Reference source : European Commission
EU Toy Safety Directive Bisphenol A (BPA) Lilial Fragrance Allergens Reproductive Toxicity CLP Regulation
The European Commission has proposed amendments to the EU Toy Safety Directive (2009/48/EC), which would significantly reduce the permitted migration limit for bisphenol A (BPA) in certain toys and prohibit the allergenic fragrance ingredient Lilial. The amendments would also update the provisions concerning testing methods for several chemicals.
The draft Commission Directive was notified to the World Trade Organization (WTO) on 11 August 2026. Comments can be submitted until 10 October 2026, with adoption currently planned for the fourth quarter of 2026.
BPA Migration Limit to Be Significantly Reduced
The Commission is proposing to reduce the migration limit for bisphenol A (BPA, CAS 80-05-7) from the current 0.04 mg/L to 0.005 mg/L in toys intended for children under 36 months and in other toys that are designed to be placed in the mouth. This represents an 87.5% reduction in the permitted migration level.
The proposal follows the European Food Safety Authority's (EFSA) updated assessment of BPA in 2023. EFSA established a tolerable daily intake (TDI) of 0.2 nanograms per kilogram of body weight per day - 20,000 times lower than the temporary TDI established in 2015. Based on this assessment, the Commission considers the existing BPA migration limit for toys to be too high.
The proposed limit of 0.005 mg/L corresponds to the limit of quantification established under the new European standard EN 71-19:2025 for the migration of BPA from toy materials.
Lilial to Be Prohibited in Toys
The draft would also prohibit the allergenic fragrance Lilial (2-(4-tert-butylbenzyl) propionaldehyde, CAS 80-54-6) in toys. Lilial is currently included among allergenic fragrances that may be used in toys provided that certain labelling requirements are met. However, since 1 March 2022, the substance has been classified as toxic for reproduction Category 1B under the EU Classification, Labelling and Packaging (CLP) Regulation. The Commission therefore proposes moving Lilial from the list of allergenic fragrances subject to labelling requirements to the list of prohibited allergenic fragrances under Annex II to the Toy Safety Directive.
Testing Provisions for BPA, Phenol and BIT to Be Updated
The proposal would also remove references to EN 71-10 and EN 71-11 as mandatory testing methods for BPA, phenol and 1,2-benzisothiazol-3(2H)-one (BIT).
The Commission explains that three more specific standards were adopted by the European Committee for Standardisation (CEN) in 2025:
According to the draft, EN 71-10 and EN 71-11 no longer represent the state of the art for testing these substances. The newer standards may subsequently be assessed and, where appropriate, referenced in the Official Journal to provide a presumption of conformity.
The existing limits for BIT (CAS 2634-33-5) and phenol (CAS 108-95-2) would not be reduced under the proposal.
Timeline and Next Steps
According to the WTO notification, the Commission intends to adopt the Directive in Q4 of 2026. Once adopted, the Directive will enter into force on the 20th day following publication in the Official Journal of the European Union. Member States would then have 12 months from publication to adopt and apply the necessary national provisions.
Companies manufacturing or placing toys on the EU market should monitor the proposal, particularly if their products are intended for young children or are designed to be placed in the mouth may contain BPA, or allergenic fragrances Lilial.