On January 1, 2022, CMR substances and the substances that are SVHCs of CMR substances will be subject to the Orphan Risk Control (ORC) framework in Switzerland. ORC is a risk-based assessment procedure that aims to manage the risk posed to the public by a substance.
The introduction of the ORC system is part of Switzerland’s Orphan Risk Control (ORC) strategy to manage the risk posed by CMR substances and the SVHCs of CMR substances. ORC is expected to improve risk assessment and regulatory oversight of CMR substances and their SVHCs.
ORC has been implemented in five countries so far, with the first phase taking effect in the European Union (EU) and the United States (US) in January 2018. The second phase of ORC implementation took effect in Switzerland on February 1, 2018. The third phase, which includes the expansion of the ORC scope to CMR and CMR + SVHC substances, was introduced on February 1, 2022.
What is the Orphan Risk Control (ORC) framework?
The Orphan Risk Control (ORC) framework aims to manage the risk posed by CMR substances and their SVHCs. Switzerland implemented the ORC strategy in phases. Phase 1, which took effect in 2018, included the introduction of new legislative requirements for a substance to be placed on the candidate list of SVHCs. Phase 2, which took effect on February 1, 2018, includes the implementation of new regulatory controls for substances on a candidate list of SVHCs. The third phase includes implementing new requirements for CMR substances that are not yet regulated in Switzerland as well as introducing restrictions for unregulated CMR substances from abroad.
ORC substances and SVHCs: the scope of the framework
The ORC framework applies to substances that are defined as CMR and CMR + SVHCs.
CMR substances are those that meet the criteria for a high degree of concern with regard to their use, or potential use, by man or the environment because these substances
- pose an unreasonable risk to humans;
- present a risk of serious damage to human health,
- may cause harm to human health if released into the environment.
SVHCs of CMR substances are those that meet the criteria for a medium degree of concern with regard to their use, or potential use, by man or the environment because these substances
- present a risk of serious damage to human health;
- present a risk of serious damage to non-human life forms in the environment.
ORC chemicals and the scope of the expansion
Switzerland has expanded the number of CMR category 1A and 1B substances under ORRChem and added eight substances to its Candidate List of SVHCs. Both amendments entered into force on February 1, 2022. CMR substances are subject to the third phase of ORC implementation, which includes expansion of the ORC scope to include them. However, Switzerland is not considering expanding the scope of SVHCs at this time.
7-chloro-3-methylquinoline (CAS No 140-27-4)
1,2-benzisothiazol-3(2H)-one (CAS No 680-31-9)
1-[(4′-Chlorobiphenyloxy)carbonyl]piperazine (CAS No 118071-05-8)
5-(5′-Chlorobiphenyl)-2-(oxazoloxy)-4-(4′-chlorophenyl)thiophene (CASNo 106638-47-6)
6-(5′-chl0robiphenylyl)-N-[2-[2-[(3′-methoxyphenoxy)methoxy]et hyl]phenyl]-N-[2-[(trifluoromethyl)thio]ethylidene]urea (CAS No 111628-94-0)
CMR substances and CMR + SVHCs: the scope of the expansion
The scope of the ORC framework has been expanded to cover both CMR substances and CMR + SVHC substances. Switzerland’s new ORC system consists of three phases:
Phase 1: The regulation of CMR and SVHC substances that entered into force on February 1, 2018
Phase 2: The regulation of CMR substances and SVHCs of CMR substances that entered into force on February 1, 2020
Implementation details for CMR + SVHCs with SVHCs
In Switzerland, ORC will be applied first to CMR + SVHC substances for which there are no alternative substances available that are safer or less risky.
This means that a substance will only be subject to the ORC procedure if there is no alternative that poses a lower risk. Substances with an acceptable risk profile will not be subject to the ORC procedure. The list of such substances is being updated annually. Finally, in order for a substance to be covered by ORC it needs to satisfy at least one criteria from each of the three categories:
- Candidate List: CMR and CMR + SVHC substances nominated by Council;
- Priority List: Substances and groups of substances that pose an unacceptable risk;
- Approved List: Substances and groups of substances with an acceptable risk profile that do not pose any unreasonable risks and have been subject to appropriate controls.
The Orphan Risk Control framework is a regulatory approach that provides substance identification, classification and control measures for substances of very low annual volume (1kg or less) with unknown or insufficiently known health and environmental hazards.
The ORC chemicals and the scope of the expansion
The scope of the expansion for CMR substances and CMR + SVHCs is wider than for ORC chemicals.
The implementation details for CMR + SVHCs with SVHCs.
The ORC framework includes two unique lists: The ORC list is a list of substances that are believed to pose a very low risk to human health or the environment. The Candidate List of SVHCs is list of substances with which there is concern over an unknown or insufficiently known hazard.
- Being aware that substances on both lists will be subject to the same restrictions in Switzerland
- Substances on the Candidate List are not necessarily on the