PNS 293 National Food Control System
PNS 293 National Food Control System
STANDARD
ICS 67.020
Foreword
The Philippine National Standard (PNS) on Principles and Guidelines for National
Food Control System was developed by the Bureau of Agriculture and Fisheries
Standards with the guidance of the Technical Working Group. This document has
been prepared by the Technical Working Group (TWG) for the development of the said
standard as per Department of Agriculture Special Orders No. 585 and 789 series of
2017. The PNS has been approved by the Secretary of the Department of Agriculture
in 2020.
This document was drafted in accordance with the editorial rules of the BPS Directives
Part 2.
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PHILIPPINE NATIONAL STANDARD PNS/BAFS 293:2020
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List of Abbreviations
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Table of Contents
Foreword .....................................................................................................................ii
List of Abbreviations ................................................................................................... iii
Introduction ................................................................................................................ 1
1 Scope .............................................................................................................. 2
2 Normative references ...................................................................................... 2
3 Objective .......................................................................................................... 2
4 Principles ......................................................................................................... 2
4.1 Protection of consumers .................................................................................. 2
4.2 The whole food chain approach ....................................................................... 2
4.3 Transparency ................................................................................................... 2
4.4 Roles and responsibilities ................................................................................ 3
4.5 Consistency and impartiality ............................................................................ 3
4.6 Risk-based, science-based and evidence-based decision making .................. 3
4.7 Cooperation and coordination between multiple competent authorities ........... 3
4.8 Preventive measures ....................................................................................... 3
4.9 Self-assessment and review procedures ......................................................... 4
4.10 Recognition of other systems .......................................................................... 4
4.11 Legal foundation .............................................................................................. 4
4.12 Harmonization.................................................................................................. 4
4.13 Resources ....................................................................................................... 4
5 Framework for the design and operation ......................................................... 4
5.1 Policy setting.................................................................................................... 6
5.2 System design ................................................................................................. 8
5.3 Implementation .............................................................................................. 12
5.4 Monitoring and system review ....................................................................... 15
Bibliography ............................................................................................................. 17
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1 Introduction
2
3 While the focus of the Principles and Guidelines for National Food Control Systems is
4 on the production, packing, storage, transport, handling and sale of foods within
5 national borders, the document is consistent with and should be read in conjunction
6 with relevant Codex texts and the national food safety legislation. Codex texts of
7 particular relevance include the Principles for Food Import and Export Inspection and
8 Certification (CAC/GL 20-1995), the Guidelines for the Design, Operation,
9 Assessment and Accreditation of Food Import and Export Inspection and Certification
10 (CAC/GL 26-1997), the Guidelines for Food Import Control Systems (CAC/GL 47-
11 2003) and the Guidelines for the Exchange of Information between countries on
12 rejections of imported foods (CAC/GL 25-1997). Reference to these texts relating to
13 food import and export control is important since, while the national food control
14 system is ultimately responsible for the safety of food offered within its border, in
15 today’s global market, much food is sourced from outside the country; hence, properly
16 designed import and export control systems, as part of the overall national food control
17 system, are essential.
18
19 In addition, the relevant chapters of the World Organization for Animal Health (OIE)
20 Terrestrial Animal Health Code and Aquatic Animal Health Code are valuable
21 resources for member governments and organizations. Documents and guidance
22 material developed by FAO and WHO may also be useful resources.
23
24 A responsible competent authority may apply these principles and guidelines, where
25 appropriate, according to their particular situations. When developing a national food
26 control system, the responsible national competent authority should ensure that the
27 objectives of the system are addressed as outlined in the principles below and should
28 allow for flexibility and modification as required to ensure the objectives can be
29 achieved.
30
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31 1 Scope
32
33 This document is intended to provide practical guidance to assist the national
34 government, and their responsible competent authority in the design, development,
35 operation, evaluation, and improvement of the national food control system. It
36 highlights the key principles and core elements of an efficient and effective food control
37 system.
38
39 It is not intended that the guidance results in “one system” being appropriate to all
40 circumstances. Rather, various approaches may be used, as appropriate to the
41 national circumstances, to achieve an effective national food control system.
42
43
44 2 Normative references
45
46 There are no normative references for this standard.
47
48
49 3 Objective
50
51 The objective of a national food control system is to protect the health of consumers
52 and ensure fair practices in the food trade.
53
54
55 4 Principles
56
57 A national food control system should be based on the following principles:
58
59 4.1 Protection of consumers
60
61 National food control systems should be designed, implemented, and maintained with
62 the primary goal to protect consumers. In the event of a conflict with other interests,
63 precedence should be given to protecting the health of consumers.
64
65 4.2 The whole food chain approach
66
67 The national food control system should cover the entire food chain from primary
68 production to consumption.
69
70 4.3 Transparency
71
72 All aspects of a national food control system should be transparent and open to
73 scrutiny by all stakeholders, while respecting legal requirements to protect confidential
74 information as appropriate. Transparency considerations apply to all participants in the
75 food chain and this can be achieved through clear documentation and communication.
76
77
78
79
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Policy Setting
Implementation
205
206
207 Figure 1. Framework for the development of a national food control system
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257 c) Characteristic 3 Continuous improvement means that the national food control
258 system should possess the capability to learn through a process of review and
259 reform utilizing mechanisms that check and evaluate whether the system is able
260 to achieve its objectives.
261
262 In order to reflect national policies and strategies, legislation should among other
263 things:
264
265 a) Frame the structure of the national food control system and its goals and
266 objectives;
267 b) Provide clarity on the roles and responsibilities of participants in the national
268 food control system, i.e. the central government, the competent authority (or of
269 each competent authority where there is more than one), third party providers
270 (where these are used), food business operators and other stakeholders as
271 appropriate;
272 c) Set out the overarching objectives of the national food control system and any
273 specific or lower order objectives that relate to participants or sectors;
274 d) Clearly define obligations for food business operators and other participants in
275 the food chain to establish and monitor controls; and
276 e) Clearly define obligations on food businesses to place only safe food on the
277 market and apply fair practices in trade.
278
279 The legislation should provide the responsible competent authority with the range of
280 powers and mechanisms sufficient to manage and operate the national food control
281 system which may include and are not limited to the following:
282
283 a) Establish standards or other management options to prevent and control food
284 borne hazards including but not limited to disease-causing organisms,
285 contaminants, veterinary drug and pesticide residues;
286 b) Establish, monitor and enforce national standards;
287 c) Recognize other competent authorities’ standards at the appropriate stage(s)
288 in the food chain;
289 d) Establish cooperative arrangements with other government entities;
290 e) Establish approaches to ensure the safety and safe use of inputs to the food
291 chain, such as food additives, pesticides, veterinary drugs;
292 f) Recognize and/or harmonize with international standards such as Codex;
293 g) Perform audits, verification, inspections and investigations, gather evidence,
294 collect and analyze samples and otherwise verify compliance with standards
295 and requirements;
296 h) Consider official recognition of inspection, audit, certification and accreditation
297 bodies;
298 i) Enforce legislation and take proportionate, dissuasive and effective action in
299 case of non-compliance with requirements including, as appropriate,
300 investigations and application of sanctions and penalties;
301 j) Ensure that risks associated with non-compliant foods are evaluated and the
302 appropriate action taken (e.g. disposal, treated appropriately or redirected);
303 k) Ensure the integrity, impartiality and independence of officially recognized
304 inspection, audit, certification and accreditation;
305 l) Enable traceability/product tracing; and
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306 m) Ensure that unsafe food is prevented from entering the market or is withdrawn
307 and dealt with appropriately.
308
309 The competent authority should engage with stakeholders including the food business
310 operators and consumers, in the development of new legislation, and when making
311 regulatory changes. The competent authority should also disseminate the legislation.
312
313 Legislation may also include provisions, as appropriate, for the registration of
314 establishments, establishment approval, licensing or registration of traders, equipment
315 design approval, penalties in the event of non-compliance and charging of fees or
316 levies.
317
318 5.2 System design
319
320 When designing a national food control system, the national government should
321 ensure the main objectives as defined in the policy are addressed as well as how to
322 incorporate the principles in Clause 4.
323
324 The design of a food control system should take into account the following elements:
325
326 a) Existing or necessary regulatory and legislative framework (laws, regulations,
327 guidelines);
328 b) How the national food control system relates to international and national
329 standards including food import and export system requirements;
330 c) The recognition of other food control systems, including equivalence;
331 d) The level and method of oversight including control programs from primary
332 production through manufacturing to transportation and distribution;
333 e) How issues and risks are managed;
334 f) Enforcement and compliance programs;
335 g) Coordination and communication between authorities with control
336 responsibilities in different parts of the food chain and with the public health
337 authorities;
338 h) Clearly defined roles and responsibilities;
339 i) Access to adequate laboratory capacity and capability;
340 j) Staff competence and training;
341 k) The resources needed to meet the objectives of the national food control
342 system, their allocation and how the system is to be funded;
343 l) Surveillance, investigation, emergency preparedness and response to food
344 borne and food related incidents;
345 m)Assessment and evaluation;
346 n) Stakeholder engagement;
347 o) International communication and harmonization; and
348 p) Periodic review and continuous improvement.
349
350 Consideration should be given to the development and implementation of a
351 standardized approach to risk management incorporating the Working principles for
352 risk analysis for food safety for application by governments (CAC/GL 62-2007).
353
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354 An appropriate system design should consider a range of factors including but not
355 limited to product risk, current scientific information, industry-based controls, and
356 system review findings. It should also provide for flexibility in the application of control
357 measures to reflect variations in these factors.
358
359 Development of an effective method of data collection across the food chain is
360 important for situational awareness, performance measurement, and continuous
361 review and system improvement. For instance, surveillance and monitoring programs
362 can be used to target priority risks.
363
364 The responsible competent authority should utilize findings from laboratories to
365 monitor trends in the food chain and assist in compliance and enforcement. Laboratory
366 access and capacity should be commensurate with the need to address priority food
367 risks.
368
369 The national food control system, including a description of its scope and operation,
370 and a clear description of the roles and responsibilities of all parties, should be fully
371 documented and publicly available to ensure its transparency and consistent
372 application of control measures. National food control systems should be designed to
373 ensure administrative procedures are in place for documentation of control programs
374 and their findings.
375
376 Control programs should be based on risk and designed to take into account a number
377 of factors including but not limited to:
378
379 a) Food safety hazards associated with different products and the risk to human
380 health posed by the food or food-related products;
381 b) Risk of unfair practices in the food trade associated with different products, such
382 as potential fraud or deception of consumers;
383 c) Information that may be available from a range of sources including
384 government, academia, scientific institutions and industry data;
385 d) Statistical data on production, trade and consumption;
386 e) Results of previous controls including analytical results;
387 f) The effectiveness and reliability of controls including those of food business
388 operators;
389 g) Knowledge of operators at various stages of the food chain; typical and atypical
390 use of products, raw materials and by-products; structure of production and
391 supply chains; production technologies, processes and practices; and relevant
392 product tracing information; and
393 h) Epidemiological data on food-borne disease.
394
395 In the absence of risk analysis, data control programs should be based on technical
396 and scientific data developed from current knowledge and practice.
397
398 Control programs should be applied at the point or points in the production or supply
399 chain where hazards can be most effectively or efficiently controlled taking into
400 account the available resources and capability. Control programs among other things
401 may cover, as appropriate:
402
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451 The responsible competent authority and any officially recognized bodies undertaking
452 compliance and enforcement activities on behalf of the responsible competent
453 authority should be resourced sufficiently and transparently to enable the national food
454 control programs to achieve its objectives without compromising the programs integrity
455 and independence. Third party providers may be approved and/or authorized to
456 implement the national food control system and the competent authority should have
457 capacity to supervise and control third party providers.
458
459 The design and implementation of a national food control system should be on a scale
460 appropriate to the resources available, while allowing for appropriate expansion.
461 Resources should be prioritized to maximize protection of public health. Resource
462 allocations made in the context of a national food control system may be attributed to:
463
464 a) Training and basic infrastructure;
465 b) Suitably qualified personnel of relevant disciplinary backgrounds;
466 c) Reliable transportation systems and equipment to perform inspection, audit and
467 verification services and transmission of samples to laboratories; and
468 d) Information, communication and technology (ICT) systems.
469
470 The design of the national food control system should incorporate timely access to
471 adequate information relating to the surveillance, investigation, and response to food
472 borne illness and food related incidents. Such information can identify the risks or
473 issues that need to be addressed and also whether or not the controls or measures in
474 place are effective.
475
476 In order to respond to food safety emergencies, consideration should be given to the
477 establishment of the national food safety emergency plan with establishment of a
478 coordination arrangement with links to public health authorities, law enforcement
479 agencies, food recall systems, risk assessment specialists, food business operators,
480 and others. Traceability/product tracing systems provides for the timely identification
481 of the sources for emergencies and allowing effective recall of affected products.
482
483 The national food control system should have procedures covering the prompt removal
484 of unsafe food which includes but not limited to recall systems for processed foods
485 and quarantine procedures for primary and postharvest products, such as
486 confiscation, rejection, etc. The responsible competent authority and food business
487 operators may adopt established procedures for recall and confiscation of product.
488 Setting up these procedures is the primary responsibility of food business operators
489 and they should ensure that products that are deemed to be unsafe should be recalled,
490 appropriately dealt with to ensure consumer protection. The responsible competent
491 authority should ensure appropriate consumer notification is carried out when
492 distribution of unsafe food has occurred.
493
494 Recall systems and other market withdrawal systems should be a coordinated effort
495 between the responsible competent authority and food business operators and be
496 effective and enforceable. If the responsible competent authority requires or requests
497 a recall, operators should have an affirmative duty to give effect to established
498 procedures to recover recalled products and to destroy or dispose of them properly.
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499 National laws should include penalties or sanctions for companies that fail to comply
500 with recall requests.
501
502 In order to promote consumer confidence in food safety and ensure fair practices in
503 the food trade, the responsible competent authority should be clear and transparent in
504 their communications relating to all aspects of the national food control system for
505 which they are responsible, including the development, implementation, and
506 enforcement of the requirements.
507
508 Communication among public health (food safety), agriculture and other relevant
509 authorities, consumers and consumer organizations, and food business operators
510 should be an on-going function of a responsible competent authority with responsibility
511 for a national food control system.
512
513 Consideration should be given to the development of communication programs to
514 provide outreach and education programs and information exchange on food safety
515 risks and mitigation steps which may be taken to reduce these risks, among regulators,
516 food business operators, consumers and academia.
517
518 When developing an educational program, the relevant authorities should clearly
519 identify the target audience, the priority content, and the strategies to be implemented.
520 The educational materials developed should use language suitable for the intended
521 audience. Basic elements of food safety educational activities should be widely
522 disseminated, preferably using mass communication.
523
524 Where appropriate, the responsible competent authority should utilize the Principles
525 and Guidelines for the Exchange of Information in Food Safety Emergency Situations
526 (CAC/GL 19-1995), IHR, OIE disease notification requirements, IPPC regulations,
527 INFOSAN, and (e.g. EU-RASFF, A-RASFF, PhilRASFF), for national and international
528 emergency notification and response.
529
530 5.3 Implementation
531
532 Following the design or modification of the national food control system, the
533 responsible competent authority should prepare an implementation plan including the
534 sequence for different elements of design suitable with their preparedness and
535 capability. This will require engagement and analysis by a variety of experts,
536 disciplines, and all stakeholders. The responsible competent authority's plan may
537 include:
538
539 a) Priorities and time frames for implementation;
540 b) Deliverables;
541 c) Responsibilities for implementation;
542 d) Allocation of resources for personnel and infrastructure;
543 e) Training and operation manuals; and
544 f) Stakeholder engagement.
545
546 Guidance and instructions relating to the national food control system, control
547 programs and compliance and enforcement, including legal requirements should be
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548 developed for responsible competent authority staff and food business operators to
549 ensure that:
550
551 a) all participants are fully aware of the objectives of the system and what is
552 expected from them;
553 b) application of legislation is consistent; and
554 c) they have the necessary resources (human, material and financial resources)
555 available to carry out their tasks.
556
557 Programs and training manuals should be developed and maintained to ensure
558 consistent application of requirements. This material should include as appropriate
559 and not limited to:
560
561 a) An organizational chart of the official control system;
562 b) Roles of each level in the hierarchy (including other relevant jurisdictions; i.e.
563 national, regional and local);
564 c) Job functions and qualifications as appropriate;
565 d) Operating procedures including methods of audit, verification, inspection and
566 control, sampling plans, and testing;
567 e) Relevant legislation and requirements;
568 f) Processes and procedures relating to compliance and enforcement;
569 g) Arrangements for coordination with relevant competent authorities and
570 stakeholders;
571 h) Relevant information about food contamination and food control;
572 i) Procedures for dealing with food safety emergencies and conducting food
573 recalls and investigations;
574 j) Relevant information on staff training; and
575 k) Formal review process of the national food control system.
576
577 National food control systems should be supported by training programs designed to
578 ensure that all appointed officers (e.g. inspectors, auditors, assessors), analysts, and
579 other individuals carrying out technical and/or professional duties receive the training
580 required to adequately perform their work assignments and maintain their professional
581 competence and ensure consistent application of requirements.
582
583 The responsible competent authority should ensure that sufficient guidance, training
584 and awareness programs targeted at all relevant stakeholders are in place to facilitate
585 effective notification of suspect cases of food related illnesses or health hazards
586 detected in the food chain. Administrative procedures or contingency plans (as
587 appropriate) should provide guidance on initiating coordination mechanisms when
588 involvement of several competent authorities is required to resolve the incident. Rapid
589 alert systems and response should be designed and implemented for this purpose.
590
591 Food business operators should also be encouraged to develop or access training and
592 education programs relevant to their activities and responsibilities. Such programs can
593 include formal education and/or academic studies, industry training organization
594 courses or individual business staff training.
595
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596 Where a responsible competent authority intends to use third party providers to
597 implement controls, before being authorized, the third-party provider should be
598 assessed against objective criteria to ensure their competency. The on-going
599 performance of officially authorized bodies should be regularly assessed by the
600 responsible competent authority. The responsible competent authority should initiate
601 procedures to correct deficiencies and, as appropriate, enable withdrawal of official
602 authorization.
603
604 Responsible competent authorities should utilize laboratories that are authorized or
605 accredited under officially recognized programs to ensure that adequate quality
606 controls are in place to ensure the reliability of test results. The authorized or
607 accredited laboratories should adhere to GLP and internationally recognized and
608 validated analytical methods.
609
610 Responsible competent authorities should ensure that authorized or accredited
611 laboratories participate in regular proficiency testing. Such testing may be organized
612 nationally or internationally, and reference laboratory may have a role in organizing
613 proficiency testing programs.
614
615 Where appropriate, the responsible competent authority should provide access to
616 educational information on food safety risks and mitigation steps, which may be taken
617 to reduce these risks.
618
619 As appropriate, the responsible competent authority should:
620
621 a) Communicate food safety issues and concerns with (relevant competent
622 authorities) trading partners;
623 b) Participate in bilateral exchange with (relevant competent authorities) trading
624 partners and international organizations related to food safety regulations and
625 their enforcement;
626 c) Communicate and collaborate with international organizations, such as FAO
627 and WHO through INFOSAN, WHO in accordance with the IHR and OIE as
628 appropriate, in cases where food(s) implicated in incidents or outbreaks of food
629 borne illness may be circulating in international trade; and
630 d) Have in place a process for engagement with stakeholders including food
631 business operators, consumers and other interested parties.
632
633 The responsible competent authority should implement a range of food control
634 activities, including inspections, audits, verification and surveillance to ensure that food
635 business operators meet their responsibilities and is in compliance with requirements.
636 Detailed procedures should be developed to articulate the key tasks and
637 responsibilities of verification of compliance and the consequences of non-
638 compliance, including repeated non-compliance.
639
640 Where a product or process is found not to be in conformity, the responsible competent
641 authority should take action to ensure that the operator remedies the situation. The
642 resulting measures should take into account any repeated non-conformity of the same
643 product or process to ensure that any action is proportionate: to the degree of public
644 health risk, potential fraud or deception of consumers. As an example to illustrate this
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645 point, the specific measures that may be applied in continuous cases of non-
646 conformity may include:
647
648 a) Increased intensity of audits and/ or inspection and/or monitoring of products
649 and/or processes; identified as being not in conformity and/or the undertakings
650 concerned;
651 b) In the most serious or persistent cases, revocation of the registration of the
652 producer and/or processor or closure of the relevant establishment; and
653 c) Other penalties and sanctions may be applied in accordance with the relevant
654 national food safety legislation.
655
656 5.4 Monitoring and system review
657
658 The effectiveness and appropriateness of the national food control system should be
659 regularly assessed against the objective of the system, effectiveness of control
660 programs, as well as against legislative and other regulatory requirements. Criteria for
661 assessment should be established, clearly defined and documented, and may also
662 include cost benefits and efficiency.
663
664 Control programs should be subject to on-going monitoring to ensure that its objectives
665 are being achieved at all stages of the food chain, including production, manufacture,
666 importation, processing, storage, transportation, distribution and trade. The
667 assessment of control programs should cover issues such as:
668
669 a) Effectiveness of control procedures;
670 b) Suitability in achieving objectives;
671 c) Whether the program has covered relevant stages in the production chain,
672 taking into account risk factors; and
673 d) Consideration of emerging trends.
674
675 The national food control system should be regularly reviewed to contribute to the
676 systems improvement, in response to for example, control program data, non-
677 compliances, food safety incidents, scientific research, and history of conformance,
678 external and self-reviews of the system and changes to product risk or the production
679 environment. Such reviews may take place at the level of system or program design
680 or implementation as appropriate.
681
682 The review of food-related non-compliances and/or incidents is an opportunity to learn
683 which can be used as a feedback loop for the planning process by the responsible
684 competent authority. A responsible competent authority should use these
685 opportunities to engage in continuous improvement by assessing an incident from first
686 signal through response and incorporating lessons learned in the design and planning
687 phase.
688
689 Responsible competent authorities should ensure that the response system in regards
690 to food safety and related events is effective, with clear communication between
691 responsible competent authorities, food business operators and consumers. These
692 systems should be periodically tested to ensure that the communication and response
693 systems work effectively.
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733 Bibliography
734
735 Codex Alimentarius Commission. (1969). General Principles of Food Hygiene
736 (CAC/RCP 1-1969). Retrieved from http://www.fao.org/fao-whocodexalimentarius/shp
737 roxy/en/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252F
738 codex% 252FStandards%252FCXC%2B1-1969%25 2FCXP_001e.pdf
739
740 Codex Alimentarius Commission. (1995). Principles and Guidelines for the Exchange
741 of Information in Food Safety Emergency Situations (CAC/GL 19-1995). Retrieved
742 from http://www.fao.org/input/download/standards/36/CXG_019e.pdf
743
744 Codex Alimentarius Commission. (2007). Working principles for risk analysis for food
745 safety for application by governments (CAC/GL 62-2007). Retrieved from
746 http://www.fao.org/3/a-a1 550t.pdf
747
748 Codex Alimentarius Commission. (2013). Principles and Guidelines for National Food
749 Control System (CAC/GL 82-2013). Retrieved from http://www.fao.org/input/
750 download/standards/13358/CXG_082e.pdf
751
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Department of Agriculture
Bureau of Agriculture and Fisheries Standards
Chairperson
Assistant Secretary Hansel O. Didulo
Dr. Pedro Dumaraos, Jr.
Office for Regulations
Department of Agriculture
Members