There are times when we all would like to hit the “reset” button and start again, and then there are times when it’s hit for us whether we like it or not. That’s what happened with substances in the European Union.
Enter the era of inventory resets, initiated by the EU’s Registration, Evaluation, Authorization and Restriction of Chemicals, better known as REACH, which seeks to modernize the legal instruments for developing modern and precise chemical control regulations. The first step, pervasive to all resets, has been to survey the industry to identify substances active in commerce today. As such, the U.S. Environmental Protection Agency asked the industry to report chemicals manufactured or imported between June 21, 2006, and Feb. 7, 2018. The reporting date has passed, but this step was just the first domino to fall.
The World Before Reset
National inventories have been mostly operating under the same basic principles: Substances listed on an inventory such as the United States’ Toxic Substances Control Act (TSCA), Canada’s Domestic Substances List (DSL), South Korea’s Korea Existing Chemicals Inventory (KECI), Japan’s Existing and New Chemical Substances (ENCS), the New Zealand Inventory of Chemicals (NZIoC) and so on are considered “existing in commerce.” When a substance is not in an inventory, this generally triggers requirements to notify authorities for manufacturing or importing.
Section 8 (b) of the Toxic Substances Control Act, for instance, commonly referred to as the “TSCA inventory,” was created some 36 years ago. And since that time, the number of chemicals in commerce has increased dramatically. In 1982, the list consisted of about 62,000 substances, but today the list has grown to 86,498 entries—an increase of about 40 percent. Since it has never been cleaned up, imagine the dust, lint and tumbleweed lurking in there!
In our jargon, we refer to these substance lists as “positive,” as product stewards are happy when a substance is listed or all components of a mixture are listed under a country-specific inventory.
“Exemptions” is also a pervasive notion of all national inventories. Examples include: For small quantities, for research and development, test marketing or naturally occurring substances to name a few. You probably guessed, inventories and defined exemptions vary and are not globally harmonized, which does not surprise product stewards.
However, for the sake of standardization, Sphera has harmonized the outputs on Safety Data Sheets (SDS), which expresses an overall conclusion of the compliance of a given mixture to a country-specific inventory.
| Context | Output Phrase |
| The mixture contains at least one substance explicitly identified as “Not listed” by a product steward. | At least one component is not listed. |
| All substances or raw material of a mixture identified as being ‘listed’ or marked exempt by a product steward. | All components are listed or exempt. |
| The mixture contains at least one substance that has no entered status for a given country inventory | Not determined. |
The statuses are carefully designed so that product stewards are explicitly informed of data gaps. Indeed, the lack of information is information, and knowing what you don’t know is a call for action to investigate: Do I have the right Chemical Abstracts Services (CAS) number? Could this be listed under an alternate CAS number? Is this a new substance? And so on. If following an investigation this substance is not registered, then a substance notification/registration process must be initiated.
TSCA Changes, Domino Falls
As we mentioned earlier, chemicals reported by the industry will be listed as “active” in the future TSCA inventory, which will further guide the U.S. Environmental Protection Agency’s rulemaking. At the time of this writing, the inventory consists of 38,338 active substances. The remainder have a “blank” status but will be explicitly listed as “active” or “inactive” in future inventory update.
From this point on, a company wanting to manufacture or import a material designated as “inactive” must notify the EPA before proceeding.
As such, although there’s a single inventory list, there is a need to precisely differentiate “Listed and Active” from “Listed and Inactive” substances individually and in mixtures. Ignoring this nuance on an SDS will only trigger doubts and questions throughout the supply chain.
Sphera, with the support of an engaged customer community, is ready to issue a working solution in early 2019 that combines data, data entry refinement and data migration to ensure a smooth transition, reviewed sentence outputs and reports for our customers.
Even small and simple regulatory changes can ripple through business requirements, which call for a sophisticated work process change or software solution update—and a chance to hit that “reset” button.
