The tropical Morinda citrifolia or noni plant is classed as a novel food under the Novel Food Regulation, which covers foods that do not have a long history of consumption in the EU even if widely consumed in other parts of the world. Derived food or drink products from noni require authorisation. A food manufacturer has submitted an application to market dried and roasted noni leaves and the Commission asked EFSA to evaluate the evidence on its safety, including scientific issues raised by Member States during the regulatory commenting period.

In order to estimate potential intake levels, the Panel used reported figures for tea consumption in the UK National Diet and Nutrition Surveys. The Panel concluded that, on the basis of the whole set of data and information provided by the applicant, the use of dried and roasted noni leaves for the preparation of infusions is safe at the anticipated intake levels.

The Panel however noted the current limitations on assessing and predicting the allergenicity of foods and the difficulties of using data from animal models to predict human allergenicity.

EFSA has previously assessed the safety of noni fruit juice , following a request from the European Commission in 2006. EFSA particularly examined the possibility that consumption of noni juice could cause adverse liver effects following four case reports in Austria. The NDA Panel found there was no convincing evidence for a causal relationship between the reported health problems and the consumption of noni juice.