Directive 2017/738 - Council Directive 2017/738 amending, for the purpose of adapting to technical progress, Annex II to Directive 2009/48/EC on the safety of toys, as regards lead - Main contents

EN

Official Journal of the European Union

L 110/6

Directive 2009/48/EC lays down migration limits for toys or components of toys, for a range of elements, including lead, in dry, liquid and scraped-off toy material. The limits for lead are 13,5 mg/kg, 3,4 mg/kg and 160 mg/kg in each toy material, respectively.

Those limits were based on the recommendations of the Dutch National Institute for Public Health and the Environment (RIVM) in a 2008 report entitled ‘Chemicals in Toys. A general methodology for assessment of chemical safety of toys with a focus on elements’. The RIVM recommendations were based on the conclusion that exposure of children to lead may not exceed a certain level, called ‘tolerable daily intake’. In that report, a tolerable daily intake of 3,6 microgram per kilogram body weight per day was determined as the toxicological reference value for lead.

Since children are also exposed to lead from sources other than toys, only a certain percentage of the toxicological reference value should be allocated to toys. In its opinion on the ‘Assessment of the bioavailability of certain elements in toys’, adopted on 22 June 2004, the Scientific Committee on Toxicity, Ecotoxicity and Environment recommended that 10 % of the maximum tolerable intake of lead should be allowed as the maximum contribution from toys. In its opinion on the ‘Evaluation of the Migration Limits for Chemical Elements in Toys’, adopted on 1 July 2010, the Scientific Committee for Health and Environmental Risks (SCHER) concurred with the approach that the uptake of lead from toys should not exceed 10 % of a toxicology-based reference value. Furthermore, since lead is considered particularly toxic, its limits in Directive 2009/48/EC were set at half the level considered safe according to the criteria of the relevant Scientific Committee, in order to ensure that only traces of lead that are compatible with good manufacturing practice should be present. Accordingly, the limits for lead were set in that Directive at 5 % of the tolerable daily intake, determined as the migration of lead from toys.

The European Food Safety Authority (EFSA) concluded that for lead, as a toxic metal, there is no threshold below which the exposure to lead has no critical health effects. Even low-level exposure to lead may cause neurotoxicity, namely damage to the nervous system and brain, in particular learning deficits. Therefore, according to that new scientific knowledge published by EFSA, the tolerable daily intake should no longer be used as the toxicological reference value.

According to EFSA, the new toxicological reference to be used for establishing lead limits is the BMDL01 (benchmark dose limit) relating to neurodevelopmental effects. The BMDL01 is the lower confidence limit (95th percentile) of the benchmark dose of a 1 % extra risk of intellectual deficits in children measured by the Full Scale IQ score, that is a decrease in IQ by 1 point on that scale. The BMDL01 is equivalent to a lead intake of 0,5 microgram per kilogram body weight per day.

The Committee for Risk Assessment established under the European Chemicals Agency agreed with EFSA that the...