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ANNEX 6. Guidelines for Developing a National Food Law

The original 1976 FAO/WHO Guidelines for Developing an Effective National Food Control System contained a Model Food Law that has been used in many developing countries. Unfortunately this model has not always been appropriate because its precepts are not consistent with all legal systems. Many concepts and issues in food law have evolved over time and these were not reflected in the Model Food Law. In addition, strict adherence to the terms of the Model Food Law meant that many countries left out provisions, concepts and standards that their individual circumstances, administrative structures and legal frameworks required.

In this document, a set of guiding principles have been prepared. These principles describe a general approach to the drafting of food legislation, and as such they should be applicable to different legal systems. There is no substitute, however, for an in-depth analysis of the legal framework and the institutional set-up that directly or indirectly govern food production, import, export, distribution, handling and sale in a particular country. Only in that way can the particular and unique national needs be met.

In addition to legislation, governments need updated and internationally accepted food standards. In recent years, many highly prescriptive standards have been replaced by horizontal standards that address the broad issues involved in achieving food safety and quality objectives. While horizontal standards are a viable approach to delivering food safety goals, they require a food chain that is highly controlled and supplied with good data on food safety risks and risk management strategies and as such may not be feasible for many developing countries.

In preparing food regulations and standards, countries should take full advantage of Codex standards and food safety and quality lessons learned in other countries. Taking into account the experiences in other countries while tailoring the information, concepts and requirements to the national context is the only sure way to develop a modern regulatory framework that will satisfy both national needs and meet the demands of the SPS Agreement, TBT Agreement and trading partners.

Form and Content of Food Law

Legal provisions relating to food regulate specific activities, namely the production, processing and sale of food. Such provisions are designed with specific purposes, such as health protection and/or the promotion of fair trade in food commodities. Most commonly, they are contained in a general law covering all food products. The law addresses specific aspects of food safety, food adulteration, food quality and food control, such as inspection, the use of additives, prevention of food contamination, food labelling and import controls.

Most modern food legislation consists of a basic law upon which all other regulatory instruments are based. However, a number of countries have enacted, side by side with this basic law concerning food products in general, other laws governing either a distinct sector of food law, certain types of food processing or specific legal aspects of the production of or trade in foodstuffs.

The general form of the basic law depends on the legislative traditions of the particular country. One established practice in highly industrialized common law countries is to enact comprehensive and detailed texts which bring together practically all general provisions which may concern food. In such cases there is little left for the administrative authorities to do beyond prescribing the technical procedures for enforcement and detailed provisions in respect of particular foods.

An alternative approach is to limit the contents of the basic law to the enabling provisions (i.e. those that set up the administrative structures to enforce the law), together with a few very general principles. This approach is to be found in less developed countries, as well as in many countries where Roman, German or Scandinavian law prevails. This system has an inherent flexibility in that, within the general framework laid down by the law, the necessary powers are delegated to the appropriate authority to make rules governing the administration of the law, and to prescribe technical regulations and standards for specific foods.

Another advantage of this second approach, in all legal systems, is that because the law is basic and all details are confined to the regulations and standards, changes can be made more easily and quickly. For example, regulations and standards may need to be changed in response to scientific advancements, and rather than approaching Parliament to amend the law, the relevant Minister or Ministers usually have the power to issue any appropriate regulations or schedules and can therefore act to take account of the new developments.

In principle, there are eight categories of provisions to be found in a basic food law:

(a) Scope and Definitions

The first category describes the ambit of the law and provides the tools for its interpretation. A provision in the food law stating its purpose, objectives and/or scope must clearly precede all others. This provision may have no real legal effect, but instead operates as a kind of policy statement explaining why the law was enacted and what purpose it is intended to serve. It also can state the areas covered by the law.

Countries often include a list of definitions of the main terms employed. In drafting the definitions, internationally agreed sources should be consulted, along with other national legislation on related issues. It must be emphasized that the list of definitions is not a glossary of food control terms in general. Those definitions that are included must be only those that appear in the body of the law. The definitions should not be overly detailed but should be designed solely for the purpose of application and interpretation of the law in question. In particular, the definitions should be drafted with consideration to who might challenge the law at some future date. For example, if the law contains a definition of to sell that provides that to sell means to exchange for money, and if the law prohibits selling adulterated food, then someone charged with violating the law might hide proof of sale and attempt to argue that since he or she gave away the food for free (and not for money) the law was not violated.

(b) General Principles

In some legal systems, the basic food law contains a group of provisions articulating general principles that will govern the food control system. For example, the law may provide that all food in circulation in the country must be safe for human consumption, or the law may prohibit the adulteration of food. Other provisions may set out the basic rules to be observed by all persons engaged in the production, processing or sale of food. It should be borne in mind, however, that there exist many differences between countries. Some countries have a detailed statement of principles in the basic law, whilst others leave these principles to be laid down in general enforcement regulations, and still others include only a statement of objectives and purposes (as outlined above) and do not elaborate principles at all.

(c) Enabling Provisions

Every law must define the nature and the limits of the powers to be exercised under it and should designate the public authorities in whom those powers are to be vested. There are two categories of powers, namely formulation and control, which are usually not delegated to the same authority and which are not necessarily exercised at the same level of authority. Naturally, the law must also establish guidelines for and limitations on the exercise of these powers. Such enabling provisions establish the legality of the enforcement rules made by the executive authority and also protect private persons against that authority's arbitrary or excessive use of its powers.

The powers vested in the government or executive authority under these enabling provisions relate to the formulation of rules for the implementation of the law and for the intervention of the authority in order to ensure that the laws and its accompanying regulations are being observed.

(d) Administrative Provisions

Most food laws contain a category of provisions that set up particular administrative structures to carry out the activities necessary to enforce the law. For example, the law may establish a Food Control Agency, which brings together the many official actors from various ministries who are implicated in food control in the country. The food law does not usually delve into great detail on the functioning of the Food Control Agency, but instead describes its mandate, defines its membership, outlines some basic rules regarding the appointment and resignation of members and the establishment of technical committees, and provides for a Secretariat, if any. The law may provide that all other details that will govern the actions of the Food Control Agency will be established by regulation or by by-laws elaborated by the Agency itself. Other administrative structures that may or may not be created or defined in the food law are an inspection service and a licensing authority (for example to grant licenses to food manufacturers or importers). The law may also empower the Agency to delegate or license certain types of enforcement activities to different government agencies.

(e) Enforcement Provisions

Because no penalty may be imposed except by virtue of legal authority, food laws contain provisions delegating to an executive authority the power to sanction as well as to take preventive measures in the public interest. It goes without saying that the limits of such powers and the conditions governing their exercise must be laid down with precision in the basic law. Offences must be defined, along with the nature and limits of the penalties that may be imposed, together with the procedures for such imposition once the commission of an offence has been duly established. The law may also outline other necessary measures for the protection of the public, such as the seizure and confiscation of suspect food or the recall of products. It should be noted, however, that in some countries, specific offences and penalties are not elaborated, but instead the food law simply refers to the general provisions of the Criminal Code and the Code of Criminal Procedure.

With the trend away from an enforcement-oriented approach in food control, some countries have incorporated concepts from food control, such as HACCP, into their food laws. In general this may be achieved through the subsidiary regulations more than through the law, as the regulations may consist of elements such as guidelines for the inspection service. Under a purely enforcement-oriented approach, improper activities (packaging, transportation, etc.) would be described in the law, and any violation would be perceived and acted upon by an inspector so charged by the law. With a more collaborative and preventive approach, the inspectors might instead be charged with simply controlling the fact that a food enterprise is exercising its own controls on its production systems.

(f) Substantive Provisions

The food law will contain many substantive provisions relating to food control, production, import, export, transport, distribution and sale. These provisions may be very basic ("all food in the country must be safe for human consumption"), or may be more detailed, in which case the details are more likely to be found in the subsidiary legislation. For example, the regulations issued under the food law may outline all the precise information that must be contained on food labels (weight, name of manufacturer, sell-by date, etc.) and may even contain model labels in a specific format that must be followed throughout the country.

(g) Regulations

In most legal systems, the food law contains a provision or provisions listing the many subject matters that the Minister may address through regulations in order to carry out the purposes of the law. The main advantage of the regulations is that they can be easily changed. The list of regulations may be extremely detailed or it may simply give broad outlines to the kinds of topics that the Minister may address. In either case, the Minister's powers are rarely limited, as in almost all cases the food law will contain a general statement that the Minister may "make all regulations he or she deems necessary to achieve the purposes of this law."

(h) Repeal and Savings

Where a new food law makes significant changes to the food control system, existing laws or regulations may have to be amended or repealed. In such cases the food law will have to list which provisions in which other laws are to be repealed or altered. However, in order not to dismantle the food control system entirely, many laws contain a provision stating that any regulations made under any provision repealed under the new law remain effective, just as if they had been issued under the new food law itself.

Form and Content of Food Regulations

As noted, the topics that may be addressed by regulations made by the executive authority under the basic law may be very broad. Generally, they fall into four categories:

(a) Regulations Affecting Food Products in Genera

Usually the purpose of this category of regulations is to establish general rules regulating the contents, handling, packaging and labelling of food products. These kinds of regulations are of particular importance in countries which do not include in the basic law rules governing the manufacture, processing and sale of food but leave it to the Minister to introduce detailed regulations. But whether or not general principles are laid down in the basic law, in one way or another a government authority must be entrusted with their implementation at the technical level.

(b) Regulations Affecting Specific Food Products

In many countries the provisions peculiar to each food may constitute specific and distinct regulations (for example novel foods, baby foods, special dietetic foods). The practice has developed in some other countries, however, of grouping such provisions, under different headings, into a comprehensive set of regulations governing food. Here, the legislative traditions may vary appreciably from one country to another.

(c) Regulations for Organizational or Coordinating Purposes

Although the main body of regulations putting into effect the food law will fall into the above two categories, there are a great number of internal regulations or 'house' rules that are of no direct concern to the public but which are required for the efficient operation of the administrative units created or empowered under the law. For example, regulations may address the functioning of the Food Control Agency, if any; the issuance, suspension and revocation of licenses of various kinds; the conduct of the inspection and analysis services; and so forth.

(d) Schedules

Many countries include detailed schedules among the subsidiary legislation to the basic food law. These will contain, for example, lists of inspection and sampling/analysis fees; models for application forms or certificates used under the law; and other detailed matters.

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