We are often asked about launching products in Europe, and with Europe being the leading market in cosmetics and the second-largest market for dietary supplements, it’s not hard to see why companies are looking to sell their products there. The supplement industry is currently a €7.2 billion industry , with projections rising to €7.9 billion by 2020. Within Europe, Western Europe is currently leading the way; however, forecasts have projected more future growth potential for the Eastern European areas. The same is true for cosmetics, with Europe representing nearly half of the global market, remaining resilient even in tough economic times. We would like to share with you some specific points to consider when determining when and how best to break into this attractive market.
First, let’s talk dietary supplements, referred to as “food supplements” in the European Union (EU). Food supplements are regulated in the EU under European Directive 2002/46/EC, which EU member states must then adopt through their own state-specific regulations. The Directive stipulates which vitamins/minerals (and their sources) are allowed. This is the first barrier that you may face from a regulatory perspective when trying to launch your products in the EU market. And while a stakeholder can request an amendment to this list, few have been successful. Products may need to be reformulated in order to be compliant for the EU.
The second obstacle has to do with individual countries in the EU, many of which have their own unique requirements to be satisfied (i.e., on top of the Directive). Now, while the EU Directive does not self regulate active ingredients other than vitamins/minerals, some countries in Europe have established additional requirements for such “other substances” (e.g., amino acids, herbs). Also, certain European countries have a mandatory product registration / notification process for food supplements, whereas others do not. The regulatory burden varies considerably between European countries, therefore.
Another unique challenge of launching food supplements in the EU is the importing process. Each country has specific requirements for importing specific categories of products, such as products made from ingredients of animal origin (including animal-sourced gelatin). The regulatory requirements for these types of products can include origin country/establishment requirements, the requirement to import through specific ports, health certificate requirements, veterinary checks, etc.
Launching food supplements into the EU is not as straightforward as, for example, launching health products into Canada where the latter has singular requirements across all its provinces. Despite being a “union” of nations, in reality Europe is still a collection of countries that have general regulations in common; for health products, they have little in common (i.e., only the simple Directive). Launching a product into Germany is not the same as launching in the Netherlands.
One important note to keep in mind, however, is something of a loophole in launching food supplements in Europe. If a food supplement is registered in one EU country, it is significantly easier to register the product in another. Because of this, the countries which are easier to register food supplements become something of a “back door” to the rest of Europe. Right now the most common back door is Belgium.
Cosmetics are treated differently than food supplements in Europe. Launching cosmetics in the EU is a more streamlined process, and the requirements are identical across each European country.. Cosmetics in the EU must be safe under normal or reasonably foreseeable conditions of use, and must comply with the requirements and associated restrictions outlined in Regulation (EC) No 1223/2009. In comparison with the USA, and even Canada, you are likely to encounter a much larger breadth of ingredient restrictions. Prior to launching any cosmetic product in the EU, the product must be registered / notified via the Cosmetic Product Notification Portal (CPNP), an electronic notification that must be completed for the first European country in which the product will be marketed. Once this notification has been completed, the product can be sold anywhere in the EU.
With cosmetics, however, the greater requirement is the safety data documentation that has to be prepared. A Product Information File (PIF) must be drawn up for each product before it is placed on the market. The PIF contains a very important, and detailed, Cosmetic Product Safety Report (CPSR). The CPSR is a detailed safety assessment of the product, including product composition, stability data, microbiological quality (preservative challenge test), toxicological profile of each of the ingredients and a signed safety assessment completed by a qualified safety assessor. These documents include a large amount of data and can potentially delay a launch date if the data is not readily available. This PIF must be updated as necessary and kept on file with the importer for 10 years after the last batch enters the market.
NHP Consulting has expertise in the European market, and can provide assistance with both food supplement, cosmetic registrations, compliant product labelling (including Nutrition Facts generation) and cosmetic safety reports. Contact us to learn more and see how we can help you expand your market.