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Chapter 9 : Regulatory Aspects

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Abstract:

The International Commission on Microbiological Specifications for Foods (ICMSF) has been requested to contribute by proposing risk-based microbiological criteria as one of the control measures, and the proposal currently annexed in the revised draft code is presented in this chapter. The main stumbling blocks identified during the preparation of the initial drafts certainly is the scope of the new code, i.e., the types of products to be included in relation to the existing definitions of infants and the definitions of infant formulae, which may vary depending on the country. The European Commission has, established microbiological criteria for formulae for special medical purposes and for infant formulae that include two food safety parameters ( and ), with detection of other as a process hygiene parameter. The importance of the adherence to good hygiene practices during preparation has been stressed in all assessments performed. While the establishment of microbiological criteria has progressed rapidly and has led to the creation and even the implementation of very similar stringent criteria throughout the world, the establishment of guidelines for the safe preparation, handling, and storage of infant feeds has lagged behind. It is evident that, as far as regulatory approaches to control are concerned, a multipronged approach is the best one. This will require continued cooperation and collaboration between hospitals, industry, and governments.

Citation: Farber J, Pagotto F, Cordier J. 2008. Regulatory Aspects, p 235-253. In Farber J, Forsythe S, Doyle M (ed), . ASM Press, Washington, DC. doi: 10.1128/9781555815608.ch9

Key Concept Ranking

Salmonella enterica
1.0205094
Bacillus cereus
0.85484225
1.0205094
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References

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1. Agence Française de Sécurité Sanitaire des Aliments (AFSSA). 2005. Recommendations d’hygiène pour la préparation et la conservation des biberons, Juillet 2005. http://www.sante.gouv.fr/htm/actu/biberon/rapport_afssa.pdf.
2. American Dietetic Association (ADA). 2004. Infant feedings: guidelines for preparation of formula and breastmilk in health care facilities. American Dietetic Association, Chicago, IL.
3. Anonymous. 2005a. Epidémie de salmonellose à Salmonella enterica sérotype Agona chez des nourrissons, France, Janvier–Avril 2005. Point final de l’investigation au 10 Juin 2005. www.invs.sante.fr/presse/2005/le_point_sur/salmonella_agona_150605/index.html.
4. Anonymous. 2005b. Enterobacter sakazakii infections associated with the use of powdered infant formula—Tennessee, 2001. Morb. Mortal. Wkly. Rep. 51:297300.
5. Anonymous. 2006. Expediente no 1-47-2110-3888-06-1: alimentos para lactantes e infantes. http://www.alimentosargentinos.gov.ar/programa_calidad/Marco_Regulatorio/CONAL/Resoluciones_Conjuntas/1_47_2110_3888_06_1_sakazakii.pdf.
6. Brouard, C.,, E. Espié,, F.-X. Weill,, A. Kérouanton,, A. Brisabois,, A.-M. Forgue,, V. Vaillant, and, H. de Valk. 2007. Two consecutive large outbreaks of Salmonella enterica serotype Agona infections of infants linked to the consumption of powdered infant formula. Pediatr. Infect. Dis. J. 26:148152.
7. Codex Alimentarius Commission (CAC). 1979. Recommended international code of hygienic practice for foods for infants and children. CAC/RCP 21-1979. Food and Agriculture Organization, Rome, Italy.
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9. Codex Committee on Food Hygiene (CCFH). 2007. CX/FH07/39/4. Codex Committee on Food Hygiene, 39th session, New Delhi, India. ftp://ftp.fao.org/codex/ccfh39/fh39_04e.pdf.
10. European Commission (EC). 2005. Commission regulation (EC) no. 2073/2005 of 15 November 2005 on microbiological criteria for foodstuffs. Official J. Eur. Union L338/126.
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12. European Food Safety Authority (EFSA). 2007. Scientific opinion of BIOHAZ Panel on the request from the Commission for review of the opinion on microbiological risks in infant formulae and follow-on formulae with regard to Enterobacteriaceae as indicators. EFSA J. 444:114.
13. Federal Register. 2006. Current good manufacturing practice, quality control procedures, quality factors, notification requirements and records and reports for the production of infant formula; reopening of the comment period. Department of Health and Human Services, USFDA. Fed. Regist. 71:4339243398.
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15. Food and Agriculture Organization-World Health Organization (FAO-WHO). 2006. Enterobacter sakazakii and Salmonella in powdered infant formula: meeting report. Microbiological risk assessment series 10. World Health Organization-Food and Agriculture Organization of the United Nations, Geneva and Rome. WHO Press, Geneva, Switzerland. http://www.who.int/foodsafety/publications/micro/mra10/en/index.html.
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21. International Organization for Standardization (ISO). 2006. Milk and milk products— detection of Enterobacter sakazakii. Technical specification ISO/TS 22964 // IDF/RM 210. International Organization for Standardization, Geneva, Switzerland.
22. Van Acker, J.,, F. de Smet,, G. Muyldermans,, A. Naessens, and, S. Lauwers. 2001. Outbreak of necrotizing enterocolitis associated with Enterobacter sakazakii in powdered milk formula. J. Clin. Microbiol. 39:293297.
23. Zink, D. 2003. FDA field survey of powdered infant formula finished products and selected ingredients for possible Enterobacter sakazakii contamination. Contaminant and Natural Toxicants Subcommittee of the Food Advisory Committee Center for Food Safety and Applied Nutrition (CFSAN) Food and Drug Administration (FDA), U.S. Department of Agriculture, APHIS, Riverdale, MD. http://www.fda.gov/ohrms/dockets/ac/03/minutes/3939m1_summary%20Minutes.htm and http://www.fda.gov/ohrms/dockets/ac/03/slides/3939s1.htm.

Tables

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Table 1

Microbiological sampling plans and recommended limits for special dietary foods (ICMSF, )

Citation: Farber J, Pagotto F, Cordier J. 2008. Regulatory Aspects, p 235-253. In Farber J, Forsythe S, Doyle M (ed), . ASM Press, Washington, DC. doi: 10.1128/9781555815608.ch9
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Table 2

Microbiological sampling plans and recommended limits for food for infants and children (ICMSF, )

Citation: Farber J, Pagotto F, Cordier J. 2008. Regulatory Aspects, p 235-253. In Farber J, Forsythe S, Doyle M (ed), . ASM Press, Washington, DC. doi: 10.1128/9781555815608.ch9
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Table 3

Microbiological specifications recommended by the Codex Alimentarius Commission (CAC, )

Citation: Farber J, Pagotto F, Cordier J. 2008. Regulatory Aspects, p 235-253. In Farber J, Forsythe S, Doyle M (ed), . ASM Press, Washington, DC. doi: 10.1128/9781555815608.ch9
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Table 4

Draft microbiological criteria for powdered infant formula, follow-up formula up to months, formula for special medical purposes, and human milk fortifiers as proposed for e revised Recommended International Code of Hygiene Practice for Foods for Infants id Children (CCFH, )

Citation: Farber J, Pagotto F, Cordier J. 2008. Regulatory Aspects, p 235-253. In Farber J, Forsythe S, Doyle M (ed), . ASM Press, Washington, DC. doi: 10.1128/9781555815608.ch9
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Table 5

Current European Union microbiological criteria for formulae for special medical purposes and for formulae for infants up to 6 months of age

Citation: Farber J, Pagotto F, Cordier J. 2008. Regulatory Aspects, p 235-253. In Farber J, Forsythe S, Doyle M (ed), . ASM Press, Washington, DC. doi: 10.1128/9781555815608.ch9
Generic image for table
Table 6

Microbiological criteria for powdered infant formula from various countries

Citation: Farber J, Pagotto F, Cordier J. 2008. Regulatory Aspects, p 235-253. In Farber J, Forsythe S, Doyle M (ed), . ASM Press, Washington, DC. doi: 10.1128/9781555815608.ch9

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