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The Center for Cosmetics and Household/Urban Hazardous Substances Regulation and Research (CCHUHSRR) of the Food and Drug Administration (FDA) hereby informs its stakeholders of the following updates covering toys and childcare articles (TCCA) regulatory policy and research:

1. Status of the implementation of the existing TCCA product authorization guidelines under FDA Circular No. 2015-002

In 2015, the FDA promulgated guidelines through FDA Circular No. 2015-002 to streamline the authorization processes for TCCA products through a product notification procedure, which also emphasized the primary responsibility of marketing authorization holders to ensure compliance with FDA-instituted standards. Throughout its implementation, gaps have been identified, including the need to upgrade the application system to be in line with the latest FDA online platforms, update labeling requirements to be consistent with the Implementing Rules and Regulation (IRR) of Republic Act No. 10620, otherwise known as the “Toy and Game Safety Labelling Act of 2013”, rationalize the certification procedures for exempted products, and update product safety standards applicable for TCCA products.

Thus, the FDA, through CCHUHSRR, is undertaking the development and update of the said FDA Circular to address such identified gaps in the current process for issuing TCCA market authorizations. The draft policy will be consulted with stakeholders and shared through official channels in due course.

2. Updates to the Licensing Application Procedures

As previously shared in the Kapihan at Talakayan sa FDA back in May 2023, the Agency is moving towards utilizing the FDA eServices Portal System as a common application platform for its regulatory services. In 2024, among other services provided by the FDA through CCHUHSRR, the licensing application procedure will be migrated to this common platform.

Included in this digitalization update will be the incorporation of updates ensuring further alignment with Republic Act No. 11032, otherwise known as the “Ease of Doing Business and Efficient Government Service Delivery Act of 2018”, such as the incorporation of the preliminary assessment step, institution of the Zero Contact policy, and the alignment of processing timelines.

3. Upcoming Policy on Safety Reporting

With an aim to enhance regulatory activities to ensure the safety of children in line with the principles of Republic Act No. 10620, the Center is currently developing a policy clarifying the reportorial requirements of untoward incidents associated with the use of TCCA products. The proposed policy aims to establish a reporting system for TCCA-related injuries, clarify roles and responsibilities of establishments involved in the supply of TCCA products, facilitate the conduct of measures to prevent harm, and raise the awareness of the public on children’s safety.

4. Research Initiatives

As part of the evidence-based approach in instituting and implementing regulations, the FDA through CCHUHSRR is currently undertaking research on and testing for phthalates in available TCCA products in the market. The results of this study will be used to better inform the intended updates to the existing restrictions under Department of Health Administrative Order 2009-0005-A limiting certain phthalate esters in TCCA products.

In this continuous effort to improve the regulatory landscape for TCCA products, the FDA calls for the cooperation of industry stakeholders to ensure compliance with, and whenever possible, surpass regulatory standards. We also call upon the public to support the initiatives of the FDA, in order to ultimately foster an environment conducive to the well-being and development of children.

For information of all concerned.

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