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Assessment of Regulatory Compliance Testing for Vitamin D in Infant Formula-Impact of Delegated Regulation (EU)
Donald L Gilliland1, Brendon D Gill2, Roger C Kissling2
1Abbott Nutrition, 3300 Stelzer Rd., Columbus, OH 43016, USA.
Insights
New European Union (EU) vitamin D limits for infant formula pose challenges for current analytical methods. Even compliant products may fail testing due to method variability, highlighting a critical gap in regulatory compliance verification.
Area of Science:
- Food Science
- Analytical Chemistry
- Regulatory Science
Background:
- European Food Safety Authority (EFSA) revised vitamin D limits for infant formula, establishing a narrower range (2-2.5 μg/100 kcal) under Commission Delegated Regulation (EU) 2019/828.
- This new range necessitates lower method reproducibility metrics compared to previous Codex Standard 72-1981 limits.
- Current analytical methods compliant with AOAC INTERNATIONAL's Standard Method Performance Requirements (SMPR®) 2011.004 face challenges meeting these stricter EU requirements.
Purpose of the Study:
- To evaluate the impact of the EU Delegated Regulation 2019/828 on the performance of AOAC Method 2016.05/ISO 20636:2018.
- To assess the likelihood of infant formula testing results falling outside the new EU vitamin D limits when using this method.
Main Methods:
- Statistical evaluation of data generated during a multi-laboratory study of AOAC Method 2016.05/ISO 20636:2018.
- Comparison of method performance against the narrow vitamin D regulatory range established by Regulation (EU) 2019/828.
Main Results:
- Methods aligned with SMPR 2011.004 are likely to produce results that do not meet the new EU vitamin D requirements.
- The performance of AOAC Method 2016.05/ISO 20636:2018, when reviewed against the EU range, indicates potential non-compliance.
Conclusions:
- A significant probability exists that well-manufactured infant formula within the EU regulatory range will fail compliance testing due to analytical method variability.
- Future analytical methods may also struggle to meet the required performance standards for this narrow regulatory range.
- Aligning proposed regulatory limits with the performance metrics of current compendial methods is recommended to ensure accurate compliance verification.
Background:
Since the publication of Standard Method Performance Requirements (SMPR®) for vitamin D in infant formula (SMPR 2011.004) by AOAC INTERNATIONAL, revised vitamin D limits have been recommended by the European Food Safety Authority (EFSA) for infant formula and adopted in Commission Delegated Regulation (EU) 2019/828. The vitamin D range introduced, 2-2.5 μg/100 kcal, is significantly narrower than previous limits specified by Codex Standard 72-1981 and requires lower method reproducibility metrics to adequately assess regulatory compliance. The narrower limits for vitamin D present a significant challenge for current-generation reference analytical methods that comply with SMPR 2011.004.
Objective:
We evaluate the impact of Delegated Regulation (EU) 2019/828 on the demonstrated performance of AOAC Method 2016.05/ISO 20636:2018 to assess the likelihood that vitamin D results produced by the method would be found outside the EU limits when testing infant formula that is compliant as manufactured.
Methods:
AOAC Method 2016.05/ISO 20636:2018, specifically data generated during multi-laboratory study, was used as a basis for statistical evaluation of the impact of the narrower EU vitamin D limits.
Results:
The review of AOAC Method 2016.05/ISO 20636:2018 method performance against the vitamin D regulatory range introduced in (EU) 2019/828 indicates methods capable of performing in alignment with SMPR 2011.004 are likely to produce results that fail to meet EU requirements.
Conclusions:
Our assessment illustrates the high probability that a well-manufactured product with vitamin D levels within the EU regulatory range would fail to meet the regulatory requirements due to analytical method variability when tested using fit-for-purpose methods. Further, required method performance cannot be expected with the future development of new methods. To avoid this, consideration should be given to aligning proposed regulatory limits with method performance metrics of current-generation compendial methods.
Highlights:
Current, state-of-the-art methods cannot consistently verify infant formula product compliance for vitamin D in accordance with (EU) 2019/828.
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