Nathan John, Author at Focal Point https://focalpointresearch.net/author/nathan-j/ Scientific, Regulatory and New Product Consultants Fri, 18 Oct 2024 21:59:00 +0000 en-US hourly 1 https://wordpress.org/?v=6.9.4 https://focalpointresearch.net/wp-content/uploads/2021/11/cropped-focal_point_chart_03-32x32.jpg Nathan John, Author at Focal Point https://focalpointresearch.net/author/nathan-j/ 32 32 126679100 Changes to the Canadian Cosmetic Notification (CNF) form requirements as of October 9, 2024 https://focalpointresearch.net/canadian-regulatory/changes-to-the-canadian-cosmetic-notification-cnf-form-requirements-as-of-october-9-2024/ Thu, 17 Oct 2024 14:33:41 +0000 https://focalpointresearch.net/?p=5552 The post Changes to the Canadian Cosmetic Notification (CNF) form requirements as of October 9, 2024 appeared first on Focal Point.

]]>

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

  1. 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.

  1. 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.

  1. 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.

  1. Identification of Product Type

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

  1. 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.

The post Changes to the Canadian Cosmetic Notification (CNF) form requirements as of October 9, 2024 appeared first on Focal Point.

]]> 5552 The Modernization of Cosmetics Regulation Act of 2022 (“MoCRA”) https://focalpointresearch.net/uncategorized/the-modernization-of-cosmetics-regulation-act-of-2022-mocra/ Mon, 30 Jan 2023 15:06:58 +0000 https://focalpointresearch.net/?p=5192 On December 29, 2022, President Joe Biden signed into law the Consolidated Appropriations Act, 2023, which includes the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). This new cosmetic legislation establishes federal standards for cosmetic business registration, product listing, recordkeeping, adverse event reporting, safety substantiation, GMP, recalls, and more. New Requirements for Cosmetics: MoCRA EXEMPTIONS: […]

The post <strong><u>The Modernization of Cosmetics Regulation Act of 2022 (“MoCRA”)</u></strong> appeared first on Focal Point.

]]> On December 29, 2022, President Joe Biden signed into law the Consolidated Appropriations Act, 2023, which includes the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). This new cosmetic legislation establishes federal standards for cosmetic business registration, product listing, recordkeeping, adverse event reporting, safety substantiation, GMP, recalls, and more.

New Requirements for Cosmetics:

  1. Adverse Event Record keeping and Serious Adverse Event Reporting:
  • Must report to FDA no more than 15 business days of event awareness
  • Must maintain all related records
  • Cosmetic product labels must list contact information for consumers to report side effects
  1. Mandatory Facility Registration and Product and Ingredient Listing:
  • Facility Registration by December 29, 2023 – All existing facilities (domestic and foreign) that engage in the manufacturing or processing of a cosmetic product for distribution in the United States must register with the FDA
  • Must be renewed every 2 years
  • Product Listing must be submitted within 120 days of market launch and it must be renewed annually
  1. Cosmetic Safety Substantiation
  • Adequate substantiation of safety is required for all cosmetics
  1. Cosmetic Labeling and Fragrance Allergen Transparency
  • Product labels must be updated to include fragrance allergens
  • June 29, 2024 – List of allergens to be declared will be proposed by FDA and finalized within 180 days of the comment period ending
  • Labeling must be updated by December 29, 2025
  1. Current Good Manufacturing Practices:
  • Manufacturers must meet GMP by 2025
  • FDA is expected to publish a proposed regulation before December 29, 2024 and finalize it by December 29, 2025
  1. Talc rule:
  • FDA to publish a proposed test protocol for asbestos in Talc by December 29, 2023
  • To be finalized 180 days after comment period ends
  1. PFAS Report:
  • FDA to assess the use of per- and polyfluoralkyl substances (“PFAS”) in cosmetic products and the scientific evidence regarding the safety of their use in cosmetics products
  • FDA will publish the results of this assessment in a public report no later than December 29, 2025
  1. Animal testing
  • No requirements specific to testing involving animals, but animal testing should not be used for the purposes of safety testing on cosmetic products and should be phased out with the exception of appropriate allowances

MoCRA EXEMPTIONS:

  • Small business exemptions apply – average gross annual sales in the United States of cosmetic products for the previous 3-year period is less than $1,000,000 AND
  • Do not engage in the manufacturing or processing of the cosmetic products listed below:
    • Cosmetic products that regularly come into contact with mucus membrane of the eye under conditions of use that are customary or usual.
    • Cosmetic products that are injected.
    • Cosmetic products that are intended for internal use.
    • Cosmetic products that are intended to alter appearance for more than 24 hours.

If you have any questions or would like further information, please contact us.

The post <strong><u>The Modernization of Cosmetics Regulation Act of 2022 (“MoCRA”)</u></strong> appeared first on Focal Point.

]]> 5192 Full Producer Responsibility for Post Consumer Waste in Ontario https://focalpointresearch.net/canadian-regulatory/full-producer-responsibility-for-post-consumer-waste-in-ontario/ Tue, 26 Oct 2021 17:11:19 +0000 https://focalpointresearch.net/?p=5075 Ontario is moving its existing waste diversion programs to a producer responsibility model.  Producers are the companies that design, create and market products and packaging. Producers will be responsible for managing and paying for the full life-cycle of their products to make recycling easier and more accessible across the province.  If you are a Producer, […]

The post Full Producer Responsibility for Post Consumer Waste in Ontario appeared first on Focal Point.

]]> Ontario is moving its existing waste diversion programs to a producer responsibility model.  Producers are the companies that design, create and market products and packaging. Producers will be responsible for managing and paying for the full life-cycle of their products to make recycling easier and more accessible across the province.  If you are a Producer, you will need to:

  • Register your 2020 tonnage with RPRA (Deadline to Register – October 1st)
  • Pay your 2021 registry Fee when submitting your 2020 supply data
  • Join a Producer Responsibility Organization (PROs)

If you would like further information on this, please do not hesitate to contact us

The post Full Producer Responsibility for Post Consumer Waste in Ontario appeared first on Focal Point.

]]> 5075