Ph. Eur. Essential Oils: Revised Monograph and New General Chapter

The European Pharmacopoeia (Ph. Eur.) Commission adopted the revised general monograph on Essential oils  together with the new chapter on Monographs on essential oils (information chapter 5.30).

Contaminants in Essential Oils

The Ph. Eur. Essential oils general monograph has been completely revised to expand the definition, production, test and labelling sections, providing additional detail and clarification. The text now offers, amongst others, more information concerning the quality of water to be used for the preparation of essential oils and includes requirements and limits for

  • Heavy metals (2.4.27),
  • Pesticide residues (2.8.13),
  • Aflatoxin B1 (2.8.18), and
  • Microbiological quality (5.1.4 or 5.1.8).

Skip Testing

The new chapter, Monographs on essential oils (information chapter 5.30), provides principles for the elaboration of monographs on essential oils, with details of production methods, chromatographic profiles and potential contaminants. The chapter also describes the conditions under which skip testing can be justified.

Both Ph. Eur. texts (Essential oils and 5.30 Monographs on essential oils) will be published in Supplement 10.7 of the Ph. Eur. (Implementation Date: 1 April 2022).

For more information please red the post in the Ph. Eur. Newsroom: Essential oils: revised monograph and new general chapter in the Ph. Eur.

Conference Recommendations

Go back

GMP Conferences by Topics