Introduction 28 1 1 5 6 11 11 14 25 14 12 13 25 14 14 25 12 15 26 On the basis of the existing models to calculate a maximum fortification level, a model adapted to the Dutch practical situation was developed for the Dutch authorities to derive for the fortification with micronutrients. This article first describes the model for the derivation of maximum amounts of micronutrient fortification in the Netherlands, and then it illustrates the use of the micronutrient specific data and assumptions in the calculation of the MSFLs for folic acid, vitamin A, and vitamin D. The article concludes with the considerations and the final allowed fortification level (AFL) of the risk management. Methods 12 14 25 29 11 14 25 Our model calculates the maximum safe level for fortification with a micronutrient per 100 kcal of the food (MSFL) for various age groups with the mathematical formula presented in Box 1. The lowest MSFL, i.e., the MSFL for the most sensitive group, is then advised to be the overall maximum acceptable fortification, as is common practice in toxicological risk assessment. Tolerable upper intake level (UL) total 28 11 25 14 25  95 95 3 10 16 23 18 20 25 14 Current intake of micronutrients from dietary supplements (SI) 22 19 22 4 9 4 25 11 14 n can will can will n Results Risk assessment: deriving MSFLs 1 2 3 28 1 3 Table 1 Maximum safe fortification levels and allowed fortification level of folic acid based on Dutch consumption data and European tolerable upper levels of intake for specific age groups Age group n UL (µg/day) 95 a SI (µg/day) 95 Max safe fortification level (MSFL) (µg/100 Kcal) Allowed fortification level (AFL) (µg/100 kcal) n n b Children 1–3 c 254 200 0 300 1,890 (67) 0   Children 4–6 c 276 300 0 300 1,995 (56) 0   Children c 312 400 0 300 2,456 (63) 27   Children c 336 600 0 300 3,154 (117) 63   Adolescents c 280 800 0 300 3,518 (150) 95   Men 18–30 c 525 1,000 0 600 4,010 (112) 67 100 100 Women c 579 1,000 0 600 2,867 (62) 93 140  Men 19–30 d 352 1,000 0 600 3,751 (130) 71 106 100 Women d 398 1,000 0 600 2,581 (76) 103 155  Men c 950 1,000 0 600 3,529 (64) 76 113  Women c 1,100 1,000 0 600 2,721 (48) 98 147  Men c 420 1,000 0 600 3,427 (109) 78 117  Women c 479 1,000 0 600 2,647 (74) 101 151  Men c 260 1,000 0 600 3,106 (119) 86 129  Women c 410 1,000 0 600 2,432 (65) 110 164  a b n c 2 d 17 21 95 95 n, can will Table 2 a Age group N UL (µg /day) 95 SI (µg /day) 95 n b Children 1–3 c 254 800 1,057 (167) 800 1890 (67) 0 Children 4–6 c 276 1,100 1,553 (262) 800 1995 (56) 0 Children 7–10 c 312 1,500 1,055 (116) 800 2456 (63) 0 Children c 336 2,000 1,153 (131) 800 3154 (117) 10 Adolescents c 280 2,600 1,429 (205) 800 3518 (150) 70 Men 19–30 b 352 3,000 1,886 (261) 1,200 3751 (130) 0 Women b 398 3,000 1,203 (162) 1,200 2581 (76) 154 Men ≥18 c 2,155 3,000 2,363 (132) 1,200 3642 (50) 0 Women c 1,679 3,000 1,350 (83) 1,200 2785 (39) 108 Women >50 c 889 1,500 1,441 (108) 1,200 2555 (53) 0 a b 17 21 c 2 95 95 n, can will Table 3 Maximum fortification levels and allowed fortification level of vitamin D based on Dutch consumption data and European tolerable upper levels of intake for specific age groups Age group n UL (µg/day) 95 SI (µg/day) 95 Max safe fortification level (MSFL) (µg/100 Kcal) Allowed fortification level (AFL) (µg/100 kcal) n n a Children b 254 25 4.8 (0.6) 10 1,890 (67) 3.6 5.4  Children 4–10 b 276 25 4.4 (0.2) 10 2,334 (50) 3.0 4.5 4.5 Children b 312 50 6.5 (0.6) 10 2,935 (100) 7.6 11.4  Adolescents b 336 50 7.6 (0.5) 10 3,509 (116) 6.2 9.2  Men c 352 50 6.5 (0.4) 10 3,751 (130) 6.0 8.9  Women c 398 50 5.2 (0.4) 10 2,581 (76) 9.0 13.5  Men b 950 50 8.9 (0.4) 10 3,529 (64) 5.9 8.8  Women b 1,100 50 6.4 (0.3) 10 2,721 (48) 8.2 12.3  Men 51–60 b 314 50 11.3 (1.2) 10 3,410 (128) 5.6 8.4  Women b 332 50 6.7 (0.6) 10 2,623 (90) 8.5 12.7  Men b 197 50 9.8 (1.0) 10 3,315 (124) 6.1 9.1  Women b 270 50 6.6 (0.6) 10 2,528 (87) 8.8 13.2  Men b 169 50 12.2 (1.8) 10 3,067 (141) 6.0 9.1  Women b 287 50 8.6 (0.8) 10 2,487 (86) 8.4 12.6  a n b 2 c 21 95 95 n, can will Folic acid 95 1 Vitamin A 28 28 95 2 Vitamin D 95 95 3 n n n Risk-management: setting AFLs for general exemption After the risk was assessed, a risk manager considered all the important issues and decided what maximum level of fortification will be allowed and included in a general exemption. In the Netherlands, proposed changes and additions to the Dutch Commodity Act are discussed with stakeholders (e.g., organizations of trade and industry, consumers organizations, authorities) in a Regular Consultation on the Commodity Act. Representatives of individual companies cannot participate in the Regular Consultation on the Commodity Act. 1 3 11 Folic acid 12 12 n 95 n 1 Vitamin D 28 n n 3 Vitamin A In contrast to the liberalization for folic acid and vitamin D, the risk manager did not liberalize the results from the risk assessments for vitamin A. To the opinion of the risk manager, exceeding the UL of vitamin A has more serious consequences for public health than exceeding the ULs for folic acid and vitamin D. In addition, the 95th percentile of habitual dietary vitamin A intake of several age groups already exceeded the UL, even without considering the vitamin A intake from dietary supplements. Furthermore, at this time no request for exemption has been received, although one product for which an exemption for folic acid was requested also contained vitamin A. So the AFL was set at 0 µg/100 kcal. The stakeholders in the consultation agreed with this decision. Exception for low-energy products An exception was made for light variants of products (low-energy products). According to the model, products low in energy may be fortified with smaller amounts of the micronutrient than the more energy-dense counterparts. In view of the obesity trend and the healthy image of light products, this was considered undesirable. Therefore, light products may be fortified with amounts similar to the amounts approved for their more energy-dense counterparts. Discussion 8 Applicability of the model 7 27 27 Risk management The discussions about the risk-assessment results with the different stakeholders worked well for the risk manager. This resulted in broad insight into the various points of view of the stakeholders. Ultimately the risk manager took the final decision, and in all these cases the stakeholders agreed with the final outcome. The risk assessment was based on the precautionary principle. However, with a view to the fact that this will be a temporary policy, the outcome of the risk assessment was judged to be rather conservative for folic acid and vitamin D. In contrast, the market may change, the date the European legislation will come into effect can be later than expected, and people may consume more fortified foods than estimated. Therefore, monitoring the intake of micronutrients from fortified foods is a very important tool for warranting the safety of the population. If monitoring shows that some groups within the population have habitual intakes that exceed the ULs, adaptations should be made. Especially children may be vulnerable. A food consumption survey is currently being conducted among children in the Netherlands. These data will provide insight into the micronutrient intake from natural foods, fortified foods and dietary supplements during 2005/2006. Additional considerations Some factors that were not taken into account in MSFL risk assessment are worth considering, and they can be implemented in the model or taken into account in the risk management if necessary. First, we made an exception for the fortification level of ‘light’ products in our risk management. This exception was not considered in the calculation and can therefore theoretically lead to micronutrient intakes that are too large even if the energy intakes are not exceptionally high. Monitoring the use of fortified ‘light’ products will be necessary to avoid frequent users exceeding the UL. Second, some products are intended for a specific population or target group only. If there is little risk that the product will be used by nontarget groups, the risk manager can make an exception to the model. Instead of using the calculated MSFL for the most vulnerable group, the MSFL for the specific target group can be used as a maximum for this specific product. Again, monitoring of the use of these products is important, and mentioning the target groups, as well as nontarget groups, on the product package might be considered. 24 International applicability of the risk-assessment model 11 The applicability of the model for this purpose depends on the availability of the input data. When calculating MSFLs valid for Europe as a whole, the availability of European data is necessary. However, data from a food consumption survey that cover all Member States of the European Union representatively are not available. Such data are not even available for all Member States individually. Furthermore, consumption data available in various Member States are often collected with different methods, in a different time frame, and for different specific population groups and the fraction of energy intake that can be fortified may differ greatly from country to country because of the various traditional diets. This makes it difficult to estimate the total habitual intake for each micronutrient and energy type at a European level. To overcome these problems, MSFLs in Europe can be set by using the available country-specific calculations and to select the most sensitive country (i.e., the country with the lowest MSFL). The maximum safe level for fortification for this country can then be applied in all Member States. Conclusion As this paper illustrates, our model for risk assessment can be used in the Netherlands to help risk managers to set maximum levels for safe addition of vitamins to foods. This has resulted in two general exemptions, one for folic acid at 100 µg/100 kcal and one for vitamin D at 4.5 µg/100 kcal. The model is flexible and can be adapted to new insights. For example, aspects concerning overage and ‘light’ products can be included with minor changes in the formula. Monitoring of the total micronutrient intake after applying a general exemption, as well as monitoring of the fortified fraction of the energy intake and the effect of the exception for light products, is recommended for evaluating the model parameters and AFLs and for making adjustments when needed.