Republic of the Philippines

Department of Health
OFFICE OF THE SECRETARY
San Lazaro Cpd., Rizal Ave.
Sta. Cruz, Manila

January 9, 2004

ADMINISTRATIVE ORDER
No. 152 s. 2004

SUBJECT: Prescribing Regulations for Irradiated Food

I. RATIONALE/BACKGROUND

Pursuant to Republic Act 3720 Section 26(a), otherwise known as the Food, Drugs and
Devices and Cosmetics Act (as amended), this Administrative Order on Regulation of
Irradiated Food is issued to ensure safety supply of irradiated food and prevent undue
risk to safety and public health in the application of ionizing radiation to reduce wastage
caused by insects, micro-organism, physiological processes and to control pests of
quarantine significance in foods.

II. SCOPE

These regulations shall cover all food irradiation and all irradiated foods, whether
produced for domestic consumption, imported or for export.

III. DEFINITION OF TERMS

1. Absorbed Dose, or sometimes simply referred to as Dose – the quantity of ionizing

radiation energy imparted per unit mass of the irradiated food.

Such dose is expressed as:

1.1 Gray (Gy) – SI unit of absorbed dose, equivalent to the absorption of 1 joule per
kilogram of food (1 Gy = 1 J/kg)

2. BFAD - Bureau of Food and Drugs, Department of Health

3. BFAR – Bureau of Fisheries and Aquatic Resources, Department of Agriculture

4. BHDT – Bureau of Health Devices and Technology, Department of Health

5. BPI – Bureau of Plant Industry, Department of Agriculture

6. Dosimetry – measurement of absorbed dose

7. Fish and Fishery Products – raw, frozen and processed fish, fishery products and
other aquatic products, e.g. shrimps

8. Food – any substance, whether processed, semi-processed or raw, which is

intended for human consumption and includes beverage, chewing gun and any other
substance which has been used in the manufacture, preparation of treatment of
“food”.
 9. Food Establishment – food manufacturer, processor or distributor.

10. Food Irradiation – the processing of food by ionizing radiation for a technological
objective or to serve a food hygiene purpose.

11. Food Irradiation Facility – a suitable facility licensed to irradiate food.

12. Ionizing Radiation any gamma rays, x-rays or corpuscular radiation capable of
producing ions directly or indirectly, as specified in IV. C- Reporting/Recording
hereof.

13. Irradiated Food – any food product, which has been subjected to treatment by
ionizing radiation with an appropriate absorbed dose. This does not apply to foods
exposed to radiation imparted by measuring instruments for inspection purposes.

14. Meat and Meat Products – raw, frozen and processed meat and poultry/livestock.

15. NMIS – National Meat Inspection Service, Department of Agriculture

16. PNRI – Philippine Nuclear Research Institute, Department of Science and

Technology

17. Plant Products - products derived from plants, either in their natural state or in
manufactured

IV. POLICIES & GUIDELINES

A. Licensing Requirements
a. General Licensing Requirements
1. Radiation treatment of food shall be carried out in a food irradiation
facility licensed and registered as required in this AO.
2. The food irradiation facility shall be designed and operated to meet
requirements of safety, efficacy and good hygienic practices of food
processing.
3. The food irradiation facility shall be staffed and operated by adequate,
trained and competent personnel
4. * Food irradiation facility shall operate within PNRI or BHDT standards
and requirements in the utilization and disposal or ionizing radiation for
food and food products

b. Specific Licensing Requirements

b.1 Food Establishment with Food Irradiation Facility

1. Food establishment with food irradiation facility shall be licensed and

controlled by BFAD.
2. A License to Operate shall be issued by BFAD if food establishment
complies with the following:
a. Current Codes General Standard for Irradiated Foods
(Annex A)
b. Current Codex Recommended International Code of
Practice of the Operation of Irradiation Facilities Used for the
Treatment of Foods (Annex B)
c. Good Manufacturing Practice (GMP) (Annex C)
3. For food establishment with existing LTO, the LTO shall indicate that
it has food irradiation facility.
 4. No food establishment shall operate a food irradiation facility without
a Radioactive Material License (Large Irradiator) from PNRI in the
case of gamma irradiation facilities or a license from BHDT in the
case of electron beam and x-ray facilities.

b.2 Food Establishment with Irradiated Product/s

1. Food establishment that indent to irradiate food product/s shall
secure a certification from BFAD.
2. A certification shall be issued to food establishments only upon
demonstration of compliance with Good Manufacturing Practices.
3. For quarantine control, the food establishment shall be accredited
and controlled by:
a. BPI for fresh fruits and vegetables
b. BFAR for fresh and frozen fish
c. NMIS for fresh and frozen meat/poultry/livestock
d. BFAD for processed food and food products

B. Standard Requirements for Food Irradiation

2. Radiation Sources

The following sources of ionizing radiation may be used for irradiation of food:
60 137
a. Gamma rays for radionuclides Co or Cs
b. X-rays generated from machine sources operated at or below an energy
level of 5MeV
c. Electrons generated from machine sources operated at or below an
energy level of 10 MeV

2. Irradiation of food is justified when it fulfils a technological objective or when it

serves a food hygiene purpose and should not be used as a substitute for good
manufacturing practice.
3. food intended for irradiation treatment must meet the general requirements of
quality and hygiene as recommended by the Codex General Principles of Food
Hygiene and other relevant Codex standards and codes of practice.
4. The food packaging materials used shall be suitable for irradiation and be
adequate to prevent re-infestation and re-contamination. Such packaging
materials should maintain their integrity during storage, transport and distribution.
5. The recommended dose ranges for the irradiation of various classes of foods for
specified treatment objectives is shown in Appendix 1. Doses outside this range
may be applied provided satisfactory information and assurance is given that the
doses applied will commensurate with technological and public health purposes
to be achieved and is in accordance with good radiation processing. Food treated
by ionizing radiation shall receive at least the minimum dose required to achieve
the desired technological effect and the maximum dose received shall not affect
the quality of the product.
6. The irradiated food shall comply with the current Codex General Standard for
Irradiated Food
7. Control of the irradiation process shall be carried out in accordance with the
current Codex Recommended International Code of Practice for the Operation of
Irradiation Facilities Used for the Treatment of Foods
7.1 Dosimetry complying with duly recognized international practices. As such
the operators shall be able to demonstrate the ability to carry out dosimetry
as provided hereunder:
a. Measure absorbed dose in an accurate and precise manner
b. Determine the dose distribution in the product.
c. Calibrate dosimetry systems, traceable to national or international
standards.
 d. Keep dosimetry records.

7.2 Procedures to physically segregate irradiated from non-irradiated products

When applicable, as visual color change radiation indicator can be affixed to the
outer package to readily distinguish irradiated from non-irradiated products.

C. Reporting/Recording
1. The facility shall submit an annual written report to BFAD, containing the following
information
a. The name of the facility
b. The reporting period (January 1 – December 31)
c. Description of food treated by ionizing radiation
d. The quantity food treated by ionizing radiation, including lot numbers and
date of irradiation.

2. Documentation process to maintain a record of each batch of food subjected to the

irradiation treatment. Such records shall be kept for a period of three (3) years and
shall be readily available for inspection by BFAD. The record shall contain:
a. The lot/code number of each batch
b. The date of irradiation
c. The type and quantity of the irradiated food
d. The packaging used during the irradiation treatment
e. All controls and measurement performed during the irradiation treatment,
particularly those related to minimum and maximum doses
f. Any incidents or deviation observed during the irradiation treatment.

D. Inspection of the Irradiation Facility and the Irradiated Food

1. Food Establishment with food irradiation facility shall be inspected by BFAD while
the compliance of standards and requirements for utilizing ionizing radiation shall
be checked/monitored by PNRI or BHTD as the case maybe, at, any time during
the validity of its license to ensure that compliance with the standards and
requirements or conditions of its license is maintained.
2. The irradiated food products wherever they are held shall be subject to
inspection in accordance with Section 27 of RA 3720 as amended.
3. Products irradiated for quarantine control shall be inspected by appropriate
agencies described in Section 5.2.2.1.

E. Labelling of Irradiated Food

1. Labeling of irradiated food shall comply with the provisions of the Codex General
Standard for Irradiated Food and the Codex General Standard for Labeling Pre-
packaged Foods and the mandatory labeling information required by BFAD for
pre-packaged food.
2. The labeling of pre-packaged irradiated food at the retail outlets shall contain the
international logo for irradiated food with the statement “treated by irradiation” or
its equivalent, in addition to the mandatory labeling information required by BFAD
for pre-packaged food.
3. The information required for pre-packaged irradiated food shall be posted and/or
conspicuously displayed in the shelves where irradiated food which are not pre-
packaged are being displayed for sale to consumers at the retail outlets.
4. Irradiated food for wholesale or distribution to retailers shall be labeled with
sufficient information to identify the product and shall be accompanied by
documents that will contain the following:
a. Irradiation facility where the products were treated and its address
b. License number of the facility and its validity period
c. Date of irradiation
 d. Purpose of irradiation

F. Re-Irradiation
1. Re-irradiation of food shall conform with Codex provision for the re-irradiation of
food.
2. Irradiated foods shall not be re-irradiated except under the following conditions:
a. Irradiated food of low moisture content such as cereals, pulses and
dehydrated food, for the purpose of controlling insect re-infestation.
b. Foods prepared from materials which have been irradiated at low dose
may be irradiated for another purpose.
c. Foods containing less than 5% of irradiated ingredients.
d. Foods irradiated in installments to a total absorbed dose required to
achieve the intended purpose.

G. Importation and Exportation of Irradiated Food

1. Importation of irradiated food shall be covered by a BFAD Certificate of Product
Registration (CPR), which shall be issued upon an application by the importer,
who shall submit the following information and documents:
a. The identity, lot number and date of irradiation of the products to be
imported
b. Name and address of the irradiation facility which treated the products
c. The country of origin
d. A certificate from the food control agency of the country of origin that the
irradiation facility is duly licensed and the irradiation process
appropriately applied.

2. importation of irradiated agricultural products such as plants products, fish and

fishery products and meat and meat products shall also follow existing import
and quarantine requirements of concerned agencies, Department of Agriculture
of raw and unprocessed foods and Bureau of Food and Drugs for processed
foods.
3. Exportation of irradiated food shall be covered by a BFAD CPR, which shall be
issued upon an application by the exporter, who shall submit the following
information and documents:
a. The identity, lot number and date of irradiation of the products to be
exported
b. Name and address of the irradiation facility which treated the products,
license number and validity period.
c. Name of the importing company and its address

4. Exportation of irradiated food for quarantine control shall follow existing export
and quarantine requirements of the concerned agencies, Department of
Agriculture of raw and unprocessed foods and Bureau of Food and Drugs for
processed foods.

The BFAD CPR and clearances from concerned Bureaus of the Department of
Agriculture shall carry the condition that the exported irradiated food shall
comply with the rules and regulations governing irradiated food in the importing
country.

V. LEGAL SANCTIONS
1. Irradiated foods that do not comply with any of the foregoing standards and
requirements shall be deemed either adulterated and/or misbranded under the
provision of R.A. 3720 as amended and may not be allowed for distribution into
commerce or be ordered withdrawn from the market unless deficiencies can be
corrected without withdrawing or recalling the said products from the market.
 2. Imposition of fines and suspension or revocation of the Certificate of Product
Registration (CPR), and/or license to operate food irradiation facility.

Any deficiencies in complying with or violators of PNRI or BHDT standards and

requirements for facilities utilizing ionizing radiation or any violations of any provisions
of this Order shall be a ground for the imposition of fines or suspension or revocation
of the CPR and/or license to operate of a food irradiation facility as properly
determined by BFAD after due notice and hearing.
3. The above administrative penalties shall be in addition to any criminal action the
BFAD may initiate in accordance with RA No. 3720 as amended, otherwise known as
the Foods, Drugs and Devices, and Cosmetics Act.

VI. SEPARABILITY/REPEALING CLAUSE

If any provision of these guidelines is declared null and void, for any reason, the
remaining provisions shall not be affected thereby and shall remain valid.

VII. EFFECTIVITY

This Order shall be effective thirty (30) days following its publication in two (2)
newspapers of general circulation, once a week for a period of one (1) month.

(Sgd) MANUEL M. DAYRIT, M.D., MSc.

Secretary of Health
 Appendix I

RECOMMEND TECHNOLOGICAL DOSE RANGE

FOR THE IRRADIATION OF FOODS

Technological Dose
Classes of Food Purpose of Treatment Range (kGy)
Minimum Maximum
Dose Dose

Class 1: Bulbs, roots and tubers Inhibition of sprouting 0.05 0.2

Class 2: Fresh fruits and a) delay of ripening 0.20 1.0

vegetables (other than
class 1) b) shelf-life extension 1.0 2.5

c) quarantine control* 0.15 1.0

Class 3: Cereals and their milled a) insect disinfectant* 0.25 1.0

products, nuts, oil seeds,
pulses, dried fruits b) reduction of microbial 1.5 5.0
load

c) inhibit sprouting 0.15 1.0

Class 4: Fish, seafood and their a) reduction of 1.0 7.0

products, frogs legs, pathogenic
freshwater and terrestrial microorganisms **
invertebrates (fresh or 1.0 3.0
frozen) b) shelf-life extension
0.1 2.0
c) control of infection by
parasites**

Class 5:Raw poultry and meat a) reduction of 1.0 7.0

and their products (fresh pathogenic
and frozen) microorganisms **
1.0 3.0
b) shelf-life extension
0.3 2.0
c) control of infection by
parasites**
Class 6: Dry vegetables, spices, a) reduction of 2.0 30.0
condiments, dry herbs pathogenic
and herbal tea microorganisms **
0.3 1.0
b) insect disinfection*

Class 7:Dried food of animal a) insect disinfection* 0.3 1.0

origin
b) control of molds 1.0 3.0

c) reduction of 2.0 7.0

pathogenic
 microorganisms**
Class 8: Ethnic food and a) reduction of ***
miscellaneous foods, pathogenic
including but not limited microorganisms **
to: health foods, ethnic ***
preparations of hospital b) sterilization
foods, gum Arabic and ***
other thickeners, military c) quarantine control*
rations, honey, space
foods, special spices,
eggs.

* Minimum dose may be specified for a particular pest

** Minimum dose may be specified keeping in mind the objective of the treatment to ensure
hygienic quality of food
*** Maximum dose to be specified for particular purpose and foodstuff