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Section III
Technical Data Sheets


Technical Data Sheet n°1
Health guarantees in the agribusiness sector -
a brief overview of the latest Community
regulations and self-regulation


Food legislation is one of the sectors that has been most heavily influenced by Community law, with more than four hundred regulatory provisions (regulations, directives, etc.) having been promulgated to harmonise the food legislation of individual Member States and to allow the free movement of food products within the Community market.

    N.B.: As a result of European Commission proposals, Community health legislation in the agribusiness sector will change in the year 2000. The following text is meant to serve only as a guide, even though a number of the elements contained in it are not expected to change.

The changes will involve both the “vertical” standards that govern each product or specific sector and the “horizontal” standards that govern general aspects common to all products, such as labelling or establishing uniform criteria for carrying out official controls.

The numerous Community provisions include two directives on official food controls (Directive 89/397 of 14.06.89 and directive 93/99/EEC of 29.10.93), as well as the directive on food hygiene (Directive 93/43/EEC of 14.06.93), which are due to have a more far-reaching impact on the activities of the prevention departments of the competent supervisory bodies.

The role entrusted to producers in the general control system is the most novel element of these directives.

A typical feature of the Community regulations is to increase the responsibilities of company managers, based on the fact that appropriate and ongoing measures to eliminate or reduce hazards can be guaranteed only by the businesses themselves internally.

According to this rationale, the producer is no longer subject only to constraints and obligations, but also plays an active role in, and has direct responsibility for, the adoption of measures to ensure food health safety. Indeed he is obliged to control the entire processing procedure, to identify the phases critical to food safety and to adopt appropriate monitoring and control measures, in line with the principles of the Hazard Analysis Critical Control Point system (H.A.C.C.P.).

For today’s producers “process control” essentially means preserving the integrity and guaranteeing the hygiene of its food products.

In other words, they must not only control the infamous “invariable factors” (criteria imposed by the laboratories), but also the “variable factors” (management) as well as pay special attention to safety and hygiene, which are both subject to controls on the basis of specific criteria.



In today’s society, nutrition is indeed playing an increasingly strategic role that hinges on two major elements:

  • product quality;
  • consumer safety.

Self-regulation is now an essential requirement for obtaining Community recognition, and European inspectors control the existence and conformity of self-regulation procedures in the food industry.

Self-regulation relies on the principle of an “obligation to guard against health hazards”. Production costs must also include the hygiene guarantees provided by food companies.

Guaranteeing health quality entails controlling the entire production cycle, the chemical, physical and bacteriological aspects of raw materials and of semi-finished products, production methods, storage, transport and, last but by no means least, product control.

Periodic controls and analyses must be carried out to verify the system’s effectiveness.

For food companies, guaranteeing the safety of food products and their compliance with health requirements is the best guarantee of hygiene and safety for consumers.

For producers, this means:

  • adapting production structures and phases to comply with the legislation;
  • training their personnel properly;
  • basing their business on sound control methods.

Official controls are the responsibility of the Health Ministry, but if self-regulation is properly managed, such official controls will become more targeted, fewer in number and less costly.


Community Directive 93/43 on food hygiene and self-regulation

Community Directive 93/43 on food hygiene stipulates that traders must adopt specific self-regulation procedures that involve identifying the critical points in their business activities.

The objective is therefore to actively involve business managers in determining and maintaining optimum health and hygiene conditions.



The method for introducing self-regulation is called H.A.C.C.P. (Hazard Analysis Critical Control Point).

The H.A.C.C.P. system is applied using a logical sequence of 12 different phases, hinging on seven basic principles.

Developing the system involves:

  • analysing potential food hazards;

  • identifying any points where there is a potential food hazard;

  • adopting decisions with regard to any critical points that have been identified which are liable to jeopardise food safety;

  • identifying and applying procedures to control and monitor these specific critical points;

  • periodically re-examining and, should the food company’s activities change, analysing any food hazards, critical points and control and monitoring procedures.

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