Revised IRR of RA 8172

Policy purposes and interpretive rule

The rules are construed to eliminate micronutrient malnutrition, particularly iodine deficiency disorders (Rule II, Section 1(a)).
The rules ensure that only iodized salt is available in the market for human and animal consumption (Rule II, Section 1(b)).
The rules require salt industry participants to carry out iodization and sale/distribution exclusively for iodized salt:
- Producers/manufacturers and importers must iodize salt they manufacture, produce, distribute, trade, and/or import (Rule II, Section 1(b.1)).
- Repakers must repack and sell only iodized salt (Rule II, Section 1(b.2)).
- Distributors, retailers, and vendors must distribute or sell only iodized salt (Rule II, Section 1(b.3)).
- Food processing and food service industries must use only iodized salt (Rule II, Section 1(b.4)).
- Food service establishments must use only iodized salt in food they serve (Rule II, Section 1(b.5)).
The rules require national and local governments to perform roles and responsibilities through necessary resources, mechanisms/incentives for the salt industry, strict enforcement, a massive public information campaign, and enactment/enforcement of ordinances (Rule II, Section 1(c)).
The rules require sustainability of the salt iodization program through concerted efforts of agencies enumerated in the rules (Rule II, Section 1(d)).
Any question or doubt on intent and meaning is resolved in accordance with the ASIN Law’s policy and purposes (Rule II, Section 1).

Coverage and key definitions

The rules apply to:
- Salt producers/manufacturers, repackers, importers, traders, distributors, and retailers, including public market vendors for salt for human or animal consumption (Rule I(a)).
- Food service establishments where food is served or sold (Rule I(b)).
- Food manufacturers/processors using salt in manufacturing processes (Rule I(c)).
- All LGUs (Rule I(d)).
- All other government agencies (Rule I(e)).
- Non-government agencies and related professional organizations involved in nutrition (Rule I(f)).
- Government and private hospitals and other institutions (Rule I(g)).
The rules define key terms for implementing the ASIN Law:
- Center for Health Development (CHD) as the former Regional Office of DOH (Rule III(a)).
- Distribution includes exchange, transmittal, conveyance, consignment, supply, delivery, trade, sale, or disposal of food-grade salt (with or without remuneration) (Rule III(b)).
- Distributor is a person/establishment that distributes, sells, or imports salt for distribution to retailers and “outer outlets” (Rule III(c)).
- Fortificant in salt iodization refers to potassium iodate or other suitable fortificant recommended and approved by DOH-BFAD, considering quality, effectiveness, stability, availability, and new discoveries (Rule III(d)).
- Food fortification is addition of nutrients to processed foods at levels above the natural state (Rule III(e)).
- Food-grade salt is salt for human and animal consumption distinguished from industrial salt (Rule III(f)).
- Food manufacturers/processors are businesses/enterprises manufacturing or processing food using salt (Rule III(g)).
- Food service establishments are hotels, restaurants, carinderias, catering firms, hospitals, canteens, and similar outlets that serve/sell food (Rule III(h)).
- Importer buys salt from outside the country (Rule III(i)).
- Industrial salt is salt used in treatment, processing, and/or manufacture of non-food commercial products (Rule III(j)).
- Iodized salt is ordinary salt with fortificant Potassium Iodate (K103) as defined in Rule III(d) (Rule III(k)).
- Iodine deficiency disorders are manifestations resulting from lack of dietary iodine that reduce intellectual and physical capacity, including goiter, mental retardation, physical and mental defects, and cretinism (Rule III(l)).
- Label means any written/printed/graphic matter on an article/container/wrapper or accompanying packaged food describing the product (Rule III(m)).
- Licensing is securing a BFAD license as manufacturer, producer, trader, or importer of iodized salt; the importer must also secure a license to manufacture and iodize the imported salt (Rule III(n)).
- Manufacturer classifications are based on annual production volume:
  - Large: exceeding 2,000 MT/year (Rule III(o)(1)).
  - Medium: more than 300 MT to 2,000 MT/year (Rule III(o)(2)).
  - Small: more than 2 MT to 300 MT/year (Rule III(o)(3)).
  - Subsistence: not exceeding 2 MT/year (Rule III(o)(4)).
- Salt iodization is addition of iodine to salt intended for human and animal consumption according to BFAD-prescribed specifications for form, fortificant, method, manner, and composition (Rule III(v)).
- Salt Iodization Advisory Board (SIAB) is the national policy/coordinating body composed of members of the NNC Governing Board, including representatives from DENR, the medical profession, and salt manufacturers (Rule III(w)).
- Signage is written/printed/graphic material not less than 8 1/2 x 11" stating the establishment uses iodized salt in compliance with the ASIN Law (Rule III(x)).
- Stores/Markets include department stores, shops, groceries, mini-marts, sari-sari stores, wet markets, and other outlets selling wholesale or retail iodized salt to consumers (Rule III(y)).
- Trading is buying and selling food-grade salt at wholesale or retail (Rule III(z)).

Iodization standards and quality controls

BFAD prescribes the following composition and standards for iodizing salt:
- Purity requirements include:
  - Identification positive for Sodium and Chloride (Rule IV, Section 1).
  - Assay (min) of 97% (dry basis) (Rule IV, Section 1).
  - Moisture (max) of 4% for refined salt and 8% for unrefined salt (Rule IV, Section 1).
  - Calcium and Magnesium (max) of 2% (Rule IV, Section 1).
  - Heavy metals limits:
    - Arsenic (max) 1.0 mg./kg (Rule IV, Section 1).
    - Cadmium (max) 0.5 mg/kg (Rule IV, Section 1).
    - Lead (max) 2.0 mg/kg (Rule IV, Section 1).
    - Mercury (max) 0.2 mg/kg (Rule IV, Section 1).
- The salt may contain natural secondary products including calcium, potassium, and magnesium compounds (Rule IV, Section 1).
Iodine levels are set based on salt origin and type of packaging/site:
- Locally produced salt:
  - Bulk (>2 kgs): 70 – 150 mg/kg (Rule IV, Section 1).
  - Retail (<2 kgs) production site: 60 – 100 mg/kg (Rule IV, Section 1).
  - Retail site: 50 – 100 mg/kg (Rule IV, Section 1).
- Imported salt:
  - Bulk (>2 kgs): 70 – 150 mg/kg (Rule IV, Section 1).
  - Retail (<2 kgs) production site: 60 – 100 mg/kg (Rule IV, Section 1).
  - Retail site: 40 – 100 mg/kg (Rule IV, Section 1).
When iodized salt is used in processing food products, iodine level may exceed the stated standard to account for iodine losses during processing (Rule IV, Section 1).
BFAD shall review and update iodization standards annually, in consultation with SIAB and other concerned parties (Rule IV, Section 1).
Failure to comply with quality specifications and labeling requirements constitutes a violation of:
- Adulteration and misbranding under Sections 14 and 15 of Republic Act No. 3720 (Food, Drugs and Cosmetics Act, as amended), and
- Relevant provisions of Republic Act No. 7394 (Consumer Act of the Philippines) (Rule IV, Section 2).
Producers must ensure quality of iodized salt prior to distribution through specific controls:
- Collect and test samples of iodized salt for iodine content at regular intervals on a daily basis, using titration and/or iodine test kits (Rule IV, Section 3(a)).
- Inspect equipment at least twice daily to ensure proper operation (Rule IV, Section 3(b)).
- Monitor mixing to ensure consistent mixing/homogeneity of iodine content in each batch (Rule IV, Section 3(c)).
- Sample each lot for integrity of salt in the package (Rule IV, Section 3(d)).
- Routinely inspect packaging and labeling for conformity to prescribed labeling requirements (Rule IV, Section 3(e)).
- Maintain records:
  - Daily control charts and weekly summaries of activities/corrective actions,
  - Kept for at least 12 months from date of manufacture (Rule IV, Section 3(f)).
- Provide traders with a Salt Iodization certification indicating the iodine level of the specified Batch No. traded/sold, and the date of iodization (Rule IV, Section 3(f)).
Iodized salt distribution and retail sale must follow first in, first out; iodized salt sold beyond twelve (12) months from the date of iodization is expired (Rule IV, Section 4).
Expired iodized salt must not be sold or distributed for human and animal consumption; it must be returned to the last seller or distributor for re-iodization (Rule IV, Section 4).
DOH through BFAD must set up a monitoring system for quality of iodized salt in collaboration with LGUs and enforcement bodies including DILG, PNP, Coast Guard, DENR, PPA, and LTO, and seek LGU and Bureau of Customs (BOC) assistance to determine production and sale volumes of locally manufactured and imported iodized salt, respectively (Rule IV, Section 5).

Importation and sale requirements

Industrial salt importation must be in bulk and never in bags or sacks (Rule IV, Section 6).
Imported salt in bulk intended for human or animal consumption must be released to the importer’s warehouse for iodization and must be inspected by BFAD after iodization; until iodized and inspected, it cannot be sold or distributed (Rule IV, Section 6).
Prior to arrival, importers must submit to BFAD a non-negotiable copy of Bill of Lading, Commercial Invoice, and packing list, if any (Rule IV, Section 6).
BFAD must endeavor not to delay the above transactions (Rule IV, Section 6).
No imported salt may be released from BOC unless BFAD issues clearance (Rule IV, Section 6).
Imported salt in bags or sacks is limited to iodized salt only, subject to BFAD inspection upon arrival (Rule IV, Section 7).
If the iodine level is below Philippine standards, the importer must iodize it to conform to Philippine standards (Rule IV, Section 7).
Pure vacuum dried salt may be imported in bags or sacks; if it will be used for human or animal consumption, it must be iodized by the importer prior to market release (Rule IV, Section 7).
Salt manufacturers/producers, traders, retailers, repackers, and stores/markets must provide proper identification/labels of iodized salt during retail display (Rule IV, Section 8).

Food use of iodized salt and labeling

Food manufacturers and producers must utilize iodized salt in their products except when using iodized salt would have an adverse effect on a specified product (Rule IV, Section 9).
In exemption cases, food manufacturers/producers must present proof to BFAD that iodized salt use has an adverse effect on the food products; the proof serves as basis for exemption from compliance with Section 5(e) of RA 8172 (Rule IV, Section 9).
BFAD submits to SIAB an annual list of:
- Food manufacturers utilizing iodized salt; and
- Those granted definite exemption (Rule IV, Section 9).
BFAD provides a list of recognized laboratories that can assess claims of adverse effect (Rule IV, Section 9).
All food manufacturers and processors must include a label on the use of iodized salt in their food products (Rule IV, Section 10).

Data systems and databases

BFAD and Department of Science and Technology (DOST) must establish a database on salt iodization (Rule IV, Section 11).

Licensing, registration, and certifications

All salt producers, manufacturers, traders, repackers, and importers must secure a License to Operate (LTO) as manufacturer from BFAD, complying with documentary and technical requirements (Annexes 1-2) (Rule V, Section 1).
BFAD may delegate to DOH-CHDs authority to renew/validate LTOs (Rule V, Section 1).
All salt (locally manufactured and imported) must be registered with BFAD (Rule V, Section 2).
Imported non-iodized salt must be iodized by the importer before sale to the public (Rule V, Section 2).
If iodization is done by the importer, the importer must issue a Salt Iodization Certification identifying the firm that iodized the salt (Rule V, Section 2).
If the imported salt is already iodized, the importer must secure a Salt Iodization certification from its suppliers (Rule V, Section 2).
Failure to secure the LTO subjects the party to sanctions under Rule VIII (Rule V, Section 3).

Agency roles in salt iodization program

DOH, as lead agency, must:
- Set and enforce standards for food-grade iodized salt and monitor compliance through BFAD by manufacturers/importers, distributors, and traders specified in Section 2, Rule VIII (Rule VI, Section 1(a)).
- Provide training on iodization technology and quality assurance through its CHDs, in coordination with DOST and Technology and Livelihood Resource Center (TLRC) (Rule VI, Section 1(b)).
- Spearhead a public information drive with LGUs and agencies including DepED and PIA, DOST provincial science and technology centers, the private sector, and students; the salt industry must assist using tri-media and social marketing for a systematic, sustained campaign (Rule VI, Section 1(c)).
- Set up and maintain a functional monitoring and evaluation system with LGUs and other agencies (Rule VI, Section 1(d)).
LGUs must support program development and sustainability with DILG coordination by:
- Enacting and enforcing local ordinances requiring outlets/supermarkets/wet markets/vendors to sell only iodized salt, requiring salt producers to iodize their salt, and requiring food service establishments (e.g., restaurants) to use iodized salt and display required signage (Rule VI, Section 2(a)).
- Monitoring presence of iodine through market inspectors/supervisors, health officers, nutritionist-dietitians, sanitary inspectors, and/or officials designated by the local chief executive (Rule VI, Section 2(b)).
- Establishing and maintaining lists of salt producers, importers, and distributors within their territorial jurisdiction, and submitting lists to BFAD within six (6) months from effectivity of this revised IRR, including required information items (Rule VI, Section 2(c)).
- Providing budget for implementation (Rule VI, Section 2(d)).
- Assisting in organizing salt producers into cooperatives (Rule VI, Section 2(e)).
- Submitting semestral accomplishment reports to DOH-CHD copy furnished to BFAD for the first three years from approval of the IRR (Rule VI, Section 2(f)).
- Assisting other government agencies in program implementation (Rule VI, Section 2(g)).
DTI must assist salt producers/manufacturers through upgrading production technologies, including soft loans and financial assistance for machines, packaging equipment, technology, fortificants, and systematic iodized salt distribution; it must:
- Monitor price and supply situation under Republic Act No. 7581 (Rule VI, Section 3(a)).
- Provide incentives by including salt iodization as a priority investment program through Board of Investments (Rule VI, Section 3(b)).
- Assist obtaining soft loans through SBGFC for machines/equipment/materials including fortificant and chemicals (Rule VI, Section 3(c)).
- Assist on package design and packaging technology through PDDCP (Rule VI, Section 3(d)).
- Provide recommendations/mechanisms to facilitate production and distribution of iodized salt for human and animal consumption (Rule VI, Section 3(e)).
DOST must:
- Develop and implement assistance programs for equipment design/fabrication (Rule VI, Section 4(a)).
- Provide technical assistance in design, maintenance, and operation of iodization machines (Rule VI, Section 4(b)).
- Transfer iodization technology (Rule VI, Section 4(c)).
- Assist iodized salt utilization and consumption promotion (Rule VI, Section 4(d)).
- Assist local producers meeting quality specifications via improved solar-evaporation methods (Rule VI, Section 4(e)).
- Continue fortification R&D supporting RA 8172 (Rule VI, Section 4(f)).
DepEd must:
- Integrate salt iodization and food fortification concepts into elementary and secondary curriculum (Rule VI, Section 5(a)).
- Monitor household use through school children (Rule VI, Section 5(b)).
- Require iodized salt use in preparation of salt-seasoned food items sold at school canteens, all food establishments within school premises, and food supplements distributed by schools (Rule VI, Section 5(c)).
- Promote use through the Teacher-Child-Parent (TCP) approach of feeding programs (Rule VI, Section 5(d)).
TLRC must:
- Provide funding assistance to qualified small producers, especially in priority provinces for poverty alleviation/industry decentralization (Rule VI, Section 6(a)).
- Develop training for micro/cottage/small enterprises via its TLDCs (Rule VI, Section 6(b)).
- Undertake nationwide tri-media information campaign promotion and business technology courses (Rule VI, Section 6(c)).
CDA must:
- Provide technical assistance to small and subsistence producers to organize cooperatives undertaking iodization and marketing, registered under CDA guidelines and applicable laws (Rule VI, Section 7(a)).
- Encourage registered cooperatives to trade only food-grade iodized salt and assist promotion and monitoring compliance (Rule VI, Section 7(b)).
DENR must:
- Provide assistance on identifying suitable land areas for salt farms; conversion requires landowner concurrence and concerned agency/entity concurrence, and DENR must ensure through EIS that proposed activities do not adversely affect salt farms and vice-versa (Rule VI, Section 8(a)).
- Monitor adoption of anti-pollution control measures by producers/manufacturers (Rule VI, Section 8(b)).
- Assist in promotion of iodized salt (Rule VI, Section 8(c)).
- Identify areas not suitable for salt production and monitor contaminants including arsenic, cadmium, lead, mercury (Rule VI, Section 8(d)).
- Assist salt farm owners to seek CARL exemption (Rule VI, Section 8(e)).
BOC (DOF) must:
- Provide BFAD a quarterly list of salt importers/consignees and immediately inform BFAD of every entry with quantities, names, and addresses; it must issue a Customs Memorandum Order (CMO) to collectors in all ports to ensure regular compliance (Rule VI, Section 9(a)).
- Hold any imported salt without BFAD clearance that the salt has been iodized; coordinate with BFAD-authorized personnel for inspection/testing; release only upon BFAD clearance (Rule VI, Section 9(b)).
- Hold non-iodized imported salt until iodized; may transfer to bonded warehouse upon importer bond favoring BFAD, forfeitable upon non-compliance with BFAD’s iodization order; iodization and bond premium costs are for importer (Rule VI, Section 9(c)).
- Cooperate with BFAD in monitoring entries in all ports; BFAD may deputize BOC personnel (Rule VI, Section 9(d)).
Any assistance to salt manufacturers/producers, traders, and importers must consider size/capability and faithful compliance with laws on health, labor and employment, environment and ecology (Rule VI, Section 10).
Collaborating agencies must submit annual accomplishment and semestral progress reports to BFAD-DOH for SIAB endorsement (Rule VI, Section 11).

Advisory board functions and reporting

SIAB consists of all members of the NNC Governing Board from specified departments, plus three (3) private sector representatives and representatives from DENR, the medical profession, and salt manufacturers mandated by the ASIN Law (Rule VII, Section 1).
The chairperson of the NNC Governing Board chairs SIAB, and the NNC Secretariat provides technical/secretariat support (Rule VII, Section 1).
SIAB functions as the policy and coordinating body on national salt iodization program and activities, formulating/coordinating/monitoring activities from production and marketing to public information campaigns (Rule VII, Section 2).
SIAB analyzes effectiveness of iodization activities and evaluates annual progress based on reports submitted by DOH and other concerned agencies implementing the Act (Rule VII, Section 2).
SIAB creates an executive committee composed of not more than five (5) members at undersecretary level to closely monitor program implementation; the NNC executive committee plus a salt industry representative may serve as SIAB execution committee (Rule VII, Section 2).
SIAB submits an annual report to the Congress of the Philippines on program status and recommendations (Rule VII, Section 2).
SIAB holds a regular meeting at least once a year (Rule VII, Section 3).

Administrative sanctions and enforcement procedures

The ASIN Law and these rules apply to the entire salt industry, including producers/manufacturers, traders, repackers, retailers, importers, and distributors, and to all food outlets/restaurants/stores and food processors using food-grade salt, provided iodized salt use does not prejudice food quality and safety (Rule VIII, Section 1).
BFAD Director may impose sanctions on violators; LGUs may provide enabling mechanisms through ordinances and public information campaigns and may impose administrative sanctions and fines on food service establishments/outlets/supermarkets/wet markets/sellers/groceries/vendors/sari-sari stores (Rule VIII, Section 1).
BFAD may delegate inspection/monitoring authority to LGUs, while LTO issuance remains with BFAD unless expressly delegated through a MOA with the BFAD Director (Rule VIII, Section 2).
BFAD imposes penalties on salt manufacturers, importers, repackers, distributors, traders, bakeries, supermarkets, groceries, and food processors, while LGUs impose penalties on hospitals, food service establishments, salt outlets, stores, and similar salt outlets under their responsibility (Rule VIII, Section 2).

BFAD administrative proceedings

Monthly inspections must be conducted by authorized Food and Drug Regulation Officers (FDROs) in premises where salt is received, held, manufactured, labeled, stored, displayed, delivered, distributed, sold, or located, or where these activities are reasonably believed to be carried out (Rule VIII, Section 3(a)(1)).
FDROs submit reports of findings and Report of Analysis, if any, to BFAD-Legal Information and Compliance Division (LICD) (Rule VIII, Section 3(a)(2)).
LICD determines whether a probable cause for complaint exists; if so, LICD files a complaint with the Office of the BFAD Director (Rule VIII, Section 3(a)(3)).
BFAD Director sends a notice requiring the respondent to file an answer under oath within ten (10) days from receipt to show valid cause in writing why no administrative sanctions should be imposed (Rule VIII, Section 3(a)(4)).
If no answer is received within the period, the BFAD Director resolves the case; if the answer raises factual issues, a hearing is conducted (Rule VIII, Section 3(a)(5)).
If fines are imposed and final/executory, LGUs may collect fines by authority of the BFAD Director; fines collected must be held in trust for exclusive use by the investigating LGU for implementation (Rule VIII, Section 3(a)(6)).
Fines imposed and collected by BFAD accrue to BFAD for use in implementation pursuant to Section 9 of RA 8172 (Rule VIII, Section 3(a)(6)).

LGU proceedings without ordinance (with MOA)

Authorized LGU officers inspect wet markets, sari-sari stores, and food outlets like restaurants, hotels, food chains, catering services, and similar establishments under LGU jurisdiction (Rule VIII, Section 3(b)(1)).
LGU officers may inspect salt producers/distributors/traders only when BFAD gives authority (Rule VIII, Section 3(b)(1)).
Samples tested with iodine below standards or negative for iodine must be sent to BFAD or nearest CHD or other BFAD-accredited laboratories for confirmatory analysis (Rule VIII, Section 3(b)(2)).
Report on violations is submitted to the local chief executive