By Dr Clive Gerada – Senior Associate and Myriah Cuschieri Debono – Legal Trainee
The long-awaited standards for the ‘seed to sale’ process of cannabis for responsible adult use have been published by ARUC on 28th February 2023 and we shall be solely dedicating this article to give a brief overview of these standards.
First and foremost, one has to keep in mind that the Maltese legislation on Cannabis is based on the principle of harm reduction and is not designed to appease commercialisation interests. The legislator aimed at ensuring that the cannabis sold to adults is only sold through non-profit associations which in turn must abide by strict technical standards and operating practices, to ensure that the cannabis delivered to the associations’ members is safe and of good quality.
Standard 1 – Operational Environment of the Premises
This standard stipulates the requirements which the associations must follow in relation to the upkeep of the premises – including their external parameters. All areas of the premises should be kept clean and the personnel working within the association should maintain proper hygiene and free from infectious diseases. In addition, associations are obliged to put in place preventative measures, such as adopting pest control monitors; processing rooms should be enclosed, controlled, monitored, well-lit and equipped with adequate filtration systems.
Standard 2 – Distribution of Cannabis Material
This mainly deals with how cannabis should be moved from the approved cultivation site (growing site) up to the point of sale or distribution to the associations’ members.
Cannabis can only be transported through vehicles and personnel approved through the ADR certification issued by Transport Malta. It should be highlighted that an authorised vehicle can only transport cannabis to only one association at a go and other associations cannot be included in the transfer of cannabis material through or from third parties. Cannabis can only be distributed from designated facilities and by individuals approved by the ARUC. At the point of sale, the distributors must verify the identity of the individuals who request cannabis and confirm their membership status before each transaction. Each member will be allowed to purchase 7grms per week, and up-to 50 grms per month.
Standard 3 – Security
The Association premises must be equipped with intruder and fire alarm systems, CCTV cameras that operate effectively 24/7 on both internal and external areas of the premises. Works carried out by third parties on the premises of the associations should be done on an exceptional basis, with an employee of the association being always present during the said works. The associations must also have in place a proposed security risk assessment from a certified entity or person, which must be renewed every 3 years.
Standard 4 – Waste management and handling
The waste created from cultivation activities, processing, movement, and distribution of cannabis shall be handled and disposed of in accordance with well-established practices.
The ‘waste’ is the unused part of the cannabis plant and the liquids that are contaminated with cannabis during the cleaning of processing areas, tools and equipment. All waste should be stored in appropriate containers to prevent odours and leakages. In addition, associations should also record and account for at all times the waste collected. Furthermore, the contaminated waste can be disposed of through a service provider licensed by ERA to handle waste contaminated with cannabis. Cannabis waste cannot be destructed, incinerated or transformed at the association’s premises.
Standard 5 – Reconciliation Process
The ‘reconciliation process’ standard states that there must be a reconciliation mechanism of all cannabis material held in order to detect, document and resolve any discrepancies between the actual amount of physical stock counted and the amount of stock that was expected to be on-hand.
It is the duty of the key officer to ensure that there is a constant record of all the stages of activity: from the processing, to the acquisition of the seed, to the distribution of the cannabis to the members. The key officer must also take an account of all the contaminated waste at all stages.
Standard 6 – Cultivation, Production & Processing of Cannabis
Associations have to adhere to a number of standards in the cultivation and processing of cannabis. Specific requirements include the botanical identification of the seeds, the segregation of the different species of cannabis, varieties and male/female plants during the entire production process, along with other requirements on soil and fertilization. Associations will be prohibited from the use of inorganic chemical herbicides and pesticides. The Associations have to follow specific cultivation methods, processes, drying requirements and other specifications on the way the product must be stored and packed.
Standard 7- Sampling & testing
This standard lists the permitted analyses and sets the acceptable limits of contaminants for each batch of tested cannabis. An independent individual must carry out the testing prior to the issuing of the permit indicating that the cannabis batch has reached the minimum stipulated requirements for release to the associations’ members.
A written procedure must also be recorded for all processes in the sampling operation. In addition, there are also standards of how the sampling should take place. Toxins and other chemicals which may be harmful to the human body when inhaled are also prohibited.
Standard 8- Packaging & labelling
Finally, with respect to the packaging and labelling of cannabis products, such products may only be distributed in packaging approved by the Authority. The packaging must be mostly plain and if it is unduly attractive and appeals to the youths or transmits information which is not impartial, it shall be rejected by the authority. The actual net weight of the cannabis found within the approved container may not vary by more than 2% from the weight indicated on the label and must never exceed 7grms in total. The material of the packaging must have the capacity to keep the contents within the container dry, free from contamination, must be opaque and translucent and most importantly children resistant.
These standards aim to create a safe and regulated market and ensure that the product members use is of a high quality. It is only through approved associations that an adult can legally buy cannabis thus ensuring that the product satisfies a list of approved standards. These standards seek to provide higher quality of cannabis than the cannabis found in the black market.