Sphera Releases Enhanced Tool to Ensure Compliance with Upcoming Regs

by | Feb 16, 2017

Regulatory demands from the European Chemicals Agency (ECHA) will increase in complexity in 2018 with the forthcoming European Substance Volume Tracking (SVT) regulations, and EHS software provider Sphera has released an enhanced version of its Intelligent Authoring software that the company says will ensure companies are able to stay in compliance with the new regulations.

Companies that manufacture and/or import chemical substances into the European Union navigate a growing array of regulatory demands from ECHA and other regulatory bodies. A new one-ton annual reporting threshold will be enacted in 2018 — driven by REACH, the primary chemical law in the EU — compared to the current reporting thresholds beginning at 100 tons. The new guidelines will affect companies and importers large and small.

Sphera’s Intelligent Authoring 4.9 is an enhanced version of its Intelligent Authoring software designed to ensure companies will be able to stay in compliance with the forthcoming 2018 European Substance Volume Tracking (SVT) regulations.

Sphera’s enhanced Intelligent Authoring also introduces a new concept called GHS by Design. The United Nations Global Harmonized System (GHS) is a model regulation providing building blocks to enable a common and consistent approach for classifying and communicating hazard information on labels and Safety Data Sheets. But as each country has applied these building blocks according to their own interpretations and variations, there are many versions of GHS. Sphera says companies want a way to use these building blocks to create GHS inspired compliance documents for other countries not currently implemented or to create a regional-type GHS compliant document that could cover multiple jurisdictions. GHS by Design gives them this capability, enabling them to easily tailor the system to create their own user-defined GHS implementations for producing sheets and labels, Sphera says.

Earlier this week, Environmental Leader reported that the European Chemicals Agency is moving forward with nanomaterial guidance regulations.

It follows the first-ever federal nanoscale chemical rule in the US, finalized last month, that will require manufacturers and companies that import or process nanomaterials, now and in the future, to report certain information to the EPA. These nano-sized versions of chemicals and are now subject to EPA regulation under the Toxic Substances Control Act.

If the European Chemicals Agency deems a chemical to be unsafe to human health or the environment, it places it on the REACH restricted substances list. US and other global businesses are affected by these regulation because REACH compliance throughout the supply chain is required to do business in Europe.

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