new certification scheme animal feed sector 2006 haccp manual … · 2012. 6. 20. · code:...

Product Board Animal Feed

GMP+ Certification Scheme Animal Feed Sector 2006

HACCP Manual

Appendix 15

© Productschap Diervoeder (The Hague, the Netherlands) All rights reserved. The information in this publication may be consulted on the screen, downloaded and printed as long as this is done for your own, non-commercial use. For other desired uses prior written permission should be obtained from the Product Board Animal Feed. Approved by the Animal Feed Sector Central College of Experts 20 Mai 2005 Adopted by the board of the Product Board Animal Feed 7 June 2005 Applicable / published 14 December 2005 Effective date 1 January 2006

GMP+ Certification Scheme for the Animal Feed Sector 2006 1 of 2 Appendix 15 : HACCP Manual (version 7 June 2005) © PDV

1. INTRODUCTION The HACCP manual is based on the HACCP criteria, as adopted by the Central College of Experts-HACCP, version 2 September 1998. Of the HACCP criteria a new version is available. The HACCP manual wil be adapted on this. The plan is to provide this new HACCP manual in November 2005. Until then the present HACCP manual willl remain valid. At this the GMP20 HACCP Manual Animal Feed Sector is still operative: Following

GMP+ Certification Scheme for the Animal Feed Sector 2006 2 of 2 Appendix 15 : HACCP Manual (version 7 June 2005) © PDV

Product Board Animal Feed

HACCP Manual Animal Feed Sector

GMP20 ; 21-03-2000 © Productschap Diervoeder (Den Haag, Nederland) – April 2003 All rights reserved. Nothing in this publication may be reproduced, stored in a database or published in any form whatsoever, whether electronic, mechanical, by photocopying or photography or by any other means, without the prior written permission of the owner/publisher.

GMP20; HACCP Manual Animal Feed Sector Version: 21-03-2000 ©PDV

Preface In June 1999, the management of the Product Board Animal Feed determined the Plan of Approach reinforcement quality assurance animal feed sector. The immediate cause to this was the Belgian affair with dioxin-contaminated feed fats, but besides there also were the dioxin affair in Brazilian citrus pulp in 1998 and the attention for animal flour traces in feedstuffs for ruminants in 1998 and 1999. These affairs gave cause to concern on the quality of the animal feed and its guarantees in society, the government and the parties in the animal production chain. Penetrating questions were asked on the completeness and adequacy of the quality level (standardization) and the quality assurance (GMP). The system of quality assurance, applied till mid 1999 for animal feedstuffs had especially been aimed at known risks in the trajectory of production, handling and processing of raw materials and basic products. The affairs mentioned before indicated that a number of possible risk factors in the raw ma-terial chain, although mostly belonging to the food branch, had insufficiently been in focus. That’s why in the Plan of Approach reinforcement quality assurance animal feed sector (June 1999) it was con-cluded that additional, structural measures were necessary in order to prevent as much as possible this kind of risks for the food chain in the future. The main objective of the Plan of Approach is to reinforce the system of standardization, assurance and checking & monitoring in such a way that the desired quality level for animal feedstuffs, in relation to the safety of the animal products for the consumer, is sufficiently guaranteed. This improved and reinforced system should permanently have the confidence of the consumer, as well as the other chain parties in the animal production and sales and of the government. Besides, also the safety for the animal is a point of attention. One of the most important sub-objectives arising from this is the reinforcement of the GMP quality system, especially with the help of the HACCP concept1) in the different chains of the animal feed sector, from raw material products up to and including the users of animal feedstuffs (cattle breeders). Through this, the animal feed sector has chosen for a system of quality guarantee (both GMP and HACCP) that is also applied in the food industry. This underlines that the animal feed sector (and the previous chains) forms part of the food industry. This choice has again been underlined in a quick scan that TNO Voeding performed in July-August 1999 on the GMP regulation animal feed sector (quality series number 58, January 2000). An impor-tant conclusion in this report is that the present GMP regulation forms a good base to build on further to use a systematic method in the identification, evaluation and control of risk factors in management. A GMP system, that is also based on ISO 9002, is a condition for the functioning of an HACCP sys-tem. In an HACCP approach, a weighed and reasonable balance should be found between preventive measures, monitoring and actual inspection and analysis of raw materials on the presence of risks that may yield problems in the consecutive chains of the animal production and sales chain. This HACCP-manual animal feed sector offers a good guideline for this purpose. Besides, companies may use the different risk stock-takings and analyses of product streams that are published by the Product Board.

1 HACCP (Hazard Analysis & Critical Control Points) is a systematic method of analyzing all chains of a produc-tion process, the identification of potential hazards and judgement of risks for the product quality and safety. This should enable the companies in a chain to establish an adequate control of all possible risks. HACCP is in the European Community in the food industry a legally obliged (and accepted) method to control food safety risks.

This HACCP manual was made by TNO Voeding in Zeist by order of the Product Board Animal Feed, assisted by a working group of experts from the compound feed industry, the sector single and the raw material trade. Prior to the determination, a consultation in a wide circle of interested people has taken place. The final version was determined by the management of the Product Board Animal Feed in March, 2000. Panel HACCP-manual animal feed sector: TNO Voeding Mw. Ir. E.W. Oosterom Ir. A.W. Barendsz Dr. Ir. P. Sterrenburg Mw. Ir. H.J. Cnossen Ing. H.L. Heeres Ir. H. Beumer

Group of experts H. Hooijer OPNV H. Kruijer OPNV Ing. H. Cazemier HISFA M.A.J.H. Litjens FOOM (Nevedi) B. den Hollander Comité van Graanhandelaren Ing. Y.Yntema FOOM (Nevedi) Ing. F. Mink KDD

It is expected that during the introduction courses and implementation of the HACCP analysis, many questions will arise. These will be included in a question and answer list (Q&A list) and published on the PDV website (www.pdv.nl). At this moment it has been decided in the first place to introduce HACCP in the chains of compound feeds and single feeds (moisture-rich and fodder products), being the chain for the cattle farm, as well as in the feed fat sector. For the compound feed sector, in part 2 of the manual an example is included of an HACCP analysis for the process steps. It is the intention to extend this part during the first six months of 2000 with a example process scheme for a simple animal feed. At the beginning of 2001 the HACCP-manual will be extended with acuminated risk analysis of a (great) number of raw materials. We hope that this manual will be a practical means for the companies for the introduction of HACCP in their quality system. Besides, we expect that this approach contributes to the further improvement of the quality standard in the animal feed sector, where the starting point is: Feed for Food. On behalf of the management, J.H.M. Kienhuis Chairman J. den Hartog Secretary The Hague, March 2000

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Index HACCP-manual Animal Feed Sector Part 1

Author: TNO Voeding/PDV Page 1 of 23 Table of Contents HACCP-manual Animal Feed Sector Part 1 Code Document

Page

HD.AL.01 1 Introduction

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2 Animal feed legislation and GMP 2.1 Animal feed legislation 2.2 Animal feed sector GMP code

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3 Quality system – general 3.1 Management responsibilities 3.2 Training and education plan 3.3 Documentation, planning and other requirements 3.4 GMP code measures 3.5 Definitions

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4 HACCP plan 4.0 Introduction 4.1 HACCP team 4.2 End product specification 4.3 Intended use 4.4 Process diagrams 4.4.1 Drawing up process diagrams 4.4.2 Symbols 4.5 Confirmation of process diagrams 4.6 Identification of hazards 4.7 Determining control measures / CCP’s 4.7.1 Introduction 4.7.2 CCP decision tree animal feed sector 4.8 Target values and critical limits for CCP’s 4.9 Monitoring CCP’s 4.10 Corrective actions for CCP’s 4.11 Verification of the HACCP system 4.12 Documentation

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10 of 23 10 of 23 10 of 23 11 of 23 12 of 23 12 of 23 14 of 23 14 of 23 14 of 23 18 of 23 18 of 23 19 of 23 19 of 23 21 of 23

5 Literature

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Enclosure 1 Summary of CCP’s and PVA’s 23 of 23

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Document: HACCP-manual Animal Feed Sector Part 1

Author: TNO Voeding/PDV Page 2 of 23 1 Introduction This is the HACCP-manual Animal Feed Sector. HACCP stands for Hazard Analysis & Critical Control Points. This process control system, which has been widely embraced in the foodstuffs industry as the system for controlling food safety, is introduced by way of this manual into the animal feed sector. The animal feed sector is already familiar with the taking of measures to ensure the safety of animal feed. The animal feed legislation and the animal feed sector GMP code already provide for a large number of quality requirements for animal feed. Referred to here are sector-wide measures which will be drawn up if potential problems are suspected at sector level or if defects appear. Company-specific situations can not always be taken into account when drawing up these measures. The added value of HACCP compared to the more repressive mechanisms mentioned is that companies can analyse their own processes in a more pro-active manner. The risk analysis show the real risks to be expected for a specific company situation. The subsequent control measures to be taken must then be formulated. The animal feed sector will, through the implementation of HACCP, fit better into the quality structure of the foodstuff sector. With the introduction of the HACCP system within companies, quality assurance in the animal feed sector will be strengthened in a recognisable manner. The scope of this manual is assurance of the safety of food and feed for humans and animals. The manual is intended for the management and (staff)employees of companies in the animal feed sector who will be developing the company-specific HACCP system. The manual comprises a general section (Part 1; code HD.AL) and a section with examples (Part 2; code HD.VB). The general section discusses the requirements to be met before a start can be made on the implementation of HACCP (Chapters 2 and 3). Chapter 4 contains a plan for setting up a HACCP system. Account has been taken as much as possible when working out this plan with measures already drawn up in the legislation or the GMP code. The symbol ! is a reference to the animal feed legislation and/or the animal feed sector GMP code. A number of examples have been included in the second section of the manual. The examples can be used as a guideline and support in the setting up of a company-specific HACCP system. The company, however, remains responsible for the development of its own system.

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Author: TNO Voeding/PDV Page 3 of 23 2 Animal feed legislation and animal feed sector GMP code Companies have to operate according to legislation concerning food- en feedsafety and GMP-codes or codes of conduct specified for the animal feed sector, before developing a HACCP system. Companies in the animal feed sector have to comply with animal feed legislation and the animal feed sector GMP code. 2.1 Animal feed legislation Animal feed companies in the Netherlands are subject to: • Dutch legislation and regulations issued by Ministries including, among others, the Ministry of

Agriculture, Environment & Fisheries; • Statutes of the Animal Feed Commodity Board (PDV). PDV is a statutory industrial organisation. This legislation and regulations have been derived from the European (‘Brussels’) legislation and regulations. At European level legislation and regulations are determined by the Council of Ministers and the European Commission in Brussels. Three types of legislation are distinguished: • Legislation is binding in all sections for all member states and has to be adopted without

modification. • Directives have to be included in or modified into national legislation within a period of time as

determined in the Directive by the national authority. • Orders are aimed at a specific target group and are binding for those to whom the order is

expressly directed. More information on the applicable legislation and regulations can be found in the series produced by the PDV ‘Animal feed legislation in the Netherlands’. ! Link to animal feed legislation 2.2 Animal feed sector GMP code Companies and organisations must have implemented GMP measures which are applicable to the sector into their businesses before they can set up a HACCP system. Examples of GMP measures are a vermin control programme and a sanitation programme. The GMP measures form the basis for the HACCP system. In the animal feed sector these GMP measures are included in the animal feed sector GMP code. The GMP code included in the GMP regulation has been written on the basis of the quality assurance standard ISO 9001. Chapter 3 deals with the relationship between ISO 9001 and HACCP. ! Link to animal feed sector GMP code

Code: HD.AL.01 Document: HACCP-manual Animal Feed Sector Part 1

Version: 1/0100 Author: TNO Voeding/PDV Page 4 of 23 3 Quality system - general A company has developed a quality management system by using the ISO 9001 quality assurance standard. A number of the requirements formulated in ISO 9001 also form the management support necessary for HACCP. These general requirements, necessary for HACCP, are described in this chapter. In addition a reference is made to a summary of the measures which have already been included in the animal feed sector GMP code. Finally, a list of necessary definitions is given in this chapter. 3.1 Management responsibilities There are a number of requirements relating to animal feed safety which fall within the responsibilities of management. These include the formulation of a quality policy, the formulation of the scope of the HACCP system, the determination of tasks, responsibilities and authorities (TRA’s) and the management review. 1. Formulation of a quality policy.

The management lays down in a quality policy, which is a part of the total company policy, what the organisation wishes to achieve in the area of food and feed safety. It is the responsibility of management to formulate the quality policy by way of concrete objectives and to communicate this within the company. The quality policy is adjusted to the expectations of the customer and it must show that the company is aware that it is part of the food chain. The management will then ensure that the development and implementation of the HACCP system runs in accordance with the planning, that the system is maintained and adjusted in good time when necessary.

! Link to animal feed sector GMP code (quality policy)

2. Formulation of the scope of the HACCP system.

The scope of the HACCP system must be indicated. The scope of this manual is the food and feed safety of products of animal origin. All product(group)s, process lines and production and storage locations for which the organisation is responsible must be involved in the system. The position of the business in the agricultural feed chain must also be indicated.

3. Management review of the HACCP system When the complete HACCP system has been developed and implemented then management must ensure that the HACCP system is maintained and reviewed where and when that is necessary. Quality objectives can also be refined. This means that there is a mechanism with the effectiveness of the system can regularly be checked.

! Link to animal feed sector GMP code (management review)

4. Tasks, responsibilities & authorities (TRA’s) When setting up the HACCP system it is also important to lay down the TRA’s of employees. As an addition to the requirements formulated in the GMP code, the tasks, responsibilities and authorities of employees with regard to food and feed safety should be

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• Addition of management and HACCP team member TRA’s (supervision of implementation of HACCP)

• Addition of TRA’s of production personnel and other operations employees

! Link to animal feed sector GMP code (Responsibilities and Authorities)

3.2 Training It is important for the setting up and implementation of the HACCP system that all personnel involved have sufficient expertise to be able to carry out their (new) tasks. Management will ensure that the employees concerned have been adequately trained. 1. HACCP team training The management representative, the quality co-ordinator and HACCP team should be trained for

HACCP. The animal feed commodity board offers sector-oriented training for this purpose. The level required can also be obtained through experience or through other courses.

2. Training of operations personnel The production and operations personnel who are responsible for the quality in the compound

feed companies must be trained to stimulate awareness of food and feed safety. If one sees the importance of one’s own role in this then the degree of involvement is greater. This can be brought about through courses which are specially aimed at operations personnel.

! Link to animal feed sector GMP code (Training) ! Link to animal feed commodity board training facilities

3.3 Documentation, planning and other requirements 1. Documentation

When establishing a quality system, it is important that there should be a clear, unambiguous structure in documents, instructions, forms and in the other documentation. This holds for HACCP documentation as well. The policy to be drawn up, the requirements to be laid down, the measures to be taken, etc. can be expressed in procedures, plans, instructions, other documents (like registration forms, specifications, etc.).

! Link to animal feed sector GMP code (quality system) ! Link to animal feed sector GMP code (Document and data control)

2. Planning

Following implementation of a quality system it is important to plan the quality checks, sampling, analyses, registrations and inspections which should be carried out according to the quality system. Schedules and/or plans are necessary for this. The planning required for HACCP can be included in, or structured in the same way as, the quality plan specified in ISO 9001. ! Link to animal feed sector GMP code (quality control plan)

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3. Other requirements

A number of ISO 9001 subjects are also essential for the functioning of a HACCP system. These are: ! Link to animal feed sector GMP code (Calibration of equipment) ! Link to animal feed sector GMP code (Inspection and testing) ! Link to animal feed sector GMP code (Quality records) ! Link to animal feed sector GMP code (Tracking and tracing)

3.4 GMP code measures The previous chapters have shown that a number of requirements must have already been met prior to the setting up of a HACCP system. The purpose of this section is to give a summary of the measures already incorporated in the legislation and the GMP code. A large number of these measures are also essential for the setting up of a HACCP system. The sequence of the measures is based on the sequence in the animal feed sector GMP code.

N.B.: This summary is intended for reference purposes and is not intended to replace the GMP code.

3.5 Definitions Control measures Measures which control a hazard to food or feed safety to such a degree that any hazard to food is prevented, eliminated or reduced to an acceptable level. # Specific control measure (CCP)

Specific control measures are specially developed and used to control the estimated risk. # General control measure (POA)

General control measures are those measures (procedures or instructions) which do not specifically apply to a single process step or which are of a global nature such as the purchasing plan, maintenance plan, cleaning plan, etc. NB: For the animal feed sector these measures have often been included in the animal feed sector GMP code.

# Periodic measure Periodic measures are measures which are carried out once and which are periodically reviewed/ assessed

Consumer Consumer (human) of products of animal origin. Target animal The animal for which the end product (compound feed or single feed) is intended. Hazard A biological, chemical or physical contaminant in food or feed with possible adverse consequences for health. Hazard-identification Identification of possible hazards in the production process using process diagrams, end product specifications, literature and other information.

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Author: TNO Voeding/PDV Page 7 of 23 GMP Good Manufacturing Practices. Series of agreements in a branch or sector in which the standard of conduct is laid down (often with respect to hygiene / food and feed safety). NB: For the animal feed sector these measures have been laid down in the animal feed sector GMP code. HACCP (Hazard Analysis & Critical Control Points) A process control system relating to food and feed safety which identifies hazards and quantifies risks. The risks are controlled using control measures. Risk The risk of a potential hazard is the result of the severity to health and the probability of occurence. Risk analysis (within HACCP) The hazard identification and risk assessment form together the risk analysis. Risk assessment The collection and evaluation of information about a hazard in order to be able to decide whether this forms a risk for food and feed safety. Validation Obtaining evidence or confirmation that the elements of the HACCP system (such as CCP's) are effective. Verification The use of supplementary information to check whether the HACCP system is (still) effective and whether it is being used as intended. Feed safety The certainty that animal feed does not cause any negative effect on the health of the target animal when it is prepared and/or consumed in the manner intended. Humans may also not be harmed as a result of consuming products of animal origin. Food safety The certainty that food does not cause any negative effect on the consumer when it is prepared and/or consumed in the manner intended.

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Author: TNO Voeding/PDV Page 8 of 23 4 HACCP plan 4.0 Introduction Hazard Analysis & Critical Control Points, HACCP, is a process control system related to food and feed safety. HACCP can be divided up into 12 steps which are described in the Codex Alimentarius. A HACCP system can be set up and used in combination with other quality systems. The way in which HACCP is described in the Codex Alimentarius has provided the standard for this manual. The HACCP plan comprises the following twelve steps: 1. Assemble the HACCP team:

The HACCP team takes care of the setting up, implementation and maintenance of the HACCP system in the company.

2. Formulate end product specifications: End product specifications and (if necessary) raw materials specifications are drawn up or obtained.

3. Identify intended use: The intended use of the product is laid down in end product specifications

4. Construct process diagrams: The production processes are shown in process steps in diagram form.

5. Confirmation of process diagrams: Process diagrams must be checked in practice after they have been formulated.

6. Identify hazards: The hazards which may be possibly expected are identified on the basis of the process diagrams and end product specifications.

7. Determine control measures / CCP’s The risk is assessed for every possible hazard to be expected (risk assessment). The type of control measure which can be used to reduce the risk is then established.

8. Determine target values and critical limits for CCP’s: Target values and critical limit values must be established for CCP’s.

9. Monitoring of CCP’s: Monitoring of process parameters is carried out in order to be able to determine whether the CCP is controlled.

10. Determine corrective actions: Determine which corrective actions will be taken if the critical limits are exceeded.

11. Verification of the system: The use of supplementary information to check whether the HACCP system is (still) working effectively.

12. Draw up the necessary documentation: The necessary documentation must be drawn up and/or the current documentation must be supplemented.

These steps are discussed in detail in the following sections. 4.1 HACCP team The HACCP team is a multi-disciplinary company team which supervises the setting up and implementation of the HACCP system. After implementation the HACCP team plays a role in the maintenance and verification of the HACCP system. The HACCP system is specific to the companyThe competence of the members of the HACCP team must guarantee the proper development and implementation of the specific HACCP system. The team is free to use the completed examples which have been included as enclosures to this manual.

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Author: TNO Voeding/PDV Page 9 of 23 The management of the company is responsible for the foundation of the HACCP team. They will ensure that the members of the HACCP team have time and, where necessary, money available for setting up and implementing the HACCP system. Both large and small companies must set up a HACCP team. The size of the team depends on the size of the company and the expertise of the members of the team. In a large company the HACCP team may consist of 5 or 6 people whereas in small companies it is possible to make do with 2 or 3 people. It is important that different areas of expertise are represented in the HACCP team. The more areas of expertise represented in the team, the more complete the HACCP system will be. In addition to various areas of expertise, the team members should be drawn from the various hierarchical levels within the company. This will ensure that HACCP will be accepted by the whole company. The areas of expertise which must be represented in every HACCP team are: • management representative (with authority to take decisions) • knowledge of methods of working on the shop floor • quality co-ordinator with insight into the quality of raw materials and end products Depending on the activities of the company, and therefore if applicable, the following areas of expertise must also be represented in the HACCP team: • knowledge of purchasing • knowledge of the production process • knowledge of storage, transport and sales • technical expertise related to the machines • knowledge of nutritional and agricultural matters Both the management representative and the quality co-ordinator in the HACCP team must follow a HACCP course or a comparable level must have been reached through experience. The HACCP team must, in addition to going through the 12 HACCP steps, ensure proper integration with quality systems and procedures which are already present. The general requirements mentioned in chapters 2 and 3 must therefore also be taken into consideration by the HACCP team and processed in the applicable documents. The company must record the composition of the HACCP team and the areas of expertise of the members of the team in a document or supplement any documentation which already exists. The expertise must be verifiable by, for example, diploma’s or demonstrable job experience. If the required expertise is not available within the company then external specialists may be involved in the work of the team. External expertise must also be recorded in the documentation.

! Link to animal feed sector GMP code (Resources)

! Link to animal feed sector GMP code (Training)

4.2 End product specifications Information about end products is necessary to be able to estimate correctly which hazards may occur in the production process or which hazards are presented by the end products (animal feed) for animals or humans. The HACCP team maps out this information using end product specifications. End product specifications give an initial indication of possible hazards. In addition to the raw materials used (ingredients) and nutritional values of the end product, other characteristics must also be specified which have an influence on feed and food safety.

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Author: TNO Voeding/PDV Page 10 of 23 These may be chemical, physical or micro-biological characteristics (in the sense of contaminants or undesirable contents) but they may also be requirements for production, storage or transport. The characteristics mentioned in the specification must be taken into consideration by the HACCP team when setting up and implementing the company-specific HACCP system. HACCP prescribes, in theory, that every end product must be described separately in a specification. It is, for practical reasons, permissible to make product groups. The products must, however, be grouped together in such a way that differences in ingredients or processing steps will not lead to additional hazards. A division into three parts can be used in drawing up the end product specifications. Generally applicable requirements and characteristics at animal feed level can be recorded “once”. These characteristics apply then for all animal feed which is produced in a company. The same can then be done for the characteristics which are common to an animal species (often a product group). Characteristics which apply specifically to the product can be recorded at product level.

N.B.: Micro-biological requirements such as ‘Salmonella absent in 25 grams’ can, for example, be recorded at animal feed or animal group level.

In order to determine which amounts of contaminants are actually in the end product, it is necessary to know about the raw materials used and their production. This means that insight is necessary into raw materials by way of raw materials specifications. An example of an end product specification is included in Part 2 of this manual.

! Link to animal feed sector GMP code (Specifications)

! Link to animal feed sector GMP code (Purchasing data)

4.3 Intended use The HACCP team finds out whether the user can keep and use the product as intended without any hazard to animal or human health. This can be taken care of by, among other things, providing the right information. The end product specification must record for which target groups the product is intended. The animal species, the age of the animal and the directions for use (including storage conditions) must be laid down. In addition there must be certainty that the feed does not, if used normally, form a risk in animal products. Giving consideration to the target groups prevents hazards from being overlooked. This includes hazards to the animal and hazards which may arise for the consumer (human) of the animal products. 4.4 Process diagrams 4.4.1 Drawing up process diagrams The HACCP team draws up a process diagram of the production process for each product (or product group) in accordance with the scope of the HACCP system. These process diagrams must indicate which process steps are used to produce a particular end product. The process diagram also indicates which raw materials and additives are used and whether any by-products are created during the process.

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Author: TNO Voeding/PDV Page 11 of 23 Each process, production or processing step must be shown separately in the process diagrams. Hazards can be identified using these company-specific process diagrams (see section 4.6 ff.). The following items are important when drawing up process diagrams: • Choose an end product or product group • Define the limits of the description of the process (start-end) • Make simple, clear diagrams • Limit the number of symbols to make things clearer and simpler • Use unambiguous terminology for products and/or processes • Work as much as possible from top to bottom and from left to right • Describe the main process for the end product or product group • Detail the main process into sub-processes • Show the relationship among the sub-processes with a connector symbol • Show raw materials and additives, semi-manufactured products, by-products and end products. A process diagram can be divided up into a main process and sub-processes. The drawing up of a main process can be useful if the process is complicated because of many process steps and/or if there are many input and output flows. The major process steps in the production process are included in the main process diagram. Each main process step is then worked out in a more detailed process diagram where all the process steps are shown separately. A map of the floor plan of the production areas can be useful when systematically mapping and verifying the production processes. 4.4.2 Symbols Four symbols are used when drawing up the process diagrams. Main process step

This symbol shows the major activities or operations for a part of the process in the main process diagram. The main process steps are worked out in more detail in sub-process diagrams. Process step This symbol indicates an activity or operation (a process step). Hazards are identified based on the process steps (see 4.6).

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Author: TNO Voeding/PDV Page 12 of 23 Product This symbol indicates a tangible product (for example a raw material) or other tangible materials (for example steam or air) which enters or leaves a process. Connector symbol This symbol indicates the beginning or end of the process diagram. When it is used as a begin symbol then the name of the process in question can be given in it. When it is used as an end symbol then the name of the next sub-process can be given in it. This shows the cohesion of the various sub-processes. Please refer for a completed example to Part 2 of this manual. 4.5 Confirmation of process diagrams After the process diagrams have been drawn up they must be checked in practice by the HACCP team. In this test the HACCP team checks the processes once again on site (verification of the process diagram). When the same operation is carried out by different persons and/or shifts it is important that the process diagrams are checked against the working methods of all these persons and/or shifts. If it is shown in practice that process steps have been missed then the process diagrams must be changed. The test is intended to make certain that the right process diagrams are used. If the process diagrams and what is done in practice agree with one another then the next step may be taken. 4.6 Hazard identification Using the end product specification and the expertise of the HACCP team, the process diagrams are used to systematically determine for every step in the process which hazards may actually be expected. This activity is called hazard identification and is part of the risk analysis. The HACCP team meets a number of times to identify these hazards per process step and to identify them as completely as possible. It is recommended that, where necessary, external advisors are used in these brainstorming sessions to avoid incompleteness due to “company blindness”. When defining the hazard the source and/or origin of the hazard can be indicated briefly. This makes the subsequent establishment of control measures simpler (see section 4.7).

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Author: TNO Voeding/PDV Page 13 of 23 A hazard can be described as a contaminant in feed which can have adverse consequences for the health of humans and animals. In addition to the hazards (risk factors) which are included in the animal feed sector GMP code, three types of hazard are distinguished: 1. Chemical hazards are undesirable chemical elements which may make the product unsafe for

consumption. They may be present in the raw materials or may contaminate the product during the production process through, for example, contact. Examples are residues of pesticides, hormones, antibiotics, heavy metals, environmental pollution, mycotoxins, PCB’s, dioxins, cleansing agents, lubricants, mineral oils, etc. Too high a concentration of desirable elements can also be a hazard and may make the product unsafe for consumption.

Animal feed sector GMP code:

Chemical hazards: Undesired substances and products Residues of additives and animal drugs Production additives Biological decomposition products Criteria for the fat ratio Minerals and acid remains

2. Microbiological hazards relate to the presence of undesirable micro-organisms. The micro-

organisms can, as a result of their (natural) presence, contamination or development, result in a product being unsafe for consumption. Consumption of the product can then cause food infections or food poisoning. A distinction is made among vegetative micro-organisms, toxigenic (toxin forming) micro-organisms and spore forming micro-organisms. Examples are Salmonella, Enterobacteriaceae and “Moulds and Yeasts” (the latter group as indicator organisms).


(Micro-)biological hazards

Veterinary risks (animal diseases) Hygiene (Salmonella control)

3. Physical hazards

Physical hazards are foreign bodies such as glass, plastic, metal components, stones, bones, etc., which may be present in the raw materials or contaminate the product. This makes the product unsafe for consumption.


Physical hazards Remains of packaging materials In the example in Part 2 a number of hazards are identified per process step. Every company must, however, evaluatet its own situation to determine with which (additional) hazards the company is confronted. It is recommended that a list is drawn up of concrete hazards from the point of view of product specifications and (business) expertise which is specific to the company. This list is the basis for going through the decision tree. ! Link to animal feed sector GMP code (Production)

! Link to animal feed sector GMP code (Chapter 3; Risk factors)

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Author: TNO Voeding/PDV Page 14 of 23 4.7 Determining control measures / CCP’s 4.7.1 Introduction When the hazards have been identified, it must be established in which process step(s) there will be a critical control point (CCP) and/or which other control measures are necessary. In order to do this, the identified hazards are subjected to the CCP decision tree for the animal feed sector. ! Link to animal feed sector GMP code (Process control)

The identified hazards must be identified for each process step. A risk analysis table can be used for this. An example of such a table is included in Part 2 of this manual. 4.7.2 CCP decision tree animal feed sector Each identified hazard must be assessed by the HACCP team using the CCP decision tree. The CCP decision tree is used to determine whether a hazard must be controlled using a specific control measure (CCP), a general measure (POA) or another periodic measure. The CCP decision tree for the animal feed sector is shown in this section. Part of the CCP decision tree is the risk assessment. This determines which type of control measure is necessary to eliminate hazards and/or to reduce risks and to control them at an acceptable level. Control measures can vary from technical/technological solutions to organisational and/or procedural measures. Where possible the control measures can be integrated with the measures in the animal feed sector GMP code. There are, therefore, various possibilities for controlling risks.

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Author: TNO Voeding/PDV Page 15 of 23 CCP decision tree animal feed sector Question 1: Are there identified hazards present which have a harmful effect on the safety of the product and/or can the hazard exist or be increased to unacceptable levels? ↓ ↓ Yes No → stop and continue 1 ↓ Question 2: Which types of control measure(s) are necessary according to the risk assessment? ↓ ↓ ↓ ↓ specific general periodic none 1 measures 4 measures 3 measure 2 ↓ ↓ ↓ ↓ → stop and continue 1 ↓ ↓ → include in verification procedures ↓ → include measures as POA’s and in verification procedures ↓ Question 3: Are the specific control measures referred to present? ↓ ↓ Yes No → modify the process or product ↓ and start again at question 1 Question 4: Has this process step been specifically developed to eliminate the risk or to reduce it to an acceptable level? ↓ ↓ ↓ No Yes → → → → → ↓ Question 5: ↓ Will the risk be eliminated in a subsequent process step or will it be reduced to an acceptable level? ↓ ↓ ↓ Yes No → → → → CCP ↓ stop and continue 1

1 Stop and continue with the next hazard Risk assessment Severity Probability of occurrence (in end product; at consumption) Great 3 4 4 Medium 2 3 4 Small 1 2 3 Small Medium Great

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Author: TNO Voeding/PDV Page 16 of 23 Risk assessment Risk assessment is a method by which classes of risk can be defined. Risk is determined by two elements, ‘severity’ and ‘probability’ of a potential hazard. The assurance for each risk class is characterised by (a combination of) control measures. Severity is the consequence for the consumer and/or the target animal when exposed to the hazard. Severity is divided into three levels: • great: fatal consequences, serious illness, irrecoverable injuries both immediately or in the longer term • medium: substantial injuries and/or illness, occurring both immediately or in the longer term • small: minor injuries and/or illness, not or hardly occurring or only in extremely high doses for a long period of time The probability is the frequency that the hazard will occur in the end product at the moment of consumption by humans and/or the target animal. The probability is based on measurements, observations or expectations in a company-specific situation and it is divided into three levels: • small: practically impossible or not probable • medium: might occur, it has been known to occur • great: occurs repeatedly

Risk class Control measures 1 No measures necessary. 2 Periodic measures are measures which often cover a one-time activity. These

measures must be reviewed periodically which means they must be checked against the insights available at that moment.

3 General control measures, such as proper hygiene facilities, procedures for cleaning and desinfection personal hygiene instructions and maintenance, vermin control, maintenance and calibration, purchasing procedures and raw materials specifications, complaint handling and recall procedures, etc. These general control measures are often called POA’s (Points of Attention) or GMP measures. For the animal feed sector these measures have mostly been included in the animal feed sector GMP code.

4 Specific control measures are specially developed and used to control the risk. In part two there is a summary of existing GMP-measures (enclosure 1) and supplementary measures are mentioned (enclosure 2).

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Author: TNO Voeding/PDV Page 17 of 23 Completing the risk analysis table (see examples in Part 2) During identification of the hazards at each process step and working through the CCP decision tree, the risk analysis table can be filled in line for line. This shows, demonstrable on paper, that the HACCP analysis has been carried out. 1. The hazards are identified per process step in the process diagram (section 4.6) and they are entered

in the risk analysis table. In the table the columns No., Process step and Hazard description are filled in per line.

2. An indication is given per hazard of which of the three categories apply (M: micro-biological, C:

chemical, F: Physical). Fill in column Cat. 3. The CCP decision tree is gone through for each hazard and consists of a number of questions. The

risk assessment is mentioned in question 2 of the decision tree. The probability, the severity and the risk class are completed in the appropriate columns in the table (columns Probability, Severity and Risk).

4. In the Explanation column there must always be a short explanation of the results per hazard. This

explanation is intended to explain the choice made by the HACCP team. In addition, this information can be used in later verifications and it can also be used by HACCP teams which have changed their composition. In this way the considerations remain accessible and clear.

5. When the decision tree has been gone through, the (control) measures must be summed up in the

column Types of measures. These can also be measures which are mentioned in the animal feed sector GMP code.

Completed examples have been included in Part 2 of this manual. A number of hazards have been identified in these risk analysis tables. The results per hazard (using the CCP decision tree) are, however, not filled in. Because this is a general example, not a company-specific situation, it is difficult to estimate the severity and probability of potential hazards. Probability, in particular, is very company-specific. The HACCP team of a company is also responsible for identifying other hazards (additional, company-specific hazards). A list is made of all the measures in the risk analysis table in the examples which have already been mentioned in the animal feed sector GMP code. A great number of hazards are, therefore, already partly controlled by one or more measures in the GMP code. In addition to this and depending on the results of the risk assessment, these measures must be supplemented with company-specific measures.

N.B.: If the risk assessment for the hazard results in a “4", then there is a CCP. Even if a number of measures are mentioned in the GMP, additional specific control measures (CCP) must be formulated in that case. If the risk assessment for a hazard results in a “2" or a “3", then the measures already recognised in the GMP may be effective enough to sufficiently reduce the hazard.

See also the summaries of measures (part 2; enclosure 1 and 2).

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Author: TNO Voeding/PDV Page 18 of 23 4.8 Target values and critical limits for CCP’s The HACCP analysis determines where specific control measures are necessary to control CCP’s in order to be able to guarantee the safety of the product. These are the measures which are divided into risk class 4 during the risk analysis. Specific control measures relate to (process) parameters which can be so controlled that hazards related to the safety of food and feed are avoided, eliminated or reduced to an acceptable level. If there were to be no control then there would be a great risk. When describing the specific control measures, target values and critical limits must be set and recorded. A target value is set for the measured value of the parameter. This value obviously lies within the critical limit values. Critical limits are values within which the measured value of the (process)parameter may vary in order to be sure that a safe product is obtained. If the limits are exceeded then there is an unacceptable situation.

N.B.: It is permitted to make use of a so-called action limit before the critical limit is reached and the process is, therefore, no longer controllable. When the action limit is attained direct action can then be taken without the critical limit actually being reached. An action limit is a value between a target value and a critical limit value.

When determining the target values and critical limits for CCP’s it is obligatory to comply with the requirements set by the relevant legislation and regulations for food and feed safety. If there are no legal requirements with respect to target values and critical limits, then the target values set with respect to CCP’s must be validated through one’s own research and described in a validation report. Such a validation report should, therefore, be available. See enclosure 1 for an example of a summary of CCP’s and POA’s. 4.9 Monitoring CCP’s Monitoring is the planned measurement, analysis and/or observation (visual testing) of the process parameters in order to be able to establish where a CCP is under control. The monitoring of CCP’s can be a continuous, semi-continuous or charge-driven measurement depending on the process step and the nature of the (process) parameter to be measured. If there is no continuous monitoring then the batch in question must be blocked from the previous measurement moment if the critical limit values are exceeded. The way in which the measurements and/or observations are carried out and recorded, the frequency of measurement and the employee responsible for monitoring must be recorded in a (job)instruction. The results of the monitoring are recorded on registration forms. ! Link to animal feed sector GMP code (Documentation)

See enclosure 1 for an example of a summary of CCP’s and PVA’s.

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4.10 Corrective actions for CCP’s After the setting of target values and critical limits and the setting up of a monitoring programme, a decision must be made on corrective actions to be carried out if a critical limit is exceeded. In that case the safety of the end product can, after all, no longer be controlled. Examples of corrective actions taken when critical limit values are axceeded are:

Example Corrective actions: identification of the non-conforming products and temporary block on the product or batch adjustment of the process; recovery of production conditions unblocking the product or the batch through actions varying from : - recovery of the product or the batch - destruction of the product or the batch - recall from the market The way in which the measurements and/or observations are carried out and recorded, the employee responsible for monitoring, the corrective action and the employee responsible must be recorded in an (job)instruction. The results of the monitoring and the results of the action to be taken in the event of deviation must be recorded on registration forms. N.B.: Corrective actions (HACCP term) should not be confused with corective measures (ISO/GMP animal feed term). See appendix 1 for an example of a summary of CCP’s and POA’s. 4.11 Verification of the HACCP system After the HACCP system has been developed and implemented periodic verification of (elements of) the system must take place. The HACCP team has a major task in this. Verification is the use of supplementary information to verify whether the system is still effective and whether it functions as intended. The verification results must be recorded in writing. Verification of (elements of) a HACCP system must consist of: 1. Verification of CCP’s

Trend analysis of measurement data for the parameters associated with the CCP’s, any deviations in the process and the corrective actions taken. The measuring equipment used for CCP’s must also be calibrated.

! Link to animal feed sector GMP code (Control of inspection, measurement and testing

equipment) 2. Verification of the HACCP system by sampling and analysis of products.

Periodic examination of end products for micro-biological and chemical characteristics is a method of finding out whether the HACCP system is still working as intended. The end product specifications are used for this. When analysis results do not conform to the end product specifications then corrective measures must be taken.

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! Link to animal feed sector GMP code (Corrective and preventive measures)

! Link to animal feed sector GMP code (Inspection and testing)

! Availability of analysis norms, sampling plan, analysis results.

3. Verification of the risk analysis.

The company-specific process diagrams and risk analysis must be reviewed as often as necessary in order to discover whether new or additional hazards may occur in the raw materials or during the production process. The HACCP team records how often this review will take place but this must be at least once a year and whenever relevant information is made known.

This review is relevant when: • an emergency is suspected • there is a report from the Early Warning System • reports from the media • updating of risk analyses at chain level • other indications (own sampling, databanks) • changes in the production process

It is even possible that hazards may be discovered which have been denied or not recognised for years. At the moment that a business has insight into the hazard potential then it should be included in the company-specific HACCP plan. Not only external factors but also the results of one’s own sampling of raw materials and finished products and/or results from databanks supply input for re-evaluating the company’s risk analysis and, if necessary, reviewing it.

4. Internal audits A large number of hazards are controlled by general procedures, regulations and instructions. These procedures and instructions are also known as Points of Attention (POA’s). An audit has, among other things, the aim to check whether the appropriate procedures and instructions are being complied with. The verification of POA’s which cover a large number of general hazards is especially important for the functioning of the system.

! Link to animal feed sector GMP code (Internal quality audits)

5. Analysis of complaints relating to food and feed safety of products.

Complaint handling also provides information within a HACCP system about the effectiveness of the system. ! Link to animal feed sector GMP code (Corrective and preventive measures)

The results of verification must be recorded. The HACCP team, which continues to play a role in the maintenance of the system, must evaluate the results of the verification and then present its findings to management. Management uses these assessments in turn for the management review as described in Chapter 3.1.

! Link to animal feed sector GMP code (Management responsibility and Management review)

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Author: TNO Voeding/PDV Page 21 of 23 4.12 Documentation Documentation plays an important role in maintaining a process control system based on HACCP. Documentation ensures that the HACCP system is demonstrably present. Documents also provide information to employees about the tasks to be carried out and the agreements made within a company. The required documentation which follows the implementation of HACCP can be included in the quality documentation required by GMP. ! Link to animal feed sector GMP code (Document and data control) ! Link to animal feed sector GMP code (Quality system) ! The availability of the relevant documentation is also indicated in all the other sections of the GMP

code. Documents which must be present for HACCP: • HACCP team document (members and areas of expertise) • End product specifications or end product group specifications • Process diagrams • Risk analysis (tables) • Description of CCP’s (in a table or summary) and associated documents • Description of POA’s (in a table or summary) and associated documents • Description of HACCP system verification procedures

Registration After implementation of the HACCP system data is collected at a number of places which has to be registered. These are: • Registration forms for the monitoring of CCP’s • Registration forms for POA’s • Verification of CCP’s • Verification of the HACCP system by sampling and analysis of products. • Verification of the risk analysis. • Internal audits • Complaints analysis ! Link to animal feed sector GMP code (Control of quality records)

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Author: TNO Voeding/PDV Page 22 of 23 5 Literature 1. Codex Alimentarius Commission - Food Hygiene - Basic Texts. Issued by the Secretariat of the Joint

FAO/WHO Food Standards Programme, © FAO/WHO, Rome, 1999. 2. GMP regulation animal feed sector Animal Feed Commodity Board, PDV compilation GMP regulation

animal feed sector. 3. Westendorp, M.C., Corstiaensen G.P. and M.H.M. van den Ekart. HACCP WORKBOOK in the meat

sector, Animals, Meat and Eggs Commodity Boards, Rijswijk, 1999. 4. Beumer, H. and A.W. Barendsz. HACCP as a tool to assess and control risks in the feed industry.

RIGRO 99-04 5. Animal feeding and food safety, Report of an FAO Expert Consultation, Rome, 10-14 March 1997.

FAO Food and Nutrition Paper 69, Rome, 1998.

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Author: TNO Voeding/PDV Page 23 of 23 Enclosure 1 Summary of CCP’s and PVA’s As was shown in steps 8 to 10 of the plan, the Codex Alimentarius shows that target values and critical limits, monitoring programmes and corrective actions must be established for CCP’s. In order to provide a clear summary of the recognised CCP’s a table can be used in which for all the CCP’s the target values and critical limits, monitoring and corrective actions are shown. This table can also give a reference to the necessary procedures, instructions and registration forms (documentation). The risk analysis often shows that general measures (POA’s and/or GMP measures) also play an essential role in the reduction of a hazard (risk class 3 of the risk assessment). It is recommended that the POA’s should be summed up in a table. Indicate, where possible, monitoring frequencies and corrective actions (this is dependent on the specific POA and will not be possible in all cases). Also indicate the necessary procedures, instructions, registration forms and other documents. ! Link to animal feed sector GMP regulation (Process control)

Example table CCP’s CCP Target

values and critical limits

Monitoring Corrective actions Documen-tation (incl. validation of CCP’s)

Frequency Responsibility Description of action

Responsibility

CCP 1 CCP 2 ... ..... .....

Example table POA’s POA Description of

POA Monitoring Corrective

actions Verification Documen-

tation POA 1 POA 2 .... .... .....

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Index HACCP-manual Animal Feed Sector Part 2 Example 1

Author: TNO Voeding/PDV Page 1 of 24 Table of Contents HACCP-manual Animal Feed Sector Part 2 Code

Document Page

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Example 1 Compound feed for broilers End product specification compound feed Main process compound feed for broilers Sub-process 1: Purchasing, transport, draw up recipe Sub-process 2: Reception, storage after reception Sub-process 3: Dosage, grinding, mixing Sub-process 4: Press meal conditioning, pelleting, cooling Sub-process 5: Storage for delivery, distribution

2 of 24 4 of 24

6 of 24 9 of 24

12 of 24 15 of 24 19 of 24

Enclosure 1: Summary of measures and references to the animal feed sector GMP code

22 of 24

Enclosure 2: Additional measures 24 of 24

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Author: TNO Voeding/PDV Page 2 of 24 Example compound feed end product specification Items for HACCP Name of product or product group Product codes or numbers Description of product(s) Intended use ! Animal species / animal group ! Age ! Directions for use (incl. storage conditions) Legal requirements Chemical contaminants, incl. specific undesirable raw materials (from animal feed legislation and others) ! Heavy metals ! Pesticides ! PCB’s and Dioxin ! Mycotoxins (Aflatoxin, DON, ZEA, Ochratoxin, etc.) ! Decomposition products (biogenic amines) Microbiological contaminants ! Pathogens (for example Salmonella) ! Spoilage flora ! Moulds and yeasts Physical contaminants ! Undesirable elements (sand, gravel, glass, metal particles, bones, etc.) Packaging Labelling/tagging with a batch identification (batch number, date) Keeping qualities (Shelf life) Transport and delivery conditions ! Transport type and form (truck, boat, pallets, etc.) ! Documents to be used

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Author: TNO Voeding/PDV Page 3 of 24 Additional items relating to quality Composition Nutritional value (Weende analysis) ! Moisture ! Crude protein ! Crude fat ! Crude cellulose ! Crude ash ! Other carbohydrates Sensory characteristics ! Colour ! Texture ! Taste (for target group) ! Flavour Physical quality characteristics ! Durability ! Hardness ! Bulk density ! Pellet length ! Meal ! Flow properties ! Particle size distribution

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Document: Example 1 compound feed for broilers

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1PURCHASING,TRANSPORT

START

2RECEPTION

5STORAGE FOR

DELIVERY

4PRESS MEAL

CONDITIONING,PELLETING,

COOLING

3DOSAGE,

GRINDING,MIXING

END

Main process diagram: Compound feed for broilers

1DRAW UP

RECIPE

2STORAGE AFTER

RECEPTION

5DISTRI-BUTION

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Main process Subject or item Type of measures Reference1

Motivation

General Relevant (applicable) animal feed legislation and regulations

Relevant legislation and

regulations

Before HACCP can be implemented, the relevant (applicable) animal feed legislation and regulations relating to feed safety must be implemented. Generic hazards (hazards which apply to the whole sector) can be controlled by way of instructions, standards, etc.

General The general measures from the animal feed sector GMP regulation are:

GMP regulation animal feed

sector

Sector-wide GMP measures or General Points of Attention are the basis for a HACCP system (prerequisites). If these measures are not present and not implemented, then no effective HACCP system can be set up.

End product specifications Lay down specifications of animal feed to be supplied and other products to be supplied

9 For target animal and subsequent consumer and for enabling to estimate the product and/or process specific hazards

Business set-up Equipping of company areas (incl. sewers) 24 Condition for good business operations

Hygiene Hygienic working so there is compliance with the law and the GMP Hygiene inspections

25 45

Condition for good business operation (among other things prevention of recontamination)

Prevention of mix/contact/ cross infection Action during mixing Assessment of subject and functioning of equipment Determination of degree of contact contamination in equipment Production sequence

22 34 36 37

Condition for good business operation (among other things prevention of recontamination)

Cleaning Cleaning programme (company areas, equipment and (internal) transport systems)

26 Condition for good business operation (among other things prevention of recontamination)

Maintenance plan Maintenance, control and inspection schedules for equipment, (internal) transport systems

39 Essential pre-requisite for the functioning of a HACCP system. Required by GMP regulation animal feed sector

Vermin, birds and pets Draw up vermin control programmes (incl. birds, pets) 29 Condition for good business operation (among other things prevention of recontamination)

Water, steam and air Control of water, steam, air quality M Condition for good business operation (among other things prevention of recontamination)

Waste Control of waste flows N Condition for good business operation (among other things prevention of recontamination)

Company-specific situation Company-specific measures Z

1 See enclosure 1 GMP regulation measures and enclosure 2 Additional Measures to the HACCP manual (part 2)

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Sub-process diagram 1: Purchasing, transport, draw up recipe

1.4transport of

raw materials

dry rawmaterials*

fluid/moisture rich raw

materials**

raw materials

specificationsraw materials,

etc.1.2

purchasing

start

1.1draw up

master recipe

1.3draw upfactoryrecipe

end

List all raw materials used and additives:*Dry raw materials: processed raw materials, pre-mixes, rejects from the food industry, return feed from farms, etc.**Fluid/ moisture rich raw materials: fluid raw materials, foodstuff industry rejects, etc.

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Sub-process 1: Purchasing, transport , draw up recipe no. Process step Hazard description Cat. Prob. Sev. Risk Type of measures Reference Motivation

1 Purchasing raw materials 1.0 General Passing on of chemical contaminants in (raw)

materials or ingredients from: • remaining raw materials from a previous

load

C • Transport of delivered raw materials • Transport guidelines

13 23

Entry and growth of undesirable micro-organisms from: • remaining materials from a previous load • rainfall, leakage or damp from the

underside of the loading platform (truck) or from the hold (ship) so that the raw material is damp

M • Transport of delivered raw materials • Transport guidelines • Work hygienically

13 23 25

1.1 Draw up master recipe Presence of undesirable chemical substances as a result of incorrect preparation method

C • Production and handling instructions 28

1.2 Purchasing Presence of chemical contaminants in excess of the norms set (dioxins, PCB's, heavy metals, mycotoxines, residues of combustion gasses)

C • Acceptance of an order • Drawing up purchasing specifications for

products and services • Evaluation and registration of suppliers,

products and services • Maximum acceptable difference between

the analysis content and the declared content

• Production and handling instructions

12 18, C

17

11

28

Presence of undesirable micro-organisms above the norm set

M • List of all raw materials used • Possession of analysis results for

delivered raw materials • Knowledge of prior history • Sampling of batches

A B

D E

Presence of physical impurities (glass, stones, metal etc.)

F • Tracking and tracing F

1.3 Draw up factory recipe .

Presence of undesirable chemical substances as a result of incorrect preparation method


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no. Process step Hazard description Cat. Prob. Sev. Risk Type of measures Reference Motivation 1.4 Transportation of raw

materials (by ship, truck, tanker)

Entry of chemical contaminants (in accordance with 1.0)

C In accordance with 1.0

Entry and growth of undesirable micro-organisms (in accordance with 1.0)

M

Additional company-specific process steps.

Additional company-specific hazards. • Company-specific measures Z

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Sub-process diagram 2: Reception, storage after reception

start

transported raw materials

2.1reception

fluid/moisture richraw materials

2.2transport

end

2.3storage of

raw materials

stored raw materials

dryraw materials

internal returnflows

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Sub-process 2: Reception, storage no. Process step Hazard description Cat. Prob. Sev. Risk Type of measures Reference Motivation 2 Reception, storage after

reception

2.0 General Chemical contamination of (raw) materials or constituents through the reception of an incorrect batch

C • Transport guidelines • Production and handling instructions

23 28

Introduction of chemical contamination of (raw) materials or constituents through remaining raw materials from previous batches in the transport systems, dust filters and plant, leakage

C • Transport guidelines • Work hygienically • Production and handling instructions • Cleaning programme • Tracking and tracing procedures

23 25 28 26

20, F

Introduction and growth of undesirable micro-organisms from remaining raw materials from previous batches in the transport systems, dust filters and plant, leakage

M • Processing of internal and external return flows

• Working with powdered meal • Registration of return flows

31 32 33

2.1 Reception (by ship, truck, tanker)

Presence chemical contaminants above the norm set

C • Reception checking • Comply with decrees and legal

requirements

21

10


M • Possession of analysis results for delivered raw materials

B

2.2 Transporting dry raw materials


C • Production and handling instructions • Cleaning programme

28 26


M

Transporting liquid and moisture rich raw materials


C


M

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no. Process step Hazard description Cat. Prob. Sev. Risk Type of measures Reference Motivation 2.3 Storage of raw materials

after reception Entry of chemical contaminants in accordance with 2.0

C • Storage instructions • further in accordance with 2.0

27

Entry and growth of undesirable micro-organisms in accordance with 2.0

M

Growth of micro-organisms through long-term storage

M



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Sub-process diagram 3: Dosage, grinding, mixing

3.1dosage

start

3.9mixing and

buffering

3.5grinding and

buffering

3.2weighing raw

materials

3.4pre-sieving

3.11mixing andtransporting

3.12Storage in press meal-

cells

3.3transport and

buffering

end

Grinding air in

dry raw materials

3.7dosage/weighing

3.8dosage/

weighing/measuring


materials

3.6filter

grinding air

Grinding airout

3.10dosage/

weighing/measuring


materials

storedraw materials

dust

stored press meal

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Sub-process 3: Dosage, grinding, mixing no. Process step Hazard description Cat. Prob. Sev. Risk Type of measures Reference Motivation 3 Dosage, grinding, mixing 3.0 General Passing on of chemical contaminants in (raw)

materials or ingredients from: • remaining raw materials or pressed meal

from previous loads in transport systems, dust filters and plant

• compressed air addition • leakage

C • Handling pre-mixes • Production sequence • Assessment of subject and functioning of

equipment • Filling of dosage silo’s for pre-mixes • Determination of the degree of contact • Maintenance programme • Action during mixing

38 37

34 35 36 39 22

Entry and growth of undesirable micro-organisms from: • Remaining raw materials or press meal

from earlier batches in transport systems, dust filters and plant

• Compressed air addition • leakage

M • Work hygienically • Production and handling instructions • Working with powdered meal • Processing of internal and external return

flows • Cleaning programme • Quality records • Control of water, power, air quality • Tracking and tracing procedures

25 28 32

31 26 59 M

20, F 3.1 Dosage Entry of chemical contaminants (in accordance

with 3.0) C • In accordance with 3.0


M

3.2 Weighing of raw materials Entry of chemical contaminants (in accordance with 3.0)

C • In accordance with 3.0


M

3.3 Transport and buffering Entry of chemical contaminants (in accordance with 3.0)



M

3.4 Pre-sieving Entry of chemical contaminant in accordance with 3.0



M

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no. Process step Hazard description Cat. Prob. Sev. Risk Type of measures Reference Motivation 3.5 Grinding and buffering Entry of chemical contaminants (in accordance

with 3.0) C • In accordance with 3.0


M

3.6 Filter grinding air Entry of chemical contaminants (in accordance with 3.0)



M

3.7 Dosage/ weighing of dry raw materials




M

3.8 Dosage/ weighing/ measuring of fluid/ moisture rich raw materials




M

3.9 Mixing and buffering Entry of chemical contaminants (in accordance with 3.0)



M

3.10 Dosage/ weighing/ measuring of fluid/ wet raw materials




M

3.11 Mixing and transporting Entry of chemical contaminants (in accordance with 3.0)



M

3.12 Storage in press meal cells Entry of chemical contaminants (in accordance with 3.0)



M


Company-specific hazards • Company-specific measures Z

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Sub-process diagram 4: Press meal conditioning, pelleting, cooling

start

4.1dosage

stored press meal

4.4conditioning

4.6cooling

4.7sieving

4.8crumbling

4.9sieving

pellets/crumbs

4.12coating

4.13Transport of

pellets/crumbs

end

4.5pelleting

4.2measurement

4.3dosage/

weighing/measuring


materials

cool air in

steam

cool air out

internalreturn flows

internalreturnflows

4.11dosage/

weighing/ measuring


materials

transportedpellets/crumbs

dry raw materials

4.10addition

Code: HD.VB.01

Version: 1/0100



Sub-process 4: Pres meal conditioning, pelleting, cooling no. Process step Hazard description Cat. Prob. Sev. Risk Type of measures Reference Motivation 4. Mixing, pressing, cooling 4.0 General Passing on of chemical contaminants in (raw)

materials or ingredients from: • remaining raw materials or pressed meal


• compressed air addition and/or boiler water• leakage

C • Handling pre-mixes • Production sequence • Assessment of subject and functioning of

equipment • Filling of dosage silo’s for pre-mixes • Determination of the degree of contact • Maintenance programme • Action during mixing

38 37 34

35 36 39 22

Introduction and growth of undesirable micro-organisms from remaining (raw) materials or constituents from earlier batches through: • remaining raw materials or press meal from

previous loads in transport systems, dust filters and plant


M • Work hygienically • Production and handling instructions • Working with powdered meal • Processing of internal and external return

flows • Cleaning programme • Quality records • Control of water, power, air quality • Tracking and tracing procedures • Process registered animal drugs • Processing of additives and animal drugs • Pelleting for stability of additives and

drugs

25 28 32 31

26 59 M

20, F

19

30

40 4.1 Dosage Introduction of chemical contaminants

(In accordance with 4.0) C • In accordance with 4.0


M

Code: HD.VB.01

Version: 1/0100



no. Process step Hazard description Cat. Prob. Sev. Risk Type of measures Reference Motivation 4.2 Steam measurement Introduction of chemical contaminants through

steam addition C • In accordance with 4.0


Introduction of chemical contaminants (in accordance with 4.0)



M

4.4 Conditioning Introduction of chemical contaminants (in accordance with 4.0)


Introduction of too high a concentration of undesirable substances or chemical contaminants through incorrect methods

C


M

4.5 Pelleting Introduction of chemical contaminants (in accordance with 4.0)

C • Instructions on heat treatment • Control of inspection, measurement and

testing equipment;

Z 47

Entry and growth of undesirable micro-organisms in fixed raw materials (in accordance with 4.0)

M • In accordance with 4.0

Entry and growth of undesirable micro-organisms through fluid raw materials (in accordance with 4.0)

M

4.6 Cooling Introduction of chemical contaminants (in accordance with 4.0)

C • Prevention of later infection following heat treatment

58

Introduction of chemical contaminants through additions to compressed air and steam



M

Introduction and growth of micro-organisms, including salmonella, through cooling air which is insufficiently clean

M

Code: HD.VB.01

Version: 1/0100



no. Process step Hazard description Cat. Prob. Sev. Risk Type of measures Reference Motivation 4.7 Sieving Introduction of chemical contaminants



M

4.8 Crumbling Introduction of chemical contaminants (In accordance with 4.0)



M

4.9 Sieving pellets/ crumbs Introduction of chemical contaminants (In accordance with 4.0)



M

4.10 Addition of dry raw materials Introduction of chemical contaminants (In accordance with 4.0)



M


Introduction of chemical contaminants (In accordance with 4.0)



M

4.12 Coating Introduction of chemical contaminants (In accordance with 4.0)



M

4.13 Transport pellets/ crumbs Introduction of chemical contaminants (In accordance with 4.0)



M

Additional company-specific process steps


Code: HD.VB.01

Version: 1/0100



Sub-process diagram 5: Storage for delivery and distribution

start

5.1storage of

pellets/crumbs

transportedpellets

and crumbs

5.2transport,

sievepellets/crumbs

5.4weighing

pellets/crumbs

5.5transport and

bufferingpellets/crumbs

5.6loading

pellets/crumbs

internalreturnflows

5.7transport tocustomer

5.8unloading

pellets/crumbs

end

deliveredpellets/crumbs

dryraw materials


materials

5.3addition

Code: HD.VB.01

Version: 1/0100



Sub-process 5: Storage for delevering, distribution no. Process step Hazard description Cat. Prob. Sev. Risk Type of measures Reference Motivation 5. Storage for delivery 5.0 General (internal transport in

the various process steps) Passing on of chemical contaminants in (raw) materials or ingredients from: • remaining raw materials or pressed meal



C • Production sequence • Assessment of subject and functioning of

equipment • Determination of the degree of contact • Action during mixing • Work hygienically • Production and handling instructions • Working with powdered meal • Processing of internal and external return

flows • Cleaning programme • Control of water, power, air quality • Tracking and tracing

37

34 36 22 25 28 32

31 26 M

20, F

Introduction and growth of undesirable micro-organisms from remaining (raw) materials or constituents from earlier batches through: • remaining raw materials or press meal from

previous loads in transport systems, dust filters and plant


M • Handling end products, prevention of infection later

• Storage of end products • End product packaging • Conservation of end products • Transport and delivery of products • Prevention of later infection following heat

treatment

53 54 55 56 57

58

5.1 Storage pellets/ crumbs Introduction of chemical contaminants (In accordance with 5.0)

C • Storage of end products • In accordance with 5.0

54


M


M

5.2 Transport, sieving pellets/ crumbs


C • Transport guidelines • In accordance with 5.0


M

Code: HD.VB.01

Version: 1/0100



no. Process step Hazard description Cat. Prob. Sev. Risk Type of measures Reference Motivation 5.3 Addition of dry and liquid /

moisture rich raw materials Introduction of chemical contaminants (In accordance with 5.0)



M

5.4 Weighing pellets/ crumbs Introduction of chemical contaminants (In accordance with 5.0)



M

5.5 Transport and buffering pellets/ crumbs




M

5.6 Loading pellets/ crumbs Introduction of chemical contaminants (In accordance with 5.0)



M

5.7 Transport to customer Introduction of chemical contaminants (In accordance with 5.0)

C • Transport guidelines • Transport and delivery of products • After-sales service: provision of correct

information to customer

23 57 H

5.8 Unloading pellets/ crumbs Introduction of chemical contaminants (In accordance with 5.0)

C • Transport guidelines • Transport and delivery of products

23 57

Introduction and growth of undesirable micro-organisms through the use of pipes and couplings contaminated by previous raw materials

M • After-sales service: provision of correct information to customer

H


Additional company-specific hazards. • Additional company-specific measures. Z

Code: HD.VB.01

Version: 1/0100


Author: TNO Voeding/PDV Page 22 of 24 Enclosure 1: Summary of measures and references to the animal feed sector GMP code The purpose of this section is to give a summary of the measures already incorporated in the legislation and the GMP code. A large number of these measures are also essential for the setting up of a HACCP system. The sequence of the measures is based on the sequence in the animal feed sector GMP code.

N.B. This summary is intended for reference purposes and is not intended to replace the GMP code.

No. Measure Reference 1 Establish quality policy 4.1.1 2 Establish T(asks), R(esponsibilities), A(uthorities) of personnel (including

organisational chart) 4.1.2.1

3 Make resources available (materials and personnel) 4.1.2.2 4 Appoint management representative 4.1.2.3 5 Management assessment of quality system 4.1.3 6 Appoint quality manual manager 4.2.1 7 Establish critical points in the process 4.9.1 et.al. 8 Planning of all examinations, tests, samples, inspections and checks to be

carried out (quality control plan) 4.2.3 et.al.

9 Lay down specifications of animal feed to be supplied and other products to be supplied

4.2.4

10 Comply with decrees and legal requirements 4.3.1 11 Max. acceptable difference between declared and analysed content of

additives and veterinary drugs. 4.3.4. et.al.

12 Acceptance of an order 4.3 et.al. 13 Transport of delivered raw materials 4.9 et.al. 14 Draw up manual (lay down quality system) 4.5.1 et.al. 15 Approval and issuing of documents and data 4.5.2 16 Modification of documents and data 4.5.3 17 Evaluation and registration of suppliers, products and services 4.6.2 et.al. 18 Draw up purchasing specifications for products and services (incl. analyses

to be carried out 4.6.3

19 Use of process registered veterinary drugs 4.7 20 Identification and tracing of products 4.8 21 Reception control (registration of types and reception of products with

documents including certificates) 4.9. et.al.

22 Action during mixing (maximum extent to which feed components may be mixed through cross contamination)

4.9.10 et.al

23 Transport guidelines (registration of loads and rides, identification of cargo spaces, transport resources, storage areas, unforeseen circumstances during transport)

4.9.10.1

24 Setting up of production areas (prevention of contact/ cross contamination) 4.9.2 25 Hygienic working procedures to comply with the law and the GMP 4.9.3 et.al. 26 Cleaning programme (production areas, equipment and (internal) transport

systems) 4.9.3

27 Storage instructions (raw materials and interim storage) 4.9.3 et.al.

Code: HD.VB.01

Version: 1/0100


Author: TNO Voeding/PDV Page 23 of 24 No. Measure Reference 28 Determine production and/or handling instructions (job instructions per

process step or part of a process such as heating, purchasing, preparation methods (recipes), transportation of fluid and moisture rich materials, transportation of dry raw materials, etc.)

4.9.3 et.al.

29 Draw up vermin control programmes 4.9.4 30 Processing of additives and vetinary drugs 4.9.5 31 Processing of internal and external return flows 4.9.5 et.al. 32 Handling dust (from internal return flows) 4.9.5 et.al. 33 Registration and working up of return flows (external) 4.9.5 et.al. 34 Assessment of design and functioning of equipment 4.9.5 et.al. 35 Filling of dosage silo’s for pre-mixes and prevention of confusion with other

additives 4.9.5. et.al.

36 Determination of the degree of contact- or crosscontamination in equipment 4.9.5.1.4 et.al. 37 Production sequence 4.9.5.1.5 et.al. 38 Handling pre-mixes 4.9.5.1.6 et.al. 39 Maintenance, control and inspection schedules for equipment and (internal)

transport systems 4.9.5.1.7 et.al.

40 Pelleting for stability of additives and drugs 4.9.5.1.9 41 Processing feed with too high a content of undesirable substances 4.9.5.2 42 List and assess additives and cleaning agents for consequences for and

safety of humans, animals and the environment 4.9.7.1.2 et.al.

43 Clear out transfer route between one batch of feed and the next 4.9.9.1 44 Examination and testing 4.10 45 Hygiene inspections 4.10.4 et.al. 46 Taking and keeping samples (for handling of “complaints”) 4.10.7 et.al. 47 Control of inspection, measurement and testing equipment 4.11 48 Select approved laboratories 4.11 49 Reviewing / dealing (blocking) of products 4.12 50 Control of non-conforming products 4.13 51 Procedure for corrective measures 4.14.2 52 Procedure for preventitive measures 4.14.3 53 Handling end products, prevention of recontamination 4.15.2 54 Storage of end products 4.15.3 55 Packaging of end products (incl. labelling) 4.15.4 56 Conservation of end products 4.15.5 57 Transport and delivery of products 4.15.6 58 Prevention of recontamination past the heat treatment 4.15.7.2 59 Quality records control 4.16 et.al. 60 Internal quality audits 4.17 61 Procedures and documentation relating to training 4.18 62 Procedures relating to after-care (product information and guidance for the

breeder, working with the requirements of the foodstuff sector) 4.19

63 Use of statistical techniques 4.20

Code: HD.VB.01

Version: 1/0100


Author: TNO Voeding/PDV Page 24 of 24 Enclosure 2 Additional measures Summary of measures which are not, or not completely, covered in the GMP although they may, possibly, be essential for the safe production of feed and food. The actual additional measures to be implemented by a company can be derived from the company-specific risk analysis within HACCP. This company-specific risk analysis will be drawn up using the examples. No. Name of measure Reference A List of all raw materials used

(based on the company-specific organisation) GMP regulation animal feed sector Risk inventories & risk analyses at chain level

B Analysis results/documents of the delivered batches of raw materials (in which the contaminants are summarised, mentioned in raw materials specifications). Quality certification of the analysis method used.

C Raw materials specifications mentioning relevant contaminants (to be agreed with suppliers) (see the HACCP manual for an example)

D Knowledge of the prior route (of the companies supplying animal feed (the chain), including carrying out audits at suppliers)

E Taking samples from batches (both raw materials and end product) for any analyses to be carried out later

F Draw up tracking and tracing procedures (including associated coding (batch identification))

G Recall procedures for delivered products H After-care: Provision of information to the customer J After-care: Pick up signals from the foodstuff sector K Look for weak points in the current GMP quality system which

should be seen as the basis of the HACCP

L Participation in databases and EWS Connection to quality systems in buyer circles

M Control of water, power, air quality Animal feeding and food safety

N Control of waste flows Animal feeding and food safety

O (Own) analysis of raw materials P Monitoring of end products Z Additional company-specific measures.

These should be supplemented by the company itself

Code: HD.VB.02

Version: 1/0400

Table of contents HACCP manual Animal Feed Sector part 2 example 2

Author: TNO Voeding/PDV Page: 1 of 25 HACCP Manual Animal Feed Sector Part 2 Table of Contents Code Document Page HD.VB.02 Example 2: Simple animal feed; potato press fibres End product specification simple animal feed 2 of 25 Main process simple animal feed potato press fibres 3 of 25 Sub-process 1: Purchase potatoes and auxiliary substances 5 of 25 Sub-process 2: Reception, storage 8 of 25 Sub-process 3: Tarra removal, washing 10 of 25 Sub-process 4: Milling 13 of 25 Sub-process 5: Fibre extraction 15 of 25 Sub-process 6: Fibre drying 17 of 25 Sub-process 7: Storage and distribution 19 of 25 Appendix 1: Summary of measures and references

to the Animal Feed Sector GMP code: 22 of 25

Appendix 2: Additional measures 24 of 25 Appendix 3: HACCP system for companies with

activities in the foodstuff industry 25 of 25

Code: HD.VB.02

Version: 1/0400

Document: Example 2 simple animal feed; potato press fibres

Author: TNO Voeding/PDV Page: 2 of 25 Sample end-product specification for simple animal feed; potato press fibres Items for attention from HACCP Name of product or product group Product codes or numbers Description of product(s) Intended use • Animal species / animal group • Age • Directions for use (incl. storage conditions) Legal requirements Chemical contaminants, incl. specific undesirable raw materials (from animal feed legislation and elsewhere) • Heavy metals • Pesticides • PCB’s and Dioxin • Mycotoxins (Aflatoxin, DON, ZEA, Ochratoxin, etc.) • Decomposition products (biogenic amines) Microbiological contaminants • Pathogens (for example Salmonella) • Decay flora • Moulds and yeasts Physical contaminants • Undesirable elements (sand, gravel, glass, metal particles, bones, etc.) Packaging Storage life Transport and delivery conditions • Transport type and form (truck, boat, pallets, etc.) • Documents to be used (including identification of bulk goods supplied) Additional points of attention relating to quality Composition Feeding value Sensory characteristics • Colour • Texture • Smell

1PURCHASE

POTATOES AND AUXILIARY MATERIALS

END

5FIBRE EXTRACTION

4MILLING

6FIBRE DRYING

7STORAGE

7DISTRIBUTION

2RECEPTION,

STORAGE

3TARRA

REMOVAL,WASHING

BEGIN

Main process diagram: Simple animal feed; wet co-product (potato press fibres)

STARCH AND FRUIT JUICE PROCESSING

Code: HD.VB.02

Version: 1/0400



Code: HD.VB.02 Version: 01/0400

Document: Example 2 simple animal feed; potato press fibres Author: TNO Voeding/PDV

Page: 4 van 25

Main process Subject or item Type of measures Reference1

Motivation

General Relevant (applicable) animal feed legislation and regulations

Relevant legislation and

regulations

Before HACCP can be implemented, the relevant (applicable) animal feed legislation and regulations relating to feed safety must be implemented. Generic hazards (hazards which apply to the whole sector) can be controlled by way of instructions, norms, etc.

General The general measures from the GMP Code Animal Feed Sector are: Animal Feed Sector GMP

Code

Sector-wide GMP measures or general Items for Attention are, as it were, the basis for a HACCP system. If these measures are not present and not implemented, then no effective HACCP system can be set up.

End product specifications Lay down specifications of animal feed to be supplied and other products to be supplied

9 For target animal and subsequent consumer and being able to estimate the product and/or process specification hazards

Business set-up Equipping of company areas (incl. sewers) 24 Conditions for good business operations

Hygiene Hygienic working so there is compliance with the law and the GMP Hygiene inspections

25 45

Conditions for good business operation (among other things prevention of infection)

Prevention of mix/contact/ cross infection Action in the event of mix/contact/ cross infection Assessment of design and functioning of equipment Determine the amount of cross-infection as a result of so-called build-ups or product remains in an installation Production sequence

22 34 36

37

Conditions for good business operation (among other things prevention of infection) Also important for changing raw materials which are processed using the same process equipment.

Cleaning Cleaning programme for production areas, CIP or other cleaning procedures for equipment and (internal) transport systems

26 Conditions for good business operation (among other things prevention of infection)

Maintenance plan Maintenance, control and inspection schedules for equipment, (internal) transport systems

39 Essential pre-condition for the functioning of a HACCP system. Required by Animal Feed Sector GMP code

Vermin, birds and pets Draw up vermin control programmes (incl. birds, pets) 29 Conditions for good business operation (among other things prevention of infection)

Water, steam and air Control of water, steam, air quality M Conditions for good business operation (among other things prevention of infection)

Waste Control of waste flows N Conditions for good business operation (among other things prevention of infection)

Company-specific situation Company-specific measures Z

1 See Appendix 1 GMP Code Measures and Appendix 2 Additional Measures in part 2 (example 2) of the HACCP Animal Feed Sector manual

Code: HD.VB.02

Version: 1/0400

Document: Example 2 simple animal feed: potato press fibres


Sub-process diagram 1: Purchase potatoes and auxiliary substances

Begin

1.3Transport of

potatoes

End

1.4Transport of

Auxiliary substances

1.1PlanningSupply of potatoes

Potatospecifications

1.2Purchase auxiliary

substances

Specification of Auxiliarysubstances



Page: 6 of 25

Sub-process 1: Purchase potatoes and auxiliary substances no. Process step Hazard description Cat. Chance Serious

ness Risk Type of measures Reference Motivation

1 Purchase potatoes and auxiliary substances

1.0 General Contamination with chemical contaminants through • Product remains / build ups in the

equipment Presence of contaminants in the

raw materials • Residues of pesticides

C • • • • •

Transport of delivered raw materials Transport guidelines Work hygienically Production and handling instructions Control of pesticides

13 23 25 28 Q

Presence, contamination or growth of undesirable micro-organisms from: • Product remains / build ups in the

equipment Presence of contaminants in the

raw material(s)

M

Presence of physical contaminants (glass, stones, metal, etc.)

F

1.1 Planning of supply of potatoes

Contamination by undesirable chemical substances (according to 1.0)


Presence, contamination or growth of undesirable micro-organisms (according to 1.0)

M

Presence of physical impurities (glass, stones, metal etc.) (In accordance with 1.0)

F

1.2 Purchase of auxiliary substances

Presence of chemical contaminants in excess of the norms set (dioxins, PCB's, heavy metals, mycotoxines, residues of combustion gasses) (according to 1.0)

C • •

•

•

•

Acceptance of an order Drawing up purchasing specifications for products and services Evaluation and registration of suppliers, products and services Maximum acceptable difference between the analysis content and the declared content Production and handling instructions

12 18, C

17

11

28

Presence of undesirable micro-organisms above the norm set (according to 1.0)

M • •

• •

List of all raw materials used Possession of analysis results for delivered raw materials Knowledge of prior history Sampling of batches

A B

D E

no. Process step Hazard description Cat. Chance Serious




Page: 7 of 25



Presence of physical impurities (glass, stones, metal etc.) (In accordance with 1.0)

F • Tracking and tracing F

1.3 Transportation of potatoes Contamination by chemical contaminants (according to 1.0)

C • •

Production and handling instructions In accordance with 1.0

28


M

Presence of physical contaminants (in accordance with 1.0)

F

1.4 Transportation of auxiliary substances

Contamination by chemical contaminants (according to 1.0)



M



Code: HD.VB.02

Version: 1/0400



Sub-process diagram 2: Reception, storage

Begin

2.1Reception of potatoes and

auxiliary substances

2.2Storage of

potatoes and auxiliary

substances

potatoes

Auxiliarysubstances Stored potatoes

Stored auxiliary substancesEnd



Page: 9 of 25

Sub-process 2: Reception and storage no. Process step Hazard description Cat. Chance Serious


2 Reception, storage after reception

2.0 General Chemical contamination of potatoes and/or auxiliary substances through the reception of an incorrect batch

C • Transport guidelines • Production and handling instructions

23 28

Chemical contamination through product remains/ build ups (in inaccessible areas) in transport systems and installations

C • Transport guidelines • Work hygienically • Production and handling instructions

23 25 28

Presence, contamination or growth of undesirable micro-organisms through product remains/ build ups in inaccessible areas in transport systems and installations

M • Cleaning programme • Tracking and tracing procedures • Processing of internal and external return

flows

26 20, F

31

Presence of physical contamination through product remains/ build ups in inaccessible areas in transport systems and installations

F • Registration of return flows • Transport of delivered raw materials • Evaluation and registration of suppliers,

products and services

33 13

17

2.1 Reception of potatoes and auxiliary substances

Presence chemical contaminants above the norm set

C • Reception checking • Comply with decrees and legal

requirements

21

10


M • Possession of analysis results for delivered raw materials

B

Presence physical contaminants above the norm set

F • Control of pesticides Q

2.2 Storage of potatoes and auxiliary substances


C • Production and handling instructions • Cleaning programme

28 26


M • Storage instructions 27


M



Sub-process diagram 3: Tarra removal, Washing

Begin

3.1Transport of

potatoesTo wash

Washing and transport water

Sand 3.2Removal of

stones and metalStones and metal

3.3Removal of vegetable

tarra

Vegetable tarra

3.5WashingClean

water Washing waterreturn

End

3.6Storage of potatoes

in storage bunker

Stored potatoes

Stored potatoes in

storage bunker

3.4Drying

Washing waterreturn

Washing water flow to purification

Code: HD.VB.02

Version: 1/0400





Page: 11 of 25

Sub-process 3: Tarra removal, washing no. Process step Hazard description Cat. Chance Serious


3 Tarra removal, washing 3.0 General Contamination with chemical contaminants

through : • Product remains / build ups in and on

transport systems and installations • Washing water (contaminated)


equipment • Determination of the degree of contact • Maintenance programme

37

34 36 39

Presence, contamination or growth of undesirable micro-organisms by/in: • Product remains / build ups in and on


M • Work hygienically • Production and handling instructions • Processing of internal and external return

flows • Cleaning programme

25 28

31 26

Contamination with physical contaminants through : • Product remains / build ups in and on


F • Quality records • Control of water, power, air quality • Tracking and tracing procedures • Control of washing water

59 M

20, F R

3.1 Transport to wash Contamination by chemical contaminants (according to 3.0)



M

Contamination by physical contaminants (according to 3.0)

F

3.2 Removal of stones and metal Contamination by chemical contaminants (according to 3.0)



M

Contact with physical contaminants (in accordance with 3.0)

F

3.3 Removal of vegetable Tarra Contamination by chemical contaminants (according to 3.0)



M

3.4 Drying Contamination by chemical contaminants (according to 3.0)



M



Page: 12 of 25



3.5 Washing Contamination by chemical contaminants (according to 3.0)



M

3.6 Storage of potatoes in storage bunker


C • Storage instructions • In accordance with 3.0

27


M


M



Code: HD.VB.02

Version: 1/0400



Sub-process diagram 4: Milling

Begin

4.2Milling

Potatoes from storage bunker

Milled

Auxiliary substance

End

4.1Transport /

Dosage auxiliary substance



Page: 14 of 25

Sub-process 4: Milling no. Process step Hazard description Cat. Chance Serious


4. Milling 4.0 •

•

• • •

General Contamination with chemical contaminants through : Product remains / build ups and/or auxiliary substances in and on transport systems and installations

C Production sequence Assessment of subject and functioning of equipment Determination of the degree of contact Maintenance programme Action during mixing

37 34

36 39 22

Presence, contamination or growth of undesirable micro-organisms by/in: Product remains / build ups and/or auxiliary substances in and on transport systems and installations

M • • •

• • • •

Work hygienically Production and handling instructions Processing of internal and external

return flows Cleaning programme Quality records Control of water, power, air quality Tracking and tracing procedures

25 28 31

26 59 M

20, F

4.1 Transportation / dosage of auxiliary substances




M

4.2 Milling Contamination with chemical contaminants (In accordance with 4.0)



M

Additionalcompany-specific process steps


Code: HD.VB.02

Version: 1/0400



Sub-process diagram 5: Fibre extraction

Begin

5.1Sieving out

of fibres Milled Starch and fruit

juice

Wet fibresAuxiliary substances End



Page: 16 of 25

Sub-process 5: Fibre extraction no. Process step Hazard description Cat. Chance Serious


5. Fibre extraction 5.0 General (incl. internal

transport in the various process steps)

Contamination with chemical contaminants through : • Product remains / build ups and/or

auxiliary substances in and on transport systems and installations


equipment • Action during mixing • Work hygienically

37

34 22 25

Presence, contamination or growth of undesirable micro-organisms by/in: • Product remains / build ups and/or

auxiliary substances in and on transport systems and installations

M • Production and handling instructions • Processing of internal and external return


28

31 26 M

20, F 5.1 Sieving out of fibres Contamination with chemical contaminants



M



Code: HD.VB.02

Version: 1/0400



Sub-process diagram 6: Fibre drying

Begin

6.1Press fibres

Wet fibresPressed fibres

EndWater



Page: 18 of 25

Sub-process 6: Fibre drying no. Process step Hazard description Cat. Chance Serious


6. Fibre drying 6.0 General (internal transport in

the various process steps) Contamination with chemical contaminants through : • Product remains / build ups in and on

transport systems and installations


equipment • Determination of the degree of contact • Action during mixing • Work hygienically

37

34 36 22 25

Presence, contamination or growth of undesirable micro-organisms by/in: • Product remains / build ups in and on


M • Production and handling instructions • Processing of internal and external return


28

31 26 M

20, F 6.1 Press fibres Contamination with chemical contaminants



M



Code: HD.VB.02

Version: 1/0400



Sub-process diagram 7: Storage and distribution

Begin

Pressed fibres

7.1Transport to storage units

7.2Storage

7.3Load pressed

fibres

7.4Transport to

customer

7.5Unload at customer

End

Delivered pressed fibres



Page: 20 of 25

Sub-process 7: Storage and distribution no. Process step Hazard description Cat. Chance Serious


7. Storage and distribution 7.0 General (internal transport in

the various process steps) Contamination with chemical contaminants through : • Product remains / build ups in and on



equipment • Determination of the degree of contact • Action during mixing

37

34 36 22

Presence, contamination or growth of undesirable micro-organisms in/through: • Product remains / build ups in and on


M • Work hygienically • Production and handling instructions • Processing of internal and external return

flows • Cleaning programme • Control of water, power, air quality • Tracking and tracing • Storage of end products • Transport and delivery of products

25 28

31 26 M

20, F 54 57

7.1 Transport to storage units Contamination with chemical contaminants (In accordance with 7.0)



M

7.2 Storage Contamination with chemical contaminants (In accordance with 7.0)

C • Storage of end products • In accordance with 7.0

54


M


M

7.3 Load press fibres Contamination with chemical contaminants (In accordance with 7.0)

C • Transport guidelines • In accordance with 7.0

23


M

7.4 Transport to customer Contamination with chemical contaminants (In accordance with 7.0)

C • Transport guidelines • Transport and delivery of products

23 57





Page: 21 of 25



7.5 Unload at customer Contamination with chemical contaminants (In accordance with 7.0)

C • Transport and delivery of products • After-sales service: provision of correct

information to customer

57 H





Code: HD.VB.02

Version: 1/0400


Author: TNO Voeding/PDV Page: 22 of 25 Appendix 1: Summary of measures and references to the animal feed sector GMP code The purpose of this appendix is to give a summary of the measures already incorporated in the legislation and the GMP code. A large number of these measures are also essential for the setting up of a HACCP system. The sequence of the measures is based on the sequence in the animal feed sector GMP code. N.B.: This summary is intended for reference purposes and does not replace the GMP code. No. Measure Reference 1 Establish quality policy 4.1.1 2 Establish T(asks), R(esponsibilities), A(uthority) of personnel (including

organisational chart) 4.1.2.1

3 Make resources available (materials and personnel) 4.1.2.2 4 Appoint management representative 4.1.2.3 5 Management assessment of quality system 4.1.3 6 Appoint quality manual manager 4.2.1 7 Establish critical points in the process 4.9.1 et.al. 8 Planning of all examinations, tests, samples, inspections and checks to be

carried out (quality control plan) 4.2.3 et.al.

9 Lay down specifications of animal feed to be supplied and other products to be supplied

4.2.4

10 Comply with decrees and legal requirements 4.3.1 11 Max. acceptable difference between declared and analysed content of

additives and animal drugs. 4.3.4. et.al.

12 Acceptance of an order 4.3 et.al. 13 Transport of delivered raw materials 4.9 et.al. 14 Draw up manual (lay down quality system) 4.5.1 et.al. 15 Approval and issuing of documents and data 4.5.2 16 Modification of documents and data 4.5.3 17 Evaluation and registration of suppliers, products and services 4.6.2 et.al. 18 Draw up purchasing specifications for products and services (incl.

analyses to be carried out 4.6.3

19 Process registered animal drugs 4.7 20 Identification and tracing of products 4.8 21 Reception control (registration of types and reception of products with

documents including certificates) 4.9. et.al.

22 Action in the event of mix/contact/ cross infection 4.9.10 et.al 23 Transport guidelines (registration of loads and rides, identification of cargo

spaces, transport resources, storage areas, unforeseen circumstances during transport)

4.9.10.1

24 Setting up of production areas (prevention of contact/ cross contami-nation)

4.9.2

25 Hygienic working so there is compliance with the law and the GMP 4.9.3 et.al. 26 Cleaning programme for production areas, CIP or other cleaning

procedures for equipment and (internal) transport systems 4.9.3

27 Storage instructions (raw materials and interim storage) 4.9.3 et.al. 28 Draw up production and/or handling instructions (job instructions per

process step or part of a process such as heating, purchasing, drawing up preparation methods, transportation of fluid and wet raw materials, transportation of dry raw materials, etc.)

4.9.3 et.al.

29 Draw up vermin control programmes 4.9.4 30 Processing of additives and animal drugs 4.9.5 31 Processing of internal and external return flows 4.9.5 et.al. 32 Working with powdered meal (from internal return flows) 4.9.5 et.al. 33 Registration and processing of return flows (external) 4.9.5 et.al.

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Author: TNO Voeding/PDV Page: 23 of 25 34 Assessment of subject and functioning of equipment 4.9.5 et.al. 35 Filling of dosage silo’s for pre-mixes and prevention of confusion with

other additives 4.9.5. et.al.

36 Determine the amount of cross-contamination as a result of so-called build-ups or product remains in an installation

4.9.5.1.4 et.al.

37 Production sequence 4.9.5.1.5 et.al. 38 Handling pre-mixes 4.9.5.1.6 et.al. 39 Maintenance, control and inspection schedules for equipment and

(internal) transport systems 4.9.5.1.7 et.al.

40 Pelleting for stability of additives and drugs 4.9.5.1.9 41 Processing feed with too high a content of undesired substances 4.9.5.2 42 List and assess additives and cleaning agents for consequences for and

safety of humans, animals and the environment 4.9.7.1.2 et.al.

43 Clear out transfer route between one batch of feed and the next 4.9.9.1 44 Examination and testing 4.10 45 Hygiene inspections 4.10.4 et.al. 46 Taking and keeping samples (for handling of “complaints”) 4.10.7 et.al. 47 Control of inspection, measurement and testing equipment; 4.11 48 Establish approved laboratories 4.11 49 Release / blocking of products 4.12 50 Management of non-standard products 4.13 51 Procedure for corrective measures 4.14.2 52 Procedure for preventive measures 4.14.3 53 Handling end products, prevention of infection later 4.15.2 54 Storage of end products 4.15.3 55 Packaging of end products (incl. labelling) 4.15.4 56 Conservation of end products 4.15.5 57 Transport and delivery of products 4.15.6 58 Prevention of later infection following heat treatment 4.15.7.2 59 Management of quality records 4.16 et.al. 60 Internal audits 4.17 61 Procedures and documentation relating to training 4.18 62 Procedures relating to after-sales service (product information and

guidance for the breeder, working with the requirements of the foodstuff sector)

4.19

63 Use of statistical techniques 4.20

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Author: TNO Voeding/PDV Page: 24 of 25 Appendix 2: Additional measures. Summary of measures which are not, or not completely, covered in the GMP although they may, possibly, be essential for the safe production of feed and food. The actual additional measures to be implemented per company follow from the company-specific hazard analysis within HACCP. This company-specific hazard analysis will be drawn up using the examples. No. Name of measure Reference A List of all raw materials used

(based on the company-specific organisation) GMP regulation animal feed sector Risk inventories & risk analyses at chain level

B Analysis results/documents of the delivered batches of raw materials (in which the contaminants are summarised, mentioned in raw materials specifications). Quality certification of the analysis method used.

C Raw materials specifications with mention of relevant contaminants (to be agreed with suppliers) (see the HACCP manual for an example)

D Knowledge of the prior history (of the companies supplying animal feed (the chain), including among other things carrying out audits at suppliers)

E Taking samples from batches (both raw materials and end product) for any analyses to be carried out later

F Draw up tracking and tracing procedures (including associated coding (batch identification))

G Recall procedures for delivered products H After-sales service: Provision of information to the customer J After-sales service: Pick up signals from the foodstuff sector K Look for weak points in the current GMP quality system which

should be seen as the basis of the HACCP

L Participation in databases and EWS Connection to quality systems in buyer circles

M Control of water, power, air quality Animal feeding and food safety

N Control of waste flows Animal feeding and food safety

O (Own) analysis of raw materials P Monitoring of end products Q Control of pesticides R Control of washing water Z Additional company-specific measures.

These should be supplemented by the company itself

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Author: TNO Voeding/PDV Page: 25 of 25 Appendix 3: HACCP system for companies with activities in the feed industry In the example given which has been added as part 2 of the HACCP Animal Feed Sector Manual, the HACCP plan has been used as it was worked out in this manual. This plan and the examples which are intended for companies which produce simple animal feeds takes full account of the animal feed legislation and the animal feed sector GMP code. In companies which are, in addition to (simple) animal feeds, also active in the feed industry, there has been HACCP for some time. It is possible that these companies have developed a HACCP system which is based on, or has been set up with the aid of, another GMP or hygiene code than the animal feed sector GMP code. It is also possible that companies have made use of a HACCP plan which is different (at detail level) from the plan given in part 1 of this manual. It is for these reasons that it is permissible to deviate from the steps shown in this manual if it can be shown that an alternative approach has been used which achieves at least the same result. Example 1: Use has been made by a company of another CCP decision tree than the animal feed sector CCP decision tree. N.B.: The Codex Alimentarius also indicates that the (global) decision tree given in the Codex must

be specified per sector and/or per situation. Example 2: A company has used the measures given in a sector-specific code as a guideline in setting up and implementing a company-specific HACCP system. In these situations there is a deviation from the plan in the HACCP animal feed sector manual. In order to ensure that, in the event of an alternative approach, no steps or activities are missed out the company which produces simple animal feeds and/or animal feed raw materials must meticulously compare the plan given in this manual with the plan being used by the company. Where there is any deviation this must be indicated and recorded in a document.