In Page Content
- Get Your Food Supplements Compliant and Notified in Europe
- From Composition Review to Regulatory Notification, Wherever You Sell
- Benefits of Regulatory Audit & Notification With FoodChain ID
- More Ways to Strengthen Your Global Supplement Compliance Strategy
- FAQ
- Request a Regulatory Audit & Notification Consultation
Get Your Food Supplements Compliant and Notified in Europe
One regulatory team audits your composition, corrects your label and files your notification with the right national authority, so your supplement reaches the market compliant and on time
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Notifier in Europe
How it Works
From Composition Review to Regulatory Notification, Wherever You Sell
Step 1
Composition Review
You provide your formulation and supporting documents; our regulatory scientists analyze the composition against the ingredient, dosage and combination rules of your target market.
Step 2
Label Development & Validation
We edit your label to meet local mandatory mentions, claims and allergen rules, you review the draft, and our regulatory team validates the final version before submission.
Step 3
Notification & Submission
You provide the required notification documents; we assemble and submit the complete dossier to the competent national or federal authority on your behalf.
Step 4
Authorities Evaluation & Follow-up
We monitor the authority’s review and respond on your behalf to any request for additional information, until your notification is accepted.
Compliance, End to End
Benefits of Regulatory Audit & Notification With FoodChain ID
Multi-Country Composition Audit
Confirm compliance before you invest
We check ingredient authorization, maximum dosages and combination rules against the regulations of each country where you plan to sell
Compliant Label Review
Avoid label-driven market withdrawals
Our specialists verify mandatory mentions, health claims, allergens and warning statements required in each target market
Local Notification Filing
File with the right authority the first time
We prepare and submit your notification dossier to the relevant national body, from DGAL in France to FDA in the US (when required: New Dietary Ingredient notifications or Structure/function claims notifications)
Authority Liaison & Follow-up
Respond to authority questions with confidence
We manage every request for additional information or objection raised during the authorities’ evaluation of your dossier
Full EU Coverage
One partner across your global markets
A single regulatory team coordinates your composition, label and notification requirements across Europe
Regulatory Monitoring
Stay compliant as rules evolve
We track changes to ingredient lists, labeling requirements and notification procedures in each country and flag what affects your product
Extend Your Compliance Capabilities
More Ways to Strengthen Your Global Supplement Compliance Strategy
Our Regulatory Audit & Notification experts work alongside these solutions so your supplement stays compliant from formulation review through market notification.
FAQ
Yes. Under EU Directive 2002/46/EC, food supplements can generally be sold without prior authorization, but most Member States require the manufacturer or distributor to notify the competent national authority before the product is first placed on the market.
No. Directive 2002/46/EC sets common composition and labeling rules, but each EU Member State designates its own competent authority and runs its own notification process, so requirements, forms and portals differ from one country to another.
In France, notification is submitted to the DGAL (Direction générale de la l’alimentation) through the online Compl’Alim portal before the product is first marketed.
In Germany, notification is filed with the BVL (Bundesamt für Verbraucherschutz und Lebensmittelsicherheit) under the national Nahrungsergänzungsmittelverordnung (NemV). In Italy, the product is registered with the Ministero della Salute (Ministry of Health) through its dedicated online notification system.
Since Brexit, Great Britain is no longer bound by EU Regulations. Food supplements are regulated under retained domestic legislation enforced by the Food Standards Agency (FSA) in England and Wales, and by Food Standards Scotland (FSS) in Scotland. In general, GB retained legislation on labeling, claims and safety requirements for food and food supplements kept the main provisions of the EU legislation applicable before 2021, but some specific GB provisions are also applicable (for example, applications for a new authorisation have to be submitted to GB Authorities). Northern Ireland continues to apply EU regulations.
The FDA regulates dietary supplements under the Dietary Supplement Health and Education Act (DSHEA) and various food provisions. Dietary supplements are not subject to FDA premarket approval; however, certain notifications are required in specific circumstances:
– If a product contains a dietary ingredient that was not marketed in dietary supplements in the United States before 1994, a New Dietary Ingredient (NDI) notification must be submitted to the FDA at least 75 days before the product is marketed.
– If structure/function claims are used on the product label, a notification must be submitted to the FDA within 30 days after the product is first marketed.
Timelines vary widely by country and pathway: pure notification systems, such as France or Belgium, can clear in a matter of weeks, while registration systems that require a full dossier review, can take several months.
The underlying safety, composition and labeling data can often be adapted from one market to the next, but each country requires its own forms, format, language and, in some cases, additional local data, so the dossier still needs to be tailored country by country.
Yes. One regulatory team coordinates composition review, label validation and notification filing across the Europe, so you have a single point of contact instead of a separate local partner for each market. See our Health & Nutrition Consulting services for the full scope of support.