Cronobacter Support
07-16-2009, 09:12 AM
5.3.6.2 Monitoring and testing by industry
Sampling and testing regimes in processing facilities are integrated sampling plans which are implemented to demonstrate the efficiency of the control measures taken to eliminate or minimize the presence of Salmonella and other Enterobacteriaceae (including E. sak.) in finished products, as well as other specified pathogens such as B. cereus and S. aureus. Such sampling plans are not necessarily identical to the ones applied by official control labs. – they may be as or more stringent, but with a different focus and different types of samples. Such integrated sampling plans are flexible and may be adapted to the findings. In particular, indications for deviations in the processing environment and line (indication for an increased risk of contamination) could lead to increased sampling (number and size of samples) and testing and investigation of the deviation.
Such sampling plans may vary among manufacturers and the parameters included (pathogens, indicators, visual inspections etc.) are adapted to the particular processing line. They integrate the following types of sample:
• dry-mix ingredients;
• finished products;
• food contact surfaces at critical processing steps; and
• environmental samples from the processing envir., in particular critical ones.
For a detailed consideration of the above, see ICMSF (2002).
5.3.7 Microbiological specifications
The current Codex microbiological spec's relating to mesophilic aerobic bacteria, coliforms and Salmonella for powdered infant formula (CAC/RCP 21-1979) are outlined in Table 4. These criteria were established many years ago and need to be reviewed in light of new developments and knowledge.
Table 4 (attached). Current Codex advisory microbiological Spec’s for dried and instant products.a
The current microbiological spec's for Salmonella were considered by the meeting to be adequate and are near the limit of practical microbiological testing. However, there is currently no requirement to test for E. sak. and the meeting concluded that the current spec’s should be reviewed based on the info. presented to the meeting. A revision of the Codex spec's should include consideration of the following:
• microorganisms and reasons for concern;
• analytical methods to be used;
• sampling plan and size of analytical units;
• microbiological limits; and
• numbers of units to be in conformity.
Using current dry-mix technology, it does not seem to be possible to ensure that powdered infant formula is free from Enterobacteriaceae such as E. sak.. Even a more stringent microbiological spec. may not be reliably effective at detecting very low numbers of organisms. Given the large quantity of the product consumed and the fact that even one contaminating bacteria is capable of growing to large numbers, a combination of risk reduction measures may be required for the effective management of the risk.
5.3.8 Reconstitution and use
5.3.8.1 Storage of open packs of formula
Edelson-Mammel and Buchanan (R. Buchanan, personal communication, 2004) studied the longterm survival of E. sak. in powdered infant formula by preparing a quantity of powdered formula to contain approx. 106 cfu/ml E. sak. when reconstituted according to the manufacturer’s instructions. Over the course of approx. 1.5 years, the spiked dry infant formula was stored at room temperature in a closed screw-cap bottle. Periodically, samples of the formula were taken, hydrated, and the level of viable cells determined by plating in duplicate on tryptic soy agar plates. During the initial 5 months of storage, the level of viable E. sak. declined approx. 2.5 log cycles (6.0 log cfu/ml to 3.5 log cfu/ml) at a rate of approx. 0.5 log cycles per month. Over the course of the subsequent year, the level of viable E. sak. declined an additional 0.5 log cycles to approx. 3.0 log cfu/ml (Figure 5). These results clearly demonstrate that E. sak. can survive for extended periods in powdered infant formula.
Figure 5 (attached). Long-term survival of Enterobacter sakazakii in powdered infant formula.
Little is known about the fate of intrinsically contaminated powdered infant formula once opened and then stored at high ambient temperature and humidity which is characteristic of tropical countries. Current info. indicates that the moisture content of powdered infant formula in such a setting would not increase to the extent that it may support growth of intrinsic contaminants.
5.3.9 Labelling and preparation
5.3.9.1 Labelling
Labelling of powdered infant formula is very comprehensive as a rule, with elements of info., advice and warning. The Codex standard for powdered infant formula requires: complete ingredient and nutrition labelling; advice on the feeding of infants (“breastfeeding is the best for your baby”); warning about inappropriate feeding of infants; and recommendations for the preparation, feeding and storage of the product as sold, opened and prepared for consumption. Depending on the law of the country, it may also contain info. on particular properties of the product.
The recommendations for the preparation of infant formula, formula for special medical purposes intended for infants, and follow-up formula at home are detailed and often accompanied by illustrations. Presently, these recommendations include the following:
“Prepare each bottle freshly before feeding – boil water – put it into a clean bottle and cool it down to about 50°C – add measured amount of powder (number of scoops) – shake vigorously – cool to drinking temperature (skin test) – feed directly – discard residues in the bottle.”
The labelling of formula for special medical purposes (FSMP) has to contain, in addition, more specific info. about the product: what makes it special? what makes it suitable for the indication it is presented for? for what disease, disorder, medical condition is it intended? are there interactions with drugs? A warning statement should be included that the product is not intended to be eaten by healthy persons and that it is only to be used under medical supervision.
Posted from ftp.fao.org/docrep/fao/007/y5502e/y5502e00.pdf
Sampling and testing regimes in processing facilities are integrated sampling plans which are implemented to demonstrate the efficiency of the control measures taken to eliminate or minimize the presence of Salmonella and other Enterobacteriaceae (including E. sak.) in finished products, as well as other specified pathogens such as B. cereus and S. aureus. Such sampling plans are not necessarily identical to the ones applied by official control labs. – they may be as or more stringent, but with a different focus and different types of samples. Such integrated sampling plans are flexible and may be adapted to the findings. In particular, indications for deviations in the processing environment and line (indication for an increased risk of contamination) could lead to increased sampling (number and size of samples) and testing and investigation of the deviation.
Such sampling plans may vary among manufacturers and the parameters included (pathogens, indicators, visual inspections etc.) are adapted to the particular processing line. They integrate the following types of sample:
• dry-mix ingredients;
• finished products;
• food contact surfaces at critical processing steps; and
• environmental samples from the processing envir., in particular critical ones.
For a detailed consideration of the above, see ICMSF (2002).
5.3.7 Microbiological specifications
The current Codex microbiological spec's relating to mesophilic aerobic bacteria, coliforms and Salmonella for powdered infant formula (CAC/RCP 21-1979) are outlined in Table 4. These criteria were established many years ago and need to be reviewed in light of new developments and knowledge.
Table 4 (attached). Current Codex advisory microbiological Spec’s for dried and instant products.a
The current microbiological spec's for Salmonella were considered by the meeting to be adequate and are near the limit of practical microbiological testing. However, there is currently no requirement to test for E. sak. and the meeting concluded that the current spec’s should be reviewed based on the info. presented to the meeting. A revision of the Codex spec's should include consideration of the following:
• microorganisms and reasons for concern;
• analytical methods to be used;
• sampling plan and size of analytical units;
• microbiological limits; and
• numbers of units to be in conformity.
Using current dry-mix technology, it does not seem to be possible to ensure that powdered infant formula is free from Enterobacteriaceae such as E. sak.. Even a more stringent microbiological spec. may not be reliably effective at detecting very low numbers of organisms. Given the large quantity of the product consumed and the fact that even one contaminating bacteria is capable of growing to large numbers, a combination of risk reduction measures may be required for the effective management of the risk.
5.3.8 Reconstitution and use
5.3.8.1 Storage of open packs of formula
Edelson-Mammel and Buchanan (R. Buchanan, personal communication, 2004) studied the longterm survival of E. sak. in powdered infant formula by preparing a quantity of powdered formula to contain approx. 106 cfu/ml E. sak. when reconstituted according to the manufacturer’s instructions. Over the course of approx. 1.5 years, the spiked dry infant formula was stored at room temperature in a closed screw-cap bottle. Periodically, samples of the formula were taken, hydrated, and the level of viable cells determined by plating in duplicate on tryptic soy agar plates. During the initial 5 months of storage, the level of viable E. sak. declined approx. 2.5 log cycles (6.0 log cfu/ml to 3.5 log cfu/ml) at a rate of approx. 0.5 log cycles per month. Over the course of the subsequent year, the level of viable E. sak. declined an additional 0.5 log cycles to approx. 3.0 log cfu/ml (Figure 5). These results clearly demonstrate that E. sak. can survive for extended periods in powdered infant formula.
Figure 5 (attached). Long-term survival of Enterobacter sakazakii in powdered infant formula.
Little is known about the fate of intrinsically contaminated powdered infant formula once opened and then stored at high ambient temperature and humidity which is characteristic of tropical countries. Current info. indicates that the moisture content of powdered infant formula in such a setting would not increase to the extent that it may support growth of intrinsic contaminants.
5.3.9 Labelling and preparation
5.3.9.1 Labelling
Labelling of powdered infant formula is very comprehensive as a rule, with elements of info., advice and warning. The Codex standard for powdered infant formula requires: complete ingredient and nutrition labelling; advice on the feeding of infants (“breastfeeding is the best for your baby”); warning about inappropriate feeding of infants; and recommendations for the preparation, feeding and storage of the product as sold, opened and prepared for consumption. Depending on the law of the country, it may also contain info. on particular properties of the product.
The recommendations for the preparation of infant formula, formula for special medical purposes intended for infants, and follow-up formula at home are detailed and often accompanied by illustrations. Presently, these recommendations include the following:
“Prepare each bottle freshly before feeding – boil water – put it into a clean bottle and cool it down to about 50°C – add measured amount of powder (number of scoops) – shake vigorously – cool to drinking temperature (skin test) – feed directly – discard residues in the bottle.”
The labelling of formula for special medical purposes (FSMP) has to contain, in addition, more specific info. about the product: what makes it special? what makes it suitable for the indication it is presented for? for what disease, disorder, medical condition is it intended? are there interactions with drugs? A warning statement should be included that the product is not intended to be eaten by healthy persons and that it is only to be used under medical supervision.
Posted from ftp.fao.org/docrep/fao/007/y5502e/y5502e00.pdf