Supercritical CO2 vs Solvent Extraction Regulatory Approval
来源: | 作者:selina | 发布时间 :2025-03-03 | 74 次浏览: | Share:

Supercritical CO2 vs Solvent Extraction Regulatory Approval

Regulatory approval plays a critical role in the **pharmaceutical, food, and cosmetics industries** when choosing an extraction method. This article compares the **regulatory acceptance** of supercritical CO2 extraction and solvent extraction, focusing on FDA, EU, and international safety standards.

1. Regulatory Compliance and Safety Standards

  • Supercritical CO2 Extraction: Recognized as **safe by the FDA, EU, and WHO**, as it does not introduce harmful solvents.
  • Solvent Extraction: Requires **additional regulatory steps** due to potential solvent residues that must be eliminated.

2. Solvent Residue Limits and Testing

  • CO2 Extraction: Requires **minimal post-processing** and meets **organic and pharmaceutical-grade purity** standards.
  • Solvent Extraction: Must undergo **strict residual solvent testing** to comply with international regulations.

3. Industry Use and Approvals

  • CO2 Extraction: Widely used in **pharmaceuticals, nutraceuticals, and clean-label food production**.
  • Solvent Extraction: Commonly used in **industrial applications**, but less preferred for high-purity products.

4. Case Study: CO2 Extraction in FDA-Approved Supplements

A U.S. supplement manufacturer switched to CO2 extraction, reducing **compliance risks** and achieving **100% solvent-free certification** for FDA approval.

5. Conclusion

For **faster regulatory approval and compliance**, **supercritical CO2 extraction** is the preferred method. Companies like **SHANGHAI NORTH BROOKS** provide **FDA and EU-compliant CO2 SUPERCRITICAL EXTRACTION MACHINE** solutions for various industries.

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