Law Summary
Definitions of Key Terms
- Important definitions include "Toy and Game", "Manufacturer", "Distributor", "Retailer", "Labeling", "Age Grading", "Cautionary Statement", "Instructional Literature", and relevant government departments (DOH, FDA, DTI, DENR, DOF, etc.).
Roles and Responsibilities of Agencies
- DOH (through FDA) develops regulations, issues authorizations, conducts monitoring and laboratory analysis, and handles reports on safety incidents.
- DTI develops standards and implements consumer education, assists FDA inspections, and disseminates information.
- Coordination with other agencies such as BOC, DILG, and DENR-EMB is mandated for effective enforcement.
Labeling and Packaging Requirements
- Toys must comply with Philippine National Standards (PNS) including having visible, clear labels in English or Filipino.
- Mandatory labeling includes FDA License to Operate number, age grading, cautionary statements, instructional literature, manufacturer’s marking, and SKU numbers.
- Labels must be durable and not conceal essential information; instructional literature must accompany products.
- Companies may request label exhaustion under conditions approved by FDA.
Safety Labeling Statements
- Cautionary statements must be conspicuous, placed on packaging and on toys themselves.
- Bulk or unpacked products must bear warnings on display bins or vending machines.
- Specific warnings exist for toys with small parts, balloons, aquatic toys, toys with sharp points, battery-operated toys, etc., and must be in English or Filipino.
- Instruction literature must provide clear assembly, use, maintenance, and safety instructions.
Exclusions
- Toys shipped directly from foreign manufacturers to consumers via mail may be exempted from labeling requirements if accompanied by appropriate cautionary materials.
- FDA may exempt specific toys but may reinstate labeling requirements for health and safety.
Inspection and Monitoring
- DOH-FDA leads market inspections, monitoring, and sampling with DTI assistance.
- Inspectors have authority to enter establishments, examine documents, conduct post-market monitoring, and report violations.
Enforcement and Penalties
- Violations subject to administrative and criminal actions under the FDA Act of 2009.
- Penalties include fines from ₱10,000 to ₱50,000 and imprisonment from 3 months to 2 years.
- Seizure and disposal of non-compliant products are enforced, with costs charged to manufacturers/distributors.
- Custodia legis applies to seized items pending case resolution.
Miscellaneous Provisions
- Misbranded or banned toys are withdrawn from sale at responsible parties’ expense.
- Incident reporting on specific toy-related hazards is mandatory.
- Budget allocations are required from DOH and DTI for implementation.
- Provisions are separable and inconsistent previous regulations are repealed.
- IRR takes effect 15 days after publication in the Official Gazette or newspapers.
This IRR ensures safety, labeling accuracy, and regulatory compliance for toys and games to protect the welfare of children and consumers in the Philippines.