At Elitepharm Laboratoires, we manufacture food supplements that are intended to be marketed in a number of different countries within the European Union, depending on the client. In order to meet these specific requirements, we have to be aware of the product regulations in each country so that we can comply with them and guarantee not only the quality of the products, but also the safety of the consumer.
The regulation of food supplements in Europe[i] is governed by two laws[ii]: the Directive on Food Supplements (Directive 2002/46/EC) and the INCO Regulation (Regulation (EU) No. 1169/2011), which regulates their communication. However, some countries also have their own specific regulations on ingredients and recommended doses.
As you can imagine, the regulation of food supplements is intense and, at times, complicated. That is why our regulatory team is here to help you navigate this process, all the way from the formulation stage — with ingredient and dosage control — to the quality control stage.
The Regulation of Food Supplements in Europe: Formulation & Claims
Adapting the dosage and ingredients for each market
At Elitepharm, our assistance begins with the formulation of food supplements. This phase is crucial as it determines the composition of the products and helps to ensure that they comply with the regulation. Our R&D team pays particular attention to the dosages that must be respected in each country where the supplement is marketed. Therefore, it is necessary for each of our clients to specify the country or countries in which they intend to market the product, as soon as the specifications are drawn up.
The regulation of food supplements in Europe is harmonized across the European Union and provides a clear framework when it comes to the list of approved vitamins and minerals. The regulation of plants, however, is a more complex matter. Although there is a list of pending plant claims, as well as a list of unauthorized plant claims, the application of these by the authorities varies from country to country.
In some cases, there are country-specific recommendations for the dosage of active ingredients. For example, the authorized daily dose of vitamin B6 in France is 12.5 mg, while it is only 0.9 mg in Germany. This difference has a major impact on the formulation of a food supplement containing Vitamin B6. In such cases, our customers have two options to ensure product compliance: we can either develop a single formulation that takes into account the maximum daily dose – in this case 0.9 mg of vitamin B6 — or we can develop two formulations that are then marketed as two different products, one for Germany and the other for France.
In addition, certain ingredients are approved in some EU countries but not in others. It is therefore possible for manufacturers to use the principle of mutual recognition to claim the use of this ingredient.
Benefits and Claims: Communicating in a Clear and Regulated way
Ingredients and actives also mean benefits and claims. These elements are also regulated, and it is not possible to communicate just any benefit based on the active ingredients in the formula.
The regulation of food supplements in Europe sets the framework for nutritional and health claims: they must be scientifically substantiated and not mislead consumers. Therapeutic claims are prohibited, and some countries have their own list of claims.
For example, Italy has its own list of approved plants that includes cranberry, even though there are no approved claims for this ingredient in other countries. In addition to its own list, Italy also has the option of using some plant claims that are awaiting approval from the European list.
Because benefits and claims regulations are complex, we remain vigilant in highlighting these sensitive issues to our clients.
Labels beyond barriers
General labeling is also ruled by the EU INCO Regulation. As for claims, they comply with other laws[iii] of the regulation of food supplements in Europe. Our role here is to check that the general labeling intended to be communicated on the product complies with this regulation[iv]. To do this, we proofread our customers’ product labels and point out any non-compliant points, if necessary.
What is a compliant label?
A compliant label must include the following information:
| Practical information |
|
| Ingredients and nutrients |
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| Safety |
|
A compliant label will include non-mandatory claims only if they are permitted in the country of marketing. We systematically warn our customers about this, as explained above. While the mandatory information is identical for the same product marketed in different countries, the claims communicated on the label may differ from one country to another. This is the case, for example, for certain plant claims that are permitted in France but not in Portugal.
In addition, the label must be in the official language(s) of the country of marketing, with clear, precise and comprehensible information.
It is important to consider all these elements, as mislabeling can result in penalties, including imprisonment in certain cases. Although we are not a consulting firm, we are familiar with the regulations in many countries, including France, Germany, Belgium, Italy, and Spain.
Bringing food supplements on the market in Europe
Once the product development stages are completed, the food supplements are placed on the market. Again, there are certain restrictions. For example, some countries, such as France, Belgium, Germany and Italy, require that the product be notified. It is therefore important to check the notification requirements of the country in which the product is marketed.
Each country has its own set of rules. Our customers market their products primarily in France and Germany, where the authorities require the product label to be sent along with a form detailing: the composition of the food supplement, the target population and any potential risk groups.
This allows our clients to register with the authorities and receive a certificate of registration. This certificate provides proof that the manufacturer is committed to ensuring that their product is compliant and that the necessary steps have been taken with the authorities.
Once the product has been marketed, the company responsible for placing the product on the market must carry out a nutri-vigilance, which ensures consumer safety by monitoring any undesirable effects caused. This nutri-vigilance is then analyzed by the authorities.
While Elitepharm’s core business is working on the entire upstream process of bringing products to market, we are also able to assist our clients in this step.
Online sales: the INCO framework
The regulation of food supplements in Europe goes beyond the initial design of the product. In fact, it also includes the control of its online communication[vii].
According to INCO, the rules differ depending on whether the information is provided before the act of purchase or at the time of delivery of the product. Before the act of purchase, it is obligatory to provide the information mentioned in the INCO regulation. This information must be identical to that on the label, except for the shelf-life date or best before date. At the time of delivery, all mandatory information must be provided. This includes the batch number, which is essential for product traceability.
The website must also display the mandatory information in the official language(s) of the country to which it is being shipped.
While one might think that virtual borders do not exist online, there are most definitely borders in the regulation of food supplements in Europe and within its member states.
Conclusion
As a food supplement manufacturer, we have a significant regulatory responsibility at every stage of product development, from the formulation phase to placing the product on the market.
Although our business is different from that of a consulting firm, it requires constant regulatory vigilance to alert and protect our customers.
We are committed to informing and educating our clients and guiding them toward good regulatory practices. In doing so, we ensure consumer safety and satisfaction.
[i] SYNADIET, Leur réglementation
[ii] SYNADIET, Quel encadrement
[iii] Règlement (UE) 1924/2006 ; Règlement (UE) 432/2012 ; Règlement (UE) 536/2013 ; Règlement (UE) 907/2013
[iv] Foodchain, Comment créer un étiquetage de complément alimentaire conforme à la réglementation européenne ?, 2023
[v] At Elitepharm, we apply the 1978 DGCCRF metrological decree to all our products, including those not marketed in France. This is why the net weight displayed is often lower than the actual weight of the product.
[vi] For vitamins and minerals, this quantity must be expressed by mass and as a percentage of the nutritional reference values defined by the INCO Regulation.
[vii] Foodchain, Quelles sont les conditions requises pour vendre des compléments alimentaires en ligne en Europe, 2023