Add to "My indicators"
Premix meets national regulations and requirements for large-scale fortification
This indicator provides information on documentation that the premix of vitamins and minerals used to fortify wheat or maize flour for large-scale fortification meets the minimum requirements for human consumption established by the official regulations and is approved for use.
Premix is a mixture of vitamins and minerals formulated to fortify wheat or maize flour. The premix must comply with adequate types and levels of nutrients added, hygiene, food safety and good manufacturing practices, thereby assuring that the premix meets the minimum requirements for human consumption established by the official regulations. The composition of premix influences the effectiveness and safety of the intervention. Premix should not affect the flour’s taste, smell, texture or baking and cooking qualities. Monitoring that the premix follows national large-scale flour-fortification standards, regulations and requirements supports intervention fidelity, acceptability, effectiveness, safety and impact.
The percentage of premix that have a Certificate of Conformity or other approval document meeting national regulations and requirements for large-scale fortification of wheat or maize flour
Numerator: the number of shipments of premix received with a Certificate of Conformity (or similar approval document) for a given period of time (e.g. the last 12 months)
Denominator: the number of premix shipments received over the same period of time
• Divide the numerator by the denominator. Multiply the result by 100 to convert the number into a percentage.
Considerations for the calculations:
• It may be important to define a target (benchmark) for this indicator (e.g. 100% every 12 months).
• This indicator can be collected and aggregated at different levels: at the individual mill, among a group of mills (such as those belonging to a milling association, or those who purchase their premix as a group), or for all mills participating in the fortification programme at a national level.
• The supplier provides a Certificates of Conformity (sometimes called a Certificate of Analysis) for all the vitamins and minerals present in each lot of premix.
• In some countries, premix is procured centrally and then distributed to mills. In these cases, the remote locations need documentation that the premix is approved for use.
approval, Certificate of Analysis, Certificate of Conformity, composition, documentation, formulation, legislation, mill inspection, premix, regulations enforcement, regulatory monitoring, requirement, vitamins and minerals
Food fortification
Output
Availability of product
School age children, 12-23 months, 24-35 months, 36-47 months, 48-59 months, 6-11 months, Adolescents, Men, Other (not any of the above, post-menopausal women, elderly), Women of reproductive age
None,
Copper, Folate, Iron, Niacin, Selenium, Vitamin A, Thiamine (vitamin B1), Vitamin B12, Riboflavin (vitamin B2), Vitamin B6, Vitamin C, Vitamin D, Vitamin E, Vitamin K, Zinc
Market-based
Some government agencies require laboratory testing from an independent or government source to verify the premix composition.
It is relatively easy and feasible to review the Certificates of Conformity (or similar documentation) for this indicator.
Without validation of premix composition through independent laboratory testing of the premix, it might not be possible to identify whether unacceptable vitamin and mineral formulations or compounds have been substituted, or that other premix-related undermining of the fortification standards or regulations has occurred.
If the premix specifications are incomplete in the standards or regulations for fortified flour and foods made with fortified flour, it may be difficult to collect this indicator, in addition to potentially jeopardizing the quality and safety of the flour fortification, thus affecting the overall programme.
In 2002, the Ministry of Health of a country published regulations related to the fortification of maize flour, including premix. Millers can only obtain the vitamin and mineral premix from companies that have registered with the Ministry of Health, and they have to keep on record a Certificate of Compliance for every batch of premix procured and used in the production of maize flour.
In this country, regulatory agency authorities visit each large-scale mill at least once per year. During this visit, they review, among other things, whether the mill has a Certificate of Conformity for each of the premix shipments received in the previous year. Across the 37 maize mills in that country, a total of 98 shipments of premix were procured during the previous year and 79 shipments had a Certificate of Conformity.
Numerator: 79
Denominator: 98
Calculation: 79/98 * 100 = 81% of the premix shipments procured in the previous year had a Certificate of Conformity.
Allen L, de Benoist B, Dary O, Hurrell R, editors. Guidelines on food fortification with micronutrients. Geneva: World Health Organization and Food and Agriculture Organization of the United Nations; 2006 (http://apps.who.int/iris/bitstream/10665/43412/1/9241594012_eng.pdf, accessed 30 October 2015).