The European Union has adopted Commission Regulation (EU) 2026/78, introducing changes to how certain carcinogenic, mutagenic, or toxic for reproduction (CMR) substances are treated under the EU Cosmetics Regulation (EC) No 1223/2009. The update reflects newly harmonised CMR classifications under the EU Classification, Labelling and Packaging (CLP) Regulation and results in new prohibitions and revised usage conditions for specific cosmetic ingredients.
Although the regulation applies directly to cosmetic products, its impact extends beyond the cosmetics sector. Chemical compliance teams, importers, distributors, and downstream users are affected through stricter expectations around substance classification, ingredient transparency, and the accuracy of Safety Data Sheets (SDSs) used across supply chains.
The amendment enters into force on 2 February 2026 and will apply from 1 May 2026, after which only cosmetic products meeting the updated requirements may be placed on the EU market.
What has Changed Under Regulation (EU) 2026/78
Under EU law, substances classified as carcinogenic, mutagenic, or toxic for reproduction (CMR) under the CLP Regulation (EC) No 1272/2008 are subject to strict controls in cosmetic products. Regulation (EU) 2026/78 reflects newly harmonised CMR classifications and results in the following changes to the Cosmetics Regulation:
- Certain substances are now fully prohibited for use in cosmetic products (listed in Annex II)
- Some substances remain permitted only under specific conditions, with revised concentration limits, use restrictions, or labeling requirements (listed in Annex III)
- Cosmetic ingredient requirements now reflect the latest scientific opinions and regulatory risk assessments at EU level
From 1 May 2026, cosmetic products that do not meet these updated requirements may no longer be placed on the EU market.
Why This Matters for Compliance Teams
Even though cosmetic products are consumer-facing, their ingredients, intermediates, and raw materials remain subject to workplace safety, transport, and chemical regulations. Changes to CMR classifications under Regulation (EU) 2026/78 directly affect SDS accuracy and compliance obligations.
When a substance is newly classified or reclassified as CMR, companies must reassess its hazard profile under the CLP Regulation and update all relevant SDSs. Organizations relying on outdated SDSs may be out of compliance immediately once the regulation takes effect, even if the affected cosmetic products are no longer sold.
Beyond Cosmetics: A Broader Chemical Safety Impact
Although the regulation targets cosmetic products, the affected CMR substances are often used in other chemical applications including industrial manufacturing, laboratories, R&D, cleaning products, distribution, and storage operations.
For these stakeholders, updated CMR classifications influence:
- Workplace risk assessments and control measures
- Employee training requirements
- Chemical inventory management and substitution decisions
Companies outside the cosmetics sector may therefore need to review SDS libraries and internal processes if they handle substances impacted by the new classifications.
Final Takeaway
Regulation (EU) 2026/78 is more than a cosmetic update. It highlights that CMR classifications have far-reaching implications for chemical safety, workplace protection, and regulatory compliance.
As the 1 May 2026 deadline approaches, organizations should proactively identify affected substances, update SDSs, and review compliance processes. Not just for this change, but to stay prepared for future regulatory updates.
Christina Joyeeta Munshi
Christina is an Operations Specialist at SDS Manager. Her expertise lies in combining her operational knowledge with strong communication skills to translate complex concepts into practical, easy-to-follow content that supports customers and enhances their experience.