Safety of Cobalt in Toys in the EU Regulatory Framework

Safety of Cobalt in Toys in the EU Regulatory Framework

Toys’ contribution to child development is an essential part of growing up. However, toys must be safe for children. For the EU, it is a priority that toys do not put children at risk. EU legislation strikes to ensure that toys comply with safety requirements that are amongst the strictest in the world, particularly concerning the use of chemical toys. The Toy Safety Directive 2009/48/EC prohibits using substances in toys if those substances are classified as carcinogenic, mutagenic, or toxic for reproduction (CMR). However, there are certain conditions under which the use of those substances can be permitted.


The Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) plays a key role here. In fact, the substance has to meet the following requirements to be excluded from the prohibition:

· To be evaluated by the Committee to be found safe;

· A lack of suitable alternative substances or mixtures available;

· The substance must not be prohibited for use in consumer articles under REACH.

Therefore, regarding this case, Cobalt has been classified as carcinogenic category 1B, mutagenic category 2, and toxic for reproduction category 1B. The toy industry flagged the presence of Cobalt in toys and toy materials as an impurity in nickel and alloys containing nickel up to 0,3%.


In the light of these considerations, SCHEER was asked:

1) To review the available data on the presence of Cobalt, in particular in toys and toy materials.

2) To assess whether Cobalt in toys and toy materials can lead to exposure.

3) To assess whether the TIE analysis of alternatives referred to in the background above can be considered sufficiently complete for the safety evaluation.

4) To evaluate whether the presence of Cobalt in toys and toy materials can be considered safe in light of exposure identified and in light of the classification of Cobalt as outlined in the background above. Safe toys and toy materials should be indicated.


The Committee has therefore met various times to discuss the aforementioned points, on 20 November 2020; on 14 September 2021; on 14 October 2021; and 16 November 2021. During the last meeting, the Working Group discussed the draft opinion and agreed on the revisions needed and on the allocation of tasks among the WG members.


Are you interested in knowing more about CMR substances? Do you intend to place your products in the EU market and wish to know about the existing requirements? Obelis can help you achieve compliance.


Federica Russo

Regulatory Affairs Department

24.11.2021


References

EUR-Lex. (18 June, 2009). Directive 2009/48/EC of the European Parliament and of the Council of 18 June 2009 on the safety of toys. OJ L 170, 30.06.2009. Retrieved on 20/12/2021 from https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02009L0048-20210521

European Commission. (2021). Toy Safety in the EU. Retrieved on 20/12/2021 from https://ec.europa.eu/growth/sectors/toys/toy-safety_en

European Commission. (2021). Request for an opinion on the safety of cobalt in toys with regard to a possible derogation from its prohibition. Retrieved on 20/12/2021 from https://ec.europa.eu/health/sites/default/files/scientific_committees/scheer/docs/scheer_q_019.pdf