In December 2012 the European Commission Health and Consumers Directorate General published a “Guidance Document for Competent Authorities for the Control of Compliance with EU Legislation on ... the Setting of Tolerances for Nutrient Values Declared on a Label” (the EC Guide). Its aim was to provide advice on calculating acceptable differences between levels of nutrients and other substances declared on a label and those established in the course of official controls in relation to ‘nutrition declaration’ or ‘nutrition labelling’ as described in Regulation EU 1169/2011; and to control compliance with the conditions of use for nutrition claims as listed in the Annex to Regulation EC 1924/2006.

The EC Guide was addressed to control authorities and food business operators; its comprehensiveness and the complexity of its rules make comprehension and application somewhat difficult in places. We have produced this simplified guidance to help food business operators set tolerances which may differ from the EC Guide, but will be compatible with it. That is, tolerance ranges calculated using this simplified guidance will be wholly contained in tolerance ranges calculated according to the EC Guide, but may be slightly narrower.

This guidance is restricted to setting tolerances on declared nutrient values. For help with labelling issues in general and nutrient labelling in particular, please contact our legislation team at regulatoryadvice@campdenbri.co.uk or visit our
food legislation advice page

Introduction

Tolerances for nutrition labelling purposes are important as it is not possible for foods to always contain the exact levels of energy and nutrients that are labelled, due to natural variations and variations from production and during storage. However, the nutrient content of foods should not deviate substantially from labelled values to the extent that such deviations could lead to consumers being misled.
The declared values should, according to the individual case, be average values and based on:

• a) analysis of the food;
• b) calculation from the known or actual average values of the ingredients used; or
• c) calculation from generally established and accepted data.

Analysis is usually the best way of arriving at a declared value. We can help with analysis or calculation here.

Regardless of how nutrition declarations are derived, food business operators should act in good faith to ensure a high degree of accuracy of those nutrition declarations. In particular, declared values should approximate to the average values across multiple batches of food and should not be established at either extreme of a defined tolerance range.

A flow diagram (section 2) shows the steps in calculating tolerance ranges, and supplementary tables (sections 3-5) provide required information. Section 6 gives worked examples of the application of this guidance to example circumstances taken from the EC Guide. In this guidance the first reference to official documents is an active hyperlink to an appropriate website; Section 7 lists these internet addresses.