Get to know the guidelines on the tolerance of substance content in dietary supplements in Europe and Poland. Find out what are acceptable differences between declared values and actual vitamin and mineral content to ensure regulatory compliance and security consumers.
Wprowadzenie
Nutritional values declared on dietary supplement labels must comply with relevant regulations and guidelines to ensure accuracy and safety for consumers. These tolerances define the acceptable differences between declared values and actual nutrient content. As specific tolerance provisions may not be specified elsewhere, the guidance below is based on technical documentation and official guidance published by relevant institutions such as the European Commission. All this is in accordance with applicable law.
Tolerances for the Nutritional Values Declared on the Labels of Dietary Supplements
General Rule of Tolerance
Tolerances define acceptable differences between the nutritional values declared on the label and those established during official controls.
Range of tolerance
Tolerance range means the difference between the upper and lower tolerance levels.
Why Are Tolerances Established?
The actual amount of a nutrient may differ from the value declared on the label. Establishing tolerance limits ensures that label information is accurate in reflecting the nutrient content of the product. Tolerances are also important to assess the correctness of the declared value during official controls.
Measurement Uncertainty
This is a parameter reflecting the precision and accuracy of the measurement, which characterizes the dispersion around the measured value. For example, for some nutrients, it may be 10 mg + / - 10%. The exact value of measurement uncertainty depends on many factors, including the limitations of the measurement instruments used, measurement conditions, and analysis methods.
Declared Values
Declared values should approximate average values from different production batches. The average value is the one that best represents the amount of a nutrient in a given product, taking into account natural raw material variability, seasonal variability, consumption patterns, and other factors.
Compatible throughout the shelf life
The measured value should be within tolerance around the declared value throughout the shelf life of the product.
Security
Safety should be considered when establishing tolerance for vitamins and minerals. Maximum levels should not be exceeded. Safety-based maximum levels for vitamins and minerals should include any tolerance.
Tolerances for Vitamins and Minerals in Dietary Supplements (no claims)
- Vitamins: -20% to +50%
- Minerals: -20% to +45%
Example for Vitamin C
- Declared value: 24 mg
- upper limit: 24,4 mg (24 mg + 50%)
- Lower limit: 19 mg (24 mg – 20%)
- Range of tolerance: from 19 mg to 36,6 mg (rounded to 37 mg)
Tolerances for Health or Nutrition Claims
Case 1A (minimum level established in claim terms of use)
- Declared value: 12 mg
- upper limit: 18 mg (12 mg + 50%)
- Lower limit: 9,6 mg (12 mg – 20%)
Case 1B (maximum level set in claim terms of use)
- Declared value: 28 mg
- upper limit: 29 mg (28 mg + 3%)
- Lower limit: 17 mg (28 mg – 40%)
Source: Food Supplements Europe – Setting of Tolerances for Nutrient Values Declared on a Label
