Safety Assessment of Citrus Flower- and Leaf-Derived Ingredients as Used in Cosmetics

2021 ◽  
Vol 40 (3_suppl) ◽  
pp. 53S-76S
Author(s):  
Christina L. Burnett ◽  
Wilma F. Bergfeld ◽  
Donald V. Belsito ◽  
Ronald A. Hill ◽  
Curtis D. Klaassen ◽  
...  
Keyword(s):  
Safety Assessment ◽  
Expert Panel ◽  
Good Manufacturing Practices

The Cosmetic Ingredient Review (CIR) Expert Panel (Panel) assessed the safety of 33 Citrus flower- and leaf-derived ingredients, which are most frequently reported to function in cosmetics as fragrances and/or skin-conditioning agents. The Panel reviewed the available data to determine the safety of these ingredients. Because final product formulations may contain multiple botanicals, each containing similar constituents of concern, formulators are advised to be aware of these constituents and to avoid reaching levels that may be hazardous to consumers. With Citrus flower- and leaf-derived ingredients, the Panel was concerned about the presence of the hydroperoxides of limonene and linalool in cosmetics. Industry should use good manufacturing practices to limit impurities that could be present in botanical ingredients. The Panel concluded that these ingredients are safe in the present practices of use and concentration when formulated to be non-irritating and non-sensitizing.

Safety Assessment of Citrus Peel-Derived Ingredients as Used in Cosmetics

2021 ◽  
pp. 109158182110326
Author(s):  
Christina L. Burnett ◽  
Wilma F. Bergfeld ◽  
Donald V. Belsito ◽  
Ronald A. Hill ◽  
Curtis D. Klaassen ◽  
...  
Keyword(s):  
Safety Assessment ◽  
Expert Panel ◽  
Cosmetic Products ◽  
Citrus Peel ◽  
Good Manufacturing Practices

The Expert Panel for Cosmetic Ingredient Safety (Panel) assessed the safety of 47 Citrus peel-derived ingredients, which are most frequently reported to function in cosmetics as skin conditioning agents. The Panel reviewed the available data to determine the safety of these ingredients. Because final product formulations may contain multiple botanical ingredients, each containing similar 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. The Panel concluded that Citrus peel-derived ingredients are safe in the present practices of use and concentration in both rinse-off and leave-on cosmetic products when formulated to be non-sensitizing and non-irritating, provided that leave-on products do not contain more than 0.0015% (15 ppm) 5-methoxypsoralen (5-MOP).

scholarly journals Safety Assessment of Rosmarinus officinalis (Rosemary)-Derived Ingredients as Used in Cosmetics

2018 ◽  
Vol 37 (3_suppl) ◽  
pp. 12S-50S ◽  
Author(s):  
Monice M. Fiume ◽  
Wilma F. Bergfeld ◽  
Donald V. Belsito ◽  
Ronald A. Hill ◽  
Curtis D. Klaassen ◽  
...  
Keyword(s):  
Clinical Data ◽  
Safety Assessment ◽  
Expert Panel ◽  
Rosmarinus Officinalis ◽  
Good Manufacturing Practices

The Cosmetic Ingredient Review Expert Panel (Panel) assessed the safety of 10 Rosmarinus officinalis (rosemary)-derived ingredients and concluded these ingredients are safe as used in cosmetics when formulated to be nonsensitizing. The R officinalis-derived ingredients are most frequently reported to function in cosmetics as skin conditioning agents or as fragrance ingredients. 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 continue to use good manufacturing practices to limit impurities that could be present in botanical ingredients.

Safety Assessment of Citrus Plant- and Seed-Derived Ingredients as Used in Cosmetics

2021 ◽  
pp. 109158182110400
Author(s):  
Christina L. Burnett ◽  
Wilma F. Bergfeld ◽  
Donald V. Belsito ◽  
Ronald A. Hill ◽  
Curtis D. Klaassen ◽  
...  
Keyword(s):  
Safety Assessment ◽  
Expert Panel ◽  
Citrus Plant ◽  
Good Manufacturing Practices

The Expert Panel for Cosmetic Ingredient Safety (Panel) assessed the safety of 30 Citrus plant- and seed-derived ingredients, which are most frequently reported to function in cosmetics as fragrances and/or skin conditioning agents. Because final product formulations may contain multiple botanicals, each containing similar constituents of concern, formulators are advised to be aware of these constituents and to avoid reaching levels that may be hazardous to consumers. With Citrus plant- and seed-derived ingredients, the Panel was concerned about the presence of the hydroperoxides of limonene and linalool in cosmetics. Industry should use good manufacturing practices to limit impurities. The Panel reviewed the available data presented and concluded that 18 of these ingredients are safe in the present practices of use and concentration when formulated to be non-irritating and non-sensitizing. The data for the remaining 12 ingredients are insufficient to determine safety.

scholarly journals Amended Safety Assessment of Chamomilla recutita-Derived Ingredients as Used in Cosmetics

2018 ◽  
Vol 37 (3_suppl) ◽  
pp. 51S-79S ◽  
Author(s):  
Wilbur Johnson ◽  
Ivan Boyer ◽  
Wilma F. Bergfeld ◽  
Donald V. Belsito ◽  
Ronald A. Hill ◽  
...  
Keyword(s):  
Safety Assessment ◽  
Expert Panel ◽  
Cosmetic Products ◽  
Good Manufacturing Practices

The Chamomilla recutita-derived ingredients in this assessment are reported to function mostly as fragrance ingredients and skin conditioning agents in cosmetic products. 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. Additionally, industry should continue to use good manufacturing practices to limit impurities that could be present in botanical ingredients. The Cosmetic Ingredient Review Expert Panel concluded that the Chamomilla recutita-derived ingredients are safe in cosmetics in the present practices of use and concentration described in the safety assessment when formulated to be nonsensitizing.

scholarly journals Safety Assessment of Achillea millefolium as Used in Cosmetics

2016 ◽  
Vol 35 (3_suppl) ◽  
pp. 5S-15S ◽  
Author(s):  
Lillian C. Becker ◽  
Wilma F. Bergfeld ◽  
Donald V. Belsito ◽  
Ronald A. Hill ◽  
Curtis D. Klaassen ◽  
...  
Keyword(s):  
Safety Assessment ◽  
Expert Panel ◽  
Achillea Millefolium ◽  
Flower Extract ◽  
Human Data ◽  
Cosmetic Ingredients ◽  
Good Manufacturing Practices ◽  
Stem Extract

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.

Safety Assessment of Citrus Fruit-Derived Ingredients as Used in Cosmetics

2021 ◽  
pp. 109158182110398
Author(s):  
Christina L. Burnett ◽  
Wilma F. Bergfeld ◽  
Donald V. Belsito ◽  
Ronald A. Hill ◽  
Curtis D. Klaassen ◽  
...  
Keyword(s):  
Safety Assessment ◽  
Expert Panel ◽  
Citrus Fruit ◽  
Cosmetic Products ◽  
Good Manufacturing Practices

The Expert Panel for Cosmetic Ingredient Safety (Panel) assessed the safety of 80 Citrus fruit-derived ingredients, which are most frequently reported to function in cosmetics as fragrances and/or skin-conditioning agents. The Panel reviewed the available data to determine the safety of these ingredients. Because final product formulations may contain multiple botanicals, each containing similar 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. The Panel concluded that these ingredients are safe for use in both rinse-off and leave-on cosmetic products when formulated to be non-sensitizing and non-irritating, provided that leave-on products do not contain more than 0.0015% (15 ppm) 5-methoxypsoralen (5-MOP).

scholarly journals Safety Assessment of Anthemis nobilis–Derived Ingredients as Used in Cosmetics

2017 ◽  
Vol 36 (1_suppl) ◽  
pp. 57S-66S ◽  
Author(s):  
Wilbur Johnson ◽  
Bart Heldreth ◽  
Wilma F. Bergfeld ◽  
Donald V. Belsito ◽  
Ronald A. Hill ◽  
...  
Keyword(s):  
Percutaneous Absorption ◽  
Safety Assessment ◽  
Expert Panel ◽  
Final Concentration ◽  
Cosmetic Products ◽  
Flower Extract ◽  
Good Manufacturing Practices ◽  
Cosmetic Formulations ◽  
Plant Constituents ◽  
Chamomile Flower

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.

scholarly journals Safety Assessment of Citrus-Derived Peel Oils as Used in Cosmetics

2019 ◽  
Vol 38 (2_suppl) ◽  
pp. 33S-59S
Author(s):  
Christina L. Burnett ◽  
Monice M. Fiume ◽  
Wilma F. Bergfeld ◽  
Donald V. Belsito ◽  
Ronald A. Hill ◽  
...  
Keyword(s):  
Clinical Data ◽  
Safety Assessment ◽  
Expert Panel ◽  
Cosmetic Products ◽  
Good Manufacturing Practices ◽  
Peel Oil

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.

Amended Safety Assessment of Methylchloroisothiazolinone and Methylisothiazolinone as Used in Cosmetics

2021 ◽  
Vol 40 (1_suppl) ◽  
pp. 20S-33S
Author(s):  
Christina L. Burnett ◽  
Wilma F. Bergfeld ◽  
Donald V. Belsito ◽  
Curtis D. Klaassen ◽  
Daniel C. Liebler ◽  
...  
Keyword(s):  
Risk Assessment ◽  
Safety Assessment ◽  
Expert Panel ◽  
Quantitative Risk Assessment ◽  
Cosmetic Products ◽  
Human Data

The Expert Panel for Cosmetic Ingredient Safety (Panel) reassessed the safety of the mixture Methylchloroisothiazolinone (MCI)/Methylisothiazolinone (MI), which functions as a preservative in cosmetic products. The Panel reviewed relevant animal and human data provided in this safety assessment, and data from the previously published safety assessment of this mixture, and concluded that MCI/MI is safe in cosmetics when formulated to be nonsensitizing, based on the results of a quantitative risk assessment or similar methodology; however, at no point should concentrations exceed 7.5 ppm in leave-on products or 15 ppm in rinse-off products.

Amended Safety Assessment of Fatty Acyl Sarcosines and Sarcosinate Salts as Used in Cosmetics

2021 ◽  
pp. 109158182110238
Author(s):  
Monice M. Fiume ◽  
Wilma F. Bergfeld ◽  
Donald V. Belsito ◽  
Ronald A. Hill ◽  
Curtis D. Klaassen ◽  
...  
Keyword(s):  
Safety Assessment ◽  
Expert Panel ◽  
Fatty Acyl ◽  
Nitroso Compounds ◽  
Acyl Residue ◽  
Cosmetic Products ◽  
Panel Report ◽  
Fatty Acyl Residue

The Expert Panel for Cosmetic Ingredient Safety (Panel) assessed the safety of 5 acyl sarcosines and 9 sarcosinate salts as used in cosmetics; all of these ingredients are reported to function in cosmetics as hair conditioning agents and most also can function as surfactants—cleansing agents. The ingredients reviewed in this assessment are composed of an amide comprising a fatty acyl residue and sarcosine and are either free acids or simple salts thereof. The Panel relied on relevant new data, including concentration of use, and considered data from the previous Panel report, such as the reaction of sarcosine with oxidizing materials possibly resulting in nitrosation and the formation of N-nitrososarcosine. The Panel concluded that these ingredients are safe as used in cosmetics when formulated to be non-irritating, but these ingredients should not be used in cosmetic products in which N-nitroso compounds may be formed.

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