Toy safety: the EU moves to protect children from potentially allergenic fragrances in toys

On December 11, 2020 the EU Commission adopted two Directives – 2020/2088 and 2020/2089 – to amend the Annex II to the Toy Safety Directive (2009/48/EC).

The said Annex concerns particular safety requirements. In Part III point 11, it provides:

  • A list of allergenic fragrances that shall not be contained in toys, unless their presence is mandatory under good manufacturing practice and does not exceed 100 mg/kg;
  • A list of allergenic fragrances that shall be listed on the toys’ label, if their concentration exceeds 100 mg/kg.

Member States have time until July 4, 2022 to transpose the two new Directives into national systems: as from July 5, 2022 they will be fully effective.


Legal background

Within the European Union legislative framework, toys are regulated by Directive 2009/48/EC, which, as all other New Approach Directives, aims to combine essential safety legal requirements with standardization, in order to create a safe and harmonized  EU Single Market.

The Directive has been applicable since July 20, 2011 and its main purpose is to ensure that toys – intended for children under 14 years of age - entering the EU market, meet high standards concerning safety and, especially, the use of chemicals (chemical safety requirements have applied since July 20, 2013).

Each amendment to the Directive is meant to ensure that the EU law is updated to the latest technology evolutions and scientific findings.

Allergenic fragrances in Europe

The main scope of the recent legislative modifications is to increase child’s protection.

In fact, the Scientific Committee on Consumer Safety (SCCS), in an opinion from 2012, noted that skin contact with a sufficient amount of certain substances can cause contact allergy that can result in dermatitis, urticaria, eczema, pigmentary anomalies and photosensitivity.

The addition of fragrances to several  consumer goods – such as toys, cosmetics, detergents and more - has become a common practice, to the point that nowadays contact allergy is a serious problem in Europe.

The most efficient secondary-prevention strategies towards adverse reactions to allergenic fragrances consist of:

- Avoiding prolonged contact with high quantity of these substances;

- Providing consumers with clear information about that substances contained in the products they are going to buy.

The implementation of the above-mentioned strategies resulted in the two lists included in Annex II to the directive on the safety of toys.

The actual changes

Before the recent legislative modifications, 55 allergenic fragrances were mentioned in the prohibited list of the Commission Directive (EU) 2020/2089. Now, the Annex contains 58 fragrances  with below new entries:

- Atranol (2,6-Dihydroxy-4-methyl-benzaldehyde, CAS number 526-37-4);

- Chloroatranol (3-Chloro-2,6-Dihydroxy-4-methyl-benzaldehyde, CAS number 57074-21-2);

- Methyl heptine carbonate (CAS number 111-12-6’), which was previously included in the labelling list.

Concerning the labelling requirements, the Annex to the Commission Directive (EU) 2020/2088 requires that 61 new fragrances (some of them with more than one CAS number) must be labelled when their concentration in toys is higher than 100 mg/kg. Additionally, two new CAS numbers for Citronellol (1117-61-9 and 7540-51-4’) are incorporated in the Annex. All considered, the labelling list now includes 71 fragrances.

In view of safety concerns, changes to the Directives have been introduced following the above-mentioned SCCS opinion, the meeting minutes of the European Commission’s subgroup Chemicals of May 3, 2018 and the meeting report of the Expert Group on toy safety of September 13, 2019.

In the latter two documents, the experts underlined that allergenic fragrances are not used only in cosmetic toys, but also in other kinds of toys, such as filled toys, soap bubbles, slime, modelling clay and paint. Moreover, it is stated that allergenicity is an intrinsic property of some substances, regardless of the fact that they are used in cosmetics or in other consumer goods, as toys. Therefore, fragrances considered risky for human safety within the cosmetic legislative framework, could present a risk in toys as well.


Francesca Santacatterina
Regulatory Affairs Department
26/01/2021


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