FINAL ASSESSMENT REPORT [ INQUIRY - s.17 ]
Full Report [ PDF format 232kb ]
EXECUTIVE SUMMARY
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 toCannabis spp.
Cannabis sativa is well known as the source of the pharmacologically-active substance,delta9-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 microgram /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 micro gram /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 micro gram /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 microgram /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 micro gram/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 fromCannabisspp. 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 Codeand 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 hemp-based 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 Cannabisspp. 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 ofCannabis spp. in food and the establishment of maximum levels for THC in specified foods.