Ref. Ares(2018)4438885 - 29/08/2018
Ref. Ares(2018)4623941 - 10/09/2018
Ref. Ares(2018)6096420 - 28/11/2018
Discussion paper from the United Kingdom:
Consideration of the novel food status of CBD extracts of hemp
Background
In the UK managing products of hemp and in particular CBD containing extracts has
become a complicated and key issue for both producers and enforcement
authorities. The novel food catalogue entries make clear that hemp products are not
novel but highly refined extracts are novel. However, in practice there is a continuum
of products on the market and we think it is important to explore the circumstances in
which extracts are no longer consistent with the history of consumption for hemp and
would therefore require authorisation under the Novel Food Regulation.
We are reaching a point in the UK where we need to be in a position to provide clear
guidance for operators in order to ensure a level playing field. We therefore welcome
the opportunity to discuss the issue and have identified some areas we feel are
important to discuss in reaching a decision on how these products should be
managed in relation to the EU novel foods framework.
We recognise that on this novel food issue, there is interaction with other legal
frameworks, including medicines and drugs. However, as these aspects are outside
the scope of consideration of this group and arrangements under these frameworks
differ from Member State to Member State, they should not be the focus of the
debate.
Key Questions
In considering the novel food status of hemp extracts we have identified the
following key questions we think need to be given consideration when
making decisions on hemp extract products, on which we would welcome
discussion with the Commission and working group colleagues:
What influences the higher level of CBD (the selling point of the product)?
Is this a selective extraction which increases the intake of CBD by consumers
compared to the non novel extracts?
Does the production process make the product novel?
Consideration of the Key Questions
What influences the higher level of CBD (the selling point for the product)?
We are aware from the information from industry that there can be a number of
reasons for the CBD in a product to be higher than traditional hemp oils. For
example, there may be naturally higher levels of CBD in the plant starting material
where a higher CBD-containing strain produced by traditional plant breeding
techniques is used, or where parts of the plant higher in CBD such as leaves, stalk
and flowers is used. It is unclear that if these naturally higher CBD levels in the plant
would be consistent with the history of consumption for hemp products and, if so,
whether this would affect the novel food status of the product.
Is this a selective extraction that alters the intake of CBD by consumers
compared to the non novel extracts?
There are cases where foods ordinarily considered to be non novel can be
considered to be novel foods when they have been obtained by a selective
extraction process e.g. green tea extract. These have largely been highly purified
extracts, but the level of purification has varied and could, at least in principle, apply
to any extract where selective extraction significantly alters consumers’ intake of the
material extracted in comparison to the non-novel version of the food.
Extracts, including seed oils, fall within the existing history of consumption for hemp
products. In products with higher levels of CBD, careful consideration needs to be
given to the techniques and level of purification required to obtain the product and
whether this may mean that the product is no longer consistent with the history of
consumption and should therefore be considered to be novel.
Some products are simple alcohol extracts of the plant subjected to a rotor
evaporation process which leads to an increased concentration of CBD. If this
process is repeated, extracts with greater concentrations can be obtained as other
components of the oil such as turpenes and flavanoids are removed. Further
advanced processes can be carried out to produce highly purified isolates of
between 60% and 99% pure CBD. The key questions are: (a) At what point is the
extract considered selective? and (b) At what level of purification is a product no
longer considered consistent with the existing history of consumption?
The European Industrial Hemp Association (EIHA) have argued that the distinction
between foods, food supplements and medicinal uses should be based on daily
dosage. However, for managing these potentially novel foods a purity criterion would
be more consistent with categorising a food within the novel food framework.
Equally, if the turpene and flavonoid components are removed in the process and
then reintroduced to the product would this result in a change to its novel food
status? And would a more concentrated ingredient that is standardised to a lower
concentration of CBD through use of Hemp oil for use by consumers be treated
differently?
Would the production process in itself be novel?
Processes not used in the food industry prior to 1997 that give rise to significant
changes in a food are considered novel. Would the use of processes to remove
undesirable substances such as THC etc. for safety reasons or in order to be
compliant with national drugs legislation mean that a product should be considered
to be novel?
Summary
In conclusion, the UK feels there is a need to consider these issues in order to
facilitate the provision of consistent advice on which hemp products should be
subject to the provisions of the Novel Foods Regulation. We are aware that in some
Member States, highly purified extracts are considered medicinal. Given the case-
by- case approach to classifying medicines, we think it is necessary to understand
how these products should be managed if they are marketed as foods. This work
could perhaps also be used to develop a framework for considering extracts ahead
of the new Article 4 process on establishing novel food status under which these
issues could be raised more regularly.