This service is part of our Scientific and Regulatory Expertise in health nutrition to help you design and launch your products in Europe, USA and Asia, through a panel of services : Novel Food consulting evaluation, Regulatory Compliance & notification, Health Claims, …
You have developed a dietary supplement
You have developed a supplement that stimulates immunity thanks to Echinacea, decreases stress with magnesium, enhances sleep quality thanks to melatonine, prepare skin to suntan with beta-carotene, body to muscle mass growth with BCAA , or designed the best slimming in the form of gummies? It is now time to put it on the market, but before that, there is a essential regulatory step to take: check the regulatory compliance of your food supplement with the European and national rules and texts in place for each the countries where you will sell them.
We take care all of this stages of regulatory compliance
We are specialist in formula analysis, labeling compliance and (mandatory) notification of your product in the countries where it is marketed.
We cover the following steps
- Regulatory audit and adjustment
We analyze the regulatory status of active ingredients, additives and verify the dosages.
- Rules of labeling
We review all mandatory information and also add specific warning due to single ingredients used
- Analyze of the communication
We review all the nutritional and health claim usable on your labeling and marketing tools
- Validation of label compliance
- Product notification in sold countries
We will prepare and submit of files for notification in the targeted countries in accordance with local regulations, with prior registration in other countries if necessary, to enable mutual recognition process. We will ensure the follow-up until authorization and will send you the proof of filing or notification or a notification certificate
- Transmission of an authorization proof
We are customers of Nutraveris* for regulatory audit and notification services (…) We are very satisfied with this partnership, which provides us with all the expertise we are looking for in regulatory support, in all phases of product development and marketing, but also with specialized, available and responsive contacts
The regulatory analysis is a prerequisite for notification and is carried out at national level. The product formula must be studied in detail in order to verify the conformity of each ingredient, whether active or additive. The more ingredients the product contains, the longer its notification takes. Labelling requires a thorough audit of the mandatory information and health claims.
The notification is the last step before the sale. In most of the EU countries but not all, it requires a return from the notified country in order to be valid, although in some countries the mere fact of notifying already allows the sale to proceed. Knowledge of the regulations of each country is essential.
They are variable, each country has its own deadlines for validation/refusal of notification. According to our daily experience, here are the delays observed.
Country | Deadline |
---|---|
Austria | Information available in quotation |
Belgium | 1 month according to the Royal Decree – Can be exceeded exceptionally. |
Bulgaria | Information available in quotation |
Croatia | Information available in quotation |
Cyprus | Information available in quotation |
Czech Republic | Information available in quotation |
Denmark | Information available after quotation (if new substances approved, can go up to 6 months) |
Estonia | Information available in quotation |
Europe | Information available in quotation |
Finland | Information available in quotation |
France | 2 month |
Germany | Immediate acknowledgement |
Greece | Between 2 months and 1 year |
Hungary | Information available in quotation |
Ireland | Information available in quotation |
Italy | Placing on the market as soon as possible after notification |
Latvia | Information available in quotation |
Lithuania | Information available in quotation |
Luxembourg | Information available in quotation |
Malta | Information available in quotation |
Monaco | Information available in quotation |
The Netherlands | Information available in quotation |
Norway | Information available in quotation |
Poland | Information available in quotation |
Portugal | Information available in quotation |
Romania | Information available in quotation |
Slovakia | Information available in quotation |
Slovenia | Information available in quotation |
Spain | 1 month |
Sweden | Not applicable |
Switzerland | Not applicable |
United Kingdom | Not applicable |
Some countries impose a fee when registering the product.
Country | Deadline |
---|---|
Belgium | 180 € |
Croatia | Information available in quotation |
Cyprus | Information available in quotation |
Denmark | Information available after quotation (if new substances approved, can go up to 6 months) |
Finland | Information available in quotation |
Greece | Information available in quotation |
Hungary | Information available in quotation |
Italy | 160.20 € |
Latvia | Information available in quotation |
Lithuania | Information available in quotation |
Malta | Information available in quotation |
Poland | Information available in quotation |
Romania | Information available in quotation |
Slovakia | Information available in quotation |
Slovenia | Information available in quotation |
Spain | 128.16 € |
- Austria
- Belgium
- Bulgaria
- Croatia
- cyprus
- Czech Republic
- Denmark
- Estonia
- Finland
- France
- Germany
- Greece
- Hungary
- Ireland
- Italy
- Latvia
- Lithuania
- Luxembourg
- Malta
- Monaco
- Netherlands
- Norway
- Poland
- Portugal
- Romania
- Slovakia
- Slovenia
- Spain
- Sweden
- Switzerland
*Nutraveris joined FoodChain ID companies in 2020. All the services, expertises and tools provided by Nutraveris are now available under the unique brand FoodChain ID.