Question & AnswerQ&A (FDA Circular No. 2015-002)
The purpose is to implement guidelines on the electronic notification of toys and childcare articles to simplify regulatory processes, support economic progress, encourage innovation, and ensure the safety and quality of these products in the Philippine market.
Toys intended for children below 14 years of age, swings/slides and similar activity toys for indoor/outdoor family domestic use, childcare articles such as feeding bottles and pacifiers, and certain exempted toys like those for children 14 years and above, toys for display, personal use, adult collectors, and donation.
The company or person responsible for placing the product in the Philippine market must apply and must hold a valid FDA License to Operate (LTO) as Manufacturer, Trader, or Distributor before applying for e-notification.
According to Section 10 of Republic Act No. 9711 cited in the circular, manufacturing, selling, importing, exporting, or distributing health products (including certain toys and childcare articles) without FDA registration is a prohibited act subject to legal penalties.
Complete laboratory test reports for Parts 1 to 3 of the PNS/ISO 8124 or its equivalent and phthalate testing if applicable, especially for toys containing polyvinyl chloride (PVC).
Packaging and labeling must include the FDA LTO number, age grading, cautionary statements/warnings, instructional literature, and manufacturer or distributor markings such as name, address, or trademark, all clearly visible on the product or wrapper.
The FDA will issue a Letter of Cancellation, remove the notified products from the list of FDA-acknowledged TCCAs, and the products will be prohibited from being sold or must be withdrawn from the market.
No, mixing product categories such as toys for children below 14 years, toys for exemption, swings/slides, and childcare articles in a single application is prohibited and will result in disapproval.
The acknowledgment is valid for one (1) year. Upon expiration, companies must apply for a new notification to continue selling the products.
Grounds include history of non-compliance, failure to submit compliance documents, submission of non-compliant labeling/packaging pictures, incomplete or altered laboratory test reports, mixing product categories in one application, and if the product poses a health hazard/risk based on advisories.