Historial: ena12004HACCP

ANNEX I

HAZARD ANALYSIS AND CRITICAL CONTROL POINTS -HACCP- PRINCIPLES AND GUIDELINES FOR THEIR APPLICATION

These guidelines are meant for those food business operators applying a procedure based on HACCP principles.

General principles

HACCP is science based and systematic, identifies specific hazards and measures for their control to ensure the safety of food. HACCP is a tool to assess hazards and establish control systems that focus on prevention rather than relying mainly on end-product testing. Any HACCP system is capable of accommodating change, such as advances in equipment design, processing procedures or technological developments.

HACCP can be applied throughout the food chain from primary production to final consumption and its implementation should be guided by scientific evidence of risks to human health. As well as enhancing food safety, implementation of HACCP can provide other significant benefits, such as the application of HACCP can aid inspection by regulatory authorities and promote international trade by increasing confidence in food safety.

The successful application of HACCP requires the full commitment and involvement of management and the work force. It also requires a multidisciplinary approach; this multidisciplinary approach should include, when appropriate, expertise in agronomy, veterinary hygiene, production, microbiology, medicine, public health, food technology, environmental health, chemistry and engineering.

Prior to application of HACCP to any business the food business operator should have implemented the prerequisite food hygiene requirements. Management commitment is necessary for implementation of an effective HACCP. During hazard identification, evaluation, and subsequent operations in designing and applying HACCP, consideration must be given to the impact of raw materials, ingredients, food manufacturing practices, role of manufacturing processes to control hazards, likely end-use of the product, categories of consumers of concern, and epidemiological evidence relative to food safety.

The intent of HACCP is to focus control at critical control points (CCP’s). HACCP should be applied to each specific operation separately. The HACCP application should be reviewed and necessary changes made when any modification is made in the product, process, or any step. It is important when applying HACCP to be flexible where appropriate, given the context of the application taking into account the nature and the size of the operation.

HACCP consists of the following seven principles:

(1) identifying any hazards that must be prevented, eliminated or reduced to acceptable levels (hazard analysis);

(2) identifying the critical control points at the step or steps at which control is essential to prevent or eliminate a hazard or to reduce it to acceptable levels;

(3) establishing critical limits at critical control points which separate acceptability from unacceptability for the prevention, elimination or reduction of identified hazards;

(4) establishing and implementing effective monitoring procedures at critical control points;

(5) establishing corrective actions when monitoring indicates that a critical control point is not under control;

(6) establishing procedures, which shall be carried out regularly, to verify that the measures outlined in paragraphs 1 to 5 are working effectively;

(7) establishing documents and records commensurate with the nature and size of the food business to demonstrate the effective application of the measures outlined in paragraphs 1 to 6.



It is recommended to proceed to the following activities in sequence.

1. HAZARD ANALYSIS

1.1. Assembly of a multidisciplinary team (HACCP team)

This team, which involves all parts of the food business concerned with the product, needs to include the whole range of specific knowledge and expertise appropriate to the product under consideration, its production (manufacture, storage, and distribution), its consumption and the associated potential hazards and should also involve as much as possible the higher management levels.

Where necessary, the team will be assisted by specialists who will help it to solve its difficulties as regards assessment and control of critical points.

The team may include specialists:

- who understand the biological, chemical or physical hazards connected with a particular product group,

- who have responsibility for, or is closely involved with, the technical process of manufacturing the product under study,

- who have a working knowledge of the hygiene and operation of the process plant and equipment,

- any other person with specialist knowledge of. microbiology, hygiene or food technology.

One person may fulfill several of these roles, provided all relevant information is available to the team and is used to ensure that the system developed is reliable. Where expertise is not available in the establishment, advice should be obtained from other sources (consultancy, guides of good hygiene practices, etc.).

The scope of the HACCP plan should be identified. The scope should describe which segment of the food chain is involved, which process of the business and the general classes of hazards to be addressed (biological, chemical and physical).

1.2. Description of the product

A full description of the product should be drawn up, including relevant safety information such as:

• composition (e.g. raw materials, ingredients, additives, etc.),
• structure and physico-chemical characteristics (e.g. solid, liquid, gel, emulsion, moisture content, pH etc.),
• processing (e.g. heating, freezing, drying, salting, smoking, etc. and to what extent),
• packaging (e.g. hermetic, vacuum, modified atmosphere),
• storage and distribution conditions,
• required shelf life (e.g. “use by date” or “best before date”),
• instructions for use,
• any microbiological or chemical criteria applicable.

1.3. Identification of intended use

The HACCP team should also define the normal or expected use of the product by the customer and the consumer target groups for which the product is intended. In specific cases, the suitability of the product for particular groups of consumers, such as institutional caterers, travelers, etc. and for vulnerable groups of the population may have to be considered.

1.4. Construction of a flow diagram (description of manufacturing process)

Whatever the format chosen all steps involved in the process, including delays during or between steps, from receiving the raw materials to placing the end product on the market, through preparation, processing, packaging, storage and distribution, should be studied in sequence and presented in a detailed flow diagram together with sufficient technical data.

Types of data may include but are not limited to:

• plan of working premises and ancillary premises,

• equipment layout and characteristics,

• sequence of all process steps (including the incorporation of raw materials, ingredients or additives and delays during or between steps),

• technical parameters of operations (in particular time and temperature, including delays),

• flow of products (including potential cross-contamination),

• segregation of clean and dirty areas (or high/low risk areas),

The following requirements are prerequisites and can be integrated in the HACCP system:

• cleaning and disinfection procedures,

• hygienic environment of the establishment,

• personnel routes and hygiene practices,

• product storage and distribution conditions.

1.5. On-site confirmation of flow diagram

After the flow diagram has been drawn up, the multidisciplinary team should confirm it on site during operating hours. Any observed deviation must result in an amendment of the original flow diagram to make it accurate.

1.6. Listing of hazards and control measures

1.6.1. list all potential biological, chemical or physical hazards that may be reasonably expected to occur at each process step (including acquisition and storage of raw materials and ingredients and delays during manufacture). Hazard has been defined in Article 3 (14) of Regulation (EC) No 178/2002.

The HACCP team should next conduct a hazard analysis to identify for the HACCP plan which hazards are of such a nature that their elimination or reduction to acceptable levels is essential to the production of a safe food.

In conducting the hazard analysis, the following should be considered:

• the likely occurrence of hazards and severity of their adverse health effects;

• the qualitative and/or quantitative evaluation of the presence of hazards;

• survival or multiplication of pathogenic micro-organisms and unacceptable generation of chemicals in intermediate products, final products, production line or line environment;

• production or persistence in foods of toxins or other undesirable products of microbial metabolism, chemicals or physical agents or allergens;

• contamination (or recontamination) of a biological (micro-organisms, parasites), chemical or physical nature of raw materials, intermediate products or final products.

1.6.2. consider and describe what control measures, if any, exist which can be applied for each hazard.

Control measures are those actions and activities that can be used to prevent hazards, eliminate them or reduce their impact or occurrence to acceptable levels.

More than one control measure may be required to control an identified hazard and more than one hazard may be controlled by one control measure e.g; pasteurization or controlled heat treatment may provide sufficient assurance of reduction of the level of both Salmonella and Listeria.

Control measures need to be supported by detailed procedures and specifications to ensure their effective implementation. For instance, detailed cleaning schedules, precise heat treatment specifications, maximum concentrations of preservatives used in compliance with the applicable Community rules.

2. IDENTIFICATION OF CRITICAL CONTROL POINTS (=CCP)

The identification of a critical point for the control of a hazard requires a logical approach. Such an approach can be facilitated by the use of a decision tree (other methods can be used by the team, according to their knowledge and experience). For the application of the decision tree, each process step identified in the flow diagram should be considered in sequence. At each step, the decision tree must be applied to each hazard that may be reasonably expected to occur or be introduced and each control measure identified. Application of the decision tree should be flexible , having consideration for the whole manufacturing process in order to avoid, whenever possible, unnecessary critical points. An example of a decision tree is shown in Figure 1, but may not be applicable to all situations. Training in the application of the decision tree is recommended.

The identification of critical control points has two consequences for the HACCP team
which should then:

ensure that appropriate control measures are effectively designed and implemented. In
particular, if a hazard has been identified at a step where control is necessary for product safety and no control measure exists at that step, or at any other, then the product or process should be modified at that step or at an earlier or later stage, to include a control measure,

establish and implement a monitoring system at each critical point.