LegalizeRegulation (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
CHAPTER I
SCOPE AND DEFINITIONS
Article 1
Aim and scope
It establishes the European Food Safety Authority.
It lays down procedures for matters with a direct or indirect impact on food and feed safety.
Article 2
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;
(i) medical devices within the meaning of Regulation (EU) 2017/745 of the European Parliament and of the Council (5).
Article 3
Other definitions
For the purposes of this Regulation:
‘food law’ means the laws, regulations and administrative provisions governing food in general, and food safety in particular, whether at Community or national level; it covers any stage of production, processing and distribution of food, and also of feed produced for, or fed to, food-producing animals;
‘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;
‘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;
‘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;
‘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;
‘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;
‘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;
‘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;
‘risk’ means a function of the probability of an adverse health effect and the severity of that effect, consequential to a hazard;
‘risk analysis’ means a process consisting of three interconnected components: risk assessment, risk management and risk communication;
‘risk assessment’ means a scientifically based process consisting of four steps: hazard identification, hazard characterisation, exposure assessment and risk characterisation;
‘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;
‘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;
‘hazard’ means a biological, chemical or physical agent in, or condition of, food or feed with the potential to cause an adverse health effect;
‘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;
‘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;
‘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;
‘final consumer’ means the ultimate consumer of a foodstuff who will not use the food as part of any food business operation or activity.
CHAPTER II
GENERAL FOOD LAW
Article 4
Scope
SECTION 1
GENERAL PRINCIPLES OF FOOD LAW
Article 5
General objectives
Article 6
Risk analysis
Article 7
Precautionary principle
Article 8
Protection of consumers' interests
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 1A
RISK COMMUNICATION
Article 8a
Objectives of risk communication
Taking into account the respective roles of risk assessors and risk managers, risk communication shall pursue the following objectives:
(a) raise awareness and understanding of the specific issues under consideration, including in cases of divergences in scientific assessment, during the entire risk analysis process;
(b) ensure consistency, transparency and clarity in formulating risk management recommendations and decisions;
(c) provide a sound basis, including, where appropriate, a scientific basis, for understanding risk management decisions;
(d) improve the overall effectiveness and efficiency of the risk analysis;
(e) foster public understanding of the risk analysis, including of the respective tasks and responsibilities of risk assessors and risk managers to enhance confidence in its outcome;
(f) ensure appropriate involvement of consumers, feed and food businesses, the academic community and all other interested parties;
(g) ensure appropriate and transparent exchange of information with interested parties in relation to risks associated with the food chain;
(h) ensure the provision of information to consumers about risk prevention strategies; and
(i) contribute to the fight against the dissemination of false information and the sources thereof.
Article 8b
General principles of risk communication
Taking into account the respective roles of risk assessors and risk managers, risk communication shall:
(a) ensure that accurate and all appropriate information is exchanged in an interactive and timely manner with all interested parties, based on the principles of transparency, openness, and responsiveness;
(b) provide transparent information at each stage of the risk analysis process from the framing of requests for scientific advice to the provision of risk assessment and the adoption of risk management decisions, including information on how risk management decisions were reached and which factors were considered;
(c) take into account risk perceptions of all interested parties;
(d) facilitate understanding and dialogue amongst all interested parties; and
(e) be clear and accessible, including to those not directly involved in the process or not having a scientific background, while duly respecting the applicable legal provisions on confidentiality and protection of personal data.
Article 8c
General plan for risk communication
The general plan for risk communication shall promote an integrated risk communication framework to be followed both by the risk assessors and the risk managers in a coherent and systematic manner both at Union and national level. It shall:
(a) identify the key factors that need to be taken into account when considering the type and level of risk communication activities needed;
(b) identify the different types and levels of risk communication activities, and the appropriate main tools and channels to be used for risk communication purposes, taking into account the needs of relevant target audience groups;
(c) establish appropriate mechanisms of coordination and cooperation in order to strengthen coherence of risk communication amongst risk assessors and risk managers; and
(d) establish appropriate mechanisms to ensure an open dialogue amongst consumers, food and feed businesses, the academic community and all other interested parties, and their appropriate involvement.
SECTION 2
PRINCIPLES OF TRANSPARENCY
Article 9
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
Public information
Without prejudice to the applicable provisions of Community and national law on access to documents, 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 3
GENERAL OBLIGATIONS OF FOOD TRADE
Article 11
Food and feed imported into the Community
Food and feed imported into the Community for placing on the market within the Community shall comply with the relevant requirements of food law or conditions recognised by the Community to be at least equivalent thereto or, where a specific agreement exists between the Community and the exporting country, with requirements contained therein.
Article 12
Food and feed exported from the Community
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 the Community.
Article 13
International standards
Without prejudice to their rights and obligations, the Community and the Member States shall:
(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 the Community is not reduced.
SECTION 4
GENERAL REQUIREMENTS OF FOOD LAW
Article 14
Food safety requirements
Food shall be deemed to be unsafe if it is considered to be:
(a) injurious to health;
(b) unfit for human consumption.
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.
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.
Article 15
Feed safety requirements
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.
Article 16
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
Responsibilities
For that purpose, they shall maintain a system of official controls and other activities as appropriate to the circumstances, including public communication on food and feed safety and risk, food and feed safety surveillance and other monitoring activities covering all stages of production, processing and distribution.
Member States shall also lay down the rules on measures and penalties applicable to infringements of food and feed law. The measures and penalties provided for shall be effective, proportionate and dissuasive.
Article 18
Traceability
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.
Article 19
Responsibilities for food: food business operators
Article 20
Responsibilities for feed: feed business operators
Article 21
Liability
The provisions of this Chapter shall be without prejudice to Council Directive 85/374/EEC of 25 July 1985 on the approximation of the laws, regulations and administrative provisions of the Member States concerning liability for defective products (6).
CHAPTER III
EUROPEAN FOOD SAFETY AUTHORITY
SECTION 1
MISSION AND TASKS
Article 22
Mission of the Authority
The mission of the Authority shall also include the provision of:
(a) scientific advice and scientific and technical support on human nutrition in relation to Community legislation and, at the request of the Commission, assistance concerning communication on nutritional issues within the framework of the Community health programme;
(b) scientific opinions on other matters relating to animal health and welfare and plant health;
(c) scientific opinions on products other than food and feed relating to genetically modified organisms as defined by Directive 2001/18/EC and without prejudice to the procedures established therein.
It shall act in close cooperation with the competent bodies in the Member States that carry out similar tasks to those of the Authority and, where appropriate, with the relevant Union agencies.
Article 23
Tasks of the Authority
The tasks of the Authority shall be the following:
(a) to provide the Community institutions and the Member States with the best possible scientific opinions in all cases provided for by Community legislation and on any question within its mission;
(b) to promote and coordinate the development of uniform risk assessment methodologies in the fields falling within its mission;
(c) to provide scientific and technical support to the Commission in the areas within its mission and, when so requested, in the interpretation and consideration of risk assessment opinions;
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