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

2021年1月20日发(作者：attack是什么意思)
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、運輸條件、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
，< br>該規定第
5
條亦要求食品
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

1
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
條制定程序，

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

。

3
、全面推行危害分析重要管制點系統
(HACCP)
。

4
、

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< br>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
建

(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
1 4
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
列在條約的附件

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 manufacturer
s ‘and
competent
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,

3
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 括條約內附錄
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.


4
(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
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
(H ACCP)
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。


5

(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
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。



6
(15) The HACCP requirements should take account of the principles contained in the
Codex Alimentarius. They should provide sufficient flexibility to be applicab
le 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
.
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

7 的地區，包括條約第
299(2)
條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< br>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.


8
(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 contro
ls
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

9
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 。


(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) < br>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< br>1999/468/EC
擬訂的程序，經執行委員會授權執行。


HAVE ADOPTED THIS REGULA
TION:

二、目錄


10
Regulation (EC) No 852/2004
如下︰

第
I
章

總則

第
1
條

適用範圍

第
2
條

名詞定義

第
II
章

食品業者之義務

第
3
條

義務

第
4
條

衛生要求

第
5
條

危害分析重要管制點

第
6
條

官方管制、認證與核可

第
III
章

良好作業指引

第
7
條

指引之發展、宣導及使用

第
8
條

國家指引

第
9
條

歐盟指引

第
IV
章

進口與出口

第
10
條

進口

第
11
條

出口

第
V
章

附則

第
12
條

執行措施與過渡期之安排

第
13
條

附件
I
與
II
之修正與改編


11
第
14
條

執委會程序

第
15
條

歐洲食品安全局
(EFSA)
之諮詢

第
16
條

向歐洲議會與執委會報告

第
17
條

廢止

第
18
條

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
條

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；



12
(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;

(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。



13
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；



(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

14
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
條

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
健康之必要措施與條件；


(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

15
to which that central authority has delegated that competence; it shall also include,
where appropriate, the corresponding authority of a third country;

(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< br>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

16
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;

(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

17
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
條

General obligation
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。



18
Article 4
第
4
條

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



19
(c) compliance with temperature control requirements for foodstuffs;

(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
條
(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
853/200 4
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
條之指引，以達到本法規定之義務
。


20

Article 5
第
5
條

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。

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;


21
(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
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︰




22
(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)
確認任何依據本條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.
本條文之執行細節可依據第
14
條
(2)
所述之程序來訂定
。該條文可促進灌輸此
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
條

Official controls, registration and approval
官方管制、認證與核可



23
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;


24
(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).

(c)
透過依據第
14
條
(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。< br>

CHAPTER III
第
III
章

GUIDES TO GOOD PRACTICE
良好規範指引

Article 7
第
7
條

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
條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
條發展。



25

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
條

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︰



(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。


26

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) < br>其適用為符合第
3
、
4
和
5
條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。


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.


27
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
條

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< br>原則採用之歐盟良好規範指引的發展之前，執委會應與
14
條所述之委員會協商。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；



28

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

(c)
考慮國際法規相關守則；



and


(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
條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、五條，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.


29
4.
執委會應與第二段所述之團體合作
，
定期邀 請第
14
條所述之委員會審查本條
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.
依據本條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
第
IV
章

IMPORTS AND EXPORTS
進口與出口

Article 10
第
10
條

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條中提及之相關食品法律
要求，應包括本法第
3
到
6
條之要求。


Article 11

30
第
11
條

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
條所
提之食品法律相關之要求，應包括本法 第
3
條到第
6
條之要求。




CHAPTER V
第
V
章


FINAL PROVISIONS
最終條款


Article 12
第
12
條

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
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
條第
2
點之程序制 定。


Article 13
第
13
條


31

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
條
( 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
條以
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.


32
2.
依據第
14< br>條
(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
條款
，
考慮相關風險因子
，
此規定排除不影響本法之目
標。



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
，< br>依據本條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:


33
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
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

34