Version 9.1
🚀 Released 31 July 2026
BOMcheck was updated to Version 9.1 to include updates to the supported Regulated and Declarable Substance Lists (RDSLs) detailed below. This release introduces a new DSL for Substances of Concern, new substance categories covering Canada's Prohibition of Certain Toxic Substances 2025 and EU MDR requirements, updates to the CMR 1A & 1B substances list, and updates to existing RoHS exemptions.
Downloadable resources to help you update your declarations are also available:
Version Summary
- New Declarable Substance List (DSL) for Substances of Concern
- New entry in the POPs DSL to ensure coverage against Canada's Prohibition of Certain Toxic Substances 2025
- New entry for materials of biological origin (applies to medical devices)
- Updates to CMR 1A & 1B substances (applies to medical devices)
- Minor substance amendments
- RoHS exemption expiry [6(a), 6(b)-I, 9(a)-III]
Resources (XMLs, CSV & PDFs)
BOMcheck v9.1 Downloads
Please note, XMLs may be subject to change prior to final release date 31/07/2026
- List of restricted and declarable substances for Supplied Articles - July 2026.pdf
- COCIR list of restricted and declarable substances for Medical Devices - July 2026.pdf
- MedTech COCIR CMR 1A and 1B substances and endocrine disruptors - July 2026.xlsx
v9.1 XML Changelog
- New Substances of Concern DSL (
BOMcheck_SoC_List) extracted from theIndustry_restricted_and_declarable_substanceslist. This is a structural separation and new substance category identity only (now00001), scope of substances unchanged; existing compliance status is automatically transferred to the new list. - New
hexabromobiphenylsubstance category added to thePOPs_Stockholm_ConventionDSL, threshold "No intentionally added content" (aligns BOMcheck with Canada's Prohibition of Certain Toxic Substances 2025) - New
Materials of Biological Originsubstance category added to theOther_Regulated_Substancesand/orIPC-1752B/Other_Regulated_SubstancesDSL, threshold "No intentionally added content" (EU MDR GSPR 13; medical-device parts only) - Update to batteries restriction identity from
Battery_Directive_substance_restrictionstoBattery_substance_restrictionsto account for the EU Battery Restriction with naming convention to allow additional battery restrictions outside of EU context.
Substance Details
Substances of Concern (SoC)
The existing entry for Substances of Concern (SoC) has been extracted from the Industry Restricted and Declarable Substances DSL into its own list. The scope of substances covered is unchanged, this is a structural separation only. Any existing compliance status for the SoC entry will be automatically transferred to the new list.
The improvement is designed to give companies greater control and visibility into where substances of concern may be present in their supply chains.
New Entry in the POPs DSL — Canada's Prohibition of Certain Toxic Substances 2025
A new substance category has been added to the POPs Stockholm Convention DSL to ensure BOMcheck aligns with new requirements from Canada's Prohibition of Certain Toxic Substances 2025.
| Substance Category | Threshold |
|---|---|
| Hexabromobiphenyl (HBB) | No intentionally added content |
New Entry for Materials of Biological Origin (applies to medical devices)
To assist with requirements under EU MDR [GSPR 13], a new substance category has been added to the Other Restricted or Declarable Substances DSL, specifically for parts which apply to medical devices.
| Substance Category | Threshold |
|---|---|
| Materials of Biological Origin | No intentionally added content |
Suppliers of parts for medical devices will be required to indicate if their parts contain any materials of biological origin, and if so, to provide information on the type of biological material (human, animal, microbial, other) and any applicable standards or controls applied.
EU MDR — CMR 1A & 1B Substances
The CMR 1A & 1B substances list in the RCD Tool has been updated to include additional substances from the REACH Candidate List.
| Substance Category | CAS Numbers |
|---|---|
| 4,4'-[2,2,2-trifluoro-1-(trifluoromethyl)ethylidene]diphenol and its salts | 1478-61-1, 75768-65-9, 126049-00-1, 577705-90-9 |
As a result:
- Existing CMR 1A & 1B declarations will be set to "Missing" for affected suppliers.
Minor Substance Amendments
- Updated CAS numbers for PFOS entries in the POPs Stockholm Convention DSL, including reclassification of the PFOS anion.
- Updated Azocolourants entry in the Industry Restricted and Declarable Substances DSL — update to the substance name, threshold and the associated infosheet to provide greater clarification to suppliers on the limits imposed.
| Substance Category | Threshold |
|---|---|
| Azocolourants and azodyes which form certain aromatic amines | Not permitted in skin-contact articles where the released aromatic amine(s) exceed 30 ppm (0.003%) |
- Additional POPs exemptions available for Medium-Chain Chlorinated Paraffins (MCCPs)
- Reclassification of Perfluoroctane sulfonate anion (CAS 45298-90-6) from PFOS-related compounds to Perfluorooctane Sulfonates (PFOS) and its salts
- Additional CAS number added to an SVHC entry which is screened-out as not likely to appear in supplied articles (4-(1,1,3,3 tetramethylbutyl)phenol, ethoxylated [covering well-defined substances and UVCB substances, polymers and homologues]
| Substance Category | CAS Numbers |
|---|---|
| Poly(oxy-1,2-ethanediyl), α-[(1,1,3,3-tetramethylbutyl)phenyl]-ω-hydroxy- | 9036-19-5 |
RoHS Exemptions Update
The following exemptions expire in December 2026 and have been updated in BOMcheck to reflect their expiry:
- 6(a): Lead in steel - set to expire for all categories
- 6(b)-I: Lead in aluminium - set to expire for categories 1-7 & 10
- 9(a)-III: Hexavalent chromium in heat pumps - set to expire for all categories
The exemptions are still selectable by suppliers but will show as non-compliant on the release of Version 9.1.