Botanicals: Does one size fit all?
There has been a lot of discussion in the regulatory and legal consultancy markets about the free movement of botanicals across the 28 Member States or lack thereof. The goal of this article is to provide some practical context to the limitations of a “one size” fits all approach to the legal assessment and regulatory guidance on the use of botanicals (plant preparations) in a foods/food supplements.
The problem National Lists
In many member states there is an absence of a harmonised list of botanicals that can be used in foods and food supplements. However, if we look at for example the BELFRIT list where we have some integration and harmonisation of national laws there are a number of pros and cons for businesses using such lists and guidance eminating from such lists to decide if your product would be compliant.
The BEL-FR-IT list is a collaboration between BELgium, FRance and ITaly in order to define and develop a common positive list of botanicals that are legal for use in food supplements.
Sounds great, 3 countries 1 list, formulators can now move forwards with no concerns that when that formulation lands on these markets there will be no problems. Wrong the list is limited in many ways such as no dose is include nor is any guidance offered over botanical extraction methods, both important factors impacting any medicinal, Safety and or Novel foods status. These limitations gives each Member State an option (legal flexibility) to restrict the use of so called authorised substances. Other issues such as interactions with certain medications or other food substances are also not stated - again resulting in the possibility of safety concerns resulting in a restriction of sale. In relation to interactions we can look at Citrus Aurantium commonly know as Seville orange which is found in a variety of common foods including orange juice and marmalade. The BELFRIT list authorises the use of Bitter Orange but has restrictions on the dose of Synephrine (an active within the skin of the fruit).
Despite this authorisation there are now restrictions where caffeine and Bitter Orange placed in a single formulation resulting in an illegal product justified on safety grounds. Following a review by Frances Food safety authority (ANSES) this mix is now banned and inserted into French legislation (co-consumption ban added to Ministerial order of 24th June 2014 establishing list of plants authorized in food supplements).
In the United Kingdom as in many of the other 28 Member States we only find guidance documents on the legality of botanicals. These guidance documents may or may not give commentary on the part of the plant, the dose or a component in the plant that maybe of approved or carry restrictions (i.e. levels of Sesbanimide A in Sesbania Grandiflora a safety concern). However, another reason national lists are limited is there is often no rationale as why a restriction or risk of medicinal status is in place.
For example Brassica oleracea is considered, as having medicinal use in the United Kingdom - as such simply accepting that such an ingredient is banned without any deeper consideration would be a mistake and limit formulation options. Brassica oleracea is also known as Cabbage. Why is a common staple of ordinary foods is considered medicinal? This is not explained on the guidance document but easily defended as a legal food ingredient and not medicinal.
Similarly, on other Member State lists many of the restrictions are historic i.e. placed on such lists prior to alterations in case law (e.g. Garlic extracts once commonly viewed as medicinal). As such understanding the case law from both member states and the European court of justice are key to advising clients and challenging member states over such restrictions.
One size dose not fit all!
As such a one size fits all approach to ingredient assessment can only be effectively carried out in the context of its use in the final product and taking into consideration dose, par of plant used, actives within the botanical, the food matrix of the final product, food vs. food supplement classification, and classifications and views from across all 28 Member States in relation to the botanical being considered as medicinal, novel and potentially unsafe.