EU Strengthens Requirements on Allergenic Fragrances in Toy Safety Directive

In the European Union (EU), toys are regulated under Directive 2009/48/EC (Toy Safety Directive, TSD, consolidated version to November 2019). Point 11 under Part III of Annex II to this piece of legislation regulates 66 allergenic fragrances in toys:

l  55 allergenic fragrances are prohibited, but their presence is allowed if these are technically unavoidable under good manufacturing practice (GMP) and each fragrance is no more than 100 mg/kg (the ‘Prohibited List’). Manufacturers should not use these prohibited allergenic fragrances intentionally

l  11 allergenic fragrances require their names to be listed on the toy, on an affixed label, on the packaging or in an accompanying leaflet if their concentrations are greater than 100 mg/kg (the ‘Labeling List’)

On December 15, 2020 the European Union (EU) published Directives (EU) 2020/2088 and (EU) 2020/2089 to revise the two lists of allergenic fragrances in the TSD.

Directive (EU) 2020/2089 deletes methyl heptine carbonate (CAS 111-12-6, entry 10) from the ‘Labeling List’ and adds the following three allergenic fragrances to the ‘Prohibited List’:

l  Atranol (CAS 526-37-4)

l  Chloroatranol (CAS 57074-21-2)

l  Methyl heptane carbonate (CAS 111-12-6)

The number of allergenic fragrances in the ‘Prohibited List’ has now been expanded from 55 to 58.

Directive (EU) 2020/2088 revises the list of 11 allergenic fragrances on the ‘Labeling List’ by incorporating two additional enantiomers (CAS 1117-61-9 and 7540-51-4) to citronellol under entry 4 and adding 61 new entries into the list – some of which contain more than one CAS number. With the deletion of methyl heptane carbonate in entry 10 in Directive (EU) 2020/2089, the overall number of entries in this list is 71.

According to both Directives, Member States are required to transpose these provisions into their national laws by July 4, 2022.

The provisions in both Directives will become effective on July 5, 2022.