July 17, 2025

The EU is updating rules to keep cosmetics safe. Regulation (EU) 2024/197 (Omnibus Regulation VII) adds 31 new CMR substances—chemicals that can cause cancer, genetic changes, or reproductive harm—to the list of banned ingredients.

From September 1, 2025, cosmetics with these substances cannot be sold in the EU unless very strict exceptions apply.

 

What Are CMR Substances?

CMR substances are harmful chemicals:

  • C = Carcinogenic: Can cause cancer
  • M = Mutagenic: Can change genes
  • R = Reprotoxic: Can affect reproduction or fertility

They are classified like this:

  • 1A: Proven CMR in humans
  • 1B: Presumed CMR from animal studies
  • 2: Suspected CMR (some evidence)

 

About Regulation (EU) 2024/197

  • Adds 31 banned chemicals to Annex II of Cosmetics Regulation (EC 1223/2009).
  • Manufacturers and importers must reformulate products and update safety documents.
  • Applies from September 1, 2025.

 

Some Important Banned Substances

Substance

CMR Type

Used In

Titanium dioxide (<10 µm)

Carc. 2

Pigments, sunscreens

Formaldehyde

Carc. 1B

Nail hardeners, preservatives

Dibutyl phthalate (DBP)

Repr. 1B

Plasticizer in nail products

Boric acid

Repr. 1B

Buffering agent

2-Butoxyethanol

Repr. 2

Solvent in perfumes, skincare

Note: Some restrictions depend on form, size, concentration, or use.

 

Why Are These Chemicals Banned?

  • Skin contact can be risky.
  • Long-term use can harm health.
  • Safer alternatives exist.

 

What Cosmetic Companies Need to Do

  1. Check Ingredients
    1. Look at all products to find banned substances.
  2. Reformulate Products
    1. Replace dangerous chemicals with safe alternatives.
  3. Update Labels & Safety Info
    1. Fix product labels, safety sheets (SDS), and marketing claims.
  4. Update Regulatory Files
    1. Make sure PIF and CPSR show safe formulas.
  5. Work With Suppliers & Distributors
    1. Get confirmation that raw materials are CMR-free and shared with distributors.

 

Are There Exceptions?

Yes, but only if:

  • No safe alternative exists.
  • Meets food safety rules.
  • SCCS confirms it is safe for cosmetics.

Currently, no exceptions apply for the 31 new substances. Companies must fully comply.

 

Conclusion

Regulation 2024/197 shows the EU cares about safety, prevention, and sustainability. Cosmetic companies need to:

  • Reformulate products
  • Update labels and safety files
  • Ensure full compliance before September 1, 2025