EU Regulation of Average Fill & Estimated Symbol “e” -- MEDICA - World Forum for Medicine


Obelis O.E.A.R.C.

EU Regulation of Average Fill & Estimated Symbol “e”

The small ‘e’,at least 3 mm high, placed in the same field of vision as the indication of the nominal weight or nominal volume, constitutes a guarantee by the packer or the importer that the prepackage meets the requirements of the Directive 76/211/EEC (on the approximation of the laws of the EU Member States relating to the making-up by weight or by volume of certain prepackaged products). This letter shall have the form shown in the drawing contained in section 3 of Annex II to Directive 71/316/EEC.

While some refer to this symbol as the “e” mark, it is not an “e”—the correct name is the Estimated Symbol. Some companies have encountered trouble by displaying this mark incorrectly, which should not occur since this symbol is the Estimated Symbol in 212E from Unicode, as listed by Microsoft Word.

This symbol is voluntary and manufacturers are not required to use it on their product labels. The symbol indicates to the EU that the manufacturer will comply with the EU Directives & Regulations of average fill. Thus, if a manufacturer lists it on a product label, they must comply.

This symbol only applies to goods shipped within the EU (such as Cosmetic products for example, which need to comply with the EU Cosmetic Directive 76/768/EEC & EU Cosmetic Regulation EC 1223/2009) and has no meaning for those shipped into the EU from non-member states (While some Non-EU manufacturers list this symbol on product labels, they typically do so to give the impression that their product is approved in the EU. For example, The United States dictates a minimum fill requirement and not an average fill market like the EU does).

Rules for using the Estimated Symbol in the European Community include:
1.The average quantity of product in a batch of prepackages shall not be less than the nominal quantity stated on the label.
2.The proportion of prepackages having a negative error greater than the tolerable negative error shall be sufficiently small for batches of prepackages to satisfy the requirements of the official reference test, as specified in legislation.
3.No prepackage having a negative error greater than twice the tolerable negative error may bear the Estimated Symbol.
4.The nominal quantity (nominal weight or nominal volume) expressed in kilograms, grams, litres, centilitres or millilitres, and marked in figures 3 mm high if it is from 200 g or 20 cl down to but not including 50 g or 5 cl, 2 mm high if it is not more than 50 g or 5 cl, followed by the symbol for the unit of measurement used or where appropriate by the name of the unit in accordance with Directive 71/354/EEC, as last amended by Directive 76/770/EEC.
5.Failure to comply with the above requirements, or violations such as incorrect size, location or font, can result in penalties such as the recall of all goods, fines, and even prohibition from conducting business in the EU.
6.Finished products of 5 g or 5 ml or less are not eligible to use this symbol.

Contact us now to find out more.