Magnesium in Food Supplements: Forms, Dosages, and When It Becomes a Drug
Why Magnesium?
In the EU supplement market, magnesium is one of the most sought-after and consumed substances; it is used to help with PMS, anxiety, cramps, and sleep issues.
However, many producers and the majority of consumers are unaware of the distinction between
Using magnesium as a real-world example, this BF-EssE guide explains the distinctions, EU labeling regulations, and the boundary between supplements and therapeutic dosages.
In the EU supplement market, magnesium is one of the most sought-after and consumed substances; it is used to help with PMS, anxiety, cramps, and sleep issues.
However, many producers and the majority of consumers are unaware of the distinction between
- Salts of magnesium (such as oxide versus citrate)
- Magnesium element (what matters legally)
- Bioavailability (the biologically significant factor)
Using magnesium as a real-world example, this BF-EssE guide explains the distinctions, EU labeling regulations, and the boundary between supplements and therapeutic dosages.
Magnesium Forms & Equivalents
Magnesium Salt | Mg per 1000 mg | Bioavailability | Common Use Cases |
Magnesium oxide | ~600 mg | Low | Cheap, mild laxative effect |
Magnesium citrate | ~160 mg | High | Anxiety, PMS, muscle tension |
Magnesium bisglycinate | ~140 mg | High | Sleep, anti-stress, gut-sensitive |
Magnesium taurate | ~70 mg | Specific | Cardiovascular health |
Magnesium chloride | ~120 mg | Moderate | Topicals, rehydration solutions |
Magnesium lactate | ~120–180 mg | Varies | Used in various therapeutic blends |
EU Labeling Requirements
Before stating on the package:
"Magnesium 400 mg" can be misleading information, but such statements are found in many supplements, referring to the salt rather than the elemental magnesium concentration.
True statement (as required by EU law):
"400 mg magnesium citrate, providing 64 mg elemental magnesium"
Regulation (EU) No 1169/2011 states that only the elemental content needs to be disclosed and utilized for calculating the %NRV.
"Magnesium 400 mg" can be misleading information, but such statements are found in many supplements, referring to the salt rather than the elemental magnesium concentration.
True statement (as required by EU law):
"400 mg magnesium citrate, providing 64 mg elemental magnesium"
Regulation (EU) No 1169/2011 states that only the elemental content needs to be disclosed and utilized for calculating the %NRV.
Upper Limits & Drug Classification
In the case of Magnesium:
In most EU countries:
Up to 250–375 mg elemental Mg = food supplement
Above that = may trigger medicinal classification
Valerian example:
The dosage in food supplements must be less than what the European Medicines Agency (EMA) has stated.
Or by local regulations. Which have higher priority than EU regulations.
In most EU countries:
Up to 250–375 mg elemental Mg = food supplement
Above that = may trigger medicinal classification
Valerian example:
- 400 mg valerian extract = supplement
- >500+ mg/day = often requires pharmaceutical registration
- About Valeriana, you can check here.
The dosage in food supplements must be less than what the European Medicines Agency (EMA) has stated.
Or by local regulations. Which have higher priority than EU regulations.
How to Verify Your Formula
Before going to market, check:
- Elemental magnesium or any other element, vitamin, herb daily dose
- Salt type and conversion factor
- Whether the form has EFSA-approved claims
- National registers (e.g., BELFRIT, BVL, ANSES, ZVA, PVD)
BF‑Esse calculates exact equivalence and regulatory-safe dosage and prepares compliant formulas for private-label clients.
- Dosage conversion
- Label compliance check
- White-label formula assistance
Final Thoughts
"How much" is merely one factor under EU food supplement law. Equally significant are the ingredient's stated purpose, elemental quantity, and chemical form. Misrepresenting content or exceeding acceptable upper intake levels (UL) may lead to regulatory resistance or need a reclassification as a therapeutic product.
It's not only magnesium; almost all vitamins, minerals, and botanicals have maximum allowed amounts, ranging from iron and melatonin to red yeast rice and valerian root. Legal sales and long-term brand safety depend on knowing the boundaries in each member state.
In order to guarantee that every product you introduce is both legally safe and scientifically sound, we at BF-EssE determine these levels during the development process.
It's not only magnesium; almost all vitamins, minerals, and botanicals have maximum allowed amounts, ranging from iron and melatonin to red yeast rice and valerian root. Legal sales and long-term brand safety depend on knowing the boundaries in each member state.
In order to guarantee that every product you introduce is both legally safe and scientifically sound, we at BF-EssE determine these levels during the development process.
Frequently Asked Questions on EU Dosage Limits for Food Supplements
It does not refer to the entire weight of the chemical (e.g., magnesium citrate or oxide), but rather to the actual amount of magnesium (Mg) that your body can absorb. Labels must state the elemental value, not the salt, according to EU rules.
Yes. The Tolerable Upper Intake Level (UL) for supplemental magnesium is typically set around 250–350 mg/day (depending on the source and member state). Higher doses may risk reclassification as a medicinal product.
Only if 400 mg is the elemental magnesium content. If your 400 mg refers to magnesium citrate salt, and only 64 mg is elemental, you must clearly label the elemental value (e.g., “64 mg magnesium”).
Absolutely. Most vitamins, minerals, and botanicals have defined maximums, NRVs, or usage restrictions in EU or national registers. These include melatonin, vitamin D, iron, and red yeast rice, among others.
Yes. BF‑Esse offers expert formulation services — including NRV calculation, element equivalence, and regulatory compliance reviews — to help brands stay legal and competitive across EU markets.
Disclaimer
The information provided on this page is for informational and educational purposes only and does not constitute legal, regulatory, or medical advice. While BF‑Esse makes every effort to ensure the accuracy of content based on current EU and EFSA guidelines, readers are responsible for verifying all information with the relevant competent authorities and up-to-date regulatory sources.
Food supplement regulations may vary by country and are subject to change. Maximum permitted dosages, labeling requirements, and health claim permissions differ across jurisdictions.
Always consult with qualified regulatory professionals or national food safety authorities before marketing or formulating a food supplement.
Food supplement regulations may vary by country and are subject to change. Maximum permitted dosages, labeling requirements, and health claim permissions differ across jurisdictions.
Always consult with qualified regulatory professionals or national food safety authorities before marketing or formulating a food supplement.