‘Clean label’ changes of colour additives in the ...

‘Clean label’ changes of colour additives in

the confectionery industry

An exploratory qualitative research on how the safety of colouring foods, in particular Safflower

extract, is assessed in the confectionery industry.

MSc. Thesis in Food Quality Management 2017-2018

Chair group Food Quality and Design

Wageningen University and Research

Title: ‘Clean label’ changes of colour additives in the confectionery industry

- An exploratory qualitative research on how the safety of colouring

foods, in particular Safflower extract, is assessed in the confectionery

industry.

Date: 29 March 2018

Project: MSc. Thesis

University: Wageningen University and Research

Study program: MSc. Food Quality Management

Course code: FQD-80436

Student: Melanie Vogel

Registration number: 940507901060

Supervisors: dr. ir. Ralf Hartemink (1st) & dr. ir. Elsbeth Spelt (2nd)

ABSTRACT

The confectionery industry tends to replace artificial colour additives by natural food colours since a

research of the University of Southampton found that the consumption of particular mixtures of artificial

food colourings and a certain preservative might increase hyperactivity in children. A category that

belongs to these natural food colours are the colouring foods. Colouring foods are beyond the scope of

the food additive regulation, since they are considered as foods. For that reason, colouring foods do not

have to undergo a safety assessment procedure before it is permitted to use. The aim of this research is

to get an in-depth understanding on how the safety of colouring foods, in particular Safflower extract,

is assessed within the confectionery industry.

This research consists of a literature analysis that aimed at describing the characteristics of Safflower,

its legal status and the effects of its consumption. Additionally, an empirical study that aimed at mapping

how the Safflower suppliers and the confectionery producing company assess the safety of Safflower

extract within their company was conducted. This empirical study includes two rounds of interviews;

with ingredient suppliers during the first round (n=5) and confectionery producing companies in the

second round (n=3).

The results of the literature analysis present a summary of the (physiochemical) characteristics of

Safflower and give a European legislative framework on the distinction between colour additives and a

colouring foods. In addition to that, fifteen beneficial effects and eight side effects for the use of

Safflower extract are described. The results of the interviews with the ingredient suppliers suggest that

in general the suppliers have limited knowledge on Safflower extract and how the safety of Safflower is

assessed in the company. The ingredient suppliers use hygienic practices, pesticide residue tests,

microbiological tests and quality and safety standards as tools to guarantee the safety of their Safflower

extract. Moreover, the results of the interviews with the confectionery producing companies show that

the safety of Safflower is assessed by checking the safety data sheets that are provided by the ingredient

supplier. The confectionery producing companies do not perform microbiological, toxicological

contaminants and pesticide residue tests, these tests are only performed by their ingredient supplier.

Overall, it seems that the ingredient suppliers and the confectionery producing companies do not

perform additional safety measurements next to the ones that are required by key legislation. In practice,

this means that more attention is paid to safety risks that arise from contaminants than on the safety of

the initial substance.

TABLE OF CONTENTS 1. Introduction to the research ............................................................................................................. 1

1.1 Background ....................................................................................................................................... 1

1.2 Scope of the research ......................................................................................................................... 3

1.3 Research aim & research questions ................................................................................................... 6

1.4 Research approach ............................................................................................................................. 6

1.5 Outline of the report .......................................................................................................................... 7

2. Literature analysis ............................................................................................................................. 9

2.1 Methodology ..................................................................................................................................... 9

2.2 An introduction on Safflower ............................................................................................................ 9

2.3 Safflower as a food colouring.......................................................................................................... 10

2.4 Effects of Carthami flos .................................................................................................................. 11

2.5 European regulatory framework ...................................................................................................... 15

2.6 US legislation on food colouring additives ..................................................................................... 20

2.7 Summary of major findings ............................................................................................................. 20

3. Interviews Safflower extract suppliers .......................................................................................... 23

3.1 Methodology ................................................................................................................................... 23

3.2 Results and discussion ..................................................................................................................... 25


4. Interviews confectionery producers ............................................................................................... 31

4.1 Methodology ................................................................................................................................... 31

4.2 Results and discussion ..................................................................................................................... 33


5. Conclusions and consideration ....................................................................................................... 41

5.1 Conclusions ..................................................................................................................................... 41

5.2 Consideration................................................................................................................................... 42

5.3 Implications for theory .................................................................................................................... 43

5.4 Implications for practice .................................................................................................................. 43

5.5 Limitations....................................................................................................................................... 44

5.6 Recommendations for further research ........................................................................................... 45

6. Evaluation ........................................................................................................................................ 47

6.1 Evaluation of the research method and process .............................................................................. 47

6.2 Evaluation of the role of the researcher ........................................................................................... 48

References ............................................................................................................................................ 49

Appendices ........................................................................................................................................... 55

LIST OF TABLES

Table 1. An overview of replacements for the “Southampton Six” ...................................................... 4

Table 2. An overview of the desk research questions for literature analysis .......................................... 6

Table 3. An overview of in vivo studies on Safflower extract .............................................................. 13

Table 4. An overview of the companies and job description of respondents ........................................ 25

Table 5. An overview of the origin of the Safflower crop and production location of the Safflower extract

............................................................................................................................................................... 26

Table 6. An overview of the company’s considerations when introducing new extracts ..................... 27

Table 7. An overview of safety measurement that are taken by the ingredient suppliers ..................... 28

Table 8. An overview of the companies and job description of the respondents ................................. 33

Table 9. Similarties and differences among confectionery producing companies on the motivations for

the use of Safflower extract ................................................................................................................... 34

Table 10. Considerations for the use of Safflower extract of confectionery producing companies ...... 35

Table 11. Similarties and differences among confectionery producing companies on quality aspects of

Safflower extract ................................................................................................................................... 36

Table 12. Similarities and differences among confectionery producing companies on how they assess

the safety of Safflower extract ............................................................................................................... 36

Table 13. Measurement tools that are used by confectionery producing companies to assess the safety

of Safflower extract ............................................................................................................................... 37

Table 14. An overview of the confectionery products produced with Safflower extract ...................... 55

LIST OF FIGURES

Figure 1. The safety concept ................................................................................................................... 5

Figure 2. Carthamus tinctorius L. ........................................................................................................... 9

Figure 3. A flow chart of the extraction process of carthamidin from Safflower petals ....................... 10

Figure 4. A flow chart of the extraction process of carthamin from Safflower petals .......................... 11

Figure 5. An overview of medicinal effects of Carthami flos ............................................................... 12

Figure 6. The differences between food additives and foods ................................................................ 16

Figure 7. Decision tree on the classification of primary extracts with colouring properties ................. 19

Figure 8. Welcome sign at the Food ingredients fair ............................................................................ 24

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1. INTRODUCTION TO THE RESEARCH In this section, a background on the research is provided, the knowledge gap is described as well as the

scope of this research, the research aim, research questions and the research approach. Lastly, the outline

of the report is presented.

1.1 Background In recent years, consumers have become more interested in ‘natural’ and healthy, minimally processed

foods and foods without artificial additives. That is why food companies use clean label attributes to

minimize negative consumer views of highly processed foods (Bagley, 2017; Katz & Williams, 2011;

Hughes, Speirs & Chapman, 2010). For example, in 2010, Heinz tomato ketchup reformulated its

product in order to remove high fructose corn syrup from the ingredient list. Heinz succeeded and

rebranded the product to Simply Heinz. As another example, Häagen-Dazs focused on a short, simple

and understandable ingredient list by the development of their new product; Häagen-Dazs Five. This ice

cream is made with only five ingredients; milk, cream, sugar, eggs and one flavour compound (Katz &

Williams, 2011). Moreover, Mars has announced that it will remove all artificial colours from its food

products. Their products range, which includes gums, chocolate, confection, food and drinks will change

incrementally over the next years (Diaz, 2016).

The aforementioned examples are part of a trend that has developed in food products during the last

decade. This trend is often summarized under the umbrella term “clean-label” (Asioli et al., 2017;

Cheung et al., 2016) and is industry-wide applied (Osborne, 2015). The use of the term clean label in

peer reviewed journals increased dramatically the past ten years. Asioli et al. (2017) stated that the

growing importance of the term could be visualised by the number of citations in one of the leading

journals “Food Technology Magazine” (18 times cited in 2011 versus 77 times cited in 2016).

Additionally, a quick search on the global search site of the library of Wageningen University and

Research showed that 321 articles are associated with “clean label”, looking at titles and abstracts. The

majority, 308 articles, were published in the last ten years (2007-2017). The food industry has started to

respond to this increasing demand for food products with a clean label by supplying food products that

are seen as cleaner by the consumer (Katz & Williams, 2011). Data from 2013 show that 27 per cent of

all the newly launched products in Europe had some sort of a clean label (Ingredion, 2014). Although

there is an increasing market shift towards clean label products and the fact that clean labelling has been

widely studied, it is not defined what “clean label” actually comprises. Chen & Hart (2016) described

that a clean label is determined by what the consumer does not want to see on the ingredient list.

Furthermore, Scott-Thomas (2013) characterized the primary meaning of ‘clean label’ as “transparency,

in terms of the wholesomeness of ingredients, a lack of artificial ingredients, and often also a lack of

common allergens.” Edwards (2013) defined a clean label as “being produced free of ‘chemicals’

additives, having easy-to-understand ingredient lists, and being produced by use of traditional

techniques with limited processing.” So far, there is no joint agreement on a definition, neither a

regulatory or legal definition (Asioli et al., 2017; Ingredion, 2014).

Since there is no definition of or set of requirements on clean labelling (Asioli et al., 2017; Ingredion,

2014; Diaz, 2016), the food industry reformulates its products and ingredient lists in order to try to meet

perceived consumer demands (Bagley, 2017). A relevant example of this is the following case from the

food colouring industry. Bateman et al. (2004) of the University of Southampton had found that the

consumption of particular mixtures of artificial food colours and the preservative sodium benzoate might

increase levels of hyperactivity in young children. These artificial colourings, well known in the media

as the “The Southampton Six”, include Tartrazine (E102), Ponceau 4R (E124), Sunset Yellow (E110),

Camoisine (E122), Quinoline Yellow (E104) and Allura Red (E129). After this research was published,

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the EFSA evaluated these artificial colours and concluded that this study provided limited evidence that

these additives had any effect on the hyperactivity in children (EFSA, 2008). However, in the meantime,

part of the food industry had started to remove these artificial colours from their products due to

consumers’ demands. Furthermore, the Food Standards Agency in the UK advised their Ministers on a

voluntary withdrawal of these colouring additives (Oplatowska-Stachowiak & Elliott, 2017). In 2009,

the European Parliament ignored the advice of the EFSA and still decided to require a mandatory

warning on every food or drink label (except drinks with more than 1.2% alcohol). The label of these

products must carry the warning: ‘may have an adverse effect on activity and attention in children’

(FSA, 2012). This mandatory warning caused that food producers tend to remove artificial food

colouring additives from their products and replace them by natural ones (Oplatowska-Stachowiak &

Elliott, 2017; Szalóki‐Dorkó, Stéger‐Máté & Abrankó, 2015). This is in particular true for the

confectionery industry, since many of these products are targeted at children (Oplatowska-Stachowiak

& Elliot, 2017; Euromonitor International, 2011).

In the last years, several challenges for the use of natural colourings (naturally derived food colour

additives and colouring foods) have been identified. Firstly, the process of producing a natural colouring

of certain degree of quality requires a controlled supply chain from field to factory. Harvesting at the

point of maximum ripeness and controlled logistics are main determents for the sustainability of a colour

hue (Stich, 2016). Also, stability is an issue of natural derived colours. Natural derived colours tend to

be less stable than synthetic ones and it is therefore important for producers to understand the properties

and stabilities for a successful replacement (Stich, 2016; FSA, 2011). For products that require a heating

step during processing, for products that are exposed to light and oxygen and/or for products with a long

shelf-life, it is more difficult to achieve the right colour. It is challenging for the food industry to develop

similar naturally derived colour hues for existing ones (FSA, 2011). Last, but not least, the reformulation

of products comes at a price. The price of replacing ingredients by more natural, organic or non-GMO

ingredients is high, since these ingredients are often short of supply and are more expensive.

Additionally, natural ingredients require in several cases higher usage levels to create the same effect as

an artificial ingredient (Oplatowska-Stachowiak & Elliott, 2017; Zemser, 2015).

In 2011, the Food Standards Agency (FSA) in the UK set up guidelines on approaches to the replacement

of the “Southampton Six” for the confectionery and beverage industry (FSA, 2011). These guidelines

give alternatives including naturally derived colours and colouring foods, which produce the same red,

orange and yellow range colours as the “Southampton Six”. In European legislation, there is no

distinction between synthetic or natural colour additives (EU No. 1333/2008). This is found in the

definition of colouring additives:

“Substances which add or restore colour in food, and include natural constituents of foods and

natural sources which are normally not consumed as foods as such and not normally used as

characteristic ingredients of food. Preparations obtained from foods and other edible natural

source materials obtained by physical and/or chemical extraction resulting in a selective

extraction of the pigments relative to the nutritive or aromatic constituents are colours”.

The range of colouring foods falls out of the scope of a food colour additive and therefore there are no

additional legislative requirements on the use of these foods. Fruit, vegetable and plant extracts do not

fall under this regulation, but pigments such as chlorophylls and carotenoids that are selectively

extracted from them do. Therefore these pigments must undergo a safety assessment before being

approved, while the fruit, vegetable and plant extracts do not (Oplatowska-Stachowiak & Elliott, 2017).

Colour additives are selectively extracted and have a high purity of the pigment extracted. Contrary, this

means that colouring foods have higher contents of undeclared (potentially unsafe) substances than the

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equivalent colour additive obtained from the same raw material (Gerstberger & Cremer, 2010). The lack

of legislation causes the risk that not every colouring food is completely safe (Oplatowska-Stachowiak

& Elliott, 2017).

However, it seems that the confectionery industry mainly focuses on the problems regarding the

production process (Stich, 2016), stability (FSA, 2011;), costs (Oplatowska-Stachowiak & Elliott, 2017;

Zemser, 2015) and the right colour combination (FSA, 2011) of the natural counterparts of the colouring

additives instead of safety. According to European legislation, food safety should be paramount for the

Food Business Operators. The food industry is obliged by European Food Law to only put food on the

market if it is safe, which implies that it is not injurious to health or unfit for human consumption (Art.

14 (EC) No. 178/2002). To date, there is no literature available on safety assessments of colouring foods,

neither on how the safety of these foodstuffs is assured at the ingredient suppliers or at producing

companies in the confectionery industry. For that reason, the aim of this research is to get an in-dept

understanding on how safety of colouring foods is assessed within the confectionery industry.

1.2 Scope of the research There is no legislative definition of or requirements on clean label products (Asioli et al., 2017;

Ingredion, 2014; Diaz, 2016). In order to meet consumer demands, the food industry reformulates its

products and adapts the ingredient lists of their products (Bagley, 2017). In literature, there are several

clean label strategies found that are adopted by the food industry:

1. Firstly, E-numbers can be written in full name instead of the number. E-numbers also include

substances like ascorbic acid (vitamin C), oxygen and pectin that generally do not raise

consumer concern. However, due to consumer aversion to E-numbers, food products with lots

of E-numbers on the label raise consumer concerns (Bagley, 2017). Therefore, E-numbers are

replaced by their full name on the label.

2. Secondly, additives can be removed from the product, while still maintaining food quality and

safety requirements (TNO, 2016).

3. Third, additives can be replaced with ingredients with similar functionality (TNO, 2016). An

example of this is the replacement of preservatives by natural herbs and spices (which have

similar effect) (Chen & Hart, 2016). Also, replacing colouring additives by colouring foods is

an example of this (Bagley, 2017; EC, 2013).

4. Lastly, the additive ingredient can be modified (TNO, 2016). For instance, modification of

starch via physical, non-chemical ways.

This research has focused on the third strategy; a replacement of a food additive by another ingredient

with similar functionality.

Furthermore, this research looked into the confectionery industry. A part of the confectionery products,

like pastilles, gums, jellies and chews, boiled sweets and chocolate with toys, are in particular targeted

at children (Euromonitor International, 2011). These confectionery products often contain(ed) colour

additives from the “Southampton Six”, which are associated with hyperactivity in children (FSA, 2011).

In addition to that, it is found that the food industry, and specifically the confectionery industry, tend to

replace artificial food colour additives by natural food colourings (Oplatowska-Stachowiak & Elliott,

2017; Szalóki‐Dorkó, Stéger‐Máté & Abrankó, 2015).

According to the Codex Alimentarius a food additive can be described as: “any substance not normally

consumed as a food by itself and not normally used as a typical ingredient of the food; the term does

not include ‘contaminants’ or substances added to food for maintaining or improving nutritional

qualities” (Codex, 1995). Food additives can be divided in several categories, including preservatives,

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antioxidants, emulsifiers, stabilisers, flavours, sweeteners and colouring agents (Feketea & Tsabouri,

2017). A market research (5000 respondents) from GNT group described that there is much consumer

distrust towards the food industry regarding colour, flavour and preservatives. Additionally, this study

found that two third of the respondents is against the use of artificial colour additives (Laemers, 2017).

Furthermore, colour additives got increased attention of consumers since hyperactivity in children was

associated with certain mixtures of colour dyes and a preservative (Bagley, 2017; Bateman et al., 2004).

In a reaction to this, the confectionery industry started to remove artificial food colouring additives of

the label and replace them by naturally derived colour additives or colouring foods (Szalóki‐Dorkó,

Stéger‐Máté & Abrankó, 2015; FSA, 2011). In European legislation, all colour additives are labelled

with an E-number, independent from the fact if they are synthetically derived or naturally derived (EC

no. 1333/2008). Colouring foods are out of the scope of the additives regulation and do not have to be

labelled with an E-number. The last decades, consumers demand less E-numbers in their products

(Ingredion, 2014; Edwards, 2013), and that is why the food industry uses colouring foods to give colour

to their products (Bryne, 2011; FSA, 2011). For that reason, this research has focused on colouring

foods.

There is a broad variety of colouring foods, including orange carrots, pumpkins, black carrots, sweet

potatoes, elderberries, tomatoes, blueberries, grapes, red cabbage, spinach, Spirulina, Hibiscus and

Safflower (Oplatowska-Stachowiak & Elliott, 2017; Stich, 2016). In this research, only one colouring

food is researched. It is hypothesized that the results of this research on one colouring food can be

generalized to the whole category of colouring foods. This particular colouring food is chosen based

upon the table below (table 1) and a review on confectionery food labels (appendix I) at two large

retailers in the Netherlands. Table 1 gives an overview of the natural replacements for the “Southampton

six” colour additives for confectionery. The information in the table is collected from several food

ingredient suppliers (Wild Flavors, Symrise, ColorMaker, DD Williamson, Overseal Natural

Ingredients).

Table 1. An overview of replacements for the “Southampton Six” (FSA, 2011; Fusaro, 2010).

Synthetic colour Colour shade Natural equivalent for confectionery

Allura Red AC

(E129) Red Elderberry, beetroot red, carmine, anthocyanin in

combination with carotene

Ponceau 4R (E124) Red Black/purple carrot, elderberry, beetroot red, carmine,

anthocyanin in combination with carotene

Tartrazine (E102) Orange Turmeric, curcumin, lutein, natural carotene, Safflower,

Beta-carotene

Sunset Yellow

(E110) Orange Paprika, annatto, cochineal, Beta-carotene

Quinoline Yellow

(E104) Yellow Turmeric, lutein, natural carotene, Safflower

Carmoisine (E122) Red Grape skin, carmine, beetroot red, anthocyanin in

combination with carotene

Since the EFSA advised to lower the Acceptable Daily Intake (ADI) of Quinoline yellow, Sunset yellow

and Ponceau 4R, it is expected for these additives to be replaced by a natural equivalent (Hughes et al.,

2010). The natural equivalents in the overview include next to colouring foods, naturally derived

colouring additives as well. For this research a colouring food was chosen that is relatively unknown as

an ingredient in the human diet, but which is used a lot in confectionery to impart colour. During the

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label review that has been performed (appendix I), Safflower extract was found in many confectionery

products as a colouring food. Therefore, this research has focused on Safflower extract.

In literature was found that no safety assessment is required for colouring foods, and thus for Safflower.

This lack of legislation creates the risk that not every colouring food is completely safe (Oplatowska-

Stachowiak & Elliott, 2017). For that reason, this research is focused on the safety concept (figure 1) of

the use of Safflower extract in the confectionery industry. According to Luning & Marcelis (2009), food

safety refers to the absence of hazards or the existence of hazard levels with an acceptable risk. In their

safety concept (figure 1), they described different hazards that could cause safety risks in foods;

biological, chemical and physical hazards. This research focused on the safety of Safflower itself, and

not on the potential contamination of Safflower extract. Luning & Marcelis (2009) described that the

use of food additives is restricted and is highly dependent on scientifically underpinned analysis to assess

the safety of the compounds and to determine acceptable concentrations. Colouring foods are not legally

defined as food additives, but are, however, added to foods to impart colour. Since the European Food

Safety Authority has no opinion on the use of Safflower as a colouring, there is no scientifically

underpinned statement on the use of Safflower. Furthermore, due to the absence of legislative

requirements on toxicological assessment, it is rather unclear whether Safflower does possess any

endogenous toxic compounds. For that reason, in this research there is looked into the safety of the

endogenous substances (in this research; the effects of the consumption of Safflower on human health)

of Safflower.

Lastly, this research focused on the parts of the supply chain where Safflower or Safflower extract is

processed. It is assumed that stakeholders further downstream the confectionery supply chain do not

assess the safety of Safflower extract, but only distribute the end product. Therefore, within this research

the ingredient suppliers and the confectionery producers are studied.

Figure 1. The safety concept (adopted from Luning & Marcelis, 2009).

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1.3 Research aim & research questions This research aims to get an in-depth understanding on how the safety of colouring foods, in particular

Safflower extract, is assessed within the confectionery industry. This is done by gaining knowledge

regarding Safflower, its use, its effects on human health and the legislation concerning Safflower extract.

In addition to that, it is explored how the safety of Safflower extracts is assessed at ingredient suppliers

and confectionery producing companies.

To achieve this aim, the following research question is guiding for this research:

How is the safety of colouring foods, in particular Safflower extract, assessed within the

confectionery industry?

Furthermore, in order to support all elements of this research question, a number of sub-questions have

been formulated:

I. What are the (physiochemical) characteristics of Safflower and Safflower extracts?

II. What effects on human health could be identified for the consumption of Safflower (extract)?

III. What is the legal status of Safflower extracts in the European Union?

IV. How is the safety of Safflower extracts assessed at the food ingredient (Safflower) supplier?

V. How is the safety of Safflower extracts assessed at confectionery producing companies?

1.4 Research approach This research consists of three different research activities; literature analysis, conducting the first round

of interviews with the ingredient suppliers and conducting the second round of interviews with the

confectionery producing companies.

During the first phase of this study, research questions I, II and III are answered by performing an in-

depth literature analysis. For these questions, desk research questions are made to guide the literature

analysis.

Table 2. An overview of the desk research questions for literature analysis.

Research question Desk research questions Paragraph

What are the (physiochemical)

characteristics of Safflower and Safflower

extracts?

What is Safflower? 2.2

What is Safflower used for? 2.2/2.3

What are the physiochemical

characteristics of Safflower extracts?

2.2/2.3

How does the production process of

Safflower extract that is used for food

colouring look like?

2.3

What is the history of use of Safflower? 2.2/2.3

What effects on human health could be

identified for the consumption of

Safflower (extract)?

What are the beneficial effects of the

consumption of Safflower (extract) on

human health?

2.4.1

What are the side effects of the

consumption of Safflower (extract) on

human health?

2.4.2

Does a toxicological assessment of

Safflower extract exist? What are the

main findings?

2.4.2

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Research question Desk research questions Paragraph

What is the legal status of Safflower

extracts in the European Union?

What is a colour additive? 2.5.1

What is an extract? 2.5.3

What is a colouring food? 2.5.1/2.5.2

What are the requirements for colouring

foods?

2.5.2/2.5.3

What are the challenges regarding this

legislation for the food industry?

2.5.2/2.5.3

Since the topic of how the safety of Safflower extract is assessed in the confectionery industry is not

extensively examined in previous research, this research aims to gather new information. Qualitative

research is a method with a maximum explorative capability (Boeije, 2010). Therefore, an exploratory

qualitative research is conducted in order to be able to answer the last two sub research questions. For

research questions IV and V an empirical study is conducted, namely face-to-face semi-structured

interviews with representatives from suppliers of Safflower extracts and confectionery producing

companies. Semi-structured interviews are a suitable tool in qualitative research to gain a true

understanding what is happening (Boeije, 2010), which is applicable to the aims of this research.

In the second phase of the research, a trip to the Food Ingredients (Fi) Europe Fair in Frankfurt was

arranged to perform the first round of interviews. The Fi Europe is a fair where leading food and

beverage suppliers, research and development, and production and marketing specialists show their

range of new and innovative ingredients and services. On this fair, face-to-face semi-structured

interviews are conducted with ingredient suppliers. The aim of these interviews was to explore how the

safety of Safflower extract is assessed at the ingredient suppliers. The results of these interviews are

used to answer sub research question IV.

During the last phase of this research, face-to-face semi-structured interviews with confectionery

producing companies are conducted. The aim of these interviews was to explore how the safety of

Safflower extract is assessed in at the confectionery producing company. The results of these interviews

are used to answer sub research question V.

1.5 Outline of the report

In the second section of this thesis report, the methodology and the results from the literature analysis

are presented. In the third section, the methodology and the results of the interviews with the ingredient

suppliers are described. The fourth section focuses on the methodology and the results of the interviews

with the confectionery producing companies. In section five, the findings from the interviews are

discussed by linking the results of this research to existing literature. In addition to that, implications for

theory and practice are described and the methodology is discussed. Section six contains the conclusions

on this research and the limitations and recommendations for further research are provided.

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2. LITERATURE ANALYSIS

This section the methodology and the results of the literature analysis are described. There are three sub

research questions that are answered in this section:

I. What are the (physiochemical) characteristics of Safflower and Safflower extracts?

II. What effects on human health could be identified for the consumption of Safflower (extract)?

III. What is the legal status of Safflower extracts in the European Union?

2.1 Methodology An in-depth literature analysis was carried out, using different scientific databases, including the

Wageningen Library Global search option, Scopus, Google Scholar and PubChem. To answer the first

two research questions combinations of the following search terms were used for the search in titles and

abstracts: Safflower, Carthamus, Carthami flos, characteristics, effects, safety, safety assessment and

review. Additionally, information was gathered by the use of the snowball principle, meaning that the

reference list and “cited by” list were used to gather new literature. There was no toxicological review

found for the use of Safflower petals. However, a review of Tu et al. (2015) was found in which they

reviewed not only several studies regarding the ethno-pharmacological, pharmacological and clinical

applications, but they also described some side effects for the use of Safflower petals.

To answer research question III, regarding the legal status of Safflower, also the website EUR-lex was

used in order to get access to European Union law. Combinations of the following search terms were

used in the search in titles and abstracts in order to answer this research question: colouring food(stuff)s,

food, colouring additives, legislation, regulation (regulatory) and European.

2.2 An introduction on Safflower

Safflower (Carthamus) is one of humanity’s oldest crops with its use in China reported over 2,200 years

ago. Also, Safflower seeds from over 4,000 years ago are found in Egyptian tombs. The plant belongs

to the Compositae or Asteraceae family,

which is a branching, thistle-like

herbaceous plant with spines on its leaves

and bracts (figure 2) (Emongor, 2010;

Dajue & Mündel, 1996). The plants are

30-150 cm tall and have yellow, orange or

red globular flower heads (Dajue &

Mündel, 1996). A great number of species

of Carthamus are identified. Carthamus

tinctorius L. is the species of which

flowers and petals are used for commercial

(food) dyes and its seed to produce

Safflower oil (Nobakht et al., 2000; Dajue

& Mündel, 1996). It is grown in hot dry

climates and nowadays mainly cultivated for its seed, that is processed as edible oil and as birdseed

(Emongor, 2010; Dajue & Mündel, 1996). Also, the flowers and oil are used for medicinal reasons, since

it has been claimed preventing heart disease (Asgarpanah & Kazemivash, 2013; WebMD, 2009).

Moreover, the addition of Carthamus tinctorius L. dyes to cloth and food has a widespread and ancient

tradition. Carthamus tinctorius L. was an important dye for the carpet-weaving industries in Eastern-

Europe, the Middle-East and India, until cheaper aniline dyes became available in the 19th century (Dajue

& Mündel, 1996).

Figure 2. Carthamus tinctorius L. (Google images).

10

2.3 Safflower as a food colouring

In foods, Safflower was used as a common substitute for saffron, due to its low price. Safflower is

therefore widely known as false saffron (Nobakht et al., 2000; Dajue & Mündel, 1996) and it has been

used to flavour and to give rice, sauces, sausages and bread a yellow to bright orange colour from its

florets (Dajue & Mündel, 1996). In Iran, Safflower have been known as “Golrang” and it was grown for

colouring rice and bread but also for colouring cloth (Asparpanah & Kazemivash, 2013). By the 18th

century, also European countries including Italy, France and Britain used Safflower to colour foods

(mainly cheese and sausages) (Ekin, 2005). More recent, the public concern over the use of synthetic

dyes in food has grown dramatically and consumers demand natural derived colours over synthetically

colours and thus the use of Safflower extract as food colouring increased (Jadhav & Joshi, 2015).

In the last decades, compounds including

quinochalones, flavonoids, alkaloids,

polyacetylene, aromatic glucosides and organic

acids have been isolated from dried Safflower

petals (further referred to as Carthami flos) (Tu et

al., 2015). Flavonoid glycosides, carthamin and

Safflower yellow are the main elements of the

Carthamus tinctorius L. flower (Asgarpanah &

Kazemivash, 2013). Water-soluble yellow

carthamidin and water insoluble red carthamin

pigments are the two pigments that can be extracted

from Carthami flos. Carthamin and carthamidin

belong to the group of flavonoids, which is a class

of plant secondary metabolites (EC, 2015; Heim,

Tagliaferro & Bobilya, 2002). The yellow pigments

can be extracted from the Carthami flos with

(slightly acidified) water, the red carthamin

pigments can be extracted by adding sodium

carbonate to the petals (Jadhav & Joshi, 2015; EC,

2015; Machewad et al., 2012). Figures 3 and 4

present flow charts for the extraction of carthamidin

and carthamin from Safflower petals. The petals of

the Safflower plant contain about 30 per cent

yellow and 0.83 per cent red pigment (Machewad

et al., 2012). The yellow pigments of the

Carthamus tinctorius flower are nowadays widely

used to colour beverages and foods (EC, 2015)

Figure 3. A flow chart of the extraction process of carthamidin

from Safflower petals (adapted from Machewad et al., 2012).

11

2.4 Effects of Carthami flos Next to its colouring properties, the consumption of Carthami flos for its medicinal effects is reported

for over 2000 years in Chinese medicine books (Tu et al., 2015; Machewad, 2012; Nagaraj, Devi and

Srinivas, 2001). However, side effects for its use are known as well (Tu et al., 2015).

Figure 4. A flow chart of the extraction process of carthamin from Safflower petals (adapted from Machewad et al., 2012).

12

2.4.1 Beneficial effects of Carthami flos

Tu et al. (2015) reviewed in their article several studies regarding the ethno-pharmacological,

pharmacological and clinical applications of Carthami flos. They identified certain impacts of the

effective compounds of Carthami flos, indicating beneficial impacts on human health (figure 5).

Figure 5. An overview of medicinal effects of Carthami flos (Tu et al., 2015).

A variety of ethno-pharmacological uses of Carthami flos have been documented in traditional Chinese

medicine books. The consumption of extractions and powders of Carthami flos are used as a remedy to

coronary heart disease and consequent chest pain (agina pectoris), hypertension and gynaecological

disease, such as infertility. Modern medical research showed that activities of Carthami flos increase, to

some extent the supply of oxygen to the heart and brain and therefore provide scientific support for the

ethno pharmacological uses of Carthami flos (Tu et al., 2015). Also in the context of pharmacological

properties Carthami flos showed to have beneficial effect on brain injury and myocardial ischemia.

Furthermore, in other scientific reports anti-inflammatory, anti-thrombotic, anti-tumour and anti-

diabetic properties are found (Tu et al., 2015; Zhang et al., 2017). At present, Carthami flos and

Safflower yellow injections have been utilized to medicate coronary heart disease, chronic pulmonary

heart disease, cerebrovascular disease, orthopaedic disease and diabetes mellitus (Tu et al, 2015).

2.4.2 Side effects of Carthami flos

Although the use of Carthami flos has several beneficial effects, the side effects of the use of it should

not be ignored. Toxicity of herbs is a serious hazard to human health and therefore this crucial issue

should be managed (Zhang et al., 2017; Mirhoseini et al., 2012). The toxicity of Carthamus red was in

vitro evaluated by Wu et al. (2013) and showed no toxicity and mortality for doses increasing to 2000

mg/kg body weight. However, there are several other in vivo studies that showed toxicity of Carthami

flos or other side effects of Safflower extracts (table 3). Studies from Liu et al. (2004) and Nobakht et

al. (2000) found that (cyto)toxic effects of safflower that could initiate renal and brain tissue damage.

Also, Tu et al. (2015) described several side effects in their review. Mirhoseini et al. (2012) found that

Carthami flos has toxic effect on the testicular tissue in mice, which can cause spermatogenetic failure.

Additionally, Bahmanpour et al. (2012) found that the consumption of higher concentrations of

Safflower extract could have an adverse effect on the testosterone level in rats and induce fertility

problems. Also, other side effects except for toxicological ones are observed. Zhang et al. (2012) found

that in guinea pigs and rats Carthami flos injections could cause sensitivity to allergic reaction.

13

Table 3. An overview of in vivo studies on Safflower extract.

Biological activity Test model Author’s conclusion Reference

Nephrotoxicity Sprague-Dawley rats were

intraperitoneal injected

with hydroxysafflor yellow

A (HSYA) for 28 days and

90 days. After this time,

the sub chronic toxicity of

HSYA was evaluated.

A treatment of 90 days of

HSYA at dose of 180 mg/kg

indicates a slight

nephrotoxicity.

Liu et al.

(2004)

Cytotoxicity Pregnant Albino mice were

divided into six groups;

each group consists of six

animals and the first group

was considered as control.

The other groups were

given 0.2, 0.8, 1.2, 1.6, and

2 mg/kg/day Carthami flos

extract by gavage during

0–8 days. After 13 days,

macro- and microscopic

observations were

conducted.

Macroscopic: At doses 0.2 and

0.8 mg/kg/day, no marked

differences between the test

groups and control. By

increased doses, the number

and size of embryos decreased,

in doses of 1.6 and 2mg/kg/day,

the embryos and even the

placenta were absorbed.

Microscopic: there were

observed changes in the

neuroepithelial cells at doses of

0.8 and 1.2 mg/kg/day. Also,

the cytotoxic effect of

Carthami flos extract on

proliferation of rat nervous cell

culture was shown. To

conclude, Carthami flos has

cytotoxic compounds.

Nobakht et

al. (2000)

Spermatogenetic

failure

Sixteen male NMRI mice

were used; whereof the

experimental group

received Carthamus

tinctorius L. extract with a

dose of 200mg/kg for 35

sequent days, and the

control group received

distilled water. After this

period, histopathology,

morphometric analysis and

spermatogenetic

assessment were

conducted.

Carthamus tinctorius L. extract

can change the testes

histological structure and lead

to spermatogenesis failure.

Mirhoseini et

al. (2012)

14

Biological activity Test model Author’s conclusion Reference

Spermatogenetic

failure

60 male Sprague-Dawley

rats were divided in five

groups. One of the groups

was made partially infertile

by injecting busulfan to the

rats. Three experimental

groups were given 10, 25

or 50 mg/kg/day Safflower

extract for 35 sequent days.

The control group received

distilled water. After this

period, the semen were

analysed.

For the busulfan treated group,

treated with the Carthamus

tinctorius L. extract had

positive effects on the values

and that indicats that the

flavonoid component could

increase blood circulation in the

reproductive system, which

could improve fertility.

However, the higher

concentrations (25 or 50

mg/kg/day) may have adverse

effects on the testosterone

levels resulting in fertility

problems.

Bahmanpour

et al. (2012)

Allergic reaction Guinea pigs were injected

with Safflower, sodium

chloride or bovine serum

albumin saline injection,

for three days. 14 days

later, the test groups were

injected with a double dose

of the test substance, to

observe whether an allergic

reaction occurred within 30

minutes.

Also, SD rats were injected

with antiserum injection.

48 hours later, they were

injected with the same test

substances and 1mL of

Evans blue. After 30

minutes they were

sacrificed and the blue dots

were observed on the

dorsal skin.

Guinea pigs:

Adverse reactions are found in

the Safflower injection group,

no mortality observed.

SD rats:

Blue spots were found on the

dorsal skin of the Safflower

injections and the bovine serum

albumin saline injection groups.

Safflower injection could

increase the sensitation to

allergic reaction.

Zhang et al.

(2012)

Additionally, since the clinical use of Carthami flos, other side effects are discovered, including angle

closure glaucoma, throat inflammation and rhinorrhagia are reported (Deng, 2012). Lastly, clinical

observations of Compes et al. (2006) showed that Carthami flos could cause occupational asthma. Tu et

al. (2015) concluded that further investigations on the side effects and safety of Carthami flos are

needed.

15

2.5 European regulatory framework There is a great variety of food colourings, which includes the addition of intensely coloured food or

other material from edible and non-edible natural sources, but also colourings with synthetic (artificial)

dyes is one of them. These food colourings have different legislative requirements since they are

distinguished by legislation on the basis of origin, extraction and consumption. These differences are

explained in this paragraph, which gives an European regulatory framework concerning the different

types of food colourings.

2.5.1 Colouring foods versus food colouring additives

Before going into depth on the topic of colours, it is important to clearly distinguish between a food

ingredient and a food additive. In the general food law ((EC) No 178/2002) the basis for the assurance

of a high level of protection of human health in relation to food is laid down. This regulation provides

common principles, the resources to create a strong science base and procedures to underpin decision-

making in the context of food safety. In this regulation, ‘food’ or ‘foodstuff’ is defined as (Article 2

(EC) No 178/2002):

“Any substance or product, whether processed, partially processed or unprocessed, intended to

be, or reasonably expected to be ingested by humans. ‘Food’ includes drink, chewing gum and

any substance, including water, intentionally incorporated into the food during its manufacture,

preparation or treatment.”

A food is different from a food additive, in the sense that a food additive it is not normally consumed as

a food and therefore not intended to be, or reasonably expected to be ingested by humans, while a food

is. This is found in regulation (EC) No 1333/2008 on food additives where a food additive is defined as

follows (Article 3 (2) (a) (EC) No 1333/2008):

“‘Food additive’ shall mean any substance not normally consumed as a food in itself and not

normally used as a characteristic ingredient of food, whether or not it has nutritive value, the

intentional addition of which to food for a technological purpose in the manufacture,

processing, preparation, treatment, packaging, transport or storage of such food results, or may

be reasonably expected to result, in it or its by-products becoming directly or indirectly a

component of such foods.”

The regulation on food additives controls which additives may be used as ingredients for the preparation

of foods. The food additives are divided in several categories, according to their functionality, including

food colours. Food colours are defined as (Annex I (EC) No 1333/2008):

““Colours” are substances which add or restore colour in a food, and include natural

constituents of foods and natural sources which are normally not consumed as foods as such

and not normally used as characteristic ingredients of food. Preparations obtained from foods

and other edible natural source materials obtained by physical and/or chemical extraction

resulting in a selective extraction of the pigments relative to the nutritive or aromatic

constituents are colours within the meaning of this Regulation.”

Additives from synthetic origin (artificial colours, nature-identical colours), selectively extracted

colours from natural origin and inorganic pigments are managed together within this regulation. The

Regulation on food additives (EU No 1333/2008) makes no distinction between synthetically or

naturally derived colour additives and therefore all these colours are labelled with an E-number. There

are 40 approved food colour additives, labelled with E-numbers ranging from E100 to E180, of which

16

15 are of synthetic origin and 25 of natural of nature identical origin (Oplatowska-Stachowiak & Elliott,

2017; Stich, 2016).

Next to the additives, there are colouring foods. By the revision of the food additive regulation in 2008,

no definition on colouring foods was provided by the European legislator (Gerstberger & Cremer, 2010).

Colouring foods are defined by Stich (2016) as: ‘foods with colouring properties’ and are used by the

food industry for over 30 years now. These foods are especially produced to impart colour to food with

other foods. Colouring foods achieve natural colouring with standardized colour intensity and hue. The

quality and intensity of the colour is highly dependent of the quality of the raw materials. Currently,

only fruits, vegetables and edible plants with high contents of pigments are used for the production of

colouring foods. Widely used examples of these colouring foods are orange carrots, pumpkins, black

carrots, sweet potatoes, elderberries, tomatoes, blueberries, grapes, red cabbage, spinach, Spirulina,

Hibiscus and Safflower (Oplatowska-Stachowiak & Elliott, 2017; Stich, 2016).

Food colours and colouring foods are both used for the colouring of foods and have comparable

sounding names. However, in European legislation, they vastly differ from each other. Food colours fall

under the scope of the food additive regulation, whereas colouring foods do not. As mentioned earlier,

colouring foods are referred to as food with colouring properties (Stich, 2016) and are therefore

“intended to be, or reasonably expected to be ingested by humans” (Article 2 (EC) No 178/2002).

Therefore, these colouring foods are considered as food and therefore are not covered by the food

additive regulation (Oplatowska-Stachowiak & Elliott, 2017).

Figure 6. The differences between food additives and foods (adopted from Stich, 2016).

As shown in figure 6, the main criterion for the distinction between food additives and colouring foods

is the degree of extraction (Oplatowska-Stachowiak & Elliott, 2017; Stich, 2016). To visualize this

distinction, the following example of spinach is given. When spinach extract is processed non-

selectively and this extract is added to the product, it is not considered as a colour additive but as a food

ingredient. However, when the spinach is selectively extracted for its chlorophyll (E140), then it is

considered a food additive and is therefore covered by the food additive regulation (Oplatowska-

Stachowiak & Elliott, 2017). In addition to that, as can be found in figure 6, food additives require

permission, where colouring foods do not require permission by the legislator. A food additive needs to

be included in the Community list of food additives (Annex II of (EC) No 1333/2008), before it is

permitted to use.

2.5.2 Legal requirements for food colour additives and colouring foods

Companies who want to introduce new food additives, like colour additives, into the European market

17

should submit an application (FSA, 2011). Article 6 of (EC) No 1333/2008 includes certain general

conditions that have to be met for an inclusion in the Community list of food additives that are approved

for use in foods and their conditions of use. First of all, no safety issues should be present at the level of

usage (Lehto et al, 2017; Stich, 2016; (EC) No. 1333/2008 Art. 6 (1)(a)). Furthermore, there should be

a technological need, which cannot be reached by means of other economically or technologically

practices (Lehto et al, 2017; (EC) No. 1333/2008 Art. 6 (1)(b)). The last general description is that a

food additive should not mislead the consumer (Lehto et al, 2017; (EC) No. 1333/2008 Art. 6 (1)(c)).

The second part of article 6 (2) (EC) No 1333/2008 shows that the food additives that are included in

the Community lists must have advantages and benefits for the consumer in terms of: “(a) preserving

the nutritional quality; (b) providing necessary ingredients or constituents for groups of consumers with

special dietary needs; (c) enhancing the quality or stability, improving organoleptic properties; (d)

aiding in the manufacture, processing, preparation, treatment, packing or storage.” In addition to this,

article 8 (EC) No 1333/2008 mention some specific condition for colours, that may be included in the

community list if it fulfils one of the following purposes as well: “(a) restoring original appearance of

food; (b) making food more visually appealing; (c) giving colour to food otherwise colourless.”

Regulation (EU) 234/2011 gives information on the implementation and the content of such an

application procedure. The general requirements for the application consist of (Magnuson et al., 2013):

Administrative data

Risk assessment data:

o Identity of the substance

o Information on particle size

o Presence of impurities

o Microbiological characteristics

o Proposed chemical and microbiological specifications

o Manufacturing process

o Methods of analysis in foods

o Reaction and fate in food

o Case of need and proposed uses

o Exposure

o Additives produced by microbiological processes

o Additives produced from genetically modified organisms

o Information on national authorisations

o Proposed normal and maximum use levels

Toxicological data:

o General framework for the toxicological evaluation of food additives

o Study protocols

o Toxicological section of the dossier (core studies and other studies)

o Data reporting

o Review of results and conclusions

Risk management data:

o Function and technological need

o Investigations on the efficacy

o Advantages and benefits for the consumer

o Information why the use would not mislead the consumer

o Compliance with specific conditions for sweeteners and colours

18

As can be derived from the requirements for application, administrative data should be provided, as well

as toxicological data, risk assessment data and risk management data. For the toxicological data this

means that the level to which the additive can be added (taking into account the Acceptable Daily Intake

(ADI)) to the products should be determined (Oplatowska-Stachowiak & Elliott, 2017) and data on

genotoxicity, mutagenicity, chronic toxicity, carcinogenicity, reproductive toxicity and allergenicity

have to be provided (EFSA, 2009).

Since colouring foods are beyond the scope of the Regulation (EC) No 1333/2008 on food additives,

colouring foods do not require permission before being used. Additionally, this means that colouring

foods do not have to undergo an application procedure to be included in the Community list. Therefore,

no administrative data, risk assessment data, toxicological data or risk management data have to be

provided to the legislator. However, colouring foods should be used conforming with other EU key

legislation, meaning it has to comply with Regulation (EU) No. 178/2002, i.e. the general food law, as

well was Regulation (EU) No. 1332/2008 (EC 2008b) for enzymes, Directive 2009/32/EC (EC 2009)

for solvent extraction and Regulation (EC) No. 1881/2006 (EC 2006) for contaminants. Also, an extract

originating from a plant or animal should comply with the pesticide residue legislation. Furthermore, if

the colouring food was not consumed to a significant degree by humans in the EU prior to 1997, it also

needs to be in compliance with the novel food regulation, Regulation (EU) No. 2015/2283 (Lehto et al.,

2017; EC, 2013).

2.5.3 Guidance notes on the classification on food extracts with colouring properties

For years the definition of selective extraction lacked in legislation, until 2013 when ‘Guidance notes

on the classification on food extracts with colouring properties’ were published (EC, 2013). Although

these Guidance notes are not intended to produce legally binding effects, it gave clarity to the food

industry on how to manage the difference between colouring additives and colouring foods (EC, 2013).

An important note is that “The Guidance only relates to extracts in which the colouring constituents are

intact (i.e. not chemically modified) and indigenous to the source material”. Whereas the term extract

is defined as “obtained by physical and/or chemical extraction, no matter whether they are labelled as

extracts or concentrates”. With regard to food safety, the following statement is made in the Guidance

notes:

“As for food safety aspects, generally, the use of colouring foods could be regarded as safe if

the levels of exposure would not exceed those resulting from normal use of the colouring foods

source materials in the human diet. Furthermore, the extraction process should not lead to the

concentration of contaminants such as naturally occurring toxicants, or to the generation of

reaction products or residues of a nature and in amounts as to be of toxicological concern (EC,

2013).”

Lastly, it is mentioned that the Guidance notes might be updated on the ground of practical experience

with the implementation and the developments in the colouring foods industry (EC, 2013).

In order to distinguish colouring foods and colour additives from each other, the Guidance notes

proposed a decision tree (figure 7). In this decision tree, there are four questions on the primary extract

with colouring properties that have to be answered.

19

Figure 7. Decision tree on the classification of primary extracts with colouring properties (adopted from EC, 2013).

The first question distinguishes food and flavourings with a secondary colouring effect from extracts

with a primary colouring effect, based upon the exception of a food additive, as described in Article 3

(2) (a) (ii) of EC No 1333/2008. Here is described that “foods, whether dried or concentrated form,

including flavourings incorporated during the manufacturing of compound foods, because of their

aromatic, sapid or nutritive properties together with a secondary colouring effect” are not considered

to be a food additive. The second question encompasses the legal requirement of a food additive being

not normally consumed as a food in itself. The third question refers to the criteria for selective extraction.

The classification of the primary extract with colouring properties is essential, because the extraction of

a product can range from simple extractions to the isolation of pure pigments. Therefore it is important

to determine if the product is no longer “a food normally consumed as such or normally used as a

characteristic ingredient of food”, or a colour additive that requires permission. Whether an extraction

is selective or not, is depending on the ratio of the pigments relative to the nutritive or aromatic

constituents ((EC) No 1333/2008). In addition to that, the Guidance notes provide guiding questions and

a calculation method (with a threshold value for selective extraction) to calculate the enrichment factor

in order to determine this ratio (EC, 2013). The fourth question is to check whether the colour additive

is already permitted in the EU. If not, then the food company is not allowed to use this colouring.

According to Stich (2016), Safflower falls under the category of colouring foods. Using the decision

tree for Safflower extract gives the following outcome. Q1: Safflower extract has a primary colouring

effect in the products it is been used. Q2: As been described in paragraph 2.2 and 2.3, Safflower petals

and Safflower oil is used for over thousands of years as a flavouring and colouring in foods. Q3: During

the literature analysis, no information was found on the ratio of extraction of the Safflower extract that

is used for food colouring. However, it is assumed that Safflower extract is not selectively extracted,

because if it was selectively extracted, it should have undergone an application procedure for the

20

inclusion in the Community list as a colour additive. As could be found in Appendix II of (EC) No

1333/2008, Safflower is not included in this list. Also, on the website of the European Safety Authority

no evaluation on the required scientific data of Safflower could be found. For that reason it is assumed

that it is not selectively extracted, and thus Safflower is categorized as a colouring food.

2.6 US legislation on food colouring additives In the US, the regulatory framework for food additives is mainly based on the US Federal Drug and

Cosmetic Act (FFDCA) and its amendments (Lehto et al., 2013). Colour additives, which are

categorized as a group of substances added to food with the goal of imparting colour to food, have

different regulation than other food additives. Colouring additives cannot be registered as ‘General

Recognised As Safe’ (GRAS), but colour additives need a valid proof of safety that should be provided

during the authorisation procedure (Lehto et al., 2013). Coloured food ingredients that are added to the

product not with the intention to colour the food, like adding cherries to cherry yoghurt, are not

considered as colour additives. Likewise, ingredients like chlorophylls, riboflavin and beta-carotene are

only considered to be colour additives when they are added to the food with the intention to impart

colour and not if they are added for nutritive value. Important here is that the colouring effect should be

unimportant when adding it to the food product (Lehto et al., 2013).

The FDA constructed a list of colour additives that are authorized to use (and also for which products).

In list 4, the list for colour additives exempt for certification and permanently listed for food use could

be found (FDA, 2015). Also, in this list, fruit and vegetable juices that can be used as colouring foods,

are included. The use of certain fruit and vegetable juices is further defined in 21 CFR 73.250 and CFR

73.260. There is described that these juices “may be safely used for the coloring of foods generally, in

amounts consistent with good manufacturing practice”. Also, the authorization for the use of Spirulina

extract, another colouring food, can be found in this list. At the end of this list, an enumeration of colour

additives that are no longer authorized is given. One of these is Safflower (American saffron) extract

(FDA, 2015). In a news update from December 2016, the FDA explained this decision (FDA, 2017).

The basis for the fruit juice and vegetable juice colour additive regulation is that the fruit of vegetable

from which the juice is made, should be safely consumed as a food. According to the FDA, the fact that

a plant material can be eaten as a food, does not mean that the juice of this plant material meet the

specifications of this regulation. In an answer to manufacturers, who had asked about the colour

additives that are made from plant materials, the FDA advised that juice made from Safflower petals

and Hibiscus flower do not meet these specifications. Therefore, these juices are no longer on the list of

authorized colour additives (FDA, 2017).

2.7 Summary of major findings This literature analysis aimed at gaining in-depth information on the (physiochemical) characteristics of

Safflower and Safflower extract and what its beneficial and harmful effects could be. Additionally, this

analysis was aimed at building a legal framework of the status of Safflower extract in the European

Union.

2.7.1 Characteristics of Safflower

Safflower (Carthamus) belongs to the Compositae or Asteraceae family, which is a branching, thistle-

like herbaceous plant with spines on its leaves and bracts (Emongor, 2010; Dajue & Mündel, 1996). The

plants are 30-150 cm tall and have yellow, orange or red globular flower heads (Dajue & Mündel, 1996).

Carthamus tinctorius L. is the species of which flowers and petals are used for commercial (food) dyes

and its oilseed to produce Safflower oil. In foods, Safflower was used as a common substitute for saffron

(Nobakht et al., 2000; Dajue & Mündel, 1996). It has been used to flavour and to give rice, sauces,

sausages and bread a yellow to bright orange colour from its florets (Dajue & Mündel, 1996). The main

21

colouring pigments in Safflower petals are water-soluble yellow carthamidin and water insoluble red

carthamin pigments.

2.7.2 Effects of Safflower extract

Next to its colouring properties, the dried petals of the Safflower crop (Carthami flos) are used for

medicinal reasons. There are fifteen beneficial effects identified in studies regarding ethno-

pharmacological, pharmacological and clinical applications of Carthami flos (Tu et al., 2015). The

consumption of Safflower extract could prevent amongst others, coronary heart disease and diabetes

mellitus. However, other in vivo studies showed four side effects for the use of Safflower extract. The

studies from Liu et al. (2004) and Nobakht et al. (2000) showed (cyto)toxic effects of Safflower that

could initiate renal and brain tissue damage in rats and mice. Additionally, Mirhoseini et al. (2012) and

Bahmanpour et al. (2012) found that Carthami flos can cause spermatogenetic failure in mice. Next to

toxicological side effects, Carthami flos has showed that it could cause sensitivity to allergic reaction in

rats (Zhang et al., 2012). In addition to that, since the clinical use of Safflower extract, another four side

effects are reported, including angle closure glaucoma, throat inflammation, rhinorrhagia and

occupational asthma (Deng, 2012; Compes et al., 2006).

2.7.3 Legal status of Safflower extracts in the European Union

Food colours fall under the scope of the food additive regulation, whereas colouring foods do not.

Colouring foods are referred to as food ingredients with colouring properties and are therefore not

covered by this food additive regulation (Oplatowska-Stachowiak & Elliott, 2017). A striking difference

between food colour additives and colouring foods is that colour additives need to be approved in the

Community list of food additives before it is permitted to use and colouring foods do not require such

an application. The content for such an application should include among others; risk assessment data

(exposure, proposed normal and maximum levels, etc.), toxicological data and risk management data.

Since colouring foods are beyond the scope of the Regulation (EC) No 1333/2008 on food additives, no

application procedure is required before it is permitted to use. This means that no administrative data,

risk assessment data, toxicological data or risk management data should be provided to the legislator

before putting it on the market. However, colouring foods should be used conforming to other EU key

legislation, including the general food law Regulation No. 178/2002, Regulation (EU) No. 1332/2008

(EC 2008b) for enzymes, Directive 2009/32/EC (EC 2009) for solvent extraction and Regulation (EC)

No. 1881/2006 (EC 2006) for contaminants.

23

3. INTERVIEWS SAFFLOWER EXTRACT SUPPLIERS

In this section, the methodology and the results of the first round of interviews are described. Here, sub

research question IV is answered: How is the safety of Safflower extracts assessed at the food ingredient

(Safflower) supplier?

3.1 Methodology The interviews that are conducted during this first round of interviews, took place at the Food Ingredients

(Fi) Europe Fair in Frankfurt, 28-30 November 2017. The Fi Europe is a fair where leading food and

beverage suppliers, research and development, and production and marketing specialists show their

range of new and innovative ingredients and services. The interviews with the representatives from the

ingredient suppliers served two purposes: (1) To map how the ingredient suppliers assess the safety of

Safflower extract. (2) To explore the company’s considerations when producing Safflower extract.

3.1.1 Selection of sample

The sample for the interviews is assembled by using purposeful selection, which means that participants

are selected according to the needs of this research (Boeije, 2010). Therefore, in order to collect suitable

suppliers for an interview, the following criteria were set:

The supplier must supply to European countries and therefore has to comply with European

legislation before putting their products on the market.

The supplier must offer Safflower yellow extract (Carthamus extract).

On the website of the Food Ingredients Europe fair all exhibitors were found and sorted by category.

For selecting suitable suppliers, the list of exhibitors was sorted on companies specialized in colours,

since there was no colouring foods category. Approximately 150 companies were found. The websites

of these companies were visited in order to investigate whether they offer Safflower extract. Eventually,

fourteen companies were found that offer Safflower extract or were assumed to offer Safflower extract.

Representatives (technical sales manager or quality assurance officer) of these companies were

contacted and approached for an interview via the matchmaking tool on the website of the Fi. Of the

twenty requests that were sent, most requests for an interview that were sent via the matchmaking tool

stayed unanswered, except for three, these were declined because of unknown reasons.

3.1.2 Design of interviews

A semi-structured interview guide (appendix II) was constructed to guide the interviews. Preparation in

the form of a topic list or interview guide is desirable in semi-structured interviews (Boeije, 2010). An

interview guide (a written list of questions, prepared in advance) is used to give guidance to the

interviewer in order to obtain comparable data at different companies (Kumar, 2011). This is necessary

to be able to make an interpretation on how the safety of colouring foods is assessed at the Safflower

extract suppliers.

The interview guide was divided in four parts, an introduction to the research, general questions,

questions on the Safflower extract and specific questions on how the safety of Safflower extract is

assessed within the company. It consisted of ten questions of which nine are open ended and one

question is closed.

The first part introduced the subjects that are being discussed during the interview. Additionally, the

introduction was used to deal with some practical issues, like asking permission for recording,

explaining the anonymous character of the research, asking for member check, etc. The second part of

the interview consisted of several general questions. The first questions were focussed on what type of

colouring foods the company offers and if these colouring foods are suitable for clean label products.

24

These are assumed as ‘easy to answer’ questions for the respondent and therefore these questions served

as an icebreaker. Also, a question was asked to investigate which kinds of industries/companies are the

customers of the ingredients supplier. This question was used to verify whether they supply to

confectionery industry. The third part of the interview was focussed on Safflower specifically. During

the literature analysis, there was little information found on the production process of Safflower extract.

Therefore, this part of the interview included questions regarding the origin of the Safflower, the

production of the extract and the composition of the extract in order to gather more specific knowledge.

Additionally, in literature it was found that the confectionery industry mainly focuses on the problems

regarding the production process (Stich, 2016), stability (FSA, 2011;), costs (Oplatowska-Stachowiak

& Elliott, 2017; Zemser, 2015) and the right colour combination (FSA, 2011) when introducing natural

colourings. However, according to European legislation, food safety should be paramount for the Food

Business Operators. That is why the respondents were asked about their considerations that are taken

into account when introducing extracts, like Safflower. The last part of the interview guide focused on

the safety of Safflower extract and how this is assessed at the Safflower supplying company. It was

found that in legislation there are different requirements for colouring additives and colouring foods

(Oplatowska-Stachowiak & Elliott, 2017). A colouring additive should undergo an application

procedure before it is permitted to use, where colouring food does not. The content for such an

application should include among others; risk assessment data, toxicological data and risk management

data (Magnuson et al., 2013). Since colouring foods are beyond the scope of the Regulation (EC) No

1333/2008 on food additives, it does not need permission and thus no application procedure is required.

Aside these legislative requirements, there was no information found on how the safety of Safflower

(extract) is assessed at companies in the confectionery industry. Also, in the fourth part of the interview

a question concerning the toxicological safety of Safflower was asked, since Tu et al. (2015) found that

there are indications that the consumption of Carthami flos could cause toxicological side effects. In

addition to that, it was found that the use of Safflower extract in foods is not authorized in the US. That

is why the last question of the interview was about this prohibition and the respondent’s opinion on this

topic.

3.1.3 Data collection

Since all twenty requests for interviews were unanswered or

declined, there were no appointments for interviews when

arriving the Fi fair. For that reason, the stands of the fourteen

selected companies were visited, and also some additional

companies that offer Safflower extract were found. Eventually,

twelve companies were found that sell Safflower extract on the

European market. The representatives of these companies were

requested to make an appointment for an interview. There were

three interviews conducted that were useful for data analysis.

These interviews were conducted in English due to the fact that

it was an international fair and the spoken language was

English.

Two companies, which were both originating from China,

participated in an interview, but ended the interview halfway.

During the interview at one of the two companies, a colleague

of the respondent came to check which topics were being

discussed. After the colleague had checked, there was a little chat between the two employees, which

resulted that the interview needed to end, because of having too little knowledge on these topics.

Figure 8. Welcome sign at the Food

ingredients fair.

25

Additionally, there were seven companies of which the ‘right’ person (technical sales manager for

colouring foods or quality assurance officer) to answer the questions was not available or the

representative could not retrieve the information by heart. Six of these companies gave the researcher

the opportunity to send an email after the fair. Several days after the Fi, an email containing the questions

of the interview guide (appendix II) was sent to these representatives. There was a quick response from

one of the companies. The other five companies were sent an reminder three days later. Eventually, one

other company did respond to this email and filled out the questionnaire. This resulted in five useful

interviews and questionnaires to analyse (n=5).

During data collection and data analysis, errors and biases were prevented in three ways:

1. Asking clear and open questions. During the interview as much as possible open questions

beginning with ‘how’ and ‘why’ are asked. Furthermore, if anything was unclear to the

respondent, the researcher elaborated on the questions in order to make it understandable.

2. Recording of the interviews. The first interview on the fair was recorded, but there was too much

ambient noise to be able to understand the conversation while playing the tape afterwards.

Therefore, there are no records of the interviews. There are transcripts made of the interviews

in summary style, to give an as good as possible overview of the answers that were given.

3. Member checking the transcripts. Member checking is obtaining feedback from the participants

of the research in order to eliminate misrepresentation and misinterpretation of the data

(Onwuegbuzie and Leech, 2007). During the introduction of the interview there is asked to the

respondent whether he/she would like to member check the transcripts afterwards.

3.1.4 Data analysis

The transcripts were analysed by use of open coding. Answers on the same questions were grouped, and

thereafter segmented to be able to see which and how often certain topics were mentioned (Boeije,

2010). These results are summarized in tables and reported in a descriptive manner. Furthermore,

illustrative quotes of the respondents were used in order to give more explanation on the topics.

3.2 Results and discussion The interviews were aimed at mapping how the ingredient suppliers assess the safety of Safflower

extract and exploring the company’s considerations when producing Safflower extract. In this

paragraph, the results of the interviews with the ingredient suppliers are discussed per topic.

3.2.1 General description of sample

There is a total of five interviews and questionnaires conducted following the visit of the Fi. On the fair,

the representatives of the companies were mostly technical sales managers, therefore three out of the

five respondents in for these interviews were technical sales manager.

Table 4. An overview of the companies and job description of respondents.

Company Job description respondent

Company 1 Technical sales director food & beverage

Company 2* Area sales manager, natural colours division

Company 3* Technical sales manager

Company 4 Head of business unit colours

Company 5 Technical sales manager

* Companies 2 and 3 were not interviewed at the fair, but a questionnaire was conducted via the email afterwards.

26

3.2.2 Types of colouring foods

With regard to which types of colouring foods the companies offer, all the representatives of the

companies mentioned that they offer Safflower as well as Spirulina and also other fruit and vegetable

extracts. From the five companies, the companies 2 and 4 offer extracts consisting only Safflower,

company 1, 3 and 5 offer colours shades, which are mixtures or blends of different kinds of colouring

food extracts. Four out of the five companies offer colouring foods as well as naturally derived colour

additives. They distinguish between colouring foods that are suitable for clean label products, and

colouring additives that are naturally derived, which are not suitable for clean label since they have to

be labelled with an E-number. Company 5 offers only colouring foods that have not to be labelled with

an E-number.

3.2.3 Industry customers

All companies sell their products to all kinds of food and beverage industries, which implies that

colouring foods are suitable for all kinds of products (different pH, water activity, treatments, etc.).

Company 1 supply mostly to customers in the beverage industry. The representative of company 4

explained how broad the range of colouring foods can be applied:

“We supply a variety of global food and beverage in all market sectors (we do not target

Pharmaceutical, Personal Care and Animal Nutrition).”

3.2.4 Origin of Safflower and Safflower extract

As can be found in table 5, most representatives of the interviewed companies did not have knowledge

on the origin of the Safflower crop. Except for company 2 and 4, the respondents could not explain

where their Safflower is grown. The representative of company 2 did not want to specify on country.

Furthermore, four out of five companies could not tell where exactly the Safflower extract was produced.

Company 1 and 5 were able to name the production locations of their company, but could not tell at

which production location the Safflower extract is produced. The respondent of company 2 mentioned

that the Safflower extract was probably produced in Denmark. However, on the product specification it

was stated that their Carthamus extract was produced in China. The representative of company 3 could

not specify where their Safflower crop or Safflower extract was originating from due to the fact that

they source their raw materials from a European partner. The relationship between those companies

formulated the respondent as follows:

“Company 3 develops blends to meet the client’s needs, our European partner produces the

blend for us”.

Table 5. An overview of the origin of the Safflower crop and production location of the Safflower extract.

Origin of Safflower Production location Safflower extract

Company 1 Not specified Berlin, Valencia. Not sure where Safflower extract is

produced.

Company 2 Asia, does not specify

country

Not sure, probably Denmark.

Company 3 Source blends from EU

partner

Source blends from EU partner

Company 4 South Africa South Africa

Company 5 Asia (respondent

guessed China or India)

Company has different production locations in Europe.

Not sure where Safflower extract is produced.

27

The representative of company 4 was able to explain a lot more about the origin of the crops that are

used for their Safflower extract, since they source their own raw material. The respondent explained that

their company supplies the seeds for the production of the Safflower crop in South Africa to the local

farmers. Furthermore, the respondent pointed out that the Safflower extract is produced near the location

where the crop is grown.

3.2.5 Composition of the Safflower extract

With regard to the composition of the Safflower extract, the representatives of the companies 1, 4 and 5

explained that Safflower yellow extract could be extracted with only acidified water from the petals.

They stated that only Safflower and acidified water could be traced back in the Safflower extract.

Furthermore, the representative of company 1 added that they offer blends and that the composition of

the Safflower extract is adapted depending on the colour shades and technical specifications that the

customer desires. Also, company 3 pointed out that they produce different compositions of extracts

depending on what the customer requires. The respondent of company 2 added a product specification

of their Safflower extract to the interview to give more clarity on the composition. In this product

specification the company described that the Safflower blend consists of Carthamus tinctorius L. extract

and maltodextrin. Further details on the composition of the extract and ingredient breakdown are

confidential. A note in the product specification made clear that the company can provide this

information after signing a confidentiality agreement.

3.2.6 Considerations on the introduction of colouring foods extracts

The respondents mentioned several considerations that their company takes into account by the

introduction of a new extract. Table 6 presents these considerations that are taken into account when

introducing an relatively new and unknown extract.

Table 6. Overview of company’s considerations when introducing new extract.

Company 1 Company 2* Company 3** Company 4 Company 5

Customer requirements

Technical requirements

Regulations

Yield

Quality

Organoleptic quality

Safety

*The representative of company 2 did not mention any considerations due to the fact that the respondent is a

technical sales manager of colouring foods and did not have enough knowledge on the production of Safflower

extract.

**The representative of company 3 mentioned that their supplier of Safflower extract manages all the agronomy

issues, and they have therefore limited information on the considerations.

Company 2 was excluded from this results paragraph, since the respondent indicated that she has no

knowledge on the production of Safflower extract. Company 3 was not excluded, but a note must be

made here. The representative of company 3 mentioned that their supplier of the Safflower extract deals

with all the agronomy issues, and they have limited information on the considerations. Regarding the

considerations, the most respondents mentioned customer requirements as a consideration that is taken

into account when introducing new extracts. The importance of customer requirements is in line with

earlier findings from Fortuin and Omta (2009). They pointed out that nowadays the industry becomes

more focused at creating products that match consumers demand. Supply chains are changing from

28

supply-based approach to a demand-based approach. In this particular case, artificial food additives (E-

numbers) are being replaced by colouring foods because of consumer distrust in artificial colours that

was raised by the Southampton study. Furthermore, technical requirements (e.g. the stability under

different pH, water activity etc.), quality and safety are mentioned twice. Company 4 said about safety

that:

“There are many examples of companies who got their raw materials or extracts from China

where other substances than Safflower are found in the extract. Also substances that are not

even allowed in the EU, which are proven to have toxicological effects.”

The representative of company 3 was the only who mentioned EU regulations as a consideration. The

respondent explained that their company follows all regulations with respect to colouring foods before

putting such an extract on the market. Other considerations that are only pointed out by company 4 are

the yield of the flower and organoleptic quality of the Safflower. The representative of company 4

described that the yield of the flower is the most important consideration. An illustrative example was

given. This respondent made clear that there are lots of Safflower crops grown in Turkey, but the yield

of these flowers is quite bad. Therefore, this company supplies the desired Safflower seeds to local

farmers in order to assure satisfying yields. Another consideration that was only named by company 4

was organoleptic quality. The respondent explained that Safflower could in some cases smell “horse-

like” and has a bad odour of which they do not want to end up in their products.

3.2.7 Safety of Safflower extract

In the context of safety, the respondents named different measurements that their companies use in order

to guarantee the safety of their Safflower extract. Table 7 gives an overview of these safety

measurements that are taken by the ingredient suppliers.

Table 7. Overview of safety measurements that are taken by the ingredient suppliers.

Company 1 Company 2* Company 3** Company 4 Company 5

Good hygiene practices

Microbiological tests

Pesticide residue tests

Certification

*The representative of company 2 did not mention any safety measurements due to the fact that the respondent is

a technical sales manager of colouring foods and did not have enough knowledge on the production of Safflower

extract. Therefore, company 2 is excluded in this result section.

**The representative of company 3 mentioned that they work closely with their supplier in order to ensure that

their products are safe foods, but did not name any safety measurements. Therefore, company 3 is excluded in this

result section.

Two companies were not able to name the safety measurements, and were therefore excluded from this

results paragraph. Company 2 mentioned that she, as a sales manager, has not enough knowledge on the

production of Safflower extract, company 3 gave the fact that they source the extract from a supplier as

a reason for this. With regard to the safety measurements, hygiene practices is most mentioned as a

measurement that is used to guarantee safe Safflower extracts. The representative of company 5

mentioned that safe products could only be made when there is a safe production process. In their

company, hygienic handling is part of this safety along the production process. In addition to that, other

measurements that are taken by company 4 and 5 are pesticide residue tests and certification of several

quality standards. Regarding pesticide residues, the representative of company 5 explained that they

have companywide guidelines next to European guidelines. If the Safflower does exceed these limits,

29

then the petals are not used for extraction. Furthermore, the representative of company 4 also mentioned

the use of microbiological testing as a safety measurement.

In terms of toxicological safety, the respondents were not able to answer this specific question with

certainty. All the companies mention that they believe or guess that toxicological assessment was done

before putting their extract on the market, but they did not know it for sure. The representative of

company 2 reacted:

“I do not know, but I am sure that we will take measures.”

The representative of company 1 stated:

“I guess there are toxicological tests performed before putting these extracts on the market,

but actually I really don’t know.”

The representative of company 5 added that there are no legislative requirements regarding toxicological

assessment. This suggests that the respondent was well informed about the legislation concerning

colouring foods. According to legislation, the ingredient suppliers are indeed not obliged to collect risk

assessment data, toxicological data and risk management data (Magnuson et al., 2013) on the Safflower

extract. The category of colouring foods have the only requirement that it has to comply with key

legislation, as described in the guidance notes (EC, 2013). Furthermore, the respondent explained that

Safflower is a colouring food, and therefore it does only require historical use of such a food (instead of

a safety assessment) in order to produce a colouring food of it. The representative of company 4 added

that colouring foods extract, for example beetroot or sweet potato are consumed a lot and that it is

obvious that there are no toxicological issues concerning these foods. Both the representatives of

company 4 and 5 explained that also Safflower has a historical use, at least in Chinese medicine. The

representative of company 4 mentioned that Safflower was used as a kind of tea, which should have

beneficial effects on the gut. The respondent elaborated on that:

“It would be great if we could legalize such health claims, but it is really hard to realize in

the EU since you need to have lots of evidence.”

3.2.8 US legislation

The last question of the interview draw attention to the fact that the use Safflower extract in foods is not

authorized in de US. All of the respondents were aware of the fact that Safflower extract is not authorized

in the US. The representatives of company 1 and 5 shared the opinion that it is not a big issue for their

company, since they offer also other natural colourings that are permitted in the US. The representative

of company 5 named as a reason for this prohibition that stories have been told of companies that

imported Chinese Safflower extracts that contained artificial colourings. The respondent emphasised

that fraudulent practices could have influenced the decision of the US to prohibit the use of Safflower

extract in foods. The representative of company 4 made an interesting comment on this question. The

respondent explained that he believes that Safflower will be authorized in the US in the coming years.

He found some similarities between Spirulina and Safflower extract, since these are both used as a

traditional medicine and have not really a use of a ‘normal’ food ingredient. Also, Spirulina is permitted

in the US for around two years now and therefore he expects Safflower to be authorized in the near

future as well.

30

3.3 Summary of major findings These interviews with ingredient suppliers were aimed at gathering information on how the safety of

Safflower is assessed at the ingredient suppliers and to identify the supplier’s considerations when

producing Safflower extract. The results of these interviews indicate that, in general, the representatives

of the interviewed companies have limited knowledge on Safflower (extract) and how the safety of the

Safflower (extract) is assessed. Furthermore, with regard to the considerations, customer requirements

is the most mentioned (three out of five) consideration that is taken into account when introducing new

extracts. Also, technical requirements (e.g. the stability under different pH, water activity etc.), quality

and safety are mentioned by two respondents. In the context of safety assessment, hygiene practices is

most mentioned as a measurement that is used to guarantee safe Safflower extracts. Other measurements

that are taken by two (out of three) of the companies are pesticide residue tests and certification of

several quality and safety standards. In addition to that, one company performs also microbiological

tests in order to assure safety. In terms of toxicological safety, the representatives of the five companies

mention that they believe or guess that toxicological assessment was done before putting their extract

on the market, but they did not know it for sure.

31

4. INTERVIEWS CONFECTIONERY PRODUCERS

In this section, the methodology and the results of the second round of interviews are described. Here,

research question V is answered: How is the safety of Safflower extracts assessed at confectionery

producing companies?

4.1 Methodology The face-to-face interviews that are conducted with the confectionery producers aimed at three goals:

(1) To map how the confectionery producing companies assess the safety of Safflower extract. (2) To

identify what measurements the confectionery companies take in order to guarantee the safety of

Safflower extract. (3) To map which considerations are taken into account when confectionery producers

use Safflower extract in their confectionery products.

4.1.1 Selection of the sample

The second round of interviews in this research are interviews that were conducted at confectionery

producing companies. The sample for these interviews was assembled by using the purposeful selection

method (Boeije, 2010). Purposeful selection means that participants are selected according to the needs

of this study. The following criteria were composed in order to find suitable companies for the

interviews:

The confectionery producing company should produce confectionery products with Safflower

extract or concentrate as a colouring.

The confectionery producing company should produce confectionery for the European market

and therefore has to be in compliance with European legislation.

The confectionery producing company should have a visiting address in the Netherlands.

Confectionery companies that met the criteria were found via the earlier performed food label review at

two large retailers in the Netherlands. In addition to that, more confectionery producing companies were

mentioned on the website of Kompass, which is an online business directory. On this website an

overview list of “sugar confectionery Holland” companies was found (Kompass, 2018). Only

companies that produce confectionery for the European market were included in this research, since

they have to comply with European legislation and are therefore relevant. Furthermore, from a practical

point of view, only confectionery producers that have a visiting address in the Netherlands were

requested for an interview.

4.1.2 Design of the interview

For these interviews a semi-structured interview guide was used (appendix IV). The interview guide

consisted of eight questions of which seven are open ended and one question is closed. The guide was

divided in three parts, an introduction to the research, general questions and specific questions regarding

the safety measurements concerning Safflower extract within the specific confectionery producing

company.

The first part included an introduction concerning the subjects that are being discussed during the

interview. Furthermore, during the introduction some practical issues are handled, like asking

permission for recording, explaining the anonymous character of the research, asking for member check,

etc. The second part of the interview consisted of general questions regarding the use of colouring foods.

These questions served as an icebreaker and to comfort respondent for the rest of the interview. In

literature was found that the confectionery industry mainly focuses on the problems regarding the

production process (Stich, 2016), stability (FSA, 2011;), costs (Oplatowska-Stachowiak & Elliott, 2017;

Zemser, 2015) and the right colour combination (FSA, 2011) when using natural colourings. In order to

32

discover whether this is also true for these confectionery companies, in this part, the respondents were

asked about their considerations that are taken into account when using Safflower extract. The last part

of the interview guide focused on the safety of Safflower extract and how this is assessed at the

confectionery producing company. Since Safflower extract is a colouring food, it does not have to

comply with the regulation on food additives (Oplatowska-Stachowiak & Elliott, 2017). Therefore, it

needs no permission from the legislator to be used. In addition to that, risk assessment data, toxicological

data and risk management data have not to be provided (Magnuson et al., 2013). That is why in this part

of the interview, the respondents were asked to indicate which of the given measurements their company

uses in order to guarantee safety. The given measurements are based upon the legislative requirements

of the key legislation, and also requirements from the regulation on food additives (EC) No. 1333/2008.

This question was asked in order to identify how the confectionery producing companies assess the

safety of Safflower extract. Next to that, this question is used to identify whether the producers only

perform measurements that are required by legislation, or whether they perform also additional tests (for

example the tests that are required for food additives). Lastly, there was no ADI or maximum dosage

found for the use of Safflower in the documents of the EFSA, legislation or scientific literature.

Therefore, a question was asked whether a maximum dosage for Safflower extract exists.

4.1.3 Data collection

Initially, there were 17 companies that seemed to comply with the criteria. The websites of these

companies were visited and it was checked if these companies process Safflower extracts in their

products. However, it was not possible for every confectionery producing company to view their product

range including corresponding food labels online and therefore it was impossible to check for every

company whether they use Safflower extract. The companies of which this was unclear were emailed

with the question if they process Safflower extract as a food colour. Eventually, it was found that seven

companies did not use Safflower extract in their production process. From the other ten companies,

representatives of the product development department or quality department were searched via

LinkedIn. Representatives of the quality and product development departments were assumed to be most

relevant for these interviews since the questions assess as well the safety measurements that are taken

as the considerations and motivations to use Safflower extract during production. When no relevant

contact person was found via LinkedIn, a phone call was made to the general phone number of the

company in order to track down the name and contact information of a representative of the product

development department or quality department. All these representatives were emailed (appendix V)

with a request to participate in this research. Three of the companies replied that they did not produce

the confectionery products with Safflower extract themselves, but purchase it from their suppliers. One

other company mentioned that they produce these products, however, the production locations were

based in Germany. The representative of this company stated that they did not have any employee

working in the Netherlands that has sufficient knowledge on Safflower extract and therefore they could

not participate in this research. From the six companies that were left, two companies did not want to

participate in the research because there was no one who could give an interview regarding Safflower

extract. The representative of another company indicated that she was not sure whether she had sufficient

knowledge on Safflower to participate in an interview. This resulted in an interview by phone, which

was used as a pilot for the following interviews.

Eventually, 3 companies (n=3) participated in the interviews, whereof two were face-to-face conducted

and one by phone. One of the interviews was performed with two representatives of the company. The

interviews were conducted in Dutch, since the representatives all had the Dutch nationality and preferred

to perform the interview in this language.

33

During the data collection and data analysis, (measurement) errors and biases are prevented in four

ways:

1. Recording of the interview. During the introduction, permission is asked for recording the

interview. All respondents gave permission for recording the interview. Afterwards, the

interviews were transcribed verbatim style (word-for-word), which makes it possible to analyse

the data by use of coding methods.

2. Asking clear and open questions. In the interview guide that was used to guide the interviews,

there is made use of as many as possible open-ended questions. Furthermore, if anything was

unclear during the interviews, the researcher explained the questions or definitions.

3. Using probes (Boyce & Neale, 2006). To get insight in the measurements that are used and in

the motivations why certain measurements are used for the guarantee of safe Safflower extract,

probes are used to gather more detailed information. Examples of probes are: Could you give

an example of this? Could you elaborate a bit more on that?

4. Member checking the transcripts. Member checking is obtaining feedback from the participants

of the research in order to eliminate misrepresentation and misinterpretation of the data

(Onwuegbuzie and Leech, 2007). During the introduction of the interview there is asked to the

respondent whether he/she would like to member check the transcripts afterwards.

4.1.4 Data analysis

Transcript in verbatim style were made from all interviews. The answers on the same questions from

the three confectionery producers were grouped for the analysis. The data was analysed by use of open

coding (Boeije, 2010), which means that the transcripts have been read carefully and were divided into

fragments. Afterwards, these fragments were compared among each other and grouped in categories.

The results are summarized in tables and reported in a descriptive manner. To illustrate the differences

and similarities among the companies, quotations are given per question.

4.2 Results and discussion The interviews with the confectionery producing companies were aimed at mapping how the

confectionery producing companies assess the safety of Safflower extract, identifying what

measurements the confectionery companies take in order to guarantee the safety of Safflower extract

and mapping the most important considerations of confectionery producers for the use of Safflower

extract in their confectionery products. The results of the interviews are described per topic. Company

1 = C1, Company 2 = C2 and Company 3 = C3.

4.2.1 General description of the sample

For these interviews, there was aimed at interviewing representatives of the confectionery producing

companies that work at the quality or product development department. As can be derived from table 8,

two of the three interviews were conducted with product developers and one with a category sourcing

manager raw materials. The job description per company representative can be found in table 8.

Table 8. An overview of the companies and job description of the respondents.

Company Job description respondent

Company 1 Category sourcing manager raw materials*

Company 2 Product developer

Company 3 Product development manager

Product developer**

* The interview with company 1 was performed by phone.

* The interview at company 3 was performed with two representatives of the company.

34

4.2.3 Motivations for the use of Safflower extract

The motivations for the confectionery producing companies are described in terms of similarities and

differences. As can be found in the table below (table 9), all three respondents explained that their

customers demand naturally derived colours. However, there is a slight difference between company 1

and company 2 and 3 in how they react to this demand. Company 1 uses a naturally derived E100 in

their products, since they stated that they have no specific customer demands for products that are

produced with only colouring foods. Company 2 and 3 use Safflower extract in most of their products,

since it is a good replacement of food colour additives that should be labelled with an E-number. The

representative of company 1 gave another motivation for the use of Safflower extract, namely stability

of the colour. The respondent explained that their company uses Safflower extract to assure that the

yellow colour stays long enough (till the end of shelf-life) in their products.

Table 9. Similarities and differences among confectionery producing companies on the motivations for the use of Safflower

extract.

Similarities Differences

C2: “The motivation for the use of Safflower is

mainly the clean label trend. E-numbers are being

replaced, also colouring additives. Safflower extract

is a nice replacement for that. [...] The demand for

colouring foods like Safflower comes from the

consumer and retail”

C3: “Market demands is the most important

motivation to use Safflower extract. [...] We have had

naturally derived colour additives in our product

range, but since an amendment of the legislation we

were advised to use colouring foods in order to

maintain the “naturalness”. [...] Our customers desire

colourings that could be labelled as concentrates on

the label instead of E-numbers.”

C1: “We have lots of customers who require

naturally derived colours and tastes.

Colouring foods are no additives, but

ingredients. We don’t have specific

customer demands for products that are

produced with only colouring foods.”

C1: “For single yellow, we use E100 in

almost every product. We use Safflower in

whipped products, for meringues etc. Because

then you bring oxygen into the product and

E100 is not as stable as Safflower. [...] So,

we use Safflower to assure that the yellow

colour stays long enough in our products.

[...]

4.2.4 Considerations for the use of Safflower extract The respondents named many considerations for the use of Safflower extract. Two out of three

companies mentioned four of these considerations. Firstly, company 1 does not use Safflower extract in

every product, due to financial and stability considerations. This company uses only Safflower extract

for particular products, since it is more light stable then E100. Also, the representative of company 3

named light stability as an important consideration for the use of Safflower extract. The second

consideration was mentioned by the representative of company 2 and the representative of company 3,

35

namely the applicability in the production process. The representative of company 3 pointed out that

this is the most important consideration for their company. Another consideration that is mentioned by

the respondents is colour hue of the Safflower extract. The representative of company 1 explained that

Safflower yellow is more ochre like yellow, and therefore they use E100 in some of their products

instead of Safflower extract. Also, the representative of company 2 named colour as an important

consideration for the use of Safflower. The fourth consideration is the costs of the extract. The

representatives of company 1 and 3 both stated that colouring foods in general are more expensive than

artificial colouring additives. These four considerations; light stability, applicability in the production

process, colour hue and costs are in line with information that was earlier found. In the background was

described that the confectionery industry mainly focuses on the problems regarding the production

process (Stich, 2016), stability (FSA, 2011;), costs (Oplatowska-Stachowiak & Elliott, 2017; Zemser,

2015) and the right colour combination (FSA, 2011) of the natural counterparts of the colouring

additives. Additionally, in this research three other considerations were identified that were mentioned

by only one of the three companies. Those considerations are the flavour of the extract, legislative

requirements and the self-life of the extract.

Table 10. Considerations for the use of Safflower extract of confectionery producing companies.

Consideration Illustrative quotation

Light stability C1: “Light stability, for one product we use a mixture of Spirulina and

Safflower. But for the single use of yellow colouring we use E100. [...] That has

everything to do with the costs per use and the stability. It is cheaper if we use

a naturally derived food colouring, like E100. But for whipped products,

meringues for example, we use Safflower because E100 is not light stable in

such products.”

C3: “Safflower has a few benefits if you compare it with curcumin. It is more

light stable, that is an additional benefit from it.”

Applicability in

the production

process

C2: “Important considerations are the technical aspects of Safflower extract;

is it a nice colour, does is suit the product? But also, how easy is it process able?

Does it blend well? Is it easily process able?”

C3: “The most important is whether we can apply the concentrate in our

process. We have process steps where colours are being dosed by the use of

pumps. When a colouring is very viscous, there are sometimes troubles in the

process.”

Colour hue C1: “E100 gives a brighter yellow hue, that is a bit more attractive. Safflower

is more ochre yellow. That is why we use E100 in our wine gums.”

C2: “Is it a nice colour, does is suit the product?”

Costs C1: “The costs for a naturally derived colouring, like E100, are less than for

Safflower. That is why we use E100 for lots of products”.

C3: “Normally, colouring foods are more expensive than an artificial powder.

[...] The purchase price of such a powder is maybe a bit higher, but you can

dilute it with a factor of 10. The reason that not all companies in Europe use

colouring foods is the higher cost”

Flavour C3: “The transition to colouring food was not always easy, because you have to

take into account the flavour as well. I mean, such concentrates also bring

flavour, they do not get that out of the concentrate.”

Legislative

requirements

C2: “The legal department is always checking the legislation concerning a raw

material before we are going to use it.”

36

Consideration Illustrative quotation

Shelf-life C3: “What we also look at is the shelf-life. [...] Within our company we follow

new raw materials for a half-year, it depends on what the shelf-life should be.

We can also follow the shelf life accelerated and under different conditions, like

in a heat cabinet with a certain humidity. We look at all those aspects before the

products enter the market.”

4.2.5 Important quality aspects for Safflower extract With regard to the quality aspects for Safflower extract, the three companies referred all to the same

aspect, namely; the colour. In addition to that, the respondent of company 3 also mentioned the flavour,

thickness and viscosity of the extract.

Table 11. Similarities and differences among confectionery producing companies on quality aspects of Safflower extract.


C1: “We see colour hue as the quality of a colour. What kind of colour

does the raw material impart to the product?”

C2: “Just what I’ve said, how does the colour look like? Safflower for

example is more ochre like than bright yellow, that has to suit with the

end product.”

C3: “That is colour intensity, but also the additional flavour, thickness

and viscosity. It is important that we don’t get any variations in raw

material from the supplier. The supplier has to deliver always the same

product, so the same intensity, always the same pigment and the same

viscosity.”

-

4.2.6 Safety assessment of Safflower extract In the context of how the confectionery producers assess the safety of Safflower extract, the respondents

answered that they assess the safety of the incoming Safflower extract by checking material safety data

sheet that are provided by their supplier. The representatives of company 2 and 3 explain that they

perform a risk assessment on the basis of these documents. The quote of company 3 illustrates that this

confectionery producing company determined the risk for Safflower extract as minimal. In addition to

this assessment, this representative of company 3 described that they check also the working and process

condition of their supplier by auditing them. The representative of company 2 also pointed out that their

legal department checks the legal limits for pesticide residues, heavy metals, microbiological and

toxicological tests and demand these limits from their suppliers.

Table 12. Similarities and differences among confectionery producing companies on how they assess the safety of Safflower

extract.


C1: “That is something our quality department does.

They are going to request safety data sheets, if they

exist. Some suppliers of colouring foods don’t have

safety data sheets because these are basically

ingredients. They request these documents and test if

they are in compliance with our requirements.”

C3: “We also check the working

conditions and the safety during

production. We audit some of our

suppliers to be able to see whether they

work in a proper way.”

37


C2: “There is a risk assessment being performed on the

basis of statements, safety data sheets and analysis

certificates.”

C3: “We check for every raw material the material

safety datasheet, all information regarding a raw

material is in there. This information is mapped by the

supplier itself. But if you think logically yourself, it

originates from a plant, which is edible, and it is only

extracted with a certain factor. If you think about where

colouring foods come from, then you know that it is

unlikely that there is a danger. With extractions I know

it is different, in high concentrations it could be toxic.

But in such a product, the risk is minimal. Everything is

lethal in high concentrations, ha-ha.”

C2: “The legal department checks the

legal limits for pesticide residues, heavy

metals, microbiological and toxicological

tests. Our supplier, but also we have to

comply with these criteria. We demand

those criteria from our suppliers”

Also, the companies were asked to indicate which of the given measurements they perform.

Table 13. Measurement tools that are used by confectionery producing companies to assess the safety of Safflower extract.

Measurement Illustrative quotation

Microbiological

testing

C1: “We do not perform microbiological tests ourselves, we assume the

values on the specification of the supplier as valid. That has everything to do

with the process we have. The end product we make is of course not sensitive to

microbiological growth.”

C2: “We use the values of the suppliers, from the analysis certificates that are

provided with the raw material. Such tests we do not perform ourselves.”

C3: “If you talk about safety, they (the supplier) perform microbiological

tests. Also, we perform also a microbiological test once a year in our own

laboratory. Just as a check that everything is fine.”

Toxicological

testing

C1: “We do not perform toxicological tests. That is actually the same story.

We assume the values in the specification as the truth.”

C2: “Same story, we do not perform these test by ourselves but we trust the

values that are provided by the supplier. “

C3: “Yes, that is done (by the supplier). We have a statement on the

toxicological tests that it is in compliance with the safety data sheet. And during

an audit, our department checks more on this, like what kind of analysis did

they perform, which aspects do they take into account during sourcing? This is

done in order to cover the risk.”

Pesticide residue

testing

C1: “Same story, idem dito.”

C2: “Same story.”

C3: ”Yes, that is done (by the supplier). We have a statement. If I’m correct,

it is described here. Pesticides residues are covered here.”

38

Table 13 shows that microbiological, toxicological and pesticide residue tests are not performed (on a

regular basis) by the confectionery companies itself. The representative of company 3 explained that

they perform a microbiological test as a check once a year. During the interviews there was asked about

both toxicological testing on contaminants and toxicological assessment of the initial substance. The

representatives of company 1 and 2 did, however, not understand this. The representative of company 3

showed the safety data sheet and the product specification of the Safflower extract during the interview,

only the values of contamination toxins like aflatoxin and mycotoxins were included in the datasheet.

The representative of company 3 explained about this:

“I don’t know if they (the supplier) test on the raw materials. There are no indications here that

they do. They only give a statement for their own end product and not for the raw material that

they source at their suppliers.”

Therefore, with regard to the toxicological tests, it is assumed that only the suppliers perform tests on

contaminants. This suggests that there are no additional tests on the initial substance performed, not at

the ingredient supplier, neither at the confectionery producing company. According to legislation, the

ingredient suppliers are not obliged to collect risk assessment data, toxicological data and risk

management data (Magnuson et al., 2013) on the initial substance. Colouring foods only have to comply

with key legislation, as described in the guidance notes (EC, 2013).

As a reason for not performing these tests, there was one important reason that was mentioned by all

three the producers, namely the trustworthiness of their supplier. The representative of company 1

explained that if their quality department screened their suppliers, and if the supplier passes this

screening, they are seen as trustworthy. This finding is in line with Fischer (2013), who pointed out that

in particular trust is an important factor in a collaboration of independent companies.

According to Mayer, Davis and Schoorman (1995) there are three main factors that influence the

perceived trustworthiness, namely ability (group of skills and competences), benevolence (the extent to

which someone is believed to do good), and integrity (adherence to a certain set of principles). These

factors are also found as the reasons for trustworthiness that are given by the confectionery producers

during the interviews. The factor ability is found in an illustrative quote of company 1:

“That is the philosophy of ... (the supplier). Within their whole production process you must be

able to pick a spoon an eat the product. It must not be harmful, but also nice to eat.”

Here, the respondent described that the philosophy of their supplier is to be able to eat the product at

every stage of the production process. This illustrates that company 1 relies on the capabilities of their

supplier that they will deliver safe products. The representative of company 2 mentioned another factor

that is influencing the trustworthiness of their supplier. The representative described that the Safflower

extract is purchased from a supplier that is one of the biggest in Europe, and that they would not ruin

their name by delivering unsafe products to their customers. This suggests that the representative of

company 2 believes that the supplier will do good to their company and deliver safe products. The

reasoning is an example of the factor benevolence, as described by Mayer et al. (1995). Lastly, the

integrity factor is noticed in a quotation of company 3. The representative of company 3 mentioned that

for Safflower extract they have a partnership with a company that has been their supplier for a long time.

The representative described the relation with their colouring food supplier:

“We assume that the supplier always deliver the same product. When the supplier changes the

origin of the raw material, they have to report it to us. When there are changes in

documentation, process or recipe, they have to report it to us. [...] In fact, we know of this

39

supplier that they are strict in their standards, therefore we like working together with this

supplier.”

This quotation illustrates that for company 3, the trustworthiness of their supplier is dependent on the

fact that their supplier adheres to their own set of standards

Other reasons for not performing these tests that are mentioned include the costs of testing and the fact

that confectionery is not vulnerable for bacteria because of it high sugar content.

With regard to the criteria that are used to determine the safety of Safflower extract all respondents

referred to criteria and limits that are laid down in legislative requirements, the product specifications,

and the safety data sheets that are provided by the supplier. The representative of company 3 added to

this:

“The supplier sets limits for both chemical as microbiological tests. Those limits we check as

well, because sometimes we sell to countries that have different legislative requirements on

those limits.”

Lastly, the respondents were asked if their company uses a maximum dosage for Safflower extract. The

representative of company 2 was not able to answer this question. The representatives of the two other

companies indicated that they use the limits that are determined by the supplier. The companies do not

investigate themselves whether there is an ADI or maximum dosage. For the use of Safflower, company

3 explained:

“That is quantum satis, I believe. Quantum satis basically means that the dosage could be

infinite, you can drink the extract purely, you can consume it purely.”

This quote confirms that colouring foods are handled as food ingredients, where the consumption is

unlimited since these food products are part of the daily diet. In addition to that, this quote illustrates

that the respondent had no specific knowledge on the definition of ‘Quantum satis’. In article 2(h) of

Regulation (EC) No 1333/2008 on food additives is described that: ‘Quantum satis’ shall mean that no

maximum numerical level is specified and substances shall be used in accordance with good

manufacturing practice, at a level not higher than is necessary to achieve the intended purpose and

provided the consumer is not misled.” This is different from the explanation of the respondent that the

dosage could be infinite. The quote suggests that the respondent did not have the correct knowledge on

this topic.

4.3 Summary of major findings The interviews with the confectionery producing companies were aimed at mapping how the

confectionery producing companies assess the safety of Safflower extract, by identifying what

measurements are used. Additionally, it aimed at mapping the most important considerations of

confectionery producers for the use of Safflower extract in their confectionery products. In the context

on how the safety of Safflower is assessed, the representatives of the three interviewed companies

indicated that they assess the safety of the Safflower extract by checking material safety data sheet that

is provided by their supplier. The companies check whether the values and criteria in the safety data

sheet are in compliance with their own criteria and legislative requirements. Furthermore, it was found

that the confectionery producing companies themselves do not perform microbiological, toxicological

and pesticide residue tests. The representatives of the confectionery producers explained that their

supplier performs these tests and that they assume the values in the product specification as true. The

major reason for not performing those tests themselves is the trustworthiness of their supplier. Other

reasons are costs of testing and the fact that confectionery is not vulnerable to bacteria. With regard to

40

the considerations for the use of Safflower extract, light stability, applicability in the production process,

colour hue and costs are mentioned by two of the three companies. Also, flavour of the extract,

legislative requirements and shelf-life are mentioned, but only by one of the three companies.

41

5. CONCLUSIONS AND CONSIDERATION

In this section the overall research question is answered, a consideration on the conclusions is given and

implications for theory and practice are discussed. In addition to that, limitations of the research are

described and recommendations for further research are provided.

5.1 Overall research question

This research aimed at getting an in-depth understanding on how the safety of colouring foods, and in

particular Safflower extract, is assessed within the confectionery industry. To achieve this aim, the

following research question was set up to guide this research:

How is the safety of colouring foods, in particular Safflower extract, assessed within the

confectionery industry?

The results of the interviews with the ingredient suppliers show that in general, the representatives of

these companies have limited knowledge on Safflower (extract) and how the safety of the Safflower

(extract) is assessed. Furthermore, it was found that most of the suppliers of the Safflower extract use

good hygiene practices as a measurement to guarantee safe Safflower extracts (table 7). Also, pesticide

residue test and microbiological tests are performed and certain quality and safety standards are

implemented. With regard to toxicological safety, it was found that the ingredient suppliers could not

answer with certainty whether toxicological assessment was performed before putting their extract on

the market.

Moreover, it was found that the confectionery producing companies are to a little extent involved in

performing safety measurements on Safflower extract. The confectionery producing companies assess

the safety of the incoming Safflower extract by checking material safety data sheets which are provided

by their ingredient supplier. These safety data sheets are checked whether they are in compliance with

the company’s own criteria and legislative requirements. The results show that the confectionery

producers themselves do not perform microbiological, toxicological contaminants and pesticide residue

tests, but these tests are performed by their ingredient supplier (table 13). The respondents rely on the

outcomes of these tests that are provided in the product specification. Trustworthiness of the supplier is

found to be the major reason not to perform these safety measurements themselves. Other reasons that

are found are the costs of testing and the fact that confectionery is not vulnerable to bacteria.

The results of this exploratory research leads to the following hypotheses:

1. The suppliers of Safflower extract do not perform additional safety tests or assessments than the

ones that are required by key legislation.

2. Confectionery producing companies do not perform the measurements that are required from

key legislation themselves; they rely on the tests that are performed by the ingredient supplier.

Overall, it may be concluded that the ingredient suppliers of Safflower extract and the confectionery

producing companies that use Safflower extract, pay more attention to safety issues arising from

contaminants than to the safety of the initial substance. These findings may suggest that safety of the

initial substance is not paramount for the ingredient suppliers and the confectionery producing

companies when producing or processing colouring foods, while they should assure the food is safe

before entering the market (Art. 14 (EC) No. 178/2002).

42

5.2 Consideration

The results of this research indicate that food ingredient suppliers perform the safety measurements that

are required by key legislation (like testing on contaminants), but no additional measurements (like

toxicological assessment of the initial substance). One could wonder why the ingredient suppliers only

perform the required tests and therefore take the risk of not complying with Article 14 of the general

food law. In that Regulation is stated that the food industry is obliged to only put food on the market if

it is safe, which implies that it is not injurious to health or unfit for human consumption (Art. 14 (EC)

No. 178/2002). In literature, no data was found on the voluntary implementation of additional safety

measurements, but an explanation for this could be found in the article of Loader and Hobbs (1999).

They explained that food safety legislation should be considered different from other sorts of regulation

since the price for food safety measurements is rather high and the benefits may be relatively small.

They described that it is unlikely that food safety measurements bring a premium for consumers, since

consumers expect safety to be provided. The majority of the consumers find safety more a right than a

privilege (Loader and Hobbs, 1999). A definition of benefit and cost of food safety is described by

Caswell (1998). This research provided a valuing system for the benefits and costs for improved food

safety. The major benefit is described as a better health to consumers, the costs are calculated using the

cost of illness, which is the value of avoided illnesses, deaths, losses in income, pain and suffering.

However, to date, there is no reported incidence of illnesses related to the use of Safflower extract. In

terms of Caswell (1998), there is no real benefit to perform additional safety measurements (like

toxicological or risk assessment), because there are no incidents of adverse health effects for Safflower

extract and therefore it would not provide better health to consumers. In addition to that, there are no

costs to be calculated since there are no illnesses or deaths to be prevented. The fact that there are no

benefits for the ingredient supplier could be a possible explanation to not perform additional safety

measurements on the Safflower petals. Another explanation could be that limited scientific knowledge

on the safety of Safflower petals is available. In literature, there is little information on the safety of

Safflower petals and on the safety risks of Safflower petals found. The lack of scientific evidence on the

side effects of Safflower petals could have caused that the ingredient suppliers remained the status quo

and therefore only followed the requirements of the key legislation to which they have to comply with.

Also, in this research was found that confectionery producing companies do not perform the

measurements that are required from key legislation themselves; they rely on the tests that are performed

by the ingredient supplier. The major reason for doing so is that the producers trust their Safflower

extract supplier. A research of Fischer (2013) described that trust is a powerful commercial asset, since

lack of trust could lead to high cost implications. Taken into account these cost implications, trust is

sometimes defined as the willingness to take risks. In the current research it may be the case that the

confectionery producing companies wanted to save the costs of testing by not performing the safety

measurements themselves. By doing this, they take the risk of a product not complying with the limits

that are stated in the product specification and also the risk that their product is unsafe, injurious to

health or unfit for human consumption (Art. 14 (EC) No. 178/2002).

In the current research it was found that the confectionery producing companies do not use a maximum

dosage for Safflower and handle Safflower extract as a food ingredient. This is in line with Stich (2016),

who categorized Safflower extract as a colouring food, which is a food ingredient. The Guidance notes

on the classification of food extracts with colouring properties (EC, 2013), which distinguish food

additives from food ingredients. The legal requirement for a food additive is that it should not be

consumed as a food in itself. Since Safflower is seen as a colouring food, it should be normally consumed

as a food. For other fruit or vegetable extracts that are colouring foods it is evident that they are normally

consumed. When looking at for instance spinach, it is obvious that it is part of the normal human diet.

43

In literature is found that Safflower petals were mainly used as a substitute for saffron (Dajue & Mündel,

1996) and that it is used to flavour and give colour (Ekin, 2005; Dajue & Mündel, 1996). It could be

doubted if the use of Safflower florets for colouring and flavouring properties can be seen as “normally

consumption” of the food. Therefore, it could be doubted whether Safflower can be seen as a food

ingredient and thus a colouring food. In addition to that, the Guidance notes noted about the safety of

colouring foods that: “As for food safety aspects, generally, the use of colouring foods could be regarded

as safe if the levels of exposure would not exceed those resulting from normal use of the colouring foods

source materials in the human diet.” For spinach, it could be assumed that the amount of spinach that

is consumed by using a spinach extract for colouring is probable less then when spinach is consumed

‘normally’ as a vegetable. However, for Safflower, this is rather unclear and vague. That is why it could

be questioned whether Safflower could be regarded as a safe colouring food. This doubt was apparently

also an issue for the FDA in the US, since Safflower extract was at first authorized as a colour additive,

but was removed from the list of authorized additives later (FDA, 2017). In the US, the basis for a fruit

or vegetable juice colour additive regulation is that the fruit or vegetable from which a juice is made,

should be safely consumed as a food. According to the FDA (2017) is the fact that the plant (in this case

Safflower) can be eaten as a food, does not mean that the juice of the plant material meet the

specifications of the regulation. These examples illustrate that the lack of knowledge concerning the

safety of Safflower and the consumption of Safflower causes that it is rather unclear whether the

Safflower could be ‘normally consumed’ or ‘safely consumed as a food’.

5.3 Implications for theory This research provides insight in the how the food ingredient suppliers and the confectionery producers

assess the safety of Safflower and Safflower extract. Since there was no literature available on how the

safety of Safflower (and Safflower extract) is assessed within the supply chain of confectionery

products, this exploratory research provides a first glance on how the safety of Safflower is assessed in

the confectionery industry.

Additionally, this research provides insights in the (limited) existing literature regarding the safety of

Safflower petals. Literature suggests that there are, next to beneficial effects, also (toxicological) side

effects of Safflower petals. The Guidance notes described that: “the extraction process should not lead

to the concentration of contaminants such as naturally occurring toxicants, or to the generation of

reaction products or residues of a nature and in amounts as to be of toxicological concern (EC, 2013)”.

The literature that is available now, gives no evidence that there is no toxicological concern for the use

of Safflower. Therefore the safe use of Safflower extract could not be guaranteed. As a consequence,

the legislation concerning Safflower extract might be adapted, like has been done by other food

colourings where safety concerns were identified (e.g. red 2G or brown FK) (Oplatowska-Stachowiak

& Elliott, 2017).

5.4 Implications for practice

Also, a number of implications for the legislator, the ingredient suppliers, confectionery producers and

consumers can be derived from the findings. The insights on the safety of Safflower and on how the

safety of Safflower is assessed at the ingredient suppliers might be of interest for the legislator,

ingredient suppliers and confectionery producers. If there is no toxicological assessment on the initial

substance is performed by the ingredient suppliers and the use of Safflower petals indeed cause some

severe side effects, as described by Tu et al. (2014), it causes a risk of adverse health effects in humans.

These adverse health effects have consequences for the whole confectionery supply chain. Consumers

will fall ill and perceive less health, confectionery producers should recall their products, ingredient

suppliers should stop the supply of Safflower extract and legislation concerning colouring foods should

be revised. But also in the long term it will have its consequences, since food safety failures raise

44

widespread awareness and it will lead to consumer confusion and mistrust of the food industry and

regulators (Powell, Jacob and Chapman, 2011). It is therefore important for the confectionery supply

chain stakeholders to be aware of this risk and its consequences.

Coming back to the introduction, an important driver for the use of colouring foods instead of colour

additives was the Southampton study. In this study was found that several food colour additives,

combined with a certain preservative, could increase hyperactivity in children. In a reaction to this, the

legislator decided on a mandatory warning on every food or drink label that contained one of these

colourings. Now the conclusions on this research are drawn, it could be questioned whether the food

industry is better off with colouring foods as a replacement of these food colouring additives. In this

research was found that for the application for an inclusion in the additive list of Regulation No

1333/2008, administrative-, toxicological-, risk assessment- and risk management data have to be

provided to the legislator (Magnuson et al., 2013). This shows that the ‘Southampton six’ colourings are

more researched, regulated and controlled than colouring foods at the moment. Combining this with the

fact that in literature severe side effects are found for the use of Safflower (Bahmanpour et al., 2012;

Mirhosseini et al., 2012; Zhang et al., 2012; Nobakht et al., 2000; Liu et al., 2004) it may be concluded

that it is wiser for the food industry to use yellow colour additives instead of Safflower extract. In

addition to this, one could wonder how consumer demands will change in reaction to these investigations

on Safflower extract. What should parents buy their children if the findings of this research are presented

in the media? Are they going to purchase confectionery with food colour additives, colouring foods or

will they seek alternatives for confectionery? In the latter case, it will cause a decrease in sales for the

confectionery industry in general.

5.5 Limitations The results from this research should, however, be interpreted with caution since several limitations

have been recognized on the methodology of this research.

For this exploratory research, a design was chosen with two rounds semi-structured face-to-face

interviews. The first round of interviews was conducted with ingredient suppliers of Safflower extract

and the second round was conducted with confectionery producing companies. For the verification of

the findings, there was chosen to give the respondents the possibility to give feedback in the form of

member validation. Boeije (2010) described that presenting transcripts and memos to respondents and

asking them whether they recognize the findings and judge them as correct is a tool for verification of

the research. At every interview there was asked for a member check. For the first round of interviews,

the respondents were asked to check the summary style transcripts, since audio records were lacking.

For the second round of interviews the respondents were requested to check the complete transcripts of

the audio records. However, during the first round of interviews, the respondents did not want to

participate in a member validation due to lack of time. For the second round, all three respondents

checked the transcripts of the interviews. The lack of validation during the first round of interviews may

have had an effect on the internal validity of the results.

The interviews with the ingredient suppliers were conducted at the Fi fair in Frankfurt. It could be

questioned whether conducting interviews at a fair is suitable for this research. Most of the employees

on such a fair are salesmen, which have perhaps not the right competences and knowledge on the safety

of Safflower. Furthermore, there was a limited number of companies that wanted to participate in this

research on the fair. A possible explanation for this is that companies on a fair have little time to sell as

much as possible products, and therefore they do not want to participate in time-consuming interviews

that have no direct benefits for them. For that reason, it might have been better to contact these

companies individually and conduct interviews at the company or by phone, instead of walking by a

45

stand at the fair. The companies would then have the possibility to find the right employee with specific

knowledge on Safflower extract. More specific and valid information could be gathered with an

employee who is specialized in Safflower and when there is no time pressure.

Another discussion point appeared when looking at the questions in the interview guide for the Fi. Now,

open questions were asked concerning the safety measurements. The results could be better analysed

when the question was asked in a way that the answers would be more comparable to each other. For

instance: Could you indicate which of the following measurements does your company take in order to

guarantee the safety of Safflower? 1. Tests on contaminants: microbiological, toxicological. 2. Pesticide

residue test. 3. Toxicological assessment of the substance. 4. Risk assessment (exposure, normal intake,

maximum intake). In this way, it would be clear which tests are being performed and also which tests

are not being performed. Furthermore, in this interview guide the difference between contaminant

toxicological testing (like aflatoxins and mycotoxins, which is required by legislation No. 1881/2006

(EC 2006) for contaminants) and toxicological testing of the initial material (which is required for food

additives, but not for colouring foods) should be clearly distinguished. Now, there was only asked how

the toxicological safety of Safflower is assured. From the answers of the representatives it is unclear

whether the company answered this question with regard to contaminant toxicological testing or to the

toxicological testing of the initial substance.

Lastly, in the scope of this research it was hypothesized that the results of this study could be generalized

over the whole category of colouring foods. However, this is difficult because the sample for an

exploratory qualitative research is rather small (Boeije, 2010). For the first round of interviews with the

ingredient suppliers, only three interviews were performed and two questionnaires have been filled out.

For the second round of interviews only three confectionery producing companies wanted to participate

in this research. An important reason for this small sample is the time limitation of this thesis project. In

addition to that, there were only limited companies who wanted to participate in this study. Several

reasons for this that are mentioned by the companies are; only a few employees per company have

expertise in the field of colouring foods and Safflower, no employees available who have time for

interviews and the fact that the production location of the confectionery are outside the Netherlands.

5.6 Recommendations for further research This research has brought forth many questions and topics that are in need of further research.

During the literature review it was found that there are indications that the use of Safflower petals has

its side effects (Tu et al., 2015). There is, however, limited literature available on the safety of Safflower

petals to conclude whether the use of Safflower extract is safe or not. Therefore, it is recommended that

further research should be conducted on the safety and side effects of Safflower petals to be able to

conclude on its safety.

Furthermore, the hypotheses that are derived from the results of this exploratory research should be

investigated in further research in order to accept or reject these hypotheses. In this research it was for

the respondents sometimes unclear whether there was asked on the toxicological assessment of

contaminants or on the initial substance. That is why a method where document analysis (product

specifications and material safety data sheets) is included next to face-to-face interviews is desirable. In

the current research was found that trustworthiness of the supplier is the major reason for the

confectionery producers to not perform safety measurements themselves. Additionally, other reasons

that are found are the costs of testing and the fact that confectionery is not vulnerable to bacteria. It is

recommended to include questions in the face-to-face interviews concerning the motivations for

performing/not performing those safety measurements in order to validate these findings.

46

Also, further investigation and clarification of European legislation is needed. In the current regulation

on food additives ((EC)1333/2008) it is rather unclear what is meant by “a food normally consumed as

such or normally used as a characteristic ingredient of food”. In addition to that, it is unclear who

decides whether a food is normally consumed as a food and therefore could be categorized as a colouring

food. Furthermore, during this research questions raised on who is responsible to monitor these

colouring foods on a European or on a national scale. Or should it not be monitored since they do not

fall under a specific legislation? Results from these studies will help to give clarity on how undefined

conditions in legislation are handled in practice.

Moreover, the current research only examined the suppliers of Safflower extract and the companies that

process Safflower extract. This resulted in a small sample, because there were only a few companies

that supply or process Safflower extract in the Netherlands or nearby. Therefore, it is suggested to

broaden the scope of the research by including more types of colouring foods a following study in order

to be able to assemble a bigger sample. There are big differences in the level of consumption of the

colouring foods. A distinction could be made on colouring foods that are ‘normally consumed as a food’

(like spinach extract) and which are not (like Safflower extract). For this last group, it is assumed that it

is more likely that they have safety risks than the colouring foods that are normally consumed. Therefore,

it is recommended for further research to include Spirulina and/or Hibiscus and/or Marigold flowers

(Tagetes erecta L.). Spirulina and Tagetes erecta L. are derived from inedible raw material (Stich, 2016)

and Hibiscus is only consumed as a medicinal tea (Hopkins et al., 2013). This is similar to the

consumption of Safflower petals, which are mainly not consumed as a food, but are consumed for its

medicinal effects or to impart flavour or colour to foods (Tu et al., 2015; Dajue & Mündel, 1996). Results

of these studies could be used in order to identify the risks for the use of inedible foods as colouring

food extracts.

Finally, this research only investigates a specific colouring food in the confectionery supply chain, but

it might be interesting to further research colouring foods (or a specific colouring food) in a different

industry. The difference in colour shades that are used might influence the degree of which E-numbers

are replaced by naturally derived colourings. In addition to that, the product characteristics might be of

influence on the colouring foods that are used. Moreover, the safety assessment of a perishable product

might be different from a non-perishable product (like confectionery). These results could be used to

get a broader understanding of the safety assessment of colouring foods in different industries.

47

6. EVALUATION

In this section, a critical reflection on the research, the research process and the role of the researcher is

given.

6.1 Evaluation of the research and the research process During the first phase of this research, a literature review was performed in order to make a background

on the topic of clean labelling with the emphasis on colours. I found that this topic was not extensively

studied yet, because there was limited scientific literature available concerning clean labelling and

colouring foods. Therefore, for this review, also online food magazines were used. Furthermore, since

this subject encompasses also legislation, EU regulations and guidance notes were reviewed in order to

give a complete overview of the problem situation.

After describing the background and the problem situation, a literature analysis was performed

systematically with the use of different search terms. During this literature analysis, it became clear that

there was much information available on colour additives, but less about the topic of colouring foods.

In addition to that, limited literature was found on the topic of Safflower. Information regarding the use,

safety and healthiness of Safflower oil could be found, but Safflower colours are made from its petals

and not its seed and therefore this literature was not or to a limited extent useful for this analysis. The

European legislation that was used for determining the legal status was complete in the sense that it gave

a good overview of the differences between a food colouring and a colouring food. It was, however, not

specifically mentioned in legislation that Safflower is a colouring food, since no list of ‘permitted

colouring foods’ exists.

The second research instrument was an empirical study with two rounds of interviews with stakeholders

of the confectionery supply chain. The first round of the interviews was conducted with Safflower

suppliers at the Food ingredients fair in Frankfurt. The data of these interviews are of pool quality since

there are a lot of issues that influenced the validity of the data. Firstly, the participants were technical

sales managers, which have limited knowledge on Safflower in particular. Secondly, the recordings of

the interviews were lacking, because there was too much ambient noise. That is why only transcripts in

summary style could be made. Transcripts in summary style are more influenced by the interpretations

of the researcher, because the researcher decides what is highlighted. Third, only three interviews were

conducted face-to-face, the other two participating companies only filled in a questionnaire that was

emailed after de fair. Fourth, after the interviews, the respondents were asked to check the transcripts.

However, none of the respondents was willing to check the transcript afterwards. Finally, the Fi was in

November and at that time I did not have much knowledge on making an interview guide because till

then I paid a lot attention to the demarcation and literature analysis of my thesis.

The second round of interviews was conducted with confectionery producing companies. When

assembling the sample, it became clear that there are only a few companies who produce these products.

There are many brands purchase these products at other confectionery producing companies. Therefore,

the sample existed of only three companies. The data gathered from these interviews give a good

overview of what is happening within these companies. Furthermore, the companies which participated

in the interviews are big players on the confectionery market. However, it is hard to generalize the data

over all confectionery producers who process Safflower extract, since it is such a little sample.

Looking back, this method seems suboptimal for this research. During the interviews with the ingredient

suppliers, I had the feeling that the safety of colouring foods, and in particular inedible plants like

Safflower, are a sensitive topic. The interviews give the respondents the option to give socially desired

answers. Therefore, in further research I would suggest to include a document analysis of the product

48

specifications and the safety data sheets in order to be able to check the answers of the respondents and

to be able to make a complete overview of the safety measurements that are taken.

The research questions are answered to a degree in which it was possible with the literature and data

available. This means that due to the limited literature that was available, the small sample and the

quality of the data, it was not possible to answer the overall research question in detail. The research

aimed at getting an in-depth understanding of how the safety of colouring foods, in particular Safflower

extract, is assessed within the confectionery industry. The results of this research do, however, not

provide an in-depth understanding on how the safety of Safflower is assessed, but the results give an in-

depth understanding on the unclear situation concerning the safety assessment of Safflower extract.

6.2 Evaluation of the role of the researcher At the beginning of the thesis project, I found it hard to demarcate the scope of the study and to come

up with a research design. This was partly due to the fact that this research did not encompasses a typical

Food Quality Management topic. During the colloquia I found out that a lot of MFQ theses are based

on the food quality functions model and the model of perceived quality. In these theses, a quality

problem is the outcome and the research is about identifying technological and managerial factors for

that problem from literature and verify these factors with an empirical study. However, this was not the

case for this research topic, since there is no real perceived quality problem. It took me long to discover

this and to come up with another research design that was applicable for this subject. Fortunately, I

found it not hard to stay disciplined to work on the thesis because the topic really spoke to me. The

drawbacks with assembling a sample and the limited data were a bit disappointing and demotivating,

but soon I found more motivation and solutions to finish my thesis successfully.

During the research process, I knew, that in the role of the researcher, I had influence on the participants

of the interviews and also on the literature that is selected and used for the background and literature

analysis. After writing my proposal, I was aware of the fact that I focused a lot on the risks of the

consumption of Safflower extract. Therefore, I included in my literature analysis also the beneficial

effects of Safflower extract. After my literature analysis, I hypothesized in my mind that the ingredient

suppliers and the confectionery companies did not perform any additional safety measurements.

Additionally, I found literature stating that there might be side effects for the use of Safflower and

therefore I assumed there was a safety risk for the use of Safflower extract. With this hypothesis in my

mind, it was hard to formulate objective questions for the interview guide. It was really helpful that

Elsbeth addressed that my interview guide seemed quite subjective. As a reaction to that, I tried to

include as many as possible open questions in my interview guide to overcome this confirmation bias.

To conclude, I learned a lot from doing this research. Looking back, I know that I did not re-invent the

wheel, but I constructed a neat report with the research skills I gained by critically evaluating peer

students and my own work. As an example, when I was critical evaluating the background and literature

of my research, I found that my writing skills have been improved since the beginning of my thesis and

therefore I was better able to correct myself.

49

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APPENDICES

Appendix I

Table 14. Overview of confectionery products produced with Safflower extract. (Information retrieved from confectionery

product label review performed at two large Dutch retailers.)

Soort snoep Naam bedrijf

AH schuimbanaantjes, wilde muizen, tumtum, gesuikerde gomballen, zure

sleutels, jungle gums, jelly beans, etc.

Albert Heijn B.V.

Gemengde peren Schuttelaar

Zure rollers, manna plofrijst, manna fruitfeest uitdeelzakjes Candy Man

Schuimharten, kikkers, perziken, happy cherries, zoute rijen, goudberen,

starmix, zure bommen, kers cola fruitgum, Maoam pinballs, etc.

Haribo Nederland

B.V.

Apekoppen, zoo mix, farm mix, apezuur, zure sticks, beesten feest,

fruitvlinders, etc.

Katja Fassin B.V.

Winegums, zoet/zuur duo winegums, pretsleutels, zoetfris duo winegums,

schuim dropfruit duo’s, etc.

Red Band/Cloetta

Holland B.V.

Dubbeldekkers, joyriders duo’s, Autodrop (Concorp

B.V.)

Harlekijntjes zachte fruitgums Festivaldi B.V.

Fruit-tella fruitgums suikervrij, fruitfoams, gummies, duo gummies,

dummy, lange jan, etc.

Perfetti van Melle

benelux B.V.

Mini candy pizza, give away congrats, give away good luck Look-o-look

international B.V.

Jumbo gummi foam, banaanschuim, gom ballen Jumbo supermarkten

B.V.

56

Appendix II The email that was sent to the ingredient suppliers after the Fi.

Dear,

During the FI in Frankfurt we have had a conversation regarding my Master thesis subject; Safflower

extract. I am a master student Food Quality Management at Wageningen University and Research, which

is situated in the Netherlands. Currently, I am working on my master thesis project, concerning clean

labelling in the confectionery industry, with the emphasis on colours. Since you didn’t have the

information available at the fair to answer my questions, you asked me to send an email to you with the

questions I would like to have answered. Below you can find the questionnaire. I really appreciate your

participation to my research. Furthermore, I would like to address that your participation is anonymous,

neither the name of your company will end up in my thesis report. Furthermore, this information is used

for educational purposes only, there are no company interests in this study. If you wish, I could send the

results of my thesis to you after I have finished my report if you are eager to know the results.

Thank you in advance!

1. Which types of colouring foods does your company offer?

2. Which of these colouring foods are suited for clean label products?

3. What kinds of industries/companies belong to your company’s customers?

4. Your company does supply Safflower extract. Where is the Safflower crop that is used for this

extract grown? (Please specify country)

5. Where is the Safflower extract produced? (Please specify country)

6. What is the composition of Safflower extract?

7. Which considerations does your company take into account when producing (relatively) new

and unknown extracts, like Safflower extract?

8. Since Safflower extract does not consist of only pure pigments, but also other substances;

what does your company do to guarantee the safety of Safflower extracts?

9. Which preventive measurements are taken in order to guarantee the toxicological safety of

Safflower extract?

10. Does your company know that Safflower extract is prohibited in the US?

If so, what is your company’s opinion about that?

Thanks for your time; I look forward hearing from you soon,

Kind regards,

Melanie Vogel

57

Appendix III The interview guide for the Fi Europe fair in Frankfurt.

INTERVIEW GUIDE FI EUROPE

General information

Date

Name of the company

Name of the representative

Job description of the representative

Time start interview

Time end interview

Member check Yes/No

End report Yes/No

Email address

Interview guide

Please let me introduce myself. I am Melanie Vogel, master student Food Quality Management at

Wageningen University and Research that is situated in the Netherlands. Currently, I am working on my

master thesis project, concerning clean labelling in the confectionery industry, with the emphasis on

colours. Therefore, I would like to ask you some questions in the context of clean labelling, colouring

foods and their use. The interview will last approximately 20 minutes and is anonymous. Also, the name

of your company will not be mentioned in the thesis report. I would like to send you the report of this

interview to you afterwards for a member check of the information. Also, if you wish, I could send the

end report of my thesis to you if you are eager to know the results. This interview is used for educational

purposes only; there are no company interests in this study. I would like to record this interview in order

to make an appropriate analysis of the interviews; do you have any problems with that?

1. Which types of colouring foods does your company offer? (Circle one)

Fruit extracts Vegetable extracts Spirulina extract Safflower extract

2. Which of these colouring foods are suited for clean label products? (Circle one)

Fruit extracts Vegetable extracts Spirulina extract Safflower extract

3. What kinds of industries/companies belong to your company’s customers? (Circle one)

Food Beverage

(Confectionery Dairy (Deli) meats)

58

4. Your company does supply Safflower extract. Where is the Safflower crop that is used for this

extract grown? (Circle one)

Europe Asia North America South America Africa

Middle East Australia

5. Where is the Safflower extract produced? (Circle one)

Europe Asia North America South America Africa

Middle East Australia

6. What is the composition of Safflower extract? (Ask for product specification)

7. Which considerations does your company take into account when introducing (relatively) new

and unknown extracts, like Safflower extract?

8. Since Safflower extract does not consist of only pure pigments, but also other substances; what

does your company do to guarantee the safety of Safflower extracts?

9. Which preventive measurements are taken in order to guarantee the toxicological safety of

Safflower extract?

10. To what extent is your company informed about the fact that Safflower extract is prohibited in

the US?

What is your company’s opinion about that?

59

Appendix IV The interview guide for the interviews at the confectionery producing companies

INTERVIEW GUIDE SNOEPGOED PRODUCENTEN

Algemene informatie

Datum

Naam bedrijf

Naam contactpersoon

Functie omschrijving contactpersoon

Tijd start interview

Tijd eind interview

Member check Ja/Nee

Eind report Ja/Nee

Email adres

Voordat we het interview beginnen zal ik mijzelf eest even voorstellen en wat informatie geven over

hoe de resultaten verwerkt zullen worden. Ik ben Melanie Vogel, master student Food Quality

Management aan Wageningen University and Research, in Nederland. Sinds afgelopen september ben

ik begonnen aan mijn afstudeerscriptie omtrent clean labelling in de snoepindustrie, met de focus op

kleurstoffen. In het kader van mijn onderzoek zou ik graag wat vragen willen stellen in de context van

kleurende voedingsmiddelen, en dan specifiek Saffloer extract en het gebruik hiervan. Het interview zal

ongeveer een half uur tot drie kwartier duren en is anoniem. De naam van uw bedrijf zal niet in het

rapport genoemd worden. Verder zou ik graag het transcript en de resultaten van dit interview door u

laten checken, om te kijken of ik de informatie goed geïnterpreteerd heb. Ook is het mogelijk om aan

het einde van mijn (in maart) scriptie het rapport te ontvangen wanneer u daarin geïnteresseerd bent.

Dit interview wordt gehouden voor educatie doeleinden, er is geen bedrijf dat belangen heeft bij dit

onderzoek. Om de data van dit interview goed te verwerken zou ik graag dit interview willen opnemen,

heeft u daar bezwaar tegen?

1. In welke producten die uw bedrijf produceert wordt Saffloer extract gebruikt?

2. Waarom gebruikt uw bedrijf kleurende voedingsmiddelen in de producten?

3. Wat is voor uw bedrijf een belangrijke overweging / Wat zijn voor uw bedrijf belangrijke

overwegingen bij het gebruik van Saffloer extract in het snoepgoed?

i. Waarom is/zijn dit een belangrijke overweging(en)?

ii. Is deze overweging/zijn deze overwegingen anders dan bij het gebruik van andere

grondstoffen?

4. Wat zijn voor uw bedrijf de belangrijkste kwaliteitsaspecten van de grondstof Saffloer extract?

60

5. Op welke manier/op welke manieren beoordeeld uw bedrijf de veiligheid van de grondstof

Saffloer extract?

6. Kunt u aangeven welke maatregelen uw bedrijf neemt voor de grondstof Saffloer extract om de

veiligheid van deze grondstof te waarborgen?

o Microbiologische tests

o Toxicologische tests

o Pesticide residue tests

o Toxicologische assessment (bijvoorbeeld: carcinogenicity, genotoxicity, reproductive

and developmental toxicity, allergenicity, hypersensitivity, intolerance)

i. Waarom voert u deze test uit?

ii. Wie voert deze test uit?

iii. Waarom voert u deze test niet uit?

7. Op basis van welke criteria bepaalt uw bedrijf uiteindelijk wat een veilig Saffloer extract is?

8. Gebruikt uw bedrijf een Acceptable Daily Intake of een maximale dosering voor de grondstof

Saffloer extract?

Afsluiting

Dat waren van mijn kant de vragen. Heeft u nog vragen of wilt u nog iets toevoegen? Anders wil ik u

graag bedanken voor de tijd die heeft u heeft vrij gemaakt voor dit interview. Het heeft mij ontzettend

geholpen bij de voortgang van mijn afstudeerscriptie. Als er achteraf naar aanleiding van dit interview

nog vragen zijn, dan kunt u mij altijd mailen of bellen.

61

Appendix V The email that was sent to the confectionery producing companies to request their participation in this

research.

Beste (contactpersoon),

Via ... heb ik uw contactgegevens gekregen. Hij/zij vertelde mij dat u mij wellicht kan helpen met mijn

afstudeeronderzoek. Ik zal mijzelf even kort voorstellen en beschrijven wat mijn vraag is.

Ik ben Melanie Vogel, een student Food Quality Management aan Wageningen University and

Research. Afgelopen september ben ik begonnen met mijn afstudeerscriptie omtrent het gebruik van een

bepaald kleurend voedingsmiddel, Saffloer. Ik voer hiervoor een kwalitatief onderzoek uit naar de

motieven voor het gebruik van kleurende voedingsmiddelen en ook hoe de veiligheid van kleurende

voedingsmiddelen, en dus specifiek Saffloer, is gewaarborgd in de supply chain van de snoep industrie.

Hiervoor heb ik eerst interviews gehouden bij leveranciers van het kleurend levensmiddel zelf, en nu

doe ik een ronde interviews bij de producenten van snoepgoed die Saffloer verwerken in hun producten.

Nu heb ik op verschillende van jullie productspecificaties (voorbeelden) gezien dat jullie deze stof

gebruiken in jullie producten. Graag zou ik u voor mijn scriptie interviewen over het gebruik van

Saffloer extract binnen uw bedrijf.

Ik hoor graag van u of u hieraan mee wilt werken.

Met vriendelijke groet,

Melanie Vogel

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