Food supplement notifications
Full consultation for your file
Do you need the notification of food supplements to be able to legally market the products in Romania, without wasting time in bureaucratic procedures?
We fully take over the notification process, from analysis of the formula and verification of documentation to the preparation and submission of the file to the competent authorities, maintaining the relationship with the authorities throughout the evaluation and managing all their requests, until obtaining the final notification.
We work with manufacturers, importers and distributors who want legal certainty and a fair, complete and efficient process, so that their products comply with the legislation in force and can be put on the market without blockages.
- National Institute of Public Health
- National Research and Development Institute for Food Bioresources – IBA Bucharest
- National register of nutritional and health claims on food products
What does the notification of food supplements mean in Romania
In order to be legally marketed in Romania, a food supplement must be notified to the competent authority, based on a file drawn up according to the applicable legal requirements. The notification confirms that the product is presented and documented in accordance with the relevant composition, labeling and marketing legislation.
We offer full support in product analysis, compliance verification, label drafting in Romanian and notification file preparation, so that the process is managed correctly, clearly and efficiently.
Full notification file
Legislative compliance
Compliance with composition and labeling requirements
Fast Processing
From the evaluation of the ingredients to obtaining the notification certificate
Our services for dietary supplement notifications
Preliminary analysis
Preliminary product analysis and notification verification, based on the list of ingredients and available documents.
Ingredient consultancy
Consultancy on the composition of the food supplement, in relation to legal requirements and lists of permitted or restricted substances.
Label drafting and verification
We write the label of the food supplement in Romanian and check its compliance with the legal requirements regarding labeling, nutrition claims and health claims.
Submission & Communication authorities
Submission of the notification file to the competent institutions and communication with the authorities until the notification certificate is obtained.
Renotation & update support
Support for re-notification, label or formula changes and documentation update in case of legislative changes.
Registration of health claims
for vitamin and mineral food supplements on the platform of the Ministry of Health.
Why work with us
Choosing a team specializing in dietary supplement notifications: you save time, reduce the risk of rejecting the file and avoid the costs of delays in market launch.
- Dedicated Experience in the preparation of notification dossiers for food supplements and the relationship with the competent authorities.
- Understanding current legislative requirements and rapid adaptation to changes in procedures or regulations.
- Solution-oriented approach, with a focus on obtaining notification in the shortest possible time, under conditions of full compliance.
- Clear communication and step-by-step support, so you always know at what stage the notification of your dietary supplement is.
Laboratory analyzes for food supplements – ISO 17025 accredited laboratories
For the submission of food supplement notification files in Romania, the authorities request analysis bulletins for the finished product and, in certain cases, for the raw materials. These analyzes must be carried out in accredited laboratories and the test reports must contain the determinations required by the legislation in force.
Through our collaborators – accredited laboratories ISO 17025 – we offer complete support for carrying out the laboratory analyzes necessary for the notification of food supplements.
Notification process
Contract & Billing
The collaboration is carried out on the basis of a contract and invoice for the services provided. After signing the contract, we begin the process of analyzing and preparing the documentation.
Ingredient check
We analyze the composition of the product to verify the possibility of notification according to the applicable legislation and lists of permitted or restricted substances.
Document supply
After confirming the possibility of notification, the customer submits the necessary technical documents for drawing up the notification file.
File preparation
Based on the documents provided, we draw up the notification file and draw up the label in Romanian, the necessary declarations and annexes according to the requirements of the competent authority.
Label approval
The label and documents are sent to the customer for verification and approval. The file is submitted only after receiving the written consent from the client.
Obtaining notification certificate
At the end of the procedure, you receive the notification certificate and related documents, necessary for the legal marketing of the product in Romania.
File submission
We submit the file to the competent authority and manage correspondence with the authority until the notification certificate is obtained.
About us
We are a team of specialists with experience in food supplement notifications, who work every day with manufacturers, importers and distributors who want to enter the Romanian market quickly and correctly. We know the requirements of the authorities very well and we know how a notification file must be built to be complete, clear and easy to approve.
We get involved in every project as in one long-term partnership, not just as in a punctual service. We help you navigate the bureaucracy, explain every step and offer you concrete solutions so that your food supplements reach the shelves as quickly as possible, respecting the legislation in force.
Our customers
Benefits for you
Reduced risk of rejection
Low risk of rejection of the dietary supplement notification file due to our experience and attention to detail.
Time saving
Time saving for your internal team, who no longer have to follow all the legislative details and bureaucratic procedures.
Clear Communication
Direct and clear communication, with periodic updates on the status of notification of your food supplement.
Frequently Asked Questions
How long does the process of notifying a dietary supplement take?
The duration of the process depends on the complexity of the product and the assessment time of the competent authority. The preparation of the file is carried out, as a rule, within 2–3 weeks of receiving all correct and complete documents.
The authority’s evaluation deadline is, in practice, approximately 30–90 days from the submission of the file, depending on the competent institution and any requests for clarifications.
Throughout the process, we manage communication with the authority and keep you informed of the status of the file
Who can request the notification of a food supplement in Romania?
The notification is made in the name of the economic operator who introduces the product on the Romanian market. This can be the manufacturer, importer or distributor of the product.
The notification certificate is issued in the name of the company from Romania or the European Union that markets the product, and the label and documentation must correspond to the economic operator holding the notification.
We provide support throughout the notification process, whether you are a manufacturer, importer or distributor.
What happens if the authorities request changes to the file?
We manage correspondence with the authorities and any requests for additions or changes. We inform you immediately and take care of the whole process until the final notification is obtained, without additional stress for you.
When can I start selling the product in Romania?
The product can be marketed after obtaining the notification certificate. In the case of supplements containing vitamins and minerals and using health claims, immediately after obtaining the certificate, the health claims are registered in the National Register of Nutritional and Health Claims. This stage is mandatory and takes place after the notification of the food supplement.
Can I sell the product in Romania if it is already notified in another EU state?
Each member state of the European Union has its own notification procedure for food supplements, and the notification obtained in another member state is not automatically valid in Romania. In general, products must be notified separately in each Member State where marketing is desired.
In certain situations, the principle of mutual recognition can be applied, but even in this case the Romanian authorities usually request the complete technical documentation and the label in Romanian, and the procedure is, in practice, similar to the standard notification.
What if I change the formula or label after notification?
Any change in composition usually requires renotification of the product.
Should the authority be notified if certain information changes after notification?
Yes. Changes such as changing the name of the product, changing the company, changing the registered office, changing the label, packaging or marketing method must be communicated to the authority by submitting annexes to the notification. These changes do not require re-notification, but must be officially declared for certificate updating.
Is it necessary to register health claims?
Yes. For supplements containing vitamins and/or minerals and using health claims, they must be registered in the National Register of Nutrition and Health Claims, according to GD no. 723/2011. The procedure is carried out after obtaining the notification certificate of the food supplement and is different from the product notification.
Can we fully manage the procedure for you?
Yes. We take care of the whole process: checking the ingredients, drafting the compliant label, drawing up the file, submitting to the authority and obtaining the notification certificate. After notification, we can also help you with the registration of health claims and the submission of annexes for possible changes.
Does the label have to be in Romanian?
Yes. The label in Romanian is mandatory for the marketing of the product in Romania and is part of the notification file. The label must comply with applicable legislation and the product must be marketed with the label in the form approved in the notification process.
Contact notifications food supplements
- Fast response within 24 hours
- Preliminary analysis for notification
- Total transparency regarding deadlines
