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The European Commission has drafted a new regulation to significantly restrict the presence of carcinogenic, mutagenic, or toxic for reproduction (CMR) substances in childcare products. The draft Regulation and its Annex are now open for public consultation until June 5, 2026.
The EU Commission has long recognized the need to enhance the protection of children from exposure to hazardous chemicals. Specifically, the regulation involves restricting the presence of CMR substances in everyday childcare articles.
In November 2022, the Commission requested support from the European Chemicals Agency (ECHA) to prepare a restriction proposal. ECHA's investigation report, published on August 23, 2023, confirmed the presence of CMR substances in childcare products, either as impurities or intentionally added for specific properties. The report highlighted that children could be exposed under normal and foreseeable use conditions, reinforcing the need for regulatory action.
Default Concentration Limits
Based on these findings, the Commission proposes to establish a default concentration limit of 10 mg/kg (0.001 % w/w) in homogeneous materials for CMR substances. The regulation establishes a dynamic link with Regulation (EC) No 1272/2008 on classification, labelling, and packaging of substances and mixtures. This means the restriction will automatically apply to any new or amended classifications of substances as CMR category 1A or 1B in the future.
Specific Concentration Limits (Appendix [YY])
To ensure effective enforcement and address specific risks, the draft regulation introduces a new Appendix [YY] detailing specific concentration limits for certain substances in homogeneous materials. The list includes formaldehyde, benzene, aromatic amines, BPA, and heavy metals (Mercury, Lead, Cadmium, Chromium VI, etc.).
Exemption
The restriction will not apply to:
Second-hand childcare products
Substances in inaccessible homogeneous materials
Childcare products that are also medical devices within the scope of Regulation (EU) 2017/745, or
Childcare products within the scope of food contact materials regulation (Regulation(EU) 1935/2004)
The draft proposes a 36-month transitional period for newly classified CMR substances, allowing industries to adapt to these new restriction limits.
The draft Regulation and its Annex can be accessed here.
