1 June 2018
EU’s Toy Safety Directive Amended So As to Lower Limit Values for Chromium VI in Scraped-off Toy Materials
On 17 May 2018, a new EU-wide law – Directive 2018/725 – was published in the Official Journal of the EU. The new Directive amends Directive 2009/48/EC, which is the framework toy safety Directive, by introducing more stringent limits on the value of Chromium VI in scraped-off toy materials, such as paints on toys, hard and soft polymers, wood, textiles and others.
Within the framework toy safety Directive, Chromium VI is deemed to be, and hence treated as, a particularly toxic substance, whose limit value, it is believed, ought to be set at half the levels of those considered safe by the relevant EU Scientific Committee.
The current limit value of 0.2 mg/kg in scraped-off toy material is based on the Virtually Safe Dose (VSD) of 0.0053 mg/kg bw/d (bodyweight per day) recommended by the Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency in 1999. However, in its 2015 opinion on Chromium VI in toys, after examining more recent scientific evidence, the EU’s Scientific Committee on Health and Environmental Risks (SCHER) recommended using a lower VSD of 0.0002 mg/kg bw/d to determine limit values for Chromium VI in toys.
Based on the new assessment, the SCHER opinion proposed revising limit values for Chromium VI in scraped-off toy materials to 0.0094 mg/kg. However, the existing test method (set out in European standard EN 71-3:2013+A1:2014) does not allow for the reliable measurement of Chromium VI at such a low concentration. It was thus decided that the limit value for Chromium VI in scraped-off toy materials be revised to 0.053 mg/kg, which is the lowest concentration that can be reliably measured using the current test method.
Accordingly, within the toy safety Directive, point 13 of Part III of Annex II has been revised as follows (the change is marked in bold below):
Hong Kong toy manufacturers should keep in mind that while the limit has been revised to 0.053 mg/kg, the European Committee for Standardization (CEN) is reviewing the test method in order to make possible the reliable detection of Chromium VI at lower levels of concentration. The Commission expects that a revised test method will be available soon, which will allow the reliable measurement of concentrations of Chromium VI down to 0.0025 mg/kg. When that becomes possible, it is likely that the limit value will be decreased further, and that manufacturers selling to EU customers will have to comply with an even lower limit value.
Hong Kong companies manufacturing consumer goods may know that Chromium is a naturally occurring element found in, among others, rocks, plants, and soil. However, the hexavalent oxidation state of Chromium, Chromium VI, exists in the environment primarily through human activity. A major source of Chromium VI is the production and use of chromium compounds (chromium trioxide, sodium chromate, sodium dichromate, ammonium dichromate and potassium dichromate).
Common uses of such compounds include manufacture of pigments and dyes, corrosion inhibitors, chemical synthesis, leather tanning, wood preservation, metal plating, and refractory production. Chromium VI can be found in a number of consumer products such as leather articles tanned with chromium sulphate, and products using pigments that are based on Chromium VI. Potential applications of such pigments in the toy sector include use in paints and varnishes, inks, vinyl and cellulose acetate plastics, textile printing, leather finishing, linoleum and paper.
Hong Kong producer-exporters should keep in mind that the framework toy safety Directive applies not only to toys, but also to products designed for use during play by children 14 years old or younger.
Member States will have to adopt and publish the legislation necessary to comply with the amendment described above by 17 November 2019, and apply it starting 18 November 2019. Though the amendment will enter into force as quickly as 6 June 2018, its actual application on economic operators, including on Hong Kong’s producers-exporters, will only occur on 18 November 2019.
The November 2019 deadline gives Hong Kong producers-exporters less than a year and a half to ensure that their toy products intended for the EU market comply with the revised stricter limit.
Please click on the following to view the Directive’s publication in the Official Journal.