Regulation (EC) No 178/2002 sets out the basic principles of food law to protect human health and consumer interests.
It applies to all stages of production, processing and distribution of food and feed.
This legislation places the primary responsibility for compliance with food law on the food business operator.
It is an important piece of legislation to be aware of as a food business. Below is an overview of what is covered by this legislation.
Food, food business and food business operator definitions
Food is any substance or product, whether processed, partially processed or unprocessed, intended to be, or reasonably expected to be ingested by humans.
- chewing gum, and
- any substance, including water, intentionally incorporated into the food during its manufacture, preparation or treatment
Food does not include:
- live animals unless they are prepared for placing on the market for human consumption
- plants prior to harvesting
- medicinal products within the meaning of Council Directives 65/65/EEC1 and 92/73/EEC
- cosmetics within the meaning of Council Directive 76/ 768/EEC
- tobacco and tobacco products within the meaning of Council Directive 89/622/EEC
- 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
- residues and contaminants
Food business is 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
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.
It is illegal to place food on the market if it is unsafe.
Food is unsafe if it is considered:
- injurious to health
- unfit for human consumption
To determine if a food is unsafe, you must consider:
- the normal conditions of use of the food by the consumer and at each stage of production, processing and distribution, and
- 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
To determine if a food is injurious to health, you must consider:
- not only 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
- the probable cumulative toxic effects
- the particular health sensitivities of a specific category of consumers where the food is intended for that category of consumers
To determine if a food is unfit for human consumption, you must consider if 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.
If the unsafe food is part of a batch, lot or consignment of food of the same class or description, then 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.
Traceability and recall and withdrawal of unsafe food
Food must be fully traceable at all stages of production, processing and distribution.
You must apply at least the ‘one step forward, one step back approach’ to traceability.
This means that you must be able to identify:
- who supplied you with food or ingredients
- who you supplied food or ingredients to (if you supply other food businesses)
Having a good traceability system means that you can respond quickly if there is a food incident or if you have identified a food as unsafe.
You must also know what to do if you have identified a food as unsafe. In this case the food must be either recalled or withdrawn from the market.
Get more detailed information on how to carry out a food recall or withdrawal in our Guidance Note No. 10.
Visit our section on traceability for information on what you must do and what records must be kept.
The Regulation establishes the principle of risk analysis and its three inter-related components i.e. risk assessment, risk management and risk communication in relation to food safety.
Risk assessment must be based on the available scientific evidence and undertaken in an independent, objective and transparent manner.
Risk management must take into account the results of risk assessment, and the opinions of EFSA as well other factors which may be relevant to the matter under consideration.
Risk communication must ensure that all appropriate information is exchanged accurately and in a timely manner with all interested parties, based on the principles of transparency, openness, and responsiveness.
The Precautionary Principle is set out as an option where, following an assessment of available information, possible harmful effects on health are identified but there is still scientific uncertainty.
In these cases, provisional risk management measures based on the precautionary principle may be made.
In 2000, the European Commission issued a Communication on the Precautionary Principle. The objective of the Communication is to outline the Commission's approach to using the precautionary principle and to establish Commission guidelines for applying it.
The Regulation establishes a framework for the greater involvement of stakeholders in the development of food law and establishes that there should 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).
Rapid Alert System for Food and Feed (RASFF)
The Regulation gives legal effect to RASFF. The system deals with the obligatory notification of any direct or indirect risk to human health, animal health or the environment within a network consisting of national competent authorities, EFSA and the European Commission.
Get more information on RASFF on the European Commission website.
Where it is evident that food or feed originating in the EU or imported from a third country is likely to constitute a serious risk to human health, animal health or the environment, and when such a risk cannot be contained satisfactorily by means of measures taken by the Member States concerned, the Commission can on its own initiative or at the request of a Member State (and following the procedure set out in the Regulation), immediately adopt certain measures set out in the Regulation.
Depending on the seriousness of the situation, emergency measures can take the form of the suspension of the marketing or use of the feed or food in question to subjecting the use and marketing of the feed or food to special conditions.
Visit our import/export section for more details on emergency measures.
Under this legislation, the Commission must draw up a general plan for crisis management for food safety.
This must be done in close collaboration with the European Food Safety Authority (EFSA) and EU Member States.
Decision (EU) 2019/300 establishes this plan. It covers the following two types of situations:
(a) Situations requiring enhanced EU coordination; and
(b) Situations requiring the setting up of a crisis unit bringing together the EU Commission as well as relevant Member States and EU agencies
The plan also sets out the practical procedures necessary for enhanced preparedness and for the management of incidents at EU level, including a communication strategy in accordance with the principle of transparency.
The plan applies to situations involving direct or indirect risks to public health deriving from food and feed, in particular in relation to any hazard in food and feed of biological, chemical and physical nature, which are not likely to be prevented, eliminated or reduced to an acceptable level by provisions in place or cannot adequately be managed solely by way of application of emergency measures.
Key responsibilities of food business operator
EU guidance document covering imports, exports, recall, traceability and responsibilities
FSAI Guidance Note No. 10 on product recall and traceability