Frequently Asked Questions

HOW ARE CONSUMER HEALTH PRODUCTS REGULATED?

Consumer health products can fall under one of three regulations, depending on the active ingredient and claims being made. Natural Health products are regulated under the Natural Health Products Regulations. Cosmetics are regulated under the Cosmetic Regulations. Non-prescription drugs and disinfectants are regulated under the Food and Drugs Regulations.

WHY USE A CONSULTANT FOR REGULATORY AFFAIRS?

Are you weighing the numerous pros and cons of bringing in a consultant vs. tackling it all in-house?

A reputable consultant will get you through the process with less pain, while your staff and management can focus on the tasks on hand and under their areas of expertise.

Dell Tech can take on all the work, we can train your key personnel to perform this work in-house, or a combination of the two. It’s your choice.

HOW DO I GET MY PRODUCT LISTED ON THE CFIA PRE-APPROVED REFERENCE LISTING?

The CFIA no longer pre-approves construction materials, packaging materials, non-food chemicals, and working apparel. The reference listing continues to be available on the CFIA website as a reference only. As the list is no longer maintained, it is up to users to verify the accuracy of the information with manufacturers.

DO I NEED TO REGISTER MY CONSUMER PRODUCT IN CANADA?

Unfortunately, the answer is not straightforward, and depends on the product and the label claims. There are at least three Canadian Government Agencies, each with unique regulatory requirements, which may necessitate product registration.

Dell Tech consultants are regulatory experts who work closely with the Canadian Government. We can evaluate your product label, interpret the appropriate regulations, and guide you towards compliance.

WHAT IS A PESTICIDE?

A pesticide is any product, device, organism, substance, or thing that is manufactured, represented, sold, or used as a means for directly or indirectly controlling, preventing, destroying, mitigating, attracting, or repelling any pest.

Pesticides can include:

  • Herbicides, which are used against weeds
  • Insecticides, which are used against bugs
  • Fungicides and Antimicrobial Agents, which are used against fungus and other microorganisms
  • Material and Wood Preservatives
  • Animal and Insect Repellents
  • Insect and Rodent-Controlling Devices, such as mosquito zappers and mouse traps
  • Algaecides, which can be used to control algae in pools and spas
WHO IS REQUIRED TO HOLD A DRUG ESTABLISHMENT LICENCE (DEL)?

Any individual or company who wishes to perform the following activities requires a Drug Establishment Licence (DEL):

  • A person who wishes to fabricate, package/label, test, import, distribute, or wholesale in Canada a finished dosage drug or bulk process intermediate.
  • A person who wishes to fabricate, package/label, test, or import in Canada an active pharmaceutical ingredient.
CAN I TRANSLATE MY US SDS INTO FRENCH FOR COMPLIANCE WITH CANADIAN SDS REGULATIONS?

Although both countries have adopted the Globally Harmonized System (GHS) for classification, the countries adopted different versions. The US started their adoption of the GHS before Canada and, as such, are using Version 3, while Canada is using Version 5.

Although the versions are similar, there are quite a few differences between the two as far as the hazard language is concerned. Dell Tech consultants are regulatory experts who work closely with the Canadian Government. We can evaluate your product and guide you towards compliance.

CAN I USE ONE SDS FOR WORLDWIDE DISTRIBUTION?

Unfortunately, the term Globally Harmonized System (GHS) is a misnomer. One SDS cannot be used worldwide. Not all countries around the world adopted the GHS. There are many countries that have chosen to continue using a system that they are familiar with and do not wish to change.

Countries that have chosen to adopt the GHS are on different versions. For example, the US is currently aligned with version 3 of the regulations, with plans to adopt later versions in the near future, whereas Canada is currently on version 5.

Not all countries adopted the same endpoints for classification, nor did they adopt the same Trade Secret disclosures.At this point in time, it is not possible to create an SDS that can be used worldwide.