EU: Toy safety – amendment to the Toy Safety Directive as regards cobalt

 

The EU Commission is conducting a public consultation with regard to an amendment to the Toy Safety Directive as regards cobalt.

Directive 2009/48/EC sets general requirements for substances classified as carcinogenic, mutagenic, or toxic for reproduction (CMR) under Regulation (EC) No 1272/2008. Substances in CMR categories 1A, 1B, or 2 are prohibited in toys, toy components, and micro-structurally distinct toy parts, except when:

• Their concentration does not exceed the limits set in Regulation (EC) No 1272/2008 for classifying mixtures as CMRs.
• They are inaccessible to children.
• Their use has been specifically authorised.

The European Commission may authorise the use of CMR category 1A, 1B, or 2 substances in toys if:

1. The relevant Scientific Committee has assessed the use as safe, particularly in terms of exposure.
2. The substance is not banned for use in consumer products under Regulation (EC) No 1907/2006.
3. For CMR 1A and 1B substances, no suitable alternative substances or mixtures exist.

Appendix A of Annex II to Directive 2009/48/EC lists the permitted CMR substances and their allowed uses.

Cobalt in Toys

In its opinion adopted 16 December 2022 (corrected 9 March 2023), the Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) found that cobalt can occur in toys as:

• An impurity in nickel and nickel-containing alloys (e.g., stainless steel, nickel silver), used for nickel plating, electro-conductive coatings, or structural parts.
• An intentional additive, such as in cobalt-based pigments, hard metals, batteries, and materials for 3D printing or 3D pens.

Cobalt (metallic) and several cobalt salts—such as cobalt sulfate, di(acetate), dinitrate, dichloride, and carbonate—are classified under Regulation (EC) No 1272/2008 as:

• Carcinogenic (Category 1B)
• Mutagenic (Category 2)
• Toxic for reproduction (Category 1B)

The classifications have applied since 1 October 2021 for metallic cobalt and 1 December 2019 for cobalt ionic forms.

Concentration and Accessibility Concerns

Toy industry data estimate cobalt contamination levels in nickel to slightly exceed:

• 0.1% in stainless steel.
• 0.3% in metallic toy parts (not stainless steel) designed to conduct electricity.

Both levels exceed the 0.1% threshold for Category 1B carcinogens in Table 3.6.2 of Regulation (EC) No 1272/2008, meaning the derogation under Part III, point 4(a) of Annex II to Directive 2009/48/EC does not apply.

Cobalt in toys can also be accessible to children—e.g., by touching metallic toy parts or pigments in powder-based cosmetics—so the “inaccessibility” derogation under Part III, point 4(b) cannot apply either.

SCHEER Safety Assessment

Following this, the Commission tasked SCHEER with evaluating cobalt’s safety in toys. SCHEER assessed six scenarios covering possible exposure routes (inhalation, oral, dermal).

SCHEER concluded that cobalt use can be permitted in:

• Metal toy components designed to conduct electric current (chemically safe).
• Stainless steel toys and components containing cobalt as a nickel impurity.
• NdFeB magnets in toys, provided they cannot be swallowed or inhaled.

Availability of Alternatives

The toy industry’s alternatives analysis (per Part III, point 4(c)(ii)) was found incomplete, as not all scenarios were considered. However, for the approved cobalt uses above, the analysis was complete and found no suitable alternative substances or mixtures.

Compliance with REACH Restrictions

Under Part III, points 4(c)(iii) and 5(c)(ii) of Annex II to Directive 2009/48/EC, CMR substances cannot be authorised if banned in consumer articles by Regulation (EC) No 1907/2006.

For cobalt:

• Entries 28 & 30 restrict its sale as a substance or in mixtures to the general public, but not in consumer articles.
• Entry 75 restricts cobalt in tattooing mixtures only.
• Entry 3 restricts cobalt in liquid ornamental articles, lamp oils, and lighter fuels—irrelevant for stainless steel, which is solid.

As a result, the amendment to Directive 2009/48/EC does not alter the application of Entry 3 to toys covered by that entry.

To find out more about product compliance for toys in EU, do not hesitate to contact the Product Compliance Institute.