The European Commission is seeking public comment on a draft revision to Annex A of Annex II to the Toy Safety Directive (2009/48/EC). The focus of the revision is on cobalt, which is classified as a CMR Category 1B (carcinogenic), CMR Category 2 (mutagenic), and CMR Category 1B (reproductive toxicant) under Regulation (EC) No 1272/2008 (CLP Regulation). Furthermore, cobalt may be present in toys through nickel impurities (e.g., slightly above 0.1% in stainless steel and up to 0.3% in non-stainless steel conductive metals, exceeding the 0.1% limit for Category 1B carcinogens under the CLP Regulation) or intentionally added (e.g., in pigments and batteries). After evaluating six exposure scenarios by the SCHEER (Scientific Committee on Health, Environment and Emerging Risks), the draft directive allows the use of cobalt in toys under certain conditions (stainless steel toys and components, conductive toy components, and neodymium iron boron magnets that are not swallowable or inhalable). Member States are required to develop compliance regulations within six months of the directive's issuance and implement it within seven months. The directive will enter into force 20 days after its publication in the Official Journal of the European Union.
Directive 2009/48/EC sets out the principles for the use of carcinogenic, mutagenic, and reprotoxic (CMR) substances in toys. Category 1A, 1B, and 2 CMR substances are generally prohibited. Exemptions are only granted if their concentrations are below the CLP regulation limits, they are out of reach of children, they have been scientifically assessed to be safe, and there are no alternatives (category 1A/1B requires additional requirements). The CLP regulation is the basis for cobalt's CMR classification. REACH Regulation (EC) No. 1907/2006 restricts the use of CMR substances in consumer products, and it is necessary to confirm that cobalt is not prohibited in consumer products under this regulation.
The main sources of cobalt in toys include:
Impurity: Nickel and nickel alloys (such as nickel silver and stainless steel). The toy industry estimates that the cobalt content is slightly over 0.1% in stainless steel and up to 0.3% in non-stainless conductive metal toy materials. Both exceed the 0.1% limit for Category 1B carcinogens specified in Table 3.6.2 of the CLP Regulation and are therefore not eligible for the "concentration exemption."
Intentionally added: Cobalt-based pigments/colorants, certain hard alloys, toy batteries, 3D pens, and 3D printing materials.
Child Exposure Risk: Cobalt and cobalt-containing materials can be exposed to children (through touching metal components, contact with cobalt-containing pigments, inhalation of dust, and oral ingestion), and are therefore not eligible for the "child-safety exemption."
Relevant toy companies need to pay close attention to the final regulations, review their supply chains, and ensure that their products meet the exemptions and limit requirements specified in the draft regulations.
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