Glossary · Regulatory

CMR substances

What it means

Substances classified as carcinogenic, mutagenic or toxic for reproduction. Under Article 15 of the EU Cosmetics Regulation they are prohibited in cosmetics unless a specific exemption applies, and newly classified CMRs are added to Annex II through regular omnibus acts.

Sources: 12

Why it matters

Missing or out-of-date regulatory work is one of the most common reasons a product is held at the border or withdrawn after launch.

How Guires CSL applies it

Guires CSL formulation, testing, clinical and regulatory teams work with CMR substances on client projects every week, from the first brief to the final product file.

EU CPSR guide

References

  1. Regulation Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products. OJ L 342, 22.12.2009, p. 59 (consolidated version 1 May 2026). eur-lex.europa.eu
  2. Regulation Commission Regulation (EU) 2025/877 of 12 May 2025 amending Regulation (EC) No 1223/2009 as regards the use in cosmetic products of certain substances classified as carcinogenic, mutagenic or toxic for reproduction (Omnibus VII). eur-lex.europa.eu

Regulations and standards are listed first, then peer-reviewed literature. Sources checked October 2026.

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