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7. ANEXOS

7.6. Anexo F Programa de IIS e IM relacionados con actividades del CAM

All food businesses will need to have adequate control throughout their business for the consistent production of safe and suitable food. A regulation is proposed that will set out minimum requirements for production, processing and handling, such as appropriate process control and corrective actions.

This regulation is necessary to ensure that businesses minimise the risk of contamination or deterioration of food on receipt and during production, processing and handling, as

applicable.

To ensure food is safe and suitable, it is proposed that a regulation requires food business operators to:

• protect food from contamination (refer to proposals on regulations for supporting systems);

• effectively control food processing parameters;

• regularly monitor that processing and handling practices operate as intended; and where appropriate:

• design and implement production, processing and handling practices; • supervise food processing and handling practices;

• have systems in place to monitor specific food safety and suitability factors; • check finished products for food safety hazards;

• document procedures and keep records; and • take corrective action.

Control of hazards

Biological hazards: microbiological hazard control

A regulation is proposed to require that the food business operator takes all practicable measures to:

• eliminate or control the level of any micro-organisms, particularly harmful pathogens, that may be present on the food for example through processes such as:

- heat treatment; - chilling and freezing;

- fermentation and acidification; - drying and concentration; - high pressure processing; and

• protect the food from the likelihood of contamination at any stage.

This regulation is necessary because pathogenic micro-organisms may be present in food and can be transferred from one food to another (e.g. from raw to cooked food), either by direct contact between the foods or by contact with shared surfaces.

For separate consultation:

Further requirements about managing the level of pathogens in food may also be identified either:

• proactively, as part of a strategic approach; or

• as a consequence of a food-borne event involving a particular organism.

Where necessary, requirements would specify the types of food, the particular organisms of interest, and the level (if any) at which they might be permitted in the food.

Biological hazards: time and temperature control

In addition to the general requirements above, there will be a requirement that the temperature of the food is controlled effectively wherever it is critical to the food’s safety and/or

suitability.

When processing and handling food that will not undergo further pathogen controls, the time the food remains at temperatures that permit the growth of pathogenic micro-organisms must be minimised.

To support innovation, these requirements will provide for equivalent alternatives to be employed.

This regulation is necessary to ensure that bacteria do not get a chance to multiply to dangerous levels or to form toxins.

For separate consultation:

Further requirements setting out time and temperature requirements for particular foods or processes may also be set, for example:

• reheating; • hot holding; • pasteurisation; and

• post-heat treatment cooling.

Physical and chemical hazard control

Allergens: Regulation will require that there is a system in place to ensure allergenic food is effectively separated from other foods, either physically or by time, with effective cleaning between processes and, where necessary, sanitation.

Physical: The provisions will require that the operator takes all practicable measures to control physical hazards that are reasonably likely to occur; e.g. foreign matter (such as glass, metal or stones). In manufacturing and processing, suitable detection or screening devices will be required where appropriate.

Chemical: Requirements proposed for managing chemical hazards from cleaning chemicals, pest control chemicals and maintenance compounds used in the business are addressed in “Regulations that relate to supporting systems” (page 41).

Requirements proposed for managing chemical contaminants in ingredients and other inputs are addressed in “Regulations that relate to finished products” (page 50).

Validation

Validation is a process by which evidence is obtained to demonstrate that food will be safe. Food business operators can demonstrate to the registration authority that food will be safe by showing that a regulatory limit has been met. Where there is no regulatory limit relevant to a food safety hazard, the operator has to identify a limit that will address the hazard.

The requirement to validate would typically apply when an operator is introducing a new cooking or processing step, or is applying a new technology (e.g. high pressure processing), or is developing novel products, processes and packaging.

A regulation is proposed to require the food business operator to:

• identify the relevant critical, regulatory or operator-defined limits that need to be validated for each food (or food group), packaging and hazard combination; and

• obtain evidence to demonstrate that the process is effective at managing that hazard. Where that evidence is not yet available, the operator will be required to develop a validation protocol and submit it to an evaluator.

The validation protocol is likely to include:

• types of evidence to be collected to demonstrate limits that ensure safety have been met; • trial design, implementation and timeframe;

• options for the management of the food until the effectiveness of the plan has been demonstrated; and

• analysis and reporting of results.

What do you think?

35.Are these proposed requirements sufficient to manage food safety and suitability as it applies to production processing and handling? If not, please identify the additional requirements needed, and explain why.