Home > Requirements of Food Business Operators (FBOs)

General principles, including FBO responsibilities:

To protect consumers against unsafe food and ensure that all stages of the food life cycle are safe and do not pose a threat to consumer health, the CAC developed the General Principles of Food Hygiene (CAC2003). The principles follow the food chain from primary production to final consumption, highlighting the key hygiene controls at each stage and offering recommendations on establishments, personal hygiene, transportation, and the application of an approach based on the hazard analysis critical control point (HACCP) system.

General rules for FBOs on hygienic foodstuffs:

Principles amplifying the general rules for FBOs on hygienic foodstuffs have been developed in the EU. The main principles are as follows:

• For food that cannot be stored safely at ambient temperatures, particularly frozen food, a cold chain must be maintained.
• The general implementation of procedures based on HACCP principles, together with the application of good hygienic practice, should reinforce FBO responsibility.
• Guides to best practice are a valuable instrument in aiding FBOs at all levels of the food chain to comply with food hygiene rules and in applying HACCP principles.
• Microbiological criteria and temperature-control requirements based on scientific risk assessments must be established.
• Imported foods must meet at least the same hygienic standards as food produced in the EU.

The U.S. food safety system is based on strong, flexible, and science-based state and federal laws and the legal responsibility of the food industry to produce safe foods.13 The system is guided by the following principles:

• Only safe and wholesome foods may be marketed.
• Regulatory decision making in food safety is science based.
• The government has enforcement responsibility.
• Manufacturers, distributors, importers, and others are expected to comply and are liable if they do not.
• The regulatory process is transparent and accessible to the public.

HACCP and the traceability requirement:

All globally recognized food safety management systems (FSMSs) are built on the HACCP risk-based approach, which includes potential hazards analysis and prevention during the production process. HACCP can be applied throughout the food chain, from primary production to final consumption. Beyond enhancing food safety, HACCP implementation provides other significant benefits. Practice has shown that FSMSs based on HACCP open up new international markets for high–value added food products. Such FSMSs also increase the efficiency of domestic markets. Most private standards, including the International Featured Standards, the BRC Global Standards, and International Organization for Standardization (ISO) 22000 developed and recognized by big retailers, are based on HACCP. Thus, compliance with HACCP principles has become obligatory among FBOs who work or plan to work with large regional or global retailers.

The seven HACCP principles, along with additional guidance, are as follows:

• Conduct a hazard analysis
• Determine the critical control points (CCPs)
• Establish critical limits
• Establish a system to monitor CCP control
• Establish the corrective action to be taken if monitoring indicates that a particular CCP is not under control
• Establish validation and verification procedures to confirm that the HACCP system is capable of addressing the issue at hand and working effectively
• Establish documentation on all procedures and recordkeeping relevant to these principles and their application

Traceability:

Food traceability is a recordkeeping tool calibrated to enable specific food items to be followed through all processes until they reach consumers. Traceability has become a legal requirement in most parts of the world. Alone, traceability does not enhance food safety, but it contributes considerably to FSMS efficiency if it is combined with food safety measures, such as those implicit in the HACCP-based approach.

Food labelling:

Food labelling is the primary means of communication linking the producer and the seller of food with the purchaser and consumer of the food. The most important rule of labeling is that the consumer should not be misled.

The core standard is the General Standard for the Labelling of Pre-packaged Food, which applies to the labelling of all pre-packaged foods sold or catered to consumers and covers certain required features of the label. Thus, it establishes the sort of information that must appear on the label of pre-packaged food, such as the name of the food, a list of ingredients, the net contents, the drained weight, the name and address of the final producer or packager, the country of origin, lot identification, date marking, storage instructions, and instructions for use. There may be additional requirements for quantitative ingredient declarations and irradiated food.

Withdrawal and recall:

The withdrawal or recall of unsafe food is one of the core responsibilities of FBOs aiming to protect customers from unsafe food. In cases of withdrawal or recall, FBOs are also responsible for cooperating with the relevant regulatory authorities.

Withdrawal is the removal of a food from the market if the food has been taken to market, but has not yet reached the public. A recall is implemented if the product has reached customers and other measures have not been sufficient to ensure a high level of health protection.

Withdrawal and recall procedures must include steps to inform and collaborate with the relevant regulatory authorities even if the FBO only suspects that the food is not fit for consumption.

Microbiological criteria for food and residues control:

Microbiological criteria play an important role in the validation and verification of HACCP procedures and other hygiene control measures. Thus, appropriate microbiological criteria must be set to determine limits of acceptability, along with food safety microbiological criteria to establish the limits above which a foodstuff should be considered unacceptably contaminated by the microorganisms that are the subject of the criteria.

In general, regulatory authorities or FBOs may use microbiological criteria to distinguish between acceptable and unacceptable raw materials, ingredients, products, or lots. The Codex Alimentarius also emphasizes the importance of microbiological criteria in the verification or validation of the efficacy of HACCP plans.

The regulation requires FBOs to perform tests as appropriate against the microbiological criteria to validate or verify that the procedures are functioning correctly based on HACCP principles and best hygienic practice.

Residues Control:

Residues control aims to protect public safety by setting maximum residue levels (MRLs) in accordance with generally recognized principles of safety assessment, taking into account any other scientific assessment of the safety of the substances concerned that may have been undertaken by international organizations, particularly the CAC.

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