Final report on the safety assessment of Juniperus communis Extract, Juniperus oxycedrus Extract, Juniperus oxycedrus Tar, Juniperus phoenicea extract, and Juniperus virginiana Extract.

The common juniper is a tree that grows in Europe, Asia, and North America. The ripe fruit of Juniperus communis and Juniperus oxycedrus is alcohol extracted to produce Juniperus Communis Extract and Juniperus Oxycedrus Extract, respectively. Juniperus Oxycedrus Tar is the volatile oil from the wood of J. oxycedrus. Juniperus Phoenicea Extract comes from the gum of Juniperus phoenicea, and Juniperus Virginiana Extract is extracted from the wood of Juniperus virginiana. Although Juniperus Oxycedrus Tar is produced as a by-product of distillation, no information was available on the manufacturing process for any of the Extracts. Oils derived from these varieties of juniper are used solely as fragrance ingredients; they are commonly produced using steam distillation of the source material, but it is not known if that procedure is used to produce extracts. One report does state that the chemical composition of Juniper Communis Oil and Juniperus Communis Extract is similar, each containing a wide variety of terpenoids and aromatic compounds, with the occasional aliphatic alcohols and aldehydes, and, more rarely, alkanes. The principle component of Juniperus Oxycedrus Tar is cadinene, a sesquiterpene, but cresol and guaiacol are also found. No data were available, however, indicating the extent to which there would be variations in composition that may occur as a result of extraction differences or any other factor such as plant growth conditions. Information on the composition of the other ingredients was not available. All of the Extracts function as biological additives in cosmetic formulations, and Juniperus Oxycedrus Tar is used as a hair-conditioning agent and a fragrance component. Most of the available safety test data are from studies using oils derived from the various varieties of juniper. Because of the expected similarity in composition to the extract, these data were considered. Acute studies using animals show little toxicity of the oil or tar. The oils derived from J. communis and J. virginiana and Juniperus Oxycedrus Tar were not skin irritants in animals. The oil from J. virginiana was not a sensitizer, and the oil from J. communis was not phototoxic in animal tests. Juniperus Oxycedrus Tar was genotoxic in several assays. No genotoxicity data were available for any of the extracts. Juniperus Communis Extract did affect fertility and was abortifacient in studies using albino rats. Clinical tests showed no evidence of irritation or sensitization with any of the tested oils, but some evidence of sensitization to the tar. These data were not considered sufficient to assess the safety of these ingredients. Additional data needs include current concentration of use data; function in cosmetics; methods of manufacturing and impurities data, especially pesticides; ultraviolet (UV) absorption data; if absorption occurs in the UVA or UVB range, photosensitization data are needed; dermal reproductive/developmental toxicity data (to include determination of a no-effect level); two genotoxicity assays (one in a mammalian system) for each extract; if positive, a 2-year dermal carcinogenicity assay performed using National Toxicology Program (NTP) methods is needed; a 2-year dermal carcinogenicity assay performed using NTP methods on Juniperus Oxycedrus Tar; and irritation and sensitization data on each extract and the tar (these data are needed because the available data on the oils cannot be extrapolated). Until these data are available, it is concluded that the available data are insufficient to support the safety of these ingredients in cosmetic formulations.