Scope
- Applies to all food irradiation facilities and irradiated foods
- Covers domestic consumption, import, and export
Definitions
- Key technical and institutional terms defined, including:
- Absorbed Dose (Gray, Gy)
- Food irradiation and irradiation facility
- Types of foods (fishery, meat, plant products)
- Regulatory bodies (BFAD, PNRI, BFAR, BPI, NMIS, BHDT)
- Dosimetry: measurement of absorbed radiation dose
- Ionizing radiation types (gamma rays, x-rays, electrons)
Policies and Guidelines
A. Licensing Requirements
- Food irradiation must be done only in licensed, registered facilities meeting safety, efficacy, and hygienic practice standards
- Facilities must have trained competent personnel
- Must operate within PNRI or BHDT standards for ionizing radiation use and disposal
- BFAD to license food establishments with irradiation facilities if compliant with:
- Codex General Standard for Irradiated Foods
- Codex Code of Practice for Irradiation Facilities
- Good Manufacturing Practices (GMP)
- Radioactive Material License from PNRI (gamma rays) or BHDT (electron beam/x-ray) is required
- Certification from BFAD needed for establishments irradiating food products, with additional accreditation by BPI, BFAR, NMIS for quarantine-controlled products
B. Standard Requirements for Food Irradiation
- Authorized radiation sources: gamma rays from 60Co or 137Cs; x-rays (<=5 MeV); electrons (<=10 MeV)
- Irradiation justified for technological or hygiene purposes; not a substitute for good manufacturing practice
- Food must meet Codex hygiene and quality requirements
- Packaging must be irradiation-suitable and prevent re-contamination or infestation
- Dose ranges prescribed per food class to ensure efficacy and quality; minimum and maximum doses must be observed
- Compliance with Codex General Standard and Code of Practice mandatory
- Quality assurance includes dosimetry, accurate dose measurement, system calibration, record-keeping
- Physical segregation of irradiated and non-irradiated products required; use of visual radiation indicators recommended
C. Reporting and Record-Keeping
- Annual reports to BFAD detailing facility name, reporting period, food treated, quantity, lot numbers, irradiation dates
- Maintain records of each batch for 3 years, readily available for inspection
- Records to include lot/code number, date, type and quantity of food, packaging, controls and measurements, incidents or deviations
D. Inspection
- BFAD inspects food irradiation facilities
- PNRI or BHDT monitor compliance with radiation standards
- Inspection of irradiated food products per Section 27 of RA 3720
- Quarantine-controlled products inspected by BPI, BFAR, NMIS, or BFAD as applicable
E. Labeling
- Must comply with Codex standards and BFAD mandatory labeling for pre-packaged foods
- Pre-packaged irradiated foods require international irradiation logo and "treated by irradiation" statement
- Information must be conspicuously displayed for non-pre-packaged irradiated foods at retail
- Wholesale/distribution labels must identify irradiation facility, license details, irradiation date, and purpose
F. Re-Irradiation
- Allowed only under Codex provisions
- Limited to specific cases such as low moisture foods for insect control, low-dose re-irradiation for other uses, foods with <5% irradiated ingredients, or installment dosing
G. Importation and Exportation
- Importation requires BFAD Certificate of Product Registration (CPR) with product ID, irradiation details, facility credentials, and certification from origin country's food control agency
- Must comply with quarantine and import requirements by Department of Agriculture and BFAD
- Exportation also requires BFAD CPR with product, facility, and importer details
- Exported irradiated foods must comply with importing countries' regulations
Legal Sanctions
- Non-compliant irradiated foods considered adulterated or misbranded under RA 3720
- May be disallowed from commerce, recalled, or withdrawn
- Fines, suspension, or revocation of CPR or facility license possible after due process
- Additional criminal penalties under RA 3720 may apply
Separability Clause
- Invalidity of any provision does not affect the validity of other provisions
Effectivity
- Effective 30 days after publication in two newspapers of general circulation for one month
Appendix I: Recommended Technological Dose Ranges
- Specific kGy dose ranges prescribed per class of food for defined purposes such as sprouting inhibition, insect disinfestation, microbial reduction, shelf-life extension, quarantine control, and sterilization
- Dose ranges ensure desired technological and public health outcomes without compromising food quality