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Your regular update for technical and industry information

EU: European commission launches public consultation on the preliminary opinion on the safety of Cobalt in toys

JULY 2022 - TOYS

The European Commission and its Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) have published a preliminary opinion1 on the safety of cobalt in toys which is now under public consultation until 18 August 2022. 

Following a request2 from the European Commission, the SCHEER evaluated the assessment from the Toys Industries of Europe (TIE) as well as information retrieved from a literature search, and performed the risk assessment for inhalation, oral and dermal exposure. 

Cobalt has been classified as carcinogenic category 1B, mutagenic category 2 and toxic for reproduction category 1B and is present in toys as an impurity in nickel and nickel-containing alloys, or cobalt may be used intentionally. The focus is on risks related to the carcinogenic properties of cobalt. 

Based on the information available, the SCHEER considers the following scenarios as relevant for the exposure assessment:

  1. Cobalt-containing metals included to allow conduction of electric current;
  2. Cobalt-containing metals that serve a function other than electrical conductance like for toys of metal, cheap jewellery for kids, fidget spinners and magnets;
  3. Kids’ make-up;
  4. 3D pens, materials for toy printers and printed toys;
  5. Cobalt-containing paintings, inks and coatings used for toys and toys made of leather or textiles;
  6. Toys containing batteries.

Inhalation
Risk due to cobalt inhalation associated with the use of cobalt-containing metals can be considered negligible. Potential risks can be associated with inhalation exposure to cobalt from powder-like toy materials like kids’ cosmetics or creative art toys containing cobalt-base pigments or colourants. For such toys, cobalt-free pigments should be used. Specific attention should be given to the ‘emerging’ use of cobalt-containing materials in 3D pens and 3D printers.

Oral exposure
Based on available toxicological reference values, the SCHEER calculated new migration limits for cobalt in toys, in relation to oral exposure. However, due to the uncertainties regarding the carcinogenic properties of cobalt after oral exposure, the SCHEER recommends reducing migration limits to the lowest technically achievable levels in the Toy Safety Directive (TSD).

Migration limit values

Category 1
Dry, brittle, powder-like or pliable toy materials

Category 2
Liquid or sticky toy materials

Category 3
Scraped-off toy materials

Current

10.5 mg/kg

2.6 mg/kg

130 mg/kg

SCHEER’s opinion

0.12 mg/kg

0.03 mg/kg

1.5 mg/kg

Dermal exposure

Dermal exposure is considered possible from metal toys, cheap kids’ jewellery, kids’ cosmetics, materials with cobalt-containing coatings or batteries as well as from materials for 3D pens or printings. Due to the low migration of cobalt to artificial sweat, the SCHEER considered the risk after dermal exposure low or negligible. The proposed REACH restriction3 on cobalt content in textiles and leather can be assumed to also protect children from sensitization from all toy materials that are in contact with the skin.

 

 

[1]  Public consultation on the Preliminary Opinion, 15 July 2022

[2]  EU: Request for an opinion on the safety of cobalt in toys with regard to a possible derogation from its prohibition, December 2020

[3]  EU: ECHA launched second public consultation on restriction on skin sensitising substances, June 2020

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