Cronobacter Support
03-02-2009, 02:32 PM
1.4 Contamination of PIF
Current manufacturing processes cannot achieve the production of sterile PIF. Contamination of PIF with E. sakazakii and Salmonella can occur intrinsically, or from extrinsic sources. Intrinsic contamination occurs at some stage during its manufacture (e.g. from the manufacturing environment, or from raw ingredients).
Recent data point to differences in the microbial ecology of Salmonella spp. and E. sakazakii. E. sakazakii is more commonly found in the manufacturing environment than Salmonella. Surveys have identified E. sakazakii in 3-14% of PIF samples (FAO/WHO, 2006), but the levels of contamination reported have been low: 0.36-66.0 cfu/100 g (Forsythe, 2005). In contrast, Salmonella is rarely found in PIF. In one survey, no Salmonella were found in samples from 141 different formulas (Muytjens, Roelofs-Willemse and Jasper, 1988). The current Codex specification for Salmonella is the absence of organisms in 60 samples of 25 g each. Specific criteria for E. sakazakii, however, are not included, but come under the general category of coliforms (CAC, 1979). The standard requires a minimum of 4 to 5 samples with <3 coliforms/g and a maximum of 1 in 5 control samples with levels >3 but <20 coliforms/g. This is currently under review in the Codex Committee on Food Hygiene.
Extrinsic contamination can occur when contaminated utensils (e.g. spoons, blenders, bottles, teats) are used for preparing or feeding PIF, or contamination may occur from the preparation environment.
While E. sakazakii and Salmonella do not grow in dry PIF, they can survive for long periods. E. sakazakii has been shown to survive up to and beyond one year in dry PIF (Forsythe, 2005). Reconstituted PIF, however, provides an ideal environment for the growth of pathogens. Storage of reconstituted PIF at temperatures not more than 5 °C will prevent the growth of Salmonella and E. sakazakii. However, held above this temperature (e.g. at room temperature), there is the potential for rapid growth of E. sakazakii or Salmonella, particularly if held for extended periods.
1.5 Breastfeeding recommendation
WHO recommends that infants should be exclusively breastfed for the first six months of life to achieve optimal growth, development and health. Thereafter, to meet their evolving nutritional requirements, infants should receive nutritionally adequate and safe complementary foods while breastfeeding continues for up to two years of age or beyond (WHO/UNICEF, 2003).
It is important to support breastfeeding and promote its benefits to infants and young children. There are, however, instances where breast milk is not available, where the mother is unable to breastfeed, where they have made an informed decision not to breastfeed, or where breastfeeding is not appropriate, e.g. where the mother is taking medication that is contraindicated for breastfeeding or the mother is HIV-positive1. Similarly, some very low-birth-weight babies may not be able to breastfeed directly, and in some cases expressed breast milk may not be available at all or available in insufficient quantities.
Infants who are not breastfed require a suitable breast-milk substitute, for example, an infant formula prepared in accordance with the present guidelines.
1.6 Purpose
The purpose of this document is to deliver recommendations on the safe preparation, storage and handling of PIF, in order to reduce the risk of infection from E. sakazakii and S. enterica. In principle, infant formula should be used only when medically indicated2 in accordance with the 10 Steps of the WHO/UNICEF Baby-Friendly Hospital Initiative (BFHI) (Appendix 2).
These present guidelines are considered to be a generic document that will provide guidance and support for countries and governments. When adapted at the country level, conditions (i.e. climatic and socioeconomic differences, etc.) within the country should be reflected. Individual countries should outline minimum training requirements for parents, caregivers, and staff in hospitals and day-care centres.
Specific details of illness associated with PIF, sources of contamination, characteristics of E. sakazakii and Salmonella have been covered in full in FAO/WHO reports (FAO/WHO, 2004, 2006) and are therefore only summarized in this document (Sections 1.2-1.4).
1.7 Scope
These guidelines provide recommendations for the preparation of PIF in care settings and in the home.
The guidelines in this document apply only to the preparation of PIF for infants no more than 12 months (as defined in Codex ALINORM 07/30/26) (CAC, 2007). Follow-up formula (as defined in Codex Standard 156-1987) (CAC, 1987) and formula for special medical purposes intended for infants (as defined in Codex Alinorm 07/30/26, Appendix II) (CAC, 2007) are considered outside the scope of this document. However, it should be noted that, in the absence of other guidance, the preparation of these formulas should follow that of PIF for infants no more than 12 months.
1Exclusive breastfeeding is recommended for HIV-infected women for the first 6 months of life unless replacement feeding is acceptable, feasible, affordable, sustainable and safe for them and their infants before that time. When replacement feeding is acceptable, feasible, affordable, sustainable and safe, avoidance of all breastfeeding by HIV-infected women is recommended. who.int/child-adolescenthealth/publications/NUTRITION/consensus_statement.htm
2The marketing of PIF should meet the requirements of the WHO/UNICEF International Code of Marketing of Breast-Milk Substitutes (WHO, 1981) and all relevant resolutions of the World Health Assembly. The aim of the Code is to contribute to the provision of safe and adequate nutrition for infants, by the protection and promotion of breastfeeding, and by ensuring the proper use of breast-milk substitutes, when these are necessary, on the basis of adequate information and through appropriate marketing and distribution.
1.8 Assumptions behind the recommendations
As PIF may contain pathogens, one of the recommendations from the joint FAO/WHO meeting in Geneva, 2004 (FAO/WHO, 2004), and the basis for the WHA resolution request, was that guidance on the preparation, use and handling of PIF is required because many people who prepare PIF (both general public and health professionals) are not aware of the risks associated with this product, nor are they familiar with best practice for its reconstitution.
The recommendations are largely based on the findings of a FAO/WHO risk assessment on E. sakazakii in PIF, conducted in January 2006 (FAO/WHO, 2006). The quantitative risk assessment model that was developed calculates the increase or decrease in the relative risk associated with different feeding practices, compared to a baseline scenario.
These recommendations apply to persons preparing and handling PIF in care settings and in the home. In general, a dramatic reduction in risk is achieved when PIF is reconstituted with water that is no less than 70 °C. Risk is controlled by minimizing the time from preparation to consumption.
These recommendations are made under the assumption that the person preparing PIF has access to safe water; soap; a clean preparation environment; boiling water; and refrigeration. Where water quality is poor, boiling, chlorination and filtration are important means to inactivate microbial pathogens and make the water safe. To disinfect water: bring to a rolling boil; add 3-5 drops of bleach to 1 litre of water; or physically remove pathogens with the appropriate filter.
In certain circumstances (e.g. developing countries, or in the case of emergencies) one or more of these resources may be unavailable. In these cases, the simplest, most effective measures for reducing the risk of illness from the use of PIF are:
• Reconstitution with boiling water and consumption as soon as the formula is cool.
• Where boiling water is not available, reconstitute PIF with safe water at room temperature, and consume immediately.
1.9 Training
All persons preparing feeds from PIF should be informed about the risk associated with PIF and trained in or informed about its safe preparation according to these guidelines. As these guidelines recommend the use of very hot water, additional information or training, or both, should be provided on the safe handling of hot water. The present guideline document is divided into two main sections. Part 2 provides guidance for the preparation of PIF in care settings, and part 3 provides guidance for the preparation of PIF in the home environment. Both sections include a rational for the recommendations provided. Both environments have many similarities and therefore part of the guidance and rational is very similar between the two sections. Depending on the targeted end user, specific guidance material using either part 2 or part 3 should be developed.
Current manufacturing processes cannot achieve the production of sterile PIF. Contamination of PIF with E. sakazakii and Salmonella can occur intrinsically, or from extrinsic sources. Intrinsic contamination occurs at some stage during its manufacture (e.g. from the manufacturing environment, or from raw ingredients).
Recent data point to differences in the microbial ecology of Salmonella spp. and E. sakazakii. E. sakazakii is more commonly found in the manufacturing environment than Salmonella. Surveys have identified E. sakazakii in 3-14% of PIF samples (FAO/WHO, 2006), but the levels of contamination reported have been low: 0.36-66.0 cfu/100 g (Forsythe, 2005). In contrast, Salmonella is rarely found in PIF. In one survey, no Salmonella were found in samples from 141 different formulas (Muytjens, Roelofs-Willemse and Jasper, 1988). The current Codex specification for Salmonella is the absence of organisms in 60 samples of 25 g each. Specific criteria for E. sakazakii, however, are not included, but come under the general category of coliforms (CAC, 1979). The standard requires a minimum of 4 to 5 samples with <3 coliforms/g and a maximum of 1 in 5 control samples with levels >3 but <20 coliforms/g. This is currently under review in the Codex Committee on Food Hygiene.
Extrinsic contamination can occur when contaminated utensils (e.g. spoons, blenders, bottles, teats) are used for preparing or feeding PIF, or contamination may occur from the preparation environment.
While E. sakazakii and Salmonella do not grow in dry PIF, they can survive for long periods. E. sakazakii has been shown to survive up to and beyond one year in dry PIF (Forsythe, 2005). Reconstituted PIF, however, provides an ideal environment for the growth of pathogens. Storage of reconstituted PIF at temperatures not more than 5 °C will prevent the growth of Salmonella and E. sakazakii. However, held above this temperature (e.g. at room temperature), there is the potential for rapid growth of E. sakazakii or Salmonella, particularly if held for extended periods.
1.5 Breastfeeding recommendation
WHO recommends that infants should be exclusively breastfed for the first six months of life to achieve optimal growth, development and health. Thereafter, to meet their evolving nutritional requirements, infants should receive nutritionally adequate and safe complementary foods while breastfeeding continues for up to two years of age or beyond (WHO/UNICEF, 2003).
It is important to support breastfeeding and promote its benefits to infants and young children. There are, however, instances where breast milk is not available, where the mother is unable to breastfeed, where they have made an informed decision not to breastfeed, or where breastfeeding is not appropriate, e.g. where the mother is taking medication that is contraindicated for breastfeeding or the mother is HIV-positive1. Similarly, some very low-birth-weight babies may not be able to breastfeed directly, and in some cases expressed breast milk may not be available at all or available in insufficient quantities.
Infants who are not breastfed require a suitable breast-milk substitute, for example, an infant formula prepared in accordance with the present guidelines.
1.6 Purpose
The purpose of this document is to deliver recommendations on the safe preparation, storage and handling of PIF, in order to reduce the risk of infection from E. sakazakii and S. enterica. In principle, infant formula should be used only when medically indicated2 in accordance with the 10 Steps of the WHO/UNICEF Baby-Friendly Hospital Initiative (BFHI) (Appendix 2).
These present guidelines are considered to be a generic document that will provide guidance and support for countries and governments. When adapted at the country level, conditions (i.e. climatic and socioeconomic differences, etc.) within the country should be reflected. Individual countries should outline minimum training requirements for parents, caregivers, and staff in hospitals and day-care centres.
Specific details of illness associated with PIF, sources of contamination, characteristics of E. sakazakii and Salmonella have been covered in full in FAO/WHO reports (FAO/WHO, 2004, 2006) and are therefore only summarized in this document (Sections 1.2-1.4).
1.7 Scope
These guidelines provide recommendations for the preparation of PIF in care settings and in the home.
The guidelines in this document apply only to the preparation of PIF for infants no more than 12 months (as defined in Codex ALINORM 07/30/26) (CAC, 2007). Follow-up formula (as defined in Codex Standard 156-1987) (CAC, 1987) and formula for special medical purposes intended for infants (as defined in Codex Alinorm 07/30/26, Appendix II) (CAC, 2007) are considered outside the scope of this document. However, it should be noted that, in the absence of other guidance, the preparation of these formulas should follow that of PIF for infants no more than 12 months.
1Exclusive breastfeeding is recommended for HIV-infected women for the first 6 months of life unless replacement feeding is acceptable, feasible, affordable, sustainable and safe for them and their infants before that time. When replacement feeding is acceptable, feasible, affordable, sustainable and safe, avoidance of all breastfeeding by HIV-infected women is recommended. who.int/child-adolescenthealth/publications/NUTRITION/consensus_statement.htm
2The marketing of PIF should meet the requirements of the WHO/UNICEF International Code of Marketing of Breast-Milk Substitutes (WHO, 1981) and all relevant resolutions of the World Health Assembly. The aim of the Code is to contribute to the provision of safe and adequate nutrition for infants, by the protection and promotion of breastfeeding, and by ensuring the proper use of breast-milk substitutes, when these are necessary, on the basis of adequate information and through appropriate marketing and distribution.
1.8 Assumptions behind the recommendations
As PIF may contain pathogens, one of the recommendations from the joint FAO/WHO meeting in Geneva, 2004 (FAO/WHO, 2004), and the basis for the WHA resolution request, was that guidance on the preparation, use and handling of PIF is required because many people who prepare PIF (both general public and health professionals) are not aware of the risks associated with this product, nor are they familiar with best practice for its reconstitution.
The recommendations are largely based on the findings of a FAO/WHO risk assessment on E. sakazakii in PIF, conducted in January 2006 (FAO/WHO, 2006). The quantitative risk assessment model that was developed calculates the increase or decrease in the relative risk associated with different feeding practices, compared to a baseline scenario.
These recommendations apply to persons preparing and handling PIF in care settings and in the home. In general, a dramatic reduction in risk is achieved when PIF is reconstituted with water that is no less than 70 °C. Risk is controlled by minimizing the time from preparation to consumption.
These recommendations are made under the assumption that the person preparing PIF has access to safe water; soap; a clean preparation environment; boiling water; and refrigeration. Where water quality is poor, boiling, chlorination and filtration are important means to inactivate microbial pathogens and make the water safe. To disinfect water: bring to a rolling boil; add 3-5 drops of bleach to 1 litre of water; or physically remove pathogens with the appropriate filter.
In certain circumstances (e.g. developing countries, or in the case of emergencies) one or more of these resources may be unavailable. In these cases, the simplest, most effective measures for reducing the risk of illness from the use of PIF are:
• Reconstitution with boiling water and consumption as soon as the formula is cool.
• Where boiling water is not available, reconstitute PIF with safe water at room temperature, and consume immediately.
1.9 Training
All persons preparing feeds from PIF should be informed about the risk associated with PIF and trained in or informed about its safe preparation according to these guidelines. As these guidelines recommend the use of very hot water, additional information or training, or both, should be provided on the safe handling of hot water. The present guideline document is divided into two main sections. Part 2 provides guidance for the preparation of PIF in care settings, and part 3 provides guidance for the preparation of PIF in the home environment. Both sections include a rational for the recommendations provided. Both environments have many similarities and therefore part of the guidance and rational is very similar between the two sections. Depending on the targeted end user, specific guidance material using either part 2 or part 3 should be developed.