Regulatory Agencies Lead External Quality Control

A country which makes flour fortification mandatory needs to also designate and equip the parties responsible for external monitoring. Along with legislation to require flour fortification, countries should allocate resources to train monitoring staff, determine which laboratories will test flour samples, and outline enforcement procedures for mills that do not meet the country standard. Fair, regular and accurate external monitoring by a regulatory agency will help ensure that the fortified flour delivers the maximum health benefits.

During external monitoring, an inspector will review written documents of the miller’s internal monitoring procedures. We recommend that food inspectors have the authority to look at all records, including invoices for premix and delivery receipts.

The inspector may also collect a 500-gram sample of flour to send to laboratories to determine whether the flour meets the country’s standard for fortification. One 500-gram sample is not representative of total production, however, and testing additional samples may be necessary for a fair analysis of the mill’s performance.

In addition to on-site inspections, government authorities may inspect data supplied by a mill. Each country’s flour fortification regulation determines the frequency of these audits. The off-site audit may be done quarterly, and the on-site audit may depend on how well the mill has performed in the past.

Each country with mandatory flour fortification determines its penalties for mills that do not comply with the country’s standards. Appropriate enforcement and quality assurance mechanisms are needed for fortification to deliver its maximum health impact. 

See a situational analysis of two decades of food fortification in Nigeria for an illustration of how regulatory monitoring is needed to help ensure that fortification reaches its maximum potential.

For more information:  

See this checklist of items that should be included in legislation, standards and monitoring documents produced by countries.

Regulations of Fortified Foods to Address Micronutrient Malnutrition: Legislation, Regulations and Enforcement 
explains the purposes and critical contents of regulatory provisions.

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Laboratories can subscribe to the “Check Sample” program of the American Association of Cereal Chemists to check their procedures and test results on a regular basis.

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