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Ashwagandha: Navigating European regulations

13 May 2019

The European market for supplements and herbal medicinal products continues to grow, offering suppliers and manufacturers new business and product development opportunities. Ashwagandha—an herbal extract in use for over 3,000 years—is attracting growing interest because of its clinically-backed benefits in addressing modern ailments.

Successfully tapping this market, however, requires a full understanding of the European regulatory framework: the legislation that must be taken into account; the potential pitfalls; and the differences that still exist between Member States. For this reason, a new downloadable report has been made available, providing regulatory experts with the knowledge and practical guidance they need to bring KSM-66 Ashwagandha products to the European market.

Ashwagandha: Navigating European regulations

What you need to know

From an EU law perspective, ashwagandha is classified as an herbal ingredient used as a food supplement. Food supplements refer to foodstuffs that supplement the normal diet, and which are concentrated sources of nutrients or other substances with a nutritional or physiological effect. In practice, this means that EU rules concerning the marketing of food supplements—and more specifically the use of herbal extracts as food supplements—apply.

In addition to taking into account legislation at the EU level, suppliers and manufacturers must also keep track of developments at the Member State level. Because there are no harmonised EU rules on herbal extracts as food supplements (unlike for vitamins and minerals), it is up to national authorities to decide whether a product is safe, and which category it falls under (is the ingredient a food supplement or medicinal product?).

Regulatory benefits

KSM-66 Ashwagandha extract enables suppliers and manufacturers to deliver effective products that meet consumer demand while avoiding getting tangled up in regulatory red tape. It is recognised in most European Member States as an herbal ingredient safe for human consumption. Some 15 pending health claims have been filed with EFSA, giving ashwagandha an advantage over other functional ingredients that have yet to start the health claims process. Clinical evidence supporting the properties of ashwagandha is another key advantage.

The report also provides valuable insights from experts and industry insiders. Dimitrios Apostolou, EU Policy analyst at Brussels-based regulatory affairs firm Shungham, provides a detailed guide around the potential pitfalls and current complexities surrounding European food supplement legislation. Tom Johnsson, founder of Swedish supplements distributor Medicine Garden, argues that having a natural ingredient with pending health claims backed by clinical studies can make life significantly easier for suppliers and manufacturers.

The report, entitled ‘Ashwagandha: Navigating European regulations’; is available for download.