Ulmus Campestris (Elm) Bark Extract
Safety Information
U.S. Food and Drug Administration (FDA)
The U.S. Food and Drug Administration (FDA) includes Ulmus Campestris (elm) bark extract on its list of demulcents approved for use in over-the-counter (OTC) oral health care drug products. When used in OTC drug products, this ingredient is called elm bark.
Expert Panel for Cosmetic Ingredient Safety
The Expert Panel for Cosmetic Ingredient Safety has deferred evaluation of this ingredient because the safety has been assessed by FDA. This deferral of review is according to the provisions of the Expert Panel procedures.
Link to Federal Register concerning FDA’s OTC finding for elm bark http://www.fda.gov/cder/otcmonographs/Oral_Health_Care/oral_health_care_…
Ulmus Campestris (elm) bark extract may be used in cosmetics and personal care products marketed in Europe according to the general provisions of the Cosmetics Regulation of the European Union.
Link to the EU Cosmetic Regulation:
http://europa.eu/legislation_summaries/consumers/product_labelling_and_p…