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European Code of Practice for Feed Additive and Premixture
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FAMI QS Code of Practice, The principles of HACCP re Codex Alimentarius General principles of Food Hygiene CAC RCP 1. 1969 Rev 4 2003 Amd 1999 Annex on Hazard Analysis and Critical Control Point HACCP. System and Guidelines for its Application,http www Codexalimentarius net. Management systems developed by associations in different Member States for example other. Codes of Practice and Quality Assurance Schemes,Code of Practice FEFAC EU. http www fefac org Code aspx EntryID 265,FEMAS AIC UK. http www agindustries org uk content template 30 30 Home Home Home mspx. GMP OVOCOM B,http www ovocom be,GMP PDV Nl,http www pdv nl index eng php switch 1.
http www q s info, The combination of the above principles provides guidance for feed additive and premixture operators in. implementing the measures necessary to ensure feed safety in European and international manufacturing. and trade In order to facilitate implementation of the Code the structure of ISO 9001 2000 Quality. Management Systems is used, In the exceptional case where a direct or indirect risk to human or animal health is related to a product. manufactured and marketed under the Code the information and recall procedures including the rapid. alert system defined in Regulation EC No 178 2002 shall apply. The text of the Code is designed to set out general requirements and to be used by operators as a tool to. develop their own procedures, A compilation of guidance is provided as annex to the Code This covers topics of special importance While. the requirements of the Code are mandatory for every operator the Guidance provides information on. how to deal with specific issues in a more detailed and practical way and may serve as further supporting. information to the Code If the operator decides to follow the procedures described in the Guidance this. will become a part of its Safety System In case that for good reasons different procedures are used the. operator must be able to provide evidence upon request that he is complying with the requirements of the. Code as well, Both the Code and Guidance will be submitted to periodical review in line with emerging new relevant. technological scientific and legislative developments or statutory modification in the sector. Note FAMI QS Code of Practice is a public document and its contents can be freely followed by any feed. additive or premixture operator, Running side by side with the Code FAMI QS Asbl has developed a parallel and independent certification.
system that is described in the Rules for Certification documents Participation in the FAMI QS auditable. system is based on voluntary commitment, Please consult the FAMI QS web page www fami qs org to have access to these documents and learn. more about how to ensure compliance with this Code of Practice. Version 5 1 April 2009,FAMI QS Code of Practice,TABLE OF CONTENTS. 1 Introduction 1,3 Terms and definitions 6,4 Management System MS 10. 4 1 General requirements 10,4 2 Management principles 10. 4 3 General documentation requirements 10,5 Management Responsibility 13.
5 1 Management commitment 13,5 2 Quality and safety policy 13. 5 3 Responsibility authority and communication 13,5 4 Management representative 14. 5 5 Management review 14,6 Resource management 16,6 1 Provision of resources 16. 6 2 Human resources 16,6 2 1 Competence awareness and training 16. 6 2 2 Personal hygiene 16,6 3 Infrastructure 17,6 3 1 Basic requirements 17.
6 3 2 Requirements for facilities production areas and equipment 17. 6 3 2 1 Facilities and production areas 17,6 3 2 2 Equipment 18. 6 4 Maintenance and control of monitoring and measuring devices 18. 6 5 Cleaning 19,6 6 Pest control 20,6 7 Waste control 21. 7 Product realisation 22,7 1 Product requirements 22. 7 1 1 Determination of requirements related to the product 22. 7 1 2 Compliance of the product to the requirements 22. 7 1 3 Customer communication 22,7 2 HACCP Program 23. 7 3 Design and development 24, 7 3 1 Development of new products and processes 24.
Version 5 1 April 2009,FAMI QS Code of Practice,7 3 2 Change control 24. 7 4 Handling of incoming materials 25,7 4 1 Sourcing of incoming materials 25. 7 4 2 Verification of incoming materials 26,7 5 Production of finished goods 27. 7 5 1 Quality control and production 27,7 5 2 Verification of processes for production 29. 7 5 3 Identification and traceability 30,7 5 4 Preservation of product 30.
7 6 Transport 30,7 6 1 General requirements 30,7 6 2 Transport of packaged goods 31. 7 6 3 Transport of bulk products 31,8 System Review 33. 8 1 General requirements 33,8 2 Internal audits 33. 9 Control of non conforming products 35,9 1 General requirements 35. 9 2 Complaint handling system 36,9 3 Recall 37,9 4 Crisis Management 38.
10 Statistical techniques 39,Version 5 1 April 2009. FAMI QS Code of Practice, The aim of this European Code of Practice is to ensure safety of feed additives and premixtures by. minimizing the risk of adulterated feed additives and premixtures entering the feed food chain. enabling an operator to implement the objectives of the feed hygiene Regulation Regulation EC. No 183 2005 and, providing measures to ensure that other applicable regulatory feed safety requirements are met. Feed is considered unsafe for its intended use if it is likely to pose a risk to has adverse effect on human or. animal health or if the food derived from food producing animals fed the feed is unsafe for human. consumption, This Code shall apply to feed additives and premixture operators at all stages of feed production from the. first placing on the market of feed additives and premixtures based on current EU legislation Therefore it. also applies to the placing on the market of feed additives and premixtures after import from third. Compliance with FAMI QS does not exonerate the operator from meeting the statutory or regulatory. requirements in each country in which the operator is active The regulatory status of feed additives can be. checked on the Community Register of Feed Additives. http europa eu int comm food food animalnutrition feedadditives registeradditives en htm. published and frequently updated by the European Commission. Version 5 1 April 2009,FAMI QS Code of Practice,3 Terms and definitions.
The following terms and definitions are used in this guide and associated annexes. Adequate The terminologies adequate where appropriate where necessary or sufficient mean. that it is up to the business operator in first instance to decide whether a requirement is necessary. appropriate adequate or sufficient to achieve the objectives of the Code In determining whether a. requirement is adequate appropriate necessary or sufficient account should be taken of the nature of. the feed and of its intended use adopted from EC Guidance Document 2005 on Regulation 852 2004 EC and modified. Agent An individual or firm authorized to act on behalf of an operator such as by executing commercial. transactions without ever taking legal responsibility of the product and the way it is supplied and provided. into the feed chain, Authorised personnel Persons who have skills permission and purpose as specified by job descriptions. process descriptions or management, Batch unit of production from a single plant using uniform production parameters or a number of such. units when produced in continuous order and stored together It consists of an identifiable quantity of. feed and is determined to have common characteristics such as origin variety type of packing packer. consignor or labelling COM 2008 124 final, Calibration The demonstration that a particular instrument or device produces results within specified. limits by comparison with those produced by a reference or traceable standard over an appropriate range. of measurements, Carrier Substance used to dissolve dilute disperse or otherwise physically modify a feed additive in order. to facilitate its handling application or use without altering its technological function and without exerting. any technological effect themselves COM 2008 124 final. Carry over Contamination of a material or product with another material or product that originates from. previous use of equipment and would alter the quality and safety beyond the established specifications. Check control Monitor and measure processes and product against policies objectives and requirements. for the product and report results,CIP Cleaning in place.
Code of Practice Document identifying the principles of feed hygiene essential to ensure the safety of feed. for animals and in turn the safety of animal products intended for human consumption. Compound feed Mixture of feed materials whether or not containing feed additives for oral animal. feeding in the form of complete or complementary feed COM 2008 124 final. Contamination The undesired introduction of impurities of a chemical or microbiological nature or of. foreign matter into or onto a raw material intermediate feed additive or premixture during production. sampling packaging or repackaging storage or transport. Corrective Action Action to eliminate the cause of a detected non conformity or other undesirable. situation Corrective action is taken to prevent recurrence whereas preventive action is taken to prevent. occurrence ISO 9000 2005, Cross Contamination Contamination of a material or product with another product. Crisis An event that represents an immediate and significant threat to animal and or human health. resulting from the production or supply of unsafe or illegal product where the product has left the. immediate control of the feed business operator synopses from articles 15 19 Regulation 178 2002 EC. Establishment Any unit of a feed business that carries out the manufacture production and or the placing. on the market of feed additives and premixtures Regulation 183 2005 EC and adapted. Version 5 1 April 2009,FAMI QS Code of Practice, Export The release for free circulation of a product or the intention to release a product for free circulation. into a non EU member state which is manufactured in an EU member state. Feed additives Substances micro organisms or preparations other than feed material and premixtures. which are intentionally added to feed or water in order to perform in particular one or more of the. following functions,favourably affect the characteristics of feed. favourably affect the characteristics of animal products. favourably affect the colour of ornamental fish and birds. satisfy the nutritional needs of animals, favourably affect the environmental consequences of animal production. favourably affect animal production performance or welfare particularly by affecting the gastro. intestinal flora or digestibility of feedingstuffs or. have a coccidiostatic or histomonostatic effect, Regulation 1831 2003 EC and Regulation 183 2005 EC.
Feed business Any undertaking whether for profit or not and whether public or private carrying out any. operation of production manufacture processing or distribution of feed additives and premixtures. Regulation178 2002 EC and adapted See Stages of production processing and distribution. Feed business operator The natural or legal persons responsible for ensuring that the requirements of. food law are met within the feed business under their control Regulation178 2002 EC and adapted See Feed. Feed hygiene The measures and conditions necessary to control hazards and to ensure fitness for animal. consumption of a feed additive or a premixture taking into account its intended use Regulation 183 2005 EC. Feed material Various products of vegetable or animal origin in their natural state fresh or preserved and. products derived from the industrial processing thereof Organic or inorganic substances whether or not. containing additives which are intended for use in oral animal feeding either directly as such or after. processing in the preparation of compound feedingstuffs or as carriers of premixtures Regulation. 1831 2003 EC, Feed safety High level of assurance that the feed feedingstuff feed additive or premixture will neither. cause harm to the farm animals when prepared or consumed according to the intended use or to the final. consumer Throughout the Code the word safety is taken to have the same meaning as feed safety. First placing on the market The initial placing on the European Union market of an additive or premixture. after its manufacture or the import of an additive or premixture See placing on the market Regulation. 1831 2003 EC, Flow diagram A systematic representation of the sequence of steps or operations used in the production. or manufacture of a particular food item Codex Alimentarius. HACCP Hazard Analysis and Critical Control Point A system which identifies evaluates and controls. hazards to feed safety Codex Alimentarius and modified. Hazard analysis The process of collecting and evaluating information on hazards and conditions leading to. their presence to decide which are significant for feed safety and therefore shall be addressed in the. HACCP plan, Hazard Biological chemical or physical agent in the feed chain with the potential to cause an adverse. health effect for animals or consumers Regulation178 2002 EC. Homogeneity The degree to which a property or a constituent is uniformly distributed throughout a. Version 5 1 April 2009,FAMI QS Code of Practice,quantity of material PAC 1990. Import The release for free circulation of a product or the intention to release a product for free. circulation into an EU member state which is manufactured in a non EU member state Regulation. 882 2004 EC and modified, Incoming material A general term used to denote raw materials delivered at the beginning of the.
production chain e g reagents solvents processing aids feed materials feed additives and premixtures. Intermediate Any material which has been processed by the operator before the final product is obtained. Manufacture production All operations encompassing receipt of materials processing packaging. repackaging labelling relabelling quality control release storage and distribution of feed additives and. premixtures and related controls, Minerals Feed materials may include minerals mentioned in Annex Part B chapter 11 of Directive. Operator See feed business operator, Placing on the market Holding products for the purposes of sale including offering for sale or for the. purposes of any other form of transfer whether or not free of charge to third parties and the sale and. other forms of transfer themselves Regulation178 2002 EC See first placing on the market. Plan To establish the objectives and processes necessary to deliver results in accordance with the. operator s policies regarding quality and safety, Premixtures Mixtures of feed additives or mixtures of one or more feed additives with feed materials or. water used as carriers not intended to direct feeding to animals Regulation 1831 2003 EC. Preventive Action Action to eliminate the cause of a potential non conformity or other undesirable. potential situation Preventive action is taken to prevent occurrence whereas corrective action is taken to. prevent recurrence ISO 9000 2005, Procedure Operations to be performed precautions to be taken and measures to be applied directly or. indirectly related to the manufacturing of a material feed additive or premixture Modified from ICH Q7A. Processing aids Any substance not consumed as a feedingstuff by itself intentionally used in the. processing of feedingstuffs or feed materials to fulfil a technological purpose during treatment or. processing which may result in the unintentional but technological unavoidable presence of residues of the. substance or its derivatives in the final product provided that these residues do not have any adverse. effect on animal health human health or the environment and do not have any technological effects on the. finished feed Regulation 1831 2003 EC, Quality Degree to which a set of inherent characteristics fulfils requirements ISO 9000 2005.
Quality Manual Document specifying the quality management system of an organisation ISO 9000 2005. Raw material Any material which enters the manufacturing process of the feed additive and or premixture. Recall Any measure aimed at achieving the return of a dangerous product that has already been supplied. or made available to consumers by the operator Regulation No 2001 95 EC. Record Written documents containing actual data, Reworking Any appropriate manipulation steps in order to ensure a feed additive or premixture will. conform to specifications, Risk A function of the probability of an adverse health effect and the severity of that effect consequential. to a hazard Regulation178 2002 EC,Safety See feed safety. Version 5 1 April 2009,FAMI QS Code of Practice, Shall Compliance with a requirement which is mandatory for compliance with this standard Obligation to. follow the exact requirement as stated by this Code. Shelf life A defined time period for which a product fully complies with it is specification if stored. appropriately, Should Means must and the activities descriptions or specifications accompanied by the word should.
are intended to be mandatory unless the manufacturer is able to demonstrate that the activity description. or specification is inapplicable or can be replaced by an alternative which must be demonstrated to provide. at least an equivalent level of quality and safety assurance Operators are obligated to achieve the goal of. the Code by appropriate means, Sign signature Confirmation of an authorised person in writing or by electronic means with controlled. Specification A list of tests references to analytical procedures and appropriate acceptance criteria that. are numerical limits ranges or other criteria for the test described It establishes the set of criteria to. which a material shall conform to be considered acceptable for its intended use Compliance to. specification means that the material when tested according to the listed analytical procedures meets. the listed acceptance criteria, Subcontracting The delivery of a service pertaining to the product provided by a third party to the. operator where no change in ownership of the product takes place. Sufficient See Adequate, Stages of production processing and distribution Any stage including import from and including the. primary production of a food up to and including its storage transport sale or supply to the final consumer. and where relevant the importation production manufacture storage transport distribution sale and. supply of feed Regulation178 2002 EC, Traceability The ability to trace and follow a food feed food producing animal or substance intended to. be or expected to be incorporated into a food or feed through all stages of production processing and. distribution Regulation178 2002 EC, Verification Application of methods procedures tests and other evaluations in addition to monitoring to.
determine compliance with a requirement,Where appropriate See adequate. Where necessary See Adequate, Written documents Paper printed documents These may be substituted by electronic photographic or. other data processing systems provided that the data will be appropriately stored during the anticipated. period of storage archive and can be made readily available in a legible form. Version 5 1 April 2009,FAMI QS Code of Practice,4 Management System MS. 4 1 General requirements, The operator shall establish document implement and maintain a management system in accordance with. the requirements of this Code, The MS shall be continually adapted in line with regulatory developments and customer requirements.
The structure of the MS shall be specific to the organisation of the operator and should include policies. requirements and process documents that reflect commitment to feed safety. The MS shall ensure that all activities carried out by the operator that could impact on the quality and feed. safety of the product are consistently defined implemented and maintained at all levels in the organisation. The MS shall include quality procedures to ensure that the product consistently conforms to the. authorization of the feed additive and the specification of the premixture s thereof. Ensure that,A documented MS is in place, The MS includes regulatory safety and customer requirements. The MS is covering all the operator s activities, Other activities are not conflicting with the feed safety requirements. 4 2 Management principles, Operators should be able to demonstrate that its employees are aware of their contribution to feed safety. and relevant EU legislation associated to their various tasks. Each operator shall perform and record the evaluation of risks associated with processes within his. operations and subsequently define controls to be applied to these based on HACCP principles. Effective change control and investigative procedures shall be in place to manage product history and. deviations from planned procedure, Procedures shall exist for the timely notification of the appropriate management of occurrences that might. pose a threat to product quality and safety These include for example complaints product recall and. audit findings, For more detailed information on the relevant legislation on feed additives and premixtures see Annex 8.
Guidance on compliance with the EU legislation on feed additives and premixtures for product realisation. Ensure that, Employees commitment to feed safety and quality can be demonstrated. HACCP principles are applied,An effective change control system is implemented. Management are informed in case of threats to product quality and feed safety. A system is in place to ensure that management is kept up dated on all relevant legislation feed and food safety. issues and other relevant guidelines,4 3 General documentation requirements. The operator shall have a system of documentation which reflects all aspects of this Code The system of. documentation shall reflect in particular the application of HACCP. Version 5 1 April 2009,Page 10 39,FAMI QS Code of Practice. Records shall contain all relevant data that will permit investigation of any non conformance or deviation s. from planned procedure s, All quality and safety related activities shall be recorded immediately after they have been performed.
The design and nature of use of records is at the discretion of the operator. MS documentation should include,a a written quality and safety policy. b a Quality Manual,c documented procedures and records and. d information needed by the operator to ensure the effective planning operation and control of its. The Quality Manual should include, a the scope of the MS including details of and justification for any exclusion. b quality procedures established as part of the MS or reference to them. c quality procedures in support of the HACCP program. d HACCP procedures to ensure feed safety,Minimum documents required include. a specifications and testing procedures for incoming materials and finished product. b master formulae and operating instructions for each product or group of products. c batch processing records for each product and,d Standard Operating Procedures SOPs.
Documents should, a have unambiguous contents the title nature and purpose shall be clearly stated. b be approved signed and dated by appropriate authorised persons No document shall be changed. without authorisation and,c be kept up to date,Version 5 1 April 2009. Page 11 39,FAMI QS Code of Practice,Ensure that,A written quality and safety policy exists. A Quality Manual is in place,Documented procedures and records are available. The scope of the MS is defined, Quality procedures are established as part of the MS.
Quality procedures cover the prerequisite program in support of the HACCP program. HACCP procedures are sufficient to ensure feed safety. Specifications and testing procedures for incoming materials and finished products are documented. Master formulae and operating instructions for each product or group of products are in place. Processing records for each batch of product are available. Standard Operating Procedures SOPs for all activities under the scope of the MS are documented. Documents are unambiguous and include title nature and purpose. Documents are approved signed and dated by appropriate authorised persons. All documents are kept up to date,Version 5 1 April 2009. Page 12 39,FAMI QS Code of Practice,5 Management Responsibility. 5 1 Management commitment, Management shall be committed to the implementation of the Code and the companies own specific. quality requirements in order to ensure feed safety and predefined quality of products. Ensure that, Management commitment to feed safety and quality can be demonstrated. 5 2 Quality and safety policy,Management shall, a Establish and put in place a quality and safety policy and ensure that objectives are established.
clearly stating the companies obligation to produce safe legal feed additives and to respect their. customers requirements, b This policy shall be communicated throughout the organisation and understood by all staff involved. in the production of feed additives, c Provide the necessary resources for the fulfilment of the quality and safety policy. d Ensure all key aspects of the Management and HACCP systems are documented reviewed updated. and communicated to key staff as frequently as might be necessary. Ensure that, The quality and safety policy specifies the operators objectives including regulatory and customer requirements. The policy is adequately communicated, The operator has the basic resources necessary to fulfil the stated objectives. Management and HACCP systems are documented reviewed updated and communicated to key staff. 5 3 Responsibility authority and communication,Management shall.
a appoint a HACCP team and team leader, b define the scope of the HACCP system by identifying the products product categories and. production sites which are covered by the system and ensuring that safety objectives are. established as part of the system, c Ensure Job descriptions are available that clearly define the responsibilities of all staff involved in. the production of feed additives and premixtures, d identify and record any problems and remedial actions with regard to products quality safety and. the operator s management system, e Initiate action s to prevent the occurrence of non conformities relating to product quality and. safety and the operator shall provide adequate resources for the implementation management. and control of the HACCP systems Further details on HACCP requirements can be found in section. Version 5 1 April 2009,Page 13 39,FAMI QS Code of Practice.
f Assign the responsibility and authority for ensuring compliance with regulatory requirements and. industry codes of practice to clearly identified competent persons. g Issue maintain and make available to the operation s staff and external bodies an organisational. chart of the operation and job descriptions,Ensure that. A suitably qualified HACCP team leader is appointed. The scope of the HACCP system is clearly defined, Job descriptions exist for each individual or group of individuals. A system is in place to identify and correct problems within the management and HACCP systems. A suitably qualified person is appointed to ensure compliance with regulatory requirements. An organisational chart is available,5 4 Management representative. Senior management should appoint a member of management who shall have responsibility and authority. that includes, a ensuring that processes needed for the management and HACCP systems are established. implemented and maintained, b reporting to top management on the performance of the management systems and any need for.
improvement and, c ensuring the promotion of awareness of customer requirements throughout the operator. Ensure that, A management representative with responsibility for quality and safety is appointed. The management representative reports to top management. The responsibility includes promotion of awareness towards customer requirements. 5 5 Management review, Management shall review the effectiveness of the Management and HACCP systems at regular defined. a Records of this review shall be maintained, b The need to update or change the Management and HACCP Systems shall be evaluated at these. c Results from external and internal audits shall be reviewed. d Customer complaints and request shall be reviewed. e Internal problems and changes to the operation processes must be reviewed. f Decisions made to change any aspect of the Management and HACCP Systems shall be. communicated to key staff,Version 5 1 April 2009,Page 14 39.
FAMI QS Code of Practice, g Management shall ensure a system is in place to audit the Management and HACCP Systems. Ensure that, A documented procedure exists for management to review the suitability and effectiveness of the MS and HACCP. Records of this review are available, The review is done periodically at predefined intervals. Conclusions drawn and actions taken are documented as part of the review. Any actions are communicated to key personnel within the organisation.


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