‘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
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‘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
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
1
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
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.”
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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.
Similarities Differences
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.
Similarities Differences
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.”
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Similarities Differences
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.”
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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.
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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).
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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
REFERENCES
Asioli, D., Aschemann-Witzel, J., Caputo, V., Vecchio, R., Annunziata, A., Næs, T., & Varela, P.
(2017). Making sense of the “clean label” trends: A review of consumer food choice behavior
and discussion of industry implications. Food Research International, 99, 58-71.
Asgarpanah, J., & Kazemivash, N. (2013). Phytochemistry, pharmacology and medicinal properties of
Carthamus tinctorius L. Chinese Journal of Integrated Medicine, 19(2), 153-159.
Bagley, L. (2017) Lifting the lid on the clean label trend. New Food Magazine. Retrieved from:
https://www.newfoodmagazine.com/news/33640/clean-label-health-ingredients/ (Accessed on
14-09-2017).
Bahmanpour, S., Vojdani, Z., Panjehshahin, M.R., Hoballah, H., Kassas, H. (2012) Effects of
Carthamus tinctorius on semen quality and gonadal hormone levels in partially sterile male rats.
Korean Journal of Urology. 53, 705–710.
Bateman, B., Warner, J. O., Hutchinson, E., Dean, T., Rowlandson, P., Gant, C. & Stevenson, J.
(2004). The effects of a double blind, placebo controlled, artificial food colourings and benzoate
preservative challenge on hyperactivity in a general population sample of preschool
children. Archives of disease in childhood, 89(6), 506-511.
Boeije, H. (2010). Analysis in qualitative research. Sage publications.
Boyce, C., & Neale, P. (2006). Conducting in-depth interviews: A guide for designing and conducting
in-depth interviews for evaluation input. Pathfinder international.
Bryne, J. (2011) Confectionery industry converting to colouring foodstuffs, says Chr. Hansen. Food