VIDEO: NOTIFICATION OF FOOD SUPPLEMENTS IN THE EU
From LegaleGo we are making a series of videos that will surely be very useful for all our customers and companies interested in regulatory compliance, being this first video dedicated to how to sell food supplements.
On this first occasion, Africa Gallego, our Director of the Food Consultancy Department, will comment on the notification of food supplements in the European Union.
First of all, it is important to note that most EU countries require the prior notification There is no single notification process valid for the whole of the EU, and each country must follow its own rules and procedures.
The first aspect to take into account is that the company distributing the products (Food Business Operator) must have a registered address in any EU country. Therefore, if a UK or Chinese company wanted to sell food supplements in any EU country, it would first need to have an “importer” based in any EU country.
As general information, we can always follow 3 steps to offer food supplements for sale in any EU country:
- First of all, the label must be translated into the official language of the country where you want to sell: Spanish in Spain, French in France, Italian in Italy…etc.
- Secondly, it is absolutely necessary to adapt each label to the internal standards of each country. Although there are common labeling rules throughout the EU, each country has its own regulations and it is necessary to study the list of ingredients, maximum authorized doses, warnings, etc. very carefully.
- And finally, once the label is perfect according to the regulations of the country where we are going to sell, we could start the notification process to the health authorities of the country in question. The notification process in most EU countries works like a “responsible declaration” which means that at the moment of notification you receive the “pre-market authorization” and you can start selling. This is the case in Spain, Italy, Portugal, Ireland, Luxembourg, Hungary, Germany….. However, in other countries such as France or Belgium, the authorities take their time to review the notification file and only if everything is correct they issue the so-called “pre-market authorization” and from then on you can start selling (the time can vary from several days to several weeks, but usually no more than 6 weeks). In any case and in all cases, it will always be the distributing company (FBO) that will be responsible for the labeling and sale of the products, so the health authorities never assume responsibility.
If you need any additional information about any EU country where you want to sell your food supplements, please do not hesitate to contact us as we will be pleased to assist you.