Newsletter

Regulatory News in the EU, UK, U.S., Canada, China and Taiwan

Shereen Aboarkaba
November 20, 2025

Health Canada Consults on Proposed Updates to Cosmetic Ingredient Hotlist

On 19th November 2025, Health Canada opened a consultation on proposed changes to the Cosmetic Ingredient Hotlist. The updates Include additions, changes to the conditions for existing entries and changes to include new substance identifiers or make minor corrections. Proposed additions are Basic Violet 4 (CAS 2390-59-2), Basic Blue 7 (CAS 2390-60-5) and Polyaminopropyl Biguanide (CAS 32289-58-0; 27083-27-8; 28757-47-3). The previously prohibited ingredient 'Symphytum spp., with the exception of Symphytum officinale' is proposed to be revised to 'Symphytum spp.', removing the exception for Symphytum officinale. Brucine, which is currently restricted on the Hotlist, is proposed to be revised to 'Brucine and its salts' and prohibited. Imperatorin, currently prohibited, is considered as subject to the entry for 'furocoumarins' and is proposed as a synonym for this restricted entry. There are also several existing entries which will be revised to add CAS numbers, synonyms, or to make minor corrections. The consultation period will run until 17th February 2026.

You may read about the proposed changes here.

California Department of Public Health Updates Reportable Ingredients List

On 17th November 2025, the CDPH (California Department of Public Health) notified of an update to its Reportable Ingredients List to include entries from the authoritative source lists cited in the California Safe Cosmetics Act (CSCA) and the Cosmetic Fragrance and Flavor Ingredient Right to Know Act of 2020 (CFFIRKA) up to October 2025.

Click here for the latest Reportable Ingredients List.

Taiwan FDA Updates List of Restricted Ingredients in Cosmetic Products

On 6th November 2025, Taiwan's Food and Drug Administration published the amended List of Restricted Ingredients in Cosmetic Products. The amended list becomes effective from 1st October 2027.

You may find the list here.

GB SAG-CS Issues Opinion on Hexyl Salicylate

On 13th November 2025, the UK's SAG-CS published its Opinion on Hexyl Salicylate. The Opinion concludes hexyl salicylate is safe for use in cosmetic products for adults and children above three years of age in hydroalcoholic-based fragrances (spray and non-spray) at 2%; rinse off products at 0.5%; leave on products at 0.3% and oral care products at 0.001%. For children under three years of age, hexyl salicylate is safe in shower gel, hand soap, shampoo, hair conditioner, body lotion, face cream, hand cream, lipstick/lip balm and fragrance products at 0.1%, and toothpaste at 0.001%.

You may read the Opinion here.

EU SCCS Publishes Final Opinion on Tea Tree Oil

On 14th November 2025, the EU SCCS published its final Opinion on Tea Tree Oil (CAS 68647-73-4). The SCCS considers the use of Tea Tree Oil as an anti-seborrheic and anti-microbial agent safe in four defended product types - up to the maximum concentration of 2.0% in shampoo, 1.0% in shower gel, 1.0% in face wash and 0.1% in face cream.

Click here to find the Opinion.

EU SCCS Publishes Five Preliminary Opinions

In November 2025, the SCCS published the following Preliminary Opinions, which remain open for comments until January 2026.

EU Council Sets Position on Simplification of Cosmetic Regulations and Signs off CLP Postponement

On 5th November 2025, the EU Council set its position on the remaining part of the Omnibus VI package on the simplification of certain requirements and procedures for chemical products, proposed in summer 2025. In the Council's mandate:

  • The time given for companies to stop selling cosmetic products containing CMR (Carcinogenic, Mutagenic and Reprotoxic) substances has been shortened from the original Commission proposal.
  • The exemption of CMR substances based on route of exposure (oral vs inhalation) has been removed.
  • Notifications for products containing nanomaterials will once again be required prior to the cosmetic product being placed on the market, rather than six months in advance

You may read the Council's press release here.

On 17th November 2025, the EU Council signed off on the 'Stop-the-Clock' legislation postponing the dates of entry into application of provisions in the CLP (Classification, Labelling and Packaging) Regulation to 1st January 2028.

Click here for the council's press release.

U.S. Enacts H.R. 5371, Adding New Requirements for Sunscreens

On 12th November 2025, the U.S. President signed H.R. 5371 into law, ending the government shutdown and providing FY2026 appropriations for the FDA. Notably, the Act directs the FDA to:

  • Update guidance and processes for topical sunscreens by accounting for historical safety data previously accepted for marketing in the U.S.
  • Consider the role of sunscreens with SPF 15+ in effective skin cancer prevention.
  • Incorporate “real-world evidence” and other broader scientific evidence when evaluating sunscreen active ingredients.

The Act also requires annual reports from the FDA on progress towards non-animal-testing alternatives for safety/efficacy data of sunscreen actives and provides funding to support the FDA's implementation of MoCRA.

You may find the bill here.

New Draft Cosmetic Standards, Opinions on Reform of Cosmetics Regulation, and Mercury Ban in China

On 17th November 2025, China's NIFDC (National Institutes for Food and Drug Control) released three draft cosmetic standards for public consultation:

1. Mercury and its Compounds (Draft for Comments)

2. o-Phenylenol and its Sodium Salt (Draft for Comments)

3. Acid Violet 43 (CI 60730) (Draft for Comments) and Drafting Instructions

Click here for the NMPA notice and related documents.

On 17th November 2025, China's NMPA (National Medicinal Products Administration) issued its 'Opinions on Deepening the Reform of Cosmetics Regulation and Promoting High-Quality Development of the Industry', outlining twenty-four reform measures to strengthen cosmetic quality and safety, optimise registration and filing management, and promote innovation.

Read the announcement here.

On 7th November 2025, China's MEE (Ministry of Ecology and Environment) released for public consultation a draft 'Announcement on the Control Requirements for 12 Types of Mercury-Added Products and the Use of Mercury Catalysts in Polyurethane Production'. The draft proposes banning the manufacture, import and export of most cosmetics containing intentionally added mercury from 1st January 2026, in line with China’s commitments under the Minamata Convention.

Click here for the MEE announcement.

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