2. GENERAL PRINCIPLES
The actual amount of a nutrient in a product may vary compared to the value declared on a label due to
factors such as the source of values (values derived from literature and calculated by recipe instead of
analysis), the accuracy of analysis, the variation in the raw materials, the effect of processing, nutrient
stability and storage conditions and storage time.
2.1 Tolerances and food safety issues
The factor of food safety is to be taken into account when setting tolerances for added vitamins and minerals
to food including food supplements. Excessive intakes of vitamins and minerals may result in adverse
effects and it is therefore necessary to set maximum amounts for them when they are added to foods or
present in food supplements. Provisions for establishing maximum amounts for vitamins and minerals are
included in Regulation (EC) No 1925/2006 on the addition of vitamins and minerals and of certain other
substances to foods and in Directive 2002/46/EC on food supplements. The tolerance range around a
declared value may extend above the maximum amount of vitamins or minerals added to foods or present in
food supplements harmonised at EU level according to the provisions in Regulation (EC) No 1925/2006 on
the addition of vitamins and minerals and of certain other substances to foods and according to the
provisions in Directive 2002/46/EC on food supplements. In this case, the maximum amount has priority
over the tolerance range around the declared value and would therefore limit the upper end of the tolerance
around the declared value.
In the absence of harmonised rules on maximum amounts in foods and food supplements Member States
may establish national rules in compliance with Articles 34 and 36 of the Treaty on the Functioning of the
European Union. However, in doing so, they should also follow the criteria laid down in Regulation (EC)
No 1925/2006 and Directive 2002/46/EC. In case the tolerance range around a declared value extends above
the maximum amount established by Member States as national rules, in compliance with Articles 34 and 36
of the Treaty on the Functioning of the European Union for which Member States should also follow the
criteria laid down in Regulation (EC) No 1925/2006 and Directive 2002/46/EC, the current practice of
handling such issues before this guidance document was agreed may be maintained.
As soon as harmonised rules on maximum amounts in foods and food supplements for vitamins and
minerals have been established in the EU legislation, it should be considered whether this guidance
document needs to be revised