June 23, 2023
Varying regulations across Member States pose challenges for the use and dose allowances of widely used botanical ingredients
The term "botanical" when applied to food is broad and can include whole, fragmented, or cut plants, plant parts, fungi, and lichens. Botanical preparations are widely used in the formulation of foods and food supplements around the world. Most people are familiar with botanical components such as ginger (Zingiber officinale), aloe vera (Aloe barbadensis miller), turmeric (Curcuma longa), and ginseng (Panax ginseng), but there is increasing interest in the use of a much wider range of botanical preparations in food.
Despite this wide range of existing food uses and increasing consumer popularity, there is a lack of consistent, unified regulatory guidance on botanicals in the European Union. This not only applies to botanicals themselves but also to the different components and preparations originating from botanicals depending on how they are processed, resulting in variations in composition and characteristics in the final product, despite the source material being the same. For example, certain components and preparations of roots, leaves, flowers, fruit, and extracts may be subject to different regulations than other components and preparations originating from the same roots, leaves, flowers, and so on.
For food and food supplement companies, the path to regulatory approval is challenging given the lack of harmonized controls in the EU. It can involve conflicting regulations between the EU and its Member States, as well as between individual Member States striving for improved safety and clarity.
A long history of regulatory challenges for botanicals
The inconsistent regulation of botanicals in the EU is, in part, due to difficulties in assessing the validity of health claim applications for botanical substances (under Regulation [EC] No. 1924/2006). Over a decade ago, the European Commission placed a backlog of approximately 1,500 applications "on hold," as the European Food Safety Authority (EFSA), the European agency charged with assessing the validity of health claims, struggled to sift through the complexities of characterizing ingredients while lacking appropriate scientific substantiation of benefits associated with proposed health claims.
To articulate their position, the European Commission published a paper in the summer of 2012, "Discussion paper on health claims on botanicals used in foods," attempting to resolve the impasse. The paper proposed two options for reviewing the claims.
The first option was to make no change to the existing approach. Each individual health claim would have to be proven to a high threshold of satisfaction to EFSA. This option was widely perceived as likely to continue the status quo, whereby most botanical health claim applications were rejected.
With no specific regulations on the use of botanicals in the EU and no consolidated list of permitted herbs and plants and their allowable preparations and concentrations, it remains the responsibility of food companies to demonstrate, if challenged, that the product they sell is safe.
The second option suggested reviewing and amending legislation by creating a special procedure for botanicals, accounting for their many years of "traditional use." This would have meant botanicals used in food supplements could be assessed like traditional herbal medicines, where safety is the main consideration and substantiation of the claim itself is less important.
More than 10 years later, the approach to be adopted is still under consideration.
With no specific regulations on the use of botanicals in the EU and no consolidated list of permitted herbs and plants and their allowable preparations and concentrations, it remains the responsibility of food companies to demonstrate, if challenged, that the product they sell is safe and provides sufficient information for consumers to make informed decisions about the ingredients in it.
Member States set their own rules for botanicals
To manage their own regional approach to botanical regulation, some EU Member States have taken up the mantle of clarifying their own regulations. Countries such as Germany, Belgium, France, and Italy have published their own lists of the ingredients they allow and prohibit, including specific conditions of use within their national markets. However, this carries consequences for the rest of the EU.
For example, take the Ayurvedic herb ashwagandha (Withania somnifera). Recently, there have been growing concerns in some Member States over its potential side effects when used in foods and supplements. Its use has recently been banned in Denmark, with countries such as Finland, Sweden, and France potentially following suit. Since the ban in Denmark, the Danish authorities have used EU's Rapid Alert System for Food and Feed to flag many products containing ashwagandha that were being marketed online. As ashwagandha can be used in foods and supplements in other Member States, this has resulted in a lack of harmonization across the EU and uncertainty regarding the use and safety of this botanical ingredient.
These harmonization issues are compounded by several EU-level regulations that any botanical ingredient or its component/preparation may fall under, such as:
- Regulation (EC) No 178/2002 on General Food Law
- Directive 2002/46/EC on food supplements
- Commission Regulation (EU) 2023/915 on maximum levels for contaminants
- Regulation (EU) No 1169/2011 on food information for consumers
- Regulation (EU) 2015/2283 on novel foods
- Regulation (EC) No 1925/2006 on fortified foods
- Regulation (EC) No 1924/2006 on nutrition and health claims made on foods
Botanical product safety and the responsibility of food and food supplement companies
The inconsistencies among EU Member States and the range of potentially applicable EU regulations can make it very difficult for producers to understand which botanical ingredients are acceptable in foods and food supplements or whether an allowable botanical ingredient is subject to formula preparation restrictions or concentration limits in the "dose" it presents to the consumer.
To help ensure product safety and distribute products effectively across the EU, food and food supplement companies can proactively assess the safety risks associated with products containing botanical ingredients. Correct classification and labeling at the start of a formulation process can save paying a high cost later, given risks such as product recalls and other sanctions if a product is determined to be noncompliant with applicable EU legislation.
What Can We Help You Solve?
Exponent's regulatory consultants can help you determine the status of individual botanicals and preparations derived from them for use in foods and food supplements. We provide training on food supplement legislation; advise on EU regulatory controls for additives, flavourings, and other ingredients; and support Member State notification and label and formulation checks for your target markets.