1、EUROPEAN CODE OF GOOD PRACTICE FOR FEED ADDITIVES AND PREMIXTURES OPERATORS歐洲飼料添加劑與預混合飼料經營者操作規范Version 5.1 Translated by:2014-02-14EUROPEAN CODE OF PRACTICEFOR FEED ADDITIVES AND PREMIXTURES OPERATORS歐洲飼料添加劑與預混合飼料經營者操作規范TABLE OF CONTENTS 目錄1 INTRODUCTION介紹 42 SCOPE范圍 73 TERMS AND DEFINITIONS術語和定義 84

2、 MANAGEMENT SYSTEM (MS 管理體系 184.1. General requirements總要求 184.2. Management Principles管理原則 184.3. General documentation requirements文件總要求 195 MANAGEMENT RESPONSIBILITY 管理職責 225.1. Management commitment 管理承諾 225.2. Quality and safety policy 質量和安全方針 225.3. Responsibility, authority and communication職

3、責，權限和溝通 235.4. Management representative管理者代表 245.5. Management review 管理評審 246 RESOURCE MANAGEMENT 資源管理 256.1. Provision of resources 資源提供 256.2. Human resources 人力資源 266.2.1. Competence, awareness and training 能力、意識和培訓 266.2.2. Personal Hygiene 個人衛生 266.3. Infrastructure 基礎設施 276.3.1. Basic requir

4、ements 基本要求 276.3.2. Requirements for facilities, production areas and equipment 設施、生產區域和 設備的要求 276.3.3. Facilities & production Areas 設施和生產區域 276.3.4. Equipment 設備 286.4. Maintenance and control of monitoring and measuring devices 監視和測量 設備的維護和控制 296.5. Cleaning 清潔 306.6. Pest control 蟲害控制 316.7

5、. Waste control 廢棄物控制 337 PRODUCT REALISATION 產品實現 347.1. Product requirements 產品要求 347.1.1. Determination of requirements related to the product 與產品有關要求的確定 347.1.2. Compliance of the product to the requirements 產品要求的符合性 347.1.3. Customer communication 顧客溝通 357.2. HACCP Programme HACCP 方案 357.3. Des

6、ign and development 設計和開發 377.3.1. Development of new products and processes 新產品和過程的開發 377.3.2. Change control 設計更改的控制 377.4. Handling of incoming materials 購進原料的處理 387.4.1. Sourcing of incoming materials 購進原料的來源 387.4.2. Verification of incoming materials 購進原料的驗證 407.5. Production of finished goods

7、 產品的生產 417.5.1. Quality Control and Production 質量控制和生產 417.5.2. Verification of processes for production 生產過程的驗證 457.5.3. Identification and traceability 標識和可追溯性 457.5.4. Preservation of product 產品防護 467.6. Transport 運輸 477.6.1. General requirements 總要求 477.6.2. Transport of packaged goods 已包裝貨物的運輸

8、487.6.3. Transport of bulk products 散裝產品的運輸 488 SYSTEM REVIEW 體系評審 508.1. General requirements 總要求 508.2. Internal audits 內部審核 509 CONTROL OF NON-CONFORMING PRODUCTS 不合格品的控制 529.1. General requirements 總要求 529.2. Complaint handling system 投訴處理系統 539.3. Recall 召回 549.4. Crisis Management 危機管理 5510 ST

9、ATISTICAL TECHNIQUES 統計技術 5711 BIBLIOGRAPHY 參考文獻 571 INTRODUCTION 介紹This European Code of Practice for Animal Feed Ingredients Operators (Code is in line with the Regulation of the European Parliament and the Council laying down requirements for feed hygiene, (Regulation 183/2005/EC, in particular a

10、rticles 20 to 22 which encourage the development of guides to good practice on hygiene and the application of HACCP principles.本歐洲動物飼料成分經營者操作規范（“規范”）符合歐洲議會和委員會制定的有關飼料衛生 法規（法規183/2005/EC）要求，尤其是20至22條款，鼓勵對良好衛生規范指南的發展和 HACCP原理的應用。Implementation of the Code aims to encourage measures to be put in place

11、to ensure the safety and quality of products covered by FAMI-QS scope; the operation of businesses in accordance with European feed hygiene requirements, and improved traceability. The Code applies equally to import from third countries of these products.本規范實施的目的在于鼓勵采取適當的措施，以確保FAMI-QS范圍所覆蓋產品的安全和質 量，

12、依照歐洲飼料衛生要求生產經營，以及提高可追溯性。本規范同樣適用于從第三國進行 這些產品的進口。The combination of the above principles provides guidance for feed business Operators in implementing the measures necessary to ensure feed safety in European and International manufacturing and trade.上述原理的結合，為飼料經營者在歐洲和國際制造和貿易中確保飼料安全而實施的必要措施 提供指南。In the

13、 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 178/2002 shall apply.一個例外情況是，當對人和動物健康產生的直接或間接風險與在本規范下生產和貿易的

14、產品 有關時，應用178/2002/EC法規所定義的通報和召回程序（包括快速預警系統）。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.本規范的正文用于建立通用的要求，并作為經營者開發其自身程序的一個工具。A compilation of Guidance is provided as annex to the Code. This covers topics of spec

15、ial 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 procedure

16、s described in the Guidance, this will become a part of its Feed Safety Management System. In case that, for good reasons, different procedures are used, the Operator must be able to provide evidence upon request that they comply with the requirements of the Code as well.指南作為本規范的一個附件，涉及了有特殊重要性的主題。當本

17、規范的要求對于所有經營者 均是強制性時，指南就如何運用更為詳細和實用的方法處理特定問題提供了信息，并且可以 進一步充當本規范的支撐信息。如果經營者決定運用指南中描述的程序，可將其作為其飼料 安全管理體系的一部分。如果，基于有利的原因，經營者使用不同的程序，他必須能夠提供 證據證明其符合本規范的要求。Both the Code and Guidance will be submitted to periodical review in line with emerging/new relevant technological, scientific and legislative develop

18、ments or statutory modification in the sector.本規范和指南將被定期提交評審，以與相關技術、科學和法規所呈現的或新的發展以及法律 相應部分的修改保持一致。The aim of this European Code of Practice is to ensure feed safety by: minimizing the risk that unsafe ingredient(s enter the feed/food chain; enabling an Operator to implement the objectives of the Fe

19、ed Hygiene Regulation (Regulation (EC 183/2005; and providing measures to ensure that other feed safety regulatory requirements are met.本規范的目的是通過以下幾個方面來確保飼料安全： 使不安全成分進入飼料/食品鏈的風險降到最低； 使經營者能夠貫徹實施飼料衛生法規(Regulation (EC No 183/2005所規定的目標；并 且 提供措施，以確保其他飼料安全監管要求得到滿足。Feed is considered unsafe for its intend

20、ed 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 is unsafe for human consumption.如果飼料有可能對人類或動物健康構成威脅（已產生不利影響），或源于食源性動物的食品 對于人類食用是不安全的，則認為該飼料針對其預期用途是不安全的。This Code shall apply to Operators at all stages of feed

21、production from the first placing on the market based on current EU legislation. Therefore it also applies to the placing on the market after import from third countries.本規范適用于基于現行歐盟法規的，從初次投放市場開始的飼料生產所有階段的經營者。因 此，本規范也適用于從第三國進口后再投放市場。Compliance with FAMI-QS does not exonerate the Operator from meetin

22、g 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 Register of Feed Additives published and frequently updated by the European Commission:符合FAMI-QS規范并不能免除經營者遵守其從事經營所在各國法規和監管要求的責任。可在 歐盟委員會公布并不斷更新的飼料

23、添加劑注冊名錄中查詢飼料添加劑監管狀態：http:/ec.europa.eu/food/food/animalnutrition/feedadditives/comm_register_feed_additives_1831-03.pdfNote: FAMI-QS Code of Practice is a public document and its contents can be freely followed by any Feed Business Operator.注：FAMI-QS操作規范是一個公開文件，其內容可被任何飼料經營者自由地使用。Running side by side

24、 with the Code, FAMI-QS Asbl has developed a parallel and independent certification system that is described in the Rules for Certification documents (Rules for Certification Bodies Rules for Operators. Participation in the FAMI-QS auditable system is based on voluntary commitment.與本規范同步，FAMI-QS Asb

25、l已建立了一個平行和獨立的認證體系，并在認證規則文件(認證 機構規則 - 經營者規則 中對其進行了描述。參與FAMI-QS審核體系基于自愿承諾。Please, consult the FAMI-QS web-page to have access to these documents and learn more about how to ensure compliance with this Code of Practice.請參閱FAMI-QS網頁以獲取這些文件，并且可獲悉更多有關如何確保符合本 規范的內容。2 SCOPE 范圍

26、The FAMI-QS scope is described in the last version of the Scope Description Document P-SCD-01. FAMI-QS范圍已在最新版本范圍描述文件P-SCD-01中進行描述。3 TERMS AND DEFINITIONS 術語和定義The following terms and definitions are used in this Code and associated documents:下列術語和定義適用于本規范及相關文件：Adequate: The terminologies “adequate”,

27、 “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,span approp

28、riate, necessary, or sufficient, account should be taken to the nature of the feed and of its intended use (adopted from EC Guidance Document 2005 on Regulation 852/2004/EC and modified.足夠: 術語 “足夠”、 “在適當情況下”、 “必要時”或 “充分” 的含義是，首先由生產經營者決定 一項要求對達到本規范的目標是否是必要、適當、足夠或充分的。在確定一項要求是否足 夠、適當、必要或充分時，應考慮飼料的性質以及其

29、預期用途的性質（摘自法規8252004EC 及2005修訂版的EC指南文件）。Agent: An individual or firm authorised to act on behalf of an Operator such as by executing commercial transactions without ever taking responsibility 序號 the product and the way it按使用說明書進行操作，動作正常為合格。合格測試工具名稱：電鉆 測試日期：2010-9-1 is supplied and provided into the f

30、eed chain.序號代理: 被授權作為經營者代表，執行商業交易的個人或公司，他們對產品和將產品供應和提 供給飼料鏈的行為不承擔法律責任。Authorised personnel: Persons who have skills, permission and purpose as specified by job descriptions, process descriptions or 標Batch: 準 of such units, when produced in1 order and stored It consists of an identifiable quantity of

31、 feed which is determined to have common characteristics, such as origin, variety, type of packing, packer, consignor or labelling. (COM(2008124 and Regulation 批次：當按連續訂單生產且存儲在一起時，來自單一工廠采用統一生產參數的生產單位或許多這樣的單位。它由可定量的飼料組成，并且由共同的特性所決定，這些特性如原產地，品 種，包裝類型，包裝者，發貨人或標簽。380 耐壓：500V 歷時1分鐘，無擊穿現象。 絕緣電阻大于等于20M歐姆 為符

32、合要求。 particular 200Mor device 測試工具名稱：拋光機 測試日期：2010-9-1 測試人：results 檢查結果（合格）1within （目測） limits 合格comparison with those耐壓試驗produced by a reference or traceable standard over 絕緣電阻大于等于 appropriate range of measurements.200M校準: 通過在適當的測量范圍內與參照或可溯源標準所產生的結果相比較，對一臺特定的儀3操作試驗additive in order to facilitate it

33、s handling, application or use without altering its technological function and without exerting any technological effect themselves. (COM(2008124 final & Regulation (EC 767/2009載體：用于溶解、稀釋、分散或其他物理的改變一種飼料添加劑，使其便于處理、應用和使 測試日期：2010-9-2 測試人：767/2009Carry-over: Contamination of a material or product w

34、ith another material or product that originates from previous use of equipment and would alter the quality and safety beyond the established specifications.殘留: 一種原料或產品對另一種原料或產品的污染（物），它源自設備的先前使用并將使其質量和安全發生改變并超出已建立的規范。Check/control: Monitor and measure processes against policies, objectives and requir

35、ements for the product and report results. The state wherein correct procedures are being followed and criteria are being met. (Codex Alimentarius檢查/控制: 根據方針、目標和產品要求對過程進行監視和測量，并報告結果。執行正確的程 序滿足標準要求(Codex Alimentarius.CIP: Cleaning-in-place.CIP：在線清洗。Code of Practice: Document identifying the principle

36、s of feed hygiene essential to ensure the safety of feed for animals and in turn the safety of animal products intended for human consumption.操作規范: 為確保動物飼料安全，從而確保供人類消費的動物產品安全，所確定的飼料衛生 要素原則的文件。Compound feed: Mixture of feed materials, whether or not containing feed additives, for oral animal feeding

37、in the form of complete or complementary feed. (COM(2008124 final & Regulation (EC 767/2009配合飼料：飼料原料的混合物，不論是否含有飼料添加劑，以全價或補充飼料的形式用于飼 喂動物。(COM(2008124 final & Regulation (EC 767/2009Contaminant: any biological or chemical agent, foreign matter, or other substances not intentionally added to fo

38、od or feed which may compromise food and/or feed safety or suitability. (Codex Alimentarius and adapted污染物：任何生物或化學物質，異物或其他物質并非有意添加于食品或飼料可能危及到食品 和/或飼料的安全性或適用性。(Codex Alimentarius and adaptedContamination: The undesired introduction of impurities/contaminant (chemical or microbiological nature or of f

39、oreign matter, into or onto a raw material, intermediate, and products covered by FAMI-QS scope during production, sampling, packaging or repackaging, storage or transport. (Codex Alimentarius and adapted污染: 在生產、取樣、包裝或二次包裝以及儲存或運輸過程中，雜質/污染物（化學或微生物 性質的物質或外部物質）進入或附著于原料、中間產品、FAMI-QS范圍覆蓋產品所造成的非 預期的傳入。(Co

40、dex Alimentarius and adaptedControl Measure: any action and activity that can be used to prevent or eliminate a feed / food safety hazard or reduce it to an acceptable level. (Codex Alimentarius and adapted控制措施：任何行動和活動，可用于防止或消除飼料/食品安全危害或將其減少到可接受的 水平。(Codex Alimentarius and adaptedCorrective Action:

41、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 22000:2005糾正措施：為消除已發現的不合格或其他不期望情況的原因所采取的措施。采取糾正措施是 為了防止再發生，而采取預防措施是為了防止發生。(ISO 22000:2005Cross-Co

42、ntamination: Contamination of a material or product with another material or product.交叉污染: 一種原料或產品與另一種原料或產品的污染。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 ha

43、s left the immediate control of the feed business Operator. (synopses from articles 15 & 19, Regulation (EC 178/2002/EC.危機：一種事件，其表現為由于不安全或不合法產品的生產和提供導致對動物或人類健康產 生直接和顯著威脅，同時該產品已脫離飼料生產經營者的直接控制。 ( 摘自 articles 15 & 19, Regulation 178/2002/EC.Critical Control Point (CCP: a step at which control c

44、an be applied and that is essential to prevent or eliminate a feed / food safety hazard or to reduce it to an acceptable level. (Codex Alimentarius and adapted關鍵控制點（CCP）：應用于防止或消除飼料/食品安全危害或將其降低到可接受的水平必不 可少的一個步驟。(Codex Alimentarius and adaptedCritical Limit: a criterion that separates acceptability fr

45、om unacceptability (Codex Alimentarius.關鍵限值：區分可接受和不可接受的標準。(Codex Alimentarius.EC: European CommissionEC: 歐盟委員會Establishment: Any unit of a feed business that carries out the manufacture/production and/or the placing on the market of products covered by FAMI-QS scope (Regulation 183/2005/EC and adapt

46、ed.企業: 從事FAMI-QS范圍所覆蓋產品的制造/生產和或將其投放市場的飼料經營的任何單位(Regulation 183/2005/EC and adapted.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.出口:為歐盟成員國生產的產品向非歐盟成員國自由流通放行或其目的是

47、為上述的自由流通 放行。Feed: Any substance or product, including feed additives, whether processed, partially processed or unprocessed, intended to be used for oral feeding to animals (Regulation 178/2002.飼料：用于飼喂動物的任何物質或產品，包括飼料添加劑，不管是經過加工、部分加工或未 經加工的產品。 (Regulation 178/2002 .Feed additives: Substances, micro-o

48、rganisms 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 (Regulation 1831/2003/EC and Regulation 183/2005/EC: favourably affect the characteristics of feed; favourably

49、 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 aff

50、ecting the gastro-intestinal flora or digestibility of feedingstuffs; or have a coccidiostatic or histomonostatic effect.飼料添加劑: 為了發揮下列一項或多項功能，有意加入飼料或水中的，不同于飼料原料和預混合飼料的物質、微生物或制品：(Regulation 1831/2003/EC and Regulation 183/2005/EC 對飼料的特性產生有利影響； 對動物產品產生有利影響； 對觀賞魚類和鳥類的顏色產生有利影響； 滿足動物的營養需求； 對動物生產的環境后果產生有利

51、影響； 對動物生產、性能或福利產生有利影響，特別是通過影響腸胃菌群或飼料的消化性； 具有抑制球蟲和組織鞭毛蟲的作用。Feed business: Any undertaking whether for profit or not and whether public or private, carrying out any operation of production, manufacture, processing, storage, transport or distribution of feed including any producer manufacturing, proces

52、sing or storing feed for feeding to animals on his own holding. (Regulation178/2002/EC and adapted. See Stages of production, processing and distribution飼料經營: 從事飼料的生產、制造、加工、儲存、運輸或分銷的任何經營活動，無論是贏利 性還是非贏利性，公共的還是私人的。(Regulation178/2002/EC and adapted. 見“生產、加工和分 銷階段”Feed business Operator: The natural or

53、 legal persons responsible for ensuring that the requirements of food/feed law are met within the feed business under their control. (Regulation178/2002/EC and adapted. See Feed business.飼料經營者: 對確保食品法規要求在其控制下在飼料經營中得以貫徹負有責任的自然人或法 人(Regulation178/2002/EC and adapted. 見“飼料經營”Feed hygiene: The measures

54、and conditions necessary to control hazards and to ensure fitness for animal consumption of a feed ingredient(s covered by FAMI-QS scope, taking into account its intended use. (Regulation 183/2005/EC.飼料衛生: 考慮其預期用途，為控制危害和確保用于動物消費的FAMI-QS范圍所涉及飼料成 分的必要措施和條件(Regulation 183/2005/ECFeed material: Various

55、products of vegetable or animal origin,whose principal purpose is to meet animals nutritional needs, in their natural state, fresh or preserved, and products derived from the industrial processing thereof. Organic or inorganic substances, whether or not containing feed additives, which are intended

56、for use in oral animal feeding either directly as such, or after processing, or in the preparation of compound feed, or as carriers of premixtures. (Regulation 767/2009/EC飼料原料:，源自植物或動物，其主要目的是滿足動物的營養需要，以其自然狀態、新鮮的 或經處理的各式各樣的產品，和源自工業加工的產品。有機或無機物質，無論是否含有飼料 添加劑，其目的是用于直接或經過加工后飼喂動物，或以配合飼料形式或作為預混料的載體 (Regul

57、ation 767/2009/EC。Feed Safety: High level of assurance that the feed (feedingstuff, feed material or products covered by FAMI-QS scope will neither cause harm to the farm animals when prepared or consumed according to the intended use, nor to the final consumer. Throughout the Code, the word Safety

58、is taken to have the same meaning as Feed Safety.飼料安全:高水平地保證飼料（飼料、飼料原料或FAMI-QS范圍所涵蓋的產品）在按照預期用 途準備或消費時不會對農場動物或最終消費者造成危害。在整個規范中，“安全”這個詞都具有與“飼料安全”相同的意思。First placing on the market: The initial placing on the European Union market of feed ingredient(s, an additive, premixture or products covered by FAMI-QS scope after its manufacture or the import of an additive or premixture. See placing on the market. (Regulation 1831/20