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Applic

ationO

verview

Food

caow rop ne Glycol USP/

EP s a prove for use in man risdic-

tions around t e n foo stu .

features low toxicity, exceptional stabil-

ity, high flash and boiling points, low

vapor pressure and broad solvency power.

It is widely used in the food-processing

industry as an additive.

Direct Food Applications

,an function as a:

Solvent and carrier in many flavor

formulations for the processed food

and beverage industry (see Solubility of

Flavoring Materials in Propylene Glycol

Table, page 4)

Solvent and carrier for colors, anti-

oxidants, enzymes and emulsifiers

Plasticizer and softening agent for

food-contact items such as cork seals Flavor extraction solvent and

processing aid in the isolation of

natural flavoring materials (extracting

vanilla from vanilla beans, for example)

Humectant and stabilizer in prepared

fruits, vegetables and bakery goods

(except in Europe)

When employed as a direct food additive,

the caloric value of propylene glycol is

defined as four calories per gram, according

to e n car o

n t e U. . oo an rug m n strat on (U.S.

FDA 21 CFR 101.9(c . (See

, .

ndirectFood Applications

Dow PG USP/EP is also suited for use in a

number of important indirect food-contact

applications:

Heat-transfer fluid typically a

formulation of an aqueous solution of PG

USP/EP together with a food-safe corrosion

inhibitor1 hat can be used in food and

beverage applications

Used to cool beer, wine, milk, juices and

brewery fermentation tanks

May be used for the freezing of wrapped

foods by immersing in propylene glycol baths

Printing ink solvent for food packaging

Plasticizer and processing aid in

cellophane film production Final rinse fluid following normal cleaning

of food-processing equipment, due to its

inherent antimicrobial properties helping

inhibit spoilage of any residual traces of food

that, if left untreated, could contaminate

future production (before the cleaned

equipment is returned to service, any resid-

ual propylene glycol is easily removed by

flushing with water)

Industry


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urity Plus

Dows customers need for purity and Dows dedicationto Good Manufacturing Practices (GMP) are the heart of

Dows Purity Plus standards. With Dows level of commit-

ment to meeting numerous standards in PG USP/EP,

customers can be confident they receive a fully compliant

PG USP/EP product from Dow.

Dows commitment to GMP is based on the IPEC-PQG ood

ManufacturingPracticesGuide for Pharmaceutical Excipients

(2006).2

Our commitment to implementing GMP through the manu-

facture, storage, packaging, transportation and distribution

of Dow PG USP/EP helps ensure that the product meets thecustomers need for Purity. The Plus comes from Dows

proven ability to offer customers:

Experience

One of the worlds leading producers of propyleneglycol

Nearly 60 years of propylene glycol manufacturing/

supply experience

Global, Reliable Supply

Five strategically located manufacturing sites and

multiple terminals

Annual global capacity exceeding 705 kilotons

Customer Support

Global Technical Service & Development and

Quality Assurance groups

Technical support for handling, storage and use of

Dow PG USP/EP

Education and Training

Detailed information and literature downloads atwww.dowpg.com

Web-based distributor GMP training module

Easy access to area Customer Information Groups(see phone numbers on last page)

Product Stewardship

Strong commitment to Responsible Care

GMP-compliant processing and handlingthroughout the supply chain

Commitment to Quality

Detailed personnel training Continual investment in maintaining and upgrading

equipment

Global distributor review, qualification and

training program

Find additional information about Dows Purity Plus

standards in the document titled Propylene Glycol

USP/EP from Dow, Purity Plus: Application of Good

Manufacturing Practices (GMP) (Form No. 117-01636X).

Product SnapshotDow PG USP/EP is a clear, colorless, practically odorless,

slightly viscous, water-soluble and hygroscopic liquid. It is

synthesized from hydrocarbon raw materials. Materials of

plant or animal origin, genetically modified organisms, sol-

vents, catalysts, additives or stabilizers are not used in the

manufacturing process or added to the final product. Dow

PG USP/EP is manufactured without known allergy-stimulating

food substances.

Dow PG USP/EP has a product shelf life of two years when

stored below 104F (40C) in closed containers protected from

UV light.


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Regulatory Status

Dow PG USP/EP is tested against

and complies with the specific

requirements of:

United States Pharmacopeia (USP)

European Pharmacopoeia (PhEuror EP)

Japanese Pharmacopoeia (JP)

Food Chemicals Codex (FCC)

Brazilian Pharmacopoeia

(Farmacopia Brasileira)

In addition, Dow PG USP/EP:

Fulfills the purity criteria for E1520,

propane-1,2-diol (PG USP/EP) detailed

n theEuropean Commission Directive

2000/63/EC for food additives,

other than colors and sweeteners

Fulfills the food additive specifica-

tion of JECFA (Joint FAO-WHO

Expert Committee on Food

Additives) Propylene Glycol

Monograph 1 (2006)3

Is certified as Kosher (Parve) for

year-round use, including Passover

(Pesach)

Complies with Halal requirements

Due to its extremely low toxicity and

long history of safe use, PG USP/EP is

generally recognized as safe (GRAS)

by the FDA for use in food applications.

PG USP/EP is manufactured by Dow

according to the guidelines defined in

the IPEC-PQG Good Manufacturing

Practices Guide for Pharmaceutical

Excipients. The IPEC-PQG GMP

guidelines are more stringent than the

principles of the Hazard Analysis and

Critical Control Point (HACCP)program, so Dow has determined that

a HACCP plan for PG USP/EP is not

necessary.

The Scientific Committee on Food of

the European Commission assigned a

full Acceptable Daily Intake (ADI) of

0-25 mg/kg bodyweight to propane-

1,2-diol (PG USP/EP) in 1996.4

Nutritional Information

Based on 100g Sample)

alories (total)* 400

Water (g) 0.2

Ash 0.005

Fat (g)** 0.0

Protein (g)** 0.0

Carbohydrates (g)* 100

holesterol (mg) 0.0otal dietary fiber (g) 0.0

Soluble fiber (g) 0.0

nsoluble fiber (g) 0.0

ron (mg) 0.0

Sodium (mg) 0.0

otassium (mg) 0.0

alcium (mg) 0.0

otal Vitamin A (IU) 0.0

itamin C 0.0

hiamin (mg) 0.0

Riboflavin (mg) 0.0

iacin (mg) 0.0

inc (mg) 0.0

*Results are ase on calculate values as state in21 CFR 101.9(c)(1) and 21 CFR 101.9(c)(6)

**Proteins and fats are not used in the manufactureof PG USP/EP, therefore they are not part of thefinal composition of the material

Note: The value for all other vitamins, mineralsand amino acids is 0.0 for PG USP/EP based on21 CFR 101.9(c)(4), 21 CFR 101.9(c)(5)and 21 CFR 101.9(c)(8)


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Solubility of Flavoring Materials in Propylene Glycol* Water Mixtures at 25C (77F)

Flavoring Percentage Propylene Glycol Solubility in ml per liter of solvent100% 80% 60% 40% 20%

Alcohol C-10 x 4.1 0.5 0.2Alcohol C-12 x 0.1 1.2 < 0.2 < 0.2Aldehyde C-16 x 22.5 0.8 0.5 0.4Allyl Butyrate 353.9 80.7 18.1 7.4 3.9

Allyl Caproate 162.8 23.4 3.8 0.5 0.3Amyl Acetate x x 18.2 15.5Amyl Butyrate 42.4 23.9 4.9 2.0 0.6so Amyl Formate x 65.1 56.2 20.3 19.9

Amyl Valerianate 93.9 19.5 3.3 0.9 0.5Anethol 54.9 6.9 2.7 0.4 < 0.2

enzaldehyde x 232.8 47.5 18.1 7.8enzyl Acetate F.F.C. x 83.9 19.9 4.1 2.7enzyl Propionate x 41.3 8.0 2.4 1.1

Cinnamic Aldehyde (99-100% pure) x 17.5 3.0 0.5 0.2Citral x .5 2.3 1.2 0.5Diacetyl (100%) x x x x 209.0Ethyl Butyrate x 133.2 37.1 3.4 0.9Ethyl Acetate x x 148.4 99.8

Ethyl Cinnamate 179.1 1.1 4.6 0.8 0.3Ethyl Formate x x x 234.1Ethyl Oxyhydrate (Conc. Special Colorless) x x x 34.8Ethyl Valerate 298.7 86.6 27.4 8.3 8.1Eucalyptol 278.5 55.8 19.7 4.5 3.4Eugenol USP x 383.8 1.2 0.5Maltol 45.9 41.2 33.4 24.5 17.7Methyl Anthranilate x 240.2 32.3 4.4 3.5Methyl Cyclopenteneolone 187.7 179.4 147.1 84.5 47.0Methyl Salicylate 191.1 7.4 9.1 2.7 1.7Nutmeg Oil 5.7 .5 2.0 1.6 1.1Ocotea Cymbarum 90.3 1.4 2.0 < 0.2 < 0.2Oil Anise 29.7 6.2 2.0 0.5 0.2Oil Bay 9.7 .8 0.5 0.2 < 0.2

Oil Bay (Terpeneless) x 4.0 1.3 0.5 0.2Oil Caraway 28.0 5.5 0.5 0.3 0.3Oil Cassia x 1.7 7.9 6.9 2.0Oil Cassia (Terpeneless) x 52.7 9.0 1.0 0.5Oil Cloves x 11.9 3.0 2.0 0.9Oil Cloves (Terpeneless) x 64.7 0.3 0.4 0.3Oil Dill Weed 13.3 0.5 0.3 < 0.2 < 0.2Oil Ginger < 0.2 Oil Lemon 9.8 6.1 3.7 2.2 0.4Oil Lime (Distilled) 18.3 .8 1.9 0.5 < 0.2Oil Mace (Distilled) (So Called) 2.5 .3 0.5 0.3 0.2Oil Peppermint x .1 0.5 0.2 < 0.2Oil Peppermint (Terpeneless) x 5.6 0.5 0.3 0.3Oil Petitgrain (Terpeneless) < 0.2 7.6 1.3 0.5 0.2Oil Pimento Leaf x 9.7 1.6 0.6 0.3Oil Sage (Spanish) 8.9 2.2 1.1 0.5 0.2Oil Sassafras 19.5 2.2 2.0 1.2 0.8Oil Spearmint (N.F XV) 8.3 0.5 0.4 0.2 0.2Oil Thyme, White (High Test) x 0.5 2.4 0.8 < 0.2Oil Wormseed (American Chenopodium) 105.0 8.3 1.2 0.5 0.3Oil Resin Celery .2 0.4 < 0.2 < 0.2 < 0.2Oil Resin Ginger mmisc. Oil Resin Pepper Immisc. Orange Oil 1.6 1.6 1.0 0.7 0.4Phenethyl Alcohol x x 240.2 32.0Phenethyl Formate 204.4 4.9 5.5 1.4 0.3

henethyl Propionate x 66.7 9.4 3.3 2.0

*The solubilities of more than 100 additional essential oils and aromatic chemicals are listed in D.D. Lakritz, American Perfumer 48, No 11,64,69 (1946)x = Miscible or soluble in all proportionsImmisc. = Immiscible or completely insoluble< = less than


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U.S. RegulationsDow PG USP/EP:

Is cleared for various uses under the U.S. FDA Food

Additive Regulations

Is generally recognized as safe (GRAS) by the U.S.

FDA according to 21 CFR 184.1666

Meets the specifications of the Food Chemicals

Codex, sixth edition (2008)

Is listed in Flavor and Extract Manufacturers

Association GRAS List: FEMA #2940

Dow supports the use of its PG USP/EP

product only for all direct and indirect food

applications of propylene glycol.

Direct Food Applications

GRAS as a multipurpose food substance under

21 CFR 184.1666 Provides foods with specific physical or technical

effects as defined in 21 CFR 170.3(o)

Maximum use levels, in accordance with GMP, are

defined in 21 CFR 184.1(b)(1), and for some specif-

ic applications in 21 CFR 170.3(n). For applications

where the level is not defined, the maximum allowable

level of propylene glycol is 2 percent.

A number of standardized foods, as defined in 21

CFR parts 133, 135 and 169, allow for the use of

optional ingredients, which are safe and suitable.

Propylene glycol will qualify where the use is suitable.

Indirect Food Applications

Unreacted: Cleared for use under 21 CFR

169.175, 175.105, 175.300, 175.320, 176.170,

176.180, 176.210, 177.1390, 177.1680, 177.2420,

177.2600, 177.2800, 178.2800, 178.3300 and

184.1666. Please consult regulations for details and

allowed regulated use.

Reacted Component: There are numerous derivatives

of propylene glycol listed in the CFR regulations.

Please consult the regulations for details.

EuropeanPropyleneDirect ood Ap

Cleared for indirect onta t y

Directive 2002/72/EC and subsequent amendments;

and ramewor eso u on re a ng o

plastic materials and articles intended to come into

contact with foodstuffs.

Regulated by European Parliament and Council

rect ve o. on oo a t ves ot er t an

colors and sweeteners, and subsequent amendments: Assigned E number E1520

Allowed as a carrier/carrier solvent for colors,

emulsifiers, antioxidants and enzymes, with a

maximum allowed level of 1 g/kg (0.1 percent),

in the foodstuff

Allowed in flavorings, with a maximum allowed

level of 3 g/kg, from all sources in foodstuffs as

consumed or as reconstituted according to the

instructions of the manufacturer, individually or

in combination

Allowed in flavorings for beverages (with the

exception of cream liqueurs, the maximum level

allowed is 1 g/l)

Purity criteria for E1520, propane-1,2-diol (PG

USP/EP) included in Commission Directive

2000/63/EC

Indirect Food Applications

Cleared for indirect food contact applications by

Directive 2002/72/EC and subsequent amendments

relating to plastic materials and articles intended to

ome into contact with foodstuffs

Authorized (when of suitable quality) as a monomer

and starting substance (propane-1,2-diol, PM/Ref

No. 23740) for manufacture of plastic materials and

articles, without restriction or specific migration

limits (SML)

Propane-1,2-diol (PM/Ref No. 81840) also

recognized as an additive for the same purpose

Included in the INS (International Numbering System)

for food additives list under the number 1520


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NOTICE: Because use con itions an applicable laws may iffer from one location to another an may change with time, the recipient

of this information is solely responsible for determining whether the information in this document is appropriate for recipients use.

Since Dow has no control over how this information may be ultimately used, all liability is expressly disclaimed and Dow assumes

no obligation or liability therefore. No warranty, express or implied, is given, nor is freedom from any patent owned by Dow or others

to e in erre .

Form No. 117-01632X-0310MCKM KAY203450A

Trademark of The Dow Chemical Company (Dow) or an affiliated company of Dow

R s sibl Car is a s r ic ark f th A rica Ch istr C cil i th U it d Stat s

www.dowpg.com

North America

Dow CIG North America4520 E. Ashman St.

9008 Building

Midland, MI 48642

Toll Free: 800-447-4369

Toll: 989-832-1542

Fax: 989-832-1465

Asia PacificDow Chemical Malaysia Sdn Bhd

Customer Information GroupLevel 6, CP Tower, Section 16/11

Jalan Damansara

46350 Petaling JayaSelangor DE, Malaysia

Toll Free: +800 7776 7776

Toll: +60 3 7958 3392Toll Free Fax: +800 7779 7779

Toll Fax: +60 3 7958 5598

Europe, India, Middle East & AfricaDow Belgium B.V.B.A.

Prins Boudewijnlaan 41

B-2650 EdegemBelgium

International Toll Free: +800 3 694 6367Toll: +32 3 450 2240

Italy Toll Free: 800 783 825

South Africa Toll Free: +800 99 5078

Fax: +32 3 450 2815

Latin America

Dow Brazil S.A.CIG-Latin/3C floor

Rua Alexandre Dumas, 1671

Chacara Santo Antonio04717-903 So Paulo, Brazil

Toll: +55-11-5188-9000

Fax: +55-11-5188-9887

Material Safety Data Sheets (MSDS) and Technical

Data Sheets (TDS) available at ww.dowpg.com

atureLiter References1. tedInhibi Glycol-BasedHeat Transfer Fluids for Food Applications, Dow Product Information, Form No. 180-01112-1299AMS,

3-320-E-1299CH-1 (http://www.fao.org/ag/agn/jecfa-additives/details.html?id=677)

PQG2. IPEC- GoodManufacturing Practices Guide for Pharmaceutical Excipients International Pharmaceutical Excipients Council

)(IPEC an Pharmaceutical Quality Group (PQG), 2006

3. JECF (Joint FAO-WHO Expert Committee on Food Additives) Propylene Glycol Monograph 1, 2006

/www.technologylubricants.com/Technical/Food%20grade%20glycol%20technical%20brochure.pdf)(http:/

4. tRepo ofthe Scientific Committee on Food on Propylene Glycol(40th series), pp. 63-64, Commission ofthe European

unities,Com 1997 (opinion expresse Septem er 20, 1996) ( ttp://ec.europa.eu/ oo / s/sc/sc /reports/sc _reports_40.p )

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