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Regulation (EC) No. 178/2002 of the European Parliament and of the Council, 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 aim of this regulation is to ensure a high level of health protection and consumer's interests. It establishes common principles and responsibilities, efficient arrangements and procedures concerning food and feed safety. If feed is unsafe, the food derived from food-producing animals that have been fed by the unsafe feed is regarded unsafe for human consumption as well.

The definitions of food, food law, food business operator (FBO), risk, hazard, traceability or primary production may be found in the Regulation.

Precautionary principle

If, 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 may be adopted. This means that if there is a reason to believe that a foodstuff an FBO possesses is unsafe, the FBO shall stop placing the foodstuff into circulation until it is sure that the foodstuff is safe.

Protection of consumer's interests

The aim is to protect the interests of consumers and to provide a basis for consumers to make informed choices in relation to the foods they consume. It shall also aim at the prevention of:

• fraudulent or deceptive practices;

• food adulteration;

• any other practices that may mislead the consumer.

If food is not safe, it must not be placed on the market.

Food is not regarded as safe if it is harmful to health or not suitable for human consumption.

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

• normal conditions of use of the foodstuff by the consumer;

• normal conditions of use of the foodstuff at each stage of production, processing and distribution;

• 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 effect from a particular food or category of foods.

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

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

• probable cumulative toxic effects;

• particular health sensitivities of a specific category of consumers where the food is intended for that category;

In determining whether any food is unfit for human consumption, regards 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.

Misleading consumers 

The consumer shall not by misled by:

• labelling, advertising or presentation of food;

• shape, appearance of packaging of food, used packaging materials, or the means of its presentation;

• location of display;

• information about food provided by any media.

Obligations of FBOs

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.

Responsibilities of FBOs

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;

• 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. If necessary, recall from consumer products already supplied to them.

If a foodstuff is or may be harmful to human health:

• inform the competent authorities of the measurements (whose aim is to prevent risks for consumers);

• collaborate with the competent authorities to solve the situation.

Traceability

To put it simply, the origin of all the substances incorporated into food must be known – when, where and what has been added, and by whom.

What?

• 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.

By whom? (Step back)

• 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 whom? (Step forward)

• Food and feed business operators shall have in place systems and procedures to identify the other businesses to which their products have been supplied.

The information by whom and to whom a food /a feed / a food-producing animal / a substance has been supplied shall be made available to the competent authorities on demand.

Food or feed which is placed on the market or is likely to be placed on the market in the European Union 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.

Moreover, the European Food Safety Authority, its role and modus operandi, and the rapid alert system RASFF – Rapid Alert System for Food and Feed – are defined in this legal provision. RASFF is an information system in which all the countries of the European Union are engaged. The purpose of the system is to efficiently exchange information concerning the dangerous food and feed that pose a threat to consumers' health and that have been found on the market within the European Union.