Po box 693 4200 AR Gorinchem, The Netherlands

1 B Requirements for a HACCP based Food safety System CCvD-HACCP, September 2002, (revision 32) page 2 of 41. 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 Version2, September 2002 Requirements for a HACCP based Food safety System CCvD-HACCP, September 2002, (revision 32) page 3 of 41. 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.

2 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.

3 National Board of Experts HACCP Po box 693 4200 AR Gorinchem, The Netherlands t: +31-183 645028 f: +31-183 621161 Web site: e mail: Requirements for a HACCP based Food safety System CCvD-HACCP, September 2002, (revision 32) page 4 of 41. CONTENTS 1 INTRODUCTION 5 2 SCOPE of APPLICATION 8 3 REFERENCE DOCUMENTS 9 4 TERMS and DEFINITIONS 10 5 HACCP SYSTEM REQUIREMENTS 13 Management responsibility 13 Policy Scope of the HACCP system Task, Responsibilities, Authorities HACCP team(s) Resources Management review Product Information 15 Product Characteristics Intended use Process Information 16 Flow Diagrams Layout Control and Verification of Process Information Pre-requisite program 17 Hazard Analysis 18 Hazard identification HACCP analysis (risk)

4 Control Measures 20 Specific Control Measures General Control Measures Parameters and Critical Limits 21 Critical process and product parameters Target values, action-limit values and critical limits Monitoring and Measuring 22 Corrective Actions 23 Validation 24 Verification 25 Documentation and records 26 Documents and document control Records 6 ANNEX I: PRE-REQUISITE PROGRAM (PRP) 29 7 ANNEX II: RELATIONSHIP BETWEEN THE REQUIREMENTS 37 AND CODEX GUIDELINES FOR THE APPLICATION OF HACCP Requirements for a HACCP based Food safety System CCvD-HACCP, September 2002, (revision 32) page 5 of 41. 1 INTRODUCTION Reference documents; legislation; background information Food safety is a global concern.

5 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 1. 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 ).

6 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 2. 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 3, as recommended by Codex, form an intrinsic part of this document Requirements for a HACCP based Food safety System.

7 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.

8 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. 1 EU Directive 93/43/EEC on the Hygiene of Foodstuffs, dated 14 June 1993 (PbEC L175). 2 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). 3 Codex Alimentarius Commission, General Principles of Food Hygiene, CAC/RCP 1-1969, Rev. 3 (1997), amended 1999. Requirements for a HACCP based Food safety System CCvD-HACCP, September 2002, (revision 32) page 6 of 41. Of course, a food business operator may also use the Requirements to develop its HACCP-based Food safety System.

9 Certification/Registration ( 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.

10 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 ( 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 4 and is audited regularly by this Accreditation Body. Accreditation concerns the reliability and competence of the Certifying Body.