After initially ignoring red-tape reduction for low-risk cosmetic-like drug products last fall, Health Canada has relented and is now quickly moving to provide a route to market for sunscreens and other low-risk drug actives already approved in trusted jurisdictions such as the European Union. This initiative was outlined in a recent Proposed Ministerial Order which is currently out for consultation with submissions due by July 14th, 2026.
The list of products included in the proposed approach are those included on List D (list of Certain Non-prescription Drugs for Distribution as Samples) and which comply with one of Health Canada’s monographs. The list of these low-risk health products includes acne therapies, anti-dandruff products, antiperspirants, antiseptic skin cleaners, athletes foot treatment, diaper rash products, medicated skin care products, oral health products (toothpastes, mouthwashes), throat lozenges, and sunscreens (both primary and secondary).
Ingredient approvals from trusted jurisdictions would then be reflected in the applicable monographs for these products (which we understand Health Canada will be working on in advance of the Order being formally approved later this year).
A copy of the Proposed Ministerial Order can be found HERE
This initiative comes after a significant effort by Cosmetics Alliance, our colleagues at Cosmetics Europe, and many of our member companies. It involved advocacy within Canada as well as having the issue raised by the European Commission at the Canada-E.U. regulatory table under the Canada-E.U. Trade agreement as a regulatory barrier to trade. CA’s efforts have included meetings with Canadian trade officials in the European Union, United Kingdom, and Ottawa.
Under the current new drug approval process, new active ingredients for these low-risk cosmetic like products must undergo the same approval process designed and intended for higher risk drug products and pharmaceuticals. This includes an over 300-day submission process and $600K fee, effectively closing the Canadian market to many new and improved active ingredients already long used in the European Union and other trusted jurisdiction. Similar regulatory impediments have also limited the use of these same actives in the United States. The Proposed Ministerial Order would eliminate this costly, time consuming, and unnecessary process.
A key factor in moving this reform initiative forward was Prime Minister Carney’s policy direction to Health Canada to assist in facilitating and diversifying Canadian trade and facilitating opportunities for Canadian-based manufacturing, while maintaining the health and safety of Canadians and Health Canada’s reputation as a respected regulator.
If approved, this initiative will open the Canadian market to a wider range of products from a greater range of trusted trading partners, as well as provide Canadian-based manufacturers with a larger pallet of ingredients for these low-risk drug products including sunscreens. It can also be referenced by U.S. colleagues to seek similar improvements in the U.S.
Over the next few weeks, CA will be reviewing the proposed order through our CA Technical Committees to inform our formal response to the consultation. We will also be providing interested member companies with information and support in preparing their own company submissions.
In terms of context, this initiative needs to be viewed in the larger context of our industry’s long-term drive for regulatory modernization for our sector of low-risk products classified as cosmetics, natural health products (NHPs), or non-prescription drugs (NPDs). This current initiative is built on the foundation of a series of advancements which CA has achieved going back many years beginning with the “lipsticks with an SPF are a drug in Canada” campaign CA launched to get attention to our need for modernization during the days of the Canada-U.S. Regulatory Reduction Council. This led to the Self-Care Framework modernization effort (which Health Canada regrettably failed to complete) which did allow for the pilot project to end “quarantine and re-testing” for sunscreens and then later other low-risk DIN products (which saved member companies an estimated $100K per SKU per year on imported DIN products).
This proof of concept supported reforms through the CUSMA process in 2020 which permanently ended “quarantine and retesting” for our products, allowed for sampling, established a statutory definition for “low-risk cosmetic-like drugs and NHPs”, and formally recognized for the first time that these products were “low-risk” and required regulation commensurate with that risk.
It was these advancements, including having already defined these products legally through the CUSMA implementation bill, along with the new policy direction of the Carney government, that allowed for this next important step in improving the route to market for new drug actives for our products.
And going forward, as we have already been discussing with Health Canada officials, this Proposed Ministerial Order will likely need various risk-based changes to the applicable GMPs and Drug Establishment Licenses (DELs) as they apply to these low-risk cosmetic-like products in order for the full benefit of this order to be achieved. These products are NOT pharmaceuticals and the applicable GMPs and manufacturing licenses will need to reflect the appropriate standards. This will likely be our next objective on the road to modernization.
CA will continue to keep you updated on further developments. Should you have any questions or comments, please contact your CA Regulatory Team.
