Commission Regulation (EU) 2026/78 materially tightens the EU Cosmetics Regulation by operationalising the automatic prohibition and restriction of substances classified as carcinogenic, mutagenic or toxic for reproduction (CMR). Effective 1 May 2026, the Regulation adds 15 substances to Annex II (Prohibited Substances), introduces new restrictions and exemptions for silver, places Hexyl Salicylate under strict use conditions, and expands the preservative framework by allowing Sodium o-Phenylphenate alongside o-Phenylphenol under defined limits.

For cosmetic companies exporting to Europe, the Regulation establishes a hard stop on placing non-compliant products on the EU market from 1 May 2026, with no grace period for reformulation or sell-through. Beyond Europe, the Regulation has predictive reach: EU-inspired regulatory systems across Africa increasingly align their prohibited and restricted substance lists with EU annex updates, making this Regulation a leading indicator of future African regulatory convergence.

Companies that proactively translate these changes into ingredient governance, portfolio rationalisation and supplier accountability will not only preserve EU market access but gain first-mover advantage in African markets that mirror EU cosmetic safety principles.

Key Regulatory Highlights for Cosmetics Companies Exporting to Europe and EU Following Markets

• Annex II (Prohibited Substances):
  15 newly classified CMR substances added, reinforcing the EU’s zero-tolerance posture for CMR exposure in cosmetics
• Silver – A Nuanced Ban with Narrow Permissions:
  Silver (massive) and silver (nano) are prohibited due to CMR Category 2 classification.
  Micron-sized silver (100 nm–1 mm) remains permitted only under tightly controlled conditions, including:
  Toothpaste and mouthwash: max 0.05%
  .Lip products and eye shadow: max 0.2%
  Any deviation results in automatic non-compliance.
• Hexyl Salicylate Added to Annex III (Restricted):
  Newly restricted with product-specific maximum concentrations, including:
  Hydroalcoholic fragrances: up to 2%
  Rinse-off products: up to 0.5%
  Leave-on products: up to 0.3%
  Oral products (toothpaste/mouthwash): 0.001%
  Use in products for children under 3 years is largely prohibited.

Preservatives – Annex V Expansion:
Sodium o-Phenylphenate is added alongside o-Phenylphenol, permitted at the same maximum authorised concentrations, with cumulative caps and inhalation/oral exposure prohibitions clearly articulated.

Strategic Spillover into Africa

Many African regulators reference EU annexes as technical benchmarks, even where not legally transposed. This Regulation therefore:

• Signals future bans and restrictions likely to surface in EU-aligned African markets because this is a safety driven update.
• Creates an opportunity for companies to standardise formulations globally, reducing market-by-market complexity.
• Positions early adopters as regulatory leaders, strengthening credibility with African authorities and distributors.

Compliance Timeline & Recommended Actions Your Company Should Have Been On

Q3 2024

• Conduct a CMR gap analysis across formulations and raw material inventories.
• Map Annex II and III changes against all EU-bound and Africa-bound SKUs.

Q4 2024 – Q2 2025

• Initiate reformulation or substitution strategies for affected products.
• Engage suppliers to obtain updated impurity profiles, particle size data and safety dossiers.

Q3 2025 – Q1 2026

• Finalise reformulations and update PIFs, Cosmetic Product Safety Reports (CPSRs) and labelling.
• Rationalise portfolios where reformulation is not commercially viable.

By 1 May 2026

• Cease placing non-compliant products on the EU market.
• Align African export portfolios to the EU-compliant baseline to future-proof market access because in many territories bans will come into effect simultaneously as in the EU.

Bottom Line

EU 2026/78 is not a routine annex update—it is a structural tightening of the EU’s CMR enforcement model with global regulatory ripple effects. Companies that treat this Regulation as a strategic inflection point, rather than a technical hurdle, will protect EU access, streamline African expansion and reinforce brand trust in an increasingly safety-led cosmetic economy.