In January, EMA's HMPC (Committee on Herbal Medicinal Products) published a "Reflection Paper" on the quality of essential oils for use in the manufacture of herbal medicinal products / traditional herbal medicinal products.
With this "Reflection Paper" aspects related to the nature and the specific production processes of essential oils should be taken into account.
Products made of essential oils belong to herbal preparations. So far, requirements on essential oils haven't been addressed enough in the existing guidelines.
Moreover, the existing HMPC guidelines on quality don't take into account the definitions laid down in the Pharmacopoeia Europea (Ph.Eur.) monograph on essential oils.
From a regulatory point of view, essential oils used as APIs in herbal products raise a broad range of questions which are emphasized by the fact that the current guidelines don't fully address the specific aspects of essential oils.
The new "Reflection Paper" calls on interested parties to provide concrete examples and comments on the whole manufacturing processes of essential oils. The feedbacks will be the basis for further discussions. Depending on them, a new guideline will be developed.
The deadline for comments is the 15th May 2013.
The complete "Reflection paper on quality of essential oils as active substances in herbal medicinal products/taditional herbal medicinal products" can be found here.
Dr Günter Brendelberger
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)