Propylene Glycol USP/EP Application Overview

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Pure Flavor Solutions
Dow Propylene Glycol USP/EP
for the Food-Processing Industry
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Purity is essential…
in the food we eat every day. Dow Propylene Glycol USP/EP1 offers one of the highest purity
propylene glycols available in the marketplace – with a specified purity of 99.8 percent or
greater, non-detectable MEG/DEG 2 contents, adherence to IPEC-PQG3 Good Manufacturing
Practices for pharmaceutical excipients, and a two-year shelf life when stored according to
Dow’s recommendations. Think of it as your security for purity.
Dow PG USP/EP offers excellent stability and versatility
as a food additive in a wide variety of direct and indirect
food-processing applications.
Direct Food Applications
•Solvent and carrier in many flavor formulations for the
processed food and beverage industry
•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)
Dow PG USP/EP is tested against and complies with the specific requirements of current USP, EP and JP.
It also meets, but is not tested against, Brazilian Pharmacopeia requirements. Dow’s stringent PG USP/EP
global manufacturing standards offer the availability of the same consistently pure, high-quality PG USP/
EP product around the world.
2
Monoethylene Glycol/Diethylene Glycol.
3
International Pharmaceutical Excipients Council/Pharmaceutical Quality Group.
4
When stored below 104 ºF (40 ºC) in closed containers, protected from UV light.
1
When used as a direct food
additive, the caloric value of Dow
Propylene Glycol USP/EP is defined as
four calories per gram, according to the general
definition for a carbohydrate given in the U.S. Food and
Drug Administration (FDA) 21 CFR § 101.9(c)(1)(i)(B).5
See Table 1 for nutritional information.
Indirect Food Applications
•Heat-transfer fluid – typically a formulation of an aqueous solution of PG
together with a food-safe corrosion inhibitor6 that 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
21 CFR Ch. I (4-1-00 Edition) § 101.9 (c)(1)(i).
DOWCAL™ N/DOWFROST™ Inhibited Propylene Glycol-based Heat Transfer Fluid. Dow Product
Information, Form No. 180-01331-0307 AMS, CH-153-316-E-0307.
5
6
Table 1: Nutritional Information
Based on 100g Sample
Calories (total)*
400
Water (g)
0.2
Ash
0.005
Fat (g)**
0.0
Protein (g)**
0.0
Carbohydrates (g)*
100
Cholesterol (mg)
0.0
Total dietary fiber (g)
0.0
Soluble fiber (g)
0.0
Insoluble fiber (g)
0.0
Iron (mg)
0.0
Sodium (mg)
0.0
Potassium (mg)
0.0
Calcium (mg)
0.0
Total Vitamin A (IU)
0.0
Vitamin C
0.0
Thiamin (mg)
0.0
Riboflavin (mg)
0.0
Niacin (mg)
0.0
Zinc (mg)
0.0
*Results are based on calculated values as stated in 21 § CFR
101.9(c)(1) and 21 § CFR 101.9(c)(6).
**Proteins and fats are not used in the manufacture of PG USP/EP;
therefore, they are not part of the final composition of the material.
Note: The value for all other vitamins, minerals and amino acids is
0.0 for PG USP/EP based on 21 § CFR 101.9(c)(4), 21 § CFR.
Excellent Quality for
Pure Confidence
Dow Propylene Glycol USP/EP offers high quality and
consistency, according to the industry’s most stringent
quality-control processes, including adherence to Good
Manufacturing Practices (GMP) from The Joint IPEC-PQC
Good Manufacturing Practices Guide for Pharmaceutical
Excipients. Dow’s commitment to GMP throughout the
supply chain enables Dow PG USP/EP to be handled
according to stringent requirements for consistent purity.
Dow PG USP/EP is tested against and certified according
to the requirements for the following standards:
•Food Chemicals Codex (FCC)
•United States Pharmacopeia (USP)
•European Pharmacopeia (PhEur or EP)
•Japanese Pharmacopeia (JP)
Dow 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, solvents, catalysts, additives or stabilizers
are not used in the manufacturing process or added to
the final product.
Dow PG USP/EP is manufactured without any known
allergy-stimulating food substances.
Dow Propylene Glycol USP/EP complies with various requirements of food applications in different
global geographies:
•Cleared for various direct and indirect food applications under U.S. FDA Food Additive Regulations.
•Generally Recognized As Safe (GRAS) by the U.S. FDA according to 21 CFR § 184.1666.
•Not approved as a multi-purpose food additive in the European Union:
– Regulated by European Parliament and Council Directive No. 95/2/EC on food additives other than 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 final foodstuffs.
– 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).
•Fulfills the purity criteria for E1520, propane-1,2-diol, detailed in the European Commission Directive 2008/84
EC for food additives, other than colors and sweeteners.7
•Fulfills the food additive specification of JECFA (Joint FAO-WHO Expert Committee on Food Additives) Propylene
Glycol Monograph 1 (2006).8
•Is certified Kosher (Parve) for year-round use, including Passover (Pesach) and also certified Halal in most Dow
PG production plants worldwide.
Dow supports the use of its PG USP/EP product only for all direct and indirect food applications of propylene glycol.
Applicable local government regulations should be consulted for details on approved and appropriate applications.
Because Dow PG USP/EP is manufactured by Dow according to the guidelines defined in the IPEC-PQG Good
Manufacturing Practices Guide for Pharmaceutical Excipients and the IPEC-PQG GMP guidelines are more stringent
than the principles of the Hazard Analysis and Critical Control Point (HACCP) program, Dow has determined that an
HACCP plan for PG USP/EP is unnecessary.
COMMISSION DIRECTIVE 2008/84/EC of 27 August 2008 laying down specific purity criteria on food additives other than colours
and sweeteners, OJ No. L253, 20.9.2008, p.1.
8
JECFA (Joint FAO-WHO Expert Committee on Food Additives) Propylene Glycol Monograph 1, 2006.
7
Robust Supply Chain for Global Reach
With nearly 60 years of experience as a leading propylene glycol (PG) manufacturer and supplier,
Dow has built a robust supply chain network that provides:
•Reliable Global Supply from strategically located manufacturing sites in the U.S., Brazil,
Germany and Australia.
•The Largest Production Capacity in North America, including plants in two different states.
•One of the World’s Largest PG Production facilities in Stade, Germany.
•Presence in South America as the only domestic supplier to produce PG in this
growing region.
•Inventory Management Solutions from strategically located terminals around the world to
help meet changing customer needs.
•Quality, Storage, Packaging and Transportation according to the world’s most stringent standards and documentation requirements for PG, including marine transport capabilities.
Exceptional Solutions for Pure Innovation
Dow Propylene Glycol USP/EP is backed by excellent service and innovation:
•Hydrogen Peroxide to Propylene Oxide (HPPO) Technology, developed in a joint
venture partnership with BASF, is one example of how Dow creates technologies that advance
quality, reliability and sustainability. This innovative, low-energy, high-yield process produces
propylene oxide in a more environmentally friendly manner by reducing wastewater by
approximately 70-80 percent and energy use by approximately 35 percent compared with
conventional propylene oxide manufacturing technology. This technological advance was
recognized with the Institution of Chemical Engineers Innovation and Excellence Award in
Core Engineering in 2009 and the U.S. Presidential Green Chemistry Challenge Award in 2010.
•TS&D Support for technical and EH&S experience to support customer application needs. In
addition, customers can contact Dow for assistance in proper handling, storage and use of
Dow PG USP/EP, in keeping with Dow’s commitment to Responsible Care®.
•In-Region Customer Service Representatives (CSRs) who are dedicated to helping
customers use Dow PG USP/EP effectively and providing support according to the
customer’s region.
•Sales Professionals who are committed to serving customers and championing their needs
throughout the sales process.
•Education and Training, Including an Online Answer Center, available to customers
24 hours a day, seven days a week at www.dowpg.com.
Purity Plus
A very high dedication to consistent quality and purity governs the entire product supply process for
Dow Propylene Glycol USP/EP.
Purity Plus describes Dow’s dedication to pure excellence in propylene glycol:
•Purity means producing and handling Dow PG USP/EP according to the industry’s most
stringent standards.
•Plus refers to the support and confidence our customers have in Dow – with nearly 60 years
of PG experience, global customer and technical support, excellent product stewardship, and
environment, health and safety practices.
Table 2: Solubility of Flavoring Materials in Propylene Glycol* – Water Mixtures at 25°C (77°F)
Percentage Propylene Glycol Solubility in ml per Liter of Solvent
Flavoring
Alcohol C-10
Alcohol C-12
Aldehyde C-16
Allyl Butyrate
Allyl Caproate
Amyl Acetate
Amyl Butyrate
Iso Amyl Formate
Amyl Valerianate
Anethol
Benzaldehyde
Benzyl Acetate F.F.C.
Benzyl Propionate
Cinnamic Aldehyde (99-100% pure)
Citral
Diacetyl (100%)
Ethyl Butyrate
Ethyl Acetate
Ethyl Cinnamate
Ethyl Formate
Ethyl Oxyhydrate
(Conc. Special Colorless)
Ethyl Valerate
Eucalyptol
Eugenol USP
Maltol
Methyl Anthranilate
Methyl Cyclopenteneolone
Methyl Salicylate
Nutmeg Oil
Ocotea Cymbarum
Oil Anise
Oil Bay
Oil Bay (Terpeneless)
Oil Caraway
Oil Cassia
Oil Cassia (Terpeneless)
Oil Cloves
Oil Cloves (Terpeneless)
Oil Dill Weed
Oil Ginger
Oil Lemon
Oil Lime (Distilled)
Oil Mace (Distilled) (So Called)
Oil Peppermint
Oil Peppermint (Terpeneless)
Oil Petitgrain (Terpeneless)
Oil Pimento Leaf
Oil Sage (Spanish)
Oil Sassafras
Oil Spearmint (N.F XV)
Oil Thyme, White (High Test)
Oil Wormseed
(American Chenopodium)
Oil Resin Celery
Oil Resin Ginger
Oil Resin Pepper
Orange Oil
Phenethyl Alcohol
Phenethyl Formate
Phenethyl Propionate
100%
x
x
x
353.9
162.8
x
142.4
x
93.9
54.9
x
x
x
x
x
x
x
x
179.1
x
x
80%
x
10.1
22.5
80.7
23.4
x
23.9
65.1
19.5
6.9
232.8
83.9
41.3
17.5
3.5
x
133.2
x
31.1
x
x
60%
4.1
1.2
0.8
18.1
3.8
x
4.9
56.2
3.3
2.7
47.5
19.9
8.0
3.0
2.3
x
37.1
x
4.6
x
x
40%
0.5
< 0.2
0.5
7.4
0.5
18.2
2.0
20.3
0.9
0.4
18.1
4.1
2.4
0.5
1.2
x
3.4
148.4
0.8
x
x
20%
0.2
< 0.2
0.4
3.9
0.3
15.5
0.6
19.9
0.5
< 0.2
7.8
2.7
1.1
0.2
0.5
209.0
0.9
99.8
0.3
234.1
34.8
298.7
278.5
x
45.9
x
187.7
191.1
5.7
90.3
29.7
9.7
x
28.0
x
x
x
x
13.3
< 0.2
9.8
18.3
12.5
x
x
< 0.2
x
18.9
19.5
8.3
x
105.0
86.6
55.8
–
41.2
240.2
179.4
37.4
3.5
11.4
6.2
1.8
34.0
5.5
31.7
52.7
11.9
64.7
0.5
–
6.1
1.8
3.3
3.1
5.6
7.6
9.7
2.2
12.2
0.5
10.5
8.3
27.4
19.7
383.8
33.4
32.3
147.1
9.1
2.0
2.0
2.0
0.5
1.3
0.5
7.9
9.0
3.0
0.3
0.3
–
3.7
1.9
0.5
0.5
0.5
1.3
1.6
1.1
2.0
0.4
2.4
1.2
8.3
4.5
1.2
24.5
4.4
84.5
2.7
1.6
< 0.2
0.5
0.2
0.5
0.3
6.9
1.0
2.0
0.4
< 0.2
–
2.2
0.5
0.3
0.2
0.3
0.5
0.6
0.5
1.2
0.2
0.8
0.5
8.1
3.4
0.5
17.7
3.5
47.0
1.7
1.1
< 0.2
0.2
< 0.2
0.2
0.3
2.0
0.5
0.9
0.3
< 0.2
–
0.4
< 0.2
0.2
< 0.2
0.3
0.2
0.3
0.2
0.8
0.2
< 0.2
0.3
1.2
Immisc.
Immisc.
1.6
x
204.4
x
0.4
–
–
1.6
x
34.9
66.7
< 0.2
–
–
1.0
x
5.5
9.4
< 0.2
–
–
0.7
240.2
1.4
3.3
< 0.2
–
–
0.4
32.0
0.3
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 proportions.
Immisc. = Immiscible or completely insoluble.
< = less than.
Want to Know More?
You can learn more about Dow Propylene Glycol USP/EP and Dow’s other propylene glycol products
at www.dowpg.com. Or contact a Dow representative to discuss your specific application needs.
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