Maria Teresa Scardigli Executive Director International Stevia Council. Stevia 2012 Conference 12 April 2012, London - UK

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Maria Teresa Scardigli Executive Director International Stevia Council Stevia 2012 Conference 12 April 2012, London - UK

Focus of Session 1. Understanding the basics of stevia regulation in European F&B: communicating the use of stevia to consumers 2. Establishing robust testing practices: the Proficiency Testing Programme for steviol glycosides

What is the International Stevia Council Global trade association Represents the interests of companies that process, and/or manufacture and market stevia sweetener products Created in October 2010 with a Global Office in Brussels Vision: To be the authoritative voice for the stevia industry in promoting the use of naturally-sourced stevia sweetener products that can improve the diets and health of people globally by addressing sugars and calories in food

ISC Current Members 11 companies:

1. Understanding the basics of stevia regulation in European F&B: communicating the use of stevia to consumers

European Approval of steviol glycosides Regulation on steviol glycosides adopted by European Commission on 11 November 2011 Published in the Official Journal of the European Union on 12 November: http://eurlex.europa.eu/lexuriserv/lexuriserv.do?uri=oj:l:2011:295:020 5:01:EN:HTML Stevia sweetened products have been on the EU market since 2 December 2011 Specifications on steviol glycosides adopted by the European Commission on 9 March 2012 Published in the Official Journal of the European Union on 22 March (page 270): http://eurlex.europa.eu/johtml.do?uri=oj:l:2012:083:som:en:html

Review of Steps 1. European Food Safety Authority (EFSA) issues a positive safety opinion on 14 April 2010 2. EFSA establishes the Acceptable Daily Intake (ADI) of 4 mg/kg bw/day 3. EFSA expresses a concern that at the maximum use levels the ADI could potentially be exceeded 4. The applicants of records two of whom are members of the ISC submitted revised use levels

Review of Steps 5. Differences in the intake assessment methodology: main reason why some of the use levels adopted in the EU for some food categories are lower 6. European Commission and Standing Committee on the Food Chain and Animal Health adopt the revised use levels and the specifications on 4 July 2011 7. Regulation went through the new comitology procedure with scrutiny of the European Parliament and Council 8. Final adoption of the regulation on food categories and use levels on 11 November 2011 and of the regulation on the specifications on 9 March 2012

EU Requirements Steviol glycosides can only be used on the food categories authorized by the Regulation and only if the final product is energy reduced and/or with no added sugar

EU Requirements Review of food categories approved at EU level: Flavoured fermented milk products including heat treated products Edible ices Fruit and vegetables in vinegar, oil, or brine Fruit and vegetable preparations excluding compote Extra jam and extra jelly Jam, jellies and marmalades and sweetened chestnut puree Other similar fruit or vegetable spreads Cocoa and Chocolate products Other confectionery including breath refreshing microsweets Chewing gum Decorations, coatings and fillings, except fruit based fillings covered by category 4.2.4 Breakfast cereals Fine bakery wares Processed fish and fishery products including molluscs and crustaceans Table Top Sweeteners in liquid form, powder form and in tablets Soups and broths Sauces Dietary foods for special medical purposes Dietary foods for weight control diets intended to replace total daily food intake or an individual meal (the whole or part of the total daily diet) Fruit nectars and vegetable nectars and similar products Flavoured drinks Beer and malt beverages Other alcoholic drinks including spirits with less than 15 % of alcohol and mixtures of alcoholic drinks with non-alcoholic drinks Potato-, cereal-, flour- or starch-based snacks Processed nuts Desserts excluding products covered in category 1, 3 and 4 Food supplements supplied in a solid form including capsules and tablets and similar forms, in a liquid form, in a syrup-type or chewable form

EU Requirements EU Commission foresees post-market monitoring EU Member States to report on exposure levels for all food additives including steviol glycosides EU Commission to ask manufacturers of products with steviol glycosides to provide information Results of the post-market monitoring likely to be expected around mid to end of 2014 If necessary, Commission will ask EFSA to perform a new refined exposure assessment

EU Requirements Regulatory process to increase the current use levels & to add new food categories to the actual list of approved food categories same process as the common authorization procedure the one steviol glycosides went through for the first ever approval only difference: process should be shorter since EFSA s assessment should take less than 6 months hopefully EFSA will be using a new and more representative methodology for intake assessments which is currently under development

EU Specifications 10 steviol glycosides (SGs) approved in Europe Products must have not less than 95% of the 10 SGs and at least 75% of Stevioside and/or Rebaudioside A Clear description of the extraction process of steviol glycosides in two main phases

EU labelling New sweetener s official name: steviol glycosides Ingredients list: either as sweetener: steviol glycosides or as sweetener: E 960 Packaging & advertising/marketing: ISC is considering the possibility to utilize on a voluntary basis terms such as with stevia, with stevia extract, with stevia extracts contained in the stevia plant, with sweeteners from the stevia plant, sweetness from a natural source or other similar sentences

EU labelling Term natural has no single harmonized definition at EU level and varies from country to country In some markets, there are very precise and qualified requirements around the term natural in the EU, milk is not allowed to carry a natural claim Research conducted by members of ISC demonstrate: global demand for calorie-free sweetness from a plant source full understanding that an extraction process is necessary to take place in order to release the sweetness of the stevia plant. The involvement of an extraction process does not impact consumer perception or acceptance of stevia extracts as natural nor do limitations on the term affect successful commercial product launches with stevia sweeteners

2. Establishing robust testing practices: the Proficiency Testing Programme for steviol glycosides

What is the Proficiency Testing Program (PTP)? PTP is a scheme to specifically measure the steviol glycoside content Aim: To allow participants to benchmark performance of their methods, analytical standards and analysts competency in a statistically relevant, blind testing scheme managed in accordance with international quality standards Outcome: To ensure analytical methods and standards employed throughout the industry are appropriate and meet minimum levels of accuracy when measuring steviol glycoside content

What is the Proficiency Testing Program (PTP)? Proficiency Testing Program for steviol glycosides helps stevia producers and the food industry continually improve methods of analysis for stevia extracts. PTP provides food and beverage manufacturers an important tool in their due diligence efforts in ensuring that they are procuring stevia extracts that meet the legal requirements for use in food. Participation in the PTP is compulsory for ISC members, demonstrating that ISC members are committed to the highest standards for the international stevia industry.

How is the PTP structured? Sustainable: Number of participants ensures it is statistically valid Independent Technical advice for participants built in to the system High Quality: Solid program support structure for participants Stable and consistent scheme materials Participant confidentiality maintained throughout scheme Recognised program standards: ISC works with a vendor - LGC Standards ltd - to administer the PTP

Who should participate? The PTP is open to any laboratory First year participants were 16 representatives from industry and regulatory agencies of which 5 are not members of the ISC Typical participants: stevia extract producers, food and beverage companies, leading safety authorities, universities and test laboratories that analyse stevia extracts Each round lasts one year and requires quarterly testing submissions: Participants requested to commit to a minimum full year of PT rounds (4 tests) to ensure creation of trend analyses Year 1 May 2011 - Feb 2012 Year 2 May 2012 - Feb 2013

First year of PTP Results: Satisfactory results of the first year tests First trends already analyzed Improvements have been identified in the course of the year and feedback from participants of first year PTP is currently been sought Final results from first year and improvements to be implemented in the second year of PTP to be discussed and agreed mid April between ISC, LGC and the Technical Advisor

Second year of PTP The schedules of the 2012-2013 PTP rounds are as follows (dispatch date of the samples):

Conclusions EU approval is a major step forward for the stevia industry: The European market is now open to stevia sweetened products The consumers are provided with an additional choice to sweeten their foods and beverages with calorie-free and new sweetener of a natural origin, stevia International Stevia Council will continue to work towards being recognized as the trusted resource center and knowledge partner for scientific and factual information on stevia

For more information visit www.internationalsteviacouncil.org

For more information contact: Executive Director: Ms Maria Teresa Scardigli, Tel: + 32 2 761 26 51 E-mail: GlobalOffice@InterntionalSteviaCouncil.org