ABSTRACT
The Expert Panel for Cosmetic Ingredient Safety (Panel) assessed the safety of Humulus Lupulus (Hops) Extract (reported functions include antimicrobial agent and hair conditioning agent) and Humulus Lupulus (Hops) Oil (reported function is fragrance). The Panel reviewed the relevant data related to these ingredients. Because final product formulations may contain multiple botanicals, each containing the same constituents of concern, formulators are advised to be aware of these constituents and to avoid reaching levels that may be hazardous to consumers. For these ingredients, the Panel was concerned about the presence of 8-prenylnaringenin, ß-myrcene, and quercetin in cosmetics, which could result in estrogenic effects, dermal irritation, and genotoxicity, respectively. Industry should use current good manufacturing practices to limit impurities and constituents of concern. The Panel concluded that Humulus Lupulus (Hops) Extract and Humulus Lupulus (Hops) Oil are safe in cosmetics in the present practices of use and concentration when formulated to be non-sensitizing.
Subject(s)
Biological Products , Cosmetics , Humulus , Consumer Product Safety , Plant Extracts/toxicity , Cosmetics/toxicityABSTRACT
Cosmetic ingredients derived from Camellia sinensis (tea) plant parts function as antioxidants and skin conditioning agents-humectant and miscellaneous. The Cosmetic Ingredient Review (CIR) Expert Panel (Panel) reviewed relevant animal and human data related to these ingredients. The use of the leaf ingredients in beverages results in much larger systemic exposures than those possible from cosmetic use. Accordingly, concern over the systemic toxicity potential of leaf-derived ingredients is mitigated. Because product formulations may contain multiple botanical ingredients, each containing the same constituents of concern, formulators are advised to be aware of these constituents and to avoid reaching levels that may lead to sensitization or other toxic effects. The Panel concluded that the C sinensis leaf-derived ingredients are safe in the present practices of use and concentration described in this safety assessment when formulated to be nonsensitizing. However, the available data are insufficient to determine whether the non-leaf-derived ingredients are safe for use in cosmetics.
Subject(s)
Camellia sinensis/chemistry , Consumer Product Safety , Cosmetics/chemistry , Plant Extracts/toxicity , Animals , Humans , Risk AssessmentABSTRACT
This is a safety assessment of Avena sativa (oat)-derived ingredients. The reported functions of these ingredients in cosmetics include abrasives, antioxidant, skin conditioning agents, absorbents, and bulking agents. The Panel reviewed relevant animal and human data related to these ingredients. Because final product formulations may contain multiple botanicals, each containing the same constituents of concern, formulators are advised to be aware of these constituents and to avoid reaching levels that may lead to sensitization or other toxic effects. The Panel stated that industry should continue to use good manufacturing practices to limit impurities and concluded that all but one of the Avena sativa (oat)-derived ingredients are safe as cosmetic ingredients in the practices of use and concentration described in this safety assessment when formulated to be nonsensitizing; data are insufficient to come to a conclusion of safety for Avena Sativa (Oat) Meristem Cell Extract.
Subject(s)
Avena/chemistry , Consumer Product Safety , Cosmetics/chemistry , Plant Extracts/toxicity , Animals , Humans , Risk AssessmentABSTRACT
This is a safety assessment of alumina and aluminum hydroxide as used in cosmetics. Alumina functions as an abrasive, absorbent, anticaking agent, bulking agent, and opacifying agent. Aluminum hydroxide functions as a buffering agent, corrosion inhibitor, and pH adjuster. The Food and Drug Administration (FDA) evaluated the safe use of alumina in several medical devices and aluminum hydroxide in over-the-counter drugs, which included a review of human and animal safety data. The Cosmetic Ingredient Review (CIR) Expert Panel considered the FDA evaluations as part of the basis for determining the safety of these ingredients as used in cosmetics. Alumina used in cosmetics is essentially the same as that used in medical devices. This safety assessment does not include metallic or elemental aluminum as a cosmetic ingredient. The CIR Expert Panel concluded that alumina and aluminum hydroxide are safe in the present practices of use and concentration described in this safety assessment.
Subject(s)
Aluminum Hydroxide/toxicity , Aluminum Oxide/toxicity , Consumer Product Safety , Cosmetics/standards , Aluminum Hydroxide/analysis , Aluminum Hydroxide/pharmacokinetics , Aluminum Oxide/analysis , Aluminum Oxide/pharmacokinetics , Animals , Consumer Product Safety/legislation & jurisprudence , Cosmetics/chemistry , Equipment and Supplies/standards , Government Regulation , Humans , Molecular Structure , Toxicity Tests/methods , Toxicokinetics , United States , United States Food and Drug AdministrationABSTRACT
Cosmetic ingredients derived from Achillea millefolium function in cosmetics as skin-conditioning agents-miscellaneous, skin-conditioning agents-humectants, and fragrance ingredients. The Cosmetic Ingredient Review Expert Panel (Panel) reviewed relevant animal and human data to determine their safety in cosmetics and raised concerns about cosmetics containing linalool, thujone, quercetin, hydroquinone, or α-peroxyachifolid. Because final product formulations may contain multiple botanicals, each containing similar constituents of concern, formulators are advised to be aware of these components and to avoid reaching levels that may be hazardous to consumers. Additionally, industry was advised to use good manufacturing practices to limit impurities. The Panel concluded that achillea millefolium extract, achillea millefolium flower extract, and achillea millefolium flower/leaf/stem extract are safe in the present practices of use and concentration in cosmetics when formulated to be nonsensitizing.
Subject(s)
Achillea/chemistry , Consumer Product Safety , Cosmetics/standards , Plant Extracts/toxicity , Plant Oils/toxicity , Animals , Consumer Product Safety/legislation & jurisprudence , Cosmetics/chemistry , Humans , Plant Extracts/analysis , Plant Extracts/pharmacokinetics , Plant Oils/analysis , Plant Oils/pharmacokinetics , Toxicity Tests/methods , Toxicokinetics , United States , United States Food and Drug AdministrationABSTRACT
The Cosmetic Ingredient Review Expert Panel (Panel) reviewed the safety of 13 Panax spp root-derived ingredients as used in cosmetics. Panax "spp" indicates that multiple species within the genus are used in cosmetics, but not all species within that genus. Four species are being considered in this safety assessment. These ingredients function mostly as skin-conditioning agents-miscellaneous, fragrance ingredients, skin-conditioning agents-humectant, skin-conditioning agents-emollient, and cosmetic astringents. The Panel reviewed available data related to these ingredients and addressed the issue of pulegone, a constituent of these ingredients and other ingredients, such as peppermint oil. The Panel concluded that these Panax spp root-derived ingredients are safe in the practices of use and concentration as given in this safety assessment.
Subject(s)
Consumer Product Safety , Cosmetics/toxicity , Panax/chemistry , Plant Extracts/toxicity , Plant Roots/chemistry , Animals , Cosmetics/chemistry , Cosmetics/pharmacokinetics , Dose-Response Relationship, Drug , Emollients/chemistry , Emollients/pharmacokinetics , Emollients/toxicity , Humans , Plant Extracts/chemistry , Plant Extracts/pharmacokinetics , Risk Assessment , Skin/drug effects , Skin/metabolism , Toxicity TestsABSTRACT
The Cosmetic Ingredient Review Expert Panel (Panel) has issued an amended safety assessment of 7 Hypericum perforatum-derived ingredients as used in cosmetics. A common name for this plant is St John wort. These ingredients function in cosmetics as skin-conditioning agents-miscellaneous and antimicrobial agents. The Panel reviewed relevant animal and human data related to the H perforatum-derived ingredients. Because formulators may use more than 1 botanical ingredient in a formulation, caution was urged to avoid levels of toxicological concern for constituent chemicals and impurities. The Panel concluded that H perforatum-derived ingredients were safe as cosmetic ingredients in the practices of use and concentration as described in this safety assessment.