On 9 April 2026, a draft Commission Regulation amending Annex XVII to Regulation (EC) No 1907/2006 (REACH) was sent to the REACH Committee for discussion, introducing a proposed restriction on substances classified as carcinogenic, mutagenic or toxic for reproduction (CMR) category 1A or 1B in childcare products. The draft is scheduled for discussion by the REACH Committee on 29 April 2026.
New Restriction for Childcare Products
The draft Regulation proposes to restrict the presence of CMR 1A and 1B substances in childcare products, which are broadly defined to include items intended for children’s sleep, hygiene, feeding, transportation, and general care.
This restriction is based on Article 68(2) of REACH and reflects the fact that children are particularly vulnerable to hazardous chemicals due to behavioural patterns such as hand-to-mouth contact and prolonged exposure.
Concentration Limits and Scope
The draft introduces a general concentration limit of 10 mg/kg (0.001% w/w) for CMR 1A/1B substances in homogeneous materials.
It also establishes a dynamic link to the CLP Regulation, meaning that newly classified CMR substances would automatically fall within the scope of the regulation, with a 36-month transition period before the restriction applies.
Detailed Limits Set Out in Annex
The annex to the draft regulation introduces a new entry in Annex XVII, together with an appendix listing substances and substance groups subject to specific concentration limits, in several cases stricter than the default threshold.
Selected examples include:
|
Substance / Group
|
CAS No.
|
Proposed limit
|
|
Formaldehyde
|
50-00-0
|
30 mg/kg
|
|
Benzene
|
71-43-2
|
5 mg/kg
|
|
Bisphenol A (BPA)
|
80-05-7
|
1 mg/kg
|
|
Bisphenol S (BPS)
|
80-09-1
|
1 mg/kg
|
|
N-nitrosodimethylamine
|
62-75-9
|
0.5 mg/kg
|
|
Benzo[a]pyrene (PAH)
|
50-32-8
|
0.5 mg/kg
|
|
Dibutyltin (DBT) compounds
|
—
|
1 mg/kg
|
|
Dioctyltin (DOT) compounds
|
—
|
1 mg/kg
|
The appendix also covers a broad range of other substances and groups, including aromatic amines, organic dyes, pesticides, phthalates, polycyclic aromatic hydrocarbons (PAHs), and metals such as arsenic, cadmium, lead, and mercury.
Exemptions
The restriction would not apply to:
- second-hand childcare products
- medical devices within the scope of Regulation (EU) 2017/745
- food contact materials covered by Regulation (EC) No 1935/2004
- materials that remain inaccessible to children under normal conditions of use
Background and Next Steps
The proposal builds on preparatory work by the European Chemicals Agency, including its 2023 investigation into the presence of CMR substances in childcare products and subsequent calls for evidence.
Following discussion by the REACH Committee, the measure may proceed towards formal adoption and publication in the Official Journal of the European Union. As proposed, the restriction would apply 36 months after entry into force, providing time for industry to comply.
