EU - Draft Delegated Directive; Toy Directive 2009/48/EG

Change regarding allergenic fragrances: Lilial 

The draft proposes removing Lilial from the list of fragrances subject to labelling requirements and adding it to the list of prohibited allergenic fragrances. The background to this is the classification of Lilial as toxic to reproduction, Category 1B, under the CLP Regulation. The draft identifies the substance as 2-(4-tert-butylbenzyl) propionaldehyde with CAS number 80-54-6. 

For manufacturers, importers and distributors, this means that labelling alone would no longer be sufficient in future. Instead, checks should be carried out to determine whether Lilial may be present in fragrance mixtures, materials or purchased components. Product groups containing intentionally added fragrances or aroma-like components are particularly affected. 

The draft proposes lowering the migration limit for bisphenol A from 0.04 mg/l to 0.005 mg/l. The new limit corresponds to the lowest value achievable using existing test methods, as specified in the draft of EN 71-19:2025. 

This reduction may be relevant for toy materials in which BPA plays a role as a starting material, residual monomer, impurity or migratable component. Existing conformity assessments should be reviewed to ensure they adequately cover the lower limit. 

Removal of references to EN 71-10 and EN 71-11 

Another key point is the planned removal of the obligation to test for BPA, BIT and phenol in accordance with EN 71-10:2005 and EN 71-11:2005. The draft notes that these standards no longer represent the state of the art for the substances in question. 

The new relevant test methods cited are EN 71-17:2025 for certain isothiazolinones, including BIT, EN 71-18:2025 for phenol, and EN 71-19:2025 for the migration of bisphenol A. Presumption of conformity with harmonized standards only arises once their references have been published in the Official Journal of the European Union.