Country Differences in the History of Use of Health Claims and Symbols

Health-related claims and symbols are intended as aids to help consumers make informed and healthier food choices but they can also stimulate the food industry to develop food that goes hand Original Research Article Hieke et al.; EJNFS, 6(3): 148-168, 2016; Article no.EJNFS.2016.018 149 in hand with a healthier lifestyle. In order to better understand the role that health claims and symbols currently have and in the future potentially can have, the objective of the CLYMBOL project (“Role of health-related claims and symbols in consumer behaviour”, Grant no 311963) is to investigate consumers’ understanding of health claims and symbols, and how they affect purchasing and consumption [1]. As part of this endeavour, it is important to understand the history of use of claims and symbols in Europe. What have consumers been exposed to and how were these health-related messages used and discussed among the public? In this study, we interviewed key stakeholders across Europe about how health claims have been regulated in their country, how health symbols have been and currently are being treated, what form of monitoring there is or should be and how both health claims and symbols have been debated in the public opinion. In 26 European Union (EU) Member States, opinions from 53 key informants from up to three different stakeholder groups were gathered: national food authorities, representatives of the food industry, and consumer organisations. While 14 Member States reported (at least partial) regulation of the use of health claims and/or symbols before the introduction of the EU Regulation (EC 1924/2006) on nutrition and health claims made on foods [2], mandatory reporting of use had only been in place in three EU Member States. A number of voluntary codes of practice for health claims and/or symbols (i.e. pre-approval or justification when challenged) was said to be in use in 15 Member States. There are only a few national databases on health claims and symbols available, the data for which is often incomplete. Only eight Member States reported having some form of database from which information about health claims and symbols could be extracted. The stakeholders interviewed expressed a strong interest in measuring the impact of health claims and symbols, particularly research into the effects on consumer behaviour (e.g. awareness and understanding, attitudes towards products carrying claims and symbols and purchase/consumption effects), public health (health outcomes and changes in national health status due to the introduction of claims and symbols on food products) and economic aspects including sales, return on investment and reputation measurements. Public debates were said to have evolved around the topics of consumer understanding of claims, acceptance as well as trust in the information presented but also the effects on vulnerable groups such as children and elderly consumers. Another field of debate was said to have been the question of the effectiveness of health claims and symbols. Lastly, stakeholders reported that public debates focussed mainly on the legislative aspects, i.e. how to apply the EU Regulation (No 1924/2006) with regards to wording issues, the evaluation process at the European Food Safety Authority (EFSA), the status of various claims and the nutrient profile modelling to be introduced in Europe.


KEY INFORMANT INTERVIEWS IN THE EU MEMBER STATES
As part of the FP7 EU-funded project CLYMBOL ("Role of health-related claims and symbols in consumer behaviour", Grant no. 311963, [1]), the objective of this pan-European study was to analyse country differences in the history of use of health claims and symbols before the introduction of the EU Regulation on Health Claims (No 1924(No /2006).

Background
Over the past decades, many countries around the world have undertaken actions to regulate the use of health claims and symbols on food products: Japan [3,4], China [5], Australia & New Zealand [6], the USA [7] or Canada [8], to name a few. For a recent overview, see [9].
In 2000, the European Commission made an attempt at harmonising legislation by introducing the Directive 2000/13/EC on labelling, presentation and advertising of foodstuffs [10] which prohibited attributing properties for prevention, treatment or cure of human diseases to food products but which was not consistently enforced throughout the EU [11]. After further initiatives, among others the concerted action project PASSCLAIM which developed draft guidelines for assessing the scientific substantiation of health claims [12], the Regulation (EC) No 1924/2006 was introduced, harmonising the use of nutrition and health claims in Europe. While the use of health claims is now regulated, health symbols are still subject to interpretation in their meaning (e.g., what is a health symbol) and use (e.g., how and when can they be used).
Prior to 2006, many European countries had different practices for allowing health claims and symbols on food products. In different countries, different types of claims were allowed (or not), on different types of products. This has led to difficulties for food producers operating across borders [11] but arguably also to a multitude of health-related messages that consumers were exposed to and that carried the potential to mislead them [13]. Furthermore, the effects of health claims, both for business and for consumer health, have been argued controversially [14,15,16,17]. As a result, public opinion in some countries has been favourable while it has been more hostile in others.
As such, the present study sets out to collect data on the history of use of health claims and symbols across the EU Member States, based on desk research and on 2-3 key informant interviews per country, i.e. with representatives of national food authorities, food industry federations and consumer organisations. While for health claims, the focus lies on national regulations prior to 2006, for health symbols we also looked at the current state of use and regulation, i.e. national interpretation of European law. Analysis of these data is hoped to contribute to a better understanding of the differences between EU countries with regard to the role of health claims and symbols in public health, food business but also consumer behaviour. Additionally, the interviews will be used to obtain information on existing databases of health claims and health symbols on the markets in the respective countries.

Interview Protocol
This interview protocol details the procedure that was followed, once stakeholders had been selected and recruited.
The interviews could be conducted via recorded telephone, face to face or a mixture of the two methods. They were semi-structured, with questions and prompts designed to be as openended as possible to encourage dialogue and minimise interviewer bias. The columns Background/Examples and Main objective of the question were designed to help the interviewer conduct the interview. If necessary, the wording of some of the questions could be adapted in order to explain what was meant. Interviewers could use the additional information and explanations in the Discussion Guideline in order to be as clear as possible in the interview.
All interviews lasted around 30 minutes.

Before the interview
 Gather and assimilate a brief amount of background information on the individuals and stakeholder groups to identify the interests they represent.  Email/phone participants to invite them to the interviews (mention purpose, estimated length of the interview, confidentiality).  Send all interviewees information about the project and the aim of the interview plus (if necessary) additional instructions via email, before the interview.  Request the interviewee to prepare and if necessary provide factual details. They can also prepare/bring with them any documents they think might be relevant to the interview.  Inform the interviewee that additional information or answers to questions they could not provide during the interview can be sent via email, after the interview.  Ensure you have a document on your national/university's ethical procedures which can be shared with the interviewee, if requested. You may also have to get approval for the interview by your organisation.  Check that all needed equipment is available and working -digital/tape recorder, spare batteries and memory cards/tapes.  Go through the interview schedule and be prepared to tailor prompts to the interviewee.  Pilot test with a couple of people in your work place to assess the length of the interview and to get familiarised with asking the questions.

During the interview
When recording: re-iterate the outline of the study, explain confidentiality of the information and the right to withdraw from the interview at any time. Obtain verbal consent to this and the interviewee's agreement to participate in the interview. Make sure that participants know that their names will not be used during any analysis or final written reports. All results will be anonymised.
 Check that the tape recorder is working, ask the participant to state their name, for example.  Follow the interview schedule (you may want to write down interesting points in case parts of the recording are difficult to understand, due to quality or volume reasons).  Use the prompts given in the Background/ Examples column of the discussion guideline. If necessary, adapt the wording of the questions, as long as the content of the question remains the same.

Structure of the Interview
1) History of the use of health claims and health-related symbols.
a. Health claims b. Health symbols 2) Monitoring health claims and symbols.
3) Measuring impact of health claims and symbols.

After the interview
 Check that the recording has worked.  Write an email or letter of thanks to the participant or participant organisation, following up any actions.  Transcribe tapes.
 Summarise the answer/findings to each question, using the grid (Excel file) that has been provided to you. This shall be done in English, regardless of which language the interview took place in.  Fill out sample data table (who was asked for an interview, who declined and who accepted (and which type of stakeholder: national authority, industry representative or consumer organisation)).  Send all documents to EUFIC as task leader.
Keep the recording and transcription of all interviews stored, in case questions arise in the reporting process.

Sample Data
Interviewers were asked to complete the following details about their interview participants for the purpose of reporting the response rates for the Stakeholder Interviews (Table 2).

Audio recorder: off
Thank you for agreeing to be interviewed today. So that I can analyse your responses fully, I would like to audio record this interview. I can assure you that all data collected from you will be held and processed in the strictest confidence in accordance with the Data Protection Act (1998), and neither you nor your organisation will be named or identifiable in any report issuing from this research. I am now going to turn on the audio recorder Audio recorder: on Can you confirm if you are you happy for the interview to be audio recorded? (await response from interviewee) Are you happy with the explanation I have given you about the nature, and purpose of this study and of what is expected of you? Do you have any further questions or is there anything you don't understand? (await response from interviewee) Are you aware that you are free to withdraw from the study at any time without needing to justify your decision? (await response from interviewee) (Commence questioning from the agreed discussion guideline)

Consumer organisation
How many people were approached for the interviews? How many refused to participate? How many interviews were conducted/people accepted to participate? Voluntary codes of practice could include: -Pre-approval (having to seek permission before using symbol on product) -Justification (justifying use of symbol only when challenged) Only if interviewee knows. Information can also be provided via Email afterwards.
Possible themes, in the sense of health benefits: general health, cardiovascular, dental etc.

Monitoring claims and symbols 10) Are food operators required
to report their use of health claims and symbols to national authorities? (if yesare databases of claims and symbols (publicly) available and could we gain access?) 11) Do you think such databases are complete?
Data bases could comprise of products bearing health claims and/or symbols, their wording/design and additional nutritional information; further info could include date of introduction of the health claim/symbol on the product

Regulation 1924/2006: Article 25: Monitoring
To facilitate efficient monitoring of foods bearing nutrition or health claims, Member States may require the manufacturer or the person placing such foods on the market in their territory to notify the competent authority of that placing on the market by forwarding to it a model of the label used for the product.
How are claims and symbols currently monitored? This could help us discover more data bases on national level.
Measuring the impact of claims and symbols 12) Do you see the need to measure the societal/ economic impact of a) of health claims? b) of health symbols?

13) If so, how could/should this be measured?
Possible impacts: health outcomes, national consumption behaviour, consumer trust, product sales, manufacturers' reputation etc.
For each topic named by the interviewee, ask the follow-up "and how should this be measured?"

Introduction
"This interview is part of CLYMBOL -Role of health-related claims and symbols in consumer behaviour -a European research project partly funded by the European Commission".

Data use and security
Interviewers explained confidentiality, the right to withdraw from the study and obtain verbal consent to participate. They further ensured that participants knew their interview data would be anonymised during analysis or final reports (Table 1).

CLYMBOL
"The objective of this project is to determine how health-related claims and symbols are understood by consumers and how they affect purchasing and consumption, taking into account both individual and country-specific differences".

Aim of the interview
"We want to better understand how the national health claims landscape looked like, prior to the 2006 Regulation issued on European level. We further want to gather insights on how the use of health symbols is being interpreted, based on European law. Our objective is to analyse country differences in the history of use of health claims and symbols by interviewing key informants/ experts in the EU Member States. Stakeholders include national food authorities, national industry representatives and consumer organisations".

Background for this task
"Different EU countries have had different practices in allowing health claims on food products previous to the recent legislation, and also health symbols initiatives have had mostly national origins. Likewise, food manufacturers and retailers have differed in the extent to which they have launched products with health claims and symbols on. As a result, the prerequisites for understanding health claims and symbols and for their effects on purchasing and consumption could differ between countries".

INTERVIEWS
It is to be noted that these interview results are based on an individual opinion/evaluation and do not necessarily reflect the organisation's view as a whole, nor that of the authors.

Country differences
Prior to 2006, health claims were reported to have been (at least partially) regulated on national level in half (13) of the EU Member States interviewed. The same number of countries reported no specific national legislation or regulatory process in place. Seven Member States additionally mentioned the Directive 2000/13/EC as a supra-national legislative act which prohibits any "labelling, presentation and advertising of foodstuffs" which could mislead consumers. It appears that this Directive was seen as a partial 'regulation' in the area of health claims, prior to 2006.
Of those countries who reported a regulatory process in place, health claims were generally allowed in two countries while they were prohibited in three other. It is noteworthy that some stakeholders interviewed mentioned that claims could still be found on food products, despite such legislation. The remaining eight Member States reported the prohibition of selected types of claims, mainly disease risk reduction.
Lastly, voluntary codes of practice were reported to have been in use in twelve Member States, prior to the Health Claims Regulation. This includes "justification when challenged" and preapproval via national institutions. The remaining fourteen countries reported no such codes of practice in place.
Concerning health symbols, only interviewees in Belgium, Spain and Sweden reported the use as being regulated. In total, eight Member States mentioned some form of voluntary code of practice which could be executed either on government level or via private organisations. The eighteen remaining Member States reported no regulation of any kind.
All interview summaries regarding country differences are presented in the Supplementary Material (Tables 1 and 2). The criteria for classification (Table 5) were defined as follows: Having national regulation for health claims in place refers to one of the following: Absence of national regulation on health claims and symbols refers to: not mentioning any national regulation, reporting "no specific regulation" or only mentioning EU legislative acts. Absence of voluntary codes for health claims and symbols refers to not mentioning any or reporting "no voluntary codes of practice".
According to the interviews, prior to 2006, health claims were mainly found on food supplements. An equally large proportion of claims was reported to have been used for dairy and fermented products.
The main types of claims were said to have revolved around heart health (blood, cardiovascular diseases, and cholesterol-lowering effects), digestion, the immune system, bone health, and general health and well-being. Claims relating to growth in children were also mentioned.
The main health symbols that were reported throughout the Member States are the Dutch Choices logo, the Swedish Keyhole, toothfriendly logos and a variation of heart symbols, often issued by national heart foundations.
Main themes associated with symbols were said to be general health and "better choice", heart health, dental health, bone health and weight loss.
Stakeholders from the EU Member States reported health symbols to be mainly found on margarine and edible fats/spreads products, e.g. in conjunction with claims around omega-3 fatty acids. Dairy products were also mentioned as being very likely to carry such symbols.

Health claims (prior to 2006)
Health symbols National regulation in place

Food categories most frequently mentioned to bear health claims in the EU (prior to 2006)
; Article no.EJNFS.2016.018

Regulation of health claims in the EU Member States (prior to 2006)
in the EU n.c.

Belgium
Certain words, pictures and references prohibited in food marketing and labelling.
Indicative positive list of allowed claims existed. Claims had to be justified only when challenged.

Bulgaria
Health claims allowed. Medical claims prohibited.
To be justified only when challenged.
Croatia n.r. Pre-approval by the Ministry of Health. Claims had to be additionally justified when challenged. Czech Republic n.r. n.c.

Denmark
Claims on wellness or physiological effects allowed if scientifically proven. Disease risk reduction claims prohibited. n.c.

Estonia
Claims referring to the risk of disease were not allowed. n.c.

Finland
Claims linked to preventing, treating or curing were prohibited. Claims on disease risk reduction allowed.

Country
National regulation Sweden n.r.

United Kingdom
Medicinal claims prohibited. Table 7. Most common health

Symbols
In addition to the health symbols in Table 7, further logos were mentioned during the interviews ( Table 8). As per CLYMBOL definitions, some of these are not seen as health symbols. Those in bold have been grouped an additional claim type: health-related ingredient claims.

Monitoring health claims and symbols
Only three Member States declare mandatory reporting: in Portugal, health symbols were said to be monitored systematically, while

Monitoring health claims and symbols
Only three Member States declared national n Portugal, health symbols were said to be monitored systematically, while in Slovenia, authorities mentioned to be monitored. Only Italian stakeholders unanimously reported a mandatory reporting both health claims and symbols.
The remaining Member States state reporting on the use of health claims and symbols. In several interviews, product launches but also specific prod technologies (e.g. GMO) were mentioned as being mandatory to report. However, these are not necessarily related to the use of health claims and symbols.
; Article no. EJNFS.2016.018 Voluntary code of practice excluded food supplements. Panel of experts to confirm scientific substantiation of physiological claims. Assessment board to monitor compliance of marketing/labelling with the A body consisting of all stakeholders defined statements that could be used as a basis for health and nutrition claims. The remaining Member States stated no reporting on the use of health claims and . In several interviews, product launches but also specific production re mentioned as being mandatory to report. However, these are not necessarily related to the use of health Databases on health claims and symbols were said to be established only in six Member States, while in two countries some form of data (or lists) exist of which information on health claims and symbols could be extracted. However, according to the interviewees, none of these databases are complete and many of them were said to not be up-to-date. Hungary "6-a-day" Denmark "Fish twice a day" Denmark "5-a-day" United Kingdom "Arrow" indicating digestive health France "Best from the test" Netherlands "KemaKeur" Netherlands Bone symbol Romania "Protect the health" Slovenia

Fig. 4. Reporting and databases on health claims/symbols in the EU Member State
All interview summaries regarding the monitoring of claims and symbols are presented Supplementary Material (Table 3).

Measuring the impact of health claims and symbols
The majority of EU Member States express strong interest in measuring the impact of health claims and symbols. The main areas of interest could be identified as consumer research (awareness and understanding of claims and symbols but also attitudes towards such information and possible effects on food choice, purchase and consumption), research into public health (health outcomes or changes in the national health status due to the use of health claims and symbols) and the analysis of the economic impact (prevalence, effect on sales, cost-benefit aspects). Methodologies

Reporting and databases on health claims/symbols in the EU Member State
ll interview summaries regarding the monitoring are presented in the

Measuring the impact of health claims
The majority of EU Member States expressed a strong interest in measuring the impact of health claims and symbols. The main areas of interest consumer research tanding of claims and symbols but also attitudes towards such information and possible effects on food choice, research into (health outcomes or changes in the national health status due to the use of health claims and symbols) and the analysis of (prevalence, effect on benefit aspects). Methodologies mentioned to measure such impact include but are not limited to surveys, in-store observation, purchase simulation, focus groups and the analysis of sales data.
However, in some countries, different views were expressed by different stakeholders. Those opposing such measurements gave a range of reasons, including doubts over the effectiveness of claims and symbols in general but also lack of know-how, responsible authorities and resources. It was further argued by some stakeholders, that measuring the impact of claims and symbols is not necessary, f reasons (see Table 11).
All interview summaries regarding the measurement of the impact of claims and symbols are presented in the Supplementary Material (Table 4).
; Article no. EJNFS.2016.018 Reporting and databases on health claims/symbols in the EU Member States mentioned to measure such impact include but store observation, purchase simulation, focus groups and the different views were expressed by different stakeholders. Those opposing such measurements gave a range of sons, including doubts over the effectiveness of claims and symbols in general but also lack of how, responsible authorities and resources. It was further argued by some stakeholders, that measuring the impact of claims and symbols is not necessary, for various ll interview summaries regarding the measurement of the impact of claims and in the Supplementary Greece, Netherlands, Slovakia, Spain No clear answer was given Ireland, UK

Fig. 5. Measuring the impact of health claims and symbols
The main topics identified revolve around consumer understanding and trust in this type of information, vulnerable consumer groups (e.g. children) but also overall effectiveness and symbols (do they lead to healthier choices and ultimately impact health?). A large proportion of debates mentioned concerns the

Measuring the impact of health claims and symbols
Country Austria, Belgium, Bulgaria, Croatia, Denmark, Finland, France, Germany, Hungary, Italy, Latvia, Lithuania, Malta, Poland, Portugal, Romania, Slovenia, Sweden Czech Republic, Estonia Greece, Netherlands, Slovakia, Spain Ireland, UK

Measuring the impact of health claims and symbols -EU overview
The main topics identified revolve around and trust in this type of information, vulnerable consumer groups (e.g. effectiveness of claims and symbols (do they lead to healthier choices and ultimately impact health?). A large proportion entioned concerns the legislative aspects, ranging from a general discussion about the Health Claims Regulation (application, wording, graphic implementation, process of approval (EFSA)) to specific aspects such as the status of certain types of claims (e. claims), underlying nutrient profiles or criteria for the use of health symbols.

EU overview
, ranging from a general discussion about the Health Claims Regulation (application, wording, graphic implementation, process of approval (EFSA)) to specific aspects such as the status of certain types of claims (e.g. botanical claims), underlying nutrient profiles or criteria for

Stakeholder perception
The topic of health claims and symbols was said to be discussed throughout most Member States, both on a public level (media reporting etc.) and within stakeholder groups (national authorities, industry and consumer representatives). While it is evident that this topic is of interest to most countries and stakeholders, the nature of the debate was reported to vary highly across the different stakeholders.
The nature of the public debate on health claims and symbols could be characterised by a variety of opinions expressed, both positive and negative towards the topic. National food authorities, representatives of the food industry and consumer organisations showed an interest in health claims and symbols in general. However, scepticism was expressed concerning specific articles of the Health Claims Regulation but also confusion with regards to the implementation (e.g. wording of the claims). Consumer organisations were mainly concerned with the potential of claims and symbols to mislead consumers and report confusion over meaning and effectiveness among shoppers. Overall, the topic was said to have received limited attention in the media, but where it has been covered, the public debate has focussed mainly on the application of the Regulation and the status of individual claims.
All interview summaries regarding stakeholder perceptions are presented in the Supplementary Material (Table 5).