Hypericum Perforatum Flower/Leaf/Stem Extract

The Food and Drug Administration (FDA) reviewed the safety of Hypericum perforatum and approved its use as a natural flavoring substance in alcoholic beverages in the hypericin-free alcoholAlcohols are a large class of important cosmetic ingredients but only ethanol needs to be denatured to prevent it from being redirected from cosmetic applications to alcoholic beverages. distillateThe purified liquid product obtained by the condensation of the vapors produced by boiling a liquid. form only. The safety of Hypericum Perforatum Flower/Leaf/Stem Extract and Oil has been assessed by the Cosmetic Ingredient ReviewThe Cosmetic Ingredient Review (CIR) was established in 1976 as an independent safety review program for cosmetic ingredients. The CIR Expert Panel consists of independent experts in dermatology, toxicology, pharmacolgy and veterinary medicine. The CIR includes participation by the U.S. Food & Drug Administration and the Consumer Federation of America. (CIR) Expert Panel. The CIR Expert Panel evaluated the scientific data and concluded that additional data were needed to determine whether or not Hypericum Perforatum Flower/Leaf/Stem Extract and Hypericum Perforatum Oil were safe for use in cosmetics and personal care products.

CIR Safety Review: Acute toxicity studies indicate that the extract was relatively nontoxic. Dietary exposure to H. perforatum flowers for 2 weeks resulted in no significant signs of toxicity, including erythema, edema of the portion of the body exposed to light, alopecia, and changes in blood chemistry. In a chronic study, dietary exposure to H. perforatum at high doses resulted in less weight gain than controls.

Mixtures containing the extract and the oil were not irritants or sensitizers. A component of the plant, hypericin is a photosensitizer. In clinical tests, a single oral administration of Hypericum Perforatum Flower/Leaf/Stem Extract resulted in hypericin appearing in the blood. With long-term dosing, a steady-state level in blood was reached after 14 days. The polyphenol fraction of H. perforatum had immunostimulating activity, whereas the lipophilic portion had immunosuppressing properties. Mixtures of the extract and the oil produced minimal or no ocular irritation in eyes. Mutagenic activity in bacteria was attributed to flavonols in one study and to quercitin in another, but other genotoxicity assays were negative.

No carcinogenicity or reproductive and developmental toxicity data were available. A mixture of the extract and the oil was not irritating in clinical studies. Adverse reactions to oral Hypericum Perforatum Flower/Leaf/Stem Extract in the clinical treatment of depression include skin reddening and itching, dizziness, constipation, fatigue, anxiety and tiredness.

Absent any basis for concluding that data on one member of a botanical ingredient group can be extrapolated to another in a group, or to the same ingredient extracted differently, these data were not considered sufficient to assess the safety of these ingredients.

The CIR Expert Panel requested the following additional information: 1) concentration of use; 2) photosensitzation and photoxicity data using visible light; 3) gross pathology and histopathology in skin and other major organ systems associated with repeated dermal exposure; 4) dermal reproductive and developmental toxicity data; 5) skin irritation and sensitization data in humans on Hypericum Perforatum Oil; and 6) ocular irritation data, if available.

Link to FDA Code of Federal Regulations for Hypericum perforatum L. leaves, flowers, and caulis http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr…

Hypericum Perforatum Extract and Oil may be used in cosmetics and personal care products marketed in Europe according to the general provisions of the Cosmetics Regulation of the European UnionUnder the general provisions of the cosmetics regulation of the EU, ingredients appearing on the following function-specific annexes must comply with the listed restrictions and/or specifications: colorants (Annex IV), preservatives (Annex V), UV filters (Annex VI) and other ingredients with specific concentration limits and/or other restrictions (Annex III). Ingredients specifically prohibited from use in cosmetic products are listed in Annex II. Other ingredients listed in the EU cosmetic ingredient database (CosIng) may be used without restrictions..

Link to the EU Cosmetic Regulation:
http://europa.eu/legislation_summaries/consumers/product_labelling_and_p…