Bijlage 13 Verordening PDV certificatie GMP diervoedersector 2003: quality Control of Feed Materials for Animal Feed GMP13; 11-4-2003

Verordening PDV certificatie GMP diervoedersector 2003

Preface 3 1 Introduction 4 2 Scope 6 3 Definitions 6 4 Basic Requirements 9 4.1 Basic Requirements for Producers 9 4.1.1 Awareness 9 4.1.2 Quality Control System 9 4.1.3 Quality Control Documentation 9 4.1.4 Independent verification 10 4.1.5 Management responsibility 10 4.1.6 Other documentation 10 4.2 Basic Requirements for Traders 11 5 Specific QC - Requirements 13 5.1 General 13 5.2 Product Specification 14 5.3 Production Process Specification 14 5.4 Hazard Identification 15 5.5 Risk Evaluation and Determination of Critical Control Points 16 5.6 Control Measures for Critical Points 17 5.7 Monitoring and Verification 21 5.8 Evaluation, Actualisation and Communication 22 6 Periodical External Verification Audit 23 7 Useful Documents 23 In June 2001 the Product Board Animal Feed (The Netherlands) laid down the first version of the Standard Quality Control of Feed Materials for Animal Feed. This standard is part of the scheme GMP+ Animal Feed, especially for the quality control of feed materials supplied from abroad. In the second half of 2001 we have had deliberations with UKASTA (United Kingdom) about the exchangeability of the Dutch QC-standard and the British FEMAS (Feed Material Assurance Scheme), both intended to assure the quality and safety of feed materials. In order to reach the exchangeability, we have added some elements in this version two of the QC - standard, especially in the explanations notes. Therefore, this version does not differ from the previous version substantially. The Product Board Animal Feed has determined this version in his meeting of 23 January 2002. At last, we want to emphasize that, when a foreign supplier has already a quality control program put in place, this QC - standard has not to replace it, or that a separate audit has to be carried out by the certification of verification body. We would support that the additional requirements in this standard are integrated in the existing quality system already put in place. And we would

• ● a pro-active approach for the control of risks in the entire production chain. With hazard analysis at chain level and HACCP (Hazard Analysis & Critical Control Points) at company level.
• ● extension of the quality control to the entire chain of suppliers of feed materials.
• ● an early warning system (EWS), which is intended to be a safety net, additionally to quality management systems like GMP, ISO 9002 and HACCP. The goal is to spot, communicate and eliminate a possible or potential hazard, which may occur not- withstanding all preventive measures.
• ● Risk assessment by scientific and expert advise and information analysis
• ● Risk management by issuing regulations, control measures, etc.
• ● Risk communication.
• ● Specific control measure (CCP): Specific control measures are specially developed and used to control the estimated risk.
• ● General control measure: 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.
• ● Periodic measure: Periodic measures are measures which are carried out once and which are periodically reviewed/ assessed
• a) Product specification: The end product specification of the feed materials: see section 5.2.
• b) Process specification: The process steps and the process conditions of the entire production process (cultivation, storage, transfer, treatment, processing, transport, etc): see divisie 5.3.
• c) Hazard identification: The identification of the hazards that may cause a contamination of the feed materials with microbiological, chemical or physical contaminants from the environment or the process: see divisie 5.4.
• d) Risk evaluation and determination of critical control point: see divisie 5.5.
• e) The control measures taken by the supplier to prevent any possible product contamination, the critical points being controlled at least: see divisie 5.6.
• f) The measurement points and checks (monitoring and verification) that are performed to determine that the control measures are being realised: see divisie 5.7.
• g) Evaluation and communication: see divisie 5.8.
• ● Formulation of the scope of the QC- system: The scope of the QC-system must be indicated. 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.
• ● Tasks, responsibilities & authorities (TRA's): When setting up the QC-system it is also important to lay down the TRA's of employees, especially the tasks, responsibilities and authorities of employees with regard to food and feed safety must be included. All personnel involved in the production, storage or handling of feed materials shall have appropriate training in safe, hygienic and effective working practices. When necessary a training must take place to make sure the personnel is competent to carry out the tasks.
• ● contracts,
• ● legislation (labelling, etc.,)
• ● tracking and tracing,
• ● documentation,
• ● Product definition.
• ● Production Process definition
• ● Hazard Identification.
• ● Risk evaluation
• ● Determination of critical points.
• ● legal demands (statutory demands in the European Community).
• ● demands from sectoral agreements (chain parties, other market parties)
• ● other GMP-requirements.
• ● additional demands from the client (for example: non GM-demands) Additionally the following items must be entered in a product specification:
• ● Name of the product
• ● Description of product (chemical, micro-biological, physical, nutritional, etc.)
• ● Intended use
• ● Transport, storage and usage rules to maintain the product characteristics
• ● The use of auxiliaries, like pesticides, insecticides, fungicides, technological processagents which are applied or added to or may come in contact with the product
• ● Specific processing steps when substances may be added to the product, like duringsteam heating, artificial drying
• ● Specific conditions during cultivation, harvesting and storage when microbiological contaminants come into existence.
• ● direct artificial drying
• ● steam injection
• ● use of technological process agents (like gypsum, free flow agents, acid regulator) andtechnical agents (like lubricants) and
• ● mycotoxins
• ● transport.
• ● Choose for less sensitive breeds
• ● Apply full crop rotation, without maize before other cereals
• ● Apply a turning up side down soil tillage
• ● Avoid damage; store and transport goods dry
• ● Scrapped
• ● Reworked
• ● Accepted by concession (if agreed by the client)
• ● Downgraded
• ● Free of possible "agribulk-unfriendly elements", such as residues of preceding cargo and/orcleansing activities.
• ● Free of vermin, in the broadest sense of the word (insects and vermin, dead or alive).
• a) an inspection company at the EN 45000 level, specialised in and accredited for feed/grainsor liquid agri-bulk, and internationally operating on a certified guarantee system such asISO 9000 or equivalent;
• b) a company inspector of the chartering party or, at his request, of the supplying party, whois included in the company's own quality system as a qualified loading inspector and whose person, function and ability have been guaranteed.
• ● Specification of the fuel quality and appointments with the supplier, based on risk evaluation Use only mineral fuels (gas, coal, petroleum) which are suitable according to the specification of the supplier.
• ● Specification of control measure to avoid contamination of fuels during storage and transport
• ● Specification of the checks of the fuel's quality
• ● Specification of the adjustment of the burner and dryer installation to avoid incomplete combustion
• ● Specification of the quality of the technical and technological aid agents
• ● Specification of de quality control of the technical and technological aid agents
• ● the quality of the water, which is used for steam injection and the technical aid agents like corrosion preventing agents
• ● the quality control of the water and the technical aid agents
• ● HACCP-manual Animal Feed Sector: a useful guide to help implement the required QC-system
• ● Standard GMP Animal Feed
• ● Risk Assessments of about 80 feed materials