EU : Updates to EU Toys Directive

 

The EU Commission has published a Draft Commission Directive amending Appendix A of Annex II to Directive 2009/48/EC of the European Parliament and of the Council on the safety of toys, as regards cobalt.

Th change is about the Inclusion, in Appendix A to Annex II of Directive 2009/48/EC (List of CMR substances and their permitted uses in accordance with points 4, 5 and 6 of Part III) of three entries (derogations) for:

• In toys and toy components made of stainless steel, as an impurity in the nickel contained in the stainless steel.
• In toy components which are intended to conduct an electric current.
• In neodymium-based magnets (NdFeB magnets) used in toys if those magnets cannot be swallowed or inhaled

The chanes have the following background:

Directive 2009/48/EC sets out general rules regarding the use of substances classified as carcinogenic, mutagenic, or toxic for reproduction (CMR) under Regulation (EC) No 1272/2008. CMR substances in categories 1A, 1B, or 2 are prohibited in toys, toy components, or distinct micro-structural parts of toys, unless:

• They are present at concentrations equal to or below the thresholds defined in Regulation (EC) No 1272/2008 for classifying mixtures as CMRs,
• They are inaccessible to children during normal or foreseeable use, or
• Their use has been explicitly authorised.

The European Commission may authorise the use of category 1A, 1B, or 2 CMR substances in toys under specific conditions. Authorisation may be granted if the relevant Scientific Committee assesses the use as safe (particularly regarding exposure), the substance is not banned for use in consumer products under Regulation (EC) No 1907/2006 (REACH), and—in the case of category 1A or 1B substances—no suitable alternatives exist. Permitted CMR substances and their specific uses are listed in Appendix A of Annex II to Directive 2009/48/EC.

In its opinion adopted on 16 December 2022 (and corrected on 9 March 2023), the Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) noted that cobalt may be present in toys as an impurity in nickel or nickel-based alloys. These materials are commonly used in toys—for instance, in nickel plating, electro-conductive coatings, and alloys like nickel silver and stainless steel. SCHEER also found that cobalt can be intentionally added to toys, such as in cobalt-based pigments and colorants, certain hard metals, batteries, and materials used for 3D pens and 3D printing.

Several forms of cobalt—including metallic cobalt and cobalt salts such as cobalt sulfate, cobalt diacetate, cobalt dinitrate, cobalt dichloride, and cobalt carbonate—are classified under Regulation (EC) No 1272/2008 as carcinogenic (category 1B), mutagenic (category 2), and toxic for reproduction (category 1B). These classifications became applicable from 1 October 2021 for metallic cobalt, and from 1 December 2019 for its ionic forms.

The toy industry has estimated that cobalt content in nickel-based materials can reach up to 0.1% in stainless steel and 0.3% in other electrically conductive metallic toy materials not made of stainless steel. These concentrations exceed the 0.1% threshold for category 1B carcinogens specified in Table 3.6.2 of Regulation (EC) No 1272/2008. As a result, the exemption provided under Part III, point 4(a) of Annex II to Directive 2009/48/EC does not apply.

Additionally, cobalt-containing materials in toys can be accessible to children during normal use—such as through direct contact with metallic parts or exposure to powder-based products (e.g. children’s cosmetics) containing cobalt salts. Therefore, the inaccessibility exemption under Part III, point 4(b) of Annex II is also not applicable to these materials.

In light of these findings, the Commission has tasked SCHEER with assessing the use of cobalt in toys, particularly focusing on exposure levels, in order to determine whether any specific uses can be deemed safe and potentially authorised under the directive.

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