Guidance Document: Cyanoacrylate-Based Adhesives used in the Application of Eyelash Extensions

November, 2009

1.0 Introduction

1.1 Objective

The purpose of this guidance document is to inform manufacturers, importers and distributors of cyanoacrylate-based eyelash adhesives about concerns with the safety and application of these products.

All cosmetic products sold in Canada must satisfy the safety requirements of section 16 of the Food and Drugs Act. This document sets out safety and training criteria that can assist manufacturers, importers and distributors to achieve a high level of safety.

1.2 Scope

Cyanoacrylate-based adhesives used in the application of false eyelash extensions are considered to be cosmetics and are therefore subject to the requirements of the Cosmetic Regulations under the Food and Drugs Act in order to be sold in Canada.

All persons associated with the sale of a cosmetic in Canada are responsible for meeting the requirements of the Act and Regulations. The manufacturer, importer or distributor is responsible for providing the Cosmetic Notification Form and requested safety information to Health Canada. Beauty service professionals should also be in contact with their supplier to confirm that the products they use are notified with Health Canada and are deemed acceptable for sale.

1.3 Application

The authority to request evidence to support the safety of a product is found under section 29 of the Cosmetic Regulations. Under this section of the Regulations, if the evidence is not provided by a specific date and/or if the information is deemed insufficient, the manufacturer may be asked to stop sale of the product.

The information is evaluated by the Cosmetics Program for completeness. Once reviewed, confirmation that all basic information has been received will be sent to the notifying company.

1.4 Background

It has come to Health Canada's attention that cyanoacrylate-based adhesives are being used and sold in the application of "semi-permanent" or "permanent" false eyelash extensions. These eyelash extensions are marketed by the beauty service industry to extend the length and thickness of eyelashes. They are applied to individual natural lashes using a cyanoacrylate-based adhesive, and usually last for the growth cycle of an eyelash hair.

Cyanoacrylate-based adhesives, also known as "instant bonding glues", have the ability to set quickly and strongly, subsequently causing tissue damage if bonded skin is forced apart. Under section 16 of the Food and Drugs Act, no person shall sell cosmetics containing substances that may cause injury to the health of the user. Due to their strong bonding properties, cyanoacrylate-based adhesives for use in the area of the eye cannot be sold unless measures are taken to make application of the product safe.

Health Canada met with several eyelash extension companies who presented information demonstrating how cyanoacrylate-based eyelash adhesives can be safely applied. After careful review of the training methods, Health Canada proposes the safety criteria for the use and sale of these adhesives found in the following section.

2.0 Guidance

To support the safety of their product, companies selling cyanoacrylate-based adhesives for the purpose of false eyelash extensions should provide Health Canada with the following information:

2.1 Training method

Health Canada requests the company providing the safety information (i.e. the "notifying company") to describe the training process in detail. The following minimum standards assist the company in satisfying Health Canada requirements when outlining the training program :

• In-class training
  In-class training is considered to be the most effective method to teach safe application of the product. DVD or web training is unacceptable.
• Duration of training
  A minimum of one full day of training is required. Longer sessions are encouraged to assure the student's confidence in the application technique.
• Student-trainer ratio
  A maximum of 5:1 student-trainer ratio so that each student receives individual attention and instruction.
• Student assessment
  The criteria used to determine a student's ability to pass/fail the certification process are to be outlined. Evaluation on a live model is recommended.
• Re-certification/re-training availability
  It is expected that students will have the opportunity to refresh their application technique as needed.

2.2 Training materials

All theoretical and practical instructional material should be submitted to Health Canada. The following topics are to be addressed in the training material/program:

• Client assessment and screening (i.e. how to determine who is suitable for the service/on what conditions a client is refused)
• Protection and immobility of the eye (i.e. product must not come in contact with the eye or eyelid)
• Application method (i.e. position of client vs. applicant, amount of adhesive applied to lash, handling techniques)
• General hygiene & safety
• First aid measures for accidental exposure or allergic reactions
• Safe removal techniques

2.3 Controlled Sale of Product

Only those trained by the notifying company (i.e. the company who has submitted the CNF and safety information to Health Canada) are to have access to the purchase of the adhesive, and be able to use the product. Health Canada requests details as to how the notifying company intends to control the sale and access of the product to only qualified and trained individuals. The following information is to be explained:

• Are certificates issued to successful students?
• How are product sales to certified individuals tracked and monitored?

2.4 Labelling of the Product

The cyanoacrylate-based adhesive must be labelled with cautionary statements. Health Canada requests a proposed label text demonstrating the following information:

"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.

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."

3.0 Implementation

This guidance applies to all cosmetic cyanoacrylate-based adhesives intended for false eyelash application for sale in Canada.

The requested information, as well as the associated Cosmetic Notification Forms, are to be submitted to the following address:

• Cosmetic Product Notification
  Consumer Product Safety Directorate
  Health Canada
  269 Laurier Avenue West
  Address Locator: 4907E
  Ottawa, ON K1A 0K9

The Cosmetics Program will review the adequacy of the information and provide confirmation to the notifying company that all safety requirements are met.

Please note: as per section 17 of the Cosmetic Regulations, the Food and Drugs Act or the Cosmetic Regulations may not be used directly or indirectly for promotional purposes. Statements such as "approved by Health Canada" or "meets Health Canada's requirements" are unacceptable and must not be found on any promotional material, websites or product labelling.

Questions?

For any questions regarding this guidance, please contact the appropriate Regional Office.

This guidance may be re-evaluated from time to time based on future regulatory or policy amendments.