430 Railroad Avenue
Gaylord, MN 55334
Date: February 10, 2014
Subject: Submission of Petition of substances for Inclusion on the National List of Substances Allowed in Organic
Production
The enclosed petition for Triethyl Citrate (TEC), Natural is being submitted by:
Michael Foods, Inc. d/b/a Abbottsford Farms
C/o Denise Ferriman, Regional Quality Manager – Core Eggs
430 Railroad Avenue
Gaylord, MN 55334
507-237-4289
Denise.ferriman@michaelfoods.com
Item A: Indicate on which section the petitioned substance will be included:
• 205.605 - Nonagricultural (nonorganic) substance allowed as ingredients in or on processed products labeled as
“organic” or “made with organic (specified ingredients or food group(s)).
Item B
1. Triethyl Citrate (TEC), Natural (Organic Compliant)
• Synonyms: Triethyl Ester; Ethyl Citrate; Citroflex 2; CITROFOL® AI
• Triethyl citrate is an ester of citric acid. It is a colorless, odorless liquid used as a food additive to stabilize foams,
especially as whipping aid for egg white.
2. Manufacturer information:
Jungbunzlauer Inc,
7 Wells Ave.
Newton Centre, MA 02459
Phone: 617-614-0223
Fax: 617-964-2921
Contact: Gretchen Tolson, Technical Service Manager
E-Mail: gretchen.tolson@jungbunzlauer.com
3. Current application/ Intended Use
• Current application is Flavor – Organic
• Intended use is whipping enhancer for egg whites during processing – Organic
4. List of methods of application for which the substance will be used:
• Whipping enhancer for organic, Hi Whip egg whites
5. Sources and detailed description of manufacturing procedures
• This product was not produced from synthetic sources, and without the use of any synthetic solvents, synthetic
carrier system or any artificial preservatives.
• Manufacture procedures are attached (Production of CITROFOL®Al)
6. Summary of any previous reviews by state or private certification programs
• The product listed above meets the Natural Flavor definition as described in FDA 21 CFR Part 101.22(a)(3), and
was produced and handled without the use of GMO’s, Irradiation or Sewage Sludge.
• This product was not produced from synthetic sources, and without the use of any synthetic solvents, synthetic
carrier systems, or any artificial preservatives.
7. Information regarding EPA, FDA and State regulatory authority registration
• 184.1911 Triethyl Citrate
• 182.1911 describes dried egg whites
8. Chemical Abstract Service (CAS) number
• CAS Number: 77-93-0
9. Physical properties and chemical mode of action
• Molecular formula: C12 H2O O7
• Molecular weight: 276.2830
• Appearance: Clear colorless liquid
• Purity (by G.C.): >99%
• Specific Gravity @ 25C: 1.1350-1.1390
• Refractive Index @ 20C: 1.4380-1.4460
• Boiling Point/Boiling Point Range (C): 260
• Flash Point (C) (Tag closed Cup): 151
• Density: 1.14 g/ml at 25C
• Vapor Pressure: 1mm @107C
• Solubility in Water (%): Slightly Soluble
• Solubility in Alcohol (%): Soluble
• Triethyl Citrate does not appear on the List of Chemicals Known to Cause Cancer Or Reproductive Toxicity, under
section 25249.8 of the CALIFORNIA SAFE WATER AND TOXIC ENFORCEMENT ACT OF 1986 (Chapter 6.6
added by Proposition 65 1986 General Election).
• Stability & Reactivity: No known materials to avoid; no known hazardous decomposition products
• Toxicological Information: None established, not listed as a carcinogen by IARC, ACGIH, NTP or OSHA.
• Ecological Information: No data available
• Disposal Considerations: Nonhazardous; not registered by DOT.
• Grade – Halal, Kosher, NI.
• Allergen: No known allergen
10. Safety information about the substance including a Material Safety Data Sheet and a substance report from the National
Institute of Environmental Health Studies.
• Material Safety Data Sheet is attached
• National Institute of Environmental Health Studies substance report is not available.
• ECOCERT Approval
11. Research information for the substance
• Michael Foods, Inc. R & D tested the Organic Egg White with and without TEC per the Technical Request R & D
code 13-3227.
• FDA 21CFR 182.1911 in dried egg whites
• Contrasting studies that do not support the use of TEC are not available.
12. Petition justification statement
Michael Foods, Inc. is requesting that Triethyl Citrate be approved for organic use ingredient in the function of
enhancing the whipping factor in pasteurized egg whites – Hi Whip.
• Triethyl Citrate is a natural, organic compliant ingredient flavor and is also used by the egg industry as a pasteurized
egg white whipping enhancer in baking, i.e. angel food cakes.
• The substance is essential for organic productions:
Michael Foods, Inc. Research and Development Department has done extensive research to find an organic
substitute to serve the same purpose and has found that there is no alternative substance.
Comparative research was completed with and without the use of Triethyl Citrate, and the research
demonstrates that in order to meet customer egg white whipping requirements the substance is necessary.
• The substance is compatible with organic production practice:
The product was produced and handled without the use of GMO, Irradiation or Sewage Sludge. GMO
position attached. The product was not produced from synthetic sources, and without the use of any
synthetic solvents, synthetic carrier systems or any artificial preservatives.
Triethyl Citrate, having been designed as containing no artificial flavor, does not - to the best of our
knowledge and belief and the manufacturer’s knowledge and belief – contain any artificial flavor and has
not had any artificial flavor added.
13. CBI STATEMENT
• This petition does not contain any confidential business information.
14. ATTACHMENTS
• Production on CITROFOL®Al (triethyl citrate)
• Product Label(s) for Triethyl citrate or products containing Triethyl citrate (Information on Standard Packaging
CITROFOL®AL)
• MSDS for Triethyl citrate
• GMO Position
• Natural Status CITROFOL®Al
• ECOCERT Approval
Natural Status CITROFOL®AI
Ladenburg, Thursday, 06 June 2013
Dear customers
Jungbunzlauer CITROFOL® AI (Triethyl Citrate; TEC) is manufactured by the natural derived raw
materials citric acid and ethanol, both based on the process of fermentation. Therefore
CITROFOL® AI can be considered as based 100 % on natural raw materials.
Citric acid and ethanol are fermented, using the naturally derived raw materials glucose syrup from
maize as well as molasses and sugar from sugar beet or sugar cane.
The strains used for the manufacturing of the raw materials are not genetically modified according
to the directive 90/219/EC and as amended in directive 2001/18/EC.
CITROFOL® AI itself is produced by esterification with additional purification and distillation steps
and is finally obtained in its highly pure form.
There is no particular law that defines the requirements for "natural" food ingredients or products.
As esterification is a chemical reaction and certain chemicals are used during the purification step
of the ester, we do not approve the "natural" status of CITROFOL® AI.
We leave it up to our customers, if they indicate their end product as natural.
With best regards,
Technical Service Manager
Production of CITROFOL® AI
(Triethyl Citrate)
CITROFOL®AI is the Jungbunzlauer trade name of triethyl citrate which is chemically,
according the IUPAC nomenclature, a 1,2,3-propane tricarboxylic acid, 2-hydroxy, triethyl
ester.
Esterification process
CITROFOL®AI is produced by acidic esterification. As starting material citric acid and
ethanol, both based on fermentation of carbohydrates raw materials, are dissolved in a
reaction vessel. After the reaction the ethanol and water are removed by evaporation and is
undergoing a rectification process to further usage in the process. Purification follows by
neutralization and washing processes. In an intermediate step material it stored. This
material can be additionally used for a second esterification by acetylation process
(CITROFOL®AII). After the purification by distillation the triethyl citrate is filled in a storage
tank. During the processing, the citrate ester passes through several filters and, before final
filling into containers or trucks, passing a final safety filter of 25 µm.
Process flow chart
The following flowchart covers the single steps of our CITROFOL®AI:
Esterification
Citric Acid
Ethanol (chemical
anhydrous +
reaction)
Evaporation
Rectification Purification
(removal
ethanol (neutralisation)
ethanol/water)
Intermediate* Purification Storage Tank
(storage tank) (destillation) (triethyl citrate)
Packing (e.g.
Filtration CITROFOL®AI
IBC/ drums)
*Raw material for acetylation
CITROFOL®AI is supplied in canisters with a net content of 25 kg, iron drums of 225 kg,
ecobulk containers (IBC) of 1.000 kg and truckloads. In a cool, dry place and in original
closed containers CITROFOL®AI can be stored for at least 3 years. A retest is recommended
after the above mentioned time.
The given information reflects the current status. Jungbunzlauer will not automatically inform about updated
information or minor changes. All sales of the described products are subject to our general conditions of sale.
Version 04.13, supersedes 08.07 -1/1- CF_AI_G10_EN
MATERIAL SAFETY DATA SHEET
JUNGBUNZLAUER INC. Page 1 of 4
Product: CITROFOL® AI Review Date: 11/16/2009
1. CHEMICAL PRODUCT AND COMPANY IDENTIFICATION
COMMERCIAL PRODUCT NAME CITROFOL® AI
COMPANY/SUPPLIER Jungbunzlauer Inc.
7 Wells Avenue
Newton Centre, MA 02459
Emergency Phone 1- 617-969-0900; 8:30 - 5:00 M-F Eastern Time
24 Hour Emergency Phone Number CHEMTREC 1-800-424-9300
Product use Plasticizer, solvent, egg white whipping aid, fixative,
deodorant active ingredient
2. COMPOSITION, INFORMATION ON INGREDIENTS
Chemical name Triethyl Citrate
Chemical characterization C12H20O7
1,2,3-Propanetricarboxylic acid, 2-hydroxy-, triethyl ester
Chemical family organic Acid Ester
Synonyms Triethyl citrate, TEC, TEC plasticizer
COMPOSITION CAS Reg. No. %
Triethyl Citrate 77-93-0 100
Hazardous impurities None
EINECS-No. 201-070-7
E-No. E 1505
3. HAZARDS IDENTIFICATION
Most important Hazard None
Emergency Overview Colorless, slightly oily liquid
Inhalation No data available
Eye contact No data available
Skin contact No data available
Ingestion No data available
Chronic No data available
Carcinogen status None
4. FIRST AID MEASURES
General advice No hazards which require special first aid measures. If
you feel unwell, seek medical advice.
Inhalation Move to fresh air. If symptoms persist, call a physician.
Skin contact Wash off with soap and plenty of water. If skin irritation
persists, call a physician.
Eye contact Flush eyes with water as a precaution. If eye irritation
persists, consult a specialist.
Ingestion Drink water as a precaution. Consult a physician if
necessary
Protection of first-aiders No hazards which require special first aid measures.
MATERIAL SAFETY DATA SHEET
JUNGBUNZLAUER INC. Page 2 of 4
Product: CITROFOL® AI Review Date: 11/16/2009
5. FIRE FIGHTING MEASURES
Flash point 151°C
Flammable limits Not available
Autoignition temperature Not available
Suitable extinguishing media water, water spray, dry powder, foam,
carbon dioxide (CO2)
Extinguishing media which
must not be used for safety reasons None
Hazardous decomposition products carbon oxides
Special protective equipment Use personal protective equipment including self-
contained breathing apparatus when fighting fire in
enclosed area.
Specific methods Standard procedure for chemical fires.
6. ACCIDENTAL RELEASE MEASURES
Personal precautions Use personal protective equipmt. Avoid dust formation.
Environmental precautions Do not allow material to contaminate ground water
system.
Methods for cleaning up Soak up with inert absorbent material (e.g. sand, silica
gel, acid binder, universal binder, sawdust).
7. HANDLING AND STORAGE
HANDLING
Technical measures/Precautions Use only in area provided with appropriate
exhaust ventilation.
Safe handling advice Use personal protective equipment.
STORAGE
Technical measures/Storage conditions Keep tightly closed in a dry and cool place.
Incompatible products No special restrictions on storage with other products.
Packaging material Intermediate Bulk Container (IBC), Iron drums
8. EXPOSURE CONTROLS, PERSONAL PROTECTION
Engineering measures Ensure adequate ventilation, especially in confined areas.
Exposure limit(s) None established for this ingredient,
Personal protection equipment
Respiratory protection No personal respiratory protective equipment normally required
Hand protection Impervious gloves, break through time >8 hours
Eye Protection Safety glasses with side shields
Skin and body protection Lightweight protective clothing
Hygiene measures Handle in accordance with good industrial hygiene and safety
practice
MATERIAL SAFETY DATA SHEET
JUNGBUNZLAUER INC. Page 3 of 4
Product: CITROFOL® AI Review Date: 11/16/2009
9. PHYSICAL AND CHEMICAL PROPERTIES
Form liquid
Color colorless/translucent
Odor slight
pH not available
Vapor pressure (25°C) 1.89 x 10-3 mm Hg
Vapor density 9.7
Boiling point 294°C
Boiling point range (1mmHg) 127°C
Pour point -45.5°C
Decomposition temperature >200°C
Evaporation rate < 1 vs. butyl acetate
Coefficient of water/oil distribution not available
Melting point/range not available
Relative density 1.135 g/cm3
Explosive properties None when properly stored
Water solubility (25°C) 65 g/kg
Solubility in other solvents
Alcohol soluble
Acetone soluble
Viscosity (25°C) 35.2 mPa.s
10. STABILITY AND REACTIVITY
Stability Stable at normal conditions
Conditions to avoid none under normal use. Hydrolyses in presence of
aqueous solution of alkali salts
Materials to avoid Incompatible with strong bases and oxidizing agents.
Hazardous decomposition products No decomposition if stored normally. Thermal decomposition can
lead to release of irritating gases and vapors.
11. TOXICOLOGICAL INFORMATION
Acute toxicity LD50/p.o./rat >32 g/kg bw(1)
LD50/i.p./mouse = 1.75 g/kg bw(2)
Local effects No skin irritation and no eye irritation (rabbit) (3)
Chronic toxicity Did not show carcinogenic effects in animal experiments.
NOEL (no-observed-effect-level) =100 mg/kg bw (3)
Reproductive toxicity Did not show mutagenic effects in animal experiments (3)
Not mutagenic in AMES Test (4)
Human experience Health injuries are not known or expected under normal use.
Patch test on human volunteers did not demonstrate
sensitization properties. (5)
MATERIAL SAFETY DATA SHEET
JUNGBUNZLAUER INC. Page 4 of 4
Product: CITROFOL® AI Review Date: 11/16/2009
12. ECOLOGICAL INFORMATION
Mobility No information available
(6)
Persistence and degradability Readily biodegradable, according to OECD test.
Ecotoxicity This product has no known eco-toxicological effects.
(6)
EC50/72h/algae =G 1
a
(7)
LC50/96h/golden orfe = 450 mg/l
(9)
EC10/18h/bacteria => 100,000 mg/L
13. DISPOSAL CONSIDERATIONS
Waste from residues/unused products Can be landfilled or incinerated when in compliance with local,
state and federal laws and regulations (contact local or state
environmental agency for specific rules).
Contaminated packaging Empty containers should be transported/delivered for local
recycling or waste disposal
14. TRANSPORT INFORMATION
Not a Hazardous Material for DOT shipping.
15. REGULATORY INFORMATION
is generally regarded as safe (GRAS) by USA FDA. 21 CFR 182.1911
The ingredient is listed on the TSCA Inventory List.
European Food Additive, E 1505
CERCLA (Comprehensive Response Compensation, and Liability Act): Not hazardous
SARA Title III (Superfund Amendments and Reauthorization Bill): Not Considered Hazardous
USP-NG listed; Ph.Eur. Listed, FEMA (3083), JECFA Flavoring agent 629
Foreign Inventory Status: Canadian DSL (Domestic Substance List)
16. OTHER INFORMATION
HMIS* Rating Health =1
Fire =1
Reactivity =0
*Hazardous Material Information System of the National Paint and Coating Association.
Sources of key data used to compile the datasheet
(1) M.Finklestein&H.Gold, Toxic. Appl. Pharmac. (1959))1, 283
(2) D.B. Meyers et all, J. pharm. Sci. (1964) 53, 774
(3) CSTEE (1999) 11th Plenary meeting on 28.9.99
(4) J.L.Heath&M.Reilly, Poult. Sci. (1982) 61, 2517
(5) Hill Top Research Report 77-1035A-71 for Pfizer Inc. (1978)
(6) Jungbunzlauer 1994, DIN 38 412 L 25
(7) Universität des Saarlandes for Jungbunzlauer 3/95, DIN 38412 L 33
(8) Universität des Saarlandes for Jungbunzlauer 3/95, DIN 38412 L 15
(9) Universität des Saarlandes for Jungbunzlauer 3/95, Cell inhibition test DIN 38412 L8
MSDS Status: Reviewed 11/16/2009.
The information given is designed only as a guidance for safe handling, use, processing, storage,
transportation, disposal, and release and is not to be considered a warranty or quality specification. The
information relates only to the specific material designated and may not be valid for such material used in
combination with any other materials or in any process, unless specified in the text.
ECOCERT Approval
Jungbunzlauer “From nature to ingredients®” approved for personal care
With the mission "From nature to ingredients®" the company commits itself to the security of man
and the environment. Jungbunzlauer is a responsible and sustainable leader in naturally derived
biodegradable ingredients. The ECOCERT approval of Jungbunzlauer products is important for all
our customers seeking ingredients to formulate natural personal care products.
With the attached approval Jungbunzlauer products have been classified as 100% natural origin
and can be used in the formulation of personal care products certified according to the ECOCERT
Natural and Organic Cosmetic Standard.
The approval was granted for the following products and production plants:
JUNGBUNZLAUER AUSTRIA AG (Austria)
Citric Acid Anhydrous Citric Acid Monohydrate
CITROCOAT® N LIQUINAT® (Citric Acid Solution)
Trisodium Citrate Anhydrous Trisodium Citrate Dihydrate
Xanthan Gum FFPC Xanthan Gum FNPC
Xanthan Gum FFCS-PC Xanthan Gum FNCS-PC
Xanthan Gum FFCSP-PC Xanthan Gum FNCSP-PC
Xanthan Gum FEDCS-PC Zinc Citrate
JUNGBUNZLAUER LADENBURG GMBH (Germany)
Calcium Lactate Gluconate Citric Acid DC
CITROFOL® AI (Triethyl Citrate) LIQUINAT® (Citric Acid Solution)
Monosodium Citrate Tripotassium Citrate
JUNGBUNZLAUER S.A. (France)
ERYLITE® Glucono-delta-Lactone
L(+)-Lactic Acid 50% Potassium-L(+)-Lactate 60%
L(+)-Lactic Acid 80% Sodium-L(+)-Lactate 50%
L(+)-Lactic Acid 88% Sodium-L(+)-Lactate 60%
L(+)-Lactic Acid 90% Sodium Gluconate
Please find enclosed the ECOCERT approval showing the INCI names and the most common
functions in their use in personal care applications.
Jungbunzlauer
Technical Service
Version 06.13, supersedes 02.13 -1/1- ECOCERT_EU_2013
Information on Standard Packaging
CITROFOL®AI
Standard Canister:
Construction: HDPE (blue coloured)
Filling weight: 25 kg
Canister weight: ca. 1.4 kg
Dimension: 358 mm x 293 mm x 418 mm
Volume 30 litres
Closure: lock closure
Example canister as used for all
CITROFOL® products
Standard Drums:
Construction: mild steel drum
Filling weight: 225 kg
Drum weight: ca.18 kg
Dimension: 571.5 mm x 585 mm x 882 mm
Volume: 216.5litres
Drums diameter: 585 mm
Drums heights: 882 mm
Closures: a) ¾ “ b) 2”
Sealant: EPDM
Example steel drums as used
for all CITROFOL® products
Standard Bulk Container (IBC):
Construction: HDPE with UV protection
Filling weight: 1000 kg
IBC weight: ca. 60 kg
Dimension: 120 x 100 cm
Filling opening: 150 mm
Steelcase: Galvanised steel tubes (18x18 mm)
Example IBC as used for all
CITROFOL® products
Version 11.12, supersedes 03.11 1/2 CF_A1_G22_EN
Standard markings on labels:
(Difference only in net weight)
Product name Chemical name and uses
Chemical formula Safe handling instruction
Specified Grade Lot number and expiry date
CAS / EC number Material code number
Symbol kosher OU Net weight
Country of Origin /Production Number of the label within the lot
Name and address of the
manufacturer
Standard Pallets:
Heat treated wood in compliance with ICCP Standard
CP-1 Pallet
Dimension: 120 x 100 x 14 cm
Weight: approx. 20 kg
CP- 3 Pallet
Dimension: 114 x114 x 14 cm
Weight: approx. 20 kg
Loading details: Numbers of units Weight Height Remark
27 canister 675 kg ca. 140 cm CP-1
4 drums 900 kg ca. 100 cm CP-3
1 IBC 1000 kg ca. 120 cm CP-1
The given information reflects the current status. Jungbunzlauer will not automatically inform about updated information
or minor changes.
Version 11.12, supersedes 03.11 2/2 CF_A1_G22_EN
GMO Position
European Manufacturing Sites
This position paper is valid for the Jungbunzlauer manufacturing sites Pernhofen / Austria,
Ladenburg / Germany and Marckolsheim / France.
The following Jungbunzlauer products
Citrics Citric Acid
LIQUINAT® Citric Acid Solution
Trisodium Citrate
Gluconates Gluconic Acid
Glucono-delta-Lactone
Sodium Gluconate
Lactics L(+)-Lactic Acid
L(+)-Lactic Acid Buffered
Potassium-L(+)-Lactate
Potassium-L(+)-Lactate / Sodium Diacetate
Potassium-L(+)-Lactate / Potassium Diacetate
Sodium-L(+)-Lactate
Sodium-L(+)-Lactate / Sodium Diacetate
Specialities Citric Acid DC
CITROCOAT® N
CITROFOL®
ESSICCUM®
sub4salt®
Special Salts Calcium Lactate Gluconate
CITROMA® (CITRATE MA in the USA)
Monosodium Citrate
Potassium Gluconate
Tricalcium Citrate
Trimagnesium Citrate
Tripotassium Citrate
Zinc Citrate
Sweeteners ERYLITE®
ERYLITE® Stevia
Xanthan Gum Xanthan Gum
Xanthan Gum Blends
are manufactured by fermentation or are based on fermentation derived products.
Version 06.13, supersedes 04.13 -1/2- GMO_EC
Micro-organisms - Production Strains
Jungbunzlauer does not use genetically modified production strains* for the manufacture of above
mentioned food additives.
*no GMO in the meaning of the European Directive 2009/41/EC which replaces
Directive 90/219/EEC and its successive amendments.
Fermentation Raw Materials
Jungbunzlauer works together solely with raw material suppliers who can exclude the processing
of genetically modified organisms (GMO).
Jungbunzlauer purchases raw materials (e.g. glucose syrup) upon a NON-GMO agreement, if they
are derived from crops for which genetically modified varieties exist (e.g. Bt maize).
For the glucose syrup production at the Jungbunzlauer plant in Pernhofen we purchase maize from
farmers upon non-GMO agreement.
Regulation on Genetically Modified Food and Feed
The regulation (EC) No 1829/2003 of the European Parliament and of the Council on genetically
modified food and feed is not applicable to above-mentioned Jungbunzlauer food additives.
Regulation on GMO Traceability
The regulation (EC) No 1830/2003 of the European Parliament and of the Council concerning the
traceability and labelling of genetically modified organisms and the traceability of food and feed
products produced from genetically modified organisms and amending Directive 2001/18/EC is not
applicable to above-mentioned Jungbunzlauer food additives.
In view of the rapid advancement of modern biotechnology and the changing framework of laws
and regulations of the European Community and its member states a statement on the usage of
genetically modified organisms can only reflect the past and present situation. As soon as new
European and National regulations on this matter will be published we commit ourselves to apply
these immediately.
In Summary
1) Jungbunzlauer does not use genetically modified microorganisms for the fermentation step of
above-mentioned food additives.
2) Above-mentioned Jungbunzlauer food additives are no genetically modified organisms as such
and they do not contain genetically modified organisms.
3) There are no labelling requirements for above-mentioned Jungbunzlauer food additives
according to Regulations (EC) No 1829/2003 and 1830/2003.
Version 06.13, supersedes 04.13 -2/2- GMO_EC