Slovenia Notifies EU of Draft Restriction on CMR 1A/1B Substances in Childcare Articles

Slovenia Notifies EU of Draft Restriction on CMR 1A/1B Substances in Childcare Articles Slovenia has notified the European Commission of a draft regulation restricting CMR 1A/1B substances in childcare articles, setting a maximum concentration of 0.001% by weight (10 mg/kg) in any homogeneous material. The measure was submitted through the EU’s TRIS notification procedure (2026/0059/SI) and is currently subject to a standstill period until 6 May 2026. The proposed rule aims to reduce children’s exposure to carcinogenic, mutagenic and reproductive toxic substances in commonly used childcare products. The regulation would apply to childcare articles placed on the Slovenian market, including items such as cots, mattresses, carrycots, hygiene kits, feeding accessories and other everyday products used by children. Authorities argue that these products may contain hazardous substances in materials such as plastics, textiles, foams and coatings.

0.001% Limit on CMR Chemicals in Childcare Products

Under the draft regulation, childcare articles must not contain CMR category 1A or 1B substances above 0.001% by weight in any homogeneous material. These classifications refer to substances listed under the EU Classification, Labelling and Packaging (CLP) Regulation as carcinogenic, mutagenic or toxic for reproduction. The definition of childcare articles is broad. It covers products designed to facilitate the sleeping, feeding, hygiene, transport or protection of children up to the age of 14. Authorities note that materials commonly used in these products can contain hazardous chemicals such as lead, cadmium, phthalates, formaldehyde, bisphenol A and certain flame retardants. These substances may migrate from product materials and lead to inhalation, dermal or oral exposure.

Compliance Requirements for Manufacturers and Importers

The draft regulation places compliance obligations on manufacturers and importers supplying childcare products to the Slovenian market. Companies would need to implement internal production control procedures or appoint authorised third parties to verify compliance. In addition, suppliers must maintain technical documentation demonstrating conformity, including analyses of homogeneous materials. Enforcement would be carried out by the Health Inspectorate of the Republic of Slovenia, which may request documentation or commission testing where necessary. Non-compliance could result in fines ranging from €3,000 to €40,000 for legal entities, depending on the nature of the infringement.

Scope and Exemptions

Several product categories are excluded from the restriction. The regulation does not apply to used childcare articles, toys, food contact materials, batteries or medical devices, as these products are already covered by other regulatory frameworks. Components that are completely inaccessible to children are also exempt. The measure is designed as a temporary safeguard, and Slovenian authorities must review its justification, implementation and effects within one year of entry into force to determine whether the restrictions should be repealed, extended or amended.