Proven Experience
With extensive experience in the German market, we have successfully developed and delivered food supplements that comply with the stringent regulations set forth by the Federal Office of Consumer Protection and Food Safety (BVL). Our expertise encompasses every stage, from formulation to delivery, ensuring adherence to both European Union directives and specific German regulations to guarantee consumer safety and product quality.
Definition of Food Supplements
In Germany, food supplements are defined as foodstuffs intended to supplement the normal diet and are concentrated sources of nutrients or other substances with a nutritional or physiological effect. They are marketed in dose form, such as capsules, tablets, powders, or liquids. These products must be safe for consumption and must not possess pharmacological effects; otherwise, they may be classified as medicinal products requiring authorization.
Notification Process.
Before marketing a food supplement in Germany, businesses are required to notify the BVL. This notification must occur no later than the first day the product is placed on the German market. The process involves submitting specific documentation to ensure compliance with legal requirements.
Steps for Notification
1.
Preparation of Documentation:
Label Sample: A copy of the product label in German, including all variations in pack sizes or flavors.
Authorization: If the notifier is acting on behalf of the responsible food business operator, an authorization letter is required.
Previous Notifications: If the product has been notified in another EU Member State, a German or English translation of the confirmation may be submitted (optional).
2.
Submission of Notification:
Complete the online form available on the federal portal and upload the required documents.
An automatically generated confirmation of receipt will be provided upon submission.
3.
Processing:
The BVL forwards the notification to the competent authorities in the federal states and to the Federal Ministry of Food and Agriculture.
The BVL does not assess the marketability of the products; compliance with food law regulations is the responsibility of the manufacturer or distributor.
Labeling Requirements
The labeling of food supplements must comply with the requirements of the Regulation (EU) No 1169/2011 and the German Food Supplements Regulation (NemV). All information should be in German and include:
- Product Name: Including the term “Nahrungsergänzungsmittel” (food supplement).
- List of Ingredients: Including active substances and their content.
- Recommended Daily Intake: Specified amount for consumption.
- Warnings and Contraindications: As applicable.
- Nutritional Information: Per serving.
- Manufacturer or Distributor Details: Name and address.
- Batch Number and Expiry Date: For traceability.
- Storage Instructions: As necessary.
Accurate labeling is crucial to avoid misleading consumers and to ensure compliance with German food law provisions.
Penalties for Non-Compliance
Failure to notify a dietary supplement to the BVL or incorrect labeling can result in fines of up to EUR 50,000. Additionally, supervisory authorities may order a product recall, leading to further costs and potential reputational damage for the company.
Additional Considerations
Substances other than vitamins and minerals with nutritional or physiological effects are subject to specific regulations. If such substances lack a history of safe use in the EU before 1997, they may be classified as “Novel Foods,” requiring prior authorization at the EU level.
We’re Certified.
Our company holds all necessary certifications, including BRC and NSF GMP, ensuring that our manufacturing processes meet the highest quality standards.
Multi-language Labelling
To enhance product appeal in Germany’s market, we offer assistance in creating labels in German, ensuring compliance with regional language requirements.