欧盟一般食品法Regulation (EC) No 852-2004中文翻译

852.2004法規翻譯

CORRIGENDA

Corrigendum to Regulation (EC) No 852/2004 of the European Parliament and of the

Council of 29 April 2004 on the hygiene of foodstuffs

(Official Journal of the European Union L 139 of 30 April 2004)

歐洲議會和歐盟理事會2004年4月29日關於食品衛生規章852/2004的修正

Regulation (EC) No 852/2004 should read as follows:

REGULATION (EC) No 852/2004 OF THE EUROPEAN PARLIAMENT AND OF

THE COUNCIL of 29 April 2004

on the hygiene of foodstuffs

一、法規摘要重點：

主要協調歐盟各會員國之食品衛生法，以確保食品在各階段生產過程之衛生標準。規範所有食品企業經營業者(包括食品運輸業者及倉儲業者)須確保遵守食品衛生規範，應符合本法附件一第A部分之一般衛生規範，並要求所有食品業者(不包括原物料生產者)須遵守附件二之一般衛生規範，如食品衛生證明、運輸件、生產設備、廢棄物處理、水質供應、人員衛生、包裝、食品之加熱處理及食品加工人員之培訓等。此外，該規定第5亦要求食品業者(除原物料初級產品之生產者外)均須採用食品衛生法規執委會(Codex

Alimentarius)所頒布之危害分析重要管制點系統(Hazard Analysis and Critical

Control Points, HACCP)之原則及相關要求規定，以確保食品衛生安全。

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN

UNION,

Having regard to the Treaty establishing the European Community, and in particular

Articles 95 and 152(4)(b) thereof,

Having regard to the proposal from the Commission (1),

Having regard to the opinion of the European Economic and Social Committee (2),

Having consulted the Committee of the Regions,

Acting in accordance with the procedure laid down in Article 251 of the Treaty (3),

依第251制定程序，

本法重點：

1、企業經營者應承擔食品安全的主要責任 。

2、應從食品的初级生產開始確保食品生產、加工和銷售之整體食品安全 。

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3、全面推行危害分析重要管制點系統(HACCP)。

4、建立食品微生物標準與食品溫度管制之要求 。確保進口食品符合歐洲標準或與其等效之標準。

Whereas:

鑑於︰

(1) The pursuit of a high level of protection of human life and health is one of the

fundamental objectives of food law, as laid down in Regulation (EC) No 178/2002

(4). That Regulation also lays down other common principles and definitions for

national and Community food law, including the aim of achieving free movement

of food within the Community.

(1) 食品法律的基本目標之一為追求人類的生命和健康的最高保護，如1993年6月14日公告之規章(EC) No 178/2002擬訂食品衛生的一般原則。此規章也擬訂其他國家和社區的食品法律的一般原則及定義，包括達成食品於歐盟區域內自由流通的目標。

(2) Council Directive 93/43/EEC of 14 June 1993 on the hygiene of foodstuffs (5) laid

down the general rules of hygiene for foodstuffs and the procedures for

verification of compliance with these rules.

(2) 1993年6月14日的委員會指令93/43/EEC在食品衛生擬訂了食品的一般衛生規則，和確認符合該法的程序。

(3) Experience has shown that these rules and procedures constitute a sound basis for

ensuring food safety. In the context of the common agricultural policy, many

directives have been adopted to establish specific health rules for the production

and placing on the market of the products listed in Annex I to the Treaty. These

health rules have reduced trade barriers for the products concerned, contributing to

the creation of the internal market while ensuring a high level of protection of

public health.

(3) 經驗顯示這些規則及程序構成確認食品安全的健全基礎。在一般農業政策內，許多指令已被採取以建立在產品製造和上市的特定衛生規則，這些規則列在約的附件 I。這些衛生規定降低了相關產品的貿易障礙，在高度保護公共衛生的同時也創造了內部市場。

(4) With regard to public health, these rules and procedures contain common

principles, in particular in relation to the manufacturers ‘and competent

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authorities’ responsibilities, structural, operational and hygiene requirements for

establishments, procedures for the approval of establishments, requirements for

storage and transport and health marks.

(4) 關於公共衛生，這些規定和程序包括一般的原則，特別是關於製造廠商和權責機關的責任、結構、操作和廠場的衛生要求、認可的程序，以及倉儲、運輸與衛生標誌的要求。

(5) These principles constitute a common basis for the hygienic production of all food,

including products of animal origin listed in Annex I to the Treaty.

(5) 這些原則組成所有食品衛生生產的一般基礎，包括約內附錄I所列的動物性產品。

(6) In addition to this common basis, specific hygiene rules are necessary for certain

foodstuffs. Regulation (EC) No 853/2004 of the European Parliament and of the

Council of 29 April 2004 laying down specific hygiene rules for food of animal

origin (6) lays down these rules.

(6) 除了這項一般的基礎之外，明確的衛生規章對某些產品為必需的。委員會於2004年4月29日之歐洲國會規章(EC) No 853/2004 擬訂具體的動物性食品之衛生規則訂定這些規則。

(7) The principal objective of the new general and specific hygiene rules is to ensure a

high level of consumer protection with regard to food safety.

(7) 新的一般和明確之衛生規則的主要目的是為了確保消費者關於食品安全之

高度保護。

(8) An integrated approach is necessary to ensure food safety from the place of

primary production up to and including placing on the market or export. Every

food business operator along the food chain should ensure that food safety is not

compromised.

(8) 為了保護從初級生產的地方到包含產品上市或出口的食品安全，整合的方法是必須的。每個在食品鏈的業者應確保其不違及食品安全。

(9) Community rules should not apply either to primary production for private

domestic use, or to the domestic preparation, handling or storage of food for

private domestic consumption. Moreover, they should apply only to undertakings,

the concept of which implies a certain continuity of activities and a certain degree

of organisation.

(9) 歐盟區域法規不適用於國內私人使用，或供應國內私人使用之國內加工、處 3

理或食品儲存。而且，其應只適用於具特定連續性的活動和一定程度組織的事業。

(10) Food hazards present at the level of primary production should be identified and

adequately controlled to ensure the achievement of the objectives of this

Regulation. However, in the case of the direct supply of small quantities of

primary products, by the food business operator producing them, to the final

consumer or to a local retail establishment, it is appropriate to protect public

health through national law, in particular because of the close relationship

between the producer and the consumer.

(10)存在於初級生產階段的食品危害應該被鑑定出並被適當的控制，以確保達成本規章的目標。然而，在初級產品少量直接供給的例子，由食品業者製造，到最終消費者或地方零售，由國家法律保護公共衛生是適當的；特別是因為製造者和消費者之間的關係密切。

(11) The application of hazard analysis critical control point (HACCP) principles to

primary production is not yet generally feasible. However, guides to good

practice should encourage the use of appropriate hygiene practices at farm level.

Where necessary, specific hygiene rules for primary production should

supplement these guides. It is appropriate for the hygiene requirements

applicable to primary production and associated operations to differ from those

for other operations.

(11)危害分析重要管控點(HACCP)的應用原則在初級生產業尚未普遍可行。不過，良好規範的指引應該鼓勵農場階段使用適當的衛生規範。必要時，初級生產的特定衛生規則應補充這些指引。適用於初級生產及相關業者的衛生要求不同於其他業者是適當的。

(12) Food safety is a result of several factors: legislation should lay down minimum

hygiene requirements; official controls should be in place to check food business

operators’ compliance and food business operators should establish and operate

food safety programmes and procedures based on the HACCP principles.

(12)食品安全由許多因素所構成︰法令應該訂定最低的衛生要求、官方管制應檢查食品業者是否遵守法令規定？食品業者應該依HACCP原則建立及執行食品安全計畫和程序

(13) Successful implementation of the procedures based on the HACCP principles

will require the full cooperation and commitment of food business employees. To

this end, employees should undergo training. The HACCP system is an

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instrument to help food business operators attain a higher standard of food safety.

The HACCP system should not be regarded as a method of self-regulation and

should not replace official controls.

(13) 依HACCP的原則為基礎，程序的成功實施需要食品業者員工之全力合作和承諾。為此目的，員工應經過訓練。HACCP系統是幫助業者達成更高標準的食品安全，而不應被認為是自主管理的方法且不應取代官方管制。

(14) While the requirement of establishing procedures based on the HACCP

principles should not initially apply to primary production, the feasibility of its

extension will be one element of the review that the Commission will carry out

following implementation of this Regulation. It is, however, appropriate for

Member States to encourage operators at the level of primary production to apply

such principles as far as possible.

(14) 雖然依HACCP原則建立之程序要求，不應一開始就使用於初級生產，其延伸的可行性將是審查的一個要件，委員會將完成接下來本規章的執行。然而，會員國鼓勵初級生產者盡可能去採用這樣的原則是適當的。

(15) The HACCP requirements should take account of the principles contained in the

Codex Alimentarius. They should provide sufficient flexibility to be applicable in

all situations, including in small businesses. In particular, it is necessary to

recognise that, in certain food businesses, it is not possible to identify critical

control points and that, in some cases, good hygienic practices can replace the

monitoring of critical control points. Similarly, the requirement of establishing

‘critical limits’ does not imply that it is necessary to fix a numerical limit in

every case. In addition, the requirement of retaining documents needs to be

flexible in order to avoid undue burdens for very small businesses.

(15) HACCP的要求應考慮國際法典中的原則。其應提供足夠的彈性以適用所有的情況，包括小型企業。尤其，必須了解在某些食品業裡，辨別危害管控點是不可能的，某些例子中，良好衛生規範可以取代危害管控點的監控。相同地，建立「關鍵界限」的要求並非指在每一例中需要固定一數量限制。除此之外，為了避免對很小的公司造成不合理的負擔，保留文件之要求需要有彈性。

(16) Flexibility is also appropriate to enable the continued use of traditional methods

at any of the stages of production, processing or distribution of food and in

relation to structural requirements for establishments. Flexibility is particularly

important for regions that are subject to special geographical constraints,

including the outermost regions referred to in Article 299(2) of the Treaty.

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However, flexibility should not compromise food hygiene objectives. Moreover,

since all food produced in accordance with the hygiene rules will be in free

circulation throughout the Community, the procedure allowing Member States to

exercise flexibility should be fully transparent. It should provide, where

necessary to resolve disagreements, for discussion within the Standing

Committee on the Food Chain and Animal Health established by Regulation (EC)

No 178/2002.

(16)彈性也適用於能夠繼續使用在任何生產、加工或食品分送階段以及廠場結構的傳統方法。彈性對於在特別限制中之區域特別的重要，尤其是地理受局限的地區，包括約第299(2)提到之最偏遠的地區。然而，彈性不應影響食品衛生的目標。而且，既然所有食品製造是依照衛生規則將在整個歐盟內自由流通，允許會員國採行彈性之作法程序應充分透明。依規章(EC) No

178/2002.，應該在食物鏈和動物衛生常務委員會討論中，提供解決歧見。

(17) The setting of objectives such as pathogen reduction targets or performance

standards may guide the implementation of hygiene rules. It is therefore

necessary to provide procedures for that purpose. Such objectives would

supplement existing food law, such as Council Regulation (EEC) No 315/93 of 8

February 1993 laying down Community procedures for contaminants in food (1),

which provides for the establishment of maximum tolerances for specific

contaminants, and Regulation (EC) No 178/2002, which prohibits the placing on

the market of unsafe food and provides a uniform basis for the use of the

precautionary principle.

(17) 設定例如病原菌降低或實施標準之目標，可以引導灌輸衛生法規的實施。為達該目的，應訂定程序。這樣的目標將補充現有的食品法律，像是1993年2月8日的執委會規章 No 315/93，製訂食品中污染物的聯盟處理程序、該法訂定特一污染物的最大容許量；規章(EC) No 178/2002禁止不安全的食品的上市，並提供統一的預防性的原則作業基礎。

(18) To take account of technical and scientific progress, close and effective

cooperation should be ensured between the Commission and the Member States

within the Standing Committee on the Food Chain and Animal Health. This

Regulation takes account of international obligations laid down in the WTO

Sanitary and Phytosanitary Agreement and the international food safety

standards contained in the Codex Alimentarius.

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(18) 考量技術和科學的發展，委員會和食物鏈與動物衛生常務委員會內的會員之間，應該確保緊密和有效的合作。本法規考慮在WTO 衛生和植物衛生協議內制訂之國際義務和國際法典的食品安全標準。

(19) The registration of establishments and the cooperation of food business operators

are necessary to allow the competent authorities to perform official controls

efficiently.

(19) 廠場的註冊與食品業者的合作是讓權責機關有效的執行官方管控所必需的。

(20) The traceability of food and food ingredients along the food chain is an essential

element in ensuring food safety. Regulation (EC) No 178/2002 contains rules to

ensure the traceability of food and food ingredients and provides a procedure for

the adoption of implementing rules to apply these principles in respect of specific

sectors.

(20)食品和食品成分於食物鏈之追溯性的要求為確保食品安全所必要的要素，規章(EC) No 178/2002包含確保食品和食品成分追溯性的規定，並依產業特性之不同，提供執行規定的程序。

(21) Food imported into the Community is to comply with the general requirements

laid down in Regulation (EC) No 178/2002 or satisfy rules that are equivalent to

Community rules. The present Regulation defines certain specific hygiene

requirements for food imported into the Community.

(21)食品進口到歐盟應符合規章(EC) No 178/2002擬定的一般要求或滿足相當於歐盟規章的要求。本規章定義進口到歐盟食品的特定衛生要求。

(22) Food exported to third countries from the Community is to comply with the

general requirements laid down in Regulation (EC) No 178/2002. The present

Regulation defines certain specific hygiene requirements for food exported from

the Community.

(22) 從歐盟出口到第三國的食品需遵守規章(EC) No 178/2002訂定之一般要求。

本規章明訂從歐盟出口之食品的特定衛生要求。

(23) Scientific advice should underpin Community legislation on food hygiene. To

this end, the European Food Safety Authority should be consulted whenever

necessary.

(23) 科學建議應支持歐盟對食品衛生立法。為此目的，歐洲食品安全局(EFSA)於必要時應進行協商事宜。

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(24) Since this Regulation replaces Directive 93/43/EEC, the latter should be

repealed.

(24)因本規章取代指令93/43 /EEC，後者將予以廢止。

(25) The requirements of this Regulation should not apply until all parts of the new

legislation on food hygiene have entered into force. It is also appropriate to

provide for at least 18 months to elapse between entry into force and the

application of the new rules, to allow the affected industries time to adapt.

(25) 此規章的要求應於食品衛生的新法生效時實施，而且應該有至少18個月的緩衝期，在正式使用新的法規前，讓食品業者有一段適應期。

(26) The measures necessary for the implementation of this Regulation should be

adopted in accordance with Council Decision 1999/468/EC of 28 June 1999

laying down the procedures for the exercise of implementing powers conferred

on the Commission (1),

(26)施行此規章之必要措施應符合1999年6月28日制定之歐盟法令1999/468/EC擬訂的程序，經執行委員會授權執行。

HAVE ADOPTED THIS REGULATION:

二、目錄

Regulation (EC) No 852/2004如下︰

第I章 總則

第1 適用範圍

第2 名詞定義

第II章 食品業者之義務

第3 義務

第4 衛生要求

第5 危害分析重要管制點

第6 官方管制、認證與核可

第III章 良好作業指引

第7 指引之發展、宣導及使用

第8 國家指引

第9 歐盟指引

第IV章 進口與出口

第10 進口

第11 出口

第V章 附則

第12 執行措施與過渡期之安排

第13 附件I與II之修正與改編

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第14 執委會程序

第15 歐洲食品安全局(EFSA)之諮詢

第16 向歐洲議會與執委會報告

第17 廢止

第18 生效日

附件I 初級生產

附件II 食品業者一般衛生要求(附件I適用者除外)

CHAPTER I

第I章

GENERAL PROVISIONS

總則

Article 1

第1

Scope

適用範圍

1. This Regulation lays down general rules for food business operators on the hygiene

of foodstuffs, taking particular account of the following principles:

1. 本法規訂定食品業者需遵守的食品衛生規範，其說明如下：

(a) primary responsibility for food safety rests with the food business operator;

(a)食品安全之基本責任歸屬於食品業者；

(b) it is necessary to ensure food safety throughout the food chain, starting with

primary production;

(b)自初級生產開始，應確保整個食物鏈之食品安全；

(c) it is important, for food that cannot be stored safely at ambient temperatures,

particularly frozen food, to maintain the cold chain;

(c) 室溫下無法安全儲存之食品(尤其是冷凍食品)，應保持於冷藏鏈(cold chain)中。

(d) general implementation of procedures based on the HACCP principles, together

with the application of good hygiene practice, should reinforce food business

operators’ responsibility;

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(d)以HACCP原則作為一般執行之基本程序，搭配食品良好衛生規範(GHP)之落實應能強化食品業者之責任；

(e) guides to good practice are a valuable instrument to aid food business operators at

all levels of the food chain with compliance with food hygiene rules and with the

application of the HACCP principles;

(e) 良好規範指引，在食物鏈的各階層之食品業者遵循食品衛生法規與HACCP原則應用，是有價值的工具。

(f) it is necessary to establish microbiological criteria and temperature control

requirements based on a scientific risk assessment;

(f) 依照科學危害評估之基礎，建立微生物標準與溫度管制要求是必須的。

(g) it is necessary to ensure that imported foods are of at least the same hygiene

standard as food produced in the Community, or are of an equivalent standard.

(g) 確保進口食品與歐盟生產之產品衛生要求相同或等效。

This Regulation shall apply to all stages of production, processing and distribution of

food and to exports, and without prejudice to more specific requirements relating to

food hygiene.

本法規應適用於所有階段的食品生產、加工、銷售與出口，並無損更詳細之食品衛生相關要求。

2. This Regulation shall not apply to:

2. 本法規不適用於︰

(a) primary production for private domestic use;

(a) 國內私人使用之初級生產；

(b) the domestic preparation, handling or storage of food for private domestic

consumption;

(b) 國內私人食用之國內食品預備、處理或儲存；

(c) the direct supply, by the producer, of small quantities of primary products to the

final consumer or to local retail establishments directly supplying the final

consumer;

(c)由生產者直接供應少量之初級產品給最終消費者，或地方零售廠場直接供應給最終消費者；

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(d) collection centres and tanneries which fall within the definition of food business

only because they handle raw material for the production of gelatin or collagen.

(d) 採集中心與鞣皮廠在食品業者的定義內，因其負責動物膠或膠質之原料生產。

3. Member States shall establish, under national law, rules governing the activities

referred to in paragraph 2(c). Such national rules shall ensure the achievement of

the objectives of this Regulation.

3. 會員國應依據國家法令建立本法第2段(c)所提及之作業程序。該國法令應確保達成本法規之目標。

Article 2

第2

Definitions

名詞定義

1. For the purposes of this Regulation:

1.本法規用詞定義如下︰

(a) ‘food hygiene’, hereinafter called ‘hygiene’, means the measures and conditions

necessary to control hazards and to ensure fitness for human consumption of a

foodstuff taking into account its intended use;

(a) food hygiene食品衛生：以下稱之為「衛生」。係指控制食品危害與確保人類健康之必要措施與件；

(b) ‘primary products’ means products of primary production including products of

the soil, of stock farming, of hunting and fishing;

(b) primary products初級產品：包括種植、養殖、狩獵以及漁撈等初級生產之產品；

(c) ‘establishment’ means any unit of a food business;

(c) establishment 廠場：表示任何食品業者之單位；

(d) ‘competent authority’ means the central authority of a Member State competent to

ensure compliance with the requirements of this Regulation or any other authority

to which that central authority has delegated that competence; it shall also include,

where appropriate, the corresponding authority of a third country;

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(d) competent authority 權責機關：係指會員國權責之中央機構確保遵從此法規或任何其他中央機構經授的權責機構。在適當時，也包括相符的第三國權責機構。

(e) ‘equivalent’ means, in respect of different systems, capable of meeting the same

objectives;

(e) equivalent 等效：係指不同的系統能達成相同的目標；

(f) ‘contamination’ means the presence or introduction of a hazard;

(f) contamination污染：係指危害之存在或導入；

(g) ‘potable water’ means water meeting the minimum requirements laid down in

Council Directive 98/83/EC of 3 November 1998 on the quality of water intended

for human consumption (1);

(g) potable water飲用水：係指符合1998年11月3日委員會指令 98/83/EC訂定之供人飲用的水;

(h) ‘clean seawater’ means natural, artificial or purified seawater or brackish water

that does not contain micro-organisms, harmful substances or toxic marine

plankton in quantities capable of directly or indirectly affecting the health quality

of food;

(h) clean seawater 乾淨海水：係指天然、人工或淨化後海水或微鹹之水，不含有直接或間接影響食品安全品質數量之微生物、有害物質或有毒之浮游生物；

(i) ‘clean water’ means clean seawater and fresh water of a similar quality;

(i) clean water 乾淨水：係指具相同品質之乾淨海水與淡水；

(j) ‘wrapping’ means the placing of a foodstuff in a wrapper or container in direct

contact with the foodstuff concerned, and the wrapper or container itself;

(j) wrapping內包材：係指與食品直接接觸之食品容器與直接包裹或覆蓋食品之包裝材料或容器；

(k) ‘packaging’ means the placing of one or more wrapped foodstuffs in a second

container, and the latter container itself;

(k) packaging 外包材：係指未與食品直接接觸之第二層包裝材料或容器；

(l) ‘hermetically sealed container’ means a container that is designed and intended to

be secure against the entry of hazards;

12

(l) hermetically sealed container密封容器：表示經過設計並有效防止危害侵入之容器；

(m) ‘processing’ means any action that substantially alters the initial product,

including heating, smoking, curing, maturing, drying, marinating, extraction,

extrusion or a combination of those processes;

(m) processing 加工：係指實質上改變產品最初狀態之任何作業程序，包括加熱、煙燻、醃漬、熟成、乾燥、鹽漬、萃取、壓擠或這些程序的組合；

(n) ‘unprocessed products’ means foodstuffs that have not undergone processing, and

includes products that have been divided, parted, severed, sliced, boned, minced,

skinned, ground, cut, cleaned, trimmed, husked, milled, chilled, frozen,

deep-frozen or thawed;

(n) unprocessed products未加工產品：係指未經加工處理之食品，包括已經被分開、分解、切斷、切片、去骨、細絞碎、剝皮、絞碎、分切、清洗、修整、剝殼、磨粉、冷藏、冷凍，凍結或解凍；

(o) ‘processed products’ means foodstuffs resulting from the processing of

unprocessed products. These products may contain ingredients that are necessary

for their manufacture or to give them specific characteristics.

(o) processed products 已加工產品：係指食物經過加工處理而成之產品，包括製造所需之原物料或加入特殊之成分。

2. The definitions laid down in Regulation (EC) No 178/2002 shall also apply.

2. 於Regulation (EC) No 178/2002擬定之定義應適用。

3. In the Annexes to this Regulation the terms ‘where necessary’, ‘where

appropriate’, ’adequate’ and ‘sufficient’ shall mean respectively where necessary,

where appropriate, adequate or sufficient to achieve the objectives of this

Regulation.

3.(略)

CHAPTER II

第II章

FOOD BUSINESS OPERATORS’ OBLIGATIONS

食品業者之義務

Article 3

第3

General obligation

13

義務

Food business operators shall ensure that all stages of production, processing and

distribution of food under their control satisfy the relevant hygiene requirements laid

down in this Regulation.

食品業者應確保食品生產、加工及運輸之任何階段，在安全管控下，符合本法相關之衛生要求。

Article 4

第4

General and specific hygiene requirements

衛生要求

1. Food business operators carrying out primary production and those associated

operations listed in Annex I shall comply with the general hygiene provisions laid

down in part A of Annex I and any specific requirements provided for in Regulation

(EC) No 853/2004.

1. 從事附件I所列之初級生產與相關作業之食品業者，應符合附件I A部份所制定之一般衛生要求以及Regulation (EC) No 853/2004之任何特殊規定。

2. Food business operators carrying out any stage of production, processing and

distribution of food after those stages to which paragraph 1 applies shall comply

with the general hygiene requirements laid down in Annex II and any specific

requirements provided for in Regulation (EC) No 853/2004.

2. 從事第一段所述之食品生產、處理與運輸之這些階段後食品業者，應符合附件II之一般衛生要求與Regulation (EC) No 853/2004之任何特殊規定。

3. Food business operators shall, as appropriate, adopt the following specific hygiene

measures:

3. 食品業者應適當採行下列特定之衛生措施︰

(a) compliance with microbiological criteria for foodstuffs;

(a) 遵守食品微生物標準；

(b) procedures necessary to meet targets set to achieve the objectives of this

Regulation;

(b) 程序需符合本規章設定之目標

(c) compliance with temperature control requirements for foodstuffs;

14

(c) 遵守食品溫度管制的要求；

(d) maintenance of the cold chain;

(d) 冷藏鏈之維持；

(e) sampling and analysis.

(e) 取樣和檢驗分析。

4. The criteria, requirements and targets referred to in paragraph 3 shall be adopted in

accordance with the procedure referred to in Article 14(2).

4. 第三段所述之標準、要求與目標，應第14(2)所提之程序採行。

Associated sampling and analysis methods shall be laid down in accordance with the

same procedure.

相關之取樣與分析方法應依相同程序訂定之。

5. When this Regulation, Regulation (EC) No 853/2004 and their implementing

measures do not specify sampling or analysis methods, food business operators

may use appropriate methods laid down in other Community or national legislation

or, in the absence of such methods, methods that offer equivalent results to those

obtained using the reference method, if they are scientifically validated in

accordance with internationally recognised rules or protocols.

5. 當本法規Regulation (EC) No 853/2004及其執行措施未指定取樣或分析方法時，食品業者可使用其他區域或國家法規中之適當方法。若無，可使用國際認可之方法或科學上經證實效果相等之方法。

6. Food business operators may use the guides provided for in Articles 7, 8 and 9 as

an aid to compliance with their obligations under this Regulation.

6. 食品業者可採行本規章第7、8、9之指引，以達到本法規定之義務。

Article 5

第5

Hazard analysis and critical control points

危害分析重要管制點系統

1. Food business operators shall put in place, implement and maintain a permanent

procedure or procedures based on the HACCP principles.

1. 食品業者應依HACCP原則建立、執行並維持HACCP制度之固定的程序。

15

2. The HACCP principles referred to in paragraph 1 consist of the following:

2. 第一段所指之HACCP原則如下︰

(a) identifying any hazards that must be prevented, eliminated or reduced to

acceptable levels;

(a) 任何危害之鑑定應預防、消除或降低至可接受程度；

(b) identifying the critical control points at the step or steps at which control is

essential to prevent or eliminate a hazard or to reduce it to acceptable levels;

(b) 判定步驟中之危害管控點或可預防、消除或降低危害至可接受程度之必要管制步驟；

(c) establishing critical limits at critical control points which separate acceptability

from unacceptability for the prevention, elimination or reduction of identified

hazards;

(c) 在臨界管制點建立臨界界限，該界限為預防、消除或降低被鑑定之危害物

分出不可接受至可接受之分界；

(d) establishing and implementing effective monitoring procedures at critical control

points;

(d) 對重要管制點建立與執行有效之監控程序；

(e) establishing corrective actions when monitoring indicates that a critical control

point is not under control;

(e) 當監控結果顯示重要管制點失控時，建立矯正之作業程序；

(f) establishing procedures, which shall be carried out regularly, to verify that the

measures outlined in subparagraphs (a) to (e) are working effectively;

(f) 建立常規之程序，並確認上述之(a)到(e)段有效地運作；

and

(g) establishing documents and records commensurate with the nature and size of the

food business to demonstrate the effective application of the measures outlined in

subparagraphs (a) to (f).

(g) 建立與食品產業性質、規模相當之文件與紀錄，以證實上述(a)至(f)確實執行。

When any modification is made in the product, process, or any step, food business

16

operators shall review the procedure and make the necessary changes to it.

當產品、製程或任何步驟被修改時，食品業者應重新審查程序並做必要之修正。

3. Paragraph 1 shall apply only to food business operators carrying out any stage of

production, processing and distribution of food after primary production and those

associated operations listed in Annex I.

3. 第一段應只適用於初級生產後實行食品生產、處理及運輸之任何階段的食品業者與附件I中的相關作業。

4. Food business operators shall:

4. 食品業者應︰

(a) provide the competent authority with evidence of their compliance with paragraph

1 in the manner that the competent authority requires, taking account of the nature

and size of the food business;

(a) 考慮食品業之性質與規模，依權責機關需要之模式，對權責機關提出符合第一段之證據；

(b) ensure that any documents describing the procedures developed in accordance

with this Article are up-to-date at all times;

(b) 確認任何依據本文描述之發展的程序文件在任何時候都是最新的；

(c) retain any other documents and records for an appropriate period.

(c) 保存任何其他的文件與紀錄到適當之期限。

5. Detailed arrangements for the implementation of this Article may be laid down in

accordance with the procedure referred to in Article 14(2). Such arrangements may

facilitate the implementation of this Article by certain food business operators, in

particular by providing for the use of procedures set out in guides for the

application of HACCP principles, in order to comply with paragraph 1. Such

arrangements may also specify the period during which food business operators

shall retain documents and records in accordance with paragraph 4(c).

5. 本文之執行細節可依據第14(2)所述之程序來訂定。該文可促進灌輸此法規，尤其提供業者為符合第一段HACCP原則之應用。該細節亦可指定食品業者依據第四段(c)應保留文件與紀錄之期限。

Article 6

第6

17

Official controls, registration and approval

官方管制、認證與核可

1. Food business operators shall cooperate with the competent authorities in

accordance with other applicable Community legislation or, if it does not exist,

with national law.

1. 食品業者應依據其他適用之法規與權責機關合作，若該區域無此法規依據，則以國家法規為主。

2. In particular, every food business operator shall notify the appropriate competent

authority, in the manner that the latter requires, of each establishment under its

control that carries out any of the stages of production, processing and distribution

of food, with a view to the registration of each such establishment.

2. 尤其在權責機關的要求下，在生產、加工、運送的任何階段，食品業者應該通知相關之權責機關。

Food business operators shall also ensure that the competent authority always has

up-to-date information on establishments, including by notifying any significant

change in activities and any closure of an existing establishment.

食品業者亦應確保權責機關掌握廠場最新的資訊，包括通報生產活動之任何顯著改變及現存廠場關閉。

3. However, food business operators shall ensure that establishments are approved by

the competent authority, following at least one on-site visit, when approval is

required:

3. 然而，當食品業者應確保廠場被權責機關核可，且在若需核可時，要求廠場每年至少有一次的現場訪查：

(a) under the national law of the Member State in which the establishment is located;

(a) 依據廠場所在之會員國之國家法律；

(b) under Regulation (EC) No 853/2004;

(b) 依據Regulation(EC) No 853/2004；

or

(c) by a decision adopted in accordance with the procedure referred to in Article

14(2).

18

(c) 透過依據第14(2)所提程序之決議

Any Member State requiring the approval of certain establishments located on its

territory under national law, as provided for in subparagraph (a), shall inform the

Commission and other Member States of the relevant national rules.

依照上述(a)段之國家法律，要求會員國核可設立於其領土之特定廠場時，應通知執委會及其他有相關法令之會員國。

CHAPTER III

第III章

GUIDES TO GOOD PRACTICE

良好規範指引

Article 7

第7

Development, dissemination and use of guides

指引之發展、宣導及使用

Member States shall encourage the development of national guides to good practice

for hygiene and for the application of HACCP principles in accordance with Article 8.

Community guides shall be developed in accordance with Article 9.

會員國應依據第8法規鼓勵發展食品衛生及HACCP原則應用之國家衛生良好作業指引。歐盟指引則應依據第9發展。

The dissemination and use of both national and Community guides shall be

encouraged. Nevertheless, food business operators may use these guides on a

voluntary basis.

國家與歐盟指引之宣導和使用應該被鼓勵。雖然如此，食品業者可基於自願使用這些指引。

Article 8

第8

National guides

國家指引

1. When national guides to good practice are developed, they shall be developed and

disseminated by food business sectors:

1. 當發展國家指引良好規範時，食品業應發展及傳播其指引︰

19

(a) in consultation with representatives of parties whose interests may be substantially

affected, such as competent authorities and consumer groups;

(a) 與其權益可能受影響之團體代表協商，如權責機關與消費者團體；

(b) having regard to relevant codes of practice of the Codex Alimentarius;

(b) 考慮國際法規之相關規範；

and

(c) when they concern primary production and those associated operations listed in

Annex I, having regard to the recommendations set out in Part B of Annex I.

(c) 當其涉及附件 I所列之初級生產與相關作業時，參考附件I part B所訂之建議。

2. National guides may be developed under the aegis of a national standards institute

referred to in Annex II to Directive 98/34/EC (1).

2. 國家指引可在Directive 98/34/EC(1)附件II所提之國家標準協會支持下發展。

3. Member States shall assess national guides in order to ensure that:

3. 會員國應評估國家指引以確保︰

(a) they have been developed in accordance with paragraph 1;

(a) 其依據第一段發展；

(b) their contents are practicable for the sectors to which they refer;

(b)對其所提及之產業，其內容為可行的；

and

(c) they are suitable as guides to compliance with Articles 3, 4 and 5 in the sectors and

for the foodstuffs covered.

(c) 其適用為符合第3、4和5之產業及所涵蓋食材之指引。

4. Member States shall forward to the Commission national guides complying with

the requirements of paragraph 3. The Commission shall set up and run a

registration system for such guides and make it available to Member States.

4. 會員國應遞送符合第三段要求之國家指引給執委會。執委會應建立並運作此類指引之認證登錄系統，並讓會員國取得此指引。

20

5. Guides to good practice drawn up pursuant to Directive 93/43/EEC shall continue

to apply after the entry into force of this Regulation, provided that they are

compatible with its objectives.

5. 良好規範指引之草擬，依據歐盟指令 93/43/EEC，在規章生效後，應在不影響其目標下繼續使用。

Article 9

第9

Community guides

歐盟指引

1. Before Community guides to good practice for hygiene or for the application of the

HACCP principles are developed, the Commission shall consult the Committee

referred to in Article 14. The objective of this consultation shall be to consider the

case for such guides, their scope and subject matter.

1. 在衛生或HACCP原則採用之歐盟良好規範指引的發展之前，執委會應與14所述之委員會協商。協商之目的應考慮上述指引其範圍與其主題。

2. When Community guides are prepared, the Commission shall ensure that they are

developed and disseminated:

2. 當歐盟指引制訂完成，執委會應確認指引可被發展並宣導︰

(a) by or in consultation with appropriate representatives of European food business

sectors, including SMEs, and other interested parties, such as consumer groups;

(a) 和歐洲合適之食品業代表協商，包括中小型企業與其他營利團體，像是消費者團體；

(b) in collaboration with parties whose interests may be substantially affected,

including competent authorities;

(b) 與其權益可能受影響之團體合作，包括權責機關；

(c) having regard to relevant codes of practice of the Codex Alimentarius;

(c) 考慮國際法規相關守則；

and

21

(d) when they concern primary production and those associated operations listed in

Annex I, having regard to the recommendations set out in Part B of Annex I.

(d) 當其關心列在附錄I之初級生產及相關運作時，考慮附錄I B部分提到之建議。

3. The Committee referred to in Article 14 shall assess draft Community guides in

order to ensure that:

3. 第14所述之執委會應評估歐盟指引草案以確認：

(a) they have been developed in accordance with paragraph 2;

(a) 該指引已依據第二段發展；

(b) their contents are practicable for the sectors to which they refer throughout the

Community;

(b) 該指引內容對於其產業在整個歐盟是確實可行的；

and

(c) they are suitable as guides to compliance with Articles 3, 4 and 5 in the sectors and

for the foodstuffs covered.

(c)依照涵括食品部分的第三、四、五，如同指引一樣，是適合的。

4. The Commission shall invite the Committee referred to in Article 14 periodically to

review any Community guides prepared in accordance with this Article, in

cooperation with the bodies mentioned in paragraph 2.

4. 執委會應與第二段所述之團體合作，定期邀請第14所述之委員會審查本例制定之任何歐盟指引。

The aim of this review shall be to ensure that the guides remain practicable and to

take account of technological and scientific developments.

此審查目的應確保指引維持為確實可行，並配合技術與科學上之發展。

5. The titles and references of Community guides prepared in accordance with this

Article shall be published in the C series of the Official Journal of the European

Union.

5. 依據本制定之歐盟指引之標題及參考應公告於歐盟官方期刊之C系列上。

CHAPTER IV

22

第IV章

IMPORTS AND EXPORTS

進口與出口

Article 10

第10

Imports

進口

As regards the hygiene of imported food, the relevant requirements of food law

referred to in Article 11 of Regulation (EC) No 178/2002 shall include the

requirements laid down in Articles 3 to 6 of this Regulation.

關於進口食品之衛生參照規章(EC) No 178/2002第11中提及之相關食品法律要求，應包括本法第3到6之要求。

Article 11

第11

Exports

出口

As regards the hygiene of exported or re-exported food, the relevant requirements of

food law referred to in Article 12 of Regulation (EC) No 178/2002 shall include the

requirements laid down in Articles 3 to 6 of this Regulation.

關於出口或再出口食品之衛生，參照Regulation (EC) No 178/2002(EC)第12所提之食品法律相關之要求，應包括本法第3到第6之要求。

CHAPTER V

第V章

FINAL PROVISIONS

最終款

Article 12

第12

Implementing measures and transitional arrangements

執行措施與過渡期之安排

Implementing measures and transitional arrangements may be laid down in

23

accordance with the procedure referred to in Article 14(2).

執行措施與過渡期之安排可依據第14第2點之程序制定。

Article 13

第13

Amendment and adaptation of Annexes I and II

附件I與II之修正與改編

1. Annexes I and II may be adapted or updated in accordance with the procedure

referred to in Article 14(2), taking into account:

1. 附件I與II可依據第14( 2 )之程序並考慮下列因素採用或更新︰

(a) the need to revise the recommendations set out in Annex I, Part B, paragraph 2;

(a) 需要修正附件I、B部分、第二段之建議；

(b) the experience gained from the implementation of HACCP-based systems

pursuant to Article 5;

(b) 依第5以HACCP為基礎之系統實施所獲得之經驗；

(c) technological developments and their practical consequences and consumer

expectations with regard to food composition;

(c) 關於食品組成技術之發展與其實際結果，及消費者之期待；

(d) scientific advice, particularly new risk assessments;

(d) 科學建議，特別是新的風險評估；

(e) microbiological and temperature criteria for foodstuffs.

(e) 食品之微生物與溫度管制標準；

2. Derogations from Annexes I and II may be granted, in particular in order to

facilitate the implementation of Article 5 for small businesses, in accordance with

the procedure referred to in Article 14(2), taking into account the relevant risk

factors, provided that such derogations do not affect the achievement of the

objectives of this Regulation.

2. 依據第14(2)之程序考慮相關風險因素，可排除附件I與II之規定。尤其為了對小型企業實施第5款，考慮相關風險因子，此規定排除不影響本法之目標。

24

3. Member States may, without compromising achievement of the objectives of this

Regulation, adopt, in accordance with paragraphs 4 to 7 of this Article, national

measures adapting the requirements laid down in Annex II.

3. 會員國可在不損害本法目標之實現，依據本文第四到七段改編附件II之要求而採用國家措施。

4. (a) The national measures referred to in paragraph 3 shall have the aim of:

4. (a) 在第三段所指之國家措施應符下列目的︰

(i) enabling the continued use of traditional methods, at any of the stages of

production, processing or distribution of food;

(i) 促使食品生產、加工處理或運輸之各階段可繼續利用傳統方法。

or

(ii) accommodating the needs of food businesses situated in regions that are

subject to special geographical constraints.

(ii) 協助地理環境受限制之食品業者之需要。

(b) In other cases, they shall apply only to the construction, layout and equipment

of establishments.

(b) 在其他狀況下，應只應用於廠場之建築、配置與設備。

5. Any Member State wishing to adopt national measures as referred to in paragraph 3

shall notify the Commission and other Member States. The notification shall:

5. 任何希望採用第三段所指之國家措施之歐盟會員國，應通知執委會與其他會員國。其通知應︰

(a) provide a detailed description of the requirements that that Member State

considers need to be adapted and the nature of the adaptation sought;

(a) 對於會員國所考慮需被改編之措施與其改編該措施之本質應有詳細之描述；

(b) describe the foodstuffs and establishments concerned;

(b) 描述食品與廠場關注的；

(c) explain the reasons for the adaptation, including, where relevant, by providing a

25

summary of the hazard analysis carried out and any measures to be taken to ensure

that the adaptation will not compromise the objectives of this Regulation;

(c) 闡述改編之原因，包含提供完成危害分析的摘要與任何採取之措施以確保其改編不會損及本法之目標達成。

and

(d) give any other relevant information.

(d) 及任何相關之資訊。

6. The other Member States shall have three months from the receipt of a notification

referred to in paragraph 5 to send written comments to the Commission. In the case

of the adaptations arising from paragraph 4(b), this period shall, at the request of

any Member State, be extended to four months. The Commission may, and when it

receives written comments from one or more Member States shall, consult Member

States within the committee referred to in Article 14(1). The Commission may

decide, in accordance with the procedure referred to in Article 14(2), whether the

envisaged measures may be implemented, subject, if necessary, to appropriate

amendments. Where appropriate, the Commission may propose general measures

in accordance with paragraph 1 or 2.

6. 其他會員國應於接到第五段所指之通知後，在3個月的時間內提出書面意見給執委會。至於在第4(b)段之改編，在會員國的要求下，此期間延長為4個月。委員會在收到14(1)內提到的一個或多個會員國的書面意見時，應該與會員國協商。依14(2)的程序，委員會可決議設想計畫是否可以執行的措施、目標，如果必要時，進行當的修正。在適當時，委員會可依照第1、2段提出一般措施。

7. A Member State may adopt national measures adapting the requirements of Annex

II only:

7. 會員國只可於以下情況時，改編附件II之要求，實施國家之管理措施：

(a) in compliance with a decision adopted in accordance with paragraph 6;

(a) 符合第六段要求所採用之決定；

or

(b) if, one month after the expiry of the period referred to in paragraph 6, the

Commission has not informed Member States that it has received written

comments or that it intends to propose the adoption of a decision in accordance

26

with paragraph 6.

(b) 如果，第六段提到的終止期之後的一個月，執委會並未通知會員國接到書面

意見或是準備提出依第六段要求所採用之決定。

Article 14

第14

Committee procedure

執委會程序

1. The Commission shall be assisted by the Standing Committee on the Food Chain

and Animal Health.

1. 執委會應由常務委員會進行食物鏈與動物衛生之協助。

2. Where reference is made to this paragraph, Articles 5 and 7 of Decision

1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.

2. 參考此段1999/468/EC第5與第7的決議，並且考量其中第8之規定。

The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three

months.

依據Decision 1999/468/EC中第5( 6 )中規定將限定於在三個月內。

3. The Committee shall adopt its Rules of Procedure.

3. 委員會應採用程序之規定。

Article 15

第15

Consultation of the European Food Safety Authority

歐洲食品安全局(EFSA)之諮詢

The Commission shall consult the European Food Safety Authority on any matter

falling within the scope of this Regulation that could have a significant impact on

public health and, in particular, before proposing criteria, requirements or targets in

accordance with Article 4(4).

依照第4(4)，尤其是在標準、要求或目標提出之前，委員會應該歐洲食品安全局(EFSA)諮詢關於在此規章內，會影響公共衛生者。

Article 16

第16

27

Report to the European Parliament and the Council

向歐洲議會與執委會報告

1. The Commission shall, not later than 20 May 2009, submit a report to the European

Parliament and the Council.

略

2. The report shall, in particular, review the experience gained from the application of

this Regulation and consider whether it would be desirable and practicable to

provide for the extension of the requirements of Article 5 to food business operators

carrying out primary production and those associated operations listed in Annex I.

略

3. The Commission shall, if appropriate, accompany the report with relevant

proposals.

略

Article 17

第17

Repeal

廢止

1. Directive 93/43/EEC shall be repealed with effect from the date of application of

this Regulation.

1. Directive 93/43/EEC 於本法生效日之後將被廢止。

2. References to the repealed Directive shall be construed as being made to this

Regulation.

2. 廢止指令應對本法做解釋。

3. However, decisions adopted pursuant to Articles 3(3) and 10 of Directive

93/43/EEC shall remain in force pending their replacement by decisions adopted in

accordance with this Regulation or Regulation (EC) No 178/2002. Pending the

setting of the criteria or requirements referred to in Article 4(3)(a) to (e) of this

Regulation, Member States may maintain any national rules establishing such

criteria or requirements that they had adopted in accordance with Directive

93/43/EEC.

3. 依照指令93/43/EEC第3(3)與第10的決議，在取代歐盟規章No 178/2002的期間，本法依然有效。在本規第4 (3) (a)到(e)設定標準或要求的期間，依 28

據歐盟指令93/43/EEC，會員國可以維持他們所採用之國家法規，例如標準或要求。

將依據本法或Regulation (EC)替換期間之決定繼續有效。依本法要求設定之標準

4. Pending the application of new Community legislation laying down rules for

official controls on food, Member States shall take all appropriate measures to

ensure the fulfillment of the obligations laid down in or under this Regulation.

4. 在食品上擬定官方管制規章之新歐盟法施用前，會員國應採取適當之措施確保本法規定義務之履行。

Article 18

第18

Entry into force

生效

This Regulation shall enter into force on the 20th day after that of its publication in

the Official Journal of the European Union.

略

It shall apply 18 months after the date on which all of the following acts have entered

into force:

(a) Regulation (EC) No 853/2004;

(b) Regulation (EC) No 854/2004 of the European Parliament and of the Council of

29 April 2004 laying down specific rules for the organisation of official controls on

products of animal origin intended for human consumption (1);

略

and

(c) Directive 2004/41/EC of the European Parliament and of the Council of 21 April

2004 repealing certain directives concerning food hygiene and health conditions

for the production and placing on the market of certain products of animal origin

intended for human consumption (2).

However, it shall apply no earlier than 1 January 2006.

This Regulation shall be binding in its entirety and directly applicable in all Member

States.

Done at Strasbourg, 29 April 2004.

29

For the European Parliament

The President

P. COX

For the Council

The President

P. M. McDOWELL

30

ANNEX I

附件 I

PRIMARY PRODUCTION

初級生產

PART A: GENERAL HYGIENE PROVISIONS FOR PRIMARY PRODUCTION

AND ASSOCIATED OPERATIONS

Part A：初級生產和相關作業之一般衛生規定

I. Scope

I. 範圍

1. This Annex applies to primary production and the following associated operations:

1. 本附件適用於初級生產和其相關作業之衛生要求：

(a) the transport, storage and handling of primary products at the place of production,

provided that this does not substantially alter their nature;

(a) 初級產品在其產地之運輸、儲存與處理上不應改變產品原有之本質；

(b) the transport of live animals, where this is necessary to achieve the objectives of

this Regulation;

(b) 為達到本法之目標，必要時以活體動物運輸；

and

(c) in the case of products of plant origin, fishery products and wild game, transport

operations to deliver primary products, the nature of which has not been

substantially altered, from the place of production to an establishment.

(c) 如為植物產品、漁產品和野味，從產地運送到廠場之初級產品的運輸作業，不應改變產品原有之本質。

II. Hygiene provisions

II. 衛生規定

2. As far as possible, food business operators are to ensure that primary products are

protected against contamination, having regard to any processing that primary

products will subsequently undergo.

2. 食品業者應盡可能確保初級產品之後續處理不會造成產品污染。

31

3. Notwithstanding the general duty laid down in paragraph 2, food business operators

are to comply with appropriate Community and national legislative provisions

relating to the control of hazards in primary production and associated operations,

including:

3. 雖然第二段已規範食品業者之一般責任，但食品業者也應適當的遵循歐盟與國家對初級生產及其相關作業危害管制之相關法令，包括︰

(a) measures to control contamination arising from the air, soil, water, feed, fertilisers,

veterinary medicinal products, plant protection products and biocides and the

storage, handling and disposal of waste;

(a) 控制來自空氣、土壤、水、飼料、肥料、獸醫藥用產品、農藥、殺蟲劑的污染以及廢棄物於儲存、處理和丟棄的措施；

and

(b) measures relating to animal health and welfare and plant health that have

implications for human health, including programmes for the monitoring and

control of zoonoses and zoonotic agents.

(b) 應建立對人類健康造成影響之相關動物衛生、健康與植物衛生之管制辦法，包括人畜共同傳染病與人畜共同傳染病傳染媒介之監控與管制計畫。

4. Food business operators rearing, harvesting or hunting animals or producing

primary products of animal origin are to take adequate measures, as appropriate:

4. 食品業者飼養、捕獲或獵取動物或生產動物性初級產品時，應採取適當之措施︰

(a) to keep any facilities used in connection with primary production and associated

operations, including facilities used to store and handle feed, clean and, where

necessary after cleaning, to disinfect them in an appropriate manner;

(a) 任何有關初級生產和作業之設施應保持乾淨，包括用來儲存和處理飼料之設施，在清潔之後，必要時以適當方式消毒；

(b) to keep clean and, where necessary after cleaning, to disinfect, in an appropriate

manner, equipment, containers, crates, vehicles and vessels;

(b) 設備、容器、魚箱、車輛和船應保持乾淨，必要時於清潔後予以消毒；

(c) as far as possible to ensure the cleanliness of animals going to slaughter and,

where necessary, production animals;

32

(c) 包括生產時，儘可能確保準備要屠宰之動物的清潔；

(d) to use potable water, or clean water, whenever necessary to prevent contamination;

(d) 使用飲用水或乾淨的水以防止污染；

(e) to ensure that staff handling foodstuffs are in good health and undergo training on

health risks;

(e) 確保人員處理食品是健康的並進行衛生風險的教育訓練；

(f) as far as possible to prevent animals and pests from causing contamination;

(f) 儘可能防止動物與病媒引起污染；

(g) to store and handle waste and hazardous substances so as to prevent

contamination;

(g) 廢棄物與危險物品之儲存和處理以防止污染；

(h) to prevent the introduction and spread of contagious diseases transmissible to

humans through food, including by taking precautionary measures when

introducing new animals and reporting suspected outbreaks of such diseases to the

competent authority;

(h) 避免人畜共通傳染病經由食品傳入和傳撥，包括當新動物引進時採取之預防措施和有可疑疾病爆發疑慮時，應向相關權責機關通報；

(i) to take account of the results of any relevant analyses carried out on samples taken

from animals or other samples that have importance to human health;

(i) 應考量動物樣品或其他對人類健康有重要影響之樣品所進行之任何相關分析結果；

and

(j) to use feed additives and veterinary medicinal products correctly, as required by

the relevant legislation.

(j) 依相關法令正確地使用飼料添加物和獸醫藥用產品。

5. Food business operators producing or harvesting plant products are to take

adequate measures, as appropriate:

5. 食品業者生產或收獲植物產品時應採取之適當措施︰

33

(a) to keep clean and, where necessary after cleaning, to disinfect, in an appropriate

manner, facilities, equipment, containers, crates, vehicles and vessels;

(a) 設備、容器、箱子、車輛和船應保持乾淨，必要時於清潔後予以消毒；

(b) to ensure, where necessary, hygienic production, transport and storage conditions

for, and the cleanliness of, plant products;

(b) 植物性產品應採衛生之生產、運輸與儲存方式生產；

(c) to use potable water, or clean water, whenever necessary to prevent contamination;

(c) 使用飲用水或乾淨的水以防止污染；

(d) to ensure that staff handling foodstuffs are in good health and undergo training on

health risks;

(d) 確保處理食品人員之健康並進行衛生風險之訓練；

(e) as far as possible to prevent animals and pests from causing contamination;

(e) 儘可能防止動物與病媒引起之污染；

(f) to store and handle wastes and hazardous substances so as to prevent

contamination;

(f) 儲存處理垃圾和危險物品時應防止污染；

(g) to take account of the results of any relevant analyses carried out on samples taken

from plants or other samples that have importance to human health;

(g) 考慮完成植物樣品或對人體健康有重要性的樣品之任何相關分析的結果。

and

(h) to use plant protection products and biocides correctly, as required by the relevant

legislation.

(h) 依法正確地使用植物防護性產品與殺蟲劑。

6. Food business operators are to take appropriate remedial action when informed of

problems identified during official controls.

6. 當官方執行管控時，當食品業者被通知鑑定有問題時，採取適當之補救措施。

III. Record-keeping

III. 保留記錄

34

7. Food business operators are to keep and retain records relating to measures put in

place to control hazards in an appropriate manner and for an appropriate period,

commensurate with the nature and size of the food business.

Food business operators are to make relevant information contained in these

records available to the competent authority and receiving food business operators

on request.

7. 食品業者應與食品業的性質及規模等，適當及適時的保留及持續紀錄關於危害管控措施。食品業者紀錄包括讓權責機關與食品業者接受的相關訊息。

8. Food business operators rearing animals or producing primary products of animal

origin are, in particular, to keep records on:

8. 食品業者如飼養動物或生產動物性初級產品，應保留以下記錄︰

(a) the nature and origin of feed fed to the animals;

(a) 餵飼動物之飼料其本質與來源；

(b) veterinary medicinal products or other treatments administered to the animals,

dates of administration and withdrawal periods;

(b) 獸醫用藥或其他對動物的處理，包括施藥日期與停藥日期；

(c) the occurrence of diseases that may affect the safety of products of animal origin;

(c) 疾病的發生可能影響動物性產品的安全；

(d) the results of any analyses carried out on samples taken from animals or other

samples taken for diagnostic purposes, that have importance for human health;

(d) 對人類健康有重大影響之動物或其他樣品所進行之診斷分析結果；

and

(e) any relevant reports on checks carried out on animals or products of animal origin.

(e) 在動物或動物性產品上完成之任何相關查核報告。

9. Food business operators producing or harvesting plant products are, in particular, to

keep records on:

9. 食品業者生產或收穫植物性產品，特別應保留以下記錄︰

(a) any use of plant protection products and biocides;

(a) 防護性產品與殺蟲劑之使用；

35

(b) any occurrence of pests or diseases that may affect the safety of products of plant

origin;

(b) 可能影響植物性產品安全性之病媒或疾病的任何事件；

and

(c) the results of any relevant analyses carried out on samples taken from plants or

other samples that have importance to human health.

(c) 任何相關於植物或其他對人類健康有重大影響樣品的分析結果

10. The food business operators may be assisted by other persons, such as

veterinarians, agronomists and farm technicians, with the keeping of records.

10. 食品業者可能經由其他人，例如獸醫、農藝學家與農場技師的幫助保持記錄。

PART B: RECOMMENDATIONS FOR GUIDES TO GOOD HYGIENE PRACTICE

Part B：良好衛生規範建議

1. National and Community guides referred to in Articles 7 to 9 of this Regulation

should contain guidance on good hygiene practice for the control of hazards in

primary production and associated operations.

1. 本規章第7到9提到之國家及聯盟的指引，應包括對初級生產及其相關作業之危害管控的良好衛生規範指引。

2. Guides to good hygiene practice should include appropriate information on hazards

that may arise in primary production and associated operations and actions to

control hazards, including relevant measures set out in Community and national

legislation or national and Community programmes. Examples of such hazards and

measures may include:

2. 良好衛生規範的指引應包括關於初級生產、相關作業及危害管控的訊息，包括歐盟與各國法律或國家與歐盟的計畫。此危害之例子可能包括︰

(a) the control of contamination such as mycotoxins, heavy metals and radioactive

material;

(a) 管制污染(如黴菌毒素、重金屬以及放射性物質)；

(b) the use of water, organic waste and fertilisers;

(b) 水的使用、有機廢物與肥料；

36

(c) the correct and appropriate use of plant protection products and biocides and their

traceability;

(c) 正確與適當使用植物防護性產品與殺蟲劑並應具追溯性；

(d) the correct and appropriate use of veterinary medicinal products and feed additives

and their traceability;

(d) 正確與適當使用獸醫用藥產品與飼料添加物並應具追溯性；

(e) the preparation, storage, use and traceability of feed;

(e) 飼料之製備、儲存、使用與追溯性；

(f) the proper disposal of dead animals, waste and litter;

(f) 死亡動物與廢棄物之適當處理；

(g) protective measures to prevent the introduction of contagious diseases

transmissible to humans through food, and any obligation to notify the competent

authority;

(g) 防止食品經由接觸傳染至人類之防護措施，一旦發生應告知權責機關；

(h) procedures, practices and methods to ensure that food is produced, handled,

packed, stored and transported under appropriate hygienic conditions, including

effective cleaning and pest-control;

(h) 程序、規範與方法確保食品生產、處理、包裝、儲存與運輸皆於適當之衛生狀況下作業，包括有效之清潔與病媒防治；

(i) measures relating to the cleanliness of slaughter and production animals;

(i) 有關屠宰與生產動物之清潔措施；

(j) measures relating to record-keeping.

(j) 記錄保留之措施。

37

ANNEX II

附件 II

GENERAL HYGIENE REQUIREMENTS FOR ALL FOOD BUSINESS

OPERATORS

(EXCEPT WHEN ANNEX I APPLIES)

食品業者一般衛生要求(附件I適用者除外)

INTRODUCTION

序言

Chapters V to XII apply to all stages of production, processing and distribution of

food and the remaining Chapters apply as follows:

第V到XII章適用於生產、加工與運輸等所有之階段，其他章節適用如下︰

- Chapter I applies to all food premises, except premises to which Chapter III applies

－ 除了第III章適用之營業場所外，其他所有之食品營業場所皆適用於第I章

- Chapter II applies to all rooms where food is prepared, treated or processed, except

dining areas and premises to which Chapter III applies

－ 第II章適用於所有食品製備、處理或加工場所，除了第III章適用的用餐區與營業場所

- Chapter III applies to those premises listed in the heading to the Chapter

－ 第III章適用於列在本章標題裡之營業場所

- Chapter IV applies to all transportation.

－ 第IV章適用於所有的運輸

CHAPTER I

第I章

General requirements for food premises (other than those specified in chapter iii)

食品營業場所之一般要求(除了第III章提及之外)

1. Food premises are to be kept clean and maintained in good repair and condition.

1. 食品營業場所保持乾淨並保持良好維護狀態。

2. The layout, design, construction, siting and size of food premises are to:

2. 食品營業場所之廠房安排、設計、建造、位置與規模應︰

38

(a) permit adequate maintenance, cleaning and/or disinfection, avoid or minimise

air-borne contamination, and provide adequate working space to allow for the

hygienic performance of all operations;

(a) 允許適當之維修、清潔與/或消毒，避免或減少空氣污染，使所有衛生操作執行。

(b) be such as to protect against the accumulation of dirt, contact with toxic materials,

the shedding of particles into food and the formation of condensation or

undesirable mould on surfaces;

(b) 能夠防止灰塵的累積、與有毒材料接觸、避免微粒掉到食品及表面上之凝結，或不良黴菌之形成；

(c) permit good food hygiene practices, including protection against contamination

and, in particular, pest control;

(c) 許可良好食品衛生規範，包括對污染之防護，尤其是病媒防治；

and

(d) where necessary, provide suitable temperature-controlled handling and storage

conditions of sufficient capacity for maintaining foodstuffs at appropriate

temperatures and designed to allow those temperatures to be monitored and,

where necessary, recorded.

(d) 必要的話，提供適當溫度控制與儲存狀況，使食品能維持在適當溫度，且設計讓這些食物的溫度可以監測，必要時予以記錄。

3. An adequate number of flush lavatories are to be available and connected to an

effective drainage system. Lavatories are not to open directly into rooms in which

food is handled.

3. 提供足量之洗手間與有效之排水系統，洗手間門不可直接開向食品作業場所。

4. An adequate number of washbasins is to be available, suitably located and

designated for cleaning hands. Washbasins for cleaning hands are to be provided

with hot and cold running water, materials for cleaning hands and for hygienic

drying. Where necessary, the facilities for washing food are to be separate from the

hand-washing facility.

4. 提供足量之洗手槽，設置位置必須易於清潔手部。洗手槽應配有熱水與冷水，並提供清洗手部之材料與擦乾之用具。必要的話，清洗食品之設備與洗手之設備必須分開。

39

5. There is to be suitable and sufficient means of natural or mechanical ventilation.

Mechanical airflow from a contaminated area to a clean area is to be avoided.

Ventilation systems are to be so constructed as to enable filters and other parts

requiring cleaning or replacement to be readily accessible.

5. 需備有合適之自然或機械通風設備。避免氣流由污染區到清潔區。通風系統的建構，讓過濾器與其他需要清理或更換的部分可得到使用。

6. Sanitary conveniences are to have adequate natural or mechanical ventilation.

6. 衛生方便性必須要有適當之自然或機器通風設備。

7. Food premises are to have adequate natural and/or artificial lighting.

7. 食品營業場所須有足夠之自然與/或人工照明。

8. Drainage facilities are to be adequate for the purpose intended. They are to be

designed and constructed to avoid the risk of contamination. Where drainage

channels are fully or partially open, they are to be so designed as to ensure that

waste does not flow from a contaminated area towards or into a clean area, in

particular an area where foods likely to present a high risk to the final consumer are

handled.

8. 排水須能達到其目的。設計與建造是為了避免汙染危害之發生。排水設備完全或部分開放之設計需可確保廢水不會從污染區流進清潔區，特別是對於那些有可能對最終消費者存在高危害性的食品處理區域。

9. Where necessary, adequate changing facilities for personnel are to be provided.

9. 必要的話可為員工更換適當之設備。

10. Cleaning agents and disinfectants are not to be stored in areas where food is

handled.

10. 清潔劑與消毒劑不應被存放於食物製備區。

CHAPTER II

第II章

Specific requirements in rooms where foodstuffs are prepared, treated or

processed (excluding dining areas and those premises specified in chapter III)

在食品製備、處理、加工流程所需之特殊空間要求 (除了第III章所提及之用餐區與營業場所)

1. In rooms where food is prepared, treated or processed (excluding dining areas and

those premises specified in Chapter III, but including rooms contained in means of

40

transport) the design and layout are to permit good food hygiene practices,

including protection against contamination between and during operations. In

particular:

1. 在食品製備、處理、加工流程所需之場所(除了第III章所提及之用餐區與

業場所，但包括運輸場所) 設計與安排須遵守良好食品衛生規範，

包括防止操作期間的污染。尤其是︰

(a) floor surfaces are to be maintained in a sound condition and be easy to clean and,

where necessary, to disinfect. This will require the use of impervious,

non-absorbent, washable and non-toxic materials unless food business operators

can satisfy the competent authority that other materials used are appropriate.

Where appropriate, floors are to allow adequate surface drainage;

(a) 地板表面需保持完好狀態並易於清潔，必要時應消毒。需使用非滲透、非吸收性、可洗及無毒之材料，除非食品業者能讓權責機關同意所使用之材料是合適的。合適的地方，地面允許適當表面排水；

(b) wall surfaces are to be maintained in a sound condition and be easy to clean and,

where necessary, to disinfect. This will require the use of impervious,

non-absorbent, washable and non-toxic materials and require a smooth surface up

to a height appropriate for the operations unless food business operators can satisfy

the competent authority that other materials used are appropriate;

(b) 牆壁表面保持完好狀態並易於清潔，必要時須消毒。需使用非滲透、非吸收性、可洗及無毒之材料，且需適當作業高度之平滑表面，除非食品業者能讓權責機關同意其他使用之材料是合適的。

(c) ceilings (or, where there are no ceilings, the interior surface of the roof) and

overhead fixtures are to be constructed and finished so as to prevent the

accumulation of dirt and to reduce condensation, the growth of undesirable mould

and the shedding of particles;

(c) 天花板(或沒有天花板，為屋頂之內部表面) 與上面固定物的建構應以防止灰塵累積並減少凝結、黴菌生長、及微粒遮擋；

(d) windows and other openings are to be constructed to prevent the accumulation of

dirt. Those which can be opened to the outside environment are, where necessary,

to be fitted with insect-proof screens which can be easily removed for cleaning.

Where open windows would result in contamination, windows are to remain

closed and fixed during production;

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(d) 窗戶與其他設施應避免灰塵累積。窗戶必須可向外打開，如果必要，需加裝易拆下清理之防蚊蠅飛入的紗窗。窗戶打開的地方若會導致污染。在食品生產過程中，窗戶必須緊閉；

(e) doors are to be easy to clean and, where necessary, to disinfect. This will require

the use of smooth and nonabsorbent surfaces unless food business operators can

satisfy the competent authority that other materials used are appropriate;

(e) 門必須是容易清洗的，如果必要，進行消毒。門必須使用光滑且非吸收性之表面，除非食品業者能讓權責機關同意所使用的其他材料是合適的；

and

(f) surfaces (including surfaces of equipment) in areas where foods are handled and in

particular those in contact with food are to be maintained in a sound condition and

be easy to clean and, where necessary, to disinfect. This will require the use of

smooth, washable corrosion-resistant and non-toxic materials, unless food

business operators can satisfy the competent authority that other materials used

are appropriate.

(f)食品處理區表面(包括設備的表面)，尤其與食品接觸之食品處理區表面需維持在完善的情況，且必須易於清潔，必要的話可消毒。必須使用光滑、可清洗之抗腐蝕與無毒之材料，除非食品業者能讓權責機關同意所使用的其他材料是合適的。

2. Adequate facilities are to be provided, where necessary, for the cleaning,

disinfecting and storage of working utensils and equipment. These facilities are to

be constructed of corrosion-resistant materials, be easy to clean and have an

adequate supply of hot and cold water.

2. 必要時提供適當操作設備做為清洗、消毒及作業用器皿與設備的儲存。這些設備由抗腐蝕材料構成，易於清潔並供應熱水與冷水。

3. Adequate provision is to be made, where necessary, for washing food. Every sink or

other such facility provided for the washing of food is to have an adequate supply

of hot and/or cold potable water consistent with the requirements of Chapter VII

and be kept clean and, where necessary, disinfected.

3. 必要時，提供足夠之洗滌槽以清洗食物。每個洗滌槽或做為清洗食品之設備應供應符合第VII章要求之熱與/或冷飲用水，必要時進行消毒。

CHAPTER III

42

第III章

Requirements for movable and/or temporary premises (such as marquees,

market stalls, mobile sales vehicles), premises used primarily as a private

dwelling-house but where foods are regularly prepared for placing on the market

and vending machines

移動式、臨時營業場所(例如路邊攤、市場攤位、移動之販售車輛)之要求，營業場所最初主要為私人住宅，但經常做為食品上市及在自動販賣機販售之製備場所

1. Premises and vending machines are, so far as is reasonably practicable, to be so

sited, designed, constructed and kept clean and maintained in good repair and

condition as to avoid the risk of contamination, in particular by animals and pests.

1. 營業場所與自動販賣機，就目前為止是合理且確實可行時，其裝置位置、設計、建構且保持乾淨並維持良好修復，且是避免污染風險的狀態，特別是對動物及昆蟲。

2. In particular, where necessary:

2. 尤其，必要的話︰

(a) appropriate facilities are to be available to maintain adequate personal hygiene

(including facilities for the hygienic washing and drying of hands, hygienic sanitary

arrangements and changing facilities);

(a) 適當之設備能夠維持適當之個人衛生(包括衛生洗手及烘手設備、健康衛生及更換設備) ;

(b) surfaces in contact with food are to be in a sound condition and be easy to clean

and, where necessary, to disinfect. This will require the use of smooth, washable,

corrosion-resistant and non-toxic materials, unless food business operators can

satisfy the competent authority that other materials used are appropriate;

(b) 與食品接觸之表面是完整且容易清洗的，必要時予以消毒。表面將要求使用光滑、可清洗、抗腐蝕及無毒性之物質，除非食品業者能讓權責機關同意使用其他之材料是合適的；

(c) adequate provision is to be made for the cleaning and, where necessary,

disinfecting of working utensils and equipment;

(c) 足夠之清洗設備，如果需要，對作業器皿及設備消毒；

(d) where foodstuffs are cleaned as part of the food business’ operations, adequate

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provision is to be made for this to be undertaken hygienically;

(d) 若食品的清潔是食品業者作業的一部分，適當的設備必須是衛生的進行。

(e) an adequate supply of hot and/or cold potable water is to be available;

(e) 需提供足夠之熱、冷飲用水；

(f) adequate arrangements and/or facilities for the hygienic storage and disposal of

hazardous and/or inedible substances and waste (whether liquid or solid) are to be

available;

(f) 適當的安排與/或衛生儲存的設施以及危害和/或不可食物質的丟棄及廢棄物(不論是液體或固體)必須是可取得使用的；

(g) adequate facilities and/or arrangements for maintaining and monitoring suitable

food temperature conditions are to be available;

(g) 足夠之設備與/或安排用於維持及偵測適當的食品溫度狀態是可取得使用的的；

(h) foodstuffs are to be so placed as to avoid the risk of contamination so far as is

reasonably practicable.

(h) 避免食品遭受污染所進行之合理操作方法。

CHAPTER IV

第IV章

Transport

運輸

1. Conveyances and/or containers used for transporting foodstuffs are to be kept clean

and maintained in good repair and condition to protect foodstuffs from

contamination and are, where necessary, to be designed and constructed to permit

adequate cleaning and/or disinfection.

1. 用於食品運輸之運輸工具與/或貨櫃須保持乾淨及維持在良好修復及保護食品免於污染的狀態，必要時，設計或建構適當之清潔與/或殺菌設備。

2. Receptacles in vehicles and/or containers are not to be used for transporting

anything other than foodstuffs where this may result in contamination.

2. 運輸工具內的容器與/或貨櫃不可用於除了食品以外之運輸，以避免污染發生。

44

3. Where conveyances and/or containers are used for transporting anything in addition

to foodstuffs or for transporting different foodstuffs at the same time, there is,

where necessary, to be effective separation of products.

3. 用在運送除食品以外之任何物品或同時運送不同食品的運輸工具與/或貨櫃，必要時，有效的區隔產品。

4. Bulk foodstuffs in liquid, granulate or powder form are to be transported in

receptacles and/or containers/tankers reserved for the transport of foodstuffs. Such

containers are to be marked in a clearly visible and indelible fashion, in one or

more Community languages, to show that they are used for the transport of

foodstuffs, or are to be marked ‘for foodstuffs only’.

4. 大體積之液態、顆粒狀或粉末形式的食品，使用容器、罐子、桶子盛裝運送。容器之標示須清楚可見且不易消除，並使用一種或一種以上之官方語言，用以表示是用來運送食品所用，或標示＜僅供食品用途＞。

5. Where conveyances and/or containers have been used for transporting anything

other than foodstuffs or for transporting different foodstuffs, there is to be effective

cleaning between loads to avoid the risk of contamination.

5. 當運送使用不同的搬運工具及/或貨櫃運送除了食品以外的任何物品，或不同性質的食品時，在裝載之間需有效的清潔以避免污染的風險。

6. Foodstuffs in conveyances and/or containers are to be so placed and protected as to

minimise the risk of contamination.

6. 食品在運輸工具與/或貨櫃應安全擺放並維護使污染風險降至最低。

7. Where necessary, conveyances and/or containers used for transporting foodstuffs

are to be capable of maintaining foodstuffs at appropriate temperatures and allow

those temperatures to be monitored.

7. 必要時，用以運送食品的運輸工具與/或貨櫃須能維持食品在適當的溫度，且能監控溫度。

CHAPTER V

第V章

Equipment requirements

設備要求

1. All articles, fittings and equipment with which food comes into contact are to:

1. 所有與食品接觸之物品、設備︰

45

(a) be effectively cleaned and, where necessary, disinfected. Cleaning and disinfection

are to take place at a frequency sufficient to avoid any risk of contamination;

(a) 有效地清潔，必要時進行消毒。可經常性的清潔及消毒，以避免任何污染的風險；

(b) be so constructed, be of such materials and be kept in such good order, repair and

condition as to minimise any risk of contamination;

(b) 建構與材料排放整齊、修復完善且在良好的狀態，以將任何污染的風險減到最低；

(c) with the exception of non-returnable containers and packaging, be so constructed,

be of such materials and be kept in such good order, repair and condition as to

enable them to be kept clean and, where necessary, to be disinfected;

(c) 對於不可重複使用之容器或包裝，其儲放亦必須維持良好的狀態並維護，如必要時應消毒；

and

(d) be installed in such a manner as to allow adequate cleaning of the equipment and

the surrounding area.

(d) 安裝之裝置設備與周圍區域也必須適度的清潔。

2. Where necessary, equipment is to be fitted with any appropriate control device to

guarantee fulfilment of this Regulation’s objectives.

2. 必要的話，設備以適當之調控設施調到適當，以確保其符合法規要求。

3. Where chemical additives have to be used to prevent corrosion of equipment and

containers, they are to be used in accordance with good practice.

3. 當化學添加物被用來防止設備或容器腐蝕時，必須遵守良好規範。

CHAPTER VI

第VI章

Food waste

食品廢棄物

1. Food waste, non-edible by-products and other refuse are to be removed from rooms

where food is present as quickly as possible, so as to avoid their accumulation.

46

1. 食品廢棄物，非食用之副產品與其他垃圾應儘快從食品生產場所除去，以避免堆積。

2. Food waste, non-edible by-products and other refuse are to be deposited in closable

containers, unless food business operators can demonstrate to the competent

authority that other types of containers or evacuation systems used are appropriate.

These containers are to be of an appropriate construction, kept in sound condition,

be easy to clean and, where necessary, to disinfect.

2. 食品廢棄物，非食用之副產品與其他垃圾應放置於密閉容器中，除非食品業者保證其他種類之容器或排放系統的使用是適當的。這些容器必須適當的建構，在良好狀態下，保持乾淨且容易清潔，如有需要可消毒。

3. Adequate provision is to be made for the storage and disposal of food waste,

non-edible by-products and other refuse. Refuse stores are to be designed and

managed in such a way as to enable them to be kept clean and, where necessary,

free of animals and pests.

3. 提供充足食品廢棄物、非食用之副產品的儲存或處理設備。垃圾儲放處之設計及規劃必須能使其保持乾淨並遠離動物及蟲害。

4. All waste is to be eliminated in a hygienic and environmentally friendly way in

accordance with Community legislation applicable to that effect, and is not to

constitute a direct or indirect source of contamination.

4. 所有廢棄物要丟棄時應以衛生且維護環境的角度進行，並遵守當局法規，不可造成直接或間接的污染。

CHAPTER VII

第VII章

Water supply

水源供應

1. (a) There is to be an adequate supply of potable water, which is to be used

whenever necessary to ensure that foodstuffs are not contaminated;

1. (a) 應有充足之飲用水供應，確保食品不受污染

(b) Clean water may be used with whole fishery products. Clean seawater may be

used with live bivalve molluscs, echinoderms, tunicates and marine gastropods;

clean water may also be used for external washing. When such water is used,

adequate facilities are to be available for its supply.

47

(b) 乾淨的水可以被用於所有的漁產品。乾淨的海水可被用於活雙殼類軟體動物、棘皮類、被囊類和海上腹足類動物；乾淨的水也可能用於外部之清洗。當需水被使用時，也應有適當水源供應設施。

2. Where non-potable water is used, for example for fire control, steam production,

refrigeration and other similar purposes, it is to circulate in a separate duly

identified system. Non-potable water is not to connect with, or allow reflux into,

potable water systems.

2. 非飲用水被使用的地方，例如用於火勢控制、蒸氣製造、冷凍及其他相關類似目的，其循環的系統應該是明顯的。非飲用水系統不可回流或連接至飲用水系統。

3. Recycled water used in processing or as an ingredient is not to present a risk of

contamination. It is to be of the same standard as potable water, unless the

competent authority is satisfied that the quality of the water cannot affect the

wholesomeness of the foodstuff in its finished form.

3. 用在加工或作為食物成份的再生水不能有導致污染的危害。其與飲用水等同標準，除非權責機關同意水的品質不會影響最終產品形式的健康。

4. Ice which comes into contact with food or which may contaminate food is to be

made from potable water or, when used to chill whole fishery products, clean water.

It is to be made, handled and stored under conditions that protect it from

contamination.

4. 與食品接觸的冰應由飲用水製成，使用乾淨水冷卻漁產品。冰必須在免於被污染下製造、處理及儲存。

5. Steam used directly in contact with food is not to contain any substance that

presents a hazard to health or is likely to contaminate the food.

5. 使用與直接與食品接觸之蒸氣不可有任何會對健康造成危害或可能污染食品的物質。

6. Where heat treatment is applied to foodstuffs in hermetically sealed containers it is

to be ensured that water used to cool the containers after heat treatment is not a

source of contamination for the foodstuff.

6. 需經過在密封容器內食品之熱處理，熱處理之後冷卻容器時所使用之水，必須確定不是食品之污染源。

CHAPTER VIII

48

第VIII章

Personal hygiene

員工個人衛生

1. Every person working in a food-handling area is to maintain a high degree of

personal cleanliness and is to wear suitable, clean and, where necessary, protective

clothing.

1. 在食物處理區工作的每位員工皆必須保持高度之個人清潔，並適當穿戴乾淨、具保護性之衣物。

2. No person suffering from, or being a carrier of a disease likely to be transmitted

through food or afflicted, for example, with infected wounds, skin infections, sores

or diarrhoea is to be permitted to handle food or enter any food-handling area in

any capacity if there is any likelihood of direct or indirect contamination. Any

person so affected and employed in a food business and who is likely to come into

contact with food is to report immediately the illness or symptoms, and if possible

their causes, to the food business operator.

2. 員工不可為帶原或成為食物性病原的攜帶者，例如：有受感染之傷口、皮膚的傳染、傷口或腹瀉。這些人將不被允許處理食品或進入任何處理食品的地區，無論是否有直接或間接污染之任何可能性。任何受感染之員工若有可能

與食品接觸，應立即告知食品管理者其疾病或症狀。

CHAPTER IX

第IX章

Provisions applicable to foodstuffs

食品之應用性

1. A food business operator is not to accept raw materials or ingredients, other than

live animals, or any other material used in processing products, if they are known to

be, or might reasonably be expected to be, contaminated with parasites, pathogenic

microorganisms or toxic, decomposed or foreign substances to such an extent that,

even after the food business operator had hygienically applied normal sorting

and/or preparatory or processing procedures, the final product would be unfit for

human consumption.

1. 除了活體動物之外，食品業者應不接受原料或成分，或任何其他用在製作產品的原料，如果已知或可合理的預期其原料有寄生蟲、病原性微生物或毒素；被分解或一定量的外來物質，即使食品業者已經按程序分類及/或製備，最終的產品將不適合人類使用。

49