Cosmetics in 2026: Critical EU & UK Regulatory Changes Every Brand Must Prepare For

March 2, 2026 by Sonal Gadekar

Regulators in the EU and UK are introducing significant cosmetic regulatory updates that will directly impact ingredient selection, labeling, safety assessments, and product claims.

Many brands are underestimating the scope — and the timeline.

Expanded fragrance allergen disclosures will require label updates. New CMR classifications may trigger reformulation. Silicone and nano ingredient changes could affect core product lines. Children’s products are under increased scrutiny. And UK regulatory divergence continues to evolve.

In this webinar, our experts will provide a practical, forward-looking breakdown of:

– The fragrance allergen labeling expansion

– Newly prohibited and restricted ingredients

– Nano ingredient updates

– Children’s cosmetic safety developments

– New CMR bans and silicone restrictions

– UK-specific regulatory shifts

– 2026 SCCS opinions and what they signal for future enforcement

If your brand sells — or plans to sell — cosmetics in the EU or UK, this is a must-attend session to understand what’s changing and how to prepare.

For Medical Device Establishments, who must register?

Owners or operators of establishments involved in producing and distributing medical devices intended for the U.S. market must register annually with FDA and pay an annual registration fee.

What information is submitted for medical device establishment registration?

In addition to registering with FDA, most owners or operators of medical device establishments must also submit a list of all devices during their annual registration renewal.

U.S. Facilities
- Initial importers must identify the manufacturers of the devices they are importing.
- A device must be listed if they fall under the any of the following:
  - Contract Manufacturer
  - Contract Sterilizer
  - Manufacturer
  - Relabeler / Repackager
  - Remanufacturer
  - Reprocessor of Single Use Device
  - Specification Developer
  - U. S. manufacturer of export only devices

Non-U.S. Facilities
- Must list devices, provide a U.S. Agent, and identify importers.

Who must provide medical device listings?

In most cases, all medical device establishments required to register with FDA must also submit a complete list of medical devices manufactured for commercial distribution in the U.S. market.

All facilities that fall under any of the following functions:

Contract Manufacturer
Contract Sterilizer
Foreign Exporter
Manufacturer
Relabeler / Repackager
Remanufacturer
Reprocessor of Single Use Device
Specification Developer
U.S. manufacturer of export only devices

What information is submitted for a medical device listing?

Medical device establishments must list any medical device made in the establishment and the activities the device is meant for.

Company function (activity)
Device product code
Proprietary names
Importer information

What is a master file?

A Master File is a secure, confidential submission of proprietary product data to a regulatory agency, such as the U.S. Food and Drug Administration (FDA), Health Canada, or the National Medical Products Association (NMPA) in China.

For Medical Device Establishments, who must register?

What information is submitted for medical device establishment registration?

Who must provide medical device listings?

What information is submitted for a medical device listing?

What is a master file?

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