CTA UK Guidance on Novel Foods and Nano Technology

Introduction:

This document has been prepared in response to the newly emerging market of CBD products containing Nano amplified CBD. These Nano CBD products appear to be entering the EU and UK market from the United States.

Nanotechnology is the manufacture and use of materials and structures at the nanometre scale (a nanometre is one millionth of a millimetre).

Sonic technology is used to break the CBD down to less than 100nm (nanometers). When the CBD is this size, around the size of our DNA, it has the ability to access all parts of the body, including breaching the blood/brain barrier.

Nano CBD products can be suspended in water and are thought to be around 10x more bioavailable than natural CBD.

The application of Nano technology in CBD products has great potential for the future. This has been realised by Greenlight medicine in Ireland who are conducting clinical trials for a range of conditions using this science. They are currently working towards a medicines license from the MHRA.

Legislation:

Currently within the food and cosmetic industry, Nanotechnology is regulated by the Food Standards Agency (FSA), the European Food Standards Agency (EFSA) and the Scientific Committee on Consumer Safety (SCCS)

Food Standards Agency (FSA):

The FSA consider any food product containing Nanotechnology as Novel Foods:

‘Nanotechnology is an emerging science and, if used to develop novel foods and processes, approval would be required under the 'Novel Foods Regulation' (Regulation (EC) No 258/97) to ensure products are safe.’

The Food Standards Agency is the UK body responsible for the assessment of novel foods. If a company wants authorisation to market food produced using nanotechnology the Agency is obliged to assess the food safety implications. The FSA will not assess the safety of using nanotechnology in the food chain unless it is asked to do so.

During any such safety assessment, the Agency will consult an independent advisory committee, the Advisory Committee on Novel Foods and Processes (ACNFP). The ACNFP comprises experts who advise the Agency on a wide range of new foods and food technologies.

The assessment of the food or food ingredient includes details of the composition, nutritional value, metabolism, intended use and the level of microbiological and chemical contaminants. Where appropriate, this might also include studies into the potential for toxic, nutritional and allergenic effects. Details of the manufacturing process used to process the food or food ingredient are also considered, because novel food production processes can render a food ‘novel’ if it alters the final composition of the food. The assessment of nano-materials will follow the guidance issued by the European Food Safety Authority in May 2011.

As well as carrying out the scientific safety assessment, the committee would also consider consumer concerns and ethical issues.

You can find more information here:

European Food Standards Agency (EFSA):

In February 2009, the European Food Safety Authority (EFSA) published its opinion on the potential risks arising from nanoscience and nanotechnologies in food and feed. The main conclusions from the opinion are:

  • the current risk assessment paradigm is appropriate for nanomaterials
  • there are limited data on oral exposure to nanomaterials and any consequent toxicity
  • there are limited methods to characterise, detect, and measure nanomaterials in food/feed

Toxicological and toxicokinetic profiles of nanomaterials cannot be determined by extrapolation from data on their equivalent non-nano forms. A case by case approach is needed.

You can find more information here: file:///C:/Users/Hpnohippy/Desktop/CTA%20UK/(EFSA)-2009-EFSA_Journal.pdf

Scientific Committee on Consumer Safety (SCCS):

You can find more information here:

Considerations:

Until Nano CBD Food Supplements have been evaluated by the FSA and the EFSA, Nano CBD products are illegal to market within the UK and the EU. The CTA UK will not tolerate any company within the UK selling these products until authorisation has been passed. The relevant authorities will be contacted if a company is found to be selling these products.

Similarly, the same applies to any company selling CBD Nano cosmetics.

It is highly likely that in the near future, Nano CBD products will be assessed. If authorisation is given, then these products will be legal to market. If this situation occurs, it is important to consider the difference in bioavailability.

Dependant on the results from the Scientific Committee Evaluation, the dosage and maximum daily allowance will have to be modified to ensure that these products do not transcend from food supplements to medicines.

Labelling requirements state that any Novel Food with Nano-materials must state (Nano) in the ingredients list. Example: CBD (Nano)

If you are made aware of any company selling CBD products using Nano technology, please contact the CTA UK Compliance Officer immediately. See details below.

Disclaimer:

The information within this document is for advice/guidance only. The CTAUK cannot guarantee accuracy in any part of this document and we will not be held responsible for any action taken against a company who have depended on any part of this document. Companies are wholly responsible for their own marketing materials and should read all the relevant UK/EU legislation to ensure conformity. If in doubt, please contact the relevant authorities.

If you notice any discrepancies, inaccurate and/or outdated information within this document, please contact the CTAUK Compliance Officer so that corrections can be made.

CTA UK Compliance Officer: Guy Coxall

E-mail: