Professional Documents
Culture Documents
M Otar Jemi 1996
M Otar Jemi 1996
77-85, 1996
Copyright © 1996 Publishedby ElsevierScienceLtd
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ELSEVIER P l h S0956-7135 (96)00003-5 0956-7135/96 $15.{X)+ 0.111)
PAPER
Food Safety Unit, World Health Organization, Geneva, Switzerland. *This paper has been prepared in connection with a
WHO Consultation - - held with the participation of FAO - - on Hazard Analysis Critical Control Point System: Concept
and Application (Geneva, 29-31 May 1995). It is based on the papers prepared by individual participants and the report of
the Consultation. The contributions of the participants are gratefully acknowledged.
tPresented by F. K~iferstein, Chief, Food Safety Unit, World Health Organization, at the 25th Congress of the World
Veterinary Association, Yokohama, Japan, 3 - 9 September 1995.
avert some 20-60% of cases of seafoodborne • The HACCP system will help target/direct
illnesses (USFDA, 1994). resources to the most critical part of the food
The HACCP system is based on seven principles: operation.
(i) conduct hazard analysis, identify hazards and • With the HACCP system one can expect an
specify control measures; (ii) identify critical control improvement in the relationship between (i) food
points (CCPs); (iii) establish critical limits at each processors and food inspectors, and (ii) food
CCP; (iv) establish monitoring procedures; (v) estab- processors and consumers. The HACCP system
lish corrective action procedures; (vi) establish verifi- provides a scientifically sound basis for demon-
cation procedures; and (vii) establish documentation strating that all reasonable precautions have been
procedures. taken to prevent a hazard from reaching the
The HACCP system has different areas of consumer. In this way, it encourages confidence in
application: the safety of food products and thus promotes
both confidence in the food industry and stability
• The HACCP system can be used as a method of
of food businesses.
food safety assurance in food production, pro-
• Data collected facilitates the work of food inspec-
cessing, manufacturing and preparation.
tors for auditing purposes.
• The HACCP system can be used as an inspection
• The HACCP system is applicable to the whole
tool in food control. It leads to more efficient
food chain, from the raw material to the end-
inspection of food operations, as the role of food
product, i.e. growing, harvesting, processing or
inspectors is centred on the assessment of the
manufacturing, transport and distribution, prepara-
HACCP plan and confirmation that it is properly
tion and consumption.
designed and operating effectively.
• The HACCP system can be readily integrated into
• The HACCP concept can also be used to study
quality management systems, e.g. ISO 9000.
food preparation practices, and to identify and
assess hazardous behaviour, which should be the
focus of health education interventions.
W H O AS A N A D V O C A T E FOR THE
• The HACCP concept can also be used in the
HACCP SYSTEM
management of food safety programmes to identify
those problems which are of greatest risk to public
The World Health Organization recognized the
health, and in order to prioritize interventions.
importance of the HACCP system for food safety at a
The additional benefits of the HACCP system can be very early stage, and has been playing a leading role
summarized as follows: in its promotion and development for almost 20
years.
• The HACCP system overcomes many of the
At regional level, WHO promoted the HACCP
limitations of traditional approaches to food safety system at a very early date in its history. A technical
control (generally based on 'snap-shot' inspection presentation made by WHO at a meeting in 1972 in
and end-product testing), including
Argentina reported on the HACCP approach to food
(i) the difficulty of collecting and examining suffi- safety (Quevedo, 1972) and the subject was then
cient samples to obtain meaningful, repre- introduced and discussed for a wider Latin American
sentative information; audience at the Inter-American Conference on
(ii) the length of time required to obtain the Foodborne Infections organized by PAHO/WHO in
results; Guatemala in 1974 (Quevedo, 1976).
(iii) the high costs incurred by end-product testing An international level, reference to the HACCP
or even product recall in the case of evidence system was first made in 1976 by the WHO Expert
of contamination; Committee on Microbiological Aspects of Food
(iv) identification of problems without under- Hygiene (WHO, 1976). The recommendations made
standing the causes; and by this Committee incited WHO to look more deeply
(v) limitations of 'snap-shot' inspection tech- into the application of the HACCP system to
niques in predicting potential food safety improve food safety. In 1980, the WHO/ICMSF
problems. Meeting on the Hazard Analysis Critical Control
• The HACCP system has the potential to identify Point System in Food Hygiene reviewed and evalu-
all conceivable, reasonably expected hazards, even ated work carried out on the application of the
where failures have not previously been experi- HACCP system and made recommendations on its
enced. It is therefore particularly useful for new possible application in industrialized and developing
operations. countries (WHO, 1982). The recommendations of
• The HACCP system is capable of accommodating this Committee were later adopted by the Joint
changes introduced, such as progress in equipment FAO/WHO Expert Committee on Food Safety in
design, improvements in processing procedures 1983, which advised that the HACCP system should
and technological developments related to the replace traditional approaches to food safety assur-
product. ance, i.e. end-product testing (WHO, 1984).
W H O has also pioneered the application of the safety requirements. Subsequently, application of the
HACCP system to cottage industries, food service HACCP system by food businesses according to the
establishments, street food vendors and homes. In Codex Guidelines will play a central role in inter-
this connection, in 1988 the W H O Consultation on national trade as well as in the fight to prevent
Health Surveillance and Management Procedures of foodborne diseases.
Food Handling Personnel recommended application Both the concept of HACCP as well as the imple-
of the HACCP system in the preparation of food and mentation of this system by food industries and
education of food handlers (WHO, 1989). In the regulatory agencies are subjects which are evolving
same year, during a Consultation on Health Educa- rapidly. In line with the recommendations of the
tion in Food Safety (WHO, 1988), the application of International Conference on Nutrition, the World
the HACCP system was put forward for selection of Health Organization is committed to continuing
risky behaviours which should be subject to educa- monitoring developments in this area, to providing
tional intervention. Since 1985 the application of the the most up to date scientific guidance on the
HACCP system in food service establishments, HACCP system, and to gathering and disseminating
cottage industries, street food vending operations and available know-how and experiences in its implemen-
homes has been field-tested in a number of countries, tation. WHO also intends to promote its application
i.e. Dominican Republic, Peru, Pakistan, Malaysia in food industries and food control agencies bv
and Zambia (WHO, 1993). A book outlining the raising the awareness of policy-markers and facili-
application of the HACCP system to food prepara- tating training for different target groups and all the
tion was also published in 1992 (Bryan, 1992). A relevant sectors.
document on the application of the HACCP system
to street vended food is also under the preparation
(WHO, 1996). P R O G R E S S IN T H E I M P L E M E N T A T I O N
OF THE HACCP SYSTEM AT
In 1993, the W H O Consultation on Training
NATIONAL LEVEL
Considerations for the Application of the HACCP
System to Food Processing and Manufacturing Indus-
Industrialized countries
tries made recommendations on the role of govern-
ments and food industries in the application of the Today, the integration of the HACCP system into
HACCP system (WHO, 1993). The recommendations food safety assurance systems by many countries.
of this Consultation formed the basis of numerous particularly industrialized ones, is an established goal.
training courses - some of them held jointly with the Up until recently, developments in the application of
Industry Council for Development (ICD) - in Argen- the HACCP system have been outside the legislativc
tina, Belize, China, Indonesia, Jordan, Mexico, framework, and many large food industries have
Philippines, Thailand and Tunisia. voluntarily adopted the HACCP system. Recently
The highlight of W H O activities in the area of the there has been increasing interest on the part of
HACCP system has been the adoption of the Codex governments to integrate an HACCP system.
Guidelines on the Application of the Hazard Analysis Recently there has been increasing interest on the
Critical Control Point system by the Codex Alimen- part of governments to integrate an HACCP-based
tarius Commission (Geneva, 1993). Although several system into their legislation and food inspcci~on
Codex Codes had already accepted the HACCP service programmes. The European Union's Cotu]ci[
principles, the Guidelines were a breakthrough in the Directive (DIR/93/43/EEC) (Article 3.2) requires that
history of the HACCP system, because until then food business operators shall identity any step in thei;
there had not been an internationally accepted text. activities which is critical to ensuring food safetv ane
The Codex Code of Practice on General Principles ensure that adequate safety procedures are identified,
on Food Hygiene, presently under revision, also implemented, maintained and reviewed on the basis
underlines the importance of an HACCP-based of the principles of the HACCP system (EEC, 1993).
approach to ensure food safety, and recommends the As a result, all food companies - large, medium and
application of the Codex Guidelines. Subsequently, small - in the European Union will be required to
all relevant Codes of Hygienic Practice may need to have m place an effective HACCP system by mid-l)c-
be revised to include the HACCP system. These cembcr 1995. Outside the EU, implementation of the
Codex Guidelines, and other Codex recommenda- HACCP system has also had some success in Europe.
tions, play a capital role in the promotion of the For example, in Romania, implementation of
HACCP system and in the haromonization of the HACCP has been facilitated by legislative provisions
approach to its application. As a result of the recent (Order of the Ministry of Health, 25 May 1994)
Sanitary and Phytosanitary Agreement reached under (Daghie, 1995).
the Uruguay Round of Multilateral Trade Negotia- The implementation of the HACCP system m
tions, the work of the Codex Alimentarius Commis- North America is relatively more advanced, in the
sion, including its standards, guidelines and USA, the National Marine Fisheries Service of the
recommendations, has increased in importance and US Department of Commerce is moving towards a
has become the reference for international food mandato U HACCP-based inspection programme.
food technologists have undergone training. Since approach provides a valuable, alternative tool for
1990 the HACCP system has been incorporated into establishing priorities in fl)od safety programmcs.
the basic training curriculum for health inspectors. In • With present developments in international trade,
Brazil, the 'Technical Regulation for the Sanitary and tendencies leaning towards the requirement
Inspections of Foods' and the 'Technical Regulation that imported foods should be produced or
for the Establishment of the Quality and Identity processed according to the HACCP system, if
Standard for Services and Products in the Food Area' developing countries fail to implement HAC('P-
give obligatory status to the use of the HACCP based systems in their food production or
system by the food industry. In Chile a draft law is processing, they may well have their food exports
being prepared (Quevedo, 1995). Other countries, rejected on the basis of inadequate food safety
e.g. Egypt, have chosen to implement the HACCP measures. The economy of most developing
system without legal procedures, and at least five out countries is such that any food export barrier
of some 200 large food industries are introducing or imposed on the grounds of inadequate food safety
have already introduced the HACCP system (Saad, measures may have tremendous negative conse-
1995). quences for the count~.
In countries (or in food businesses) where food is • However, over and above its importance from a
predominantly produced/processed by small or food export point of view, the HACCP system is ol
artisanal industries for local consumption, the incen- inestimable value in the prevention of foodbornc
tive to introduce the HACCP system has been diseases. In this context, it should be remembered
weaker. Its implementation is perceived as an that the developing countries bear the heaviest
exercise requiring a broad and high level of technical burden of foodborne diseases in thc world.
expertise as well as important financial resources. Governments in developing countries should
Concentration of functions, i.e. one person having therefl)re give equal attention to the application of
more than one responsibility, is experienced, causing the HACCP system when producing, processing,
practical difficulties in the implementation of the manufacturing and preparing food for local
HACCP system, e.g. time, conflicts of interest. consumption.
However, in view of the high prevalence of Therefore, it is likely that in future the HA(;('P
foodborne diseases in the developing world, and the system will be introduced into the legislative and
limitation of resources, the potential benefits that the enforcement structure of developing countries, in
application of the HACCP system may afford in which case its adoption by small food industries will
comparison to the problems faced are more become a matter of survival. And, the economic and
important for developing countries: social stakes with regard to implementation of the
• The current approach for ensuring food safety, HACCP system in developing countries ~ue
which is based on periodic, visual inspection of considerable.
fl~od facilities, and end-product testing by food Although use of the HACCP system as a regula-
control laboratories, is resource-intensive. In many tory tool and as a food safety assurance system will
developing countries, laboratory facilities for lead in the long term to resource savings due to a
microbial or chemical examination of food are reduction in the number of inspections, fewer cases
either lacking or deficient. Food inspectors may of foodborne diseases, and an increased food export
not even have the necessary tools to inspect, potential, in the initial phase of HACCP introduction
sample or transport food samples to control there will be a need for accrued resources, particu-
laboratories. The HACCP system provides a cost- larly fl~r training food inspectors and food safety
effective and alternative approach to traditional assurance personnel. As many countries lack suffi-
food control, permitting the food safety risks to be cient expertise in the HACCP system, the inter-
pin-pointed without necessarily having to resort to national community (in particular international
expensive microbiological and chemical analysis of organizations such as WHO, FAO, UNIDO and
foods (except for verification purposes). ILO) have important roles to play in gathering
• The HACCP system also provides a basis for together expertise and experiences in industrialized
prioritizing foods or highlighting food operations countries to make them available for introducing
which could pose a greater risk to health, thus HACCP in developing countries.
enabling resources to be focused on priority health
problems. As a result, there will be fewer but more
efficient inspections. The potential benefits, in SOME RECENT INTERNATIONAL
terms of resource savings, are therefore all the D E V E L O P M E N T S IN T H E C O N C E P T
more important for developing countries whose AND STRATEGY FOR IMPLEMENTING
economies are frail, and whose resources for THE HACCP SYSTEM
inspection and facilities for food analysis are scant.
In countries where foodborne disease surveillance Worldwide interest in the application of the HACCP
programmes are weak or non-existent, the HACCP system in food business or as an inspection tool by
regulatory agencies has generated needs with regard
to: (i) standardization of the approach to the applica- of the text was, though, not delayed for further
tion of the HACCP system and the terminology used; refinement at that time as it was considered to be too
(ii) harmonization of the requirements regarding its important to be further postponed. However, the
implementation, and the responsibilities of different implementation of the HACCP system is progressing
sectors; and (iii) guidance for training in the HACCP rapidly. Many countries are in the process of
system. integrating the HACCP system into their regulatory
The Codex Guidelines for the Application of the mechanisms. In many countries, the application of
Hazard Analysis Critical Control Point system have the HACCP system to imported food may also
been instrumental in harmonizing the approach to become a mandatory requirement. As a result,
the application of the HACCP system and the tremendous needs for training in the HACCP system
terminology used; however, these Guidelines contain and for development of support materials have been
some ambiguities which, if allowed to persist, may generated. It is a matter of urgency to provide the
lead to a conflicting interpretation of the HACCP necessary clarification with regard to the application
system, and to impediments in the harmonization of of the HACCP system.
food safety requirements. Also, as countries become more and more com-
In this context, it should be recalled that the work mitted to a move from prescriptive food hygiene rules
of the Codex Alimentarius Commission, including the to an HACCP-based approach, guidance is needed
above-mentioned Guidelines, plays an important role on strategies for its implementation. The role of
in health and international trade. In particular, the governments and industries needs to be clearly
Final Act which concluded the GATT Uruguay defined. The W H O Consultation on Hazard Analysis
Round of Multilateral Trade Negotiations (and which Critical Control Point system to Food Manufacturing
established the World Trade Organization) recog- (WHO, 1993), as well as the FAO Expert Technical
nizes, inter alia, Codex standards, guidelines and Meeting on the Hazard Analysis Critical Control
recommendations as references for sound scientific Point Principles in Food Control (Vancouver,
and adequate food safety requirements under its side- December 1994) (FAO, 1995) addressed the role of
agreement on sanitary and phytosanitary measures the different sectors in applying the HACCP system.
(commonly referred to as the SPS Agreement). However, the need for an overall strategy for imple-
Consequently, Codex texts will be used by WTO as mentation of the HACCP system remained.
the basis for arbitration for trade disputes involving To address current problems and needs for further
health and safety issues. guidance, W H O convened a Consultation in May
Examples of problems which are encountered in 1995 with the participation of FAO. This meeting was
the interpretation and understanding of the Guide- entitled Hazard Analysis Critical Control Point System:
lines relate to definitions and terminology and Concept and Application and had two main objectives:
processes for identification of hazards and Critical (i) to examine problems met in applying the Codex
Control Points. In terms of definitions and termin- Guidelines for the Application of the Hazard
ology, the term 'preventive measures' is misunder- Analysis Critical Control Point system and provide
stood as it does not embody the notion of recommendations on updates to the Guidelines;
minimization or elimination of hazards. There is also and (ii) to review the implementation strategy for the
a need to define terms such as control measures, HACCP system (WHO, 1995).
hazard analysis, and verification in order to ensure
consistent interpretation of the Guidelines. An
FAO/WHO Codex Guidelines for the application of
FAO/WHO Expert Consultation on the Application
the Hazard Analysis Critical Control Point system:
of Risk Analysis to Food Standards Issues (Geneva,
proposal for amendment
March 1995) made recommendations with regard to
the application of risk analysis in the HACCP system. The Consultation reviewed the problems met with
The report of that Consultation touches on some of regard to the interpretation and application of the
the terminology to be used in relation to HACCP HACCP system and in particular those related to the
(e.g. hazard, risk), and points to the necessity for a Codex Guidelines, and provided some amendments
review of the definitions used in the Codex Guide- which would ease their application. Among the more
lines (WHO, 1995). significant changes, was a proposal to separate the
Also, the Codex Guidelines do not convey the fact principles from the Guidelines for Application. This
that the decision tree used in the text is just an suggestion was made in order to facilitate the integra-
example. Consequently, this decision tree is seen as tion of the HACCP principles into the national legis-
an impediment in using the Guidelines for raw lation without actually regulating the application of
agricultural products. The guidance given for identi- the HACCP system in detail. Definitions of the terms
fication of hazards and determination of Critical 'Critical Control Point', 'HACCP', 'hazard' and
Control Point(s) is also found in practice to be 'monitor' were revised, while definitions for some
unclear and misleading. other terms such as 'control', 'control measures',
The need to improve the Guidelines was acknow- 'hazard analysis', 'step', 'verification', etc., were
ledged at the time of their adoption. The publication developed. Also, the guidance given for steps 6 and 7
relating to hazard identification and analysis as well and related food inspectors; and street food vendors
as determination of critical control points was revised (WHO, 1996).
to make it explicitly clear that the suggested decision
tree was not applicable in all situations and that other
approaches may indeed be used. CONCLUSION
Another major recommendation related to the
term 'Hazard Analysis Critical Control Point system' The H A C C P system is an effective tool for a food
which does not easily translate into other languages. safety assurance. Its, application for the prevention of
It was r e c o m m e n d e d that the term should read: foodborne diseases is of tremendous value, and in
"Hazard Analysis and Critical Control Points international food trade its application has become
system". indispensable. Progress in its implementation varies
from country to country and depends on the commit-
ment and recognition of policy-makers as well as the
Strategy for the implementation of the HACCP funds which are made available for this specific
system purpose. In developing countries, lack of expertise
The Consultation developed some considerations for and resources for training are two of the impedi-
the implementation of the H A C C P system by govern- ments to progress in its implementation, and most of
ment agencies and food industries. Among others, the progress made has been with regard to food for
the Consultation defined in detail their respective international trade. Paradoxically, these countries arc
roles. It also underlined the need for governments to those which have the greatest need for this system,
develop an implementation strategy which reflects the because of the high prevalence of foodborne diseases
needs of the country, and which is time and resource- and lack of resources to meet the high costs of tradi-
realistic. G r e a t e r emphasis was placed on this latter tional approaches.
issue, i.e. H A C C P is evolving. Worldwide, the interest in the
application of H A C C P in the food industries is
• it was r e c o m m e n d e d that the time-scale be
growing, and regulatory agencies are being adapted
adapted to allow enough time and opportunities to make their inspection systems compatible with the
for training. Where legislation is enacted, sufficient industry-based H A C C P system. Both progress and
time should be given for training and implementa- problems encountered in the implementation of the
tion before enforcement action is taken. H A C C P system must be monitored on a regular
• in the initial stages, the implementation of the basis, and guidance on this subject should be
H A C C P system would require enormous resources updated. The recent W H O Consultation on Hazard
in terms of qualified personnel, technical support Analysis Critical Control Point System: Concept and
facilities and financial inputs, particularly to ensure Application (held with the participation of FAO) has
necessary training. Therefore, both the private been a step towards this objective ( W H O , 1995).
sector and government should contribute to Training in H A C C P for food inspectors and
mobilizing the necessary resources. personnel in food businesses will be a key to its
Consideration was also given to the pros and cons of successful implementation, provided that the training
the mandatory application of the H A C C P system. is standardized so that a common understanding is
Although the Consultation did not prescribe any developed between food businesses and food
r e c o m m e n d e d approach, it stressed that legislative or inspectors.
regulatory approaches should concentrate on what is
to be achieved and not how it should be achieved,
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