Venom from Honeybee (Apis mellifera). EC No. 104

July 2009: Application from Nelson Honey and Marketing (New Zealand) Ltd., to approve venom from the honeybee (Apis mellifera) as a novel food ingredient. Rejected December 2010

Background

An application has been submitted by Nelson Honey and Marketing (New Zealand) Ltd., for authorisation of venom from the honeybee (Apis mellifera) as a novel ingredient to be added into honey. The novel ingredient is obtained from bees via a milking apparatus procedure, dried and added to honey. The applicant states that the novel ingredient may help to alleviate symptoms of arthritis. Honey containing venom has been on the New Zealand market since 1996, however it is considered novel in the EU. 

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: Rejected

Before any new food product can be introduced on the European market, it must be rigorously assessed for safety. In the UK, the assessment of novel foods is carried out by an independent committee of scientists appointed by the Food Standards Agency, the Advisory Committee on Novel Foods and Processes (ACNFP).

Following an initial public consultation on the application and the discussion of this application by the ACNFP at its meetings between July 2009 and April 2010, the Committee has formulated a negative initial opinion on this Bee venom ingredient. It recommends that bee venom is not approved as a novel ingredient in the EU, on the basis that the Committee cannot be certain that the ingredient is safe for all consumers and the Committee cannot identify any additional data that could be generated to remove this uncertainty.

All Member States agreed with the UK that this novel ingredient should not be authorised. As a result the Food Standards Agency informed the applicant on 1 December 2010 that bee venom for addition to honey cannot be placed on the EU market.

Application Files