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“FAMI-QS” European F eed A dditives and Pre MI xtures Q uality S ystem

“FAMI-QS” European F eed A dditives and Pre MI xtures Q uality S ystem. Context and insights. Comment. Please use the link “back” in the upper right corner to jump to the general content page

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“FAMI-QS” European F eed A dditives and Pre MI xtures Q uality S ystem

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  1. “FAMI-QS”European Feed Additives and PreMIxtures Quality System Context and insights

  2. Comment • Please use the link “back” in the upper right corner to jump to the general content page • Please use the links in the various pages starting the different chapters to take you quickly to your point of interest • Please use the links to the internet to access some information there quickly The Expert Group of FAMI-QS

  3. Content • Regulatory background • The FAMI-QS Concept • The Association • The Certification • The Code • Products • Manufacturing • HACCP • Non-Conformances The Expert Group of FAMI-QS

  4. Content • Regulatory background • The FAMI-QS Concept • The Association • The Certification • The Code The Expert Group of FAMI-QS

  5. Hygiene in the feed chain • Directive 95/69/EC • (present) • The Feed hygiene Regulation proposal • (finalized 12/04, published January 2005 as 183/2005/EC, effective as of 01/01/06) The Expert Group of FAMI-QS

  6. Directive 95/69 – “Establishments” • Approval for activities which, are considered potentially hazardous to animals, humans or the environment. • Registration for products considered less sensitive. • In both cases establishments and intermediaries must comply with detailed "quality control" requirements. • Compliance is a precondition before approval (inspection by the competent authority) can be given. • The obligation to comply with those requirements continues once approval/registration has been obtained. The Expert Group of FAMI-QS

  7. Feed Hygiene Regulation • 95/69 'enriched' by the Feed Hygiene Regulation • Integrate the manufacturing and distribution of feed additives, premixtures and complete feedingstuffs in a global food chain • Integrate, in particular, HACCP principle • Scope • Feed Business • Feed additives, premixtures, feed materials, feedingstuffs • Farmers • Imports The Expert Group of FAMI-QS

  8. Feed Hygiene Regulation • Obligations for the chain: • Good Manufacturing Practices (including logistics) • Microbiological criteria (specific) • Hazard Analysis of Critical Control Points (HACCP) • Financial Guarantees • Approval / Registration • Guides for application of: • Good Manufacturing Practices • HACCP The Expert Group of FAMI-QS

  9. Content • Regulatory background • The FAMI-QS Concept • The Association • The Certification • The Code The Expert Group of FAMI-QS

  10. Advantages • Optimisation of efforts for feed safety by agreed upon measures • Auditable harmonized code throughout EU, thus • Minimization of need for checks by authorities, users The Expert Group of FAMI-QS

  11. Compliance • A tool for complying with the Feed Hygiene Regulation, which: • encourages the development of systems to good practice for hygiene • requires the application of HACCP principles • Positive dynamic with chain partners The Expert Group of FAMI-QS

  12. Basis • Code is based on established guidelines such as • Codex Alimentarius (HACCP) • EN ISO 9001:2000 • Management systems developed in different countries like GMP+, FEMAS, Q+S, … • EU proposal on feed hygiene The Expert Group of FAMI-QS

  13. Information • Information about the Code itself, as well as the association and the certification process can be found under www.fami-qs.org The Expert Group of FAMI-QS

  14. Content • Regulatory background • The FAMI-QS Concept • The Association • The Certification • The Code The Expert Group of FAMI-QS

  15. The Association • 'European Feed Additives and PreMIxtures Quality System Association' • 'Not-for-profit' association (Asbl under Belgian law) • Formally created on May 04, 2004 • First General Assembly in Brussels in May 2004 • Second General Assembly in Brussels in January 2005 The Expert Group of FAMI-QS

  16. Purpose and Activities • Manage and co-ordinate all activities related to the EU Feed Additives and premixture Quality System – FAMI-QS • Establish, register and maintain the FAMI-QS system • Rule the use of the code • Coordinate adequate certification systems The Expert Group of FAMI-QS

  17. Membership Structure • Full members • Manufacturers or traders of FA or PM • Members of FEFANA • Min. 5, no max., full voting rights • Associate members • Involved in the feed additive or premixture business • FAMI-QS certified The Expert Group of FAMI-QS

  18. Adisseo ADM Ajinomoto Alltech BASF Degussa DSM FinnFeeds Lohmann Novus Novozymes Phytobiotics The Full Members* *status June 2005 The Expert Group of FAMI-QS

  19. The Board, Secretary General and Quality Manager • Rolf-Dieter Reinhardt (BASF) • Hermann Roth (Phytobiotics) • Matthew Russel (Alltech) • Manfred Peisker (ADM) • Didier Jans (Secretary General) • Ioan Paraian (Quality Manager/Coordinator) The Expert Group of FAMI-QS

  20. FAMI-QS Asbl flowchart The Expert Group of FAMI-QS

  21. The History • Development of the Code of Practice (April ’03 – April ’04) • FAMI-QS founded (May ’04) • Training of certification bodies (June ‘04) • Coordination meeting with Partner Platform (national organisations for feed quality systems, June ‘04) • FAMI-QS internal approval of certification bodies (mid-July) • Final versions (ver. 1) of Code of Practice and Description of Certification Process (July ‘04) • Web site (August ’04) • Start of certification process, audits (September ‘04) • Second version of Code published in June 2005 • First seven guidance with more detailed information on topics such as transportation, HACCP, hygiene etc published The Expert Group of FAMI-QS

  22. The Status • First companies certified (15 companies / 30 sites)* • Increasing interest from other companies who plan to become certified, including companies from outside EU (India, China) (another 15 companies / 30 sites)* * Status June 2005 The Expert Group of FAMI-QS

  23. Content • Regulatory background • The FAMI-QS Concept • The Association • The Certification • The Code The Expert Group of FAMI-QS

  24. Granting a FAMI-QS Certificate • Recognised certification bodies only, certification bodies required to achieve accreditation under ISO 45011 • Recognition is provided by the FAMIQS organisation • Certification body responsibilities: • Planning • Assessment of documents • Audits • Audit reports • Certification • Use of certificate is conditioned to FAMI-QS membership (associate or full) The Expert Group of FAMI-QS

  25. Certification of EU operators • All EU based operators should be certified by 01 Jan. 2006 • Operators buying Feed Additives from another EU based operator should provide a verifiable plan with milestones and deadlines for ensuring the certification of their supplier (in case a supplier is not certified yet). • This case covers the period until January 2006. The Expert Group of FAMI-QS

  26. Certification of Importers and Manufacturers outside the EU • Operators buying Feed Additives from a non EU operator should provide a verifiable plan with milestones and deadlines for ensuring the certification of the supplier and the initial manufacturer of the Feed Additive. • Deadline for the supplier and initial manufacturer to apply for FAMI-QS certification shall not be later than end 2006, and for getting certification no later than end 2007. • It is the auditor's responsibility and obligation to check that above mentioned deadlines are respected. Failure to do this would create a critical non conformity at the operator's (this means a withdrawal of the certificate). The Expert Group of FAMI-QS

  27. One certificate for entire EU (...) hereby certifies that the company: (...) has implemented and maintains a Quality Management System in compliance with the FAMI-QS Standard (ver. xx, date dd/mm/yy) on the following site(s): (…) for the placing on the market of feed additives belonging to the following category(ies) and functional group(s): (…) Audits, documented in a report, have verified that the Management System fulfils the requirements of this standard. This certificate is valid until: (...) The validity of this certificate can be verified on the FAMI-QS web site (www.fami-qs.org) N.B.: For premixtures, the information about feed additive categories is not relevant The Expert Group of FAMI-QS

  28. Content • Regulatory background • The FAMI-QS Concept • The Association • The Certification • The Code The Expert Group of FAMI-QS

  29. The Code • The Code provides among other items requirements for good manufacturing of • Products • Handling of ingredients • Traceability • HACCP • Logistics (incl. warehousing, transportation) • Its consists of text and questions which are both used to define the requirements • Details and explanations can be found in the following slides • The Code can be found on the FAMI-QS homepage under documents (or click here) The Expert Group of FAMI-QS

  30. The Code • Products • Manufacturing • HACCP • Non Conformances The Expert Group of FAMI-QS

  31. The Code • Packaging & labelling • Quality Control • Verification • Blending • Warehousing & Storage • Transport • Cleaning • HACCP • Non Conformances • Products • Specification • Suppliers • Incoming Materials • Stability • Traceability • Manufacturing • Building and Equipment • Work Environment • Finished Goods The Expert Group of FAMI-QS

  32. Specifications 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. The Expert Group of FAMI-QS

  33. Specifications Principle: The specification ensures that an ingredient used always has a predefined agreed upon quality. The Expert Group of FAMI-QS

  34. Specifications • Specifications are needed for • Incoming raw materials • Packaging materials • Final products • Labels The Expert Group of FAMI-QS

  35. Specifications • Specifications need to …. • Be adequate to control the quality of the material for its intended use and contain e.g. • Acceptance limits • Reference to the method • Reflect possible hazards e.g. • Microbiology were applicable • Undesirable substances were applicable • Take into account regulatory requirements • Be part of the change control procedure and need to be amended if applicable The Expert Group of FAMI-QS

  36. Suppliers Principle: As the goal is to ensure safety throughout the whole food and feed chain the risks brought in from suppliers have to be considered and controlled equally well as risks brought in by the operator The Expert Group of FAMI-QS

  37. Suppliers • Suppliers of incoming materials must be • Evaluated • A risk consideration must be made for raw materials and primary packaging • Samples tested for at least selected criteria in case of raw materials • Agreements made • Statements requested • Approved • According to defined criteria including where necessary audit results • Listed in an internal list of approved suppliers • The list must be reviewed periodically, at least once a year • Evaluated for their continuous performance The Expert Group of FAMI-QS

  38. Suppliers • Targets • All suppliers of Feed additives or premixtures must be approved according to FAMI-QS • For other raw materials appropriate risk analysis must be conducted . The Expert Group of FAMI-QS

  39. Suppliers • Interim measures • All EU based FA and PM operators should be certified by January 2005. • Operators buying feed additives (FA) from another EU based operator should provide a verifiable plan with milestones and deadlines for ensuring the certification of their supplier (in the case a supplier is not certified yet). This case covers the period until January 2005, cf. 1. • Operators buying FA from a non EU operator should provide a verifiable plan with milestones and deadlines for ensuring the certification of the supplier and the initial manufacturer of the FA. Deadline for the supplier and initial manufacturer to apply for FAMI-QS certification shall not be later than end 2006, and for getting certification no later than end 2007. • It is the auditor's responsibility and obligation to check that above mentioned deadlines are respected. Failure to do this would create a critical non conformity at the operator's (this means a withdrawal of the certificate). The Expert Group of FAMI-QS

  40. Incoming Materials • Incoming material: A general term used to denote raw materials (starting materials, reagents, solvents), process aids, packaging and labelling materials • Raw material: Any material which enters the manufacturing process of the feed additive and/or premixture. The Expert Group of FAMI-QS

  41. Incoming Materials Principle: Incoming materials are one of the critical points to potentially include hazards for humans or environment into the product. Thus they must be strictly controlled in order to avoid such hazards. The Expert Group of FAMI-QS

  42. Incoming Materials • Requirements for approval of incoming materials must be established. They are • Risk considerations • Sourcing only from suppliers listed internally as approved • Specifications, including test methods The Expert Group of FAMI-QS

  43. Incoming Materials It is important to define • Transport • Storage • Processing • Handling before usage of incoming materials in order to ensure that no adulteration or additional risk arises The Expert Group of FAMI-QS

  44. Incoming Materials • When the incoming material is received the operator has to verify • supplier’s lot number • full supplier’s name of product • date of receipt • quantity received • any findings of deviations on agreed upon quality. These are to be reported to the quality control unit The Expert Group of FAMI-QS

  45. Incoming Materials • Retained sample • To be kept for the period of shelf life, either at the supplier or the operator • Rejected material • Must be strictly controlled by proper identification/storage to avoid unauthorized usage The Expert Group of FAMI-QS

  46. Stability • A proper shelf life has to be established in order to indicate for the customers, how long the guaranteed specification can be expected. • Stability has to be defined, preferably by measurements, or if applicable (e.g. in case of premixtures) theoretical considerations can be used • Indications about storage conditions which ensure specifications throughout the shelf life period must be given The Expert Group of FAMI-QS

  47. Traceability Principle: ‘Traceability’ means 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; products (178/2002/EC) The Expert Group of FAMI-QS

  48. Traceability Incoming materials • Maintain a register, that contains the names and addresses of manufacturers of incoming materials, additives or of intermediaries • Confirmation by the supplier to have a traceability system established or verification through an audit (future requirement) The Expert Group of FAMI-QS

  49. Traceability Product traceability during manufacturing • Identify and record the product by suitable means throughout product realisation • The nature and quantity of the additives and premixes produced, the respective dates of manufacture and, where appropriate, the number of the batch or of the specific portion of production in the case of continuous manufacture The Expert Group of FAMI-QS

  50. Traceability Deliveries • the name and addresses of the intermediaries or manufacturers or users to whom the additives or premixes have been delivered must be recorded • Indicate the nature and quantity of the additive or premix delivered and, where appropriate, the number of the batch or of the specific portion of production in the case of continuous manufacture The Expert Group of FAMI-QS

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