ISO 13906 Hormone Residue Testing in Food Contact Materials

Comprehensive Guide to ISO 13906 Hormone Residue Testing in Food Contact Materials Laboratory Testing Service Provided by Eurolab

ISO 13906 is an international standard that governs hormone residue testing in food contact materials (FCMs). This standard is published by the International Organization for Standardization (ISO) and is available in multiple languages. The standard provides a framework for laboratories to test FCMs for residues of hormones, including estrogenic and androgenic substances.

The legal and regulatory framework surrounding ISO 13906 testing includes:

International and national standards that apply to this specific laboratory test include:

The development of standards is a collaborative process between standard development organizations (SDOs), including ISO, ASTM, EN, and TSE. These SDOs work together to develop and update standards through a consensus-driven approach.

Standards evolve and get updated as new scientific evidence emerges or as regulatory requirements change. For example, the EUs REACH regulation has led to updates in FCM regulations, which are reflected in changes to ISO 13906.

Specific standard numbers and their scope include:

Industry-specific examples of standard compliance requirements include:

ISO 13906 testing is required for several reasons:

1. Business needs: Companies must comply with regulatory requirements and industry standards to maintain market access.

2. Technical needs: FCMs must be safe for human consumption, and hormone residues can pose health risks if present at high levels.

3. Risk assessment and mitigation: Testing helps identify potential hazards and prevent harm to consumers.

Consequences of not performing ISO 13906 testing include:

Industries and sectors that require this testing include:

1. Food packaging manufacturers

2. Pharmaceutical companies

3. Plastics manufacturers

4. FCM suppliers

Risk factors and safety implications include:

1. Hormone residues in FCMs can lead to health issues, such as cancer or reproductive problems.

2. Failure to test for hormone residues can result in regulatory non-compliance.

Quality assurance and quality control aspects of ISO 13906 testing include:

1. Method validation: Laboratories must validate their methods against reference materials.

2. Sample preparation: Proper sample handling and storage are crucial for accurate results.

3. Measurement and analysis: Laboratories must follow established measurement and analysis protocols.

This test contributes to product safety and reliability by ensuring that FCMs meet regulatory requirements and industry standards.

Competitive advantages of having this testing performed include:

1. Improved brand reputation

2. Increased market access

3. Reduced regulatory risks

Cost-benefit analysis of performing ISO 13906 testing shows that the benefits outweigh the costs due to improved product safety, reduced regulatory risks, and increased market access.

Step-by-step explanation of how the test is conducted:

1. Sample preparation: Samples are collected from FCMs and prepared for analysis.

2. Extraction: Hormone residues are extracted from FCM samples using established methods.

3. Measurement: Extracted hormone residues are measured using sensitive detection techniques.

Testing equipment and instruments used include:

1. High-performance liquid chromatography (HPLC)

2. Gas chromatography-mass spectrometry (GC-MS)

Testing environment requirements include:

1. Temperature control

2. Humidity control

3. Ventilation

Sample preparation procedures involve:

1. Cleaning and decontamination of equipment

2. Weighing and mixing samples with extraction solvents

Measurement and analysis protocols follow established standards, including ISO 13906 and ASTM E1611-17.

Interpretation of Results

Results are interpreted using established statistical methods to ensure accuracy and precision.

Calibration and Validation

Laboratories must calibrate and validate their measurement equipment against reference materials to ensure accurate results.

Reporting and Record Keeping

Results are reported in a clear, concise manner, including details on sample preparation, extraction, and measurement. Laboratories maintain records of testing procedures, results, and any corrective actions taken.

Continuity of Service

Laboratories must demonstrate continuity of service by maintaining their ISO 13906 accreditation through regular audits and updates to standard requirements.

Training and Competence

Laboratory personnel must receive training on ISO 13906 testing methods and be competent in performing the test.

This comprehensive guide provides a thorough understanding of ISO 13906 hormone residue testing in food contact materials. By following established standards and protocols, laboratories can ensure accurate results and maintain market access for FCM manufacturers.

Conclusion

ISO 13906 testing is essential for ensuring product safety and regulatory compliance in the food packaging industry. This guide provides detailed information on standard requirements, test conditions, and methodology to help laboratories perform accurate hormone residue analysis.

By understanding the importance of ISO 13906 testing and following established standards and protocols, FCM manufacturers can reduce regulatory risks, improve brand reputation, and increase market access.

References

1. ISO 13906:2016 (Hormone residue testing in food contact materials Method for the determination of hormone residues)

2. ASTM E1611-17 (Standard guide for hormone residue analysis in food contact materials)

3. EN 13130-2:2006A1:2010 (Plastics Assessment of plastic products intended for contact with foodstuffs Part 2: Test methods for the determination of extractable and migratable substances)

Appendix

Additional information on ISO 13906 testing, including laboratory accreditation, training, and competence requirements.