BfR Warns About High-Dose Vitamin D Bolus Supplements

# BfR Warns About High-Dose Vitamin D Bolus Supplements

BfR warns that high bolus doses of Vitamin D (500 µg every 20 days) pose health risks including increased falls and bone fractures, especially when combined with Vitamin K2.

This development has far-reaching implications for manufacturers, distributors, and consumers of food supplements in Europe. Below, we analyze the details and consequences of this important news.

Regulatory Context and Background

European regulation of food supplements is in a continuous development process. This change is part of efforts to strengthen consumer protection while enabling innovation.

Legal Framework

Food supplements in the EU are subject to a complex regulatory framework: - Directive 2002/46/EC: Basic framework directive for food supplements - Regulation (EC) No 1924/2006: Regulation of nutrition and health claims - Regulation (EC) No 1925/2006: Addition of vitamins, minerals, and certain other substances - Regulation (EU) 2015/2283: Novel Food Regulation for novel foods

Practical Impacts on Companies

The new regulations have direct and indirect effects on various business areas:

Product Development and Formulation - Review of existing product formulations for compliance - Adjustment of dosages to new maximum levels or usage conditions - Development of alternative formulations in case of restrictions - Consideration of new requirements in product innovation

Labelling and Marketing - Updating labels and packaging - Adjusting product information and warnings - Reviewing advertising statements and claims - Training sales teams on new requirements

Quality Management and Compliance - Implementation of new testing procedures and controls - Updating specifications and work instructions - Documentation of all changes and adjustments - Regular compliance audits

Supply Chain Management - Review and qualification of suppliers - Ensuring traceability - Adjustment of purchasing specifications - Risk assessment in the supply chain

Timeline and Implementation

For successful implementation of the new requirements, companies should:

1. Immediate Analysis (Weeks 1-2): Identify affected products and assess need for action 2. Planning (Weeks 3-4): Develop an implementation plan with priorities and resources 3. Implementation (Months 2-3): Carry out necessary changes to products and processes 4. Validation (Month 4): Verify effectiveness of measures 5. Monitoring: Continuous compliance monitoring

Practical Recommendations

For companies in the supplement industry, the following recommendations apply:

1. Immediate Assessment: Check immediately if and how your products are affected 2. Compliance Check: Conduct a comprehensive compliance check 3. Documentation: Ensure all required documents are complete and up to date 4. Expert Consultation: Consult compliance experts or lawyers if uncertain 5. Proactive Communication: Inform customers and partners transparently about changes 6. Continuous Monitoring: Stay informed about further developments

Further Information and Sources

Detailed information on this development can be found at the original source: [BfR](https://www.behrs.de/news/neue-bfr-stellungnahme-zu-vitamin-d-in-nahrungsergaenzungsmitteln-2226)

For questions regarding the compliance of your products, the team at Supplement-Check.eu is available. Our tools and consulting services help you meet regulatory requirements and bring your products safely to market.

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*This article was created by the Supplement-Check.eu news team and is based on official sources from regulatory authorities. Last update: 12.01.2026*

*Disclaimer: This article is for informational purposes only and does not constitute legal advice. For specific legal questions, please consult a specialist attorney.*