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  1. #1
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    Wink stevia to be approved and cyclamates limited by Food Standards Australia New Zealand

    stevia to be approved and cyclamates limited by Food Standards Australia New Zealand: JMC Geuns critiques of two recent stevia studies by Nunes: Murray 2007.05.29
    http://groups.yahoo.com/group/aspartameNMmessage/1437

    http://www.foodstandards.gov.au/news...s2007/23may20\
    07fsanzmullsc3567.cfm

    FSANZ mulls changes to food laws

    Food Standards Australia New Zealand (FSANZ) today invited comment
    on proposed changes to the Australia New Zealand Food Standards Code –
    regulations that apply to all food sold in Australia and New Zealand.

    Among the changes being contemplated are the deletion of two antibiotics from the Code,
    the use of steviol glycosides and cyclamates as sugar substitutes,
    a genetically modified corn variety and a food additive for wine.

    FSANZ is inviting comment from the general public, the food industry, health
    professionals and government agencies on the proposed changes to the Code.
    FSANZ summarises all submissions in a final report and explains what action, if
    any, it has taken in response to issues raised in submissions.

    Steviol glycosides as intense sweeteners (Application A540 – Draft Assessment)

    The Plant Sciences Group of Central Queensland University and Australian Stevia Mills Pty Ltd have applied for the Code to be amended to allow the use of steviol glycosides as an intense sweetener for a wide variety of foods.
    Steviol glycosides extracted from the herbStevia rebaudianaare 250-300 times sweeter than sucrose.
    We have estimated the dietary exposure of consumers at the maximum levels
    proposed by the applicant and have concluded that there are no public health and safety concerns.
    Comment is invited.

    Review of cyclamate permissions (Proposal P287 – Draft Assessment)

    A FSANZ-commissioned survey in 2004 on the consumption of intense sweeteners in Australia and New Zealand concluded that the estimated dietary exposure of some consumers of cyclamate products for retail sale exceeded the acceptable daily intake (ADI) for cyclamate.
    The major contributors to estimated dietary cylcamate exposures were water-based flavoured drinks (eg. soft drinks, cordials).
    We are therefore intending to reduce the maximum permitted level for cyclamates in water-based flavoured drinks and to allow the use of cyclamates in tabletop sweeteners.
    We believe these measures will protect the public health and safety of
    consumers.
    We invite comment from all interested parties.

    Submissions: FSANZ welcomes public comment from industry, public health
    professionals, government agencies and consumers.
    Details of all the assessments above can be found on Food Standards Australia New Zealand .
    Submissions close on 4 July 2007 .

    Media contact: Lydia Buchtmann 0401 714 265 (Australia) or +61 401 714 265 (from New Zealand)

    [ See later in this post for extracts from 89page review. ]

    Food Standards Australia New Zealand

    Food Standards Australia New Zealand FSANZ

    Australia:
    Boeing House 55 Blackall Street BARTON ACT 2600
    Ph: +61 2 6271 2222 Fax: +61 2 6271 2278
    Reception: reception@foodstandards.gov.au
    PO Box 7186 Canberra BC ACT 2610 Australia

    Information/Publications Officer: info@foodstandards.gov.au
    For: Copies of publications, fact sheets and brochures;
    Website enquiries;
    Consumer enquiries.

    Standards Management Officer: slo@foodstandards.gov.au
    for: making an application;
    progress with the assessment of applications or proposals or completed
    applications;
    making submissions on applications and proposals which have been released for public comment;
    Gazettal of amendments to the Code.

    New Zealand:
    Level 6 108 The Terrace WELLINGTON NEW ZEALAND
    Ph: +64 4 473 9942 Fax: +64 4 473 9855
    PO Box 10559 The Terrace, Wellington 6036 New Zealand
    email: info@foodstandards.govt.nz

    http://www.foodstandards.gov.au/stan...iona540stevi3\
    096.cfm

    Application A540 - Stevol Glycosides as Intense Sweeteners

    Draft Assessment Report - 23 May 2007 [ word | pdf 584 kb ]

    Inital / Draft Assessment Report 7 December 2005 [ word | pdf 187 kb ]

    http://www.foodstandards.gov.au/_src..._DAR_FINAL.pdf 89
    pages

    pag1 3-07
    23 May 2007
    DRAFT ASSESSMENT REPORT
    APPLICATION A540
    STEVIOL GLYCOSIDES AS INTENSE SWEETENERS
    DEADLINE FOR PUBLIC SUBMISSIONS: 6pm (Canberra time) 4 July 2007
    SUBMISSIONS RECEIVED AFTER THIS DEADLINE WILL NOT BE CONSIDERED
    (See ‘Invitation for Public Submissions’ for details)
    For Information on matters relating to this Assessment Report or the assessment process generally, please refer to Food Standards Australia New Zealand: Standards Development
    Send blank post to: <br />aspartameNM-subscribe@onelist.com to join<br />free,open, list with searchable archives for toxicity issues.<br />Richard \"Rich\" T. Murray Room For All 1943 Otowi Road Santa Fe, NM 87505<br />rmforall@comcast.net 505-501-2298

  2. #2
    Join Date
    Jun 1999
    Location
    Santa Fe, NM 87505, USA
    Posts
    63

    Default

    [ Continued ]

    http://www.foodstandards.gov.au/stan...iona540stevi3\
    096.cfm

    Application A540 - Stevol Glycosides as Intense Sweeteners

    Draft Assessment Report - 23 May 2007 [ word | pdf 584 kb ]

    Inital / Draft Assessment Report 7 December 2005 [ word | pdf 187 kb ]

    http://www.foodstandards.gov.au/_src..._DAR_FINAL.pdf 89 pages

    pag1 3-07
    23 May 2007
    DRAFT ASSESSMENT REPORT
    APPLICATION A540
    STEVIOL GLYCOSIDES AS INTENSE SWEETENERS
    DEADLINE FOR PUBLIC SUBMISSIONS: 6pm (Canberra time) 4 July 2007
    SUBMISSIONS RECEIVED AFTER THIS DEADLINE WILL NOT BE CONSIDERED
    (See ‘Invitation for Public Submissions’ for details)
    For Information on matters relating to this Assessment Report or the assessment process generally, please refer to Food Standards Australia New Zealand: Standards Development

    pages 87-89 Attachment 5

    Summary of Submissions

    Initial Assessment

    Sixteen submissions were received in response to the Initial Assessment Report.

    Fourteen submissions supported the progression of the Application to Draft
    Assessment with industry submissions strongly supporting the approval of steviol glycosides as an intense sweetener.

    Two submissions suggested deferring the Draft Assessment until after JECFA had evaluated the additional studies requested at its 63rd meeting.

    Submitter Comments

    Complementary Healthcare Council (CHC)
    The CHC has no concerns with the progression of this application.

    Department of Human Services Victoria (DHS)
    DHS notes steviol glycosides are not permitted for use in the EU
    or USA, however, are approved and used in other countries.
    DHS will provide further comment at the Draft Assessment stage
    after reviewing the toxicological and dietary modelling data.

    Crop & Food Research New Zealand
    Crop & Food Research New Zealand support A540 based on
    Initial Assessment.
    It is noted that safety literature has not been examined
    by Crop and Food Research.

    DIC International (Australia) Pty. Ltd.
    DIC International strongly supports A540.
    DIC International also provided additional information including:
    • history and manufacturing process of stevia;
    • merits and defects of stevia as a sweetener;
    • metabolism of stevia;
    • some additional Toxicological information; and
    • countries where stevia is approved for use.

    Fonterra Brands Australia (P& B)
    Fonterra Brands Australia (P & B) supports progression of A540
    to Draft Assessment.
    Additional Comments:
    • Steviol glycosides would provide alternative intense sweeteners
    for use.
    • Consumer research shows interest in low caloric foods.
    • Suggest FSANZ may consider why this additive is not permitted
    for use in the US or Europe.

    SA Department of Health SA Department of Health
    has no objections to the progression of this application.

    88

    Submitter Comments
    New Zealand Food Safety Authority (NZFSA)
    NZFSA supports A540 proceeding to Draft Assessment.
    Additional comments to consider in the Draft Assessment include:
    • only a temporary ADI has been set with JECFA waiting for
    further data (does this application contain the extra information
    requested by JECFA?);
    • consideration needs to be given to JECFA concerns regarding
    pharmacological effects particularly in relation to Type I & II diabetics;
    • NZFSA believe dietary modelling needs to consider exposure
    from table top sweeteners;
    • NZFSA is aware of a dietary supplement sold in NZ as ‘Stevia
    Dietary Supplement’ which contains 60 mg Stevia rebaudiana
    Bertoni extract per 1g serving; and
    • NZFSA suggests clarification be sough re: status of
    stevia from the Novel Foods Reference Group.

    New Zealand Juice & Beverage Association Inc (NZJBA)
    NZJBA support A540. NZJBA believe that this will extend the
    number of approved sweeteners available increasing consumer choice.

    Australian Beverages Council Ltd (ABCL)
    ABCL supports approval of steviol glycosides as a food additive.
    Additional comments:
    • Temporary JECFA ADI is based on a 200-fold safety factor
    assuming a mid-dose of 970 mg/kg of stevioside was the NOEL
    in rat carcinogenicity study. ABCL and the University of
    Queensland believe it to based on a NOEL of 2,000 mg/kg.
    Believe the ADI can safely be assessed at 4 times that set by JECFA
    • ABCL requests FSANZ approves a use level of steviol
    glycosides at 1000 ppm in water based flavoured beverages and
    fruit and vegetable juice products. ABC note that milk and soy
    containing beverages will require more stevia sweeteners
    because of their protein and fat contents and request amount
    permitted to be 1000 ppm.
    • ABCL suggests dietary modelling should be conservative in
    assumptions of market use. They suggest dietary modelling
    should be based on current uses of aspartame and other
    approved sweeteners are appropriate.
    • ABCL believes that JECFA’s assessment of steviol glycosides
    replacing 20-30% of sugar is very optimistic market assessment.
    • ABCL believe there will be consumer benefit through controlled
    energy intake while enjoying food and beverages.
    • ABCL also notes the potential development of a new
    agricultural crop for Australia.

    89

    Submitter Comments

    Australian Stevia Mills Supports application A540.
    Additional comments
    • Stevia is a safe natural alternative to artificial sweeteners
    • Stevia does not promote calories
    • Stevia is safe to use in baked products and products with varying pH.
    • Currently no artificial sweeteners are locally owned products,
    potential cash crop for Australia.
    Successful trials in Eastern states of Australia.
    • The federal government supports development of stevia through
    projects under RIRDC.
    • Potential stakeholder benefits to federal and state governments,
    diabetic and obese people, general public in reducing dental caries

    Australian Food and Grocery Council (AFGC)
    Supports A540 – Steviol glycoside as an intense sweetener.

    Health & Herbs Ltd Supports A540 – Steviol glycoside as a sweetener

    Queensland Health -Environmental Health Unit
    Believe FSANZ should defer further assessment until 2007 when
    additional studies on pharmacological effects of the sweetener
    (required by FAO/WHO).
    Suggest delay will not be significant to industry as other intense sweeteners
    are available.
    Also notes that EU and USA do not currently permit steviol glycosides.

    Cadbury Schweppes
    Supports A540 – Steviol glycosides as a sweetener in a broad
    range of products

    NSW Food Authority
    Recommends waiting for further toxicological data required by JECFA.
    Notes that the NFRG formed the view that stevia is a novel food,
    therefore the novelty of this food will need to be assessed

    Food Technology Association of Victoria Inc
    Supports A540 – Steviol glycosides as a sweetener


    page 33 Conclusions

    This review of supplementary data indicated that stevioside is metabolised
    completely to steviol in the gastrointestinal tract, which is absorbed into the blood stream and then exerts a pharmacological effect by lowering blood pressure and blood glucose. While the precise mechanism of pharmacological action remains to be defined, stevioside is unlikely to produce
    hypoglycaemia or hypotension in humans at concentrations encountered in the diet. Studies previously reviewed by JECFA confirm the low toxicity potential of stevioside.
    On this basis, there are unlikely to be any safety issues associated with the use of stevioside as a sweetener.
    No suitable human study was identified that could serve as a basis of an ADI for stevioside.
    However, steviol glycosides are well tolerated and unlikely to have adverse
    effects on blood pressure, blood glucose or other parameters in normal, hypotensive or diabetic subjects at doses up to 11 mg/kg bw/day.

    The adequacy of the existing database and a new study in humans provides a basis for revising the uncertainty factors that were used by JECFA to derive the temporary ADI for steviol glycosides in 2005.
    In particular, the evidence surrounding the pharmacological effects of steviol glycosides on blood pressure and blood glucose has been strengthened so
    that the additional 2-fold safety factor for uncertainty related to effects in
    normotensive or diabetic individuals is no longer required.

    As the ADME data indicated that stevioside is completely converted to steviol in animals and humans, the ADI is expressed in terms of steviol equivalents. This allows for any variability in the individual glycosides in mixtures of steviol glycoside extracts (e.g. different ratios of stevioside/rebaudioside) to be accounted for by the ADI being expressed in steviol equivalents.
    Therefore, based on this complete metabolism, a conversion factor of 40% from the steviol glycoside, stevioside (relative molecular mass: stevioside, 805; steviol, 318) to steviol is used to calculate the ADI.

    Therefore a full ADI of 4 mg/kg bw/day, derived by applying a 100-fold safety
    factor to the NOEL of 970 mg/kg bw/day (equivalent to 383 mg/kg bw/day steviol) in a 2-year rat study, has been established.
    At the next highest dose equivalent to 2000 and 2400 mg/kg bw/day in males and female rats, respectively reduced bodyweight gain and survival were
    observed.
    Send blank post to: <br />aspartameNM-subscribe@onelist.com to join<br />free,open, list with searchable archives for toxicity issues.<br />Richard \"Rich\" T. Murray Room For All 1943 Otowi Road Santa Fe, NM 87505<br />rmforall@comcast.net 505-501-2298

  3. #3
    Join Date
    Jun 1999
    Location
    Santa Fe, NM 87505, USA
    Posts
    63

    Default

    [ Continued ]

    REFERENCES

    Abudula R, Jeppesen PB, Rolfsen SED et al (2006)
    Rebaudioside A potently stimulates secretion
    from isolated mouse islets: studies on the dose, glucose and calcium-dependency.
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    Barriocanal LA, Palacios M, Benitez G et al (2006)
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    Bopp and Price P (2001) Cyclamate:
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    Chan P, Tomlinson B, Chen YJ et al (2000)
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    Chen TH, Chen SC, Chan P et al (2005)
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    Chen J, Jeppesen PB, Abudula R et al (2006)
    Stevioside does not cause increased basal insulin
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    Ferri LAF, Alves-Do-prado W, Yamada SS et al (2006)
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    Ferreira EB, Neves F, Da Costa MAD (2006)
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    Gardana C, Simonetti P, Canzi E et al (2003)
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    Geuns JMC, Augustijns P, Mols R et al (2003)
    Metabolism of stevioside in pigs and intestinal
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    Geuns JMC (2004)
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    Geuns JMC and Pietta P (2004)
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    Geuns, J.M., Buyse, J., Vankeirsbilck, A., Temme, E.H., Compernolle, F., Toppet,
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    Identification of steviol glucuronide in human urine.
    J Agric Food Chem, 5, 2794-2798.

    Geuns JMC, Buyse J, Vankeirsbilck A et al (2006b)
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    Goto A and Clemente E (1998)
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    Gregersen S, Jepperson PB, Holst JJ and Hermansen K (2004)
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    Hong J, Chen L, Jeppesen PB (2006)
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    Hsieh MH, Chan P, Yuh-Mou S et al (2003)
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    Hutapea AM, Toskulkao C, Buddhasukh D et al (1997)
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    Hutapea AM, Toskulkao C, Wilairat P and Buddhasukh D (1999)
    High-performance liquid chromatographic separation
    and quantification of stevioside and its metabolites.
    J. Liq. Chrom. & Rel. Technol, 22, 1161-1170.

    Jeppesen PB, Gregersen S, Poulsen CR and Hermansen K (2000)
    Stevioside acts directly on
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    Jeppesen PB, Gregersen S, Alstrup KK and Hermansen K (2002)
    Stevioside induces
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    Phytomedicine, 9, 9-14.

    Jeppesen PB, Gregersen S, Alstrup KK and Hermansen K (2003)

    Antihyperglycemic and blood pressure-reducing effects of stevioside
    in the diabetic Goto-Kakizaki rat.
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    Koyama E, Sakai N, Ohori Y et al (2003a)
    Absorption and metabolism of glycosidic sweeteners of stevia mixture
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    Koyama E, Kitazawa Y, Ohori O et al (2003b)
    In vitro metabolism of the glycosidic sweeteners,
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    Lailerd N, Saengsirisuwan V, Sloniger JA et al (2004)
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    in insulin-sensitive and insulin-resistant rat skeletal muscle.
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    Lee CN, Wong KL, Liu JC (2001)
    Inhibitory effect of stevioside on calcium influx to produce antihypertension.
    Planta Medica, 67, 796-799

    Liu JC, Kao PK, Chan P et al (2003)
    Mechanism of the antihypertensive effect of stevioside in anaesthetised dogs.
    Pharmacology (Basel), 67, 14-20

    Melis MS (1996)
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    Simonetti P, Gardana C, Bramati L and Pietta PG (2004)
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    Starratt AN, Kirby CW, Pocs R and Brandle JE (2002)
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    Sung LH (2002)
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    Totté, N., Charon,L., Rohmer, M., Compernolle, F., Baboeuf, I., Geuns, J.M.C.,
    2000.
    Biosynthesis of the diterpenoid steviol, an ent-kaurene derivative
    from Stevia rebaudiana Bertoni,
    via the methylerythritol phosphate pathway.
    Tetrahedron Letters 41, 6407-6410.

    Wang LZ, Goh BC, Fan L and Lee HS (2004)
    Sensitive high-performance liquid chromatography/mass spectrometry method
    for determination of steviol in rat plasma.
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    WHO (1999)
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    Food Additives Series No. 42, WHO, Geneva.

    WHO (2005)
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    (steviol glucosides). WHO Technical Report Series No. 928, WHO, Geneva.

    Wingard RE, Brown JP, Enerlin FE et al (1980)
    Intestinal degradation and absorption of the glycosidic sweeteners stevioside
    and rebaudioside A.
    Experientia, 36, 519-520.

    Wong KL, Lin JW, Liu JC (2006)
    Antiproliferative effect of isosteviol on angiotension-II-treated rat
    aortic smooth muscle cells.
    Pharmacology, 76, 163-169.
    ///////////////////////////////////////////////////////////


    Yahoo! Groups
    FDA's corrupt war against safe herbal sweetener stevia,
    Mary Nash Stoddard, 2006 January,
    Aspartame Consumer Safety Network: Murray 2007.05.24

    [ See also:

    stevia, balanced factual detailed review in Wikipedia: Murray
    2007.05.19
    Yahoo! Groups
    Stevia - Wikipedia, the free encyclopedia

    Yahoo! Groups
    two recent warning studies on stevia toxicity on rats and bacteria, AP
    Nunes et al, 2007 April, 2006 Dec, links to 18 positive abstracts from
    2000 February to 2004 January: Murray 2007.05.03

    At the end of this post, I link to my 5 previous reviews in 2005
    August that give 18 full abstacts in PubMed on stevia toxicity from
    2000 February to 2004 January, which do not find that stevia is
    practically toxic to humans in ordinary use -- and give an opposite
    positive abstract using the Comet assay in 2002 December, and then
    share the conclusion from the full text of another study on
    mutagenicity, T Terai et al 2002 July. ]
    Send blank post to: <br />aspartameNM-subscribe@onelist.com to join<br />free,open, list with searchable archives for toxicity issues.<br />Richard \"Rich\" T. Murray Room For All 1943 Otowi Road Santa Fe, NM 87505<br />rmforall@comcast.net 505-501-2298

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