欧洲饲料添加剂与预混合饲料经营者操作规范V5.1

1、EUROPEAN CODE OF GOOD PRACTICE FOR FEED ADDITIVES AND PREMIXTURES OPERATORS欧洲饲料添加剂与预混合饲料经营者操作规范Version 5.1 Translated by:2014-02-14EUROPEAN CODE OF PRACTICEFOR FEED ADDITIVES AND PREMIXTURES OPERATORS欧洲饲料添加剂与预混合饲料经营者操作规范TABLE OF CONTENTS 目录1 INTRODUCTION介绍 42 SCOPE范围 73 TERMS AND DEFINITIONS术语和定义 84

2、 MANAGEMENT SYSTEM (MS 管理体系 184.1. General requirements总要求 184.2. Management Principles管理原则 184.3. General documentation requirements文件总要求 195 MANAGEMENT RESPONSIBILITY 管理职责 225.1. Management commitment 管理承诺 225.2. Quality and safety policy 质量和安全方针 225.3. Responsibility, authority and communication职

3、责，权限和沟通 235.4. Management representative管理者代表 245.5. Management review 管理评审 246 RESOURCE MANAGEMENT 资源管理 256.1. Provision of resources 资源提供 256.2. Human resources 人力资源 266.2.1. Competence, awareness and training 能力、意识和培训 266.2.2. Personal Hygiene 个人卫生 266.3. Infrastructure 基础设施 276.3.1. Basic requir

4、ements 基本要求 276.3.2. Requirements for facilities, production areas and equipment 设施、生产区域和 设备的要求 276.3.3. Facilities & production Areas 设施和生产区域 276.3.4. Equipment 设备 286.4. Maintenance and control of monitoring and measuring devices 监视和测量 设备的维护和控制 296.5. Cleaning 清洁 306.6. Pest control 虫害控制 316.7

5、. Waste control 废弃物控制 337 PRODUCT REALISATION 产品实现 347.1. Product requirements 产品要求 347.1.1. Determination of requirements related to the product 与产品有关要求的确定 347.1.2. Compliance of the product to the requirements 产品要求的符合性 347.1.3. Customer communication 顾客沟通 357.2. HACCP Programme HACCP 方案 357.3. Des

6、ign and development 设计和开发 377.3.1. Development of new products and processes 新产品和过程的开发 377.3.2. Change control 设计更改的控制 377.4. Handling of incoming materials 购进原料的处理 387.4.1. Sourcing of incoming materials 购进原料的来源 387.4.2. Verification of incoming materials 购进原料的验证 407.5. Production of finished goods

7、 产品的生产 417.5.1. Quality Control and Production 质量控制和生产 417.5.2. Verification of processes for production 生产过程的验证 457.5.3. Identification and traceability 标识和可追溯性 457.5.4. Preservation of product 产品防护 467.6. Transport 运输 477.6.1. General requirements 总要求 477.6.2. Transport of packaged goods 已包装货物的运输

8、487.6.3. Transport of bulk products 散装产品的运输 488 SYSTEM REVIEW 体系评审 508.1. General requirements 总要求 508.2. Internal audits 内部审核 509 CONTROL OF NON-CONFORMING PRODUCTS 不合格品的控制 529.1. General requirements 总要求 529.2. Complaint handling system 投诉处理系统 539.3. Recall 召回 549.4. Crisis Management 危机管理 5510 ST

9、ATISTICAL TECHNIQUES 统计技术 5711 BIBLIOGRAPHY 参考文献 571 INTRODUCTION 介绍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.本欧洲动物饲料成分经营者操作规范（“规范”）符合欧洲议会和委员会制定的有关饲料卫生 法规（法规183/2005/EC）要求，尤其是20至22条款，鼓励对良好卫生规范指南的发展和 HACCP原理的应用。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.本规范实施的目的在于鼓励采取适当的措施，以确保FAMI-QS范围所覆盖产品的安全和质 量，

12、依照欧洲饲料卫生要求生产经营，以及提高可追溯性。本规范同样适用于从第三国进行 这些产品的进口。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.上述原理的结合，为饲料经营者在欧洲和国际制造和贸易中确保饲料安全而实施的必要措施 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.一个例外情况是，当对人和动物健康产生的直接或间接风险与在本规范下生产和贸易的

14、产品 有关时，应用178/2002/EC法规所定义的通报和召回程序（包括快速预警系统）。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.本规范的正文用于建立通用的要求，并作为经营者开发其自身程序的一个工具。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.指南作为本规范的一个附件，涉及了有特殊重要性的主题。当本

17、规范的要求对于所有经营者 均是强制性时，指南就如何运用更为详细和实用的方法处理特定问题提供了信息，并且可以 进一步充当本规范的支撑信息。如果经营者决定运用指南中描述的程序，可将其作为其饲料 安全管理体系的一部分。如果，基于有利的原因，经营者使用不同的程序，他必须能够提供 证据证明其符合本规范的要求。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.本规范和指南将被定期提交评审，以与相关技术、科学和法规所呈现的或新的发展以及法律 相应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.本规范的目的是通过以下几个方面来确保饲料安全： 使不安全成分进入饲料/食品链的风险降到最低； 使经营者能够贯彻实施饲料卫生法规(Regulation (EC No 183/2005所规定的目标；并 且 提供措施，以确保其他饲料安全监管要求得到满足。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.如果饲料有可能对人类或动物健康构成威胁（已产生不利影响），或源于食源性动物的食品 对于人类食用是不安全的，则认为该饲料针对其预期用途是不安全的。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.本规范适用于基于现行欧盟法规的，从初次投放市场开始的饲料生产所有阶段的经营者。因 此，本规范也适用于从第三国进口后再投放市场。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规范并不能免除经营者遵守其从事经营所在各国法规和监管要求的责任。可在 欧盟委员会公布并不断更新的饲料

23、添加剂注册名录中查询饲料添加剂监管状态：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操作规范是一个公开文件，其内容可被任何饲料经营者自由地使用。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.与本规范同步，FAMI-QS Asb

25、l已建立了一个平行和独立的认证体系，并在认证规则文件(认证 机构规则 - 经营者规则 中对其进行了描述。参与FAMI-QS审核体系基于自愿承诺。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.请参阅FAMI-QS网页以获取这些文件，并且可获悉更多有关如何确保符合本 规范的内容。2 SCOPE 范围

26、The FAMI-QS scope is described in the last version of the Scope Description Document P-SCD-01. FAMI-QS范围已在最新版本范围描述文件P-SCD-01中进行描述。3 TERMS AND DEFINITIONS 术语和定义The following terms and definitions are used in this Code and associated documents:下列术语和定义适用于本规范及相关文件：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.足够: 术语 “足够”、 “在适当情况下”、 “必要时”或 “充分” 的含义是，首先由生产经营者决定 一项要求对达到本规范的目标是否是必要、适当、足够或充分的。在确定一项要求是否足 够、适当、必要或充分时，应考虑饲料的性质以及其

29、预期用途的性质（摘自法规8252004EC 及2005修订版的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 序号 the product and the way it按使用说明书进行操作，动作正常为合格。合格测试工具名称：电钻 测试日期：2010-9-1 is supplied and provided into the f

30、eed chain.序号代理: 被授权作为经营者代表，执行商业交易的个人或公司，他们对产品和将产品供应和提 供给饲料链的行为不承担法律责任。Authorised personnel: Persons who have skills, permission and purpose as specified by job descriptions, process descriptions or 标Batch: 准 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：当按连续订单生产且存储在一起时，来自单一工厂采用统一生产参数的生产单位或许多这样的单位。它由可定量的饲料组成，并且由共同的特性所决定，这些特性如原产地，品 种，包装类型，包装者，发货人或标签。380 耐压：500V 历时1分钟，无击穿现象。 绝缘电阻大于等于20M欧姆 为符

32、合要求。 particular 200Mor device 测试工具名称：抛光机 测试日期：2010-9-1 测试人：results 检查结果（合格）1within （目测） limits 合格comparison with those耐压试验produced by a reference or traceable standard over 绝缘电阻大于等于 appropriate range of measurements.200M校准: 通过在适当的测量范围内与参照或可溯源标准所产生的结果相比较，对一台特定的仪3操作试验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载体：用于溶解、稀释、分散或其他物理的改变一种饲料添加剂，使其便于处理、应用和使 测试日期：2010-9-2 测试人：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.残留: 一种原料或产品对另一种原料或产品的污染（物），它源自设备的先前使用并将使其质量和安全发生改变并超出已建立的规范。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检查/控制: 根据方针、目标和产品要求对过程进行监视和测量，并报告结果。执行正确的程 序满足标准要求(Codex Alimentarius.CIP: Cleaning-in-place.CIP：在线清洗。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.操作规范: 为确保动物饲料安全，从而确保供人类消费的动物产品安全，所确定的饲料卫生 要素原则的文件。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配合饲料：饲料原料的混合物，不论是否含有饲料添加剂，以全价或补充饲料的形式用于饲 喂动物。(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：任何生物或化学物质，异物或其他物质并非有意添加于食品或饲料可能危及到食品 和/或饲料的安全性或适用性。(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: 在生产、取样、包装或二次包装以及储存或运输过程中，杂质/污染物（化学或微生物 性质的物质或外部物质）进入或附着于原料、中间产品、FAMI-QS范围覆盖产品所造成的非 预期的传入。(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：任何行动和活动，可用于防止或消除饲料/食品安全危害或将其减少到可接受的 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纠正措施：为消除已发现的不合格或其他不期望情况的原因所采取的措施。采取纠正措施是 为了防止再发生，而采取预防措施是为了防止发生。(ISO 22000:2005Cross-Co

42、ntamination: Contamination of a material or product with another material or product.交叉污染: 一种原料或产品与另一种原料或产品的污染。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.危机：一种事件，其表现为由于不安全或不合法产品的生产和提供导致对动物或人类健康产 生直接和显著威胁，同时该产品已脱离饲料生产经营者的直接控制。 ( 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关键控制点（CCP）：应用于防止或消除饲料/食品安全危害或将其降低到可接受的水平必不 可少的一个步骤。(Codex Alimentarius and adaptedCritical Limit: a criterion that separates acceptability fr

45、om unacceptability (Codex Alimentarius.关键限值：区分可接受和不可接受的标准。(Codex Alimentarius.EC: European CommissionEC: 欧盟委员会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.企业: 从事FAMI-QS范围所覆盖产品的制造/生产和或将其投放市场的饲料经营的任何单位(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:为欧盟成员国生产的产品向非欧盟成员国自由流通放行或其目的是

47、为上述的自由流通 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.饲料：用于饲喂动物的任何物质或产品，包括饲料添加剂，不管是经过加工、部分加工或未 经加工的产品。 (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.饲料添加剂: 为了发挥下列一项或多项功能，有意加入饲料或水中的，不同于饲料原料和预混合饲料的物质、微生物或制品：(Regulation 1831/2003/EC and Regulation 183/2005/EC 对饲料的特性产生有利影响； 对动物产品产生有利影响； 对观赏鱼类和鸟类的颜色产生有利影响； 满足动物的营养需求； 对动物生产的环境后果产生有利

51、影响； 对动物生产、性能或福利产生有利影响，特别是通过影响肠胃菌群或饲料的消化性； 具有抑制球虫和组织鞭毛虫的作用。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饲料经营: 从事饲料的生产、制造、加工、储存、运输或分销的任何经营活动，无论是赢利 性还是非赢利性，公共的还是私人的。(Regulation178/2002/EC and adapted. 见“生产、加工和分 销阶段”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.饲料经营者: 对确保食品法规要求在其控制下在饲料经营中得以贯彻负有责任的自然人或法 人(Regulation178/2002/EC and adapted. 见“饲料经营”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.饲料卫生: 考虑其预期用途，为控制危害和确保用于动物消费的FAMI-QS范围所涉及饲料成 分的必要措施和条件(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饲料原料:，源自植物或动物，其主要目的是满足动物的营养需要，以其自然状态、新鲜的 或经处理的各式各样的产品，和源自工业加工的产品。有机或无机物质，无论是否含有饲料 添加剂，其目的是用于直接或经过加工后饲喂动物，或以配合饲料形式或作为预混料的载体 (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.饲料安全:高水平地保证饲料（饲料、饲料原料或FAMI-QS范围所涵盖的产品）在按照预期用 途准备或消费时不会对农场动物或最终消费者造成危害。在整个规范中，“安全”这个词都具有与“饲料安全”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