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EU: European Commission adopts extended lists of regulated allergenic fragrances in toys

DECEMBER 2020 - TOYS PRODUCTS

Earlier in March this year¹, in order to increase children’s protection from possible adverse health effects caused by potentially allergenic fragrances in toys, the European Commission (EC) proposed to update the list of allergenic fragrances that are prohibited and the list of allergenic fragrances that require labelling under the Toy Safety Directive 2009/48/EC. 

On 15 December 2020, the EC adopted the updated lists and published two Directives^{2, 3} amending Annex II to the Toy Safety Directive. The new rules will be effective from 5 July 2022 in all Member States.

The list of allergenic fragrances that require labelling on the toy, on an affixed label, on the packaging or in an accompanying leaflet if the added concentrations of any of those fragrances exceed 100 mg/kg is amended as follows

• Addition of two individual enantiomeric forms of citronellol (CAS# 1117-61-9; 7540-51-4) in entry 4;
• Removal of entry 10 – methyl heptine carbonate, as it will be prohibited under the new rule;
• Addition of 61 new fragrances, the total number of fragrances would be increased to 71.

The list of allergenic fragrances that are prohibited in toys unless such presence is technically unavoidable under good manufacturing practice and does not exceed 100 mg/kg is amended as follows:

• Addition of three new fragrances: 

1. Atranol (2,6-Dihydroxy-4-methyl-benzaldehyde) (CAS# 526-37-4);
2. Chloroatranol (3-Chloro-2,6-Dihydroxy-4-methyl-benzaldehyde (CAS# 57074-21-2);
3. Methyl heptine carbonate (CAS# 111-12-6) (currently requires labelling only);

• The total number of prohibited fragrances would be increased to 58.

EC decides to adopt measures to improve the protection of children from allergenic fragrances as it is aware of the trend of manufacturers adding fragrance chemicals to many types of consumer products, including children’s toys and cosmetic products. All these cumulative exposures by the dermal route may cause contact allergies in children and it is recognised as a common, significant and relevant problem in Europe.

A survey⁴ carried out by the Environmental Protection Agency in Denmark earlier shows the presence of allergenic fragrances in toys such as modelling clays, slimes, dolls, and rubber bands. On EC’s Rapid Alert System – Safety Gate, there are notifications regarding allergenic fragrances in various toys including colour pencils, felt-tip pens and plastic toys.

[1]  EU: European Commission proposed to update the list of regulated allergenic fragrances in toys, March 2020

[2]  Directive (EU) 2020/2088 amending Annex II to Directive 2009/48/EC as regards the labelling of allergenic fragrances in toys

[3]  Directive (EU) 2020/2089 amending Annex II to Directive 2009/48/EC as regards the prohibition of allergenic fragrances in toys

[4]  Survey of allergenic substances in products targeted children – toys and cosmetic products, published by the Danish Environmental Protection Agency