MERCOSUR Updates Regulation to Ban Two CMR Substances in Cosmetics and Personal Care Products

Resumen de la actualización

The new resolution incorporates conclusions from the European Chemicals Agency’s Risk Assessment Committee, which classified diphenyl(2,4,6-trimethylbenzoyl) phosphine oxide (CAS 75980-60-8) y N,N-dimethyl-p-toluidine (CAS 99-97-8) as category 1B carcinogenic, mutagenic, or toxic to reproduction (CMR) substances. These substances are now formally banned in MERCOSUR for use in the covered product categories.

A sixty-day transition period will apply after each State Party incorporates the resolution into national law. All member states must complete incorporation by May 3, 2026. 

What Has Changed

The amendment to Resolution GMC 62/2014 explicitly prohibits the use of the two CMR-classified substances in cosmetics, perfumes, and personal hygiene products. Products that are already regulated or registered must follow the same requirement and be updated within the sixty-day adaptation period once the resolution is integrated into each national regulatory framework.

The measure applies to companies responsible for product formulation, compliance documentation, and registration activities within MERCOSUR jurisdictions.

Fecha límite para comentarios

There is no public consultation period associated with this update.

Por qué es importante

This regulatory update provides greater clarity and alignment with international chemical safety assessments, ensuring consistent classification of high-risk CMR substances across MERCOSUR. It strengthens consumer protection, improves regulatory harmonization, and supports efficient compliance transitions through clearly defined adaptation timelines while maintaining a manageable burden on industry.

Who Should Review This Update

This resolution is relevant for regulatory affairs teams, quality and compliance units, product safety specialists, R&D formulation teams, y regional market access functions operating within MERCOSUR member states.

Próximos pasos para las partes interesadas

Stakeholders should review all current formulations to identify the presence of banned substances and prepare reformulation, or substitution plans where necessary. It is essential to track each country’s incorporation timeline to ensure compliance within the sixty-day adaptation period following national adoption. Organizations should also update regulatory filings and technical documentation accordingly.

As companies evaluate product impacts across multiple jurisdictions, the ability to monitor regulatory changes and anticipate implementation timelines becomes critical. This is where an automated regulatory intelligence system can support ongoing compliance.

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Preguntas frecuentes

What substances are banned under MERCOSUR Resolution GMC 27/2025?

The resolution bans diphenyl(2,4,6-trimethylbenzoyl) phosphine oxide y N,N-dimethyl-p-toluidine, both classified as category 1B CMR substances, in personal hygiene products, cosmetics, and perfumes.

What is the adaptation period for compliance?

Manufacturers have a sixty-day adaptation period after each MERCOSUR State Party incorporates the resolution into national law.

What is the deadline for MERCOSUR member states to incorporate this resolution?

All State Parties must incorporate Resolution GMC 27/2025 into their national legal frameworks by May 3, 2026.

How can companies use RegASK to monitor MERCOSUR regulatory changes?

RegASK provides timely regulatory intelligence, tracking updates like Resolution GMC 27/2025 across all MERCOSUR jurisdictions and helping teams identify compliance gaps, manage transition deadlines, and streamline documentation workflows through automated insights and expert validation.