The EU has informed the WTO of its intention to revise the two lists of allergenic fragrances in the toy safety directive. The amendments are proposed to enter into force in Q2 of 2022.
In the European Union (EU), toys are regulated under Directive 2009/48/EC (the Toy Safety Directive, TSD, version consolidated to November 2019). Point 11 under Part III of Annex II to this piece of legislation regulates 66 allergenic fragrances in toys:
- 55 allergenic fragrances are prohibited, but their presence is allowed subject to being technically unavoidable under good manufacturing practice (GMP) and each fragrance is no more than 100 mg/kg (the ‘Prohibited List). It is important to note that manufacturers should not intentionally use these prohibited allergenic fragrances.
- 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)
In March 2020, the World Trade Organization (WTO) circulated two notifications from the European Union (EU) announcing its intention to revise the two lists of allergenic fragrances falling under Point 11 of Part III to Annex II to the TSD. These two notifications are:
- G/TBT/N/EU/705 of March 17, 2020 under WTO document number 20-2079.
- G/TBT/N/EU/706 of March 17, 2020 under WTO document number 20-2088.
The notification in point 1 above deletes methyl heptine carbonate (entry 10) from the Labeling List and adds the following three fragrances to the Prohibited List:
- Atranol (CAS 526-37-4)
- Chloroatronol (CAS 57074-21-2)
- Methyl heptine carbonate (CAS 111-12-6)
This expands the list of prohibited allergenic fragrances from 55 to 58.
The notification in point 2 above revises the list of 11 allergenic fragrances on the Labeling List by adding two enantiomers to citronella under number 4 (CAS 1117-61-9 and 7540-51-4) and incorporating 61 new entries into the list – some of which contain more than one CAS number. With the deletion of methyl heptine carbonate (CAS 111-12-6) in entry 10 from the notification in point 1 above, the overall number of entries in this list is 71.
According to the two WTO notifications, these revisions are proposed to be adopted in Q4 of 2020 and enter into force in Q2 of 2022.
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