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Regulation (EC) No 178/2002 of the European Parliament and of the CouncilShow full title

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

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CHAPTER IU.K.SCOPE AND DEFINITIONS

Article 1U.K.Aim and scope

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 diversity in the supply of food including traditional products, whilst ensuring the effective functioning of the F1... market. 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.

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, F2...

F2...

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

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.

Article 2U.K.Definition of ‘food’

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.

‘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.

‘Food’ shall not include:

(a)

feed;

(b)

live animals unless they are prepared for placing on the market for human consumption;

(c)

plants prior to harvesting;

(d)

medicinal products within the meaning of Council Directives 65/65/EEC(1) and 92/73/EEC(2);

(e)

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

(f)

tobacco and tobacco products within the meaning of Council Directive 89/622/EEC(4);

(g)

narcotic or psychotropic substances within the meaning of the United Nations Single Convention on Narcotic Drugs, 1961, and the United Nations Convention on Psychotropic Substances, 1971;

(h)

residues and contaminants.

Article 3U.K.Other definitions

For the purposes of this Regulation:

1.‘food law’ means the laws, regulations and administrative provisions governing food in general, and food safety in particular, F3...; it covers any stage of production, processing and distribution of food, and also of feed produced for, or fed to, food-producing animals;

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;

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;

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;

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;

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;

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;

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;

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

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

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

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;

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;

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;

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;

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;

17.‘primary production’ means the production, rearing or growing of primary products including harvesting, milking and farmed animal production prior to slaughter. It also includes hunting and fishing and the harvesting of wild products;

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.

[F419.appropriate authority” means—

(a)in relation to England, the Secretary of State;

(b)in relation to Wales, the Welsh Ministers;

(c)in relation to Scotland, the Scottish Ministers;

20.third country” means any country or territory other than the British Islands.]

CHAPTER IIU.K.GENERAL FOOD LAW

Article 4U.K.Scope

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.

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.

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F64.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

SECTION 1U.K.GENERAL PRINCIPLES OF FOOD LAW

Article 5U.K.General objectives

1.Food law shall pursue one or more of the general objectives of a high level of protection of human life and health and the protection of consumers' interests, including fair practices in food trade, taking account of, where appropriate, the protection of animal health and welfare, plant health and the environment.

F72.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

3.Where international standards exist or their completion is imminent, they shall be taken into consideration in the development or adaptation of food law, except where such standards or relevant parts would be an ineffective or inappropriate means for the fulfilment of the legitimate objectives of food law or where there is a scientific justification, or where they would result in a different level of protection from the one determined as appropriate in [F8Great Britain].

Article 6U.K.Risk analysis

1.In order to achieve the general objective of a high level of protection of human health and life, food law shall be based on risk analysis except where this is not appropriate to the circumstances or the nature of the measure.

2.Risk assessment shall be based on the available scientific evidence and undertaken in an independent, objective and transparent manner.

3.Risk management shall take into account the results of risk assessment, and F9... other factors legitimate to the matter under consideration and the precautionary principle where the conditions laid down in Article 7(1) are relevant, in order to achieve the general objectives of food law established in Article 5.

Article 7U.K.Precautionary principle

1.In specific circumstances where, following an assessment of available information, the possibility of harmful effects on health is identified but scientific uncertainty persists, provisional risk management measures necessary to ensure the high level of health protection chosen in [F10Great Britain] may be adopted, pending further scientific information for a more comprehensive risk assessment.

2.Measures adopted on the basis of paragraph 1 shall be proportionate and no more restrictive of trade than is required to achieve the high level of health protection chosen in [F10Great Britain], regard being had to technical and economic feasibility and other factors regarded as legitimate in the matter under consideration. The measures shall be reviewed within a reasonable period of time, depending on the nature of the risk to life or health identified and the type of scientific information needed to clarify the scientific uncertainty and to conduct a more comprehensive risk assessment.

Article 8U.K.Protection of consumers' interests

1.Food law shall aim at the protection of the interests of consumers and shall provide a basis for consumers to make informed choices in relation to the foods they consume. It shall aim at the prevention of:

(a)fraudulent or deceptive practices;

(b)the adulteration of food; and

(c)any other practices which may mislead the consumer.

SECTION 2U.K.PRINCIPLES OF TRANSPARENCY

Article 9U.K.Public consultation

There shall be open and transparent public consultation, directly or through representative bodies, during the preparation, evaluation and revision of food law, except where the urgency of the matter does not allow it.

Article 10U.K.Public information

F11... Where there are reasonable grounds to suspect that a food or feed may present a risk for human or animal health, then, depending on the nature, seriousness and extent of that risk, public authorities shall take appropriate steps to inform the general public of the nature of the risk to health, identifying to the fullest extent possible the food or feed, or type of food or feed, the risk that it may present, and the measures which are taken or about to be taken to prevent, reduce or eliminate that risk.

SECTION 3U.K.GENERAL OBLIGATIONS OF FOOD TRADE

[F12Article 11U.K.Food and feed imported into Great Britain

Food and feed imported into Great Britain for placing on the market within Great Britain must comply with the relevant requirements of food law or conditions recognised by Great Britain to be at least equivalent thereto or, where a specific agreement exists between the United Kingdom and an exporting country, with requirements contained therein.]

Article 12U.K.Food and feed exported from [F13Great Britain]

1.Food and feed exported or re-exported from [F14Great Britain] for placing on the market of a third country shall comply with the relevant requirements of food law, unless otherwise requested by the authorities of the importing country or established by the laws, regulations, standards, codes of practice and other legal and administrative procedures as may be in force in the importing country.

In other circumstances, except in the case where foods are injurious to health or feeds are unsafe, food and feed can only be exported or re-exported if the competent authorities of the country of destination have expressly agreed, after having been fully informed of the reasons for which and the circumstances in which the food or feed concerned could not be placed on the market in [F14Great Britain].

[F152. Where the provisions of a bilateral agreement concluded between the United Kingdom and a third country are applicable, food and feed exported from the United Kingdom to that third country must comply with those provisions.]

Article 13U.K.International standards

[F16The appropriate authorities must—]

(a)

contribute to the development of international technical standards for food and feed and sanitary and phytosanitary standards;

(b)

promote the coordination of work on food and feed standards undertaken by international governmental and non-governmental organisations;

(c)

contribute, where relevant and appropriate, to the development of agreements on recognition of the equivalence of specific food and feed-related measures;

(d)

give particular attention to the special development, financial and trade needs of developing countries, with a view to ensuring that international standards do not create unnecessary obstacles to exports from developing countries;

(e)

promote consistency between international technical standards and food law while ensuring that the high level of protection adopted in [F17Great Britain] is not reduced.

SECTION 4U.K.GENERAL REQUIREMENTS OF FOOD LAW

Article 14U.K.Food safety requirements

1.Food shall not be placed on the market if it is unsafe.

2.Food shall be deemed to be unsafe if it is considered to be:

(a)injurious to health;

(b)unfit for human consumption.

3.In determining whether any food is unsafe, regard shall be had:

(a)to the normal conditions of use of the food by the consumer and at each stage of production, processing and distribution, and

(b)to the information provided to the consumer, including information on the label, or other information generally available to the consumer concerning the avoidance of specific adverse health effects from a particular food or category of foods.

4.In determining whether any food is injurious to health, regard shall be had:

(a)not only to the probable immediate and/or short-term and/or long-term effects of that food on the health of a person consuming it, but also on subsequent generations;

(b)to the probable cumulative toxic effects;

(c)to the particular health sensitivities of a specific category of consumers where the food is intended for that category of consumers.

5.In determining whether any food is unfit for human consumption, regard shall be had to whether the food is unacceptable for human consumption according to its intended use, for reasons of contamination, whether by extraneous matter or otherwise, or through putrefaction, deterioration or decay.

6.Where any food which is unsafe is part of a batch, lot or consignment of food of the same class or description, it shall be presumed that all the food in that batch, lot or consignment is also unsafe, unless following a detailed assessment there is no evidence that the rest of the batch, lot or consignment is unsafe.

7.Food that complies with specific [F18legislation in force in the relevant constituent territory of Great Britain] governing food safety shall be deemed to be safe insofar as the aspects covered by the specific F19... provisions are concerned.

8.Conformity of a food with specific provisions applicable to that food shall not bar the competent authorities from taking appropriate measures to impose restrictions on it being placed on the market or to require its withdrawal from the market where there are reasons to suspect that, despite such conformity, the food is unsafe.

F209.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Article 15U.K.Feed safety requirements

1.Feed shall not be placed on the market or fed to any food-producing animal if it is unsafe.

2.Feed shall be deemed to be unsafe for its intended use if it is considered to:

  • have an adverse effect on human or animal health;

  • make the food derived from food-producing animals unsafe for human consumption.

3.Where a feed which has been identified as not satisfying the feed safety requirement is part of a batch, lot or consignment of feed of the same class or description, it shall be presumed that all of the feed in that batch, lot or consignment is so affected, unless following a detailed assessment there is no evidence that the rest of the batch, lot or consignment fails to satisfy the feed safety requirement.

4.Feed that complies with specific [F21legislation in force in the relevant constituent territory of Great Britain] governing feed safety shall be deemed to be safe insofar as the aspects covered by the specific F22... provisions are concerned.

5.Conformity of a feed with specific provisions applicable to that feed shall not bar the competent authorities from taking appropriate measures to impose restrictions on it being placed on the market or to require its withdrawal from the market where there are reasons to suspect that, despite such conformity, the feed is unsafe.

F236.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Article 16U.K.Presentation

Without prejudice to more specific provisions of food law, the labelling, advertising and presentation of food or feed, including their shape, appearance or packaging, the packaging materials used, the manner in which they are arranged and the setting in which they are displayed, and the information which is made available about them through whatever medium, shall not mislead consumers.

Article 17U.K.Responsibilities

1.Food and feed business operators at all stages of production, processing and distribution within the businesses under their control shall ensure that foods or feeds satisfy the requirements of food law which are relevant to their activities and shall verify that such requirements are met.

F242.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F25. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Article 18U.K.Traceability

1.The traceability of food, feed, food-producing animals, and any other substance intended to be, or expected to be, incorporated into a food or feed shall be established at all stages of production, processing and distribution.

2.Food and feed business operators shall be able to identify any person from whom they have been supplied with a food, a feed, a food-producing animal, or any substance intended to be, or expected to be, incorporated into a food or feed.

To this end, such operators shall have in place systems and procedures which allow for this information to be made available to the competent authorities on demand.

3.Food and feed business operators shall have in place systems and procedures to identify the other businesses to which their products have been supplied. This information shall be made available to the competent authorities on demand.

4.Food or feed which is placed on the market or is likely to be placed on the market in [F26Great Britain] shall be adequately labelled or identified to facilitate its traceability, through relevant documentation or information in accordance with the relevant requirements of more specific provisions.

[F275.The appropriate authority may make regulations for the purpose of applying the requirements of this Article in respect of specific sectors.]

Article 19U.K.Responsibilities for food: food business operators

1.If a food business operator considers or has reason to believe that a food which it has imported, produced, processed, manufactured or distributed is not in compliance with the food safety requirements, it shall immediately initiate procedures to withdraw the food in question from the market where the food has left the immediate control of that initial food business operator and inform the competent authorities thereof. Where the product may have reached the consumer, the operator shall effectively and accurately inform the consumers of the reason for its withdrawal, and if necessary, recall from consumers products already supplied to them when other measures are not sufficient to achieve a high level of health protection.

2.A food business operator responsible for retail or distribution activities which do not affect the packaging, labelling, safety or integrity of the food shall, within the limits of its respective activities, initiate procedures to withdraw from the market products not in compliance with the food-safety requirements and shall participate in contributing to the safety of the food by passing on relevant information necessary to trace a food, cooperating in the action taken by producers, processors, manufacturers and/or the competent authorities.

3.A food business operator shall immediately inform the competent authorities if it considers or has reason to believe that a food which it has placed on the market may be injurious to human health. Operators shall inform the competent authorities of the action taken to prevent risks to the final consumer and shall not prevent or discourage any person from cooperating, in accordance with national law and legal practice, with the competent authorities, where this may prevent, reduce or eliminate a risk arising from a food.

4.Food business operators shall collaborate with the competent authorities on action taken to avoid or reduce risks posed by a food which they supply or have supplied.

Article 20U.K.Responsibilities for feed: feed business operators

1.If a feed business operator considers or has reason to believe that a feed which it has imported, produced, processed, manufactured or distributed does not satisfy the feed safety requirements, it shall immediately initiate procedures to withdraw the feed in question from the market and inform the competent authorities thereof. In these circumstances or, in the case of Article 15(3), where the batch, lot or consignment does not satisfy the feed safety requirement, that feed shall be destroyed, unless the competent authority is satisfied otherwise. The operator shall effectively and accurately inform users of the feed of the reason for its withdrawal, and if necessary, recall from them products already supplied when other measures are not sufficient to achieve a high level of health protection.

2.A feed business operator responsible for retail or distribution activities which do not affect the packaging, labelling, safety or integrity of the feed shall, within the limits of its respective activities, initiate procedures to withdraw from the market products not in compliance with the feed-safety requirements and shall participate in contributing to the safety of food by passing on relevant information necessary to trace a feed, cooperating in the action taken by producers, processors, manufacturers and/or the competent authorities.

3.A feed business operator shall immediately inform the competent authorities if it considers or has reason to believe that a feed which it placed on the market may not satisfy the feed safety requirements. It shall inform the competent authorities of the action taken to prevent risk arising from the use of that feed and shall not prevent or discourage any person from cooperating, in accordance with national law and legal practice, with the competent authorities, where this may prevent, reduce or eliminate a risk arising from a feed.

4.Feed business operators shall collaborate with the competent authorities on action taken in order to avoid risks posed by a feed which they supply or have supplied.

F28Article 21U.K.Liability

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F29CHAPTER IIIU.K.EUROPEAN FOOD SAFETY AUTHORITY

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F30CHAPTER IVU.K.RAPID ALERT SYSTEM, CRISIS MANAGEMENT AND EMERGENCIES

SECTION 1U.K.RAPID ALERT SYSTEM

F30Article 50U.K.Rapid alert system

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F30Article 51U.K.Implementing measures

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F30Article 52U.K.Confidentiality rules for the rapid alert system

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

SECTION 2U.K.EMERGENCIES

Article 53U.K.Emergency measures for food and feed F31...

1.[F32Where it is evident that food or feed originating in or entering Great Britain is likely to constitute a serious risk to human health, animal health or the environment, the appropriate authority may make regulations, containing one or more of the following measures, depending on the gravity of the situation—]

(a)in the case of food or feed [F33originating in [F34Great Britain]]:

(i)

suspension of the placing on the market or use of the food in question;

(ii)

suspension of the placing on the market or use of the feed in question;

(iii)

laying down special conditions for the food or feed in question;

(iv)

any other appropriate interim measure;

(b)[F35in the case of food or feed [F36entering Great Britain]]

(i)

suspension of [F37the entry] of the food or feed in question from all or part of the F38... country concerned and, where applicable, from the F38... country of transit;

(ii)

laying down special conditions for the food or feed in question from all or part of the F38... country concerned;

(iii)

any other appropriate interim measure.

[F392A.For the purpose of this Article, “entering Great Britain” means the action of bringing food or feed into Great Britain from any country outside of Great Britain.]

F402.. . . . . . . . . . . . . . . . . .

Textual Amendments

F30Article 54U.K.Other emergency measures

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

SECTION 3U.K.CRISIS MANAGEMENT

F30Article 55U.K.General plan for crisis management

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F30Article 56U.K.Crisis unit

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F30Article 57U.K.Tasks of the crisis unit

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Textual Amendments

CHAPTER VU.K.PROCEDURES AND FINAL PROVISIONS

[F41SECTION 1 U.K. EXERCISE OF THE DELEGATION, COMMITTEE AND MEDIATION PROCEDURES]

[F42 Article 57a U.K. Procedure

1 .Regulations made by the Secretary of State or the Welsh Ministers under this Regulation are to be made by statutory instrument.

2 .For regulations made by the Scottish Ministers under this Regulation, see section 27 of the Interpretation and Legislative Reform (Scotland) Act 2010.

3 .A statutory instrument containing regulations made by the Secretary of State under this Regulation is subject to annulment in pursuance of a resolution of either House of Parliament.

4 .A statutory instrument containing regulations made by the Welsh Ministers under this Regulation is subject to annulment in pursuance of a resolution of Senedd Cymru.

5 .Regulations made by the Scottish Ministers under this Regulation are subject to the negative procedure (see section 28 of the Interpretation and Legislative Reform (Scotland) Act 2010).

6 .Regulations made under this Regulation may—

(a)contain consequential, incidental, supplementary, transitional or saving provision;

(b)make different provision for different purposes.]

F43Article 58U.K.Committee

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F44Article 59U.K.Functions assigned to the Committee

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F45Article 60U.K.Mediation procedure

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[F46[F47SECTION 2U.K.FINAL PROVISIONS]]

F48Article 61U.K.Review clause

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F49Article 62U.K.References to the European Food Safety Authority and to the Standing Committee on the Food Chain and Animal Health

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F50Article 63U.K.Competence of the European Agency for the Evaluation of Medicinal Products

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F51Article 64U.K.Commencement of the Authority's operation

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Article 65U.K.Entry into force

This Regulation shall enter into force on the 20th day following that of its publication in the Official Journal of the European Communities.

Articles 11 and 12 and Articles 14 to 20 shall apply from 1 January 2005.

F52. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F53...

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