7 April 2017
EU Council Adopts Directive Imposing Tight Restrictions on Concentration of Lead in Toys
On 27 March 2017, the EU Council adopted a new Council Directive reducing the permitted concentration of lead in toys. The text is identical to the Commission’s Proposal on the same matter tabled on 9 September 2016. The future law, which is soon to be published in the EU’s Official Journal and implemented EU-wide, will impact on Hong Kong traders which export any type of toy to the EU market. For this reason, the content of the Directive and its date of implementation should be carefully considered.
Currently, Directive 2009/48/EC on the safety of toys lays down a list of elements which are presumed to be harmful to children. These elements include, for example, aluminium, cadmium, copper and lead, in dry, liquid and scraped-off toy material. Each of these elements is allocated a maximum permitted migration limit, by means of a table in Annex II, part III, point 13 of the Directive. Hong Kong manufacturers of toys are likely to be already familiar with this table.
The current migration limits for lead are 13.5 mg/kg in dry (e.g., chalk) material; 3.4 mg/kg in liquid or sticky (e.g., finger paint) material, and 160 mg/kg in scraped off (e.g., paint) material.
However, these current migration limits are no longer believed to offer children an adequate level of protection, in light of an improved understanding of the hazards of lead exposure. Specifically, it is now understood that there is no threshold below which exposure to lead does not have any critical health effects.
As children are recognised as being an especially vulnerable segment of the population in terms of toxic exposure, there is a special need to reduce to the maximum extent possible the exposure of children to lead, by, for example, targeting toys. The European Food Safety Authority (EFSA), when delivering an opinion on this matter, emphasised that even low-level exposure to lead was liable to cause damage to the nervous system and brain of children, which in turn could lead to learning difficulties.
To achieve a higher standard of protection by reducing children's exposure to lead, it appears from the introduction in the new Directive that the EU considered it paramount to move away from the existing approach which is based on a maximum safe ‘tolerable daily intake’. As an alternative, the EFSA proposed a new toxicological reference to be used for establishing lead limits: the benchmark dose limit (BMDL), which relates to neurodevelopmental effects. The BMDL is set at 0.5 micrograms per kilogram body weight per day.
The Risk Assessment Committee (RAC) established under the European Chemicals Agency (ECHA) agreed that the BMDL should be considered the highest tolerable exposure for lead. To highlight the need for tougher measures, the RAC pointed out that the current average level of lead in European children’s blood was up to four times higher than the highest tolerable exposure limit.
To bring the current migrations limits for lead, existing in Directive 2009/48/EC, within compliance with the BMDL threshold and align them with this latest scientific data, the Commission concluded that an amendment to the table in Annex II, part III of the Directive was required and a proposal was drafted accordingly.
When Member States were given the opportunity to vote on this proposal at a meeting on 4 October 2016, only one delegation raised their opposition to the measure. This was insufficient to constitute a blocking minority. This Member State vote paved the way for the Council to formally adopt the Directive introducing the amendment on 27 March 2017. Once published in the Official Journal and transposed by Member States, it will ensure that reduced migration limits for lead are implemented uniformly throughout the EU.
The three current migration limits for lead are contained in one row, which is found in Annex II of Directive 2009/48/EC on the safety of toys. The amendment of the migration limits thus signifies replacing the current three migration limits in the table with three new migration limits. The implementation in Member State law will lead to the same change. In short:
Article 1 of the new Directive replaces the current migration limits for lead by introducing the following new migration limits:
Migration limits from toys or components of toys:
Article 2 of the new Directive stipulates that the Member States have to transpose the amended migration limits into national law. This must be done, at the latest, by the date falling 18 months after publication of the Directive in the EU’s Official Journal. Member States are required to start applying the new limits from that date, and to communicate the transposition measures to the European Commission.
Hong Kong traders will therefore only have one and a half years from the date of publication to prepare for the new migration limits and adjust their products accordingly. As a consequence, it is recommended that affected traders take steps now, even before publication, to ensure their products fulfil the new criteria by the date of entry into effect.
As a result of the new Directive, some Hong Kong traders may find that certain categories of toys may be completely banned from being marketed in the EU. For instance, the marketability of arts and crafts toys, made with raw materials naturally contaminated with lead, is likely to be affected.
Please click on the following link to view the proposed Directive.