欧盟一般食品法Regulation (EC) No 178-2002中文翻译

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(Acts whose publication is obligatory)

歐盟一般食品法Regulation (EC) No 178/2002

歐洲議會和歐盟理事會2002年1月28日第853號有關食品規章

REGULATION (EC) No 178/2002 OF THE EUROPEAN PARLIAMENT AND OF

THE COUNCIL

of 28 January2002

laying down the general principles and requirements of food law, establishing the

European Food

SafetyAuthorityand laying down procedures in matters of food safety

一、法規重點摘要:

於2005年1月1日起一般食品法(178/2002號法規生效,並同時成立歐洲食品安全局(European Food Sfety Authority, EFSF),以協調各會員國執行與食品安全有關之法規,如食品之可追溯性、防止有害食品(含有害物質)進入市場、食品供應鏈業者(含進出口商)之義務(包括配合實施歐盟食品及飼料快速警報系統)、標示規範、不合符食品安全標準時須自市場撤回之規定。

歐盟食物鏈及動物健康常務委員會(Standing Committee on the Food Chain and Animal Health)為協調各會員國執行上述法規有關食品之可追溯性、防止有害食品進入市場、食品業者之義務及對進出口商之要求(178/2002號法規第11,12及16至20條)等一般原則及基本規範,已制定指導綱領,並同時協助相關業者瞭解,以徹底落實相關規範。相關新規範將適用於所有食品、動物飼料、動物用藥、保育類植物、肥料以及所有食物鏈業者,包括農場經營、食品之加工、運輸、儲存、配送及零售等。

另外,在標示規範方面,歐盟為在食物鏈建立可追溯性系統,所有食品及飼料均須標示生產者之姓名、地址、產品名稱及交易日期,相關資料須保存至少5年,以供追查之需。該法規第18條雖未明確規範標示資料,惟基本上應包括下列兩類資訊:

(1)供應商姓名地址及其供應之產品名稱、銷售對象姓名地址及銷售產品名稱、交易或交貨日期。

(2)產品之交易量、條碼、其他相關資訊(如定量包裝或散裝、水果或蔬菜種類、原料或加工產品)。該可追溯性法規(或標示規範)雖未強

制要求第三國出口商配合執行,惟輸入歐盟之進口產品須落實相關規

定,為避免重新黏貼標示之困擾,歐盟進口商勢必將要求出口商配合

實施。

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其他相關規定尚包括:

(1)發現食品不符食品安全標準時要求自市場撤回之規定。

(2)食品業者之義務【包括配合實施歐盟食品及飼料快速警報系統(Rapid Alert System for Food and Feed, RASFF)】。

此外,協調歐盟各會員國之食品衛生法(第852/2004號規定)將於2006年1月生效,其中有關動物用藥、保育類植物等相關規範亦須配合本項規定實施。

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

歐洲國會與歐盟市議會

Having regard to the Treaty establishing the European Community, and in particular Articles 37, 95, 133 and Article 152(4)(b) thereof,

考慮歐盟建立的條約,尤其是其中的第37、95、133、及152(4)(b)條

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

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

Having regard to the opinion of the Committee of the Regions (3),

Acting in accordance with the procedure laid down in Article 251 of the Treaty (4),

Whereas:

然而

(1) The free movement of safe and wholesome food is an essential aspect of the internal market and contributes significantly to the health and well-being of citizens, and to their social and economic interests.

食品安全的自由移動在內部市場是重要的部分,且明顯對市民的健康、其社經福利造成影響。

(2) A high level of protection of human life and health should be assured in the pursuit of Community policies.

在執行聯盟政策時,應確保高度保護人類生命及健康。

(3) The free movement of food and feed within the Community can be achieved only

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if food and feed safety requirements do not differ significantly from Member State to Member State.

在聯盟內食品、飼料的自由移動可以達到,除了在會員國間食品與飼料安全要求沒有明顯不同。

(4) There are important differences in relation to concepts, principles and procedures between the food laws of the Member States. When Member States adopt measures governing food, these differences may impede the free movement of food, create unequal conditions of competition, and may thereby directly affect the functioning of the internal market.

會員國之間的食品法律、原則、概念有明顯的差異。當會員國採用管理食品的措施時,這些差異可能會阻礙食品的自由流通,建立不平等的競爭情況,可能直接影響內部市場的功能。

(5) Accordingly, it is necessary to approximate these concepts, principles and procedures so as to form a common basis for measures governing food and feed taken in the Member States and at Community level. It is however necessary to provide for sufficient time for the adaptation of any conflicting provisions in existing legislation, both at national and Community level, and to provide that, pending such adaptation, the relevant legislation be applied in the light of the principles set out in the present Regulation.

於是,需要去瞭解這些概念、原則及程序,以便於建立在會員國及聯盟層級執行食品及飼料一般基礎措施。然而,在現有的立法下,需要提供足夠的時間去採行受爭議的條款,且在採行期間,在現有法規的原則下,相關的立法可以被採用。

(6) Water is ingested directly or indirectly like other foods, thereby contributing to the overall exposure of a consumer to ingested substances, including chemical and microbiological contaminants. However, as the quality of water intended for human consumption is already controlled by Council Directives 80/778/EEC (5) and 98/

83/EC (6), it suffices to consider water after the point of compliance referred to in Article 6 of Directive 98/83/ EC.

水是直接攝食或藉由食物攝食入,因此消費者有可能暴露在攝入的物質包括化學或微生物污染物下。然而,飲用水的品質已經由決議80/778/EEC (5) 與98/ 83/EC (6)管控,符合決議98/83/ EC的水視為飲用水。

(7) Within the context of food law it is appropriate to include requirements for feed, including its production and use where that feed is intended for food-producing animals. This is without prejudice to the similar requirements which have been

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applied so far and which will be applied in the future in feed legislation applicable to all animals, including pets.

在食品法令的範疇下,包括對飼料的要求。包括飼料的製造跟使用。其不違反現行之相關要求,且適用於未來的動物飼料的法律中。

(8) The Community has chosen a high level of health protection as appropriate in the development of food law, which it applies in a non-discriminatory manner whether food or feed is traded on the internal market or internationally.

在建立食品法律時,歐盟已經選擇健康的高標準。不論食品或飼料是在內部市場或國際間流通。

(9) It is necessary to ensure that consumers, other stakeholders and trading partners have confidence in the decision-making processes underpinning food law, its scientific basis and the structures and independence of the institutions protecting health and other interests.

在食品法律的基礎下,需要確認消費者與業者在做決定時是有信心的,其科學基礎、結構與保障健康及其他權益建立的獨立性。

(10) Experience has shown that it is necessary to adopt measures aimed at guaranteeing that unsafe food is not placed on the market and at ensuring that systems exist to identify and respond to food safety problems in order to ensure the proper functioning of the internal market and to protect human health. Similar issues relating to feed safety should be addressed.

為了確保內部市場的適當的作用,經驗已經顯示採行保證不安全的食品不上市、辨識及反應食品安全系統的措施是必要的。相關的飼料安全與相關的議題已經被提出。

(11) In order to take a sufficiently comprehensive and integrated approach to food safety, there should be a broad definition of food law covering a wide range of provisions with a direct or indirect effect on the safety of food and feed, including provisions on materials and articles in contact with food, animal feed and other agricultural inputs at the level of primary production.

為了對食品安全採取足夠、通盤的方法,應要有廣泛的食品法令的定義,涵蓋直接或間接對飼料或食品的影響,包括材料的條款或與食品、動物飼料及其他農產品輸入在初級生產的層級的相關法律。

(12) In order to ensure the safety of food, it is necessary to consider all aspects of the food production chain as a continuum from and including primary production and the

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production of animal feed up to and including sale or supply of food to the consumer because each element may have a potential impact on food safety.

為了確認食品的安全性,需要考慮食品製造鏈的所有部份,做為初級生產、動物飼料的製造、販售、食品供給到消費者的連貫性。因為個階段可能有對食品安全的潛在衝擊。

(13) Experience has shown that for this reason it is necessary to consider the production, manufacture, transport and distribution of feed given to food-producing animals, including the production of animals which may be used as feed on fish farms, since the inadvertent or deliberate contamination of feed, and adulteration or fraudulent or other bad practices in relation to it, may give rise to a direct or indirect impact on food safety.

經驗顯示這些原因需要去考慮飼料的生產、加工、運輸及配送,包括動物的製造準備用來做為養魚場的飼料,因為有意或無意的飼料污染、攙假或其他不好的相關案例,可能會產生直接或間接對食品安全的衝擊。

(14) For the same reason, it is necessary to consider other practices and agricultural inputs at the level of primary production and their potential effect on the overall safety of food.

相同的理由,在初級生產的層級,需要考慮其他規範與農產品的輸入及其他潛在食品安全性的影響。

(15) Networking of laboratories of excellence, at regional and/or interregional level, with the aim of ensuring continuous monitoring of food safety, could play an important role in the prevention of potential health risks for citizens.

合格實驗室網絡,在區域與/或區域間的層級,在確保食品安全的連續偵測下,可扮演對市民潛在健康危害的預防的角色。

(16) Measures adopted by the Member States and the Community governing food and feed should generally be based on risk analysis except where this is not appropriate to the circumstances or the nature of the measure. Recourse to a risk analysis prior to the adoption of such measures should facilitate the avoidance of unjustified barriers to the free movement of foodstuffs.

(17) Where food law is aimed at the reduction, elimination or avoidance of a risk to health, the three interconnected components of risk analysis - risk assessment, risk management, and risk communication - provide a systematic methodology for the determination of effective, proportionate and targeted measures or other actions to

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protect health.

(18) In order for there to be confidence in the scientific basis for food law, risk assessments should be undertaken in an independent, objective and transparent manner, on the basis of the available scientific information and data.

為了對食品法律的科學基礎有信心,在現有的科學資訊及數據的基礎下,應該以獨立、有目的且公開的態度執行風險評估。

(19) It is recognised that scientific risk assessment alone cannot, in some cases, provide all the information on which a risk management decision should be based, and that other factors relevant to the matter under consideration should legitimately be taken into account including societal, economic, traditional, ethical and environmental factors and the feasibility of controls.

科學的風險評估是不能單獨進行的,在某些案例中,應依所有提供的資訊做風險評估,考慮相關事件的其他因子應該合法地,考慮包括社會、經濟、傳統、道德及環境因子及管控的可行性。

(20) The precautionary principle has been invoked to ensure health protection in the Community, thereby giving rise to barriers to the free movement of food or feed. Therefore it is necessary to adopt a uniform basis throughout the Community for the use of this principle.

已經喚起預防原則去確保聯盟的健康保障,因此產生食品或飼料的自由移動屏障。因此使用此原則時,需要採用統一的基礎。

(21) In those specific circumstances where a risk to life or health exists but scientific uncertainty persists, the precautionary principle provides a mechanism for determining risk management measures or other actions in order to ensure the high level of health protection chosen in the Community.

在這些特定的情況,生命或健康存在的風險存在,但是科學不確定度持續,預防原則提供一機制去決定風險評估措施或其他行動,為了確保聯盟高度健康保護。

(22) Food safety and the protection of consumer's interests is of increasing concern to the general public, non-governmental organisations, professional associations, international trading partners and trade organisations. It is necessary to ensure that consumer confidence and the confidence of trading partners is secured through the open and transparent development of food law and through public authorities taking the appropriate steps to inform the public where there are reasonable grounds to

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suspect that a food may present a risk to health.

食品安全與消費者權益對一般公眾的關心、非政府組織的保護是高度關心的、專業的組織、國際貿易間的組織。需要去確認消費者的信賴度與業者的信賴度是安全的,經由開放與公開食品法律發展,由公家機關採取適當的程序去告知大眾有合理的理由去懷疑食品可能存在對健康的危害。

(23) The safety and confidence of consumers within the Community, and in third countries, are of paramount importance. The Community is a major global trader in food and feed and, in this context, it has entered into international trade agreements, it contributes to the development of international standards which underpin food law, and it supports the principles of free trade in safe feed and safe, wholesome food in a non-discriminatory manner, following fair and ethical trading practices.

在聯盟內消費者信心與安全,在第三國是很重要的。聯盟是食品與飼料的主要的全球貿易商,在此範圍內,已進入國際貿易協定,在食品法律的基礎下,其導致食品法律的發展、支持自由貿易在安全飼料、在非區別行為的所有食品,公正與種族貿易規範的原則。

(24) It is necessary to ensure that food and feed exported or re-exported from the Community complies with Community law or the requirements set up by the importing country. In other circumstances, food and feed can only be exported or

re-exported if the importing country has expressly agreed. However, it is necessary to ensure that even where there is agreement of the importing country, food injurious to health or unsafe feed is not exported or re-exported.

必須確認食品及飼料出國或再次從歐盟出口遵照聯盟或進口國建立的要求。在其他情況,如果進口國已經表示同意,食品與飼料只可以被出口或再次出口。然而,需要確認有進口國的許可,傷害健康的食品或不安全的飼料不可出口或再次出口。

(25) It is necessary to establish the general principles upon which food and feed may be traded and the objectives and principles for the contribution of the Community to developing international standards and trade agreements.

在食品與飼料買賣下,需要建立一般原則及目標讓聯盟發展國際標準及貿易協定。

(26) Some Member States have adopted horizontal legislation on food safety imposing, in particular, a general obligation on economic operators to market only food that is safe. However, these Member States apply different basic criteria for establishing whether a food is safe. Given these different approaches, and in the

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absence of horizontal legislation in other Member States, barriers to trade in foods are liable to arise. Similarly such barriers may arise to trade in feed.

在食品安全的前提下,一些會員國已經採用水平立法,尤其對業者在市場的責任,只有食品是安全的。然而,這些會員國採用不同的基礎標準去建立是否食品是安全的。這些不同方法,在缺乏其他會員國的水平立法下,食品的貿易層障是容易發生的。同樣的,這些屏障也可能發生在飼料的貿易中。

(27) It is therefore necessary to establish general requirements for only safe food and feed to be placed on the market, to ensure that the internal market in such products functions effectively.

因此只對上市的安全食品及飼料建立一般要求是必須的,去確認這些產品的功效在國內市場是有效的。

(28) Experience has shown that the functioning of the internal market in food or feed can be jeopardised where it is impossible to trace food and feed. It is therefore necessary to establish a comprehensive system of traceability within food and feed businesses so that targeted and accurate withdrawals can be undertaken or information given to consumers or control officials, thereby avoiding the potential for unnecessary wider disruption in the event of food safety problems.

(29) It is necessary to ensure that a food or feed business including an importer can identify at least the business from which the food, feed, animal or substance that may be incorporated into a food or feed has been supplied, to ensure that on investigation, traceability can be assured at all stages.

(30) A food business operator is best placed to devise a safe system for supplying food and ensuring that the food it supplies is safe; thus, it should have primary legal responsibility for ensuring food safety. Although this principle exists in some Member States and areas of food law, in other areas this is either not explicit or else responsibility is assumed by the competent authorities of the Member State through the control activities they carry out. Such disparities are liable to create barriers to trade and distort competition between food business operators in different Member States.

(31) Similar requirements should apply to feed and feed business operators.

(32) The scientific and technical basis of Community legislation relating to the safety of food and feed should contribute to the achievement of a high level of health

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protection within the Community. The Community should have access to high-quality, independent and efficient scientific and technical support.

(33) The scientific and technical issues in relation to food and feed safety are becoming increasingly important and complex. The establishment of a European Food Safety Authority, hereinafter referred to as ‘the Authority’, should reinforce the present system of scientific and technical support which is no longer able to respond to increasing demands on it.

(34) Pursuant to the general principles of food law, the Authority should take on the role of an independent scientific point of reference in risk assessment and in so doing should assist in ensuring the smooth functioning of the internal market. It may be called upon to give opinions on contentious scientific issues, thereby enabling the Community institutions and Member States to take informed risk management decisions necessary to ensure food and feed safety whilst helping avoid the fragmentation of the internal market through the adoption of unjustified or unnecessary obstacles to the free movement of food and feed.

(35) The Authority should be an independent scientific source of advice, information and risk communication in order to improve consumer confidence; nevertheless, in order to promote coherence between the risk assessment, risk management and risk communication functions, the link between risk assessors and risk managers should be strengthened.

(36) The Authority should provide a comprehensive independent scientific view of the safety and other aspects of the whole food and feed supple chains, which implies wide-ranging responsibilities for the Authority. These should included issues having a direct or indirect impact on the safety of the food and feed supply chains, animal health and welfare, and plant health, However, it is necessary to ensure that the Authority focuses on food safety, so its mission in relation to animal health, animal welfare and plant health issues that are not lined to the safety of the food supple chain should be limited to the provision of scientific opinions. The Authority’s mission should also cover scientific advise and scientific and technical support on human nutrition in relation to community legislation and assistance to the commission at its request on communication linked to community health programmes.

(36) 權責機關應提供一有關安全和所有食品飼料供應鏈之全面獨立科學見解,其表示權責機關多方面責任。這些應包括有關直接或間接影響食品飼料鏈安全、動物健康及福利和植物健康之問題。但是,其應確保權責機關專注於食品安全,

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所以,其關於動物健康、動物福利以及植物健康,但不屬於食品供應鏈安全之任務應限制於科學意見內。權責機關之任務應包括科學建議和科學、技術上關於人體營養之聯盟法規和在聯盟要求下對公共安全計畫溝通之幫助。

(37) Since some products authorised under food law such as pesticides or additives in animal feed may involve risks to the environment or to the safety of workers, some environmental and worker protection aspects should also be assessed by the Authority in accordance with the relevant legislation.

(37) 鑿於某些經食品法批准之產品例如在動物飼料中之殺蟲劑或添加物可能有對環境或員工安全之風險,其環境及員工保護方面也應被權責機關依去有關之法規進行評估。

(38) In order to avoid duplicated scientific assessments and related scientific opinions on genetically modified organisms (GMOs), the Authority should also provide scientific opinions on products other than food and feed relating to GMOs as defined by Directive 2001/18/EC (1) and without prejudice to the procedures established therein.

(38) 為了防止基因改造產品重複的科學評估和相關之科學意見,權責機關應依據法令2001/18/EC (1) 提供除了有關基因改造之飼料食品產品外的科學意見,並且不損害在其內訂定之程序。

(39) The Authority should contribute through the provision of support on scientific matters, to the Community's and Member States' role in the development and establishment of international food safety standards and trade agreements.

(39) 權責機關應在科學事件上經由提供支持,對聯盟及會員國在國際食品安全標準及貿易協定建立和創建之角色有所貢獻。

(40) The confidence of the Community institutions, the general public and interested parties in the Authority is essential. For this reason, it is vital to ensure its independence, high scientific quality, transparency and efficiency. Cooperation with Member States is also indispensable.

(40) 聯盟機構一般大眾以及權責機關內有興趣之第三機構之信心是極重要的。為此目的,維持其獨立性高科學品質透明度和有效性實不可或缺的。和其他會員國合作也是必須的。

(41) To that effect the Management Board should be appointed in such a way as to secure the highest standard of competence, a broad range of relevant expertise, for instance in management and in public administration, and the broadest possible

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geographic distribution within the Union. This should be facilitated by a rotation of the different countries of origin of the members of the Management Board without any post being reserved for nationals of any specific Member State.

(41) 為此,管理會應基於鞏固權責之最高標準,大範圍的相關專業,例如是在管理方面和公共管理,以及在歐盟內最廣擴之可能的地理分布。此管理可經由沒有任何特一會員國經營。並由管理會不同國家之成員的輪替管理。

(42) The Authority should have the means to perform all the tasks required to enable it to carry out its role.

(42) 權責機關應有完成所有必須之作業之法以能夠執行其任務。

(43) The Management Board should have the necessary request on communication linked to Community health powers to establish the budget, check its implementation., draw up internal rules, adopt financial regulations, appoint members of the Scientific Panels and appoint the Executive Director.

(43) 管理會應在共同體衛生權力之溝通上有必需的要求以建立其預算,檢查其執行、建立內部規定、通過經濟法令、指定科學小組成員和執行組長。

(44) The Authority should cooperate closely with competent bodies in the Member States if it is to operate effectively. An Advisory Forum should be created in order to advise the Executive Director, to constitute a mechanism of exchange of information, and to ensure close cooperation in particular with regard to the networking system. Cooperation and appropriate exchange of information should also minimise the potential for perging scientific opinions.

(44) 權責機關如果要有效的執行,應和會員國之權責機構密切的合作。一諮詢討論會應被創建以建議其執行組長建立資訊交換之程序並確保通系統的密切合作。

(45) The Authority should take over the role of the Scientific Committees attached to the Commission in issuing scientific opinions in its field of competence. It is necessary to reorganise these Committees to ensure greater scientific consistency in relation to the food supply chain and to enable them to work more effectively. A Scientific Committee and Permanent Scientific Panels should therefore be set up within the Authority to provide these opinions.

(45) 權責機關應接管委員會之科學委員會在其權責內發布之科學意見。重新組織這些委員是必須的以確保有關於食品供應練更好的科學一致性以及使其能夠更有效的工作。應因此在權責範圍內建立一科學委員會和永久科學小組。

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(46) In order to guarantee independence, members of the Scientific Committee and Panels should be independent scientists recruited on the basis of an open application procedure.

(46) 為了保證獨立性,科學委員會之成員和小組應為公開徵招之獨立科學家。

(47) The Authority's role as an independent scientific point of reference means that a scientific opinion may be requested not only by the Commission, but also by the European Parliament and the Member States. In order to ensure the manageability and consistency of the process of scientific advice, the Authority should be able to refuse or amend a request providing justification for this and on the basis of predetermined criteria. Steps should also be taken to help avoid perging scientific opinions and, in the event of perging scientific opinions.

(48) The Authority should also be able to commission scientific studies necessary for the accomplishment of its duties, while ensuring that the links established by it with the Commission and the Member States prevent duplication of effort. It should be done in an open and transparent fashion and the Authority should take into account existing Community expertise and structures.

(49) The lack of an effective system of collection and analysis at Community level of data on the food supply chain is recognised as a major shortcoming. A system for the collection and analysis of relevant data in the fields covered by the Authority should therefore be set up, in the form of a network coordinated by the Authority. A review of Community data collection networks already existing in the fields covered by the Authority is called for.

(50) Improved identification of emerging risks may in the long term be a major preventive instrument at the disposal of the Member States and the Community in the exercise of its policies. It is therefore necessary to assign to the Authority an anticipatory task of collecting information and exercising vigilance and providing evaluation of and information on emerging risks with a view to their prevention.

(51) The establishment of the Authority should enable Member States to become more closely involved in scientific procedures. There should therefore be close cooperation between the Authority and the Member States for this purpose. In particular, the Authority should be able to assign certain tasks to organisations in the Member States.

(52) It is necessary to ensure that a balance is struck between the need to use national

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organisations to carry out tasks for the Authority and the need to ensure for the purposes of overall consistency that such tasks are carried out in line with the criteria established for such tasks. Existing procedures for the allocation of scientific tasks to the Member States, in particular with regard to the evaluation of dossiers presented by industry for the authorisation of certain substances, products or procedures, should be re-examined within a year with the objective of taking into account the establishment of the Authority and the new facilities it offers, the evaluation procedures remaining at least as stringent as before.

(53) The Commission remains fully responsible for communicating risk management measures. The appropriate information should therefore be exchanged between the Authority and the Commission. Close cooperation between the Authority, the Commission and the Member States is also necessary to ensure the coherence of the global communication process.

(54) The independence of the Authority and its role in informing the public mean that it should be able to communicate autonomously in the fields falling within its competence, its purpose being to provide objective, reliable and easily understandable information.

(55) Appropriate cooperation with the Member States and other interested parties is necessary in the specific field of public information campaigns to take into account any regional parameters and any correlation with health policy.

(56) In addition to its operating principles based on independence and transparency, the Authority should be an organisation open to contacts with consumers and other interested groups.

(57) The Authority should be financed by the general budget of the European Union. However, in the light of experience acquired, in particular with regard to the processing of authorisation dossiers presented by industry, the possibility of fees should be examined within three years following the entry into force of this Regulation. The Community budgetary procedure remains applicable as far as any subsidies chargeable to the general budget of the European Union are concerned. Moreover, the auditing of accounts should be undertaken by the Court of Auditors.

(58) It is necessary to allow for the participation of European countries which are not members of the European Union and which have concluded agreements obliging them

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to transpose and implement the body of Community law in the field covered by this Regulation.

(59) A system for rapid alert already exists in the framework of Council Directive

92/59/EEC of 29 June 1992 on general product safety (1). The scope of the existing system includes food and industrial products but not feed. Recent food crises have demonstrated the need to set up an improved and broadened rapid alert system covering food and feed. This revised system should be managed by the Commission and include as members of the network the Member States, the Commission and the Authority. The system should not cover the Community arrangements for the early exchange of information in the event of a radiological emergency as defined in Council Decision 87/600/Euratom (2).

(60) Recent food safety incidents have demonstrated the need to establish appropriate measures in emergency situations ensuring that all foods, whatever their type and origin, and all feed should be subject to common measures in the event of a serious risk to human health, animal health or the environment. Such a comprehensive approach to emergency food safety measures should allow effective action to be taken and avoid artificial disparities in the treatment of a serious risk in relation to food or feed.

(61) Recent food crises have also shown the benefits to the Commission of having properly adapted, more rapid procedures for crisis management. These organisational procedures should make it possible to improve coordination of effort and to determine the most effective measures on the basis of the best scientific information. Therefore, revised procedures should take into account the Authority's responsibilities and should provide for its scientific and technical assistance in the form of advice in the event of a food crisis.

(62) In order to ensure a more effective, comprehensive approach to the food chain, a Committee on the Food Chain and Animal Health should be established to replace the Standing Veterinary Committee, the Standing Committee for Foodstuffs and the Standing Committee for Feedingstuffs. Accordingly, Council Decisions 68/ 361/EEC (1), 69/414/EEC (2), and 70/372/EEC (3), should be repealed. For the same reason the Committee on the Food Chain and Animal Health should also replace the Standing Committee on Plant Health in relation to its competence (for Directives 76/895/EEC (4), 86/ 362/EEC (5), 86/363/EEC (6), 90/642/EEC (7) and 91/ 414/EEC (8)) on plant protection products and the setting of maximum residue levels.

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(63) 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 (9).

(64) It is necessary that operators should have sufficient time to adapt to some of the requirements established by the present Regulation and that the European Food Safety Authority should commence its operations on 1 January 2002.

(65) It is important to avoid confusion between the missions of the Authority and the European Agency for the Evaluation of Medicinal Products (EMEA) established by Council Regulation (EEC) No 2309/93 (10). Consequently, it is necessary to establish that this Regulation is without prejudice to the competence conferred on the EMEA by Community legislation, including powers conferred by Council Regulation (EEC) No 2377/90 of 26 June 1990 laying down a Community procedure for the establishment of maximum residue limits of veterinary medicinal products in foodstuffs of animal origin (11).

(66) It is necessary and appropriate for the achievement of the basic objectives of this Regulation to provide for the approximation of the concepts, principles and procedures forming a common basis for food law in the Community and to establish a European Food Safety Authority. In accordance with the principle of proportionality as set out in Article 5 of the Treaty, this Regulation does not go beyond what is necessary in order to achieve the objectives pursued,

HA VE ADOPTED THIS REGULATION:

CHAPTERI

第I章

SCOPE AND DEFINITIONS

範圍與定義

Article 1

第1條

Aim and scope

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目標與範圍

1. This Regulation provides the basis for the assurance of a high level of protection of human health and consumers' interest in relation to food, taking into account in particular the persity in the supply of food including traditional products,

whilst ensuring the effective functioning of the internal market.

本規章提供確保食品對人體健康及消費者權益高度保護的基礎,尤其考慮供應的食品(包括傳統食品)差異性,以確在內部市場有效的運作。

It establishes common principles and responsibilities, the means to provide a strong science base, efficient organisational arrangements and procedures to underpin decision-making in matters of food and feed safety.

本規章建立了一般的原則及責任。方法提供健全的科學基礎、有效率的組織安排及程序,去支持食品、飼料安全的事務決定。

2. For the purposes of paragraph 1, this Regulation lays down the general principles governing food and feed in general, and food and feed safety in particular, at Community and national level.

第一段的目的,本規章擬定一般食品及飼料的一般原則,尤其是在歐盟及國內的食品及飼料安全的部分。

It establishes the European Food Safety Authority.

本規章建立了歐盟食品安全局。

It lays down procedures for matters with a direct or indirect impact on food and feed safety.

本規章也擬定了會對食品及飼料直接或間接產生衝擊事物的程序。

3. This Regulation shall apply to all stages of production, processing and distribution of food and feed. It shall not apply to primary production for private domestic use or to the domestic preparation, handling or storage of food for private domestic consumption.

本規章應適用於食品與飼料生產、製造、運送的所有階段。不適用於供應國內私人食品初級生產、前處理、製備或儲存的使用。

Article 2

第2條

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Definition of ‘food’

食品之定義

For the purposes of this Regulation, ‘food’ (or ‘foodstuff’) means any substance or product, whether processed, partially processed or unprocessed, intended to be, or reasonably expected to be ingested by humans.

為了符合本規章的立義,「食品」是指任何不論是否經過加工,供人食用或可合理預期讓人類攝食的產品。

‘Food’ includes drink, chewing gum and any substance, including water, intentionally incorporated into the food during its manufacture, preparation or treatment. It includes water after the point of compliance as defined in Article 6 of Directive 98/83/EC and without prejudice to the requirements of Directives 80/778/EEC and 98/83/EC.

「食品」包括飲料、口香糖;或在製造、前處理或製備時添加於食品之任何物質,包括水。水的定義需遵循歐盟指令98/83第6條的要求,且與歐盟指令80/778 、98/83的要求一致。

‘Food’ shall not include:

「食品」不包括

(a) feed; 飼料

(b) live animals unless they are prepared for placing on the market for human

consumption; 活體動物(除非牠們被製備成產品上市供人食用)

(c) plants prior to harvesting; 採收前的植物

(d) medicinal products within the meaning of Council Directives 65/65/EEC (1) and 92/73/EEC (2); 在議會指令65/65及92/73中所指的藥物產品

(e) cosmetics within the meaning of Council Directive 76/ 768/EEC (3);

委員會指令76/ 768所指的化妝品

(f) tobacco and tobacco products within the meaning of Council Directive

89/622/EEC (4);

在委員會指令89/622所指的菸草及菸草製品

(g) narcotic or psychotropic substances within the meaning of the United Nations

Single Convention on Narcotic Drugs, 1961, and the United Nations Convention

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on Psychotropic Substances, 1971;

在1961年United Nations Single Convention on Narcotic Drugs及1971年the United Nations Convention on Psychotropic Substances 所指的麻醉劑或精神病用藥

(h) residues and contaminants.

殘留物及污染物

Article 3

第3條

Other definitions

其他定義

For the purposes of this Regulation:

依本規章的目的

1. ‘food law’ means the laws, regulations and administrative provisions governing food in general, and food safety in particular, whether at Community or national level; it covers any stage of production, processing and distribution of food, and also of feed produced for, or fed to, food producing animals;

「食品法律」是指不論是否在聯盟或國家的層級的一般用來掌控食品,尤其是食品安全的法令、條款、規章。其涵蓋食品生產、加工及運輸的所有階段、生產產品的飼料、或生產食品的動物。

2. ‘food business’ means any undertaking, whether for profit or not and whether public or private, carrying out any of the activities related to any stage of production, processing and distribution of food;

「食品產業」意指任何不論是否為營利、公家或私人的,完成任何關於食品製造、加工及運送活動的企業。

3. ‘food business operator’ means the natural or legal persons responsible for ensuring that the requirements of food law are met within the food business under their control; 「食品業者」意指自然人或法人負責確保其所控制的食品營業符合食品法律的要求

4. ‘feed’ (or ‘feedingstuff’) means any substance or product, including additives, whether processed, partially processed or unprocessed, intended to be used for oral feeding to animals;

飼料(或食品)意指不論是否經過加工,供給動物食用的任何物質或產品,包括添加物。

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5. ‘feed business’ means any undertaking whether for profit or not and whether public or private, carrying out any operation of production, manufacture, processing, storage, transport or distribution of feed including any producer producing, processing or storing feed for feeding to animals on his own holding;

「飼料產業」意指完成任何飼料生產、製造、加工、儲存、運送或販售之不論是否為營利、公家或私人的行業

6. ‘feed business operator’ means the natural or legal persons responsible for ensuring that the requirements of food law are met within the feed business under their control; 飼料業者意指自然人或法人負責確認在其管控下,飼料業符合食品法律的要求

7. ‘retail’ means the handling and/or processing of food and its storage at the point of sale or delivery to the final consumer, and includes distribution terminals, catering operations, factory canteens, institutional catering, restaurants and other similar food service operations, shops, supermarket distribution centres and wholesale outlets;

零售意指食品的處理與/或加工,在販售點的儲存或送到最終消費者,包括到配銷末端、供餐經營業者、工廠餐廳、機關供膳、餐廳及其他食品服務業、商店、超級市場、配送中心及大型量販店。

8. ‘placing on the market’ means the holding of food or feed for the purpose of sale, including offering for sale or any other form of transfer, whether free of charge or not, and the sale, distribution, and other forms of transfer themselves;

上市意指食品或飼料為了販售的目的,包括提供作為銷售或任何其他轉移的型式,對論是否收費,販售、配銷及其他型式的轉移。

9. ‘risk’means a function of the probability of an adverse health effect and the severity of that effect, consequential to a hazard;

「風險」指健康負面影響的可能性及其影響的嚴重性、隨之發生的危害。

10. ‘risk analysis’ means a process consisting of three interconnected components: risk assessment, risk management and risk communication;

「風險分析」意指連接危害評估、危害管理及危害溝通的過程

11. ‘risk assessment’ means a scientifically based process consisting of four steps: hazard identification, hazard characterisation, exposure assessment and risk characterisation;

「風險評估」是指以危害辨識、危害鑑定、暴露評估及風險鑑定的四項以科學為基礎的程序。

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12. ‘risk management’ means the process, distinct from risk assessment, of weighing policy alternatives in consultation with interested parties, considering risk assessment and other legitimate factors, and, if need be, selecting appropriate prevention and control options;

「風險管理」指不同於風險評估的程序,衡量利益團體諮詢中的替代政策,考慮風險評估或其他合理的因子,如果需要時,選擇適合的預防或管控建議。

13. ‘risk communication’ means the interactive exchange of information and opinions throughout the risk analysis process as regards hazards and risks, risk-related factors and risk perceptions, among risk assessors, risk managers, consumers, feed and food businesses, the academic community and other interested parties, including the explanation of risk assessment findings and the basis of risk management decisions; 「風險溝通」指在關於危害及風險、風險相關因子、風險預測的分析程序下,在風險評估者、風險管理者、消費者、食飼食品業者、學術團體或其他利益團體,包括風險評估發現的解釋及風險管理決定的基礎,相互交換訊息及意見。

14. ‘hazard’means a biological, chemical or physical agent in, or condition of, food or feed with the potential to cause an adverse health effect;

「危害」表示生物學、化學或物理的物質,存在食品或飼料中可能造成有害健康的潛在問題;

15. ‘traceability’ means the ability to trace and follow a food, feed, food-producing animal or substance intended to be, or expected to be incorporated into a food or feed, through all stages of production, processing and distribution;

「追溯性」表示具有追蹤食品、食物、生產食品的動物或物質,或期望併入一種食品或食物,或透過產品、加工和配送的階段;

16. ‘stages of production, processing and distribution’ means any stage, including import, from and including the primary production of a food, up to and including its storage, transport, sale or supply to the final consumer and, where relevant, the importation, production, manufacture, storage, transport, distribution, sale and supply of feed;

「生產、加工和配送階段」表示包括進口、包括從主要生產的食品,接近包括儲存、運輸、銷售或提供給消費者相關的進口、生產、加工、儲存、運送、配送、銷售和供應的任何階段;

17. ‘primary production’ means the production, rearing or growing of primary

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products including harvesting, milking and farmed animal production prior to slaughter. It also includes hunting and fishing and the harvesting of wild products; 「初級生產」表示初級產品之生產、飼養和生長,包括收獲、擠乳及屠宰前之飼養;亦包括打獵和捕魚及野生產品的收獲。

18. ‘final consumer’ means the ultimate consumer of a foodstuff who will not use the food as part of any food business operation or activity.

「最終消費者」表示食品最終的消費者,其不會將食品作其他任何食品經銷營業或活動。

CHAPTERII

第II章

GENERAL FOOD LAW

一般食品法

Article 4

第4條

Scope

範圍

1. This Chapter relates to all stages of the production, processing and distribution of food, and also of feed produced for, or fed to, food-producing animals.

本章包括所有食品之生產、加工、配送及飼料生產或餵飼生產食品的動物的相關階段。

2. The principles laid down in Articles 5 to 10 shall form a general framework of a horizontal nature to be followed when measures are taken.

應依第5條到第10條規定行成水平管理架構以展開管理措施。

3. Existing food law principles and procedures shall be adapted as soon as possible and by 1 January 2007 at the latest in order to comply with Articles 5 to 10.

現有的食品法之原則和程序應於2007年1月1日實施以符合第5條到第10條法規規定。

4. Until then, and by way of derogation from paragraph 2, existing legislation shall be implemented taking account of the principles laid down in Articles 5 to 10.

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