List of Prohibited and Restricted Cosmetic Ingredients (The Cosmetic Ingredient Hotlist)

Proposed Changes to the Cosmetic Ingredient Hotlist (October 23, 2009)

Health Canada welcomes comments to this proposal which are to be received no later than 60 calendar days from the above date.

Items to be Added:

The entries for the ingredients listed below have been added as a restriction or a prohibition.

The following ingredients have been further restricted or added as a prohibition in cosmetic products to reflect their addition to Schedule 1 of the Canadian Environmental Protection Act (CEPA 1999), as assessed through the Government of Canada's Chemicals Management Plan (CMP), due to health concerns:

CMP Batch 1

• Hydroquinone (123-31-9)
  • Restricted to hair dye products and nail products
  • Permitted at concentrations equal to or less than 0.3% as an oxidizing colouring agent for hair dyes.  The inner and outer labels of hair dye products containing hydroquinone must carry a cautionary statement, in English and French, to the effect: "Contains hydroquinone."; "Do not use to dye eyelashes or eyebrows."; "Rinse eyes immediately if the product comes into contact with eyes."
  • Permitted at concentration equal to or less than 0.02% in nail products (after mixing for use).  The inner and outer labels of nail products containing hydroquinone must carry a cautionary statement, in English and French, to the effect: "Avoid skin contact."; "Read directions carefully before using."
• Methyloxirane monomer (propylene oxide) (75-56-9)
• Naphthalene (91-20-3)
• Toluene Diisocyanates (TDIs) including, 2,4-diisocyanato-1-methyl-benzene (2,4-toluene diisocyanate) (584-84-9); 2,6-diisocyanato-1-methyl-benzene (2,6 toluene diisocyanate) (91-08-7); and 1,3-diisocyanatomethyl-benzene (mixed isomers of toluene diisocyanate) (26471-62-5)

CMP Batch 2

• Epichlorohydrin (Oxirane, (chloromethyl)) (106-89-8)
• 4,4'-Isopropylidenediphenol (Bisphenol A) (80-05-7)
• Isoprene monomer (1,3-Butadiene, 2-methyl) (78-79-5)

The ingredients below have been added as a prohibition because they are manufactured with epichlorohydrin:

• HC Blue No. 4 (158571-57-4)
• HC Blue No. 5 (68478-64-8, 158571-58-5)

The following ingredients have been added as a restriction in cosmetic products to reflect the requirements set out under the Canadian Environmental Protection Act's (CEPA 1999) New Substances Notification Regulations, as assessed by the New Substances Program:

• Alcohols, C13-15, reaction products with N-[3-(dimethoxymethylsilyl)-2-methylpropyl]- 1,2-ethanediamine, glycidol and hydroxyterminated di-Me siloxanes (237753-63-8)
  • A person that proposes a significant new activity for this substance shall provide the Minister of the Environment, at least 90 days prior to the commencement of the proposed significant new activity, information as per Order 2007-87-10-01 published January 9, 2008, Amending the Domestic Substances List under the Canadian Environmental Protection Act's New Substances Notification Regulations (Chemicals and Polymers)
• Siloxanes and Silicones, 3-[(2-aminoethyl)amino]propyl Me, di-Me, hydroxy- and methoxy-terminated, polymers with polyethylene-polypropylene glycol bis(2-methyl-2-propen-1-yl) ether (921936-12-1)
  • A person that proposes a significant new activity for this substance shall provide the Minister of the Environment, at least 90 days prior to the commencement of the proposed significant new activity, information as per Significant New Activity Notice No. EAU-395, published January 12, 2008, under the Canadian Environmental Protection Act's New Substances Notification Regulations (Chemicals and Polymers)
• Siloxanes and Silicones, 3-[(2-aminoethyl)amino]propyl Me, hydroxy-terminated, polymers with hydrogen terminated di-Me siloxanes and polyethylene glycol bis(2-methyl-2-propen-1-yl) ether (929218-99-5)
  • A person that proposes a significant new activity for this substance shall provide the Minister of the Environment, at least 90 days prior to the commencement of the proposed significant new activity, information as per Significant New Activity Notice No. EAU-396, published January 12, 2008, under the Canadian Environmental Protection Act's New Substances Notification Regulations (Chemicals and Polymers)

Entries to be Amended:

The entries for the ingredients listed below are to be amended for clarification, to include new information or to include new requirements.

The entry has been revised to update the wording:

• Siloxanes and Silicones, 3-[(2-aminoethyl)amino]-2-methylpropyl Me, di-Me, reaction products with N,N,N-trimethyloxiranemethanaminium chloride (495403-02-6)
  • A person that proposes a significant new activity for this substance shall provide the Minister of the Environment, at least 90 days prior to the commencement of the proposed significant new activity, information as per Significant New Activity Notice No. EAU-135, published November 13, 2004, under the Canadian Environmental Protection Act's New Substances Notification Regulations (Chemicals and Polymers)

Hotlist Comment Period

Companies have 60 days to review the proposed changes and respond. Furthermore, companies who have notified products containing proposed Hotlist ingredients will be sent a letter notifying them of the intended changes. Provided there are no comments received initiating further review within this time, the proposed Hotlist decisions will become final.

Submit your comments to:

• Hotlist Coordinator, Cosmetics Program
  Health Canada
  MacDonald Building
  123 Slater Street, 4^th Floor, Address Locator 3504D
  Ottawa, Ontario.
  K1A 0K9

• Telephone: 613-946-6452
• Facsimile: 613-952-3039
• E-mail: cosmetics@hc-sc.gc.ca

Changes to the Hotlist

Changes to the Hotlist do not undergo an extensive regulatory amendment process. The list is considered to be an elaboration of section 2 and 16 of the Food and Drugs Act (classification and safety of cosmetics) and section 24 of the Cosmetic Regulations (avoidable hazard labelling). It also includes all individual prohibitions and restrictions as outlined in the Cosmetic Regulations.

Currently, the list is updated once or twice per year by a Hotlist committee consisting of Cosmetics Division scientists. The group meets on a regular basis to review and discuss ingredients of concern. Conclusions are based on weight of evidence - information is gathered through recognized scientific journals, as well as opinions/decisions on the safety of cosmetic ingredients made by national/international counterparts and expert panel groups.

Hotlist Update Procedure

1. Decision to add ingredient to Hotlist.
2. Proposed changes to the Hotlist are prepared for publication on the Web; comment period opens.
3. Letters to companies are generated advising them of their options and 60-day notice to respond.
4. Company responds or 60-day period expires; comment period closes.
5. Official Hotlist is published.

This process offers greater transparency to all stakeholders and affords companies the opportunity to provide data to Health Canada to support the safety of an ingredient.