Italy, France, Spain, Germany and most countries in the European Union require notification of food supplements to the authorities by electronic means or through dedicated portals. The legal term is “notification”, although the term registration is often used in the industry.
Legally, food supplements can be sold immediately after notification, under EU law, Authorities may take some time to review the labels and provide feedback. We recommend considering 1-3 months in Belgium, Spain and France.
No. Only food business operators based in the European Union can register food supplements. Only in the case of Ireland special conditions apply. Monaco and San Marino also have, respectively, special arrangements with France and Italy.
No, botanicals are currently regulated at national level. France, Belgium, Italy, and to some extent Spain tend to have similar rules. However, France often has more stringent requirements than Italy. Germany’s regulation of botanicals is largely based on case-law and is particularly complex.
False! Regulations on food supplements are not fully harmonised, even for vitamins and minerals. Under EU law, national regulations apply, and have to be followed. Specific expertise is required. Mutual recognition applies but Member States assess such requests on a case-by-case basis, often ignoring requests, which would require redress in court. Moreover, some national regulations are based on health risks; in other cases, product rejections or issues on the marketplace are based on the classification as medicines or as food supplements. In either case, mutual recognition does not apply. The instances in which mutual recognition can be applied are in fact limited.
No. Dietary supplements do not currently require registration in the US. However, there are several other requirements.
Yes. The European Court of Justice said so, although some rules exist. Food supplements are intended to supplement the normal diet with substances with a nutritional and / or physiological effect, and not to prevent, treat, cure disease, which is a function of medicinal products. The borderline is not always so clear and national interpretations on the subject can diverge. Some Member States have identified medicinal amounts of substances used both in the food and medicinal domains, but there is no consensus on the approach and on the amounts. In this context, a further complicating factor is the push for ever stronger claims on food supplements, making the issue extremely complex and requiring an accurate technical and regulatory assessment.
The regulatory requirements for the food supplement sector in the EU vary because of lack of harmonization at European Union level. This requires careful analysis of the composition and an assessment of labelling when products cross your EU country’s borders. The assessment always requires knowledge of the relevant national regulations in each Member State, sometimes includes interaction with the competent authorities, needs language skills and greatly benefits from extensive experience in different markets. Hylobates has over 10 years of experience in all key European markets. The assessment permits entering new markets with compliant products, from a regulatory standpoint, but also with convincing claims and labels for the local consumer.
Yes. Despite the low level of harmonization, especially in terms of composition requirements, it is possible to create a formula that is compliant in a large number of member states, without necessarily having to reduce the competitive edge of the product. This however requires careful assessment and skills in multi-country assessment.
In Europe, besides the EU’s borders, there are interesting markets for food supplements. A very large market is obviously the United Kingdom. Despite Brexit, there is still moderate, but real, divergence from the EU, although the situation is rapidly evolving. For example, a food business operator with an address in the UK is now required, and access to the EU for products of animal origin from the UK is increasingly difficult.
Switzerland is a very interesting market also given the potential to use various official languages in the labels of food and food supplements. Norway is also relevant especially when deciding to market in the Scandinavian territory.
There are also markets a little further away, both from a geographical and regulatory point of view, such as Ukraine, which have excellent potential.
The regulatory differences can be really significant and even constitute an insurmountable barrier. It is necessary to have a thorough knowledge of the specific rules and to deal with qualified experts. Language barriers may be significant and a global network of experts, with central coordination and quality assurance, is necessary to successfully enter these markets, from the Middle East (particularly Dubai and the UAE), Asia, the US, Canada, and Latin America.
Having a unique formula of a food supplement can have significant advantages from a production, economic and marketing point of view. However, extensive, current, practical knowledge of regulatory requirements, backed by local experts and supported by legal counsel where needed, is required together with an information system to develop multi-country formulations. Risk assessment may be necessary. We have developed these skills over the years.
Aesthetic effects such as skin elasticity do not fall within the application of Regulation (CE) 1924/2006 on claims. Beauty claims can be communicated as voluntary information when the company can scientifically substantiate the effects stated and communication is related to aesthetic effects only. However an accurate and expert regulatory assessment should be performed on a case by case basis.
Absolutely yes ! This is an EU-wide requirement under Reg. (EC) No 852/2004. Some national authorities do check for registration at the time of notification, and this is the case of Italy.