March 20, 2017
JOINT DA and DOH-FDAADMINISTRATIVE ORDER
No. ______
Series of 2017
SUBJECT:Delineation of Functions and Shared Responsibilities in the Enforcement of Organic Labelingand Regulation of Processed and Prepackaged Organic Food
WHEREAS, Section 2 (Declaration of Policy) of the Republic Act(R.A.) No. 10068 (Organic Agriculture Act of 2010) declares that it is the policy of the State to promote, propagate, develop further and implement the practice of organic agriculture in the Philippines that will cumulatively condition and enrich the fertility of the soil, increase farm productivity, reduce pollution and destruction of the environment, prevent the depletion of natural resources, further protect the health of farmers, consumers and the general public, and save program for the promotion of community-based organic agriculture systems which include, among others, farmer-inputs, together with a nationwide educational and promotional campaign for their use and processing, as well as the adoption of agricultural system as a viable alternative shall be undertaken;
WHEREAS, Section 16(Registration of Organic Food and Organic Input Producers) of R.A. No. 10068 provides that all “organic food and input establishments” must register with the Director of the Department of Agriculture – Bureau of Agriculture and Fisheries Standards (DA-BAFS);
WHEREAS, Section 17 (Labeling of Organic Produce) of R.A. No. 10068 provides that only products with third party certification can be labeled as “organic;”
WHEREAS, Section 11 (j) of R.A. No. 3720, as amended by R.A. No. 9711(Food and Drug Administration Act of 2009) prohibits the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertisement,or sponsorship of any health product without the Certificate of Product Registration from Food and Drug Administration (FDA);
WHEREAS, Section 11 (k) of R.A. No. 3720, as amended by R.A. No. 9711, prohibits the manufacture, importation, exportation, trading, transfer or distribution of any food establishment by any natural or juridical person without the license to operate from the FDA;
WHEREAS, Section 18 (Specific Responsibilities of the Department of Health) of R.A. No. 10611 (Food Safety Act of 2013) mandates the Department of Health (DOH) to bear the specific responsibility of ensuring the safety of all “food processing and product packaging activities”; and for the FDA, a food regulatory agency under the DOH, to implement a “performance-based food safety control management system”;
WHEREAS, Section 28 (Licensing, Registration of Establishments) of R.A. No. 10611 mandates that appropriate authorizations shall be developed and issued in the form of a permit, license and certificate of registration or compliance that would cover establishments, facilities engaged in production, post-harvest handling, processing, packing, holding or producing food for consumption in accordance with the mandated issuances of regulatory agencies issuing such authorizations. Further, it orders that special derogations shall be provided due to geographical location and after an assessment of risks, especially for micro, small and medium-sized food business operators and health products;
WHEREAS, the DOH-FDA issued Administrative Order(AO) No. 2014-0029 (Rules and Regulations on the Licensing of Food Establishments and Registration of Processed Food, and Other Food Products, and For Other Purposes), as amended by AO No. 2016:0003 (Guidelines on the Unified Licensing Requirements and Procedures of FDA), FDA Circular No. 2016:0006 (New Format for License to Operate for Establishments Regulated by FDA) and FDA Circular No. 2016:0007 (Notifications of Sources of Raw Materials Low Risk, Medium Risk and High Risk Prepackaged Processed Food Products), provides procedures to issue appropriate authorizations in the form of a permit, license and certificate of registration or compliance that would cover establishments, facilities engaged in packing, holding or producing food for consumption in accordance with mandated issuances of FDA, which issues such authorizations;
WHEREAS, Section 16 (Registration of Organic Food and Organic Input Producers), Rule 16.6 of the Implementing Rules and Regulations (IRR) of R.A. No. 10068 provides that the DA and the FDA shall draft their own joint guidelines on the regulation of “processed organic food”;
NOW, THEREFORE,the DA and the DOH-FDA hereby adopt and prescribe the following Joint Administrative Order (JAO) covering the functions, roles and shared responsibilities in the regulation of “processed and prepackaged organic food”, as it is hereby adopted and prescribed, for the information and guidance of all concerned.
Section 1. Objectives
This Order has the following objectives:
1.1 To provide guidelinesin the licensing of organic food processors or manufacturers and distributors (i.e. importers, exporters, wholesalers, and traders);and the registration of processed and prepackaged organic food in the country;
1.2 To delineate the functions and roles of DA and DOH-FDA according to the mandates of existing laws implemented by both agencies; and
1.3 To ensure protection of the health and welfare of the consumers against false and misleading information, labels, and advertisement, promotional and marketing materials.
Section 2. Definition of Terms
For purposes of this Order, the following terms shall mean:
2.1Advertising–refers to the business of conceptualizing, presenting or making available to the public, through any form of mass media, fact, data or information about the attributes, features, quality or availability of food and its related products for the purpose of promoting its sale or distribution and enhancing economic activity.
2.2 Certification–means the procedure by which official certifying bodies or officially recognized certifying bodies provide written attestation that food or food control systems conform to applicable organic agriculture standards and requirements. Certification may be, as appropriate, based on a range of inspection activities, which may include continuous inspection, auditing of quality assurance systems, and examination of finished products.
2.3 Distributor/Importer/Exporter–means any establishment that imports or exports raw materials, ingredients and/or finished products for its own use or for wholesale distribution to other establishments or outlets. If the distributor/importer/exporter sells to the general public, it shall be considered a retailer.
2.4 Food Establishment–means a sole proprietorship, a partnership, a corporation, an institution, an association, or an organization engaged in the manufacture, importation, exportation, sale, offer for sale, distribution, donation, transfer, use, testing, promotion, advertising, or sponsorship of health products including the facilities and installations needed for its activities.
2.5 Food/Dietary Supplement –means a processed food product intended to supplement the diet that bears or contains one or more of the following dietary ingredients: vitamin, mineral, amino acid, herb, or other dietary substance of botanical, animal, artificial or natural origin to increase the total daily intake in amounts conforming to the latest Philippine recommended energy and nutrient intakes or internationally agreed minimum daily requirements. It is usually in the form of capsules, tablets, liquid gels, powders or pills and is not represented for use as a conventional food or as the sole item of a meal or diet or a replacement for drugs and medicines.
2.6 Food Business–refers to any undertaking, whether public or private, that carries out any of the activities related to, or any changes of the food supply chain.
2.7Inspection–refers to the examination of food, food production facilities or establishments, and the management and production systems of food businesses, including the examination of documents, finished product testing and registration, and of the origin and destination of production inputs and outputs to verify compliance with legal requirements by an agency mandated to perform food safety regulatory and/or enforcement functions.
2.8Label–refers to the display of written, printed or graphic matter upon the immediate container, tag, literature or other suitable material affixed thereto for the purpose of giving information as to identify components, ingredients, attributes, directions for use, specifications and such other information as may be required by law or regulations.
2.9Labeling–includes any written, printed or graphic matter that is present on the label, accompanies the food, or is displayed near the food, including that for the purpose of promoting its sale or disposal.
2.10Licensing –means the process of approval of an application to operate or establish an establishment prior to engaging in the manufacture, importation, exportation, sale, offer for sale, distribution, transfer, and where applicable the use, testing, promotion, advertisement, and/or sponsorship of health products.
2.11Manufacturer –means an establishment engaged in any and all operations involved in the production of organic products including preparation, processing, compounding, formulating, filling, packaging, repackaging, altering, ornamenting, finishing, and labeling with the end in view of its storage, sale or distribution. Further, no manufacturer shall be engaged in the production of processed organic food and processed (non-organic) food within the same enclosed facilities, using the same equipment or procedure or systems of production.
2.12Official Accreditation–refers to the procedure by which DA-BAFS having jurisdiction over Organic Certifying Bodies (OCB), formally recognizes the competence of an inspection and/or certification body to provide inspection and certification services.
2.13Organic –is a labeling term that denotes products considered organic based on the Philippine National Standards (PNS) for organic agriculture.
2.14 Organic Certificate –means a written or equivalent assurance issued by an officially accreditedOCB that a production system conforms to applicable organic standards and requirements.
2.15Organic Certifying Body (OCB)–refers to a body/entity responsible for verifying that a product sold or labeled as “organic” is produced, processed, prepared, handled and imported according to relevant PNS and other relevant guidelines.
2.16Prepackaged Food–refers to processed food made up in advance in a container, labeled and ready for sale to the consumer, or for catering purposes.
2.17Postmarket Surveillance –refers to activities, after market authorization has been issued, relating to safety and quality monitoring of processed organic food. This shall also include, among others, adverse events reporting, product safety update reporting, collection and testing of processed organic food products in the market.
2.18Processed Food–refers to the processed or partially processed product intended forhuman consumption that is obtained from any action that substantially alters initial rawmaterials or products or ingredients. The processing stage of the food supply chain is that stage that substantially alters the initial raw materials or product or ingredients including, but not limited to, heating, smoking, curing, maturing, drying, marinating, extraction, extrusion, and a combination of those processes intended to produce food. It may or may not be prepackaged.
2.19Registration –means the process of approval of an application to register processed organic food prior to engaging in the manufacture, importation, exportation, sale, offer for sale, distribution, transfer, and where applicable, the use, testing, promotion, advertisement, and/or sponsorship of processed organic food.
2.20Third Party Certification or Independent Certification –is defined as when a firm requires that its suppliers meet a certain standard and requests an independent organization that is not involved in the business relationship to control the compliance of suppliers.
SECTION 3. Scope
3.1. ThisOrder shall cover all food establishments and food business operators engaged in the manufacture and/or distribution (i.e., import, export or wholesale, or trade and repacking) of processed and prepackaged organic foodincluding food/dietary supplements, locally certified by theDA-BAFS officiallyaccredited OCB.
3.2 All advertisement, promotional and marketing materials with claims on organic are also covered.
Section 4. Specific Responsibilities ofDA and DOH-fda
The following are the specific tasks of DA and DOH-FDA:
4.1 The DA-BAFS and the DOH-FDA shall be jointly responsible for the development of standards for processed and prepackaged organic food.
4.2 The DOH-FDA shall be responsible for the licensing of food establishments engaged in the manufactureand/or distribution of processed organic food products.
4.3 The DOH-FDA shall only recognize organic certificate issued by the DA-BAFS officially accredited OCB as part of its registration requirements for locally processed and imported prepackaged organic foodproducts.FDA approval of organic claim on the label shall be based on this organic certificate and its AO No. 2014-0030 (Revised Rules and Regulations Governing the Labeling Prepackaged Products Further Amending Certain Provisions of AO No. 88-B).
4.4The DOH-FDAshall be responsible for themonitoring of manufacturers, importers, exporters and wholesalers of processed and prepackaged food products with organic claims.
4.5The DOH-FDA and DA’s Regulatory Agencies and BAFS shall share databases[subject to approval of requests].
Section 5. ENFORCEMENT OF ORGANIC LABELING
The DA, through its concerned Regulatory Agencies, and the DOH-FDA shall institute additional measures to ensure the mandatory enforcement of labeling requirements for organic products.
Section 6. HANDLING OF COMPLAINTS
The DA, through its concerned Regulatory Agencies, and the DOH-FDA shall institute guidelines on the handling of complaints relative to the mandatory enforcement of labeling requirements for organic products.
SECTION 7.SEPARABILITY CLAUSE
If any provision in this Order or application of such provision to any circumstances is held invalid, the remainder of the provisions of this Order shall not be affected thereby.
SECTION 8. REPEALING CLAUSE
All previous DA and DOH issuances that are inconsistent in part or in whole to this Order are hereby rescinded, repealed or amended accordingly.
Section 9. Effectivity.
This Joint Administrative Order shall take effect fifteen (15) days after its publication in two (2) newspapers of general circulation and filingwith the National Administrative Register of the University of the Philippines Law Center (UPLC).
NOW, THEREFORE, the Department of Agriculture and Department of Health, through their respective Secretaries, have herein below affixed their signatures to this Joint Administrative Order this ______day of ______, 2017.
EMMANUEL F. PIÑOL / PAULYN JEAN B. ROSELL-UBIALSecretary / Secretary
Department of Agriculture / Department of Health
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