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en-17194-determination-of-citrinin-in-red-yeast-rice-food-supplements
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Determination of Citrinin in Red Yeast Rice Food Supplements: EN 17194 Testing Services

EN 17194 is a European standard that outlines the requirements for the determination of citrinin in red yeast rice food supplements. This standard is published by the European Committee for Standardization (CEN) and is part of the EN series, which covers various aspects of food safety.

Legal and Regulatory Framework

The legal and regulatory framework surrounding EN 17194 testing services is governed by various international and national standards. The Food Safety Authority of Ireland (FSAI), the European Food Safety Authority (EFSA), and the World Health Organization (WHO) are some of the key organizations that play a crucial role in shaping the regulatory landscape.

International and National Standards

EN 17194 is based on ISO/TS 18723, which is an international standard for the determination of citrinin in red yeast rice food supplements. The European Union has also adopted this standard as part of its legislative framework. Member states are required to ensure that their national laws and regulations comply with EU directives and regulations.

Standard Development Organizations

The CEN is responsible for developing and publishing EN standards, including EN 17194. The CEN works closely with other standard development organizations, such as the International Organization for Standardization (ISO) and the American Society for Testing and Materials (ASTM), to ensure that international standards are aligned.

Standard Evolution and Updates

Standards evolve over time to reflect changes in technology, scientific knowledge, and regulatory requirements. EN 17194 is regularly reviewed and updated by the CEN to ensure that it remains relevant and effective.

Standard Numbers and Scope

The standard number for EN 17194 is EN 17194:2020. The scope of this standard includes:

  • Red yeast rice food supplements

  • Determination of citrinin content

  • Methodology and testing requirements

    • Compliance Requirements

    EN 17194 compliance is mandatory for manufacturers and suppliers of red yeast rice food supplements in the European Union. Compliance with this standard ensures that products meet safety and quality standards.

    EN 17194 testing services are essential to ensure the safety and quality of red yeast rice food supplements. The reasons for conducting this test include:

  • Business and Technical Reasons: Citrinin is a toxic substance that can cause adverse health effects. Testing for citrinin content ensures that products meet regulatory requirements and minimize the risk of contamination.

  • Consequences of Non-Compliance: Failure to conduct EN 17194 testing can result in product recalls, fines, and damage to reputation.

  • Industries and Sectors: EN 17194 applies to manufacturers and suppliers of red yeast rice food supplements, including those operating in the pharmaceutical, dietary supplement, and food industries.

  • Risk Factors and Safety Implications: Citrinin contamination can lead to adverse health effects, including liver damage and kidney failure. Testing for citrinin content ensures that products are safe for consumption.

  • Quality Assurance and Quality Control: EN 17194 testing services contribute to product safety and reliability by ensuring compliance with regulatory requirements.

    • EN 17194 testing services involve a series of laboratory tests that determine the citrinin content in red yeast rice food supplements. The test conditions and methodology include:

  • Testing Equipment and Instruments: High-performance liquid chromatography (HPLC) and mass spectrometry (MS) instruments are used to analyze samples.

  • Sample Preparation Procedures: Samples are prepared using a combination of mechanical and chemical methods.

  • Testing Parameters and Conditions: Temperature, humidity, pressure, and other environmental factors are controlled to ensure accurate testing results.

  • Measurement and Analysis Methods: HPLC-MS is used to detect and quantify citrinin content in samples.

  • Calibration and Validation Procedures: Instruments are calibrated regularly to ensure accuracy and precision.

    • EN 17194 testing services provide detailed reports that include:

  • Report Format and Structure: Reports follow a standardized format, including sections on test results, conclusions, and recommendations.

  • Interpretation of Test Results: Test results are interpreted to determine citrinin content levels and compliance with regulatory requirements.

  • Certification and Accreditation Aspects: EN 17194 testing services are certified by accredited laboratories that meet international standards.

  • Traceability and Documentation Requirements: All testing activities, including sampling, testing, and reporting, are documented and traceable.

    • Conclusion

    EN 17194 is a European standard that outlines the requirements for determining citrinin content in red yeast rice food supplements. This standard ensures compliance with regulatory requirements, minimizes the risk of contamination, and contributes to product safety and reliability. EN 17194 testing services are essential for manufacturers and suppliers operating in the pharmaceutical, dietary supplement, and food industries.

    Persuasive Conclusion

    EN 17194 testing services offer numerous benefits, including:

  • Compliance with Regulatory Requirements: Ensures that products meet regulatory requirements and minimize the risk of contamination.

  • Product Safety and Reliability: Contributes to product safety and reliability by ensuring compliance with regulatory requirements.

  • Reputation Protection: Protects manufacturers and suppliers reputation by ensuring compliance with regulatory requirements.

    • By partnering with accredited laboratories, manufacturers and suppliers can ensure that their products meet EN 17194 standards and comply with regulatory requirements.

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