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加拿大卫生部对更新化妆品成分常用表(Hotlist)的建议开展公众咨询

信息来源:2013-11-28    发布日期:2013-11-28    阅读:819次
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建议包括更改成分常用表的格式和增加及修订常用表。

背景:

化妆品成分常用表是一种管理工具, 即加拿大卫生部通过此常用表向某些物质的制造商或其他人传达食品药品法(Food and Drugs Act)关于化妆品一般禁止规定。2011年3月,常用表最后一次更新。

此次建议的公众评议期为60天。另外,已向递交化妆品通告申请表的所有通告者发出了通知。

建议:

为了提高常用表的可读性和功能性,建议更改其格式(参见如下新增和修订举例成分表的格式)。更新后的常用表将分为两个表,即禁用成分表和限用成分表。

以下物质都是被建议新增为限用或禁用成分,且它们的健康问题已经过加拿大化学品管理计划(Chemicals Management Plan,CMP)根据1991年加拿大环境保护法(Canadian Environmental Protection Act)的评估。

溶剂红23(Solvent Red 23, CAS: 85-86-9)

建议该物质新增为禁止用于黏膜部位及其周围的化妆品,如眼、鼻、口。溶剂红23通过口腔接触对健康含有潜在的遗传毒性和致癌毒性,最初被列入“煤焦油燃料”条目中。此外,根据化妆品法规第24条的规定,含有溶剂红23的染发类产品须有以下安全使用指南:请勿用于睫毛或眉毛;请勿在眼、鼻、口部位及其周围使用本产品。

1:溶剂红23Solvent 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)

建议增加此物质用于停留类身体保湿产品的限用条件,即限用浓度为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%  

以下物质已列入常用表中,但须新增某些特定项以便更好地限制其使用:

表3:间苯二酚(Resorcinol, CAS: 108-46-3),亚甲基乙二醇(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"  

以下物质建议修订以明确其要求:

α-羟基酸(果酸)(Alpha-hydroxy acids (AHAs)

α-羟基酸(果酸)已列入常用表中,但并未设置最高限用浓度。加拿大卫生部的专家认为该物质在化妆品中的浓度超过30%是不能接受的。

表4:α-羟基酸(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:
  1. pH levels;
  2. AHA concentrations
  3. directions for use
  4. 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)

现用常用表关于甲醛的规定项未考虑到头发拉直产品释放甲醛造成的吸入健康危害。此外,建议增加非气溶胶型化妆品中的甲醛限用浓度为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."


视黄醇(Retinol, CAS: 68-26-8)

表6:视黄醇(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  


其它修订项

除上述变化外,现有的几种成分条目已作出修订,包括新的别名和CAS号。欲获取完整的更新表,请联系化妆品工作组。

公众咨询

利益相关方可通过电子邮件提交,或以书面形式向加拿大卫生部提交关于更新化妆品成分常用表的建议或其他任何建议。如可以,请提供相关证据。截止期限为2013年12月16日。

http://www.hc-sc.gc.ca/cps-spc/legislation/consultation/2013/hotlist_cosmetic_liste-critique/consult-eng.php

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