Requirements_For_A_HACCP_Based_Food_Safety_System_3rd.Version.doc

Requirements for a HACCP based Food Safety System

S P E C I F I C A T I O N

REQUIREMENTS
FOR A

HACCP BASED
FOOD SAFETY SYSTEM

Compiled by the

National Board of Experts – HACCP

The Netherlands.

The Hague, the Netherlands: 3rd Version, September 2002

This is the authorised English translation of the specification “Eisen voor een op HACCP gebaseerd voedselveiligheids-systeem” (3rd version, September 2002), being one of three documents which regulate the Certification Scheme for operational HACCP based food safety systems.
The two other documents; the “Certification Regulations” and the “Regulations for the National Board of Experts – HACCP” are also published by the National Board of Experts – HACCP.

Certifying Bodies operating the Certification Scheme for operational HACCP based food safety systems have to comply with the “Requirements for Certification Bodies”, also established and published by the National Board of Experts – HACCP.

The Certification Scheme for HACCP based Food Safety Systems is maintained by the National Board of Experts - HACCP.

Certification/Registration of HACCP based Food Safety Systems on the basis of the preceding versions of this specification has been accredited by the Dutch Accreditation Council (RvA) since 1997.

Copyright 2002 National Board of Experts - HACCP

Price: EURO 23,00 (excluding VAT).

All rights reserved. No part of this publication may be reproduced and/or published in any form, by means of printed matters, photocopy, microfilm, recording or any other method or technology, without preceding written approval by the National Board of Experts - HACCP.

National Board of Experts - HACCP,
Secretariat: P.O. Box 93202, 2509 AE, The Hague, The Netherlands.
Web site: foodsafetymanagement.info
e mail: [e-mail]

CONTENTS

1 INTRODUCTION 4

2 SCOPE of APPLICATION 7

3 REFERENCE DOCUMENTS 8

4 TERMS and DEFINITIONS 9

5 HACCP SYSTEM REQUIREMENTS 12
5.1 Management responsibility 12
5.1.1 Policy
5.1.2 Scope of the HACCP system
5.1.3 Task, Responsibilities, Authorities
5.1.4 HACCP team(s)
5.1.5 Resources
5.1.6 Management review
5.2 Product Information 14
5.2.1 Product Characteristics
5.2.2 Intended use
5.3 Process Information 15
5.3.1 Flow Diagrams
5.3.2 Layout
5.3.3 Control and Verification of Process Information
5.4 Pre-requisite program 16
5.5 Hazard Analysis 17
5.5.1 Hazard identification
5.5.2 HACCP analysis (risk)
5.6 Control Measures 19
5.6.1 Specific Control Measures
5.6.2 General Control Measures
5.7 Parameters and Critical Limits 20
5.7.1 Critical process and product parameters
5.7.2 Target values, action-limit values and critical limits
5.8 Monitoring and Measuring 21
5.9 Corrective Actions 22
5.10 Validation 23
5.11 Verification 24
5.12 Documentation and records 26
5.12.1 Documents and document control
5.12.2 Records

6 ANNEX I: PRE-REQUISITE PROGRAM (PRP) 27

7 ANNEX II: RELATIONSHIP BETWEEN THE “REQUIREMENTS” 35
AND CODEX GUIDELINES FOR THE APPLICATION OF HACCP

1 INTRODUCTION

Reference documents; legislation; background information

Food safety is a global concern. Not only because of the continuing importance for public health, but also because of its impact on international trade. Effective Food Safety Systems shall therefore manage and ensure the safety and suitability of foodstuffs.

In many countries world-wide, legislation on the safety and suitability of foodstuffs requires “HACCP” to be put in place by any food business or organisation, whether profit-making or not and whether public or private, carrying out any or all of the following activities: preparation, processing, manufacturing, packaging, storage, transportation, distribution, handling or offering for sale or supply of foodstuffs. According to EU Directive 93/43/EEC on Food Hygiene all food business operators in the European Union shall implement HACCP EU Directive 93/43/EEC on the Hygiene of Foodstuffs, dated 14 June 1993 (PbEC L175).
. They shall ensure that adequate safety procedures are identified, documented, maintained and reviewed on the basis of the principles used to develop the system of HACCP (“Hazard Analysis and Critical Control Point”).

The Joint FAO/WHO Codex Alimentarius Commission describes a series of steps, including the 7 HACCP principles giving guidance for the application of the HACCP system Codex Alimentarius Commission, “Hazard Analysis and Critical Control Point (HACCP) System and
Guidelines for its Application”, Annex to CAC/RCP 1-1969, Rev. 3 (1997).
.
Also, Codex advises that minimum hygiene measures should be in place before HACCP is implemented: ”Prior to application of HACCP to any sector of the food chain, that sector should be operating according to the Codex General Principles of Food Hygiene, the appropriate Codex Codes of Practice, and appropriate food safety legislation.”

These prerequisite programs should be well specified and documented, fully operational and verified in order to facilitate the successful application and implementation of HACCP. The General Principles of Food Hygiene Codex Alimentarius Commission, “General Principles of Food Hygiene, CAC/RCP 1-1969, Rev. 3
(1997), amended 1999.
, as recommended by Codex, form an intrinsic part of this document “Requirements for a HACCP based Food Safety System”.

Specific food safety requirements are detailed in legislation, hygiene codes, customer or consumer specifications. Where specific requirements do not exist, the General Principles on Food Hygiene will be applied (see Annex I). Furthermore, the 7 principles and the guidelines for the application of HACCP have been combined in this Specification with basic elements of quality management systems (ISO 9000) to establish “The Requirements for a HACCP based Food Safety System”.
The reference documents used to formulate the “Requirements” have been specified in Chapter 3.
The “Requirements” are primarily focused on actions and activities to ensure food safety. The assurance of food suitability is considered to be an obligatory part of a quality management system, unless deviations may lead to unsafe foodstuffs.

The need for a Standard or Specification

The specification “Requirements for a HACCP based Food Safety System” has been developed by and is placed under the authority of the National Board of Experts – HACCP in order to make a normative document/standard available. All parties involved in the food chain are represented on the National Board of Expert - HACCP.
The specification can be used by Certifying Bodies to assess the continuous compliance of HACCP-based Food Safety Systems as developed and implemented by food business operators.

Of course, a food business operator may also use the “Requirements” to develop its HACCP-based Food Safety System.

Certification/Registration (e.g.of HACCP-based Food Safety Systems) signifies that by means of a formal statement (a certificate) and/or mark, notice is given with justified confidence that a product, process or service or system is in conformance with a pre-defined standard or (technical) specification. This includes the ability of the company to maintain conformance with the standards or specifications.

In order to issue such a formal statement, the HACCP-based Food Safety System of a food business operator needs to be assessed. Certification and repetitive surveillance audits are to be effectively performed by a Certifying Body which is an independent institution (whether or not governmental) that has both the authority as well as the confidence to operate a certification system within which the interests of all involved parties are represented.

For confidence the Certifying Body must use the published “Requirements” and the “Certification Regulations” in an agreed manner. The “Requirements” are documented in such a way to allow an effective assessment of the status and performance of the HACCP-based Food Safety System, as implemented by the food business operator. In the “Certification Regulations”, specific criteria are stated which have to be met by the Certifying Body when selecting a competent HACCP audit team, and rules which govern the way the certification process is designed and offered (e.g. the minimum auditor time) have to be followed.

Authority is obtained when the Certifying Body is formally accredited by a recognised Body to operate the certification system for HACCP based Food Safety Systems The certification bodies must meet “General requirements for bodies operating assessment and
certification / registration of quality systems”, ISO/IEC Guide 62:1996 (EN 45012) and
the Standards for auditing (ISO 10011, Part 1, 2 and 3).
and is audited regularly by this Accreditation Body. Accreditation concerns the reliability and competence of the Certifying Body.
The document “Requirements for Certification Bodies” elaborates the accreditation requirements.

It must be understood that certification of a HACCP-based Food Safety System is not a guarantee of a food business operator’s continuous food safety performance. The value added to a food business operator with a certified HACCP-based Food Safety System lies in the efforts made by the operating company to maintain that HACCP system and its commitment to continuously improve its food safety performance.

Requirements for a HACCP based Food Safety System

The requirements in this Specification provide a basis for compliance of a HACCP-based Food Safety System with (inter)national legislation and codes of practice. They include the necessary management system requirements. The structure, the sequence and interaction of the assessment process is detailed in Figure 1.

In the description of every clause, the scope of the requirements is detailed. Using these clauses, the audit team assesses the documented HACCP-based Food Safety System as well as the implementation and operation of the system on the 'shop floor'.

The “Requirements” lay down a generic set of requirements. An operational HACCP-based Food Safety System shall be, as a minimum, in compliance with these Requirements. In Annex II of this document each heading or paragraph of the “Requirements” refers to the corresponding text in the HACCP guidance document of Codex Alimentarius Codex Alimentarius Commission, “Hazard Analysis and Critical Control Point (HACCP) System and
Guidelines for its Application”, Annex to CAC/RCP 1-1969, Rev. 3 (1997).

.

Figure 1. The structure of a HACCP-based Food Safety System

5.1 Management
responsibility

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5.11 Verification

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5.2
Products

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5.5 Hazard
Analysis

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5.6.1 Specific Control Measures
related to CCP’s

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5.10
Validation

5.7
Critical limits

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5.8 Monitoring

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5.9 Corrective
actions

5.3
Processes

5.4
PRP
Annex 1

5.6.2 General Control Measures

5.12 Documentation and Registration

In order to make the system transparent and enable assessment, the food business operator shall provide information as indicated in these “Requirements”. For each specific condition (product / product group / process / sector), specific requirements shall be detailed by the food business operator. The audit team shall assess this complete system of generic and company specific requirements.

The first version of these “Requirements” (then called “Criteria”) has been developed in co-operation with several Certification Bodies in the Netherlands in the area of food materials and processing, under the authority and responsibility of the National Board of Experts - HACCP. The 1st version was published on May 15, 1996.

Due to the modification of the Codex Alimentarius (Alinorm 97/13A, Appendix II) in 1997, a revision of the Requirements became necessary. The National Board of Experts - HACCP was also able to draw on their experience in order to improve the quality of the “Requirements”. The 2nd version of the “Requirements” was published in September 1998 and translated into English in February 1999.

Recent developments with respect to HACCP-based Food Safety System and developments within Codex, as well as new proposals for Food Hygiene Regulations (thereby repealing the current referenced EU Directives and Regulations), have necessitated a further revision: this 3rd version!
2 SCOPE of APPLICATION

In this document, requirements have been specified to be used during the assessment of operational HACCP systems (HACCP-based Food Safety Systems) which ensure the safety of foodstuffs during preparation, processing, manufacturing, packaging, storage, transportation, distribution, handling or offering for sale or supply in any sector of the food chain.

The “Requirements” are basically applicable to all food businesses or organisations, whether profit-making or not, and whether public or private.

Obviously, the food business operators shall have identified any step in their activities which is critical to ensure food safety and shall have developed, implemented, maintained and reviewed adequate safety procedures, applying the principles of HACCP, including the general principles of food hygiene, and where appropriate the relevant codes of practice and the food safety legislation.

These “Requirements” are not intended for application by suppliers and / or service companies to food businesses, like suppliers of packaging materials, food equipment, industrial cleaning services, etc..

3 REFERENCE DOCUMENTS

The “Requirements for a HACCP-based Food Safety System” are based on the following reference documents:

1
World-wide:
Joint FAO/WHO Codex Alimentarius Commission,
- General Principles of Food Hygiene, CAC/RCP 1-1969, Rev. 3 (1997), amended 1999.
- Hazard Analysis and Critical Control Point (HACCP) System and Guidelines for its Application, Annex to CAC/RCP 1-1969, Rev. 3 (1997).

2
International level:
European Union
2a
General Food law
Regulation (EC) no 178/2002, laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety, dated 28 January 2002.

2b
Council Directive 93/43/EEC on the Hygiene of Foodstuffs, dated 14 June 1993 (PbEC L175);
Specific