March 20, 2017

JOINT DA and DOH-FDA ADMINISTRATIVE ORDER

No. ____________
Series of 2017

SUBJECT: Delineation of Functions and Shared Responsibilities in the

Enforcement of Organic Labeling and 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;

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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 guidelines in 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

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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:

2.1 Advertising 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.

2.7 Inspection 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.

2.8 Label 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

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 information as to identify components, ingredients, attributes, directions for use,
specifications and such other information as may be required by law or regulations.

2.9 Labeling 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.

2.10 Licensing 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.

2.11 Manufacturer 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.

2.12 Official 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.

2.13 Organic 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

accredited OCB that a production system conforms to applicable organic standards and
requirements.

2.15 Organic 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.

2.16 Prepackaged Food refers to processed food made up in advance in a container, labeled
and ready for sale to the consumer, or for catering purposes.

2.17 Postmarket 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.

2.18 Processed Food refers to the processed or partially processed product intended for
human consumption that is obtained from any action that substantially alters initial raw
materials 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,
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 extrusion, and a combination of those processes intended to produce food. It may or may
not be prepackaged.

2.19 Registration 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.

2.20 Third 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. This Order 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 food including food/dietary supplements, locally
certified by the DA-BAFS officially accredited OCB.

3.2 All advertisement, promotional and marketing materials with claims on organic are also
covered.

SECTION 4. SPECIFIC RESPONSIBILITIES OF DA 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
manufacture and/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 food products. 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).

4.4 The DOH-FDA shall be responsible for the monitoring of manufacturers, importers,
exporters and wholesalers of processed and prepackaged food products with organic claims.

4.5 The DOH-FDA and DAs Regulatory Agencies and BAFS shall share databases [subject to
approval of requests].

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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 filing with 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. PIOL PAULYN JEAN B. ROSELL-UBIAL

Secretary Secretary
Department of Agriculture Department of Health

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