Even products that are compliant in one country in the EU can be subject to import delay or medicinal classification problems in Austria, especially for non-EU brands. This guide covers the health supplements compliance process in Austria.
Regulatory Authority for Health Supplements in Austria
In Austria, health supplements are regulated as foods under EU and Austrian food laws. The market supervision, product testing, and enforcement are the responsibility of the Austrian Agency for Health and Food Safety (AGES).
Austria does not mandate pre-market approval, but products are extensively checked for non-conformance of ingredients, claims, and labelling.
What Are Health Supplements Under Austrian Regulations?
According to Austrian legislation, a health supplement is a food that’s intended for use as a supplement to a normal diet. They are packed with concentrated nutrients or with a substance that has a nutritional or physiological effect, and are sold by measured dose.
Common ingredients include:
- Vitamins and minerals
- Amino acids and fatty acids
- Plant extracts and botanicals
Health supplements are not medications and do not claim to cure, treat, or prevent diseases.
Compliance Checklist for Health Supplements Approval in Austria
Prior to the market entry, companies should ensure that:
- Ingredients compliance with EU food and novel food regulations
- No treatment or cure for any medical or disease condition
- German compliant labelling and warnings
- Only authorised nutrition and health claims
- The recommended daily intake is given
- Low levels of vitamins and minerals
- Technical documents and CoAs are provided
- Represented by a food business operator or EU importer in the EU
- Records of GMP and traceability are kept
Health Supplements Registration Process in Austria (Step-by-Step)
Follow the steps below to legally enter the health supplements market in Austria:
Step 1: Find Out What Category The Product Belongs To
The product should be deemed as a food supplement. Medicines may be products that are marketed as having disease treatment or prevention properties.
Step 2: Check Ingredient Compliance
Assess compliance with:
- Directive 2002/46/EC
- Novel Food Regulation (EU) 2015/2283
- Regulation (EC) No. 1925/2006 on restricted substances
Austria is an active rejector of products containing unauthorised novel foods and/or unsafe levels of food ingredients.
Step 3: Review Labelling Requirements
Labels must include:
- Recommended daily intake
- Caution: not to exceed the recommended daily dose
- Statement that supplements are not substitutes for a varied diet
- Child safety warning
- Nutrient amounts and NRVs (when applicable)
Claims that are misleading and/or health or disease-related are not acceptable.
Step 4: Validation of Health and Nutrition Claims
The right to use health claims can only be granted by the European Union.
Step 5: Create Technical Documentation
Companies should maintain:
- Product specifications
- Information on ingredients and formulations
- Certificates of Analysis (CoAs)
- Safety and traceability records
- GMP documentation
These documents could be requested at inspections or on customs review.
Step 6: Ensure Import and EU Operator Compliance
Compliance and traceability are the responsibility of a food business operator or importer, both located in the EU, and appointed by the non-EU manufacturers.
Step 7: Monitor Post-Market Compliance
AGES regularly tests supplements for:
- Labeling violations
- Unauthorized claims
- Unsafe nutrient levels
- Microbial contamination
- Novel food non-compliance
Documents Required for Health Supplements Registration in Austria
Companies should maintain:
- Food supplement identified as such
- Ingredient list with allergen declaration
- Recommended daily intake
- Mandatory warnings
- Net quantity and shelf life
- Batch number
- Storage instructions
- The food business operator’s name and address
- NRV values for vitamins and minerals (where available)
- Product label and artwork
- Certificates of Analysis (CoAs) and safety documentation
During inspections and import controls, AGES may ask for compliance documentation.
Labelling Requirements for Health Supplements in Austria
Supplements available in Austria must meet the requirements of the Food Information Regulation (LMIV) and those specific to supplements. Labels must include:
- Food supplement identified as such
- Names of nutrients or substances contained
- Recommended daily intake
- The amount of active ingredient in each dose
- Mandatory warnings
- Ingredient list and allergen declaration
- Net quantity, batch number, and shelf life
- The name and address of the food business operator
The labels for vitamins and minerals are required to include nutrient reference values (NRVs) as well. Claims that are misleading, disease-related, or cosmetic use claims are not allowed.
Licensing Requirements for Health Supplements in Austria
Health supplements are not subject to a separate product licence or notification in Austria.
But companies need to make sure that:
- Ingredients are allowed for supplementation
- Labels and health claims are compliant with EU and Austrian rules
- An EU-based importer or a food business operator is identified for non-EU products
Medicinal claims may necessitate a medicinal classification assessment for products.
GMP Requirements for Health Supplements in Austria
Manufacturers have to put in place and use hygienic procedures based on HACCP and traceability.
Companies should maintain:
- Batch traceability records
- Certificates of Analysis (CoAs)
- Records of microbiological and contaminant tests
- Raw material and supplier documentation
- Quality and storage controls
Health Claims and Advertising Regulations in Austria
Only claims that are registered under the EU Register of Health Claims may be used. Companies cannot:
- Claim to cure, treat, or prevent diseases
- Exaggerate or make false statements
- Recommend a dietary supplement in place of a well-balanced meal
- Use cosmetic-style recommendations
These restrictions are in relation to labelling, advertising, and electronic communication media.
Import Regulations for Health Supplements in Austria
For non-EU firms, it is essential to ensure:
- The importer or food business operator of the food is identified in the European Union.
- Labels comply with the Austrian and European standards.
- Ingredients are compliant with the Novel Food Regulation.
- Technical documentation & safety information exists
In Austria, supplementation with substances containing THC, high concentrations of vitamins, microbes, and novel, potentially unapproved ingredients are areas of enforcement.
Health Supplement Registration Timelines in Austria
Health supplements in Austria are not subject to pre-market registration or approval.
The timing for market entry depends on:
- Ingredient and novel food assessment
- Label and claims review
- German label preparation
- Technical documentation readiness
- Import and customs clearance
Health Supplement Registration Costs in Austria
Health supplements are not subject to registration or notification fees in Austria.
However, companies should budget for:
- Assessment of ingredients or novel foods
- Label and claims review
- German label translation
- Product testing and CoAs
- GMP documentation
- Import, customs, and EU operator costs
- Regulatory consulting support
Products may require reformulation or medicinal classification review, which can increase costs.
Conclusion
Import controls, German labelling requirements, and EU operator obligations create additional compliance requirements for non-EU manufacturers.
Artixio can help you with it. We provide regulatory assessment, labelling review, claims compliance, and market entry support for supplement companies in Austria and other EU markets. Companies can contact Artixio at info@artixio.com.
FAQs
1. Do health supplements have to be labelled in German in Austria?
Yes. Mandatory food information and supplement warnings must be provided in German for products sold in Austria.
2. Are health claims pre-approved in Austria?
Only health claims authorised under the EU Register of Health Claims may be used. Companies must comply with EFSA-reviewed claim conditions.
