FOR FEED ADDITIVES AND - FAMI-QS...2015/06/08 · 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

欧洲饲料添加剂与预混合饲料经营者操作规范

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EUROPEAN CODE OF GOOD PRACTICE

FOR FEED ADDITIVES AND

PREMIXTURES OPERATORS

FAMI-QS Code of Pactice FAMI-QS操作规范

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EUROPEAN CODE OF 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

TABLE OF CONTENTS 目录

1 INTRODUCTION介绍 ...................................................................................... ...............................4

2 SCOPE范围 ............................................................................................................................... ..7

3 TERMS AND DEFINITIONS术语和定义 ............................................................................................ 8

4 MANAGEMENT SYSTEM (MS) 管理体系 ...................................................................................... 18

4.1. General requirements总要求 ................................................................................. 18

4.2. Management Principles管理原则 .......................................................................... 18

4.3. General documentation requirements文件总要求 ............................................... 19

5 MANAGEMENT RESPONSIBILITY 管理职责 ................................................................................... 22

5.1. Management commitment 管理承诺 .................................................................... 22

5.2. Quality and safety policy 质量和安全方针 ........................................................... 22

5.3. Responsibility, authority and communication职责，权限和沟通 ........................ 23

5.4. Management representative管理者代表 .............................................................. 24

5.5. Management review 管理评审 ............................................................................. 24

6 RESOURCE MANAGEMENT 资源管理 ........................................................................................... 25

6.1. Provision of resources 资源提供 ........................................................................... 25

6.2. Human resources 人力资源 .................................................................................. 26

6.2.1. Competence, awareness and training 能力、意识和培训................................... 26

6.2.2. Personal Hygiene 个人卫生................................................................................... 26

6.3. Infrastructure 基础设施 ......................................................................................... 27

6.3.1. Basic requirements 基本要求 ................................................................................ 27

6.3.2. Requirements for facilities, production areas and equipment 设施、生产区域和

设备的要求 ......................................................................................................................... 27

6.3.3. Facilities & production Areas 设施和生产区域 .................................................... 27

6.3.4. Equipment 设备 ..................................................................................................... 28

6.4. Maintenance and control of monitoring and measuring devices 监视和测量

设备的维护和控制.............................................................................................................. 29

6.5. Cleaning 清洁 .......................................................................................................... 30


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6.6. Pest control 虫害控制 ............................................................................................ 31

6.7. Waste control 废弃物控制 ..................................................................................... 33

7 PRODUCT REALISATION 产品实现 ................................................................................................ 34

7.1. Product requirements 产品要求 ........................................................................... 34

7.1.1. Determination of requirements related to the product 与产品有关要求的确定 34

7.1.2. Compliance of the product to the requirements 产品要求的符合性 ................... 34

7.1.3. Customer communication 顾客沟通...................................................................... 35

7.2. HACCP Programme HACCP 方案 ........................................................................... 35

7.3. Design and development 设计和开发 ................................................................... 37

7.3.1. Development of new products and processes 新产品和过程的开发................... 37

7.3.2. Change control 设计更改的控制 ........................................................................... 37

7.4. Handling of incoming materials 购进原料的处理 ................................................. 38

7.4.1. Sourcing of incoming materials 购进原料的来源 .................................................. 38

7.4.2. Verification of incoming materials 购进原料的验证 ............................................. 40

7.5. Production of finished goods 产品的生产 ............................................................. 41

7.5.1. Quality Control and Production 质量控制和生产 ................................................. 41

7.5.2. Verification of processes for production 生产过程的验证 ................................... 45

7.5.3. Identification and traceability 标识和可追溯性 .................................................... 45

7.5.4. Preservation of product 产品防护 ......................................................................... 46

7.6. Transport 运输 ........................................................................................................ 46

7.6.1. General requirements 总要求 ................................................................................ 46

7.6.2. Transport of packaged goods 已包装货物的运输 ................................................. 48

7.6.3. Transport of bulk products 散装产品的运输 ........................................................ 48

8 SYSTEM REVIEW 体系评审 ......................................................................................................... 50

8.1. General requirements 总要求 ................................................................................ 50

8.2. Internal audits 内部审核 ........................................................................................ 50

9 CONTROL OF NON-CONFORMING PRODUCTS 不合格品的控制 ....................................................... 52

9.1. General requirements 总要求 ............................................................................... 52

9.2. Complaint handling system 投诉处理系统 ............................................................ 53

9.3. Recall 召回 ............................................................................................................. 54

9.4. Crisis Management 危机管理 ................................................................................ 55

10 STATISTICAL TECHNIQUES 统计技术 ............................................................................................. 57

11 BIBLIOGRAPHY 参考文献 ........................................................................................................... 57


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1 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 articles 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 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，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 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 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 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 developments or statutory modification in the sector.


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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 Feed 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 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 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 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 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 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.pdf

Note: 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 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 Asbl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。

http://ec.europa.eu/food/food/animalnutrition/feedadditives/comm_register_feed_additives_1831-03.pdf


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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.

请参阅FAMI-QS网页www.fami-qs.org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。

http://www.fami-qs.org/



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2 SCOPE 范围

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。


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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”, “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 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预期用途的性质（摘自法规825／2004／EC

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 legal responsibility of the product and the way it is supplied and provided into the feed chain.

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 management.

被授权人员: 由职位描述、工艺说明或管理规定的具有技能、许可和用途的人员。

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 which is determined to have common characteristics, such as origin, variety, type of packing, packer, consignor or labelling. (COM(2008)124 final and Regulation 767/2009/EC)

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。(COM(2008) 124 final and Regulation 767/2009/EC)

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.

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

器或装置产生的结果处于规定的限定内的证明。

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 & 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

用而不改变其技术功能且本身并不施加任何技术作用的物质。(COM(2008)124 final & Regulation (EC)

767/2009)

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.

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


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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 requirements 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 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.

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 in the form of complete or complementary feed. (COM(2008)124 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(2008)124 final & Regulation (EC) 767/2009)

Contaminant: any biological or chemical agent, foreign matter, or other substances not intentionally added to food 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 adapted)

Contamination: The undesired introduction of impurities/contaminant (chemical or microbiological nature or of foreign 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。(Codex Alimentarius and adapted)

Control 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 adapted)

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 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 22000:2005)

Cross-Contamination: 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。


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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 (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 can 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 adapted)

Critical Limit: a criterion that separates acceptability from unacceptability (Codex Alimentarius).

关键限值：区分可接受和不可接受的标准。(Codex Alimentarius).

EC: European Commission

EC: 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 adapted).

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-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 (Regulation 1831/2003/EC and Regulation 183/2005/EC):

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.

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)


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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, processing 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 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 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/EC)

Feed material: Various 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 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(Regulation 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’ 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。


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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 1831/2003/EC and adapted)

首次投放市场: 在生产后或进口后首次将饲料原料，添加剂，预混料或FAMI-QS范围所覆盖

产品在欧盟市场投放。见“投放市场” (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 or feed item. (Codex Alimentarius and adapted)

流程图: 用于某一特定食品或饲料的生产或制造的系列步骤或操作的系统化表示法。(Codex

Alimentarius and adapted)

HACCP (Hazard Analysis and Critical Control Point): A system which identifies, evaluates, and controls hazards to feed safety. (Codex Alimentarius and modified)

HACCP (危害分析和关键控制点): 一个识别、评价和控制危害以达到饲料安全的体系。(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. (Codex Alimentarius)

危害分析: 收集和评价有关危害的信息和导致它们出现的条件，确定哪些对饲料安全是重要

的，然后在HACCP计划中加以强调的过程。(Codex Alimentarius)

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)

危害 : 饲料链中有可能对动物或消费者造成有害影响的生物、化学或物理性物质。(Regulation178/2002/EC)

Homogeneity: The degree to which a property or a constituent is uniformly distributed throughout a quantity of material. (PAC; 1990)

均匀性：一种特性或组分在某一定量物质中整个区域内均匀分布的程度。(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)

进口:非欧盟成员国生产的产品向欧盟成员国自由流通放行或其目的是为上述的自由流通放

行。(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, premixtures and products covered by FAMI-QS scope).

购进的原料: 一个通用术语，用于表示在生产链开始点交付的原材料（如，试剂、溶剂、加

工助剂、饲料原料、饲料添加剂、预混合饲料和FAMI-QS范围所覆盖产品）。

Intermediate (product): Any material which has been processed by the Operator before the final product is obtained. Substance that is manufactured for and consumed in or used for chemical processing in order to be transformed into another substance. (REACH Article 3(15)).

中间产品: 在获得最终产品之前已经过经营者加工过的任何原料。作为化学过程生产和消费

的物质，为了转变为另外的物质。(REACH Article 3(15)).


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Labelling: means the attribution of any words, particulars, trademarks, brand name, pictorial matter or symbol to a feed by placing this information on any medium referring to or accompanying such feed, such as packaging, container, notice, label, document, ring, collar or the Internet, including for advertising purposes (Regulation 767/2009/EC).

贴标签：将任何关于饲料属性的文字、条目、商标、品牌、插图或符号的这些信息通过任何

媒介提及或附加在该饲料上，如包装、容器、通知、标签、文件、指环、项圈或网络，包括

广告目的。 (Regulation 767/2009/EC).

Manufacture/production: All operations encompassing receipt of materials, processing, packaging, repackaging, labelling, relabelling, quality control, release, storage, and distribution of feed additives, premixtures and products covered by FAMI-QS scope and related controls.

制造/生产: 围绕饲料添加剂和预混料以及FAMI-QS范围所覆盖产品的原料接收、加工、包

装、二次包装、贴标签、二次标签、质量控制、发放、储存和分配以及相关控制的所有操

作。

Minerals: Feed materials may include minerals mentioned in Annex Part B, chapter 11, of Directive 96/25/EC (amended by Directive 98/67/EC).

矿物质: 饲料原料可包括Annex Part B, chapter 11, of Directive 96/25/EC提及的矿物质。(amended by Directive 98/67/EC).

MS: Management System

MS: 管理体系

Operator: See ‘feed business Operator’.

经营者: 见“饲料经营者”。

Placing on the market: Holding products for the purposes of sale, including offering for sale or any other form of transfer, whether free of charge or not, and the sale, distribution and other forms of transfer themselves. (Regulation178/2002/EC) (See ‘first placing on the market’).

投放市场: 为了销售的目的持有产品，包括为销售或为其他转让形式向第三方的提供（无论

是否免费）以及销售，分销和其他形式的转让。 (Regulation178/2002/EC) (见“首次投放市场”)

Plan: To establish the objectives and processes necessary to deliver results in accordance with the Operator’s policies regarding quality and safety.

计划:建立目标和必要的过程，以达到符合经营者有关质量和安全政策的结果。

Premixtures: Mixtures of feed additives or mixtures of one or more feed additives with feed materials or water used as carriers, not intended for direct feeding to animals. (Regulation

1831/2003/EC).

预混合饲料: 饲料添加剂的混合物或一种或多种饲料添加剂与作为载体的饲料原料或水的混

合物，不用于对动物的直接饲喂。(Regulation 1831/2003/EC)

Prerequisite Programs (PRPs): Basic conditions and activities which are necessary to maintain a hygienic environment throughout the feed/food chain suitable for the production, handling and provision of safe end products. Specified procedure(s) or instruction(s), specific to the nature and size of the operation, that enhance and/or maintain operational conditions to enable more effective control of feed safety hazards, and/or that control the likelihood of introducing feed safety hazards to and their contamination or proliferation in the product(s) and product processing environment. Alternative terms for PRPs may be used. For instance, the terms Good Manufacturing Practice (GMP), Good Agricultural Practice (GAP) and Good Hygienic Practice (GHP). (ISO 22000:2005 and adapted)


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前提方案：从饲料/食品链生产、处理和安全终产品提供全过程保持卫生环境所必要的基本

条件和活动。特定的程序或指令，操作过程的特殊类型和规模，用于提高和/或维持操作条

件，以便能够更有效控制饲料安全危害，和/或控制饲料安全危害及其污染引入产品和产品

加工环境的可能性。有时可以使用PRPS的替代术语。比如，良好操作规范（GMP），良好农

业规范（GAP），良好卫生规范（GHP）。(ISO 22000:2005 and adapted)

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)

预防措施：为消除潜在的不合格或其他不期望情况的原因所采取的措施。采取预防措施是为

了防止发生，而采取纠正措施是为了防止再发生。(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 or products covered by FAMI-QS scope. (Modified from ICH Q7A). A specified way to carry out an activity or a process. (ISO 9000:2005)

程序: 与原料、或FAMI-QS范围所覆盖产品的生产相关的直接或间接执行的操作、采取的预防

措施和使用的方法。（根据ICH Q7A修改）为进行某项活动或过程所规定的途径（ISO9000：2005）

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)

加工助剂: 任何本身不作为饲料被消费的物质，有意被用于饲料或饲料原料的加工过程，以

便在处理或加工过程中实现某种技术目的，这种处理或加工可能会导致非故意但技术上不可

避免的这种物质的残留或这种物质的派生物出现在最终产品中，但这种残留不得对动物健

康、人类健康或环境有任何有害的影响，也不得对最终产品饲料有任何技术影响。(Regulation

1831/2003/EC)

Quality: Degree to which a set of inherent characteristics fulfils requirements. (ISO 9000:2005)

质量：一组固有特性满足要求的程度。(ISO 9000:2005)

Quality Manual: Document specifying the quality management system of an organisation. (ISO

9000:2005)

质量手册：规定组织质量管理体系的文件。(ISO 9000:2005)

Raw material: Any material which enters the manufacturing process of the feed additive and/or premixture and/or products covered by the FAMI-QS scope. See ‘Incoming Material’.

原材料: 进入饲料添加剂和／或预混合饲料和/或FAMI-QS范围所覆盖产品生产过程的任何原

料。见“购进的原料”

Recall: Any measure aimed at achieving the return of an unsafe feed that has already placed on the market by a feed business Operator. Feed is considered unsafe if it has an adverse effect on human or animal health and/or will make the food derived from food-producing animals unsafe for human consumption (adaptation of the definitions in Directive No 2001/95/EC and Regulation 178/2002)

召回：实现将饲料生产经营者已投放市场的不安全饲料收回为目的的任何措施。饲料被认为

是不安全的，如果其对人类或动物健康有不利的影响，和/或使来自食源性动物的食品对于

人类消费有是不安全的。(adaptation of the definitions in Directive No 2001/95/EC and Regulation 178/2002)


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Record: Written documents containing actual data. Document stating results achieved or providing evidence of activities performed. (ISO 9000:2005)

记录 : 包含实际数据的书面文件。阐明所取得的结果或提供所完成活动的证据的文件

（ISO9000；2005）

Requirement: need or expectation that is stated, generally implied or obligatory. (ISO 9000:2005)

要求：明示的，通常隐含的或必须履行的需求或期望（ISO9000：2005）

Reworking / rework: Any appropriate manipulation steps in order to ensure that a product covered by FAMI-QS scope will conform to specifications. Action on a non-conforming product to make it conform to the requirements. (ISO 9000:2005)

返工: 为了确保FAMI-QS范围所覆盖产品符合规范而采取的任何适当的操作步骤。为使不合格

产品符合要求而对其采取的措施。(ISO 9000:2005)

Risk: A function of the probability of an adverse health effect and the severity of that effect, consequential to a hazard. (Regulation 178/2002/EC)

风险 : 一种有害健康的影响与该影响导致一种危害的严重程度的概率的函数。(Regulation178/2002/EC)

Risk assessment: means a scientifically based process consisting of four steps: hazard identification, hazard characterisation, exposure assessment and risk Characterisation (Regulation

178/2002/EC).

风险评估:是指以科学为基础的过程包括四个步骤:危害识别、危害描述、接触评估和风险描

述。(Regulation 178/2002/EC).

Safety: See ‘feed safety’.

安全: 见“饲料安全”。

Site: area in which animal feed is handled, together with any immediate surrounding area. (adapted

from PAS 222)

现场：动物饲料处理区连同任何直接的周边地区。(adapted from PAS 222)

Shall: Compliance with a requirement which is mandatory for compliance with this standard (Obligation to follow the exact requirement as stated by this Code).

应: 符合要求；为了符合本标准，该要求是强制性。（有义务遵守本规范规定的准确要求）

Shelf life: A defined time period for which a product fully complies with its specification if stored appropriately.

保质期: 一个被定义的时间期限，在这个期限内如果存放适当，产品应完全符合其规范的要

求。

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).

应当: 意思是“必须”，用到“应当”这个词的活动、说明或规范都意指是强制性的，除非生产

商能够证明这种活动、说明或规范是不适用的，或可以用其他可选方案来代替，但必须证明

该选择方案至少能够提供相等水平的质量和安全保证（经营者有义务通过适当的手段达到本

规范的目标）。


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Sign / signature: Confirmation of an authorised person in writing or by electronic means with controlled access.

签署 / 签名: 被授权人以书面或电子方式对所控制范围的批准/确认。

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. Document stating requirement (ISO

9000:2005).

规范: 一列参照分析程序进行的试验，以及由数字限定、范围或描述试验的其他标准组成的

适当的接受标准。它建立了一套标准，只有一种原料符合这个标准才能被认为可接受用于其

目的用途。“符合规范”意思是在根据所列的分析步骤进行试验时，原料达到所列的接收标

准。文件要求(ISO 9000:2005)。

Subcontractor / 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.

分包方 / 分包：附属于产品的服务的交付，由第三方提供给经营者，同时产品所有权不发生

变化。

Sufficient: See “Adequate”.

充分的: 见 “足够的”。

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 import, production, manufacture, storage, transport, distribution, sale and supply of feed. (Regulation 178/2002/EC)

生产、加工和分销的阶段: 任何阶段，包括进口，从一种食品的初级生产，直到它的存储、

运输、向最终消费者销售或供应，以及与之相关的，饲料的进口、生产、制造、存储、运

输、分配、销售和供应。(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. (Regulation 178/2002/EC)

可追溯性: 追溯和跟踪一种食品、饲料、食源性动物、以及用于或预期用于通过生产、加工

和销售的所有阶段合成一种食品或饲料的物质的能力。(Regulation178/2002/EC)

Undesirable substances: any substance or product, with the exception of pathogenic agents, which is present in and/or on the product intended for the animal feed and which presents a potential danger to animal or human health or to the environment or could adversely affect livestock production. (Directive 2002/32/EC)

不良的物质: 除病原体之外的任何物质或产品，存在于用于动物饲料的产品中和/或产品上，

其对动物或人类健康或环境具有潜在危险，或可能严重影响畜牧生产。(Directive 2002/32/EC)

Validation: obtaining evidence that the control measures will be effective. (ISO 22000:2005)

确认：获取证据以证实控制措施有效。(ISO 22000:2005)

Verification: Confirmation, through the provision of objective evidence that specified requirements have been fulfilled (ISO 22000:2005)

验证: 确认，通过提供客观证据对规定要求已得到满足的认定 (ISO 22000:2005)


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Where appropriate: See“Adequate”.

适当时: 见“足够的”。

Where necessary: See “Adequate”.

必要时: 见“足够的”。

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.

书面文件: 用纸张印刷的文件。这些可以用电子格式、照片格式或其他数据处理系统代替，

只要在预期的保存期内数据得到适当的储存（存档）并且能够以易读的方式很容易的获得。


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4 MANAGEMENT SYSTEM (MS) 管理体系

4.1. General requirements 总要求

The Operator shall establish, document, implement and maintain a management system (MS) in accordance with the requirements of this Code.

经营者应按本规范的要求建立管理体系，形成文件，加以实施和保持。

The MS shall be continually adapted in line with regulatory developments and customer requirements.

管理体系应持续地保持与法规发展和顾客需求相适宜。

The structure of the MS shall be specific to the organisation of the Operator and should includes policies, requirements and process documents that reflect commitment to feed safety.

管理体系的结构应体现经营者的组织机构，并且应当包括反映对饲料安全承诺的方针、要求

和过程文件。

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.

管理体系应确保经营者实施的可能影响产品质量和饲料安全的所有活动，在组织的各层次得

到一致地确定、实施和保持。

The MS shall include quality procedures to ensure that the product consistently conforms to the authorisation of the feed additive and the specification of the premixture(s) as the other products covered by FAMI-QS scope thereof.

管理体系应包括质量程序，以确保产品持续符合饲料添加剂的许可注册和预混合饲料的规

格，同时包括FAMI-QS范围所覆盖的其他产品。

4.2. Management Principles 管理原则

Operators shall be able to demonstrate that its employees are aware of their contribution to feed safety and relevant EU legislation associated to their various tasks.

经营者应当能够证明其员工知道他们为饲料安全所做的贡献以及与其工作相关的欧盟法规。

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.

Ensure that: 确保

A documented MS is in place; 建立了适宜的文件化的管理体系；

The MS includes regulatory, safety and customer requirements; 该管理体系包括法律法规，安全和顾客要求；

The MS is covering all the Operator’s activities; 体系覆盖经营者的所有活动；

Other activities are not conflicting with the feed safety requirements. 其他的活动不能与饲料安全要求冲突。


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每个经营者应执行并记录与其生产经营过程相联系的风险评价以及基于HACCP原理应用于这

些生产经营过程的后续的规定控制。

Effective change control and investigative procedures shall be in place to manage product history and deviations from planned procedure.

有效的更改控制和调查程序应适宜于管理产品历史记录以及与策划的程序的偏离。

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.

应建立适当的管理可能引起产品质量和安全威胁产生的及时通报的程序。程序包括例如，投

诉、产品召回和审核发现。

4.3. General documentation requirements 文件总要求

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 plan.

经营者应建立一个反映本规范所有方面的文件化的体系。此文件化的体系尤其应体现HACCP

计划的应用。

Records shall contain all relevant data to permit investigation of any non-conformance or deviation(s) from planned procedure(s).

记录应包括可对任何不符合或与所策划程序的偏离进行调查的所有相关资料。

All quality and safety related activities shall be recorded immediately after they have been performed.

所有质量和安全相关活动应在其发生后立即被记录。

The design and nature of use of records is at the discretion of the Operator.

记录的设计和使用的类型由经营者自行确定。

MS documentation shall include: 管理体系文件应当包括:

a) a written quality and safety policy; 书面的质量和安全方针；

b) a Quality Manual; 质量手册;

Ensure that: 确保

Employees commitment to feed safety and quality can be demonstrated; 员工对饲料安全和质量的承诺能被证实；

HACCP principles are applied; HACCP原理被应用；

An effective change control system is implemented; 一个有效的更改控制体系被实施；

Management are informed in case of threats to product quality and feed safety; 如果有产品质量和饲料安全的威胁产生，管理者应被告知；

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 requirements and guidelines. 建立一个体系来确保对针对相关法规、饲料和食品安全问题，以及其他相关要求和指导文件的管理保持实时更新。


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c) documented procedures and records; and 形成文件的程序和记录；以及

d) information needed by the Operator to ensure the effective planning, operation, and

control of its processes. 经营者为确保有效的策划、运行、及其过程的控制所需的信

息。

The Quality Manual shall include: 质量手册应当包括:

a) the scope of the MS, including details of and justification for any exclusion;

管理体系的范围，包括任何删减的细节和正当的理由；

b) quality procedures established as part of the MS, or reference to them;

作为管理体系组成部分而编制的质量程序，或对其引用；

c) quality procedures or references in support of the HACCP programme;

支持HACCP方案的质量程序或引用；

d) HACCP procedures or references to ensure feed safety.

确保饲料安全的HACCP程序或引用。

Minimum documents required include: 最低文件要求包括：

a) specifications and testing procedures for incoming materials and finished product;

用于购进原料和最终产品的规范与检验程序；

b) master formulae and operating instructions for each product or group of products;

每种或每类产品的配方和作业指导书；

c) batch processing records for each product; and

每个产品的批次加工记录；以及

d) Standard Operating Procedures (SOPs).

标准操作程序。

Documents shall: 文件应当

a) have unambiguous contents: the title, nature and purpose shall be clearly stated;

有明确的内容：标题、性质及目的应被清楚地规定；

b) be approved, signed and dated by appropriate authorised persons. No document shall be changed without authorisation; and

经适当的授权人批准，签名并标注日期。未经授权不应对文件进行修改；并且

c) be kept up to date. 保持更新。


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Ensure that: 确保

A written quality and safety policy exists; 书面的质量和安全方针被建立；

A Quality Manual is in place; 质量手册是适宜的；

Documented procedures and records are available; 文件化的程序和记录可获取；

The scope of the MS is defined; 管理体系的范围被确定；

Quality procedures are established as part of the MS; 质量程序作为管理体系的组成部分被建立；

Quality procedures cover the prerequisite program in support of the HACCP program;

质量程序覆盖作为支持HACCP计划的前提方案；

HACCP procedures are sufficient to ensure feed safety; HACCP程序能够确保饲料安全；

Specifications and testing procedures for incoming materials and finished products are documented;

用于购进原料和最终产品的规范与检验程序已形成文件；

Master formulae and operating instructions for each product or group of products are in place;

每种或每类产品的配方和作业指导书是适宜的；

Processing records for each batch of product are available; 可提供每个产品的批次加工记录；

Standard Operating Procedures (SOPs) for all activities under the scope of the MS are documented;

管理体系范围内的所有活动的标准操作程序已文件化；

Documents are unambiguous and include title, nature and purpose;

文件是明确的，并且包括标题、类型及目的；

Documents are approved, signed and dated by appropriate authorised persons;

文件经适当的授权人批准，签名并标注日期；

All documents are kept up to date. 所有文件均保持更新。


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5 MANAGEMENT RESPONSIBILITY 管理职责

5.1. Management commitment 管理承诺

Management shall be committed to the implementation of the Code and the Operators own specific quality requirements in order to ensure feed safety and predefined quality of products

管理者应承诺执行本规范以及经营者自身特定的质量要求，以确保饲料安全和产品预期的质

量。

5.2. Quality and safety policy 质量和安全方针

Management shall: 管理者应

a) establish a quality and safety policy, ensure that objectives are established, clearly state the companies obligation to produce safe and legal feed products covered by FAMI-QS scope and to respect their customers requirements;

建立一个质量和安全方针，确保建立目标，明确规定公司有责任生产安全和合法的

FAMI-QS范围所覆盖的饲料产品及考虑顾客要求。

b) communicate this policy throughout the organisation, which shall be understood by all staff involved in the production of products covered by FAMI-QS scope.

方针应在组织内得到沟通，并且被参与FAMI-QS范围所覆盖产品生产的所有员工理

解。

c) provide the necessary resources for the fulfilment of the quality and safety policy;

提供必要的资源以贯彻质量和安全方针。

d) ensure that all key aspects of the Management and HACCP systems are documented, reviewed, updated and communicated to key staff as frequently as might be necessary.

e) 确保管理和HACCP体系所有重要方面均被记录、评审、更新并且有必要尽可能经常地

通报主要工作人员。

Ensure that: 确保

The quality and safety policy specifies the Operators objectives including regulatory and customer

requirements; 质量和安全方针制定出包括法规和顾客要求的生产商目标；

The policy is adequately communicated; 方针已得到充分沟通；

The Operator has the basic resources necessary to fulfil the stated objectives;

生产商有必要的基础资源以履行其表述的目标；

Management and HACCP systems are documented, reviewed, updated and communicated to key

staff. 管理和HACCP体系被记录、评审、更新并且通报主要工作人员。

Ensure that:确保

Management commitment to feed safety and quality can be demonstrated.

管理者对饲料安全和质量的承诺能被证实。


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5.3. Responsibility, authority and communication 职责，权限和沟通

Management shall: 管理者应

a) appoint a HACCP team and team leader; 任命HACCP小组和组长；

b) define the scope of the HACCP system, by identifying the product(s) categorie(s) and production sites, which are covered by the system and ensuring that safety objectives are established as part of the system;

通过识别体系覆盖的产品/产品类别和生产地址以及确保作为体系一部分的安全目标已

建立，界定HACCP体系范围；

c) ensure that job descriptions are available to clearly define the responsibilities of all staff involved in the production of products covered by FAMI-QS scope;

确保职位描述适于明确界定参与FAMI-QS范围所覆盖产品生产的全体员工的职责。

d) identify and record any problems and corrective actions with regard to product quality, safety and the Operator’s management system;

识别和记录与产品质量、安全和经营者的管理体系相关的任何问题和纠正措施；

e) initiate action(s) to prevent the occurrence of non-conformities relating to product quality and safety, 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 7.2).

采取措施以防止与产品质量和安全有关的不符合的发生；并且经营者应提供充分的资源

用于HACCP管理体系的实施，管理和控制。关于HACCP要求的详情见第7.2节；

f) assign responsibility and authority to ensure compliance with regulatory requirements and industry codes of practice to clearly identified competent persons;

指定职责和权限，明确识别有能力胜任的人员，以确保遵守法规要求和行业规范。

g) issue, maintain and make available to the operation’s staff and external bodies an organisational chart of the operation including job descriptions.

发布，维护并提供给生产人员和外部机构一个运行的组织机构图和岗位描述。

Ensure that:

A suitably qualified HACCP team leader is appointed; 一个合适的有资格的HACCP组长被任命；

The scope of the HACCP system is clearly defined; HACCP体系的范围被清楚识别；

Job descriptions exist for each individual or group of individuals; 职务说明制定到每个个人或群体；

A system is in place to identify and correct problems within the management and HACCP systems;

识别和纠正管理和HACCP体系中所存在的问题的系统已建立；

A suitably qualified person is appointed to ensure compliance with regulatory requirements;

已任命合适的有资格的人员，以确保符合法规要求；

An organisational chart is available. 组织机构图可获取。


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5.4. Management representative 管理者代表

Senior management shall appoint a member of management who shall have responsibility and authority that includes:

最高管理者应当任命一名具有以下职责和权限的管理层成员：

a) ensuring that processes needed for the management and HACCP systems are established, implemented and maintained;

确保管理和HACCP体系所需的过程得到建立、实施和保持；

b) reporting to top management on the performance of the management systems and any need for improvement; and

向最高管理者报告管理体系的绩效和任何改进的需求；以及

c) ensuring the promotion of awareness of customer requirements throughout the Operators organisation.

确保在经营者整个组织内提高满足顾客要求的意识。

5.5. Management review 管理评审

Management shall review the effectiveness of the Management and HACCP systems at regular defined intervals:

最高管理者应在规定的时间间隔定期评审管理和HACCP体系的有效性：

a) records of this review shall be maintained; 评审的记录应被保存；

b) the need to update or change the Management and HACCP systems shall be evaluated at

these reviews; 在评审中，应对管理和HACCP体系的变更和更新的需求进行评价；

c) results from external and internal audits shall be reviewed;

外部和内部审核的结果应被评审；

d) customer complaints and requests shall be reviewed; 顾客抱怨和要求应被评审；

e) internal problems and changes to the operation processes must be reviewed;

生产过程内部问题和变更必须被评审；

Ensure that: 确保

A management representative with responsibility for quality and safety is appointed;

具有质量和安全职责的管理者代表被任命；

The management representative reports to top management;

管理着代表向最高管理者汇报；

The responsibility includes promotion of awareness towards customer requirements.

职责包括提高满足顾客要求的意识。


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f) decisions to change any aspect of the Management and HACCP systems shall be communicated to key staff;

对管理和HACCP体系的任何方面做出的变更决定应与主要人员沟通；

g) Management shall ensure that a system is in place to audit the Management and HACCP systems.

最高管理者应确保审核管理和HACCP体系的系统已建立。

6 RESOURCE MANAGEMENT 资源管理

6.1. Provision of resources 资源提供

Management shall identify and provide the necessary resources in order that the manufacture, processing, storage and transport of products are carried out in an efficient and safe manner.

管理者应识别和提供必需的资源，使得产品的生产、加工、贮存和运输在有效和安全的方式

下进行。

Feed businesses must have sufficient staff possessing the skills and qualifications necessary for the manufacture of the products concerned.

饲料生产经营企业必须有具备与产品制造有关的必要技能和资格的足够的工作人员。

Management shall provide sufficient and appropriately designed infrastructure, work environment facilities, production areas and equipment.

管理者应提供足够的和经适当设计的基础设施，工作环境，设施，生产区域和设备。

Provide water of a suitable quality, e.g. potable water, so that the product complies with feed safety requirements.

提供适当质量的水，如饮用水，使得产品符合饲料安全要求。

Ensure that: 确保

A documented procedure exists for management to review the suitability and effectiveness of the MS

and HACCP; 最高管理者评审管理体系和HACCP体系适宜性和有效性的文件化程序已制定

Records of this review are available; 评审记录可获取；

The review is done periodically at predefined intervals; 评审在预先设定的时间间隔内定期进行；

Conclusions drawn and actions taken are documented as part of the review;

得出的结论和采取的措施作为评审的组成部分被记录；

Any actions are communicated to key personnel within the organisation.

所有措施应在组织内与关键人员进行沟通。

Ensure that: 确保

An organisational chart exists and is updated; 具有最新的组织机构图；

Appropriate persons have been assigned responsibilities to comply with external requirements;

适当的人被指定相关职责，以满足外部要求；

The design is appropriate. 设计是适当的。


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6.2. Human resources 人力资源

6.2.1. Competence, awareness and training 能力、意识和培训

Employees and managers shall have the necessary skills, competencies, qualifications, training and awareness to be able to effectively execute their respective tasks, thereby ensuring the conformity of product(s) to the expected quality and feed safety (specifically the HACCP team).

员工和管理人员应具备必要的技能，能力，资格，培训和意识，以便能够有效地执行各自的

任务，从而确保产品符合预期质量和饲料安全（特别是HACCP小组）。

Education and training of personnel shall be documented and maintained.

人员的教育和培训应形成记录并予以保持。

In particular, the team must be properly trained and rehearsed with the appropriate procedures.

尤其是，团队应通过适当的程序进行培训和演练。

Staff shall be trained in appropriate standards of hygienic behaviour in order to contribute to the overall feed safety part of the food chain.

员工应就适宜的卫生行为标准进行培训，使得其为食品链中的总体饲料安全做贡献。

6.2.2. Personal Hygiene 个人卫生

The management shall: 管理者应：

a) ensure that personnel hygiene facilities are clearly and suitably designated, located and maintained;

确保人员卫生设施被清楚和适当的指定、放置和维护。

b) provide appropriate work wear such as protective clothing, safety footwear and maintain them in hygienic conditions;

提供适当的工作服，如防护服和安全鞋，并保持它们符合卫生条件。

If gloves are worn, control is needed to ensure that there is no risk of contamination of the finished product from them.

如果手套被用旧，控制其未对成品造成任何污染危害。

c) establish clear rules on smoking and eating/drinking on site. If necessary, separate facilities for these activities shall be provided;

建立有关在现场吸烟和进食/饮水的明确规则。如有必要，为这些活动提供单独的设

施。

d) ensure that visitors and contractors respect the hygiene requirements when visiting/working on the site.

Ensure that: 确保

The staff is sufficient and skilled to comply with expected tasks and requirements;

员工充足并有技能，以符合预期任务和要求；

Job descriptions are available and updated. 岗位描述适宜并更新。


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确保访客和承包商在参观/工作现场遵守卫生要求。

6.3. Infrastructure 基础设施

6.3.1. Basic requirements 基本要求

Where applicable, the Operator shall provide appropriate work environment in line with local Regulations to achieve product conformity.

适用时，经营者应提供符合当地法规的适宜的工作环境，以达到产品符合性。

Adequate ventilation, controlable humidity, temperature setting, lighting and hygienic design of plants and equipment shall be provided.

应提供足够的通风，湿度和温度设定可控制，照明和工厂及设备的卫生设计。

6.3.2. Requirements for facilities, production areas and equipment 设施、生产区域和设备的要求

The lay-out, design, construction and size of the facilities and equipment shall:

设施和设备的布局、设计、建造和规格应：

a) permit adequate cleaning and/or disinfection; 允许充分清洗和/或消毒；

b) be such as to minimise the risk of error and to avoid contamination, cross-contamination and any generally adverse effects on the safety and quality of the feeds.

这样，以使出错的风险最小化，以及避免污染、交叉污染和对饲料安全和质量的任何

通常的不利影响。

6.3.3. Facilities & production Areas 设施和生产区域

Where necessary, ceilings and overhead fixtures must be designed, constructed and finished to prevent the accumulation of dirt and to reduce condensation. Growth of undesirable microorganisms and the shedding of particles that can affect the safety and quality of feed shall be kept under control.

Ensure that: 确保

Necessary competence are available in disciplines concerning: 必要的能力涉及以下学科：

o Feed safety; 饲料安全；

o HACCP (see 7.2 HACCP program); HACCP（见7.2HACCP方案）；

o Hygiene; 卫生；

o Quality; 质量；

o Health and safety; 健康和安全；

o Environment; 环境；

Level of competence is documented and maintained; 能力水平应形成文件和保持；

There is a sufficient level on personal hygiene facilities and personnel hygiene.

个人卫生设施和个人卫生维持在充分的水平上。


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必要时，天花板和架空装置必须设计，建造及完成，以防止污染的积累和减少凝结，以及不

良微生物的生长和能够影响饲料安全和质量的微粒的脱落应持续受控。

Ventilation systems and devices shall be sufficient in number and capacity to prevent grease or condensation from collecting on walls and ceiling.

通风系统和设备应在数量和能力上是充足的，以防止油脂或凝结物在墙壁和天花板上聚集。

If necessary to keep rooms free of excessive steam and condensation, mechanical ventilation of sufficient capacity shall be provided.

如果有必要保持房间没有过多的水汽和凝结物，应提供有足够能力的强制通风。

If necessary, heating, cooling or air-conditioning systems shall be designed and installed so that air-intake or exhaust vents do not cause contamination of products, equipment or utensils.

如果必要，加热、冷却或空调系统应被设计和安装，使得进风口或排风口不能造成产品、设

备或器具的污染。

Lighting must be of sufficient intensity to ensure that hygienic conditions can be maintained throughout the production and storage areas, as well as where equipment and utensils are cleaned including hand-washing areas and toilets.

照明必须有足够的亮度以确保整个生产和储存区域的卫生条件能够保持，以及洗手区和盥洗

室内的设备和器具被清洁。

Water used in feed manufacture shall be of suitable quality.

饲料生产用水应保持适宜的质量。

It shall be ensured that drainage lines and sewage systems are watertight and of sufficient capacity.

应当确保排水系统和污水处理系统密封防水，并有足够的能力。

Drainage facilities must be adequate for the purpose intended, they must be designed and constructed to avoid the risk of contamination.

排水设施对于预期的目的必须是足够的：必须被设计和建造，以避免污染的风险。

6.3.4. Equipment 设备

Manufacturing equipment shall be located, designed, constructed and maintained to suit the manufacture of the products concerned.

生产设备应当放置、设计、建造和维护，以适合有关产品的生产。

The equipment must be designed to facilitate manual or Cleaning In Place (CIP) and/or disinfection by having surfaces that are smooth, free of sharp angles, corners, crevices and with smooth welds.

设备必须被设计的易于手工操作或在线清洗（CIP）和/或消毒，具有平滑的、无锐角、无角

落、无裂缝、具有焊缝平滑的表面。

Where applicable, equipment must be placed away from walls to allow easy access for cleaning and to prevent pest infestation.

适用时，设备必须放置的远离墙壁，以方便清洁和防止虫害。


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6.4. Maintenance and control of monitoring and measuring devices 监视和测量设

备的维护和控制

A documented maintenance programme for manufacturing operations shall be implemented.

有关生产操作过程（所用的监视测量设备）的文件化维护计划应予以执行。

Records shall be kept of work carried out. 记录应予以保持以证实工作已完成。

The Operator shall establish processes to ensure that monitoring and measurement can be carried out in a manner consistent with documented procedures.

经营者应建立过程，以确保按照与文件化程序相一致的方式实施监视和测量。

All scales and metering devices used in the manufacture of feed shall be appropriate for the range of weights or volumes to be measured and shall be tested for accuracy regularly according to the risks.

用于饲料生产的各种天平和测量设备，应适合于所测量的重量或数量范围，并应根据风险定

期检测准确性。

Where necessary to ensure valid results, measuring equipment shall:

有必要确保有效的结果时，测量设备应：

a) be calibrated or verified at specified intervals or prior to use, against measurement standards traceable to international or national measurement standards. Where no standards exist, the basis for calibration or verification shall be recorded;

对照能溯源到国际或国家标准的测量标准，按照规定的时间间隔或在使用前进行校准

或检定。当不存在上述标准时，应记录校准或检定的依据；

b) be adjusted or re-adjusted as necessary; 进行调整或必要时进行在调整；

c) be identified to enable the calibration status to be determined;

Ensure that: 确保

The facility is designed to facilitate a good environment as described in 6.3.3;

设施被设计以帮助达到6.3.3 所描述的良好环境；

The facility is designed to make it easy to clean; 必要时，设施被设计以易于清理；

The facility is suitable to minimize feed safety risks; 设施适于使安全危害最小化；

Necessary utilities are available, e.g: 必需的公共设施可获得，如：

o Potable water or other water quality; 饮用水或其他水质；

o Steam; 蒸汽；

o Pressured air; 压缩空气；

o Heating system; 供热系统；

o Extraction units; 萃取设备；

o Other relevant utility systems. 其他相关公共设施系统。


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得到识别，以确定其校准状态；

d) be safeguarded from adjustments that would invalidate the measurement result; and

防止可能使测量结果失效的调整；并且

e) be protected from damage and deterioration during handling, maintenance and storage.

在搬运、维护和贮存期间防止损坏或失效。

In addition, the Operator shall assess and record the validity of the previous measuring results when the equipment is found not to conform to requirements. The Operator shall take appropriate action on the equipment and any product that might have been affected. Records of the results of calibration and verification shall be maintained.

此外，当发现设备不符合要求时，经营者应对以往测量结果的有效性进行评价和记录。经营

者应对该设备和任何可能受影响的产品采取适当的措施。校准和验证结果的记录应予以保

持。

When used in the monitoring and measurement of specified requirements, the ability of computer software to satisfy the intended application should be verified. This verification should be undertaken prior to initial use and reconfirmed if necessary.

当计算机软件用于规定要求的监视和测量时，应验证其满足预期用途的能力。验证应在初次

使用前进行，必要时再确认。

6.5. Cleaning 清洁

A cleaning and inspection programme shall be introduced and documented. The effectiveness of the programme shall be demonstrated.

清洁和检查方案应被提出并文件化。方案的有效性应被证实。

All indoor and outdoor areas, buildings, facilities and other equipment must be kept clean and in good state to function as intended, to prevent contamination.

所有室内外区域、建筑物、设施和设备必须保持清洁并处于良好状态，以发挥应有的作用并

防止污染。

Containers and equipment used for the transport, storage, conveying, handling and weighing of feed shall be kept clean.

Ensure that: 确保：

A formal calibration system is in place; 正式的校准系统是适宜的；

This includes items to be calibrated; 包括将被校准的项目；

Appropriate calibration intervals are defined; 以规定适当的校准间隔；

Calibration results are documented; 校准结果形成文件；

A formal preventive maintenance system exists; 存在一个正式的预防性维护系统；

Appropriate maintenance intervals are defined; 已规定适当的维护间隔；

Maintenance work is documented; 维护工作形成文件；

Maintenance work does not interfere with product safety. 维护工作未影响产品安全。


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用于饲料运输、储存、输送、处理和称重的容器和设备应保持清洁。

A schedule shall be implemented with methods, agents used and frequency of cleaning including responsibilities for the tasks.

计划表应根据清洁所使用的方法、制剂和频率来实施，包括该工作的职责。

Cleaning can be carried out by e.g. physical methods like scrubbing and vacuum cleaning or chemical methods using alkaline or acidic agents and methods without the use of water.

清洁可以采用例如物理方法如洗涤、真空清洗或使用碱性或酸性药物的化学方法和不使用水

的方法来进行。

Where appropriate disinfection may be necessary after cleaning, but traces of detergents and disinfectants shall be minimised.

在适当的情况下，清洗后进行消毒可能是必要的，但洗涤剂和消毒剂的残留应减至最低。

Cleaning agents shall be used and stored according to the manufacturer’s instruction(s), clearly labelled, separately stored from raw materials and finished products and applied properly to avoid contamination of raw materials and finished products.

清洁剂应按照制造商的说明书使用和保存，应被清楚地标识，与原料、成品分开单独存放并

且正确应用，以避免污染原料和成品。

After a wet cleaning procedure, the machinery coming into contact with feed shall be dry enough for the next production.

经过湿洗程序后，与饲料接触的机械应足够干燥以进入下一步生产。

6.6. Pest control 虫害控制

There shall be a written plan for pest control including description of periodic inspections and their results. Effectiveness of the plan shall be demonstrated.

应当有一个书面虫害控制计划，包括定期检查及结果的描述。计划的有效性应被证实。

Ensure that: 确保

A formal cleaning program exists, covering: 建立了一个正式的清洁方案，包括：

o Daily house-keeping; 每天日常清扫；

o Periodic deep cleaning; 周期性深度清洁；

o Cleaning after maintenance; 维修后的清洁；

The program defines responsibility; 该方案规定了职责；

Post evaluation is covered; 事后评价已进行；

Cleaning records are filled-in daily; 清洁记录被每天填写；

Procedures on cleaning of equipment exist, and support hygiene and feed safety;

存在设备清洁程序，并且支持卫生和饲料安全；

Employees are trained in cleaning procedures and the training is documented.

员工接受了有关清洁程序的培训，并且培训行程文件。


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A schedule shall be implemented with areas, facilities and equipment to be inspected including frequency, details of pesticides, fumigation agents or traps used as well as responsibilities for these tasks.

计划表应根据拟检查的区域、设施及设备来实施，包括所使用的杀虫剂、熏蒸药剂及诱捕器

的频率和详细情况，以及该工作的职责。

Pesticides, fumigation agents or traps used shall be suitable and comply with local regulations for the purpose concerned. They shall be used and stored according to the manufacturer’s instruction, clearly marked and separately stored from raw materials and finished products and applied properly to avoid contamination of raw materials and finished products.

所用的农药、熏蒸药剂或诱捕器应是适宜的并符合相关的当地法规，并按照制造商的说明书

使用和保存，进行明确标记，并与原来和成品分开单独存放的和正确应用，以避免对原材料

和成品的污染。

The positions of traps and bait stations shall be mapped.

应绘制诱捕器和诱饵站的位置图。

The HACCP plan shall consider the risk of contamination due to infestation or use of pesticides.

HACCP 计划应考虑由于虫害或杀虫剂的使用而造成的污染所带来的风险。

Spoilage and dust shall be controlled to prevent pest invasion.

腐败和灰尘应加以控制，以防止害虫侵入。

The results of the pest control shall be part of the yearly management review.

虫害控制的结果应作为年度管理评审的组成部分。

Windows and other openings must, where necessary, be proof against pests. Doors must be close-fitting and proof against pests when closed.

必要时，窗户和其他开口处必须密封以防虫。门必须能关紧，当关闭时应保证密封以防虫。


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6.7. Waste control 废弃物控制

Waste and materials not suitable as feed should be isolated and identified. Any such materials containing hazardous levels of veterinary drugs, contaminants or other hazards shall be disposed of in an appropriate way and not used as feed:

不适合作为饲料的废弃物和材料应被分离和识别。含有有害级别的兽药，污染物或其他危害

的任何材料应以适当的方式处置，而不被用作饲料：

a) waste is clearly identified and disposed in a manner which avoids contamination of raw

materials and finished product; 明确识别废弃物，并以避免污染原料和制成品的方式来

处置；

b) waste is stored in closed or covered containers at defined waste accumulating areas;

将废弃物储存在密封或有盖容器内，放置在规定的废弃物收集区内；

c) waste accumulating areas are cleaned regularly; 定期对废弃物收集区进行清洁；

d) waste containers shall be clearly marked and designated for that purpose only;

废弃物容器应被清楚地标识，并被指定仅作为废弃物容器使用。

e) Sewage, waste and rainwater shall be disposed of according to local regulations and in a manner which ensures that equipment and the safety and quality of feed is not affected.

污水、废弃物和雨水应根据当地法规，以确保设备与饲料的安全和质量不会受到影响

的方式来处置。

Ensure that: 确保

A formal (documented) preventive pest control system is in place;

一个适当的正式的（文件化）预防性虫害控制系统；

The responsibility - In-house or contracted – are defined;

职责：内部或外部合同承包者；

Relevant preventive measures are taken: 相关的预防措施被实施：

o Rodents, outside and inside; 啮齿动物，外部和内部；

o Insects, flying and crawling; 昆虫，飞行和爬行；

o Birds; 鸟类；

o Other relevant pests; 其他相关害虫。

A map or schematics exist showing the locations of preventive measures and are updated;

具有最新的显示预防措施位置的图表（如捕鼠图）；

Pest activities are documented; 虫害活动特点应被文件化；

Applied pesticides/chemicals are suitable for the purpose (Product Data Sheet);

使用的杀虫剂化学品与其目的相匹配（产品资料表）；

pesticides/chemicals are legal; 杀虫剂/化学品合法。

The plant is maintained reasonably clear of infestation.


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7 PRODUCT REALISATION 产品实现

7.1. Product requirements 产品要求

7.1.1. Determination of requirements related to the product 与产品有关要求的确定

The Operator shall determine:经营者应确定：

a) statutory and regulatory requirements related to the product;

与产品有关的法律法规要求；

b) requirements specified by the customer, including requirements related to delivery and post-delivery activities; and

顾客规定的要求，包括与交付及交付后活动有关的要求；并且

c) requirements not stated by the customer but necessary for specified or intended use, where known.

顾客虽然没有明示，但规定的用途或已知的预期用途所必需的要求。

7.1.2. Compliance of the product to the requirements 产品要求的符合性

The Operator shall monitor the compliance of products with the relevant product requirements

and shall ensure that: 经营者应监视与产品有关要求的符合性并应确保：

a) product requirements are defined; 产品要求得到规定；

b) the Operator has the ability to meet the defined requirements; and

经营者有能力满足规定的要求；并且

c) the existence and handling of products for export outside the EU and which cannot, from a regulatory point of view, be placed on the EU market, is described in the Operator's MS. If the Operator markets such non-EU compliant products, the Operator should maintain a list

Ensure that: 确保

A system to identify external requirements is implemented; 一个用于识别外部要求的系统被实施；

The external requirements are communicated and complied with; 外部要求被沟通和遵照执行；

Requirements and compliance are documented; 要求和符合性被文件化；

Requirements specified by customers are controlled and implemented. 顾客指定的要求被控制和实施。

Ensure that: 确保

Waste materials are properly identified to avoid mix-up with production materials;

废弃物得到适当识别，以避免与生产材料混合；

Waste is handled properly to avoid risks for workers or environment, both internally and externally.

废弃物得到妥善处理，以避免来自工人或环境，内部和外部的风险。


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of products which may be marketed in the EU and those which may be marketed outside the EU only.

出口到欧盟以外以及从法律角度不在欧盟市场销售的产品的处理和保存，应在经营者的

管理体系中描述。如果经营者从事不符合欧盟要求的产品的贸易，经营者应当保持一个

产品清单，注明可能在欧盟境内贸易和可能仅在欧盟以外贸易的那些产品。

Should product requirements change, the Operator shall ensure that relevant documents are amended and that relevant personnel are made aware of the changed requirements. (See also section 7.3.2).

若产品要求变更，经营者应确保相关文件得到修改，并确保相关人员知道已变更的要求。

（可参看7.3.2）

7.1.3. Customer communication 顾客沟通

The Operator shall determine and implement effective arrangements for communicating with

customers in relation to: 经营者应对以下方面确定并实施与顾客沟通的有效安排：

a) product information; 产品信息；

b) enquiries, contracts or order handling, including amendments; and

问询、合同或订单的处理，包括对其修改；并且

c) customer feedback, including complaints. 顾客反馈，包括抱怨。

7.2. HACCP Programme HACCP 方案

The purpose of the HACCP programme is to ensure feed safety in a controlled manner based on a systematic procedure. The programme comprises any activities and process steps ranging from purchase of raw materials to transport of the finished products.

HACCP方案的目的是确保饲料安全在一个基于系统性程序的受控状态。该方案由从原材料的

采购到成品的运输每一活动和过程步骤组成。

Ensure that: 确保

Procedures are in place to comply with identified requirements.

程序是适宜的以满足所识别要求。

Ensure that: 确保：

Relevant product information is in place; 相应的产品信息是适宜的；

The information is communicated to the customer; 信息传达到顾客；

Information provided by customers are received and implemented. 顾客提供的信息已被接受和执行。


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In the hazard analysis, a survey shall be conducted to identify all potential hazards. Based on this analysis, hazards shall be classified according to risk and possible Critical Control Points (CCP’s) shall be identified and control procedures established.

在危害分析中，应当进行一个调查以识别所有潜在的危害。基于这个分析，危害应根据其风

险进行分类，并且可能的关键控制点（CCP’s）应被识别，控制程序应被建立。

Special attention shall be paid to hazards requiring specific control measures.

应对需要特定控制措施的危害予以特别关注。

It is recommended that Operators follow the guidance for application of HACCP provided in the Codex Alimentarius Guidelines, which are based on the following 7 principles:

推荐经营者遵循食品营养法典指导方针中HACCP应用指南，它是基于以下7个原理：

1. conduct a hazard analysis; 进行危害分析。

2. determine the critical control points (CCPs); 确定关键控制点。

3. establish critical limits; 建立关键限值。

4. establish a system to monitor the control of each CCP;

建立关键控制点的监视系统。

5. establish the corrective action to be taken if controls should fail;

建立关键限值失效时采取的纠正措施。

6. establish a procedure to verify that all the aspects of the HACCP system are working

effectively; 建立HACCP体系有效性验证程序。

7. document all procedures and records to demonstrate that the HACCP system is working effectively.

记录证实HACCP 体系有效运行的所有程序与记录

Among the risks to be considered during a HACCP analysis are issues such as homogeneity and/or microbiology.

在HACCP分析中，有的危害被定为均匀度和/或微生物。

Further requirements on HACCP can be found in the following sections of the Code:

有关HACCP的进一步要求可自规范的以下章节找到：

3 Terms and definitions; 术语与定义

4.2 Management principles; 管理原则

4.3 General documentation requirements; 文件总要求

5.2 Quality and safety policy; 质量和安全方针

5.3 Responsibility, authority and communication; 职责，权限和沟通

5.4 Management representative; 管理者代表

5.5 Management review; 管理评审

6.2.1 Competence, awareness and training; 能力、意识和培训

6.5 Cleaning; 清洁


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6.6 Pest control; 虫害控制

7.3.1 Development of new products and processes; 新产品和过程的开发

7.4.1 Sourcing of incoming materials; 购进原料的来源

7.5.1 Quality control and production; 质量控制和生产

7.5.2 Verification of processes for production; 生产过程的验证

7.6.1 Transport. General requirements; 运输总要求

9.1 Control of nonconforming products. General requirements. 不合格产品的控制总

要求

7.3. Design and development 设计和开发

7.3.1. Development of new products and processes 新产品和过程的开发

The Operator shall plan and control the design and development of products or processes related to safety.

经营者应对产品或与安全有关过程的设计和开发进行策划和控制。

The safety of products covered by FAMI-QS scope shall be assured during the developmental stages of a new product through application of HACCP principles.

在新产品的开发过程中通过HACCP原理的运用，确保FAMI-QS范围所覆盖产品的安全。

7.3.2. Change control 设计更改的控制

Design and development changes shall be identified and corresponding records maintained.

设计与开发的更改应予以识别且相关记录应予以保存。

All changes shall be reviewed, verified and validated, as appropriate, and approved before implementation.

适当时，应当对所有的更改进行评审、验证和确认，并在实施前得到批准。

The review of design and development changes shall include evaluation of the effect of the changes on product safety.

设计和开发更改的评审应包括对产品安全变化影响的评估。

Records of the results of the review and any necessary actions shall be maintained.

Ensure that: 确保

Development plans are issued prior to relevant phases of the development process;

先于开发过程各相关阶段，制定开发计划；

The development plan considers risks related to safety; 开发计划考虑到与安全相关的危害；

HACCP is considered. HACCP 被考虑。


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评审结果及任何必要措施的记录应予以保持。

7.4. Handling of incoming materials 购进原料的处理

7.4.1. Sourcing of incoming materials 购进原料的来源

The approval of good quality suppliers and the selection of excellent ingredients is a key aspect of any Operators quality and safety management system(s). Poor raw materials can result in the production of poor quality finished product and may also compromise the safety of the Operator’s entire process. All Operators shall therefore put special emphasis on ensuring that their suppliers and ingredients are of the required quality and standard.

优质供方的批准和优秀原料的选择是任何经营者质量和安全管理体系的一个重要方面。劣质

的原材料会导致劣质成品的生产，并且还可能危害经营者整个过程的安全。因此，所有的经

营者应当特别注重确保其供方和材料达到所要求的质量和标准。

7.4.1.1 Management requirements 管理要求

a) Purchasing information shall describe the product to be purchased, including, where appropriate, requirements for approval of purchased product.

采购信息应表述拟采购的产品，适当时，包括对所购买产品批准的要求。

b) Selection and approval of all raw materials shall include their origin, transport, storage, processing and handling.

对所有原材料的选择和批准应包括其来源，运输，储存和处置。

c) Any potential hazard associated with a raw material shall be documented.

与原材料相关的任何潜在的危害应形成文件。

d) Each raw material shall have a written specification, including quality agreement, which is amended when change of documented parameters takes place.

每种原料应有书面规范，包括质量协议，当所列参数发生变化时规范应得到修订。

e) In addition to the analytical characteristics of the raw material, the specification shall include, where appropriate, details of any undesirable substance with which the raw material may typically be associated, and any other hazards or limitations associated with the raw material which have been considered in the Operator’s HACCP system.

Ensure that: 确保

A formal change control procedure exists; 建立了正式的更改控制程序；

Changes are approved before implementation; 更改在执行前被批准；

Changes are monitored and documented; 更改均已监控并形成文件；

Changes are revised, verified, validated and resulting documents are archived; 更改已被修订，查实、验证和存档；

Safety, quality, legal requirements are taken into account in the change control procedure.

更改控制程序覆盖安全、质量和法规的要求。


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除了原料的分析特性外，适当时，规范应当包括，与原料有典型性关联的非预期物质

的详细资料，以及与产品有关的在经营者的 HACCP 体系中已予以考虑的其他任何危害

或限值。

f) Where appropriate, requirements for analytical monitoring shall be defined.

适当时，分析和监视要求应被规定。

g) In case the material is a product (which is covered by FAMI-QS certificate) imported from outside the European Union, a written confirmation of its compliance with the current EU feed regulations issued by the supplier is needed. Documentation is required that these products covered by FAMI-QS certificate are produced in compliance with the EU legislation.

如果原料是一种从欧盟以外进口的FAMI-QS产品，需要供方提供符合现行欧盟饲料法规

的书面证明。应提供这些FAMI-QS产品的生产符合本规范附录。

h) There shall be a list of internally approved suppliers and each supplier shall be subject to periodical review.

应有内部被批准供方的名录并应对每一个供方进行定期评审。

i) The Operator shall evaluate and select suppliers based on their ability to supply products in accordance with the Operator’s requirements. Criteria for selection, evaluation and re-evaluation shall be established.

经营者应基于供方按经营者的要求供应产品的能力评价和选择供方。应制订选择、评

价和重新评价的准则。

j) Records of any relevant analytical and monitoring results and records of the evaluations on the supplier and necessary actions arising from that evaluation shall be maintained.

所有相关的分析和监视结果、对供方的评价以及评价所引起的任何必要的措施的记录

应予保持。

7.4.1.2 Realization requirements 实现要求

k) Every raw material shall be evaluated to assess any potential hazard associated with it; this shall be carried out according to HACCP principles for all materials falling under the scope of the Regulation (EC) No 183/2005 on Feed Hygiene.

每种原料应予以评估以评价与其有关的任何潜在的危害，这应对(EC) No 183/2005饲料

卫生法规范围内的所有原料按照HACCP原理执行。

l) There shall be a check that these products covered by FAMI-QS are being produced in compliance with the requirements of this Code and with the EU legislation.

应检查这些FAMI-QS产品在符合本规范的条件下生产。


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7.4.2. Verification of incoming materials 购进原料的验证

Each batch entering the site shall be uniquely registered by means of a batch number, full name of product, date of receipt and quantity received. Any damage shall be reported to an appropriate responsible unit, e.g. the quality control unit.

每批进入现场的原料应根据批号、产品的名称、接收日期和接收数量进行唯一的登记。任何

损伤应向相关的责任部门，如质量控制部门报告。

If the incoming material is delivered in bulk, a receipt and storage procedure must be in place. If silos are emptied, this shall be recorded and cleaning must be evaluated.

如果购进的原料是散装交付，接收证据和存储程序必须到位。如果筒仓已空，应记录此情况

并且必须评估清洁状况。

Incoming materials shall be checked and formally approved prior to use according to written procedures. Samples of these materials shall be retained. Where appropriate, a retained sample shall be available for at least the shelf life of the material, either at the suppliers or the Operators.

购进原料在使用前应当根据书面程序进行检查与正式批准。这些原料的样品应当被保留。适

当时，留样应在供方或经营者处，至少保存至购进原料的保质期。

Handling of incoming product shall be in accordance with its status. For example, a received product which is deemed unfit for use must be identified as such and segregated from those products released for use. In the same light, perishable materials should be treated as appropriate to ensure their wholesomeness before use.

购进产品的处置应当根据其状况，例如，已收到的被认为是不适合使用的产品必须标识并与

那些放行使用的产品隔离。同样，易腐材料应当被适当处理，以确保他们在使用前的卫生安

全。

If incoming materials are rejected and thus not incorporated because of non-compliant with the specification or for any reason related to product quality and safety, their disposal, destination, or return to supplier shall be recorded.

Ensure that: 确保

New suppliers are covered by an approval process; 新供方通过批准过程列入合格供方；

Approved suppliers are documented, reviewed, re-evaluated and the documentation is up-to-date;

被批准的供方被形成文件、评审和再评价，并且上述文件是最新的；

The review is done periodically at a predetermined interval; 供方评审以预先规定的时间间隔周期性进行；

Purchased incoming material has an agreed specification; 采购的原材料有一个经双方认可的产品规范；

Specifications comply with feed safety topics and legislative requirements.

规范符合饲料安全主题和法规要求。


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如果购进原料由于任何与产品质量和安全有关的原因被拒收，进而不被使用，应记录其处

置、去向或退回供方的情况。

7.5. Production of finished goods 产品的生产

7.5.1. Quality Control and Production 质量控制和生产

The Operator shall plan and carry out production and service provision under controlled conditions. Production areas shall be controlled so that access for non-authorised personnel can be prevented.

经营者应策划并在受控条件下进行生产和服务提供。生产区域应予以控制，以防止未经授权

人员进入。

Controlled conditions shall include, as applicable: 适用时，受控条件应当包括：

Ensure that: 确保

A written procedure on handling of incoming materials exists; 建立了有关购进原料处置的书面程序；

Incoming materials are registered uniquely and include:

对购进原材料进行了唯一性的登记，包括：

o Supplier’s name and lot/batch number; 供方名称，批号

o Operator’s lot/batch number; 生产商的批号

o Name of material; 原料名称

o Quantity and date of receipt; 数量和接收日期

o Possible expiry date; 可能的有效期

Incoming bulk materials are stored according to adequate separation procedures;

购进的散装原料根据适宜的分隔程序储存；

Materials are inspected before, during and after unloading;

原料在卸载（入库）前，卸载（入库）中和卸载（入库）后背检验；

The inspection includes contamination, pest infestation and documentation of findings;

检验包括污染物、虫害侵袭和调查结果文件；

Non-conformities are recorded; 不合格品被记录；

Records of inspection results are documented and archived; 检验结果的记录被文件化及存档

Records of supplier guarantees and other relevant supplier documentation kept;

供方的质量保证书或其他相关文件记录被保存；

Incoming materials are released before use; 购进原料在使用前被放行；

Documentation is maintained in case a product is returned to the supplier.

如果原料被退回供方，反映此事的文件被保留。


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a) The availability of information that describes the characteristics of the finished product.

获得表述成品特性的信息。

Each product shall have a written specification, which is amended when any

change takes place. 每种产品应有书面规范，当发生变化时予以修订。

Each product shall have a unique name or code.

每种产品应有惟一的名称或代码。

Details of packaging and labelling shall be available. Product labelling shall be in accordance with the relevant EU feed legislation.

应获得包装和标签的详细信息。产品标签应符合相关欧盟饲料法规。

Each package shall be labelled by a unique identifier (which can be a combination of codes) in order that the batch to which it belongs can subsequently be identified and traced.

每一包装应标明唯一的识别码（可能是代码组合），以便其所属的批次能够

在随后被识别与追溯。

All finished product shall be inspected prior to dispatch, in accordance with written procedures, to ensure it meets specification. A retention sample of adequate size shall be taken of each batch and held, as a minimum, for a time equivalent to the defined shelf life of the product. The samples must be sealed and labelled, stored in a manner that shall prevent abnormal change, and kept at the disposal of the authorities for a period appropriate to the use.

所有成品在放行前应当根据书面程序检验以确保符合规范。每批产品应抽取

并保存足够样品，最短的留存时间应等同于确定的产品保质期。样品必须密

封、标识以及应以防止异常变化的方式进行储存，并且在权威部门的安排下

保存，使之在适当时候被使用。

If products are rejected and thus not put into circulation for any reason related to product quality and safety, their disposal, destination, or return to supplier shall be recorded.

如果产品由于任何产品质量和安全的原因被拒收和未进入流通领域，它们的

处置、去向、或退回供方应予以记录。

b) The availability of work instructions: 获得作业指导书：

The different stages of production shall be carried out according to written procedures aimed at defining, controlling and monitoring the critical points in the manufacturing process.

生产的不同阶段应按照书面程序实施，这些程序的目的是定义、控制、监视

生产过程中的关键点。

These shall include procedures to address the risk of carry-over.

应包括处理残留风险的程序。

c) Rules governing packaging: 规范对包装的管理：

Where products are packaged, care shall be taken to avoid contamination and cross-contamination during the packaging process, and to ensure that packaged


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products are correctly identified and labelled in compliance with the provisions of relevant feed regulations.

在产品包装场所，应注意避免在包装过程中的污染和交叉污染，同时确保包

装的产品被正确的标识并依据相关的饲料法规的规定加贴标签。

Packaging shall be appropriate to product type, with the objective of maintaining the contents for its intended shelf life. Packaging shall be considered under HACCP analysis.

包装应与产品的类别相适应，以保持所包装的产品达到预期的保质期为目

标。应基于HACCP分析考虑包装。

Pallets shall be serviceable, clean and dry. All pallets which are returned after a particular use shall be inspected and if necessary cleaned before re-use.

托架（集装箱）应耐用，清洁和干燥。应检查所有特殊使用后退回的托架

（集装箱），如有必要，重复使用前应进行清洁。

d) Rules controlling storage: 规范对贮存的控制

Finished products shall be clearly identified and stored in clean dry conditions. Access to these materials shall be restricted to authorised personnel only.

成品应能被清晰的识别并贮存在清洁干燥的环境。只有被授权人员才有权处

置这些产品。

Incoming materials, active substances, carrier substances, products which meet the specifications – and those which do not – shall be stored in suitable designed places , adapted and maintained, in order to ensure appropriate storage conditions which manage the risks of contamination and possible infestation by harmful organisms. Packed materials shall be stored in appropriate packaging.

满足规范的和那些不满足规范的购进原料、活性物质，载体和产品，应贮存

在指定的适当地点，并进行调整和维护，以确保适当的储存条件来管理污染

和可能的有机有害物侵袭的风险。包装材料应储存在适宜的包装中。

Materials shall be stored in a manner which enables easy identification, avoids cross-contamination and prevents deterioration. A stock rotation system shall be in place.

物料存储时宜使之易于区别，避免交叉污染，防止腐败。宜有库存周转系

统。

The storage environment shall be set up in a manner which minimises the risk of damage to packaging and spillage of material.

存储环境的设立宜使包装材料损坏和材料泄露的风险降到最低。

e) Rules concerning loading and delivery: 规范与装运和交付有关的活动

Products shall be delivered with the protection of animal and human health as prime considerations in mind.

产品交付应时刻铭记以保护动物及人类健康为首要考虑。

Containers and equipment used for transport, storage, conveying, handling and weighing shall be kept clean. Cleaning procedures shall consider such containers and equipment.


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用于内部运输、贮存、输送及称重的容器与设备应保持清洁。清洁程序应当

考虑这种容器与设备。

A final inspection shall take place to ensure delivery of safe and high quality product.

应进行最终检验以确保交付安全高品质的产品。

Ensure that: 确保

Production areas are accessible to authorised personnel only;生产区域只有被授权人方可入内；

Production is run according to formal production planning; 按照正式的生产计划进行生产；

The production plan is distributed to relevant persons; 生产计划发到有关人员；

Production records are kept to prove compliance with master formula; 生产记录被保存以证明符合配方；

Cross-contamination is prevented or controlled; 交叉污染被防止和控制；

Each product has a specification, unique name and/or code; 每一产品均有产品规范，唯一名字和/或代码；

Each product has a predefined label; 每一产品均有预先确定的标签。

Finished products are clearly marked and identified; 终产品被清楚的标识和识别；

Each product has a predefined packaging instruction;每一产品均有预先确定包装作业指导书；

The packaging process is controlled to avoid contamination and mix-up; 包装过程受控，以避免污染和混淆；

Deliveries are inspected prior to dispatch; 交付的产品在分派前进行了检验；

This inspection is documented; 检验形成记录。

Non-conforming products are segregated and stored in a manner to prevent failures; 不合格品被隔离保存，以防止其被使用；

Storage facilities are adequate to the purpose; 储存设施对于其用途是足够的；

Storage facilities are operated in a manner to prevent failures during handling;

储存设施以避免在操作期间出现故障的方式进行操作；

Storage facilities are suitable to the purpose, e.g. cleanliness, ventilation, dry, and temperature

controlled; 储存设施对于其用途是适合的，如清洁、通风、干燥和适宜的温度；

A defined stock rotation system is in place, e.g. FIFO “First In, First Out”; 建立库存周转系统，如先进先出；

Outdated stock is controlled and segregated. 过期库存受控并被隔离；

Loose bulk materials are controlled and segregated from other loose bulk material.

大宗散装原料是否受控并彼此有效隔离。


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7.5.2. Verification of processes for production 生产过程的验证

The Operator shall verify any processes for production. This includes any processes where deficiencies become apparent only after the product is in use or has been delivered.

经营者应对生产的任何过程实施验证，包括仅在产品使用或交付之后问题才显现的过程。

Verification shall demonstrate the ability of these processes to achieve expected results. Frequency of verifications shall be considered under the Operator’s HACCP system. Particular attention shall be given to carry-over and homogeneity.

验证应当证实这些过程实现预期结果的能力。验证的频次应在经营者的HACCP 体系框架下来

考虑。特别应注意残留和均匀性。

The Operator shall establish arrangements for these processes including:

经营者应对这些过程作出安排，包括：

a) defined criteria for review and approval of the manufacturing processes;

为生产过程的评审和批准所规定的准则；

b) approval of equipment; 设备的认可；

c) qualification of personnel; 人员资格的鉴定；

d) use of specific methods and procedures; and 特定的方法和程序的使用；以及

e) requirements for records. 记录的要求。

7.5.3. Identification and traceability 标识和可追溯性

To ensure traceability, the Operator shall: 为确保可追溯性，经营者应：

a) identify and record the product by suitable means throughout product realisation; and

在产品实现的全过程中使用适宜的方法识别与记录产品；

b) maintain a register, that contains: 保持登记，包括：

the names and addresses of manufacturers of incoming materials, feed additives, functional feed ingredients or of intermediates. Incoming materials shall be verified according to section 7.4.2.

购进原料、饲料添加剂、功能性饲料成分或中间体的生产者的名称与地址。购

进原料应根据7.4.2验证。

the nature and quantity of the products produced covered by FAMI-QS scope,

Ensure that: 确保

A written verification procedure is in place; 书面的验证程序是适宜的；

Verification data demonstrates that all production processes achieve planned results; 验证数据证实所有的生产过程实现策划的结果；

Verification data of production demonstrates that carry-over is controlled.

验证生产的数据证实残留被控制。


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生产的FAMI-QS范围所覆盖产品的性质和数量，

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 manufacturing, and

各自的生产日期，适当时，在连续生产条件下的批次或生产的特定部分的数

量，以及

the names and addresses of the intermediaries, manufacturers or users to whom the products covered by FAMI-QS scope have been delivered.

已交付的FAMI-QS范围所覆盖产品的中间商、生产商或使用者的名称和地址。

7.5.4. Preservation of product 产品防护

The Operator shall establish the shelf life of a product and preserve the conformity of the product during processing and delivery to the intended destination.

经营者应确定产品的保质期并在交付到预定的地点期间针对产品的符合性提供防护。

Preservation measures shall include product identification, handling, packaging, storage and protection. Preservation shall also apply to the constituent parts of a product.

防护措施应包括标识，搬运，包装，贮存与保护。防护也应适用于产品的组成部分。

7.6. Transport 运输

7.6.1. General requirements 总要求

Transportation of raw material and finished products are critical points in the process. Impurities that are hazardous to humans or animals may get in contact with the final product. Measures

Ensure that: 确保

A traceability system is in place, including tracing back from the final product through quality control data and batch records to the raw materials used and the suppliers;

一个追溯系统是适宜的，包括通过质量控制数据和批次生产记录从成品追溯到使用的原材料及其供方；

Deliveries can be traced to customers, including customer name, date, batch and amount.

交付能被追溯到顾客、包括顾客名字、日期、批次和数量。

Ensure that: 确保

a preservation programme is implemented to ensure stability of the product ; 一个确保产品稳定的方案被实施；

the product environment is controlled during storage in order to maintain compliance of the quality and safety requirements.

储存期间产品的环境受控，以保证其符合质量和安全需要。


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must be taken to ensure that the transportation of raw material and finished products is adequate in order to minimize the risk of contamination.

原料和成品的运输是整个产品生产过程的关键点。危害人类或动物的杂质可能会接触到成

品。必须采取措施，以确保原料和成品的运输对于最大限度地减少污染的危险是适宜的。

Two categories of finished products have to be considered: transportation of packed goods and transportation of bulk materials, either liquid or solid.

两类成品必须被考虑：已包装货物的运输和散装物料的运输，无论是液体或固体。

Where distribution or transport is performed by a subcontractor, the transporter shall be selected on the basis that it can satisfy product safety and reliability criteria.

凡是分发或运输是由分包商进行的，应在能够满足产品安全性和可靠性标准的基础上选择运

输者。

The Operators’ HACCP programme shall take transport into consideration when formulating the requirements on suppliers and transporters.

经营者的HACCP计划在明确表述对供方和运输方的要求时，应考虑到运输。

The Operator must communicate its requirements on transportation to the transporter. These requirements shall be documented and verified regularly.

经营者必须向运输方通报其对运输的要求；这些要求应形成文件并被定期验证。

The Operator’s evaluation of the performance of the transporter shall confirm the effectiveness of the transporter’s actions to meet the requirements.

经营者对运输方能力的评价应确认运输方对满足要求所采取的措施的有效性。

When transport of finished products is arranged and the buyer takes responsibility for the transport, it is the Operator’s responsibility to communicate, to the buyer, that the requirements in this Code will be applied on the transport before and during loading and during transportation/delivery.

当成品运输的交付期限已做出安排，并且在买方承担运输职责的情况下，经营者有责任与买

方进行沟通，将本标准中的要求应用于装货和运输/交付及其之前的运输。

Ensure that: 确保

Agreements with subcontracted transporters are documented; 与分包运输方的协议已文件化；

Selection of transporters takes into consideration their ability to fulfill the Operators requirements as

certified by this Code; 选择运输方应考虑到他们履行本规范中生产商要求的能力；

Transporters are controlled, evaluated and meet expected quality and safety requirements;

运输方受控，已被评价并满足预期的质量和安全要求；

Requirements in this Code are applied by the Operator also to transports arranged by the buyer.

本规范的要求由生产商或负责运输逇买方实施。


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7.6.2. Transport of packaged goods 已包装货物的运输

Products covered by FAMI-QS certificate shall not be transported, even if sealed, with goods that compromise the safety of the raw material or the finished product.

即使密封的FAMI-QS所覆盖范围认证的产品也不应与危害原材料或成品安全的货物同时运

输。

The package for the raw material or the finished product shall provide adequate protection against deterioration or contamination that may occur during transportation.

原材料或成品的包装应当提供充分的保护，防止可能发生在运输过程中的变质或污染。

7.6.3. Transport of bulk products 散装产品的运输

A system shall be in place to safeguard against contaminants which may compromise the integrity of products covered by FAMI-QS certificate according to applicable existing regulations.

应根据适用的现行法规适当地建立体系，以防止可能损害FAMI-QS认证所覆盖的产品完整性

的污染。

The Operator shall ensure that the transporter of bulk products has sufficient knowledge about handling products covered by the FAMI-QS scope. In the best case, this shall be proven by a transporter’s certification to a recognized standard.

经营者应确保散装产品运输方有关于FAMI-QS 范围所覆盖产品处理的足够知识。在最好的情

况下，应该通过运输方针对已认可标准的认证来证明。

Valid information about the product to be loaded must be given by the Operator to the transporter. The transporter can then define the suitable container to provide the best protection.

关于拟装载产品的有效信息必须由经营者提供给运输方。运输方能够选取适当的容器/集装

箱，以提供最佳的保护。

If cleaning of a container is required, the cleaning method shall be chosen to clean possible contaminants from the previous loads

如果需要对容器/集装箱进行清洗，清洗方法应选择能够清洁来自以前装载的可能的污染

物。

The transporter shall provide cleaning certificate(s) with the following information:

运输方应提供包括以下信息的清洁证明书：

Ensure that: 确保

Procedures are in place to ensure product integrity during transport;

适宜的程序以确保产品在运输过程中的完整性；

Packaging provides adequate protection for the raw material or finshed goods.

包装能够对原材料或成品提供充分的保护。


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a) information that enables container traceability; 能够提供容器/集装箱追溯性的信息；

b) previous load(s); 以前的装载记录；

c) method of cleaning; 清洁方法；

d) cleaning company; 清洁公司；

e) if applicable, information about the cleaning of discharge/unloading equipment.

适用时，关于已清洗的卸货设备的相关信息。

After cleaning, the efficiency of the cleaning operation must be checked and recorded.

清洗后，清洗操作的有效性必须被检查和记录。

Exceptions from the requirement on cleanliness may be done if the previous load does not compromise the safety of the one to be loaded.

如果先前的装载不会损害将要装载产品的安全，可以考虑不按上述具体清洁要求来执行。

Ensure that: 确保

Procedures are in place to control all relevant risks found in the Operators HACCP plan;

程序已建立，来控制生产商HACCP体系发现的所有相关风险;

If cleaning is required, the cleaning certificates shall include all relevant information needed to evaluate if the supplied container is suitable for loading;

如果需要清洁，清洁证明书应包括评估所提供的容器/集装箱是否适合装载所需要的所有有关资料;

Procedures are in place to safeguard against unwanted or forbidden contaminants.

程序已建立，以保护不受不需要或禁止的污染物侵害。


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8 SYSTEM REVIEW 体系评审


The Operator shall document measures taken to ensure that the MS is working efficiently. This may include planning, implementing and monitoring processes which demonstrate product conformity. Monitoring processes shall include collection of measurements, analysis of data, conclusions and if relevant, issuing of procedures which improve the MS.

经营者应证明已采取措施以确保管理体系的有效运行。这应包括策划、实施与监视证明产品

符合性的过程。监视过程应包括测量结果的收集，数据分析，结论，和有关改进管理体系程

序的发布。

8.2. Internal audits 内部审核

The Operator shall ensure that internal audits are performed to verify that the MS is: 经营者应确

保内审的实施以验证管理体系：

a) effectively implemented and maintained; 有效实施与保持；

b) in compliance with regulatory and other defined requirements;

与法规和其他规定要求的符合性；

c) the scope of the audits is defined and their frequency are scheduled in relation to the risk associated with the activity to be audited; and

应确定审核范围，且审核频次应根据被审核的活动的风险来确定。并且

d) covering that auditors shall be trained, competent and independent.

审核员应被培训，有相应能力以及有独立性。

Internal audits may also be used to identify potential opportunities for improvements.

内部审核也可用于识别潜在的改进机会。

Corrective actions shall be scheduled and verified when completed.

纠正措施应被计划，并应在完成时验证。

Ensure that: 确保

A formal review system exists; 建立了一个正式的评审体系；

The system includes collection of data; 体系包括数据收集；

The system includes analysis of the data; 体系包括数据分析；

The system includes conclusions; 体系包括结论；

The system includes actions for improvement originating from the conclusion;

体系包括为来自结论的改进而采取的措施；

Time scales for improvements are defined and maintained.

改进的时间范围应予以规定和保持。


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The schedule for conducting internal audits shall be documented and include planning, reports and details of suggested improvements. The detailed audit programme shall, as a minimum, include:

实施内部审核的方案应形成文件并包括策划，报告和改进建议的细节。审核方案应当详细，

至少包括：

a) preparation and issue of audit plans; 审核计划的编制与发布；

b) methods used to conduct the audits; 实施审核的方法；

c) reporting of findings; 审核发现报告；

d) scope of the audit; 审核范围；

e) distribution of reports. 报告分布。

Ensure that: 确保

A scheduled audit program is in place; 建立一个预定的审核方案；

Internal audits are carried out; 内部审核被实施；

The scope of audits are defined; 审核范围被确定；

Feed safety issues are included in the scope; 饲料安全问题已列入范围；

The frequency of audits are defined; 审核频次已规定；

The auditors are experienced and suitably trained; 审核员有经验并被适当培训；

Audits and non-conformities are reported and documented; 报告审核和不符合并形成文件；

Reports are distributed to key staff; 报告分发给主要人员；

A formal follow-up of non-conformities is reported; 报告（不符合的）正式的后续措施；

Corrected non-conformities are verified. 被纠正的不符合被验证。


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9 CONTROL OF NON-CONFORMING PRODUCTS 不合格品的控制


The Operator shall establish a documented procedure for dealing with products which do not

comply with intended requirements. 经营者应建立文件化的程序以处置不符合预期要求的产

品。

The procedure shall include: 程序应当包括：

a) identification of product and batch code; 识别产品及批号；

b) documentation of any non-conformance, corrective action(s) and verification steps;

记录任何不符合、纠正措施与验证步骤；

c) evaluation of the cause of the non-conformance; 分析不符合原因；

d) segregation of affected batch or batches; 隔离受影响批或批次；

e) provision for disposal of products where appropriate; 适宜时，提供对产品的处置；

f) recording of internal information of relevant parties. 有关方面内部信息的记录。

Responsibility for review and disposal of the non-conforming product shall be defined.

应规定评审与处置不合格品的职责。

A non-conforming product shall be reviewed in accordance with documented procedures and action to be taken in one of the following ways:

应当根据文件化程序，按下列方式评审和处理不合格品：

a) rework; 返工

b) reclassification or dispensation/dispatch; or 重新分级/派遣

c) rejection and subsequent destruction or disposal. 拒绝接收以及随后销毁或处理。

Records of all non-conformances must be maintained in accordance with document control procedures and archived for an appropriate time.

必须根据文件控制程序保持所有不符合的记录并以恰当的时间存档。

The approval and use of reworks (e.g. from rejects, customer returns or spillage) shall be considered within the HACCP system. Potential reworks which are not approved become waste material and shall be dealt with according to waste disposal procedures.

返工（例如，来自拒收、顾客退回或损坏）的批准和使用应在HACCP体系中加以考虑。未被

批准的潜在返工成为废品，并应当根据废弃物处置程序加以处置。


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9.2. Complaint handling system 投诉处理系统

A formalised documented procedure on complaint handling shall exist and shall include requirements to:

应建立正式的形成文件的投诉处理程序，并应当包括以下要求：

a) allocate responsibility for controlling complaints; 指定有关管理投诉的职责；

b) record name of complaining customer; 记录投诉客户的名称；

c) record product name and identification code; 记录产品名称及识别代码；

d) reason for complaint - identify and record each complaint; and 投诉的原因-分析和记录每

个投诉；并且

e) reply to the complaining customer. 回复投诉的客户。

Corrective actions shall be carried out in a timely and effective manner, with consideration given to the frequency and seriousness of complaints.

纠正措施的实施应当基于及时和有效的方式，并且应考虑抱怨发生的频次及严重程度。

Where possible, complaint information shall be used to avoid recurrence and implement ongoing improvements.

可能时，投诉信息应用以避免重复发生并实施改进。

Ensure that: 确保

A formal system on how to handle non-conforming products exists;

建立了一个如何处理不合格的正式体系；

The procedure covers: 程序覆盖：

o Product Identification; 产品识别鉴定；

o Documentation of non-conformities; 不合格的文件证据；

o Evaluation of root causes; 根本原因的评价；

o Documentation of corrective actions and verification steps; 采取纠正措施和验证步骤的证据；

o Segregation, handling and assessment of non-conforming product, including:

不合格品的隔离、处置和评估，包括：

Rejected materials; 拒收的材料；

Accepted materials with restrictions; 限制接收的材料；

Justification of potential alternative use within feed safety requirements;

饲料安全要求中潜在替代使用的理由；

The staff is aware of these procedures; 工作人员了解这些程序；

A clear marking or other means of controlling non-conforming products exists;

建立明确的标志或其他方式来控制不合格产品。

Records of non-conformities are maintained. 不合格的记录被保持。


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9.3. Recall 召回

A formal recall procedure shall be documented so that customers can be informed immediately of any irregularities that may compromise feed safety. The recall procedure shall be regularly reviewed to ensure conformance with the quality manual and regulatory requirements and the Operator’s organization.

正式的召回程序应想成文件，以便顾客能够及时就可能危及饲料安全的任何违规情况得到通

知。应定期评审召回程序以确保与质量手册、法规要求以及经营者组织结构的符合性。

The recall procedure shall include requirements to: 召回程序应当包括的要求：

a) define and allocate responsibility for the recall process; 规定和指定召回过程的职责；

b) identify each batch of non-conforming product including consequences to other product

batches or raw materials throughout the entire process; 识别每一个不合格品批次，包括

在整个过程中与其他产品批次或原料的关系；

c) identify the destination of affected batches; 识别受影响批次的最终去向；

d) notify customers of affected batches and coordinate product return;

通知顾客受影响批次并协调产品返回；

e) describe procedures for the handling and reassessment and/or disposal of recalled product(s) including segregation from other products and materials;

描述有关召回产品的处理、重新评估和/或包括与其他产品的材料隔离的处置的程序；

f) maintain records of product recall(s) and components from production and/or distribution to the affected customers.

保持产品召回以及从生产和/或交付至受影响顾客过程中成分的记录；

Simultaneously with the above listed action points, it is important to limit recurrence by:

Ensure that: 确保

A formal customer complaint handling system exists; 建立了正式的顾客投诉处理系统；

Responsibility for controlling complaints is defined; 投诉控制的职责已规定；

The system includes sufficient customer and product information; 系统包括充分的顾客和产品信息；

The complaints are evaluated according to: 投诉依据以下方面进行评价：

o Cause; 原因

o Seriousness; 严重性；

o Customer; 顾客；

o Other relevant topics; 其他相关主题

The complaint topics are used to prevent reoccurrence;投诉的主题被用于预防事故再发生；

The related corrective actions are carried through; 已充分采取相关纠正措施；

Operator’s feedback is given to the customer. 经营者的信息反馈给顾客。


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同时，针对上述措施的要点，重要的是要限制再次发生，通过：

- ensuring immediate corrective and preventive actions are undertaken;

确保立即采取了纠正和预防措施；

- verifying that corrective and preventative actions are effective.

验证纠正和预防措施是有效的。

Operators may also remove products from the market for reasons other than feed safety. These cases shall be handled in the same manner described here.

经营者也可以根据饲料安全以外的原因从市场撤回产品：这些情况应当按照上述描述的同样

方式来处理。

The recall procedure shall be tested at least annually to ensure functionality. Such tests shall be documented and evaluated for improvements.

召回程序应至少每年进行一次测试，以确保其效果。这种测试应形成文件并进行评价用以改

进。

9.4. Crisis Management 危机管理

If a feed business Operator considers or has reason to believe that a feed which it has imported, produced, processed, manufactured or distributed does not satisfy the feed safety requirements, it must immediately initiate procedures to recall the feed in question from the market and inform the competent authorities thereof. In such cases the last version of the “Feed Safety Incident and Crisis Management Procedure for Operators and CBs” (P-CM-01) of the Code must be applied.

如果饲料生产经营者认为或有理由相信，已进口、生产、加工、制造或分发的饲料不符合安

全要求，必须立即启动程序以从市场上召回存在问题的饲料并告知主管当局。在这种情况

下，必须应用规范中最新版本的“经营者和认证机构的饲料安全事件和危机管理程序”（P-

CM-001）

a) The crisis management procedure shall be documented.

危机管理程序应当形成文件

b) Responsibility shall be defined for notifying customers and regulatory authorities.

Ensure that: 确保

A formal recall procedure exists; 建立了正式的召回程序；

Responsibility is assigned to an appropriate person; 职责分配给适宜的人；

The recall process is adequately described; 召回过程被充分描述；

The recall procedure includes handling, reassessment and/or disposal of recalled product;召回程序包括对召回产品处理，评估和/或处置；

Effective corrective and preventive actions are implemented; 实施了有效的纠正和预防措施；

Any recall is recorded; 所有的召回均被记录；

The recall procedure is tested regularly; 召回程序被定期测试；

The test recalls are documented; 测试的召回被记录；

The outcomes of the test recalls are evaluated. 测试召回的结果被评价。


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应规定告知顾客和监管机构的职责

c) Responsibility within the operation for product recall(s) shall be defined.

应规定执行产品召回的职责

It is important to emphasize that a crisis may result in a Rapid Alert situation (RASFF) or originate from such.

需重点强调的是危机可能会导致快速预警或与次相关的情况。

Ensure that: 确保

A crisis management procedure exists; 建立了微机管理程序；

Responsibility for notifying customers and regulatory authorities is defined;

规定了告知顾客和监管机构的职责；

Responsibility for conduction a product recall is defined.

规定了执行产品召回的职责。


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10 STATISTICAL TECHNIQUES 统计技术

The Operator shall, where appropriate, evaluate and identify the need for the use of statistical techniques.

适当时，经营者应评估和识别使用统计技术的需求。

Where statistical techniques are applied, the need for these techniques shall be demonstrated.

对于应用了统计技术的地方，应证实确实需要这些技术。

The adequacy of these techniques shall be demonstrated:

使用这些技术的充分性应被证实：

a) standard error shall be calculated and documented; 标准误差应被计算和记录；

b) standard error must be of an appropriate level to sufficiently ensure feed safety;

标准误差必须在一个适当的水平，以充分确保饲料安全；

c) data exceeding standard error and trends shall be monitored;

超过标准误差数据和趋势应被监测；

d) Corrective actions shall be specified in the event of a breach of error limits.

当超出误差允许范围的情况发生时，应明确指定相应的纠正措施。

11 BIBLIOGRAPHY 参考文献

In order to facilitate implementation of the Code, the structure of ISO 9001:2008, Quality Management Systems, is used.

为了便于本规范的实施，采用了ISO 9001：2008质量管理体系的结构。

In order to align the Code with current animal feed legislation and various activities on national, industrial and/or association levels, it takes into account the principles of feed and food safety as well as HACCP principles that are set out in various international documents further down and EC legislation, in particular:

Ensure that: 确保

The use of statistical techniques has been evaluated and defined;

统计技术的使用已被评价和规定；

An overview of each statistical method is available;

各种统计方法的概述均可获得；

The applicability of methods is documented;

方法的适用性已形成文件；

The Operator possesses the necessary statistical competencies;

生产商拥有必要的统计能力；

Corrective actions are defined for results outside of the standard error.

对于在标准误差以外的结果，规定纠正措施。


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为了保持与各国、行业和/或协会通行的动物饲料法规和各种要求的水平一致，本规范参考了在不同

的国际文献及欧洲法规中所阐述的饲料和食品安全原理和HACCP原理，尤其是：

The European Commission’s White Paper on Food Safety, COM (1999) 719 final.

http://ec.europa.eu/dgs/health_consumer/library/pub/pub06_en.pdf

Regulation (EC) No 183/2005 of the European Parliament and of the Council of 12 January 2005 laying down requirements for feed hygiene (and repealing Council Directive 95/69/EEC and Commission Directive 98/51/EEC (apart from article 6 on Interim measures), laying down conditions and arrangements for approving and registering establishments and intermediaries in the animal feed sector).

http://eur-lex.europa.eu/LexUriServ/site/en/oj/2005/l_035/l_03520050208en00010022.pdf

Directive 98/51/EC.

http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:31998L0051:EN:HTML

Regulation (EC) No 1831/2003 of the European Parliament and of the Council on additives for use in animal nutrition.

http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSLEG:2003R1831:20100901:EN:PDF

Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority.


Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules.


Other documents: 其他文件：

The relevant Codes of practice of the Codex Alimentarius.

http://www.Codexalimentarius.net/.

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/.

http://ec.europa.eu/dgs/health_consumer/library/pub/pub06_en.pdf


http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:31998L0051:EN:HTML




http://www.codexalimentarius.net/

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