Apoderament veïnal i enfortiment de la xarxa associativa

Are the final products stored ambient, chilled or frozen?

Step

1 Ambient Refer to Production

Zone Decision Tree 2 Chilled or frozen

Are products or ingredients within the area open to the environment (i.e. neither

packaged nor fully enclosed in tanks or pipes etc.)?

Does the product support the growth of pathogens or the survival of pathogens, which could subsequently grow during the normal storage or use of the product unless

stored chilled or frozen?

Does the area contain products which, on the basis of cooking instructions and known

customer use*, undergo full cooking** prior to consumption?

Have all vulnerable products received, prior to entry into the area, a heat treatment

equivalent to 70˚C for 2 minutes?

Step

High-risk area – for example, cooked meats, paté, houmous, prepared meals without

garnishes, dairy desserts with cooked components

* If the product is ready to eat or ready to heat, or on the basis of known customer use, is likely to be eaten without adequate cooking, then proceed to step 5.

** Thermal treatment equivalent to 70˚C for 2 minutes

*** Raw or not pH/a_w stabilised so will support the growth of Listeria monocytogenes

FIGURE 6 PRODUCTION ZONE DECISION TREE 1 – CHILLED AND FROZEN PRODUCTS

APPE N D IC E S

Are the final products stored ambient, chilled or frozen?

Step

1 Chilled or frozen Refer to Production

Zone Decision Tree 1 Ambient

Are products or ingredients within the area open to the environment (i.e. neither

packaged nor fully enclosed in tanks or pipes etc.)?

Does the area contain products which, on the basis of cooking instructions and known

customer use*, undergo full cooking** prior to consumption?

Will vegetative pathogens (e.g. Salmonella) with the potential to cause food poisoning survive and grow during normal use and

storage of the product? Or is the nature of the food matrix (e.g. high fat) such that it protects and enables a very low level of pathogen to survive and cause poisoning?

Step

Is the raw material(s) a known source of contamination for vegetative pathogens

(which could subsequently cross-contaminate finished product) AND does the site’s manufacturing process include a process step which removes the pathogen

(i.e a pathogen-kill step)?

Ambient high care – for example, manufacture of chocolate from raw cocoa beans, manufacture of peanut butter from

raw peanuts, heat-treated flour Yes

Yes

* If the product is ready to eat or ready to heat, or on the basis of known customer use, is likely to be eaten without adequate cooking, then proceed to step 4.

** Thermal treatment equivalent to 70˚C for 2 minutes

It should be noted that where the product has cooking instructions for the consumer that are equivalent to a full cook, then the product may be considered as low risk. In these situations, the site is expected to have a full validation, which the auditor can refer to, demonstrating that the cooking instructions are appropriate and that the product will achieve the correct temperature/time when the cooking instructions are used.

The purpose of physical segregation is to provide a self-contained area where uncovered (i.e. unprotected) high-risk products are handled after the microbiological kill step (e.g. thermal processing) until fully protected, usually by means of packaging.

The segregating barrier must be capable of preventing the risk of cross-contamination from:

•

pathogens which may be present in a low-risk environment or on products or ingredients that have not received a full cook

•

all people moving between the high-risk area and other areas except through designated changing areas

•

the movement of all equipment, utensils or materials into the high-risk area except through designated ports with sanitising controls in place

•

water or other liquids on the floor, washing into the high-risk area

•

airborne contaminants (e.g. dust particles or water droplets).

The ideal barrier is a full wall separating the high-risk area from other areas. In assessing the suitability of the segregating barrier a risk assessment must have been carried out and documented.

It is expected that newly built factories will employ full wall separation where high-risk facilities are required.

Time segregation is not an acceptable alternative to physical segregation for high-risk areas.

HIGH CARE (CHILLED AND FROZEN)

This is an area designed to a high standard where practices relating to personnel, ingredients, equipment, packaging and environment aim to minimise product contamination by pathogenic micro-organisms. Segregation (see below) of the high-care area and access arrangements to the area shall minimise the risk of product contamination. Products which require handling in a high-care area meet all of the following:

•

The finished products require chilling or freezing during storage.

•

All microbiologically susceptible components have received a process to reduce the microbiological contamination to acceptable levels (typically 1–2 log reduction of micro-organisms such as Listeria species) before entry to the area.

•

The finished products are vulnerable to the growth of pathogens or the survival of pathogens, which could subsequently grow during the normal storage or use of the product (e.g. if a frozen product is defrosted but not immediately consumed).

•

The finished products are ready to eat² or ready to heat³ or, on the basis of known consumer use, are likely to be eaten without adequate cooking.

Although all vulnerable ingredients and products have, before entry to the high-care area, received a process to reduce

pathogenic bacteria to a level to make them safe to eat, spoilage organisms will be present and shall be controlled by temperature and shelf life. Examples of products considered as high care include sandwiches and prepared salads.

Products produced in high-care areas may themselves present hazards to other products; for instance, the use of salad products, even when processed by rinsing in chlorine solution to reduce microbial load, may still present an increased risk, and this needs to be taken into account when planning hygiene regimes and production controls within the high-care area.

It is important that the high-care area is effectively protected from re-contamination from the low-risk zones. This segregation is most effectively achieved by full physical segregation by means of walls which separate the high-care area from other factory areas.

The segregating barrier must be capable of preventing the risk of cross-contamination from:

•

pathogens which may be present in a low-risk environment or on products or ingredients that have not received a full cook

•

all people moving between the high-care area and other areas except through designated changing areas

•

the movement of all equipment, utensils or materials into the high-care area except through designated ports with sanitising controls in place

APPE N D IC E S

In assessing the suitability of the segregating barrier a risk assessment must have been carried out and documented. Alternative controls may be accepted where all the objectives above can be met.

It is expected that newly built factories will employ full wall separation where high-care facilities are required.

AMBIENT HIGH CARE

This is an area designed to a high standard where practices relating to personnel, ingredients, equipment, packaging and environment aim to minimise product contamination by pathogenic micro-organisms. Ambient products that are handled in these areas are vulnerable, as the pathogens are known to survive on the product (i.e. this area is different from low-risk areas because products handled in low-risk areas either intrinsically, or by design, do not support the growth or survival of pathogens, or are designed to undergo a later validated kill step).

Products which require handling in this area meet all of the following:

•

A raw material(s) is prone to contamination with a vegetative pathogen (e.g. Salmonella species).

•

The production process includes a process step which removes or reduces the pathogen (e.g. a microbiological kill step).

(Where there is no effective step it is assumed that any risk associated with the raw material is controlled as part of the raw material risk assessment.)

•

The finished products are stored at ambient temperatures (i.e. greater than 5°C).

•

The finished products are ready to eat² or ready to heat³ or, on the basis of known consumer use, are likely to be eaten without adequate cooking.

•

The finished products are such that vegetative pathogens could survive and grow in normal use, subsequently causing food poisoning, or are of a nature (e.g. fatty foods) that enables food poisoning to result from a very low level of contamination with a pathogen.

Examples of processes that require an ambient high-care processing area include the manufacture of chocolate from raw cocoa beans, the production of milk powder from raw liquid milk or the manufacture of peanut butter from raw peanuts.

Ambient high-care products do not include those products where the risk of vegetative pathogen contamination from the raw material has been controlled at an earlier stage in the supply chain. For example, a biscuit manufacturer purchasing ready-made chocolate for incorporation into a biscuit would not be considered ambient high care as the risk is associated with raw cocoa beans and has been controlled by the chocolate supplier. The biscuit manufacturer would, however, be expected to have a raw material risk assessment process(es) in place that ensured the raw material received met the appropriate standards.

The site will need to assess the level of risk that these products represent and introduce appropriate risk-based controls to minimise the potential for cross-contamination. Depending on the product these controls may be similar to those for high risk or high care. The controls used and the risk assessment demonstrating these are appropriate must be documented.

It should be noted that the BRC Standard includes only two clauses relating to specific requirements for ambient high care (clauses 4.3.1 and 4.3.7). Clauses which refer to either high risk or high care (without reference to ambient products) are not applicable to ambient high care.

LOW RISK

The significance to human health of microbiological contamination in low-risk areas is reduced because the products either:

•

do not support the growth of pathogens (either intrinsically or by design of the product) or the survival of pathogens, which could subsequently grow during the normal storage or use of the product

•

are designed to undergo a later kill step that ensures the product is safe to eat.

The hygiene standards in such areas generally require greater emphasis on preventing foreign body and allergen contamination but good manufacturing practices, including good process flow, are still expected.

Products manufactured in this area include the following:

•

Products which will always require cooking by the consumer before consumption (e.g. raw meat and fish). Where consumer cooking instructions are provided, these must be fully validated.

•

Products that are processed within the final container (e.g. canned).

•

Products unsuitable for the growth and/or survival of pathogens which are stored and distributed as ambient products (e.g.

preserves, pH-controlled products such as pickles, low a_w foods such as dried pasta and sugar confectionery).

•

Ready-to-eat products stored chilled or frozen to preserve the quality of the product, but which have other controls to prevent the growth of pathogens (e.g. hard cheese).

•

Raw materials or prepared products and mixes before undergoing a kill step prior to transfer into high-risk or high-care areas.

Examples of products considered as low risk include raw meat, sugar and flour.

In document PLA DE BARRIS DE BARCELONA CONSELL ASSESSOR. Informe sobre el desplegament del Pla (página 53-60)