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加拿大衛(wèi)生部對更新化妝品成分常用表（Hotlist）的建議開展公眾咨詢

信息來源：2013-11-28 發(fā)布日期：2013-11-28 閱讀：1202次

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小中大

建議包括更改成分常用表的格式和增加及修訂常用表。

背景：

化妝品成分常用表是一種管理工具，即加拿大衛(wèi)生部通過此常用表向某些物質(zhì)的制造商或其他人傳達食品藥品法（Food and Drugs Act）關(guān)于化妝品一般禁止規(guī)定。2011年3月，常用表最后一次更新。

此次建議的公眾評議期為60天。另外，已向遞交化妝品通告申請表的所有通告者發(fā)出了通知。

建議：

為了提高常用表的可讀性和功能性，建議更改其格式（參見如下新增和修訂舉例成分表的格式）。更新后的常用表將分為兩個表，即禁用成分表和限用成分表。

以下物質(zhì)都是被建議新增為限用或禁用成分，且它們的健康問題已經(jīng)過加拿大化學品管理計劃（Chemicals Management Plan，CMP）根據(jù)1991年加拿大環(huán)境保護法（Canadian Environmental Protection Act）的評估。

溶劑紅23（Solvent Red 23, CAS: 85-86-9）

建議該物質(zhì)新增為禁止用于黏膜部位及其周圍的化妝品，如眼、鼻、口。溶劑紅23通過口腔接觸對健康含有潛在的遺傳毒性和致癌毒性，最初被列入“煤焦油燃料”條目中。此外，根據(jù)化妝品法規(guī)第24條的規(guī)定，含有溶劑紅23的染發(fā)類產(chǎn)品須有以下安全使用指南：請勿用于睫毛或眉毛；請勿在眼、鼻、口部位及其周圍使用本產(chǎn)品。

表1：溶劑紅23（Solvent Red23, CAS: 85-86-9）
Ingredient information			Restrictions
Chemical	CAS＃	Synonyms and related compounds	Conditions of use	Warnings and cautionary statements
Solvent Red 23	85-86-9	CI 26100; Red No.25; Tetrazobenzene-beta- Naphthol; Sudan Red BK; 2-Naphthalenol,1-[[4- (Phenylazo)Phenyl]A zo]-; D&C Red no.17; Red 17; Toney Red; Sudan III	Not permitted in cosmetics intended to be used on or around mucosal membranes such as eyes, nose or mouth. Additionally see "Coal tar dye."	Hair dye products containing Solvent Red 23 must contain directions to inform people not to use the cosmetic to dye eyelashes or eyebrows and not to use the cosmetic in or around the eye, mouth or nose. The following statements may be placed on the label of a cosmetic to achieve that objective "Do not use to dye eyelashes or eyebrows." "Do not use in or around the area of the eye, mouth or nose."

己二酸二乙基己酯（Diethylhexyl Adipate, CAS: 103-23-1）

建議增加此物質(zhì)用于停留類身體保濕產(chǎn)品的限用條件，即限用濃度為6%。

表2：己二酸二乙基己酯（Diethylhexyl Adipate, CAS: 103-23-1）
Ingredient information			Restrictions
Chemical	CAS＃	Synonyms and related compounds	Conditions of use	Warnings and cautionary statements
Diethylhexyl Adipate	103-23-1	DEHA; Dioctyl Adipate; Bis(2-Ethylhexyl)Hexanedioate	Not permitted in leave-on body moisturizers in excess of 6.0%

以下物質(zhì)已列入常用表中，但須新增某些特定項以便更好地限制其使用：

表3：間苯二酚（Resorcinol, CAS: 108-46-3），亞甲基乙二醇（Methylene Glycol, CAS: 463-57-0）
Ingredient information			Restrictions
Chemical	CAS＃	Synonyms and related compounds	Conditions of use	Warnings and cautionary statements
Resorcinol	108-46-3		Not permitted in cosmetics intended for use on the skin. Additionally see "Coal tar dye."
Methylene Glycol	463-57-0		See "Formaldehyde"

以下物質(zhì)建議修訂以明確其要求：

α-羥基酸（果酸）（Alpha-hydroxy acids (AHAs)

α-羥基酸（果酸）已列入常用表中，但并未設(shè)置最高限用濃度。加拿大衛(wèi)生部的專家認為該物質(zhì)在化妝品中的濃度超過30%是不能接受的。

表4：α-羥基酸（果酸）
Ingredient information			Restrictions
Chemical	CAS＃	Synonyms and related compounds	Conditions of use	Warnings and cautionary statements
Alpha-hydroxy acids	77-92-9; 79-14-1; 50-21-5; 6915-15-7; 79-33-4; 5949-29-1; 617-73-2; 90-64-2; 35249 - 89-9	Including, but not limited to citric acid; glycolic acid; lactic acid; malic acid; mandelic acid; Ammonium glycolate; glycolic acid + ammonium glycolate; alpha-hydroxyethanoic acid + ammonium alpha-hydroxyethanoate; alpha-hydroxyoctanoic acid; alpha-hydroxycaprylic acid; hydroxycaprylic acid; mixed fruit acid; triple fruit acid; tri-alpha hydroxy fruit acids; alpha hydroxy and botanical complex; L-alpha hydroxy acid and glycomer in cross-linked fatty acids alpha nutrium	Permitted at total concentrations equal to or less than 10% and a pH equal to or greater than 3.5. Preparations containing concentrations of AHAs between 10% and 30% or a pH between 3.0 to 3.5 may be permitted for professional use if the manufacturer provides Health Canada with evidence of their safety including: pH levels; AHA concentrations directions for use clinical studies demonstrating minimal skin irritation Preparations intended to be diluted in bath water may contain levels of citric acid exceeding 10%.	All skin products containing AHAs at concentrations equal to or greater than 3% shall carry cautionary statements to the effect: "Use only as directed.", "Avoid contact with the eyes.", "If irritation persists, discontinue use and consult a physician.", "It is recommended that prior to exposure to the sun, users cover areas where AHAs have been applied with sunscreen.", "Contact of the product with the skin must be of limited frequency or duration."

甲醛（Formaldehyde, CAS: 50-00-0）

現(xiàn)用常用表關(guān)于甲醛的規(guī)定項未考慮到頭發(fā)拉直產(chǎn)品釋放甲醛造成的吸入健康危害。此外，建議增加非氣溶膠型化妝品中的甲醛限用濃度為0.01%。

表5：Formaldehyde (50-00-0)
Ingredient information			Restrictions
Chemical	CAS＃	Synonyms and related compounds	Conditions of use	Warnings and cautionary statements
Formaldehyde	50-00-0		Not permitted in aerosol cosmetics. Permitted at concentrations equal to or less than 0.01% in non-aerosol cosmetics that release formaldehyde vapours when used according to directions. Permitted at concentrations equal to or less than 0.1% in oral cosmetics. Permitted at concentrations equal to or less than 0.2% in non-oral cosmetics as a preservative only. Permitted at concentrations equal to or less than 5.0% in nail hardeners only. However, it must be sold with nail shields, directions for use and directions that inform the user about the presence of this substance in the cosmetic.	The label of a nail hardener containing formaldehyde must inform the user about the presence of that substance in the cosmetic. The following statement may be placed on the label to achieve that objective "This product contains formaldehyde which has the potential to cause skin sensitivity."

視黃醇（Retinol, CAS: 68-26-8)

表6：視黃醇（Retinol, CAS: 68-26-8）
Ingredient information			Restrictions
Chemical	CAS＃	Synonyms and related compounds	Conditions of use	Warnings and cautionary statements
Retinol and its esters	68-26-8; 127-47-9; 79-81-2	Vitamin A; Retinyl acetate; Retinyl palmitate	Permitted at concentrations equal to or less than 1.0% retinol equivalents. NB: Please be aware of the conversion factor between retinol and other retinol equivalents. For example, 1.0% w/w retinol is equivalent to 1.15% w/w retinyl acetate and to 1.83% w/w retinyl palmitate