Cosmetic registration Archives - Focal Point

Changes to the Canadian Cosmetic Notification (CNF) form requirements as of October 9, 2024

Nathan John — Thu, 17 Oct 2024 14:33:41 +0000

There are number of changes that are in effect as of October 09, 2024 for the Cosmetic Notification (CNF) form requirements

Changes to the CNF came info force on October 09, 2024. The new CNF has been released by Health Canada.
Changes include having to identify whether the cosmetic is a leave-in or rinse-off product, use of different concentration ranges compared to those used previously, the need for label contact details to be listed, requiring a Canadian entity / Responsible Canadian Party / Canadian Agent to be listed, removal of the need to include distributor information.
At this time, Health Canada has informed stakeholders that the requirement to list a Canadian entity / Responsible Canadian Party / Canadian Agent will not be mandatory on the CNF until early 2025 (exact date to be confirmed) as this has a significant impact to a lot of companies. The Canadian entity / Responsible Canadian Party / Canadian Agent will be the primary contact that Health Canada will reach out to, should they require any action in relation to a notified product.
- There are ongoing discussions with Health Canada to clarify the responsibilities that this Canadian entity / Responsible Canadian Party / Canadian Agent is to have
- It is believed that the Canadian entity / Responsible Canadian Party / Canadian Agent will function as a contact between the brand owner and Health Canada, however, at this time, the regulations detail a lot more responsibility
- The Canadian entity / Responsible Canadian Party / Canadian Agent bears the same responsibility as a manufacturer
The above requirement for a Canadian entity / Responsible Canadian Party / Canadian Agent will not apply to any CNFs that have already been filed and will only impact new or amendment CNFs filed as of Oct. 09, 2024.

Additional Changes to the Cosmetic Regulations

Ingredient Disclosure Flexibility

For cosmetics sold in small packages, there will be more flexible options for ingredient disclosure. Alternatives such as attaching a tag, tape or card or providing information via a website are now permitted to ensure consumers are informed.

Strengthened Cosmetic Notification Requirements

There is now a requirement to notify Health Canada when a cosmetic is discontinued. The regulations have also been amended to allow Health Canada to halt the sale of a product if the notification requirements are not met or if requested information is not provided.

Removal of Distributor Information

Distributor information will no longer be required on the cosmetic notification. Given that Health Canada can follow up with the manufacturer, importer or Canadian entity / Responsible Canadian Party / Canadian Agent, as needed, regarding distribution of the product for compliance and enforcement purposes.

Identification of Product Type

Cosmetics must now specify whether they are rinse-off or leave-on products in their notifications.

Fragrance Allergen Disclosure

A new mandate will require the disclosure of fragrance allergens on cosmetic labels if they exceed a certain limit. The transition period for the implementation of the changes is three years (July 31, 2026) for new products placed on the market, and five years (July 31, 2028) for existing products to sell through.

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Canadian Cosmetic Regulations Updated!

Srishti Chaudhari — Wed, 01 May 2024 16:39:03 +0000

As a part of updates made to Cosmetic Regulations in Canada published in the Canada Gazette Part II, Health Canada amended regulations to align with EU’s 81 fragrance allergen labeling requirements setting the implementation dates as: July 31, 2026 for new products placed on the market, and July 31, 2028 for existing products.

To begin complying, it is recommended to get an expanded allergen list from all fragrance suppliers and then updating artwork based on analyses of each formula while understanding the disclosure requirements applicable. Health Canada is offering the option for cosmetics sold in small packages, to disclose the entire list of ingredients on a website. A bilingual statement must be made on the label directing the consumers to access the list of ingredients. Certain definitions have also been changed throughout the regulations to ensure the appropriate interpretation of all the terms listed.

Some notable changes have been made to the cosmetic notification requirements:
– The number of concentration ranges have been increased from 7 to 13 to ensure more accurate data is collected.
– A declaration about the formulation being a leave-on or rinse-off product is now required on the CN.
– Mentioning the contact details on the inner label is now mandatory to enable customers to reach out and report any concerns associated with the product.
– There is no longer a requirement for the name and address of the Canadian distributor.
– Any request for additional information made by the Minister must be responded to within 10 days by the manufacturer or importer.
– Health Canada now has authority to stop the sale of a product if the notification requirements are not met or the information requested is not provided.
– The importer will now be responsible to provide evidence of safety. For the purposes of protecting proprietary information, a foreign manufacturer/third party can provide this information to Health Canada on behalf of the importer.

The Regulations will come into force in two parts – the disclosure of fragrance allergens will come into force two years after the day on which they were registered while all the other amendments will come into force 180 days after the day on which they were registered.

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FDA unveils its portal for cosmetic regulation – Cosmetics Direct

Srishti Chaudhari — Tue, 19 Dec 2023 16:48:02 +0000

The FDA has finally launched its much-awaited Cosmetics Direct portal planned under the Modernization of Cosmetics Regulation Act (MoCRA) of 2022, marking a pivotal moment in the regulation of cosmetics within the US. This online platform, seamlessly integrated with the FDA Direct portal, represents a significant stride towards ensuring the safety of cosmetic products in the market.

The portal is designed to simplify and expedite the registration process for facilities engaged in cosmetic businesses and for listing of products sold in the US. By providing a centralized platform, the FDA aims to enhance the efficiency of regulatory procedures, making it easier for industry professionals to comply with industry standards and guidelines.

The FDA has also extended the deadline for submissions, moving the compliance date from Dec. 29, 2023, to July 1, 2024. If you require any assistance with filing your submissions via the Cosmetics Direct portal, please reach out to us. Our team is here to guide and support you through the process, ensuring a smooth experience for all stakeholders involved.

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