Review of Grain Fortification Legislation, Standards, and Monitoring Documents.

Objective: Analyze the content of documents used to guide mandatory fortification programs for cereal grains.

Methods: Legislation, standards, and monitoring documents, which are used to mandate, provide specifications for, and confirm fortification, respectively, were collected from countries with mandatory wheat flour (n=80), maize flour (n=11), and/or rice (n=6) fortification as of January 31, 2015, yielding 97 possible country-grain combinations (e.g., Philippines-wheat flour, Philippines-rice) for the analysis. After excluding countries with limited or no documentation, 72 reviews were completed, representing 84 country-grain combinations. Based on best practices, a criteria checklist was created with 44 items that should be included in fortification documents. Two reviewers independently scored each available document set for a given country and food vehicle (a country-grain combination) using the checklist, and then reached consensus on the scoring. We calculated the percentage of country-grain combinations containing each checklist item and examined differences in scores by grain, region, and income level.

Results: Of the 72 country-grain combinations, the majority of documentation came from countries in the Americas (46%) and Africa (32%), and most were from upper and lower middle-income countries (73%). The majority of country-grain combinations had documentation stating the food vehicle(s) to be fortified (97%) and the micronutrients (e.g., iron) (100%), fortificants (e.g., ferrous fumarate) (88%), and fortification levels required (96%). Most (78%) stated that labeling is required to indicate a product is fortified. Many country-grain combinations described systems for external (64%) monitoring, and stated that industry is required to follow quality assurance/quality control (64%), though detailed protocols (33%) and roles and responsibilities (45%) were frequently not described.

Conclusions: Most country-grain combinations have systems in place for internal, external, and import monitoring. However, documentation of other important items that would influence product compliance to national standard, such as roles and responsibilities between agencies, the cost of regulating fortification, and enforcement strategies, are often lacking. Countries with existing mandatory fortification can improve upon these items in revisions to their documentation while countries that are beginning fortification can use the checklist to assist in developing new policies and programs.