Cannabidiol, or CBD, is one of at least 85 active cannabinoids identified within the Cannabis plant. It is a major phytocannabinoid, accounting for up to 40% of the Cannabis plant’s extract, that binds to a wide variety of physiological targets of the endocannabinoid system within the body. Although the exact medical implications are currently being investigated, CBD has shown promise as a therapeutic and pharmaceutical drug target. In particular, CBD has shown promise as an analgesic, anticonvulsant, muscle relaxant, anxiolytic, antipsychotic and has shown neuroprotective, anti-inflammatory, and antioxidant activity, among other currently investigated uses. CBD’s exact place within medical practice is still currently hotly debated, however as the body of evidence grows and legislation changes to reflect its wide-spread use, public and medical opinion have changed significantly with regards to its usefulness in a number of medical conditions ranging from anxiety to epilepsy. From a pharmacological perspective, Cannabis’ (and CBD’s) diverse receptor profile explains its potential application for such a wide variety of medical conditions. Cannabis contains more than 400 different chemical compounds, of which 61 are considered cannabinoids, a class of compounds that act upon endogenous cannabinoid receptors of the body. Cannabinoid receptors are utilized endogenously by the body through the endocannabinoid system, which includes a group of lipid proteins, enzymes, and receptors that are involved in many physiological processes. Through its modulation of neurotransmitter release, the endocannabinoid system regulates cognition, pain sensation, appetite, memory, sleep, immune function, and mood among many other bodily systems. These effects are largely mediated through two members of the G-protein coupled receptor family, cannabinoid receptors 1 and 2 (CB1 and CB2). CB1 receptors are found in both the central and peripheral nervous systems, with the majority of receptors localized to the hippocampus and amygdala of the brain. Physiological effects of using cannabis make sense in the context of its receptor activity as the hippocampus and amygdala are primarily involved with regulation of memory, fear, and emotion. In contrast, CB2 receptors are mainly found peripherally in immune cells, lymphoid tissue, and peripheral nerve terminals. Tetrahydrocannabinol (THC) and cannabidiol (CBD) are two types of cannabinoids found naturally in the resin of the marijuana plant, both of which interact with the cannabinoid receptors that are found throughout the body. Although THC and CBD have been the most studied cannabinoids, there are many others identified to date including cannabinol (CBN), cannabigerol (CBG), [DB14050] (CBDV), and [DB11755] (THCV) that can be found within the medical cannabis. While both CBD and THC are used for medicinal purposes, they have different receptor activity, function, and physiological effects. If not provided in their activated form (such as through synthetic forms of THC like [DB00470] or [DB00486]), THC and CBD are obtained through conversion from their precursors, tetrahydrocannabinolic acid-A (THCA-A) and cannabidiolic acid (CBDA), through decarboxylation reactions. This can be achieved through heating, smoking, vaporization, or baking of dried unfertilized female cannabis flowers. The primary psychoactive component of Cannabis, delta 9-tetrahydrocannabinol (Δ9-THC), demonstrates its effects through weak partial agonist activity at Cannabinoid-1 (CB1R) and Cannabinoid-2 (CB2R) receptors. This activity results in the well-known effects of smoking cannabis such as increased appetite, reduced pain, and changes in emotional and cognitive processes. In contrast to THC’s weak agonist activity, CBD has been shown to act as a negative allosteric modulator of the cannabinoid CB1 receptor, the most abundant G-Protein Coupled Receptor (GPCR) in the body. Allosteric regulation is achieved through the modulation of receptor activity on a functionally distinct site from the agonist or antagonist binding site which is clinically significant as direct agonists (such as THC) are limited by their psychomimetic effects such as changes to mood, memory, and anxiety. In addition to the well-known activity on CB1 and CB2 receptors, there is further evidence that CBD also activates 5-HT1A/2A/3A serotonergic and TRPV1–2 vanilloid receptors, antagonizes alpha-1 adrenergic and µ-opioid receptors, inhibits synaptosomal uptake of noradrenaline, dopamine, serotonin and gamma-aminobutyric acid (GABA), and cellular uptake of anandamide, acts on mitochondria Ca2+ stores, blocks low-voltage-activated (T-type) Ca2+ channels, stimulates activity of the inhibitory glycine-receptor, and inhibits activity of fatty amide hydrolase (FAAH). CBD is currently available in Canada within a 1:1 formulation with tetrahydrocannbinol (THC) (as the formulation known as “nabiximols”) as the brand name product Sativex. It is approved for use as adjunctive treatment for symptomatic relief of spasticity in adult patients with multiple sclerosis (MS). Sativex was also given a conditional Notice of Compliance (NOC/c) for use as adjunctive treatment for the symptomatic relief of neuropathic pain in adult patients with multiple sclerosis and as adjunctive analgesic treatment for moderate to severe pain in adult patients with advanced cancer. In April 2018, a Food and Drug Administration advisory panel unanimously recommended approval of Epidiolex (cannabidiol oral solution) for the treatment of two rare forms of epilepsy – Lennox-Gastaut syndrome and Dravet syndrome, which are among the two most difficult types of epilepsy to treat. Epidiolex was granted Orphan Drug designation as well as Fast Track Approval from the FDA for further study in these hard to treat conditions. Notably, phase 3 clinical trials of Epidiolex have demonstrated clinically significant improvement in Lennox-Gastaut syndrome and Dravet syndrome. On June 25th, 2018, Epidiolex was approved by the FDA to be the first CBD-based product available on the US market.
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Cannabidiol
Drug Overview
What is Cannabidiol?
Masuu Global provides end-to-end Environmental Risk Assessment (ERA) support for pharmaceutical and healthcare products, covering Phase I environmental exposure assessment, Phase II environmental fate and effects assessment, data-gap analysis, testing strategy, laboratory coordination and final regulatory-ready reporting.
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Regulatory Framework
Assessment Methodology
Masuu Global follows a science-based, tiered and risk-based ERA methodology, aligned with applicable international regulatory requirements. For human medicinal products, our approach is primarily guided by the EMA Guideline EMEA/CHMP/SWP/4447/00 Rev. 1, effective 1 September 2024, together with relevant OECD Test Guidelines and regional regulatory requirements.
EMA — Environmental Risk Assessment
Assessment of potential environmental exposure associated with the use, manufacture and disposal of medicinal products, with a structured approach to determine whether further environmental assessment is required.
Phase I — Environmental Exposure Assessment
Initial screening to determine potential environmental exposure, covering PEC calculation, physicochemical properties, usage and dosage data, environmental entry pathways, and persistence and fate considerations.
Phase II — Environmental Fate & Effects Assessment
Where Phase I indicates further assessment is required, Phase II provides detailed evaluation of environmental fate, persistence and ecological effects — including biodegradation, bioaccumulation, aquatic toxicity, PNEC derivation and PEC/PNEC risk characterisation.
OECD & International Testing Principles
Where laboratory studies are required, testing strategies are designed with consideration of relevant OECD Test Guidelines, GLP expectations and applicable regulatory requirements.
Risk-Based Environmental Assessment
Integration of physicochemical data, environmental fate information, ecotoxicological data, existing literature, published studies, regulatory databases, usage data, and environmental monitoring data.
Weight-of-Evidence (WoE) Approach
A scientifically justified WoE approach integrates existing data and avoids unnecessary testing wherever scientifically and regulatorily justified.
ERA Assessment Pathway
Phase I → Phase II → Risk Characterization
Each phase builds on the prior tier — screening first, escalating only when the evidence demands it.
Environmental Exposure Assessment
Initial screening to determine whether the substance requires progression to Phase II.
- Product and substance information review
- Indication, dose and usage assessment
- PEC calculation and environmental exposure estimation
- Physicochemical property review
- Initial environmental risk screening
- Determination of Phase II requirement
Environmental Fate & Effects
Detailed evaluation when Phase I triggers further assessment.
- Biodegradation, hydrolysis & photolysis
- Adsorption/desorption behaviour
- Bioaccumulation potential
- Algal, Daphnia and fish toxicity
- Chronic ecotoxicity, where required
- PEC/PNEC risk characterisation
Laboratory Coordination & Study Execution
When regulatory testing is mandatory, Masuu coordinates with qualified GLP/appropriate testing laboratories and specialized scientific partners — giving clients a single point of contact across the full testing lifecycle.
Final ERA Report — Contents
- Executive summary
- Substance & product information
- Environmental exposure assessment
- Phase I evaluation
- Phase II assessment (where applicable)
- Environmental fate assessment
- Ecotoxicological assessment
- PEC/PNEC calculations
- Risk characterisation
- Data gap evaluation
- Testing rationale
- Risk mitigation considerations
- References and supporting scientific evidence
How We Work
Report Preparation Process
Every ERA follows a structured, tiered workflow designed to deliver scientifically defensible and regulator-ready assessments.
Comprehensive Data Collection
Product, substance, usage, physicochemical, toxicological, environmental and regulatory information collected and reviewed.
Phase I Environmental Screening
Environmental exposure assessment and determination of whether the assessment can conclude at Phase I or requires progression.
Phase II Evaluation
Detailed environmental fate and ecotoxicological assessment when Phase II is triggered.
Data Gap & Testing Strategy
Missing information identified and available alternatives evaluated before recommending additional testing.
Consortium Testing Support
Where testing is mandatory, Masuu coordinates with qualified testing partners through its Consortium Model.
Scientific & Regulatory Review
Integration and critical review of generated and existing data by experienced scientific and regulatory experts.
Final ERA Delivery
Comprehensive ERA report with transparent methodology, scientific rationale, calculations, conclusions and regulatory recommendations.
Ex-Agency Advantage
Why Masuu Global?
Our experienced regulatory and scientific experts bring a practical regulatory perspective — helping clients understand not only what data are required, but why they are required and how regulators may evaluate them.
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