Food Safety Management Systems

Abstract

This book, in particular, addresses the application of food safety management system. Food safety systems should be designed to control the production process and be based on preventive principles and concepts. With this type of systems, it is intended to implement measures that ensure efficient control by identifying points or stages where the health hazards of consumers can be controlled. The Hazard Analysis and Critical Control Points (HACCP) methodology is currently the internationally accepted benchmark for the implementation of food safety systems. The growing number of legal diplomas and controls linked to food safety, as well as the increasing demands of consumers, have created strong and growing pressures on food businesses and on the development of food safety standards to help them meet those requirements. It is within this framework that, with this book, it is intended to present in a systematic way the main relevant elements for an adequate understanding of the HACCP methodology. Thus, it is intended to transmit a set of technical information that can facilitate the implementation of a food safety management system capable of satisfying legal requirements and meeting the HACCP certification requirements.

Full text

Food Safety
Management Systems
Fahmi Abu Al-Rub
GAVIN
CONFERENCES & PUBLISHERS

III
Food Safety Management Systems
Editors
Prof. Fahmi Abu Al-Rub
FOODQA Coordinator. Director of the Applied Scientic Research Fund, and Professor at Jordan
University of Science and Technology in Jordan
Penelope Shibhab
CEO of Jordan. Co for Antibody Production-MONOJO
Safwan Abu Al-Rub
M.D, Researcher at Jordan. Co for Antibody Production-MONOJO
Dr. Paulo Baptista
P&B – Consultores Associados
ISBN: 978-1-951814-02-1
DOI: 10.29011/978-1-951814-02-1-003
Published: June 2020
Published by GAVIN eBooks
5911 Oak Ridge Way,
Lisle, IL 60532, USA

IV
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https://gavinpublishers.com/ebooks/index

V
INDEX
Introduction
1. European Legislation in Food Safety 01
1.1 General Food Law
1.1.1. Principles
1.1.2. Precautionary Principle
1.1.3. Procedures
1.2. Labelling and Nutrition
1.2.1. Food Labelling Legislation
1.2.2. Nutrition and Health Claims
1.2.3. Food Supplements
1.2.4. Addition of Vitamins and Minerals
1.2.5. Natural Mineral Waters
1.2.6. Food For Specic Groups
1.3. Biological Safety
1.3.1. Antimicrobial Resistance
1.3.2. Crisis Preparedness and Management
1.3.3. Food Hygiene
1.3.4. Food-Borne Diseases (Zoonoses)
1.3.5. Food Irradiation
1.4. Chemical Safety
1.4.1. Contaminants
1.4.2. Residues of Veterinary Medicines
1.4.3. Hormones in Meat
1.4.4. Pesticides Residues
1.4.5. Food Contact Materials
1.5. Food Improvement Agents
1.5.1. Additives
1.5.2. Flavourings
2. Good Practice Code/Codex Alimentarius 21
2.1. e Codex Alimentarius
2.2. e General Principles of Food Hygiene of the Codex Alimentarius
2.2.1. Codex Standards
2.2.2. Recommended Codes of Good Practices
2.2.3. General Guidelines
3. HACCP System 25
3.1. Introdcution
3.2. e Concept of the HACCP System

VI
3.3. e History of the HACCP System
3.4. e Principles of the HACCP
3.5. e HACCP Methodology
3.5.1. HACCP Team
3.5.2. Product Description
3.5.3. Intended Use for the Product
3.5.4. Construction of the Flowchart
3.5.5. Verication of the Flowchart
3.5.6. Hazard Analysis
3.5.7. Determination of Critical Control Points (CCP’S)
3.5.8. Establishment of Critical Limits
3.5.9. Establishment of Monitoring System
3.5.10. Establishment of Corrective Actions
3.5.11. Establishment of Verication Procedures
3.5.12. Documents and Registers
4. Food Safety Standards for Certication 53
4.1. Introduction
4.2. Requirements of Food Safety Standards
4.2.1. BRC Food
4.2.1.1. Senior Management Commitment
4.2.1.2. e Food Safety Plan – HACCP
4.2.1.3. Food Safety and Quality Management System
4.2.1.4. Site Standards
4.2.1.5. Product Control
4.2.1.6. Process Control
4.2.1.7. Personnel
4.2.2. IFS Food
4.2.2.1. Senior Management Commitment
4.2.2.2. Quality and Food Safety Management System
4.2.2.3. Resource Management
4.2.2.4. Planning and Production Process
4.2.2.5. Measurement, Analysis, Improvement
4.2.2.6. Food Defense and External Inspections
Bibliography
Keywords (Index)
Glossary
Abbreviations

VII
PREFACE
This book, in particular, addresses the application of food safety management system. Food safety
systems should be designed to control the production process and be based on preventive principles and
concepts. With this type of systems, it is intended to implement measures that ensure efcient control
by identifying points or stages where the health hazards of consumers can be controlled. The Hazard
Analysis and Critical Control Points (HACCP) methodology is currently the internationally accepted
benchmark for the implementation of food safety systems. The growing number of legal diplomas and
controls linked to food safety, as well as the increasing demands of consumers, have created strong and
growing pressures on food businesses and on the development of food safety standards to help them
meet those requirements.
It is within this framework that, with this book, it is intended to present in a systematic way the main
relevant elements for an adequate understanding of the HACCP methodology. Thus, it is intended to
transmit a set of technical information that can facilitate the implementation of a food safety management
system capable of satisfying legal requirements and meeting the HACCP certication requirements.

VIII
ACKNOWLEDGEMENT
The authors wish to acknowledge the European Commission Education, Audiovisual and Culture
Executive Agency (EACEA), Managing programmes and activities on behalf of the European Commission
Erasmus+ for co-funding the project: “Fostering Academia Industry Collaboration in Food Safety and
Quality-FOODQA: 574010-EPP-1-2016-1-JO-EPPKA2-CBHE-JP”

IX
DeDication
To,
Our beloved teams at MonoJo Biotech and the Jordan University of Science and
Technology (JUST) and everyone who contributed towards the success of this series
of e-books.
This series of e-books has been prepared for the FOODQA Project which was co-
funded by EU through Erasmus+.
The series of e-books has been composed with passion and is available for public
access to provide a high quality reference on the best practices in food quality and
safety that can be used by the food industry, relevant governmental bodies, students,
professors, and academics.
Our heartfelt gratitude goes towards our Jordanian and European partners who
dedicated their precious time and effort towards the success of this entire project.
We dedicate this work to our beloved country, Jordan, and its people and to our
European partner countries.
- Prof. Fahmi Abu Al-Rub, Dr. Penelope Shihab, and
Dr. Safwan Abu Al-Rub

1
This Project has been funded with support form the European Commission.
This Publication reects the views only of the author, and the commission cannot be held
responsible for any use Which may be made of the information contained therein
Chapter 1
EUROPEAN LEGISLATION IN FOOD SAFETY
Eleutério Silva, Paulo & Beatriz
Consultores Associados, Lda, eleuterioacursio@gmail.com
INTRODUCTION
All actors in a food chain have a responsibility to ensure the safety of food products at the stages of
intervention, irrespective of the nature of the activities they carry out. Food safety systems should be
designed to control the production process and be based on preventive principles and concepts. With
this type of systems, it is intended to implement measures that ensure efcient control by identifying
points or stages where the health hazards of consumers can be controlled. The Hazard Analysis and
Critical Control Points (HACCP) methodology is currently the internationally accepted benchmark
for the implementation of food safety systems. This methodology has a scientic basis and is based
on a systematic approach. The implementation of a HACCP System facilitates compliance with
legal requirements and allows the most efcient use of resources in the immediate response to food
safety issues. The increasing globalization of the food trade has also led to the need to harmonize
international food security control measures. In 1993 the Codex Alimentarius Commission published
the HACCP code, which was transposed into Community law by Council Directive no. 93/43/EEC of
14 June 1993. However, since 1986 this Commission has recommended that food application of self-
monitoring systems based on HACCP principles. The growing number of legal diplomas and controls
linked to food safety, as well as the increasing demands of consumers, have created strong and
growing pressures on food businesses and on the development of food safety standards to help them
meet those requirements. To this end, they have standardization bodies which, as in some countries
(e.g. Denmark, the Netherlands, Ireland, Australia), have developed national standards specifying
requirements for food safety management systems.
Chapter Objectives
• PresentthekeyEuropeanLegislationconcerningtheGeneralFoodLaw
• PresentthekeyEuropeanLegislationregardinglabellingandnutritionanditsimportancefor
food safety
• PresentthekeyEuropeanLegislationregardingthecontrolofbiologicalandchemicalinfood
products
• PresentthekeyEuropeanLegislationconcerningtheuseofadditivesandavouringsinfood
products

2
This Project has been funded with support form the European Commission.
This Publication reects the views only of the author, and the commission cannot be held
responsible for any use Which may be made of the information contained therein
It is within this framework that, with this book, it is intended to present in a systematic way the main relevant elements
for an adequate understanding of the HACCP methodology. Thus, it is intended to transmit a set of technical information
that can facilitate the implementation of a food safety management system capable of satisfying legal requirements
and meeting the HACCP certication requirements, thus constituting a reference manual implementation of HACCP
Systems.
This book is organized in four sections:
• European legislation in food safety.
• Codex Alimentarius.
• HACCP system.
• Food safety standards.
Through these themes, the general objectives are:
• Introduce the Codex Alimentarius, highlighting in particular the set of codes of good practice and general principles
of food hygiene available and discussing the relevance of the implementation of good manufacturing practices
(GMP) as a prerequisite for the implementation of a food safety system.
• Explain the current legal framework as regards general hygiene standards for foodstuffs, listing the main legal
requirements that an establishment engaged in the preparation, processing, manufacture, packaging, storage,
transport, distribution, handling, sale or placing of foodstuffs is subject.
• Present the concept and principles and discuss the methodology of implementation of a HACCP System, describing
and illustrating in detail the steps inherent in this process.
• To present the certication requirements associated with the implementation of a HACCP System according to
certication standards such as IFS and BRC.
GENERAL FOOD LAW
Principles
e general principles of food and feed law are outlined in the General Food Law Regulation (Regulation no. 178/2002
Articles5to10).eyformahorizontalframeworkunderpinningallUnionandnationalmeasuresrelatingtofood
and feed. ey cover all stages of the production, processing and distribution of food.
e general objectives of food law are:
• Guarantee a high level of protection of human life and health and the protection of consumer’s interests. Also
guarantee fair practices in food trade, taking into account animal health and welfare, plant health and the
environment.
• Ensurefree movementoffood andfeedmanufactured andmarketedinthe EuropeanUnion,in accordance
with the General Food Law Regulation.
• Facilitate global trade of safe food by taking into account international standards and agreements when
developing European Union legislation, except where this might undermine the high level of consumer
protection pursued by the European Union.
Risk analysis principle
eGeneral Food Law Regulationestablishesthe principleofrisk analysisinrelationtofoodandestablishes the
structuresandmechanismsforthescienticandtechnicalevaluations,whichareundertakenbytheEuropeanFood
Safety Authority (EFSA).

3
This Project has been funded with support form the European Commission.
This Publication reects the views only of the author, and the commission cannot be held
responsible for any use Which may be made of the information contained therein
Depending on the nature of the measure to be used, food law, and in particular measures relating to food safety
must be supported by scientic information. e European Union has been at the forefront of the development of
riskanalysisprinciplesandtheirsubsequentinternationalacceptance.Foodlawisbasedonthethreeinter-related
componentsofriskanalysis:
• Riskassessment.
• Riskmanagement.
• Riskcommunication.
Risk assessment must be undertaken in an independent, objective and transparent manner based on the best
availableknowledge.
Risk managementis theprocessof weighingpolicyalternatives inthelightofresultsofariskassessmentand,if
required,selectingtheappropriateactionsnecessarytoprevent,reduceoreliminatetherisk.Intheriskmanagement
phase,thedecisionmakersneedtoconsiderarangeofotherinformationinadditiontothescienticriskassessment,
such as:
• Mosteectiveriskreductionactionsdependingonthepartofthefoodsupplychainwheretheproblemoccurs.
• Feasibilityofcontrollingarisk.
• Socio-economic eects.
• Environmental impact.
Risk communicationistheinteractiveexchangeofinformationandopinionthroughouttheriskanalysisprocess
amongriskassessors,riskmanagers,consumers,foodbusinesses,academics,otherinterestedparties.
Precautionary principle
e precautionary principle (Article no. 7 of the General Food Law – Regulation no. 178/2002) refers to specic
situations where:
erearereasonablegroundsforconcernthatanunacceptablelevelofrisktohealthexiststheavailablesupporting
informationanddataarenotsucientlycompletetoenableacomprehensiveriskassessmenttobemade.
Whenfacedwiththesespeciccircumstances,decisionmakersorriskmanagersmaytakemeasuresorotheractions
basedon theprecautionaryprinciple,whileseeking morecompletescienticdata.Suchmeasureshavetocomply
with the principles of non-discrimination and proportionality and should be provisional until the time when more
comprehensiveinformationconcerningtheriskcanbegatheredandanalyzed.
Requirements
Safety requirements
e safety of food is of critical importance. Consumers must have condence and assurance that the food they buy
will do them no harm or have an adverse eect.
eGeneralFoodLawRegulationestablishesthatonlysafefoodcanbeplacedontheEuropeanUnionmarketorfed
to food-producing animals. It also establishes basic criteria for establishing whether a food is safe.

4
This Project has been funded with support form the European Commission.
This Publication reects the views only of the author, and the commission cannot be held
responsible for any use Which may be made of the information contained therein
Traceability
Food traceability throughout the food chain is very important for the protection of consumers, particularly when
food are found to be faulty. e General Food Law Regulation denes traceability as the “ability to trace and follow
food, feed, and ingredients through all stages of production, processing and distribution”. Traceability should:
1. Facilitatewithdrawalofunsafefoodfromthemarket.
2. Provide consumers with targeted and accurate information on specic products.
3. Cover all food and all food business operators, without prejudice to existing legislation on specic sectors.
4. Aectimporterswhoarerequiredtobeabletoidentifyfromwhomtheproductwasexportedinthecountryof
origin.
5. Oblige businesses to be able to identify at least the immediate supplier of the product in question and the
immediatesubsequentcustomers,withtheexemptionofretailerstonal consumers- onestepback-onestep
forward.
MoredetailedtraceabilityrequirementsinthecontextoftheGeneralFoodLawRegulationarelaiddownforcertain
specic sectors, namely:
• Foods of animal origin: Regulation no. 931/2011.
• Sprouts and sprout seeds: Regulation no. 208/2013.
Operators Responsibilities
e primary responsibility is adopted to ensure compliance with food law - particularly the safety of the food business
operators. When food is unsafe, business operators are obliged to withdraw or recall it. ey are also obliged to notify
thecompetentnationalauthoritiessoastobeabletolaymonitorwhethertheappropriatemeasureshavebeentaken
orrequirethatadditionalmeasuresbetakenforreducingoreliminatingafoodsafetyrisk.
Procedures
e General Food Law Regulation sets out certain procedures related to food safety. In particular, it provides for 4
measures:
• e establishment of the Rapid Alert System for Food and Feed (RASFF).
• e establishment of the Standing Committee on Plants, Animals, Food and Feed (PAFF Committee).
• e adoption of emergency measures.
• e establishment of a general plan for crisis management.
Rapid alert system for food and feed
eprimaryfocusoftheEuropeanUnion(EU)isonmaintainingahighlevelofsafetyandensuringquickresponses
toanythreatsthatdoarise.Onekeytoolusedtoreactrapidlytofoodandfeedsafetyemergenciesandincidentsisthe
Rapid Alert System for Food and Feed. RASFF enables information to be shared eciently between its members (EU-
28 national food safety authorities, European Commission, EFSA, Norway, Liechtenstein, Iceland and Switzerland).
RASFFmembershaveto notify the RASFFif they takesuchmeasuresas withdrawing or recalling food or feed
productsfromthemarketinordertoprotectconsumershealthandifrapidactionisrequired.

5
This Project has been funded with support form the European Commission.
This Publication reects the views only of the author, and the commission cannot be held
responsible for any use Which may be made of the information contained therein
Standing committee on plants, animals, food and feed
ePAFFCommitteeplaysakeyroleinensuringthatEuropeanUnionmeasuresonfoodandfeedsafety,animal
health & welfare as well as plant health are practical and eective. It delivers opinions on dra measures that the
Commission intends to adopt. e PAFF Committee is composed by representatives of all Member States and
presided by a European Commission representative. e PAFF Committee's mandate covers the entire food supply
chain - from animal health issues on the farm to the product on the consumers table - helping the European Union
todealeectivelywithhealthrisksateverystageoftheproductionchain.
Emergency measures
Wherefood,includingthoseimportedfromanon-EUcountrypresentsaseriousrisktohumanhealth,theEuropean
Commission can put in place protective measures, following an opinion from the PAFF Committee and:
• SuspendtheplacingonthemarketoruseofproductsoriginatingfromtheEU.
• Suspend imports of products originating from non-EU countries.
Suchaction canbeinitiatedby the EuropeanCommissionitselforrequested byaMemberState.However, if the
EuropeanCommissiondoesnotactaerhavingbeeninformedoftheexistenceofarisk,theEUcountryconcerned
maytakeinterimprotectivemeasures.Withinaperiodof10workingdays,theCommissionmustreferthematterto
thePAFFCommitteewithaviewtoextending,amendingorrevokingthenationalmeasures.
Crisis management
Sometimes,incidentsrelatedtofoodthatposepotentialseriousriskstohumanhealthcannotbemanagedproperly
within routine procedures. In such cases, the European Commission, the EFSA and the aected European Union
countries shall follow the general crisis-management plan as adopted by Decision no. 2004/478/EC.
Inthe case ofaseriousrisk, the EuropeanCommissionmustimmediatelyset upacrisisunit,with scienticand
technical support from EFSA. is crisis unit is responsible for collecting and evaluating all relevant information
andidentifyingtheoptionsavailableforpreventing,eliminatingorreducingtherisktohumanhealth.Management
procedures are laid down in Decision no. 2004/478/EC. In order to allow the application of the general plan for
crisismanagement,MemberStatesarealsorequiredtodrawuptheirowncontingencyplanstoapplyinemergency
situations. According to Article no. 13 of Regulation no. 882/2004, these contingency plans must outline the national
administrative authorities to be engaged in crisis management, and their respective responsibilities and authorities,
as well as the channels and procedures for communication between the relevant players.
LABELLING AND NUTRITION
Food Labelling Legislation
e Regulation no. 1169/2011 on the provision of food information to consumers entered into application on 13
December 2014. is law combines 2 Directives into one legislation:
• Directive no. 2000/13/EC - Labelling, presentation and advertising of foodstus.
• Directive no. 90/496/EEC - Nutrition labelling for foodstus.
Key elements
ekeyelementscontainedintheRegulationno.1169/2011thataremandatoryintermsoflabellingare:
• e name of the food.

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responsible for any use Which may be made of the information contained therein
• e list of ingredients.
• Any ingredient or processing aid listed in Annex II or derived from a substance or product listed in Annex II
causing allergies or intolerances used in the manufacture or preparation of a food and still present in the nished
product, even if in an altered form.
• equantityofcertainingredientsorcategoriesofingredients:
• enetquantityofthefood.
• e date of minimum durability or the ‘use by’ date.
• Any special storage conditions and/or conditions of use.
• e name or business name and address of the food business operator.
• e country of origin or place of provenance where provided.
• Instructionsfor use where it would be dicult to make appropriate use of the food in the absence of such
instructions.
Withrespecttobeveragescontainingmorethan1,2%byvolumeofalcohol,theactualalcoholicstrengthbyvolume:
A nutrition declaration
Some exceptions or specic rules are detailed in specic articles (Articles 17 to 28).
Nutrition Declaration
Rules for application of a nutrition declaration are detailed in Section 3 – Articles 29 to 35 – of Regulation no.
1169/2011. e mandatory nutrition declaration shall include the following: i) energy value, and ii) the amounts of
fat, saturates carbohydrate, sugars, protein and salt. Where appropriate, a statement indicating that the salt content
is exclusively due to the presence of naturally occurring sodium may appear in close proximity to the nutrition
declaration.
e content of the mandatory nutrition declaration may be supplemented with an indication of the amounts of one
or more of the following:
• Mono-unsaturated fats.
• Polyunsaturated fats.
• Polyols.
• Starch.
• Fiber.
• Any of the vitamins or minerals listed in point 1 of Part A of Annex XIII, and present in signicant amounts as
dened in point 2 of Part A of Annex XIII of Regulation no. 1169/2011.
Origin Labelling
For fresh, chilled and frozen meat of swine, sheep, goats and poultry it is mandatory the indication of country of
origin or place of provenance for fresh chilled and frozen meat of swine, sheep, goats and poultry aer an impact
assessment.

7
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This Publication reects the views only of the author, and the commission cannot be held
responsible for any use Which may be made of the information contained therein
Nutrition and Health Claims
European Union rules on nutrition and health claims have been established by Regulation no. 1924/2006. is
regulation is the legal framework used by food business operators when they want to highlight the particular
benecial eects of their products, in relation to health and nutrition, on the product label or in its advertising.
e rules of this Regulation apply to nutrition claims and to health claims. e nutritional claims that can be used are:
• Low energy.
• Energy reduced.
• Energy-free.
• Low fat.
• Fat-free.
• Low saturated fat.
• Saturated fat-free.
• Low sugars.
• Sugars-free.
• With no sugars added.
• Low sodium/salt.
• Very low sodium/salt.
• Sodium-free or salt-free.
• No added sodium/salt.
• Source of ber.
• High ber.
• Source of protein.
• High protein.
• Source of [name of vitamin/s] and/or [name of mineral/s].
• High [name of vitamin/s] and/or [name of mineral/s].
• Contains [name of the nutrient or other substance].
• Increased [name of the nutrient].
• Reduced [name of the nutrient].
• Light/Lite.
• Naturally/Natural.
• Source of Omega-3 fatty acids.
• High Omega-3 fatty acids.
• High Monounsaturated fat.

8
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responsible for any use Which may be made of the information contained therein
• High Polyunsaturated fat.
• High unsaturated fat.
e conditions for its use are described in the Annex of Regulation no. 1924/2006. e objective of those rules is to
ensure that any claim made on foods labelling, presentation or advertising in the European Union is clear, accurate
andbasedonscienticevidenceandtopreventtheuseofclaimsthatcouldmisleadconsumersontheEUmarket.
e rules ensure the free circulation of foods bearing claims, as any food company may use the same claims on its
products anywhere in the European Union.
Food Supplements
Asanadditiontoanormaldiet,foodbusinessoperatorsmarketfoodsupplements,whichareconcentratedsources
ofnutrients(orothersubstances)withanutritionalorphysiologicaleect.Suchfoodsupplementscanbemarketed
in“dose”form,suchaspills,tablets,capsules,liquidsinmeasureddoses,etc.
e objective of the harmonized rules on those products in Directive no. 2002/46/EC is to protect consumers against
potentialhealthrisksfromthoseproductsandtoensurethattheyarenotprovidedwithmisleadinginformation.
With respect to the safety of food supplements, the Directive lays down a harmonized list of vitamins and minerals
that may be added for nutritional purposes in food supplements (in Annex I to the Directive no. 2002/46/EC and
following amendments). e Annex II of the Directive contains a list of permitted sources (vitamin and mineral
substances) from which those vitamins and minerals may be manufactured. e trade of products containing
vitamins and minerals not listed in Annex II is prohibited.
MemberStatesmay,formonitoringpurposes,requestnoticationtotheircompetentauthorityoftheplacingonthe
marketintheirterritoryofafoodsupplementproductinaccordancewithArticle10oftheDirectiveno.2002/46/EC.
Addition of Vitamins and Minerals
A wide range of nutrients and other ingredients are used in food manufacturing, such as):
• Vitamins.
• Minerals including trace elements.
• Amino acids.
• Essential fatty acids.
• Fiber.
• Various plants and herbal extracts.
Suchnutrientsoringredientsareaddedtofoodinorderto"enrich"or"fortify"thefoodinquestion,soastoaddor
emphasize particular nutritional characteristics.
Regulation no. 1925/2006 harmonizes the provisions regarding the addition of vitamins and minerals and of certain
othersubstancestofoods.isRegulationensurestheeectivefunctioningoftheinternalmarketwhilstproviding
a high level of consumer protection.
In Annex I of the Regulation no. 1925/2006 it is presented the list of vitamins and minerals which may be added to
foods. In Annex II presents a list of the sources of vitamins and minerals which may be added to foods. Annex I and
Annex II have been amended later on by three Commission Regulations to include additional substances:

9
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This Publication reects the views only of the author, and the commission cannot be held
responsible for any use Which may be made of the information contained therein
• Regulation no. 2017/1203.
• Regulation no. 119/2014.
• Regulation no. 1161/2011.
• Regulation no. 1170/2009.
Annex III presents a list of substances other than vitamins or minerals whose use in foods is prohibited, restricted or
under Community scrutiny. Annex III has been amended by Commission Regulation no. 2015/403.
Vitamin and mineral substances may be considered for inclusion in the lists following the evaluation of an appropriate
scientic dossier concerning the safety and bioavailability of the individual substance by EFSA.
e Regulation provides for the setting of maximum amounts of vitamins and minerals in these products via PAFF
Committee.Minimumamountsarelinkedtothe notionof signicantamount,wherethis isdenedaccordingto
Annex XIII to Regulation (EU) No 1169/2011.
eCommission,onitsowninitiativeorattherequestofaMemberState,mayinitiatetheprocedureunderArticle
8 of the Regulation to prohibit, restrict or put under Union scrutiny a substance other than vitamins or minerals or
an ingredient containing such a substance that is added to foods or used in the manufacture of foods. is could
happen where the use of such substances in foods would result in the ingestion of amounts greatly exceeding those
reasonably expected to be ingested under normal conditions of consumption of a balanced and varied diet and/or
wouldotherwiserepresentapotentialrisktoconsumers.
Natural Mineral Waters
ere are dierent categories of waters intended for human consumption such as natural mineral waters and spring
waters.Naturalmineralwatersmaybedistinguishedfromordinarydrinkingwaterbytheirpurityatsourceandtheir
constant level of minerals. Spring waters are intended for human consumption in their natural state and are bottled
at source.
eDirectiveno.2009/54/ECregulatesthemarketingandexploitationofnaturalmineralwaters.Certainprovisions
of this Directive are also applicable to spring waters such as the microbiological requirements and labelling
requirements.
eDirectiveno.2003/40/EC establishes the list, concentrationlimitsandlabellingrequirementsforthe natural
mineral waters and the conditions for using ozone-enriched air for the treatment of natural mineral waters and
spring waters.
Natural mineral waters and spring waters may be treated at source to remove unstable elements and some undesirable
constituents in compliance with the provisions laid down in Article 4 of the Directive no. 2009/54/EC. Treatments
other than ltration or decanting with possible oxygenation have to be assessed and authorized at EU level prior to
their use by industry. Regulation no. 115/2010 lays down the conditions for use of activated alumina for the removal
ofuoridefromnaturalmineralwatersandspringwaters.
Natural mineral waters are subject to an authorization procedure carried out by the competent authorities of the
EU Member States or by European Economic Area (EEA) countries. e lists of natural mineral waters ocially
recognized by the Member States of the EU and of the EEA (Iceland and Norway) are published by the European
Commission in the Ocial Journal of the European Union. ese lists are regularly updated.

10
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responsible for any use Which may be made of the information contained therein
Food for Specic Groups
e Regulation no. 609/2013 on food intended for infants and young children, food for special medical purposes,
and total diet replacement for weight control ('Food for Specic Groups') entered in force from 20th July 2016. is
Regulation aims to protect specic vulnerable groups of consumers (infants and young children, people with specic
medicalconditionsand peopleundertakingenergy-restricteddiets to lose weight) by regulatingthecontentand
marketingoffoodproductsspecicallycreatedforand marketedto them.Italsoaimsto increaselegalclarityfor
business and to facilitate correct application of the rules. is Regulation:
• Strengthens provisions on foods for vulnerable population groups to ensure their protection.
• Setsgeneral compositional and labelling rulesandrequiretheCommissionto adopt, through delegatedacts,
specic compositional and labelling rules for.
• Infantandfollow-onformula.
• Processed-cerealbasedfoodandotherbabyfood.
• Foodforspecialmedicalpurposes.
• Totaldietreplacementforweightcontrol.
• Simpliestheregulatoryframework,byeliminatingthoserulesthatareunnecessaryandcontradictoryandby
replacingthem with anewFrameworkwhich takes intoaccountthedevelopmentson the marketandinEU
food law.
• Establishes a single European Union list of substances that can be added to these foods including minerals and
vitamins.
• RequirestheEuropeanCommissiontotransferrulesongluten-freefoodsandverylowglutenunderRegulation
no. 1169/2011 on food information to consumers in order to ensure clarity and consistency.
• Establishes that meal replacement products for weight control should be regulated solely under Regulation no.
1924/2006 on nutrition and health claims in order to ensure legal certainty.
BIOLOGICAL SAFETY
Antimicrobial Resistance
Antimicrobial resistance is the ability of microorganisms to resist antimicrobial treatments, especially antibiotics.
Antimicrobial resistance is a natural phenomenon but an accumulation of factors, including excessive and
inappropriate use of antimicrobial medicines on humans and animals and poor hygiene or infection control practices,
transformed antimicrobial resistance into a serious threat to public health worldwide. Antimicrobial resistance is
already responsible for an estimated 25,000 deaths per year in the European Union. Current worldwide mortality
from Antimicrobial Resistance is estimated at 700,000 deaths per year.
It also has wide impacts on the economy, with higher costs of treatments and economic losses due to reduced
productivitycausedbysickness.IntheEUaloneitisestimatedthatantimicrobialresistanceannuallycostsEUR1.5
billionin healthcarecostsandproductivity losses.eWorldBank warns that,by2050, drug-resistantinfections
could cause global economic damage on a par with the 2008 nancial crisis.

11
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responsible for any use Which may be made of the information contained therein
Crisis Preparedness and Management
EUlegislationisbuiltinaccordancewiththepreventionprinciple.Itthusaimsatpreventingoutbreaksoffood-borne
disease through a set of comprehensive standards, such as good hygiene, limits of residues of substances used in the
foodchain,own-checks,ocialcontrols.
Nevertheless, crises occasionally occur. Past food and feed safety crises (such as BSE - - bovine spongiform
encephalopathy - in the 90's, dioxin in 1999, verotoxin-producing Escherichia coli (VTEC) in sprouts in 2011)
caused human suering and even deaths. In addition, they had a tremendous impact on the European economy.
Preparedness and management of crisis related to food and feed safety aims to avoid or minimize the health and
economic impact of possible future crisis.
e basic requirements areset-up on the Regulation no. 178/2002 (in Articles no. 55 to 57). e Commission
Decision no. 2004/478/EC addresses a general plan for food crisis management.
Inorderto supportactionbytheEU agencies,theEuropeanUnionisequippedwithrapidalertsystems allowing
real-time exchange of information on:
• Distribution and investigations of aected food and feed batches (RASFF).
• And real-time exchange of information on human cases (Early Warning Response System - EWRS).
e EU coordinates investigations both on the public health side (information from human cases) and towards
the food source in dierent Member States by organizing, if needed daily, meetings of the responsible national
coordinators. It also tries to streamline the communication to citizens and trade partners, for instance on advice
to travelers. EFSA and the European Centre for Prevention and Control of Diseases (ECDC) provide at a very early
stagejointrapidoutbreakassessmentssupportinginvestigationsbythepublichealthandfoodsafetyauthorities.
Food Hygiene
Rules on hygiene of foodstus were adopted by the European Union in April 2004 through the Regulation no.
852/2004, 853/2004 and 854/2004. e 2004 rules merged, harmonized and simplied detailed and complex hygiene
requirementspreviouslycontainedinanumberofDirectivescoveringthehygieneoffoodstusandtheproduction
andplacingonthemarketofproductsofanimalorigin.eserulesareinplacesince2006,applicabletoallfoodand
allfoodoperatorsrightthroughthefoodchain(“fromfarmtofork”).
Food-Borne Diseases (Zoonoses)
Some infections in animals, the so-called zoonoses, such as brucellosis, salmonellosis and listeriosis, can be
transmitted to humans in particular through contaminated food and in some cases, by contact with the live or
slaughtered animal.
Specic measures against zoonoses exist in EU legislation relating to Veterinary Public Health. For instance, rules
concerning BSE are laid down in Regulation no. 999/2001 and measures to inspect meat for the presence of parasites,
such as Cysticercus and Trichinella, are included in the legislation concerning meat hygiene (Regulations no. 853/2004,
854/2004 and 2015/1375).
As a follow up of the 2000 White Paper on Food Safety and based on scientic advice, two Regulations were adopted
to cut the incidence of food borne diseases such as Salmonella in the European Union:
• Regulation no. 2160/2003 on the control of Salmonella and other specied food-borne zoonotic agents.

12
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responsible for any use Which may be made of the information contained therein
• Directive no. 2003/99/EC on the monitoring of zoonoses and zoonotic agents.
Food Irradiation
Irradiation is physical treatment of food with high-energy ionizing radiation to:
• Destroy micro-organisms, viruses, bacteria or insects.
• Prevent germination and sprouting of potatoes, onions and garlic.
• Slow down ripening and ageing of fruit and vegetables.
• Prolong the shelf life and prevent food-borne diseases in meat, poultry and seafood.
Its use is limited but authorized in many countries. Treating food with ionizing radiation may be authorized if:
• ere is reasonable technological need.
• It poses no health hazard.
• It benets consumers.
• It does not replace hygiene, health or good manufacturing or agricultural practice.
Irradiated food or one containing irradiated ingredients must be labelled. Food irradiation has nothing to do with
radioactive contamination of food resulting from a spill or an accident.
CHEMICAL SAFETY
Contaminants
Contaminants are substances that have not been intentionally added to food. ese substances may be present in
foodasaresultofthevariousstagesofitsproduction,packaging,transportorholding.eyalsomightresultfrom
environmentalcontamination.Sincecontaminationgenerallyhasanegativeimpactonthequalityoffoodandmay
implyarisktohumanhealth,theEUhastakenmeasurestominimizecontaminantsinfoodstus.
e EU established maximum levels for dierent contaminants. ese maximum levels might be applicable to all or
just to some type of food products. Maximum levels of the same contaminant might be dierent for dierent types
of foods. e following basic principles of EU legislation on contaminants in food are laid down in Directive no.
315/93/EEC:
• Food containing a contaminant to an amount unacceptable from the public health viewpoint and in particular
atatoxicologicallevel,shallnotbeplacedonthemarket.
• Contaminantlevelsshallbekeptaslowascanreasonablybeachievedfollowingrecommendedgoodworking
practices.
• Maximum levels must be set for certain contaminants in order to protect public health.
Maximum levels for certain contaminants in food are set in Regulation no. 1881/2006. Maximum levels in certain
foods are set for the following contaminants:
• Nitrate.

13
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responsible for any use Which may be made of the information contained therein
• Mycotoxins(Aatoxins,OchratoxinA,Patulin,Deoxynivalenol,Zearalenone,FumonisinsandCitrinine).
• Metals (Lead, Cadmium, Mercury, Inorganic tin, Arsenic).
• 3-MCPD.
• Dioxins.
• Dioxin-likePCBs.
• Nondioxin-likePCBs.
• Polycyclic Aromatic Hydrocarbons (PAH) (benzo(a)pyrene) and sum of 4 PAHs).
• Melamine.
• Erucic acid.
Residues of Veterinary Medicines
Food-producing animals may be treated with veterinary medicines to prevent or cure disease. ese substances may
leave residues in the food from treated animals. Food may also contain residues of pesticides and contaminants to
which animals have been exposed to. In all cases, the levels of residues in food should not harm the consumer.
e EU countries must implement residue monitoring plans to detect the illegal use or misuse of authorized
veterinary medicines in food producing animals and investigate the reasons for residue violations. e Non-EU
countriesexportingtothe EUmustimplementaresiduemonitoringplanwhichguaranteesanequivalentlevel of
food safety as that of the EU.
e European Medicines Agency (EMA) is responsible for assessing Maximum Residue Limits for veterinary
medicinalproductsmarketedintheEU.MemberStatesneedtomonitorfoodofanimaloriginforthepresenceof
residues.ekeylegislationcoveringresiduesofveterinarymedicinalproductsisthefollowing:
• Directive no. 96/22/EC: Bans the use of certain substances in food producing animals.
• Directive no. 96/23/EC:Establishesresiduemonitoringplans,samplingfrequencyandrangeofsubstancesto
be tested for.
• Decision no. 97/747/EC: Includes additional sampling frequencies for milk, eggs, honey, rabbits and game
meat.
• Decision no. 98/179/EC:Establishesrulesfortakingocialsamplesandaccreditationrequirementsforocial
laboratories.
• Directive no. 2001/82/EC: Establishes the rules for the authorization and use of veterinary medicinal products.
• Decision no. 2002/657/EC: Establishes rules for the validation of analytical methods used in the residue
monitoring plan.
• Directive no. 2005/34/EC:EstablishesMinimumRequiredPerformanceLimits(MRPLs)forresiduesofcertain
veterinary medicines not permitted to be used in the EU but which may present in imported food.

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responsible for any use Which may be made of the information contained therein
• Regulation no. 396/2005: Establishes maximum residue limits for pesticides in food.
• Regulation no. 1881/2006: Establishes maximum levels for contaminants in food.
• Regulation no. 470/2009: Establishes procedures for the Setting of Maximum Residue Limits (MRLs) for
veterinary medicines in food.
• Regulation no. 37/2010: Establishes a list of MRLs for permitted substances.
Hormones in Meat
In 1981, with Directive no. 81/602/EEC, the EU prohibited the use of substances having a hormonal action for
growth promotion in farm animals such as oestradiol 17ß, testosterone, progesterone, zeranol, trenbolone acetate
and melengestrol acetate. is prohibition applies to Member States and imports from third countries. e legal
instrument in force is the Directive no. 96/22/EC as amended by Directive no. 2003/74/EC. ese Directives
establishedtheprohibitionoftheuseinstockfarmingofcertainsubstanceshavingahormonalorthyrostaticaction
and of ß-agonists.
Pesticide Residues
e term pesticides include, amongst others: herbicides, fungicides, insecticides, acaricides, nematicides,
molluscicides, rodenticides, growth regulators, repellents, rodenticides and biocides. Pesticide can be dened as
something that prevents, destroys, or controls a harmful organism ('pest') or disease, or protects plants or plant
products during production, storage and transport.
e most common use of pesticides is in the form of plant protection products (PPPs). e term 'pesticide' is oen
used interchangeably with 'plant protection product', however, pesticide is a broader term that also covers non plant/
crop uses, for example biocides. Plant protection products are pesticides that protect crops or desirable or useful
plants. ey are primarily used in the agricultural sector but also in forestry, horticulture, amenity areas and in-home
gardens. A plant protection product usually contains more than one component. e active component against pests/
plant diseases is called 'active substance'. An active substance is any chemical, plant extract, pheromone or micro-
organism (including viruses), that has action against pests or on plants, parts of plants or plant products. Active
substances have one of the following functions:
• To protect plants or plant products against pests/diseases, before or aer harvest.
• Toinuencethelifeprocessesofplants(suchassubstancesinuencingtheirgrowth,excludingnutrients).
• To preserve plant products.
• To destroy or prevent growth of undesired plants or parts of plants.
Approval of active substances
Before an active substance can be used within a plant protection product in the EU, it must be approved by the
European Commission. Active substances undergo an intensive evaluation and peer-review by Member States and
the European Food Safety Authority before a decision can be made on approval.
e main steps for the approval of an active substance in the EU are the following:
• Application to an EU country called Rapporteur Member State (RMS).
• RMS veries if the application is admissible.

15
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responsible for any use Which may be made of the information contained therein
• RMS prepares a dra assessment report.
• EFSA issues its conclusions.
• Standing Committee for Food Chain and Animal Health votes on approval or non-approval.
• Adoption by the Commission.
• Publication of a Regulation in the EU Ocial Journal.
Normallyittakes2.5to3.5yearsfromthedateofadmissibilityoftheapplicationtothepublicationofaRegulation
approving a new active substance. is time varies depending on the degree of complexity and detail of the dossier.
Maximum residue limits
e traces pesticides leave in treated products are called 'residues'. A maximum residue limits (MRL) is the highest
level of a pesticide residue that is legally tolerated in or on food or feed when pesticides are applied correctly (GAP -
Good Agricultural Practice). e amounts of residues found in food must be safe for consumers and must be as low
as possible. e European Commission xes MRLs for all food and animal feed products. ese can be found in the
database on the European Commission website (http://ec.europa.eu/food/plant/pesticides/eu-pesticides-database/
public/?event=homepage&language=EN).
Food Contact Materials
Before being consumed, food products might come into contact with many materials during its production,
processing, storage, preparation and serving. Such materials are called Food Contact Materials (FCMs). Food contact
materials are either intended to be brought into contact with food, are already in contact with food, or can reasonably
be brought into contact with food or transfer their constituents to the food under normal or foreseeable use. is
includes direct or indirect contact. Examples include:
• Packagingmaterials.
• Containers for transporting food.
• Equipmentstoprocessfood.
• Tools and utensils.
etermdoesnotcoverxedpublicorprivatewatersupplyequipment.
FCMsshouldbesucientlyinertsothattheirconstituentsneitheradverselyaectconsumerhealthnorinuence
thequalityofthefood.ToensurethesafetyofFCMs,theEUlawestablishesrulesthatfoodbusinessoperatorsmust
comply with.
e EU rules on food contact materials can be of general scope, that means, apply to all FCMs or apply to specic
materials only. EU law can be complemented with Member States national legislation if specic EU rules do not exist.
esafetyof Food Contact Materialsistestedbythe business operatorsplacing them on the market,andbythe
competentauthoritiesoftheMemberStatesduringocialcontrols.Scienticknowledgeandtechnicalcompetence
on testing methods is being maintained by the European Reference Laboratory for Food Contact Materials (EURL-
FCM).

16
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responsible for any use Which may be made of the information contained therein
EU general legislation
Regulationno.1935/2004providesaharmonizedlegalEUframework.Itsetsoutthegeneralprinciplesofsafetyand
inertness for all Food Contact Materials (FCMs).
eprinciplessetoutinRegulationno.1935/2004requirethatmaterialsdonot:
• Release their constituents into food at levels harmful to human health.
• Change food composition, taste and odor in an unacceptable way.
Moreover,theframeworkprovides:
• Special rules on active and intelligent materials (they are by their design not inert).
• Power to enact additional eu measures for specic materials (e.g. For plastics).
• e procedure to perform safety assessments of substances used to manufacture fcms involving the european
food safety authority.
• e rules on labelling including an indication for use (e.g. As a coee machine, a wine bottle, or a soup spoon)
or by reproducing the appropriate symbol.
• Requirementsfordocumentationcomplianceandtraceability.
EU regulation on good manufacturing practices
Regulation no. 2023/2006 ensures that the manufacturing process is well controlled so that the specications for
FCMs remain in conformity with the legislation:
• Premises t for purpose and sta awareness of critical production stages.
• Documentedqualityassuranceandqualitycontrolsystemsmaintainedatthepremises,and
• Selection of suitable starting materials for the manufacturing process with a view to the safety and inertness of
the nal articles.
Good manufacturing rules apply to all stages in the manufacturing chain of food contact materials.
EU legislation on specic materials
In addition to the general legislation, certain FCMs — ceramic materials, regenerated cellulose lm, plastics, as
well as active and intelligent materials — are covered by specic EU measures. ere are also specic rules on some
starting substances used to produce FCMs.
Plastic materials
e most comprehensive specic EU measure is Regulation no. 10/2011 on plastic materials. It sets out rules on the
composition of plastic FCMs and establishes a Union List of substances that are permitted for use in the manufacture
of plastic FCMs. e Regulation also species restrictions on the use of these substances and sets out rules to
determine the compliance of plastic materials and articles. is Regulation has been regularly amended (Regulations
no. 1282/2011, no. 1183/2012, no. 202/2014, no. 865/2014, no. 174/2015, no. 1416/2016, no. 752/2017).
An important mechanism to ensure the safety of plastic materials is the use of migration limits. ese limits specify

17
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responsible for any use Which may be made of the information contained therein
the maximum amount of substances allowed to migrate to food. For the substances on the Union list the Regulation
sets out Specic Migration Limits (SMLs). ese are established by EFSA on the basis of toxicity data of each specic
substance.Toensuretheoverallqualityoftheplastic,theoverallmigrationtoafoodofallsubstancestogethermay
notexceedtheOverallMigrationLimit(OML)of60mg/kgfood,or10mg/dm2ofthecontactmaterial.
e Regulation sets out detailed migration testing rules. Although migration testing in the food prevails, migration is
usually tested using simulants. ese simulants are representative for a food category and are done under standardized
time/temperatureconditions,representativeforacertainfooduse,andcoversthemaximumshelflifeofpackedfood.
Toensurethesafety,qualityandcomplianceofplasticmaterials,adequatedataonthecompositionof(intermediate)
materials must be communicated via the manufacturing chain, up to but not including the retail stage. For this
purpose, a 'Declaration of Compliance' (DoC) needs to be provided. e DoC is based on supporting documentation
which documents the reasoning on the safety of a plastic food contact material, and which must be provided to
enforcementAuthoritiesontheirrequest.
Active and intelligent materials
Activeandintelligentmaterialsextendtheshelf-lifebymaintainingorimprovingtheconditionofpackagedfood,by
releasing or absorbing substances to or from the food or its surrounding environment. As a result they are exempted
from the general inertness rule in Regulation no. 1935/2004. e specic rules are dened in the Regulation (EC) No
450/2009 addressing their specic purpose, such as:
• Absorptionofsubstancesfromfoodpackaginginteriorsuchasliquidandoxygen,
• Release of substances into the food such as preservatives.
• Indicate expiry of food through labelling that changes Colour when maximum shelf life or storage temperature
is exceeded.
Active materials do not include systems that absorb substances entering from the atmosphere, such as active oxygen
barriers.
Other materials
Regulation no. 10/2011 sets out criteria for the composition of new plastic materials. However, aer these materials
have been used, they do not comply anymore with this regulation as they may have been contaminated with other
substances. erefore, a separate Regulation exists to control the recycling processes: Regulation no. 282/2008 on
recycled plastic materials and articles intended to come into contact with foods
Other specic regulations exists for ceramics: Directive no. 84/500/EEC – approximating EU countries laws on
ceramic articles intended to come into contact with foods; regenerated cellulose lm: Directive no. 2007/42/EC -
materials and articles made of regenerated cellulose lm intended to come into contact with foods.
Other legislation on specic substances also exists: Regulation no. 1895/2005 - restricting use of certain epoxy
derivatives in materials and articles intended to come into contact with food; Directive no. 93/11/EEC – concerning
the release of N-nitrosamines and N-nitrosatable substances from rubber teats and soothers. From the 1st July 2011
kitchenwaremadeofmelamineorpolyamideoriginatingorconsignedfromChinaorHongKongmustcomplywith
the import rules of Regulation no. 284/2011.

18
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responsible for any use Which may be made of the information contained therein
FOOD IMPROVEMENT AGENTS
Foodadditives,foodenzymesandfoodFlavouringsarealsoknownas’foodimprovementagents’.Foodimprovement
agents are added to food for dierent reasons. Among others, food additives preserve, Colour and stabilize food
duringitsproduction,packagingorstorage.Enzymeshavespecicbiochemicalactionswhich servetechnological
purposes in a certain stage of the food chain. Flavourings give or change the odor or taste to food.
Additives
Additives are substances used for a variety of reasons - such as preservation, Colouring, sweetening - during the
preparation of food. e European Union legislation denes additives as ‘any substance not normally consumed as a
food in itself and not normally used as a characteristic ingredient of food, whether or not it has nutritive value’. Added
tofood fortechnological purposesinitsmanufacture,processing,preparation,treatment,packaging,transportor
storage, food additives become a component of the food.
Additives can be used for various purposes. EU legislation denes 26 functional classes of food additives in foods
and food enzymes:
• Acidity regulators.
• Acids.
• Anti-cakingagents.
• Anti-foaming agents.
• Antioxidants.
• Bulkingagents.
• Carriers.
• Colours.
• Emulsiers.
• Emulsifying salts.
• Firming agents.
• Flavour enhancers.
• Flour treatment agents.
• Foaming agents.
• Gelling agents.
• Glazing agents.
• Humectants.
• Modied starches.
• Packaginggases.

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responsible for any use Which may be made of the information contained therein
• Preservatives.
• Propellants.
• Raising agents.
• Sequestrants.
• Stabilizers.
• Sweeteners.
• ickeners.
EU rules
e safety of all food additives that are currently authorized has been assessed by the Scientic Committee on
Food (SCF) and/or the European Food Safety Authority. All additives in the EU must be authorized and listed with
conditions of use in the EU's positive list based on:
• A safety assessment.
• e technological need.
• Ensuring that use of the additive will not mislead consumers.
Regulation no. 1333/2008 sets the rules on food additives: denitions, conditions of use, labelling and procedures.
It contains:
• Annex I: Technological functions of food additives.
• Annex II: EU list of food additives approved for use in food additives and conditions of use.
• Annex III: European Union list of food additives approved for use in food additives, food enzymes and food
Flavourings, and their conditions of use.
• Annex IV: Traditional foods for which certain Member States may continue to prohibit the use of certain
categories of food additives.
• Annex V: Additives labelling information for certain food Colours.
elistofauthorizedfoodadditivesapprovedforuseinfoodadditives,enzymesandavouringscanbefoundin
the Annex of Commission Regulation no. 1130/2011 which amends Annex III to Regulation no. 1333/2008. e
additivesapprovedforuseinavouringscanbefoundinpart4ofthisAnnex.
Foodadditivesmustcomplywithspecicationswhichshouldincludeinformationtoadequatelyidentifythefood
additive, including origin, and to describe the acceptable criteria of purity. Regulation no. 231/2012 laid down
specications for food additives listed in Annexes II and III to Regulation no. 1333/2008.
An up-dated EU database concerning authorized additives it is available in the European Commission website
(https://webgate.ec.europa.eu/foods_system/main/?sector=FAD&auth=SANCAS).

20
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responsible for any use Which may be made of the information contained therein
Flavourings
Flavourings are products added to food in order to impart or modify odor and/or taste. EU legislation denes several
typesofavourings:
• Flavouring substances.
• Flavouring preparations.
• ermalprocessavourings.
• Smokeavourings.
• Flavour precursors.
• Otheravourings.
eEURulesonavouringsandcertainfoodingredientswithavouringpropertiesareintendedtoensureahigh
levelofprotectionofhumanhealthandahighlevelofconsumerprotection.Regulationno.1334/2008onavourings
andcertainfoodingredientswithavouringpropertiesforusein/onfoodslaysdowngeneralrequirementsforsafe
use of avourings and provides denitions for dierent types of avourings.e Regulationsets out substances
forwhichanevaluationandapprovalisrequired.eUnionlistofavouringsubstances,approvedforuse inand
on foods, was adopted on 1 October 2012 and was introduced in Annex I of this Regulation. e Union list of
avouringshasbeenamendedseveraltimeinthefollowingRegulations:no.545/2013,no.985/2013,no.246/2014,
no. 1098/2014, no. 648/2015, no. 1102/2015, no. 1760/2015, no. 54/2016, no. 55/2016, no. 178/2016, no. 637/2016,
no. 692/2016, no. 1244/2016, no. 378/2017. e Regulation prohibits the addition of certain natural undesirable
substances as such to food and lays down maximum levels for certain substances, which are naturally present in
avouringsandinfoodingredientswithavouringsproperties,butwhichmayraiseconcernforhumanhealth.
Anup-datedEUdatabaseconcerningauthorizedfoodadditivesthatcanbeusedasavouringscanbefoundinthe
European Commission website (https://webgate.ec.europa.eu/foods_system/main/?sector=FAD&auth=SANCAS).
ere is also a separate Union list of smoke avouringprimary products. Regulation no. 1321/2013 established
theEUlistofsmokeavouringprimaryproductsforuseassuchinfoodsandfortheproductionofderivedsmoke
avourings.

21
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responsible for any use Which may be made of the information contained therein
Chapter 2
GOOD PRACTICE CODE/ CODEX ALIMENTARIUS
Paulo Baptista
P&B – Consultores Associados, paulonlbaptista@net.sapo.pt
THE CODEX ALIMENTARIUS
e Codex Alimentarius Commission (CAC) was created in 1962 at a conference on legal standards for food organized
by the Food and Agriculture Organization of the United Nations and the World Health Organization. e members
of the Codex Alimentarius Commission are the Member States of Food And Agriculture Organization (FAO) and
WHO that have notied their interest in participating in the group. e organization of the Codex Alimentarius
Commission is structured in committees of three types:
• Horizontal, to address problems of a general nature.
• Vertical, organized in a product logic.
• Regional, structured around geographical areas: Africa, Asia, Europe and Latin America.
e Codex Alimentarius consists of a set of documents ofvarious kinds, grouped into two main groups: food
standards and advisory provisions. Food standards aim to protect consumer health and ensure uniform application
of practices in international trade through their international acceptance. e provisions of a consultative nature
come in the form of codes of practice, guidelines and other recommendations and are therefore not binding on the
part of the Member States. ese are intended to guide and promote the development and establishment of food
requirements.
Chapter Objectives
• IntroducetheCodexAlimentarius,highlightinginparticularthesetofcodesofgoodpractice
and general principles of food hygiene available
• Discusstherelevanceoftheimplementationofgoodpracticesasaprerequisiteforthe
implementation of a food safety system and the relevance of the Codex Alimentarius to
support the conduct of hazard analysis when implementing such systems
• Presentgoodpracticesthatshouldbeincludedinmostcodesofgoodpracticeandwhich
shouldbeadequatelyensuredpriortotheimplementationofafoodsafetymanagementsystem

22
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responsible for any use Which may be made of the information contained therein
e provisions of the Codex Alimentarius include standards for the main processed, semi-processed or raw foods,
raw materials and also include aspects related to the distribution of food products. Codex Alimentarius also addresses
issues related to food hygiene, food additives, pesticide residues, contaminants, labeling and presentation, methods
of analysis and sampling. e elaboration of these standards involves Committees of Experts and consultants of
FAO and WHO, which provide the scientic considerations that support the recommendations of practices for the
internationaltradeoffoodproductsandofgoodpracticesinthegeneralityofthequestionsrelatedtofood,forTo
ensure their safety when made available to the consumer.
Acceptance of Codex Alimentarius standards by a country shall be in accordance with its established legal and
administrative procedures regarding the distribution of the product concerned within the territory under its
jurisdiction, regardless of whether it is locally produced or imported. Acceptance of the standards can be total,
scheduledorwithspecicrestrictions.Fullacceptancemeansthatacountryensuresthattheproductinquestionis
distributed freely, in accordance with Codex Alimentarius standards, within the territory under its jurisdiction. In
this way, it also ensures that products that do not conform to the standards are not distributed. Scheduled acceptance
means that the country indicates its intention to accept the standard aer a certain period of time. It also means
that it will not impede the distribution of products within its area of jurisdiction, provided that they meet the
requirementsspecied bythe Codex Alimentarius.Acceptance with specic restrictionsmeansthatthe country
accepts the standard, except in certain respects, which must be detailed in its acceptance statement, explaining the
reasons for these restrictions. A country which accepts a Codex Alimentarius standard in one of the ways provided
shall be responsible for the uniform and impartial application of the provisions of that standard.
THE GENERAL PRINCIPLES OF FOOD HYGIENE OF THE
CODEX ALIMENTARIUS
Codex Standards
Since 1966, the Codex Alimentarius Commission has produced a set of nearly 250 standards covering all major
processed, semi-processed or raw foods. is list has been extended permanently, with the concern of including new
productsthatarebeingintroducedinthemarketandaregainingexpression.
Recommended Codes of Good Practices
e CAC / RCP-1 - International Code of Recommended Practice for General Principles of Food Hygiene (CAC,
1999a) has been published by the Codex Alimentarius Commission since 1969, which is still today the international
reference in principles of food hygiene. e eort of the Codex Alimentarius Commission to update its documents
incorporatingtherelevantelementsarisingfromthedevelopmentoftechnicalandscienticknowledgewillnotbe
surprising. CAC / RCP-1 (CAC, 1999a), prepared in 1969, underwent three revisions and one amendment in 1999,
at which time the description of the HACCP methodology - Hazards Analysis and Critical Control Points (Hazard
Analysis and Identication of Critical Control Points).
Based on this latest version of CAC / RCP-1 it is possible to enumerate as objectives of the General Principles of Food
Hygiene of the Codex Alimentarius the following:
• Identication of basic food hygiene principles applicable throughout the food chain (from primary production
to the nal consumer) in order to achieve the objective of ensuring the supply of safe food to the nal consumer.
• e recommendation of an approach based on the HACCP system as a means of increasing food safety.

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responsible for any use Which may be made of the information contained therein
• Denition of the methodology for implementing these principles.
• e provision of guidelines for specic codes, which may be necessary in certain sectors of the food chain,
processes or products, in order to increase food safety in associated activities.
e General Principles of Food Hygiene apply to the entire food chain, from primary production to the nal
consumer, establishing hygienic conditions necessary to produce food that is safe for consumption.
e General Principles of Food Hygiene of the Codex Alimentarius considered in CAC / RCP-1 recommend hygiene
practices at various levels and are structured in ten sections:
• Section I: Objectives.
• Section II: Scope, use and denitions.
• Section III: Primary production.
• Section IV: Establishment: project and facilities.
• Section V: Control of operations.
• Section VI: Establishment: maintenance and sanitation.
• Section VII: Establishment: personal hygiene.
• Section VIII: Transport.
• Section IX: Product Information and Consumer Communication.
• Section X: Training.
General Guidelines
Another set of relevant Codex Alimentarius documents are the General Guidelines. ese guidelines are laid down
for the implementation of a diverse set of procedures. As regards the implementation of food safety systems, CAC
/ GL-21 - Principles for the Establishment and Application of Microbiological Criteria for Foods (CAC, 1997) and
CAC/GL-30-PrinciplesandGuidelinesfortheApplicationandMicrobiologicalRiskAssessment(CAC,1999b)are
probably the most important documents in that they establish some relevant guidelines for biological hazard analysis
methodology (Baptista, P. and Venâncio, A., 2003).
e Codex Alimentarius also has Lists of Maximum Residue Limits (e.g. pesticides, veterinary drug residues) which
are a very important source of information in the preparation of a HACCP Plan, namely in establishing critical limits
associated with critical control points (see Chapter 3) for chemical hazards.
e list of Codex Alimentarius standards, codes of good practice, general guidelines and maximum residue limits,
are available at the Codex Alimentarius website (http://www.fao.org/fao-who-codexalimentarius/standards/list-of-
standards/en/).

25
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responsible for any use Which may be made of the information contained therein
Chapter 3
HACCP SYSTEM
Paulo Baptista
P&B – Consultores Associados, paulonlbaptista@net.sapo.pt
INTRODUCTION
All actors in a food chain have a responsibility to ensure the safety of food products in the
intervening stages, irrespective of the nature of the activities they carry out. Contrary to
the commonly accepted idea that food safety is something that should only be ensured
by the food industry, the existence of food safety systems is a requirement for all units,
whether industrial or not, where the preparation, processing, manufacture, Packaging,
storage, transport, distribution, handling and sale or making available to the consumer of
foodstuffs.
The HACCP System is designed to control the production process and is based on
principles and preventive concepts. It is intended to apply measures that guarantee an
efcient control, through the identication of points or stages where the hazards can
be controlled, which can be of biological, chemical or physical nature (Baptista, P. and
Venâncio, A., 2003).
This system is scientically based and is based on a systematic approach that not
only ensures food safety but also reduces operational costs by reducing the need for
microbiological analysis and destruction or reprocessing for safety, of the nal product.
Chapter Objectives
• PresenttheconceptandprinciplesoftheHACCPSystem
• PresentthemethodologyofimplementationofaHACCPSystem,describingindetailthesteps
inherent in this process
• Illustrate the implementation methodology of a HACCP System, pointing out, whenever
possible,themainelementstobetakenintoaccountineachstepoftheimplementation
• ProvideinformationtosupporttheunderstandingoftheHACCPmethodologyandtofacilitate
its implementation in a company, in particular in the steps related to hazard analysis, the
determination of critical control points, the establishment of critical limits and the establishment
of the monitoring system

26
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responsible for any use Which may be made of the information contained therein
The implementation of the HACCP System reduces the need for inspection and analysis of the nal
product, thus increasing consumer condence and safety. The implementation of a HACCP System
facilitates compliance with legal requirements and allows the most efcient use of resources in the
immediate response to food safety issues.
The HACCP System can be applied in all stages of food processing and development, from primary
production to the nal consumer. However, a HACCP Plan is specic to each product / process, and the
respective study and planning must be carried out on a case-by-case basis. A HACCP System must be
able to adapt to changes such as innovations in equipment design, process procedures and technological
developments. In the following sections the concept, principles and history of the HACCP System are
presented in more detail and the respective implementation methodology is discussed.
THE CONCEPT OF THE HACCP SYSTEM
e HACCP system is based on the identication of food safety hazards to the consumer that may occur along the
food processing chain, on the assessment of those hazards and on Control in order to ensure food safety.
e Hazard Analysis and Critical Control Points (HACCP) system is a systematic approach to biological, chemical
and physical hazards, rather than inspection and testing of nal products, and is therefore a preventive system through
which,byidentifyingofpotentialrisks,preventivemeasuresaretakentoreducethelikelihoodofoccurrencesthat
couldjeopardizethesafetyofproductsandconsequentlyofconsumers.
HACCPisbasedonanengineeringsystemknownasFailureModeandEectAnalysis(FMEA),whichidentiesat
eachstepoftheprocesstheerrorsthatcanoccur,theirprobablecausesandtheireects,toestablishthemostadequate
control mechanisms. us, the HACCP System is a management tool that establishes an eective methodology for
controlling hazards. It is a rational, logical, integrated, continuous and systematic system. It is rational because it
is based on recorded data on the causes of diseases transmitted by foodborne diseases. It is logical and integrated
sinceitconsiderstherawmaterials,processandsubsequentuseoftheproductinthesubsequentriskanalysis.Asa
continuous system, it allows the detection of potential problems before they occur, or when they arise, facilitating the
immediate application of corrective actions. Finally, it is systematic, leading to a comprehensive plan, resulting from
an analysis methodology covering all operations, processes and control measures.
HACCPiscompatiblewith otherqualitycontrolsystems.ismeans thatsafety,qualityandproductivity canbe
addressed together, resulting in benets for consumers, which is expressed in the growing benet to the health of
consumers and the development of organizations and the economy in general.
THE HISTORY OF THE HACCP SYSTEM
e rst event that led to the establishment of the HACCP System is associated with W.E. Deming. In the 1950s,
Deming developed the Total Quality Management (TQM) system, which is a production-oriented system, while
aimingtoimprovequalityandreducecosts.
However, it was a second event that proved decisive in the development of the HACCP System. In the 1960s, the
National Aeronautics and Space Administration (NASA), following an assessment of the origins of diseases that could
aect astronauts during a space mission, identied those resulting from food poisoning as the most important. e
result led to the collaboration of the Pillsbury Company with the US Army and NASA to develop a program for the
production of safe food for the American space program. us, the Pillsbury Company developed and adopted the

27
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responsible for any use Which may be made of the information contained therein
HACCP System to ensure more safety while simultaneously reducing the number of inspections to the nal product.
e HACCP System was rst introduced by the Pillsbury Company in 1971 at a food safety conference and published
therstdocumentdetailingtheHACCPtechniquein1973.
In the United States, this system served as a basis for the FDA to develop legal standards for the production of low
acid foods, and used as a reference for training of FDA inspectors.
e National Academy of Sciences in 1985, responding to food control and inspection agencies, recommended the
use of the HACCP System in food safety programs, having in 1988 the International Commission for Microbiological
Specications in Foods (ICMSF - International Commission on Microbiological Specication for Foods) suggested
theuseoftheHACCPSystemasthebasisforqualitycontrolfromahygienicandmicrobiologicalpointofview.
e Codex Alimentarius Commission has incorporated the "Guidelines for the Implementation of the HACCP
System" (ALINORM 93 / 13a, Appendix II) at its twentieth meeting in Geneva, Switzerland, from 28 June to 7 July
1993. e Recommended International Practices - General Principles of Food Hygiene [CAC / RCP 1-1969, Rev. 3,
Amd.1 (1999a)] was last amended in 1999.
e European Union has harmonized the general rules for foodstus, incorporating the principles of the HACCP
system, by adopting the Directive no. 93/43/EEC of 14 June 1993.
THE PRINCIPLES OF HACCP
e HACCP System is based on a set of 7 fundamental principles:
• Principle 1: Hazard analysis.
• Principle 2: Determination of critical control points (CCPs).
• Principle 3: Establishment of critical limits.
• Principle 4: Establishment of a monitoring system.
• Principle 5: Establishment of corrective actions.
• Principle 6: Establishment of verication procedures.
• Principle 7: Establishment of documentation and registration.
For proper implementation of the HACCP System, it is very important to properly understand and interpret the
exact meaning of these principles.
Principle 1 - Hazard analysis
Conductinga hazardanalysisrequires theidenticationof the potentialhazardsassociated withallphasesofthe
process, from raw materials to the nal consumer. Inherent in this analysis of hazards is the assessment of the
probability of occurrence and the severity of the hazard identied, as well as the analysis of possible preventive
measures established for its control, in order to determine their signicance.
Principle 2 - Determination of critical control points
It is based on the determination of critical control points (CCPs) that can be controlled to eliminate the hazard or
minimizethelikelihoodofitsoccurrence.Acriticalcontrolpointshallbeapoint,procedure,operationorstageat

28
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responsible for any use Which may be made of the information contained therein
which control shall be applied and shall be essential to prevent, reduce to acceptable levels or eliminate a hazard
related to food safety.
Principle 3 - Establishment of critical limits
It consists in establishing the critical limits that must be ensured in order to ensure that each CCP is controlled.
Critical limit means the value or criterion that dierentiates acceptance from non-acceptance of the process.
Principle 4 - Establishment of the monitoring system
It consists in the establishment of a monitoring system to ensure systematic monitoring of CCPs. As a monitoring
system is meant the observation or measurement of control parameters to assess whether a critical control point is
within acceptable values.
Principle 5 - Establishment of corrective actions
ItpresupposestheestablishmentofcorrectiveactionstobetakenwhenmonitoringindicatesthataparticularCCP
is not under control. Loss of control means a deviation from the critical control limit of a CCP.
Principle 6 - Establishment of verication procedures
It is based on the establishment of verication procedures to conrm the eectiveness of the HACCP System.
Verication means the application of methods, procedures, tests and other assessments to conrm compliance with
the HACCP Plan and the eectiveness of the HACCP System.
Principle 7 - Documents and registers
It is based on the establishment of documentation on all procedures and records appropriate to these principles and
their application. e records constitute the evidence of the performance of activities associated with the operation
of the HACCP System.
THE HACCP METHODOLOGY
epracticalimplementationofaHACCPSystemnormallyfollowsamethodologyconsistingof12sequentialsteps,
which is based on the 7 stated principles. In fact, the 7 steps of the implementation methodology of the HACCP
System are directly related to the 7 HACCP Principles. To these are added 5 preliminary steps that correspond to the
structuring of the team that will develop the study and planning of HACCP and the compilation of information of
support relevant for conducting the analysis of hazards:
• Step 1: Establishment of the HACCP Team.
• Step 2: Description of the product.
• Step 3: Identication of the intended use.
• Step 4:Constructionoftheowchart.
• Step 5:Conrmationoftheowchartintheeld.
• Step 6: Hazard identication and analysis, analysis and identication of preventive measures to control
identied hazards (Principle 1).
• Step 7: Determination of critical control points (Principle 2)

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• Step 8: Establishment of critical control limits for each CCP (Principle 3).
• Step 9: Establishment of the monitoring system for each CCP (Principle 4).
• Step 10: Establishment of corrective actions (Principle 5).
• Step 11: Establishment of verication procedures (Principle 6).
• Step 12: Establishment of control of documents and data (Principle 7).
Figure 3.1shows the sequence and interaction of the HACCP methodology steps, and the identication of the
associated HACCP Principles.

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(Ste p 1)
(Ste p 2)
(Ste p 3)
(Ste p 4)
(Ste p 5)
(Ste p 6)
(Ste p 7)
(Ste p 11)
(Ste p 12)
Establishment of verification procedures (principle 6)
Establishment of control of documents and data (principle 7)
Note: the
dashed boxes
are additional
steps to Codex
logic
(Ste p 10)
Establishment of corrective actions
(principle 5)
Identification of the intended use
Construction of the flowchart
Establishment of the HACCP Team
Existing control measures
Confirmation of the flowchart in the field
Establishment of critical control
limits for each CCP (principle 3)
(Ste p 8)
(Ste p 9)
Establishment of the monitoring
system for each CCP (principle 4)
Determination of critical control points (principle 2)
Complemen tary food
security measures
(GMP, GHP, GDP, GAP, GVP)
Hazard identification and analysis, analysis and identification
of preventive m easures to control identified hazards
(principle 1)
Descri ption of the produ ct
Figure 3.1: The sequence and interaction of the steps of the HACCP methodology.
HACCP Team
The HACCP team
e HACCP study and planning should be performed by a multidisciplinary team - the HACCP Team - which
shouldincludepeoplefromvariousareas(e.g.Quality,Production,Packaging)selectedonthebasisofcriteriasuchas:
• Your responsibilities.

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• Yourknowledgeandexperienceinthecompany.
• Yourknowledgeandexperienceregardingrelevantproducts,processesandhazardswithinthescopeofthe
HACCP study. e HACCP Team should, where necessary in certain phases of the study, be extended with
elementsfromotherareaswhoseknowledgeandexperienceisrelevantinthosephases.eHACCPTeam
may,ifnecessary,includeoutsideconsultantswhopossessknow-howandinformation,whichdonotexistin
the company, which are indispensable for the conduct of the HACCP study.
HACCP team coordinator
e HACCP Team should have a coordinator. e HACCP Team should not be organized conditioned by the
hierarchical structure of the company.
e HACCP Team Coordinator will be responsible for.
• EnsurethatthecompositionoftheHACCPTeamisadequatefortheneedsoftheHACCPstudytobecarried
out.
• Suggest modications in the HACCP Team whenever necessary.
• CoordinatetheworkoftheHACCPTeam.
• Ensure that the pre-established plan is followed.
• DistributeworkandresponsibilitiestoHACCPteammembers.
• Ensure the use of a systematic approach in conducting the HACCP study.
• Ensure that the scope of the HACCP study is fully considered.
• Coordinate the meetings of the HACCP Team, ensuring the conditions for unrestricted participation of all its
elements.
• Ensurethatdeviationsand/orconictsbetweenelementsoftheHACCPTeamortheirdepartmentsareavoided.
• Establish mechanisms for the decisions of the HACCP Team to be communicated to the organization.
• Represent the HACCP Team before the Directorate / Administration.
• Be thoroughly familiar withtheHACCPstudyandhaveathoroughknowledgeofthecompany'sactivities.
Initial Training
e HACCP Team should receive initial training regarding the HACCP Principles, the implementation and
application of the HACCP System.
Initial training shall ensure that:
• eHACCPTeamworkingroupswithsharedgoalsandusingthesamelanguage.
• attheobjectivesoftheHACCPstudyareadequatelyunderstoodbyall.

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Resources
e number of meetings will depend on the scope of the study, on the complexity of the company's activities
of the means involved in carrying out the HACCP study. Meetings should be of limited duration, follow a pre-
establishedagenda,andbeheldatafrequencythatkeepstheHACCPTeaminvolved,butsucientlyspaced
toallowthenecessaryinformationtobeobtainedatalltimes(e.g.bi-weekly).InbetweenmeetingsHACCP
TeammembersshouldcarryouttheworkthattheCoordinatorwilldistributeinordertomaketheHACCP
Team meetings more eective. It is suggested that the elements for discussion assembled or prepared by the
various members of the HACCP Team be pre-distributed by the others so that they can analyze them in a timely
manner.Inthisway,at the HACCPTeammeeting,thediscussionand decision-making phase can be more
quicklyentered.
eBoardshoulddemonstrateitsinvolvementbyensuringtheallocationofresourcesrequiredfortheHACCP
study, namely:
• Time / people for the HACCP Team.
• e costs of initial training.
• e necessary documentation.
• Access to analytical laboratories.
• Access to sources of information (e.g. Universities, research centers, Ocial authorities, Consultants,
Technical and Scientic literature, Databases, etc).
Product Description
In the implementation of a HACCP System, the HACCP Team should begin by describing the food, which
descriptionshouldtakeintoaccountboththerawmaterialsusedandthenalproduct.
Raw material
At the level of the description of the raw materials the HACCP.
Team should characterize:
• Typeofrawmaterials,packagingmaterials,methodoftransportationandpackaging.
• Percentage in the nal product.
• Source.
• Physical-chemical characteristics (pH, Water activity - wa, Viscosity, Temperature, Concentration in
aqueoussolution,...).
• Microbiological characteristics.
• Conservation conditions.
• Preparation / processing conditions before use.

33
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Final product
Forthenalproduct,thedescriptionshouldtakeintoaccountthefollowingelements:
• General characteristics (Composition, Volume, Structure, ...).
• Physical-chemical characteristics (pH, Water activity, Type and concentration of additives, Modied atmosphere,
Storage temperature, ...).
• Microbiological characteristics.
• Information at labeling level (Product life, Conservation instructions / Preparation mode, ...).
• Storage and distribution conditions.
Intended Use for the Product
Aerdescribingtheproduct,theHACCPTeamshouldreecttheconditionsofuseoftheproductbytheconsumer.
eHACCPTeamshouldtakeintoaccounttheidenticationofthe normalcustomer/consumergroupsandthe
assessment of the existence of potentially sensitive consumer groups among them, in terms of ingredients (e.g. gluten,
lactose),andinterms oflevelofmicrobiologicalcontamination(e.g.infants,elderly,sick).ecommunicationto
the consumer of the presence of ingredients to which certain groups are intolerant and the conditions of preparation
/ processing of the product by the consumer are essential in order to avoid their misuse. is communication is
madethroughthelabeling,meetingthelegalrequirementsattheleveloffoodlabelingestablishedinRegulationno.
1169/2011.
is evaluation of the intended use by the consumer, which is important in assessing the danger associated with
improper use of the same, may even determine the recasting of the product and / or process to adapt it to the actual
conditions of use of the consumer without such conditions ere are more signicant hazards.
Construction of the Flowchart
Asimportantasanadequatedescriptionof the productandits intendeduseisthe knowledgeofallstagesof the
process, from the raw materials to the nal product, given that it is this set of information that will support the
realization of the HACCP study. e description of processes and their interactions can be described in a systematic
waywiththeuseofowcharts.econstructionofowchartsshouldtakeintoaccount:
• esequenceofallstepsofthemanufacturingprocess.
• e phases in which inputs of raw materials and intermediate products (Including subcontracted products) occur.
• ephaseswherere-workorrecyclingofrawmaterials/productsoccurs.
• e phases where intermediate products, by-products or waste are removed.
• e time / temperature conditions throughout the process.
Inadditiontotheowcharts,theplantlayoutshouldbetakenintoaccountwiththelayoutoftheequipment(Baptista,
P.andNoronha,J.,2003).isinformationisrelevantbecauseitisthebestwayoffacilitatingthesubsequentcross-
contaminationhazardanalysis.us,onplantfacilitiesandequipmentlayoutshouldbemarked:
• Personnel circuits.

34
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responsible for any use Which may be made of the information contained therein
• e circuits of raw materials, intermediate products and nal products.
• Potential pathways of cross-contamination.
• Areas of segregation.
Verication of the Flowchart
Sincesometimesthe construction of theowchartis totally or partially carried out intheroom,itis essential to
ensurethat the owchartelaboratedcorrespondstothepresentsituation.isstepisveryimportantbecause, in
manycases,organizationsalreadyhaveprocessowcharts,plantplansandequipmentlayouts,developedatagiven
moment,butdonothaveroutinesforupdatingthesedocuments.Inthissituation,orintheabsenceoffullowcharts,
it is recommended that the HACCP Team begin by collecting or initial conrmation of the information at the facility.
Attheend,aertheconstructionoftheowchart,theHACCPTeammustconrmitbyfollowingtheprocess.is
should be done several times throughout production, covering all operations, to ensure that processes are always
conducted in the same way. e possibility of this not occurring increases when there is a greater turnover of process
operators and when companies operate in turns, particularly when operators have a direct intervention in the control
ofoperatingconditions.ConrmationoftheowchartmustalsoinvolveallelementsoftheHACCPTeam,sincethe
multi-disciplinarityoftheircompetenciesisrelevanttoanadequateconrmationofalltheinformationsupported
intheowcharts.isapproachisalsoextendabletotheconrmationofthefacilityplanandequipmentlayout.
Hazard Analysis
HazardanalysisisthekeyelementinthedevelopmentoftheHACCPPlan.ehazardanalysisconsistsofaprocess
of collecting and evaluating the information on the hazards and the circumstances that result in their presence, in
order to decide what are the signicant ones for the safety of the food and which should therefore be addressed in the
HACCP Plan (Baptista, P. and Venâncio, A., 2003).
Conducting hazard analysis requiresidentif ying the potential hazards associated with all stages of the process,
fromrawmaterialstonalconsumers.Inherentinthis analysisofhazardsis theriskassessmentaccordingtothe
probability of occurrence and the severity of the hazard identied, in order to determine their signicance. Only
thedangersconsidered signicant are taken to the "decision tree" to identify critical control points.e analysis
of hazards also presupposes the analysis of possible preventive measures established for the control of signicant
hazards.
Hazard analysis must be performed for each product or process type and for each new product. In addition, the
hazard analysis of a product associated with any type of process should be reviewed whenever there is any change in
the raw material, product formulation, processing or expected use of the product by the consumer. Hazard analysis
musttakeintoaccountbiological,chemicalandphysicalhazards(Baptista,P.andVenâncio,A.,2003).
In order to perform a duly sustained hazard analysis, it may be necessary to carry out some process parameter
measurements in order to conrm the actual operating conditions. Some examples of measurements that may be
relevant depending on the product or type of process include"
• Time-temperature combinations of the product, in processes involving the transfer of heat - heating or cooling
of products.
• pH and wa (water activity) of the product during processing and at the end, preferably at room temperature or
takingintoaccountthecorrectionstobemadeatroomtemperature.

35
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This Publication reects the views only of the author, and the commission cannot be held
responsible for any use Which may be made of the information contained therein
• Pressure in under-pressure processes such as sterilization processes (e.g. Cans of preserves).
• Microbiological analyzes of samples, in process evaluation studies and determination of the life time for new
products.
e data of the processes obtained with these measurements and other available information related to the process
data shall be analyzed in order to determine the implications of the operational conditions on the food safety of the
products produced. Some examples include:
• Comparison of the time-temperature registers of the processes with the data of optimal temperatures of growth
of microorganisms and the temperature ranges in which they can be multiplied (Table 3.1).
• Comparison of wa and pH values of the product with the intervals in which growth or destruction of pathogenic
microorganisms may occur (Table 3.1).
• e evaluation of product stability (AFNOR, 1998).
Biological
Hazards
Parameters
Tmín
(ºC)
TMax
(ºC) pHmín pHMax wa Mín
NaCIMax
(%)
Bacillus cereus 4 55 4.3 9.3 0.92 10
Campylobacter jejuni 30 45 4.9 9.5 0.987 2
Clostridium botulinum 3.3 45 5 90.97 5
Clostridium botulinum 10 48 4.6 9.0 0.94 10
Clostridium perfringens 10 52 5.0 9.0 0.93 7
Escherichia coli 6.5 49.4 4.0 9.0 0.95 6.5
Enterotoxin staphylococcus 10 50 4.76 9.02 0.86 12
Listeria monocytogenes -0.4 45 4.4 9.4 0.92 10
Salmonella spp. 5.2 46.2 3.7 9.5 0.94 8
Shigella spp. 6.1 47.1 4.8 9.34 0.96 5.2
Staphylococcus aureus 750 4 10 0.83 20
Staphylococcus aureus – toxin 10 48 4 9.8 0.85 10
Vibrio parahaemolyticus 5 45.3 4.8 11 0.94 10
Vibrio cholerae 10 43 5 10 0.97 6
Vibrio vulnicus 843 5 10 0.96 5
Yersinia enterocolitica -1.3 42 4.2 10 0.945 7
Table 3.1: Main conditions for the occurrence of some of the main biological hazards.
Source: (FDA, 2001)
Hazardanalysisshall be performedinasystematicandsequentialmannerinordertominimizethe likelihood of
not identifying all signicant hazards. Particular attention in this analysis should be given to the raw materials and
the process, which are, directly or indirectly, the origin of most occurrences of dangerous situations that were not
properlycontrolledandreectedtotheconsumer.
At the level of the analysis of hazards related to raw materials it is important to consider, when selecting and / or
receiving various issues, such as:

36
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responsible for any use Which may be made of the information contained therein
• Are there pathogenic micro-organisms, toxins, chemicals or physical objects that may be present?
• Do the raw materials used incorporate preservatives or other additives in their formulation?
• Is any ingredient (e.g. Additive) dangerous if used in excess or, if used in less than recommended amount, can
result in a danger of allowing the growth of microorganisms or germination of sporulated cells?
• How can the acidity and water activity of raw materials aect the growth of micro-organisms in the nal product?
• At what temperature conditions should the raw materials be maintained during storage and transport?
Whenanalyzingprocessing-relatedhazards,includingaspectsrelatedtotheowofrawmaterialsandproductand
the movement of operators, it is also possible to list some of the issues that may facilitate the identication of hazards:
• Contaminantscancomeincontactwiththeproductduringthisprocessoperation,throughoperators,equipment
or utensils (Baptista P, and Noronha, J., 2003)?
• Can any pathogenic microorganism multiply or survive during this stage of the process to the point of danger?
• e operations are performed by operators, respecting good manufacturing practices and good hygiene practices
(Baptista P, and Saraiva, J., 2003)?
• Are there later steps that eliminate or can reduce the identied hazards to acceptable levels (Baptista P, and
Venâncio, A., 2003)?
Risk Assessment
Riskassessmentisgenerallyqualitative,obtainedbycombiningexperimentaldata,epidemiological,localorregional
data, and specic bibliographic information. Epidemiological data are an important tool for assessing risks by
demonstrating products that are potentially hazardous to consumer health.
Tocarryoutariskassessment,thefollowingelementsmustbetakenintoaccount:
• Review of customer complaints.
• Return of lots.
• Results of laboratory tests.
• Data from monitoring programs for foodborne disease agents.
• Information on the occurrence of animal diseases or other situations that may have implications for human
health.
Severity
Not all microorganisms are classied in the same way when assessing their potential to cause disease. is potential,
or the type of danger that a microorganism represents, varies from zero to very serious. In hazard analysis a hazard
classication by level can be established. One possibility is to classify the severity into three levels: High (3), Medium
(2) and low (1), which can be characterized as follows:
High:Seriouseectsonhealth,requiringhospitalizationandevendeath.

37
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responsible for any use Which may be made of the information contained therein
Average: e pathogenicity is lower as well as the degree of contamination. e eects can be reversed by medical
care, however they may include hospitalization.
Low: e most common cause of outbreaks, with rare or limited subsequent spread. Relevant when the food
ingested contains a great amount of pathogens, being able to cause indisposition and malaise, being necessary
medical attention.
Table 3.2showssomeexamplesofcontaminationsthatarelikelytofallintothisclassication.
Classication Examples
HIGH
Biological: Clostridium botulinum toxin, Salmonella Typhi, S. Paratyphi A e B, Shigella dysenteriae,
Vibrio cholerae O1, Vibrio vulnicus, Brucella melitensis, Clostridium perfringens type C, hepatitis
A and E viroses, Listeria monocytogenes (in some groups), Escherichia coli O157:H7, Trichinella
spiralis, Taenia solium (in some cases).
Chemical: Direct contamination of foods by chemical products or indirect contamination such us
as heavy metals, like mercury, that enter in the food chain or by used non-authorized additives or
excessive concentrations of additives that can cause a serious food poisoning to a large number of
persons or to a specic group of persons.
Physical: foreign bodies and unwanted fragments that may cause injury or damage to the consumer,
such as stones, glasses, needles, metals, sharp and perforating objects, constituting a risk to
consumer life.
MEDIUM
Biological: outras Escherichia coli enteropatogénicas, Salmonella spp., Shigella spp., Streptococcus
ß-hemolítico, Vibrio parahaemolyticus, Listeria monocytogenes, Streptococcus pyogenes, rotavírus,
vírus (tipo) Norwalk, Entamoeba histolytica, Diphyllobothrium latum, Cryptosporidium parvum.
LOW
Biological: Bacillus cereus, Clostridium perfringens tipo A, Campylobacter jejuni, Yersinia
enterocolitica, toxina do Staphylococcus aureus, the majority of parasites.
Chemical: chemical substances allowed in foods that may cause mild reactions such as drowsiness
or transient allergies.
Table 3.2: Hazard classication examples for severity.
Probability
Riskisalsoafunctionofthelikelihoodofahazardoccurringinaprocessandaectingthesafetyofthefood.e
probabilityassessmentpresupposesastatisticalanalysis.Althoughtherearedataonthequantitativeriskassessment
of some chemical and biological hazards, their numerical determination is not always available. Similar to what is
done for severity assessment, levels should be established for the probability, and the respective limits should have an
associatedquantication(e.g.numberofoccurrencesperyear,basedontheoccurrences/historyoftheorganization
orbased on Epidemiologicaldata),even when expressedqualitatively. A possibleclassication,also with3levels:
high (3), medium (2), low (1), may be considered. Sometimes a fourth level is used: null.
Identication of Signicant Hazards
Based on this classication for the severity and probability of occurrences, the severity versus probability map,
presented in Figure 3.2, was constructed to dene the combinations for which the risks are signicant. ese
correspond to shaded combinations.

38
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Figure 3.2: Map of severity versus probability of occurrences - Identication of signicant hazards (example).
Inthiscaseitisconsideredthat,irrespectiveoffrequency,adangerwithahighseverityshouldbeconsideredasa
signicant hazard. e denition of severity - probability combinations that correspond to signicant hazards should
bemadebyeachcompanytakingintoaccountthenumberoflevelsitconsideredandthelimitsitsetforeachlevel.
Annex (Annex II) presents a form for recording a hazard analysis.
Determination of Critical Control Points
In order to determine the points in the process where controls should be applied in order to prevent, eliminate or
reduce hazards to acceptable levels - Critical Control Points - the so-called "decision tree" is used. e "decision tree"
(Figure 3.3)is aprotocolconsistingof asequenceof structuredquestions,appliedat eachstepofthe process,to
determineifagivencontrolpointatthisstageoftheprocessconstitutesaCriticalControlPoint.efourquestions
used in the decision tree and their interpretation are presented here.
Not a CCP STOP
Not a CCP STOP
STOP
NO
YES
YES
Not a CCP
CRITICAL CONTROL
POINT
Mofify step, p rocess or
product
Q2. Is this step specifically designed to eliminate or
reduce the likely occurrenc e of a hazard to na
accptable level?
Q3. Could contamination with identified hazard occur
in excess of acceptable l evels or could these increase
to unacceptable level s
Q4. Will a subsequen t step eliminate hazard or reduce
the likely occurrence to an acc eptable level?
NO
NO
YES
YES
Q1. Do preventive measures exist for th e identified
hazard?
NO
YES
Is control al this step necessary for
safety?
NO
Figure 3.3: Decision Tree.
Q1. Are there preventive measures for the hazard identied?

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QuestionQ1shouldbeinterpretedasaskingwhethertheoperatorcoulduseapreventativemeasureforthisoperation
to control the identied hazard (e.g. temperature control, visual inspection, metal detector). If the answer to Q1 is
"yes" then the control measures that the operator could use and follow for Q2 of the decision tree should be described.
If the answer is "no", i.e. no preventive measure, the manner in which the hazard identied will be controlled before
or aer the manufacturing process shall be indicated. If it is necessary to ensure food safety, the operation, process
or product must be modied in such a way as to provide for a preventive measure. is means that, for all signicant
hazards implemented, preventive measures must be in place.
Q2. Has this step been specically designed to eliminate the possible occurrence of the hazard or to reduce it to an
acceptable level?
If the process or operation is designed for the specic purpose of eliminating the possible occurrence of the hazard
or reducing it to an acceptable level the response shall be "yes" and shall be passed to Q4.
Ifthestageisnotspecicallydesigned,answer"no"andproceedtothenextquestion(Q3).
Q3. Can contamination of identied hazard occur above acceptable levels, or may it increase to unacceptable levels?
QuestionQ3 isintendedtoverifythatthehazardhasanimpact onthesafety oftheproduct,takingintoaccount
thelikelihood andseverityassociatedwithit.Regardlessofwhether theansweris "yes"or"no",itshould justifya
response, for future reference. is is especially useful in dealing with certain dangers which may be controversial and
whereitisnecessarytoreviewtheriskanalysis,inparticularasaresultofchangesintheprocessorthecharacteristics
of the raw materials and the intended end product.
If the company's history or if the scientic literature suggests that the contamination with the identied hazard may
increase to an unacceptable level and result in a health hazard, the answer should be "yes" and then move on to the
next"tree"questionOfdecision":questionQ4.
If the contamination does not pose a signicant threat to health or there is no possibility of occurrence, the answer
should be "no", implying that this hazard is not a signicant hazard. In this situation one should move to the
application of the decision tree to the next signicant danger identied in the process.
Q4.Willasubsequentstepeliminatetheidentiedhazardorreducethepossibleoccurrencetoanacceptablelevel?
epurposeofthisquestionistoidentifyhazardswhichposeathreattohumanhealthorwhichmayincreasetoan
unacceptablelevelandtoassesswhetherthesehazardswillbecontrolledbyasubsequentoperationintheprocess.
Ifthereisnosubsequentstepintheprocesstocontrolthehazard,theresponseshouldbe"no"andinthiscasethe
step under review becomes a CCP and should be identied as such.
Ifthereisanysubsequentoperationintheprocessthatwilleliminatetheidentiedhazardorreduceittoanacceptable
level,theresponseshouldbe"yes",inwhichcasethestepdoesnotconstituteaCCP.However,thesubsequentsteps
that control the hazard must be identied before proceeding to the next identied hazard.
e determination of CCPs concludes the HACCP study phase. e following steps, encompassing principles 3 to 7
of the HACCP System, lead to the development of the HACCP Plan. e HACCP Plan includes the establishment
of: (i) critical limits, (ii) the monitoring system, (iii) corrective actions. e HACCP System is completed with the
establishment of verication procedures and maintenance of HACCP.

40
This Project has been funded with support form the European Commission.
This Publication reects the views only of the author, and the commission cannot be held
responsible for any use Which may be made of the information contained therein
Establishment of Critical Limits
Critical limits
For the critical control points identied in the previous step it is necessary to establish the respective critical limits,
understood as the value or the criterion that dierentiates the acceptability from the non-acceptability. Critical limits
must be established for each parameter associated with a CCP. e parameters associated with each CCP must
clearlydemonstratethatitiscontrolled(e.g.,temperature,time,owrate,relativehumidity,wateractivity,pH).e
criticallimitsmustcomplywith legallyestablishedrequirementsandbein conformitywithexistingscientic and
technicalknowledge. Wheneverpossible,critical limitsshouldbesupported byevidence.Criticallimits based on
subjective data (e.g. visual inspection) must be supported by clear specications of what is considered acceptable or
unacceptable.
e establishment of critical limits should be done within the scope of the HACCP Team. In establishing these limits,
the HACCP Team may use various sources of information, including:
• Data from scientic publications or research.
• Legalrequirements.
• Specialists(e.g.Consultants,Foodengineers,Microbiologists,Equipmentmanufacturers,Universityprofessors
and Rresearchers).
• Experimental studies (e.g. Internal, Sub-contracted or Performed by third parties).
If the information necessary to establish the critical limits is not available, a conservative value should be established,
whilerelyingontechnical-scienticknowledge,inparticularthatassociatedwithotherproducts.ebibliographic
referencesusedinthereasoningofthedecisionstakenconstitutethedocumentationsupportingtheHACCPSystem
and should therefore be registered (e.g. Table 3.3).
Potential hazards Product temperature Maximum accumulated time of
exposition
Bacillus cereus toxins
4- 6ºC
7-10ºC
11- 21ºC
Above 21ºC
5 days
17 hours*
6 hours*
3 hours
Campylobacter jejuni 30-34ºC
Above 34ºC
48 hours
12 hours
Clostridium botulinum Tipo A, and
proteolyptic B e F
10-21ºC
Above 21ºC
11 hours*
2 hours*
Clostridium botulinum Tipo E, e non-
proteolytic B e F
3.3-5ºC
6- 10ºC
11-21ºC
Above 21ºC
7 days
> 2 days
11 hours
6 hours
Clostridium perfringens
10- 12ºC
13- 14ºC
15- 21ºC
Above 21ºC
21 days
1 day
6 hours*
2 hours*

41
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responsible for any use Which may be made of the information contained therein
Escherichia coli
7-10ºC
11-21ºC
Above 21ºC
14 days
6 hours
3 hours
Listeria monocytogenes
-0.4-5C
6- 10º C
11-21ºC
Above 21ºC
7days
2 days
12 hours*
3 hours*
Salmonella spp.
5.2-10ºC
11-21ºC
Above 21ºC
14 days
6 hours
3 hours
Shigella spp.
6.1-10ºC
11-21ºC
Above 21ºC
14 days*
12 hours*
3 hours*
Staphylococcus aureus toxins
7-10ºC
11-21ºC
Above 21ºC
14 days
12 hours*
3 hours
Vibrio cholerae
10ºC
11-21ºC
Above 21ºC
21 days
6 hours*
2 hours*
Vibrio parahaemolyticus
5-10ºC
11-21ºC
Above 21ºC
21 days
6 hours*
2 hours*
Vibrio vulnicus
8-10ºC
11-21ºC
Above 21ºC
21 days
6 hours
2 hours
Yersenia enterocolitica
-1.3-10ºC
11-21ºC
Above 21ºC
1 day
6 hours
2.5 hours
Table 3.3: Time / Temperature Guide to Control Growth of Pathogens and Formation of Toxins in Sea Foods.
* Additional data needed
Source: FDA
Parte Superior do Formulário
Operational limits
Inpractice,inanyprocessing,itisdesirablethatstepscanbetakenwhenmonitoringprocessesindicateatendency
for loss of control, even before the critical threshold is reached. It is therefore appropriate to establish more restrictive
limits,knownasoperationallimits,which,onceachieved,willgiverisetotheinitiationofcorrectiveactionswithout
any violation of the critical limits.
is approach reduces the number of situations where critical limits are reached, with costs substantially lower than
those that would inevitably be associated if critical limits were reached (e.g. acidication process: critical limit = 4.6
and operational limit = 4.4).

42
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This Publication reects the views only of the author, and the commission cannot be held
responsible for any use Which may be made of the information contained therein
Establishment of Monitoring System
Monitoring system
emonitoringconsistsofcarryingoutaplannedsequenceofmeasurementsofthecontrolparameterstoevaluateif
their respective critical limits are respected. e monitoring should provide timely information to enable corrective
action to be taken to keep the process under controlbefore segregation and / or product rejection (e.g. time /
temperaturemeasurements,saltconcentration,pH,wateractivity)shouldbeundertaken.Inpractice,ashasalready
been pointed out, it is oen desirable for such monitoring to aect operational limits in order to provide a safety
margin, allowing some time to adjust the process before the critical limit is exceeded.
In addition to measuring the level of process performance at the critical control point and, by trend analysis, to
anticipate any loss of control, the monitoring also aims to record the level of system performance by to comply with
the HACCP Plan.
In addition to measuring the level of process performance at the critical control point and, by trend analysis, to
anticipate any loss of control, the monitoring also aims to record the level of system performance by to comply with
the HACCP Plan.
Monitoring methodology
e monitoring of a critical control point may be carried out continuously or batch by batch. Continuous monitoring
ispreferablesince itallows,morereliably,toidentify deviations from established values more quickly.However,
this type of monitoring is not always possible, oen because of the very nature of the measurement (e.g. it is not
possibletodoitinrealtimeasittakessometimetoperformthemeasurement/analysis)orassociatedcosts.Insuch
situations,samplingsizeandfrequencyshouldbedenedtakingaccountoftheprocessvariabilityitself,thedistance
between the critical limit and the operational limit, and the ability to intervene in order to correctly identify the
potentially aected product and to trigger Corrective actions when deviations occur.
Whenproblemsaredetected,themonitoringfrequencyshouldbeincreaseduntiltherootcauseoftheproblemhas
been identied and eective corrective actions have been implemented.
Measurements of a physical-chemical nature (e.g. time, temperature, pH, moisture content) or visual observations
are preferably used for the rapidity of their realization.
e monitoring plan for critical control points is what is commonly called the HACCP Plan. is should indicate
which:
• Critical control points.
• e control parameters associated with each critical point (e.g. Time, Temperature, pH, wa).
• Critical limits of control for each CCP.
• e method as parameters will be monitored (e.g. Temperature probe, Stopwatch, pH meters).
• efrequencyofmonitoring.
• Who is responsible for monitoring.
• Actionstobetakenincaseofdeviationfromtheestablishedcriticallimits.
• e location where the monitoring data is recorded.

43
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This Publication reects the views only of the author, and the commission cannot be held
responsible for any use Which may be made of the information contained therein
Annex (Annex II) presents a model for the preparation of the HACCP Plan.
Monitoring should be performed by trained personnel with dened knowledge and authority to specify and
implement corrective actions where necessary. Monitoring procedures and associated records shall provide operators
with sucient informationto enable them to take decisions on the acceptance or rejection ofa product and to
support the initiation of appropriate corrective actions or the immediate communication of deviations to those
having the authority to trigger such actions.
Persons with responsibility for monitoring critical points should:
• Knowtheprocesstheyaremonitoring.
• Knowthemonitoringprocessandcarryoutthemonitoringactivitieswiththeestablishedfrequency.
• Record monitoring results.
• Interpret the results of monitoring and trigger, where necessary, corrective actions in accordance with the
authority assigned to it in the HACCP Plan.
• Immediately report deviations within critical limits.
Establishment of Corrective Actions
Corrective action may be dened within a HACCP system as an action or procedure to be implemented when the
results of CCP monitoring indicate a loss of control, i.e.: a deviation from the critical limit of a CCP. ese procedures
should detail:
• eactionstobetakentoensurethattheCCPisbroughtbackintocontrollimits.
• e authority for the denition / implementation of corrective action.
• Whatactionstotaketodealwiththedefectiveproduct.
When a deviation occurs it is expected that it will be identied if the monitoring system is properly implemented.
e monitoring system should also allow action on the processes when monitoring results indicate a tendency to
lose control of a CCP. In this latter situation, the corrective actions to be implemented should allow the process to be
broughtbacktooperationallimitsbeforeadeviationbeyondcriticallimitsoccurs.
In case of deviations from the critical limits, that is, if they are violated, the company must:
• Have a system to identify deviations when they occur.
• Have eective procedures for isolating, clearly identifying and controlling all product produced during the
deviation period.
• Evaluatethe product using a qualied person to ensure that: (i) e sampling is appropriate to identify the
extent of the problem, as well as appropriate testing; (ii) e assessment is based on a logical and systematic
analysis, and (iii) e product is not released until the assessment determines that there is no potential hazard.
Depending on the nature and extent of the diversion, the product may have diverse destinations ranging from its
reprocessing or use in another type of process or product to disposal.

44
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This Publication reects the views only of the author, and the commission cannot be held
responsible for any use Which may be made of the information contained therein
With the implementation of corrective actions, it is intended:
• Determine the cause of the problem.
• Takeactiontoavoidrecurrence.
• Follow up through monitoring and reassessment to ensure the eectiveness of the implemented action.
Following the implementation of the corrective action, consideration should be given to the need to revise the
HACCP system in order to prevent any recurrence.
e corrective actions implemented should be recorded to demonstrate the control of products aected by the
diversionandtoprovideinformationregardingthecorrectiveactiontakenthatsupportsthemanagementactivity
of the HACCP System.
Establishment of Verication Procedures
e purpose of the verication is to determine:
• If the HACCP System is implemented according to the HACCP Plan (correct determination of the PCC, correct
denitionoftheparametersandrespectivecriticallimitsofcontrol,adequatemonitoring)andthatthenecessary
corrective measures have been implemented.
• IfthecurrentHACCP Planisproperly developedandimplementedtakinginto accountthecurrentproducts
and processes, that is, it proves to be eective.
Vericationproceduresshall clearlystatetheresponsibility,frequencyand methods used. Vericationshould be
carriedoutbyqualiedpersonnelwithknowledgeoftheHACCPPlan/System(e.g.elementsoftheHACCPTeam)
capable of detecting deciencies in the plan or its implementation. is activity must be carried out:
• Upon completion of the HACCP study, for validation.
• Whenever there is a change that may aect hazard analysis (e.g. Change of raw materials, Product or process).
• When a deviation occurs.
• Whenscienticknowledgeofnewpotentialhazardsorcontrolmeasures.
• Due to unsatisfactory results in the scope of auditing.
• Faced with customer or consumer complaints.
• At regular intervals, according to a predetermined program.
e verication of the HACCP System involves the analysis of HACCP documents and their records, the scientic
evaluation of all the hazards considered, to ensure that all those that could be considered signicant and the analysis
ofcriticalthresholddeviationsandactionscorrectionstakenforeachdeviation.Periodicvericationshouldhelpto
improvetheHACCPPlanbyexposingandstrengtheningweaknessesinthesystemandeliminatingunnecessaryor
ineectivecontrolmeasures.Keyvericationactivitiesinclude:
• Validation of the HACCP plan.

45
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responsible for any use Which may be made of the information contained therein
• Audits to the HACCP System.
• Collection and analysis of samples.
Validation of the HACCP plan
evalidationof the HACCPPlancorrespondsto the activity of assessing whether the HACCPPlan adequately
identies and controls all signicant hazards to food safety or reduces them to an acceptable level. e evaluation
shouldbesupportedinareviewoftheliteraturetoensureanadequatescienticandtechnicalbasisfordecisions.
Validation of the HACCP Plan should include:
• Review of hazard analysis.
• Determination of CCPs.
• Justicationforcriticallimits(e.g.legalrequirementsoravailablescienticdata).
• Evaluation of monitoring results / records of the HACCP Plan.
• Analysis of corrective actions implemented and their eectiveness.
• Review of HACCP audit reports.
• Review of changes to the HACCP Plan.
• Review of previous validation reports.
• Review of diversion reports.
• Evaluation of the eectiveness of corrective actions implemented.
• Review of information on customer and consumer complaints.
• Reviewof the links between the HACCP Plan and the good manufacturing and hygiene practice programs
(Baptista P, and Saraiva J. 2003).
Audits to the HACCP system
Audits, as part of the verication, are performed to compare the actual practices and procedures of the HACCP
System with those written in the HACCP Plan. Audits of the HACCP System are intended to carry out independent
and systematic assessments through on-site observations, interviews and document and record analysis to determine
whether the procedures and activities set out in the HACCP Plan are eectively implemented and are complied with.
e on-site observation can be used to verify several elements of a HACCP Plan, of which the following stand out:
• Properdescriptionofproductsandowcharts.
• Compliance with PCC monitoring in accordance with the HACCP Plan.
• e execution of the processes within the established critical limits.
• Records of HACCP activities (e.g. Monitoring records as established in the HACCP Plan, Corrective action
records triggered against deviations from established critical limits, calibration records of inspection and
measurementequipment).

46
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responsible for any use Which may be made of the information contained therein
Auditsshouldbeplannedandcarriedoutatanappropriatefrequencytoensurethemaintenanceoftheeectiveness
oftheHACCPsystem,takingintoaccountthespecicitiesoftheproductsintermsofriskandthevariabilityofthe
processes. At the very least, a full audit of the HACCP System should be carried out once a year. Following failure
situations of the HACCP System, the need to carry out extraordinary audits that were not initially planned should
also be considered.
Sample collection and analysis
e verication may also include a sampling plan and analysis. e sampling and analysis plan consists of the
collectionandanalysisofproductsamplesandrawmaterialstoensurethatcriticallimitsareadequateforproduct
safety. Sampling of raw materials may be carried out to verify the supplier, in particular where the reception of the
raw material constitutes a critical control point. is verication is even more critical when it is intended to change
supplier of raw materials.
Ingeneral,samplingandmicrobiologicalanalysisarenotadequatetoensurethesafetyofthefood.Microbiological
analyzers are rarely eective in monitoring CCP and cannot be used as a means of controlling the process due to
delayed analytical procedures and the inability to deliver results in real time. However, microbiological analyzers are
usefulincheckingtheHACCPSystemwhen criticallimitsareestablishedto eliminateor reducepathogenstoan
acceptable level to verify the eciency of the HACCP Plan and to ensure that the identied microbiological limits
are not exceeded. e performance of microbiological analyzers is very useful in process validation (AFNOR, 1998).
Samples of products may also be collected at points of sale and analyzed for any problems not considered in the
hazardanalysis,butwhichmayarisealongthefoodchainduetoinadequatestorageorhandlingoftheproductof
customers. Microbiological analysis shall be carried out in accordance with a pre-established program which shall
takeinto accountthenatureofthe processesandthe level ofriskassociatedwith therawmaterials andproducts
(Table 3.4, Table 3.5).
Food group Product Category
Meat
Steaks
dried sh
ham – raw (Parma/country style)
kebabs
meat meals (shepherds/cottage pie, casseroles)
meat pies (steak and kidney, pasty)
meat, sliced (cooked ham, tongue)
meat, sliced (beef, haslet, pork, poultry)
pork pies
poultry (unsliced)
salami and fermented meat products
sausages (smoked)
sausage roll
scotch egg
tripe and other offal
1
2
5
2
2
1
4
3
1
2
5
5
1
1
4

47
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Seafood
crustaceans (crab, lobster, prawns)
herring/roll mop and other raw pickled sh
other sh (cooked)
seafood meals
molluscs and other shellsh (cooked)
smoked sh
3
1
3
3
4
4
Dessert
cakes, pastries, slices, and desserts - with dairy cream
cakes, pastries, slices, and desserts - without dairy cream
cheesecake
mousse/dessert
tarts, ans, and pies
3
2
5
1
2
Savoury
cheese-based bakery products
fermented foods
an/quiche
mayonnaise/dressings
pâté (meat, seafood, or vegetable)
Spring rolls
2
5
2
2
3
3
Vegetable
Coleslaw
fruit and vegetables (dried)
fruit and vegetables (fresh)
prepared mixed salads and crudités
rice
vegetables and vegetable meals (cooked)
3
3
5
4
3
2
Dairy
Cheese 5
ice cream, milk shakes (non-dairy) 2
ice lollies, slush, and sorbet 2
yoghurt/frozen yoghurt (natural)
5
2
2
5
Ready-to-eat meals pasta/pizza
meals (other)
2
2
Sandwiches and lled
rolls
with salad
without salad
with cheese
5
4
5
Table 3.4: Categories of risk for different product types.
Source: Guidelines for the microbiological quality of some ready-to-eat foods sampled at the point of sale (adapted)
(Gilbert R.J. et al. 2000).

48
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responsible for any use Which may be made of the information contained therein
Food category
(see table 3.5) Criterion
Microbiological quality (CFU per gram unless stated)
Satisfactory Acceptable Unsatis-
factory
Unacceptable/
potentially hazardous*
1
2
3
4
5
1-5
1-5
1-5
1-5
1-5
1-5
1-5
1-5
1-5
1-5
1-5
1-5
Aerobic colony count (a)
30°C/48h
Indicator organisms (b)
Enterobacteriaceae (c)
E. coli (total)
Listeria spp (total)
Pathogens
Salmonella spp
Campylobacter spp
E. coli O157 & other VTEC
V. cholerae
V. parahaemolyticus (d)
L. monocytogenes
S. aureus
C. perfringens
B. cereus and other
pathogenic
Bacillus spp (e)
<103
<104
<105
<106
N/A
<100
<20
<20
(1)
(1)
(1)
(1)
<20
<20**
<20
<20
<103
103-<104
104-<105
105-<106
106-<107
N/A
100-<100
20-<100
20-<100
20-<100
20-<100
20-<100
20-<100
103-<104
≥ 104
≥ 105
≥ 106
≥ 107
N/A
≥ 104
≥ 100
≥ 100
100-<103
N/A
100-<104
100-<104
103-<104
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
(2)
(2)
(2)
(2)
≥ 103
≥ 100
≥ 104
≥ 104
≥ 105
Table 3.5: Microbiological quality criteria for ready-to-eat foods.
(1) Not detected in 25 grams.
(2) Detected in 25 grams.
N / A: Not applicable.
*: Based only on high colony counts and / or organism counts. In the absence of other criteria of unacceptability it is
unlikely to succeed.
**: not detected in 25 grams of certain long-lasting products in refrigerators.
(a): colony counting guidelines may not apply to certain fermented foods, for example salami, soft cheese, and
unpasteurized yogurts. These foods fall into category 5. Acceptability is based on the appearance, smell, texture and
levels of absence of indicators of organisms or pathogens.
(b): in certain situations, the strains may be pathogenic.
(c): not applicable to fresh fruit, vegetables and vegetable salads.
(d): relevant only for sh.
(e): if the bacillus count exceeds 104 CFU / g, the micro-organism shall be identied.
The terms used to express the microbiological quality of ready-to-eat foods are:
Satisfactory - the test results indicate a good microbiological quality result.
Acceptable - a level indicating the microbiological quality threshold.
Unsatisfactory - the test results indicate that more samples will be needed and that ofcials from the ofcial bodies
may wish to carry out another inspection to check whether hygienic food production practices are appropriate.

49
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responsible for any use Which may be made of the information contained therein
Unacceptable / potentially dangerous - test results indicate that it is necessary to locate the source of the problem;
A detailed risk analysis is recommended. Such results can lead to court action, especially if they occur in more than
one sample.
Source: Guidelines for the microbiological quality of some ready-to-eat foods sampled at the point of sale (adapted)
(Gilbert, R.J. et al., 2000).
ey shall also be carried out where there is evidence that the food safety status may have changed, in particular
where:
• It is found that the critical control limits are violated.
• Recordsreviewsindicateinadequatemonitoring.
• Complaints or rejection of the product by customers or consumers.
• New scientic data will emerge.
Verication Frequency
VericationproceduresshouldbescheduledatafrequencythatensuresthattheHACCPPlanremainscurrentand
properlyimplementedandthattheHACCPPlanisfullycompliedwith.efrequencyofvericationactivitiescan
bemodiedovertime.echangesshalltakeintoaccountthehistoryofthevericationactivitiesandtherecordsof
deviations.eremayevenbeareductioninthefrequencyoftheseactivities,aslongasthisdoesnotcompromise
the maintenance of the level of condence in the implemented HACCP System.
e verication procedures of the HACCP System should be documented and the results from these activities should
be recorded. e verication is not only necessary when there is a change in the supplier of raw materials but also
whenthere isalsoachangeinthe productoruponmakinganymodicationsin the processingprocedureorthe
intended use of the product.
Documents and Registers
e HACCP System is a documented system. An adequate establishment of documentation is essential for an
eective implementation of the HACCP System. Figure 3.4 shows the hierarchy of documentation normally found
in a HACCP management system.
Food Safety Policy
Legal and
Normative
Requirements
HACC P Manual
Study and HACC P Pla n
Proc edure a nd Instruc tio n
Politics
Legal
Manag eme nt
Planning
Operative
Figure 3.4: Documentary structure of a HACCP system.
erecordsare evidence of activities and constitute animportantsourceofinformationtosupport an adequate
implementation of a HACCP System and ensure its revision when necessary.

50
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responsible for any use Which may be made of the information contained therein
Types of Documents and Records
Among the documents and records to be considered in a HACCP System are the following:
• e procedures describing the HACCP System.
• Documents and data used in hazard analysis and establishment of the HACCP Plan (e.g. Data used to dene
control measures and establishment of critical control limits; data obtained in process validation and product
shelf-life).
• Descriptions of the products and their expected use.
• Flowcharts of production processes.
• Hazard analysis and the determination of critical points.
• e HACCP Plan, including the description of critical limits for each CCP and its monitoring.
• Records associated with CCP monitoring.
• e reports / minutes / minutes produced at HACCP Team meetings.
• Deviations and associated corrective / preventive actions.
• HACCP audit reports.
• Product Technical Data Sheets.
• Technical Data Sheets of Raw Materials.
• Identication cards of the state of inspection and testing.
• Sanitation plan (Baptista P. 2003).
• Pest control plan (Baptista P. 2003).
• Training plan.
• Training records (e.g. Program content, Summaries, Attendance list).
• Calibration Plan.
• Calibration records (e.g. Calibration certicates).
• Maintenance plan.
• Maintenancerecords(e.g.,Equipmentregistrationforms).
• Internal Audit Plan.
• Internal Audit Reports.
• HACCP Team Meeting Minutes.
• Registration Control Table.
• Document Control Table.
• Various procedures (e.g. Management review by the Management, Control of Documents and Data, Control
of Inspection, Measurement and Monitoring Equipment, Treatment of Nonconformities, Corrective and
Preventive Actions, Control of HACCP Records, Internal HACCP Audits, Training).

51
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responsible for any use Which may be made of the information contained therein
Figure 3.5: Links between the various document types and records with the structure of the HACCP System and
associated activities.
Management of documents and records
Documents and records shall be managed in accordance with a specic procedure. ey must:
• Find themselves indexed.
• Be available for consultation where needed for the activity.
• May be modied / updated (procedures and forms).
• Be maintained during pre-dened periods, established based on the life time of the product and other criteria,
namely of a legal nature.
• Indicate the update status.
Anadequatearchiveofrecordsmakesitpossibletoprove,underanycircumstances,thattheHACCPPlanprocedures
arebeingcompliedwithinaccordancewiththerequirementsoftheHACCPSystem.us,theserecordsareusedto
demonstrate compliance with the specic critical limits established for each CCP in food processing. Records review
canalsobeaninstrumentforidentifyingtrendsandmakingadjustmentstooperationallimits.

53
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responsible for any use Which may be made of the information contained therein
Chapter 4
FOOD SAFETY STANDARDS FOR CERTIFICATION
Paulo Baptista
P&B – Consultores Associados, paulonlbaptista@net.sapo.pt
INTRODUCTION
Although it is very important to have an HACCP system implemented, in many situations this is not
sucient to establish commercial relations with potential customers. Customers, in particular large
retailers, want to have condence that their supplier have eective HACCP system implemented
capableofassuringthequality,foodsafetyandlegalityoftheproductstheyaresellingintheirshops.
is is even more relevant when large retailers have many food products with their own brands.
ese products are not produced by the retailers but by industrial food companies. Independently of
this fact, the responsibility for these products not only from the manufacturer but also for the owner
of the brand: the retailer. In European Union, the rst importer of products from outside this region
is legally responsible for those products in case on any food safety or legal event that might happen.
is legal responsibility lead the larger European retailers to implement mechanisms to ensure that
the products they are purchasing are safe and will not harm the health of the consumers. On the
past large retailer implement audit procedures to their suppliers to verify the compliance of those in
relationtotheirrequirements.Morethan20yearsagothelargeEUretailers,rstintheUKandlater
incontinentalEuropestarteddevelopingcommonstandardsforauditingsuppliers.IntheUKitwas
Chapter Objectives
• Presenttheimportanceoffoodsafetycerticationfortheestablishmentofcommercial
relationships
• Presentthetypeofrequirementspresentin2nd party certication schemes
• Shortlypresenttherequirementsoftwo2nd party certication schemes: IFS and BRC

54
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responsible for any use Which may be made of the information contained therein
created the British Retail Consortium (BRC) that developed and standard (BRC Food) and a certication scheme
for auditing food suppliers. A similar standard was later developed by the associated members of the German retail
federation and of its French counterpart: e International Featured Standard (IFS). is Standard is now managed
by IFS Management GmbH.
e objectives of these standards are common:
• To establish common standards with uniform evaluation system.
• Toworkwithaccreditedcerticationbodies andqualiedapprovedauditors,allowingacredibleindependent
assessmentofacompany’sfoodsafetyandqualitysystems.
• To ensure comparability and transparency throughout the entire supply chain.
• To reduce costs and time for both suppliers and retailers.
• Toassistsitesandtheircustomerstocomplywithlegalrequirementsforfoodsafety.
REQUIREMENTS OF FOOD SAFETY STANDARDS
Inthissection it will be shortlypresentedthestructureofthetwo standardsinterms of requisitesapplicableto
companies searching one of these certications:
• BRC – Global Standard Food Safety (issue 7, from January 2015).
• IFS – International Featured Standard - Food.
eobjectiveistoprovideaquickoverviewoftherequirementsofthesestandardsandtoallowtheidenticationof
the points of connection with the HACCP system and recognize the additional elements that need to be addressed
in such type of certication schemes. More detailed information can be found in the BRC Food standard (Global
Standard Food Safety – issue 7, January 2015) and IFS Food standard (IFS Food – version 6.1, November 2017).
BRC FOOD
BRC Food is composed of 7 sections:
• Senior Management Commitment.
• e Food Safety Plan – HACCP.
• Food Safety and Quality Management System.
• Site Standards.
• Product Control.
• Process Control.
• Personnel.
Inthissub-sectionarepresentedthelistofthekeypointslinkedwitheachgroupofrequirementsanddesignatedas
“statementofintent”,foreachoneofthesectionsmentionedbefore.Someofthegroupofrequirementsareconsidered
ofkeyimportanceandthosearedesignatedas“fundamental”.

55
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responsible for any use Which may be made of the information contained therein
e nal result of the audit is depends on the number and the type of non-conformities. Non-conformities can be
graded as minor, major or critical. e combination of the number of the dierent types of non-conformity will
determine if certication is achieved and with which grade.
Senior Management Commitment
Senior management commitment and continual improvement
Statement of Intent (Fundamental): e site’s senior management shall demonstrate they are fully committed to
theimplementationoftherequirementsof the Global StandardforFood Safety and to processeswhichfacilitate
continualimprovementoffoodsafetyandqualitymanagement.
Organisational structure, responsibilities and management authority
Statement of Intent: e company shall have a clear organisational structure and lines of communication to enable
eectivemanagementofproductsafety,legalityandquality.
The Food Safety Plan - HACCP
Statement of Intent (Fundamental): e company shall have a fully implemented and eective food safety plan
based on Codex Alimentarius HACCP principles.
• e HACCP food safety team – Codex Alimentarius Step 1.
• Prerequisiteprogrammes.
• Describe the product – Codex Alimentarius Step 2.
• Identify intended use – Codex Alimentarius Step 3.
• Constructaprocessowdiagram–CodexAlimentariusStep4.
• Verifyowdiagram–CodexAlimentariusStep5.
• List all potential hazards associated with each process step, conduct a hazard analysis and consider any measures
to control identied hazards – Codex Alimentarius Step 6, Principle 1.
• Determine the critical control points (CCP) – Codex Alimentarius Step 7, Principle 2.
• Establish critical limits for each CCP – Codex Alimentarius Step 8, Principle 3.
• Establish a monitoring system for each CCP – Codex Alimentarius Step 9, Principle 4.
• Establish a corrective action plan – Codex Alimentarius Step 10, Principle 5.
• Establish verication procedures – Codex Alimentarius Step 11, Principle 6.
• HACCPdocumentationandrecordkeeping–CodexAlimentariusStep12,Principle7.
• Review the HACCP plan.

56
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responsible for any use Which may be made of the information contained therein
Food Safety and Quality Management System
Food safety and quality manual
Statement of Intent: ecompany’s processesandprocedurestomeetthe requirementsof thisStandardshall be
documented to allow consistent application, facilitate training, and support due diligence in the production of a safe
product.
Documentation control
Statement of Intent: e company shall operate an eective document control system to ensure that only the correct
versions of documents, including recording forms, are available and in use.
Record completion and maintenance
Statement of Intent: e site shall maintain genuine records to demonstrate the eective control of product safety,
legalityandquality.
Internal audit
Statement of Intent (Fundamental): e company shall be able to demonstrate it veries the eective application of
thefoodsafetyplanandtheimplementationoftherequirementsoftheGlobalStandardforFoodSafety.
Supplier and raw material approval and performance monitoring
Management of suppliers of raw materials and packaging
Statement of Intent (Fundamental): e company shall have an eective supplier approval and monitoring system
toensurethatanypotentialrisksfromrawmaterials(includingpackaging)to thesafety,authenticity,legalityand
qualityofthenalproductareunderstoodandmanaged.
Raw material and packaging acceptance and monitoring procedures
Statement of Intent: Controlsontheacceptanceofrawmaterialsincludingpackagingshallensurethatthesedonot
compromisethesafety,legalityorqualityofproductsandwhereappropriateanyclaimsofauthenticity.
Management of suppliers of services
Statement of Intent: e company shall be able to demonstrate that where services are outsourced the service
isappropriateandanyrisks presented to food safety,legalityandqualityhavebeenevaluatedtoensureeective
controls are in place.
Management of outsourced processing
Statement of Intent: Whereanyprocessstepinthemanufactureorpackingofaproductwhichisincludedwithin
thescope ofcerticationis subcontractedtoa thirdpartyor undertakenatanothersite,this shallbemanagedto
ensureitdoesnotcompromisethesafety,legality,qualityorauthenticityoftheproduct.
Specications
Statement of Intent: Specicationsshall exist for raw materials including packaging, nished productsand any
product or service which could aect the integrity of the nished product.

57
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responsible for any use Which may be made of the information contained therein
Corrective and preventive actions
Statement of Intent (Fundamental): e site shall be able to demonstrate that it uses the information from identied
failuresinthefoodsafetyandqualitymanagementsystemtomakenecessarycorrectionsandpreventrecurrence.
Control of non-conforming product
Statement of Intent: e site shall ensure that any out-of-specication product is eectively managed to prevent
un-authorised release.
Traceability
Statement of Intent (Fundamental): esiteshallbeabletotraceallrawmaterialproductlots(includingpackaging)
from its suppliers through all stages of processing and dispatch to its customers and vice versa.
Complaint handling
Statement of Intent: Customer complaints shall be handled eectively and information used to reduce recurring
complaint levels
Management of incidents, product withdrawal and product recall
Statement of Intent: e company shall have a plan and system in place to manage incidents eectively and enable
thewithdrawalandrecallofproductsshouldthisberequired.
Customer focus and communication
Statement of Intent:ecompanyshallensurethatanycustomer-specicpoliciesorrequirementsareunderstood,
implemented and clearly communicated to relevant sta and, where appropriate, suppliers of raw materials,
packagingandservices.
Site Standards
External standards
Statement of Intent: e production site shall be of suitable size, location and construction, and be maintained to
reducetheriskofcontaminationandfacilitatetheproductionofsafeandlegalnishedproducts.
Security
Statement of Intent: Security systems shall ensure that products are protected from the or malicious contamination
while under the control of
the site.
Layout, Product Flow and Segregation
Statement of Intent (Fundamental):e factor y layout, ow of processes andmovement of personnel shall be
sucienttopreventtheriskofproductcontaminationandtocomplywithrelevantlegislation.
Building fabric, raw material handling, preparation, processing, packing and storage areas
Statement of Intent: e fabrication of the site, buildings and facilities shall be suitable for the intended purpose.

58
This Project has been funded with support form the European Commission.
This Publication reects the views only of the author, and the commission cannot be held
responsible for any use Which may be made of the information contained therein
Utilities – water, ice, air and other gases
Statement of Intent: Utilities used within the production and storage areas shall be monitored to eectively control
theriskofproductcontamination.
Equipment
Statement of Intent:Allfood-processingequipmentshallbesuitablefortheintendedpurposeandshallbeusedto
minimisetheriskofcontaminationofproduct.
Maintenance
Statement of Intent: Aneectivemaintenanceprogrammeshallbeinoperationforplantandequipmenttoprevent
contaminationandreducethepotentialforbreakdowns.
Sta facilities
Statement of Intent: Stafacilitiesshallbesucienttoaccommodatetherequirednumberofpersonnel,andshall
bedesignedandoperatedtominimisetheriskofproductcontamination.efacilitiesshallbemaintainedingood
and clean condition.
Chemical and physical product contamination control - Raw material handling, preparation, processing,
packing and storage areas
Statement of Intent: Appropriatefacilitiesandproceduresshallbeinplacetocontroltheriskofchemicalorphysical
contamination of product.
• Chemical control.
• Metal control.
• Glass, brittle plastic, ceramics and similar materials.
• Productspackedintoglassorotherbrittlecontainers.
• Wood.
Foreign body detection and removal equipment
Statement of Intent: e risk of product contamination shall be reduced or eliminated by the eective use of
equipmenttoremoveordetectforeignbodies.
• Foreignbodydetectionandremovalequipment.
• Filters and sieves.
• MetaldetectorsandX-rayequipment.
• Magnets.
• Opticalsortingequipment.
• Container cleanliness – glass jars, cans and other rigid containers.

59
This Project has been funded with support form the European Commission.
This Publication reects the views only of the author, and the commission cannot be held
responsible for any use Which may be made of the information contained therein
Housekeeping and hygiene
Statement of Intent (Fundamental):Housekeepingandcleaningsystemsshallbeinplacewhichensureappropriate
standardsofhygienearemaintainedatalltimesandtheriskofproductcontaminationisminimised.
Waste/waste disposal
Statement of Intent: Waste disposal shall be managed in accordance with legal requirements and to prevent
accumulation,riskofcontaminationandtheattractionofpests.
Management of surplus food and products for animal feed
Statement of Intent: Eective processes shall be in place to ensure the safety and legality of by-products of the
primary processing activity of the site.
Pest control
Statement of Intent: e whole site shall have an eective preventive pest control programme in place to minimise
therisk of infestation and there shall be theresourcesavailabletorespondrapidlytoanyissueswhichoccur to
preventrisktoproducts.
Storage facilities
Statement of Intent:Allfacilitiesusedforthestorageofrawmaterials,packaging,in-processproductsandnished
products shall be suitable for its purpose.
Dispatch and transport
Statement of Intent: Procedures shall be in place to ensure that the management of dispatch and of the vehicles and
containersusedfortransportingproductsfromthesitedonotpresentarisktothesafety,securityorqualityofthe
products.
Product Control
Product design/development
Statement of Intent: Product design and development procedures shall be in place for new products or processes and
anychangestoproduct,packagingormanufacturingprocessestoensurethatsafeandlegalproductsareproduced.
Product labelling
Statement of Intent (Fundamental):Productlabellingshallcomplywith the appropriatelegal requirementsand
contain information to enable the safe handling, display, storage and preparation of the product within the food
supply chain or by the customer.
Management of allergens
Statement of Intent (Fundamental): e site shall have a system for the management of allergenic materials which
minimisestheriskofallergencontaminationofproductsandmeetslegalrequirementsforlabellinginthecountry
of sale.

60
This Project has been funded with support form the European Commission.
This Publication reects the views only of the author, and the commission cannot be held
responsible for any use Which may be made of the information contained therein
Product authenticity, claims and chain of custody
Statement of Intent: Systemsshallbeinplacetominimisetheriskofpurchasingfraudulentoradulteratedfoodraw
materials and to ensure that all product descriptions and claims are legal, accurate and veried.
Product packaging
Statement of Intent: Productpackagingshallbeappropriatefortheintendeduseandshallbestoredunderconditions
to prevent contamination and minimise deterioration
Product inspection and laboratory testing
Statement of Intent: e company shall undertake or subcontract inspection and analyses which arecritical to
conrmproductsafety,legalityandquality,usingappropriateprocedures,facilitiesandstandards.
• Product inspection and testing
• Laboratory testing
Product release
Statement of Intent: e site shall ensure that nished product is not released unless all agreed procedures have
been followed.
Process Control
Controls of operations
Statement of Intent (Fundamental):e site shall operatetodocumentedproceduresand/orwork instructions
that ensure the productionof consistently safe and legal productwith the desired quality characteristics, in full
compliance with the HACCP food safety plan.
Labelling and pack control
Statement of Intent (Fundamental): e management controls of product labelling activities shall ensure that
products will be correctly labelled and coded.
Quantity-weight, volume and number control
Statement of Intent:esiteshalloperateaquantitycontrolsystemwhichconformstolegalrequirementsinthe
countrywheretheproductissoldandanyadditionalindustrysectorcodesorspeciedcustomerrequirements.
Calibration and control of measuring and monitoring devices
Statement of Intent:e site shall be able to demonstratethatmeasuringequipmentis sucientlyaccurateand
reliable to provide condence in measurement results.
Personnel
Training: Raw material handling, preparation, processing, packing and storage areas
Statement of Intent (Fundamental):e company shall ensure that all personnel performing workt hataects
productsafety,legalityandqualityaredemonstrablycompetenttocarryouttheiractivity,throughtraining,work
experienceorqualication.

61
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This Publication reects the views only of the author, and the commission cannot be held
responsible for any use Which may be made of the information contained therein
Personal hygiene: Raw material handling, preparation, processing, packing and storage areas
Statement of Intent: e site’s personal hygiene standards shall be developed to minimise the risk of product
contamination from personnel, be appropriate to the products produced and be adopted by all personnel, including
agency-supplied sta contractors and visitors to the production facility.
Medical screening
Statement of Intent: e company shall have procedures in place to ensure that employees, agency sta contractors
or visitors are not a source of transmission of food-borne diseases to products.
Protective clothing: Employees or visitors to production areas
Statement of Intent: Suitable site-issued protective clothing shall be worn by employees, contractors or visitors
workinginorenteringproductionareas.
IFS FOOD
IFS Food is composed of 6 sections:
• Senior Management Responsibility.
• Quality and Food Safety Management System.
• Resources Management.
• Planning and Production Process.
• Measurements, Analysis, Improvements.
• Food Defense Plan and External Inspections.
In IFS Food, there are 4 scoring possibilities for each requirement:
• A: Fullcompliancewiththerequirementspeciedinthestandard(scored20points).
• B: Almostfull compliance with the requirement specied in the standard,butasmall deviation was found
(scored 15 points).
• C: Onlyasmallpartoftherequirementhasbeenimplemented(scored5points).
• D:erequirementintheStandardhasnotbeenimplemented(scored-20points).
InIFS,therearealso2otherkindsofnon-conformities:MajorandKO.Bothwillleadtoasubtractionofpointsfrom
thetotalamount.Amajornon-conformityisgivenwhenthereis asubstantialfailuretomeettherequirementsof
thestandard,whichincludesfoodsafetyand/orthelegalrequirementsoftheproductionanddestinationcountries.
A major non-conformity can also be given when the identied non-conformity can lead to a serious health hazard.
Amajornon-conformitywillsubtract15% ofthepossibletotalamountofpoints.InIFSFood,therearespecic
requirementswhicharedesignatedasKOrequirements(KO–KnockOut).Ifduringtheaudittheauditorestablishes
thattheserequirementsarenotfullledbythecompany,thisresultsinnon-certication.
In this sub-section are presentedthe list of the topics of requirementslin kedw ithe achs ection oft hestandard
mentionedbefore.Inthecorrespondingsectionarealsodetailedthe10KOrequirements:

62
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responsible for any use Which may be made of the information contained therein
• Responsibility of the senior management.
• System of each CCP.
• Personnel hygiene.
• Raw material specications.
• Recipe compliance.
• Foreign material management.
• Traceability system.
• Internal audits.
• Procedure for withdrawal and recall.
• Corrective actions.
Senior Management Commitment
• Corporate policy/Corporate principles.
• Corporate structure.
KO No. 1: e senior management shall ensure that employees are aware of their responsibilities related to food
safetyandqualityandthatmechanismsareinplacetomonitortheeectivenessoftheiroperation.Suchmechanisms
shall be clearly identied and documented.
• Customer focus.
• Management review.
Quality and Food Safety Management System
Quality Management
• Documentationrequirements.
• Recordkeeping.
Food Safety Management
1. HACCP system.
2. HACCP team.
• Assemble HACCP team (CA Step 1).
3. HACCP analysis.
• Describe product (CA Step 2).
• Identify intended use (CA Step 3).
• Constructowdiagram(CAStep4).

63
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responsible for any use Which may be made of the information contained therein
On-siteconrmationoftheowdiagram(CAStep5).
Conduct a hazard analysis for each step (CA Step 6 – Principle 1).
Determine critical control points (CA Step 7 – Principle 2).
Establish critical limits for each CCP (CA Step 8 – Principle 3).
Establish a monitoring system for each CCP (CA Step 9 – Principle 4).
KO No. 2: Specic monitoring procedures shall be established for each CCP to detect any loss of control at that CCP.
Records of monitoring shall be maintained for a relevant period. Each dened CCP shall be under control. Monitoring
and control of each CCP shall be demonstrated by records. e records shall specify the person responsible as well as
the date and result of the monitoring activities.
Establish corrective actions (CA Step 10 – Principle 5).
Establish verication procedures (CA Step 11 – Principle 6).
Establishdocumentationandrecordkeeping(CAStep12–Principle7).
Resource Management
Human resources management
Human resources
• Personnel hygiene.
KO No. 3:erequirementsforpersonnelhygieneshallbeinplaceandappliedbyallrelevantpersonnel,contractors
and visitors.
• Protective clothing for personnel, contractors and visitors.
• Procedures applicable to infectious diseases.
Training and instruction
Sanitaryfacilities,equipmentforpersonnelhygieneandstafacilities
Planning and Production Process
Contract agreement
Specications and formulas
• Specications.
KO No. 4: Specications shall be available and in place for all raw materials (raw materials/ ingredients, additives,
pack-agingmaterials,rework).Specicationsshall beuptodate,unambiguousand be in compliancewith legal
requirementsand,ifexisting,withcustomerrequirements
• Formula/recipes.
KO No. 5: Where there are customer agreements in relation to the product formula/recipe and technological
requirements,theseshallbecompliedwith.

64
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responsible for any use Which may be made of the information contained therein
• Product development/Product modication/ Modication of production processes.
• Purchasing.
• Productpackaging.
• Factory location.
• Factory Exterior.
• Plantlayoutandprocessows.
Constructional requirements for production and storage area
• Constructionalrequirements.
• Walls.
• Floors.
• Ceilings/Overheads.
• Windows and other openings.
• Doors and gates.
• Lighting.
• Air conditioning/Ventilation.
• Water supply.
• Compressed air.
• Cleaning and disinfection.
• Waste disposal.
• Riskofforeignmaterial,metal,brokenglassandwood.
KO No. 6: Based on hazard analysis and assessment of associated risks, procedures shall be in place to avoid
contamination with foreign material. Contaminated products shall be treated as non-conforming products.
• Pest monitoring/Pest control.
• Receipt of goods and storage.
• Transport.
• Maintenance and repair.
• Equipments.
• Traceability (including GMOs and allergens).
KO No. 7: A traceability system shall be in place which enables the identication of product lots and their relation
tobatchesof rawmaterials,packagingin directcontactwithfood,packagingintendedorexpectedtobe indirect

65
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This Publication reects the views only of the author, and the commission cannot be held
responsible for any use Which may be made of the information contained therein
contact with food. e traceability system shall incorporate all relevant receiving processing and distribution records.
Traceability shall be ensured and documented until delivery to the customer.
• Genetically modied organisms (GMOs).
• Allergens and specic conditions of production.
• Food Fraud.
Measurments, Analysis, Improvements
Internal audits
KO No. 8: Eective internal audits shall be conducted according to a dened agreed audit program and shall cover
atleastallrequirementsoftheIFSStandard.Scopeandfrequencyofinternalauditsshallbedeterminedbyhazard
analysisandassessmentofassociatedrisks.isisalsoapplicableforo-sitestoragelocationsownedorrentedby
the company.
• Site factory inspections.
• Process validation and control.
• Calibration,adjustmentandcheckingofmeasuringandmonitoringdevices.
• Quantitychecking(quantitycontrol/llingquantities).
• Product analysis.
• Productquarantine(blocking/hold)andproductrelease.
• Management of complaints from authorities and customers.
• Management of incidents, product withdrawal, product recall.
KO No. 9: ere shall be an eective procedure for the withdrawal and recall of all products, which ensures
that involved customers are informed, as soon as possible. is procedure shall include a clear assignment of
responsibilities.
• Management of non-conformities and non- conforming products.
• Corrective actions.
KO No. 10: Correctiveactionsshallbeclearlyformulated,documentedandundertaken,assoonaspossibletoavoid
further occurrence of non-conformity. e responsibilities and the timescales for corrective action shall be clearly
dened. e documentation shall be securely stored, and easily accessible.
Food Defense and External Inspections
• Defense assessment.
• Site Security.
• Personnel and Visitor Security.
• External Inspections.

66
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This Publication reects the views only of the author, and the commission cannot be held
responsible for any use Which may be made of the information contained therein
Bibliography
1. AFNOR, Norme expérimentale XP V 01-003 – Lignes Directrices pour l’Elaboration d’un Protocole
de Validation de la Durée de Vie Microbiologique, AFNOR – Association Française de Normalisation,
Paris, France, 1998.
2. Baptista, P.e Noronha J (2003). Segurança Alimentar em Estabelecimentos Agro-Alimentares:
Projecto e Construção, Forvisão – Consultoria em Formação Integrada, Guimarães, Portugal.
3. Baptista, P.e Saraiva J (2003). Higiene Pessoal na Indústria Alimentar, Forvisão – Consultoria em
Formação Integrada, Guimarães, Portugal.
4. Baptista, P.e Venâncio A (2003). Os Perigos para a Segurança Alimentar no Processamento de
Alimentos, Forvisão – Consultoria em Formação Integrada, Guimarães, Portugal.
5. Baptista P (2003). Higiene e Desinfecção de Equipamentos e Instalações na Indústria Agro-
Alimentar, Forvisão – Consultoria em Formação Integrada, Guimarães, Portugal.
6. CAC, CAC/GL 021-1997 – Principles for the Establishment and Application of Microbiological Criteria
for Foods, CAC - Commission do Codex Alimentarius.
7. CAC, CAC/GL 030-1999 – Principles and Guidelines for the Conduct of Microbiological Risk
Assessment, CAC - Commission do Codex Alimentarius.
8. CAC, CAC/RCP 1-1969, Rev.3, And. 1 - General Principles of Food Hygiene, CAC - Codex
Alimentarius Commission.
9. Gilbert R.J, Donovan T, Little C, Nye K, Ribeiro C.D, et al (2000). Guidelines for the microbiological
quality of some ready-to-eat foods sampled at the point of sale, PHLS Advisory Committee for Food
and Dairy Products, Communicable Disease and Public Health 3: 163-167.
10. ISO, ISO 9001:2015 – Quality Management Systems – Requirements, International Standards
Organization, Geneva, Switzerland.
11. ISO, ISO 22000:2005 – Food Safety Management Systems - Requirements, International Standards
Organization, Geneva, Switzerland.

67
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responsible for any use Which may be made of the information contained therein
Keywords (Index)
A
Acidity regulators
Acids
Analysis
- Samples
- Of hazards
Anti-cakingagents
Anti-foaming agents
Antioxidants
Audit
B
Bulkingagents
C
Carriers
Certication
- References
-Requirements
Codes of good practice
Codex Alimentarius
Colours
Conservation
Control measures
Corrective actions
Critical control point
D
Decision tree
Documents
- Control
- Types
E
Emulsiers
Emulsifying salts

68
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This Publication reects the views only of the author, and the commission cannot be held
responsible for any use Which may be made of the information contained therein
Equipmentsmeasuring
F
Facilities
Firming agents
Flavour enhancers
Flour treatment agents
Flowchart
- Construction
- Verication
Foaming agents
Food
Food Safety Policy
G
Gelling agents
Glazing agents
Good manufacturing practices
H
HACCP
- Communication
- Concept
- History
- Methodology
- Principles
- Resources
- Review
- Team
- Team Coordinator
HACCP Plan
Hazard
- Identication
- Potential
- Relevant
Hygiene
- food (rules / general principles)

69
This Project has been funded with support form the European Commission.
This Publication reects the views only of the author, and the commission cannot be held
responsible for any use Which may be made of the information contained therein
I
ISO 22000:2005
ISO 9001: 2015
L
Layout
Legislation
Limit
- Critical
- Operational
M
Management
- Responsibility of the
Methods
Modied starches
Monitoring
- Methodology
- Objectives
N
Notication
P
Packaginggases
Parasites
Pathogenic micro-organisms
Pesticide
Preservatives
Probability
Product
- Description
- Final
- Intended Use
Propellants
Q
Quality Management System

70
This Project has been funded with support form the European Commission.
This Publication reects the views only of the author, and the commission cannot be held
responsible for any use Which may be made of the information contained therein
R
Raising agents
Raw material
Register
Riskassessment
S
Sanitation
Sequestrant
Severity
Stabilisers
Storage
Suppliers
Sweeteners
T
ickeners
Toxins
Training
Transport
Glossary
Acidity regulators-Substanceswhichalterorcontroltheacidityoralkalinityofafoodstu.
Acids - Substances which increase the acidity of a foodstu and/or impart a sour taste to it.
Action-Actiontakenwhenmonitoringresultsdemonstratethatcriticallimitshavebeenexceededorestablished
procedures have not been met.
Anti-caking agents - Substances which reduce the tendency of individual particles of a foodstu to adhere to one
another.
Anti-foaming agents - Are substances which prevent or reduce foaming.
Antioxidants - Substances which prolong the shelf-life of foods by protecting them against deterioration caused by
oxidation, such as fat rancidity and colour changes.
Audit (HACCP) - Systematic review to determine if the activities of the HACCP System and the associated results
are in accordance with the established plan, and implemented eectively, and are adequate to ensure that the
objectives are achieved.
Bacteria - A single-cell microorganism usually between 0.5 and 10 μm in length or diameter, with rigid walls that
multiply by dividing into two.

71
This Project has been funded with support form the European Commission.
This Publication reects the views only of the author, and the commission cannot be held
responsible for any use Which may be made of the information contained therein
Biological hazard-Anyunacceptablegrowthorsurvivalofbacteriainfoodsthatmayaecttheirsafetyorquality,
or the production or persistence of substances such as toxins, enzymes or products resulting from microbial
metabolism in food.
Bulking agents - Substances which contribute to the volume of a foodstu without contributing signicantly to its
available energy value.
Carriers - Substancesusedtodissolve,dilute,disperseorotherwisephysicallymodifyafoodadditiveoraavouring,
food enzyme, nutrient and/or other substance added for nutritional or physiological purposes to a food without
altering its function (and without exerting any technological eect themselves) in order to facilitate its handling,
application or use.
Colours - Substances which add or restore colour in a food, and include natural constituents of foods and natural
sources which are normally not consumed as foods as such and not normally used as characteristic ingredients
of food. Preparations obtained from foods and other edible natural source materials obtained by physical and/
or chemical extraction resulting in a selective extraction of the pigments relative to the nutritive or aromatic
constituents are colours within the meaning of this Regulation.
Control measure - Activity necessary to prevent or eliminate hazards or reduce their presence to acceptable levels.
Critical control limit - Value or criterion that dierentiates acceptance from non-acceptance of the process.
Critical control point (CCP) - Point, procedure, process step or element of the food chain in which control can be
applied which is essential to prevent, reduce to acceptable levels or eliminate a food safety hazard.
Decision tree-Sequenceofissuesthatcanbeappliedateachstageoftheprocess,toarelevantidentiedhazard,in
order to determine whether it constitutes a critical control point.
Emulsiers - Substances which make it possible to form or maintain a homogenous mixture of two or more
immiscible phases such as oil and water in a foodstu.
Emulsifying salts - Substances which convert proteins contained in cheese into a dispersed form and thereby bring
about homogenous distribution of fat and other components.
Firming agents - Substanceswhichmakeorkeeptissuesoffruitorvegetablesrmorcrisp,orinteractwithgelling
agents to produce or strengthen a gel.
Flavour enhancers - Substances which enhance the existing taste and/or odour of a foodstu.
Flour treatment agents - Substances,other than emulsiers, which are added to our or dough to improve its
bakingquality.
Flowchart-Systematicrepresentationofthesequenceandinterrelationbetweenstagesandoperationsusedinthe
preparation of a given food product.
Foaming agents - Substanceswhichmakeitpossibletoformahomogenousdispersionofagaseousphaseinaliquid
or solid foodstu.
Food Safety - Guarantee that the product will not aect the consumer's health when processed and / or consumed
according to its intended use.
Gelling agents - substances which give a foodstu texture through formation of a gel.
Glazing agents - Substances which, when applied to the external surface of a foodstu, impart a shiny appearance
or provide a protective coating.

72
This Project has been funded with support form the European Commission.
This Publication reects the views only of the author, and the commission cannot be held
responsible for any use Which may be made of the information contained therein
Good hygienic practices (GHP) - Guidelines, methods and activities designed and monitoring to promote and
maintain health through the use of sanitary conditions.
Good manufacturing practices (GMP) - Preventive measures related to internal and external conditions of the
organization,withthe aim of avoiding orreducingthelikelihoodofcontaminationof the product by sourcesof
internal and external origin.
HACCP - A systematic analysis involving the application of methods, procedures, tests or other evaluations
(eg audits, measurements) to conrm compliance with the HACCP Plan and verify its eectiveness.
HACCP Plan - Document prepared in accordance with HACCP principles to ensure control of relevant hazards
within the HACCP management system.
HACCP system - A system that controls the hazards that are relevant to food safety through critical control points.
Hazard (in food)-Anybiological,physicalandchemicalpropertythatcanmakeafoodharmfultoconsumption.
Hazard analysis - A process for collecting and evaluating information on potential hazards and the conditions that
may lead to their presence in food, in order to decide which hazards are relevant to food safety and which should
therefore be considered in the HACCP Plan.
Humectants - Substances which prevent foods from drying out by counteracting the eect of an atmosphere having
alowdegreeofhumidity,orpromotethedissolutionofapowderinanaqueousmedium.
Modied starches - Substances obtained by one or more chemical treatments of edible starches, which may have
undergoneaphysicalorenzymatictreatment,andmaybeacidoralkalithinnedorbleached.
Mold - Microscopic plants - fungi - lamentous that develop in soil, air, water and food.
Monitoring -Aplannedsequenceofobservationormeasurementofcontrolparameterstoassesswhether(acritical
control point) is within acceptable values.
Operational limit - Limit which, once achieved, will lead to the initiation of corrective action in order to avoid that
the critical limit is reached.
Packaging gases - Gases other than air, introduced into a container before, during or aer the placing of a foodstu
in that container.
Parasites-Organismsthatgrow,nourishandprotectthemselvesinadierentorganismandtakewhattheyneed
from it.
Pathogenic micro-organism - A micro-organism capable of causing disease.
Pesticide – Is a product/substance that prevents, destroys, or controls a harmful organism (pest) or disease, or
protects plants or plant products during production, storage and transport.
pH-Anindexusedtomeasuretheacidity/alkalinityofasolution,representstheinverseofthelogarithmofthe
concentration of the H3O+ ion.
Potential hazard - Hazard that, theoretically, can occur.
Preservatives - Substances which prolong the shelf-life of foods by protecting them against deterioration caused by
micro-organisms and/or which protect against growth of pathogenic micro-organisms.
Propellants - Gases other than air which expel a foodstu from a container.

73
This Project has been funded with support form the European Commission.
This Publication reects the views only of the author, and the commission cannot be held
responsible for any use Which may be made of the information contained therein
Raising agents - substances or combinations of substances which liberate gas and thereby increase the volume of a
dough or a batter.
Register- Evidence of the accomplishment of the activities associated with the operability (of the HACCP System).
Relevant (or signicant) hazard-Potentialhazardrequiringcontrolaccordingtohazardanalysis.
Risk -Consequencesofagivenhazardoccurring,measuredbytheprobabilityandseverityofthehazard.
Sequestrants - Substances which form chemical complexes with metallic ions.
Stabilisers - Substanceswhich make it possible to maintain the physical-chemical state of a foodstu; stabilisers
include substances which enable the maintenance of a homogenous dispersion of two or more immiscible substances
in a foodstu, substances which stabilise, retain or intensify an existing colour of a foodstu and substances which
increase the binding capacity of the food, including the formation of cross-links between proteins enabling the
binding of food pieces into re-constituted food.
Sweeteners - Substances used to impart a sweet taste to foods or in table-top sweeteners.
ickeners - Substances which increase the viscosity of a foodstu.
Toxins - Chemical substances produced by certain microorganisms present in food, which may develop in the food
or in the body aer consumption of contaminated food.
Validation (HACCP) - Conrmation, through objective evidence, that the HACCP management system ensures
food safety.
Virus - Very small microorganisms, less than 0.1 μm in diameter. e viruses do not have cells, like the other
microorganisms, being constituted by nucleic acid coated by a protein. ey need a host to multiply in living cells.
Water activity (wa) - Measurement of water available in food for micro-organisms, expressed as the quotient
between the water vapor pressure of the food and the pure water vapor pressure.
Abbreviations
AFNOR – Association Française de Normalisation
Wa – Water Activity
BRC – British Retail Consortium
BSE - Bovine spongiform encephalopathy
CAC – Codex Alimentarius Commission
CCP – Critical Control Point
CFU – Colony-forming unit
DoC – Declaration of Compliance
EC – European Community
ECDC – European Centre for Prevention and Control of Diseases
EEA – European Economic Area
EEC – European Economic Community
EFSA – European Food Safety Authority

74
This Project has been funded with support form the European Commission.
This Publication reects the views only of the author, and the commission cannot be held
responsible for any use Which may be made of the information contained therein
EMA – European Medicines Agency
EU – European Union
EURL-FCM – European Reference Laboratory for Food Contact Materials
EWRS - Early Warning Response System
FAO – Food and Agriculture Organization
FCMs – Food Contact Materials
FDA – Food and Drug Administration
FMEA – Failure Mode and Eect Analysis
GAP – Good Agricultural Practices
GDP – Good Distribution Practices
GHP – Good Hygienic practices
GL – Guidelines
GMP – Good Manufacturing Practices
GVP – Good Veterinary Practices
HACCP – Hazard Analysis and Critical Control Point
ICMSF – International Commission on Microbiological Specication in Foods
IFS – International Featured Standard
ISO – International Standards Organization
MRLs – Maximum Residues Limits
MRPLs –MinimumRequiredPerformanceLimits
NASA – National Aeronautics and Space Administration
OML –Overall Migration Limits
PAFF Committee – Standing Committee on Plants, Animals, Food and Feed
PPPs – Plant Protection Products
RASFF -Rapid Alert System for Food and Feed
RCP – Recommended Code of Practices
RMS - Rapporteur Member State
SCF – Scientic Committee on Food
SMLs – Specic Migration Limits
TQM – Total Quality Management
US – United States
VTEC – Verotoxin-producing Escherichia coli
WHO – World Health Organization

Prof. Fahmi Abu Al-Rub is a Member of Trustees at the
German Jordan University. He is a professor of Chemical
and Biochemical engineering at Jordan University of Science
Technology (JUST). Prof. Abu Al-Rub is the Director of the
Applied Scientic Research Fund (ASRF); an NGO non-
prot organization that aims at promoting the innovation
and entrepreneurial culture among young researchers.
Prof. Abu Al-Rub is managing more than 25 international
projects. He published more than 90 books, journal papers,
and conference proceeding on food quality management
systems, biosorption, wastewater treatment, renewable
energy, and thermodynamics. Prof. Abu Al-Rub received
the King Abduallah the Second Award in Innovation in
2016, and Abdel-Hameed Shoman Award for Young Arab
Researchers 2001.
ISBN: 978-1-951814-02-1