Regulatory Services

In Europe, food supplements must adhere to European Directive 2002/46/EC and also conform to any relevant local regulations within each specific country. SustChem assists in registering your food supplements and ensures their compliance across the European region.

Registration of your products in all European Union Countries

Food supplements are subject to distinct registration prerequisites in every country where they are distributed. Each member country has its specific registration requirements. SustChem offers the following services:

• Submission of registration documentation in accordance with national regulations.
• Development of a registration strategy for multiple countries to streamline the application of the mutual recognition principle.
• Provision of evidence of submission, notification, or registration as dictated by each country’s legislation.
• Ongoing monitoring of the registration process.

Dossier preparation

Ensuring the safety of any food supplement in the market is paramount, requiring the construction of a comprehensive dossier that demonstrates compliance with all European requirements. Additionally, specific national agencies may request this information upon product notification, and scientific evidence is essential for health-related claims.

SustChem aids in this process by:

• Gathering mandatory documents from your suppliers.
• Providing guidance on sourcing information from professional literature.
• Preparing your dossiers and conducting regulatory analysis.
• Monitoring the progress of ongoing dossiers and offering guidance in case of inspections by competent authorities.

Review of your labels, nutritional information and health or nutritional claims

The labeling of food supplements is regulated by the European Commission’s Regulation No. 1169/2011, which stipulates the mandatory information for all labels.

SustChem provides the following services:

• A comprehensive label review to assist in determining your product’s positioning in the market.
• Validation of the mandatory information and nutritional guidance displayed on your labels.
• Tailoring regulatory compliance to your specific product positioning and communication approach.
• Assessment of health claims in comparison with the list of authorized claims, while awaiting the outcome of an evaluation under EC Regulation No. 1924/2006 concerning health claims.

Ensuring the ‘Nutrivigilance’ for your products

After introducing your food supplements to the market, it is highly advisable to closely track developments in the related legislation as it evolves.

SustChem provides a service to continuously monitor the active substances within your products in collaboration with the RASFF (Rapid Alert System for Food and Feed).