Propylene Glycol (CAS 57-55-6) is a widely utilized chemical compound, recognized for its safety and efficacy across multiple industries. Regulatory bodies worldwide, including the U.S. Food and Drug Administration (FDA), have established guidelines and designations that underscore its safety profile. NINGBO INNO PHARMCHEM CO.,LTD. adheres to these standards, ensuring their Propylene Glycol products meet all necessary regulatory requirements.

Regulatory Status and Safety Designations

Propylene Glycol holds a favorable regulatory standing, particularly its USP grade:

  • Generally Recognized As Safe (GRAS): The FDA classifies Propylene Glycol as GRAS for use as a food additive. This designation signifies that based on scientific evidence and expert consensus, the substance is considered safe for its intended use in food under conditions of the marketplace. This is a critical factor for its widespread adoption in the food industry.
  • Pharmaceutical Grade Compliance: USP grade Propylene Glycol meets the rigorous standards set by the United States Pharmacopeia. This ensures its suitability for use as a solvent, stabilizer, and excipient in pharmaceuticals, contributing to the safety and efficacy of medications. Its role as a pharmaceutical excipient is well-documented and regulated.
  • Cosmetic Ingredient Review: In the cosmetics industry, Propylene Glycol has been evaluated and found safe for use in cosmetic products at concentrations commonly used. Its safety as a cosmetic ingredient is well-established.
  • International Regulations: While regulatory standards may vary slightly by region, Propylene Glycol is generally approved for use in food, pharmaceuticals, and cosmetics in major markets like Europe and Canada, often with specific usage guidelines.

Safety Profile and Considerations

Propylene Glycol is known for its low acute toxicity and low potential for skin irritation or sensitization compared to other glycols. However, like any chemical, appropriate handling and usage are important:

  • Low Toxicity: Its low toxicity profile makes it a preferred choice over ethylene glycol, especially in applications where human exposure is possible.
  • Handling Precautions: While generally safe, good industrial hygiene practices should be followed when handling bulk quantities, such as ensuring adequate ventilation.
  • Specific Applications: In very rare cases of extremely high consumption, particularly through medicinal routes, adverse effects have been noted, but these are far outside the scope of normal dietary or cosmetic exposure.

When sourcing Propylene Glycol, understanding its regulatory compliance and safety profile is paramount. NINGBO INNO PHARMCHEM CO.,LTD. prioritizes product quality and regulatory adherence, ensuring that their Propylene Glycol (CAS 57-55-6) meets the highest standards for its intended applications, whether as a food additive, pharmaceutical excipient, or in other diverse uses including industrial applications.