Orientation:
This class is brought to you from outside sources. Go to the Ship’s Library to read over the information and listen to the specialist’s videos. Your animated instructor will not be present for this class. Take a comforting beverage and get cozy.
Health Canada Regulations-
We all know regulations can help keep us safe and healthy. However, working with government regulations for selling products can be intimidating. But you already know how to make safe products.
Understanding and keeping up with them is an important step in becoming a solo entrepreneur in the cosmetic field. So you’ve come a very long way!
Nevertheless, I suggest you take a breath before beginning this journey. The government can help direct you if and when confusion occurs. :) The links and videos on this page should be helpful.
You don’t need to complete this step to earn your diploma in Practical Potions, but you will need to do so before you sell your products.
We are not experts on regulations, but here are some resources to explore.
If you choose to market your products, you must fill out forms for each product you decide to sell. This does not apply to products made and used for personal or family purposes.
The Government of Canada says–
In Canada, the oversight and regulation of cosmetics fall under Health Canada through the Cosmetic Regulations under the Food and Drugs Act. This regulatory framework ensures that cosmetics sold in Canada are safe to use and do not pose any health risks. It mandates that all cosmetic products must provide a list of ingredients, and these ingredients must adhere to the restrictions set forth by Health Canada. This list is essential for consumers, particularly those with allergies or sensitivities.
Health Canada also requires manufacturers and importers to notify them about the products they plan to sell in the Canadian market. This notification, which includes information about the product’s ingredients, must be submitted within ten days of the product’s first sale.
Notably, the regulation stipulates that cosmetics should not contain prohibited substances. Where restricted ingredients are used, they must be within the limits or concentrations specified by Health Canada. This is crucial for ensuring the safety and efficacy of cosmetic products.
Prohibited Substances List– https://www.canada.ca/en/health-canada/services/consumer-product-safety/cosmetics/cosmetic-ingredient-hotlist-prohibited-restricted-ingredients/hotlist.html
In addition to these regulations, manufacturers must maintain up-to-date records of all sales and any reported health problems associated with their products. These records aid Health Canada in monitoring product safety and taking necessary actions if a health risk is identified.
Here is A Video By Regulatory Consultants Ltd. on Canadian Regulations
Cosmetic Labelling in Canada
Navigating the intricate world of cosmetic labelling in Canada is crucial to ensure any product you sell complies with various regulations.
A fundamental aspect of these regulations is understanding where specific information must be placed on a product. The ‘principal display panel’ (PDP) is the part of the label visible to consumers under normal purchasing conditions and is often on the front of the package.
Language requirements are also crucial. Labels must offer information in both official languages, English and French. This bilingual requirement applies to the product’s identity—its common name or function—and the net quantity, which must be displayed in metric measurements with a clear space between the number and the unit.
The manufacturer or Canadian dealer’s name and address should also be on the outer packaging but never solely on the bottom. This can be in either language or both.
Safety is paramount, so any avoidable hazards and cautions associated with the product must be clear. This includes usage instructions, cautionary symbols, and warnings, all of which must be bilingual.
The ingredient list is also tightly regulated. Ingredients above a one percent concentration are listed in descending order, while those under one percent can be listed in any order. Fragrances and flavours are denoted as ‘perfume’ or ‘aroma,’ CI numbers or colour names list colourants. A general ingredient list is permissible for colour cosmetics offering various shades, with specific colourants indicated by a plus/minus symbol or a statement acknowledging potential variations.
Ingredients may be listed using their European Union (EU) common names, the English and French equivalents, or all three. This detailed information must also appear on the inner label, with the only exceptions being the net quantity and ingredient list.
The following YouTube video is by Regulatory Consultants on Labelling.
Cosmetic Regulation Review
In Canada, Health Canada closely monitors the sale of cosmetics to ensure safety and compliance with several key regulations, including the Food and Drugs Act and the Consumer Packaging and Labelling Act.
Cosmetics are defined under Canadian law as any substance or combination intended for cleansing, beautifying, promoting attractiveness, or altering the appearance of the skin, hair, and teeth, including deodorants and perfumes. This definition spans a wide range of products, from those used in professional aesthetic services to hand soaps in public institutions and even products crafted at home or sold at local markets.
How a product is marketed—specifically, the claims about its performance—can influence its classification. Above all, cosmetics must be produced, prepared, preserved, packaged, and stored in sanitary conditions to ensure they are safe for consumer use and do not pose health risks when used as intended.
While specific guidelines for establishing a product’s safety are not laid out in the legislation, the onus is on manufacturers to prove and ensure the safety of their products. Health Canada provides a Cosmetic Ingredient Hotlist, a scientifically grounded resource that lists prohibited and restricted substances in cosmetic products. This Hotlist is regularly updated in response to new scientific evidence, helping manufacturers stay compliant and protecting consumer health.
Here is a List of other potentially helpful links. You have seen them before in Practical Potions 1.
If you need help submitting your form, please get in touch with hc.cosmetics.sc@canada.ca for assistance.
Notify Health Canada about a cosmetic by filling out the Cosmetic Notification Form.
https://healthycanadians.gc.ca/apps/radar/CPS-SPC-0007.08.html
Submit additional documents related to your cosmetic product after a notification has been sent: https://healthycanadians.gc.ca/apps/radar/HCT-TSC-0001.08.html
Review the Guidance document: How to complete a Cosmetic Notification Form to ensure the cosmetic notification forms are completed correctly. https://www.canada.ca/en/health-canada/services/consumer-product-safety/cosmetics/notification-cosmetics/guidance-document-complete-cosmetic-notification-form.html
Would you like some help submitting your HTML form? https://www.canada.ca/en/health-canada/services/consumer-product-safety/cosmetics/notification-cosmetics/guidance-document-complete-cosmetic-notification-form/help-forms.html
For Direction- https://canadagazette.gc.ca/rp-pr/p1/2023/2023-02-11/html/reg4-eng.html
Essentials of Stability Testing in Skincare Formulation
Let’s discuss the essentials of stability testing for your skincare products. Keeping an eye on your products’ pH levels and preservative effectiveness is key to ensuring their long-term success.
Why Stability Testing is Important
It’s a valuable practice to monitor your product’s pH regularly. The pH can shift over time, potentially affecting the product’s performance or safety. Knowing how long your product will remain stable allows you to plan its shelf life and ensure it’s still effective for your customers.
How to Monitor Stability
To track this, test your product’s pH at key intervals. Ideally businesses might do this at the time of production, then again at 1 month, 3 months, 6 months, 12 months, 18 months, 24 months, and 30 months. Regular testing ensures preservatives remain effective and helps you spot any changes in appearance, texture, or scent early on. This length of testing isn’t always practical, but even a couple of months of testing will give you some feedback about product vulnerabilities. It can save a lot of cost, embarrassment and lack of consumer trust.
Preservative Efficacy Test (Challenge Test)
The challenge test is a lab-based test that exposes your product to microorganisms to evaluate how well your preservatives prevent contamination. It helps determine the most suitable preservative and its minimum effective concentration. While this is typically done by larger companies, it can be valuable if you’re planning to become a large company. If it’s not feasible for you right now, (and it isn’t for most of us), you can still manage stability effectively with regular monitoring.
Testing for Small Businesses
For us with small businesses, a practical approach is to create a detailed database for each product. This should include production date, batch number, batch size, pH values at various intervals, observations of changes in appearance, texture, or scent, and accelerated stability test results. A simple excel spreadsheet can keep you organized and help you track the stability of your products over time.
Organizing Batch Numbers
Having a consistent system for batch numbering is a great way to keep track of everything. For example, a Frankincense Cream made in September 2025 might be labeled FC-25-09, Batch 3. Recording this on your spreadsheet and product packaging makes it easier to manage inventory, track the product’s performance, and address any issues quickly. Make a note of whatever system you use to keep track. It is very easy to get confused about meaning. Use a legend, FC=Frankincense Cream. Day of Month, Year and Batch Number.
Accelerated Stability Testing
Accelerated stability testing is another tool that can help speed up the process. By exposing your product to higher temperatures and humidity, you can simulate long-term aging in a shorter time. While it doesn’t replace long-term testing, it can give you useful insights into how your product will hold up over time.
Stability testing doesn’t need to be complicated or expensive. With regular pH testing, careful record-keeping, and consistent observations, you can ensure your products stay safe and effective. This process also makes it easier to handle product recalls, manage inventory, and build trust with your customers.
Stay organized, test regularly, and consistently record your results. This will help your products will be more stable. It also provides ongoing learning and improvement. This feedback lets your company improve with experience and time and fosters quality, facilitates necessary recalls, and improves inventory management.
I do not have deep expertise with this issue, but Perry Romanowski does. He’s not Canadian but is an expert in many areas, including Stability Testing.