New Research Reveals Sports Nutrition Benefits of L-Carnitine Resonate

Increasing the awareness of L-carnitine’s benefits among sporty millennials represents a significant untapped business opportunity for dietary supplement manufacturers. That’s the key take-away message from an exclusive online survey commissioned by the Switzerland-based company Lonza, which produces and markets the premium Carnipure® L-carnitine ingredient.

Independent researchers questioned 202 consumers in the United Kingdom, aged between 18 and 35, who exercise at least three times a week. They were questioned about their attitudes and behaviours regarding dietary supplement usage and, in particular, L-carnitine.

Researchers found that 39% of the consumers surveyed were current users of supplements containing L-carnitine, and that these respondents consumed L-carnitine predominantly for sports nutrition-related benefits such as exercise recovery, weight management, increased energy, muscle building and improved endurance. However, 52% of respondents stated they never used L-carnitine, with 81% of this group saying they had never heard of it. Nevertheless, once the benefits of L-carnitine were explained to them, 76% of non-users said they were now more likely to introduce it to their dietary supplement regime.

More details and analyses of the survey findings are contained in a new report published by Lonza called ‘Carnipure® L-Carnitine: Sports Nutrition for the Millennial Generation’.

Jeff Della Valle, Marketing Manager Nutrition and a co-author of the report, said: “Our market research highlights a unique new business opportunity among non-users of L-carnitine. After some aided awareness of the supplement’s benefits, these consumers were asked if they would be more likely to use it in future and, encouragingly, more than three quarters of them said they would. This finding means dietary supplement companies have an opportunity to tap into this goodwill towards L-carnitine with high-quality products backed by the trusted Carnipure® brand”.

Ilya Zhivkovich, Global Head of Marketing Lonza Nutrition, added: “We view millennials as a high priority target for sports nutrition supplements. These consumers are committed to optimizing their wellness through regular exercise and healthy eating. They value dietary supplements for the benefits they offer and tend to be discerning shoppers who seek out products that offer them the assurance of quality and efficacy”.

He continued: “In this context, L-carnitine has a great story to tell. It is effective, safe and – as demonstrated by the results of our consumer survey – offers valuable benefits that resonate with today’s millennial consumers. Dietary supplement manufacturers and marketers can leverage the strong positive feelings millennials have about L-carnitine and the benefits it provides”.

Schermata 2016-07-25 alle 10.27.50

da Nutrafoods 15(2) 2016

The health benefits of NUTRIOSE® soluble fibre

Two new health claims for NUTRIOSE® have just been published in the Official Journal of the European Union L 142/5. These confirm that NUTRIOSE® soluble fibre contributes to the maintenance of tooth mineralization by reducing tooth demineralization, and also by inducing lower postprandial glycaemic responses.

The two authorized claims pertain to non-fermentable carbohydrates (oral health) on the one hand and non-digestible carbohydrates (reduction of glycaemic response) on the other. Both effects are achieved by Nutriose® soluble fibre. The claims have been authorized in connection with Article 13(1) pertaining to generic claims applicable to all.

The health benefits are backed by the results of eight clinical studies conducted in four regions of the world. The quality and scientific rigour of the Roquette Group were acknowledged by experts on the Dietetic Products, Nutrition and Allergies panel of the European Food Safety Authority (EFSA) in August 2013 and October 2014, when they delivered a positive opinion on the two claim applications submitted in January 2013 and February 2014, respectively.

The two claims are:

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The consumption of foods/beverages containing “non-fermentable” carbohydrates (such as NUTRIOSE®) instead of “fermentable” carbohydrates may maintain tooth mineralization by decreasing tooth demineralization.

The consumption of foods/drinks in which non-digestible carbohydrates (such as NUTRIOSE®) replaced sugars induced lower post-prandial glycemic and insulinemic responses than sugar-containing foods/drinks.

NUTRIOSE® soluble fibre: a versatile ingredient 

The ingredient incorporates nutritional assets essential for food manufacturers. A non-viscous soluble fibre with a neutral taste, NUTRIOSE® is obtained from cereals (wheat and corn) and is classified as a food ingredient. It can be easily used to improve the nutritional profile of a wide range of foodstuffs. In addition, it offers outstanding digestive tolerance.

In accordance with Article 10(3) of European Regulation (EC) No 1924/2006, the health benefits of NUTRIOSE® soluble fibre can be indicated on end product packaging provided that it respects the usage conditions and includes the authorized health benefit claim.

For example, in the case of a biscuit with reduced sugars obtained with NUTRIOSE®, the package may indicate: ‘Reduced blood glucose impact’ provided that 30% of the sugars usually used in these biscuits are substituted with Nutriose®. At the same time, it must quote the official claim ‘Consumption of foods/drinks containing NUTRIOSE® instead of sugars induces a lower blood glucose rise after their consumption compared to sugar-containing foods/drinks’.

An international initiative 

This initiative confirms the Roquette Group’s willingness to raise awareness about the importance of the health benefits of its NUTRIOSE® soluble fibre for Europe and beyond. The benefits of the ingredient are already recognized in some areas of the world. In Canada, for example, NUTRIOSE® soluble fibre recently obtained the status of ‘dietary fibre’. In Korea, the Korean Food and Drug Administration (KFDA) has issued a favourable scientific opinion on the claim related to the prebiotic aspect of NUTRIOSE®.

Roquette adopts a proactive approach to the support, promotion and demonstration of its products’ health benefits. The Group’s priority is innovation in the service of customers and consumer health.

Schermata 2016-07-25 alle 10.27.34

Giellepi S.p.A.

Giellepi S.p.A. announces the start of activities at their new research centre, an ultramodern structure of over 1,500 square metres of pharmaceutical, technological and scientific research and development laboratories and offices.

In an increasingly competitive and global market, Giellepi proposes a strategic innovative approach to creating new raw materials and new formulations in the food supplements, medical devices and food for medical purposes field.

Giellepi’s research activity aims to increase knowledge of the active substances present in raw materials, their metabolic function, bioavailability and safety for use in food supplements.

Innovation related to more effective and safer raw materials translates into specific formulations which are evaluated in preclinical and clinical studies.

Giellepi’s Health Science Division is a point of reference for companies wishing to operate in the high quality health products market with effective and safe products supported by scientifically proven data.

The high scientific validity of Giellepi products is obtained with the use of modern production technologies thanks to important partnerships and an international network created over 20 years of activity in the sector.

Giellepi’s new headquarters will host the Health Science Academy, which consists of leading international companies, research institutes, universities and opinion leaders operating in the sector, with the aim of disseminating research results and encouraging a health improvement culture.

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Super growth for ‘super’ foods

Superfoods are frequently marketed as the answer to our health problems and now new research from Mintel has highlighted the popularity of these nutrient-packed foods. Mintel GNPD (Global New Products Database) reveals that between 2011 and 2015 there was a phenomenal 202% increase globally in the number of new food and drink products launched featuring the terms ‘superfood’, ‘superfruit’ or ‘supergrain’, with a 36% rise in 2015.

Schermata 2016-07-25 alle 10.19.10There seems to be no end to the popularity of these so-called wonder foods. In 2015, the USA played host to the most ‘super’ food and drink launches (30%), followed by Australia (10%), Germany (7%), the UK (6%) and Canada (6%) (Table 1).

The surge in launches comes as a result of strong consumer demand for highly nutritious products. Today, more than seven in 10 consumers in France (72%), Germany (71%), Italy (73%) and Spain (72%) agree that the health-promoting benefits of natural foods, for instance fruit and vegetables, are preferable to the added benefits of functional foods.

What is more, the research reveals that the superfood sensation has spread beyond food and drink. While 43% of products launched between 2011 and 2015 with the words ‘superfood’, ‘superfruit’ or ‘supergrain’ in the product description were in the food category, and 11% fell under the drink category, as many as three in 10 (30%) were found in beauty and personal care products, while 12% were in the health and hygiene category and 4% were in the pet category.

Stephanie Mattucci, Global Food Science Analyst at Mintel, said: “The popularity of ‘super’ products is clear as food and drink manufacturers globally are tapping into a demand for these nutritionally dense ingredients. But superfoods are not only limited to food and drink, they are regularly springing up in the beauty, health and hygiene and pet food aisles as a result of today’s consumers becoming much more aware of what they are putting into and onto their bodies”.

Schermata 2016-07-25 alle 10.19.29In particular, the trend towards a wheat-free diet has resulted in a growing number of products containing ancient ‘supergrains’. And while quinoa and buckwheat have become household names in recent years, chia has seen the biggest rise in usage. Between 2014 and 2015, there was a 70% increase in launches of food and drink products containing chia, while food and drink products containing teff rose by 31%. Meanwhile, the percentage of food and drink products containing quinoa rose by 27% (Fig. 1).

Stephanie continues: “Desire for healthier, less refined alternatives to wheat has fuelled the rediscovery of ancient grains. Flavourful and nutrient-dense ancient grains have begun to change the negative perception of some carbohydrates by leveraging their nutritional profile and rich heritage. Ancient grains offer an alternative to wheat but also come bundled with functional and nutritional components, and provide new flavours and textures. They are a great way for free-from products to talk about health”.

In conjunction with launch activity hype, there is strong consumer interest in ancient grains as 30% of UK pasta consumers say that pasta made with ancient grains, for instance quinoa, is healthier than regular pasta. What’s more, usage of these heritage grains is high, as two in five (41%) of US consumers have eaten ancient grain-based cereals.

According to Stephanie: “Whilst the number of products containing ancient grains have been rising, next we could see the popularity of sprouting ancient grains. The ancient, accidental process of sprouting, where whole grains are soaked and left to germinate has largely been eliminated by modern processing techniques. There has been a return to this ancient practice, with controlled ‘sprouting’ practices being introduced, as the nutritive advantage of sprouted grains is being recognised. The ancient grain quinoa is leading the comeback of sprouted grains”.

And while ancient grains have been in the spotlight over the past year, added attention has also been directed at pulses, with the UN announcing 2016 as the International Year of Pulses. Over the past 2 years, the percentage of food and drink products launched containing green split peas has grown by 126%, while that containing coral lentils has grown by 62% and that containing yellow split peas has increased by 21%.

As Stephanie says: “Pulses can be used to add a range of natural health benefits to food and drink products. Additionally, healthy pulses are staples in many ethnic cuisines, offering manufacturers a pathway for product innovation for convenience-seeking ethnic food explorers”.

Mintel research reveals that super seeds have also seen an upward trend in usage. Over the past 2 years, the percentage of food and drink products containing chia seeds has risen by 70%, while that containing pumpkin seeds has grown by 27% and that containing sunflower seeds has grown by 22%.

Stephanie adds: “Some seeds, including chia and pumpkin seeds, offer complete protein, with all nine essential amino acids in the correct ratios. However, a lot of protein from seeds is incomplete. Blending seeds can help improve the quality of protein”.

Going forward, it seems that turmeric known for its anti-inflammatory benefits and moringa, said to have beauty and anti-aging properties, could be the superfoods to watch.

Stephanie concludes: “Turmeric has potential as an ingredient in supplements and functional food and drink products, particularly within products aimed at the growing senior population. Additionally, moringa could be used in anti-ageing beauty food products. Whilst currently the ingredient is used in many beauty launches, the leaves are nutritional powerhouses”.

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da Nutrafoods 15(2) 2016

Food Supplements and the Public Health System:

The food supplements market in Italy is very important as 8 out of 10 people use supplements to maintain their well-being throughout a life that, on average, is becoming longer: according to a recent ISTAT study, Italy has the highest average age (44.4 years) of all European countries and the record for the proportion of over 65-year-olds (21.2%) and over-85-year-olds (3%). In addition, life expectancy has risen to 83 years for men and to 87 years for women (OECD report Health at a Glance 2015).

“At the same time”, says Alessandro Colombo, President of the AIIPA Food Supplements Group INTEGRATORI ITALIA, “despite these data the ‘expected years of good health’ at age 65 are 10 for men and 13 for women. At over 65, in fact, as emerged from the 2014 OSMED report by AIFA, the public health system pharmaceutical expenditure for every individual is six times the amount spent for those in the lower age categories”.

A 2013 study published in the United States by Frost & Sullivan calculated the possible reductions in serious economic and social costs that would result from the use of dietary supplements from 2013 to 2020 in a population over 55 years of age at risk of complications from chronic illness. It demonstrated that:

1. Omega 3, group B vitamins, phytosterols and plant fibres could drastically reduce repeated myocardial heart failure in individuals with coronary heart disease and create savings of between US$2.8 and 26.5 billion.

2. Supplementation with lutein and zeaxantin could save almost US$7.4 billion in a population with age-related eye disease.

3. Supplementation with calcium, vitamin D and magnesium could generate savings of between US$4.3 and US$8.6 billion in populations affected by osteoporosis.

More recently, research by Frost & Sullivan explored the benefits of consumption of omega 3 EPA+DHA food supplements in Europe among those aged 55 and over (157.6 million people or 31% of the total EU population). The study found that cost savings would be €64.5 billion over a 5-year period or €12.9 billion per annum (as there would be 1.5 million fewer CVD-attributed hospital events across the EU between 2013 and 2020).

“In France”, continues Colombo, “a 2015 study, published in PLOS ONE on the impact of the consumption of probiotics on the population estimated savings of €6.6 million in terms of fewer sick days due to respiratory infections, of €473,000 in probiotic treatments and of €1.5 million worth of sick days. In total, savings of up to €37.7 million were calculated for the public health system”.

These important numbers indicate how some supplements can help both improve the health of subjects at risk and also reduce the social and public health costs resulting from illness. It is for these reasons that INTEGRATORI ITALIA proposes to establish of a think tank and a private and public sector working group to discuss implementing a national intervention plan focused on healthy lifestyle choices and the consumption of supplements that have proven efficacy in populations at risk.

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da Nutrafoods 15(2) 2016

Omega 3 Food Supplements:

EFSA has increasingly recognized the importance of stakeholder engagement in the scientific risk assessment process. Just recently, on 16 March 2016, the Management Board adopted the EFSA Strategy 2020 document and discussed the development of a new approach to stakeholder engagement.

The EFSA Strategy 2020 document is the final outcome of a 2-year consultation between EFSA staff, led by the Executive Director Bernhard Url, and its Management Board. In addition to restating EFSA’s aim to foster international cooperation, the Strategy also sets out a series of principles to help improve stakeholder engagement over the next 5 years.

One of the key strategic and operational objectives outlined by EFSA in its Strategy is to strengthen trust in its stakeholders, and to prioritise public and stakeholder engagement in the process of scientific assessment.

What has been proposed?

The Implementation Plan, which is annexed to the Strategy, sets out that EFSA will launch a more inclusive and targeted approach to stakeholder engagement in 2016. A first draft outline on the structure and functioning of this new approach was considered by the EFSA Management Board at the management meeting on 16 March.

The current EFSA proposal, which is subject to further discussion by the Board, foresees the establishment of two permanent platforms, a larger accredited Stakeholder Platform Forum and a Stakeholder Bureau, the former to provide yearly strategic input to EFSA’s work plans and the latter to act as an adviser on stakeholder engagement.

In addition, similar to the stakeholder model of the European Chemicals Agency (ECHA), EFSA foresees the establishment of smaller targeted platforms to engage with EFSA at the more specialised technical levels, such as mandate working groups, scientific colloquia, discussion groups, roundtables, communicators’ labs and information sessions. Since the EFSA Management Board felt at its meeting on 16 March that the currently proposed model required further elaboration, EFSA is now in the process of presenting a revised proposal to the Board. The final stakeholder engagement model, to be presented to the Board for adoption during course of this year, is therefore expected to include considerable changes.

Next steps?

After an impact assessment study on a priority list of stakeholder engagement measures (from the so-called EFSA ‘TERA project’) due in May 2016, the EFSA Management Board may in June 2016 decide upon the first measures for implementation. It remains to be seen how these will work out in practice, but the steps as currently suggested by EFSA’s Executive Director and Management Board are likely to bring additional value to stakeholder engagement in the current EFSA risk assessment process.

In order to better understand the potential value of food supplementation to society, Food Supplements Europe (FSE) has commissioned economic consultants to evaluate the potential healthcare cost savings that could be derived from supplement intake in the European Union.

In April 2016, Christopher Shanahan (Frost & Sullivan) published a report on Healthcare Cost Savings of Omega 3 Food Supplements in the European Union that is freely available for download on the FSE website (www.foodsupplementseurope.org).

The objective of Healthcare Cost Savings of Omega 3 Food Supplements in the European Union is to explore if cost savings could be realised, in the form of avoided healthcare-related expenditures, from the use of an omega 3 EPA+DHA supplement. This report examines the body of clinical research examining the hypothesis that the use of omega 3 EPA+DHA supplements can potentially reduce cardiovascular disease (CVD)-attributed hospital utilisation costs in the European Union among those at high risk of experiencing a costly, CVD-attributed event.

A total of 38.4 million CVD-attributed hospital events occurring in 24% of the target population are expected over the next 5 years (2016–2020) among adults age 55 and older in the EU. The total cost of addressing CVD in the EU will be €1,328 billion over the next 5 years, or €34,637 per event over the same period.

Study Methods

A random-effects systematic review approach was used to determine the effect of using an omega 3 food supplement on the occurrence of a CVD-attributed medical event. A literature search was conducted and 18 randomised controlled trials (RCT) were identified that examined the association between omega 3 EPA+DHA use and the occurrence of a CVD event. The study’s findings were aggregated and the expected relative risk reduction was determined and then used as an input into a theoretical economic scenario model which determined the difference in benefits and costs EU healthcare policy makers can expect if everybody in a targeted population with high CVD risk consumed a daily omega 3 supplement. The result of this theoretical economic analysis provides insight into potential healthcare cost savings per capita and per EU country that could be realised through the targeted use of omega 3 EPA+DHA food supplements.

The relative risk of an individual in the target population experiencing a CVD-attributed adverse event is reduced by 4.9% given daily use of 1,000 mg of omega 3 EPA+DHA food supplements. This corresponds to over 1.5 million avoided CVD-attributed hospital events throughout the EU over the next 5 years.

Economic Findings (for the entire EU)

It is expected that 20% of the target population in the EU today is already taking omega 3 and realizing some of its potential health benefits. Table 1 summarizes the total potential economic benefits that could be realised if 100% of the EU target population took 1,000 mg omega 3 EPA+DHA food supplements daily.

Conclusion

This analysis shows that significant healthcare cost savings could be realised through a concerted effort to identify high CVD-risk populations and motivate them to use omega 3 EPA+DHA supplements. Because a significant portion of benefits is in the form of saved consumer expenditures related to informal post-event CVD management costs such as home nursing, medical equipment for home use and lost productivity, a significant portion of economic benefits would be conferred to the final consumer of omega 3. However, avoided CVD-event costs also have derived benefits for other stakeholders, such as gained tax revenue from saved productivity, which is a benefit to the government, and from lower treatment costs incurred by both public and private healthcare payers such as private insurance companies. Overall, this health-to-wealth assessment can be used by all stakeholders including consumers, healthcare providers, employers and policymakers as a way to better quantify the benefits of using omega 3 food supplements. Understanding this link will help key stakeholders-potential omega 3 supplement users, healthcare providers, governments, private insurance companies and employers-make recommendations about the best course of action to help minimise current and future costs and maximise benefits.

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da Nutrafoods 15(2) 2016

EFSA Strategy 2020:

EFSA has increasingly recognized the importance of stakeholder engagement in the scientific risk assessment process. Just recently, on 16 March 2016, the Management Board adopted the EFSA Strategy 2020 document and discussed the development of a new approach to stakeholder engagement.

The EFSA Strategy 2020 document is the final outcome of a 2-year consultation between EFSA staff, led by the Executive Director Bernhard Url, and its Management Board. In addition to restating EFSA’s aim to foster international cooperation, the Strategy also sets out a series of principles to help improve stakeholder engagement over the next 5 years.

One of the key strategic and operational objectives outlined by EFSA in its Strategy is to strengthen trust in its stakeholders, and to prioritise public and stakeholder engagement in the process of scientific assessment.

What has been proposed?

The Implementation Plan, which is annexed to the Strategy, sets out that EFSA will launch a more inclusive and targeted approach to stakeholder engagement in 2016. A first draft outline on the structure and functioning of this new approach was considered by the EFSA Management Board at the management meeting on 16 March.

The current EFSA proposal, which is subject to further discussion by the Board, foresees the establishment of two permanent platforms, a larger accredited Stakeholder Platform Forum and a Stakeholder Bureau, the former to provide yearly strategic input to EFSA’s work plans and the latter to act as an adviser on stakeholder engagement.

In addition, similar to the stakeholder model of the European Chemicals Agency (ECHA), EFSA foresees the establishment of smaller targeted platforms to engage with EFSA at the more specialised technical levels, such as mandate working groups, scientific colloquia, discussion groups, roundtables, communicators’ labs and information sessions. Since the EFSA Management Board felt at its meeting on 16 March that the currently proposed model required further elaboration, EFSA is now in the process of presenting a revised proposal to the Board. The final stakeholder engagement model, to be presented to the Board for adoption during course of this year, is therefore expected to include considerable changes.

Next steps?

After an impact assessment study on a priority list of stakeholder engagement measures (from the so-called EFSA ‘TERA project’) due in May 2016, the EFSA Management Board may in June 2016 decide upon the first measures for implementation. It remains to be seen how these will work out in practice, but the steps as currently suggested by EFSA’s Executive Director and Management Board are likely to bring additional value to stakeholder engagement in the current EFSA risk assessment process.

In order to better understand the potential value of food supplementation to society, Food Supplements Europe (FSE) has commissioned economic consultants to evaluate the potential healthcare cost savings that could be derived from supplement intake in the European Union.

In April 2016, Christopher Shanahan (Frost & Sullivan) published a report on Healthcare Cost Savings of Omega 3 Food Supplements in the European Union that is freely available for download on the FSE website (www.foodsupplementseurope.org).

The objective of Healthcare Cost Savings of Omega 3 Food Supplements in the European Union is to explore if cost savings could be realised, in the form of avoided healthcare-related expenditures, from the use of an omega 3 EPA+DHA supplement. This report examines the body of clinical research examining the hypothesis that the use of omega 3 EPA+DHA supplements can potentially reduce cardiovascular disease (CVD)-attributed hospital utilisation costs in the European Union among those at high risk of experiencing a costly, CVD-attributed event.

A total of 38.4 million CVD-attributed hospital events occurring in 24% of the target population are expected over the next 5 years (2016–2020) among adults age 55 and older in the EU. The total cost of addressing CVD in the EU will be €1,328 billion over the next 5 years, or €34,637 per event over the same period.

Study Methods

A random-effects systematic review approach was used to determine the effect of using an omega 3 food supplement on the occurrence of a CVD-attributed medical event. A literature search was conducted and 18 randomised controlled trials (RCT) were identified that examined the association between omega 3 EPA+DHA use and the occurrence of a CVD event. The study’s findings were aggregated and the expected relative risk reduction was determined and then used as an input into a theoretical economic scenario model which determined the difference in benefits and costs EU healthcare policy makers can expect if everybody in a targeted population with high CVD risk consumed a daily omega 3 supplement. The result of this theoretical economic analysis provides insight into potential healthcare cost savings per capita and per EU country that could be realised through the targeted use of omega 3 EPA+DHA food supplements.

The relative risk of an individual in the target population experiencing a CVD-attributed adverse event is reduced by 4.9% given daily use of 1,000 mg of omega 3 EPA+DHA food supplements. This corresponds to over 1.5 million avoided CVD-attributed hospital events throughout the EU over the next 5 years.

Economic Findings (for the entire EU)

It is expected that 20% of the target population in the EU today is already taking omega 3 and realizing some of its potential health benefits. Table 1 summarizes the total potential economic benefits that could be realised if 100% of the EU target population took 1,000 mg omega 3 EPA+DHA food supplements daily.

Conclusion

This analysis shows that significant healthcare cost savings could be realised through a concerted effort to identify high CVD-risk populations and motivate them to use omega 3 EPA+DHA supplements. Because a significant portion of benefits is in the form of saved consumer expenditures related to informal post-event CVD management costs such as home nursing, medical equipment for home use and lost productivity, a significant portion of economic benefits would be conferred to the final consumer of omega 3. However, avoided CVD-event costs also have derived benefits for other stakeholders, such as gained tax revenue from saved productivity, which is a benefit to the government, and from lower treatment costs incurred by both public and private healthcare payers such as private insurance companies. Overall, this health-to-wealth assessment can be used by all stakeholders including consumers, healthcare providers, employers and policymakers as a way to better quantify the benefits of using omega 3 food supplements. Understanding this link will help key stakeholders-potential omega 3 supplement users, healthcare providers, governments, private insurance companies and employers-make recommendations about the best course of action to help minimise current and future costs and maximise benefits.

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da Nutrafoods 15(2) 2016

Creatine:

Creatine overview: description, uses and current regulatory status

Creatine is a well-characterized food ingredient described by the European Food Safety Authority (EFSA) as a ‘non-essential nitrogenous organic acid that occurs in vertebrates and that is also synthesised in the human body from L-arginine, glycine and L-methionine. Approximately 95% of the creatine pool in the body is located in skeletal muscle’. Because of these features, creatine is a key ingredient for food supplement formulations targeted at sportspeople. From a regulatory viewpoint it is permitted as a food ingredient throughout the EU, even if its use is not fully harmonized. Indeed, the maximum permitted daily intake varies among different Member States (e.g., in Italy up to 6 g is permitted for sportspeople).

In addition, the permitted chemical forms should be evaluated because their novel food status may not have been clarified. Creatine monohydrate is the primary source of creatine and is well characterized; creatine citrate and pyruvate are formally permitted as food supplement ingredients (see the EC Novel Food catalogue); however, the novel food status of other sources (e.g., malate, AKG, etc.) is less clear.

Finally, a health claim that creatine consumption increases physical performance during short-term, high intensity, repeated exercise bouts has already been favourably assessed by the EFSA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies, 2011) and is authorised under Reg. 432/2012. This claim can be used only for food which provides a daily intake of 3 g of creatine (which is also the amount needed to obtain the beneficial effect) and for foods targeting adults performing high intensity exercise.

EFSA opinions

If creatine is used in food or food supplements, it is subject to EU food law. Any health claim on such products needs to be authorised following a scientific opinion issued by the EFSA.

In 2016 the Austrian company AlzChem AG submitted an application for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No. 1924/2006 via the Competent Authority of Austria. The EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to creatine in combination with resistance training and improvement in muscle strength [1].

According to the applicant, the most common form of creatine marketed is creatine monohydrate and it identifies the following as a health claim to be evaluated: ‘creatine contributes to the maintenance of muscle function in the elderly’. Muscle function can be assessed via different physical exercises. According to the applicant, creatine also helps to prevent physiological age-related loss of muscle mass. The mechanism by which creatine exerts the claimed effect is well documented and involves the role of creatine in muscle energy homeostasis (via the creatine kinase/creatine phosphate [CK/CrP] system with regeneration of ATP). In addition, creatine supplementation may be able to support muscle hypertrophy through several molecular mechanisms (e.g., cell swelling, alteration of the expression of myogenic transcription factors, increased satellite cell mitotic activity, and improvement in the CrP/ATP energy ratio of cells). The target population proposed by the applicant was older people over 55 years of age of both sexes who are physically active (they should engage regularly in low and moderate intensity exercise including muscle strengthening activities). Finally, the applicant proposed 3 g as a daily dose.

The EFSA Panel evaluated the claim proposed taking into account the approach established in the general guidance for stakeholders on the evaluation of Article 13.1, 13.5 and 14 health claims and the scientific requirements for health claims related to physical performance outlined in the specific EFSA guidance.

The Panel considered creatine a sufficiently characterized food ingredient and asked the applicant to provide clarification regarding the target and the claimed effect. Once this clarification was received, EFSA determined that the claim was to refer to muscle strength, which is a specific aspect of muscle function, and that muscle strength is a beneficial physiological effect. In addition, the Panel considered that 1-RM and isometric strength tests proposed by the applicant were appropriate to assess muscle strength in human studies. On the other hand, outcome variables related to motor functional performance and body composition were not considered direct measures of muscle strength. Ten human studies investigating the effect of creatine in combination with resistance training on muscle strength have been considered by the EFSA NDA Panel: in six of them creatine was given daily throughout the intervention period. In the remaining four studies creatine was administered only on training days (three times per week).

According to the Panel, the human studies submitted provide evidence for an effect of creatine, consumed at doses of at least 3 g/day in combination with regular resistance training (three times per week for several weeks) of moderate intensity, on muscle strength in adults over the age of 55. Therefore, the Panel confirmed the existence of a cause and effect relationship between the consumption of creatine in combination with resistance training and improvement in muscle strength.

The Panel established that the wording reflecting the scientific evidence is as follows: ‘daily creatine consumption can enhance the effect of resistance training on muscle strength in adults over the age of 55’.

Regarding conditions and restrictions of use, the Panel stated that ‘in order to obtain the claimed effect, 3 g of creatine should be consumed daily in conjunction with a resistance training which allows an increase in the workload overtime. Resistance training should be performed at least three times per week for several weeks, at an intensity of at least 65–75% of one repetition maximum. The target population is adults over the age of 55, who are engaged in regular resistance training’.

Authorization

A positive scientific opinion from the EFSA NDA Panel is the first step in obtaining an authorization for a health claim, but a specific EC Regulation is still required. That specific EC Regulation will also establish conditions and restrictions for use of the claim, taking into account the EFSA opinion. Currently the health claim is at working group stage. If authorized with the specific regulation, the EU Regulation 432/2012 will be updated with the addition of the new health claim.

References

1. Panel on Dietetic Products, Nutrition and Allergies (2016) Creatine in combination with resistance training and improvement in muscle strength: evaluation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006. EFSA J 14:4400

da Nutrafoods 15(2) 2016

Probiota 2016

NutraIngredients’ Probiota, the leading annual event for the global prebiotic, probiotic and microbiota food and pharma industries, was held in February 2016 in Amsterdam. Leading experts presented the latest scientific, technical and market insights, and business and academic leaders from around the world came together to discuss innovation and growth in today’s market.

Yolanda Sanz, a member of the Dietetic Products, Nutrition and Allergies (NDA) Panel at EFSA delivered an interesting presentation. Since Regulation (EC) No 1924/2006 entered into force, the NDA Panel has evaluated over 570 scientific opinions related to health claims in this area, including all Article 13.1 claims (except for those put on hold by the European Commission) and additional applications submitted pursuant to Articles 13.5 and 14. In the context of disease risk reduction, Yolanda Sanz explained why claims needed to establish an independent association between the risk factor and an increased risk of infection: “Regarding the risk reduction claims, what I can tell you is the applications we have received so far refer to the reduced incidences of infection … None of them have been positive and this may be due to the difficulties you find in identifying and assessing risk factors.”

Dr Sanz discussed the scientific evidence submitted to EFSA, arguing that there had to be clear evidence of a biological basis through which the risk factor contributed to the infection. Submitted evidence would need to show modification of this risk factor. As an example, she mentioned the health claims made to satisfy Article 13.5 (newly developed scientific data/proprietary data) and Article 14 (reduction of disease risk and children’s development and health). Of the 155 applications related to this area till July 2015, 58 applications were subsequently published or adopted. The rest were rejected or withdrawn.

Dr Sanz also discussed recent efforts made by EFSA to improve  the dialogue by the different stakeholders of guidance on gut immune pathogen claims.

With the industry heavily represented at the event, the lack of clarity on the approvals process became a major sticking point, with many believing that changes to the assessment process were a prerequisite to gain a clear understanding of the scientific requirements needed to obtain approval.

When questioned on the potential ‘billion dollar’ negative impact of not allowing the use of the term ‘probiotic’ to describe foods, Dr Sanz replied: “From the industry point of view, I understand the position. But this is an issue that EFSA plays no part in. From a scientific point of view, I think we should be able to have claims in the field and we should in the future be able to generate evidence that support claims.”

On the back of a large number of rejected health claims, food and drink manufacturers are now looking to seek a nutrition claim where, for example, the probiotic bacterial strain could be used as a generic descriptor. This led to the question of whether probiotics should have their own form of regulation where a proven effect in treating diseases was demonstrated but was not used as a medicine. Dr Sanz commented: “In this case you could take another route and instead of applying for health claims, you could also try to apply for uses in the medical area … With medical foods the context is completely different because you have to submit a notification demonstrating that there is an advantage from a nutritional point of view for this disease or disorder … I can’t see how probiotics can go down this route, but the pharmacological route is a possibility.”

Dr Sanz concluded by commenting on EFSA’s position on the ongoing discussing concerning pre-submissions and discussions of health claims. She was also asked whether the updates would make it easier for EFSA to reduce the failure rate of applications in the future: “The process will be easier for both sides. But the point is the resources EFSA has at its disposal to carry out these tests. We have to take into account the number of countries within the European Union and the number of pre-submissions we receive.”

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da Nutrafoods 15(2) 2016

‘Sabinsa on Wheels’ science summit

Sabinsa Europe GmbH hosted Sabinsa on Wheels, a day‐long science summit on Zugspitze, the highest mountain in Germany, on Wednesday 16 March 2016. In addition to describing the latest clinical studies on Sabinsa’s proprietary dietary supplement ingredients for the popular health and cosmetic sectors, industry experts offered their perspectives on timely industry subjects. The sessions drew 40 R&D experts from throughout Europe. This event, the latest of Sabinsa’s renowned scientific retreats, marked the 10th anniversary of Sabinsa Europe GmbH. Guest speakers and topics included: Jorg Grunwald, Analyze & Realize, Berlin, discussing new ideas for foods and supplements based on plant extracts; and Cedric Bourges, Nutraveris, France, who presented ‘Regulatory Landscape for Food Supplements in Europe: Basis and Evolution in This Complex but Necessary Area’. Speakers from Sabinsa, presenting topics ranging from curcumin research to probiotic stability, inflammation and cosmetic ingredients, included: Nagabhushanam Kalyanam, PhD, President of R&D, Sabinsa; Ajax Mohammed, Vice President, Sabinsa Europe; and Umar Jan, Technical Sales Manager, Sabinsa Europe. “The Sabinsa on Wheels program presented a unique opportunity to give our customers in-depth information in person about the science supporting Sabinsa’s ingredients and technologies, and we were pleased to see such good attendance”, said Ajax Mohammed. “We very much appreciated our esteemed special guest speakers sharing their insights.” The night before the retreat, attendees stayed at the Eibsee Hotel in Grainau, close to the ancient towns of Garmisch-Partenkirchen, and took a cable car to Zugspitze for the meeting. The Zugspitze is the highest mountain in Germany, home to three glaciers and Germany’s highest ski resort. Right at the top, an impressive 360° panorama provides extensive views over 400 mountain peaks in four countries.

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da Nutrafoods 15(2) 2016