Directorate-General for Health and Food Safety
A public consultation on this Opinion was opened on the website of the non-food scientific committees between 01 August and 28 September 2014. Information about the public consultation was broadly communicated to national authorities, international organisations and other stakeholders.
Thirteen organisations and individuals provided a total of 95 comments on the different chapters and subchapters of the Opinion during the public consultation. Among the 13 organisations participating in the consultation were public health institutions, public authorities and private companies, notably from the toy industry.
Each contribution was carefully considered by the SCHER and the scientific Opinion has been revised to take account of relevant comments.
Content of the opinion:
The SCHER reviewed scientific documents on the health effects of chromium VI in order to assess the relevance of the oral cancer potency for the safety levels laid down for chromium VI in the Toy Safety Directive.
In its Opinion, the SCHER concludes that the current migration limits for chromium VI from toys should be revised downwards and be based on a lower value. This ‘safe dose’ has been determined on the basis of new scientific studies. Considering a virtual safe dose of 0.0002 µg/kg bw/d based on data from the 2008 US National Toxicology Programme study and using the current approach of the Toy Safety Directive, the SCHER proposes the following revised migration limits for chromium VI: 0.0094 mg/kg toy for scraped-off toy materials, 0.0008 mg/kg toy material for dry, (powder-like or pliable) toy materials and 0.0002 mg/kg toy material for liquid or sticky toy materials, respectively.
The SCHER acknowledges that the proposed migration limits are conservative and may not be achievable for certain toy materials. The Committee also points out that detection methods for chromium VI migration are affected by limitations and may not be sufficiently sensitive. The Opinion emphasizes that children are a vulnerable subgroup for exposure to chromium VI. Considering that children’s exposure limits to chromium VI may already have been reached through drinking water, air and other sources, any additional exposure to chromium VI from toys should be minimised to the lowest achievable levels using the best available technology.