EU Plans to Regulate CMR Substances in Childcare Products under REACH

SG 065/26

European Union (EU) plans to restrict carcinogenic, mutagenic or toxic for reproduction (CMR) category 1A and 1B substances in childcare products.

In April 2026, the European Commission’s Comitology Register announced that a draft regulation concerning the restriction of CMR 1A and 1B substances in childcare products had been transmitted to the REACH Committee for further consideration. This draft law would add a new entry to Annex XVII of Regulation (EC) No. 1907/2006 ‘Registration, Evaluation, Authorization and Restriction of Chemicals (Annex XVII of REACH)

What does this draft regulation require?

Key provisions in the draft law include:

• Providing a legal definition for ‘childcare products’ and their scope of restrictions, including several derogations (see Table 1 below)
• Setting restriction limits for CMR 1A and 1B substances falling under Regulation (EC) No 1272/2008 ‘Classification, Labeling and Packaging of Substances and Mixtures (CLP Regulation, current consolidated version to September 2025) in the homogeneous materials of childcare products (see Table 1 below)
• Establishing specific concentration limits for a list of restricted substances in the homogeneous materials of childcare products listed under Appendix [YY]:
  • 30 mg/kg formaldehyde
  • 30 mg/kg for each of 26 listed aromatic amines
  • 5 mg/kg benzene
  • 1 mg/kg for each of bisphenol A (BPA) and bisphenol S (BPS)
  • 1 mg/kg for each of three specified chlorinated aromatic hydrocarbons
  • 10 mg/kg arsenic (As) compounds (as As metal) or 0.2 mg/kg extractable As
  • 10 mg/kg cadmium (Cd) and its compounds (as Cd metal) or 0.1 mg/kg extractable Cd
  • 3 mg/kg chromium (VI) compounds (as Cr VI metal) for total dry weight of leather and 1 mg/kg extractable Cr VI for other materials
  • 10 mg/kg cobalt (Co) and its compounds (as Co metal) or 1 mg/kg extractable Co
  • 10 mg/kg lead (Pb) and its compounds (as Pb metal) or 0.2 mg/kg extractable Pb
  • 0.5 mg/kg mercury (Hg) (as Hg metal) or 0.02 mg/kg extractable Hg
  • 0.05 mg/kg each of three specified N-nitrosamines
  • 50 mg/kg for each of eight specified organic dyes
  • 1 mg/kg dioctyltin (DOT) compounds (as DOT)
  • 1 mg/kg dibutyltin (DBT) compounds (as DBT)
  • 0.5 mg/kg for each of 11 listed polyaromatic hydrocarbons (PAHs)
  • 0.5 mg/kg for the sum of five listed pesticides
  • 50 mg/kg for each of 15 listed phthalates and 100 mg/kg for the sum of those 15 phthalates
  • 30 mg/kg quinoline

Highlights of the draft law are summarized in Table 1

Table 1

Who is impacted?

The draft law would affect stakeholders across the juvenile products supply chain, including manufacturers, importers, retailers and other intermediaries operating in the EU market.

When will it apply?

The regulation will enter into force (EIF) 20 days following its publication in the Official Journal of the EU (OJEU) and will apply 36 months later.

Additionally, it is important to note that Slovenia is separately planning to regulate CMR 1A and 1B substances in childcare articles (SafeGuardS 26/26).

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