SCHEER - Scientific Opinion on the safety of the presence of cobalt in toys

SCHEER WG on Toys
SCHEER members: Emanuela Testai (Chair), Renate Krätke (Rapporteur), Teresa Borges, Peter Hoet, Rodica Mariana Ion, Ana Proykova, Theo Samaras (Weight of Evidence)
SCCS member: Pieter-Jan Coenraads
Contact:SANTE-SCHEERec [dot] europa [dot] eu (SANTE-SCHEER[at]ec[dot]europa[dot]eu)
On request from: European Commission
Adopted on: 16 December 2022

Corrigendum adopted on 9 March 2023: Corrected version contains changes on page 27 related to ECHA and REACH restriction procedure.

The Toy Safety Directive 2009/48/EC prohibits the use of substances in toys if those substances are classified as carcinogenic, mutagenic or toxic for reproduction. To permit the use of a CMR substance, a derogation of this rule is possible when the substance is evaluated by a relevant Scientific Committee and found to be safe in particular in view of exposure. Another possibility for derogation is that there are no suitable alternative substances or mixtures available. 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 e.g. in cobalt-containing colourants. The SCHEER evaluated the safety of the use of cobalt in toys based on a report provided by Toy Industries of Europe (TIE) and additional information from publicly available literature. The SCHEER identified possible sources for exposure to cobalt from toys which need to be considered. With the exception of few cases (e.g. cobalt-containing metals for conduction of electric current), information and data essential for an adequate exposure assessment were lacking. In these cases, therefore, no quantitative exposure and hence risk assessment was possible.

Risk due to cobalt inhalation associated with the use of cobalt-containing metals can be considered negligible; a potential risk can be associated for inhalation exposure to cobalt from chalks and chalk bombs as well as from powder-like toy materials, containing cobalt-based pigments/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.

For the 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 for cobalt after oral exposure the SCHEER recommends reducing migration limits to the lowest technically achievable levels.

For the dermal exposure, the restrictions proposed in the ECHA-RAC Opinion on cobalt content of textiles and leather can be assumed to also protect children from sensitization from all toy materials that are in contact with the skin.

The analysis of alternatives as performed so far by TIE, is considered insufficient.

Due to their availability the SCHEER recommends that cobalt-free pigments should be used.

Keywords:

Cobalt, toys, pigments, risk assessment, inhalation, oral, carcinogenicity 

Opinion to be cited as:

SCHEER (Scientific Committee on Health, Environmental and Emerging Risks), Opinion on the safety of cobalt in toys, 16 December 2022.