In Europe, food supplements must comply with European Directive 2002/46/EC as well as any local legislation in each country. EcoMundo registers your food supplements and guarantees your compliance throughout Europe.
Validation of your labels and Nutritional Information
Validation of your Health or Nutritional claims
Validation of your formulas
Registration of your products in all European countries
‘Nutrivigilance’ of your products
Food supplements in Europe are subject to Directive 2002/46/EC (or the "Food Supplements Framework Directive") but also to national laws that are specific to each EU state. The first thing to understand in order to comply is that, depending on the state to which you wish to export or import your food supplements, different rules will apply.
What does the EU Directive say?
Directive 2002/46/EC defines what a food supplement is by making a distinction between "nutrients" and "other substances with a nutritional or physiological effect". It lays down general principles on food supplements and establishes information obligations concerning their labelling, claims, etc.
The reason why the procedure for marketing a food supplement can vary so much from one EU Member State to another is precisely because we are talking about a directive and not a regulation. In practice, a directive does not apply directly in the Member States. They must first transpose it into the law of their country, which regularly leads to differences in interpretation from one country to another.
What other regulations do you need to know about for compliance?
There are other European regulations that come into play. There are 2 in particular to consider.
The first is the EU Regulation 1169/2011 (or INCO Regulation) which defines the labelling standards for food supplements (listing of allergens and country of origin of the supplement, size of text, etc.).
The second, Regulation EC 1924/2006, concerns nutrition or health claims (e.g. "contains omega 6"). It defines what a claim is, which ones manufacturers are allowed to use, how they can apply and how it will be assessed.
In addition, it should be noted that only those nutrients listed in the list of accepted nutrients may be used in the composition of a food supplement.
What are the regulatory requirements and/or procedures that vary from country to country?
As explained above, in order to export or import your products into Europe, you need to comply with specific national laws in addition to these European directives and regulations. For example, depending on the country, you may not always be subject to notification requirements, and if you are, the cost of this notification may vary.
Also, some EU countries carry out checks on a more or less regular basis to verify the compliance of food supplements already placed on the market. As a matter of fact, it is not because a notification is accepted that a product is necessarily compliant. It is therefore better to prevent compliance issues in advance.
How to ensure the compliance of your food supplement?
Firstly, it is necessary to check the compliance of your formula (according to the law of the country of export), then to ensure that all the compulsory information appears on the label, and finally to check the compliance of your claims.
Next, you will need to compile a dossier containing all the data intended to prove that your food supplement does not present a risk to human health (for example, proof of your claims). This dossier may be required for the next step in your compliance, namely the registration of your product in the country to which you wish to export it. Finally, you will have to ensure the nutrivigilance of your product once it has been placed on the market. This means that you will have to continue to monitor over time that your product remains compliant.