U.S. Food and Drug Administration (FDA)

September 2010 – GRN 329

Date of Closure: 9-Sep-10
Substance: Rebaudioside A purified from the leaves of Stevia rebaudiana (Bertoni) Bertoni
Intended Use: General purpose sweetener in various food categories
Specification: Rebaudioside A (≥ 97%),
Limits On: Lead (≤ 1 mg/kg), arsenic (≤ 1 mg/kg), residual methanol (≤ 0.2%) and microbial contaminants (within specified limits)

July 2010 – GRN 323

Date of Closure: 9-Jul-10
Substance: Purified steviol glycosides with rebaudioside A and stevioside as the principal components
Intended Use: General purpose sweetener in various food categories
Specification: Total steviol glycosides (> 95 %), Reb A + Stevioside (≥ 81), Inclusion of Reb C, Dulcoside A, Rubusoside, Steviolbioside, Reb B, Reb D, Reb F
Limits On: Reb C (≤ 15%), rubusoside (≤ 2%), steviolbioside (≤ 2%), Reb B (≤ 2%), Reb D (≤ 2.5%), Reb F (≤ 3%), dulcoside A (≤ 2%), moisture (≤ 5%), lead (< 1mg/kg), arsenic (<1 mg/kg), residual methanol (<200 mg/kg), residual ethanol (<5000 mg/kg) and microbial contaminants (within specified limits)

May 2010 – GRN 318

Date of Closure: 15-May-10
Substance: Rebaudioside A purified from the leaves of Stevia rebaudiana (Bertoni) Bertoni
Intended Use: General purpose sweetener in foods, excluding meat and poultry
Specification: Reb A (≥ 95%)
Limits On: Moisture (≤ 6%), lead (≤ 1 mg/kg), arsenic (≤ 1 mg/kg), residual ethanol (< 5000 mg/kg) and microbial contaminants (within specified limits)

March 2010 – GRN 304

Date of Closure: 22-Mar-10
Substance: Purified steviol glycosides with rebaudioside A and stevioside as the principal components
Intended Use: As a general-purpose sweetener in foods, excluding meat and poultry products, at levels determined by good manufacturing practice
Specification: Total steviol glycosides( > 95%)
Limits On: Moisture (≤ 5%), lead (< 1 mg/kg), arsenic (< 1 mg/kg), residual methanol (< 200 mg/kg), residual ethanol (< 5000 mg/kg) and microbial contaminants (within specified limits)

March 2010 – GRN 303

Date of Closure: 22-Mar-10
Substance: Rebaudioside A purified from the leaves of Stevia rebaudiana (Bertoni) Bertoni
Intended Use: As a general-purpose sweetener in foods, excluding meat and poultry products, at levels determined by good manufacturing practice
Specification: Reb A (≥ 95%)
Limits On: Moisture (< 5%), lead (< 1 mg/kg), arsenic (< 1 mg/kg), residual methanol (< 200 mg/kg), residual ethanol (< 5000 mg/kg) and microbial contaminants (within specified limits)

August 2009 – GRN 287

Date of Closure: 28-Aug-09
Substance: Purified steviol glycosides with rebaudioside A and stevioside as the principal components
Intended Use: As a general-purpose sweetener in foods, excluding meat and poultry products and infant formulas, at levels determined by good manufacturing practice
Specification: Total steviol glycosides (> 95 %)
Limits On: Moisture (< 6%), ash (< 1%), lead (< 1 mg/kg), Arsenic (< 1 mg/kg) and microbial contaminants (within specified limits))

August 2008 – GRN 282

Date of Closure: 11-Aug-09
Substance: Purified steviol glycosides with rebaudioside A and stevioside as the principal components
Intended Use: As a general-purpose sweetener in foods, excluding meat and poultry products, provided that food standards of identity do not preclude such use, at levels determined by good manufacturing practice
Specification: Reb A (≥ 97%)
Limits On: Steviol glycosides (≤ 3%), (moisture (< 6%), ash (< 0.2%), residual ethanol (≤ 5%), lead (≤ 1 mg/kg), Arsenic (< 1 mg/kg) and microbial contaminants (within specified limits)

July 2009 – GRN 278

Date of Closure: 20-Jul-09
Substance: Rebaudioside A purified from the leaves of Stevia rebaudiana (Bertoni) Bertoni
Intended Use: As a sweetener in baked products, beverages (non-alcoholic), breakfast cereals, coffee and tea, confections and frostings, dairy product analogs, fats and oils, forzen dairy desserts, fruit and water ices, milk (whold and skim), milk products, processed fruits and fruit juices, processed vegetables and vegetable juices, snack foods, soft candy, sugar substitutes, sweet sauces, toppings and syrups, meal replacement food products, and medical foods at levels determined by good manufacturing practices, as well as use as a table top sweetener
Specification: Reb A (≥ 97%)
Limits On: Moisture (< 5%), lead (< 0.5 mg/kg), arsenic (< 0.5 mg/kg), residual methanol (< 200 mg/kg), residual ethanol (< 1000 mg/kg) and microbial contaminants (within specified limits)

June 2009 – GRN 275

Date of Closure: 11-Jun-09
Substance: Purified steviol glycosides with rebaudioside A as the principal components
Intended Use: As a table top sweetener
Specification: Steviol glycosides (≥ 95%)
Limits On: Ash (< 1%), residual methanol (< 200 mg/kg), residual ethanol (< 5000 mg/kg), arsenic (< 1 mg/kg) and lead (≤ 1 mg/kg)

December 2008 – GRN 253

Date of Closure: 17-Dec-08
Substance: Rebaudioside A purified from Stevia rebaudiana (Bertoni) Bertoni
Intended Use: As a general-purpose sweetener in foods, excluding meat and poultry products, provided that food standards of identity do not preclude such use, at levels determined by good manufacturing practice
Specification: Reb A (≥ 97%)
Limits On: Other steviol glycosides (≤ 3%), lead (≤ 1 mg/kg), residual methanol (≤ 0.2%), residual ethanol (≤ 0.5%) and microbial contaminants (within specified limits)

December 2008 – GRN 252

Date of Closure: 17-Dec-08
Substance: Rebaudioside A purified from Stevia rebaudiana (Bertoni) Bertoni
Intended Use: As a general-purpose sweetener in foods, excluding meat and poultry products, provided that food standards of identity do not preclude such use, at levels determined by good manufacturing practice
Specification: Reb A (≥ 95%)
Limits On: Stevioside (< 2%), steviol (< 0.005%), moisture (< 5%), lead (≤ 1 mg/kg), arsenic (< 1 mg/kg), cadmium (< 1 mg/kg), residual methanol (< 300 mg/kg), residual ethanol (< 1 g/kg) and microbial contaminants (within specified limits)

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