CMR Substances in Cosmetics: What Changes with the European Correction and What Manufacturers and Importers Must Do

Key data

If your company manufactures, imports or distributes cosmetics in the European Union, this error correction requires you to review your formulations and technical documentation. The European Commission published on 23 July 2026 the correction of Regulation (EU) 2026/78, which in turn amends Regulation (EC) No 1223/2009, the framework regulation on cosmetic products in the EU.

What is relevant is that it is not a "simple" error correction: the changes introduced may alter which substances are prohibited, which are restricted, at what maximum concentrations they are permitted and under what conditions of use. If your product was formulated in accordance with the original text of Regulation (EU) 2026/78 published on 13 January 2026, you need to verify whether the correction affects you.

What does this regulation establish?

Regulation (EC) No 1223/2009 is the European regulation governing cosmetic products: permitted, prohibited and restricted ingredients, labeling, safety and manufacturer responsibility. Within this regulation, Annexes II, III and IV contain the lists of prohibited substances, restricted substances and authorized colorants, respectively.

Regulation (EU) 2026/78, published on 13 January 2026, updated those lists regarding substances classified as CMR (carcinogenic, mutagenic or toxic for reproduction). The error correction published on 23 July 2026 corrects errors detected in that text. According to available information, the corrected errors may affect:

• Lists of prohibited or restricted substances: a substance may have been incorrectly classified or with erroneous data in the original text.
• Maximum permitted concentrations: the numerical limit of a restricted substance may have been published with an error.
• Conditions of use: application restrictions (type of product, application area, warnings) may contain errors that this correction addresses.

The correction does not introduce new restrictions in itself, but modifies the legally binding text of Regulation (EU) 2026/78. The text that prevails is the corrected one, not the original.

Economic and operational impact

For companies in the cosmetics sector, an error correction of this type has direct operational consequences and potentially costly:

• Review of formulations: if a maximum concentration or condition of use has changed from the original text, already formulated or in-production products may need adjustments.
• Update of technical sheets and safety dossiers: the product information file (PIF) must reflect the current regulatory text, including corrections.
• Review of labeling: if warnings or conditions of use for any substance have been corrected, the labeling of the final product may need modification.
• Risk of market withdrawal: non-compliance with CMR restrictions may result in withdrawal of products from the European market and the imposition of administrative sanctions by the competent national authorities.
• Cost of inaction: marketing a product that does not comply with current CMR restrictions—even through lack of knowledge of the correction—does not exempt from legal responsibility.

Who does it affect?

• Cosmetic manufacturers based in the EU: directly responsible for compliance with Regulation (EC) No 1223/2009 and its amendments.
• Importers of cosmetics in the EU: assume the obligations of the manufacturer when the product comes from outside the EU.
• Distributors of cosmetic products: must ensure that the products they market comply with current regulations, including corrections.
• Product Safety Assessors: must review and update safety reports if any evaluated substance is affected by the correction.
• R&D and Regulatory Affairs departments of cosmetics companies: are the first to analyze the impact of the correction on the product portfolio.

Practical example

Imagine a Spanish company that manufactures a sunscreen with an ingredient classified as a restricted CMR substance. Regulation (EU) 2026/78, published in January 2026, set a maximum concentration for that substance. The company adjusted its formulation to that limit and updated its safety dossier.

Now, the error correction published on 23 July 2026 modifies some of the data of that restriction—for example, the maximum concentration or conditions of use. If the company does not review the corrected text and markets the product with the formulation or labeling based on the original erroneous text, it will be in breach of current regulations, even though it acted in good faith in January. Market surveillance authorities (in Spain, the AEMPS) may order the withdrawal of the product and apply administrative sanctions.

What should companies do now?

1. Consult the consolidated text of Regulation (EU) 2026/78 including the error correction published on 23 July 2026 in the EU Official Journal, to identify exactly what data has been corrected.
2. Identify the CMR substances affected by the correction and cross-reference them with the company's product portfolio to determine if any product is impacted.
3. Review and update the formulations of affected products if maximum concentrations or conditions of use have changed from the original text.
4. Update safety dossiers (PIF) and safety evaluation reports to reflect the corrected and current regulatory text.
5. Review the labeling of affected products and plan necessary changes if warnings or conditions of use have been modified by the correction.
6. Inform suppliers and distributors of changes that affect them, especially if there are products already in the distribution channel that may need to be withdrawn or updated.
7. Document all actions taken as evidence of due diligence in the event of an inspection by market surveillance authorities.

Official source

Consult full regulation at official source

Disclaimer: This article is for informational purposes only and does not constitute legal advice. For specific decisions, consult a qualified professional. Source: https://eur-lex.europa.eu/./legal-content/AUTO/?uri=OJ:L_202690617