NCM 105 Nutrition and Diet Therapy Legal Mandates

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College of Health Sciences

NAME: MACAM, LEA ANGEL DOMINIQUE L. COURSE/YEAR/SECTION: BSN 2B


SUBJECT: NUTRITION AND DIET THERAPY LAB PROFESSOR: MISCHELLE CONDENO
Regulatory System In The Country To
NCM 105 Nutrition Protect Consumer Health And Facilitate
Market Access Of Local Foods And Food
and Diet Therapy Products, And For Other Purposes”
otherwise known as the “Food Safety Act of
2013”.
Legal Mandates Related to
Nutrition and Diet Therapy
THE IMPLEMENTING RULES AND
REGULATIONS OF REPUBLIC ACT Rule 1.2 These rules are promulgated to
NO. 10611, “AN ACT TO facilitate compliance with the provisions of
STRENGTHEN THE FOOD SAFETY the Food Safety Act of 2013.
REGULATORY SYSTEM IN THE
COUNTRY TO PROTECT CONSUMER Rule 1.3 The Food Safety Act of 2013 shall
HEALTH AND FACILITATE be the framework for implementing the farm
MARKET ACCESS OF LOCAL FOODS to fork Food Safety Regulatory System.
AND FOOD PRODUCTS, AND
FOR OTHER PURPOSES” SECTION 2. Declaration of Policy. –
OTHERWISE KNOWN AS Section 15, Article II of the 1987 Philippine
THE “FOOD SAFETY ACT OF 2013.” Constitution declares that the State shall
protect and promote the right to health of the
Pursuant to the provisions of Section 39, people and instil health consciousness
Republic Act 10611, otherwise known as the among them. Furthermore, Section 9, Article
“Food Safety Act of 2013”, the Department XVI provides that the State shall protect
of Agriculture (DA) and the Department of consumers from trade malpractices and from
Health (DOH) hereby jointly adopt and substandard or hazardous products. Toward
promulgate the following Rules and these ends, the State shall maintain a farm to
Regulations: fork food safety regulatory system that
ensures a high level of food safety, promotes
ARTICLE I fair trade and advances the global
competitiveness of Philippine foods and
DECLARATION OF POLICY AND food products.
OBJECTIVES
SECTION 3. Objectives. – To strengthen
SECTION 1. Short Title. – This Act shall be the food safety regulatory system in the
known as the “Food Safety Act of 2013”. country, the State shall adopt the following
specific objectives:
Rule 1.1 These Rules and Regulations shall
be known as the Implementing Rules and (a) Protect the public from food-borne and
Regulations (IRR) of Republic Act 10611, water-borne illnesses and unsanitary,
“An Act To Strengthen The Food Safety
College of Health Sciences

NAME: MACAM, LEA ANGEL DOMINIQUE L. COURSE/YEAR/SECTION: BSN 2B


SUBJECT: NUTRITION AND DIET THERAPY LAB PROFESSOR: MISCHELLE CONDENO
unwholesome, misbranded or adulterated SECTION 4. Definition of Terms. – For the
foods; purposes of this Act, the following terms
shall be defined as follows:
(b) Enhance industry and consumer
confidence in the food regulatory system; (a) Advertising refers to the business of
and conceptualizing, presenting or making
available to the public, through any form of
(c) Achieve economic growth and mass media, fact, data or information about
development by promoting fair trade the attributes, features, quality or availability
practices and sound regulatory foundation of food and its related products for the
for domestic and international trade. purpose of promoting its sale or distribution
and enhancing economic activity.
Towards the attainment of these objectives,
the following measures shall be (b) Adulteration refers to an act which leads
implemented: to the production of food which:

(1) Delineate and link the mandates and (1) Bears or contains any poisonous or
responsibilities of the government agencies deleterious substance that may render it
involved; injurious to the health of the public;

(2) Provide a mechanism for coordination (2) Bears or contains any added poisonous
and accountability in the implementation of or deleterious substance in amounts
regulatory functions; exceeding established maximum limits or
standards for good manufacturing practice;
(3) Establish policies and programs for
addressing food safety hazards and (3) Contains in whole or in part filthy, putrid
developing appropriate standards and or decomposed substance that is unfit for
control measures; human consumption;

(4) Strengthen the scientific basis of the (4) Has been prepared, packed or held under
regulatory system; and unsanitary conditions;

(5) Upgrade the capability of farmers, (5) In whole or in part, is the product of a
fisherfolk, industries, consumers and diseased animal or an animal which has died
government personnel in ensuring food through ways other than slaughter;
safety.
(6) Is in a container having in whole or in
ARTICLE II part any poisonous or deleterious substance;

DEFINITION OF TERMS (7) Has been intentionally subjected to


radiation unless the use of radiation is in
conformity with an existing regulation or
exemption;
College of Health Sciences

NAME: MACAM, LEA ANGEL DOMINIQUE L. COURSE/YEAR/SECTION: BSN 2B


SUBJECT: NUTRITION AND DIET THERAPY LAB PROFESSOR: MISCHELLE CONDENO
(8) Becomes injurious to health because of (e) Control measure refers to any action and
the omission or abstraction of a valuable activity that can be used to prevent or
constituent; or if any substance has been eliminate food safety hazard or to reduce it
substituted wholly or in part; or if damaged to an acceptable level.
or made inferior which has been concealed
in any manner; or if any substance has been (f) Crisis management refers to a proactive
added thereto or mixed or packed therewith approach of addressing a situation, where a
so as to increase its bulk or weight, or risk to consumers, animal or plant health
reduce its strength or to make it appear cannot he controlled by normal existing
better or greater than it is; mechanisms, through a plan which can be
activated when such emergency arises.
(9) Has not been prepared in accordance
with current acceptable manufacturing (g) Food refers to any substance or product
practice as promulgated by way of whether processed, partially processed or
regulation; and unprocessed that is intended for human
consumption. It includes drinks, chewing
(10) Uses expired ingredients. gum, water and other substances which are
intentionally incorporated into the food
(c) Authorization refers to the permission during its manufacture, preparation and
embodied in a document granted by a treatment.
regulatory agency to a natural or juridical
person who has submitted an application for (h) Feed refers to any substance or product,
a food business operation from primary including additives, intended to be used for
production, post harvest handling, oral feeding to animals.
distribution, processing, manufacture,
importation, exportation, sale, and offer for (i) Food-borne illnesses refer to diseases,
sale, distribution, transfer and preparation usually either infectious or toxic in nature,
for human consumption. The authorization caused by agents that enter the body through
can take the form of a permit, license, the ingestion of food.
certificate of registration and certificate of
compliance or exemption or any similar (j) Food business refers to any undertaking,
document. whether public or private, that carries out
any of the activities related to, or any of the
(d) Contaminant refers to any substance not stages of the food supply chain.
intentionally added to food which is present
in such food as a result of the production (k) Food business operator refers to a
(including operations carried out in crop person engaged in the food business
industry, animal husbandry and veterinary including one’s agents and is responsible for
medicine) post harvest handling, ensuring that the requirements of this Act
manufacturing, processing, preparation, are met by the food business under one’s
treatment, packing, packaging, transport or control.
holding of such food as a result of
environmental contamination.
College of Health Sciences

NAME: MACAM, LEA ANGEL DOMINIQUE L. COURSE/YEAR/SECTION: BSN 2B


SUBJECT: NUTRITION AND DIET THERAPY LAB PROFESSOR: MISCHELLE CONDENO
(l) Food hygiene  (hereinafter referred to as in accordance with the appropriate civil
hygiene) refers to the measures and service rules and regulations.
conditions necessary to control hazards that
could lead to food-borne illnesses and to (q) Food safety regulatory system refers to
ensure fitness for human consumption of a the combination of regulations, food safety
food of plant or animal origin taking into standards, inspection, testing, data
account its intended use. collection, monitoring and other activities
carried out by food safety regulatory
(m) Food law  refers to the laws, regulations agencies and by the LGUs in the
and administrative provisions governing implementation of their responsibilities for
food in general, donated food and food the control of food safety risks in the food
safety at any stage of production, supply chain.
processing, distribution and preparation for
human consumption. (r) Food supply chain refers to all stages in
the production of food from primary
(n) Food safety refers to the assurance that production, post harvest handling,
food will not cause harm to the consumer distribution, processing and preparation for
when it is prepared or eaten according to its human consumption. Preparation is the
intended use. cooking or other treatments to which food is
subjected prior to its consumption.
(o) Food safety regulatory agencies
(FSRAs) refer to the following national (s) Good agricultural practices (GAP)  refer
government agencies: to the practices that address environmental,
economic and social sustainability for on-
Under the Department of Agriculture (DA) – farm processes, and which result in safe and
the Bureau of Animal Industry, the National quality food and nonfood agricultural
Meat Inspection Service, the Bureau of products.
Fisheries and Aquatic Resources, the Bureau
of Plant Industry, the Fertilizer and Pesticide (t) Good manufacturing practices refer to a
Authority, the Philippine Coconut Authority, quality assurance system aimed at ensuring
the Sugar Regulatory Administration and the that products are consistently manufactured,
National Food Authority. packed, repacked or held to quality
standards appropriate for the intended use. It
Under the Department of Health (DOH) – is thus concerned with both manufacturing
the Food and Drug Administration, the and quality control procedure.
Center for Food Regulation and Research
and the Bureau of Quarantine. (u) Good hygienic practices refer to all
practices regarding the conditions and
(p) Food safety officer refers to a measures necessary to ensure the safety and
professionally qualified and properly trained suitability of food at all stages of the food
officer appointed by a food safety regulatory chain.
agency or by local government units (LGUs)
College of Health Sciences

NAME: MACAM, LEA ANGEL DOMINIQUE L. COURSE/YEAR/SECTION: BSN 2B


SUBJECT: NUTRITION AND DIET THERAPY LAB PROFESSOR: MISCHELLE CONDENO
(v) Hazard Analyses and Critical Control source, a certifying body or by scientific
Points (HACCP)  refer to a science-based evidence.
system which identifies, evaluates and
controls hazards which are significant for (bb) Official control refers to all types of
food safety at critical points during a given controls and control activities made by
stage in the food supply chain. regulatory agencies to verify compliance
with standards, operating procedures,
(w) Hazard refers to a biological, chemical practices and other regulatory requirements.
or physical agent in food with a potential to It includes routine monitoring of food
cause adverse effect on health. establishments and more intensive checks
involving inspections, verifications, audits,
(x) Inspection  refers to the examination of sampling and testing of samples and recall
food, food production facilities or of defective products.
establishments, and the management and
production systems of food businesses, (cc) Person refers to any person, natural or
including the examination of documents, juridical including, but not limited to, the
finished product testing and registration, and following persons: (i) food business
of the origin and destination of production operators; and (ii) food safety officers and
inputs and outputs to verify compliance with other regulatory personnel of the DA, the
legal requirements by an agency mandated DOH and the Department of the Interior and
to perform food safety regulatory and/or Local Government (DILG).
enforcement functions.
(dd) Post harvest stages refer to the stages
(y) Label refers to the display of written, in the food supply chain involving the
printed or graphic matter upon the minimal transformation of plant and animal
immediate container, tag, literature or other foods after primary production such as
suitable material affixed thereto for the removal of field heat for fruits, slaughter of
purpose of giving information as to identify animals, sorting, grading and cutting of fresh
components, ingredients, attributes, plant and animal foods, icing and freezing,
directions for use, specifications and such and the milling and storage of grain.
other information as may be required by law
or regulations. (ee) Primary production refers to the
production, rearing or growing of primary
(z) Micro, small and medium enterprise products including harvesting, milking and
(MSME) refers to food businesses as defined farmed animal production up to slaughter;
within the classification of industries by the and the rearing and growing of fish and
Department of Trade and Industry (DTI). other seafood in aquaculture ponds. It also
includes fishing, and the hunting and
(aa) Misbranding refers to deliberate catching of wild products.
labelling or advertising of food that is
misleading, where the labelling and/or (ff) Processing refers to any action that
advertising claims certain food properties substantially alters the initial raw materials
that cannot be supported by a reliable or product or ingredients including, but not
College of Health Sciences

NAME: MACAM, LEA ANGEL DOMINIQUE L. COURSE/YEAR/SECTION: BSN 2B


SUBJECT: NUTRITION AND DIET THERAPY LAB PROFESSOR: MISCHELLE CONDENO
limited to, heating, smoking, curing, (mm) Traceability refers to the ability to
maturing, drying, marinating, extraction, follow the movement of a food through
extrusion and a combination of those specified stages of production, processing
processes intended to produce food. and distribution.

(gg) Risk refers to the likelihood of an (nn) Monitoring refers to the systematic


adverse health effect and the severity of this gathering of data through the sampling of
effect following exposure to a hazard. commodities as well as monitoring of food-
borne diseases, collation and interpretation
(hh) Risk analysis  refers to a process of collected data.
consisting of three (3) interrelated
components: risk assessment, risk Rule 4.1 Other terms used in these Rules and
management and risk communication. Regulations are defined as follows:

(ii) Risk assessment refers to the scientific Rule 4.1a Accreditation is the formal


evaluation of known or potential adverse recognition by an independent body,
health effects resulting from human generally known as an accreditation body
exposure to biological, chemical and that a certification body is capable of
physical hazards. carrying out certification. Accreditation is
not obligatory but it adds another level of
(jj) Risk management refers to the process of confidence, as ‘accredited’ means the
weighing policy alternatives to accept, certification body has been independently
minimize or reduce assessed risks and if checked to make sure it operates according
necessary, to select and implement to international standards. In the Philippines,
appropriate prevention and control the official accreditation body is the
measures. Philippine Accreditation Bureau (PAB).
Food Safety Regulatory Agencies can
(kk) Risk communication refers to the provide Official Accreditation  which is the
interactive exchange of information and procedure by which a government agency
opinions during the course of risk analysis having jurisdiction formally recognizes the
on the hazards and risks among risk competence of an inspection and/or
assessors, risk managers, consumers, food certification body to provide inspection and
and feed business operators, academia and certification services.
other stakeholders.
Rule 4.1b Act refers to Republic Act 10611
(ll) Food safety standards refer to the formal or the Food Safety Act of 2013.
documents containing the requirements that
foods or food processors have to comply Rule 4.1c Agriculture or Fishery
with to safeguard human health. They are Establishment means the farm, fishing
implemented by authorities and enforced by vessel, buildings, and other facilities of a
law; and are usually developed and food business used for production of
published under the auspices of a national primary and postharvest foods (including
standards body. operations carried out in the crop industry,
College of Health Sciences

NAME: MACAM, LEA ANGEL DOMINIQUE L. COURSE/YEAR/SECTION: BSN 2B


SUBJECT: NUTRITION AND DIET THERAPY LAB PROFESSOR: MISCHELLE CONDENO
animal husbandry, aquaculture, and fish examination of finished products. Official
capture), postharvest handling, preparation, Inspection and Certification Systems are
treatment, packaging, transport and/or administered by FSRAs or government
storage, but excluding those sites, buildings agencies having jurisdiction.
and structures, such as laboratories,
administrative offices and other areas where Rule 4.1h Code of Good Agricultural
food is not handled and where people Practices (GAP) for Food Safety means
handling food do not enter. Agriculture or practices used to prevent or reduce the risk
Fishery Establishment shall also include of hazards occurring during production,
facilities involved in activities related to harvesting, and postharvest handling of
agrochemicals and other inputs in the produce.
primary and postharvest stages of
production. Rule 4.1i Code of Good Animal Husbandry
Practices (GAHP) for Food Safety means
Rule 4.1d Aquaculture refers to fishery practices used to prevent or reduce the risk
operations involving all forms of breeding, of hazards related to food safety occurring
raising and farming of fish and other fishery during production, harvesting, postharvest
species in fresh, brackish and marine water handling of poultry, livestock and their
areas. products as sources of human food as well
as ensuring animal health and welfare.
Rule 4.1e Audit  refers to a systematic and
functionally independent examination to Rule 4.1r Fraud or Fraudulent
determine whether activities and related Practice refers to any act or omission,
results comply with planned objectives. including a misrepresentation, that
knowingly or recklessly misleads, or
Rule 4.1f Batch means a set of units of a attempts to mislead, a party to obtain a
product that is uniform in character and financial or other benefits or to avoid an
quality obtained from a given process under obligation or for other reasons.
practically identical circumstances and
produced in a given place within one defined Rule 4.1s FSCO means Food Safety
production period. The food business Compliance Officer designated by the Food
operator must define the batch. Business Operator.

Rule 4.1g Certification means the procedure Rule 4.1t High risk activities means


by which official certification bodies or activities commonly applied in any part of
officially recognized certification bodies the food supply chain that may cause food-
provide written or equivalent assurance that borne diseases to consumers if left
foods or food control systems conform to uncontrolled.
food safety requirements. Certification of
food may be, as appropriate, based on a Rule 4.1u Labelling includes any written,
range of inspection activities which may printed or graphic matter that is present on
include continuous on-line inspection, the label, accompanies the food, or is
auditing of quality assurance systems, and
College of Health Sciences

NAME: MACAM, LEA ANGEL DOMINIQUE L. COURSE/YEAR/SECTION: BSN 2B


SUBJECT: NUTRITION AND DIET THERAPY LAB PROFESSOR: MISCHELLE CONDENO
displayed near the food, including that for conditions. A lot can consist of several
the purpose of promoting its sale or disposal. batches.

Rule 4.1v Laboratory Accreditation means Rule 4.1z National Dairy Authority


an attestation conveying formal (NDA) is a Food Safety Regulatory Agency
demonstration of a laboratory’s competence under the Department of Agriculture
and capability to carry out specific scientific
and technical tests or analytical service with Rule 4.1aa Packaged  is primary or
respect to food products. postharvest food made up in advance in a
container with or without the label, for
Rule 4.1w Licensing by the DA  means the further processing, for catering purposes, or
process by which DA FSRAs approve an for sale to institutional buyers and/or
application, of a person, corporation, consumers.
cooperative, agriculture or fishery
establishment, or other juridical persons, for Rule 4.1bb Point of Entry means a passage
authority to operate an establishment or to for international entry or exit of travelers,
engage in any activity in the primary baggage, cargo, containers, conveyances,
production and postharvest stages of the goods and postal parcels as well as agencies
food supply chain to produce safe primary and areas providing services to them on
and postharvest animal and plant food and entry or exit.
inputs. It includes facilities involved in
activities related to agrochemicals and other Rule 4.1cc Post-market surveillance  refers
inputs in the primary and postharvest stages to activities involved in safety and quality
of production. The approval will require monitoring of primary and postharvest food,
proving capability to operate a facility or production inputs, processed and
establishment or to engage in activities in prepackaged food after market authorization
the primary production and postharvest has been issued. This shall also include
stages of the food supply chain and covered among others adverse events reporting,
by the license. product safety update reporting, collection
and testing of food products in the market.
Rule 4.1x Licensing by the DOH means the
process of approval by the DOH of an Rule 4.1dd Precautionary Measures  are
application to operate or establish an protective interim measures used where
establishment prior to engaging in the there is uncertainty as to the existence or
manufacture, importation, exportation, sale, extent of risks to human health without
offer for sale, distribution, transfer, and having to wait until the reality and
where applicable the use, testing, promotion, seriousness of those risks become fully
advertisement, and for sponsorship of apparent through the establishment of
processed and prepackaged food products. sufficient scientific data.

Rule 4.1y Lot refers to a set of units of a Rule 4.1ee Prepackaged  is processed food


product which has been produced and/or made up in advance in a container, labeled
manufactured and/or packaged under similar
College of Health Sciences

NAME: MACAM, LEA ANGEL DOMINIQUE L. COURSE/YEAR/SECTION: BSN 2B


SUBJECT: NUTRITION AND DIET THERAPY LAB PROFESSOR: MISCHELLE CONDENO
and ready for sale to the consumer, or for the adequacy of a food business operator’s
catering purposes. quality and safety management.

Rule 4.1ff Private Testing Rule 4.1kk Risk Categorization refers to the


Laboratory means a legal entity, other than classification of food businesses, food
a government testing laboratory, that operations and/or food products as high risk,
engages in the business of conducting tests, medium risk or low risk based on inherent
calibration, assay, examination and potential food safety risks in the
measurements, or analytical services with production/processing system and/or on the
respect to fresh and processed food products possibility of the presence of
and farm inputs. microbiological and chemical hazards in the
food produced; and history of compliance by
Rule 4.1gg Recalls mean actions taken to the establishment with its quality and safety
remove a product from the market. management systems and pertinent
regulations.
Rule 4.1hh Registration by DA means the
process by which DA FSRAs enter Rule 4.1ll Risk Management Plan as
information about agriculture and fishery required by the FDA, means a set of food
establishments engaged in the primary product vigilance activities and interventions
production and postharvest stages of the designed to identify, characterize, prevent or
food supply chain including facilities minimize risks relating to food products, and
involved in activities related to the assessment of effectiveness of those
agrochemicals and other inputs in the interventions. The risk management plan is a
primary and postharvest stages of requirement for the issuance of the
production, in an official list or official appropriate authorization.
system for entering names and information
of the DA FSRAs. Rule 4.1mm Risk Management Plan of the
DA-FSRA refers to a framework for
Rule 4.1ii Registration by DOH  means the prioritizing food-borne risks and for
process of approval of an application to optimizing risk management options and
register processed and pre-packaged food control measures. It provides for monitoring
products prior to engaging in the and reviews as a basis for continuing
manufacture, importation, exportation, sale, improvement of food safety measures.
offer for sale, distribution, transfer, and
where applicable, the use, testing, promotion Rule 4.1nn Street-vended foods or Street
advertisement, and for sponsorship of food Foods means ready-to-eat foods prepared
products. and/or sold by vendors in the streets and
other public places.
Rule 4.1jj Risk-Based Inspection refers to
inspection focused on risk factors (i.e. those ARTICLE III
that may cause food-borne disease in
consumers if left uncontrolled) to determine BASIC PRINCIPLES OF FOOD
SAFETY
College of Health Sciences

NAME: MACAM, LEA ANGEL DOMINIQUE L. COURSE/YEAR/SECTION: BSN 2B


SUBJECT: NUTRITION AND DIET THERAPY LAB PROFESSOR: MISCHELLE CONDENO
SECTION 5. Food Safety Requirements. should aid consumers in avoiding specific
–  To ensure food safety, the following health effects from a particular food or
general guidelines shall be observed: category of foods.

Rule 5.1 Food safety requirements shall Rule 5a.2 All information provided to
guide decision-making on potential adverse consumers on food and its preparation, such
health effects that may occur from the as during cooking demonstrations, cooking
consumption of the food and the need to shows, fresh and processed food product
identify risk management options. launching and other similar activities, shall
observe the requirements for hygienic food
Rule 5.2 The food business operator (FBO) handling and other practices for safe food
and the regulatory agency shall take the preparation.
necessary steps to be knowledgeable of the
conditions under which food could become (b) In determining whether food is injurious
unsafe or injurious to health. to health, regard shall be given to the
following:
(a) In determining whether food is unsafe,
the following shall be considered: (1) The probable immediate, short-term or
long-term effects on subsequent generations
(1) The normal conditions of the use of food of that food on health;
by the consumer;
Rule 5b.1. The DOH shall monitor the
Rule 5a.1. Food shall be presented in effects of food on the health of individuals
accordance with their intended use as and on subsequent generations (e.g. non-
provided for in the specific guidelines communicable diseases, micronutrient
developed and determined by the FSRA. deficiencies).

(2) The normal conditions maintained at (2) The probable cumulative effects; and
each stage of primary production,
processing, handling, storage and (3) The particular health sensitivities of a
distribution; specific category of consumers where the
food is intended for that category.
(3) The health of plants and animals from
where the food is derived; (c) In determining whether food is unfit for
human consumption, regard shall be given to
(4) The effect of feeds, crop protection the unacceptability of the food according to
chemicals and other production inputs on its intended use due to contamination by
otherwise healthy plants and animals; and extraneous matter or through putrefaction,
deterioration or decay;
(5) The information provided to the
consumer. This includes the information Rule 5c.1 In declaring a food unfit for
provided on the label or any information human consumption, the condition of the
generally available to the consumer. This food shall be evaluated through physical,
College of Health Sciences

NAME: MACAM, LEA ANGEL DOMINIQUE L. COURSE/YEAR/SECTION: BSN 2B


SUBJECT: NUTRITION AND DIET THERAPY LAB PROFESSOR: MISCHELLE CONDENO
chemical, microbiological, microscopic and SECTION 6. Food Law Objectives. – Food
other tests, whenever necessary. law shall aim for a high level of food safety,
protection of human life and health in the
(d) Where unsafe food, is part of a batch, lot production and consumption of food. It shall
or consignment of food of the same class or also aim for the protection of consumer
description, it shall be presumed that all interests through fair practices in the food
food in that batch, lot or consignment is also trade.
unsafe;
Rule 6.1 These general principles shall serve
(e) Food that complies with specific national as the framework for the development of
law or regulations governing food safety food safety standards, regulations and
shall be deemed safe insofar as the aspects measures for meeting the objectives of the
covered by national law and regulations are Act to ensure a high level of food safety and
concerned. However, imported food that is fair practices in the food trade.
declared unsafe, by the competent authority
of the exporting country after entry into the SECTION 7. Use of Science-based Risk
country shall be withdrawn from the market Analysis. – The following shall guide the
and distribution channels; and use of science and risk analysis in food
safety regulation:
(f) Compliance of a food product with
specific standards applicable to a specific (a) The development of food safety
food shall not prohibit the competent legislation and standards and the conduct of
authorities to take appropriate measures or inspection and other official control
to impose restrictions on entry into the activities shall be based on the analysis of
market or to require its withdrawal from the risk, except where this approach is not
market, where there is reason to suspect that feasible due to circumstances, or due to the
such food product shows food safety related nature of the control measure;
risks.
Rule 7a.1 Risk analysis shall be the basis for
Rule 5f.1 FSRAs shall restrict entry into the the development of food safety standards
market or apply other measures to protect and regulations. It shall objectively combine
consumer health when food meeting specific and analyze scientific data on food safety
standards is subsequently found to be a hazards in order to arrive at the best options
potential source of food safety related risks. for managing food-borne risks.
The measures shall be enforced until new
scientific data are obtained and/or after Rule 7a.2 The risk analysis shall cover all
appropriate testing and inspection are carried hazards directly or indirectly, intentionally
out to confirm safety of the food. or unintentionally introduced into the food.
This shall include hazards coming from
ARTICLE IV packaging materials, cleaning agents, and
other sources.
GENERAL PRINCIPLES
College of Health Sciences

NAME: MACAM, LEA ANGEL DOMINIQUE L. COURSE/YEAR/SECTION: BSN 2B


SUBJECT: NUTRITION AND DIET THERAPY LAB PROFESSOR: MISCHELLE CONDENO
Rule 7a.3 Risk categorization shall guide the (c) Risk management shall take into account
DA and the DOH in the conduct of food the results of risk assessment relevant to
establishment inspections, testing and local conditions, potential for enforcement,
evaluation of food products, and/or for cost of compliance and others as may be
implementing any other official control relevant to the situation;
measures. The DA and the DOH shall
classify food businesses and their operations Rule 7c.1 DA and DOH shall use a Risk
as high risk, medium risk, or low risk. Management Plan based on the principles of
risk analysis to develop and implement a
Rule 7a.4 The FSRAs shall implement Food Safety Regulatory System with a
measures, even in the absence of risk mechanism for monitoring, review and
analysis, under the following circumstances: continuous improvement.

 In cases of emergency situations Rule 7c.2 The choice of risk management


declared by national and/or options shall consider the cost of
international authorities, unforeseen compliance, impact on the ability of the
events, or other situations posing an industry to innovate and to be competitive,
imminent danger to public health due the feasibility of implementation, potential
to food-borne hazards; for verification and enforcement,
 Food safety hazard has not been consistency with existing domestic and
identified but relevant scientific international food standards and with the
information suggests a link between country’s international obligations, and
consumption of a food and the others.
appearance of serious health effects;
and (d) Risk communication shall be carried out
 Other similar circumstances. between risk assessors and risk managers in
a transparent manner. Food safety risks shall
(b) Risk assessment shall be based on sound also be communicated to farmers, fisherfolk
scientific evidence and shall be undertaken and food business operators to encourage
in an independent, objective and transparent compliance with the implementation of
manner. Scientific information as obtained control measures and to relevant sectors of
from scientific literature, epidemiological society affected by the law or the risks
and monitoring studies and other data that addressed in order to strengthen confidence
supports the risk assessment shall be used; in its provisions; and

Rule 7b.1 DOH and the DA shall cooperate Rule 7d.1 The risk communication strategy
in establishing an effective system for shall be discussed between risk assessors
developing and sharing scientific data from and managers early in the process to ensure
local epidemiological, monitoring and two-way communication.
surveillance studies for use in the
assessment of risk. Rule 7d.2 The strategy should designate the
person who will present information to the
public and the manner through which it shall
College of Health Sciences

NAME: MACAM, LEA ANGEL DOMINIQUE L. COURSE/YEAR/SECTION: BSN 2B


SUBJECT: NUTRITION AND DIET THERAPY LAB PROFESSOR: MISCHELLE CONDENO
be done. The information shall be conveyed Rule 8a.5 Penalties shall be imposed against
in the most appropriate means and shall incidents of adulteration, misbranding and
include the nature of food-borne risks and other forms of fraud in accordance with
the measures that can be taken by Article XII Section 37(e) Section 38 of the
stakeholders to prevent, reduce, or eliminate Act.
the risk.
Rule 8a.6 The FBOs shall be fully compliant
(e) Food business operators shall be with all regulatory requirements prior to
encouraged to implement a HACCP-based marketing, advertising, or promoting
system for food safety assurance in their products.
operations.
(b) Prevention of misrepresentation in the
SECTION 8. Protection of Consumer labelling and false advertising in the
Interests. – The protection of consumer presentation of food, including their shape,
interest shall be geared towards the appearance or packaging, the packaging
following: materials used, the manner in which they are
arranged, the setting in which they are
(a) Prevention of adulteration, misbranding, displayed, and the product description
fraudulent practices and other practices including the information which is made
which mislead the consumer, and available about them through whatever
medium. Where relevant, the presentation of
Rule 8a.1 Any of the acts indicated in the goods shall provide consumers a basis to
definition for adulteration shall constitute make informed choices in relation to the
adulteration. food they purchase.

Rule 8a.2 Any misinformation or misleading Rule 8b.1 The DA and the DOH shall
information on the label or other information strengthen the enforcement of labelling and
materials shall also constitute misbranding. advertising requirements by intensifying
post-market surveillance.
Rule 8a.3 FBOs engaged in processed and
prepackaged foods shall secure market Rule 8b.2 The DA and the DOH shall
authorization from the Food and Drug develop and set the standards on labelling
Administration (FDA) for their and advertising.
establishment and their products prior to
manufacture and market distribution as per SECTION 9. Setting of Food Safety
existing regulations. Standards. – The DA and the DOH shall set
the mandatory food safety standards. The
Rule 8a.4 Food inspection and monitoring following shall guide the setting of
systems shall include assessing the potential standards:
for adulteration, misbranding, and other
forms of fraud. (a) Standards shall be established on the
basis of science, risk analysis, scientific
advice from expert body/bodies, standards
College of Health Sciences

NAME: MACAM, LEA ANGEL DOMINIQUE L. COURSE/YEAR/SECTION: BSN 2B


SUBJECT: NUTRITION AND DIET THERAPY LAB PROFESSOR: MISCHELLE CONDENO
of other countries, existing Philippine (c) The DA and the DOH shall establish the
National Standards (PNS) and the standards policies and procedures for country
of the Codex Alimentarius Commission participation at Codex and the incorporation
(Codex), where these exist and are of Codex standards into national regulations.
applicable; The current National Codex Organization
(NCO) is herein designated as the Body to
Rule 9a.1 The DA and the DOH shall serve this purpose. The DA and the DOH
develop, adopt, amend and/or revise food shall designate a third level officer as
safety standards according to the principles coordinator for Codex activities for their
and procedures in the Act The DA shall respective departments; and
establish standards and codes of practice for
fresh foods or foods from the primary Rule 9c.1 The DA and the DOH shall ensure
production and postharvest sectors of the that the country contributes effectively to the
food supply chain and the DOH-FDA, for development of international standards at
processed and prepackaged foods. Codex as these underpin food safety
regulations, promote harmonization and
Rule 9a.2 Recommendations of the Office contribute to the development of national
International des Epizooties (OIE), standards.
International Plant Protection Convention
(IPPC), and other international bodies Rule 9c.2 Country participation in the work
relevant to food safety may also be of the Codex Alimentarius Commission
considered in developing food safety (CAC) shall be implemented through the
standards. NCO and its Manual of Operations. The
consultative process being implemented by
Rule 9a.3 To the extent feasible, the DA and the NCO involving public and private
DOH shall endeavour to harmonize national stakeholders shall be strengthened.
standards with international and regional
standards. (d) Participation at Codex shall be in
accordance with the principles of RA10611
(b) Codex standards shall be adopted except and shall be financially supported by the
when these are in conflict with what is government
necessary to protect consumers and
scientific justification exists for the action Rule 9d.1 The DA and the DOH shall fund,
taken; as specified in the NCO Manual of
Operations, the attendance to Codex
Rule 9b. 1 Policies and procedures for the meetings and of activities related to ensuring
adoption of Codex standards or other effective participation of the country in the
appropriate standards into national standards work involved in the development of Codex
and regulations shall be established by the standards. The NCO shall prepare a program
DA and the DOH. of activities and budget for funding by the
DA and DOH.
Rule 9b.2 Adoption of standards other than
Codex shall be based on risk assessment.
College of Health Sciences

NAME: MACAM, LEA ANGEL DOMINIQUE L. COURSE/YEAR/SECTION: BSN 2B


SUBJECT: NUTRITION AND DIET THERAPY LAB PROFESSOR: MISCHELLE CONDENO
SECTION 10. Precaution. –  In specific direct or through representative bodies
circumstances when the available relevant unless the urgency of the problem does not
information for use in risk assessment is allow it; and
insufficient to show that a certain type of
food or food product does not pose a risk to Rule 11a.1 The DA and the DOH, whenever
consumer health, precautionary measures they develop food safety regulation, shall
shall be adopted. When such precautionary consult relevant stakeholders including
measures are issued, the following rules consumer groups and the industry through
shall govern: public consultations.

(a) The adopted measure shall remain Rule 11a.2 Following public consultations
enforced pending the submission of or at an appropriate time, FBOs may inform
additional scientific information based on the DA and the DOH in writing of the
the nature of the risk and type of information impact of the regulation on business.
needed to clarify the scientific uncertainty;
and (b) In cases where it is suspected that food
may pose a risk to human health, regulatory
(b) The measure shall be no more restrictive authorities shall take appropriate steps to
to trade than required and should be inform the general public about the nature of
proportionate to the level of protection the risk to health, the affected foods, types
required for consumers. of food and the necessary measures to
prevent, reduce or eliminate the risk.
Rule 10b.1 The FSRAs shall implement
precautionary measures to protect the health Rule 11b.1 The DA and the DOH shall
of its consumers whenever a food safety risk develop a Risk Communication Plan to fully
exists but scientific data are inadequate. The and effectively inform the general public
needed scientific data shall be established about food safety risks.
within a reasonable period of time as
determined by the DA or the DOH. SECTION 12. Application to Trade. –
Foods imported, produced, processed and
SECTION 11. Transparency. – The distributed for domestic and export markets
implementing agencies shall conduct public shall comply with the following
consultation and disseminate relevant requirements:
information to ensure the following:
(a) Food to be imported into the country
Rule 11.1 Food safety measures shall be must come from countries with an
notified to the World Trade Organization equivalent food safety regulatory system and
(WTO) in accordance with international shall comply with international agreements
obligations. to which the Philippines is a party.

(a) Public consultation during the Rule 12a.1 The DA and the DOH shall
preparation, evaluation and revision of food determine whether the country of origin has
legislation shall be open, transparent and an equivalent food safety regulatory system
College of Health Sciences

NAME: MACAM, LEA ANGEL DOMINIQUE L. COURSE/YEAR/SECTION: BSN 2B


SUBJECT: NUTRITION AND DIET THERAPY LAB PROFESSOR: MISCHELLE CONDENO
which is compliant with international Phytosanitary Measures (SPS) Agreement
agreements. and Codex.

Rule 12a.2 The FSRAs shall develop Rule 12b.3 Importers shall notify the DA
protocols and procedures to evaluate a and the DOH of incoming food shipments
foreign country’s food safety regulatory within a period prescribed by the FSRA
system and determine its equivalence with before these arrive at port of entry. The
that of the national system. notification shall be called the Import
Notification Document (IND) and shall
Rule 12a.3 List of countries determined by contain among others, the information
the FSRAs to have equivalent food safety needed by the DA or the DOH to determine
regulatory system shall be made available whether or not the food will require physical
and used in determining eligibility to export inspection on arrival.
into the Philippines.
Rule 12b.4 The BOC shall provide the DA
(b) Imported foods shall undergo cargo and the DOH with the Inward Foreign
inspection and clearance procedures by the Manifest of arriving vessels of AISL and
DA and the DOH at the first port of entry to non-AISL members and break bulk
determine compliance with national organizations as the vessels arrive.
regulations. This inspection by the DA and
the DOH shall always take place prior to Rule 12b.5 Arriving shipments may or may
assessment for tariff and other charges by not require physical inspection based on its
the Bureau of Customs (BOC). The BOC risk categorization as high risk, medium risk
and the Association of International and low risk.
Shipping Lines (AISL) shall provide the DA
and the DOH documents such as the Inward Rule 12b.6 Arriving shipments may or may
Foreign Manifest of Arriving Vessels to not require laboratory testing. If a shipment
enable the DA and the DOH to identify requires testing, it may be held at the port or
shipments requiring food safety inspection. transferred to another location. The physical
Shipments not complying with national transfer of the shipment while awaiting
regulations shall be disposed according to laboratory testing is not an indication that
policies established by the DA and the the shipment has been cleared for entry.
DOH; and
Rule 12b.7 Imported shipments shall meet
Rule 12b.1 The DA and the DOH shall Philippine standards and regulations and
develop the regulations on cargo/shipment those of the country of origin. Where no
inspections and clearance procedures for standards exist in the country of origin, the
imported products prior to assessment of the FSRAs of the country of origin or the
BOC for the appropriate tariffs. importer shall demonstrate that the shipment
was produced under a food safety regime
Rule 12b.2 Inspections and clearance equivalent to national standards.
procedures shall be consistent with Article
IV of the Act, the Sanitary and
College of Health Sciences

NAME: MACAM, LEA ANGEL DOMINIQUE L. COURSE/YEAR/SECTION: BSN 2B


SUBJECT: NUTRITION AND DIET THERAPY LAB PROFESSOR: MISCHELLE CONDENO
Rule 12b.8 Within one hundred eighty (180) SECTION 13. Principal Responsibility of
days after the approval of this IRR, the DA Food Business Operators. – Food business
and the DOH, in consultation with the BOC, operators shall ensure that food satisfies the
shall develop the regulations and set the requirements of food law and that control
parameters of the inspection and clearance systems are in place to prevent, eliminate or
procedures of imported food shipments. The reduce risks to consumers.
inspection and clearance procedures shall be
conducted by the DA and the DOH within Rule 13.1 FBOs shall be primarily
their respective jurisdiction. responsible for ensuring safety of their food
products and compliance of their production
Rule 12b.9 The approved regulations shall and distribution/trading systems to the
be subject to periodic review and requirements of the Act.
amendment as necessary.
Rule 13.2 FBOs shall ensure that foods they
(c) Exported foods shall at all times comply produce are prepared according to standards,
with national regulations and regulations of codes of practice and other control measures
the importing country. Returned shipments as prescribed by the FSRAs that prevent or
shall undergo border inspection clearance as minimize food safety hazards or reduce the
provided in Section 12(b) hereof. hazards to acceptable levels.

Rule 12c.1 The DA and the DOH, in Rule 13.3 Farmers and fisherfolks as well as
consultation with the BOC, shall develop FBOs in small and micro industries shall be
and issue the regulations on exported foods assisted by the DA and DOH in coordination
under their respective jurisdiction within 180 with the local government units (LGUs) to
working days after the approval of this IRR. implement the standards and codes of
practice.
Rule 12c.2 Similarly, the DA and the DOH,
in consultation with the BOC, shall develop Rule 13.4 FBOs in the primary production
and issue regulations on returned shipments and postharvest stages, processed and
of foods under their respective jurisdiction prepackaged sector of the food supply chain
within 180 working days after the approval shall be encouraged to implement a
of this IRR. HACCP-based approach or an equivalent
food safety control program in their
Rule 12c.3 The approved regulations shall operations.
be subject to periodic review and
amendment as necessary. Rule 13.5 When required by markets, FBOs
shall implement a HACCP-based system or
ARTICLE V an equivalent food safety control program in
their operations.
RESPONSIBILITIES ON FOOD
SAFETY Rule 13.6 FBOs operating within the
jurisdiction of the BOQ of the DOH shall
ensure that their food products comply with
College of Health Sciences

NAME: MACAM, LEA ANGEL DOMINIQUE L. COURSE/YEAR/SECTION: BSN 2B


SUBJECT: NUTRITION AND DIET THERAPY LAB PROFESSOR: MISCHELLE CONDENO
Good Manufacturing Practices Rule 14a.1.3 Large and medium scale food
(GMP)/HACCP provisions and that their businesses engaged in the manufacture of
food handlers and stewards have valid BOQ processed and prepackaged food shall
health certificates. designate a FSCO who is preferably a
graduate of food-related courses including
SECTION 14. Specific Responsibilities of but not limited to food technology, food and
Food Business Operators. – Food business nutrition, chemistry, microbiology,
operators shall have the following chemical/sanitary engineering, veterinary
responsibilities under the Act: medicine, fisheries, agriculture. Graduates of
other courses must have work experience on
(a) Food business operators shall be food safety.
knowledgeable of the specific requirements
of food law relevant to their activities in the Rule 14a.2 The FSCO shall oversee the
food supply chain and the procedures implementation of the food safety programs
adopted by relevant government agencies and activities of the food business consistent
that implement the law. They shall adopt, with the provisions of this IRR.
apply and be well informed of codes and
principles for good practices. Micro and Rule 14a.3 The FBO shall ensure that the
small industries shall be assisted to facilitate designated FSCO attends the required
their adoption of such practices; trainings conducted by DA, DOH, LGU or
other recognized training service providers.
Rule 14a.1 All food businesses shall
designate a Food Safety Compliance Officer Rule 14a.4 FBOs shall, in accordance with
(FSCO) who has passed a prescribed the general principles of food safety, identify
training course for FSCO recognized by the and evaluate the hazards that could affect
DA and/or the DOH. food, identify and implement preventive
controls to significantly minimize or prevent
Rule 14a.1.1 For micro and small the occurrence of such hazards. The FBOs
enterprises, the owner may serve as the shall ensure that such food is not
FSCO or a consultant FSCO may be adulterated, contaminated, misbranded, and
employed part time or full time basis. misleading. FBOs shall monitor the
performance of control measures and
Rule 14a.1.2 Large and medium scale food maintain monitoring records as a matter of
businesses engaged in the production of routine practice.
food in the primary and postharvest sector of
the food supply chain shall designate a Rule 14a.5 FBOs shall be proactive in
FSCO who is preferably a graduate of food- monitoring sustained compliance to
related courses including but not limited to standards and relevant regulatory policies.
agriculture, animal science, fisheries, FBOs shall immediately report to the
veterinary medicine, food technology, concerned FSRA any food safety issue
chemistry, chemical/industrial/sanitary which may put the consumer’s health in
engineering. Graduates of other courses danger.
must have work experience on food safety.
College of Health Sciences

NAME: MACAM, LEA ANGEL DOMINIQUE L. COURSE/YEAR/SECTION: BSN 2B


SUBJECT: NUTRITION AND DIET THERAPY LAB PROFESSOR: MISCHELLE CONDENO
Rule 14a.6 FBOs shall develop their be compliant with all regulatory
respective product recall program, in requirements upon determination of the DA
accordance with the requirement of the and/or the DOH.
concerned FSRA, to handle the products that
are not safe or not in compliance with food (c) Food business operators shall allow
safety requirements. inspection of their businesses and
collaborate with the regulatory authorities on
Rule 14a.7 FBOs producing processed and action taken to avoid risks posed by the food
prepackaged food shall develop a Risk product/s which they have supplied; and
Management Plan as basis for the issuance
of appropriate authorizations by the DOH. Rule 14c.1 FBOs shall allow authorized
officers of the FSRAs to enter at an
(b) If a food business operator considers or appropriate time any establishment
has reason to believe that a food which it including agriculture or fishery
produced, processed, distributed or imported establishment in which food is produced,
is not safe or not in compliance with food processed and/or stored or to enter any
safety requirements, it shall immediately vehicle used to transport food to inspect for
initiate procedures to withdraw the food in compliance with food safety regulations.
question from the market and inform the
regulatory authority; Rule 14c.2 In case of non-compliance with
food safety regulations, FBOs shall & ensure
Rule 14b.1 FBOs shall immediately report to that adequate and appropriate corrective and
the FSRA products that are not safe or not in preventive actions agreed between the FBO
compliance with food safety requirements. and the FSRA shall be undertaken in a
They shall also report any incident that timely and effective manner. The actions
indicated that the said product has caused or undertaken shall be subject to verification by
contributed to the death, serious illness or the FSRA.
serious injury to a consumer or any person.
The same shall be withdrawn from the (d) Where the unsafe or noncompliant food
market, in accordance with their respective product may have reached the consumer, the
product recall program, and disposed operator shall effectively and accurately
according to the procedures prescribed by inform the consumers of the reason for the
the DA and/or the DOH. withdrawal, and if necessary, recall the same
from the market.
Rule 14b.2 Food not fully or adequately in
compliance with food safety regulations but Rule 14d.1 The FBO shall inform the
which can be brought into compliance concerned FSRA and the consumer of the
through simple methods such as re-labelling, unsafe or non-compliant food product to be
re-packaging, sorting and/or cooking, may withdrawn from the market in accordance
be recommended to be brought into with the approved product recall program.
compliance by the FBO if the method of
treatment proposed is acceptable to the DA SECTION 15. Principal Responsibilities of
and/or the DOH. The resulting product shall Government Agencies. –  The DA, the DOH,
College of Health Sciences

NAME: MACAM, LEA ANGEL DOMINIQUE L. COURSE/YEAR/SECTION: BSN 2B


SUBJECT: NUTRITION AND DIET THERAPY LAB PROFESSOR: MISCHELLE CONDENO
the DILG and the LGUs shall have the Rule 15a.5 Primary production and
following responsibilities: postharvest handling activities include
transport and dry and/or cold storage of
(a) The DA shall be responsible for food primary and postharvest foods are subject to
safety in the primary production and post- the requirements of the Act.
harvest stages of food supply chain and
foods locally produced or imported in this Rule 15a.6 The DA shall prescribe the
category; control measures, standards, Codes of
GAP/GAHP/GAqP for Food Safety, other
Rule 15a.1 In performing this responsibility, codes of practice, and other requirements for
the DA shall ensure that all laws, standards, the safety of primary and postharvest foods,
policies, and programs assuring the safety of both locally produced and imported under
primary and postharvest food, foods locally this category, and shall verify that these
produced or imported under this category requirements are met.
are implemented.
Rule 15a.7 To ensure food safety during
Rule 15.a.2 Primary food is food obtained primary production, the health of plants and
from the primary production stage of the animals from where the food is derived, the
food supply chain. Primary production refers effects of feeds, crop and aquaculture
to the production, rearing or growing of protection chemicals, veterinary drugs,
primary products including harvesting, biological products, and other production
milking and farmed animal production up to inputs shall be considered and made part of
slaughter, and the rearing and growing of food safety regulations.
fish and other seafood in aquaculture ponds.
It also includes fishing, and the hunting and Rule 15a.8 The DA shall assist the LGUs in
catching of wild products. establishing a mechanism for the issuance
and enforcement of ordinances and
Rule 15a.3 Postharvest food is food obtained regulations for food safety based on national
from postharvest stages of the food supply standards within their territorial jurisdiction.
chain. Postharvest stages involve minimal
transformation of plant and animal foods Rule 15a.9 The DA shall strengthen the
after primary production such as removal of monitoring and surveillance system for
field heat for fruits, slaughter of animals, hazards in the primary production and
sorting, grading and cutting of fresh plant postharvest stages of the food supply chain.
and animal foods, icing and freezing, and the
milling and storage of grain. (b) The DOH shall be responsible for the
safety of processed and prepackaged foods,
Rule 15a.4 Postharvest handling activities foods locally produced or imported under
are essential to food safety and trade as these this category and the conduct of monitoring
activities control hazards and enhance the and epidemiological studies on food-borne
marketability of primary and postharvest illnesses;
foods.
College of Health Sciences

NAME: MACAM, LEA ANGEL DOMINIQUE L. COURSE/YEAR/SECTION: BSN 2B


SUBJECT: NUTRITION AND DIET THERAPY LAB PROFESSOR: MISCHELLE CONDENO
Rule 15b.1 In performing this responsibility, objectives for the control of chronic
the DOH shall ensure that all health laws, diseases. It shall provide guidance to LGUs
standards, policies, and programs assuring in the nutrition labelling of food served in a
the safety of processed and prepackaged FSE.
foods, processed foods but not prepackaged,
foods locally produced or imported under Rule 15b.7 The DOH shall strengthen the
this category and the conduct of monitoring post-market surveillance system for
and epidemiological studies on food-borne monitoring sustained compliance with
illnesses shall be strictly implemented. product standards and regulations including
measures to control misbranding,
Rule 15b.2 Processed food is the product adulteration, and other forms of fraud in
obtained from the processing stage of the locally produced and imported processed
food supply chain. The processing stage of and prepackaged food in the market.
the food supply chain is that stage that
substantially alters the initial raw materials Rule 15b.8 The DOH, through the National
or product or ingredients including, but not Epidemiology Center (NEC) now known as
limited to, heating, smoking, curing, the Epidemiology Bureau (EB), shall
maturing, drying, marinating, extraction, conduct the monitoring and epidemiological
extrusion and a combination of those studies on food-borne illness.
processes intended to produce food.
Rule 15b.9 The DOH through the BOQ shall
Rule 15b.3 Transport and storage of ensure sanitation and food safety measures
processed and prepackaged foods shall be in FSEs at points of entry, in-flight catering
subject to the requirements of the Act. services and domestic and international
shipping vessels.
Rule 15b.4 The DOH through the FDA shall
prescribe the control measures, standards, Rule 15b.10 The DOH shall assist the LGUs
regulations and requirements for the safety in establishing a mechanism for the issuance
of processed and prepackaged foods, and and enforcement of ordinances and
shall verify that these and all requirements regulations for food safety based on national
of food law related to activities and standards within their territorial jurisdiction.
products, including locally produced and
imported processed food products under this (c) The LGUs shall be responsible for food
category, are met. safety in food businesses such as, but not
limited to, activities in slaughterhouses,
Rule 15b.5 The DOH through the FDA shall dressing plants, fish ports, wet markets,
ensure compliance with the food and supermarkets, school canteens, restaurants,
nutrition labelling requirements for catering establishments and water refilling
processed and prepackaged food. stations. The LGU shall also be responsible
for street food sale, including ambulant
Rule 15b.6 The DOH shall prescribe the vending;
requirements for nutrition labelling of
processed and prepackaged food to meet
College of Health Sciences

NAME: MACAM, LEA ANGEL DOMINIQUE L. COURSE/YEAR/SECTION: BSN 2B


SUBJECT: NUTRITION AND DIET THERAPY LAB PROFESSOR: MISCHELLE CONDENO
Rule 15c.1 The LGUs shall be responsible Rule 15e.1 The DA and the DOH shall
for the implementation of the food safety establish mechanisms for coordinating with
requirements of foods produced within their the LGUs in enforcing national food safety
areas of jurisdiction. They shall be guided standards and regulations in food businesses
by national regulations. This shall include within their areas of jurisdiction.
primary, postharvest, processed and
prepackaged foods marketed in traditional Rule 15e.2 The DA and the DOH may
markets as well as restaurants and school delegate official controls to the LGUs and
canteens, catered foods, street vended, specify the conditions under which this shall
and/or ambulant-vended foods and the take place.
requirements for activities and facilities for
the production, handling, processing, (f) The DA and the DOH shall capacitate the
preparation, transport and storage of these LGUs and provide necessary technical
foods. assistance in the implementation of their
food safety functions under their
Rule 15c.2 The DA and the DOH shall jurisdiction. In compliance with this
establish a mechanism to assist the responsibility, they shall provide training to
concerned LGUs in ensuring that foods the DILG and the LGUs and shall
produced outside but marketed within their periodically assess the effectiveness of these
area of jurisdiction meet DA and DOH food training programs in coordination with the
safety requirements. DILG; and

Rule 15c.3 The DA and the DOH shall Rule 15f.1 The DA and the DOH shall
coordinate and provide technical assistance develop and implement capacity building
to LGUs in the enactment of ordinances and programs for the LGUs such as but not
regulations pertaining to their jurisdiction in limited to training courses, advocacy,
the Act. information dissemination and including
participation in national, regional, and
(d) The DILG, in collaboration with the DA, international activities on food safety.
the DOH and other government agencies
shall supervise the enforcement of food Rule 15f.2 The DA and the DOH shall
safety and sanitary rules and regulations as conduct training programs for LGU food
well as the inspection and compliance of safety inspectors and other LGU personnel.
business establishments and facilities within
its territorial jurisdiction; Rule 15f.3 The DA and the DOH shall
regularly evaluate the effectiveness of
(e) The LGUs may be called upon by the training programs and develop assessment
DOH and the DA to assist in the criteria for this purpose.
implementation of food laws, other relevant
regulations and those that will hereafter be (g) The DA and the DOH, in cooperation
issued; with the LGUs, shall monitor the presence
of biological, chemical, and physical
contaminants in food to determine the nature
College of Health Sciences

NAME: MACAM, LEA ANGEL DOMINIQUE L. COURSE/YEAR/SECTION: BSN 2B


SUBJECT: NUTRITION AND DIET THERAPY LAB PROFESSOR: MISCHELLE CONDENO
and sources of food safety hazards in the (e) The Bureau of Plant Industry (BPI), for
food supply chain. plant foods;

Rule 15g.1 The DA and the DOH shall link (f) The Fertilizer and Pesticide Authority
and coordinate with LGUs to monitor (FPA), for pesticides and fertilizers used in
hazards in the food supply chain. Monitoring the production of plant and animal food;
shall be used among others, to determine the
effectiveness of the food safety regulatory (g) The Philippine Coconut Authority
system. (PCA), for fresh coconut;

SECTION 16. Specific Responsibilities of (h) The Sugar Regulatory Administration


the Department of Agriculture. – The DA (SRA), for sugar cane production and
shall be responsible for the development and marketing; and
enforcement of food safety standards and
regulations for foods in the primary (i) The National Food Authority (NFA), for
production and postharvest stages of the rice, corn and other grains.
food supply chain. It shall monitor and
ensure that the relevant requirements of the Rule 16.1 The DA FSRAs for primary and
law are complied with by farmers, fisher postharvest foods and agriculture and
folks and food business operators. Pursuant aquaculture inputs for primary production
thereto, the DA Secretary shall ensure that indicated in Section 16 (a) to (i) shall be
the food safety regulatory mandates and referred to as the DA FSRAs. They shall
functions for fresh plant, animal, fisheries strengthen their food safety regulatory
and aquaculture foods of the DA agencies systems based on a risk management plan
are clearly defined. The agencies under the with provisions for review and monitoring
DA with food safety regulatory functions are for continuous improvement.
the following:
Rule 16.2 The mandate for food safety in the
(a) The Bureau of Animal Industry (BAI), DA shall be the responsibility of the DA
for food derived from animals including Secretary, assisted by the Heads of the DA
eggs and honey production; FSRAs, Bureau of Agriculture and Fisheries
Standards (BAFS) and the Food
(b) The National Dairy Authority (NDA), Development Center (FDC), and the
for milk production and post harvest concerned Undersecretary supervising them.
handling; The Undersecretary for Policy and Planning,
Research and Development (R&D) and
(c) The National Meat Inspection Service Regulations shall provide oversight
(NMIS), for meats;
Rule 16.3 The DA Undersecretary for Policy
(d) The Bureau of Fisheries and Aquatic and Planning, R&D and Regulation shall
Resources (BFAR), for fresh fish and other ensure that all regulatory issuances are
seafoods including those grown by compliant with national policies and
aquaculture; international commitments, oversee
College of Health Sciences

NAME: MACAM, LEA ANGEL DOMINIQUE L. COURSE/YEAR/SECTION: BSN 2B


SUBJECT: NUTRITION AND DIET THERAPY LAB PROFESSOR: MISCHELLE CONDENO
technical support to DA FSRAs provided by in developing/implementing food safety
BAFS and FDC and DA participation in all regulations.
national and international activities on food
safety. Rule 16.7 BAFS shall establish the policies
and procedures for a transparent, science-
Rule 16.4 The DA FSRAs shall implement based mechanism for the development of
the official controls for verifying that standards, which shall include but shall not
primary and postharvest foods meet be limited to the following activities:
regulatory requirements for consumer
health, consumer protection, and trade. They  Preparation of the Priority List for
shall be responsible for the registration of standards development
food businesses, licensing of agriculture and  Qualification and terms and
fishery establishments, official certification conditions for members of the DA
of products and services, official pool of scientific experts
accreditation of inspection and certifying  Promoting functional separation but
bodies, and other official controls prescribed effective interaction between the DA
by the regulatory system and in compliance pool of scientific experts and the DA
with the international commitments. FSRAs
 Ensuring effective sourcing of
Rule 16.5 The DA Secretary may put into scientific data including the design of
place arrangements among the DA FSRAs technical projects for data generation
when necessary to improve efficiency and  Validation and impact evaluation of
cost-effectiveness of services. standards and codes of practice
The Bureau of Agriculture and Fisheries Rule 16.8 The BAFS shall organize the DA
Product Standards (BAFPS) shall develop pool of scientific experts for the
food safety standards including those for development of food safety standards and
organic agriculture. The BAFPS shall the provision of scientific advice to the
establish the mechanism for the Secretary, the Undersecretary for Policy and
development of science-based food safety Planning, R&D and Regulations, the DA
standards for fresh plant, animal, fisheries FSRAs and the NCO. The members of the
and aquaculture foods and shall use the DA pool of scientific experts shall come
services of experts from the FSRA, other from academe, research institutions, and
government agencies, academe and private other relevant organizations.
sector.
Rule 16.9 BAFS shall organize Technical
Rule 16.6 BAFPS now known as the Bureau Working Groups (TWGs) to develop food
of Agriculture and Fisheries Standards safety standards based on the scientific
(BAFS) shall be the DA agency responsible advice of the DA pool of scientific experts.
for developing, adopting, and/or
amending/revising food safety standards and Rule 16.10 The members of the DA pool of
codes of practice for primary and scientific experts and the TWGs shall be
postharvest foods for the use of DA FSRAs
College of Health Sciences

NAME: MACAM, LEA ANGEL DOMINIQUE L. COURSE/YEAR/SECTION: BSN 2B


SUBJECT: NUTRITION AND DIET THERAPY LAB PROFESSOR: MISCHELLE CONDENO
entitled to honoraria and other allowable Rule 16.15 FDC shall prepare the guidelines
emoluments for every meeting attended in for the provision of testing, training and
relation to their functions, subject to existing research services to the DA within one year
laws, rules and regulations. from the implementation of this IRR.

The Food Development Center (FDC) of the When necessary and when funds allow, the
NFA shall provide scientific support in appropriate food safety units shall be created
testing, research and training. within the above-stated agencies. To
strengthen these organizations, they shall be
Rule 16.11 FDC shall be the Coordinating provided with the necessary personnel out of
Laboratory for DA Laboratories and in this the existing manpower of the DA.
capacity shall;
Rule 16.16 The DA FSRAs, BAFS, FDC
 Coordinate testing activities and and the Office of the Undersecretary for
conduct comparative testing as Policy and Planning, R&D and Regulations
necessary shall create functional food safety units,
 Promote the implementation of Good whenever necessary, to implement their food
Laboratory Practice (GLP) safety functions. In doing so, the DA may
 Provide testing services to DA utilize or restructure existing units. Funds
FSRAs for the analysis of chemical, shall be provided by the DA and its agencies
biological and physical contaminants concerned with the implementation of the
in food, particularly those requiring Act Additional requirements shall be subject
analysis at very low levels using to the usual government processes, rules and
specialized equipment regulations.

Rule 16.12 FDC shall implement research Finally, the DA shall, in coordination with
projects to support science-based food safety other government agencies, monitor the
policies, standards and regulations and presence of contaminants in foods of plant,
coordinate these projects with the Bureau of animal and fishery origin and shall
Agricultural Research (BAR) and the formulate and implement measures to
academe. address incidents of food contamination.

Rule 16.13 FDC shall develop and conduct Rule 16.17 The DA shall coordinate with the
relevant training programs on food safety for DOH in establishing an effective system
DA FSRAs and FBOs in coordination with between them and with other government
the Agricultural Training Institute (ATI). agencies for the collection and analysis of
data on food safety hazards in the food
Rule 16.14 FDC shall collect fees for supply chain.
testing, training and research services it
provides to DA FSRAs, FBOs and other SECTION 17. The Undersecretary for
interested parties. Policy and Planning, Research and
Development (R&D) and Regulations. –
Oversight functions for the Food Safety Act
College of Health Sciences

NAME: MACAM, LEA ANGEL DOMINIQUE L. COURSE/YEAR/SECTION: BSN 2B


SUBJECT: NUTRITION AND DIET THERAPY LAB PROFESSOR: MISCHELLE CONDENO
shall be assigned to the Undersecretary for Rule 18a.1 The DOH through FDA shall be
Policy and Planning, R&D and Regulations. responsible for the overall regulation of all
activities pertaining to processed food
The Undersecretary for Policy and Planning, (prepackaged or not prepackaged) including,
R&D and Regulations shall directly but not limited to, inspection, licensing,
supervise the Food Development Center and registration, post-market monitoring, and
the BAFS and shall be the coordinator for laboratory analysis. It shall regulate the
Codex activities at the DA and the Codex manufacture, importation, exportation,
Contact Point. distribution, sale, offer for sale, transfer,
promotion, advertisement, sponsorship of,
Rule 17.1 The FDC of NFA shall be under and/or, where appropriate, the use and
the direct supervision of the Undersecretary testing of all processed and prepackaged
for Policy and Planning, R&D and food products and food supplements/dietary
Regulations after undergoing legal processes supplements.
to make the direct supervision possible.
Rule 18a.2 The FDA Center for Food
Rule 17.2 The Office of the Undersecretary Regulation and Research (CFRR) shall
for Policy and Planning, R&D and implement the official controls for verifying
Regulations shall be the Codex Contact that processed and prepackaged foods meet
Point (CCP) and shall oversee the DA regulatory requirements for consumer
participation in the work of the CAC and the health, consumer protection, and trade.
NCO.
Rule 18a.3 The FDA through the Regional
The Undersecretary for Policy and Planning, Field Offices (RFOs), in performing their
R&D and Regulations shall be provided primary function of inspecting
with the necessary manpower and funds establishments and monitoring their
from existing resources to ensure the smooth compliance, shall strengthen the effective
and efficient discharge of its functions. enforcement of GMP, HACCP, and other
risk-based control measures.
Rule 17.3 The requirements for funds and
manpower to support the oversight functions (b) The FDA Center for Food Regulation
of the Undersecretary for Policy and and Research shall be responsible for
Planning, R&D and Regulations shall implementing a performance-based food
initially be provided by the DA. safety control management system which
shall include, but not limited to, the
SECTION 18. Specific Responsibilities of following:
the DOH. – The DOH shall bear the
following specific responsibilities: (1) Development of food standards and
regulations;
(a) The DOH shall ensure the safety of all
food processing and product packaging Rule 18b1.1 The FDA CFRR Product
activities. Research and Standards Development
Division shall be responsible for developing,
College of Health Sciences

NAME: MACAM, LEA ANGEL DOMINIQUE L. COURSE/YEAR/SECTION: BSN 2B


SUBJECT: NUTRITION AND DIET THERAPY LAB PROFESSOR: MISCHELLE CONDENO
adopting, and/or amending/revising food imported processed and prepackaged food in
safety standards and codes of practice for the market.
processed and prepackaged foods. It shall
strengthen and ensure sustained (3) Enforcement of HACCP and other risk-
development of science-based policies and based control measures;
continued updating of quality work
procedures. The policies and procedures (4) Strong participation in Codex and other
shall be incorporated in the FDA systems international standard setting bodies,
including but not limited to:
Rule 18b4.1 The FDA CFRR shall ensure
1. Food standards and regulations to be the regular participation of country delegates
researched, developed, to activities of Codex and other international
amended/revised, or updated standard setting bodies. It shall strengthen
2. Development of protocol, procedures the country’s positions through the conduct
and qualifications for the and use of science-based studies and
identification, recognition or research taking into consideration all sources
organization of a pool of multi- of scientific information.
disciplinary food experts from
relevant regulatory, health, academe, (5) Communication of risks and
research institutions, professional development of interactive exchange among
organizations to be known as DOH stakeholders;
Joint Scientific Expert Group QSEG)
which shall provide scientific advice Rule 18b5.1 The FDA CFRR shall
to the DOH and its joint undertaking collaborate with the Health Promotion and
with other agencies including the Communication Service (HPCS) in the
NCO development and implementation of a risk
3. The JSEG shall be entitled to communication system on food safety as
allowable honoraria and other identified by recognized risk assessors. The
emoluments for every meeting system shall include consultative discussions
attended in relation to their functions among stakeholders to maintain local and
subject to accounting and auditing international linkages on food safety.
rules and regulations and availability
of funds (6) Establishment of laboratories for food
safety and strengthening the capabilities of
(2) Post-market monitoring; existing laboratories;

Rule 18b2.1 The FDA CFRR shall establish Rule 18b6.1 The FDA CFRR Laboratory
and maintain the post-market monitoring shall strengthen the conduct of quality
system (PMS), including programs for monitoring activities through laboratory
monitoring, fact-finding activities, testing/analysis of processed and
procedures for risk-based inspection, and prepackaged food, regular participation in
collection for testing of locally produced and Proficiency Testing (PT), continuous
performance of method development,
College of Health Sciences

NAME: MACAM, LEA ANGEL DOMINIQUE L. COURSE/YEAR/SECTION: BSN 2B


SUBJECT: NUTRITION AND DIET THERAPY LAB PROFESSOR: MISCHELLE CONDENO
validation or verification, upgrading its including in-flight catering, food service
equipment, oversight the FDA satellite establishments, sea vessels and aircraft, as
laboratories and laboratory accreditation of provided for in the implementing rules and
food testing laboratories. regulations (IRR) of Republic Act No. 9271
and Presidential Decree No. 856, otherwise
(7) Development of a database of food known as the “Code on Sanitation of the
safety hazards and food-borne illness from Philippines”.
epidemiological data;
Rule 18c.1 The BOQ shall adopt HACCP
Rule 18b7.1 The FDA CFRR shall develop a system; enforce GMP-HACCP provisions
database of common food safety hazards and and guidelines; conduct surveillance of
food and water-borne diseases in human infectious diseases including food
coordination with the EB and the DA. and water-borne disease outbreaks
potentially entering the country; develop
(8) Strengthening R&D capabilities on data base system and conduct periodic
product safety and quality standards; and monitoring and evaluation of Food Safety
program in its area of responsibility;
Rule 18b8.1 The FDA CFRR shall identify institute processes and procedures, including
national areas of research and development reasonably appropriate risk-based preventive
on food product safety and quality and controls that provide the same level of
institute strategies in their implementation, public health protection including issuance
foster collaboration with partner institutions, of Health Certificate to stewards and food
conduct capacity building and improvement handlers and Vibrio cholera Clearance
activities for effective translation of research Certificate for all outgoing foodstuff as
results into policy and practices, and required for both domestic and international
undertake, when appropriate, oversight/audit suppliers; provide relevant safety regulation
of related researches that would ensure the inputs to the FSRCB.
safety and quality of food products.
Rule 18c.2 The BOQ shall coordinate with
(9) Certification of food safety inspectors. the LGUs in recognizing the areas of
responsibility as defined in Article V,
Rule 18b9.1 The FDA CFRR shall allocate Section 18(c) of the Act.
funds for the certification of food safety
inspectors (International Organization for (d) The National Epidemiology Center
Standardization (ISO) 17020). Certification (NEC), the Research Institute of Tropical
of food safety inspectors may be given by Medicine (RITM) and the National Center
recognized third party certifying bodies for Disease Prevention and Control
accredited by the PAB. (NCDPC) shall conduct and document
epidemiological monitoring studies on food-
(c) The Bureau of Quarantine (BOQ) shall borne illnesses for use in risk-based policy
provide sanitation and ensure food safety in formulation. Food safety risk assessment
its area of responsibility in both domestic bodies shall be established for this purpose.
and international ports and airports of entry,
College of Health Sciences

NAME: MACAM, LEA ANGEL DOMINIQUE L. COURSE/YEAR/SECTION: BSN 2B


SUBJECT: NUTRITION AND DIET THERAPY LAB PROFESSOR: MISCHELLE CONDENO
Rule 18d.1 The NEC, now named as the EB (f) The NCDPC shall strategize actions to
of the DOH, through its Public Health help ensure the safety of food, reduce the
Surveillance Division, shall be responsible risk of food contamination and food-borne
for the overall planning, management, diseases, address the double burden of
direction, evaluation, and impact assessment micronutrient deficiencies and non-
for the prevention and control of food- and communicable diseases and to regularly
water-borne illness programs. evaluate the progress made.

Rule 18d.2 The RITM, Reference Rule 18f.1 The DPCB, in collaboration with
Laboratory in coordination with EB shall FDA and other offices within the DOH,
conduct confirmation of samples from shall develop strategic actions on risk
human with food and water-borne diseases. management activities or programs relating
to food safety that affects health; review
Rule 18d.3 The NCDPC, now named as the existing guidelines to improve policies
Disease Prevention and Control Bureau pertaining to micronutrient supplementation,
(DPCB), shall conduct a periodic evaluation food fortification of food products and food
of DOH food safety related programs to labelling; develop guidelines on the
determine its effectiveness in achieving decontamination and disposal of
legislated intent, purposes, and objectives in contaminated, adulterated and sub-standard
coordination with other DOH offices. It shall processed and prepackaged food products;
also provide technical assistance and and provide guidance for LGUs in issuing
logistics in the conduct of surveillance of ordinances to control excessive consumption
outbreak or epidemic investigations. of food substance leading to the
development of non-communicable diseases
(e) The National Center for Health such as, but not limited to, diabetes,
Promotion (NCHP) shall be responsible for hypertension, cardiovascular diseases,
advocating food safety awareness, obesity and others.
information and education to the public.
Rule 18f.2 The DOH through DPCB, in
Rule 18e.1 The NCHP now named as the coordination with DILG, shall assist in the
HPCS shall be responsible for advocating development of food safety guidelines for
food safety awareness, information and the FSEs relating to the prevention of non-
education to the public. communicable diseases.

Rule 18e.2 HPCS shall develop Health (g) The DOH and the FDA Center for Food
Promotion and Communication (HPC) Regulation and Research shall be
and/or risk communication plan for food strengthened in terms of establishing food
safety in collaboration with the FDA, safety functional divisions and incremental
DPCB, EB, BOQ, and other concerned staffing of food safety officers and experts
government agencies; and lead the and be provided with funds including the
implementation of the HPC Plan in fees collected from services.
collaboration with the DOH concerned
offices, LGUs and other partners.
College of Health Sciences

NAME: MACAM, LEA ANGEL DOMINIQUE L. COURSE/YEAR/SECTION: BSN 2B


SUBJECT: NUTRITION AND DIET THERAPY LAB PROFESSOR: MISCHELLE CONDENO
Rule 18g.1 The FDA CFRR shall be in other relevant food safety policies as
charge of the food safety regulatory program references.
of the FDA-DOH. It shall create a Food
Safety and Quality Division within CFRR (b) The DILG shall support the DOH and
for this purpose. The Division shall provide the DA in the collection and documentation
technical assistance to the DOH Secretariat of food-borne illness data, monitoring and
of the FSRCB. research.

SECTION 19. Specific Responsibilities of (c) The DILG and the LGUs shall participate
the DILG and the LGUs. –  The DILG and in training programs, standards development
the LGUs shall bear the following and other food safety activities to be
responsibilities: undertaken by the DA, the DOH and other
concerned national agencies.
(a) The LGUs shall be responsible for the
enforcement of the “Code on Sanitation of ARTICLE VI
the Philippines” (Presidential Decree No.
856, December 23, 1975), food safety FOOD SAFETY REGULATION
standards and food safety regulations where COORDINATING BOARD (FSRCB)
food is produced, processed, prepared and/or
sold in their territorial jurisdiction. This shall SECTION 20. Powers and Functions.
include, but shall not be limited to, the – There is hereby created a Food Safety
following: Regulation Coordinating Board, hereinafter
referred to as the Board, with the following
(1) Sanitation particularly in public markets, powers and functions:
slaughterhouses, micro and small food
processing establishments and public eating Rule 20.1 The FSRCB shall establish the
places; policies and procedures for decision making
and its implementation. This shall be carried
(2) Codes of Practice for production, post out as soon as the FSRCB is organized.
harvest handling, processing and hygiene;
Rule 20.2 The FSRCB, when necessary,
(3) Safe use of food additives, processing may seek the assistance and advice of
aids and sanitation chemicals; and technical persons and other agencies on
matters needed in food safety decision
(4) Proper labelling of pre-packaged foods. making.

Rule 19a.1 The FSRAs shall coordinate with (a) Monitor and coordinate the performance
and assist the DILG and LGU in and implementation of the mandates of the
implementing and enforcing its food safety DA, the DOH, the DILG and the LGUs in
function and encourage them to use the food food safety regulation;
safety regulations and standards including
food additives, food/nutrition labelling and
College of Health Sciences

NAME: MACAM, LEA ANGEL DOMINIQUE L. COURSE/YEAR/SECTION: BSN 2B


SUBJECT: NUTRITION AND DIET THERAPY LAB PROFESSOR: MISCHELLE CONDENO
RULE 20a.1 The FSRCB shall monitor and (d) Establish the policies and procedures for
evaluate DA-DOH coordination including coordination among agencies involved in
but not limited to the following areas: food safety;

 Policy and regulatory issues that Rule 20d.1 The FSRCB shall develop a
arise from the implementation of system for the timely exchange of
measures and official controls; information between the DA, the DOH, the
 Effect of regulations on food import DILG, and the LGUs on matters related to
and export trade activities; food safety.
 Exchange of information on
standards and regulatory issuances (e) Continuously evaluate the effectiveness
and scientific data on hazards, of enforcement of food safety regulations
epidemiological studies, monitoring and research and training programs;
and surveillance activities and
others; Rule 20e.1 The FSRCB shall review the
 The management of risk, the control effectiveness and appropriateness of
of fraud, and the identification and enforcement of food safety regulations,
evaluation of emerging risks; and coordinated regulatory activities, research,
 Evaluation of the impact of testing, and training programs. The review shall be
training and research programs. carried out at the end of each year unless
relevant information from monitoring and
(b) Identify the agency responsible for surveillance activities indicate the need for
enforcement based on their legal mandates an earlier review of said activities.
when jurisdiction over specific areas
overlap; (f) Regularly submit reports to the
Congressional Committees on Health,
(c) Coordinate crisis management and Agriculture and Food, and Trade and
planning during food safety emergencies; Industry; and

Rule 20c.1 The FSRCB shall be responsible Rule 20f.1 The FSRCB shall submit an
for preparing a crisis management plan and annual report to the Congressional
the Chair and Co-Chair shall lead food Committees on Health, Agriculture, Food,
control activities during an actual crisis. The and Trade and Industry as required by the
Co-chair of the FSRCB shall be specifically Act.
responsible for crises originating from
and/or affecting primary production and the (g) Accept grants and donations from local
postharvest handling portion of the food and international sources.
supply chain.
Rule 20g.1 The FSRCB may apply
Rule 20c.2 All members of the FSRCB shall for/accept grants from local and
contribute information that will strengthen international sources to fund research,
decision-making during the crisis. training programs, and monitoring and
College of Health Sciences

NAME: MACAM, LEA ANGEL DOMINIQUE L. COURSE/YEAR/SECTION: BSN 2B


SUBJECT: NUTRITION AND DIET THERAPY LAB PROFESSOR: MISCHELLE CONDENO
surveillance activities on food safety except industry associations/ organizations and/or
from entities regulated by FSRAs. consumer groups as resource persons as may
be deemed necessary.
SECTION 21. Organization. – Within thirty
(30) days from the effectivity of this IRR, Rule 21a.4 In the event that the FSRCB
the Secretaries of the DA, the DOH and the requires voting as recourse for decision
DILG shall organize the Board in making, all member departments namely
accordance with the following rules: DOH, DA, DILG, Department of Trade and
Industry (DTI), Department of Science and
(a) The Board shall be chaired by the DOH Technology (DOST), and Leagues of
Secretary and co-chaired by the DA Barangays, Municipalities, Cities and
Secretary. The alternate chair for the DOH Provinces shall each be entitled to one vote.
shall be the FDA Director General and the
alternate co-chair for the DA Secretary shall (b) Within twelve (12) months from the
be the Undersecretary for Policy and effectivity of this Act, the Board shall
Planning, R&D and Regulations. The submit a manual of procedures containing
members of the Board shall be the heads of the rules for the conduct of meetings and
the food safety regulatory agencies of the decision-making, among others;
DA, the Director of the FDA Center for
Food Regulation and Research, a Rule 21b.1 The FSRCB shall create a TWG
representative field operator of the DILG to prepare a manual of procedures within
with the rank of a Director, the heads of twelve (12) months from the approval of this
Leagues of Barangays, Municipalities, Cities IRR. The manual of procedures shall contain
and Provinces and a representative each the rules and procedures for the conduct of
from the DTI and the DOST with the rank of the FSRCB’s activities, meetings, and
a Director. Directors of other DOH agencies decision-making.
with food safety concerns shall join the
meeting as it may be deemed necessary by (c) The Board shall be assisted by
the DOH; administrative and technical secretariat at
the DOH. Both the DOH and the DA shall
Rule 21a.1 The heads of DOH agencies with establish functional divisions and shall
food safety concerns that shall join the organize the administrative and technical
meeting as determined by the DOH personnel for the operation of the Board.
including but not limited to BOQ, EB, The personnel needed under this section
DPCB, HPCS, Bureau of Local Health shall be taken from the existing manpower
Development (BLHD), and RITM. of each department; and

Rule 21a.2 The heads of FDC and BAFS Rule 21c.1 The DOH shall establish the
shall be represented at the FSRCB as administrative Secretariat to the FSRCB.
determined by the FSRCB. The Food Safety and Quality Division
created within the FDA CFRR shall provide
Rule 21a.3 The FSRCB may invite technical assistance to the FSRCB
representatives from the academe, food
College of Health Sciences

NAME: MACAM, LEA ANGEL DOMINIQUE L. COURSE/YEAR/SECTION: BSN 2B


SUBJECT: NUTRITION AND DIET THERAPY LAB PROFESSOR: MISCHELLE CONDENO
Secretariat in addition to its major activities direct or indirect risk to human health from
relating to food safety. food.

Rule 21c.2 The DA through the DA Rule 23.2 The protocols and procedures for
Undersecretary for Policy and Planning, the national rapid alert system for food and
R&D and Regulations shall create a feed shall consider existing international
functional division from where the systems.
administrative and technical support to the
DA participation to the FSRCB shall be Rule 23.3 The FSRCB shall designate a
designated. national contact point for the national rapid
alert system for food and feed.
(d) Funds shall be allocated by the
respective agencies concerned with food SECTION 24. Emergency Measures.
safety to pay for the organization of – Where it is evident that food originating
meetings, participation of Board members, from within the country or imported from
secretariat, experts and the expenses of a another country is likely to constitute serious
working group to be created by the Board to risk to human health, the Board, in
prepare its manual of procedures. coordination with the FSRAs of the DOH
and the DA, shall immediately adopt one or
SECTION 22. Accountability for Food more of the following measures, depending
Safety Regulation.  – The FSRAs of the DA on the gravity of the situation:
and the DOH, in coordination with the
LGUs, shall be responsible in ensuring food (a) In the case of food of national origin:
safety at various stages of the food supply
chain within their specified mandates. (1) Suspension of its distribution in the
market or the use of the food in question;
Rule 22.1 Responsibility and oversight
functions for the implementation of (2) Laying down special conditions for the
coordinated activities shall reside in the food in question; and
Chair and Co-Chair of the FSRCB.
(3) Any other appropriate interim measures.
ARTICLE VII
(b) In the case of food from another country:
CRISIS MANAGEMENT
(1) Suspension of imports of the food from
SECTION 23. Rapid Alert System. – A rapid all or parts of the third country concerned
alert system for the notification of a direct or and, where applicable, from the third
indirect risk to human health due to food country of transit;
shall be established by the FSRCB.
(2) Laying down special conditions for the
Rule 23.1 A national rapid alert system for food in question from all or part of the third
food and feed shall be established to identify country concerned; and
and subsequently notify of the existence of a
College of Health Sciences

NAME: MACAM, LEA ANGEL DOMINIQUE L. COURSE/YEAR/SECTION: BSN 2B


SUBJECT: NUTRITION AND DIET THERAPY LAB PROFESSOR: MISCHELLE CONDENO
(3) Any other appropriate interim measures. a part of the Food Safety Regulatory System
of the DA and the DOH.
SECTION 25. Plan for Crisis
Management. – The Board, in coordination (b) The frequency of official controls shall
with the FSRAs and other relevant be proportionate to the severity and
government agencies, shall prepare a general likelihood of occurrence of the food safety
plan for the management of a threat to food risks being controlled;
safety such as radiation contamination of
food, food shortage requiring coordinated Rule 26b.1 Official control procedures shall
action and other crisis situations which may be risk-based and shall include risk-based
compromise food safety. This plan shall inspection, testing, certification and audits.
specify the situations representing a direct or
indirect risk to human health deriving from (c) Official controls shall be based on
food which are not likely to be prevented, appropriate techniques, implemented by an
eliminated or reduced to an acceptable level. adequate number of suitably qualified and
experienced personnel and with adequate
Rule 25.1 In the event of food shortage or funds, facilities and equipment
other emergency situations, the equivalency
requirements for food safety regulatory Rule 26c.1 Food inspection shall be carried
system in Section 12 of the Act may be out by inspectors under the supervision of
reconsidered upon evaluation of the FSRAs food safety officers (FSO) or equivalent
and approval of the FSRCB. personnel who are graduates of food-related
courses including but not limited to
ARTICLE VIII chemistry, food and nutrition, food
technology, microbiology, chemical/sanitary
IMPLEMENTATION OF FOOD engineering, veterinary medicine, fisheries,
SAFETY REGULATIONS agriculture. To qualify as FSO, graduates
must have training and/or work experience
SECTION 26. Policies on Official Controls. in food safety.
–  Official controls are established to verify
compliance with food laws and regulations Rule 26c.2 FSO or equivalent personnel
and shall be prepared by each agency. The involved in food inspection shall pass a
following shall govern the exercise of certified training course on food inspection
official controls: every three years.

(a) Official controls shall be implemented by Rule 2 6c.3 The FSRAs shall ensure that
way of regulations prepared by the FSRAs adequate funds, facilities, and equipment for
in accordance with the principles established the implementation of official controls are
in this Act; provided.

Rule 26a.1 Official controls shall be based Rule 26c.4 Testing for official controls shall
on Section 26 (a) to (h) of the Act. It shall be be carried out by professionally licensed
College of Health Sciences

NAME: MACAM, LEA ANGEL DOMINIQUE L. COURSE/YEAR/SECTION: BSN 2B


SUBJECT: NUTRITION AND DIET THERAPY LAB PROFESSOR: MISCHELLE CONDENO
personnel depending on the test methods (g) Provisions shall be made for official
being implemented. controls to be delegated to other competent
bodies as determined by the regulatory
(d) The regulatory agency or body agency and of the conditions under which
performing official controls shall meet this shall take place. When official controls
operational criteria and procedures are delegated, appropriate coordination and
established by the agencies to ensure other procedures including oversight shall be
impartiality and effectiveness; in place and effectively implemented. The
accountability over the delegated function
(e) Any personnel of FSRAs such as, but not shall remain with the regulatory agency; and
limited to, food inspectors shall perform
official controls at the highest level of Rule 26g.1 Third party service providers of
competence and integrity, ever mindful of inspection, testing and certification activities
conflict of interest situations; can be officially accredited by the FSRAs or
accredited to the appropriate ISO standard
Rule 26e.1 Any personnel of the FSRAs, by the PAB.
who in the performance of their official
function obtain proprietary information, (h) The agencies responsible for the
shall observe strict confidentiality in the implementation of official controls shall be
handling and use of said information. provided with the necessary funding and
technical support out of their existing budget
(f) Policies and procedures for official to perform official controls according to the
controls shall be documented in a manual of principles indicated in this Act.
operations to ensure consistency, high
quality, uniformity, predictability and Rule 26h.1 The funds necessary to
transparency; implement the manual of procedures for
official controls shall be provided by the DA
Rule 26f.1 A manual of procedures for food and the DOH.
inspectors shall be developed by FSRAs
within a reasonable period of time after the SECTION 27. Traceability. – Traceability
approval of this IRR. Initial funding for the shall be established for foods at relevant
development of this manual of procedures stages of production, post harvest handling,
shall be provided by the DA and the DOH. processing or distribution, when needed to
ensure compliance with food safety
Rule 26f.2 Food testing laboratories shall requirements. The rule on traceability shall
have manuals on GLP, calibration also cover production inputs such as feeds,
procedures, and a manual of validated food additives, ingredients, packaging
testing methods compliant with Codex/ISO materials and other substances expected to
requirements. Steps shall be taken to be incorporated into a food or food product.
accredit food testing laboratories to ISO To ensure traceability, food business
17025. operators are required to:
College of Health Sciences

NAME: MACAM, LEA ANGEL DOMINIQUE L. COURSE/YEAR/SECTION: BSN 2B


SUBJECT: NUTRITION AND DIET THERAPY LAB PROFESSOR: MISCHELLE CONDENO
(a) Be able to identify any person or Rule 27.2 The traceability system
company, from whom they have been established by the FBOs shall be verified by
supplied with: the concerned FSRAs.

(1) Food; Rule 27.3 The DA and other concerned


agencies of the DOH shall assist the EB in
(2) A food-producing animal; tracing food-borne disease outbreak from
production to consumption.
(3) Production chemicals as pesticides and
drugs; and SECTION 28. Licensing, Registration of
Establishments. – Appropriate
(4) Production, post-harvest handling and authorizations shall be developed and issued
processing inputs such as feeds, food in the form of a permit, license and
additives, food ingredients, packaging certificate of registration or compliance that
materials, or any substance expected to be would cover establishments, facilities
incorporated into food or food product. engaged in production, post-harvest
handling, processing, packing, holding or
(b) Establish and implement systems and producing food for consumption in
procedures which allow the above accordance with the mandated issuances of
information to be available to the regulatory regulatory agencies issuing such
authorities on demand; and authorizations. Special derogations shall be
provided due to geographical location and
(c) Establish systems and procedures to after an assessment of risks, especially for
identify the other businesses, to which their micro, small and medium-sized food
products have been supplied. This business operators and health products.
information shall be made available to the
regulatory authorities upon demand. Rule 28.1 Authorizations shall be issued
when products or establishments have been
Traceability in case of food-borne disease verified by examination or objective
outbreak shall be established by the National evidence, to meet specified requirements of
Epidemiology Center (NEC) of the DOH. the Act for the product or the establishment.
In issuing appropriate authorizations, the
Rule 27.1 FBOs shall be required to FSRAs may consider modifying or updating
establish a traceability system which will existing authorization or establish new ones
indicate at the minimum where the as necessary.
food/food ingredient immediately came
from and where it will immediately proceed. Rule 28.2 As part of their regular mandates,
The systems implemented by FBOs shall be the LGUs shall issue business permits to
based on principles and standards of Codex FBOs indicating compliance with the
and other international standard bodies. sanitation code and such other food safety
requirements that may be prescribed. Such
permit authorizes FBOs to market their
products within their territorial jurisdiction.
College of Health Sciences

NAME: MACAM, LEA ANGEL DOMINIQUE L. COURSE/YEAR/SECTION: BSN 2B


SUBJECT: NUTRITION AND DIET THERAPY LAB PROFESSOR: MISCHELLE CONDENO
Rule 28.3 The DA and DOH shall issue Rule 29d.1 Methodologies for inspection
appropriate authorizations to FBOs in shall be incorporated in the manual and shall
accordance with mandated issuances of undergo periodic review.
FSRAs authorizing FBOs to market their
products for national and/or international SECTION 30. Food Testing Laboratories.
markets. – The following shall guide the management
and operation of food testing laboratories:
SECTION 29. Inspection of Food Business
Operators. – Regular inspection of food (a) Food testing shall be carried out by
business operators shall be performed by the laboratories accredited in accordance with
FSRAs or the control bodies delegated to international standards. Those that are not
conduct the activity. In addition, the currently accredited shall apply for
following rules shall be followed in the accreditation within a specified period of
conduct of inspections: time;

(a) Inspection shall take into account Rule 30a.1 DA and DOH laboratories shall
compliance with mandatory food safety conform to the national and/or international
standards, the implementation of HACCP, standards for GLP and method validation.
good manufacturing practices and other They shall seek and maintain accreditation
requirements of regulations; to ISO 17025.

(b) The frequency of inspections shall be Rule 30a.2 Food testing can be carried out
based on the assessment of risks. by third party laboratories officially
Establishments producing high risk foods or accredited by the FSRAs. The criteria for the
carrying out high risk activities shall be official accreditation of third party
inspected more frequently; laboratories shall be established by the
FSRAs.
(c) Inspectors shall have defined skills on
risk-based inspection and shall be regularly (b) Testing shall be carried out using the
evaluated based on suitable procedures to internationally approved procedures or
verify their continuing competence methods of analysis that have been
validated;
Rule 29c.1 Inspectors shall attend training
programs designed to strengthen their Rule 30b.1 Food testing laboratories shall
capabilities in the inspection of food, conduct verification of the validated test
systems and technologies. Training methods or procedures.
programs shall establish competence
through but not limited to examinations and (c) Laboratories shall be organized and
certifications. managed to prevent conflict of interest in the
conduct of testing;
(d) Appropriate procedures shall be in place
to ensure that the results of inspection are
interpreted in a uniform manner.
College of Health Sciences

NAME: MACAM, LEA ANGEL DOMINIQUE L. COURSE/YEAR/SECTION: BSN 2B


SUBJECT: NUTRITION AND DIET THERAPY LAB PROFESSOR: MISCHELLE CONDENO
(d) Laboratories shall be staffed with The different FSRAs shall identify training
analysts with the required expertise and needs and the appropriate training programs.
professional competence, and Mandatory training programs shall be
developed and implemented by accredited
Rule 30d.1 The competence of the training providers.
laboratory analysts shall be regularly
assessed. Rule 31.1 All training programs on food
safety shall include the requirements of the
(e) FSRAs may recognize private testing Act.
laboratories accredited by the Philippine
Accreditation Office (PAO) of the DTI to Rule 31.2 The DA and the DOH shall
support their testing needs. develop and conduct food safety trainings
designed specifically for FSCOs, the FBOs,
ARTICLE IX and the FSRAs. Other government
institutions, the academe, professional
TRAINING AND CONSUMER associations and third party service
EDUCATION providers may also conduct food safety
trainings provided that these are recognized
SECTION 31. Training. – Skills training by the FSRAs.
and other instructional/educational activities
shall be regularly provided to food business Rule 31.3 The DA and the DOH may partner
operators, food handlers and to government with other government institutions, the
personnel as follows: academe, professional associations and third
party service providers in providing these
(a) Food business operators particularly food safety trainings.
micro, small and medium scale enterprises
shall be trained on the requirements of food SECTION 32. Consumer Education. – A
safety regulations and the understanding of consumer education program shall be
these requirements. Personnel shall be developed by the DA, the DOH and the
trained on HACCP, on the codes of good LGUs in partnership with the Department of
practice and on technologies that will enable Education, the implementation of which
them to comply with regulations; shall be carried out by the latter.

(b) Mandatory training on safe food SECTION 33. Funding. – Funds shall be


handling and similar courses shall be provided for the development and
implemented for food handlers of food implementation of training and consumer
businesses; and education programs.

(c) Government personnel shall be trained Rule 33.1 The DA and the DOH shall
on the scientific basis for the provisions of provide funds for the development and
the law and on the conduct of official initial implementation of training and
controls. consumer education programs through the
College of Health Sciences

NAME: MACAM, LEA ANGEL DOMINIQUE L. COURSE/YEAR/SECTION: BSN 2B


SUBJECT: NUTRITION AND DIET THERAPY LAB PROFESSOR: MISCHELLE CONDENO
regular appropriations of FSRAs and other assisting farmers, fisherfolk, micro, small
relevant agencies. and medium scale enterprises and other
stakeholders to enable them to comply with
ARTICLE X food safety regulations.

FOOD-BORNE ILLNESS Rule 35.1 The DA and the DOH shall


MONITORING, SURVEILLANCE AND include cost-effective technologies and
RESEARCH codes of practice relative to food safety
regulations in their respective research
SECTION 34. Food-borne Illness agenda or research priorities.
Monitoring and Surveillance. – The
government, in support of risk analysis, shall Rule 35.2 The DA and the DOH shall
implement the following programs: engage the academe and other relevant
institutions in the conduct of research.
(a) An integrated food-borne disease
monitoring system that links to the sources Rule 35.3 Results of such research shall be
of food contamination in collaboration with used in the development of policies and
the DOH-NEC and the NCDPC; and improvement of food safety regulations.

Rule 34a.1 The DOH-NEC and the NCDPC ARTICLE XI


shall collaborate with the FSRAs in
strengthening the sharing of information on POLICY ON FEES
food-borne diseases for the development of
appropriate risk management measures. SECTION 36. Collection of Fees. – The
DA, the DOH and the LGUs, where
(b) Identification of hazards in the food applicable, shall be allowed to collect fees
supply chain and assessment, of levels of for the inspection of food products,
exposure to the hazards. production and processing facilities,
issuance of import or export certificates,
Rule 34b.1 The DA and DOH shall link and laboratory testing of food samples and other
coordinate their activities in identifying and fees as may be deemed necessary.
monitoring hazards in the food supply chain
such as pesticide residues, food additives, Fees shall be based on an officially-
veterinary drug residues in food and approved procedure for estimating the cost
chemical, biological, and other contaminants of the activity undertaken and shall be
under their jurisdiction. The results shall be subject to government accounting and
used to create a database on the national auditing rules and regulations.
food safety situation.
Rule 36.1 FSRAs shall issue a schedule of
SECTION 35. Research. – The government fees for services provided.
and academe shall develop and implement a
program of research on cost effective ARTICLE XII
technologies and codes of practice for
College of Health Sciences

NAME: MACAM, LEA ANGEL DOMINIQUE L. COURSE/YEAR/SECTION: BSN 2B


SUBJECT: NUTRITION AND DIET THERAPY LAB PROFESSOR: MISCHELLE CONDENO
PROHIBITIONS, PENALTIES AND SECTION 38. Penalty. – Any person who
SANCTIONS shall violate any provision of this Act shall
suffer the penalties provided hereunder:
SECTION 37. Prohibited Acts. – It shall be
unlawful for any person to: Rule 38.1 The existing rules of procedures
in administrative proceedings in each FSRA
(a) Produce, handle or manufacture for sale, shall be applied in the handling of cases and
offer for sale, distribute in commerce, or violations committed under the Act and its
import into the Philippines any food or food IRR. The Executive Order No. 292 or the
product which is not in conformity with an Administrative Code and the Rules of Court
applicable food quality or safety standard shall be applicable in suppletory manner.
promulgated in accordance with this Act.
Rule 38.2 Prior to, or pending administrative
(b) Produce, handle or manufacture for sale, proceedings, any temporary preventive
offer for sale, distribute in commerce, or measures being exercised by each FSRA
import into the Philippines any food or food shall apply.
product which has been declared as banned
food product; (a) For the first conviction, a fine of not less
than Fifty thousand pesos (P50,000.00) but
(c) Refuse access to pertinent records or not more than One hundred thousand pesos
entry of inspection officers of the FSRA; (P100,000.00) and suspension of appropriate
authorization for one (1) month shall be
(d) Fail to comply with an order relating to imposed;
notifications to recall unsafe products;
(b) For the second conviction, a fine of not
(e) Adulterate, misbrand, mislabel, falsely less than One hundred thousand pesos
advertise any food product which misleads (P100,000.00) but not more than Two
the consumers and carry out any other acts hundred thousand pesos (P200,000.00) and
contrary to good manufacturing practices; suspension of appropriate authorization for
three (3) months shall be imposed;
(f) Operate a food business without the
appropriate authorization; (c) For the third conviction, a fine of not less
than Two hundred thousand pesos
(g) Connive with food business operators or (P200,000.00) but not more than Three
food inspectors, which will result in food hundred thousand pesos (P300,000.00) and
safety risks to the consumers; and suspension of appropriate authorization for
six (6) months shall be imposed;
(h) Violate the implementing rules and
regulations of this Act. (d) For violation resulting in slight physical
injury of a person, upon conviction, a fine of
not less than Two hundred thousand pesos
(P200,000.00) but not more than Three
hundred thousand pesos (P300,000.00) and
College of Health Sciences

NAME: MACAM, LEA ANGEL DOMINIQUE L. COURSE/YEAR/SECTION: BSN 2B


SUBJECT: NUTRITION AND DIET THERAPY LAB PROFESSOR: MISCHELLE CONDENO
suspension of appropriate authorization for payment of fine and service of sentence shall
six (6) months shall be imposed. The also be imposed.
offender shall also pay the hospitalization
and rehabilitation cost of a person; If the offender is an alien, said alien shall be
summarily deported after payment of fine
(e) For violation resulting in less serious or and service of sentence and perpetually
serious physical injury of a person, upon barred from entering the country.
conviction, a fine of not less than Two
hundred thousand pesos (P200,000.00) but Any director, officer or agent of a
not more than Three hundred thousand pesos corporation who shall authorize, order or
(P300,000.00) and suspension of appropriate perform any of the acts or practices
authorization for one (1) year shall be constituting in whole or in part a violation of
imposed. The offender shall also pay the Section 37 hereof, and who has knowledge
hospitalization and rehabilitation cost of a or notice of noncompliance received by the
person; corporation from the concerned department,
shall be subjected to the penalties under this
(f) For violation resulting in death of a section.
person, upon conviction, the penalty of
imprisonment of not less than six (6) months In case the violation is committed by, or in
and one (1) day but not more than six (6) the interest of a foreign juridical person duly
years and one (1) day and a fine of not less licensed to engage in business in the
than Three hundred thousand pesos Philippines, such license to engage in
(P300,000.00) but not more than Five business in the Philippines shall immediately
hundred thousand pesos (P500,000.00) and be revoked.
permanent revocation of appropriate
authorization to operate a food business Rule 38.3 The administrative penalties
shall be imposed. provided under the Act shall be in addition
to whatever penalties provided under other
If the offender does not have the appropriate relevant laws which may penalize the same
authorization, the imposable fines shall be acts.
doubled.
Rule 38.4 For violation of prohibited acts of
If the offender is a government personnel, in the Act and its IRR, both criminal action in
addition to the penalty prescribed herein, court and the administrative action may be
said personnel shall be subjected to the instituted separately and independent of one
appropriate civil service laws. another. The filing of the administrative
complaint and the imposition of
If the offender is a naturalized citizen, in administrative penalties shall be lodged with
addition to the penalty prescribed herein, the the concerned FSRA.
naturalization certificate and the registration
in the civil registry of said citizen shall be Rule 38.5 The filing of action for violation
cancelled. Immediate deportation after of prohibited acts resulting in death of a
person and the imposition of the
College of Health Sciences

NAME: MACAM, LEA ANGEL DOMINIQUE L. COURSE/YEAR/SECTION: BSN 2B


SUBJECT: NUTRITION AND DIET THERAPY LAB PROFESSOR: MISCHELLE CONDENO
corresponding penalty of imprisonment shall secretariat shall be provided by the DA,
be lodged with the appropriate courts, DOH and DILG from their existing funds
and manpower complements.
ARTICLE XIII
Rule 39.3c The functions, duties and
FINAL PROVISIONS responsibilities pertaining to one FSRA but
is presently being performed by another
SECTION 39. Implementing Rules and FSRA pursuant to previous formal
Regulations. – These implementing rules agreements or issuances shall be
and regulations are jointly issued by DA and continuously performed by the latter until
the DOH as mandated by Section 39 of the the same are transferred to the concerned
Food Safety Act 2013. FSRA.

Rule 39.1 The IRR of the Act may be jointly Rule 39.3d The transfer and absorption of
amended and/or updated, if the need arises, the functions, duties and responsibilities
by the DA and the DOH. belonging to the former shall be in
accordance with the transition plan to be
Rule 39.2 All doubts in the interpretation of finalized and approved during the first
the IRR shall be resolved in favour of the Board meeting and implemented within 24
protection of the health of consumers and in months from the effectivity of this IRR.
a manner consistent with the declared Notwithstanding, the transfer and absorption
policies and objectives of RA 10611. of the functions, duties and responsibilities
shall take effect immediately after 24
Rule 39.3 Transitory Provisions: months from the effectivity of this IRR.

Rule 39.3a Within thirty (30) days from the Rule 39.3e The transition plan shall include,
effectivity of this IRR, the Secretaries of the among others:
DA, the DOH, and the DILG shall organize
the FSRCB. i. The efficient transfer of all processed and
pre-packaged food applications (product
Rule 39.3b An ad hoc secretariat is hereby registration and license of establishments)
created to assist and support the Secretaries and consumer complaints with the
of the DA, the DOH, and the DILG in Consumer Arbitration Officer of the
identifying the members of the FSRCB and Department of Agriculture on processed and
prepare the agenda for the first Board pre-packaged food, together with all the
meeting. It shall be composed of at least 2 required documents, records and relevant
representatives from each Department. The information to the DOH-FDA;
ad hoc secretariat shall automatically cease
to function immediately upon the ii. The DOH-FDA, with the assistance of
organization of an administrative and DA-BFAR, shall pursue in securing EU
technical secretariat pursuant to Article VI, certification to processed fish products
Section 21 (c) of the Act. The funding and exported to EU; and
personnel requirements for the ad hoc
College of Health Sciences

NAME: MACAM, LEA ANGEL DOMINIQUE L. COURSE/YEAR/SECTION: BSN 2B


SUBJECT: NUTRITION AND DIET THERAPY LAB PROFESSOR: MISCHELLE CONDENO
iii. The DA and DOH shall jointly undertake SECTION 1. Title. This Act shall be known as
an information dissemination to notify “An Act for Salt Iodization Nationwide
relevant stakeholders of the transfer of (ASIN)”. SECTION 2. Declaration of Policy. It
regulatory activities based on their mandates is hereby declared the policy of the state to
and endeavour to continuously coordinate protect and promote the health of the people, to
and cooperate for the effective maintain an effective food regulatory system and
implementation of the Food Safety Act. to provide the entire population especially
women and children with proper nutrition. For
SECTION 40. Separability Clause. – If any this purpose, the State shall promote the
provision of these implementing rules and nutritional fortification of food and combat
regulations is declared invalid or micronutrient malnutrition as a priority health
unconstitutional, the other provisions not program for the nation. SECTION 3. Purposes.
affected thereby shall remain in full force The purposes of this Act are to: a) contribute to
and effect. the elimination of the micronutrient malnutrition
in the country, particularly iodine deficiency
SECTION 41. Repealing Clause. – All laws, disorders, through cost-effective preventive
presidential decrees, executive orders, rules measure of salt iodization; b) require all
and regulations inconsistent with the producers/manufacturers of food-grade salt to
provisions of the Food Safety Act 2013 and iodize the salt that they produce, manufacture,
these implementing rules and regulations are import, trade or distribute; c) require the
hereby repealed, amended or modified Department of Health (DOH) to undertake the
accordingly. salt iodization program and for its Bureau of
Food and Drugs (BFAD) to set and enforce
SECTION 42. Effectivity. – These standards for food-grade iodized salt and to
implementing rules and regulations shall monitor compliance thereof by the food-grade
take effect fifteen (15) days after its salt manufacturers; d) require the local
government units (LGU), through their health
publication in two (2) newspapers of general
officers and nutritionist/dietitians, or in their
circulation.
absence through their sanitary inspectors, to
http://www.officialgazette.gov.ph/downloads/20 check and monitor the quality of food-grade salt
15/02feb/20150220-IRR-RA-10611.pdf being sold in their market in order to ascertain
that such salt is properly iodized; e) require the
Department of Trade and Industry (DTI) to
regulate and monitor trading of iodized salt; f)
[REPUBLIC ACT NO. 8172]
direct the Department of Science and
AN ACT PROMOTING SALT Technology (DOST) in collaboration with the
IODIZATION NATIONWIDE AND FOR Technology and livelihood Resource Center
RELATED PURPOSES (TLRC) to initiate, promote, and cause the
transfer of technology for salt iodization; 2 g)
Be it enacted by the Senate and House of authorize the National Nutrition Council (NNC)
Representatives of the Philippines in Congress the policy-making and coordinating body in
assembled. nutrition, to serve as the advisory board on salt
iodization; h) provide mechanisms and
College of Health Sciences

NAME: MACAM, LEA ANGEL DOMINIQUE L. COURSE/YEAR/SECTION: BSN 2B


SUBJECT: NUTRITION AND DIET THERAPY LAB PROFESSOR: MISCHELLE CONDENO
incentives for the salt industry in the production, more than three hundred metric tons (300m.t.) to
marketing and distributi0on of iodized salt; and two thousand metric tons (2,000m.t.) per year. l)
i) ensure the sustainability of the salt iodization Large producer/manufacturer - one who
program. SECTION 4. Definition of Terms. For produces, imports trades in, or distributes salt
purposes of this Act, the following terms shall exceeding two thousand metric tons
mean: a) Micronutrient malnutrition - a disorder (2,000m.t.)per year 3 SECTION 5.
resulting from deficiencies in Vitamin A, iron, Applicability. a) This act shall apply to the entire
iodine and other micronutrients which the body salt industry, including salt
needs in minute quantities everyday. b) Iodine producers/manufacturers, importers, traders and
deficiency disorders - a broad spectrum of distributors, as well as government and non-
deficiencies resulting from lack of iodine in the government agencies involved in salt iodization
diet which leads to the reduction of intellectual activities. b) Iodized salt that conforms to the
and physical capacity affecting everyone who is standards set by the BFAD to meet national
iodine deficient and may manifest as goiter, nutritional needs shall be made available to
mental retardation, physical and mental defects, consumers, Provided, That the implementation
and cretinism. c) Food fortification - the addition of this act shall be enforced over a staggered
of nutrients to processed foods at levels above period of one (1) year for large and medium
the natural state. d) Salt iodization - the addition producers/manufacturers, two (2) years for small
of iodine to salt intended for human or animal salt producers/manufacturers and five (5) years
consumption in accordance with specifications for subsistence producers/manufacturers. c) All
as to form, fortificant, methods, manner and food outlets, restaurants, and stores are hereby
composition as may be prescribed by the BFAD. required to make available to customers only
e) Food-grade salt - salt for human and animal iodized salt in their establishment upon
consumption as distinguished from industrial effectively of this Act. These establishments
salt. f) Regulatory requirements - the provision shall be monitored with the help of the Lug’s
of all applicable laws, regulations, executive through its health officers and
orders, and other enactments related to food nutritionists/dietitians or in their absence, the
quality and safety, purity, nutritional sanitary inspectors to check and monitor the
composition and other aspects of food regulation quality of food-grade salt being sold or served in
or control. g) Industrial salt - salt used in the such establishments. d) In areas endemic to
treatment, processing and/or manufacture of iodine deficiency disorders, iodized salt shall be
non-food commercial products. h) Manufacturer made available. Local government officials at
- one who produces , imports trades and the provincial and municipal levels shall provide
distributes salt. i) Subsistence mechanisms to ensure enforcement of this
producer/manufacturer - one who produces, provision through ordinances and public
trades in or distributes salt not exceeding two information campaigns. e) All food
metric tons (2m.t.) of salt per year. j) Small manufacturer/processors using food-grade salt
producer/manufacturer - one who produces, are also required to use iodized salt in the
imports trades in or distributes salt ranging from processing of their products and must comply
more than two metric tons (2m.t.) to three metric with the provisions of the Act not later than one
tins (3m.t.) per year. k) Medium (1) year from its effectivity: Provided, That the
producer/manufacturer - one who produces, use of iodized salt shall not prejudice the quality
imports trades in, or distributes salt ranging from and safety of their food products. Provided,
College of Health Sciences

NAME: MACAM, LEA ANGEL DOMINIQUE L. COURSE/YEAR/SECTION: BSN 2B


SUBJECT: NUTRITION AND DIET THERAPY LAB PROFESSOR: MISCHELLE CONDENO
however, That the burden of proof and testing suitable for use as salt farms with the purpose of
for any prejudicial effects due to iodized salt protecting such areas from environmental risks
fortification lies on the said food to ensure sustainability of iodized salt
manufacturer/processor. f) Salt production. SECTION 7. Public Information.
producers/manufacturers shall register with the The benefits and rationale of the use of iodized
BFAD which shall maintain updated registry of salt shall be adequately disseminated and
salt producers/manufacturers and shall monitor promoted through organized systematic and
compliance with the salt iodization program. g) nationwide information campaign which shall
All food-grade salt shall be labeled in a manner involve major sectors of society to be
that is true and accurate, not likely to mislead spearheaded by the DOH in cooperation and
purchasers and in accordance with the coordination the LGU’s and other government
requirements prescribed by the BFAD. h) For a agencies concerned, particularly the Department
period of three (3) years from the effectivity of of Education, Culture and Sports (DECS), the
the Act, the DOH shall provide free iodized salt Philippine Information Agency (PIA), provincial
to indigents residing in sixth class municipalities science centers, private sectors and students. The
as may be allowed by their annual implementing agency, in coordination with PIA,
appropriations. SECTION 6. Support to the Salt shall seek the cooperation of the media sector in
Industry. - The following agencies and public information dissemination. Salt iodization
institutions shall support the salt iodization and its benefits shall also be included and given
program through their respective internal emphasis in all levels of health subjects in both
programs: a) The DTI is hereby required to private and public schools. SECTION 8. The
assist and support local salt Salt Iodization Advisory Board. - The National
producers/manufacturers in upgrading their Nutrition Council (NNC), as presently
production technologies to0 include iodization composed, including representatives of the
by helping them obtain soft loans and financial DENR, the medical profession and the salt
assistance for the procurement of salt iodization manufacturers shall serve as the salt iodization
machines, packaging equipment and technology advisory board and shall function as the policy
and fortificant; and by ensuring systematic and coordinating body on salt iodization
distribution of the iodized salt in the market; 4 b) programs and activities. It shall coordinate the
the Cooperative Development Authority (CDA) efforts of all agencies concerned and monitor the
shall assist the formation of cooperatives of local implementation of the provisions of this Act. It
salt producers/manufacturers in order that they shall also submit an annual report to the
can economically engage in salt iodization and Congress of the Philippines on the progress of
distribution of iodized salt; c) the DOST, in the salt iodization program and offer
collaboration with the TLRC, shall develop and recommendations for its improvement.
implement comprehensive programs for the SECTION 9. Sanctions. - The procedures for
acquisition of design and manufacture of salt imposing sanctions under this Act and
iodization machines and transfer of salt investigating the premises where any salt is
iodization technology to small and subsistence received, held, manufactured, labeled, stored,
local salt producers/manufacturers; and d) the displayed, delivered, distributed, sold, or
Department of Environment and Natural located, or where it is reasonably belied these
Resources (DENR) and other appropriate activities are being carried out or where salt is
government agencies shall identify areas that are located, shall be in accordance with the
College of Health Sciences

NAME: MACAM, LEA ANGEL DOMINIQUE L. COURSE/YEAR/SECTION: BSN 2B


SUBJECT: NUTRITION AND DIET THERAPY LAB PROFESSOR: MISCHELLE CONDENO
provisions of Republic Act No. 7320, otherwise (2) national newspapers of general circulation,
known as the Food, Drugs and Cosmetics Act whichever is earlier. Approved. (Sgd) JOSE DE
As Amended. Provided, That any person, VENECIA (Sgd) NEPTALI A. GONZALES
whether natural or judicial, who violates any of Speaker of the House President of Senate of
the provisions of this Act or any of the rules and Representatives This Act which is a
regulations promulgated for its effective consolidation of Senate Bill No. 1132 and House
implementation shall be punished by a fine of Bill No. 45 was finally passed by the Senate and
not less than One thousand pesos (P1,000.00) the Hose of Representatives lon November 16,
not more than One hundred thousand pesos 1995 and November 15, 1995, respectively.
(P100,000.00); Provided, however, That if the (Sgd) CAMILO L. SABIO (Sgd) HEZEL P.
violation is committed by any officer, director or GACUTAN Secretary General Secretary of the
member of a business and a juridical entity Senate House of Representatives Approved:
acting beyond the scope of his authority, such December 20, 1995 (Sgd) FIDEL V. RAMOS
officer, director or member responsible therefor President of the Philippines 6 IMPLEMENTING
shall be personally liable for the fine: Provided, RULES AND REGULATIONS OF REPUBLIC
further, That such violation shall suffer a ACT No. 8172 AN ACT PROMOTING SALT
revocation of its business permit and/or ban of IODIZATION NATIONWIDE AND FOR
its product from the market: Provided, finally, RELATED PURPOSES BACKGROUND
That the BFAD, in coordination with the LGU’s Pursuant to Section 2 of the Republic Act No.
concerned, shall be authorized to impose and 8172, entitled "An Act Promoting Salt
collect the fines from the violators, and such Nationwide" (ASIN), approved by the President
collections shall accrue to the BFAD for its use on 20 December 1995 and which took effect on
in the implementation of this Act. 5 SECTION 20 January 1996, mandating the Department of
10. Appropriations. - The amount necessary for Health (DOH) as the lead agency in the
the implementation of this Act shall initially be implementation of said Act and, in accordance
charged to the appropriations of its agencies with Section 11 of said Act mandating to DOH
concerned as may be appropriated under the to formulate the Implementing Rules And
current General Appropriations Act. Thereafter, Regulations (IRR) in cooperation with the other
such as amount may be necessary for its government agencies involved in the
implementation shall be included in the annual implementation of the law, the following Rules
General Appropriations Act. SECTION 11. and Regulations are hereby adopted to
Implementing Rules and Regulations. - The implement effectively the provisions of R.A. No.
DOH in cooperation with the agencies 8172. RULE I COVERAGE SECTION I. These
concerned shall formulate the necessary rules Rules and Regulations shall apply to: a) All
and regulations for the effective implementation producers/manufacturers/importers/traders of
of this Act within sixty (60) days from its salt for human or animal consumption, b) All
approval. SECTION 12. Separability Clause. - If restaurants and other food establishments where
any portion of this Act is declared invalid, the food is being served hot or cold, c) All food
remainder of this Act shall be affected by such manufactures/processors using salt in their
declaration and shall remain valid and manufacturing processes, d) All local
enforceable. SECTION 13. Effectivity Clause. - government units (LGUs) e) All other
This Act shall take effect fifteen (15) days after government agencies, f) All non-governmental
its publication in the Official Gazette or in two agencies and related professional organizations;
College of Health Sciences

NAME: MACAM, LEA ANGEL DOMINIQUE L. COURSE/YEAR/SECTION: BSN 2B


SUBJECT: NUTRITION AND DIET THERAPY LAB PROFESSOR: MISCHELLE CONDENO
and g) All government and private hospitals and The policy also mandated the Department of
other institutions. Health, the National Nutrition Council,
Department of Agriculture, in coordination
https://www.fda.gov.ph/wp-
with other national government agencies,
content/uploads/2021/05/Republic-Act-No.-
local government units, civil society
8172.pdf
organizations, and other stakeholders to
create the implementing rules and regulation
RA 11148 : “Kalusugan at of the policy. It shall cover all nutritionally-
at-risk population, with focus on pregnant
Nutrisyon ng Magnanay and lactating women, all Filipino children
Act” who are newly born up to two years of age.
The policy should also prioritized population
RA 11148 was enacted into law last 29 living in geographically isolated and
November 2018 as “ An Act Scaling Up the disadvantaged areas (GIDAs), unserved and
National and Local Health and Nutrition underserved communities such as the
Programs Through A Strengthened indigenous people, areas with high
Integrated Strategy for Maternal, Neonatal, prevalence of malnutrition, persons in the
Child Health and Nutrition in the First One vulnerable sectors, and those communities
Thousand (1000) Days of Life, affected by a crisis or arm conflict.
Appropriating Funds Therefore, and for
Other Purposes”. Generally, the policy aims RA 11148 also identifies all the services
to scale up nutrition intervention programs needed for the first 1000 days of life, from
in the first one thousand (1000) days of a prenatal check-ups, immunization of
child’s life, and allocate resources in the pregnant and children, dietary
sustainable manner to improve the supplementation programs for the target
nutritional status and address the groups, training of health and nutrition
malnutrition of infants and young children workers, provision of other health and
from zero (0) to two (2) years old, nutrition services, psychosocial stimulation,
adolescent females, pregnant, and lactating and provision of other assistance that each
women to ensure growth and development stakeholder may offer. It also clarifies the
of infants and young children. This will role of each national government agencies
provide a comprehensive, sustainable, and partners in the implementation of the
multisectoral strategies and approaches to program. - EMArcinue
address health and nutrition problems of
newborns, infants and young children, https://nnc.gov.ph/index.php/regional-
pregnant and lactating women, and offices/luzon/region-ii-cagayan-valley/3679-ra-
adolescent females by providing policy 11148-kalusugan-at-nutrisyon-ng-magnanay-
environment, evidence-based nutrition act.html
interventions, and institutionalized first 1000
days program in all development plans of
both the national and local government.

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