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SAFEGUARDS | Cosmetics, Personal Care & Household NO. 007/16

Following an end of consultation on a number of proposed changes to the Cosmetic ingredient Hotlist on August 26, 2015, Health Canada has announced and published a new Hotlist in December 2015.

The format of the Cosmetic Ingredient Hotlist has been changed in this update by adding an additional column to present the maximum concentration permitted of restricted ingredients and the associated warning and cautionary statements separately. In this update, restrictions on four cosmetic ingredients have been amended and one new entry has been included in the prohibition list.

Amendments on restriction list:
  • Methylisothiazolinone/Methylchloroisothiazolinone (MI/MCI), in combination, (CAS No. 26172-55-4; CAS No. 282-20-4), is now further restricted in its application. It is only allowed to have MI/CMI as a preservative in rinse-off cosmetic products only at a maximum level of 0.0015%. It becomes a prohibited substance in leave-on cosmetic products. 

Maximum Concentration Permitted

Warning and Cautionary Statements

2015 Cosmetics Ingredient Hotlist

Maximum permitted level in rinse-off products: 0.0015% (15ppm) in rinse-off products only.

Prohibited in leave-on products

-

2014 Cosmetics Ingredient Hotlist

Maximum permitted level in rinse off products: 0.0015% (15ppm)

Maximum permitted level in leave on products: 0.00075% (7.5ppm)

-

  • Cyanoacrylate-based adhesives (CAS No. 7085-85-0; CAS No. 137-05-3; CAS No. 10586-17-1), including but not limited to Ethyl cyanoacrylate, Methyl cyanoacrylate, Isopropyl cyanoacrylate, has its restriction changed on eyelash extension and other cosmetics. When it is used as an ingredient in an eyelash extension product, the product is only allowed for professional use, while direct sale to consumer is forbidden. Warning and cautionary statements have been amended into two sets as well to best fit and describe the application of eyelash extension and other cosmetics. Description of training methods and training materials are now waived upon notification. However, they shall be kept for record.

Conditions of Use by product type

Warning and Cautionary Statements

2015 Cosmetics Ingredient Hotlist

Cyanoacrylate adhesives for eyelash extensions: for professional use only (i.e., not for direct sale to consumers).

Eyelash extension for professional use:

  1. "For application by trained professionals only"
  2. "Ensure the eye is protected and immobilized during application."
  3. “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.

Other Cosmetics:

Other Cosmetics:

  1. "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."

2014 Cosmetics Ingredient Hotlist

For adhesives used in the area of the eye for the application of false eyelashes, manufacturers and/or distributors of glues must submit the following information to Health Canada to demonstrate safety of the product: (a) Description of training method; (b) Submission of all training materials; and (c) Description of measures taken by notifying company to limit the sale and access of the product to qualified and trained individuals.

The inner and outer label of the cosmetic shall carry cautionary statements to the effect of: “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. ATTENTION. COLLE INSTANTANÉMENT À LA PEAU. ÉVITER TOUT CONTACT AVEC LES YEUX, LA BOUCHE ET LA PEAU. TENIR HORS DE LA PORTÉE DES ENFANTS. Paupières collées: consulter un médecin. Peau collée: tremper et séparer graduellement. Ne pas utiliser dans la région oculaire.”

  • Peroxide and peroxide-generating compounds (CAS No. 124-43-6; CAS No. 1305-79-9; CAS No. 7722-84-1; CAS No. 1335-26-8; CAS No. 7632-04-4; CAS No. 1314-22-3), including but not limited to Urea peroxide; calcium peroxide; calcium dioxide; hydrogen peroxide; magnesium peroxide; sodium perborate; zinc peroxide. Cautionary statements have been updated in new hotlist in order to best describe and reflect the current patterns of use of tooth whitening products.

Conditions of Use by product type

Warning and Cautionary Statements

2015 Cosmetics Ingredient Hotlist

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.

3) 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.

NB: Be aware of the conversion factor between hydrogen peroxide and other peroxide‐generating compounds. For example, 10% carbamide (urea) peroxide is approximately equivalent to 3% hydrogen peroxide.

"If irritation (such as redness, swelling, soreness) of the gums or the mouth occurs, discontinue use and consult an oral health professional."

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

"Consult your oral health professional before prolonged use of this product."

"Avoid swallowing the cosmetic or part thereof."

"Avoid contact of the product with the eye."

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

2014 Cosmetics Ingredient Hotlist

Manufacturers of oral products containing peroxides or peroxide-generating compounds must submit the following information to Health Canada:

(a) data on the pH of the cosmetic product, when it is applied to the tooth or teeth, to ensure that theproduct is in compliance with section 13 of the Cosmetic Regulations, i.e. that the pH is greater than or equal to 4.0; and

(b) 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.

NB: Be aware of the conversion factor between hydrogen peroxide and other peroxide-generating compounds. For example, 10% carbamide (urea) peroxide is approximately equivalent to 3% hydrogen peroxide.

The labels of oral cosmetics containing peroxides or peroxide-generating compounds shall carry cautionary statements to the effect:

"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."

"Use for periods of longer than 14 days is to be only under the supervision of a dentist."

"Avoid swallowing the cosmetic or part thereof."

"Avoid contact of the product with the eye."

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

  • p-Phenylenediamine and its salts (CAS No. 106-50-3; CAS No. 624-18-0; CAS No. 16245-77-5), including but not limited to p-Phenylenediamine HCL; p-Phenylenediamine sulphate; has its maximum permitted level at 3% after dilution with an oxidizer included in the restriction on oxidative hair dyes. P-Phenylenediamine salts sand its related compounds are newly included in the entry.

Maximum Concentration Permitted

Warning and Cautionary Statements

2015 Cosmetics Ingredient Hotlist

Prohibited in products intended for use on the skin.

Maximum permitted level in oxidative hair dyes: 3% after dilution with an oxidizer

For oxidative hair dyes only:

On the inner label and the outer label of the cosmetic :

"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 anda 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."

2014 Cosmetics Ingredient Hotlist

Not permitted in products intended for use on the skin.

Permitted only in oxidative hair dyes provided warnings and cautionary statements are met.

The inner label and the outer label of the cosmetic products carry the following warning: “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. MISE EN GARDE: Ce produit contient des ingrédients qui peuvent causer de l'irritation cutanée chez certaines personnes: il faut donc d'abord effectuer une épreuve préliminaire selon les directives ci-jointes. Ce produit ne doit pas servir à teindre les sourcils ni les cils: en ce faisant, on pourrait provoquer la cécité."

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.

  • Addition on prohibited list: Prostaglandins, their salts, derivatives and analogs, associate with therapeutic function, which are also present on the prescription drug list.

Ingredient

CAS No.

Synonyms and Related Compounds (Including but not limited to)

Prostaglandins, their salts and derivatives and their 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

It is crucial for all cosmetic, personal care and household products to be safe effective and stable. SGS provides testing, inspection, auditing and consulting services to manufacturers, distributors and importers to ensure a high level of product quality in every area. Our state of the art laboratories offer custom-made solutions for chemical, biophysical, microbiological, stability and biological aspects. We also have extensive capabilities in performance testing, claim support studies and consumer panels. Our testing is conducted according to customer specific or recognised standard methods, some of which were developed by SGS. Our cosmetic safety assessors and other technical experts can support customers by making sure new products comply with regulatory requirements. Please do not hesitate to contact us for further information or visit our website.

Reference source:

For enquiries, please contact:

Queenie Tse
Technical Service Executive, Cosmetics, Personal Care & Household
t: +852 2765 3672

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