Sunett Quality Information Pack

Specialty Food & Pharma
Ingredients you can trust

Quality Information Pack
(Acesulfame K)
Released by: Version December 2022
Giacomo Vitarelli Frank Goergen

Director Business Food Ingredients Sr. Manager Quality & Food Safety
Food Ingredients
Disclaimer
The information presented in this Sunett ® Quality Information Pack is based on our present
state of knowledge and is intended to provide general notes on our products and their uses.
It must not be construed as guaranteeing specific properties of the products described herein
or their suitability for a particular application. The user of Sunett ® is solely responsible for
investigating whether existing patents are infringed by the use of Sunett®. Additionally, the
user is solely responsible for investigating and checking the regulatory approval status with
respect to any intended use of Sunett®. Any sales and/or the deliveries of Sunett® are always
subject to our General Terms and Conditions, unless otherwise agreed between the parties
in writing. Any reference to laws, regulations, standards, guidelines etc. refers to such laws,
regulations, standards, guidelines etc. as in force and effect as of December 2022.
This Sunett® Quality Information Pack supersedes all provisions and concepts contained in
any and all prior Sunett® quality information packs.
Table of Contents
page
1. CONTACTS .......................................................................................................................4
2. GENERAL INFORMATION ................................................................................................5
3. PRODUCTION...................................................................................................................5
3.1 Production Process of Sunett® .........................................................................................5
3.2 Production Flow Chart ......................................................................................................5
3.3 Source of Sunett® ............................................................................................................6
3.4 Manufacture of Sunett® (in Germany only) .......................................................................6
3.5 Ingredient Declaration .......................................................................................................6
3.6 Change Control System ....................................................................................................6
3.7 Lot Size..............................................................................................................................7
3.8 Irradiation ..........................................................................................................................7
3.9 Pest Control .......................................................................................................................7
3.10 Cleaning Agents ...............................................................................................................7
3.11 Personal and Plant Hygiene Program ................................................................................7
3.12 Foreign Object Recognition in the Production of Sunett® .................................................7
3.13 Traceability / Retained sample ...........................................................................................8
4. PACKAGING AND LABELING ...........................................................................................8

4.1 Packaging and Coding .......................................................................................................8
4.2 Labeling, Storage and Distribution, Storage Conditions .....................................................9
4.3 Product Label (example) ..................................................................................................10
5 PROPERTIES..................................................................................................................11
5.1 Structural Formula of Sunett® .........................................................................................11
5.2 Analytical Laboratory .......................................................................................................11
5.3 Microbiological Properties ................................................................................................12
5.4 Food Grade Compliance ..................................................................................................12
5.4.1 Product Specification Sunett® Food Grade ....................................................................13
5.4.2 Certificate of Analysis Food Grade (example) ..................................................................14
5.5 Pharma Grade Compliance..............................................................................................15
5.5.1 Product Specification Pharma Grade ...............................................................................15
5.5.2 Certificate of Analysis Pharma Grade (example) ..............................................................17
5.5.3 Compliance to ICH Q3C Guideline for Residual Solvents ..............................................18
5.5.4 Compliance regarding ICH Q3D Guideline on Elemental Impurities ................................18
5.5.5 IPEC risk evaluation regarding nitrosamine......................................................................18
5.6 Allergens ..........................................................................................................................18
5.7 Genetically Modified Organisms (GMO) ..........................................................................19
5.8 Nutritional Information ......................................................................................................19
5.9 Vegan Statement .............................................................................................................20
5.10 Absence of Specific Substances ......................................................................................20
Page 2 of 36
Celanese Food Ingredients Quality Information Pack
Global Quality Management Sunett®
5.10.1 Non-containing Dioxins, PCBs or PHAs ...........................................................................20
5.10.2 Mycotoxin Data ................................................................................................................21
5.10.3 Nitrofen ............................................................................................................................21
5.10.4 Latex ................................................................................................................................21
5.10.5 Compliance with the California Proposition 65 .................................................................21
5.10.6 Compliance with Toxic Substance Control Act (TSCA) ...................................................21
5.10.7 Non-containing Substances mentioned in the Prohibited List of WADA ..........................21
5.10.8 Palm Oil ..........................................................................................................................21
5.10.9 Transmitting Animal Spongiform Encephalopathy / Certificate of Suitability .....................21
5.10.10 Absence of ethylene oxide and 2-chloroethanol ...............................................................22
5.11 Animal Non-Testing Declaration.......................................................................................22
6 QUALITY AND FOOD SAFETY MANAGEMENT .............................................................22

6.1 DIN EN ISO Certification ..................................................................................................22
6.2 Good Manufacturing Practice (GMP) of Sunett® ............................................................22
6.3 HACCP + Flow Chart .......................................................................................................22
6.4 HARPC according to the FDA Preventive Controls Rule .................................................24
6.5 Shelf Life Certificate Sunett® and Stability Testing Program (IPEC) ................................24
6.6 Supplier Approval ............................................................................................................25
6.7 Sustainability....................................................................................................................25
6.8 Kosher Certification..........................................................................................................25
6.9 Halal Certification .............................................................................................................25
6.10 Food Safety and Security Management System .............................................................25
7 QUESTIONS & ANSWERS .............................................................................................27
8 ATTACHMENT ................................................................................................................34
8.1 ICH Q3C - Residual Solvents ...........................................................................................34
8.2 Table and Report according to ICH – Q3D-Guideline for Elemental Impurities.................35
8.3 GMO Questionnaire .........................................................................................................36
Page 3 of 36
1. CONTACTS
Address: Nutrinova Germany GmbH

Am Unisys-Park 1
65843 Sulzbach (Taunus)
Germany
Production Facility: Sunett® Plant

Building D 483
Industriepark Höchst
65926 Frankfurt / Main
Germany
Quality Contact: Mr. Frank Goergen

Sr. Manager Quality & Food Safety
Phone: +49 69 45009 1378
E-mail: frank.goergen@celanese.com
Product Stewardship/
Regulatory Contact: Dr. Mari Stavanja
Fellow Product Stewardship
Phone: +1 972 443 4983
E-mail: mari.stavanja@celanese.com
Contact for Sales/

General Inquiries
EMEA: foodingredients-emea@celanese.com
Asia: foodingredients-AP@celanese.com
Americas: foodingredients-AM@celanese.com
Web: https://www.celanese.com/about-us/food-ingredients
Emergency Contact: 24 h Emergency No: +49 69 305 6418

(Please contact only in emergency situations)
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2. GENERAL INFORMATION
Sunett® (Acesulfame K) is manufactured in a closed production system which meets all legal
requirements for environmental protection and plant safety.
A modern computer-supported process routing system controls the production process. The continuous
in-process-control shall provide a constant high quality of the operation of the manufacturing process,
as well as a constant product quality.
Safety and quality-relevant control points are registered in a database and are frequently monitored.
The results of this monitoring are documented in writing and are available if needed. At Celanese Food
Ingredients, the HACCP (Hazard Analysis and Critical Control Points) program and additionally
Hazards Analysis Risk-Based Preventive Controls (HARPC) have been implemented, to prevent
mistakes and hazards and to achieve a predictable product quality. Employees are checking the critical
control points and risk-based preventive controls according to schedule.
All raw materials are obtained from authorized suppliers and are checked according to a testing plan.
The operations of the manufacturing process as well as the application of state-of-the-art technology
require qualified personnel. A training plan is drawn up every year for each employee. The
implementation of the plan is continuously checked.
Whereas the production itself is a closed system, the finished product encounters the environment in
the filling area for the first time. Consequently, the hygienic demands on employees, plant and
packaging are very high.
3. PRODUCTION
3.1. Production Process of Sunett®

The high-intensity sweetener Sunett® (Acesulfame K) is manufactured synthetically according to a
process developed by former Hoechst AG / Celanese Food Ingredients, Germany, through the
cyclization of acetoacetamide-N-sulfonic acid with sulphur trioxide and the neutralization with potassium
hydroxide.
3.2 Production Flow Chart
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Celanese Food Ingredients has developed SOPs for plan hygiene. Below there are the most frequent
questions:
Premises and Facilities

Are floor drains equipped with Back Flow Prevention Devices? Yes
Are there separate areas for receipt, identification, sampling and Yes
quarantine of incoming materials, pending release or rejection
Are there separate areas for holding rejected materials before further Yes
disposition (e.g. return, reprocessing or destruction)
Are there separate areas for Storage of released materials Yes
3.3 Source of Sunett®
Source YES NO
Animal X
Vegetable X
Mineral X
Natural X
Nature Identical X
Chemical/Synthetic X
3.4 Manufacture of Sunett® (in Germany only)

Celanese Food Ingredients high-intensity sweetener Sunett® (Acesulfame K) is manufactured in
Germany by:
Nutrinova Germany GmbH
Am Unisys-Park 1
65843 Sulzbach (Taunus), Germany
Production Facility:
Sunett® Plant, Building D 483
Industriepark Höchst
65926 Frankfurt / Main, Germany
Nutrinova Germany GmbH is the only western manufacturer of Acesulfame K.
3.5 Ingredient Declaration

Ingredient /
Country Technical Function
Component % in
Supplier Of (e.g. emulsifier, color,
List of all ingredients Product
Origin processing aid, etc.)
contained in Sunett®
Nutrinova
Acesulfame K 100 Germany Sweetener
Germany GmbH
3.6 Change Control System

Changes with respect to our product Sunett® (Acesulfame K) and its production are subject to a Change
Control Policy which is part of Celanese Food Ingredients Food Safety & Security Management System.
According to such a change control system all changes that affect or may affect the quality / purity of
our product are subject to the prior approval by the Celanese Food Ingredients Hazards Analysis Critical
Control Point Team (HACCP) led by Celanese Food Ingredients Quality Management.
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3.7 Lot Size
The lot size of Sunett® (Acesulfame K) is defined as a 48h production. The assignment of lot numbers
(a ten digit number) is controlled by SAP. Each lot is linked to specific material numbers. The
combination of lot and material numbers guarantee a definite classification and consistent traceability.
3.8 Irradiation
Neither the starting materials nor our end product are irradiated during production. This is in compliance
with the irradiation legislation of the EU Directive 1999/2/EC as amended, the US FDA regulation 21
CFR 179 and the Japanese Food Sanitation Act.
3.9 Pest Control

Celanese Food Ingredients has an active pest control program in place, carried out by an external pest
control contractor. The company conducts all control procedures and is completing all relevant
documentation.
Methods
Insect control: UV lights are used to attract insects which then are caught on sticky film.
Any insect will be identified and counted.
Internal rodent control: Non-poisoned baited traps are positioned according to available plan.
External rodent control: Secure metal traps with toxic baits are placed externally according to
available plan.
Checking procedure
All control methods are checked weekly and once every month by the pest control company. In case of
action required, this task is conducted and documented by the pest control company. If no action is
required, the premises will be certified by the pest control company.
Documentation
The documentation is archived for ten years.
3.10 Cleaning Agents

Only cleaning agents which have been approved for use in the food sector are applied. They are diluted
according to the manufacturer’s specifications and applied according to the regulations of our cleaning
plans.
3.11 Personal and Plant Hygiene Program

The personal and plant hygiene program conforms to the requirements of the GFSI-recognized FSSC
22000 standard and other food safety standards, e.g. BRC, GMA-Safe etc.
3.12 Foreign Object Recognition in the Production of Sunett®

The Sunett® (Acesulfame K) production process takes place within a closed system. A modern,
computer-based process control system directs the course of the production process. The filling
process of the end product is conducted in special filling rooms according to the Food GMP standard.
Thus, the hygienic requirements for people, equipment and packaging materials are high. To exclude
the contamination of our product with foreign objects, we have integrated the following measures for
the recognition and avoidance of foreign objects into our production and filling processes:
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1. Filtration of the liquid sweetener
2. Sieving of the dried product, pore size less than 1000 micron / 18 U.S. Mesh.
3. Permanent magnets (9000 GAUSS) located before filling of final packages
4. Metal detectors located during / after filling process
The functional check of the metal detector is done daily, before and after filling the manufactured
batch.
Sensitivity (Cardboard Box): 2.5 mm stainless steel, 2.2 mm steel, 3.0 mm brass.
Sensitivity (Big Bag): 2.0 mm stainless steel, 1.5 mm steel, 1.8 mm brass.
Sensitivity (customized packaging): 2.5 mm stainless steel, 2.0 mm steel, 3.0 mm brass.
3.13 Traceability / Retained Sample

The European General Law Regulation 178/2002 requires a system for traceability for food ingredients
and primary packaging. Celanese Food Ingredients meets these requirements. Traceability is
warranted through all stages of purchase of raw materials, packaging materials, production, processing
and distribution and allows a complete traceability within only few hours’ time.
Celanese Food Ingredients has implemented an identification tool based on SAP in combination with
an EAN 128 bar coding system to identify shipment units and trace them back through all stages of the
supply chain to the manufacturing and packaging process. Additionally, an internationally readable
Serial Shipping Container Code (SSCC) is implemented.
For each manufactured batch we take a retained sample from final product and keep it for 6 years from
the date of manufacture.
4. PACKAGING AND LABELING
4.1 Packaging and Coding

Sunett® (Acesulfame K) is filled into 10 and 25kg cardboard boxes with polyamide inner liners or with
polyethylene inner liners depending from the grade which are closed with blue plastic quick fasteners.
The polyamide and polyethylene for the inner liner conforms to food legislation governing products in
contact with food, including Regulation (EU) 10/2011 and FDA regulations 21 CFR 177.
The packaging materials are lot numbered and traceable. The used packaging materials comply with
the Directive 1935/2004/EC.
The boxes are labeled on one side with the product name Acesulfame K and underneath with batch
number, material number, date of manufacture and best before date. They are sealed with
polypropylene adhesive tape which is printed with our company name.
Cardboard Box
In order to protect them from humidity and for transport reasons the pallet stacks are covered with a
polyethylene stretch film and get secured. To maintain the product quality, we recommend storing the
products at ambient temperature (max. 30 °C), dry (max. 65 % relative humidity), in the originally closed
packaging and protected from sunlight.
Page 8 of 36
Packaging Material Weight (kg) Size (mm)
approx.
Collapsible cardboard box (10 kg) Corrugated cardboard 0.5 384 x 180 x 230
Collapsible cardboard box (25 kg) Corrugated cardboard 0.8 384 x 280 x 280
Pallet CP1* Chamber dried wood 19 1000 x 1200 x 138
Inliner (10 kg) HDPE 0.06 290 x 700
Inliner (25 kg) HDPE 0.08 390 x 800
Packaging Material Weight (kg) Size (mm)
approx.
Inliner (10 kg) PA 0.03 480 x 700
Inliner (25 kg) PA 0.06 700 800
*Stamped with IPPC (International Plant Protection Convention)
Big Bag
The big bag is sealed using a numbered seal. The packaging unit is wrapped with a PE stretch film.
Packaging Material Weight (kg) approx. Size (mm)

Big bag 500 kg PE/PP 1.9 880 x 880 x 550
Big bag 1000 kg PE/PP 2.5 880 x 880 x 1020
MOSH/MOHA
Regarding MOSH (Mineral Oil Saturated Hydrocarbons) and MOAH (Mineral Oil Aromatic
Hydrocarbons) the packaging materials comply with the current limits set by the Federal Institute for
Risk Assessment (BfR).
The inks used for the printing of the packaging material are free of mineral oil compounds.
If the packaging material contains a functional barrier layer of plastic, its effectiveness is proved per Art.
13, para. 2, 3 and 4 or Art. 14, para. 2 and 3 of the European regulation no. 10/2011.
4.2 Labeling, Storage and Distribution, Storage Conditions

The units which are ready for dispatch can be identified and retraced at any time by the following details:
• Material number
• Lot number
• Product name
• E number
• CAS-No
• Company name and address
• Date of manufacturing
• Best before date
• Country of origin
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The finished products are stored at temperature and humidity monitored warehouse under GMP
conditions (FSSC-certified). Removal from storage takes place according to the principle of first in first
out (FIFO).
Transport and dispatch are carried out exclusively by authorized haulage contractors. The regulations
governing the dispatch of food are observed.
During the storage of our products the following requirements must be fulfilled:
• Ambient temperature: max 30°C
• Dry conditions (max 65 % relative humidity)
• Protection from direct sunlight.
If Sunett® (Acesulfame K) is stored under these conditions in unopened, originally sealed packaging
unit, the shelf life is 5 years from date of manufacturing.
4.3 Product Label (Example)

Labeling according to Globally Harmonized System of Classification and Labelling of Chemicals (GHS)
by the United Nations which was adopted by the EU under Regulation (EC) No 1272/2008 on
classification, labeling and packaging of substances and mixtures.
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5. PROPERTIES
5.1 Structural Formula of Sunett®
5.2 Analytical Laboratory

Our laboratory is situated at the Industriepark Höchst, Frankfurt, Germany and belongs to the Celanese
Group. Quality Management (QM) department is independent from production and responsible for the
whole quality control process. The laboratory conducts analytical tasks for incoming raw material, in-
process testing and for the final release of Sunett® (Acesulfame K). Release of product is controlled by
SAP.
Analytical Testing & Subcontracting (Question & Answers)
Are all analytical testing performed by an internal laboratory?

Yes, excluding microbiological conducted by an external laboratory and partly heavy metal testing.
Does your company utilize Third Parties to complete a portion of or all of the GMP related
activities?
Yes, these are according to the requirements of food GMP.
Calibration In-house
Testing of in-coming materials In-house
Testing of in-process materials In-house
Residual Solvents Testing In-house
Final release testing In-house (and/or external laboratory)
Microbiological Testing External accredited laboratory
Heavy Metal Testing In-house or external ISO certified laboratory
Retain sample policy:

We store retain samples of Sunett® (Acesulfame K) for 6 years from date of manufacture.
Page 11 of 36
5.3 Microbiological Properties
Sunett® (Acesulfame K) is produced synthetically and is virtually free from microorganisms. Any viable
microorganisms are killed at temperatures occurring during production and subsequent drying. Sunett®
is virtually free from water; therefore, it is very unlikely that microorganisms can grow on Sunett®.
Sunett® (Acesulfame K) is packed under hygienic conditions and all people involved in packing have
been properly trained and wear required protective clothing.
Microbiological testing is conducted by Institute Fresenius, an external accredited laboratory according
to the requirements of Ph. Eur. and USP-NF.
Microbiological Specification of Sunett® (Acesulfame K)
Property CFU
Total Mesophilic Count < 10 in 1 g

Yeasts < 10 in 1 g
Molds < 10 in 1 g
Enterobacteria < 10 in 1 g
Staphylococcus aureus negative in 1 g
Pseudomonas aeruginosa negative in 1 g
Escherichia coli negative in 1 g
Salmonellae negative in 10 g
5.4 Food Grade Compliance
The food quality of Sunett® fulfills the purity requirements of the FAO/WHO/CODEX/JECFA, those of
the US Food Chemicals Codex (FCC) 13th edition, the JSFA 9th edition and the EU Commission
Regulation 231/2012.
Acesulfame K has been adopted by the FAO/WHO Codex Alimentarius Commission as food additive
and approved in the US according to 21CFR 172.800, Japan according to the Japanese Food
Sanitation Act and the EU according to the Regulation (EC) No 1333/2008 and currently is going
through re-evaluation in accordance with Commission Regulation (EU) No 257/2010 of 25 March 2010
setting up a programme for the re-evaluation of approved food additives in accordance with Regulation
(EC) No 1333/2008.
Page 12 of 36
5.4.1 Product Specification Food Grade
Please contact Nutrinova Germany GmbH for the official product specification documents.
Page 13 of 36
5.4.2 Certificate of Analysis Food Grade (example)
Page 14 of 36
5.5 Pharma Grade Compliance
Sunett® is conforming to the monographs published by the European Pharmacopoeia, US
Pharmacopoeia and Japanese Pharma Excipient list. Following please find our Celanese Specification
and example of the Certificate of Analysis.
5.5.1 Product Specification Pharma Grade

Please contact Nutrinova Germany GmbH for the official product specification documents.
Page 15 of 36
Page 2:
Page 16 of 36
5.5.2 Certificate of Analysis Pharma Grade (example)
Page 17 of 36
5.5.3 Compliance to ICH Q3C Guideline for Residual Solvents
Each batch Sunett® Pharma Grade is tested with GC for Residual Solvents including Triethylamine and
Dichloromethane.
According to EP/USP General Chapter <467> Organic Volatile Impurities/Residual Solvents and the
ICH Harmonised Tripartite Guideline for residual solvents (EMA/CHMP/ICH/82260/2006) in the
updated version hereby we confirm, that no Class 1 solvents are likely to be present in Sunett ® Pharma
Grade.
Dichloromethane, as a Class 2 solvent is used during the manufacturing process. Results are on our
Certificate of Analysis. Limit for Dichloromethane per Nutrinova specification is 5 ppm. Limit according
to ICH < 600 ppm.
Triethylamine, as a Class 3 solvent is used during the manufacturing process according to GMP. Limit
for Triethylamine per Nutrinova specification is 5 ppm. Triethylamine is limited according to ICH with
GMP.
5.5.4 Compliance regarding ICH Q3D Guideline on Elemental Impurities

Sunett® (Acesulfame K) is fully in compliance with the ICH Q3D Guideline EMA/CHMP/ICH/
353369/2013 (“Guideline on elemental impurities”) and its implementation in USP-NF and Ph Eur.
5.5.5 IPEC risk evaluation regarding nitrosamine

According to IPEC a risk evaluation with regards to nitrosamine formation has been conducted. Based
on the performed risk analysis of nitrosamine contamination regarding chemical structure of the used
raw materials and the conditions of the manufacturing process of Sunett® (Acesulfame K) Pharma grade
the formation of potential Nitrosamines impurities can be ruled out.
5.6 Allergens
Allergens (Question & Answers)

Does the product contain any No,
animal or plant-derived Sunett® is manufactured synthetically without using animal or
ingredients? plant derived ingredients.
Does the product contain any No,
ingredients identified as allergens? Sunett® is manufactured synthetically without using
ingredients identified as allergens.
Is a cross-contamination possible? No,
Sunett® is manufactured synthetically in a dedicated plant. A
potential cross-contamination during mixing, filling, packaging
and storage can be ruled out because none of the allergens
listed below nor products containing allergens as listed below
are handled during manufacture and storage in the
production side.
Sunett® (Acesulfame K) complies with the EU Regulation 1169/2011, the US Food Allergen Labeling
and Consumer Protection Act and the Japanese Food Labeling Act as part of the Food Sanitation Act,
and does not contain any ingredients listed as following:
• Cereals containing gluten namely wheat, rye, barley, oats, spelt, kamut or their hybridised strains,
and products thereof
• Crustaceans and products thereof
• Eggs and products thereof
• Fish and products thereof
• Peanuts and products thereof
• Soybeans and products thereof
Page 18 of 36
• Milk and products thereof (including lactose)
• Nuts, namely: almonds (Amygdalus communis L.), hazelnuts (Corylus avellana), walnuts (Juglans
regia), cashews (Anacardium occidentale), pecan nuts (Carya illinoinensis (Wangenh) K. Koch),
Brazil nuts (Bertholletia excelsa), pistachio nuts (Pistacia vera), macadamia or Queensland nuts
(Macadamia ternifolia), and products thereof
• Celery and products thereof
• Mustard and products thereof
• Sesame seeds and products thereof
• Sulphur dioxide and sulphites
• Lupin and products thereof
• Molluscs and products thereof
• Fabaceae or Leguminosae including chick peas
• Other materials with high allergenic potential
Furthermore, Sunett® (Acesulfame K) does not contain any of the following substances or products
thereof:
garlic buckwheat coconut seasonings
millet stone fruits pine nut rice
vanillin glutamate benzoic acid maize
5.7 Genetically Modified Organisms (GMO)

Sunett® (Acesulfame K) contains no genetically modified organisms (GMO) or components and is not
obtained from genetically modified crops.
The starting materials used in the production of our Sunett® have not been manufactured by the use of
genetically modified micro-organisms. Thus, our product is not obliged to be labeled according to EU
Regulations 1829/2003 and 1830/2003 respectively nor according to the Japanese Food Sanitation
Act.
5.8 Nutritional Information

Sunett® (Acesulfame K) has the following nutritional values:
Based on 100 g Sunett® according to regulation (EC) No 1924/2006

Energy value (kcal/KJ) 0
Total Carbohydrates (g) 0
• Dietary fiber 0
• Sugars/Added Sugars 0
Fat (g) 0
Cholesterol (mg) 0
Protein (g) 0
Sodium (g) 0
Potassium (g) 19.6
Calcium (g) 0
Iron 0
Vitamin D 0
Page 19 of 36
5.9 Vegan Statement
Sunett® (Acesulfame K) is manufactured without the use of animal matter or products derived from
animal origin. At no stage of production and processing, use has been made of products of animal
origin including:
➢ ingredients (including additives, carriers, aromas, fragrances, flavorings and enzymes) or
➢ processing aids or
➢ substances which are not additives but are used in the same way and with the same purpose as
processing aids
This comprises especially:

• No meat or any other slaughter products, e.g. offal
• No fish or any other marine animals
• No eggs
• No honey
• No milk
• No wax of animals such as wool fat/lanoline, beeswax or shellac
• No fur, no leather, no silk
• No royal jelly
• No colouring agents of animal origin
• No substances, which were bleached with animal charcoal
• No substances, which were clarified with animal substances such as gelatine or fish bladder
• No substances manufactured, obtained or produced from the above-mentioned substances.
In addition, the raw materials used for the manufacture of Sunett® (Acesulfame K) are Sulfamic Acid,
Diketene and Sulphur Trioxide. The production process can be divided into the following steps:
• Chemical synthesis
• Crystallization from water
• Drying
• Packaging
• Storage
• Shipment
5.10 Absence of Specific Substances
5.10.1 Non-containing Dioxins, PCBs or PAHs

Our products comply to Commission Regulation (EC) No. 1881/2006 and do not contain Dioxins
(PCDD / FCDF) or PCBs nor polycyclic aromatic hydrocarbons.
Page 20 of 36
5.10.2 Mycotoxin Data
Sunett® (Acesulfame K) is produced synthetically without use of agricultural raw materials, which
excludes possible contamination by mycotoxins.
Does the product conform to

Mycotoxin legislative maximum levels?
YES NO N/A
Total Aflatoxins X
Aflatoxin B1 X
Ochratoxin A X
Patulin (Apples only) X
5.10.3 Nitrofen
Sunett® (Acesulfame K) does not contain any Nitrofen.
5.10.4 Latex
Latex is not used during the manufacturing process. Therefore Sunett® (Acesulfame K) does not
contain any Latex.
5.10.5 Compliance with California Proposition 65

Proposition 65 includes chemicals known to the state of California to cause cancer or reproductive
toxicity. Sunett® (Acesulfame K) is not carcinogenic or reproductive toxicant, therefore it is not listed
in the Proposition 65 list and does not require a warning label.
5.10.6 Compliance with Toxic Substance Control Act (TSCA)

Acesulfame K as a food additive (sweetener) is regulated by USFDA under the Federal Food, Drug,
and Cosmetic Act (FFDCA), therefore Sunett® (Acesulfame K) is exempted from the TSCA Inventory.
5.10.7 Non-containing Substances mentioned in the Prohibited List of WADA

None of the substances mentioned in the World Anti-Doping Agency (WADA) code of prohibited
substances are present in Sunett® (Acesulfame K). In addition, Sunett® is manufactured synthetically
in a dedicated plant, therefore a cross-contamination with any substances mentioned in the WADA
code of prohibited substances can also be ruled out.
5.10.8 Palm Oil

Palm oil, palm kernel oil and/or palm oil derivatives are not used in the manufacturing process,
furthermore, these are not stored in our manufacturing plant nor in our warehouse. So a cross-
contamination can be ruled out.
5.10.9 Transmitting Animal Spongiform Encephalopathy / Certificate of Suitability

Sunett® (Acesulfame K) is manufactured synthetically in a dedicated plant, not used for any other
purpose. All raw materials used are of petrochemicals and inorganic chemicals and no animal/
ruminant material is used.
Therefore, guideline EMA/410/01 (as revised) on minimizing the risk of transmitting animal spongiform
encephalopathy agents via human and veterinary medicinal products and a Certificate of Suitability
are not applicable for our products.
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5.10.10 Absence of ethylene oxide and 2-chloroethanol
Sunett® (Acesulfame K) has not been treated with ethylene oxide and none of the raw materials used
in the production has been treated with ethylene oxide. The presence of ethylene oxide and the
breakdown product 2-chloroethanol can therefore be ruled out.
5.11 Animal Non-Testing Declaration

Sunett® (Acesulfame K) has not been subjected to animal testing for cosmetic or toiletry applications
by our company or tested on its behalf after January 1 st, 1998, nor does it contain any material from
animal origin.
6. QUALITY AND FOOD SAFETY MANAGEMENT
6.1 DIN EN ISO Certification

Celanese Food Ingredients, including the Sunett® plant, has been certified according to the
requirements of DIN EN ISO 9001:2015, DIN EN ISO 14001:2015, both since 1997, FSSC 22000,
version 5.1 (DIN EN ISO 22000:2018, ISO/TS 22002-1:2009 and additional 22000 requirements) and
Food Defense of IFS Food Standard, version 6.1 of chapter 6. The current certificates are available at
https://www.celanese.com/certificate-search/BU_Food_Ingredients
6.2 Good Manufacturing Practice (GMP) of Sunett®

The manufacture, filling, packaging and storage of our products are conducted according to the
regulations of Current Good Manufacturing Practice (GMP) in Manufacturing, Packing, or Holding
Human Food (21 CFR Part 110 and 21 CFR Part 117). Thus, Celanese Food Ingredients provides a
very high standard of food safety and hygiene during all processing, filling and storage steps. Our safety
and hygiene system were inspected according to the requirements of FSSC 22000 standard.
6.3 HACCP
The Nutrinova Hazards Analysis Critical Control Point ( HACCP) system is based upon the principles
of the HACCP system of Codex Alimentarius (ALI-Norm 97/13, Annex 2, created by FAO/WHO), an
internationally accepted standard for food and food safety. It also fulfills the HACCP requirements of
British Retail Consortium Standard (BRC) and ISO 22.000. Additionally HACCP is part of the external
GFSI recognized FSSC 22000 certification and the Nutrinova Food Ingredients HACCP system and
plan is external audited yearly.
PRINCIPLE 1: Conduct a hazard analysis

PRINCIPLE 2: Determine the Critical Control Points (CCP’s)
PRINCIPLE 3: Establish critical limit(s)
PRINCIPLE 4: Establish a system to monitor control of the CCP
PRINCIPLE 5: Establish the corrective action to be taken when monitoring indicates it that a
particular CCP is not under control
PRINCIPLE 6: Establish procedures for verification to confirm that the HACCP system is working
effectively
PRINCIPLE 7: Establish documentation concerning all procedures and records appropriate to
these principles and their application
A HACCP team is responsible for implementing and maintaining the Celanese Food Ingredients
HACCP system. They have to check if the HACCP system is working correctly and effectively. In
relation to this, audits of the HACCP system are conducted by internal auditors at least once a year.
Page 22 of 36
The Board of Management and HACCP teams are kept informed about the results by an audit report
as well as during the yearly management review.
The Celanese Food Ingredients HACCP system is validated routinely by the multi-disciplinary team.
Within this scope, comprehensive reviews of particular hazard analysis and HACCP plan are
conducted. The defined critical limit of particular Critical Control Points (CCP’s) and Quality Control
Points (QCP’s) are validated and fitted accordingly, if appropriate. The CCP’s and QCP’s are checked
on accuracy. In the case of changes and/or new information, it will be necessary to check whether the
HACCP system and/or hazard analysis will also need to be changed. If so, an adoption of the HACCP
plan and system will be conducted and documented.
According to the HACCP concept, testing plans and regulations are established to detect and prevent
errors. This procedure maintains a high standard of hygiene and safety:
• Spatial separation of the production and the filling areas

• Regular cleaning according to approved cleaning SOPs
• Personal hygiene
• Protective filtering
• Metal detectors / metal separators / sieves
• Glass and plastic policy
• Hygiene controls of the filling area
• Microbiological control
The determined particular Critical Control Point (CCP’s) in the Sunett® production is metal detection
and magnetic separation at the end of the filling process, see flow-chart:
Page 23 of 36
6.4 HARPC according to the FDA Preventive Controls Rule
Additionally to the HACCP-System, Celanese Food Ingredients has implemented Hazards Analysis
Risk-Based Preventive Controls according to the Preventive Controls for Human Food Rule as
outlined in Title 21 Part 117 of the Code of Federal Regulations (21 CFR 117). FDA has established
different types of preventive controls, each requiring monitoring, corrective action, verification, and
record keeping procedures:
• Process preventive controls

• Sanitation preventive controls
• Allergen preventive controls
• Supply chain preventive controls
• Recall Plan
• Other controls
For each preventive control, verification activities are conducted to take into account the nature of the
preventive control and its role in our Celanese Food Ingredients food safety system.
To document the Celanese Food Ingredients preventive controls food safety system a specific Food
Safety Plan has been developed by the trained PCQI (a qualified individual who has completed
training in the development and application of risk-based preventive controls).
The Sunett® Food Safety Plan consists of the following information:
• Facility Information
• Preliminary Information
• Good Manufacturing Practices (GMP) & Prerequisite Programs
• Biological, chemical, physical and radiological hazards & Preventive Controls Determination
• Process Preventive Controls
• Food Allergen Preventive Controls
• Sanitation Preventive Controls
• Supply-Chain Preventive Controls
• Recall Plan
The Food Safety Plan is adapted continuously and as a whole reanalyzed at least every 3 years.
6.5 Shelf-Life Certificate Sunett® and Stability Testing Program (IPEC)

The shelf-life of Sunett® (Acesulfame K) is
5 years from date of manufacture
provided that the product is stored in the originally closed packaging, protected from sunlight, at ambient
temperature (max. 30 °C) and dry (max. 65 % relative humidity) conditions.
Stability Testing Program is done according to the “Good Manufacturing Practise Guide for Bulk
Pharmaceutical Excipients” of the International Pharmaceutical Excipients Councils (IPEC, version
2017, Chapter 8.2.4.7).
It is a documented testing and evaluation program in place to assess the stability characteristics of the
excipient Sunett® (Acesulfame K). The results of the stability testing are used in determining appropriate
storage conditions and re-evaluation or expiration dates. The testing program is on-going and includes
the following:
• The number of lots, sample sizes and test intervals
• Storage conditions and test methods sufficient to indicate stability
• Storage of the excipient Sunett® (Acesulfame K) in original closed packaging.
Page 24 of 36
6.6 Supplier Approval
Only approved suppliers are allowed to deliver packaging and raw materials. Suppliers will be approved
according to the Standard Operation Procedure (SOP) for supplier approval which includes
questionnaires, audits, samples/ analytical control, product specification, etc. In addition, the incoming
packaging and raw materials are controlled according to the SOP for packaging and raw material testing
SOP´s. All approved suppliers are listed and communicated to the proper functions.
6.7 Sustainability
Celanese is a registered supplier on EcoVadis for Corporate Social Responsibility (CSR). Our
manufacturing site in Frankfurt is audited according to SEDEX standard (also CSR) and ISO 50001
(Energy Management System) and ISO 14001 (Environmental Management System) certified.
Celanese EHS Policy and Guiding Principles can be found in the Environmental Governance Section
of the Sustainability Site: https://sustainability.celanese.com/
6.8 Kosher Certification

The processing, filling and packaging are regularly inspected by an authorized and globally recognized
Rabbinate. The current Kosher Lamehadrin (Parve) and Passover certificate is available on
https://www.celanese.com/certificate-search/BU_Food_Ingredients.
6.9 Halal Certification

The processing, filling and packaging are regularly inspected by an authorized and globally recognized
Halal organization. The current Halal certificate is available on
https://www.celanese.com/certificate-search/BU_Food_Ingredients.
6.10 Food Safety and Security Management System
Celanese Food Ingredients is committed to produce high quality and safe food additives. Official
certificates are available on https://www.celanese.com/certificate-search/BU_Food_Ingredients.
FSSC 22000*, version 5.1 (DIN EN ISO 22000:2018, ISO/TS 22002-1:2009 and additional FSSC 22000
requirements)
ISO 9001:2015 (Quality Management System)
ISO 14001:2015 (Environmental Management System)
ISO 22000:2018 (Food Safety Management System)
Food Defense of IFS Food (version 6.1 at chapter 6)
GMP (Good Manufacturing Practices)
GDP (Good Distribution Practices)
HACCP (Hazard Analysis and Critical Control Point)
HARPC (Hazard Analysis and Risk-Based Preventive Controls according to FSMA)
EC Directive 178/2002 (Traceability)
FDA Food Safety Modernization Act
FSMA Final Rule for Mitigation Strategies to Protect Food Against Intentional Adulteration
Risk Management
Control program for food safety and hygiene
Traceability of the product and its used raw and auxiliary materials and packaging
materials up to 6 years
Page 25 of 36
Purchase of raw, auxiliary and packaging materials only from approved suppliers
Customer audits upon request
Complete control of the manufacturing process
Crisis Management
Emergency Availability 24 hours 7 days a week
*FSSC 22000 is one of the most important GFSI-recognized certification programs for the Food industry. GFSI (Global Food Safety
Initiative) is a global, industry wide set of standards and requirements that a certification program must meet (https://mygfsi.com).
Page 26 of 36
7. QUESTIONS & ANSWERS
Do you have a document that describes Yes

your quality systems, e.g. Quality Manual?
To whom does QA report within your To the Director Business, Food Ingredients
organization?
Is QA independent of production? Yes
Do you have an internal auditing system Yes

(i.e. self-inspection program)?
If so, please describe. According to the Internal audit protocol
Do you have a Supplier Evaluation Prog? Yes
Describe the method of evaluation (i.e. Questionnaire, audit, specification, analytical

audit by mail etc.). raw material release, etc.
Do you have an approved list of suppliers Yes, Quality Management, Product

and which department is responsible for Stewardship, Production & Purchasing
approving and disapproving suppliers?
In case you supplied a customer with a Yes, system for recall in place, a responsible
defective product, would you or your person is available 24h / 7days
distributor notify the customers and is Emergency number: + 49 (0)69 305 6418
there a recall procedure in place?
If so, please describe how products are According to the Crisis Management System
recalled. in place
Describe your procedure to handle SAP Complaint Management System

customer complaints?
Are complaints investigated and records Yes

maintained on file?
Are deviations and non-conformances Yes

investigated, documented and filed?
Do you have a formalized documentation Yes

control system in place?
If yes, please describe this system. Documentation Control System in place with
approval documents
How long do you keep the analytical and 6 years
the production records?
Page 27 of 36
Who is responsible for the release of your Quality Manager
product into the market?
Does QA perform a batch record review? Yes, done by Quality Management.

If so, is it part of your release decision?
Does the product comply with the TSE N/A*. Sunett® is manufactured synthetically
Note for Guidance EMEA/410/01? without using animals as source of material.
Does the product comply with the ICH Yes, Dichloromethane (Class 2) is used during
Q3C Guideline production, results for “Residual solvent”
(Residual Solvents)? mentioned in CoA for Sunett® Pharma Grade
Does the product comply with German N/A*. Sunett® (Acesulfame K) is produced
Guideline "Aflatoxin VerbotsV dated synthetically without use of agricultural raw
19.07.00"? materials, which excludes possible
contamination by mycotoxins.
Analytical Control (QC – Quality Control)
Is QC independent of production? Yes

What kind of laboratory facilities do you Analytical laboratory
have?
Do you use any contract laboratory? Yes
Institute SGS Fresenius,
Taunusstein, Germany:
• Microbiological testing
CLAS laboratory,
Industriepark Höchst, Germany
Have you qualified/ evaluated these Yes

contract laboratories?
Do you release incoming raw materials Yes
based on Supplier Certificates of Analysis
(CoA)?
If so, do you perform any testing on your Yes
own?
Do you have procedures that define the Yes
control of raw materials?
Are there formal written procedures in Yes
place for all analyses performed?
N/A = Not applicable
Page 28 of 36
Are the analytical methods used Yes
validated?
Please provide product specifications and Test methods are mentioned on CoA
test methods of the product in question.
Do you analyze according to the current Yes, our methods are validated against the
Pharmacopoeia Testing Methods? official Ph. Eur. and USP-NF methods.
If yes, according to which one, e.g. Ph. Both Ph. Eur. and USP-NF
Eur., USP-NF?
Will you provide a Certificate of Analysis Yes
(CoA) with each shipment, including
actual analytical data to customers?
How long is the product stable and how 5 years from date of manufacture, stability data
do you assess the shelf life? (i.e. are according to IPEC guidelines
stability-testing data for the product in
question available?)
Which storage or handling conditions do Store in the originally closed packaging, at
you recommend for the product? ambient temperature (max. 30 °C), dry
(temperature, humidity) conditions (max. 65 % relative humidity) and
protected from sunlight.
Who performs the sampling and who Trained personal
performs the testing of:
▪ raw materials
▪ in-process checks and
▪ finished products
Do you keep records of all samples Yes
entering the laboratories?
Do these records include: Yes
▪ date sample received
▪ identity of samples
▪ testing results
▪ date sample taken and
▪ name of person who took sample
Do you have procedures defining the Yes
handling of quality
documents regarding
▪ update
▪ approval and
▪ use and archiving
How are Out-Of-Specification (OOS) Via SAP system, process in place
results investigated and documented in
the laboratories?
Describe your procedure for analytical SOP in place
reagent standardization.
Page 29 of 36
How do you assure that testing equipment is SOP in place
calibrated at appropriate intervals?
Describe any electronic data processing SAP QM module
systems, which are used in the laboratory (i.e.
LIMS).
Are these systems validated? Yes
What kind of water do you use in the laboratory? Demineralised water
Please state the physical/ chemical and the Pharma filter in place, micro checks
micro-biological quality of this type of water. routinely done
How often do you control this type of water? Once per month
Production and Process

General Questions
To whom does the production report within your To the Director Business, Food
organization? Ingredients
Do you manufacture/handle products of high No

activity or toxicity such as -lactams, other
antibiotics, cytotoxins or pesticides on the site?
Do you manufacture other products than the one No, it is a dedicated plant for Sunett®
being questioned in your manufacturing facility (Acesulfame K) production
(Monoplant?)
Are all the manufacturing steps for the stated Yes

material performed at this site (including
purification and packaging, etc.)?
Did you work out risk analysis of production Yes

processes using tools like HACCP?
If so, please give document reference number. DQS certificate FSSC 22000
Registration No. 003122 FSSC
Do you issue a batch record for each batch/lot Yes
manufactured?
Is non-conforming final product ever mixed with No

conforming product to bring it into specification?
Is there a formal procedure for production Yes

deviations in place?
Who does approve such deviations? SOP in place
Are room and equipment log books available? Yes

Page 30 of 36
Do all product containers bear identification Yes
labels, e.g. stating batch/lot number, product
name, etc.?
How do you mark the status of your SOP in place

manufacturing equipment (e.g. <cleaned>,
<calibrated>, <in use>)?
Describe the segregation and control of SAP positive release, red and green
approved, quarantined and rejected material. labels, separated storage areas
Do you have segregated dispensing areas for Yes

different raw materials?
Is there a maintenance and preventive Yes

maintenance program for all relevant pieces of
equipment in place?
Describe your procedure for instrument SOP in place

calibration.
Are there written procedures and schedules Yes

covering these calibrations?
Are rest and eating areas separate from other Yes
areas?
Do you have a pest control program against Yes, monitored monthly according to
rodents, vermin and other animals? pest control program
Page 31 of 36
Product related Questions
Is your production process continuous or Batch= 48h production

batch?
Do you use dedicated equipment for the Yes

production of the product in question?
Describe the convention used for batch or SAP code

lot numbering.
Does the lot number represent one Yes

homogenous production run?
Are there validated yield ranges for the Yes

manufacturing process?
Are deviations investigated and Yes

documented?
Are there cleaning procedures in place for Yes

each area and piece of equipment?
Are your manufacturing and cleaning Yes

processes validated?
Are manufacturing and cleaning procedures Yes

approved by QA?
Are there separate dust extraction facilities N/A

in areas where dust is generated?
Is compressed air filtered and dried? Yes, Pharma filter

Please indicate type of filters
Do you clean the ventilation and dust Yes, according to SOP / cleaning schedule
extraction systems according to a defined
plan and with which frequency?
Please state the different types of water Only water according to German
used in production. “Trinkwasserverordnung” (tab water
regulation) purified and filtered
Please state the physical/ chemical and the According to German “Trinkwasser-
micro-biological quality of this type of water. verordnung” (tab water regulation)
How often do you control this type of water? Monthly
Page 32 of 36
Describe any electronic data processing SAP system
systems which are used in production. Production control system
Is the product directly filled into the shipping Directly filled into final packaging. We have
pack after production and then stored until a contracted warehouse in Worms,
shipment or is the product first stored in Germany where the final product is stored
containers and only filled into the shipping until distribution.
pack just before shipment?
What kind of containers do you use (fiber Cardboard box with PA inner liner or
drums, inner linings etc.)? 500/1000kg Big Bags
Packaging materials are delivered with
protective cover.
Are there special pre-cautions (e.g. nitrogen, No

desiccant for packing)?
What measures have you implemented to Sieve, metal detection, permanent magnets
make sure that the product is not
contaminated by foreign matters? Yes, depending on grade we use magnetic
Do you sieve the material before final stainless steel 1000µm (18mesh), 600µm
packing (if so, what mesh size)? Do you use (30 mesh) und 355µm (45 mesh).
magnetic bars to remove metal particles?
Under what conditions do you store the final Ambient temperature (max 30° C), dry (rel.
product (temperature, humidity)? humid max 65%) and protected from
sunlight
How do you make sure that Customer Input into SAP
Purchase Orders, packaging and shipping
requirements are followed?
Can you pack to order (Yes/No) or do you Standard pack size

have standard pack sizes?
Is each bag/container labeled with the name Yes

of the product and lot no.?
Will each box/big bag on a pallet bear the lot Yes

no. and/or description clearly visible?
Do you put different batches of one product No, only one batch per pallet
on one pallet?
Do you keep records of all shipments to Yes
customers, including batch number and
quantity?
Page 33 of 36
8. ATTACHMENT
8.1 ICH Q3C (R8) - Residual Solvents

We confirm that Sunett® (Acesulfame K) complies with the Guideline EMA/CHMP/ICH/82260/2006.
Supplier Trade Name Sunett® (Acesulfame K)

Nutrinova Germany GmbH
Am Unisys-Park 1
Manufacture by
65843 Sulzbach (Taunus)
Germany
Class 1 Solvents
The product in question was manufactured (including all manufacturing steps) with the use of
Class 1 Solvents?
 Yes  No
Class 2 Solvents
The product in question was manufactured (including all manufacturing steps) with the use of Class 2
Solvents?
 Yes  No
Name of Nutrinova specification Complies with ICH

Class 2 Solvent [ppm] Guideline Q3C for
Residual Solvents
Dichloromethane 5 Yes
Class 3 Solvents
The product in question was manufactured (including all manufacturing steps) with the use of Class 3
Solvents?
 Yes  No
Name of Maximum Nutrinova specification Complies with ICH

Class 3 Solvent Concentration [ppm] [ppm] Guideline Q3C for
Residual Solvents
Triethylamine <5 5 Yes
Page 34 of 36
8.2 Table and Test Report according to ICH – Q3D-Guideline for Elemental Impurities
Sunett® is fully in compliance with the ICH Q3D Guideline. None of the elements mentioned in this
guideline is added intentionally during production. Nevertheless, Sunett® is analyzed regularly per ICP-
MS on different elements mentioned in this guideline, the reports can be received on request. Following
an overview regarding the analyzed elements:
Element Class Oral Intentionally If not LOD CFI

concentration acc added intentionally (of used Specification
ICH Q3D, Table added but Method) [μg/g]
A2.2. likely to be [μg/g]
[μg/g] present
Cd 1 0,5 No No 0,01 0,10
Pb 1 0,5 No No 0,02 0,10
As 1 1,5 No No 0,02 0,10
Hg 1 3 No No 0,01 0,01
Co 2A 5 No No 0,02 0,10
V 2A 10 No No 0,02 0,02
Ni 2A 20 No No 0,02 0,02
Tl 2B 0,8 No No 0,02 0,02
Au 2B 10 No No 0,02 0,02
Pd 2B 10 No No 0,10 0,10
Ir 2B 10 No No 0,10 0,10
Os 2B 10 No No 0,10 0,10
Rh 2B 10 No No 0,10 0,10
Ru 2B 10 No No 0,10 0,10
Se 2B 15 No No 0,20 0,20
Ag 2B 15 No No 0,02 0,02
Pt 2B 10 No No 0,10 0,10
Li 3 55 No No 0,10 0,10
Sb 3 120 No No 0,02 0,10
Ba 3 140 No No 0,02 0,10
Mo 3 300 No No 0,02 0,10
Cu 3 300 No No 0,02 0,10
Sn 3 600 No No 0,20 0,20
Cr 3 1100 No No 0,02 0,10
Page 35 of 36
8.3 GMO Questionnaire
Does the product conform to the current EU food regulations?
 Yes  No
Does the product contain genetically modified material?
 Yes  No
Has the product been tested to be free of genetically modified material

(i.e. < 1%)?
 Yes  No
Has the product been sourced from non-genetically modified raw materials by
means of segregation measures (i.e. only non-GM materials in the entire supply
chain)?
 Yes, only non-GM materials in the entire supply chain  No
Page 36 of 36

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Specialty Food & Pharma

Ingredients you can trust

Released by: Version December 2022

Giacomo Vitarelli Frank Goergen

2. GENERAL INFORMATION ................................................................................................5

4. PACKAGING AND LABELING ...........................................................................................8

6 QUALITY AND FOOD SAFETY MANAGEMENT .............................................................22

7 QUESTIONS & ANSWERS .............................................................................................27

Address: Nutrinova Germany GmbH

Production Facility: Sunett® Plant

Quality Contact: Mr. Frank Goergen

Contact for Sales/

Emergency Contact: 24 h Emergency No: +49 69 305 6418

3.1. Production Process of Sunett®

3.2 Production Flow Chart

Premises and Facilities

3.3 Source of Sunett®

3.4 Manufacture of Sunett® (in Germany only)

3.5 Ingredient Declaration

3.6 Change Control System

3.9 Pest Control

3.10 Cleaning Agents

3.11 Personal and Plant Hygiene Program

3.12 Foreign Object Recognition in the Production of Sunett®

3.13 Traceability / Retained Sample

4. PACKAGING AND LABELING

4.1 Packaging and Coding

Packaging Material Weight (kg) approx. Size (mm)

4.2 Labeling, Storage and Distribution, Storage Conditions

4.3 Product Label (Example)

5.1 Structural Formula of Sunett®

5.2 Analytical Laboratory

Analytical Testing & Subcontracting (Question & Answers)

Are all analytical testing performed by an internal laboratory?

Retain sample policy:

Microbiological Specification of Sunett® (Acesulfame K)

Total Mesophilic Count < 10 in 1 g

5.4 Food Grade Compliance

5.5.1 Product Specification Pharma Grade

5.5.4 Compliance regarding ICH Q3D Guideline on Elemental Impurities

5.5.5 IPEC risk evaluation regarding nitrosamine

Allergens (Question & Answers)

5.7 Genetically Modified Organisms (GMO)

5.8 Nutritional Information

Based on 100 g Sunett® according to regulation (EC) No 1924/2006

This comprises especially:

5.10 Absence of Specific Substances

5.10.1 Non-containing Dioxins, PCBs or PAHs

Does the product conform to

5.10.5 Compliance with California Proposition 65

5.10.6 Compliance with Toxic Substance Control Act (TSCA)

5.10.7 Non-containing Substances mentioned in the Prohibited List of WADA

5.10.8 Palm Oil

5.10.9 Transmitting Animal Spongiform Encephalopathy / Certificate of Suitability

5.11 Animal Non-Testing Declaration

6. QUALITY AND FOOD SAFETY MANAGEMENT

6.1 DIN EN ISO Certification