MICROBIOLOGICAL QUALITY AND SAFETY IN DAIRY INDUSTRY

Module 1. Concepts of quality, safety and food laws

Lesson 4
CONSIDERATIONS IN FOOD LAWS AND REGULATIONS

4.1 Introduction

The development of relevant and enforceable food laws and regulations is an essential component of a modern food control system. Food laws traditionally consist of legal definitions of unsafe food and the prescription of enforcement tools for removing unsafe food from commerce and punishing responsible parties for the lapse. Food law generally does not provide punitive powers to the control agencies with a clear mandate and authority to prevent food safety problems. Hence, food safety programmes are reactive and enforcement-oriented rather than preventive and holistic in their approach to reduce the risk of food-borne illness. To the extent possible, modern food laws should not only be permitted with necessary legal powers and prescriptions to ensure food safety, but also allow the competent food authority or authorities to build preventive approaches into the system.

4.2 Definition of Food Standards

In addition to legislation governments need updated 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 In recent years, many highly prescriptive standards have been replaced by horizontal standards that address the broad issues involved in achieving food safety objectives. While horizontal standards are a viable approach to delivering food safety goals, these 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. The horizontal approach makes it possible to take a general overview of a particular situation, and facilitates implementation, particularly for food businesses working in many sectors, including not only manufacturers, but also for commerce and distribution. Similarly, many standards on food quality issues have been cancelled and replaced by labelling requirements. In preparing food regulations and standards countries should take full advantage of Codex standards and food safety 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 both satisfy national needs and meet the demands of the SPS Agreement and trading partners.

4.3 Food Legislation

Food legislation should include the following aspects:

• It must provide a high level of health protection;
• It should be based on high quality, transparent and independent scientific advice following risk assessment, risk management and risk communication;
• It should include provision for the use of precaution and the adoption of provisional measures where an unacceptable level of risk to health has been identified and where full risk assessment could not be performed;
• It should include provisions for labelling the product holistically and for the right of consumers to have access to accurate and sufficient information;
• It should provide for tracing of food products and for their recall in case of problems;
• It should include clear provisions indicating that primary responsibility for food safety and quality rests with producers and processors;
• It should include obligation to ensure that only safe and fairly presented food is placed on the market;
• It should also recognize the country's international obligations particularly in relation to trade and
• It should ensure transparency in the development of food law and access to information.

4.4 General Food Law

Humanity has imbibed certain hygienic practices since man started understanding the value of food. The unstinted quest made the man to have some control over production, processing, supply and consumption of food. The well established practices took the form of accepted laws. The present day governments enacted these laws legally enforceable through various administrative rules and regulations.

4.4.1 Definition of food

Food or foodstuff means any substance or products whether processed, partially processed or unprocessed that will provide sufficient nutrient and is 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.

4.4.2 The main objective of food law

It is to protect both the health and interests of the consumer. Consumer health is assured by the provision of safe food produced with due regard for plant health and the environment. All legislation must aid the free flow of food within the internal market for the general interests of all consumers. Generally, it applies to all stages of production, processing and distribution of food. All food, which is placed on the market, must be fit for human consumption and must not injure human health according to its intended use. The focus on potential injury to health must be both short- and long-term with due regard to subsequent generations and cumulative effects. If any food within any one lot, batch or consignment is unsafe, the entire lot, batch or consignment must be withdrawn from the market. At all times consumer safety being paramount is focused to ensure a high level of protection of human health and consumers' interests in relation to food, taking into account diversity, including traditional products, whilst ensuring the effective functioning of the internal market. If food complies with community provisions but is otherwise deemed unsafe, it should not be placed on the market.

The integrated ‘farm to fork’ approach is considered to be a general principle for food and feed safety policy. It guarantees a high level of safety for foodstuffs and food products marketed within all the stages of production and distribution chains. It involves both food and feed products produced and those imported from other countries.

4.4.3 General principles of food law

The regulation (official order) establishes several basic principles for food to be marketed. Food regulation is principally composed of three distinct areas: general principles of food law; the creation of the Food Safety Authority and the rapid alert system, crisis management and emergencies. The basic principles are outlined in the text below:

4.4.3.1 Food safety

Food is not allowed to be placed on the market if it is unsafe. Food is considered unsafe if it is injurious to health or unfit for human consumption. This general food safety requirement implies that although a product that complies with all specific requirements of food legislation (e.g. contaminants in food, etc.); it is not allowed on the market if a new hazard is found for which no requirements yet exist.

The following assumptions should be checked in order to establish food safety:
a. Unsafe: the normal conditions of use of the food by the consumer at each stage of production, processing and distribution are taken into account as well as the information provided to the consumer.

b. Injurious to health: probable immediate, short term and long term effects (including future generations) of the food to health, probable cumulative toxic effects and particular health sensitivities of a specific category of consumers should be considered.

c. Unfit for human consumption: 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 food that is found to be unsafe is part of a batch, lot or consignment, it is presumed that all the food is unsafe, unless a detailed assessment proves that there is no evidence that the rest of the batch is unsafe. Food that complies with specific requirements on food safety is considered safe in so far as it concerns specific issues for which the requirements are set. If however, despite compliance to these requirements, the competent authorities have reasons to suspect that the food is not safe, they can still require its withdrawal from the market.

4.4.3.2 Responsibilities

Food business operators at all stages of production, processing and distribution of food are primarily responsible for safe food. They have to ensure that food under their control meets all the safety requirements of the law. If the food is unsafe, they cannot place it on the market. Further, they are obliged to withdraw and report to the competent authority if they have suspicion that their food products do not meet the standards.

4.4.3.3 Traceability

The Regulation includes provisions on the traceability of food in the food chain. At all times the origin of food products must be retrieved. Strictly speaking the requirements apply to food and feed businesses (including importers). These people are obliged to:

• know and document from whom they have bought their food (ingredients)
• know and document to whom they supply their products
• Label at length their products so that they can establish traceability in case of a food safety problem.

However, importers are likely to be requested to trace faults in the food chain. Importers are legally responsible for marketing the food and therefore must be able to guarantee that the food brought onto the market meets all requirements.

4.4.3.4 Precautionary principle

The General Food Law establishes that food legislation is based on scientific risk analysis. This analysis consists of risk assessment, risk management and risk communication.

Risk assessments are based on the available scientific evidence and must be undertaken in an independent, objective and transparent manner. Risk management takes the results of the risk assessment into account, but also the opinions of the Food Safety Authority. If after an assessment of available information the possibility of harmful effects on health is identified, but scientific uncertainty persists, provisional measures may be necessary. The findings need to be communicated to the retailer, manufacturer and notified to the consumer. This whole exercise is called the precautionary principle. Such measures need to be proportionate and no more restrictive of trade than is required to achieve the high level of health protection. The measures are reviewed within a reasonable period of time. This period depends on the nature of the risk to health and the type of scientific information needed to clarify uncertainty.

4.4.3.5 Presentation

Food law aims at the protection of the interests of consumers in relation to the foods they consume. Provision of food law about the food labelling, advertising and presentation of food including their shape, appearance, packaging and packaging materials used cannot mislead consumers.

4.4.3.6 Rapid alert system for food and feed (RASFF)

The regulation gives legal effect to RASFF. The regulatory 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, Food Regulatory Authority of India (FRAI). The regulation also confers special powers on taking emergency measures. Where it is evident that food originating in the country, or imported from a another country, is likely to constitute a serious risk to human health, animal health or the environment and that such a risk cannot be contained satisfactorily by means of measures taken by the Member States.

4.4.3.7 Emergency measures

Where it is evident that food originating in the community or imported from another 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 gravity of the situation, emergency measures can take the form (1) of the suspension of the marketing or use of the food in question (2) to subjecting the use and marketing of the food to special conditions.

4.4.3.8 Crisis management

It provides for the creation of a crisis unit. This crisis unit will be set up by the FRAI and will provide scientific and technical assistance if necessary.