Robert Anton*, Mauro Serafini**, Luc Delmulle

European Food and Feed Law Review, Volume 9 (2014), Issue 6, Page 391 - 398

History of use is a concept that has been introduced in medicinal law as a key element for the establishment of the nature and effects of traditional herbal medicinal products. It has not yet gained recognition in the area of food law. This paper explores to what extent the concept of tradition of use can be applied to identify botanical preparations and, in particular, botanical extracts in view of the assessment of their safety and benefit. The paper provides definitions of the various types of preparations and provides examples of traditional preparations of various botanicals. It also addresses the relationship with the EU novel foods legislation.

Guillaume Cousyn, Stefania Dalfrà, Bruno Scarpa, Joris Geelen, Robert Anton, Mauro Serafini, Luc Delmulle

European Food and Feed Law Review, Volume 8 (2013), Issue 3, Page 187 - 196

Harmonizing the Use of Plants in Food Supplements in the European Union: Belgium, France and Italy – A first Step

Robert Anton, Mauro Serafini, Luc Delmulle

European Food and Feed Law Review, Volume 8 (2013), Issue 5, Page 321 - 328

Over centuries, plants have been used for various properties, both in foods and medicinal products. Their effects on humans have been gathered through experience, and the knowledge has been passed from generation to generation. Legislation that has been developed to cover these products differs from country to country, which makes harmonisation complex and difficult.

Robert Anton, Mauro Serafini, Luc Delmulle

European Food and Feed Law Review, Volume 7 (2012), Issue 2, Page 74 - 80

In the European Union (EU), botanicals have a long tradition of use for their health effects. Their medicinal use has evolved more recently. Medicinal products containing botanicals can be registered as traditional herbal medicinal products in the EU if bibliographical or expert evidence is available that the product has been in medicinal use throughout a period of at least 30 years. For food use however, the effects observed must be proven under the new health claims rules. The substantiation required relies mainly on the availability of randomised controlled trials. Evidence from traditional use is not considered. This is bound to lead to the loss of an important heritage. The consideration of traditional evidence from various sources is a valid scientific discipline. This paper is aimed at providing a framework for data collection in support of traditional use for botanicals. It provides guidance on how traditional use can be incorporated into the totality of the evidence and can be used as a basis for the assessment leading to the acceptance of health effects for botanicals.

Robert Anton, Mauro Serafini, Luc Delmulle

European Food and Feed Law Review, Volume 7 (2012), Issue 5, Page 241 - 250

The safety assessment of botanicals has been subject of a number of publications and recommendations in recent years. These publications have proposed flow charts for the safety assessment of botanicals and identified data that would be required to perform such risk assessments. An important element, often ignored or undervalued in the various systems proposed for the safety assessment, is information and experience from the traditional use of the plant or plant preparation. This paper explores the various systems proposed and aims to identify the critical and essential requirements that manufacturers of botanical food supplements should observe to verify and assure the safety of their products.