1.   Are the proposed ingredients considered to be Novel within the EU?

"This classification, which is defined in the legislation, includes ingredients that are completely new and also ingredients that have been used previously in a certain form but that are now manufactured using a novel process.  The use of such materials in foods is only permissible where the materials have received full novel foods approval."

"Following the introduction of ingredients produced by nanotechnology, the European Commission has stated that all such ingredients are to be considered as novel foods which thus require approval under the conditions of the novel foods legislation.

Generally, when considering food ingredients, ’nano’ is taken to be a dimension of the order of 100 nm and below.  Nanotech ingredients of concern are those that have been deliberately created such that they are composed of discrete functional and structural parts, either internally or at the surface, many of which will have one or more dimensions of the order of 100 nm or less.  This is one area where the ‘sieve dimensions’ in ingredient specifications can be of importance."

2.   Have the ingredients been irradiated?

"Under current legislation, only certain categories of foods are permitted to be irradiated at approved irradiation facilities and up to specific maximum levels.

All irradiated foods have to be labelled as such.  Very few supplement ingredients are permitted to be irradiated, but a number of illegally irradiated ingredients are known to come in from countries outside of the EU.  In general, irradiation is not permitted for botanicals or products of animal origin in supplements. "

3.   Are all the ingredients from a non-genetically modified (GM) source?

"Legislation is in place in the EU that controls the use of genetically modified organisms in foods and food ingredients.

It is essential to have specifications from the supplier confirming that the ingredient is obtained from a non-GM source as defined in the legislation.  If GM ingredients are used, or the ingredients are from GM sources, this must be stated on the label in accordance with the legislation."

4. Traceability

"Traceability’ means the ability to trace a raw material that is intended to be incorporated into a food supplement, through all stages of production, processing and distribution.

Systems and procedures should be in place to ensure that records of traceability are maintained and are readily available in the event of the information being requested by the authorities.

A comprehensive system of traceability enables targeted, rapid and accurate withdrawals to be undertaken, or specific information to be given to consumers or the authorities, thereby avoiding the potential for unnecessary wider disruption in the event of a safety concern.