This standard covers the production, preparation and use of products available in powdered form, specifically manufactured to be used for infants and young children either as a breast milk substitute, to supplement infant formula or fortify human milk, or in combination with other foods as part of the weaning diet. Products included are infant formulae, follow-up formulae, formulae for special medical purposes intended for infants and which serve as the sole source of nutrition, human milk fortifiers, and powdered formulae for special medical purposes for infants and young children intended to partially replace or supplement breast milk, infant formulae or follow-up formulae. This standard does not apply to ready-to-use liquid formulae for direct human consumption.

Contents

1. Scope and Used

2. Complementary Reference

3. Terms and Definitions

4. Primary Production

5. Establishment: Design and Facilities

6. Control of Operation

7. Establishment and Sanitation

8. Establishment: Personal Hygiene

9. Transportation

10. Product Information and Consumer Awareness

11. Training

Annex A (Informative) Microbiological Criteria For Powdered Infant Formula, Formula For Special Medical Purposes And Human Milk Fortifiers

Annex B (Informative) Microbiological Criteria For Powdered Follow-Up Formulae And Formulae For Special Medical Purposes For Young Children

Annex C (Informative) Guidance For The Establishment Of Monitoring Programs For Salmonella، Enterobacter Sakazakii (Cronobacter Species) And Other Enterobacteriaceae In High Hygiene Processing Areas And In Powdered Formula Preparation Units

References