Mandatory Labeling of Dietary Supplements in the EU
Beginning in 2024, the European Union will require mandatory labeling for dietary supplements as part of its effort to enhance quality control and consumer protection. For businesses, compliance with these new labeling standards will be essential for legal market access in the EU. This article explores key requirements for labeling dietary supplements, implementation stages, and necessary steps for adherence to the new regulations.
Regulatory Requirements for Dietary Supplement Labeling in the EU
Under the new EU regulation, each dietary supplement must carry a unique identification code to facilitate tracking from production to consumer. The updated rules mandate the clear listing of all ingredients, potential contraindications, and manufacturer details, aiming to reduce the circulation of counterfeit and low-quality products.
Innovations in Dietary Supplement Labeling
The labeling system for 2024 introduces several updates, including digital codes and a centralized tracking database. Manufacturers will be required to register all dietary supplements in the EU’s system, simplifying regulatory verification and oversight.
Purpose of Dietary Supplement Labeling
Labeling dietary supplements in the EU helps protect consumers by preventing substandard products from reaching the market. It also supports quality control and brand protection, enabling easy identification of authentic products. In a competitive market, mandatory labeling further builds consumer trust by guaranteeing product authenticity.
Regulatory Bodies Overseeing Dietary Supplement Labeling
The European Food Safety Authority (EFSA), national health authorities, and quality control agencies will be responsible for monitoring compliance. Customs services and independent certification laboratories will also participate in inspections.
Phased Implementation and Timeline for Dietary Supplement Labeling
The labeling rollout is structured in stages:
- 2023: Pilot testing and database establishment.
- Early 2024: Mandatory registration for all new dietary supplements.
- Mid-2024: Mandatory labeling across all dietary supplement categories.
- End of 2024: Comprehensive testing and enforcement for labeled products on the market.
Regulations Governing Dietary Supplement Labeling in the EU
Key regulations include:
- EU Regulation No. 1169/2011 on food information for consumers.
- Directive 2002/46/EC on dietary supplements.
- EU Regulation No. 178/2002 on food safety principles and requirements.
Dietary Supplement Categories Requiring Labeling in the EU
Mandatory labeling applies to the following categories:
- Supplements containing vitamins and minerals.
- Products derived from plant extracts.
- Supplements targeting digestive, immune, and cardiovascular health.
- Sports nutrition and energy recovery supplements.
Penalties for Non-compliance in Dietary Supplement Labeling
Producing or selling unlabeled dietary supplements can result in substantial fines, product seizure, sales bans, and even criminal penalties for violators.
Digital Codes for Dietary Supplement Labeling
A digital code—a unique sequence of numbers and symbols—will be assigned to each product for identification. This code, which can be scanned by regulatory authorities and consumers, simplifies product verification.
Preparing for Dietary Supplement Labeling Compliance
To comply with labeling requirements, companies must:
- Register products in the EU tracking system.
- Complete certification and quality testing.
- Apply digital codes in a readable format.
- Train staff to understand and manage labeling standards.
Cost of Labeling Codes for Dietary Supplements
The cost of obtaining a labeling code will vary based on product volume and certification specifics, with discounts available for large quantities to help reduce costs.
Conclusion and Disclaimer from BF-ESSE
BF-ESSE provides guidance and support for adapting to the new labeling requirements. This document is for informational purposes only and does not constitute legal advice. For specific legal guidance, please consult EU regulatory specialists.