AXIO | Proficiency Testing schemes 2025
PT-PH-21 Compliance with Labelling
Many dietary supplements are products of natural origin, which leads to equally natural variations in their composition. It is therefore important that tolerances can be applied to the nutritional labelling of these products, without the values being able to deviate too substantially from the values indicated on the label. However, the next challenge lies in determining whether the product aligns with regulatory guidelines. In the USA, the Code of Federal Regulation Title 21 (21 CFR 101.9(g)(3)) and (g)(4)), also called USP Monograph: Minerals Tablets , set some clear rules on what is considered compliant or not. To determine whether a measurement result aligns with a specification and demonstrates compliance with regulations, it is crucial to also consider the associated measurement uncertainty. The 2021 Eurachem guide Use of Uncertainty Information in Compliance Assessment offers guidance on incorporating uncertainty when assessing compliance with pecified limits. Measurement Uncertainty Any analytical measurement is subject to an uncertainty. In practice the uncertainty may arise from many possible sources, including (but not limited to), sampling, matrix effects, uncertainties of masses and volumetric equipment, approximations, etc. An analytical measurement result is complete only when it is accompanied by a statement of the associated uncertainty. https://www.eurachem.org/index.php/publications/guides/quam
36 lgcstandards.com/AXIO
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