeling recommendation. Action level 1 for 5 g (peanuts) serving size is ≤40 ppm. Action level 2 for 5 g (peanuts) is ≥40, at this point precautionary labeling is required.

For the peanut is means: 0.20 (reference dose) x (1000/5 g (serving size)) = 40. (19) A few advantages of the VITAL 2.0 program for Tradin:

- Because Tradin is an international company, VITAL 2.0 could be helpful in the development of worldwide quantitative guidelines for the declaration of ‘may contain’ statement on food products.

- Due to the reference doses and action levels Tradin will be able to make better and informed decisions about declaring cross-contamination.

- The customers of Tradin will be informed with reliable information. For the allergic consumer this will lead to a bigger range of products to choose from and a growing trust in ‘may

contain’ statements on food products. Is VITAL 2.0 applicable for Tradin?

Where in the organization does Vital 2.0 fits best? Several options are possible:

 Is VITAL 2.0 applicable at the beginning of the supply chain?

 In the warehouse were samples of the raw materials can be taken?

 Is VITAL 2.0 more applicable to the customer?

The table below was the result of the mind map session. During the mind map session the four main parts of Tradin were taken into account: ‘supplier, storage, subcontractor and customer’.

Additionally, the table is divided into two communication streams: ‘standard communication’ and ‘not standard communication’. The process of the mind map session is shown in appendix VI.

Table 3: Result of the mind-map session

Standard communication

As the table shows, ‘standard communication’ consists of the supplier questionnaires, physical control at entrance and the product specifications. The questionnaires are filled in by the supplier of the raw materials. The physical control is performed at the warehouse where the raw materials are stored. For example, they take 25 kilo of a product and spread it on a clean metal table. They check the product for things that don’t belong in the product naturally. This could be twigs, stones or sand. But also other impurities caused by cross contact of other raw materials. The specification will always be send to the customer along with the purchase contract. So this information is classified as

‘standard communication’. Not standard communication

As the table shows, ‘not standard communication’ consists of the subcontractor, complaints and VITAL 2.0. Subcontractors are used when raw materials must undergo extra cleaning steps, which increase the change on contamination. The use of subcontractors isn’t a daily activity and handling complains doesn’t happen every day as well, so for this reason they belong to the ‘not standard communication’ stream. Also VITAL 2.0 belongs to ‘not standard communication’ and is associated with handling complaints. Why is VITAL 2.0 part of the ‘not standards communication’ and why is it linked to complaints?

Classifying VITAL 2.0 in the organization is based on multiple factors, such as time, money and the practical application like the frequency and method of sampling. At the moment Tradin Organic is

growing and growing. This means more customers, more raw materials to be shipped and more work for the quality department. In practice, it is not feasible to perform a VITAL 2.0 calculation for each batch, because it will take a lot of extra time in addition to the current work for the quality

department. Also, Tradin must adhere to certain budgets and it will cost a lot of money to analyze all incoming batches on cross-contamination of allergens. Besides, knowledge how to enable a

representative sample which is applicable to the whole batch is necessary and will take time. (30) Taking into account these important factors, it is not feasible to include VITAL 2.0 in the daily activities, so a more realistic option for VITAL 2.0 could be the ‘not standard communication’. VITAL 2.0 is linked to ‘complaints’ because the program can be used to check if the complaint is valid. And because claims can lead to high costs, Tradin will be able to take the necessary costs for VITAL to solve the complaint and to stop the claim as much as possible.

3.2 Key results survey

To indicate the opinion and perception of the customers about the current communication of cross-contamination, a research was done through a survey. The survey was unstructured and consisted of eight open questions. The survey was sent to 16 customers of Tradin and six of them replied. A. copy of the survey is available in appendix VII.

The majority of the responses were substantively similar. However, the most interesting question of the research was answered differently and varied. A brief summary of the six most relevant questions will be described.

The question how customers label their own cross-contamination was answered with ‘processed in an environment which handles…’ and ‘may contain traces of…’ The majority of the respondents answered that they would copy the ‘?’ on their own label, and that they highly depend on Tradin information. The question if they perform analytical testing themselves was answered equally with ‘yes’ and ‘no’. Another result was that the majority did not know the Vital 2.0 program or that companies were not ready yet to apply. The most interesting question about how customers prefer to be informed by Tradin about cross-contamination was answered differently and varied. The answers were:

 By the use of ‘ALBA-list, +/- and the chance’

 By the use of ‘the current question mark on the specification (‘?’)’

 By the use of ‘contains allergens because of carryover’

 By the use of ‘may contain traces of…’ or ‘contains…’

 ‘More comprehensive’

 ‘Declaration in the product lines, site and storage. And indicating the controlled allergens and those that are not controlled.’

By applying the invented option for declaration (‘P’ and ‘F’) it creates the opportunity to satisfy several of these preferences. By using this way of declaration the ALBA list will still be used, as well as ‘+/-‘sign if allergens are present or absent. Also, the declaration will provide more information about cross-contamination on Production line and Field. In short, the whole declaration will be more comprehensive.

Because of the different and varied responses of the survey, the information resulting from the survey should be used as a global indication of the perception and opinion of the customer and not to make a real statement.

3.3 Decision tool

The decision tool is an important result of this research. The decision tool creates the opportunity to provide a risk based assessment which can help by deciding whether a cross-contamination should be declared or not. The tool is composed of six main subjects that indicate the global chain of Tradin:

 Supplier: General

 Supplier: Raw material from field

 Supplier: Raw material after processing

 Storage/transport

 Processing at subcontractor

 Customer

Based on these four main subjects, applicable questions are asked. These questions will be answered with ‘Yes’ or ‘No’. Based on the risk relevance of the question, a certain scoring is linked to the answers. At the end, all the scores are summed and there will be a final score. This final score will decide whether a cross-contamination should be declared or not.

- Score below 70: declaring is not necessary - Score higher then 70: declaring is required The underlying relevance of the question is based on:

 Most common situation: which situations are common within Tradin which can influence the relevance of a question?

 Experience: Work experience within this particular field. Based on work experience of colleagues a certain score is linked to certain questions.

 Personal intuition: What can increase or reduce the risk of cross-contamination according to common sense?

It should be kept in mind that the content of the decision tool is a dynamic process that can change over the course of time. Questions and scoring can be added or changed to optimize the tool. It is expected that the tool will be more comprehensive in time.

In which cases Tradin should apply the decision tool is described and explained in chapter 4.3

‘Advice’.

3.4 Statement cross-contamination labeling

As said before in the introduction, Tradin wants to have a statement which explains the risk based assessment of cross-contamination of allergens. In case of complaints or questions Tradin can send this statement to the customer (part of ‘not standard’ communication). This statement makes clear that the judgement is risk based and what factors were taken into account. A copy of the statement is available in appendix VIII.

4. Discussion

Tradin should use the information provided by the suppliers as leading and this information is the input for the decision tool, this tool can be a guide to decide whether a cross-contamination should be declared on the product specification or not. An important result of this thesis is that ‘may contain’ labeling is viewed by consumers as overused and not useful so this phrase isn’t going to be used to communicate cross-contamination to the customer. VITAL 2.0 can be used with complaints to check if the complaint is valid and in that way VITAL 2.0 can help avoid claims.

It will be used as ‘not standard communication’ because it will take a lot of extra time in addition to the current work for the quality department and it would cost a lot of money for Tradin to analyse all incoming batches.

4.1 Comparison to other studies

Allergic reactions and how common they are to a particular food in a population can vary. For example, mustard and celery allergy are not common in the UK but are much more common in Eastern Europe, and fish allergy is more prevalent in Scandinavian countries than in the UK. However, it should be kept in mind that people from high prevalence areas may travel to low prevalence areas where the product is sold and that some products should not be consumed at the intended

destination. (31)

It is very hard to say that a product is allergen free because of different circumstances. Tradin depends on the information given by the supplier about allergens. This means that clear

communication between Tradin and the suppliers is necessary and the information given by the suppliers needs to be right. (28) Tradin needs to translate the information that is delivered by the supplier into a right communication model for their customers.

There are a lot of different ways to communicate cross-contaminations. ‘May contain’ is widespread and according to the FDA consumers prefer a label with a similar wording. However, other studies reported that this way of labeling is overused and not useful. Also, consumers are increasingly ignoring the ‘may contain’ labeling. (32)

To indicate the content of a cross-contamination with VITAL 2.0, it is important to take a

representative sample which is comparable to the whole batch. However, the cross-contamination will not always be spread homogeneously over the product. So, depending on the sampling method, values can be determined which are not representative to the whole product/ batch. (33) Besides, the consistency of the product is important as well. It is more difficult to get a representative sample of products with coarse consistency, than for liquid products, because of the ease of spreading of the allergen.

The wording ‘may be present...’ used by VITAL 2.0 is based on a risk assessment, which means there is a plausible chance consumers will take this wording more seriously in contract to other commonly used labels, because they will link this kind of labeling to VITAL 2.0. However, the director of Allergen Consultancy advised not to use this wording, unless the whole allergen management is based on VITAL 2.0. The main reason for this is to avoid future confusion among consumers. (22)

4.2 Strengths and limitations

One of the strengths of this study is that there’s a lot of information available on the internet about allergens and cross-contamination of allergens, as well as the effects of allergens on health. Also, information how consumers judge the allergen labeling and how they think about allergen labeling can be found on the internet. There have been a few researches about how the customer thinks of different types to declare cross-contamination of allergens and this information was used in the thesis.

There was also the possibility to have contact with Tradin’s customers in the form of a survey and this helped to answer the question how cross-contamination should be declared in the most informative way instead of with the ‘?’.

The information on the question how the customers of Tradin think of the current communication of cross-contamination of allergens came from the survey. The survey was sent to 16 of Tradin’s customers but not all of them replied. The most important question of the survey was how customers would like to be informed about cross-contamination regarding to the product specification. All the customers replied with different responses, so it’s hard to make valuable statements on six responses, especially when the answers are varied.

A limitation of this research is that there aren’t a lot of studies about the declaration of cross-contamination of allergens concerning trade companies. Most researches are focused on the perception of the consumer and what the consumer thinks of different ways to communicate cross-contamination of allergens on packages, not about how companies would like to be informed by the trade company that sells the raw materials. The limitation of open questions in the survey is a very wide diversity of answers. For six responses it isn’t a real problem, but in case of more responses categorization of the answers will be more difficult.

5. Conclusion

The current way of declaring cross-contamination of allergens with the ‘?’ isn’t the best and most informative way to inform the customer. Tradin needs the best possible way to declare cross-contamination on the product specification so that the customers can use this information to inform the consumer.

The information about cross-contamination of allergens should be judged through the use of supplier’s information and the decision tool. Together this provides a more risk-based judgment, which decides whether a cross-contamination should be declared or not. Because the traditional ‘may contain’ (or a similar wording) is more focused on the customer then on business-to-business, other (invented) possibilities have also been considered. In conclusion it can be said that the best way to communicate this information to the customers is by a more informative declaration which indicates the origin of the cross-contamination (‘P’ or ‘F’).

6. Advice

Product specification

The differences in declaration of allergens between EU and USA are important for updating the product specifications. If Tradin uses the LeDa list, all of the allergens that are legislated in the EU and in the U.S.A are covered. At the moment Tradin uses the ALBA (now LeDa) list for the product

specifications, however not all of the allergens in the LeDa list are present on the product

specifications. For instance mollusks aren’t currently present on the product specification, but are asked for in the supplier’s questionnaire. Beef, pork and chicken are currently present on the product specification, but are not asked for in the supplier’s questionnaire. Since Tradin doesn’t have

products that could involve one of these complementary allergens, the recommendation would be to remove these allergens from the allergen declaration on the product specification. Also glutamate should be removed from the product specification because this is an additive and not relevant for Tradin. Tradin should communicate this information by using the ‘P’ (production line) and ‘F’ (field) on the allergen declaration because in this way the product specification will be more comprehensive and will contain more information about the origin of the cross-contamination. Also, by applying this type of declaration it creates the opportunity to satisfy several of the preferences of Tradin’s

customers (regarding the survey). Decision tool

The recommendation would be to use the decision tool only in case it is unclear whether an allergen needs to be declared on the product specification. It can also be used when a customer has questions about why a type of cross-contamination is declared on the product specification. The decision tool is part of the ‘not standard’ communication because it is not feasible to make it part of the standard communication, it will take a lot of time to judge every single product with the help of the tool. Examples of practical situations in which it is unclear whether a cross-contamination should be declared or not:

- What action should Tradin take if they find a peanut between the cocoa beans occasionally? Should ‘peanut’ be declared as a possible cross-contamination on the product specification? - Should the cross-contaminations of snails (Molluscs) in Raspberries IQF be declared on the

product specification?

- Oil products: In case the factory also produces other types of oils (like sesame oil/soybean oil/peanut oil), should cross-contamination of these types of oil be declared on the product specification?

- In case the supplier has several production locations, and one of the locations produces an allergen, how should Tradin deal with this?

- Case: Three different suppliers of poppy seeds form the same origin. One supplier indicates sesame as a contamination, but the other two suppliers indicate no possible contamination. How should Tradin deal with this? Should sesame be declared as a cross-contamination on the product specification or not?

Statement

Tradin should send the statement to the customer only in case of questions or complaints about the allergen declaration. The statement explains were the decision is based on and that the

interpretation of cross-contamination is to the best of Tradin’s knowledge, but should not be considered as a warranty of any kind without analytical verification.

Vital2.0

Tradin should use VITAL 2.0 in case of complaints which could lead to claims. In this case a sample will be taken from the product and send to the laboratory (customer or Tradin can take the sample) who will analyse it on the concerning allergen. The results from the laboratory will be put into the VITAL 2.0 calculator, as well as the serving size of the product. The recommendation would be to determine the serving size as in worst case scenario. In this manner all possible cases will be taken into account.

Further research

In case of the decision tool and subcontractors further research will be recommended. The decision tool can be more comprehensive and more focussed on certain products and characteristics of the product. For example, it could be an option the make one decision tool for bulk products, and one for regular packed products. The reason for this is because the risks for bulk products differ a lot to other products. Another option could be to make one decision tool for liquid/powder products and one for products with other consistencies. Subcontractors like ‘ De Vrij’ should also be further investigated. Important is to investigate in what way ‘ De Vrij’ could reduce or increase the risk of

5. References

1. Tradin Organic. Our company. Global operations.

Derived from: http://tradinorganic.com/our-company/global-operations 2. Irish Health. Most allergen labels ‘unnecessary’.

Derived from: http://www.irishhealth.com/article.html?id=19420 3. Food Standards Agency. Science. Allergy intolerance.

Derived from: http://www.food.gov.uk/science/allergy-intolerance/label

4. Allen K, Turner P, Pawanker R, et al. Precautionary labelling of food allergen content: are we ready for a global framework? World allergy organization journal 2014;7:4

5. Skal. Infobladen. Biologische teelt van gewassen.

Derived from: http://www.skal.nl/assets/Infobladen/Infoblad-Biologische-teelt-van-gewassen.pdf 6. Allergenenconsultancy. Informatie. Invloed procesbewerkingen.

Derived from: http://www.allergenenconsultancy.nl/in/invloed_procesbewerkingen

7. Burks AW, Tang M, Sicherer S, et al. ICON: Food allergy. J Allergy Clin Immunol 2012;129(4):907 8. American college of Allergy, Asthma & Immunology. Allergies. Types. Food allergies.

Derived from: http://acaai.org/allergies/types/food-allergies 9. Allergy UK. Food intolerance. Allergy or intolerance.

Derived from: https://www.allergyuk.org/food-intolerance/allergy-or-intolerance 10. Asthma and Allergy Foundation of America. Asthma overview.

Derived from: https://www.aafa.org/display.cfm?id=8&sub=16&cont=413

11. Boyce JA, Assa’ad A, Burks WA, et al. Guidelines for the diagnosis and management of food allergy in the United States: report of the NIAID-Sponsored Expert Panel. J Allergy Clin Immunol 2010;126:S18

12. Anaphylaxis Campaign. What is anaphylaxis. Signs and symptoms.

Derived from: http://www.anaphylaxis.org.uk/what-is-anaphylaxis/signs-and-symptoms#2 13. Gendel SM. Comparison of international food allergen labeling regulations. Regul Toxical Pharmacol 2012;63:279

14. Allergenenconsultancy. Informatie. Allergenen.

Derived from: http://www.allergenenconsultancy.nl/in/Allergenen 15. Allergenenconsultancy. Informatie. Wetgeving.

Derived from: http://www.allergenenconsultancy.nl/in/wetgeving

16. Food Allergy & Anaphylaxis Connection Team. Food Allergy. Food labeling. Food Allergen Labeling & Consumer Protection Act (FALCPA)

Derived from:

http://www.foodallergyawareness.org/foodallergy/food_labeling10/food_allergen_labeling_%2B_co nsumer_protection_act-23/

17. Food and Drug Administration. Food Allergen Labeling and Consumer Protection Act. 2006. Derived from: http://www.fda.gov/downloads/Food/GuidanceRegulation/UCM179390.pdf

18. European Federation of Allergy and Airways Diseases Patients Associations. Food allergies – the European concern. Abstracts from the 7th EFA conference.

Derived from: http://www.epha.org/1/330

19. Blom WM, Houben GF. Actiegrenswaarden voor een mogelijke kruisbesmetting van een levensmiddel met allergenen. Ned Tijdschr Allergie & Astma 2013;13:74

20. Food Safety Authority of Ireland. Press releases. 94% of Precautionary Food Allergen Labels are Unreliable.

Derived from: https://www.fsai.ie/news_centre/press_releases/AllergenSurvey28062011.html 21. Allergenenconsultancy. Nieuws. Etikettering kruisbesmetting verwarrend.

Derived from: http://www.allergenenconsultancy.nl/nieuws.php?nid=145 22. Ravenhorst van, M. Allergenenconsultancy

23. Barnett J, Leftwich J, Muncer K, et al. How do peanut and nut-allergic consumers use information on the packaging to avoid allergens? Allergy 2011;66:977

24. Foodmagazine. Features. ‘May contain warnings’… What do they really mean?

Derived from: http://www.foodmag.com.au/features/may-contain-warnings-what-do-they-really-mean

25. Food Allergy Research and Resource Program. Thresholds for allergenic foods. Derived from: https://farrp.unl.edu/thresholds-for-allergenic-foods

26. Coutts J, Fielder R. Management of food allergens. 1st. West Sussex: Blackwell publishing Ltd; 2009. p. 203-4

27. Mills ENC, Valovirta E, Madsen C, et al. Information provision for allergic consumers – where are we going with food allergen labelling? 2004;59:1266-1267

28. Crevel RWR, Baumert JL, Luccioli S, et al. Translating reference doses into allergen management practice: Challenges for stakeholders. Food Chem Toxicol 2014;67:278

29. Food protection. Downloads. VITAL 2.0 and Action Levels.

Derived from: https://www.foodprotection.org/downloads/library/pfaff.pdf 30. Loubser M. Raw materials and process sampling. 2006:4

31. Food Standards Agency. May contain guide.

Derived from: http://www.food.gov.uk/sites/default/files/multimedia/pdfs/maycontainguide.pdf 32. Anaphylaxis campaign. What is anaphylaxis. ‘May contain’ food labelling.

Derived from: http://www.anaphylaxis.org.uk/what-is-anaphylaxis/knowledgebase/may-contain-food-labelling

33. Allergenenconsultancy. Informatie. Drempelwaarden.

Appendix II Suppliers and cross-contamination declaration *For privacy reasons the names of the suppliers are left out.

Supplier Raw Material Cross-contamination Presented on

* Palm Oil Soy Production line, Field

* Glucose syrup Gluten Site

Wheat Gluten Production line, site,

storage

* Icing Sugar Fructose Field

* Coconut Milk Carmine Production line

* Sunflower Oil Oleum Soy Site

Sunflower Oil Soy, Nuts, Peanuts, Seeds and products thereof

Site

* Margarine Wheat Field, Site, Storage

Soy, Sulphite Production line, Field, Site, Storage

* Naturesweet Sulphite Production line, Field, Site,

Supplier Raw Material Cross-contamination Presented on * Lindseed, Sesame Gluten, Soy, Mustard,

Sesame

Production line, Site, Storage

* Lentils Wheat, Mustard Site, Storage

* Rice Nuts, Seame Site, Storage, (?)

* Sunflower Kernels Soy Field

* Flax Seeds Gluten, Wheat, Soy, Nuts,

Mustard, Sesame, Rye, Sulphite, Milk lactose, Peanuts, Eggs, Lupine, Mollusks, Fish

Site, Storage

* Cashews Soy, Mustard, Sesame Site

* Rice Gluten, Soy, Sesame, Lupin Traces possible

* Pomegranate seeds Nuts Field

Sulphite Site

* Raisins Sulphite Site

* Coconut Sulphite Site

* Buckwheat Soy Field

* Rice, Buckwheat,

Bulgur, Flax Seeds, Quinoa, Sesame

Wheat, Soy, Mustard, Sesame

Production line, Field, Site, Storage

* Flax Seeds Sulphite Production line, Field, Site,

Storage

* Sunflower kernels Sesame Field

* Lentils Gluten Site, Field

Mustard Field

Lupin Field

* Sundried Tomatoes Nuts Site, Storage

* Sunflower Lecithion Mollusks Production line, Site,

Storage

* Chia Powder Gluten, Wheat Site, Storage

* Mustard seeds Wheat Production line

* Bananachips Coconut Production line, Field, Site,

Storage

* Sesame, peanuts Nuts, peanuts, sesame Production line, Site, Field

* Buckwheat, sunflower

kernels

Soy, Nuts, Sesame, Peanuts Site, Field

* Pumpkin Soy, peanuts Site, Storage

* Pumpkin Gluten, Soy, Sesame Field

* Peas Soy Site, Storage

* Lentils, mustard seeds Gluten, Wheat, Mustard Production line, Site, storage

* Sunflower kernels,

kidney beans

Soy Site, Storage

* ? Wheat, Mustard Production line, Field, Site,

Storage, Grown

* Amaranth Sesame Production line, Site,

Soy Production line, Site, Storage,

Sunflower kernels Gluten, Wheat, Sesame, Rye, Lupine, Legumes

Production line

* Sesame Paste Soy, Nuts, Peanuts Site, Storage

* Quinoa Gluten, Wheat, Sesame Production line

* Buckwheat Wheat, Soy Site, storage

* Kidney Beans, Pumpkin

Kernels, Sunflower Kernels

Soy Site storage

* Couscous Gluten Production line, Site

Wheat, Soy, Mustard, Sulphite, Milk lactose, Eggs, Lupine

Site

Appendix III Frequencies of allergens

Type of cross-contamination Number of times present

Soy 22x Sesame 15x Wheat 13x Gluten 13x Mustard 9x Nuts 9x Sulphite 8x Peanuts 7x Lupine 5x Rye 2x Milk lactose 2x Egg 2x Molluscs 2x Fructose 1x Carmine 1x Seeds 1x Fish 1x Coconut 1x Legumes 1x

Appendix IV Product specific cross-contamination

Product Origin Cross-contamination

Org Mango Dried Slices Burkina Faso Nuts, Nut oil, Peanuts, Peanut oil Org Sunflower Kernels Confectionary China Soy protein, Gluten, Legumes Org Sunflower Kernels Bakery Romania + Bulgaria Maize

Org Pumpkin Kernels Shine Skin AA grade

China Soy protein, Gluten, Maize, Nuts,

Sesame

Org Pumpkin Kernels GWS Grade A China Maize

Org Pumpkin Kernels AA grade China Maize

Org Pumpkin Seeds Snow White for oil China Maize

Org Brown Flax Seeds Uncleaned Ukraine Legumes

Org Brown Flax Seeds Uncleaned Russia Gluten, Wheat, Legumes

Org Brown Flax Seeds Uncleaned Poland, Kazakhstan, China Gluten, Wheat, Maize, Legumes

Org Brown Flax Seeds Cleaned Russia Gluten, Wheat, Legumes

Org Brown Flax Seeds Cleaned Poland, Kazakhstan Gluten, Wheat, Maize

Org Brown Flax Seeds Broken Netherlands Legumes

Org Brown Mustard Seeds Canada Legumes

Org Blue Poppy Seeds Turkey Sesame

Org Hazelnut Paste ‘Medium’ Turkey Peanut, Peanut oil

Org Cashew Pieces Roasted Netherlands Peanut, Peanut oil

Org Cashew Kernels Dry Roasted and Salted

Netherlands Peanut, Peanut oil

Org Hulled Millet non-glutinous small Ukraine Wheat, Gluten

Org Hulled Buckwheat China Soy protein, Gluten, Maize

Org Brown Couscous France Chicken’s egg, Soy protein

Org Green Laird Lentils Canada Gluten, Wheat

Org Milestone Lentils Canada Gluten, Wheat

Org Beluga (black) Lentils Canada Gluten, Wheat

Org Brown Lentils Canada Gluten, Wheat

Org Red Lentils Turkey Gluten, Wheat

Org Red Split Lentils Turkey Gluten, Wheat

Org Red Split Lentils Oil Polished Turkey Gluten, Wheat

Org Unhulled Green Peas Canada Gluten, Wheat

Org Green Split Peas Canada Gluten, Wheat

Org Caraway Seeds Egypt Soy protein, Soy oil, Gluten,

Wheat, Rye, Nuts, Nut oil, Peanuts, Sesame, Mustard, Soy lecithin, Soy flour, Soy meal

Appendix VI Mind-mapping result

At the beginning of the research, the focus was more on the VITAL 2.0 program. It wasn’t clear yet where in the process VITAL could be used best, so a mind mapping session was set up. After the mind mapping session, it became clear that VITAL couldn’t be used as a daily programme for Tradin, since VITAL is more suitable for final products. This is concluded after e-mail contact with Marjan van Ravenhorst, consultant at ‘Allergenen Consultancy’.

Appendix VII Survey

Survey

Dear customer,

For research we are interested in how customers interact with (information of) cross-contamination of allergens and what their visions are. This helps us to enable improvements in the communication of cross-contamination of allergens. Your answers will be treated confidentially and will not be provided to third parties. This survey contains 8 questions and duration will take maximal 15 minutes.

Name of your organization:

Raw materials that you purchase at Tradin: Survey Questions

1. What is your final product? Please describe briefly where Tradin raw materials are being used for.

2. Do the raw materials undergo production processes at your company? If yes, which ones?

There are different ways to declare cross contamination. Examples are: ‘may contain’ ‘may contain traces of…‘ ‘made on the same production line as… ‘ ‘produced in a factory which handles…’ or by using ‘+/-‘ or ‘?’

3. How do you declare cross contamination on your own products?

4. To what extent do you depend on Tradin information regarding cross-contamination? (Is this allergen information useful for your own communication towards customers?)

5. Do you perform (analytical) testing for allergens yourself?

6. How would you like to be informed about cross contamination regarding to the product specification? (What kind of allergen labeling do you prefer?)

The VITAL (Voluntary Incidental Trace Allergen Labeling) system is an essential standardized allergen risk assessment tool for food producers. VITAL 2.0 allows food producers to assess the impact of allergen cross contact and provide appropriate precautionary allergen labeling on their products. Our current product specification

communicates cross contamination by using a question mark in the allergen list.

See example 

7. If Tradin indicates with a "?" that there is a possible cross-contamination in the product, do you copy this information on your label?

8. Are you familiar with VITAL 2.0?

- If yes, in which way would you use VITAL 2.0 in your own company?