Regulatory Compliance Audit and Notification

Supplements Services

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 & notificationHealth Claims, …

Service Details

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

  1. Regulatory audit and adjustment

    We analyze the regulatory status of active ingredients, additives and verify the dosages.

  2. Rules of labeling

    We review all mandatory information and also add specific warning due to single ingredients used

  3. Analyze of the communication

    We review all the nutritional and health claim usable on your labeling and marketing tools

  4. Validation of label compliance

  5. 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

  6. 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

NMC Lab’

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.

CountryDeadline
AustriaInformation available in quotation
Belgium1 month according to the Royal Decree – Can be exceeded exceptionally.
BulgariaInformation available in quotation
CroatiaInformation available in quotation
CyprusInformation available in quotation
Czech RepublicInformation available in quotation
DenmarkInformation available after quotation (if new substances approved, can go up to 6 months)
EstoniaInformation available in quotation
EuropeInformation available in quotation
FinlandInformation available in quotation
France2 month
GermanyImmediate acknowledgement
GreeceBetween 2 months and 1 year
HungaryInformation available in quotation
IrelandInformation available in quotation
ItalyPlacing on the market as soon as possible after notification
LatviaInformation available in quotation
LithuaniaInformation available in quotation
LuxembourgInformation available in quotation
MaltaInformation available in quotation
MonacoInformation available in quotation
The NetherlandsInformation available in quotation
NorwayInformation available in quotation
PolandInformation available in quotation
PortugalInformation available in quotation
RomaniaInformation available in quotation
SlovakiaInformation available in quotation
SloveniaInformation available in quotation
Spain1 month
SwedenNot applicable
SwitzerlandNot applicable
United Kingdom Not applicable

Some countries impose a fee when registering the product.

CountryDeadline
Belgium180 €
CroatiaInformation available in quotation
CyprusInformation available in quotation
DenmarkInformation available after quotation (if new substances approved, can go up to 6 months)
FinlandInformation available in quotation
GreeceInformation available in quotation
HungaryInformation available in quotation
Italy160.20 €
LatviaInformation available in quotation
LithuaniaInformation available in quotation
MaltaInformation available in quotation
PolandInformation available in quotation
RomaniaInformation available in quotation
SlovakiaInformation available in quotation
SloveniaInformation available in quotation
Spain128.16 €
  • 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

Audit Notification of Supplements

*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.