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EU: European Commission proposes to update the list of regulated allergenic fragrances in toys   

MARCH 2020 – RELEVANT FOR:TOY AND CHILDREN'S PRODUCTS

On 17 March 2020, the European Commission (EC) notified the World Trade Organization (WTO) of two draft Directives1, 2 amending Annex II to the Toy Safety Directive 2009/48/EC in order to strengthen the allergenic fragrances requirement in toys. The two lists which include, respectively, the allergenic fragrances that are prohibited and require labelling, will be expanded if the Directives are adopted. The consultation period has been started and will end on 16 May 2020.

At present, 55 allergenic fragrances are banned under the Toy Safety Directive; all toys must not contain prohibited fragrances unless their presence is technically unavoidable under good manufacturing practice and the concentration does not exceed 100 mg/kg. In addition, another 11 allergenic fragrances are only allowed to be used if necessary labelling requirement is fulfilled.

The EC is now proposing to add the following three chemicals into the list of prohibited allergenic fragrances. All of them had been evaluated as not safe to be used in cosmetic products. The list would then be expanded to contain 58 entries.

Name

CAS number 

Atranol (2,6-Dihydroxy-4-methyl-benzaldehyde)

526-37-4 

Chloroatranol (3-Chloro-2,6-Dihydroxy-4-methyl-benzaldehyde)

57074-21-2

Methyl heptine carbonate*

111-12-6


*Currently on the list of allergenic fragrances requiring labelling.

As for the list of allergenic fragrances need to be labelled, the proposed amendments include: 
  • 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;
  • Addition of 61 new fragrances, the total number of fragrances would be increased to 71.

In 2012, the Scientific Committee on Consumer Safety (SCCS) published an Opinion on fragrance allergens in cosmetic products3, which indicates that adding fragrance chemicals to consumer products such as toys has become a trend and it contributes significantly to the fragrance exposure of the consumer. Based on the Committee’s opinion and the study carried out in Denmark4, the Commission decided to further restrict the use of allergenic fragrances in toys. Considering that the fragrances that pose a risk when used in cosmetics could also present a risk in toys, the Commission stressed the importance of taking account of the study on fragrances in cosmetics when evaluating the relevant toy requirements. 

 

[1] Draft Directive and its annex amending Annex II to Directive 2009/48/EC as regards the prohibition of allergenic fragrances in toys (Link 1)

[1] Draft Directive and its annex amending Annex II to Directive 2009/48/EC as regards the prohibition of allergenic fragrances in toys (Link 2)

[2] Draft Directive and its annex amending Annex II to Directive 2009/48/EC as regards the labelling of allergenic fragrances in toys (Link 1)

[2] Draft Directive and its annex amending Annex II to Directive 2009/48/EC as regards the labelling of allergenic fragrances in toys (Link 2)

[3] Opinion of the SCCS on fragrance allergens in cosmetic products 

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

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