THE new MD of the European Industrial Hemp Association (EIHA) says it is preparing to challenge Europe’s on-going efforts to undermine the continent’s CBD industry – whilst also keeping a close eye on developments in the UK.
Just a few weeks ago Francesco Mirizzi replaced Lorenza Romanese as Managing Director of the trade body, which he has served over the last five years as its Senior Policy Advisor.
The start of his tenure has been marked with the controversial determination by the European Food Safety Authority (EFSA) of a safe dose of two milligrams (mg) per day of CBD for an adult of 70kg – or, less than one-tenth of a drop of water.
He told Business of Cannabis: “Let’s start on a positive note; this is the first time that EFSA has acknowledged there is a safe level of CBD…in a way that is good.
“However this is extremely low; it does not make a great deal of sense and is impossible to achieve.
“The key issue in EFSA’s determination is the uncertainty factor which has been applied to the data from the industry’s novel food applications; it is set at the highest possible level.
“This is the same data we have access to and if a lower uncertainty factor were to be applied by EFSA then a more sensible ADI (average daily intake) of 17.5mg – the one which we recommend – can be achieved.”
EFSA has applied an uncertainty factor of 400 – twice as strict as the usual standard of 200 – in its recently-announced public consultation which runs until October 14. Its 2mg upper daily limit contrasts with 60mg in Australia and 200mg in Canada.
Mr Mirizzi continued: “This use of this very conservative uncertainty factor will be challenged by ourselves. We believe we have science on our side. Our approach to developing our recommended ADI is based on a rigorous examination of the toxicological data.”
“EFSA has focused too much on the precautionary principle and in doing so it can pretty much justify whatever level it wants.
“When we meet with EFSA we will attempt to explain how they have used the data in a way which is overly-cautions and restrictive.”
One of the requests of EIHA will be to see if EFSA will be flexible enough to allow its Novel Food application to proceed with the higher limit.
Prior to the meeting with EFSA, which is not expected to be until November, EIHA will be speaking to the European Commission where it hopes to convince it that its food authority needs to relax its hard-line approach.
It was back in June 2022 that the EC called a halt to the processing of CBD Novel Food applications due to concerns over its safety profile. In particular, concerns were raised over the potential harm to the pregnant women, potential damage to the liver and the nervous system.
Nevertheless, in the UK EIHA’s Novel Food application is one of three to pass through to the final stage of the arduous process.
The UK s recommended daily dose is higher than EFSA’s at 10mg per day, and EIHA, along with fellow market participants, is pressing for a higher limit.
The UK Food Standards Agency recently announced a 12-week public consultation to discuss the authorisation of three applications, which represent nearly 3,000 CBD isolate products.
“What is happening in the UK is a much more positive and reasonable approach. The FSA encourages dialogue with applicants whilst EFSA is much more closed,” he adds.
If approved this presents a conundrum for the industry as approved products will be corralled into the established 10mg limit while the thousands of products that are still ‘pending’ in the Novel Food approval process, with higher CBD levels, will still be on the market.
Mr Mirizzi added: “In that situation we will have products that are ‘legal’ with lower ADI’s than those other products that are still on the market. This is something we will need to discuss with the FSA.”
The CBD Novel Food agenda will eventually limit the sale of whole-plant, natural extracts, which industry bodies stipulate are traditional foods and as such should be excluded from the process.
An earlier attempt by EIHA to pursue this established food approval pathway through an Article 4 submission has stalled and is unlikely to be revived for now, he adds.
As a result of the regulators interventions EIHA says the CBD industry has ‘shrunk’ to a degree although he contends the larger companies are still performing well in the market, and suggests that any shrinking in the size of the market may be due to the passing of the ‘peak, CBD-hype phase’.
One further significant development since Mr Mirizzi’s appointment has been the EC’s moves to overhaul hemp regulations.
This could see the entire hemp plant, including flowers, not just the seeds and stems, recognised as an agricultural product by the start of 2027, and THC limits could rise to 0.5%.
“We have been lobbying for these changes over the last five years. At first we had to raise awareness of the potential of hemp and we believe we have done a pretty good job.
“There will be further discussions in Parliament and the Commission, but both now seem aligned and there is now a clear determination to recognise the whole of the hemp plant.”
While he accepts that it may be more difficult for countries like Italy to accept this change, as it has recently sanctioned hemp flowers, he contends that it is now looking for a way out of these self-imposed shackles and contends this EC mechanism may provide them with a timely pathway out.
Mr Mirizzi added: “The positive trend in Europe is to now clearly differentiate between low-THC hemp and high-THC cannabis and without being overly-optimistic we believe this will continue and these changes will happen in early 2027, if not before.”
The post ‘Five Years Of Hard Work Has Brought European Hemp In From The Cold’ appeared first on Business of Cannabis.
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Just a few weeks ago Francesco Mirizzi replaced Lorenza Romanese as Managing Director of the trade body, which he has served over the last five years as its Senior Policy Advisor.
The start of his tenure has been marked with the controversial determination by the European Food Safety Authority (EFSA) of a safe dose of two milligrams (mg) per day of CBD for an adult of 70kg – or, less than one-tenth of a drop of water.
He told Business of Cannabis: “Let’s start on a positive note; this is the first time that EFSA has acknowledged there is a safe level of CBD…in a way that is good.
Restrictive Uncertainty Factor
“However this is extremely low; it does not make a great deal of sense and is impossible to achieve.
“The key issue in EFSA’s determination is the uncertainty factor which has been applied to the data from the industry’s novel food applications; it is set at the highest possible level.
“This is the same data we have access to and if a lower uncertainty factor were to be applied by EFSA then a more sensible ADI (average daily intake) of 17.5mg – the one which we recommend – can be achieved.”
EFSA has applied an uncertainty factor of 400 – twice as strict as the usual standard of 200 – in its recently-announced public consultation which runs until October 14. Its 2mg upper daily limit contrasts with 60mg in Australia and 200mg in Canada.
Mr Mirizzi continued: “This use of this very conservative uncertainty factor will be challenged by ourselves. We believe we have science on our side. Our approach to developing our recommended ADI is based on a rigorous examination of the toxicological data.”
“EFSA has focused too much on the precautionary principle and in doing so it can pretty much justify whatever level it wants.
“When we meet with EFSA we will attempt to explain how they have used the data in a way which is overly-cautions and restrictive.”
One of the requests of EIHA will be to see if EFSA will be flexible enough to allow its Novel Food application to proceed with the higher limit.
UK CBD Conundrum
Prior to the meeting with EFSA, which is not expected to be until November, EIHA will be speaking to the European Commission where it hopes to convince it that its food authority needs to relax its hard-line approach.
It was back in June 2022 that the EC called a halt to the processing of CBD Novel Food applications due to concerns over its safety profile. In particular, concerns were raised over the potential harm to the pregnant women, potential damage to the liver and the nervous system.
Nevertheless, in the UK EIHA’s Novel Food application is one of three to pass through to the final stage of the arduous process.
The UK s recommended daily dose is higher than EFSA’s at 10mg per day, and EIHA, along with fellow market participants, is pressing for a higher limit.
The UK Food Standards Agency recently announced a 12-week public consultation to discuss the authorisation of three applications, which represent nearly 3,000 CBD isolate products.
“What is happening in the UK is a much more positive and reasonable approach. The FSA encourages dialogue with applicants whilst EFSA is much more closed,” he adds.
If approved this presents a conundrum for the industry as approved products will be corralled into the established 10mg limit while the thousands of products that are still ‘pending’ in the Novel Food approval process, with higher CBD levels, will still be on the market.
Mr Mirizzi added: “In that situation we will have products that are ‘legal’ with lower ADI’s than those other products that are still on the market. This is something we will need to discuss with the FSA.”
The CBD Novel Food agenda will eventually limit the sale of whole-plant, natural extracts, which industry bodies stipulate are traditional foods and as such should be excluded from the process.
An earlier attempt by EIHA to pursue this established food approval pathway through an Article 4 submission has stalled and is unlikely to be revived for now, he adds.
Hemp Overhaul
As a result of the regulators interventions EIHA says the CBD industry has ‘shrunk’ to a degree although he contends the larger companies are still performing well in the market, and suggests that any shrinking in the size of the market may be due to the passing of the ‘peak, CBD-hype phase’.
One further significant development since Mr Mirizzi’s appointment has been the EC’s moves to overhaul hemp regulations.
This could see the entire hemp plant, including flowers, not just the seeds and stems, recognised as an agricultural product by the start of 2027, and THC limits could rise to 0.5%.
“We have been lobbying for these changes over the last five years. At first we had to raise awareness of the potential of hemp and we believe we have done a pretty good job.
“There will be further discussions in Parliament and the Commission, but both now seem aligned and there is now a clear determination to recognise the whole of the hemp plant.”
While he accepts that it may be more difficult for countries like Italy to accept this change, as it has recently sanctioned hemp flowers, he contends that it is now looking for a way out of these self-imposed shackles and contends this EC mechanism may provide them with a timely pathway out.
Mr Mirizzi added: “The positive trend in Europe is to now clearly differentiate between low-THC hemp and high-THC cannabis and without being overly-optimistic we believe this will continue and these changes will happen in early 2027, if not before.”
The post ‘Five Years Of Hard Work Has Brought European Hemp In From The Cold’ appeared first on Business of Cannabis.
Continue reading...
