Checklist of Key Itemsa and All Possible Scoring Options in Fortification Legislation, Standards, and Monitoring Documents
| Item | Scoring Options | References |
|---|---|---|
| General | ||
| 1. States that legislation applies to at least one food vehicle fit for human consumption (types/grades to be fortified) | (2) States at least one type fit for human consumption (0) Does not state | 10, 12, 17, 22 |
| 2. States the public health objective; purpose and scope of legislation | (2) States the public health objective or general purpose of legislation (0) Does not state | 10, 13, 17, 22 |
| 3. References latest available science or accepted international norms and recommendations, particularly for items that may not be covered in the country's documents | (2) States the documents referenced (0) Does not state | 12, 17, 21 |
| 4. Provides definitions that include terms that are specific to fortification (e.g., fortified food, premix, fortificant, food vehicle) | (2) States at least one term related to fortification (0) Does not state | 17, 22 |
| 5. Provides repeals (if there is at least one prior document about fortification) | (2) States repeals (0) Does not state (N/A) No prior documents about fortification | 12, 17 |
| 6. Provides effective date or gives grace period for when fortification is to begin (e.g., effective 6 months from signing) | (2) States effective date or grace period for when fortification is to begin (e.g., effective 6 months from signing) (0) Does not state | 12, 17 |
| Micronutrients/Premix | ||
| 7. States nutrients required | (2) States nutrients (0) Does not state | 8, 10, 12, 13, 21 |
| 8. States fortificants (chemical compounds) to be used (including fortificants that are allowable as options) | (2) States fortificants for at least one nutrient (0) Does not state | 8, 10, 12, 13, 21 |
| 9. States fortification levels | (2) States a range or number with +/- (1) States one number only (0) Does not state | 8, 10, 13, 21 |
| 10. States consideration of bioavailability/biological activity of fortificants | (2) States some consideration of bioavailability (mentions these or related terms) (0) Does not state any consideration | 9 |
| 11. States consideration of nutrient stability | (2) States consideration of nutrient stability (0) Does not state any consideration | 11 |
| Costing | ||
| 12. States that the cost of fortification is regulated through cost-sharing schemes (between government, industry, consumers) or tax measures (to assist industry) | (2) States consideration of either cost regulation method (0) Does not state any consideration | 10, 12, 13 |
| 13. States consideration of the financial responsibility (of the government) of monitoring and enforcing fortification (schedule of fees, budget) | (2) Shows consideration that monitoring costs money (0) Does not state any consideration | 10, 13, 19, 21, 22 |
| Labeling | ||
| 14. Includes some sort of statement/label/logo that makes it clear that the product is fortified | (2) Includes a statement, label, or logo (0) Does not include statement, label, or logo | 8, 10, 12, 13, 18 |
| 15. Provides guidance on health claims that can be made for this product (specific to micronutrients added through fortification) | (2) Provides guidance on health claims specific to micronutrients added through fortification (0) Does not provide | 12, 15, 20 |
| Internal Monitoring (Conducted by Industry) | ||
| 16. States requirement for sampling as part of internal monitoring (e.g., describing number of samples, amount, frequency, individual vs. composite, where samples are taken in the process, and percent considered passing) | (2) States that samples should be taken as part of internal monitoring (1) States that samples should be taken (generally) (0) States that samples should not be taken (N/A) Does not describe the sampling process | 1, 8, 12, 22, 23 |
| 17. States that industry is required to follow quality assurance/quality control in regards to fortification | (2) States requirement of quality assurance/quality control for fortification (0) Does not state requirement | 1, 8, 12, 22, 23 |
| 18. States applicability of using qualitative testing (e.g., spot tests, iChecks) to determine the presence or absence of a vitamin or mineral | (2) States applicability of spot test to determine presence/absence of vitamin or mineral specific to internal monitoring (1) States applicability of spot test to determine presence/absence of vitamin or mineral generally (0) Does not state | 11, 21 |
| External Monitoring (Conducted by Government) | ||
| 19. States requirement for external monitoring at the production site to assure compliance with standards and regulations | (2) States requirement for external monitoring or the need for audits/inspections (0) Does not state requirement | 1, 9, 10, 12, 15, 17, 18, 21, 22, 23 |
| 20. Describes protocols and systems for regulatory monitoring | (2) Includes checklists or provides detailed description of regulatory monitoring procedures (1) Does not explicitly describe, but references protocols and systems for regulatory monitoring (0) Does not describe | 1, 13, 21 |
| 21. If there are two or more government agencies involved in external monitoring, clarifies the roles and responsibilities between different government agencies in external monitoring | (2) Clarifies roles and responsibilities for more than one agency (1) Clarifies roles and responsibilities for one agency (0) Clarifies roles and responsibilities for no agencies (N/A) Only one government agency involved | 12, 21, 23 |
| 22. Allows for monitoring to be conducted often enough that problems can be identified and addressed on a timely basis; specifies a timeline for inspections (e.g., once every 6 months, increasing to once every 2 months if a discrepancy is found) | (2) Describes frequency and how it is responsive to the needs of industry or the stage of fortification implementation (1) Makes mention of a timeline (0) Does not state | 1, 16, 18, 23 |
| 23. States requirement for sampling as part of external monitoring (e.g., describing number of samples, amount, frequency, individual vs. composite, where samples are taken in the process, and percent considered passing) | (2) States that samples should be taken as part of external monitoring (1) States that samples should be taken (generally) (0) States that samples should not be taken (N/A) Does not describe the sampling process | 1, 8, 12, 22, 23 |
| 24. States applicability of using qualitative testing (e.g., spot tests, iChecks) to determine the presence or absence of a vitamin or mineral | (2) States applicability of spot test to determine presence/absence of vitamin or mineral specific to external monitoring (1) States applicability of spot test to determine presence/absence of vitamin or mineral generally (0) Does not state | 21 |
| 25. States registration is required in order to use a logo/be licensed to produce fortified foods | (2) Describes some type of registration or licensing (0) Does not state that registration or licensing is required | 17, 18 |
| Commercial Monitoring (Conducted by Government) | ||
| 26. Provides justification for commercial monitoring at retail stores | (2) Provides justification for commercial monitoring (0) Does not provide justification for commercial monitoring | 21 |
| 27. Describes protocols and systems for commercial monitoring | (2) Includes checklists or provides detailed description of commercial monitoring procedures (1) Does not explicitly describe, but references protocols and systems for commercial monitoring (0) Does not describe | 1, 13, 21 |
| 28. If there are two or more government agencies involved in commercial monitoring, clarifies the roles and responsibilities between different government agencies in commercial monitoring | (2) Clarifies roles and responsibilities for more than one agency (1) Clarifies roles and responsibilities for one agency (0) Clarifies roles and responsibilities for no agencies (N/A) Only one government agency involved | 12, 21, 23 |
| 29. Allows for monitoring to be conducted often enough that problems at the production site or import companies can be identified and addressed on a timely basis; specifies a timeline for inspections (e.g., once every 6 months) or works with production companies to correct noncompliance | (2) Describes frequency and how it is responsive to the needs of industry or the stage of fortification implementation (1) Makes mention of a timeline (0) Does not state (N/A) No commercial monitoring occurs | 1, 16, 18, 23 |
| 30. States requirement for sampling as part of commercial monitoring (e.g., describing number of samples, amount, frequency, individual vs. composite, where samples are taken in the process, and percent considered passing) | (2) States that samples should be taken as part of commercial monitoring (1) States that samples should be taken (generally) (0) States that samples should not be taken (N/A) Does not describe the sampling process | 1, 8, 12, 22, 23 |
| Import Monitoring (Conducted by Government) | ||
| 31. Provides justification for import monitoring at points of entry | (2) Provides justification for import monitoring (0) Does not provide justification for import monitoring | 21 |
| 32. Describes protocols and systems for import monitoring | (2) Includes checklists or detailed description of import monitoring procedures (1) Does not explicitly state, but references protocols and systems for import monitoring (0) Does not state | 1, 13, 21 |
| 33. If there are two or more government agencies involved in import monitoring, clarifies the roles and responsibilities between different government agencies in import monitoring | (2) Clarifies roles and responsibilities for more than one agency (1) Clarifies roles and responsibilities for one agency (0) Clarifies roles and responsibilities for no agencies (N/A) Only one government agency involved | 12, 21, 23 |
| 34. States requirement for sampling as part of import monitoring (e.g., describing number of samples, amount, frequency, individual vs. composite, where samples are taken in the process, and percent considered passing) | (2) States that samples should be taken as part of import monitoring (1) States that samples should be taken (generally) (0) States that samples should not be taken (N/A) Does not describe the sampling process | 1, 8, 12, 22, 23 |
| Enforcement/Penalties | ||
| 35. Indicates roles and responsibilities in enforcing the legislation | (2) States the role and responsibilities of government in enforcement (0) Does not state | 14, 17, 22 |
| 36. States incentives to start fortification | (2) States any incentives to encourage fortification initiation (e.g., tax incentives for new equipment or premix) (0) Does not state | 13, 17, 22 |
| 37. States incentives to continue fortification, including ensuring compliance | (2) States any incentives to encourage the continuation of fortification (e.g., transport priority, favorable tax or tariff treatment, or patent rights) (0) Does not state | 13, 17, 22 |
| 38. States penalties to compel compliance | (2) States any penalties (0) Does not state | 12, 13, 14, 17, 22 |
| 39. Penalties are objectively defined (e.g., first penalty=$100, second penalty=$300) | (2) Penalties are objectively laid out in the document (e.g., first penalty=$100, second penalty=$300) (0) Penalties are not objectively laid out (N/A) No penalties are stated (answered 0 to previous question) | 10 |
| 40. States that enforcement is required to include feedback and support to improve performance and correct noncompliance | (2) Requires any feedback/support to improve performance (0) Does not require | 1, 10, 17, 18, 21, 23 |
| Laboratory | ||
| 41. References required analytical assays for nutrients (e.g., liquid chromatography-mass spectrometry for folic acid, atomic absorption for iron and zinc) | (2) References required assays (0) Does not state requirements | 8 |
| 42. States recognition that laboratory results are subject to several sources of variation and do not provide conclusive evidence of compliance or noncompliance | (2) States recognition that lab results are subject to variation (0) Does not state recognition | 21 |
| 43. Focuses on the quantitative analysis of "marker" micronutrients such as iron | (2) Focuses on quantitative analysis of marker micronutrient such as iron (0) Does not state | 12, 21, 23 |
| Reporting | ||
| 44. States how government monitoring results are shared with stakeholders | (2) States how results are shared with stakeholders (0) Does not state how results are shared | 17 |
↵a As identified in the literature and by content experts.