Scope and Coverage
- Applies to all local manufacturers, importers, and distributors of toys sold or given free in the Philippines
Objective
- Establish guidelines for licensing manufacturers, importers, and distributors of toys in the Philippines
Definition of Terms
- Accreditation: Formal recognition by DOH that an entity meets performance standards
- Accredited Testing Laboratories: Laboratories accredited by DTI or WTO Mutual Recognition Agreement member agencies
- Applicant: Local or foreign entity seeking a License to Operate (LTO)
- Batch: Quantity of toys produced under one manufacturing order with uniform quality
- BHDT: Bureau of Health Devices and Technology under DOH
- Child: Person below eighteen (18) years old chronologically or mentally
- Conformity Assessment: DOH evaluation of a batch of toys for health and safety compliance
- Clearance for Customs Release: DOH document allowing Bureau of Customs to release imported toys post conformity assessment
- Distributor: Entity selling or delivering toys for commerce, excluding manufacturers or retailers
- Establishment: Importer, manufacturer, or distributor of toys
- HRDRD: Health Related Device Regulation Division of BHDT
- Label: Printed or graphic matter affixed to toy product for information on identity and safety
- License to Operate (LTO): Authorization issued by BHDT to compliant manufacturers, importers, distributors
- Manufacturer: Entity assembling or processing toys; includes representatives of imported toys
- PNS: Philippine National Standards for Safety of Toys
- Testing Laboratory: Facility measuring characteristics or performance of toys
- Toy: Object intended as plaything for children under 18
- Trademark: Symbol or device used to distinguish the toy product owner
General Policies and Guidelines
- All toys must comply with current PNS and future amendments
- Manufacturers, importers, distributors must apply for LTO from DOH/BHDT prior to marketing
- New toy batches require conformity assessment submission before marketing
- Exemptions include specified non-toy products like sports equipment, fireworks, bicycles for public travel
- Non-compliant toys found in post-market surveillance must be recalled and properly disposed of at the establishment's expense
- Importation of used, unsanitary donated toys is prohibited
- LTO is revoked upon ownership or management change
- LTO validity is three years, renewable, subject to suspension or revocation
- Grounds for LTO disapproval or revocation include misrepresentation, falsified documents, non-compliance, refusal of inspection
- DOH may conduct administrative hearings and impose sanctions such as LTO suspension, revocation, product seizure
Analysis and Testing Requirements
- Accredited laboratories conduct required toy tests following PNS
- Test results only accepted from DTI-accredited, DOH-recognized, or WTO MRA member labs
- Foreign test results must be in English and authenticated by the Philippine consulate
Documentary Requirements
- Initial LTO application requires application form, business registration, tax clearance, toy samples/photos, lab test results, labeling, vicinity map, disposal plan
- Renewal requires application form, tax clearance, affidavit of continuous compliance
- Deficient applications get 30-calendar day correction period, else discarded
- Fees based on capitalization; late renewal subject to 50% surcharge
- LTO number must appear on toy packaging or protective covering
Labeling and Packaging Requirements
- Must comply with PNS for Safety of Toys
- Labels must include: registered brand name, trademark, product model, business info, manufacture place/date, LTO number, warnings, instructions, age requirements
- Foreign language info must be translated to Filipino and/or English
- Labels must be durable and legible under normal handling
Monitoring and Inspection
- BHDT conducts monitoring, inspection, and surveillance for compliance
- Equipment used for measurements must be regularly calibrated and documented
- BHDT technical staff may enter premises with bureau order to inspect, request documents, sample products
- Companies must maintain relevant records for inspection
- Coordination with government agencies and NGOs emphasized
Roles and Functions of Centers for Health Development (CHD)
- Assist BHDT in implementing regulations
- Disseminate information, provide application forms in remote areas
- Coordinate with BHDT and LGUs
- Receive LTO applications in remote areas for forwarding to BHDT
Handling of Appeals
- BHDT Director issues LTO and imposes sanctions
- Establishments may file motions for reconsideration within 15 days to the Office of the Undersecretary for Health Regulations
- Subsequent appeals to the same Office within 15 days are final and executory
Penal Provisions
- Violations subject to fine of not less than PhP1,000 or imprisonment from 6 months up to 5 years or both
- Other penalties per Republic Act 7394 (Consumer Act of the Philippines) also apply
Transitory Provisions
- Six-month compliance period for existing toys containing hazardous substances upon publication
- Certificate of pending application available upon company request
Separability Clause
- Invalidity of any provision does not affect the others
Repealing Clause
- Prior inconsistent administrative orders and rules are repealed or amended accordingly
Effectivity
- Regulations take effect 15 days after publication in an official gazette or newspaper of general circulation