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

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

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

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:

(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.

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

(3) The free movement of food and feed within the Community can be achieved only if food and feed safety requirements do not differ significantly from Member State to Member State.

(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.

(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.

(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.

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

(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.

(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.

(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.

(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.

(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 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.

(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.

(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.

(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.

(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 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.

(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.

(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.

(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.

(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 suspect that a food may present a risk to health.

(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.

(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.

(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.

(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 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.

(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.

(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 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 supply chains, which implies wide-ranging responsibilities for the Authority. These should include 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 linked to the safety of the food supply chain should be limited to the provision of scientific opinions. The Authority's mission should also cover scientific advice 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.

(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.

(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(7) and without prejudice to the procedures established therein.

(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.

(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.

(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 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.

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

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

(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 diverging scientific opinions.

(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.

(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.

(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 diverging scientific opinions and, in the event of diverging scientific opinions between scientific bodies, procedures should be in place to resolve the divergence or provide the risk managers with a transparent basis of scientific information.

(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 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 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(8). 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(9).

(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(10), 69/414/EEC(11), and 70/372/EEC(12), 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(13), 86/362/EEC(14), 86/363/EEC(15), 90/642/EEC(16) and 91/414/EEC(17)) on plant protection products and the setting of maximum residue levels.

(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(18).

(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(19). 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(20).

(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,

HAVE ADOPTED THIS REGULATION:

Modifications etc. (not altering text)

C1 Regulation applied (with modifications) (1.10.2023) by The Windsor Framework (Retail Movement Scheme: Public Health, Marketing and Organic Product Standards and Miscellaneous Provisions) Regulations 2023 (S.I. 2023/959), regs. 1(2), 4(a), Sch. 1 (with regs. 7, 8)

CHAPTER I U.K. SCOPE AND DEFINITIONS

Article 1 U.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.

Textual Amendments

F1 Word in Art. 1(1) omitted (31.12.2020) by virtue of The General Food Law (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/641), regs. 1, 6(a); 2020 c. 1, Sch. 5 para. 1(1)

F2 Words in Art. 1(2) omitted (31.12.2020) by virtue of The General Food Law (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/641), regs. 1, 6(b); 2020 c. 1, Sch. 5 para. 1(1)

Article 2 U.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(21) and 92/73/EEC(22);

(e)

cosmetics within the meaning of Council Directive 76/768/EEC(23);

(f)

tobacco and tobacco products within the meaning of Council Directive 89/622/EEC(24);

(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 3 U.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.

[F4 19. “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.]

Textual Amendments

F3 Words in Art. 3(1) omitted (31.12.2020) by virtue of The General Food Law (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/641), regs. 1, 7(a); 2020 c. 1, Sch. 5 para. 1(1)

F4 Art. 3(19)(20) inserted by The General Food Law (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/641), regs. 1, 7(b) (as substituted by S.I. 2020/1504, regs. 1(2), 10(3)); 2020 c. 1, Sch. 5 para. 1(1)

CHAPTER II U.K. GENERAL FOOD LAW

Article 4 U.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.

F5 3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F6 4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F5 Art. 4(3) omitted (31.12.2020) by virtue of The General Food Law (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/641), regs. 1, 8; 2020 c. 1, Sch. 5 para. 1(1)

F6 Art. 4(4) omitted (31.12.2020) by virtue of The General Food Law (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/641), regs. 1, 8; 2020 c. 1, Sch. 5 para. 1(1)

SECTION 1 U.K. GENERAL PRINCIPLES OF FOOD LAW

Article 5 U.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.

F7 2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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 [F8 Great Britain].

Textual Amendments

F7 Art. 5(2) omitted (31.12.2020) by virtue of The General Food Law (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/641), regs. 1, 9(a); 2020 c. 1, Sch. 5 para. 1(1)

F8 Words in Art. 5(3) substituted (31.12.2020) by The General Food Law (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/641), regs. 1, 9(b) (as substituted by S.I. 2020/1504, regs. 1(2), 10(4)); 2020 c. 1, Sch. 5 para. 1(1)

Article 6 U.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.

Textual Amendments

F9 Words in Art. 6(3) omitted (31.12.2020) by virtue of The General Food Law (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/641), regs. 1, 10; 2020 c. 1, Sch. 5 para. 1(1)

Article 7 U.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 [F10 Great 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 [F10 Great 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.

Textual Amendments

F10 Words in Art. 7 substituted (31.12.2020) by The General Food Law (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/641), regs. 1, 11 (as substituted by S.I. 2020/1504, regs. 1(2), 10(5)); 2020 c. 1, Sch. 5 para. 1(1)

Article 8 U.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 2 U.K. PRINCIPLES OF TRANSPARENCY

Article 9 U.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 10 U.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.

Textual Amendments

F11 Words in Art. 10 omitted (31.12.2020) by virtue of The General Food Law (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/641), regs. 1, 12; 2020 c. 1, Sch. 5 para. 1(1)

SECTION 3 U.K. GENERAL OBLIGATIONS OF FOOD TRADE

[F12 Article 11 U.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.]

Textual Amendments

F12 Art. 11 substituted (31.12.2020) by The General Food Law (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/641), regs. 1, 13 (as substituted by S.I. 2020/1504, regs. 1(2), 10(6)); 2020 c. 1, Sch. 5 para. 1(1)

Article 12 U.K. Food and feed exported from [F13 Great Britain]

1. Food and feed exported or re-exported from [F14 Great 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 [F14 Great Britain].

[F15 2. 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.]

Textual Amendments

F13 Words in Art. 12 heading substituted (31.12.2020) by The General Food Law (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/641), regs. 1, 14(a) (as substituted by S.I. 2020/1504, regs. 1(2), 10(7)(a)); 2020 c. 1, Sch. 5 para. 1(1)

F14 Words in Art. 12(1) substituted (31.12.2020) by The General Food Law (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/641), regs. 1, 14(b) (as substituted by S.I. 2020/1504, regs. 1(2), 10(7)(a)); 2020 c. 1, Sch. 5 para. 1(1)

F15 Art. 12(2) substituted (31.12.2020) by The General Food Law (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/641), regs. 1, 14(c); 2020 c. 1, Sch. 5 para. 1(1)

Article 13 U.K. International standards

[F16 The 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 [F17 Great Britain] is not reduced.

Textual Amendments

F16 Words in Art. 13 substituted (31.12.2020) by The General Food Law (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/641), regs. 1, 15(a); 2020 c. 1, Sch. 5 para. 1(1)

F17 Words in Art. 13(e) substituted (31.12.2020) by The General Food Law (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/641), regs. 1, 15(b) (as substituted by S.I. 2020/1504, regs. 1(2), 10(8)); 2020 c. 1, Sch. 5 para. 1(1)

SECTION 4 U.K. GENERAL REQUIREMENTS OF FOOD LAW

Article 14 U.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 [F18 legislation 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.

F20 9. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F18 Words in Art. 14(7) substituted (31.12.2020) by The General Food Law (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/641), regs. 1, 16(a)(i) (as substituted by S.I. 2020/1504, regs. 1(2), 10(9)); 2020 c. 1, Sch. 5 para. 1(1)

F19 Word in Art. 14(7) omitted (31.12.2020) by virtue of The General Food Law (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/641), regs. 1, 16(a)(ii) (as substituted by S.I. 2020/1504, regs. 1(2), 10(9)); 2020 c. 1, Sch. 5 para. 1(1)

F20 Art. 14(9) omitted (31.12.2020) by virtue of The General Food Law (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/641), regs. 1, 16(b); 2020 c. 1, Sch. 5 para. 1(1)

Article 15 U.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 [F21 legislation 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.

F23 6. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F21 Words in Art. 15(4) substituted (31.12.2020) by The General Food Law (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/641), regs. 1, 17(a)(i) (as substituted by S.I. 2020/1504, regs. 1(2), 10(10)); 2020 c. 1, Sch. 5 para. 1(1)

F22 Word in Art. 15(4) omitted (31.12.2020) by virtue of The General Food Law (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/641), regs. 1, 17(a)(ii) (as substituted by S.I. 2020/1504, regs. 1(2), 10(10)); 2020 c. 1, Sch. 5 para. 1(1)

F23 Art. 15(6) omitted (31.12.2020) by virtue of The General Food Law (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/641), regs. 1, 17(b); 2020 c. 1, Sch. 5 para. 1(1)

Article 16 U.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 17 U.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.

F24 2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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

Textual Amendments

F24 Art. 17(2) omitted (31.12.2020) by virtue of The General Food Law (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/641), regs. 1, 18(a); 2020 c. 1, Sch. 5 para. 1(1)

F25 Words in Art. 17 omitted (31.12.2020) by virtue of The General Food Law (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/641), regs. 1, 18(b); 2020 c. 1, Sch. 5 para. 1(1)

Article 18 U.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 [F26 Great 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.

[F27 5. The appropriate authority may make regulations for the purpose of applying the requirements of this Article in respect of specific sectors.]

Textual Amendments

F26 Words in Art. 18(4) substituted (31.12.2020) by The General Food Law (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/641), regs. 1, 19(a) (as substituted by S.I. 2020/1504, regs. 1(2), 10(11)(a)); 2020 c. 1, Sch. 5 para. 1(1)

F27 Art. 18(5) substituted (31.12.2020) by The General Food Law (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/641), regs. 1, 19(b) (as substituted by S.I. 2020/1504, regs. 1(2), 10(11)(b)); 2020 c. 1, Sch. 5 para. 1(1)

Article 19 U.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 20 U.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.

F28 Article 21 U.K. Liability

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

Textual Amendments

F28 Art. 21 omitted (31.12.2020) by virtue of The General Food Law (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/641), regs. 1, 20(a); 2020 c. 1, Sch. 5 para. 1(1)

F29 CHAPTER III U.K. EUROPEAN FOOD SAFETY AUTHORITY

SECTION 1 U.K. MISSION AND TASKS

Article 22 U.K. Mission of the Authority

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

Article 23 U.K. Tasks of the Authority

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

SECTION 2 U.K. ORGANISATION

Article 24 U.K. Bodies of the Authority

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

Article 25 U.K. Management Board

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

Article 26 U.K. Executive Director

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

Article 27 U.K. Advisory Forum

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

Article 28 U.K. Scientific Committee and Scientific Panels

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

SECTION 3 U.K. OPERATION

Article 29 U.K. Scientific opinions

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

Article 30 U.K. Diverging scientific opinions

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

Article 31 U.K. Scientific and technical assistance

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

Article 32 U.K. Scientific studies

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

Article 33 U.K. Collection of data

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

Article 34 U.K. Identification of emerging risks

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

Article 35 U.K. Rapid alert system

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

Article 36 U.K. Networking of organisations operating in the fields within the Authority's mission

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

SECTION 4 U.K. INDEPENDENCE, TRANSPARENCY, CONFIDENTIALITY AND COMMUNICATION

Article 37 U.K. Independence

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

Article 38 U.K. Transparency

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

Article 39 U.K. Confidentiality

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

Article 40 U.K. Communications from the Authority

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

Article 41 U.K. Access to documents

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

Article 42 U.K. Consumers, producers and other interested parties

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

SECTION 5 U.K. FINANCIAL PROVISIONS

Article 43 U.K. Adoption of the Authority's budget

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

Article 44 U.K. Implementation of the Authority's budget

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

Article 45 U.K. Fees received by the Authority

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

SECTION 6 U.K. GENERAL PROVISIONS

Article 46 U.K. Legal personality and privileges

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

Article 47 U.K. Liability

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

Article 48 U.K. Staff

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

Article 49 U.K. Participation of third countries

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

Textual Amendments

F29 Ch. 3 omitted (31.12.2020) by virtue of The General Food Law (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/641), regs. 1, 20(b); 2020 c. 1, Sch. 5 para. 1(1)

F30 CHAPTER IV U.K. RAPID ALERT SYSTEM, CRISIS MANAGEMENT AND EMERGENCIES

SECTION 1 U.K. RAPID ALERT SYSTEM

F30 Article 50 U.K. Rapid alert system

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

F30 Article 51 U.K. Implementing measures

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

F30 Article 52 U.K. Confidentiality rules for the rapid alert system

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

SECTION 2 U.K. EMERGENCIES

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

1. [F32 Where 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 [F33 originating in [F34 Great 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) [F35 in the case of food or feed [F36 entering Great Britain]—]

(i)

suspension of [F37 the 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.

[F39 2A. 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.]

F40 2. . . . . . . . . . . . . . . . . . .

Textual Amendments

F31 Words in Art. 53 heading omitted (31.12.2020) by virtue of The General Food Law (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/641), regs. 1, 20A(a) (as inserted by S.I. 2020/1504, regs. 1(2), 10(13)); 2020 c. 1, Sch. 5 para. 1(1)

F32 Words in Art. 53(1) substituted (18.4.2022) by The Food and Feed Safety (Miscellaneous Amendments and Transitional Provisions) Regulations 2022 (S.I. 2022/377), regs. 1(2), 4(2)(a)

F33 Words in Art. 53(1)(a) substituted (31.12.2020) by The General Food Law (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/641), regs. 1, 20A(b)(ii) (as inserted by S.I. 2020/1504, regs. 1(2), 10(13)); 2020 c. 1, Sch. 5 para. 1(1)

F34 Words in Art. 53(1)(a) substituted (18.4.2022) by The Food and Feed Safety (Miscellaneous Amendments and Transitional Provisions) Regulations 2022 (S.I. 2022/377), regs. 1(2), 4(2)(b)

F35 Words in Art. 53(1)(b) substituted (31.12.2020) by The General Food Law (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/641), regs. 1, 20A(b)(iii) (as inserted by S.I. 2020/1504, regs. 1(2), 10(13)); 2020 c. 1, Sch. 5 para. 1(1)

F36 Words in Art. 53(1)(b) substituted (18.4.2022) by The Food and Feed Safety (Miscellaneous Amendments and Transitional Provisions) Regulations 2022 (S.I. 2022/377), regs. 1(2), 4(2)(c)(i)

F37 Words in Art. 53(1)(b)(i) substituted (18.4.2022) by The Food and Feed Safety (Miscellaneous Amendments and Transitional Provisions) Regulations 2022 (S.I. 2022/377), regs. 1(2), 4(2)(c)(ii)

F38 Word in Art. 53(1)(b)(i)(ii) omitted (31.12.2020) by virtue of The General Food Law (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/641), regs. 1, 20A(b)(iv) (as inserted by S.I. 2020/1504, regs. 1(2), 10(13)); 2020 c. 1, Sch. 5 para. 1(1)

F39 Art. 53(2A) inserted (18.4.2022) by The Food and Feed Safety (Miscellaneous Amendments and Transitional Provisions) Regulations 2022 (S.I. 2022/377), regs. 1(2), 4(3)

F40 Art. 53(2) omitted (31.12.2020) by virtue of The General Food Law (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/641), regs. 1, 20A(b)(iv) (as inserted by S.I. 2020/1504, regs. 1(2), 10(13)); 2020 c. 1, Sch. 5 para. 1(1)

F30 Article 54 U.K. Other emergency measures

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

SECTION 3 U.K. CRISIS MANAGEMENT

F30 Article 55 U.K. General plan for crisis management

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

F30 Article 56 U.K. Crisis unit

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

F30 Article 57 U.K. Tasks of the crisis unit

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

Textual Amendments

F30 Ch. 4 omitted (except Art. 53) (31.12.2020) by virtue of The General Food Law (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/641), regs. 1, 20(c) (as substituted by S.I. 2020/1504, regs. 1(2), 10(12)); 2020 c. 1, Sch. 5 para. 1(1)

CHAPTER V U.K. PROCEDURES AND FINAL PROVISIONS

[F41 SECTION 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.]

Textual Amendments

F42 Art. 57a substituted (31.12.2020) by The General Food Law (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/641), regs. 1, 21(aa) (as inserted by S.I. 2020/1504, regs. 1(2), 10(14)); 2020 c. 1, Sch. 5 para. 1(1)

F43 Article 58 U.K. Committee

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

Textual Amendments

F43 Art. 58 omitted (31.12.2020) by virtue of The General Food Law (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/641), regs. 1, 21(a); 2020 c. 1, Sch. 5 para. 1(1)

F44 Article 59 U.K. Functions assigned to the Committee

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

Textual Amendments

F44 Art. 59 omitted (31.12.2020) by virtue of The General Food Law (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/641), regs. 1, 21(a); 2020 c. 1, Sch. 5 para. 1(1)

F45 Article 60 U.K. Mediation procedure

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Textual Amendments

F45 Art. 60 omitted (31.12.2020) by virtue of The General Food Law (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/641), regs. 1, 21(a); 2020 c. 1, Sch. 5 para. 1(1)

Textual Amendments

F41 Substituted by Regulation (EU) 2019/1243 of the European Parliament and of the Council of 20 June 2019 adapting a number of legal acts providing for the use of the regulatory procedure with scrutiny to Articles 290 and 291 of the Treaty on the Functioning of the European Union (Text with EEA relevance).

[F46 [F47 SECTION 2 U.K. FINAL PROVISIONS]]

F48 Article 61 U.K. Review clause

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Textual Amendments

F48 Art. 61 omitted (31.12.2020) by virtue of The General Food Law (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/641), regs. 1, 21(a); 2020 c. 1, Sch. 5 para. 1(1)

F49 Article 62 U.K. References to the European Food Safety Authority and to the Standing Committee on the Food Chain and Animal Health

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Textual Amendments

F49 Art. 62 omitted (31.12.2020) by virtue of The General Food Law (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/641), regs. 1, 21(a); 2020 c. 1, Sch. 5 para. 1(1)

F50 Article 63 U.K. Competence of the European Agency for the Evaluation of Medicinal Products

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Textual Amendments

F50 Art. 63 omitted (31.12.2020) by virtue of The General Food Law (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/641), regs. 1, 21(a); 2020 c. 1, Sch. 5 para. 1(1)

F51 Article 64 U.K. Commencement of the Authority's operation

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Textual Amendments

F51 Art. 64 omitted (31.12.2020) by virtue of The General Food Law (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/641), regs. 1, 21(a); 2020 c. 1, Sch. 5 para. 1(1)

Article 65 U.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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F52 Words in Art. 65 omitted (31.12.2020) by virtue of The General Food Law (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/641), regs. 1, 21(b); 2020 c. 1, Sch. 5 para. 1(1)

Textual Amendments

F46 Inserted by Regulation (EU) 2019/1243 of the European Parliament and of the Council of 20 June 2019 adapting a number of legal acts providing for the use of the regulatory procedure with scrutiny to Articles 290 and 291 of the Treaty on the Functioning of the European Union (Text with EEA relevance).

F47 Substituted by Regulation (EU) No 652/2014 of the European Parliament and of the Council of 15 May 2014 laying down provisions for the management of expenditure relating to the food chain, animal health and animal welfare, and relating to plant health and plant reproductive material, amending Council Directives 98/56/EC, 2000/29/EC and 2008/90/EC, Regulations (EC) No 178/2002, (EC) No 882/2004 and (EC) No 396/2005 of the European Parliament and of the Council, Directive 2009/128/EC of the European Parliament and of the Council and Regulation (EC) No 1107/2009 of the European Parliament and of the Council and repealing Council Decisions 66/399/EEC, 76/894/EEC and 2009/470/EC.

F53 ...

Textual Amendments

F53 Words in Signature omitted (31.12.2020) by virtue of The General Food Law (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/641), regs. 1, 22; 2020 c. 1, Sch. 5 para. 1(1)

(1)

OJ C 96 E, 27.3.2001, p. 247.

(2)

OJ C 155, 29.5.2001, p. 32.

(3)

Opinion delivered on 14 June 2001 (not yet published in the Official Journal).

(4)

Opinion of the European Parliament of 12 June 2001 (not yet published in the Official Journal), Council Common Position of 17 September 2001 (not yet published in the Official Journal) and Decision of the European Parliament of 11 December 2001 (not yet published in the Official Journal). Council Decision of 21 January 2002.

(5)

OJ L 229, 30.8.1980, p. 11. Directive repealed by Directive 98/83/EC.

(6)

OJ L 330, 5.12.1998, p. 32.

(7)

Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC (OJ L 106, 17.4.2001, p. 1).

(8)

OJ L 228, 11.8.1992, p. 24.

(9)

OJ L 371, 30.12.1987, p. 76.

(10)

OJ L 255, 18.10.1968, p. 23.

(11)

OJ L 291, 19.11.1969, p. 9.

(12)

OJ L 170, 3.8.1970, p. 1.

(13)

OJ L 340, 9.12.1976, p. 26. Directive as last amended by Commission Directive 2000/57/EC (OJ L 244, 29.9.2000, p. 76).

(14)

OJ L 221, 7.8.1986, p. 37. Directive as last amended by Commission Directive 2001/57/EC (OJ L 208, 1.8.2001, p. 36).

(15)

OJ L 221, 7.8.1986, p. 43. Directive as last amended by Commission Directive 2001/57/EC.

(16)

OJ L 350, 14.12.1990, p. 71. Directive as last amended by Commission Directive 2001/57/EC.

(17)

OJ L 230, 19.8.1991, p. 1. Directive as last amended by Commission Directive 2001/49/EC (OJ L 176, 29.6.2001, p. 61).

(18)

OJ L 184, 17.7.1999, p. 23.

(19)

OJ L 214, 24.8.1993, p. 1. Regulation amended by Commission Regulation (EC) No 649/98 (OJ L 88, 24.3.1998, p. 7).

(20)

OJ L 224, 18.8.1990, p. 1. Regulation as last amended by Commission Regulation (EC) No 1553/2001 (OJ L 205, 31.7.2001, p. 16).

(21)

OJ 22, 9.2.1965, p. 369. Directive as last amended by Directive 93/39/EEC (OJ L 214, 24.8.1993, p. 22).

(22)

OJ L 297, 13.10.1992, p. 8.

(23)

OJ L 262, 27.9.1976, p. 169. Directive as last amended by Commission Directive 2000/41/EC (OJ L 145, 20.6.2000, p. 25).

(24)

OJ L 359, 8.12.1989, p. 1. Directive as last amended by Directive 92/41/EEC) (OJ L 158, 11.6.1992, p. 30).