The technical note "Management of cannabis waste in the context of activities that produce cannabis for medicinal purposes" was published on 8 February 2022. This note was drawn up jointly by the Portuguese National Authority for Medicines and Healthcare Products and the Portuguese Environmental Agency (APA).
It became necessary to establish a legal framework to manage cannabis waste – in particular, its classification, transport and treatment – because of the special conditions relating to the activity and the characteristics of this product. Moreover, the specific laws on the use of cannabis for medicinal purposes, including the most recent Law 33/2018 of 18 July 2018 (for further details, see "Three years of medical cannabis law in Portugal"), provide no regulation in this regard.
The key issues covered by the technical note are as follows:
- Waste must be classified based on the nature of the activity from which the waste originated, in accordance with the European Waste List (EWL) published in Decision 2014/955/EU. As a result, cannabis waste produced from different economic activities will be subject to different rules. For instance, the production of extracts, preparations and medicines from the flowers of the cannabis plant that are processed in the pharmaceutical industry fall under the subchapter of EWL 07 05 – waste from the manufacture, formulation, distribution and use of pharmaceutical products.
- Under the basic principles of the General Waste Management Framework, the waste producer is responsible for ensuring the treatment of waste. In the context of cannabis for medical purposes, for example, this would include the pharmaceutical company. This must be done by sending the waste to a treatment operator that is properly licensed for this purpose. It is possible to consult a list of waste treatment operators through the Waste Management Operations Licensing Information System platform, available on the APA website.
- Cannabis plant waste can be sent to one of the following destinations: composting, anaerobic digestion, direct agricultural recovery, landfill or incineration. Here, the waste hierarchy principle applies and, under this principle, recovery operations should be preferred over disposal operations. As a result, the landfill and incineration options will only be used in exceptional cases.
- In turn, waste from cannabis extracts, preparations and medicines must be sent for incineration, and this waste must be properly packed in sealed packages with tamperproof labelling. The packaging may only be opened when the waste is incinerated; this is done in the presence of a witness identified by the producer, who attests, under oath, to the destruction of all the waste that was delivered.
- The technical note introduces the obligation for all those involved in the chain to submit data on the waste managed via the Integrated Electronic Waste Registration System. These records must be maintained for a minimum of three years and made available to the competent authorities whenever requested. If the pharmaceutical company, as a waste producer, sends the waste to a treatment operator, the pharmaceutical company must submit data not only on the waste managed, but also on the waste treatment operator.
For further information on this topic please contact Ricardo Rocha at PLMJ by telephone (+351 213 197 300) or email ([email protected]). The PLMJ website can be accessed at www.plmj.com.