EC expands list of allergenic substances in Toy Directive

In recent years, it has become a trend to add chemical fragrances to toys, as in model clay or slime, as well as dolls or plush. As a result, there is a significant contribution to exposure to these substances, which can be absorbed through the skin and potentially cause allergic reactions.

In response, two directives were adopted in December 2020 - 2020/2089 and 2020/2088 - to amend the lists in point 11, Part III of Annex II of the Toys Directive (2009/48/EC). This will ban the most dangerous fragrances in toys. The fragrances that are still allowed must be explicitly mentioned on the label so that consumers are informed and can make their own choice.

These are the following two lists:

1. Prohibited list - contains 55 allergenic fragrances. These may not be used in toys unless their presence is technically unavoidable according to Good Manufacturing Practice (GMP) and does not exceed the limit of 100 mg/kg. This limit applies to each fragrance substance.
2. Labeling list - contains 11 allergenic fragrances. These allergenic fragrances must be listed on the toy, on an attached label, on the packaging or in an enclosure if they are added to the toy at a concentration greater than 100 mg/kg.

Summary of changes

Directive (EU) 2020/2089

1. Deletes Methyl heptine carbonate (CAS 111-12-6, entry 10) from the labeling list;
2. List of prohibited allergenic fragrances expanded from 55 to 58 allergenic fragrances to include the following substances:
• Atranol (CAS: 526-37-4);
• Chloroatranol (3-chloro-2,6-dihydroxy-4-methylbenzaldehyde) (CAS: 57074-21-2);
• Methyl heptine carbonate (CAS: 111-12-6).

Directive (EU) 2020/2088
List of allergenic fragrances to be labeled expanded from 11 to 71 allergenic fragrances, by:

1. Addition of two separate forms of citronellol (CAS #1117-61-9 and 7540-51-4) under entry 4;
2. Addition of 61 new fragrances.

Member states have until July 4, 2022, to adopt and publish the laws, regulations and administrative provisions necessary to comply with these directives. As of July 5, 2022, the directives will be fully effective.

Need support?

Do you have questions about what specific requirements your toys need to meet? Précon Quality Services can help! We have a team with extensive experience in training, advising and supporting product compliance for toys. Please feel free to contact us at +31 30 65 66 010 or info@precongroup.com.