EC Proposes Limits on CMR Substances in Childcare

On May 8, 2026, the European Commission published an initiative focused on reducing children’s exposure to substances classified as carcinogenic, mutagenic or toxic for reproduction. These substances may be present in childcare articles used in daily care activities such as sleep, hygiene, feeding and soothing. The proposal introduces amendments to Annex XVII of REACH Regulation (EC) No 1907/2006. It targets Category 1A and 1B CMR substances listed in Annex VI of Regulation (EC) No 1272/2008. By defining restrictions and limits for these substances in childcare products, the initiative advances product safety expectations across the European Union. The draft act remains open for consultation until June 5, 2026, offering stakeholders an opportunity to provide input before finalization.

The European Commission proposal sets concentration limits for specific CMR substances in childcare articles at the homogeneous material level. The proposal applies to products intended for sleep, relaxation, hygiene, feeding or sucking.

Key limits include:

• 30 mg/kg formaldehyde
• 30 mg/kg for each of 26 aromatic amines
• 5 mg/kg benzene
• 1 mg/kg for BPA and BPS
• 1 mg/kg for specified chlorinated aromatic hydrocarbons
• Heavy metals such as arsenic, cadmium, lead, cobalt and mercury with defined limits and extractable thresholds
• 0.05 mg/kg for selected N-nitrosamines
• 50 mg/kg for specific organic dyes
• Limits for organotin compounds such as DOT and DBT
• 0.5 mg/kg for listed PAHs and pesticide sums
• 50 mg/kg individual and 100 mg/kg total for specified phthalates
• 30 mg/kg quinoline

For CMR Category 1A and 1B substances not listed, a general limit of 10 mg/kg applies.

The restriction does not apply to second-hand products, inaccessible materials, medical devices under Regulation (EU) 2017/745, or materials governed by food contact Regulation (EC) No 1935/2004. The proposal applies without limiting stricter requirements set in other EU legislation.

How to achieve conformity

Manufacturers and suppliers should assess childcare articles against the proposed concentration limits for CMR substances. A structured testing program can identify substances that exceed thresholds at the homogeneous material level. Early evaluation supports informed decisions on material selection, formulation and product design before restrictions take effect. Monitoring regulatory developments and consultation outcomes also supports timely alignment with final requirements.

How to navigate compliance with UL Solutions

UL Solutions applies deep technical knowledge in chemical compliance and product safety to support organizations managing evolving substance restrictions. Our services help identify potential risks, assess materials and validate compliance against proposed limits. With targeted testing and advisory support, companies can reduce exposure to non-compliance and strengthen confidence in market readiness for childcare products.

Source 

European Commission. Childcare articles – restriction on substances classified as carcinogenic, mutagenic or toxic for reproduction (CMR).