Scope and Coverage
- Products covered include:
- Toys for children under 14 years old.
- Exempt toys such as:
- Toys for children 14 years and above.
- Toys for display or exhibits, not marketed in the Philippines.
- Toys for personal or adult collector use.
- Toys for donation or charitable missions.
- Swings, slides, and similar indoor/outdoor family activity toys.
- Childcare articles like feeding bottles, sippy cups, pacifiers, teething aids, bottle nipples, baby toothbrushes, and feeding sets.
License to Operate (LTO) Requirements
- Companies must have a valid FDA LTO as Human Use Household Substance (HUHS) Manufacturer, Trader, or Distributor before e-notification.
- Expired LTOs cause automatic disapproval of applications.
- LTO renewal applications must be filed 3 months prior to expiration.
- Documents required for toy exemption applications vary per category but generally include a Letter of Intent, laboratory test reports, notarized affidavits of undertaking, bills of lading, invoices, packing lists, and pictures showing compliance with labeling and packaging requirements.
- Applicants for certain exemptions (e.g., display or donation toys) must obtain a Certificate of Exemption for LTO.
- Exemption fees depend on the net worth of the shipment, ranging from PHP 1,000 to PHP 3,000.
Marketing Authorization
- Valid FDA LTO and acknowledged notification serve as proof of product registration; clearance from the FDA CCRR is no longer required.
- These documents are necessary for Customs release and to legally market TCCAs.
- Post-marketing surveillance includes audits, laboratory testing, market sampling, recalls, and product seizures.
- Non-compliant products are removed from the FDA website and market.
Applicability and Notification Procedure
- Companies must notify FDA by securing an e-notification account and submitting complete product details online.
- Notification includes product info (brand, model, age grading), product source, and declarations of responsibility.
- Up to 5 SKUs per notification, from the same category and source, allowed.
- Different product categories require separate notifications.
- Non-functional or unsanitary donated TCCAs are banned from entry and must be re-exported.
Grounds for Disapproval or Cancellation
- Companies with non-compliance history or failure to submit required documents.
- Failure to provide compliant labeling and packaging pictures within 30 days.
- Submission of incomplete or altered lab reports.
- Mixing product categories in one application.
- Product poses health risks based on advisories and warnings.
Changes of Information
- Any amendments or changes require a new notification application.
Laboratory Test Reports
- Must be complete, specific to each SKU, and from accredited laboratories.
- Reports must be in PDF/PNG format and properly named.
- Testing standards include PNS/ISO 8124 parts and phthalate testing where applicable.
Labeling and Packaging Requirements
- Mandatory submission of pictures of packaging and labeling.
- Compliance with RA 10620 (Toy and Game Safety Labeling Act) and its IRR required.
- Labeling must include LTO number, age grading, warnings, instructions, and manufacturer information.
- For small items, include leaflets/tags, cartons, or other labeling aids.
- Non-compliance leads to penalties.
Transitory Provisions
- Manual notifications no longer accepted from March 2, 2015.
- Pending manual applications before this date will be processed under previous rules.
Required Documents
- Authorization letter for account request.
- TCCAs E-Notification Account Assessment Slip.
- Official receipt or payment slip.
- Laboratory test reports specific to product category.
Application Procedure
- Request e-notification account via email with required details and authorization.
- Use FDA website to fill online notification form with complete and correct data.
- Upload scanned documents and pictures in appropriate formats and sizes.
- Payment made at FDA cashier or Landbank using issued assessment slips.
- Acknowledged notifications or disapprovals sent via e-notification account.
- 30-day period to submit labeling and packaging pictures after acknowledgment; failure leads to cancellation.
Fees and Payment
- PHP 100 plus PHP 10 legal research fund per notification.
- Payments accepted via FDA Cashier or Landbank.
- Fees subject to FDA guideline changes.
- Assessment slips valid for 14 days.
Processing Time
- Application processing period is 14 calendar days from payment verification.
Notification Validity and Cancellation
- Valid for one year from acknowledgment.
- New notification required after expiration for continued market sales.
- Notifications cancelled if any item fails compliance, affecting all items within the same notification.
Separability Clause
- Invalid provisions shall not affect the rest of the order which remains in effect.
Effectivity
- Guidelines effective March 2, 2015.