Cosmetics and CMR substances 2026: what changes with the EU Regulation correction

Key data

Cosmetic manufacturers operating in the EU have an immediate obligation: to review their formulations against the changes introduced by the correction of Regulation (EU) 2026/78, which amends Regulation (EC) No. 1223/2009 on CMR substances. The correction was published on 19 May 2026, but its entry into force is set retroactively on 13 January 2026, meaning the amendments are enforceable from that date.

The focus is on the technical annexes of Regulation (EC) 1223/2009, which list prohibited or restricted substances in cosmetics. Any change in those annexes—even if it is a correction of errors—can alter the permitted concentration limits or conditions of use of ingredients already on the market.

What does this regulation establish?

Regulation (EU) 2026/78 amends Regulation (EC) No. 1223/2009, which is the framework regulation for cosmetic products in the European Union. The amendment focuses specifically on substances classified as CMR: carcinogenic, mutagenic or reproductive toxic.

This correction of errors—identified as CELEX:32026R0078R(02)—introduces adjustments to the original text of Regulation (EU) 2026/78 published on 13 January 2026. The corrections may affect:

• The concentration limits permitted for certain CMR substances in cosmetic formulations.
• The conditions of use under which certain substances may continue to be used.
• The lists of prohibited or restricted substances contained in the technical annexes of Regulation (EC) 1223/2009.
• The labelling requirements resulting from changes in the classification or restriction of ingredients.

The regulation being amended—Regulation (EC) 1223/2009—is the central legal reference for all cosmetic products marketed in the EU. Any alteration to its annexes has direct effect on products already on the market.

Economic and operational impact

The impact of this correction is not merely documentary. It affects concrete business processes that have real costs:

The operational cost will depend on the number of affected references and whether the corrections introduce substantial changes in limits or conditions of use. Companies with a larger number of SKUs containing CMR ingredients are the most exposed.

Who does it affect?

The regulation applies to all companies involved in the cosmetics value chain in the EU:

• Cosmetic product manufacturers with formulations containing CMR substances listed in the annexes of Regulation (EC) 1223/2009.
• Importers who introduce cosmetic products into the European market from third countries.
• Distributors who market cosmetic products in the EU, including wholesalers and retailers.
• Product responsible persons (responsible person as defined in Regulation 1223/2009) who guarantee product compliance.
• Laboratories and formulators who develop new formulations or adapt existing ones for sector clients.

Practical example

A manufacturer of moisturising creams using a preservative classified as a CMR substance in its formulations receives notification of this regulatory correction. Its action process should be as follows:

1. Identifies in the Product Information File (PIF) which ingredients in its formulation are classified as CMR.
2. Consults the updated annexes of Regulation (EC) 1223/2009 to verify whether the correction has modified the concentration limit or conditions of use of that preservative.
3. If the correction introduces a more restrictive limit than currently used, it must adjust the formulation or replace the ingredient before continuing to market the product.
4. Updates the PIF, reviews the labelling and, if there is stock on the market with the previous formulation that no longer complies, initiates the withdrawal process.

This process may involve reformulation costs, new safety analyses and updating marketing materials, in addition to the time required to adapt the production chain.

What should companies do now?

1. Access the full text of the correction published in the Official Journal of the EU (CELEX:32026R0078R(02)) and compare it with the original Regulation (EU) 2026/78 to identify exactly what has changed in the technical annexes.
2. Audit the product catalogue to identify which references contain CMR substances that may be affected by changes in limits or conditions of use.
3. Verify compliance of each formulation against the new limits or conditions established in the updated annexes of Regulation (EC) 1223/2009.
4. Update the Product Information File (PIF) for each affected reference to reflect compliance with the corrected regulation.
5. Review the labelling of affected products to ensure it correctly reflects the ingredients and complies with updated requirements.
6. Communicate changes to suppliers and distributors to ensure that the entire supply chain operates with compliant ingredients and products.
7. Evaluate stock on the market: if there are marketed products that no longer comply with the corrected restrictions, initiate the withdrawal process to avoid administrative sanctions.