Philippine Food Fortification Program IRR

Legal basis and governing policy

Section 12 of Republic Act No. 8976 authorizes the formulation of these implementing rules and regulations for effective implementation by authorized DOH officials and representatives in consultation with other concerned government agencies, non-government organizations, private sector, and consumer groups.
The State’s policy requires protection and promotion of the people’s right to health and instilling health consciousness (Section 2, Article II of the Constitution, as reflected in Republic Act No. 8976).
Republic Act No. 8976 recognizes nutritional deficiencies in energy, iron, vitamin A, iodine, thiamin, and riboflavin, and (to a minor extent) deficiencies in ascorbic acid, calcium, and folate.
Republic Act No. 8976 declares food fortification essential where there is a demonstrated need to increase intake of an essential nutrient by one or more population groups, based on dietary, biochemical, or clinical evidence of deficiency.
Republic Act No. 8976 requires fortification to compensate for nutrient loss due to processing and/or storage and to compensate for inadequacies in the Filipino diet based on present needs measured using the most recent Recommended Dietary Allowance (RDA).

Defined terms for food fortification

Acceptable standards on food fortification are fortification requirements set by the DOH through BFAD in consultation with other concerned agencies and industry representative groups.
BFAD means the Bureau of Food and Drugs of the Department of Health.
Brown-rice means palay with the hull removed; it is also known as “dehulled rice” or “husked rice.”
Cooking Oil means edible oil derived from vegetable sources intended for human consumption, including its use in food preparation or processing other food products.
DOH means the Department of Health as lead agency in implementation and monitoring.
Food service establishment means hotels, restaurants, carinderias, catering firms, hospitals, and other related outlets that serve or sell food to customers.
Fortification means addition of nutrients to processed foods/food products at levels above the natural state, as a strategy to control micronutrient deficiency by adding a micronutrient deficient in the diet to a widely consumed food for specific at-risk groups.
Fortificant means a substance added to food (in chemical or natural form) to increase its nutrient value.
Glutinous rice means rice whose grains are white and opaque and coagulates into a sticky mass when cooked.
Importer means any person (natural or juridical) that brings in food/food products from other countries for its own use or for wholesale/retail distribution to other food establishments/outlets; an importer may also be a manufacturer.
Manufacturers means: the refinery for refined sugar or cooking oil; the miller for flour, rice, or imported processed foods/food products; or the processor for other processed foods/food products.
Maximum tolerable level means the reference point to check safety and quality using individual samples.
Minimum acceptable level means the level of fortificant required by BFAD that must appear on the label and be present at the retail level.
NNC means the Governing Board of the National Nutrition Council.
Micronutrient means an essential nutrient required in very small quantities, with recommended intakes in milligrams or micrograms.
Nutrient means any chemical substance needed by the body for functions including providing heat/energy, building and repairing tissues, and regulating life processes; nutrients are found chiefly in foods, and some can be synthesized or produced through biosynthesis.
Nutrition facts means the statement/information on food labels indicating the nutrient(s) and their quantity in processed foods/food products.
Nutrition labeling means describing processed foods/food products based on selected nutrient content; it appears on labels as “Nutrition Facts.”
Processed food or food products means food subjected to processing such as milling, drying, concentrating, canning, or ingredient addition that changes physico-chemical and/or sensory characteristics of the raw material.
Quality control procedures are planned and systematic activities within the quality system demonstrating adequate confidence that fortification requirements are fulfilled.
Recommended Dietary Allowance (RDA) means nutrient intake levels considered adequate to maintain health and provide reasonable reserves in body tissues of nearly all healthy persons.
Refined sugar means raw sugar processed into white, crystalline household and processed-food ingredient sugar, including sugar beets and sugar-containing flavoring/coloring matter where sugar content is over 65% by dry weight; for this IRR, refined sugar substitutes fortifiable such as Very High Pol Low Color sugars, Plantation whites, and sulphitated white are considered refined sugar.
Repacker may be a manufacturer, tollee, or distributor that packs from bulk to retail packaging.
Sangkap Pinoy Seal Program means a strategy authorizing manufacturers to use the DOH seal of acceptance for processed foods/food products after products meet defined criteria; the seal guides consumers in selecting nutritious foods.
Staple food means basic food normally consumed daily by the general population, e.g., rice, flour, sugar oil.
Tollee means any person (natural or juridical) including trader, buyer/seller, repacker, or producer who owns raw materials such as raw sugar, palay, crude vegetable oil, and wheat grains and engages refinery/miller for a fee (tolling fee).
Unprocessed food means food not treated to substantially change its original state, even if divided, boned, skinned, cut, cleaned, trimmed, fresh-frozen, or chilled.
Wheat flour means a powdery product primarily made from milling wheat grains.

Coverage, program systems, and licensing

The Philippine Food Fortification Program covers all imported or locally processed foods or food products for sale or distribution in the Philippines for human consumption, except as provided under Section 2 of Rule X.
The program consists of two systems: (a) voluntary food fortification and (b) mandatory food fortification for specified products enumerated in Section 6 of Republic Act No. 8976 and any others required by the NNC under the same section.
These IRR rules apply to manufacturers/producers, importers, traders, tollees, retailers, and repackers for food products covered under Section 2 of Rule IV, and to restaurants and food service establishments where fortified food products are encouraged to be served.
Business establishments (except food service establishments) must be duly licensed by concerned government agencies such as National Food Authority for rice, BFAD for wheat flour, Sugar Regulatory Administration for sugar, and Philippine Coconut Authority for cooking oil.
Licensed establishments must inform BFAD prior to the process of fortification and must register products with BFAD prior to distribution.
Government agencies listed for licensing must enter a Memorandum of Agreement with BFAD regarding the licenses.

Voluntary fortification under SPSP

Under the Sangkap Pinoy Seal Program (SPSP), the DOH encourages fortification of processed foods/food products based on DOH rules and regulations issued by the DOH through BFAD after effectivity of Republic Act No. 8976.
Manufacturers that opt to fortify but do not apply for registration under SPSP must fortify according to acceptable standards on food fortification set by DOH through BFAD.
Over- or under-fortification limits must follow DOH guidelines for food fortification embodied in DOH Administrative Order No. 4-A series of 1995 and other necessary DOH guidelines issued in consultation with concerned industry and/or government agencies.

Mandatory fortification standards and responsibilities

Mandatory fortification applies to the following staple foods in accordance with DOH standards through BFAD, subject to Section 2 of Rule X:
- All rice, except brown rice and locally produced glutinous rice, fortified with iron with these minimum and maximum levels:
  - Iron (Ferrous Sulfate): 60 mg Fe/kg raw rice (minimum) and 90 mg Fe/kg raw rice (maximum tolerable).
  - Other fortificants approved by DOH/BFAD: minimum and maximum set by BFAD.
- Wheat flour fortified with vitamin A and iron with these minimum and maximum levels:
  - Vitamin A (Retinol palmitate/acetate): 3.0 mg/kg as retinol (minimum) and 6.5 mg/kg as retinol (maximum tolerable).
  - Iron (Elemental Iron): 70.0 mg Fe/Kg (minimum) and 105 mg Fe/Kg (maximum tolerable), with electrolytic/hydrogen reduced and particle size < 50 microns.
  - Iron (Ferrous Sulfate or Ferrous Fumarate): 50.0 mg Fe/Kg (minimum) and 75.0 mg Fe/Kg (maximum tolerable).
  - Other approved fortificants: minimum and maximum set by BFAD.
- Refined sugar for human consumption fortified with vitamin A with these minimum and maximum levels:
  - Vitamin A (Retinol palmitate): 5.0 mg/Kg (minimum) and 30.0 mg/Kg (maximum tolerable).
  - Other approved fortificants: minimum and maximum set by BFAD.
- Cooking oil for human consumption fortified with vitamin A except for export, with these minimum and maximum levels:
  - Vitamin A (Retinol palmitate): 12.0 mg RE/L (minimum) and 23 mg RE/L (maximum tolerable).
  - Other approved fortificants: minimum set by BFAD; maximum set by BFAD.
- Other staple food products fortified with appropriate nutrients required by NNC when nutrition surveys show need and scientific findings show feasibility of fortification.
- Fortification required by NNC does not require further legislation but proceeds through DOH/BFAD regulations issued in consultation with other concerned agencies and industry organizations.
Mandatory fortification responsibilities are allocated as follows:
- Locally processed staple food products must be fortified by the manufacturer.
- If the manufacturer is not the owner of raw sugar, crude vegetable oil, palay, and wheat grains, the tollee must notify the refinery or miller of the destination of processed food, whether for export, for production of other processed food products, or for direct human consumption.
- If mandatory fortification by the tollee is not required but the tollee nevertheless sells or distributes the same where fortification is required, the tollee is responsible for the non-fortification.
- The miller or refiner must report monthly to BFAD any non-fortification required by the tollee.
- Imported staple food products must be fortified by the manufacturer at the place of manufacture; if not fortified at source, the importer must fortify before release for sale or distribution in the Philippines.
- Repackers must repack only staple food products that have been fortified.
Fortified staple food product labels offered for sale in the market must include:
- A statement of the fortificant added, and
- The amount present within the shelf life of the product.

Quality assurance, implementation, monitoring, and reporting

The agencies responsible for implementation must establish a quality assurance system for food fortification in accordance with Section 7 of Republic Act No. 8976.
Manufacturers/importers and repackers must establish their own quality assurance systems that conform to the implementing agency’s quality assurance system, using Annex 1 (General Quality Assurance System for Food Fortification) as a guide.
The DOH through BFAD is the lead agency in implementation and monitoring.
The DOH leads planning of food fortification activities, including promotion and advocacy through the Sangkap Pinoy Seal Program and other nutrition promotion programs.
Products accepted under SPSP may use the SPSP seal.
The DOH may charge reasonable fees and use SPSP fee collections for promotional and advocacy activities on nutrition; BFAD may collect reasonable fees for registration of fortified products.
The NNC serves as the policymaking and coordinating advisory body on food fortification and must conduct a periodic review at least once every five years or upon petition by an industry mandated to fortify products to determine whether mandatory fortification is still needed.
The NNC review must use the FNRI national nutrition survey date and/or assessment of the Philippine Plan of Action on Nutrition (PPAN), and other nutrition surveillance systems.
Monitoring and review assistance is required from:
- SRA for sugar,
- NFA for rice,
- PCA for cooking oil,
- Bureau of Customs for imported products,
- and other agencies enumerated in Rule IX.
BFAD must continue monitoring and reviewing fortification of wheat flour.
BFAD must formulate standard operating procedures (SOP) for monitoring implementation.
LGUs must assist monitoring of foods mandated to be fortified in public markets, retail stores, and food service establishments.
LGUs must check whether fortified product labels contain nutrition facts stating the nutrient added and quantity.
LGUs must designate only one set from authorized officials under Republic Act No. 8976, Section 8:
- Health officers, or
- Agricultural officers, or
- Nutritionist-dieticians, or
- Sanitary Inspectors.
LGUs must inform BFAD which designated officer set will monitor fortified products and must submit monitoring reports to BFAD in the manner and form prescribed by BFAD.
Business establishments in local food industries and importers of processed foods covered by the Act must submit to DOH:
- Annual reports indicating industrial concerns relative to food fortification, and
- Reporting on production, marketing, and distribution of food-fortified products they manufacture.
The Bureau of Customs must inform DOH through BFAD of all imported rice, sugar, wheat flour, and cooking oil prior to release to enable BFAD to determine whether imported products are already fortified.
BFAD must conduct a final inspection ensuring imported products are fortified and registered with BFAD as fortified products before sale and distribution.

Support for affected manufacturers and budgeting

The DTI, through BOI, must assist affected manufacturers in upgrading technologies by helping obtain soft loans and financial assistance for procurement of technologies and machines, and must provide incentives by including food fortification as a priority investment/activity.
DTI incentives may include exemption from customs duties and national internal revenue taxes on imported capital equipment and spare parts and inputs required in fortifying food products, tax credits on the portion of food products fortified, and tax credit on domestic capital equipment and/or spare parts equivalent to the normal duty on the imported counterpart.
The DOST must assist affected manufacturers by developing and implementing a comprehensive program for acquisition, design, and manufacture of new machines and technologies, and transfer these technologies and machines to manufacturers.
The Land Bank of the Philippines (LBP) and LIVECORP must grant loans at preferential rates of interest to manufacturers of fortified food products.
Manufacturers under mandatory and voluntary fortification programs may avail of analytical laboratories of government agencies and institutions for nutrient analysis at reasonable cost, and specified agencies with accredited facilities must assist manufacturers.
The Department of Finance through the Bureau of Internal Revenue may grant tax credits to business establishments that undertake food fortification before the effectivity of mandatory food fortification.
Agencies mandated to implement and support the program under Rule VIII and Rule IX must allocate part of their budgets for implementation and support of the program.

Non-compliance and administrative sanctions

Non-compliance with the food fortification process includes acts where:
- Fortification level does not comply with the requirements under Rule VI, Section 1, except when deviation is justified and properly declared on the product label;
- The fortificant used is different from that approved by DOH/BFAD; or
- The fortification process does not conform to Rule VII.
Exceptions may be allowed, subject to BFAD approval, in cases of:
- Dietary supplements for which established standards are already prescribed by DOH through BFAD; and
- Products intended for exports or for use in producing other processed food products where the fortified product used for food processing may affect the processed product by the fortificant.
Administrative sanctions for violations entitle DOH through BFAD, after due notice and hearing, to impose applicable sanctions including:
- Deny registration of new processed foods and staple food products that do not comply with fortification requirements, and not allow such products to be sold in the market;
- Order recall or withdrawal of noncompliant products from the market if already sold and distributed;
- For the first violation, impose a fine of not less than PHP 300,000 and impose suspension of registration of the products;
- For the second violation, impose a fine of not more than PHP 600,000 but not less than PHP 300,001, and impose suspension of product registration;
- For the third violation, impose a fine of not more than PHP 1,000,000 but not less than PHP 600,001, and impose cancellation of product registration.
If the violator is a juridical entity, the person responsible for the violation is jointly and solidarily liable with the juridical entity for administrative fines.
If the violation is attended by manifest intention to mislead, defraud, or deceive the consuming public, the maximum fine and revocation of License to Operate and License to sell are imposed.
Appeals from BFAD decisions are handled by the Secretary of Health, who may delegate administrative investigation to an adjudication board composed of:
- BFAD as Chairman;
- DILG;
- DTI;
- an official from SRA or NFA or PCA or BFAD, as the case may be (sugar, rice, cooking oil, or wheat flour, respectively); and
- an industry representative nominated by the industry organization whose product is subject of investigation, provided the representative is not personally involved in the matter.
Further action after the adjudication board decision remains subject to BFAD rules and procedures.

International commitments, repeals, separability, amendments

No provision is intended to violate treaties and international agreements to which the Philippines is a party.
All administrative orders, circulars, and rulings on food fortification issued by DOH and/or BFAD and other agencies involved in nutrition regulation that are inconsistent or contrary to Republic Act No. 8976 or these IRR are repealed or amended.
If any part of these rules and regulations is declared null and void by a court of competent jurisdiction, the remaining portions remain legal and valid and in full effect.
Amendments to these IRR must be made in the same manner as formulation, through consultative meetings of the same agencies involved in formulation as required by Section 12 of Republic Act No. 8976.