ABSTRACT
The Expert Panel for Cosmetic Ingredient Safety (Panel) assessed the safety of 10 Ginkgo biloba-derived ingredients, which are most frequently reported to function in cosmetics as skin conditioning agents or antioxidants. The Panel reviewed the available data to determine the safety of 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. The Panel was concerned about the presence of ginkgolic acid in cosmetics. Industry should use good manufacturing practices to limit impurities. The Panel concluded that 5 Ginkgo biloba leaf-derived ingredients are safe in the present practices of use and concentration described in this safety assessment when formulated to be non-sensitizing; data are insufficient to determine the safety of the remaining 5 ingredients under the intended conditions of use in cosmetic formulations.
Subject(s)
Cosmetics , Ginkgo biloba , Ginkgo biloba/toxicity , Consumer Product Safety , Plant Extracts/toxicity , Cosmetics/toxicity , AntioxidantsABSTRACT
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
The Expert Panel for Cosmetic Ingredient Safety (Panel) reviewed the safety of M piperita (peppermint)-derived ingredients. The Panel reviewed data relevant to the safety of these ingredients. Because final product formulations may contain multiple botanicals, each containing the same constituent(s) of concern, formulators are advised to be aware of these constituents and avoid reaching levels that may be hazardous to consumers. Industry should continue to use good manufacturing practices to limit impurities that could be present in botanical ingredients. The Panel concluded that M piperita (Peppermint) Oil, Extract, Leaf, and leaf-derived ingredients are safe in cosmetics in the present practices of use and concentration when formulated to be non-sensitizing, and that the available data are insufficient for determining that M piperita (Peppermint) Flower/Leaf/Stem Extract, M piperita (Peppermint) Flower/Leaf/Stem Water, and M piperita (Peppermint) Meristem Cell Culture are safe under the intended conditions of use in cosmetic formulations.
Subject(s)
Cosmetics , Mentha piperita , Consumer Product Safety , Plant Extracts/toxicity , Allergens , Cosmetics/toxicityABSTRACT
The Expert Panel for Cosmetic Ingredient Safety (Panel) reviewed the safety of 26 apple-derived ingredients, which reportedly function mostly as skin conditioning agents in cosmetic products. Because apple-derived ingredients may be obtained from different apple cultivars, the composition of ingredients derived from different cultivars should be similar to that of ingredients reviewed in this safety assessment. Additionally, industry should continue to use good manufacturing practices to limit impurities that could be present in botanical ingredients. The Panel reviewed the available data to determine the safety of these ingredients and concluded that 21 of these ingredients are safe in cosmetics in the present practices of use and concentrations described in this safety assessment. However, the Panel also determined that the available data are insufficient to determine the safety of Pyrus Malus (Apple) Root Extract, Pyrus Malus (or Malus Domestica) (Apple) Stem Extract, Malus Domestica (Apple) Callus Extract, and Malus Domestica (Apple) Oil.
Subject(s)
Cosmetics , Malus , Consumer Product Safety , Toxicity Tests , Cosmetics/toxicity , Plant Extracts/toxicity , Risk AssessmentABSTRACT
The Expert Panel for Cosmetic Ingredient Safety (Panel) assessed the safety of 9 Centella asiatica-derived ingredients, which reportedly function primarily as skin conditioning agents in cosmetic products. The Panel reviewed relevant data relating to the safety of these ingredients. The Panel concluded that Centella Asiatica Extract, Centella Asiatica Callus Culture, Centella Asiatica Flower/Leaf/Stem Extract, Centella Asiatica Leaf Cell Culture Extract, Centella Asiatica Leaf Extract, Centella Asiatica Leaf Water, Centella Asiatica Meristem Cell Culture, Centella Asiatica Meristem Cell Culture Extract, and Centella Asiatica Root Extract are safe in the present practices of use and concentration in cosmetics, as described in this safety assessment, when formulated to be non-sensitizing.
Subject(s)
Centella , Cosmetics , Consumer Product Safety , Risk Assessment , Plant Extracts/toxicity , Cosmetics/toxicityABSTRACT
The Expert Panel for Cosmetic Ingredient Safety (Panel) reviewed the safety of 19 plant-derived proteins and peptides, which function mainly as skin and/or hair conditioning agents in personal care products. The Panel concluded that 18 plant-derived proteins and peptides are safe as used in the present practices of use and concentration as described in this safety assessment, while the data on Hydrolyzed Maple Sycamore Protein are insufficient to determine safety.
Subject(s)
Consumer Product Safety , Cosmetics , Cosmetics/toxicity , Peptides/toxicity , Plant Extracts , Plant Proteins , Risk AssessmentABSTRACT
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
The Cosmetic Ingredient Review Expert Panel assessed the safety of 14 citrus-derived peel oil ingredients and concluded that these ingredients are safe for use in cosmetic products when finished products, excluding rinse-off products, do not contain more than 0.0015% (15 ppm) 5-methoxypsoralen, and when formulated to be nonsensitizing and nonirritating. The citrus-derived peel oil ingredients are most frequently reported to function in cosmetics as fragrances and/or skin conditioning agents. The Panel reviewed the available animal and clinical data to determine the safety of 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. Industry should use good manufacturing practices to limit impurities that could be present in botanical ingredients.
Subject(s)
Citrus , Cosmetics/toxicity , Plant Oils/toxicity , 5-Methoxypsoralen/toxicity , Animals , Consumer Product Safety , Fruit , Humans , Plant Oils/chemistry , Toxicity TestsABSTRACT
The Cosmetic Ingredient Review Expert Panel (Panel) assessed the safety of 244 plant-derived fatty acid oils as used in cosmetics. Oils are used in a wide variety of cosmetic products for their skin conditioning, occlusive, emollient, and moisturizing properties. Since many of these oils are edible, and their systemic toxicity potential is low, the review focused on potential dermal effects. The Panel concluded that the 244 plant-derived fatty acid oils are safe as used in cosmetics.
Subject(s)
Consumer Product Safety , Cosmetics/toxicity , Fatty Acids/toxicity , Plant Oils/toxicity , Toxicity Tests/methods , Animals , Cosmetics/chemistry , Emollients/chemistry , Emollients/toxicity , Fatty Acids/chemistry , Humans , Plant Oils/chemistryABSTRACT
Anthemis nobilis (Roman chamomile) flower extract, anthemis nobilis flower oil, anthemis nobilis flower powder, and anthemis nobilis flower water are ingredients that function as fragrance ingredients and skin-conditioning agents in cosmetic products. These ingredients are being used at concentrations up to 10% (anthemis nobilis flower water) in cosmetic products. The available data indicate that these 4 ingredients are not irritating or sensitizing. Chemical composition data and the low use concentrations suggest that systemic toxicity would not be likely if percutaneous absorption of constituents were to occur. Formulations may contain more than 1 botanical ingredient; each may contribute to the final concentration of a single component. Manufacturers were cautioned to avoid reaching levels of plant constituents that may cause sensitization or other adverse effects. Industry should continue to use good manufacturing practices to limit impurities in the ingredient before blending into cosmetic formulations. The Expert Panel concluded that these ingredients are safe in the present practices of use and concentration in cosmetics, when formulated to be nonsensitizing.
Subject(s)
Chamaemelum , Cosmetics/toxicity , Plant Preparations/toxicity , Animals , Consumer Product Safety , Cosmetics/chemistry , Cosmetics/pharmacokinetics , Humans , Plant Preparations/chemistry , Plant Preparations/pharmacokinetics , Risk Assessment , Toxicity TestsABSTRACT
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) reviewed the safety of animal- and plant-derived amino acid mixtures, which function as skin and hair conditioning agents. The safety of α-amino acids as direct food additives has been well established, based on extensive research through acute and chronic dietary exposures and the Panel previously has reviewed the safety of individual α-amino acids in cosmetics. The Panel focused its review on dermal irritation and sensitization data relevant to the use of these ingredients in topical cosmetics. The Panel concluded that these 21 ingredients are safe in the present practices of use and concentration as used in cosmetics.
Subject(s)
Amino Acids/analysis , Amino Acids/toxicity , Cosmetics/toxicity , Dermatitis, Irritant/etiology , Hair Preparations/toxicity , Plant Extracts/toxicity , Animals , Chemical Safety , Consumer Product Safety , Humans , Risk Assessment , Safety , Skin Irritancy Tests , United StatesABSTRACT
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.
Subject(s)
Biological Products/toxicity , Consumer Product Safety , Cosmetics/chemistry , Hypericum/chemistry , Plant Extracts/toxicity , Animals , DNA Damage/drug effects , Humans , Randomized Controlled Trials as Topic , Reproduction/drug effects , Toxicity TestsABSTRACT
The Cosmetic Ingredient Review Expert Panel (Panel) assessed the safety of 24 Vitis vinifera (grape)-derived ingredients and found them safe in the present practices of use and concentration in cosmetics. These ingredients function in cosmetics mostly as skin-conditioning agents, but some function as antioxidants, flavoring agents, and/or colorants. The Panel reviewed the available animal and clinical data to determine the safety of these ingredients. Additionally, some constituents of grapes have been assessed previously for safety as cosmetic ingredients by the Panel, and others are compounds that have been discussed in previous Panel safety assessments.
Subject(s)
Consumer Product Safety , Cosmetics/chemistry , Plant Extracts/toxicity , Vitis/chemistry , Animals , Carcinogenicity Tests , DNA Damage/drug effects , Female , Flowers/chemistry , Flowers/toxicity , Humans , Male , Plant Extracts/chemistry , Plant Leaves/chemistry , Plant Leaves/toxicity , Plant Roots/chemistry , Plant Roots/toxicityABSTRACT
PEGylated oil is a terminology used to describe cosmetic ingredients that are the etherification and esterification products of glycerides and fatty acids with ethylene oxide. The Cosmetic Ingredient Review Expert Panel (Panel) considered the safety of PEGylated oils, which function primarily as surfactants in cosmetic products. The Panel reviewed relevant animal and human data provided in this safety assessment and concluded that the 130 chemically related PEGylated oils were safe as cosmetic ingredients in the present practices of use and concentration when formulated to be nonirritating.
Subject(s)
Castor Oil/analogs & derivatives , Cosmetics/toxicity , Dermatitis, Irritant/etiology , Polyethylene Glycols/toxicity , Surface-Active Agents/toxicity , Animals , Castor Oil/toxicity , Consumer Product Safety , Humans , Risk Assessment , United StatesABSTRACT
BACKGROUND: Both active and inactive ingredients in sunscreen may cause contact dermatitis. OBJECTIVES: This study aimed to describe allergens associated with a sunscreen source. METHODS: A cross-sectional analysis of patients patch tested by the North American Contact Dermatitis Group between 2001 and 2010 was performed. RESULTS: Of 23,908 patients patch tested, 219 (0.9%) had sunscreen coded as an allergen source. Patients who were male, with occupational dermatitis, or older (older than 40 years) had significantly lower rates of allergic reactions to sunscreens; the most commonly affected areas were the face and exposed sites (P < 0.0001). The top 3 most frequent allergens in sunscreens were benzophenone-3 (70.2% for 10% concentration, 64.4% for 3% concentration), DL-alpha-tocopherol (4.8%), and fragrance mix I (4.0%). Less than 40% of positive patch test reactions were detected by the North American Contact Dermatitis Group screening series of 65 to 70 allergens. CONCLUSIONS: A supplemental antigen series is important in detecting allergy to sunscreens.
Subject(s)
Allergens/adverse effects , Dermatitis, Contact/diagnosis , Dermatitis, Contact/epidemiology , Sunscreening Agents/adverse effects , Aged , Allergens/analysis , Benzophenones/adverse effects , Benzophenones/analysis , Cross-Sectional Studies , Dermatitis, Contact/etiology , Female , Humans , Incidence , Male , Middle Aged , North America/epidemiology , Patch Tests , Retrospective Studies , Risk Factors , Sunscreening Agents/analysisABSTRACT
BACKGROUND: The North American Contact Dermatitis Group (NACDG) tests patients with suspected allergic contact dermatitis to a broad series of screening allergens and publishes periodic reports. OBJECTIVE: The aims of this study were to report the NACDG patch-testing results from January 1, 2007, to December 31, 2008, and to compare results to pooled test data from the previous 2 and 10 years to analyze trends in allergen sensitivity. METHODS AND MATERIALS: Standardized patch testing with 65 allergens was used at 13 centers in North America. χ analysis was used for comparisons. RESULTS: A total of 5085 patients were tested; 11.8% (598) had an occupationally related skin condition, and 65.3% (3319) had at least 1 allergic patch test reaction, which is identical to the NACDG data from 2005 to 2006. The top 15 most frequently positive allergens were nickel sulfate (19.5%), Myroxylon pereirae (11.0%), neomycin (10.1%), fragrance mix I (9.4%), quaternium-15 (8.6%), cobalt chloride (8.4%), bacitracin (7.9%), formaldehyde (7.7%), methyldibromoglutaronitrile/phenoxyethanol (5.5%), p-phenylenediamine (5.3%), propolis (4.9%), carba mix (4.5%), potassium dichromate (4.1%), fragrance mix II (3.6%), and methylchloroisothiazolinone/methylisothiazolinone (3.6%). There were significant increases in positivity rates to nickel, methylchloroisothiazolinone/methylisothiazolinone, and benzophenone-3. During the same period of study, there were significant decreases in positivity rates to neomycin, fragrance mix I, formaldehyde, thiuram mix, cinnamic aldehyde, propylene glycol, epoxy resin, diazolidinyl urea, amidoamine, ethylenediamine, benzocaine, p-tert-butylphenol formaldehyde resin, dimethylol dimethyl hydantoin, cocamidopropyl betaine, glutaraldehyde, mercaptobenzothiazole, tosylamide formaldehyde resin, budesonide, disperse blue 106, mercapto mix, and chloroxylenol. Twenty-four percent (1221) had a relevant positive reaction to a non-NACDG supplementary allergen; and 180 of these reactions were occupationally relevant. CONCLUSIONS: Periodic analysis, surveillance, and publication of multicenter study data sets document trends in allergen reactivity incidence assessed in the patch test clinic setting and provide information on new allergens of relevance.