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Truvia webinar final
- 1. Truvia ™ rebiana Zero-calorie sweetness from the stevia leaf Background briefing: history and safety assessment
- 5. From Green to White Steviol Glycosides Stevioside Rebaudioside A Others Rebiana The first fully characterised, highpurity form of rebaudioside A Other components Stevia rebaudiana Bertoni or “ stevia ”
- 10. Rebiana safety programme objective Demonstrate the safety of rebiana for consumption by all consumers , in all foods, for all eating occasions in all countries
- 16. Diabetes study: Glycosylated hemoglobin at baseline to weeks 4, 8, 12, 16 *P-values for the change from baseline are for the analysis of covariance with baseline value as the covariate. All values were ranked prior to analysis. Maki et al. (2008) Food and Chem Toxicol. 46:S47-S63 Glycosylated hemoglobin Rebaudioside A (n=60) Placebo (n=62) p-value* Mean ±SEM Baseline (%) 6.71 ± 0.11 6.70 ± 0.10 0.964 Week 4 Δ (%) 0.02 ± 0.03 0.02 ± 0.903 0.982 Week 8 Δ 0.11 ± 0.05 0.04 ± 0.04 0.574 Week 12 Δ 0.11 ± 0.05 0.07 ± 0.05 0.248 Week 16 Δ 0.11 ± 0.06 0.09 ± 0.05 0.355
- 19. Expert reviews - 2008 Food and Chemical Toxicology Published safety studies Joint FAO/WHO Expert Committee on Food Additives (JECFA) Comprehensively examined the safety data and set a permanent ADI GRAS (Generally Recognised As Safe) Independent Expert Panel Critically reviewed Truvia ™ rebiana database of studies Determined its safety for general purpose use as a sweetener Food and Drug Administration (FDA) Issued no-objection letter Rebiana affirmed as Generally Recognised as Safe (GRAS) Toxicology Forum Panel multi-stakeholder symposium Reviewed safety of rebaudioside A
- 20. Expert reviews - 2009/10 French Food Safety Agency AFSSA Assessed safety of rebaudioside A Temporary legal approval of ≥97% rebaudioside A for up to a maximum of 2 years, for use in certain food and beverages in France, published on 6 September 2009 First market in EU to approve European Food Safety Authority (EFSA) Reviewed safety of steviol glycosides, including rebaudioside A Expert panel’s Scientific Opinion officially published on 14 April 2010
- 25. For further information or to request Food and Chemical Toxicology reprints contact: Amy Boileau, Ph.D, R.D. Manager, Regulatory & Scientific Affairs Food Ingredients & Systems, Cargill [email_address] Truvia™ sweetener Zero-calorie sweetness from the stevia leaf
Hinweis der Redaktion
- To be introduced by moderator Vivienne Parry This week - on 14 April 2010 European Food Standards Authority published a positive Scientific Opinion on steviol glycosides Very important milestone in process towards European approval of stevia-based low calorie sweeteners, including Truvia™ sweetener, made by Cargill Truvia™ sweetener is the US brand leader in this new category of natural origin, plant-based sweeteners derived from the stevia leaf Purpose of this briefing is to provide an overview of the research and safety program which supports Truvia™ sweetener Introduce Dr * Amy Boileau, manager of Scientific and Regulatory Affairs at Cargill * Doctor not used in the US unless medical but important for European scientific audience. - While webinar taking place, you can submit questions to Amy at any time, and she will answer as many as we have time for at the end of her presentation. [ Just enter your question in the box provided on the right hand side of your screen – check]
- Over to Amy : welcome and thank you for joining us What I’m going to cover is The unique story of this unique plant – stevia –whose claim to fame is its natural sweetness Rebiana – the ingredient at the heart of this new category of stevia based sweeteners The wealth of scientific research that underpins it Numerous expert assessments of this safety by regulatory bodies – or bodies acting on behalf of regulators Finally = implications for consumers
- 21 st century is catching up with knowledge that’s been around for centuries among the peoples of South America
- Lots of different words, unfamiliar names – let’s start with the vocabulary, which can seem complicated Stevia – a plant whose botanical name is stevia rebaudiana … . and the word generally used to describe extracts of stevia plant
- NB amy to mention versatility across types of foods and drinks Vivienne – either intervene – or Q at the end “What kind of applications is Truvia rebiana suited for?
- OUR PROGRAM INCLUDED intake, metabolism, pharmacokinetics, safety and randomized, controlled, double-blind human studies. First, we had to understand consumer intake levels. We evaluated rebiana for average and high-usage consumers to set dose levels in our safety studies. Next we went to pharmacokinetics and metabolism study This was to confirm that rebiana and stevioside were handled the same way in the body Safety, reproductive and developmental studies were conducted at very high doses to look at any effects on organ systems or reproductive health. Clinical studies included: A four-week multi-center study evaluating the effect of rebiana on blood pressure in people with normal to low-normal blood pressure and A 16-week multi-center study assessing the impact of rebiana on blood sugar in people with type 2 diabetes.
- Mention why clinical studies focused on normal – low blood pressure, not those with high BP
- Commentary to point out – for those who forget their maths and what P value means – figures of 0.05 or less would be significant These figures show that in these blood pressure studies, when comparing the group ingesting rebaudioside A with the placebo group after 4 weeks, there were no figures of less than 005 We also looked at whether the results were clinically significant – and they weren’t. (you’ll be able to download these charts at your leisure later)
- It is clear from the results of the research that rebiana is safe for its intended use. Bringing together, assessing and documenting the basis for safety of high purity rebaudioside A was a critical milestone in the development of this zero-calorie sweetener derived from the stevia leaf. It was also transparent – publishing and sharing the findings Publication of this safety assessment, based on the comprehensive research accumulated to date, paved the way for the regulatory approval , and the long-awaited availability of rebiana in foods and beverages.
- Stick exactly to slide re France: but also stress significant first step for Europe
- EFSA’s ANS Panel stated that ADI would be exceeded at maximum proposed use levels for steviol glycosides For comparison, the ADI is equivalent to approximately 23 teaspoons of Truvia™ tabletop sweetener every day over the course of a lifetime Projected use levels were based on provisional industry estimates. In practice, maximum use limits in certain food and beverage categories may need to be adjusted before a final regulation is issued by the EU
- RHB’s draft of concluding comment.