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Example 5: Apple juice (Apple drink) - South America


There is a significant risk that levels of patulin in apple juice produced in South America will exceed a 50 µg/kg target level. A survey carried out on apple juice in Chile (Canas, P. 1996) found a 28% incidence of samples of apple juice and apple concentrate exceeding this limit.

Apple juice produced in Latin America is different to that produced in Europe in that it has added sucrose and water, as well as the preservative sodium metabisulphite.

Task 1 - The HACCP team

An appropriate HACCP team will be composed of: a HACCP consultant, a mycotoxicologist, a mycologist, a quality assurance manager at the processing plant, a process engineer, representatives of the farmers and the Department of Agriculture, and a scientific secretary. A specialist in the area of fruit juice production and legislative matters will be consulted as and when necessary.

Tasks 2 and 3. - Product Description and Intended Use, Verified.

This information is given in Table 11.

Tasks 4 and 5 - The Commodity Flow Diagram (CFD), Verified (Figure 12)

The CFD will be prepared and verified by a series of visits to the orchards and processing plant. A typical CFD is presented in Figure 12.

Task 6 - Mycotoxin hazard analysis and identification of control measures

a) Identification of mycotoxin hazard

Patulin was the only mycotoxin hazard identified in this product. A number of European countries including Switzerland, Belgium, Austria and France have a 50 µg/Litre limit. The lowest limit is 30 µg/kg, in Romania.

Table 11. Description and Intended Use of End Product

Name of Product

Apple juice


13° Brix apple juice with added sugar, preservative (sodium metabisulphite) and water. Filtered through 5 micron filter, pasteurised at 90°C for 2 minutes

Conditions of storage

Bulk tank at reduced temperature until processed.
Ambient temperature when processed

Shelf Life

Six month at ambient. Chilled and consumed within4 days once opened

Intended use

Consumed without further heating.


Glass bottle or tetrapack - 1 litre

Customer specification

Acid level important to product taste. Within microbiological and mycotoxin guidelines

Target Consumer

Local consumption and export. All age groups

b) Identification of steps in the CFD where mycotoxin contamination is most likely to occur.

Each step in the CFD will be considered in turn.

Patulin contamintion is likely to be produced in the orchard during growing (Step 1) and during bulk storage (Step 3). There is little risk of further contamination during transportation, but damage to apples at this stage can increase the risk of subsequent contamination.

At the factory, patulin contamination is most likely to increase during storage at Step 8.

There is likely to be patulin contamination present in the apples, or the resultant apple juice, at every step in the commodity chain. Hence it is important to both minimise contamination, and reduce levels of contamination to the acceptable level.

Fig. 12. HACCP Process Flow-diagram: Apple juice

c. Possible Patulin Control Measures

Contamination of the juice can be prevented at steps where rotten or rotting apples can be rejected from the process, either in the orchard when the fruit is harvested, or during sorting in the factory.

Post-harvest patulin contamination can be eliminated, or significantly reduced, by storage at <10°C, and by minimising storage times.

Washing, and in particularly pressure spraying, has been shown to be effective in removing patulin from apples.

Patulin can also be removed from apple juice by filtration, when patulin bound to solid particles of apple flesh are removed.

Inactivation of Penicillium expansum spores during pasteurisation at Step 11 will reduce the risk of patulin production in the finished juice.

Tasks 7 to 10: Development of a HACCP Plan

A spreadsheet summarising the HACCP plan for patulin in apple juice is given in Table 12. The development of the plan at each step in the CFD is given below.

Step 1: Farm, growing in the orchard - GAP

Growth of the mould Penicillium expansum, and subsequent patulin contamination, can occur pre-harvest, where it is associated with damaged and over-ripe fruit. Good Agricultural Practice (GAP) will minimise insect and bird damage.

Step 2: Farm, at harvest - CCP1

The control measure at this step is to efficiently reject rotten and damaged apples during harvesting. Rotten apples are much more likely to contain high levels of patulin than sound looking apples. In one study (Sydenham, E. W., 1995), as much as 70% of patulin present in a batch of over-ripe apples was removed by sorting and removing visually mouldy apples. Application of this control measure at Step 2 is considered a CCP because it will reduce mould contamination to an acceptable level.

The effect of this CCP on levels of patulin in the system should not be considered in isolation. The HACCP team will consider the cumulative effects of subsequent CCPs and will judge whether levels of patulin in the final product are likely to exceed acceptable levels. The HACCP team will also consider the fact that removal of mouldy apples at this step will reduce the risk of subsequent patulin production, especially during on-farm storage. There is a subsequent sorting step at Step 6, so it could be argued that sorting is not required here. However, there are strong arguments to support sorting at both steps. Failure to sort at Step 1 will result in greatly increased patulin production at Steps 3, and unnecessary transportation of rotten fruit. There is little doubt that application of this sorting control measure at Step 1 is important for the production of apple juice containing acceptable levels of patulin.

The critical limit for this CCP will relate to the percentage of visibly mouldy apples remaining after sorting, and will be determined by the sorting efficiency which can reasonably be expected at this stage. For this example, the HACCP team considered that 99 per cent of mouldy apples should be removed at this step. The procedure will be monitored by trained supervisors and verified by a grading check on representative samples.

Table 12. HACCP Plan Worksheet, Apple Juice, S. America

Process Step

Description of hazard

Control Measures


Critical limits

Monitoring Procedures

Corrective actions




Minimise damage caused by birds and insects




Remove mouldy and damaged apples
Avoid trash and soil contamination


<1% visibly mouldy apples

Visual observation


Farm records

Cooling and
bulk storage


Reduce risk factors
Handling and storage at <10°C to minimise mould growth


All staff to be trained

Check training records
Automated readout

Adjust temperature
Check monit. System
Inspect fruit

Farm records



Avoid damage and mould contamination




Inspect and reject low-grade apples with >10% mould apples


<10% damaged fruit

Quality check on representative sample

Reject batch

Factory records

Factory Sorting


Remove mouldy apples


<1% visibly mouldy apples

Visual observation of samples

Discard or re-sort
Adjust inspection procedure

Operator log % reject



Leach patulin from apples. Remove rotten parts of fruit containing patulin with pressure spraying


Critical soaking time and pressure of spray system

Time of soaking step; regular check of water spray pressure

Repeat the washing step

Factory records

Bulk storage


Temperature control to <10°C in store, and minimise time in store


<10°C temperature or
<48 hours in store

Thermometer reading
Storage time

Check monitoring system Inspect fruit

Factory records



Batch segregation



Patulin Mould

Remove patulin in particles


Size and quality of particles remaining

Laboratory test

Un-block/replace filter
Re-filter juice

Factory records



Destroy Penicillium expansum spores


Correct time/Temp.

Automated readout


Factory records

Aseptic filling


Storage & dispat


Step 3: Farm, bulk storage - GAP

Application of GAP and GSP is necessary to minimise rotting of fruit and subsequent patulin production during bulk storage. Storage of sound apples is important and the length of storage should be minimised, unless refrigerated storage facilities are used.

Step 4: Transportation - GAP

There is little risk of patulin contamination during short duration journeys, but any physical damage sustained during transportation, including loading and unloading, will predispose the fruit to subsequent mould attack and possible patulin contamination. The correct handling of fruit is therefore required.

Step 5: Factory procurement - GMP

Procurement of batches of low-grade apples, with a high percentage of damaged and rotten fruit, are to be avoided. It could be argued that, with a sorting step to follow, the procurement of low-grade apples would be permissible. However, batches containing >10% rotten fruit, say, will be extremely difficult to sort manually, and the levels of patulin likely to be present will make it difficult to attain an acceptable level of patulin in the finished product.

Step 6: Factory sorting - CCP2

The control measure is sorting to remove visibly mouldy apples. This CCP will reduce the level of mould to an acceptable level, and make a major contribution towards achieving an acceptable level of patulin in the final product. Sorting will both remove mouldy apples missed during sorting at Step 2, and remove apples that have subsequently become mouldy at Steps 3 and 4.

As for Step 1, the critical limit for this CCP will be the acceptable percentage of mouldy apples remaining after the sorting procedure, and monitoring will be by use of a trained supervisor.

Step 7: Factory, washing - CCP3

The control measure is washing the apples using high-pressure water spraying to remove rotten apple flesh, and patulin, from the fruit. Studies (Acar, J., 1998, & Sydenham, E.W., 1995) have shown that washing in this way can remove more than half of the patulin present in the fruit. The critical limits for this CCP will be related to the pressure of the sprays and the duration of the washing step. The water pressure will be monitored using pressure gauges and the washing step will be timed.

Patulin levels will be reduced at this step, but spores will be suspended in the water. This inoculum will increase the risk of mould growth during bulk storage.

Step 8: Bulk storage of whole apples - CCP4

The control measure is to prevent mould growth and patulin production by storing at reduced temperature. If refrigerated storage is not available, then storage time must be minimised. The critical limits are either a storage temperature of <=10°C or a maximum storage time at ambient temperature of 48 hours. These critical limits for temperature are monitored by means of a calibrated thermometer, preferably with a continuous chart read-out, and the storage period is monitored by a timing device.

Step 9: Pressing/extraction process - GMP

Good Manufacturing Practice will ensure that the presses are cleaned regularly to prevent a build-up of mouldy apple waste which could be a source of patulin contamination.

Step 10: Filtration - CCP5

The control measure is the removal of fine, patulin-rich particles held in suspension in the crude juice. Research has shown (Acar, J., 1998) that a significant reduction in levels of patulin can be achieved using filtration. Conventional clarification by means of a rotary vacuum precoat filter resulted in a 39% reduction in levels of patulin, and ultrafiltration resulted in a 25% reduction. Critical limits are set for the size and quantity of particles remaining in the apple juice after filtration. These critical limits are monitored by microscopic examination of samples of apple juice.

Step 11: Pasteurisation - CCP

This step is a CCP for the control of bacterial hazards. However, it can also be considered as a CCP for control of the patulin hazard since pasteurisation will destroy spores of Penicillium expansum, and therefore prevent any subsequent mould growth, and patulin production, in submerged culture in the apple juice.

Although patulin levels are unlikely to be reduced significantly during pasteurisation, mould spores will be destroyed and the risk of patulin being produced subsequently in the apple juice will be reduced.

Step 12: Asceptic packaging process - GMP

Following pasteurisation, it is important to prevent the re-introduction of micro-organisms, including mould spores, during packaging. These procedures are covered by GMP.

Packaging is selected which will protect the juice from contamination by micro-organisms, e.g. tetra packs, or glass bottles with air-tight seals for the lid.

Step 13: Storage and dispatch - GMP

No subsequent contamination with patulin is likely.

Tasks 11: Establish verification procedures

The HACCP plan will be audited quarterly, and amended as necessary.

Tasks 12: Establish documentation and record keeping

The HACCP Plan will be fully documented, and appropriate records kept at each CCP.


Acar, J., Gokman, V., Taydas, E. E. (1998). 'The effect of processing technology on the patulin content of juice during commercial apple juice concentrate production'. Zeitschrift fur Lebensmittel-Untersuchung und-Forschung A-Food Research and Technology 207, 328-331.

Anon (1999). 'Guidance on the control of patulin in directly pressed apple juice.' Published by the UK Ministry of Agriculture, Fisheries and Food, Ergon House, 17, Smith Square, London SW1P 3JR.

Canas, P., Aranda, M. (1996). 'Decontamination and inhibition of patulin-induced cytotoxicity.' Environmental Toxicology & Water Quality 11, 249-253.

Sydenham, E. W., Vismer, H. F., Marasas, W. F. O., Brown, N., Schlechter, M., Vanderwesthuizen, L., Rheeder, J. P. (1995). 'Reduction of patulin in apple juice samples - influence of initial processing.' Food Control 6, 195-200.

[2] GHP = Good Horticultural Practice

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