On June 3, 2021, there were two updates concerning the Toy Safety Directive: the first concerns an amendment from the European Commission that limits aniline as a dangerous substance in toys; the other is SCHEER’s new opinion, the Toxicological reference values for certain organic chemicals emitted from squishy toys with regard to adopting limit values under the Toy Safety Directive 2009/48/EC ‘Chemicals in squishy toys’.
Aniline limitation
The Commission has published Directive (EU) 2021/903, which amends the Toy Safety Directive 2009/48/EC, including aniline in Appendix C to Annex II. Appendix C of the Directive refers to specific limit values for chemicals in toys for children under 36 months or toys in contact with the mouth. The amendment adopts the following values: “30 mg/kg after reductive cleavage in textile toy material and leather toy material, 10 mg/kg as free aniline in finger paints and 30 mg/kg after reductive cleavage in finger paints” (European Commission, 2021). The amendment provides an implementation period for the Member States to introduce the provisions in their national laws by December 4, 2022, given that, from December 5, 2022, these provisions will be fully applicable.
SCHEER Opinion on organic chemicals in squishy toys
SCHEER published an opinion on a number of organic chemicals that can be located in squishy toys. The Committee addressed three points.
· Review of specific data on toxicity of the organic compounds. Concerning the review, SCHEER considered also the Danish Environmental Protection Agency Report (2018) and the Swedish Chemicals Agency Report (2019). The Committee reviewed the scenario of inhalation and contact in the mouth and particularly “ingestion, sucking and chewing” (SCHEER, 2021).;
· Provide advice on the toxicological reference value for these organic compounds, where SCHEER generated a table with all essential information;
· Give advice on value limits for these organic compounds under the Directive. Regarding this last point, the Committee took into consideration three inhalation scenarios. The Opinion includes the complete results, parameters and formulas for calculation and the emission limit values in relation to the most conservative exposure scenarios, which is the third inhalation scenario of a three-year-old child asleep in a room with a number of squishy toys (40) and squishing one.
Toys Safety Directive
The Toys Safety Directive 2009/48/EC provides the safety criteria for a toy to circulate on the EU market. Therefore, manufacturers should ensure that their toys are compliant with the Directive’s requirements and processes. We can support you in the task, contact us!
Anna Karavasili
Regulatory Affairs Departments
24.08.2021
Contact Obelis to receive excellent assistance on this and many other matters on your products’ route towards EU compliance!
References:
· European Commission. (2021). COMMISSION DIRECTIVE (EU) 2021/903 of 3 June 2021 amending Directive 2009/48/EC of the European Parliament and of the Council as regards specific limit values for aniline in certain toys. Retrieved on 20/08/2021 from https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32021L0903&from=EN.
· SCHEER. (2021). Toxicological reference values for certain organic chemicals emitted from squishy toys with regard to adopting limit values under the Toy Safety Directive 2009/48/EC ‘Chemicals in squishy toys’. Retrieved on 24/08/2021 from https://ec.europa.eu/health/sites/default/files/scientific_committees/scheer/docs/scheer_o_019.pdf
· European Commission. (2009). Directive 2009/48/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 18 June 2009 on the safety of toys. Retrieved on 20/08/2021 from https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:02009L0048-20191118&from=EN.
· European Commission. (2021). Toy Safety: Commission limits the presence of a harmful substance in toys. Retrieved on 20/08/2021 from https://ec.europa.eu/growth/content/toy-safety-commission-limits-presence-harmful-substance-toys_en.