ISO 28997 Hormone Residue Testing in Infant Nutrition
The ISO 28997 series of standards is designed to address critical issues in food safety, particularly focusing on the presence of hormone residues. Specifically, this service focuses on ISO 28997-1:2016, which provides requirements for the determination of estradiol (E2), testosterone (T), and progesterone (P4) in infant formula. This standard is crucial as it ensures that hormone residues do not exceed safe limits, thereby protecting infants from potential adverse health effects.
Testing hormone residues involves a meticulous process starting with sample collection and preparation. The specimen must be collected under strict conditions to ensure its integrity. Following collection, the sample undergoes extraction using appropriate solvents like acetonitrile or methanol. Once extracted, the samples are purified through solid-phase extraction (SPE) cartridges, followed by derivatization for improved detection.
The heart of this testing lies in chromatographic techniques such as liquid chromatography-tandem mass spectrometry (LC-MS/MS). LC-MS/MS is chosen due to its high sensitivity and selectivity, making it capable of detecting even trace levels of hormones. Chromatographic separation allows for the effective resolution of various compounds present in infant formulas.
After chromatography, the eluent passes into the mass spectrometer where ions are formed through electrospray ionization (ESI). The ions undergo fragmentation and measurement by the tandem MS system to identify specific compounds based on their unique mass-to-charge ratios. This process ensures accurate identification of hormones even at very low concentrations.
The acceptance criteria for this testing are stringent, as they directly impact infant health and safety. The limits set forth in ISO 28997-1:2016 ensure that the levels of estradiol, testosterone, and progesterone do not exceed safe thresholds. These standards have been developed to provide a harmonized approach across different countries, ensuring consistent quality and safety.
Given the critical nature of infant nutrition, this testing is essential for manufacturers to comply with international regulations. It helps in maintaining product integrity by preventing contamination that could lead to hormonal imbalances in infants. The results from such tests are used not only internally but also externally as part of regulatory submissions ensuring compliance and trustworthiness.
Understanding the intricacies involved in this testing is vital for quality managers, compliance officers, R&D engineers, and procurement personnel who must ensure that their products meet stringent safety standards. This service plays a pivotal role in safeguarding infant health by providing accurate and reliable data on hormone residues present in infant formula.
Industry Applications
Infant Formula Manufacturers: Ensuring compliance with ISO 28997-1 is essential for manufacturers to meet regulatory requirements. This standard helps them maintain product integrity and protect infant health by ensuring hormone residues do not exceed safe limits.
- Retailers: Retailers can trust the quality of products sold, knowing they have been tested according to international standards.
- Government Agencies: Regulatory bodies use these test results for monitoring and enforcing compliance with safety regulations.
| Sample Types | Test Methodologies | Acceptance Criteria |
|---|---|---|
| Estradiol (E2) | Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) | <10 ng/L |
| Testosterone (T) | Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) | <25 ng/L |
| Progesterone (P4) | Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) | <10 ng/L |
| Hormones Tested | Acceptance Criteria | Testing Methodology |
|---|---|---|
| Estradiol (E2) | <10 ng/L | Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) |
| Testosterone (T) | <25 ng/L | Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) |
| Progesterone (P4) | <10 ng/L | Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) |
Eurolab Advantages
Expertise and Experience: Eurolab boasts a team of highly skilled scientists with years of experience in food safety testing. Our staff are well-versed in the latest technologies and methodologies, ensuring accurate results every time.
State-of-the-Art Facilities: Equipped with cutting-edge laboratories and instruments, including high-performance liquid chromatographs and mass spectrometers, Eurolab guarantees precise and reliable test outcomes. Our facilities are regularly audited to ensure compliance with international standards.
Comprehensive Reporting: We provide detailed reports that not only include the test results but also interpretative comments on their significance. This helps our clients understand the implications of the test findings, facilitating informed decision-making.
Customer Support: Our dedicated customer support team is always available to assist with any queries or concerns you may have regarding your tests. We strive for a seamless experience from sample submission to result delivery.
Quality and Reliability Assurance
To uphold the highest standards of quality and reliability, Eurolab adheres strictly to international guidelines such as ISO/IEC 17025. This accreditation ensures that our laboratory operations meet stringent technical criteria for competence in testing and calibration services.
Our commitment to accuracy is further demonstrated through rigorous internal audits and external reviews conducted by independent bodies. These processes ensure continuous improvement and alignment with the latest scientific advancements.
The use of advanced instrumentation like high-performance liquid chromatographs (HPLC) and mass spectrometers (MS) ensures precise measurements and reliable data generation. Our quality management system is designed to eliminate any potential sources of error, guaranteeing the integrity of our test results.
By choosing Eurolab for your hormone residue testing needs in infant nutrition, you can rest assured that your products will meet the highest safety standards. Our expertise, state-of-the-art facilities, and unwavering commitment to quality make us the preferred choice for food and feed testing services.
