Risk assessment is the second step in the three-step legal framework designed to allow the European Union (EU) to rapidly detect, assess, and respond to health and social threats caused by new psychoactive substances (NPS). On this page you can learn the role of the risk assessment in the EU earl warning system (EWS) and how it support decision-making on the need to control new psychoactive substances at EU level.
About EU risk assessment
Risk assessment is the second step in the three-step legal framework designed to allow the European Union (EU) to rapidly detect, assess, and respond to health and social threats caused by new psychoactive substances (NPS). The risk assessment step is an important procedure to support decision-making on the need to control new psychoactive substances at EU level.
Based on the findings of the initial report, the European Commission may request the EMCDDA to formally assess the potential risks posed by a new psychoactive substance and to draw up a risk assessment report, where there are indications in the initial report to believe that the substance may pose severe public health risks and, where applicable, severe social risks.
In order to carry out the risk assessment, the EMCDDA convenes a special meeting under the auspices of its Scientific Committee. For the purpose of this meeting, the Scientific Committee may be extended by additional experts from the Member States from scientific fields that are not represented, or not sufficiently represented, in the Scientific Committee, but whose contribution is necessary for the balanced and adequate assessment of the possible risks. In addition, the European Commission, the EMCDDA, Europol, and the European Medicines Agency (EMA) each have the right to nominate two observers. The EMCDDA acts as the secretariat for the risk assessment.
The EMCDDA operating guidelines for the risk assessment of new psychoactive substances provide a methodological and procedural basis for carrying out a risk assessment, including providing a conceptual framework using a weight-of-evidence approach.
The risk assessment is carried out on the basis of the available scientific and law enforcement information and any other relevant scientific evidence provided to the Scientific Committee by the Member States reported through the EU Early Warning System, the EMCDDA, Europol, EMA, the European Chemicals Agency (ECHA), the European Food Safety Authority (EFSA), and the European Centre for Disease Prevention and Control (ECDC).
The legal basis for the risk assessment of new psychoactive substances is provided in Regulation (EC) No 1920/2006 and in Framework Decision 2004/757/JHA.
Regulation (EC) No 1920/2006 has regard to the Treaty establishing the European Community (TEC), and in particular Article 152 thereof, and the Treaty on the Functioning of the European Union (TFEU), and in particular Article 168 thereof. Article 168(1) of the TFEU provides that drugs-related health damage is considered a public health issue of concern for the EU.
The Framework Decision in its turn has regard to the Treaty on European Union (TEU), in particular Article 31(e) and Article 34(2)(b) thereof, and the TFEU, in particular Article 83(1) thereof. These articles concern judicial cooperation in criminal matters between Member States of the European Union. Article 83(1) of the TFEU provides that illicit drug trafficking is considered a particularly serious crime with a cross-border dimension, motivating judicial cooperation in criminal matters within the EU.
The Framework Decision provides for a common approach to tackle illicit drug trafficking, which poses a threat to the health, safety and quality of life of citizens of the Union, to the legal economy and to the stability and security of the Member States.
The Framework Decision was amended by Directive (EU) 2017/2103 in order to include new psychoactive substances in the definition of ‘drug’. Simultaneously, the Regulation was amended by Regulation (EU) 2017/2101.
Article 1(4) of the Framework Decision defines a ‘new psychoactive substance’ as a substance in pure form or in a preparation that is not covered by the 1961 United Nations Single Convention on Narcotic Drugs, as amended by the 1972 Protocol, or by the 1971 United Nations Convention on Psychotropic Substances, but may pose health or social risks similar to those posed by the substances covered by those conventions.
Article 1(1) of the Framework Decision defines a ‘drug’ as a substance covered by the 1961 United Nations Single Convention on Narcotic Drugs, as amended by the 1972 Protocol, or by the 1971 United Nations Convention on Psychotropic Substances; and any of the substances listed in the Annex to the Framework Decision. The substances listed in the Annex are those psychoactive substances that are already subject to control measures adopted in accordance with Joint Action 97/396/JHA and Council Decision 2005/387/JHA, and those substances that will be subjected to control measures by delegated acts adopted in accordance with the Framework Decision, based on a risk assessment carried out pursuant to Article 5c of the Regulation.
Thus, while the Regulation focuses on public health, the Framework Decision concerns judicial cooperation in criminal matters. Both pieces of legislation work together. The Regulation has been designed to ensure a high level of human health protection and to complement the Member States’ actions in reducing drugs-related health damage, including exchange of information and prevention, more specifically where this concerns new psychoactive substances, which can pose serious cross-border threats to health. The Framework Decision has been designed to support a common approach and provides for procedures to include new psychoactive substances within the definition of ‘drug’, thereby extending the application of the Union criminal law provisions that apply to illicit drug trafficking to new psychoactive substances posing severe public health risks and, where applicable, severe social risks. This approach also strengthens law enforcement and judicial cooperation across the Union after a new psychoactive substance is brought under the definition of a ‘drug’.
Conceptual framework for risk assessment
Based on the experience gained with risk assessments of new psychoactive substances and consistent with advances in methodologies used for the risk assessment of substances in areas such as food safety, chemicals, consumer products, and medicines, a weight-of-evidence approach is used for assessing the risks posed by new psychoactive substances. In line with the definition provided by the European Commission’s Scientific Committee on Health, Environmental and Emerging Risks (SCHEER), a weight-of-evidence approach is ‘a process of weighted integration of lines of evidence to determine the relative support for hypotheses or answers to a question’. To reach valid conclusions or answers to questions, a structured methodology is followed, containing the elements of:
- a problem statement;
- the identification, collection and selection of possible sources of evidence;
- an assessment and weighing of individual lines of evidence and integration of lines of evidence; and
- an uncertainty analysis (description of uncertainties)
Further information on this weight-of-evidence approach is provided in the EMCDDA operating guidelines for the risk assessment of new psychoactive substances.
In general, the scientific knowledge on a NPS will accumulate over time and as experience with the substance develops. In the interim, risk assessments are based on a broad range of available evidence, the quality of which needs to be appraised. Data reliability and relevance need to be assessed and weighed separately. An important part of the assessment involves an analysis of the possible nature and risks of the substance with reference to similar known substances. This is important because, in part, data on the effects of new substances are often extremely limited. Such comparisons need not be restricted to controlled drugs but may include other substances with similar chemical characteristics, pharmacological actions, psychological and behavioural effects, or which otherwise offer relevant insights into the possible risks of the substance.
At the risk assessment stage, the prevalence of use of a new psychoactive substance will usually be low. As such, the majority of the available information comes from forensic and toxicology laboratories, law enforcement agencies, and anecdotal reports. Especially important here are reports relating to cases of non-fatal and fatal poisonings in which exposure to the NPS under assessment has been confirmed by chemical analysis of biological samples taken from cases.
The concept of risk includes both the element of probability that some harm may occur (usually defined as ‘risk‘) and the degree of seriousness of such a harm (usually defined as ‘hazard‘). Substance-related risks can originate from several sources, and it is essential to clarify their type and origin. The risk assessment conceptual framework differentiates between a) sources from which substance hazards emanate, and b) types of hazardous effects that may be caused by substance use.
A consideration of the risk–benefit ratio of a NPS is also needed. Factors that may need to be considered include whether the substance has legitimate uses (e.g., potential therapeutic benefits), industrial use or other economic value may be taken into account. Substances with a known therapeutic value may be exempted from risk assessment.
Risk assessment report
On completion of the risk assessment, a report is drawn up by the Scientific Committee containing an analysis of the scientific and law enforcement information available, reflecting all opinions held by the members of the Committee. The risk assessment report is then submitted to the Commission and Council of the European Union for decision making. The risk assessment report contains:
- available information on the chemical and physical properties of the new psychoactive substance and the methods and the precursors used for its manufacture or extraction;
- available information on the pharmacological and toxicological properties of the new psychoactive substance;
- an analysis of the health risks associated with the new psychoactive substance, in particular with respect to its acute and chronic toxicity, abuse liability, dependence-producing potential, and physical, mental and behavioural effects;
- an analysis of the social risks associated with the new psychoactive substance — in particular its impact on social functioning, public order and criminal activities, and the involvement of criminal groups in the manufacture, distribution and distribution methods, and trafficking of the new psychoactive substance;
- available information on the extent and patterns of use of the new psychoactive substance, its availability and potential for diffusion within the Union;
- available information on the commercial and industrial use of the new psychoactive substance, the extent of such use, as well as its use for scientific research and development purposes;
- other relevant information, where available.
EMCDDA risk assessments
Since 1997, the EMCDDA has conducted 37 risk assessments on new psychoactive substances. Over 70% of these assessments have been conducted since 2012, which reflects the growth in the market and an increase in harms reported in recent years.
|Risk assessment of 3-MMC||2022|
|Risk assessment of 3-CMC||2022|
|Risk assessment of 4F-MDMB-BICA||2021|
|Risk assessment of MDMB-4en-PINACA||2021|
|Risk assessment of isotonitazene||2020|
|Risk assessment of methoxyacetylfentanyl||2018|
|Risk assessment of cyclopropylfentanyl||2018|
|Risk assessment of AB-CHMINACA||2018|
Decision making on control measures
The third and final step of the EU response is to consider the need for control measures. Based on a risk assessment report the European Commission may decide to submit the new psychoactive substance to control measures. For this, they adopt a delegated act amending the Annex of the Framework Decision in order to add the new psychoactive substance to it and provide that the new psychoactive substance pose severe public health risks and, where applicable, severe social risks at Union level, and that it is included in the definition of ‘drug‘.
For this, the European Commission needs to take into account whether the extent or patterns of use of the new psychoactive substance and its availability and potential for diffusion within the Union are significant, and whether the harm to health caused by the consumption of the new psychoactive substance, associated with its acute or chronic toxicity and abuse liability or dependence-producing potential, is life-threatening. The harm to health is considered life-threatening if the new psychoactive substance is likely to cause death or lethal injury, severe disease, severe physical or mental impairment or a significant spread of diseases, including the transmission of blood-borne viruses.
In addition, the European Commission also needs to take into account whether the social harm caused by the new psychoactive substance to individuals and to society is severe, and, in particular, whether the impact of the new psychoactive substance on social functioning and public order is such as to disrupt public order, or cause violent or anti-social behaviour, resulting in harm to the user or to other persons or damage to property, or whether criminal activities, including organised crime, associated with the new psychoactive substance are systematic, involve significant illicit profits or entail significant economic costs.
For those new psychoactive substances that are added to the Annex of the Framework Decision, Member States which have not yet done so have to bring into force the laws, regulations and administrative provisions necessary to apply the provisions of the Framework Decision to those substances as soon as possible but no later than six months after the entry into force of the delegated act amending the Annex.
If, within six weeks of the date of receipt of the risk assessment report, the European Commission considers that it is not necessary to adopt a delegated act to include the new psychoactive substance or substances in the definition of ‘drug‘, it has to present a report to the European Parliament and to the Council of the European Union explaining the reasons for not doing so.