|
2005 ANZFA
An Application was received on 16 July 1998 from
Ecofibre Industries Association of
Australia to permit the use of products from low delta 9-tetrahydrocannabinol
(THC) Cannabis
spp. such as hempseed and hempseed oil as food. The Food Standards
Code currently lists
Cannabis spp. as a prohibited botanical. There is, therefore,
currently no permission to sell as
food, or in food, any of the varieties of Cannabis sativa or
any part of this species in food in
Australia. In New Zealand, there are no food regulations specifically
related to Cannabis spp.
Cannabis sativa is well known as the source of the pharmacologically-active
substance, delta
9-tetrahydrocannabinol (THC). Hemp or ‘industrial’
hemp, while a Cannabis species, is a low
THC variety and is not considered to have any psychoactive properties.
THC is produced in
specialised glands found only on the leaf surface of the Cannabis
plant. The main food
source, the seed, while containing no THC, is wrapped in specialised
leaves called the calyx
that do produce THC and cause some contamination of the outside
of the seed coat.
The rationale for seeking to market hemp foods in Australia
and New Zealand is largely based
on the favourable nutrient profile of hempseed/hempseed oil.
Hempseeds are an excellent
source of unsaturated fatty acids and an additional source of
essential fatty acids. The foods
currently being made internationally with hempseed and hempseed
oil include health bars,
salad oils, non-soy tofu, non-dairy cheeses, non-dairy milks,
additives to breads, biscuits and
cakes, butter pastes, as well as whole seed, raw or roasted.
THC is associated with effects on the central nervous system,
the immune system,
reproduction, and post-natal development, as well as with psychotropic
effects. In relation to
the latter, the studies available indicate the more sensitive
individuals require a minimum oral
dose of 10 mg THC per person and most individuals require an
oral dose of 15-20 mg per
person in order to experience an effect. Thus, the lowest psychotropic
effect level is in the
order of 140 µg/kg bw (body weight).
The most sensitive adverse effects observed in humans seem to
be related to skill
performance (standing steadiness, hand-eye coordination, reaction
time, numbers test)
following oral administration. In a study involving young adults,
slight but reversible effects
were seen at the lowest dose level of 5 mg/person (equivalent
to 60 µg/kg bw in this study).
There were no psychotropic effects observed at this dose level.
In order to take account of the
possible variability in response in the human population, an
uncertainty factor of 10 was
applied to this lowest-observable-effect level (LOEL) in order
to derive an overall tolerable
daily intake (TDI). Thus, the overall tolerable daily intake
for the human population is 6
µg/kg bw.
The safety assessment report concludes that, on the basis of
the data available, there is no
evidence of adverse health effects in humans at low levels of
THC exposure and a tolerable
daily intake of 6 µg/kg bw can be established. If the
products from industrial hemp plants are
used as food, the level of THC in the final products should
be such that the dietary intake of
THC is no greater than 6 µg/kg bw per day.
Proposed MLs for various commodities containing industrial hemp
were derived by estimating
a maximum concentration of THC in the commodity that would not
result in consumers
exceeding the tolerable daily intake for THC. On this basis,
a maximum permitted level of 10
mg/kg is proposed for hempseed oil, 5 mg/kg for hempseed, 0.2
mg/kg for hemp-based
beverages and 0.2 mg/kg for other hemp-containing foods.
It is proposed that industrial hemp products be regulated under
the recently finalised Novel
Food Standard, Standard A19 in Volume 1 and Standard 1.5.1 in
Volume 2. Products derived
from Cannabis spp. are non-traditional foods in Australia and
New Zealand because they do
not have a history of significant human consumption by the broad
community. They are also
novel foods for the purpose of the Standard because there is
insufficient knowledge in the
broad community to enable safe use. Maximum levels of THC would
be established in
Standard A12 - Metals and Contaminants in Food - in Volume 1
of the Food Standards Code
and in Standard 1.4.1 – Contaminants and Natural Toxicants
– in Volume 2 of the Food
Standards Code. In order to address the potential for misrepresentation
of industrial hempbased
foods as having an association with illicit drug use, a specific
condition of use is
proposed under the Novel Food Standard to prevent labelling
and advertising of industrial
hemp-based foods in this way.
Cannabis spp. are also regulated under a range of State, Territory,
Commonwealth and New
Zealand legislation not related specifically to food. The proposed
change to the food
legislation will not alter the status of industrial hemp products
under other legislation. Other
legislative changes may be required to allow the sale of industrial
hemp-based foods in all
jurisdictions. The Ministerial Council on Drug Strategy is supportive
of a coordinated
national approach to the control of products derived from Cannabis
spp., including removal
of the current total prohibition on the use of Cannabis spp.
in food and its replacement with
maximum permitted levels of THC in certain food products. The
current State government
licensing arrangement for growing industrial hemp will remain
in place and should reduce the
need for monitoring of THC levels in domestically produced food
products by enforcement
agencies. Imported food will need to be monitored by AQIS under
the Imported Food
Program. In relation to the possibility of industrial hemp-based
foods interfering with blood
and urine tests for THC arising from drug use, the available
evidence from the USA indicates
that this is very unlikely, but confirmatory studies in Australia
and New Zealand on this
matter may be necessary.
There is considerable commercial and community interest in having
available industrial
hemp-based foods, both in terms of potential health benefits
and marketing and export
opportunities. Hemp industry leaders have indicated that the
ongoing viability of the industry
is linked to the ability to market both fibre and food products
derived from industrial hemp
plants. The current prohibition on Cannabis spp. use in food,
in the absence of identified
public health and safety concerns, could be contrary to Australia’s
and New Zealand’s
obligations as members of the World Trade Organization.
The conclusions of the Final Assessment Report are:
• There are no public health and safety concerns associated
with the use of food products
containing derivatives of industrial hemp, provided there is
compliance with the
proposed maximum levels for THC in hempseed, oil derived from
hempseed and other
products derived from industrial hemp.
• Industrial hemp products can provide an additional dietary
source of essential fatty acids.
• Foods containing derivatives of industrial hemp do not
produce any psychotropic effects,
and cannot be used as a source of THC.
• The proposed change to the food legislation is consistent
with the section 10 objectives
of the Australia New Zealand Food Authority Act 1991 at the
time the Application was
made to ANZFA.
• The proposed changes to the food legislation will not
alter the status of industrial hemp
products under other State, Territory or New Zealand legislation.
Other legislative
changes may be required to allow the sale of industrial hemp-based
foods in all
jurisdictions.
• The current licensing arrangements for growing industrial
hemp plants should
significantly reduce the need for enforcement of the proposed
maximum levels for THC
in domestically produced industrial hemp-based foods. Imported
foods will be
monitored under the Imported Food Program administered by the
Australian Quarantine
and Inspection Service (AQIS).
• There is considerable commercial and community interest
in having available industrial
hemp-based foods and in developing a industrial hemp industry
in Australia and New
Zealand. The vast majority of public submissions supported the
application.
• The current prohibition on Cannabis spp. use in food,
in the absence of identified public
health and safety concerns, could be contrary to Australia’s
and New Zealand’s
obligations as members of the World Trade Organization.
• The regulatory impact assessment indicates that, for
the preferred regulatory option,
namely, remove the prohibition on the use of Cannabis spp. in
food and establish
maximum levels for THC in foods, the benefits of the proposed
amendment outweigh the
costs.
The recommendation from the Final Assessment Report is removal
of the total prohibition on
the use of Cannabis spp. in food and the establishment of maximum
levels for THC in
specified foods.
|
|
