1、1852.2004 法規翻譯CORRIGENDACorrigendum 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 shou
2、ld read as follows: REGULATION (EC) No 852/2004 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 29 April 2004on 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
3、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 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 Euro
4、pean 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
5、 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 。22、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、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
6、 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)
7、 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
8、 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
9、 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
10、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 3principles, in particular in relation to the manufacturers and competent authorities responsibilities, structural, operational and hygiene requirements for
11、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 pr
12、oducts 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 dow
13、n 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
14、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 safet
15、y 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 o
16、nly 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 contro
17、lled 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 t
18、hrough 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) pri
19、nciples 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 requ
20、irements 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 la
21、y 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
22、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. 5To this end, employees should undergo training. The HACCP system is an instrument to help food business operators attai
23、n 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 pr
24、ocedures 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 opera
25、tors 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
26、 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 mon
27、itoring 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 businesse
28、s. (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, p
29、rocessing 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, 6including the outermost regions referred to in Article 299(2) of the Treaty. However, flexibility
30、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
31、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
32、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 exi
33、sting 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 marke
34、t 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 technic
35、al 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 Agr
36、eement and the international food safety standards contained in the Codex Alimentarius. 7(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 com
37、petent 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 an
38、d 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 gener
39、al 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)
40、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
41、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。8(24) Since this Regulation replaces Directive 93/43/EEC, the latter
42、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 applicati
43、on 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 t
44、he 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 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
45、 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9第 13 條 附件 I 與 II 之修正與改編第 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S
46、cope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) i
47、t 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
48、 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; 10(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 instr
49、ument 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 shal
