Regulatory updates: Establishing safe limits across Europe

By Olivia Brown

- Last updated on GMT

© vovashevchuk / Getty Images
© vovashevchuk / Getty Images

Related tags Vitamin d Vitamin d supplementation Vitamin d deficiency Nutrition Efsa

Recent regulatory updates in Europe include a new consultation on Manganese, an update to the EFSA upper limit (UL) for vitamin D, and renewed supplementation recommendations in Denmark.

Establishing safe intake levels for Manganese

Following a request from the European Commission (EC), the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver a scientific opinion on the tolerable upper intake level (UL) for manganese.

In its draft scientific opinion on the upper limit​ EFSA finds that there are no adequate data to establish a UL, safe levels of intake of manganese were therefore provided ranging from 8 mg/day for adults ≥ 18 years (including pregnant and lactating women) and between 2 and 7 mg/day for other population groups.

In order to be able to derive an upper intake level (UL), EFSA has also released a technical report. This document focuses on the collection and appraisal of scientific evidence that could be used to derive an upper intake level (UL).

A lack of human studies examining association between exposure during sensitive time windows such as pregnancy and lactation was identified as a major data gap. While some case reports suggesting that relatively high manganese intake from supplements over longer periods may cause adverse neurological symptoms were identified, the report highlighted that limited conclusions can be drawn from case reports alone.

EFSA vitamin D review

The EFSA panel on Nutrition, Novel Foods, and Food Allergens (NDA) has reviewed and delivered a scientific opinion​ on the upper intake levels for vitamin D.

In addition, it was requested that a conversion factor (CF) should be proposed for calcidiol monohydrate into vitamin D​for labelling purposes.

Following this, systematic reviews of the literature were performed to investigate the bioavailability of calcidiol monohydrate compared with vitamin D3. ​In addition, the adverse health effects of excess intakes were also analysed, mainly with regards to persistent hypercalcaemia and endpoints related to musculoskeletal health, such as falls and bone fractures.

A conversion factor of 2.5 for calcidiol monohydrate into vitamin D3​ was proposed for labelling purposes as a result of the review. This would mean 1 µg vitamin D is to equivalent 1 µg cholecalciferol (vitamin D3​), 1 µg ergocalciferol (vitamin D2​), and 0.4 µg calcidiol monohydrate or 40 IU.

In addition, the decided UL remained unchanged with limits of 100 µg/d for adults (≥ 18 years including pregnant and lactating women) and adolescents aged 11-17 years. Persistent hypercalciuria was selected as the critical endpoint on which to base the decided UL of vitamin D.

“Based on available intake data, European populations are unlikely to exceed the UL, except for regular users of food supplements containing high doses of vitamin D,” the report highlighted.

Denmark for daily vitamin D

The DVFA (Danish Veterinary and Food Administration) has renewed its recommendations that all Danes should take a vitamin D supplement of 5-10 µg daily during the winter months (from October to April), adding that some groups in the population may need more than this.

The IADSA report explained that the recommendations following a study conducted in 2020 by the Norwegian Cancer Society, which showed that almost every fifth Dane who did not take vitamin supplements had a vitamin D deficiency by the spring.

The report continued: “While vitamin D is found in food, Denmark recognises that it is very difficult to meet vitamin D needs through food alone. Studies of Danes' diets show that they only meet a small part of their vitamin D needs via the food they eat.

“The Danish Food and Veterinary Administration therefore recommends that everyone from the age of 4 take a supplement of vitamin D from the beginning of October to the end April.”

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