Pharmanager Development, provider of services and tools to guarantee the conformity and effectiveness of your products

Dietary supplements

Dietary supplements require in-depth expertise to meet regulatory and scientific requirements at every stage of their development. Pharmanager Development supports you in identifying regulatory challenges, product positioning, claim validation, and ensuring compliance in your communications.

With our Phinn® regulatory and scientific database, we provide reliable and up-to-date information to enhance compliance and innovation in your products.

Our recognized expertise enables us to help our clients ensure the safety, efficacy, and regulatory compliance of their dietary supplements in France, Europe, and international markets.

 

What are the regulations for dietary supplements?

2002/46/EC

This directive partially harmonizes national legislation on dietary supplements. It sets general requirements for composition, labeling, and market placement within the European Union.

1924/2006/EC

This regulation governs the use of nutrition and health claims. It ensures that all claims used on dietary supplements are scientifically proven and understandable to consumers.

1169/2011/EU

It establishes general labeling rules for dietary supplements and food products in Europe. This regulation aims to provide clear, transparent, and comprehensive information to consumers.

Ensuring product compliance

We assess the composition of your dietary supplements, verify ingredient specifications, and analyze their compliance with current legislation.

Label verification

We analyze your labels to ensure compliance with Regulation (EU) No 1169/2011, including mandatory information, readability, and transparency for consumers.

Validation of nutrition and health claims

We help validate your claims, ensuring they comply with Regulation (EC) No 1924/2006 and are backed by solid scientific evidence.

Registration of dietary supplements

We handle declarations in Europe and third countries to ensure fast and compliant product registration across different markets.

Preparation of technical dossiers

We compile comprehensive technical dossiers for your finished products, including Annex II for plants and substances, and provide scientific and regulatory support during inspections or evaluations.

Regulatory and scientific monitoring

We conduct active monitoring to anticipate legislative changes in France, Europe, and beyond, allowing you to adapt your products to evolving regulations.

Pharmanager Development supports you in:

We support you at every stage of your dietary supplements’ lifecycle to ensure their compliance with current regulations. Our services cover product development, technical verifications, and dossier management for a successful market launch.

We also conduct in-depth analysis of health and nutrition claims to ensure your products meet legal requirements. With our scientific and regulatory expertise, we streamline the validation process to facilitate a fast and secure market entry.

Our answers to your questions

Which ingredients are allowed in a dietary supplement?

Authorized ingredients vary depending on national and European legislation. Regular regulatory monitoring and precise analysis of substances used are essential to ensure compliance.

What are the labeling requirements for dietary supplements?

Labeling must comply with Regulation (EU) No 1169/2011, including clear information on composition, usage instructions, and nutrition or health claims.

Why create a technical dossier for dietary supplements?

A technical dossier ensures product compliance, including composition, toxicological data, and scientific evidence to validate health or nutrition claims.

What are the risks of non-compliance for dietary supplements?

Risks include penalties, product withdrawals, and loss of consumer trust. A rigorous compliance review minimizes these risks.

Need expert guidance in this evolving and increasingly demanding regulatory landscape?