Contract manufacturer of dietary supplements and the requirements of German and EU law

Dietary supplements placed on the German market are subject to both the EU Framework Regulation and national federal legislation. Each batch of product undergoes multi-stage composition verificationbefore it goes to the retail chains. The following article describes what legal norms determine the activities of entities engaged in the manufacture of formulations to order.

What EU regulations set the standards for acceptable ingredients of supplements?

Directive 2002/46/EC harmonises at Community level the list of vitamins and minerals authorised for use in nutritional preparations. The European Food Safety Authority (EFSA) assesses the risks associated with new substances and issues opinions as a basis for setting acceptable doses. Regulation (EC) No 1924/2006 restricts the scope of health and nutrition claims to be made on labels. The contract manufacturer is obliged to use only substances included in the approved Union lists, which excludes any modification of the formula.

Why does German law impose separate requirements on supplement manufacturers?

Germany has transposed the EU directive into national law in the form of the Special Purpose Foodstuffs Regulation (NeMV). Certified contract manufacturer take these procedures into account at the design stage of the documentation accompanying the product. Failure to notify before placing the product on the market constitutes a breach of the NeMV regulations and may result in a lot being withdrawn from the market. Detailed guidelines are published by the Federal Institute for Risk Assessment (BfR), indicating safe levels of active substances.

How do quality management systems ensure product compliance with control standards?

Companies that manufacture on demand implement the principles of Good Manufacturing Practice (GMP), the application of which is documented in detailed operating procedures. Hazard analysis based on HACCP methodology identifies critical control points throughout the manufacturing chain. Each series of supplements is subjected to analytical studies confirming the compliance of the composition with the approved specification. The contract manufacturer archives the inspection reports for the period required by the regulations, which facilitates the conduct of audits of certification bodies.

Key Takeaways - Contract Manufacturer and Regulatory Requirements

The EU directive harmonises the list of authorised substances and EFSA verifies safe dose levels. National federal regulations require prior official notification before the product is placed on the market. Factories use GMP and HACCP methodologies, compiling audit evaluation reports.

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FAQ

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What documents are required when reporting a supplement to BVL?

The notification shall include the quantitative composition of the product, the particulars of the notifying entity and the design of the label. BVL verifies the compliance of the notification with the requirements of the NeMV before the product is released for distribution.

How do EU requirements differ from German national regulations?

The EU Directive establishes a common database of ingredients and labelling rules for all Member States. Germany has additionally imposed a notification obligation and applies the BfR guidelines on levels of active substances.

For what purpose do manufacturing plants keep HACCP documentation?

HACCP procedures indicate the points in the process where the risk of contamination is highest. The reports are archived in the event of an audit and are evidence of compliance with the required manufacturing standards.

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