26 Nov 2019
Revised Limits for Aluminium in Toys Adopted for Application EU-wide
On 19 November 2019, the Official Journal of the EU published Commission Directive 2019/1922 which amends the EU’s framework toy safety law, Directive 2009/48/EC, as regards aluminium. Hong Kong sellers of toys to EU customers may be aware that Directive 2009/48/EC already lays down migration limits for aluminium from toys or components of toys. Until now, the limits for aluminium are 5,625 mg/kg for dry, brittle, powder-like or pliable toy material, 406 mg/kg for liquid or sticky toy material and 70,000 mg/kg for scraped-off toy material. Pursuant to recommendations from EU experts consulted by the European Commission, these limits have now been revised.
It is reported that the EU Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) has reviewed the available data on the toxicity of aluminium, taking into account the different tolerable intake levels for aluminium established by the European Food Safety Authority, among others. The SCHEER considered, in its ‘Final opinion on tolerable intake of aluminium with regard to adapting the migration limits for aluminium in toys’ a tolerable daily intake (TDI) of 0.3 mg/kg body weight per day as an appropriate base for revising the migration limits for aluminium from toys.
It is stated that since children are exposed to aluminium also through sources other than toys, only a certain percentage of the TDI should be allocated to the exposure from toys when calculating the limits. The maximum contribution from toys to the daily intake recommended by the Scientific Committee on Toxicity, Ecotoxicity and the Environment in its 2004 opinion is 10%. In 2010, this percentage was confirmed by the Scientific Committee on Health and Environmental Risks in its opinion on ‘Risk from organic CMR substances in toys’ and in its opinion on ‘Evaluation of the migration limits for chemical elements in toys’.
The SCHEER thus applied 10% of the TDI, multiplied by the average weight of a child under three years of age (estimated at 7.5 kg) and divided by the daily quantity of toy material ingested. That quantity was estimated at 100 mg/day for dry, brittle, powder-like or pliable toy material, 400 mg/day for liquid or sticky toy material and 8 mg/day for scraped-off toy material.
On the basis of that calculation, the SCHEER proposed revised migration limits for aluminium from toys of:
- 2,250 mg/kg for dry, brittle, powder-like or pliable toy material,
- 560 mg/kg for liquid or sticky toy material and
- 28,130 mg/kg for scraped-off toy material
These became the proposed migration limits.
Hong Kong toy manufacturers should know that compliance with the proposed migration limits can be verified with the test method set out in European standard EN 71-3:2013+A3:2018, the reference of which has been published in the Official Journal of the European Union. These migration limits, it is stated, can be easily enforced, since they are several thousand times higher than the lowest concentration that can be reliably quantified with the test method set out in the standard. European standards can generally be purchased from CEN National Members and Affiliates.
In order to advise the Commission in the preparation of legislative proposals and policy initiatives in the area of toy safety, the Commission established the Expert Group on Toys Safety. The mission of its subgroup Working Group on chemicals in toys (subgroup Chemicals) is available to provide advice to the Expert Group on Toys Safety with regard to chemical substances that may be used in toys. The subgroup Chemicals considered, at its meeting around two years ago, that the migration limits proposed by SCHEER were appropriate.
It is further noted that market surveillance data on aluminium in toys from approximately 5,800 tests has showed compliance with the abovementioned revised migration limits in almost all cases. Data from writing instrument manufacturers, for example, on approximately 250 samples, seem to suggest that a substantial part of the writing materials are already compliant with those limits.
The Expert Group on Toys Safety agreed, therefore, that the migration limits for aluminium should be amended. In light of the available scientific evidence and expert opinions, the Commission deemed it necessary to adapt the hitherto applicable migration limits for aluminium from toys or components of toys to technical and scientific developments, by replacing them with the abovementioned revised migration limits.
Thus, new Commission Directive 2019/1922 stipulates that in point 13 of part III of Annex II to Directive 2009/48/EC on toy safety, in the table, the entry for aluminium is replaced by the following:
|Element||mg/kg in dry, brittle, powder-like or pliable toy material||mg/kg in liquid or sticky toy material||mg/kg in scraped-off toy material|
Member States are required to adopt and publish, by 19 May 2021 at the latest, the laws, regulations and administrative provisions necessary to comply with new Commission Directive 2019/1922. Hong Kong traders should take note that Member States are then obliged to apply those provisions from 20 May 2021.