The 2021 version is finally out. Here’s a run-down of some of the more notable changes. The illustrations here should be clickable to enlarge the view. (For just a quick glance at some snapshots, look here.)
Two new GHS versions
Selecting a GHS version, for classification of the SDS product.
We added GHS versions:
UN 7
GB (Great Britain)
to the existing ones:
CA (Canada)
EU (EU/EEA)
UN 3, 4, 5, and 6
US
When you select a GHS version on the “2 Hazards” tab of the SDS form, you are indicating which hazard (H-) statements, precautionary (P-) statements, and pictograms the program will associate with the GHS classifications you add to the Hazard table.
Updated GHS version: “EU”
We also made some minor updates to the EU version, to reflect cumulative changes included in "Guidance on labelling and packaging in accordance with Regulation (EC) No 1272/2008, Version 4.1, May 2020" (a newer release, v. 4.2, is available here). These changes include elimination of some classification categories/divisions, and revisions in some of the P-statements associated with classifications
“EU” vs. “GB”
Presently, the GB GHS version includes the same H-statement, P-statement, and pictogram associations as the EU version, but is intended for SDS products distributed in Great Britain (England, Scotland, and Wales) under the UK REACH regulation. Over time, however, it is possible that the EU and GB versions will diverge.
Because the Brexit exit date preceded certain EU/EEA regulatory changes, there are differences in cut-off concentrations for mixture components with respiratory and skin sensitivity. Similarly, updated EU/EEA requirements require identification of components containing nanoform particles and those having endocrine-disrupting properties. These changes can affect SDScribe™ recommendations on which components should be included in SDS Section 3.
Subcategory adjustment preference (new)
A new preference allows you to enable or disable a feature that has been present as a default for some time: The program can add or remove the “A” subcategory from certain classifications, when switching GHS versions: Carc. 1/1A; Eye Irrit. 2/2A; Muta. 1/1A; Resp. Sens. 1/1A; and Repr. 1/1A.
Subcategory adjustment option (File -> Preferences).
The functionality is useful because certain GHS versions lack subcategories for some classifications. The UN GHS “4” version used by the “Suggestions” report includes both “Eye Irrit. 2” and “Eye Irrit. 2A”, whereas the “US” version has only “Eye Irrit. 2A”. With this preference, if the “Suggestions…” dialog recommends an “Eye Irrit. 2” classification for your product, then the program will automatically convert it to “Eye Irrit. 2A” if you have selected “US” as the GHS version for the SDS.
A reminder at the bottom of the “Suggestions…” dialog indicates whether subcategory adsjustment is enabled or not.
Unique Formula Identifier (UFI, new)
UFI, upper right on the “1 Identification” tab of the SDS.
This is a recent EU/EEA requirement for GHS-classified mixtures, the purpose of which is to enable EU poison control centers to provide more relevant information in emergencies. The program places the UFI in Section 1 of the generated SDS, and on labels you generate on the “GHS label” tab.
Unlike most fields in the program, entry into this one requires uppercase alphanumerics in four clusters of four digits. The program also performs certain types of validations to ensure the number is correct.
You generate the UFI on the ECHA Poison Centres web site; you must also submit relevant emergency information via a Poison Centre Notification (PCN) using the ECHA submissions portal.
The UK does not have the same system. However, you can submit SDSs voluntarily by emailing them to the National Poisons Information Service (NPIS), Product Notification (sds.nips@nhs.net).
REACH: EU and UK registration numbers (new)
Both the EU REACH and UK REACH registration numbers can be entered on the “1 Identification” tab of a substance-type SDS.
EU REACH and UK REACH number locations on the “1 Identification” tab of the SDS. For a substance-type SDS.
For mixture-type SDSs, there are separate columns for the EU REACH and UK REACH numbers in the Component table, on the “3 Composition” tab. If the EU or UK REACH numbers are available in the linked Substance record, the program will copy them over when you add the component to the table.
The EU REACH number of a component (if any) will appear in the SDS Component table, after you add the component to the SDS.
UK REACH has adopted an identification number for registered substances that is similar in form to EU REACH. However, the numbers themselves are not interchangeable. The program restricts entry to numeric values and hyphens on the “1 Identification” (SDS) and “Identification” (Substance) tabs, but not for entry into the Component table (“3 Composition” tab) of the SDS.
Nanoform particles (new)
EU/EEA requirements to identify and characterize nanoparticles (“sets of nanoforms”) on safety data sheets went into effect in January 2021.
Checkbox on the “1 Identification” tab to indicate the presence of nanoform particles.
Data flow for nanoform characteristics, from (1) the linked Substance record for a component to the Component table (SDS Section 3.2); or (2) from the linked Substance record to the SDS for a substance-type product (SDS Section 3.1).
Endocrine-disrupting properties (new)
EU/EEA requirements to identify endocrine-disrupting properties of a product on the SDS went into effect in January 2021. The program includes endocrine-disrupting properties on the “11.3 Toxicological” and “12 Ecological” tabs of the SDS, and on the equivalent tabs of Substance records, so that you can paste content from individual components onto the SDS.
Pasting endocrine disrupting information from a component onto the SDS.
Action items dialog enhancements
The action items dialog, accessed by clicking on the progress bars (“1 Identification” tab of the SDS).
Acute toxicity: more entry options for Substances
Additional entry areas for acute toxicity information, “Toxicological table” tab of Substance entry form. (The program performs ATE mix calculations in the “Suggestions…” dialog, “2 Hazards” tab of the SDS.)
When measured/experimentally-derived acute toxicity point values are available for a component of a mixture, you can now enter them in the component’s linked Substance record. The program will use the values when it calculates acute toxicity estimates for the product, in the “Suggestions…” dialog.
“Suggestions…” dialog / report improvements
“Suggestions…” dialog, on “2 Hazards” tab of SDS form.
New “Multi-select” button option: “Component GHS classifications”
The “Multi-select” button (“2 Hazards” tab of SDS), new “Component GHS classifications” option.
In addition to selecting any GHS classification to add to the Hazard table, you can also select from the combined classifications of all of the SDS components.
Omit row analysis for components: more options and improved explanations
This analysis is available by clicking on the header of the “Omit row” column of the Component table, and selecting either “Suggest using min concentrations…” (the “Min %” column values) or “Suggest using max concentrations…” (the “Max %” column values).
“Omit” analysis options, Component table, “3 Composition” tab of SDS.
Physical-chemical properties: additional fields for GHS revisions “7” and “EU”
Changes for UN GHS “7” and/or “EU” include:
Physical state is now a separate field.
Color is required rather than appearance (we recommend also including appearance, however).
Particle characteristics
Supplementary information of physical hazard classes. (We added a pop-up button menu with content based upon UN GHS rev. 7 descriptions.)
DOT hazardous materials table (new)
This addition was needed to offer shipping information for the “14.1 Transport (US)” tab of the SDS form. If you’re upgrading from an earlier version of SDScribe™, the program will prompt you to import the DOT table records.
DOT hazmat table, accessible from the File menu.
Shipping suggestions dialog (new)
This dialog appears when you click on the Find shipping information button, on the “14.1 Transport (US)” or “14.2 Transport (EU)” tabs. The upper list contains GHS hazards from the “2 Hazards” tab of the SDS. Some of the GHS hazards are mapped to proper shipping names and classes in the lower list, so that clicking on a blue-text row in the upper list displays corresponding DOT classifications in the lower list. Double-clicking a row in the lower list will return the proper shipping name and transport hazard class from that row to the SDS form.
SDS generation options improvements
The dialog, used to generate the SDS, has been reorganized for improved ease of use. It also has an additional option for including component names in English for a non-English SDS. Some jurisdictions may require this feature.
SDS generation options dialog, displayed just before generating the SDS.
GHS labels: Bilingual label
English on the left, the non-English language on the right.
FDA labels: “FDA label” tab on the SDS (new, optional)
This tab includes its own set of sub-tabs. The first two (“Label content 1” and “Label content 2”) enable you to enter information for an FDA Drug-Facts-type label, including areas above and below the “Drug Facts” box itself. The next two tabs enable you to generate the label, in English and non-English word processing areas.
As with the GHS labels and with the SDS itself, you can print directly from the program, or save a file on disk in “.doc” or other formats.
You will need an optional license to generate the FDA label without “demo” markings.
“FDA label” tab on SDS form, showing a sample on the “Build label English” sub-tab.
Component table (“3 Composition” tab), showing new “FDA” column view with associated columns. The new columns provide information on ingredients for the Drug Facts label.
Batches: VOC calculations, more unit costs, improved batch sheet.
The program can now estimate regulatory and actual volatile organic content in batches. To enable the calculations, you must enter certain weight percent concentrations on the ingredients’ linked Substance records.
Also shown are new unit costs per container and per pound. The printed batch sheet has received some minor updates, plus an option to print in slightly larger fonts.
“Items” tab of Batch entry form, showing new VOC and unit cost field (calculated values).
Setting volatiles concentrations, on the linked Substance record for an ingredient.
Batch sheet, sample first page print (partial).
User fields for Substance records, “Notes/other” tab (new)
You can use these as you please: five checkbox fields and five alphanumeric fields. Click on the raised “buttons” to name the fields.
Lower part of “Notes/other” tab on Substance form, showing new user fields.
Browse list enhancements
Substances browse list, showing part of the new, hierarchical Search button menu.
The “S[u]bset” button on browse lists can now “remember” a particular set of records, during your current session in that section of the program.