Gathering consumption data on specific consumer groups of energy drinks 1

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Suggested citation: Zucconi S., Volpato C., Adinolfi F., Gandini E., Gentile E., Loi A., Fioriti L.; “Gathering consumption

EXTERNAL SCIENTIFIC REPORT

Gathering consumption data on specific consumer groups of energy drinks

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NOMISMA-ARETÉ Consortium

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:

Silvia Zucconia, Chiara Volpatoa,Felice Adinolfia, Evita Gandini a, Enrica Gentileb, Alberico Loi b, Linda Fioriti b

a Nomisma SpA b Areté Srl 1 Question No EFSA-Q-2011-00309. 2

The Nomisma-Areté consortium acknowledges the EFSA steering Group and in particular the following staff members for their support and teamwork: Tobin Robinson (EMRISK Unit), Arianna Chiusolo (EMRISK Unit), Andrea Altieri (EMRISK Unit), Jean-Lou Dorne (EMRISK Unit), Davide Arcella (DCM Unit).

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Supporting Publications 2013:EN-394 2

ABSTRACT

At the end of 2011, a study was commissioned by EFSA to the Consortium Nomisma-Areté, with the objective of gathering consumption data for “energy” drinks (ED) in specific consumer groups (adults, adolescents and children) in EU. The study also aims at estimating, for each consumer group, the exposure to specific active ingredients (caffeine, taurine, and D-glucurono-y-lactone) from ED consumption, and the relative contribution of ED to the total caffeine exposure. Moreover, specific consumption habits (co-consumption with alcohol and consumption associated to intense physical exercise) were analysed for adolescents and adults.

Between February and November 2012, the study team conducted an EU-wide questionnaire-based survey - involving more than 52.000 participants from 16 different EU Member States3 - among adults (14.500 participants), adolescents (32.000), and children (5.500).

The highest prevalence of consumption4 was observed for the adolescent consumers group (68%). In adults prevalence for consumption was 30%, and 18% in children. Among consumers, no relevant differences were observed in the target groups for prevalence of high chronic consumers5 (12% in adults and adolescents, 16% in children) and high acute consumers6 (11% for adults and 12% for adolescents).

Concerning co-consumption with alcohol, similar prevalence was observed for adults (56%) and adolescents (53%). Consumption associated to sport activities showed prevalence of 52% in adults and 41% in adolescents.

Among ED consumers, the estimated average exposures from ED to caffeine, taurine and D-glucurono-y-lactone were higher in children (1,01, 12,83 and 5,13 mg/kg b.w./day, respectively) than adolescents (0,38, 4,6 and 1,65 mg/kg b.w./day, respectively) and adults (0,32, 3,82 and 1,78 mg/kg b.w./day, respectively). The calculated contribution from ED consumption to total caffeine exposure was 8% for adults, 13% for adolescents and 43% for children. The contribution increased for the high chronic consumers to 13% in adults, 16% in adolescents and 48% in children.

© Nomisma-Areté consortium 2012. Parts of this publication may be reproduced, provided acknowledgement is given to the „Nomisma-Areté consortium‟, along with the authors, title and year of publication as mentioned on page 1.

KEY WORDS

Energy drinks, caffeine, taurine, D-glucurono-y-lactone, active ingredients, survey, consumption.

3_{Austria, Belgium, Cyprus, Czech Republic, Germany, Greece, Finland, France, Hungary, Italy, Poland,}

Romania, Spain, Sweden, The Netherlands, United Kingdom.

4_{In the present study “consumers” of ED are subjects who declared to have drunk ED at least once over the last}

year.

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In the present study “high chronic” consumers are respondents who regularly consumed ED “4-5 days a week” or more (identified in relation to a frequency distribution for ED consumption greater than or equal to the 90th percentile).

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In the present study “high acute” consumers are respondents consuming 1 litre or more of ED per single session in the case of adults and 1,065 litres or more of ED per single session in the case of adolescents (identified in relation with declared volume consumed in a single session and setting the threshold at the 90th percentile).

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SUMMARY

At the end of 2011, a study was commissioned by EFSA to the Consortium Nomisma-Areté, with the objective of gathering consumption data for “energy” drinks (ED) in specific consumer groups (adults, adolescents and children) in EU). The study also aims at estimating, for the different consumer groups, the exposure to specific active ingredients (caffeine, taurine, and D-glucurono-y-lactone) from ED consumption, and the relative contribution of ED to the total caffeine exposure. Moreover, specific consumption habits (co-consumption with alcohol and consumption associated to intense physical exercise) should be analysed for adolescents and adults.

Between February and November 2012, the study team conducted an EU-wide questionnaire-based survey - involving more than 52.000 participants from 16 different EU Member States7(MS) - among adults (14.500 participants), adolescents (32.000), and children (5.500).

Survey results

Adults

Around 30% of adults interviewed declared to have consumed ED at least once during the last year, with prevalence varying among MS from 14% in Cyprus to 50% in Austria, and mainly (53%) in “young adults” (18-29 years). Among ED consumers, the average volume consumed was 2 L/month. Approximately 12% of adult consumers were identified as “high chronic” consumers, i.e. consuming ED 4-5 times/week or more (13,3% in “young adult” consumers), consuming an average volume of 4,5 L/month.

“High acute” consumers (consuming at least 1 L/single session), were 11% of the total adult ED consumers, mainly in “young adults” (13,4%).

The co-consumption of ED and alcohol was evidenced for around 56% of adult ED consumers (71% in “young adults”). ED consumption in relation with physical exercise resulted for 52% of adult ED consumers, mainly (55%) in “old adults” (50-65 years).

The average exposure to caffeine from ED was 22,4 mg/day (0,32 mg/kg b.w.8/day) for adult ED consumers, and the ED contribution to the total caffeine exposure was 8%. Caffeine exposure from ED increased to 48,3 mg/day (0,7 mg/kg b.w./day) in high chronic consumers, with a ED relative contribution of approximately 13%.

Average exposure to taurine from ED was 271,9 mg/day (3,82 mg/kg b.w./day) in adult ED consumers, rising to 585,79 mg/day (8,49 mg/kg b.w./day) in high chronic consumers. Average exposure to D-glucurono-y-lactone from ED was 125,95 mg/day (1,78 mg/kg b.w./day) on average for ED consumers, up to 268,84 mg/day (3,91 mg/kg b.w./day) in high chronic consumers.

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Austria, Belgium, Cyprus, Czech Republic, Germany, Greece, Finland, France, Hungary, Italy, Poland, Romania, Spain, Sweden, The Netherlands, United Kingdom.

8_{Data on the exposure expressed for kg of body weight (b.w.) were calculated for each consumer on the basis of}

declared body weight collected through the survey. In case of missing data, data on body weight from EFSA scientific opinion “Guidance on selected default values to be used by the EFSA Scientific Committee, Scientific Panels and Units in the absence of actual measured data” (EFSA, 2012) were adopted.

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Adolescents

Prevalence of ED consumption was 68%, varying from 48% in Greece to 82% in Czech Republic9, and mainly observed (73%) in the 15-18 age subgroup. Among ED consumers, the average volume consumed was 2,1 L/month.

Around 12% of adolescent consumers were identified as “high chronic” consumers, i.e. consuming ED 4-5 times/ week or more, with an average ED volume of 7 L/month.

Around 12% of adolescent ED consumers resulted to be “high acute” consumers, i.e. consuming at least 1,065 L of ED per single session.

Co-consumption of ED and alcohol was observed in 53% of adolescent ED consumers, mainly (59%) in the 15-18 years subgroup, while ED consumption in relation with physical exercise resulted to interest 41% of adolescent consumers, mainly (48%) in the 10-14 years subgroup.

The average exposure to caffeine from ED was 23,5 mg/day (0,38 mg/kg b.w./day) for adolescent ED consumers, with an average contribution of ED to the total caffeine exposure of 13%. The caffeine exposure from ED increased to 75,08 mg/day (1,18 mg/kg b.w./day) in high chronic consumers, contributing to 16% of total caffeine exposure.

The average exposure to taurine from ED was 283,9 mg/day (4,6 mg/kg b.w./day) in adolescent ED consumers, rising up to 924,3 mg/day (14,5 mg/kg b.w./day) in high chronic consumers. Average exposure to D-glucurono-y-lactone from ED was 100,14 mg/day (1,65 mg/kg b.w./day), up to 311,6 mg/day (4,9 mg/kg b.w./day) in high chronic consumers.

Children

Prevalence of ED consumption was 18%, mainly (19%) observed in the 6-10 years subgroup, and varying among MS from 6% in Hungary to 40% in in Czech Republic. Among ED consumers, the average volume consumed was 0,49 L/week.

Approximately 16% of ED consumers resulted to be “high chronic” consumers, i.e. consuming ED 4-5 times/ week or more, with an average volume of around 0,95 L /week.

Average caffeine exposure from ED was 21,97 mg/day (1 mg/kg b.w./day), with a relative contribution of ED to total caffeine exposure of 43%. Caffeine exposure from ED increased to 42,9 mg/day (1,98 mg/kg b.w./day) in high chronic consumers, with a ED relative contribution of 48%. Average exposure to taurine from ED was 278,37 mg/day (12,83 mg/kg b.w./day), increasing to 543,57 mg/day (25,05 mg/kg b.w./day) in the high chronic consumers.

Finally, average exposure to D-glucurono-y-lactone from ED was 111,35 mg/day (5,13 mg/kg b.w./day), increasing to 217,43 mg/day (10 mg/kg b.w./day) for high chronic consumers.

Literature review

Results emerging from the literature review highlighted a limited availability of recent and comprehensive studies or surveys at EU level, providing reliable data on ED consumption and exposure to specific ingredients (caffeine, taurine, and D-glucurono-y-lactone). Such limitation did not allow an analysis of the evolution of ED consumption over time.

9_{The highest prevalence of ED consumption among total respondents was observed in Belgium (85%) but not}

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Supporting Publications 2013:EN-394 5 Recommendations

The project represented the first effort at European level of data collection on ED consumption and contribution to some active ingredients (caffeine, taurine, and D-glucurono-y-lactone) exposure, in specific consumer groups and in different MS. Due to the exponential growth rate which characterised the ED market over the last years, the study team suggests to monitor possible further increases in ED consumption and eventually consider the possibility to update the study.

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“Energy” drinks (ED) constitute a relatively new product category in the wider soft drinks market. Lipvitan D™, launched in Japan in 1960 by Taisho Pharmaceuticals, can be considered the first ED ever. The diffusion of ED in Europe started in 1987 with the launch of Red Bull™, a beverage containing taurine and produced in Austria, which quickly gained popularity in Europe and, from 1997 onwards, also in the USA. Commercial success of Red Bull™ sparked the proliferation of similar products on the market.

With an agreed definition of “ED” still missing, such category includes a variety of non-alcoholic beverages containing caffeine, taurine and vitamins (often in combination with other ingredients), marketed for their actual or perceived effects as stimulants, energizers and performance enhancers. For this reason, ED – which should not be confused with isotonic beverages and “sport drinks” – are usually included in the wider group of “functional foods”.

The most common active substance in ED is caffeine, which is often combined also with taurine, D-glucurono-y-lactone, guaranà, maltodextrin, ginseng, carnitine, creatine and gingko biloba; other common ingredients are vitamins and - usually – artificial and natural sweeteners (which are added also to “mask” the unpleasant flavour of some ingredients).

Caffeine is an alkaloid, acting as central nervous system stimulant. It is present in many beverages and food products: its content in ED can vary from 70 to 400 mg/L and more (maximum limits concerning caffeine content are set by regulations in many countries).

Taurine is an amino acid naturally produced by human body, and it is essential for cardiovascular function, and development and function of skeletal muscle, the retina and the central nervous system

D-glucurono-y-lactone is naturally present in human body, as important structural component of connective tissues.

The rapid expansion of ED consumption has been one of the most notable trends in the soft drinks market of many countries (see next §). However, such expansion has also created concern in the scientific community, in national and international institutions dealing with health-related issues, as well as in the public opinion, in the light of a number of issues which are often associated to ED consumption. Indeed in the last years the attention for such issues has been remarkable in scientific literature, in institutional communication by national health agencies, in specialist publications focusing on the soft drinks sector10, and also in the general media.

The issue of ED consumption and over-consumption is highly debated from a scientific point of view, especially for what the possible related health effects are concerned. Indeed a number of studies (Alford et al., 2011; Reissig et al., 2009; SHC, 2012; Arria et al., 2011; Marin Institute, 2011; Oteri et al., 2007) have recently investigated on potential and/or detected effects of “active” ingredients (caffeine, taurine, D-glucurono-y-lactone, etc.) on highly sensitive subjects (children, pregnant women, heart patients, etc.), or on potential and/or detected effects of co-consuming of ED with alcohol or with other products containing active ingredients.

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A recent example is the article “ANSES warns French nation of risky alcohol energy drink mix”, featured on Beverage Daily.com website on June 07, 2012: http://www.beveragedaily.com/Regulation-Safety/ANSES-warns-French-nation-of-risky-alcohol-energy-drink-mix

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Moreover, the issue of co-consumption of ED with alcohol is cause of particular concern, as it appears to be quite common among youths (Marin Institute, 2007; Miller, 2008; SHC, 2009). Indeed health effects of co-consumption of alcohol and ED have been dealt with by a number of scientific studies (Arria et al., 2010; Alford et al. 2011; Brache and Stockwell, 2011; Oteri et al., 2007) and technical reports (BfR, 2008; EUCAM, 2008, 2009).

Finally, also the association between sport practice and high levels of consumption of ED has raised some concern, as the combined effect of intense physical effort and of the stimulant action of ED could pose health risks for some subjects.

In 2003 the Scientific Committee on Food of the European Commission (DG SANCO)11 classified ED consumption levels into “mean chronic”, “high chronic” and “acute” (table 1).

Table 1 – ED consumption levels

Consumption N° of 250 ml cans per day ml/day

Mean chronic 0,5 125

High chronic 1,4 350

Acute 3,0 750

Source: DG SANCO - Scientific Committee on Food (2003)

Increasing consumption of ED implies a higher exposure to caffeine, taurine and D-glucurono-y-lactone. Higher exposure to such active substances by children and young adults was identified as a potential emerging risk at European Food Safety Authority’s (EFSA) Advisory Forum meeting of 19th-20th May 2010. Indeed available information suggests that ED consumption is becoming more and more widespread among youths, especially in relation with mass-entertainment and sport practice. Despite the high scientific interest related to the possible side effects of ED, the limited availability of detailed and updated information on ED consumption in the EU has been highlighted by many experts and stakeholders.

EFSA commissioned the present study to gather consumption data for ED and data on exposure to specific ingredients (caffeine, D-glucurono-y-lactone, taurine) in the context of ED consumption, for specific consumer groups (children, adolescents and adults) and addressing specific moments of consumption. The study is also aimed at estimating the relative contribution of ED to the total exposure to caffeine, D-glucurono-y-lactone and taurine in the diet (in comparison with the exposure deriving from consumption of coffee, tea, cola drinks and cacao, chocolate products, coffee-based beverages, etc.).

The market of ED in Europe

In the context of the overall market for non-alcoholic beverages, ED are usually considered as a segment of the wider category of “functional beverages”.

According to Zenith International’s Global Energy Drinks Report (2009), world total consumption of ED in 2008 reached 3,9 billion litres (compared to 2 billion litres in 2003). Per capita consumption at world level was equal to 0,8 litres (up from 0,4 litres in 2003). North America accounted for a 37% share of overall world consumption in 2008, with the Asia/Pacific area accounting for another 30%; the share of Western Europe on world total was equal to 15%.

According to estimates by Euromonitor International, the expansion of the ED market at global level has continued at a fast pace also in recent years (table 2).

11_{European Commission health & consumer protection directorate-general Scientific Committee on Food,}

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Table 2 – Growth of the functional drinks market at world level by segment (2006 – 2011; million litres)

Segments 2006 2011 (forecast) % growth

(2011 vs. 2006) Sports drinks 9.871 13.302 + 35% Energy drinks 2.429 3.534 + 45% Functional drinks - TOTAL 12.621 17.202 + 36% Source: Euromonitor

On the basis of data provided by the Canadean’s Global Beverage Report (2008), the annual growth rate for the ED segment in the 2008-2013 period was forecast at +9,3%, compared to a growth rate of +2,6% for the overall non-alcoholic beverages market.

Red Bull™ is by far the leading brand at world level (40% of total sales in 2008), with Monster™ (owned by Hansen’s Beverage Company) and Rockstar™ ranked second and third, respectively (table 3).

Table 3 – Leading ED brands at world level (2008, market shares)

Brands share Red Bull™ 40% Monster™ 23% Rockstar™ 12,3% AMP™ 8% Full Throttle™ 4% Doubleshot™ 2% NOS™ 1,5% No Fear™ 1,4%

Private Labels (retailers’ brands) 1%

SOBE Adrenaline™ 0,7%

Source: Bevnet

With regards to the ED market in Europe, it has experienced a rapid growth of consumption, especially from 2005 onwards (Zenith International, 2008). Total production of ED in Europe was estimated at around 490 million litres in 2007, for a value of approximately 3,8 billion Euros. The expansion of the market has been especially remarkable in some MS (Germany and United Kingdom in particular12), and has often resulted in a proliferation of brands, with frequent launch of new products, many of them with eminently national diffusion. “Convenience” ED (many of them marketed under private label) and innovative product typologies (“energy shots”, “pre-mixed alcoholic

12_{According to Zenith International data featured in the annual reports of the British Soft Drinks Association}

(BSDA), ED consumption in the United Kingdom has grown from 175 million litres in 2000 (1,5% of total soft drinks consumption) to 495 million litres in 2011 (3,4% of total soft drinks consumption, for an increase of 183% in terms of volume). Per capita consumption levels have increased from 3 litres per person in 2000 to 7,9 litres per person in 2011. In other MS the growth has been less intense, and overall consumption volumes are quite limited; in Italy, for instance, consumption of ED (according to GFK-Eurisko data published on MARK UP magazine, April 2009 and April 2010 issues) has passed from 2,67 million litres in 2006 to 2,97 million litres in 2009 (an increase of 11%).

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ED”, etc.) have also appeared in some national markets (Alard, Marìn, Cubillo, 2010; EUCAM, 2008 and 2009).

Red Bull™ is by far the leading brand in virtually all national markets; smaller market shares are held by other international brands (Monster™, Burn™), by national brands (of which some are however owned by multinational groups) and by private labels.

Outline of the relevant EU labeling legislation

A short overview of the most relevant European legislation on food labelling - with particular attention to the rules concerning beverages containing active ingredients – is provided hereafter.

Directive 2000/13/EC of the European Parliament and of the Council on “the approximation of the laws of the MS relating to the labelling, presentation and advertising of foodstuffs”. The Directive defines mandatory food information to be provided by producers, in order to assure a high level of protection of consumers’ health and interests. According to this Directive, among the other features (such as the name of the food) it is mandatory to indicate the list of ingredients and the quantity of certain ingredients, or category of ingredients, on the product label.

Directive 2002/67/EC of the European Commission on “the labelling of foodstuffs containing quinine, and of foodstuffs containing caffeine”. The Directive establishes that beverages containing more than 150 mg of caffeine per litre must be labelled with the term “high caffeine content”, in a position close to the name of the food. Furthermore a clear indication of the amount of caffeine per 100 ml in the product must be provided in the label. In this Directive ED are explicitly indicated as caffeine containing products which, according to the Scientific Committee for Food opinion of 21st January 1999, do not represent a cause of concern for their contribution to the total consumption of caffeine (only for adults, pregnant women excluded). Regulation (EU) No 1169/2011 of the European Parliament and of the Council on “the provision of food information to consumers”. From 14th

December 2014 this Regulation will enforce additional caffeine labelling for high caffeine drinks and foods where caffeine is added for its physiological effects13. In particular, the following categories of beverages must be labelled with the statement “High caffeine content. Not recommended for children or pregnant or breast-feeding women” placed near the name of the product and followed by the caffeine content specified in mg per 100 ml:

- beverages intended for consumption without modification, containing at least 150 mg/l of caffeine;

- beverages in concentrated or dried form which after reconstitution contain caffeine in a proportion in excess of 150 mg/l.

The aforementioned provisions will instead not apply for:

- drinks based on coffee, tea or coffee or tea extract where the name of the food includes the term “coffee” or “tea”;

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- beverages where caffeine is added as a flavouring rather than for a physiological purpose: in this case the term “caffeine” must appear in the ingredients list under the section “flavouring(s)”.

As for labelling on beverages containing taurine and D-glucurono-y-lactone, there are no specific rules to be enforced to indicate these substances.

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TERMS OF REFERENCE

As already outlined, the main purpose of the study is gathering information and data on consumption of ED and of some specific ingredients (specifically caffeine, taurine and D-glucurono-y-lactone) in well-defined consumer groups in a number of EU MS. The targeted groups of consumers include children (from 3 to 10 year old), adolescents (from 10 to 18), and adults (from 18 to 65); a focus is also foreseen on adolescents and adults practising intense physical exercise and co-consuming ED with alcohol. According to the terms of reference, in the context of the study:

Consumption of ED is analysed at MS level and expressed per subgroup and per unit of time, in order to reflect acute and chronic exposure.

Consumption of and exposure to specific ingredients (caffeine, taurine, D-glucurono-y-lactone) are analysed per subgroup for acute and chronic ED consumers in each MS. As for caffeine consumption, the relative contribution of ED is determined and compared with caffeine consumption from major sources in the diet (coffee, tea, cola drinks and cacao, chocolate products, coffee based beverages, etc) to assess whether ED consumption is adding to exposure to caffeine or whether their consumption is substituting exposure via more traditional foods.

This contract was awarded by EFSA to: Consortium Nomisma-Areté Contractor: Consortium Nomisma-Areté

Contract title: Gathering consumption data on specific consumer groups of energy drinks Contract number: CFT/EFSA/EMRISK/2011/03

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1. INTRODUCTION AND OBJECTIVES

According to the terms of reference, the main objectives of the study can be identified in the following: - Gathering data about consumption of ED in the EU MS (Objective 1);

- Collecting data at MS level about the exposure to specific active ingredients (caffeine, taurine, D-glucurono-y-lactone) due to ED consumption, and estimating the relative contribution of ED to caffeine exposure, compared with caffeine consumption from major sources in the diet (Objective 2).

In order to achieve the above mentioned objectives, a specific data collection strategy was defined, based on three main elements:

1. review of the relevant literature dealing with the subjects of interest available in the different MS and published over the last three years;

2. consultation of the relevant stakeholders (experts of EFSA national focal points; officials of competent authorities in the field of public health; representatives of the main beverages industry associations both at European and national levels);

3. ad hocsurvey, aimed at gathering primary data on the consumption of ED and on the exposure to specific ingredients.

The present document constitutes the final report for the study “Gathering consumption data on specific consumer groups of energy drinks”, commissioned by EFSA to the Consortium Nomisma-Areté at the end of 2011.

According to the tender specifications for the study, and taking into account EFSA’s guidelines for the submission of official reports, the document is structured as follows:

- A description of the methodology applied in the study (chapter 2); - A description of the results of the study (chapter 3), divided into:

o A description of the results from the literature review (§ 3.1);

o A description of the results from the stakeholders’ consultation (§ 3.2);

o Final results from the survey (§ 3.3), as a summary of data on acute and chronic consumption of ED in the previously mentioned subgroups of the population, including summary statistics for each Member State (MS) and for all MS for which data were available.

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2. MATERIALS AND METHODS

Due to the complexity of the study and the kind of information required for the purpose of the analysis, a specific data collection strategy was defined, including a combination of different methods and tools (Figure 1).

Figure 1: Data collection strategy

As foreseen in the data collection strategy, the preliminary phase of the study included:

- Literature review, carried out also with the support and contribution of selected stakeholders. - Identification and contact of stakeholders, aimed at ensuring their contribute to the study via

interviews (stakeholders’ consultation). - Survey.

The following paragraphs provide details regarding the methodology and tools adopted for each main phase and specific element of the data collection strategy.

2.1. Literature review

The literature review was performed with the main objectives of:

- Identifying and collecting relevant studies, papers and articles, as well as previous surveys performed during the last three years with respect to the consumption of ED, the occurrence of specific ingredients and human exposure to active ingredients.

- Identifying and collecting information and data useful to correctly define the survey design as well as specific contents for the questionnaires.

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1. Identification of the available literature and information sources, in the light of the previously defined objectives and scope of the study.

2. Analysis of the documents collected during step 1. 3. Synthesis of the most relevant documents.

4. Use of the relevant literature for the purposes of the study (survey design and contents of questionnaires).

The first phase of the literature review was mainly based on web-based research (specialized magazines, dedicated web-sites, institutional sources, etc.). After this preliminary phase, stakeholders’ consultation played a relevant role in supporting the identification of additional sources and studies as well as the selection of the proper and most relevant papers for the purposes of the study. Stakeholders were asked to comment on the preliminary list of references and sources collected by the study team, and to eventually add missing references or sources (§ 2.2).

Literature review was focused on recent bibliography (published between 2008 and 2011) addressing ED and/or their specific ingredients, in terms of consumption habits and possible health effects caused by these products/ingredients. Due to the specific objectives of the study, however, studies and reports dealing exclusively with health effects of ED were deemed as falling outside the scope of the study itself.

From the complete list of the relevant literature, resulting from the stakeholders’ consultation (Appendix A), a number of references featuring meaningful insights about the research topics were selected (§ 3.1.2).

2.2. Stakeholders’ consultation

Two different rounds of stakeholders’ consultations were planned: before (pre-survey consultation) and after the survey (post-survey consultation).

The main objectives of the pre-survey stakeholders’ consultation is summarised as follows:

a) Supporting literature review, and specifically the identification of relevant sources, studies and surveys dealing with the issue of ED consumption over the last 3 years.

b) Supporting the collection of data on ED market.

c) Supporting and validating the identification of relevant ED brands for the different MS.

d) Supporting the identification, for each MS, of relevant food products in the diet contributing to the exposure to active ingredients (caffeine, taurine, D-glucurono-y-lactone).

After the conclusion of the survey, stakeholders who had participated to the first round of consultation were contacted again as part of the post-survey consultation, whose main objective was to share with experts the structure of methodology adopted for the study as well as results emerging from the first round of consultations.

On the basis of the aforementioned objectives, the categories of stakeholders involved in the pre- and post-survey consultations include:

- Experts from EFSA national focal points14.

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Focal Points act as an interface between EFSA and the national food safety authorities, research institutes, consumers and other stakeholders. The Focal Point network is made up of members from all 27 EU Member States, Iceland and Norway, as well as observers from Switzerland and (potential) EU candidate countries.

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- Representatives of the main industry associations, both at European level (Union of European Soft Drinks Associations; Energy Drinks Europe; etc.), and at MS level (national associations of soft drinks producers).

- Researchers and experts in soft drinks and ED, in particular project managers of relevant studies on ED and related themes (e.g. University of Wien; European Centre for Monitoring Alcohol Marketing – EUCAM, etc.).

- Representatives of consumers’ organizations at EU level (e.g. European Consumers’ Organization – BEUC).

The pre-survey consultation was carried out between February and May 2012.

The post-survey consultation was carried out in November 2012, when the survey activities were approaching completion.

2.2.1. Pre-survey and post-survey consultations

Starting from the identification of the relevant categories of stakeholders to be involved, the study team selected a list of experts in the study subjects, specifically including:

- experts from MS national health institutes/organisations; - representatives of EU-level industry organisations; - representatives of national industry organisations;

- other experts in the field of ED (academics, consultants, etc.), with special focus on ED consumption and composition.

The final list of stakeholders to be contacted and the list of questions to be asked were validated by the Steering Group prior to the start of the consultation. The final list of stakeholders also included ones from MS not covered by the survey, for a total of 40 experts (Appendix B).

All the interviewed experts were provided in advance (Appendix C and D) with: - list of questions;

- list of relevant literature collected by the study team;

- list of relevant information sources identified by the study team;

- list of the main ED brands marketed in the EU, compiled by the study team on the basis of the literature review;

- list of food products in the diet (other than ED) supposed to play a significant role in the assumption of caffeine, taurine, D-glucurono-y-lactone, theophylline and theobromine, compiled by the study team on the basis of the information retrieved through the literature review.

The minutes of the interview were sent to each interviewee for validation.

Interviews for the pre-survey consultation were organized around three main topics: literature and sources; ED market; active ingredients. However, the choice of semi-structured interviews, based on open-ended questions, encouraged experts not to limit their contributions to such topics, but to provide also general comments on the study as a whole, as well as additional inputs and ideas.

Some stakeholders were also involved in the post-survey consultations, in which the structure of the methodology adopted for the survey, as well as results emerging from the first round of consultations were shared with them.

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Supporting Publications 2013:EN-394 18 2.3. Survey

The literature review and the pre-survey stakeholders’ consultation enabled the study team to better define the reference frame for the survey, which actually represented the main source of data and information for the study.

As already outlined, the survey aimed at collecting primary data on different population targets, and specifically:

1) children (3-10 years old); 2) adolescents (10-18 years old); 3) adults (18-65 years old); as well as:

a) adolescents and adults practising intense sport activities; b) adolescents and adults consuming ED mixed with alcohol.

For each target group mentioned at points from 1 to 3 above, a dedicated questionnaire was prepared and translated in all the languages of the MS covered by the survey. In the specific case of children aged 3-5 an additional questionnaire addressed to parents was also prepared.

The survey was structured to collect data and information to achieve both Objective 1 and 2 (chapter 1). Questions related to each objective covered a specific section in the questionnaire. Each questionnaire started with an introductive section aimed at gathering some preliminary information on the respondent (gender, age, education level, etc.), followed by two dedicated sections, for each of the two objectives. Additional consumer profile information (e.g. on lifestyle, such as “smoker or not”) was collected through specific questions.

Objective 1: Data on ED consumption – Study design A. This section featured a number of questions mainly aimed at investigating:

- Frequency and volume of consumption.

- Reasons for consumption and consumption habits. - Main typologies, size formats and brands consumed.

- ED consumption and sport activities (in adults and adolescents). - Co-consumption of ED and alcohol (in adults and adolescents).

Objective 2: Data on consumption of other food products containing caffeine, taurine, D-glucurono-y-lactone – Study design B. This section featured a number of questions mainly aimed at investigating:

- Relevant food products in the diet that constitute a source of caffeine, taurine and D-glucurono-y-lactone.

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Supporting Publications 2013:EN-394 19 2.3.1. Selection of MS involved in the survey

The survey covered 16 MS out of 27, selected in order to guarantee an adequate coverage of the whole EU population and of the different consumption styles.

The following selection criteria were adopted:

- Size of ED potential market in terms of population in the relevant age group (from 3 to 65 years). - Balance among different geographical areas supposed to have potentially different consumption

habits (Western vs. Eastern countries, Northern vs. Southern countries).

- Balance among different food consumption patterns (e.g. Mediterranean countries vs. Nordic countries).

On the basis of these criteria (also taking into account preliminary findings emerging from the literature review), and after final validation by the Steering Group, the following 16 MS were selected for the survey: 1. Austria 2. Belgium 3. Cyprus 4. Czech Republic 5. Germany 6. Greece 7. Finland 8. France 9. Hungary 10. Italy 11. Poland 12. Romania 13. Spain 14. Sweden 15. The Netherlands 16. United Kingdom 2.3.2. Study design

In order to guarantee a wide coverage of each targeted group, the survey was differently defined on the basis of the target. A description of the survey structure and for each targeted group is provided below.

1. Children

A. Children 3-5 years old

Survey carried out with schools' support ("school survey").

Paper questionnaires, featuring images aimed at helping children to correctly understand each question and call back to mind food products and beverages. Questionnaires to be filled in by children, at school, with the help of their teachers. Additional questionnaires to be filled in by parents, aimed at collecting more accurate information on the children’s consumption habits and at confirming/adjusting what declared by children in the respective questionnaire. B. Children 6-10 years old

“School survey”.

Paper questionnaires, featuring images aimed at helping children to correctly understand each question and call back to mind food products and beverages. Questionnaires to be filled in by children, at school, with the help of their teachers. For a small sample of children, questionnaires to be filled in also by parents (specifically required for schools covering both the target groups).

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For children and adolescents, the sample of schools for MS was determined on the basis of each target group (Tables 4 and 5). Official registries containing the complete list of schools, with related contact details, were requested to the Ministries of Education and other competent Authorities of the MS covered by the survey. On this basis, sampling activities were carried out on the complete lists of schools for each level involved (pre-primary, primary, secondary).

For the survey on adults (18-65 years), a mixed mode was preferred, integrating CAWI and CATI methods. The questionnaires (adults, adolescents, children and parents) were translated in all the relevant languages for the MS covered by the survey, in order to promote people’s cooperation and participation.

5. Adolescents and adults Co-Consuming ED with alcohol (CC)

Covered via questionnaires already addressed to adolescents and adults (points 2 and 3 above).

At least one situation of co-consuming during the last year.

Target covered by Adolescents and Adults Survey (points 2 and 3 above).

4. Adolescents and adults practising Intense Physical Exercise (IPE)

Covered through the questionnaires already addressed to adolescents and adults (points 2 and 3 above).

Practice of sport and/or physical exercise at least twice a week.

Target covered by Adolescent and Adults Survey (points 2 and 3 above).

3. Adults (18-65 years old)

Mixed mode survey – CAWI (Computer Assisted Web Interview) e CATI (Computer Assisted Telephone Interview).

Maximum share of telephone interviews = 20%.

2. Adolescents

A. Adolescents 10-13 years old “School survey”.

Web questionnaires or alternatively paper questionnaires to be filled in by students.

B. Adolescents 14-18 years old “School survey”.

Web questionnaires or alternatively paper questionnaires to be filled in by students.

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Details on the minimum sample dimension defined for each country, in terms of schools to be contacted, are provided in Table 4.

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Table 4: Sample design – Number of schools included in the sample by country

PRE-SCHOOL (20x3)(a) PRIMARY SCHOOL (20x5)(a) LOWER SECONDARY (25x3x2)(a) UPPER SECONDARY (22x5x3)(a) Austria 25 25 10 6 Belgium 30 30 12 5 Cyprus 5 5 5 5 Czech Republic 25 25 10 6 Finland 20 20 10 5 France 100 100 39 23 Germany 100 100 39 23 Greece 18 18 7 5 Hungary 28 28 11 7 Italy 90 90 35 22 Netherlands 40 40 16 10 Poland 75 75 30 18 Romania 40 40 16 10 Spain 79 79 31 19 Sweden 25 25 10 6 United Kingdom 100 100 39 24 TOTAL 800 800 320 194

SCHOOL SAMPLE AND POTENTIAL CONTACTS

(a)Average number of pupils/students per class (class size) multiplied for the average number of school year levels.

The number of contacts with schools in each MS was defined by means of a specific sampling methodology: the total number of potential contacts was distributed among the 16 MS according to the total population; the numbers obtained were then adjusted in order to guarantee a minimum number of contacts in the less compared to the more populous MS. The methodology adopted for the definition of sample size is therefore proportional with adjustments.

The sample of schools to be contacted in each MS was defined by random sampling methodology, aimed at guaranteeing nation-wide coverage and representativeness of the group of interviews in terms of geographical areas for each target group.

During the survey activities, the initially planned number of schools to be contacted was significantly increased, in order to guarantee a sufficient coverage also in those countries where the actual participation rate resulted to be much lower than initially expected (50%).

The replacement procedure was based on the representativeness of the sample, including three more schools from the same region, with similar characteristics (level of education, area, number of students, etc.).

Even if the sample was built on these premises, the results cannot be deemed as fully matching the scheme initially proposed, as the participation rate in the survey strongly depended on the schools’ availability.

Therefore, a more intense effort was driven towards replacements and recalls in the MS where the number of potential ED consumers resulted to be lower.

Details regarding the expected number of “consumers” (consumption of ED at least once over the last year) to be reached for each target category are reported in Table 5.

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Table 5: Sample design – Expected number of consumers to be reached through the survey

3-10 years old 10-18 years old 19-65 years old IPE(b) CC(b) Austria 200 270 180 72 72 Belgium 240 280 150 60 60 Cyprus 40 60 50 20 20 Czech Republic 200 280 150 60 60 Finland 160 250 150 60 60 France 800 1.100 450 180 180 Germany 800 1.100 450 180 180 Greece 144 200 150 60 60 Hungary 224 310 150 60 60 Italy 720 1.000 430 172 172 Netherlands 320 450 150 60 60 Poland 600 820 350 140 140 Romania 320 450 190 76 76 Spain 632 860 400 160 160 Sweden 200 270 150 60 60 United Kingdom 800 1.100 450 180 180 TOTAL 6.400 8.800 4.000 1.600 1.600 CONSUMERS(a) of which:

(a) At least one intake over the last year.

(b) Samples for IPE and CC are referred to both adolescents and adults.

2.3.3. Pilot study and quality checks

The tools used in the survey, including questionnaires, were validated following a specific procedure. All the documents were drafted on the basis of the study team’s expertise in surveys on food consumption habits, with particular respect to the target groups covered by the study.

Relevant literature in the dietary assessment methodology field has been reviewed in order to use up-to-date methods to assess the consumption habits on a target population15. Moreover, a review of empirical studies on consumption habits was also made16, in order to grasp the critical aspects of the tools already used in other surveys and to avoid as much as possible bias in the outcomes of the survey.

15_{One of the reference papers used was “Dietary Assessment Methodology” F. E. Thompson, A. F. Subar,}

National Cancer Institute, Bethesda, Maryland, 2008.

16_{Specific reference was made to Safefood (A review of health effect of stimulant drinks), Expochi (Dietary}

exposure assessments for children in Europe), Food4You project (Healthy Lifestyle in Europe by Nutrition in Adolescence, European food information council) and Catch kids club (survey on consumption habits in youngsters). Edmunds, L.D. and Ziebland, S. (2002) Validation of a fruit and vegetable questionnaire for 7–9 year olds. Health Education Research 17: 211-20.

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Professional translators were used to translate documents into the relevant languages; the use of simple wording and a close cooperation between the translators and the study team also ensured that all the survey questions and annexed documents were easy to understand.

National experts the pre-survey consultations allowed to tailor the questionnaires to national characteristics concerning the main ED brands and/or other common food products/beverages containing caffeine.

Questionnaires for surveys in schools were tested through a pilot survey in 3 MS (Italy, France and UK). A sample of schools for each level was contacted to complete the pilot questionnaires and to gather comments/suggestions on the structure and wording. Also head teachers or educational experts of some schools not involved in the pilot survey provided useful remarks and suggestions on the survey approach and questionnaires. Comments and suggestions gathered during the pilot phase were used for fine-tuning methodology and related tools prior starting the survey.

Checks on the documents were initially based on the content validity, which was already part of the tender specifications and which was tested with the Steering Group.

The specificity validity was achieved through adjustment of the standard methodology for investigating food consumption habits to the specific kind of product considered, i.e. ED: in particular, the consumption time reference scale and the occasions of consumption were based on each specific type of product.

Moreover, a validation of the sensitivity was achieved through three check questions regarding ED consumption, to have further confirmation of the same and to avoid “non-consumers”. These check questions also allowed the selection of subgroups of consumers in the population and the investigation of their specific consumption habits.

The external validity was assured by the outcomes of the pilot survey and by the stakeholders’ consultations, with the aim of allowing generalization of the survey results to the entire reference population.

As for qualitative checks on the filled in questionnaires, accuracy in compiling the questionnaire was assured by the constrains foreseen in the online questionnaires (adults and adolescents), which enabled to continue with the compilation only if all the previous questions had been answered, and blocked the compilation in case of “unrealistic” answers regarding age, weight, slept hours, etc.

With specific reference to ED consumption, in all those cases where the respondent had indicated a product which is not an ED (e.g. sport drink), the respondent was reclassified as non-ED consumer, and all the answers concerning ED consumption and related habits were consequently excluded from the analysis.

As far as outliers are concerned, in all those answers where a number specification was required (e.g. “number of cans consumed in an average week”), a reclassification or elimination was always made for clearly extreme - and hence probably unrealistic - figures (e.g. 100 cans/week). An additional reclassification was made with specific regards to coffee consumption, in order to assure coherence in the overall consumption of the three product typologies: specifically, when respondents declared to consume more than 15 cups per day17 of beverages with coffee - combining declared consumption data espresso, coffee (instant, ground, ice-coffee) and cappuccino - the number of cups consumed daily has been reclassified as maximum 5 cup per day for each typology.

17

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Finally, the validity of results was also guaranteed by the choice to carry out the survey over a quite long time period (from March to November), thus avoiding - or at least sharply reducing - possible distortions due to seasonal trends in consumption.

2.3.4. Data processing methods for calculating the exposure to active ingredients

Processing methods used for calculating the exposure to active ingredients (caffeine, taurine and D-glucurono-y-lactone) for each subject interviewed (“row analysis” of the data) were applied to data on: The exposure was derived:

1. ED consumption;

2. consumption of other food products and beverages containing the active substances object of the analysis.

Such calculations were made for both ED consumers and all respondents18, and allowed to define the relative contribution of ED consumption as a source of caffeine, taurine and D-glucurono-y-lactone through the diet.

Throughout the analysis, calculations were always based on the data of the single respondent, while average data were used solely to give the final outputs/elaborations or to define the threshold for further breakdowns of the analysis (i.e. acute or chronic consumption). Final results on the exposure to active substances were expressed in mg/day and in mg/kg bw/day.

2.3.4.1. Caffeine exposure from ED consumption

Calculation started from ED consumption data retrieved via survey. Data on number of cans of ED consumed in an average month were combined with data on:

a. the size of cans usually consumed;

b. the top-three ED brands usually consumed;

c. the relative importance of the favourite ED brand among the top-three products; d. caffeine content of the ED brands concerned (table 6 and 7);

in order to calculate the overall caffeine exposure from ED consumption, weighted according to the relative importance of the top-three ED brands consumed (each respondent was asked to indicate the three main ED brands consumed, in decreasing order of importance, and to specify the per cent share of his/her favourite brand in his/her total ED consumption).

In the specific case of children, a different method had to be used, as no question about the top-three ED brands was asked. In this case, the average content of caffeine – as well as concerning D-glucurono-y-lactone and taurine - of the first 3 brands of ED comprehensively indicated by children has been used.

With regards to the format of ED, a specific analysis was performed for the “energy shots” format: in this case, the occurrence of active substances results to be remarkably different (and normally higher) from that of the “standard” EDs, and to sharply vary from one energy shot brand to another. Table 7 provides the contents of active ingredients for the energy shots brands cited by respondents and

18

The calculation of the total exposure (ED and other foods/beverages) is not available for all the respondents in the target group of adults, since in this case respondents who declared not to consume ED were not asked additional information on the consumption of other food and beverages containing active ingredients.

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analysed in the study. When the exact occurrence of active ingredients was not available or considered not fully reliable, a standardized content of active substances was applied19 (§ 2.3.6).

19_{The contents adopted for the calculations are: 1.345 mg/L for caffeine, 4.000 mg/L for taurine and 2.400 mg/L}

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Table 6: Content of active ingredients in different ED brands included in the questionnaire (1)

Brand name Caffeine (mg/L) Taurine (mg/L) D-glucurono-y-lactone

(mg/L)

Atomic™ 300 3700 2400

Bad Dog™ 300 4000 Not present

Battery™ 320 4000 Not present

Big Energy Shock™ 322 4000 (b) Not present

Blu™ 300 (a) 4000 b Not present

Bomba™ 320 4000 Not present

Booster energy drink™ 300 (a) 4000 (b) 2400(b)

Brava Italia™ 320 4000 Not present

Bullet™ 300 (a) 4000 (b) Not present

Burn™ 320 4000 2400

Carrefour™ 300 (a) 4000 (b) 2400(b)

Chillo™ 300 (a) 4000 (b) 2400(b)

Clever™ 320 300 2400(b)

Control™ 300 (a) 4000 (b) 2400(b)

Crazy horse™ 150 28 Not present

Dark dog™ 320 4000 Not present

Effect™ 320 4000 2400

Fireball™ 300 (a) 4000 (b) 2400(b)

Flying horse™ 300 (a) 4000 (b) 2400(b)

Full Throttle™ 288 2420 Not present

Green go™ 300 4000 Not present

Grizzly™ 300 (a) 4000 (b) 2400(b)

Hell™ 320 4000 (b) Not present

KX (Tesco)™ 300 4000 2400

Long Horn™ 320 Not present Not present

Mad bat™ 300 (a) 4000 (b) 2400(b)

Mixxed up™ 300 4000 (b) Not present

Mad croc™ 320 4000 240

Monster™ 307 4000 Not present

MX Maximim™ 300 (a) 4000 (b) 2400(b)

Nalu™ 320 Not present Not present

Natural Magic™ 300 (a) 4000 (b) 2400(b)

Power horse™ 320 4000 2000

Premium XO™ 300 (a) 4000 (b) Not present

Raw™ 300 (a) 4000 (b) 2400(b)

Real Power™ 300 (a) 4000 (b) 2400(b)

Red Bull™ 320 4000 2400

Red Devil™ 300 4000 Not present

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(mg/L)

Rhino's™ 120 4000 (b) 2400(b)

Rienergy Refresher™ 303 4000 2400

Rockstar™ 300 4000 Not present

Rodeo™ 320 4000 2400

Semtex™ 320 4000 Not present

Sexy Italia™ 300 (a) ₄₀₀₀(b) ₂₄₀₀(b)

Shark™ 350 4000 2400(b)

Tiger™ 320 4000 Not present

Tonino Lamborghini™ 320 4000 2400

V™ 310 2000 250

V Power™ 300 (a) 4000 (b) 2400(b)

V12™ 300 (a) 4000 (b) 2400(b)

White Tiger™ 320 Not present Not present

28 Black Acai™ 320 Not present Not present

Note: values highlighted by the light grey background were assumed, as no information on actual content could be retrieved. (a) assumed as equal to the value in König, 2011.

(b) assumed as equal to the modal value.

(1) Contents of relevant substances in different ED brands indicated as “other” by respondents in the questionnaire are provided in Appendix F.

Table 7: Content of active ingredients in different energy shots brands

(mg/L) size (ml)

Battery™ 1345 (a) 4000 b 2400(b) 63 (a)

Burn energy shot™ 1600 4000 1400 50

Dark Dog™ x10 Shot 1600 16000 Not present 63 (a)

Mad Croc energy shot™ 13300 (a) 4000 b 2400(b) 60 (a)

Monster Hitman Energy

Shot™ 880 2247 Not present 89

Red Bull energy shot™ 1333 6666 4000 60

Relentless energy shot™ 1600 (a) 4000 b 2400(b) 50 (a)

Rhino's energy shot™ 1345 (a) 4000 b 2400(b) 63 (a)

Rockstar energy shot™ 1345 (a) 4000 b 2400(b) 63 (a)

Shark energy shot™ 1070 4000 Not present 75

Tiger energy shot™ 1333 16670 Not present 60

Note: values highlighted by the light grey background were assumed, as no validated information on actual content could be retrieved.

(a) assumed as equal to the average of other energy shots indicated in the survey (b) assumed as equal to the modal value of occurrence in standard ED

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Calculation of the daily exposure to caffeine deriving from ED consumption was made through the following formula:

ED_caffeine_daily exposure = (ED_monthly volume * ED_caffeine_content) / 30 where:

ED_caffeine_daily exposure = daily exposure to caffeine deriving from ED consumption (mg)

ED_monthly volume = volume of ED consumed in a month (l), calculated by combining the number of cans consumed in an average month with the size of the cans

ED_caffeine_content = content of caffeine in ED (mg/l), weighted according to the brands consumed

2.3.4.2. Caffeine exposure from consumption of other food products and beverages

Caffeine exposure from consumption of other food products and beverages was calculated by combining data:

a. on consumption frequency (daily or weekly, according to the type of product concerned); b. on quantities consumed in a single occasion (taking into account container size or item weight,

whenever relevant);

c. on caffeine content of each product .

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Table 8: Caffeine occurrence in other food products and beverages: relevant parameters considered in the calculations

Type of product Container Size with caffeine

(mg/L or mg/kg)

decaffeinated (mg/L or mg/kg)

Espresso Coffee cup 0,03 l 1916 250

Coffee (instant, ground, ice coffee…) mug 0,24 l 400 10,7

Cappuccino cup 0,15 l 250 50

Tea (instant, tea bag, ice tea…) cup/glass 0,25 l 100 25

Hot chocolate cup 0,25 l 150

Chocolate bars* 0,10 kg 180

Dark chocolate 0,10 kg 340

Milk chocolate 0,10 kg 183

White chocolate 0,10 kg 0

Chocolate snacks (e.g. Mars, KitKata 0,05 kg 140

Dark chocolate 0,05 kg 264

Milk chocolate 0,05 kg 142

White chocolate 0,05 kg 0

Colas (e.g. Coca Cola, Pepsi) glass 0,25 l 79,2 0

(a)= whenever no distinction was made between dark, milk and white chocolate, values for generic chocolate products as featured in König J.) were used for calculations.

Sources:

König J., 2011., Final report: Assessment of caffeine intake in a representative sample of the Austrian population (age 14-39 years).

NZFSA - New Zealand Food Safety Authority (2010), Risk profile: caffeine in energy drinks and energy shots. Report prepared by the Institute of Environmental Science and Research Limited (ESR).

Food Safety Promotion Board (2002), A review of the health effects of stimulant drinks – Final Report, Safe Food, Cork, Ireland.

Web page on caffeine - University of Washington: http://faculty.washington.edu/chudler/caff.html Websites of individual producers.

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The general calculation method can be illustrated through an example referred to espresso coffee. Total consumed volume in a week was calculated through the formula:

tot_espresso_week = number of cups per day * content of a cup (l) * weekly consumption frequency Daily exposure was then calculated by applying the formula:

espresso_daily_exposure = (tot_espresso_week * caffeine content espresso mg/l) / 7

The above method was applied (mutatis mutandis) for the various types of coffee, tea and hot chocolate. In the case of chocolate bars, chocolate snacks and colas, no questions about daily consumption frequency were asked, as such products are not always consumed on a regular daily basis20. Daily exposure for such products was hence calculated ex-post, through the formulas:

tot_product_week = (product content or size in l or kg * weekly consumption volume) product_daily_exposure = (tot_product_week * product caffeine content mg/l or mg/kg) / 7

In these specific cases, consumption volumes of each item were associated to the respective content of caffeine, and consumption frequency (already specified in the question – not in the answer) was reclassified on a daily basis, thus obtaining the exposure to caffeine in mg/day for each specific food/beverage for each respondent.

2.3.4.3. Contribution of ED to total caffeine exposure

Total daily caffeine exposure was calculated as the sum of both daily exposure from ED consumption (§ 2.3.4.1) and daily exposure from consumption of all other food products and beverages (§ 2.3.4.2). Daily exposure from ED consumption was then referred to the above total, to express ED contribution to caffeine exposure as % of total daily exposure.

Forthe relative contribution of ED to the total exposure to active substances, the mean value presented in this analysis is calculated as a ratio between the mean exposure to the ingredient (e.g. caffeine) deriving from ED and the total exposure to the ingredient (e.g. caffeine), on the other.

2.3.4.4. Contribution of ED to total exposure to taurine and D-glucurono-y-lactone

The calculation of daily exposure to taurine and D-glucurono-y-lactone from ED consumption was carried out by applying the same method used for calculating daily exposure of caffeine from ED consumption for the three targets involved in the survey (§ 2.3.4.1).

On the contrary, lack of data on content of taurine and D-glucurono-y-lactone in specific food products and beverages (except for limited “spot” information) did not allow to apply the analytical method of calculation of daily exposure used for caffeine (§ 2.3.4.2). As a consequence, data on daily exposure to taurine and D-glucurono-y-lactone from consumption of other food products and beveragesother than ED were not possible to be included in analysis for adolescents and children.

20

For these specific items a weekly frequency has been used, also taking into account indications from the relevant literature references; the adoption of a week as the reference time frame also allowed to include in the analysis all respondents consuming less frequently than once a day.