Tolerance of a nutrient means an acceptable difference between the quantity declared on the labelling in association with nutrition labelling and the quantity established under regulatory control. When setting tolerances, food safety and misleading the consumer have been taken into account.
Food control complies with the tolerances given in the EU Guidance on Tolerance (Guidance Document for Competent Authorities for the Control of Compliance with the Following EU Legislation December 2012):
https://ec.europa.eu/food/sites/food/files/safety/docs/labelling_nutrition-vitamins_minerals-guidance_tolerances_1212_fi.pdf
It is important to define the tolerances for nutrients, as there is an inherent variation in the nutrient levels in foods. In addition, variations in nutrient levels arise, for example, because of production and storage conditions. The measured values must be within the tolerances throughout the durability.
The Guidance on Tolerances provides the tolerances for the nutrients declared in nutrition labelling and the rounding guidelines applicable to the values declared (Table 4). Table 1 shows the tolerances for vitamins and minerals. Tolerance limits vary depending on whether it is a regular food or a food supplement. In addition, the tolerance differs when it is controlled to ascertain whether the conditions of a nutrition or health claim are met or whether a fortified food contains a set minimum amount of a vitamin or a mineral.
Table 1
| Food | Tolerances (including measurement uncertainty of the analytical method) | |
| Vitamins | Minerals | |
| Food other than food supplement | + 50 %* / - 35 % | + 45 % / - 35 % |
| Food supplement | + 50 %* / - 20 % | + 45 % / - 20 % |
|
Nutrients for which a nutrition or health claim has been made in accordance with Regulation (EC) No 1924/2006 OR a fortified food in accordance with Regulation (EC) No 1925/2006 ** |
+ 50 %*/- MU*** | + 45 % /- MU*** |
* For vitamin C in liquids, higher upper tolerance values could be accepted
** When monitoring the conditions for the use of a nutrition or health claim in accordance with Regulation (EC) No 1924/2006, where a minimum or maximum level is specified in the conditions, or when controlling to ensure that a food fortified in accordance with Regulation (EC) No 1925/2006 contains the required minimum amount of fortified vitamin or mineral (15% of the reference values for solid foods and 7.5% for liquid foods)
*** A tolerance of only the measurement uncertainty of the analytical method applies (MU = measurement uncertainty).
1. Example of tolerances for food
Organic semi-skimmed milk contains natural calcium 120 mg/100 ml. The amount is stated on the nutrition label, but no nutrition claim is made. Under the rounding rules in the Guidance on Tolerances (see Table 4 of the EU Guidance on Tolerances), three significant figures are taken into account for calcium. The declared amount is thus between 119.5 and 120.4 mg /100 ml.
Table According to Annex 1, tolerance for a mineral in a food is + 45% / -35%.
The lower limit of the tolerance is thus 119.5-119.5 * 0.35 = 77.7 and the upper limit 120.4 + 120.4 * 0.45 = 175. Given the rules of rounding, if the analytical result obtained under official control is between 77.7 and 175 mg / 100 ml, the result is considered to be within the tolerances.
2. Example of tolerances to be applied if a food is the subject of a nutrition or health claim
Potassium has been added to juice drink and the claim 'contains potassium' appear on the label. The packaging states that the food contains 150 mg/100 ml of potassium.
Under the Nutrition and Health Claims Regulation, the use of the claim “contains potassium” is subject to the condition that the food contains at least a significant amount of potassium as defined in Annex XIII to Food Information Regulation (EU) No 1169/2011. For liquid foods, this is 7.5% of the daily reference intake, i.e. 150 mg/100 ml for potassium.
Under the rounding rules in the Guidance on Tolerances (see Table 4 of the EU Guidance on Tolerances) for potassium, three significant figures are taken into account, so the declared amount of 150 mg/100 ml means 149.5-150.4 mg / 100 ml.
In the case of official controls, the analytical result for potassium is 147 mg/100 ml and the method used has a measurement method uncertainty of ± 4%. Under the Guidance on Tolerances, the tolerance allowed when controlling the limits of the condition for the use of a claim is roughly the same as the measurement uncertainty of the analytical method. When the measurement uncertainty (147 + 147 x 0.04 = 152.88) is added to the potassium amount detected in the analytical result, the product is found to be within the tolerance.
3. Foods for particular nutritional use
The Guidance on Tolerances does not apply to dietetic products in accordance with Ministry of Agriculture and Forestry Decree 121/2010. For the time being, the previous guidelines on tolerances for Evira (now the Finnish Food Authority) will apply to dietetic products, pending the adoption of tolerances for foods for particular nutritional uses at community level in the context of the reform of the legislation on foods for particular nutritional uses. The following tolerances may therefore be allowed for nutrients declared in dietetic products: Nutrient deficiencies: maximum -20% Nutrient excesses: minerals maximum + 20%, vitamins maximum + 50%, vitamin C maximum + 100% In addition, the measurement uncertainty of the analytical method used is taken into account Where composition requirements (maximum and/or minimum limits) have been determined for a particular nutrient for a dietetic product, the levels analysed may deviate from these limits only by the measurement uncertainty of the method of analysis.