THOUSANDS of CBD businesses are expecting to have their products validated over the coming weeks with two of the main Novel Food consortia submitting their completed applications to UK and European authorities.
In a press release the Association for the Cannabinoid Industry – which is representing around one-third of total applicants – says it submitted its application, along with toxicology studies, to the UK Food Standards Agency.
Likewise, the European Industrial Hemp Association (EIHA) which represents some 170 Companies, also with thousands of products, submitted applications to be validated for its CBD isolate and synthetic CBD to the FSA and the European Food Safety Authority (EFSA) on Friday November 4.
Lower Daily Intake
EIHA’s submission also included details of its toxicology studies and as a result of the findings it is recommending an acceptable daily intake (ADI) for CBD of 17.5mg per day.
This is well below the current levels recommended by the UK FSA of 70mg per day.
Lorenza Romanese, Managing Director, of EIHA told BusinessCann: “For the isolate CBD we observed effects in four organs, including the liver and the kidney.
“Therefore, the derived NOAEL (non-observable adverse effect level) is lower than we initially expected and lower than what is indicated in the existing literature.
“This led us to infer an Acceptable Daily Intake (ADI) of 17.5 mg (one milligram or thousandth of a gram) per day of CBD, which has been proposed to EFSA and FSA.”
Higher Level For Full Spectrum
However, she went on to say that it expects the findings from the toxicology studies with its full-spectrum CBD – to be submitted early next year – will recommend a higher ADI due to its ‘less concentrated formulation’ and ‘promising preliminary results’.
In a letter to members EIHA goes on to say that formulations must contain a maximum CBD content of 10% and additional labelling requirements will be needed including not recommending use for children, pregnant and lactating women, or for it to be consumed alongside any other hemp food product.
Earlier this year the UK FSA published the complete version of its Public List which features over 200 suppliers covering over 12,000 products.
Public List Removals
However, since then almost 100 products have been removed from the list for a variety of reasons.
An FSA spokesperson told BusinessCann: “We don’t release information on why individual products are removed from the list, but removal can be due to various reasons, for example: at request of the applicant, to remove duplicates, or because they do not comply with other aspects of food law.”
One company which has seen one of its products removed is UK firm Savage Cabbage. Its product is a ‘CBDa Full Spectrum Hemp Extract 30ml Natural Flavour’.
Jade Proudman, CEO of Savage Cabbage, told BusinessCann: “The FSA have made an interesting decision as they have stated that any product that reference CBDa as its primary description must have its own Novel Food Application.
“As our Savage Cabbage CBDa oil is an isolated compound which is mixed with CBD and is not one of our full spectrum products it will be removed from the shelves under this rule. Whilst we understand their current position we find it frustrating and do not feel this is a science based decision.”
In relation to the ACI application it also said that it is currently collating the data required to support its members EFSA novel food submissions.
The ACI refused to comment further on its applications saying it will ‘wait until its receives feedback from the FSA on the status of its data package’.
Just a handful of products on the Public List have been validated to date. Once validated they will have to undergo a risk assessment before being finally authorised for sale.
A full list of the items which have now been removed from the public list is featured below.