SPLENDA Sucralose Granular 113011

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Customer Specification

Subject: SPLENDA® Sucralose Granular (DFF-1) Document No: 770401.4

Product(s): Sucralose – Granular (DFF-1) Master Category #: N/A


Record Series #: 1840
Review Frequency: 3 Years
This specification is the property of Tate & Lyle and contains CONFIDENTIAL information that must not be photocopied
or distributed outside Tate & Lyle without permission.

1. DESCRIPTION:

SPLENDA® Sucralose Granular (DFF-1) solid is a sweet, white to off-white, practically odorless,
crystalline powder and is fit for human consumption.

2. PROPERTIES, REQUIREMENTS AND TEST METHODS:

2.1 Appearance White to off-white, crystalline powder TM 1012

2.2 Assay 98.0% to 102.0%, anhydrous basis TM1129

2.3 Water content (KF) NMT 2.0% TM 1123

2.4 pH Decrease of one pH unit maximum TM 1090

2.5 (A) Identity (IR) The infrared spectrum corresponds to that TM1130
of a similarly prepared reference
and and and
(B) Identity (HPLC) The relative retention time corresponds TM 1129
to that of the sucralose standard in the
assay procedure
and and and
(C) Identity (TLC) Rf value of principal spot in chromatogram TM1138
of test solution corresponds to that of
standard solution as obtained for the test
for related substances

2.6 Related Substances Passes test (NMT 0.5%) TM 1138


(Other Chlorinated Disaccharides)

2.7 Hydrolysis Products Passes test (NMT 0.1%) TM 1120


(Chlorinated Monosaccharides)

2.8 Specific Rotation +84.0 to +87.5 [∝] 20 anhydrous basis TM 1137


D

2.9 Organoleptic Evaluation Passes test TM1126

®
SPLENDA is a trademark of McNeil Nutritionals, LLC

Document Issue Date: 30-Nov-11 Released By: Kareen Sim


Page 2 of 6

Customer Specification

Subject: SPLENDA® Sucralose Granular (DFF-1) Document No: 770401.4

Product(s): Sucralose – Granular (DFF-1) Master Category #: N/A


Record Series #: 1840
Review Frequency: 3 Years
This specification is the property of Tate & Lyle and contains CONFIDENTIAL information that must not be photocopied
or distributed outside Tate & Lyle without permission.

2.10 Particle Size X10 >80 um


X50 140 – 300 um TM 1324

2.11 Residue on Ignition NMT 0.7% TM1134


(Sulfated Ash)

2.12 Lead NMT 1 ppm TM 1515

2.13 Arsenic (as As) NMT 3 ppm TM 1474

2.14 Methanol NMT 0.1% TM 1484

2.15 Triphenylphosphine oxide NMT 1 ppm TM 1139

2.16 Heavy Metals (as Pb) NMT 10 ppm TM 1136

2.17 Clarity Must Comply TM 1084

3. MICROBIOLOGICAL REQUIREMENTS:

3.1 Total Aerobic Count 250/g maximum TM 1498

3.2 Yeasts/Molds 50/g maximum TM 1499

3.3 Coliforms Negative to test (< 10/g) TM 1504

3.4 E. coli Negative to test (< 10/g) TM 1504

3.5 S. aureus Negative to test (< 10/g) TM 1501

3.6 Salmonella Negative to test (Absent in 25g) TM 1502

Document Issue Date: 30-Nov-11 Released By: Kareen Sim


Page 3 of 6

Customer Specification

Subject: SPLENDA® Sucralose Granular (DFF-1) Document No: 770401.4

Product(s): Sucralose – Granular (DFF-1) Master Category #: N/A


Record Series #: 1840
Review Frequency: 3 Years
This specification is the property of Tate & Lyle and contains CONFIDENTIAL information that must not be photocopied
or distributed outside Tate & Lyle without permission.

4. CERTIFICATIONS:

4.1 SPLENDA® Sucralose Granular (DFF-1) solid meets FCC and JECFA specifications and EU
specification (Directive 2008/60/EC).

4.2 Kosher for Passover


SPLENDA® Sucralose Granular (DFF-1) solid is certified as Kosher Pareve and Kosher for
Passover by the Orthodox Jewish Community of Singapore and bears this organization’s
symbol.

4.3 Halal
®
SPLENDA Sucralose Granular (DFF-1) solid is certified as Halal by Majlis Ugama Islam
Singapura and bears this organization’s symbol.

4.4 Genetically Modified Organisms:


SPLENDA® Sucralose is not produced from ingredients or processing aids derived by genetic
modification. SPLENDA® Sucralose does not contain genetically modified organisms and
labeling is not required under EC regulations 1829/2003 and 1830/2003.

4.5 BSE:
No animal derived ingredients are used in the production of SPLENDA® Sucralose. There are
no animal derived ingredients used in the facility where sucralose is produced.

4.6 Allergens:
SPLENDA® Sucralose does not contain any commonly known sources of allergenic responses.
Labeling is not required under FDA Food Allergen Labeling and Consumer Protection Act of
2004 (FALCPA) or under the EU Directive 2007/68/EC.

4.7 Bioterrorism Regulation Facility Registration:


SPLENDA® Sucralose production facilities are registered with the U.S. FDA in accordance with
the requirements of the "Security and Bioterrorism Preparedness and Response Act of 2002".

Document Issue Date: 30-Nov-11 Released By: Kareen Sim


Page 4 of 6

Customer Specification

Subject: SPLENDA® Sucralose Granular (DFF-1) Document No: 770401.4

Product(s): Sucralose – Granular (DFF-1) Master Category #: N/A


Record Series #: 1840
Review Frequency: 3 Years
This specification is the property of Tate & Lyle and contains CONFIDENTIAL information that must not be photocopied
or distributed outside Tate & Lyle without permission.

5. PACKAGING, HANDLING, STORAGE, AND MARKING:

5.1 Supplier Packaging:


SPLENDA® Sucralose Granular (DFF-1) solid is packaged in an appropriate container.

5.2 Handling and Storage Conditions:


SPLENDA® Sucralose Granular (DFF-1) solid must be maintained at a Controlled Room
temperature as defined by USP/NF - 77°F (25°C) or b elow, with a maximum temperature never
to exceed 95°F (35°C). SPLENDA ® Sucralose Granular (DFF-1) must be stored away from
odoriferous material. Reseal container before storing unused product.

5.3 Shipping Requirements:


SPLENDA® Sucralose Granular (DFF-1) solid may be shipped under standard shipping
conditions if total shipping time will not exceed 48 hours. If shipments of longer than 48 hours
are necessary, every effort should be made to ship the product under Controlled Room
Temperature as defined by USP/NF - 77oF (25oC) or below, with a maximum temperature not to
exceed 95oF (35oC) or by next day courier. If a standard shipment is unavoidably delayed,
adherence to Controlled Room Temperature conditions should be confirmed and documented.

5.4 Markings:
Markings will include product name, lot number, date of manufacture, best used by date,
material number, ingredients, net weight, Kosher and Halal Certification, manufacturer
information, and will specify usage information.

6. TESTING REQUIREMENTS:

6.1 A Certificate of Analysis (COA) will be provided with each shipment.

6.2 Properties and requirements in sections 2.1 – 2.10 and 3.1 – 3.6 will be analyzed for each lot
produced.

6.3 Properties in sections 2.11 to 2.17 will be analyzed minimally on a quarterly basis.

6.4 If in-house customer testing is required upon receipt, it is recommended that this product be
tested for compliance of assay, pH, and Organoleptics. These tests will provide the most
information about the product without performing the entire battery of tests listed in section 2.

Document Issue Date: 30-Nov-11 Released By: Kareen Sim


Page 5 of 6

Customer Specification

Subject: SPLENDA® Sucralose Granular (DFF-1) Document No: 770401.4

Product(s): Sucralose – Granular (DFF-1) Master Category #: N/A


Record Series #: 1840
Review Frequency: 3 Years
This specification is the property of Tate & Lyle and contains CONFIDENTIAL information that must not be photocopied
or distributed outside Tate & Lyle without permission.

7. SHELF LIFE:

It is recommended that this product be used within 24 months of manufacture, while stored under
conditions stated in section 5.2.

8. RECOMMENDED USAGE CONDITIONS:

Buyer shall not use the Product in any application in which the pH of any product of manufactured good
containing the Product is greater than 7.0, excluding applications of baked goods, in which Buyer shall
not use the Product in any application in which the pH of any product or manufactured good containing
the Product is greater than 8.0.

9. SAFETY PRECAUTIONS:

Consult appropriate MSDS and other relevant resources for personal protective equipment and other
precautions.

Document Issue Date: 30-Nov-11 Released By: Kareen Sim


Page 6 of 6

Customer Specification

Subject: SPLENDA® Sucralose Granular (DFF-1) Document No: 770401.4

Product(s): Sucralose – Granular (DFF-1) Master Category #: N/A


Record Series #: 1840
Review Frequency: 3 Years
This specification is the property of Tate & Lyle and contains CONFIDENTIAL information that must not be photocopied
or distributed outside Tate & Lyle without permission.

This Page Confidential - Not To Be Sent To Customers

Change History:

REV DATE DESCRIPTION OF CHANGE(S) DCA #


.0 08/15/06 Original Document – K. Ramige 4667
.0 08/25/06 Admin Change – Header Site-Changed from McIntosh to Singapore – 4667
K. Ramige
.1 12/18/06 Section 8-Added baked goods pH information to match Terms & 4733
Conditions of Sale clause – K. Ramige for R. Lock Footer-Updated
Address-K. Ramige
.2 08/07/07 Updated to new header. Aligned specification with FCC testing 4845
requirements. Section 2.5 – Added two identity tests (IR and TLC);
2.6-Related Substances-Changed range from “passes test”; 2.8
Specific Rotation-Changed range from “on a dry basis” 2.6, 2.7 and
2.11- added supplementary descriptions; 2.15-TPPO-Changed range
from “0.0001% max”; 2.17-Added Clarity; Section 4.1 –Removed
USP and added EU cert; Added 4.2 – Kosher for Pareve and
Passover and 4.3 Halal statements; Section 5.4-Updated to include
Kosher & Halal Certs; Added Sections 6.1-6.3- reporting
requirements on COAs; re-numbered 6.4. Section 7 –Removed
storage verbiage and referenced section 5.2. Revised Section 9-
Safety Precautions – K. Ramige
.2 05/28/08 Admin Change: Sec 2.6 - Added NMT 0.5% to range; Sec 2.7 - 4845
Added NMT 0.1% to range; Sec 4.6 - Changed from “EU Directive
2006/142/EC” to “EU Directive 2007/68/EC”. – R. Dexter
.2 06/01/09 Admin Change: Deleted “Site” from Header and deleted Address 4845
from Footer. – R. Dexter
.4 06/11/09 Sec. 4.7 – Revised statement to eliminate McIntosh address. – R. 5191
Dexter
4a 08-Sept-11 • Made changes to section 4.1:Replace Directive 2006/128/EC CDRF_2011_0177
to Directive 2008/60/EC
• Change format
• Transfer Document Ownership to Singapore
4b 30-Nov-11 Admin Changes CDRF_2011_0247
Add Document Issue Date, Released By in document footer
Reflect Revision number in document header

Document Issue Date: 30-Nov-11 Released By: Kareen Sim

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