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PHILIPPINE
NATIONAL
STANDARD
PNS/BAFS 354:2022
ICS 67.020
Validation of Food Safety Control Measures —
Guidelines
BUREAU OF AGRICULTURE AND FISHERIES STANDARDS
BPI Compound, Visayas Avenue, Diliman, Quezon City, 1101 Philippines
Trunkline: (632)8928-8741 to 64 loc 3301-3319
E-mail: info.dabafs@gmail.com
Website: www.bafs.da.gov.ph
PHILIPPINE NATIONAL STANDARD
PNS/BAFS 354:2022
Validation of Food Safety Control Measures — Guidelines
ICS 67.020
i
Foreword
In the Philippines, Section 9 (Setting of food safety standards) of the Republic Act No.
10611 (Food Safety Act [FSA] of 2013) mandated the Department of Agriculture (DA)
and Department of Health (DOH) to “adopt Codex standards, except when these are
in conflict with what is necessary to protect consumers and scientific justifications
exists for the action taken” (DA & DOH, 2015). To fulfill these mandates under the FSA
of 2013, the Bureau of Agriculture and Fisheries Standards (BAFS) of the Department
of Agriculture (DA) issued a call for proposal to the DA Food Safety Regulatory
Agencies (FSRA) in 2021. The BAFS-DA requested the DA FSRA to prioritize their
top 10 Codex standards based on their regulatory, trade, and market requirements.
Among the list of applicable Codex standards for primary and postharvest foods, the
DA-FSRA identified CXG 69-2008 (Guidelines for the validation of food safety control
measures) as one of the priority standards for adoption.
In response, the BAFS-DA initiated the development of the Philippine National
Standard (PNS) on the guidelines for the validation of food safety control measures
with the guidance of a Technical Working Group (TWG) in 2022. This TWG was
officially created under Special Order (SO) No. 103, series of 2022 (Creation of TWG
for the development of PNS for agriculture and fishery products, machineries, and
infrastructures), SO No. 350, series of 2022 (Addendum to Special Order No. 103),
and SO No. 487, series of 2022 (Addendum to Special Order No. 103). The TWG was
composed of representatives from the relevant government agencies,
academe/research institutions, private sector organizations, and Civil Society
Organizations (CSO). The draft PNS underwent a series of TWG meetings and
stakeholder consultations conducted physically and via online platforms before its
endorsement to the DA Secretary for approval.
This PNS is an adaptation of the CXG 69-2008, amd. 2013 (Guidelines for the
validation of food safety control measures). Any modifications from the original Codex
document to consider the conditions in the Philippines are written in italicized text for
distinction. This document was written in accordance with the formatting and editorial
rules of the Standardization Guide No. 1 (Writing the Philippine National Standards)
developed by the Standards Development Division (SDD) of the BAFS-DA.
PHILIPPINE NATIONAL STANDARD
PNS/BAFS 354:2022
Validation of Food Safety Control Measures — Guidelines
ICS 67.020
ii
Table of Contents
Foreword ..................................................................................................................... i
1 Scope .............................................................................................................. 1
2 Normative References ..................................................................................... 1
3 Terms and Definitions ...................................................................................... 1
4 Concept and Nature of Validation .................................................................... 3
5 Tasks prior to Validation of Control Measures ................................................. 3
5.1 Identify the hazards ......................................................................................... 3
5.2 Identify the food safety outcome required ........................................................ 4
5.3 Identify the measures that are to be validated ................................................. 4
6 The Validation Process .................................................................................... 6
6.1 Approaches for validating control measures .................................................... 6
6.2 Steps involved in the validation process .......................................................... 8
6.3 Results of the validation process ..................................................................... 9
7 Need for Re-validation ..................................................................................... 9
7.1 System failure .................................................................................................. 9
ANNEX A (Interrelationships among validation, monitoring, and verification) .......... 11
ANNEX B (Examples of validation of food safety control measures) ....................... 13
Bibliography ............................................................................................................. 21
PHILIPPINE NATIONAL STANDARD
PNS/BAFS 354:2022
Validation of Food Safety Control Measures — Guidelines
ICS 67.020
1
1 Scope
These guidelines apply to validation of control measures at the primary
production and postharvest stages of the food chain. These guidelines are
intended as guidance to Food Business Operators (FBO) and competent
authorities on the validation of individual control measures, a limited
combination of control measures, or sets of control measure combinations
forming a food safety control system. The food safety control system may
include, Good Agricultural Practices (GAP), Good Animal Husbandry Practices
(GAHP), Good Aquaculture Practices (GAqP), Good Hygiene Practices (GHP),
Hazard Analysis Critical Control Point (HACCP), and other relevant codes of
practice and food safety requirements.
The tools, techniques, and statistical principles that would be used to validate
specific food safety control measures are beyond the scope of the current
document. Advice on specific applications should be acquired from scientific
organizations, competent authorities, process control experts, or related
sources of scientific expertise that can provide the specific principles and best
practices upon which the validation of a specific control measure should be
based.
These guidelines were adopted from CXG 69-2008, amd. 2013 (Guidelines for
the validation of food safety control measures) with some modifications to
consider the conditions in the Philippines.
2 Normative References
The following documents are referred to in the text in such a way that some or
all their contents constitute the requirements of this document. The latest
edition of the referenced documents (including any amendments) applies.
Codex Alimentarius Commission. (CAC). (2013b). Guidelines for the
validation of food safety control measures. (CXG 69-2008, amd. 2013).
https://www.fao.org/fao-who-codexalimentarius/sh-
proxy/de/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fs
ites%252Fcodex%252FStandards%252FCXG%2B69-
2008%252FCXG_069e.pdf
3 Terms and Definitions
For the purpose of this standard, the following definitions apply:
3.1
competent authority
official government organization/agency(ies) having jurisdiction (CAC, 2013a).
In the context of the Department of Agriculture (DA), competent authority refers
PHILIPPINE NATIONAL STANDARD
PNS/BAFS 354:2022
Validation of Food Safety Control Measures — Guidelines
ICS 67.020
2
to the bureau or agency mandated by law with responsibility and competence
for ensuring and supervising the implementation of sanitary and phytosanitary
(SPS) measures, regulations, or standards (DA, 2022)
3.2
control measure
any action and activity that can be used to prevent or eliminate a food safety
hazard or reduce it to an acceptable level (Food Safety Act [FSA] of 2013, 2013)
3.3
food business operator (FBO)
person engaged in food business including one's agents and is responsible for
ensuring that the requirements of this Act are met by the food business under
one's control (FSA of 2013, 2013)
3.4
food safety control system
combination of control measures that, when taken as whole, ensures that food
is safe for its intended use (CAC, 2013b)
3.5
monitoring
act of conducting a planned sequence of observations or measurements of
control parameters to assess whether a control measure is under control (CAC,
2013b)
3.6
postharvest food
food obtained from postharvest stages of the food supply chain (DA &
Department of Health [DOH], 2015)
3.7
postharvest stages
stages in the food supply chain involving minimal transformation of plant and
animal foods after primary production such as removal of field heat for fruits,
slaughter of animals, sorting, grading, and cutting of fresh plant and animal
foods, icing and freezing, and the milling and storage of grain (FSA of 2013,
2013)
3.7
primary food
food obtained from the primary production stage of the food supply chain (DA
& DOH, 2015)
3.8
primary production
production, rearing, or growing of primary products including harvesting,
milking, and farmed animal production up to slaughter, and the rearing and
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