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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 Dows 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. Dows 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 F (40 C) in closed containers, protected from UV light.
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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
5 6
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.
*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.
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.
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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 Dows dedication to pure excellence in propylene glycol: Purity means producing and handling Dow PG USP/EP according to the industrys 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 25C (77F)
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 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 1.2 Immisc. Immisc. 1.6 x 204.4 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 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 0.4 1.6 x 34.9 66.7 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 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 < 0.2 1.0 x 5.5 9.4 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 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 < 0.2 0.7 240.2 1.4 3.3 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 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 < 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.
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