Navigating Changes In Cosmetic Regulations: What You Need To Know About Health Canada's Modifications.

On April 24, 2024, Health Canada announced significant amendments to the Cosmetic Regulations under the Food and Drugs Act, marking an important shift in the way cosmetic products are regulated in the country. These updates aim to enhance transparency, improve safety, and ensure better oversight of the cosmetics industry. As part of Health Canada's ongoing mission to protect Canadians' health, these changes emphasize the disclosure of cosmetic ingredients, particularly fragrance allergens, and introduce new requirements for labelling and product safety.

In this blog, we’ll break down the key amendments, what they mean for the cosmetics industry, and how professionals in regulatory affairs and toxicology play a crucial role in ensuring compliance with these new standards.

A Snapshot of Canada's Cosmetic Regulation Framework

Since the early days of the Food and Drugs Act in 1939, Health Canada has been entrusted with safeguarding public health, particularly in overseeing cosmetics sold within the country. Initially treated as part of the broader category of "drugs," cosmetics received separate regulation under the Act in 1977. The primary focus has always been to ensure that products are safe for consumers and free from harmful substances.

Key highlights of Health Canada's approach include:

• Mandatory ingredient disclosure: Since 2006, cosmetic labels have been required to list ingredients using the International Nomenclature of Cosmetic Ingredients (INCI) system, which helps harmonize ingredient labelling with international standards.
• Post-market monitoring: Cosmetic manufacturers and importers are required to notify Health Canada within 10 days of the sale of any product, with over 57,000 notifications processed annually.
• Fragrance allergen disclosure: In line with international practices, Health Canada has mandated the disclosure of fragrance allergens on cosmetic labels.

These regulations aim to ensure transparency and consumer safety while also aligning with evolving global standards, particularly those followed by the European Union.

What are the key modifications?

The recent amendments to the Cosmetic Regulations introduce several important changes, primarily focused on ingredient disclosure, product safety, and oversight. Here’s a breakdown of the key updates:

1. Disclosure of Fragrance Allergens:
   A significant amendment requires the disclosure of certain fragrance allergens on cosmetic labels. Manufacturers will need to list these allergens if they exceed specified concentration limits. The implementation of this provision will be delayed until April 12, 2026, providing businesses time to adapt to the new requirements.

1. Flexibility for Small Package Labelling:
   Manufacturers of small cosmetic products will be allowed to provide a complete ingredient list on a website, with the product packaging directing consumers to the online resource. This will help companies comply with labelling regulations while avoiding overcrowded labels on smaller packaging.

1. Enhanced Oversight and Clarification of Definitions:
   The definitions of "manufacturer" and "importer" have been clarified, and notification requirements have been strengthened. This includes new provisions for reporting the discontinuation of sales, as well as mandatory response timelines to Ministerial requests. These changes are designed to ensure greater accountability within the cosmetics industry.

1. Modernized Labelling Requirements:
   The new regulations also include updated labelling guidelines. For example, the requirement for identifying rinse-off versus leave-on products has been clarified, which is essential for determining appropriate safety and efficacy measures. Additionally, the requirement to list distributor information on cosmetic notifications has been removed.

1. Safety Evidence Requirement:
   Importers may now be required to provide safety evidence for their products, in addition to manufacturers. This provision ensures that all parties involved in the sale and distribution of cosmetics in Canada are held accountable for the safety of the products they bring to market.

The Role Maven’s Expertise:

As these amendments take effect, professionals in regulatory affairs and toxicology will be instrumental in guiding companies through the compliance process. Here's how these key roles contribute:

• Regulatory Affairs Professionals: These experts are essential in interpreting the amendments and ensuring that all product formulations, labels, and documentation comply with the new regulatory framework. They work closely with product development teams to ensure ingredients are correctly disclosed, and they also handle communications with Health Canada regarding product notifications and safety evidence.
• Toxicologists: Toxicologists play a critical role in assessing the safety of ingredients used in cosmetic products. They evaluate whether ingredients meet the safety standards set by Health Canada, particularly when it comes to ensuring that products do not pose any harm to consumers. With the new requirement for safety evidence from importers, toxicologists will be called upon to provide scientific evidence to support product safety and compliance with the updated regulations.

Conclusion:

Health Canada’s amendments to the Cosmetic Regulations represent a significant step toward improving product transparency, safety, and consumer protection in the cosmetics industry. By understanding and preparing for these changes, companies can navigate the evolving regulatory landscape with confidence. Regulatory affairs professionals and toxicologists will be key partners in ensuring compliance and maintaining the safety and trust of consumers in the Canadian market.

At Maven, we assist cosmetic companies with the right planning and expert support, continue to deliver the updated regulations.