Instructions on purity specifications for preparations used as food supplements

EU Directives concerning identification and purity specifications, and references to other specifications

  1. If an EU Directive referred to below under item A or item B contains identification and purity specifications for a particular food supplement, these specifications shall apply.
  2. If an EU Directive contains no specifications, the specifications of the Codex Alimentarius shall apply (item C). These are based on the identification and purity specifications of the JECFA (Joint FAO/WHO Expert Committee on Food Additives).
  3. If there are no EU Directive specifications and no Codex Alimentarius specifications, other JECFA specifications shall apply (item C).
  4. If there are no specifications as referred to above in points 1-3, the purity specifications recommended in the European Pharmacopea shall apply.

A. Decree of the Ministry of Trade and Industry on purity specifications for food supplements and certain classification methods 546/2007 (

B. EU Directives that specifically apply to vitamin and mineral preparations

1. Commission Directive 95/45/EC of 26 July 1995 laying down specific purity criteria concerning colours for use in foodstuffs (OJ L 226, 22.9.1995, p. 1, Celex 395L0045) as amended by:

  • Commission Directive 1999/75/EC of 22 July 1999 (OJ L 206, 5.8.1999, p. 19, Celex 399L0075), and
  • Commission Directive 2004/47/EC of 16 April 2004 (OJ L 113, 20.4.2004, p. 24, Celex 32004L0047).

2. Commission Directive 96/77/EC of 2 December 1996 laying down specific purity criteria on food additives other than colours and sweeteners (OJ L 339, 30.12.1996, p. 1, Celex 396L0077) as amended by:

  • Commission Directive 98/86/EC of 11 November 1998 (OJ L 334, 9.12.1998, p. 1, Celex 398L0086),
  • Commission Directive 2002/82/EC of 15 October 2002 (OJ L 292, 28.10.2002, p. 1, Celex 302L0082), and
  • Commission Directive 2006/129/EC of 8 December 2006 (OJ L 346, 9.12.2006, p. 15, Celex 32006L0129).

C. Other specifications

Published identification and purity specifications:

Food supplements for which the Codex Alimentarius provides identification and purity specifications can be found online in the list CAC/MISC 6 “List of Codex advisory specifications for food additives” ( )

Identification and purity specifications recommended by the Codex and other JEFCA specifications can be found online in the “Combined Compendium of Food Additive Specifications” at and in FAO JECFA Monographs 1, Volume 1-3 (2005), FAO JECFA Monographs 3 (2006) and FAO JECFA Monographs 4 (2007), FAO, Rome. The classification methods to be used in identification and purity studies can be found at the same address online and in FAO JECFA Monographs 1, Volume 4 (2005), FAO, Rome.