Sporopollenin shells. EC No.151

May 2014: Application from Sporomex Ltd. in the UK for the authorisation of Sporopollenin shells from the club moss Lycopodium clavatum under the Novel Food Regulation (EC) 258/97. Applicaiton passed to the EC under Regulation (EC) 2015/2283.

Background

This page is for an Application from Sporomex Ltd.  for Sporopollenin., a shell made from an unique polmers to be used in foodstuffs.

All pollens and spores possess an outer shell, which protects the genetic material and nutrients. The shell is made from a unique polymer, known as sporopollenin. Sporopollenin shells are produced by emptying spores from Lycopodium clavatum of their genetic, lipid and protein material to leave an empty sporopollenin shell. The applicant’s intention is to fill the empty shell with functional ingredients such as fish oils or vitamins.

The applicant states that sporopollenin shells will therefore function as a system to deliver functional ingredients more effectively into the body. The novel ingredient plus its contents make a powder which could be incorporated into food or drink by the consumer or manufacturer. Sporopollenin shells and their ingredients could be incorporated into a range of foods (including, food supplements, bakery products, breakfast cereals, dairy products and dairy analogues, foods for special medical purposes and foods for use in energy-restricted diets for weight reduction and other foods for particular nutritional uses as defined in Directive 2009/39/EC).

Legal Backgroud

Before a novel food can be marketed legally in EU it requires a pre-market safety assessment under the Novel Food Regulation (EU) 2015/2283, previously 258/97 (EC). This is the Regulation establishes the legal basis for novel foods and the process for submitting a novel food authorisation(s).

One of the major changes under the revised Regulation, was the centralisation of the authorisation process at the EU level. Prior to this, applications for new novel foods were underwent initial assessment in a Member State to achieve an EU wide authorisation. This application was received by the UK under Regulation 258/97 EC and was assessed by our independent experts the Advisory Committee on novel foods and processes.

Application Status: Passed to the EC

The application for Sporopollen was assessed by the UK under Regulation 258/97 (EC). The application was accepted in May 2014 and was reviewed by the Committee to assess it whether the proposed use met the requirements under the regulation. Namely that it is safe, not misleading and would not put consumers as a nutritional disadvantage.

The Committee reviewed thiss dossier multple times bettwen 2014 and 2017, producing different opinions; most of which requested for more information  from the applicant. These opinions weres shared with the other Member States. As this assessment was not completed prior to the 1st of January 2018 under Regulaton 258/97 the application was passed to the European Commission under regulation 2015/2283. 

Application Files