Consultation on proposed changes to the Cosmetic Ingredient Hotlist

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Cosmetics Program
Consumer Product Safety Directorate
Health Canada
Ottawa, Canada

June 26, 2015

Subject: Consultation on proposed changes to the Cosmetics Ingredient Hotlist

Dear Stakeholder:

The purpose of this document is to solicit comments on a proposal to amend the Cosmetic Ingredient Hotlist. The proposal includes the following:

  • changes to improve the wording of the entries on the Hotlist
  • additions and amendments to the Hotlist

Background

The Cosmetic Ingredient Hotlist is an administrative tool that Health Canada uses to communicate to manufacturers and others that certain substances, when present in a cosmetic, may contravene (a) the general prohibition found in  section 16 of the Food and Drugs Act or (b) a provision of the Cosmetic Regulations. In addition, the Hotlist communicates that certain substances, with no known purpose in a cosmetic formulation, make it unlikely for the product to meet the definition of a cosmetic under the Food and Drugs Act.

Proposed changes to the Hotlist are put forward as needed. The last update to the Hotlist was in April 2014. Conclusions are based on weight of evidence. Information is gathered through a review of recognized scientific journals, as well as opinions or decisions made by national or international counterparts and expert panel groups.

The proposed changes to the Hotlist are posted for consultation on Health Canada’s website for a 60-day comment period. Upon finalization, a notice is sent to all notifiers who have submitted a Cosmetic Notification Form that includes any of the affected ingredients.

Proposed changes to the wording of the entries on the Hotlist

To improve the readability and functionality of the Cosmetics Ingredient Hotlist, the current entries were re-worded in such a way to better fit the table format introduced in the previous Hotlist update. In the proposed update to the Hotlist, repeated text has been eliminated, an extra column has been added to highlight the maximum concentration levels from other requirements, and entries have been reworded in order to ensure consistency and clarity.

Proposed additions to the Hotlist

The substances below are proposed to be added to the Hotlist as prohibited ingredients in cosmetic products due to their therapeutic functions.

Prostaglandins, their salts and derivatives and their analogs

Prostaglandins and their analogs are proposed to be added as a prohibited ingredient in cosmetic products due to their presence on the Prescription Drug List and their therapeutic functions.

Table 1: Prostaglandins, their salts and derivatives and their analogs
Ingredient CAS Synonyms and Related Compounds (Including but not limited to)
Prostaglandins, their salts, derivatives and analogs 745-65-3;
155206-00-1;
40665-92-7;
363-24-6;
35121-78-9;
40666-16-8;
130209-82-4;
59122-46-2;
209860-87-7;
157283-68-6;
81846-19-7;
120373-36-6;
130209-76-6;
1005193-64-5;
157283-66-4
Alprostadil;
Bimatoprost;
Cloprostenol;
Dinoprostone;
Epoprostenol;
Fluprostenol;
Latanoprost;
Misoprostol;
Tafluprost;
Travoprost;
Treprostinil;
Unoprostone;
Dehydrolatanoprost;
Ethyl Travoprostamide;
Trifluoromethyl Dechloro Ethylprostenolamide;
Isopropyl Phenylhydroxypentene Dihydroxycyclopentylheptenate;
Isopropyl Cloprostenate

Proposed amendments to the Hotlist

The following ingredients are proposed to be amended to reflect changes in requirements.

Methylisothiazolinone / Methylchloroisothiazolinone, in combination:

This entry is proposed to be amended in order to add a new condition for methylisothiazolinone/methylchloroisothiazolinone when used in combination, as a prohibited substance in leave-on cosmetic products. Following an internal review of scientific literature, Health Canada proposes this prohibition in order to reduce the potential for sensitization when using leave-on cosmetic products, such as moisturizers and body creams. The preservative can still be used in rinse-off products, such as shampoos and shower gels, to a maximum concentration of 0.0015 % or 15 ppm. This proposal aligns with actions taken in the European Commission which will take effect in July 2015.

Table 2: Methylisothiazolinone / Methylchloroisothiazolinone
Ingredient information Restriction
Chemical CAS Synonyms and Related Compounds (including but not limited to) Conditions of Use by product type Maximum Concentration Permitted Warnings and Cautionary Statements (to the effect of)
Methylisothiazolinone / Methylchloroisothiazolinone, in combination 26172-55-4; 2682-20-4   a) Not permitted in leave-on products  
b) rinse-off products b) 0.0015% (15 µg/mL or 15 ppm)

Cyanoacrylate-based adhesives

This entry is proposed to be amended in order to reflect the policy change in requirements for cyanoacrylate-based eyelash adhesives. Notifiers of cyanoacrylate-based adhesives for the application of false eyelashes will no longer be required to submit descriptions of their training methods and training materials to Health Canada upon notification. These products should only be sold and used by trained professionals and must contain cautionary statements to ensure the eye is protected and immobilized during application.

Table 3: Cyanoacrylate-based adhesives
Ingredient information Restriction
Chemical CAS Synonyms and Related Compounds (including but not limited to) Conditions of Use by product type Maximum Concentration Permitted Warnings and Cautionary Statements (to the effect of)
Cyanoacrylate-based adhesives 7085-85-0; 137-05-3; 10586-17-1 Ethyl cyanoacrylate; Methyl cyanoacrylate; Isopropylcyanoacrylate a) Cyanoacrylate adhesives for eyelash extensions must be sold for only  professional use (i.e., not for direct sale to consumers) a) “For application by trained professionals only" and "Ensure the eye is protected and immobilized during application."

“WARNING.  BONDS SKIN INSTANTLY. AVOID CONTACT WITH EYES, MOUTH AND SKIN. KEEP AWAY FROM CHILDREN.  Eyelid bonding:  consult a physician. Skin bonding:  soak and ease apart gently.”
b) other products b)“WARNING.  BONDS SKIN INSTANTLY. AVOID CONTACT WITH EYES, MOUTH AND SKIN. KEEP AWAY FROM CHILDREN.  Eyelid bonding:  consult a physician. Skin bonding:  soak and ease apart gently. Not for use in the area of the eye.”

Peroxide and peroxide-generating compounds:

In order to better reflect current use patterns for tooth whitening products, this entry is proposed to be amended by replacing the cautionary statement to the effect of: ”Use for periods of longer than 14 days is to be only under the supervision of a dentist." With a cautionary statement to the effect of: “Consult your dentist before prolonged use of this product.”

Table 4: Peroxide and peroxide-generating compounds
Ingredient information Restriction
Chemical CAS Synonyms and Related Compounds (including but not limited to) Conditions of Use by product type Maximum Concentration Permitted Warnings and Cautionary Statements (to the effect of)
Peroxide and peroxide-generating compounds 124-43-6; 1305-79-9; 7722-84-1; 1335-26-8; 7632-04-4; 1314-22-3 urea carbamide peroxide; calcium peroxide; calcium dioxide; hydrogen peroxide; magnesium peroxide; sodium perborate; zinc peroxide Manufacturers of oral products containing peroxides or peroxide-generating compounds must submit the following information to Health Canada:
(1) data on the pH of the cosmetic product, when it is applied to the tooth or teeth, to ensure that the product is in compliance with section 13 of the Cosmetic Regulations, i.e. that the pH is greater than or equal to 4.0; and

(2) product labelling demonstrating that all cautionary statement requirements have been met.

If an oral cosmetic contains more than 3% hydrogen peroxide (or equivalent), notifiers must submit safety evidence that the product does not cause the saliva or soft tissue of the oral cavity to exceed 3% hydrogen peroxide, and is safe when used as directed. Evidence may include analog studies from recognized sources or independent clinical research.
“If irritation (such as redness, swelling, soreness) of the gums or the mouth occurs, discontinue use and consult a dentist.”

“Products containing peroxides are not recommended for use by children under 12 years of age.”

“Consult your dentist before prolonged use of this product.”

“Avoid swallowing the cosmetic or part thereof.”

“Avoid contact of the product with the eye.”

Tooth whitening systems shall also carry:

“Avoid direct contact of the active surface of the tooth whitening product with the gums and/or salivary flow.”

P-phenylenediamine:

This entry is proposed to be amended as follows:

1) Adding a maximum concentration of 3% after dilution with an oxidizer. A limit of 3% after dilution with an oxidizer has been concluded to be adequately protective in an extensive review by the United States’ Cosmetic Ingredient Review panel.

2) Adding PPD p-phenylenediamine salts to the list of synonyms and related compounds. PPD is a potent sensitizer, its HCL and sulfate salts have also the same sensitization potential.

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Table 5: P-phenylenediamine
Ingredient information Restriction
Chemical CAS Synonyms and Related Compounds (including but not limited to) Conditions of Use by product type Maximum Concentration Permitted Warnings and Cautionary Statements (to the effect of)
p-Phenylenediamine and its salts 106-50-3; 624-18-0; 16245-77-5 p-phenylenediamine HCL; p-phenylenediamine sulfate a) Not permitted in products intended for use on the skin.
b) Permitted only in oxidative hair dyes provided warnings and cautionary statements are met.b) 3% after dilution with an oxidizer b) “CAUTION: This product contains ingredients that may cause skin irritation on certain individuals and a preliminary test according to accompanying directions should first be made. This product must not be used for dying the eyelashes or eyebrows. To do so may cause blindness."

Instructions to the following effect accompany each package of hair dye:

(i) the preparation may cause serious inflammation of the skin in some persons and a preliminary test should always be carried out to determine whether or not special sensitivity exists; and

(ii) to make the test, a small area of skin behind the ear or on the inner surface of the forearm should be cleansed, using either soap and water or alcohol, and a small quantity of the hair dye as prepared for use should be applied to the area and allowed to dry. After 24 hours, the area should be washed gently with soap and water. If no irritation or inflammation is apparent, it is usually assumed that no hypersensitivity to the dye exists. The test should, however, be carried out before each application. On no account should the hair dye be used for dyeing eyebrows or eyelashes as severe inflammation of the eye or even blindness may result.

Other miscellaneous amendments:

In addition to the above changes, several existing ingredient entries have been amended to include new synonyms and Chemical Abstract Service Registry (CAS) numbers. Some entries have been updated also to correct inconsistencies between the English and French versions.

Comments

The Government of Canada is committed to providing the Canadian public and other stakeholders with the opportunity to participate in the development of regulatory initiatives. Health Canada invites stakeholders to submit comments on the proposed updates to the Cosmetics Ingredient Hotlist, or any other suggestions. As applicable, please supply evidence to support your comments.

Please provide comments no later than August 26, 2015. Comments may be submitted by email or in writing to:

Mail:
Hotlist Coordinator
Cosmetics Program
Consumer Product Safety Directorate
Health Canada
269 Laurier Avenue West
Address Locator: 4908A
Ottawa, ON  K1A 0K9

Stay informed

Please refer to the Consumer Product Safety section of the Health Canada website to stay informed of this initiative.

Additionally, you may subscribe to the cosmetics mailing list to receive the latest news and information about Health Canada's efforts in the area of cosmetics.

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