This technical regulation applies to liquid or powdered infant formula, follow-on formula for older infants (6 to 12 months), products for young children (12 to 36 months), and formulas for special medical purposes from birth to 12 months intended to meet special nutritional and medical needs. It does not apply to formulas for special medical purposes for children over one year of age. The regulation sets requirements for product composition, quality, labeling, and safety.
Contents
1. Scope and Field of Application
2. Complementary References
3. Definitions
4. General Requirements
5. Nutritional Composition for Infant Formula
6. Nutritional Composition for Follow-on Formula for Older Infants
7. Nutritional Composition for Formulas for Special Medical Purposes from Birth to 12 Months
8. Nutritional Composition for Products for Young Children
9. Texture and Particle Size
10. Additives
11. Flavourings
12. Pesticide Residues
13. Veterinary Drug Residues
14. Radionuclide Limits
15. Contaminants
16. Microbiological Criteria
17. Hygiene Requirements
18. Packaging
19. Fill of the Container
20. Handling, Transportation, and Storage
21. Registration
22. Labelling
23. Health and Nutrition Claims and Statements on the Label
24. Marketing
Appendix (1) - Essential and Semi-Essential Amino Acids in Mother's Formulations
Appendix (2) - Reference Values for Vitamins and Minerals for Children from 6 Months to 3 Years
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