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Essential oils: revised monograph and new general chapter in the Ph. Eur.

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16 April 2021
Strasbourg, France

The 169th Session of the European Pharmacopoeia (Ph. Eur.) Commission, held in March, saw the adoption of the revised general monograph on Essential oils (2098) and of the new chapter on Monographs on essential oils (information chapter) (5.30).

The Essential oils general monograph has been completely overhauled to expand, among others, the definition, production, test and labelling sections, providing additional detail and clarification. The text now offers more information concerning the herbal drugs and the quality of water to be used for the preparation of essential oils and gives requirements 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).

The new chapter, Monographs on essential oils (information chapter) (5.30), provides underlying 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 is justified and the various uses of rectification.

Both texts will be published in Supplement 10.7 of the Ph. Eur.

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