The European Commission (EC) has asked the Scientific Committee on Health, Environment and Emerging Risks (SCHEER) to provide scientific opinions on the safety of titanium dioxide in toys to consider whether it may violate the ban. The Toy Safety Directive 2009/48/EC prohibits the use of substances classified as carcinogenic, mutagenic or toxic to reproduction (CMR) in toys. However, the use of such substances may be permitted under certain conditions. In order to allow the use of Category 2 CMR substances, the substance must be evaluated by the relevant scientific committee and determined to be safe, especially in terms of exposure. Another condition is that the substance is not prohibited from being used in consumer products under the Chemical Registration, Evaluation, Authorization and Restriction (REACH) regulations. Powdered titanium dioxide containing 1% or more particles with an aerodynamic diameter ≤ ten microns (μm) has been classified as inhaled carcinogen category 2.
SCHEER calls for the following scientific information:
Chemical and physical specifications of titanium dioxide for toys;
Particle size distribution of pigment-grade titanium dioxide for toys;
Migration or release of titanium dioxide in toys; and
Exposure measurement of titanium dioxide used in toys.
The submission deadline is April 28, 2021. However, after this date, the information solicitation will still be open, and other studies (for example, ongoing studies and studies not completed by the deadline) may be passed on to the working group at a later stage, if needed.
Review existing data on inhalation exposure caused by the use of titanium dioxide, especially in toys and toy materials; and
Assess whether the use of titanium dioxide in toys and toy materials can be considered safe based on the determined exposure and the classification of titanium dioxide as carcinogenic category 2. The safe toys and toy materials should be stated.
According to the timetable in the European Commission’s request, the preliminary opinion is expected to be in the middle of 2021, and the final opinion is in the fall of 2021.
Lynn L. Bergeson won for his in-depth and extensive understanding of the Toxic Substances Control Act (TSCA), the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), EU chemical registration, evaluation, authorization and restriction International reputation. REACH), especially how these regulatory programs relate to nanotechnology, industrial biotechnology, synthetic biology, and other emerging transformative technologies. Her knowledge and participation in the policy process enables her to develop customer-centric strategies, whether it is...
Since 1996, Carla Hutton has been monitoring, researching and writing about regulatory and legislative issues that may affect Bergeson & Campbell, PC (B&C®) customers. She is responsible for creating multiple monthly and quarterly regulatory updates for B&C's clients, as well as other documents, such as chemical-specific global assessments of regulatory developments and trends. She writes memos on regulatory and legislative developments for B&C clients, providing targeted, timely and customer-applicable information...
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