Synthite Industries Private Limited Synthite Valley, Kolenchery T +91484 2834200 E info@s ynthite.

com
Kerala 682 311, India F +91484 2834351 W www.s ynthite.com

PRODUCT INFORM ATION SHEET

Description of Product: Natural Caffeine Powder (Anhydrous)

Product Code: 5010000676
Customer: HERBALIFE

Genus: Com m on Name: Plant Part:

Coffee Robusta Caffeine Powder Coffee Beans

Storage condition: Store in full, tight Excipients/Carrier: Shelf Life:

containers in a cool dry place protected Nil 2 years
from light and oxidation.

Ph ysical Characteristics Specification Test Method Reference

Identification Chromatographic Profile HPLC

Appearanc e Crystalline Powder Organoleptic
Col or White Organoleptic
Odour Odorless Organoleptic
T ast e Characteristic Organoleptic

Chemical Characteristics Specification Test Method Reference

Assay for Active 98.5-101.5% By HPLC Liquid Chromatography
(Caffeine)
Loss On Drying 8.5%max Moisture by gravimetry
Solubility in water Soluble Visual

Heavy Metal Specification Test Method Reference

Lead <1 ppm AOAC 19th Edition
Arsenic <1 ppm AOAC 19th Edition
Cadm ium <1 ppm AOAC 19th Edition
Mercury <0.5 ppm AOAC 19th Edition
Copper < 30 ppm External lab
Tin <250 ppm External lab
Methyl mercury <0.25 ppm External lab
Mycotoxin Specification Test Method Reference
Aflat oxins
<10 ppb ASTA 24.2, 1997 Edition
(B1 + B2 + G1 + G2)
Aflat oxin B1 < 5 ppb ASTA 24.2, 1997 Edition
Synthite Industries Private Limited Synthite Valley, Kolenchery T +91484 2834200 E info@s ynthite.com
Kerala 682 311, India F +91484 2834351 W www.s ynthite.com

Microbiology Specification Test Method Reference

T ot al Plat e Count < 1000cfu/ gm BAM, online January,2001 Chapt er-3
T ot al Yeast & Mold < 100cfu/ gm BAM, online, April, 2001, Chapt er – 18
E. Coli < 3 m pn/g BA M, online, February, 2013 Chapt er – 4
S.aureus < 10 cfu/g BAM, online, March, 2016 Chapter – 12
Salm onella Absent in 25g BAM, online, Aug ust, 2016 Chapt er – 5
Enterobacteriaceae 100 cfu/g Max ISO 21528-2:2017 E
Listeria Monocytogens Absent in 25g External lab (ISO 11290-1)
Bacillus cereus <100 cfu/g ISO 7932:2004 E
Sulphite reducing clostridia <100 cfu/g ISO 15213:2003 E

Pesticide residue 213 Per FSSAI As per FSSAI

Melamine 2.5 ppm max External lab

Divya Narasimhan

From: Aniket Ramesh Ingale (Synthite Bangalore) <[email protected]>

Sent: May 17 2019 16:57
To: Divya Narasimhan
Cc: Sumit Nitnaware; Shashi Shekhar; Jesus Ortega-Haquet; Kishan H R; Sruthi Liz Kuriakose (Synthite
Kolenchery)
Subject: Re: [External] Re: Reg: Natural Caffeine Powder (Anhydrous) (2160025692/10), R00504
Attachments: image007.png; image005.png; NUTRITIONAL STATEMENT-5010000676.pdf

Dear Divya,

Kindly find attached Nutritional Data and clarification on below points.

1. I noticed that the number 2160025692/10 is indicated on PDS and other documents. It is on the COA also.
Please help me with the below‐

 Is 2160025692/10, the product code of this material ? ‐ Sample number, Product Number is 5010000676
 If this is the product code of the material, then what is the batch/lot number of the sample that was sent to
us?
 If this is a lab produced batch and it has no lot number, can the manufacturing date be taken as the lot
number ‐ It's not a lab prepared sample

2. E coli: Is < 3 mpn/g also the detection limit of the method? ‐ Detection limit is 3 mpn/g

3. S aureus: Is < 10 cfu/g also the detection limit of the method? ‐ Detection limit is 10 cfu/g

4. ID: Can you provide the chromatograph of the reference standard. Attached the chromatogram of the sample ‐
2160025692/10 (lot manufactured ‐ 25.03.2019)

6. Nutritional Information : We will await the lab report ‐ attached

On Mon, May 13, 2019 at 3:00 PM Divya Narasimhan <[email protected]> wrote:

Dear Aniket,

Thank you very much for your email and for working on this request.

I have summarised the pending items below:

1. PDS (Product Data Sheet): PDS is missing in the attached, kindly provide updated PDS with the lot#
2160025692/10, Sample Number & Qty and Mfg. Date, removed.
1
 2. E coli: We understand that the spec for E coli is set at < 3 mpn/g (based on BAM method). Is < 3 mpn/g also the
detection limit of the method? Can you confirm that a minimum sample size of 10 g was used for testing E coli?

3. S aureus: We understand that the spec for S aureus is set at < 10 cfu/g (based on BAM method). Is < 10 cfu/g
also the detection limit of the method? Can you confirm that a minimum sample size of 10 g was used for
testing S aureus?

4. ID: Method of analysis, reference standard used for testing sigma standard.

5. Allergen Control Program: CIP flow chart.

6. Nutritional Information.

7. Non‐BSE Statement(BSE)

Look forward to your response at the earliest.

Thanks and Regards,

Divya Narasimhan| Sr. Specialist ‐ Documents Control| Quality Assurance|

Herbalife | #15, RMZ Pinnacle, Commissariat Road, Bengaluru ‐ 560025 |

Phone: 080 46442176 ext.‐75062198 | Mobile +91 9148785937 | [email protected]

From: Aniket Ramesh Ingale (Synthite Bangalore) <[email protected]>

Sent: May 13 2019 13:36
To: Divya Narasimhan <[email protected]>
Cc: Sumit Nitnaware <[email protected]>; Shashi Shekhar <[email protected]>; Jesus Ortega‐Haquet
<[email protected]>; Kishan H R <[email protected]>; Sruthi Liz Kuriakose (Synthite Kolenchery)
<[email protected]>
Subject: Re: [External] Re: Reg: Natural Caffeine Powder (Anhydrous) (2160025692/10), R00504

2
Dear Divya,

Kindly find attached reply on below mentioned points.

1.PDS and Certificate of Analysis(COA):

a) On attached PDS, can the lot# 2160025692/10, Sample Number & Qty and Mfg. Date, be
removed from the PDS, as this gives the impression that the PDS is “lot” specific ‐ Corrected
Product Data Sheet is attached in the mail.

b) Total Plate Count (< 10000 cfu/g) and Total Yeast & Mold (< 500 cfu/g) actual values are
not reported on COA lot#2160025692/10. Are these values also the detection limit of the
method? If not, can actual values be provided for COA lot#2160025692/10, can actual results be
reported going forward, on the COA ‐ These are actual values only, we are sure that in future
batches the microbiology results will be under herbalife permissible limits.

2. ID chromatogram: Can you confirm attached ID chromatogram is for lot#2160025692/10, as the lot
number is not indicated. Additionally, please confirm which of these is the reference standard. We need the
chromatogram of both the sample (lot#2160025692/10) and reference standard ‐ Corrected ID
chromatograph is attached for your reference, we will share the Method of analysis, reference standard
used for testing sigma standard.

3.Allergen Statement(ALR): Since the attached Allergen statement indicates some allergens as “present in the
same manufacturing plant”, can you please provide your Allergen Control Program ‐ As explained we are
doing change over from product to product which comprises of steam washing of complete plant along
with cleaning in place with cleaning agent, flow chart for the same will be submitted by end of the day.
4.Nutritional Information(NUT): Please provide a nutritional statement for this material. ‐ Sample has been sent
to third party lab for nutritional data analysis, the results are expected within 8‐10 working days.

5. Storage Conditions(STO): Please provide the storage conditions for this material. Please note that we
cannot accept this information on the MSDS. Kindly add this to the PDS or provide a separate statement.
Email statement is also acceptable ‐ You need to keep the drum in sealed condition in cool and dry place
without any exposure to the sun & moisture.
3
 6. Non‐BSE Statement(BSE): Please provide a Non‐BSE Statement for this material ‐ Non‐BSE statement will
be sent to you by the end of the day.

Additionally, please help address the below on the PDS and COA:

1.Yeast & Mold, Lead and Mercury: We understand, that you have set higher specs for the below (compared to
Herbalife Specs) based on natural batch variation, but can you confirm based on the results on the attached
COA(lot# 2160025692/10), that if tested, this material will meet Herbalife Specs as listed below? ‐ Our
product test results will be within herbalife specs for all the supplies.

On Fri, May 10, 2019 at 11:28 AM Divya Narasimhan <[email protected]> wrote:

Dear Aniket,

Thank you for the documents.

Any updates on our request for samples for lot#2160025692/10? Please note that a 150g sample would suffice. If
available, please kindly send to Kishan’s attention.

Please note the pending items below:

List of pending items:

1. PDS and Certificate of Analysis(COA):

a) On attached PDS, can the lot# 2160025692/10, Sample Number & Qty and Mfg. Date,
be removed from the PDS, as this gives the impression that the PDS is “lot” specific.

b) Total Plate Count (< 10000 cfu/g) and Total Yeast & Mold (< 500 cfu/g) actual values are
not reported on COA lot#2160025692/10. Are these values also the detection limit of the
method? If not, can actual values be provided for COA lot#2160025692/10, can actual results be
reported going forward, on the COA.

2. ID chromatogram: Can you confirm attached ID chromatogram is for lot#2160025692/10, as the lot
number is not indicated. Additionally, please confirm which of these is the reference standard. We need the
chromatogram of both the sample (lot#2160025692/10) and reference standard.
4
 3. Allergen Statement(ALR): Since the attached Allergen statement indicates some allergens as “present in the
same manufacturing plant”, can you please provide your Allergen Control Program.
4. Nutritional Information(NUT): Please provide a nutritional statement for this material.

5. Storage Conditions(STO): Please provide the storage conditions for this material. Please note that we
cannot accept this information on the MSDS. Kindly add this to the PDS or provide a separate statement.
Email statement is also acceptable.

6. Non‐BSE Statement(BSE): Please provide a Non‐BSE Statement for this material.

Additionally, please help address the below on the PDS and COA:

1. Yeast & Mold, Lead and Mercury: We understand, that you have set higher specs for the below (compared
to Herbalife Specs) based on natural batch variation, but can you confirm based on the results on the
attached COA(lot# 2160025692/10), that if tested, this material will meet Herbalife Specs as listed below?

a. Yeast and Mold: ≤300 cfu/g

b. Lead: 1 ppm max
c. Mercury: 0.5 ppm max

2. E coli: We understand that the spec for E coli is set at < 3 mpn/g (based on BAM). Is < 3 mpn/g also the
detection limit of the method? Can you confirm that a minimum sample size of 10 g was used for testing E
coli?

3. S aureus: We understand that the spec for S aureus is set at < 10 cfu/g (based on BAM). Is < 10 cfu/g also the
detection limit of the method? Can you confirm that a minimum sample size of 10 g was used for testing S
aureus?

S No Parameter Herbalife Specification Method Spec/ PDS COA Comments

Your spec for Yea
you reduce your s
Yeast & Mold BAM, USP or forward ? If not, p
1 ≤300 cfu/g < 500cfu/g < 500cfu/g
Count equivalent
Can you confirm
this material will
None detected when
BAM, USP or Can you confirm
2 E coli tested in a sample size < 3 mpn/g < 3 mpn/g
equivalent detection limit of
of 10 gm min
None detected when
BAM, USP or Can you confirm
3 S aureus tested in a sample size < 10 cfu/g < 10 cfu/g
equivalent the detection lim
of 10 gm min
5
 Your spec for Lea
4 Lead 1 ppm max ICP‐MS or equivalent 2 ppm max 2 ppm max your spec from 2
not, please let us

Your spec for Me

5 Mercury 0.5 ppm max ICP‐MS or equivalent 1 ppm max 1 ppm max reduce your spec
forward ? If not, p

I look forward to your response at the earliest possible. Thank you for understanding.

Thanks and Regards,

Divya Narasimhan| Sr. Specialist ‐ Documents Control| Quality Assurance|

Herbalife |

From: Kishan H R
Sent: May 09 2019 16:38
To: Divya Narasimhan <[email protected]>
Cc: Sumit Nitnaware <[email protected]>; Shashi Shekhar <[email protected]>; Jesus Ortega‐Haquet
<[email protected]>
Subject: RE: [External] Re: Reg: Natural Caffeine Powder (Anhydrous) (2160025692/10), R00504

COA Attached with result mentioned against specs.

The link ed image cannot be display ed. The file may hav e been mov ed, renamed, or deleted. Verify that the link points to the correct file and location.

Regards,

H R KishanI Senior Buyer– Global Strategic SourcingI India

Herbalife Nutrition I #Condor Mirage, 101/1, Richmond Road, Bangalore‐560025, India

Board# 91‐ 80‐ 46011300|Direct# 91‐80‐ 46011318| Mobile‐07899150918

Email : [email protected]

6
From: Kishan H R
Sent: 09 May 2019 04:36 PM
To: Divya Narasimhan <[email protected]>
Cc: Sumit Nitnaware <[email protected]>; Shashi Shekhar <[email protected]>; Jesus Ortega‐Haquet
<[email protected]>
Subject: RE: [External] Re: Reg: Natural Caffeine Powder (Anhydrous) (2160025692/10), R00504

Dear Divya,

I have received the documents from Synthite team, Attached FYI.

I would request you to please attach in ARCO as well.

The link ed image cannot be display ed. The file may hav e been mov ed, renamed, or deleted. Verify that the link points to the correct file and location.

Regards,

H R KishanI Senior Buyer– Global Strategic SourcingI India

Herbalife Nutrition I #Condor Mirage, 101/1, Richmond Road, Bangalore‐560025, India

Board# 91‐ 80‐ 46011300|Direct# 91‐80‐ 46011318| Mobile‐07899150918

Email : [email protected]

From: Divya Narasimhan

Sent: 06 May 2019 12:19 PM
To: Aniket Ramesh Ingale (Synthite Bangalore) <[email protected]>
Cc: Kishan H R <[email protected]>; Dr Viju Jacob (Synthite Kolenchery) ([email protected])
<[email protected]>; John Joshy Kondody (Synthite Kolenchery) ([email protected])
<[email protected]>; Binu Skaria(Synthite Kolenchery) ([email protected])
<[email protected]>; Sumit Nitnaware <[email protected]>; Shashi Shekhar <[email protected]>;
Jesus Ortega‐Haquet <[email protected]>
Subject: RE: [External] Re: Reg: Natural Caffeine Powder (Anhydrous) (2160025692/10), R00504

7
Dear Aniket,

Thank you for your email.

Please note my comments below and kindly help address these:

List of pending items:

1. Certificate of Analysis(COA) and PDS:

a) Attached COA indicates lot# 2160025692/10. This is also on the PDS. Can the lot#
2160025692/10, Sample Number & Qty and Mfg. Date, be removed from the PDS, as this gives
the impression that the PDS is “lot” specific.

b) Attached COA lot# 2160025692/10 indicates the “Result” column as “Specification”.

Can this be indicated as “Results” for more clarity.

c) Total Plate Count (< 10000 cfu/g) and Total Yeast & Mold (< 500 cfu/g) actual values are
not reported on COA lot#2160025692/10. Are these values also the detection limit of the
method? If not, can actual values be reported on the COA for these parameters going forward.

2. Allergen Statement(ALR): Please fill out the attached Herbalife Allergen template or confirm the absence of
below in this material, as the attached Allergen Statement that was provided does not cover these:

a. Tree Nuts, and products thereof (provide type of nuts e.g. Almonds, Beech Nuts, Brazil Nuts,
Butternut, Cashews, Chestnuts, Chinquapin, Coconut, Hazelnut/Filbert, Ginkgo Nuts, Hickory Nuts,
Lychee Nuts, Macadamia Nuts, Pecans, Pine Nuts, Pili Nuts, Pistachio, Shea Nut, Walnuts,
Queensland Nuts).

b. Wheat, and products thereof.

c. Natural Latex.

d. Gluten [Wheat (including Spelt and Kamut), Oats, Barley, Rye and Triticale].

3. Composition / Full Disclosure(CMP): Please provide a composition statement of this material.

4. Harmonized Tariff Schedule(HTS): The attached HTS document is missing the HTS number. We can accept
your response on the HTS via email as well.
5. Nutritional Information(NUT): Please provide a nutritional statement for this material.
6. Storage Conditions(STO): Please provide the storage conditions for this material. Please note that we cannot
accept this information on the MSDS. Kindly add this to the PDS or provide a separate statement.
7. Non‐BSE Statement(BSE): Please provide a Non‐BSE Statement for this material.

8
Additionally, please help address the below on the PDS and COA:

1. Yeast & Mold, Lead and Mercury: We understand, that you have set higher specs for the below (compared
to Herbalife Specs) based on batch variation, but can you confirm based on the results on the attached
COA(lot# 2160025692/10), that if tested, this material will meet Herbalife Specs as listed below?

a. Yeast and Mold: ≤300 cfu/g

b. Lead: 1 ppm max
c. Mercury: 0.5 ppm max

2. E coli: We understand that the spec for E coli is set at < 3 mpn/g (based on BAM). Is < 3 mpn/g also the
detection limit of the method? Can you confirm that a minimum sample size of 10 g was used for testing E
coli?

3. S aureus: We understand that the spec for S aureus is set at < 10 cfu/g (based on BAM). Is < 10 cfu/g also the
detection limit of the method? Can you confirm that a minimum sample size of 10 g was used for testing S
aureus?

S No Parameter Herbalife Specification Method Spec/ PDS COA Comments

Your spec for Yea
you reduce your s
Yeast & Mold BAM, USP or forward ? If not, p
1 ≤300 cfu/g < 500cfu/g < 500cfu/g
Count equivalent
Can you confirm
this material will
None detected when
BAM, USP or Can you confirm
2 E coli tested in a sample size < 3 mpn/g < 3 mpn/g
equivalent detection limit of
of 10 gm min
None detected when
BAM, USP or Can you confirm
3 S aureus tested in a sample size < 10 cfu/g < 10 cfu/g
equivalent the detection lim
of 10 gm min
Your spec for Lea
4 Lead 1 ppm max ICP‐MS or equivalent 2 ppm max 2 ppm max your spec from 2
not, please let us

Your spec for Me

5 Mercury 0.5 ppm max ICP‐MS or equivalent 1 ppm max 1 ppm max reduce your spec
forward ? If not, p

I look forward to your response at the earliest possible. Thank you for understanding.

9
Thanks and Regards,

Divya Narasimhan| Sr. Specialist ‐ Documents Control| Quality Assurance|

Herbalife | #15, RMZ Pinnacle, Commissariat Road, Bengaluru ‐ 560025 |

Phone: 080 46442176 ext.‐75062198 | Mobile +91 9148785937 | [email protected]

From: Aniket Ramesh Ingale (Synthite Bangalore) <[email protected]>

Sent: May 06 2019 09:49
To: Divya Narasimhan <[email protected]>
Cc: Kishan H R <[email protected]>; Dr Viju Jacob (Synthite Kolenchery) ([email protected])
<[email protected]>; John Joshy Kondody (Synthite Kolenchery) ([email protected])
<[email protected]>; Binu Skaria(Synthite Kolenchery) ([email protected])
<[email protected]>; Sumit Nitnaware <[email protected]>; Shashi Shekhar <[email protected]>
Subject: [External] Re: Reg: Natural Caffeine Powder (Anhydrous) (2160025692/10), R00504

CAUTION: This email originated from outside of the organization. Do not click links or open attachments unless you recognize
the sender and know the content is safe.

Dear Divya,

Kindly find attached list of documents, we have already submitted a sample of 1 Kg, sample has been delivered on
4th April in Richmond road office.

COA for the same is attached in the documents zip file, we will share the composition statement soon as caffeine is a
pure extract from

coffee there aren't any additives in the product.

we will submit the chromatograph soon.

reagrding TYMC, e coli & s aureus, lead & mercury, the source of the product is natural green coffee beans & they
are bound to fluctuate from batch to batch, depending upon change in climatic conditions.

10
that's the reason why we have considered higher range.

Free Sample despatched details

Inbox x

Synthite Customer Service <[email protected]> Thu, Apr 4, 8:40 AM

to kishanh, customerservice, me

Item Details

Sample No/Item Code / Item Description/Quantity/UoM

2160030471/10/NEWPRODUCT/CAFFEINE/1.000 /kg

Provide the tracking number in the below site to track the consignment.

Way Bill No. R50102340 / www.dtdc.com

11
 The link ed image cannot be display ed. The file may hav e been mov ed, renamed, or deleted. Verify that the link points to the correct file and location.

Best Regards,

Aniket Ingale

Regional Sales Manager - South

The link ed image cannot

be d isplay ed. The file may
hav e been mov ed,
ren amed, or deleted.
Verify that the link poin ts
to the correct file and
location.

Synthite Industries Ltd | Pathi Resham, No 39,Krishnagar Industrial Area,

Dharamaram College Post, Hosur Road | Bangalore - 560 029

T + 91 080 25503692| M + 91 9353017604| F + 91 080 25503691

E [email protected] | W www.synthite.com

INDIA | CHINA | SRILANKA | BRAZIL | USA

On Fri, May 3, 2019 at 12:11 PM Divya Narasimhan <[email protected]> wrote:

Hi All,

I have updated the list of documents below with the additional request for a Non‐BSE Statement(BSE).

Thanks and Regards,

12
Divya Narasimhan| Sr. Specialist ‐ Documents Control| Quality Assurance|

Herbalife | #15, RMZ Pinnacle, Commissariat Road, Bengaluru ‐ 560025 |

Phone: 080 46442176 ext.‐75062198 | Mobile +91 9148785937 | [email protected]

From: Kishan H R
Sent: May 02 2019 16:19
To: [email protected]
Cc: Divya Narasimhan <[email protected]>; Dr Viju Jacob (Synthite Kolenchery) ([email protected])
<[email protected]>; John Joshy Kondody (Synthite Kolenchery) ([email protected])
<[email protected]>; Binu Skaria(Synthite Kolenchery) ([email protected])
<[email protected]>
Subject: RE: Reg: Natural Caffeine Powder (Anhydrous) (2160025692/10), R00504

Looping Synthite team to expedite this project.

The link ed image cannot be display ed. The file may hav e been mov ed, renamed, or deleted. Verify that the link points to the correct file and location.

Regards,

H R KishanI Senior Buyer– Global Strategic SourcingI India

Herbalife Nutrition I #Condor Mirage, 101/1, Richmond Road, Bangalore‐560025, India

Board# 91‐ 80‐ 46011300|Direct# 91‐80‐ 46011318| Mobile‐07899150918

Email : [email protected]

From: Divya Narasimhan

Sent: 02 May 2019 02:27 PM
To: [email protected]
Cc: Kishan H R <[email protected]>
Subject: Reg: Natural Caffeine Powder (Anhydrous) (2160025692/10), R00504
Importance: High

Dear Aniket,
13
Hope this finds you well.

I am reaching out to you with the below document request for Natural Caffeine Powder (Anhydrous)
(2160025692/10), R00504 as we are in the process of internally qualifying it for use. I have attached the COA and
some templates also for your convenience, to provide the information requested.

Please also kindly provide 3 X100g sample from the same lot (accompanied with a COA and ID Chromatogram) to
the following address. Kindly email me the tracking number once the samples are dispatched.

H R Kishan I Senior Buyer– Global Strategic Sourcing I India

Herbalife Nutrition I #Condor Mirage, 101/1, Richmond Road, Bangalore‐560025, India

Board# 91‐ 80‐ 46011300|

List of documents required:

1. Certificate of Analysis(COA) (Current COA)

2. Allergen Statement(ALR) (Please fill out the attached template)
3. Composition / Full Disclosure(CMP)
4. Harmonized Tariff Schedule(HTS)
5. Nutritional Information(NUT)
6. Shelf Life(SHE)
7. Storage Conditions(STO)
8. Non‐BSE Statement(BSE)

Additionally, please help address the below on the PDS and COA:

S No Parameter Herbalife Specification Method Spec/ PDS COA Comments

Your spec for Ye
Yeast & Mold BAM, USP or
1 ≤300 cfu/g < 500cfu/g < 500cfu/g you reduce your
Count equivalent
forward ? If not,

14
 None detected when
BAM, USP or Can you confirm
2 E coli tested in a sample size < 3 mpn/g < 3 mpn/g
equivalent detection limit o
of 10 gm min
None detected when
BAM, USP or Can you confirm
3 S aureus tested in a sample size < 10 cfu/g < 10 cfu/g
equivalent the detection lim
of 10 gm min
Your spec for Le
4 Lead 1 ppm max ICP‐MS or equivalent 2 ppm max 2 ppm max your spec from 2
not, please let u

Your spec for M

5 Mercury 0.5 ppm max ICP‐MS or equivalent 1 ppm max 1 ppm max reduce your spe
forward ? If not,

I look forward to your response at the earliest possible. Thank you for understanding.

Thanks and Regards,

Divya Narasimhan| Sr. Specialist ‐ Documents Control| Quality Assurance|

Herbalife | #15, RMZ Pinnacle, Commissariat Road, Bengaluru ‐ 560025 |

Phone: 080 46442176 ext.‐75062198 | Mobile +91 9148785937 | [email protected]

‐‐

For Email Disclaimer, please visit http://www.synthite.com/synthite/EmailDisclaimer.html

‐‐

Best Regards,

15
 Aniket Ingale

Regional Sales Manager - South

The link ed image cannot

be d isplay ed. The file may
hav e been mov ed,
ren amed, or deleted.
Verify that the link poin ts
to the correct file and
location.

Synthite Industries Ltd | Pathi Resham, No 39,Krishnagar Industrial Area,

Dharamaram College Post, Hosur Road | Bangalore - 560 029

T + 91 080 25503692| M + 91 9353017604| F + 91 080 25503691

E [email protected] | W www.synthite.com

INDIA | CHINA | SRILANKA | BRAZIL | USA

‐‐

Best Regards,

Aniket Ingale

Regional Sales Manager - South

The link ed image cannot

be d isplay ed. The file may
hav e been mov ed,
ren amed, or deleted.
Verify that the link poin ts
to the correct file and
location.

Synthite Industries Ltd | Pathi Resham, No 39,Krishnagar Industrial Area,

Dharamaram College Post, Hosur Road | Bangalore - 560 029

T + 91 080 25503692| M + 91 9353017604| F + 91 080 25503691

E [email protected] | W www.synthite.com

INDIA | CHINA | SRILANKA | BRAZIL | USA

For Email Disclaimer, please visit http://www.synthite.com/synthite/EmailDisclaimer.html

‐‐

Best Regards,

Aniket Ingale

Regional Sales Manager - South

The link ed image cannot

be d isplay ed. The file may
hav e been mov ed,
ren amed, or deleted.
Verify that the link poin ts
to the correct file and
location.

Synthite Industries Ltd | Pathi Resham, No 39,Krishnagar Industrial Area,

16
Dharamaram College Post, Hosur Road | Bangalore - 560 029
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17
Divya Narasimhan

From: Aniket Ramesh Ingale (Synthite Bangalore) <[email protected]>

Sent: May 14 2019 17:40
To: Divya Narasimhan
Cc: Sumit Nitnaware; Shashi Shekhar; Jesus Ortega-Haquet; Kishan H R; Sruthi Liz Kuriakose (Synthite
Kolenchery)
Subject: Re: [External] Re: Reg: Natural Caffeine Powder (Anhydrous) (2160025692/10), R00504
Attachments: image007.png; reherbalifedocumentation.zip; PIS-2160025692-10.pdf

Dear Divya,

Kindly find attached non BSE statement, STO declaration, MOA for caffeine & allergen control plan used for cleaning the
manufacturing facility thoroughly before change over to the new product extraction.

1. PDS (Product Data Sheet): PDS is missing in the attached, kindly provide updated PDS with the lot#
2160025692/10, Sample Number & Qty and Mfg. Date, removed.

Updated product data sheet is attached for your reference.

2. E coli: We understand that the spec for E coli is set at < 3 mpn/g (based on BAM method). Is < 3 mpn/g also the
detection limit of the method? Can you confirm that a minimum sample size of 10 g was used for testing E coli?
‐ We confirm the minimum sample was 10 g

3. S aureus: We understand that the spec for S aureus is set at < 10 cfu/g (based on BAM method). Is < 10 cfu/g
also the detection limit of the method? Can you confirm that a minimum sample size of 10 g was used for
testing S aureus? ‐ We confirm the minimum sample was 10 g

4. ID: Method of analysis, reference standard used for testing sigma standard. ‐ Reference standard used for ID
chromatograph was sigma standard.

5. Allergen Control Program: CIP flow chart. ‐ Attached

6. Nutritional Information ‐ We have sent the sample to third party lab for analysis.

Non‐BSE Statement(BSE) ‐ Attached

1
On Mon, May 13, 2019 at 3:00 PM Divya Narasimhan <[email protected]> wrote:

Dear Aniket,

Thank you very much for your email and for working on this request.

I have summarised the pending items below:

1. PDS (Product Data Sheet): PDS is missing in the attached, kindly provide updated PDS with the lot#
2160025692/10, Sample Number & Qty and Mfg. Date, removed.

2. E coli: We understand that the spec for E coli is set at < 3 mpn/g (based on BAM method). Is < 3 mpn/g also the
detection limit of the method? Can you confirm that a minimum sample size of 10 g was used for testing E coli?

3. S aureus: We understand that the spec for S aureus is set at < 10 cfu/g (based on BAM method). Is < 10 cfu/g
also the detection limit of the method? Can you confirm that a minimum sample size of 10 g was used for
testing S aureus?

4. ID: Method of analysis, reference standard used for testing sigma standard.

5. Allergen Control Program: CIP flow chart.

6. Nutritional Information.

7. Non‐BSE Statement(BSE)

Look forward to your response at the earliest.

Thanks and Regards,

2
Divya Narasimhan| Sr. Specialist ‐ Documents Control| Quality Assurance|

Herbalife | #15, RMZ Pinnacle, Commissariat Road, Bengaluru ‐ 560025 |

Phone: 080 46442176 ext.‐75062198 | Mobile +91 9148785937 | [email protected]

From: Aniket Ramesh Ingale (Synthite Bangalore) <[email protected]>

Sent: May 13 2019 13:36
To: Divya Narasimhan <[email protected]>
Cc: Sumit Nitnaware <[email protected]>; Shashi Shekhar <[email protected]>; Jesus Ortega‐Haquet
<[email protected]>; Kishan H R <[email protected]>; Sruthi Liz Kuriakose (Synthite Kolenchery)
<[email protected]>
Subject: Re: [External] Re: Reg: Natural Caffeine Powder (Anhydrous) (2160025692/10), R00504

Dear Divya,

Kindly find attached reply on below mentioned points.

1.PDS and Certificate of Analysis(COA):

a) On attached PDS, can the lot# 2160025692/10, Sample Number & Qty and Mfg. Date, be
removed from the PDS, as this gives the impression that the PDS is “lot” specific ‐ Corrected
Product Data Sheet is attached in the mail.

b) Total Plate Count (< 10000 cfu/g) and Total Yeast & Mold (< 500 cfu/g) actual values are
not reported on COA lot#2160025692/10. Are these values also the detection limit of the
method? If not, can actual values be provided for COA lot#2160025692/10, can actual results be
reported going forward, on the COA ‐ These are actual values only, we are sure that in future
batches the microbiology results will be under herbalife permissible limits.

2. ID chromatogram: Can you confirm attached ID chromatogram is for lot#2160025692/10, as the lot
number is not indicated. Additionally, please confirm which of these is the reference standard. We need the
chromatogram of both the sample (lot#2160025692/10) and reference standard ‐ Corrected ID
chromatograph is attached for your reference, we will share the Method of analysis, reference standard
used for testing sigma standard.

3
 3.Allergen Statement(ALR): Since the attached Allergen statement indicates some allergens as “present in the
same manufacturing plant”, can you please provide your Allergen Control Program ‐ As explained we are
doing change over from product to product which comprises of steam washing of complete plant along
with cleaning in place with cleaning agent, flow chart for the same will be submitted by end of the day.
4.Nutritional Information(NUT): Please provide a nutritional statement for this material. ‐ Sample has been sent
to third party lab for nutritional data analysis, the results are expected within 8‐10 working days.

5. Storage Conditions(STO): Please provide the storage conditions for this material. Please note that we
cannot accept this information on the MSDS. Kindly add this to the PDS or provide a separate statement.
Email statement is also acceptable ‐ You need to keep the drum in sealed condition in cool and dry place
without any exposure to the sun & moisture.

6. Non‐BSE Statement(BSE): Please provide a Non‐BSE Statement for this material ‐ Non‐BSE statement will
be sent to you by the end of the day.

Additionally, please help address the below on the PDS and COA:

1.Yeast & Mold, Lead and Mercury: We understand, that you have set higher specs for the below (compared to
Herbalife Specs) based on natural batch variation, but can you confirm based on the results on the attached
COA(lot# 2160025692/10), that if tested, this material will meet Herbalife Specs as listed below? ‐ Our
product test results will be within herbalife specs for all the supplies.

On Fri, May 10, 2019 at 11:28 AM Divya Narasimhan <[email protected]> wrote:

Dear Aniket,

Thank you for the documents.

Any updates on our request for samples for lot#2160025692/10? Please note that a 150g sample would suffice. If
available, please kindly send to Kishan’s attention.

4
Chaithra .

From: Shaiju T H (Synthite Kolenchery) <[email protected]>

Sent: Tuesday, May 28, 2024 4:59 PM
To: Samyukta Hegde
Cc: Manjula (Synthite Kolenchery); Jerin joseph (Synthite Kolenchery); Anu Varghese
(Synthite Kolenchery); Shibin I J; Krishnakumar T (Synthite Kolenchery)
Subject: Re: [External] Re: Document request: R00504 CAFFEINE POWDER, NATURAL----
EC186200
Attachments: INGREDIENT STATEMENT-5010000676 (1).pdf; Herba life PIS-5010000676.pdf; Herba
life COA 421H231726 (1) (1).pdf; Herba life COA 421K230311 (1).pdf

Follow Up Flag: Follow up

Flag Status: Flagged

Dear Samyukta,

1. We have received samples 2800014529/10 (400g) and 2800014529/20(100g). Only these sample
numbers are indicated on the label. Could you please provide the actual lot numbers and COA
for the samples? Two COAs Attached.
2. PDS is missing below parameters, can these be added? PIS Updated and Attached

Parameter Specification
Pesticide Residue 213 Per FSSAI
Melamine 2.5 ppm max

3. We understand that lot# 421H231726 not tested for below parameters. Could you please provide
future COA template for below parameters, and can you please acknowledge on below spec and
test frequency? We can provide Bacillus cereus and Sulfite reducing clostridia (SRC) in every
lot in future consignments. As per FSSAI we are testing the highlighted parameters every
6 months

Parameter Specification Test Frequency

Pesticide 213 Per FSSAI First 3 delivery lots and once a
Residue year
Copper 30 ppm max First 3 delivery lots and once a
year
1
 Tin 250ppm max First 3 delivery lots and once a
year
Melamine 2.5 ppm max First 3 delivery lots and once a
year
Methyl mercury 0.25 ppm max First 3 delivery lots and once a
year
Bacillus cereus ≤100 cfu/g (IS 5887 Part 6 or ISO Each lot
7932)
Sulfite reducing ≤100 cfu/g ( ISO 15213) Each lot
clostridia (SRC)

4. Composition statement doesn’t indicate the % range of ingredient. Is this 100% NATURAL
CAFFEINE POWDER? Attached
5. Please provide Storage condition: PIS updated

Thanks and Regards,

Samyukta Hegde| Document Specialist, Quality Assurance

| Prestige Shantiniketan, Tower-C, White Field Main Road, Bangalore 560048

Mobile: +91 7795677545 | [email protected]

From: Shaiju T H (Synthite Kolenchery) <[email protected]>

Sent: Monday, May 27, 2024 4:08 PM
To: Samyukta Hegde <[email protected]>
Cc: Manjula (Synthite Kolenchery) <[email protected]>; Jerin joseph (Synthite Kolenchery)
<[email protected]>; Anu Varghese (Synthite Kolenchery) <[email protected]>; Shibin I J
<[email protected]>; Krishnakumar T (Synthite Kolenchery) <[email protected]>
Subject: [External] Re: Document request: R00504 CAFFEINE POWDER, NATURAL---- EC186200

Dear Samyukta,

2
Samyukta Hegde

From: Shaiju T H (Synthite Kolenchery) <[email protected]>

Sent: Monday, June 10, 2024 5:11 PM
To: Samyukta Hegde
Cc: Manjula (Synthite Kolenchery); Jerin joseph (Synthite Kolenchery); Anu Varghese (Synthite Kolenchery); Shibin I J; Krishnakumar T (Synthite
Kolenchery); Divya Narasimhan
Subject: Re: [External] Re: Document request: R00504 CAFFEINE POWDER, NATURAL---- EC186200
Attachments: PFD-5010000676 (1).pdf; Declaration 5010000676.pdf

Follow Up Flag: Follow up

Flag Status: Flagged

Dear Samyukta,

Please have the documents.

On Tue, Jun 4, 2024 at 10:44 AM Samyukta Hegde <[email protected]> wrote:

Hi Shaiju,

Thanks for providing the documents. Kindly address below comments,

1. Per Old mfg flow chart, material is extracted via hot water extraction, where in new mfg flow chart, extraction process via water and calcium
hydroxide. Please clarify.

Attached

1
 2. In all previous documents material name provided as “Natural Caffeine Powder (Anhydrous)”, where in new documents “NATURAL CAFFEINE
EXTRACT 98.5%”. Please let us know why material name has been changed. Please provide product code equivalence statement, if both are
same.

Declaration attached

3. Please confirm the testing frequency for Total Aflatoxins (B1+B2+G1+G2), Aflatoxin B1 (Herbalife testing frequency is ‘First 3 delivery lots and
once a year’).

We can provide the result for every batch

Thanks and Regards,

Samyukta Hegde| Document Specialist, Quality Assurance

| Prestige Shantiniketan, Tower-C, White Field Main Road, Bangalore 560048

Mobile: +91 7795677545 | [email protected]

From: Shaiju T H (Synthite Kolenchery) <[email protected]>

Sent: Tuesday, May 28, 2024 4:59 PM
To: Samyukta Hegde <[email protected]>
Cc: Manjula (Synthite Kolenchery) <[email protected]>; Jerin joseph (Synthite Kolenchery) <[email protected]>; Anu Varghese (Synthite Kolenchery)