3E's newest ERC and ERC+ releases create a successful partnership between software and sustainability

Introduction: 3E's update includes numerous enhancements and is a new frontier for software automation

3E always strives to make our products better for our customers and this involves making sure that the most relevant, up to date content and datapoints are added to our software solutions.

In our latest 2504 release, 3E provides enhanced content for customers pertaining to:

• Revolutionizing Physical-Chemical, Toxicological and Ecotoxicological (PCTEC) data management
• OSHA's HazCom Standard support
• Substance groups enhancements
• EU sustainability enhancements – Ecodesign for Sustainable Products Regulation (ESPR), Corporate Sustainability Reporting Directive (CSRD), and EU Taxonomy Framework
• Adaptation of several Asia Pacific (AP) regulations

Together, these upgrades simplify compliance, ensure data transparency, and pave the way for a more sustainable future. With these additions and enhancements, 3E's ERC and ERC+ Suite product lines helps customers strategize about how to comply with upcoming requirements and promote sustainable business practices as leaders in their industry. This blog explores the groundbreaking improvements in our biggest release to date.

Understanding compliance challenges and opportunities

Companies are faced with an increasingly complex regulatory structure. When operating in multiple jurisdictions, companies face regional (e.g., EU), federal (e.g. OSHA), and state/provincial (California (CA) Prop 65) requirements. Given the diversity of regulations that apply to companies, the complex supply chains involved, and the constant revisions of chemical regulatory requirements (e.g., Per- and polyfluoroalkyl substances (PFAS bans), companies are facing very specific requirements despite operating in wide markets.

Understanding the challenges involved with chemical compliance

In turn, companies have a variety of pain points when it comes to compliance.

1. How to allocate resources for regulatory compliance (e.g., Toxic Substances Control Act (TSCA), CA Prop 65) in contrast with sustainability initiatives (e.g., the EU's Corporate Sustainability Reporting Directive (CSRD) and other methods of carbon emission reporting).
2. How to screen product ingredients for Substances of Concern (SoC) and, by doing so, help companies identify problematic substances.
3. How to manage frequent regulatory updates and standards across different regions.

Understanding the opportunities involved in chemical compliance

Depending upon the size of a company's internal team, and frankly even with a large internal team, it can be laborious to track all aspects of regulatory compliance and then turn that information into action. Just this one task – regulatory tracking and horizon scanning – can usurp internal resources such that the goal of forecasting changes and positioning a company as a leader in both compliance and sustainability can be lost.

Software tools like 3E's are at the forefront of helping companies in a multitude of industries take advantage of new market opportunities. Below you will find a few of 3E's biggest enhancements for 3E ERC and ERC+.

PCTEC 2.0: Advancing the Globally Harmonized System of Classification and Labelling of Chemicals (GHS)

PCTEC stands for Physical-Chemical, Toxicological and Ecotoxicological data. It is a broad set of data that can be used for various regulatory purposes. PCTEC is a broad set of data that stems from REACH registration dossiers published at the European Chemicals Agency (ECHA) CHEM Database (ECHA data).

The primary purpose of the data set that is provided by 3E is the assessment of the hazards of chemical substances according to the Purple Book criteria, in the context of Safety Data Sheet (SDS) authoring. The data is organized to support both decision-making regarding which data should be used as the basis for classifications as well as standardized disclosure in sections 11 and 12 of the SDS.

Our PCTEC data comes from two sources:

1. Data from Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) registration dossiers published by ECHA. PCTEC data points are represented in public sources in a wide variety of ways. For example (non-exhaustive):

• Different ways of reporting the same study result
• Different ways of reporting the same tested species
• Different units of measure for the same endpoint
• Large bodies of free text reporting a study result

The result of this is a very high degree of heterogeneity in how data are reported. As part of the PCTEC product, 3E doesn't just take the data as provided, but imposes a standardization layer on top of the data to achieve a consistent format. Due to the high volume of ECHA data, 3E is using AI technology for the purpose of data normalization and standardization.

2. Data evaluated by a 3E-internal team of experts who are knowledgeable about the process of GHS classification – the Base Component Library (BCL data). BCL data represents the work of a team of experts who look for all publicly available PCTEC data for chemical substances, from multiple sources, including ECHA. Once the data has been located, the team applies their expertise to evaluate which data points are the appropriate ones to use as the basis for a scientifically sound GHS classification.

How does 3E help?

PCTEC data can be very complex. 3E allows customers to automate certain processes. 3E allows customers to use a consistent format defined per endpoint (e.g., acute oral toxicity) and across sources. The result is simplify decision-making, allow for consistent disclosure in sections 11 and 12 of SDS and provide a reduced set of fully-translated phrases representing the data set. By using Artificial Intelligence (AI), 3E utilizes automation to help customers support data-driven decision making.

OSHA's HazCom amendment pursuant to the GHS Rev. 7

Recently, GHS underwent its seventh revision, known as GHS Rev. 7. This revision brings about significant changes to how hazardous substances and mixtures are classified and labeled, affecting both manufacturers and employers who handle these chemicals.

One major change is the addition of a new hazard category for chemically unstable gases. This means that more chemicals will now be classified as hazardous, requiring updated safety measures and procedures.

In addition to this new category, there are also changes to existing hazard classes and categories, such as revising the criteria for flammable liquids. This change will have an impact on how these substances are labeled and stored in the workplace.

Another important aspect of GHS Rev. 7 is the introduction of new precautionary statements and pictograms. These new symbols will provide more detailed information about potential hazards, helping workers to better understand the risks associated with handling certain chemicals.

It is crucial for both manufacturers and employers in the US to review how OSHA's amendment to the HazCom Standard impacts them and to stay updated on these changes to ensure that their chemical management processes are in compliance. Although OSHA's amendment was effective as of July 2024, there are built in transitional periods for compliance – January 2026 for substances and July 2027 for mixtures.

This update completes the OSHA compliance solution to include all US-specific updates. This not only ensures the safety of workers, but it also helps to prevent costly fines and penalties for non-compliance.

How does 3E help?

In the previous 3E ERC+ 2410 release, 3E introduced the ability to comply with the updated HazCom standard in common with the Purple Book revision 3 to revision 7.

Now in the 3E ERC+ 2504, the finishing touches help customers understand the elements that are specific to the US. Specifically, an enhanced format for Section 2 of the SDS makes the various hazards (both intrinsic changes in physical form and mixtures from reactions with other chemicals) fully transparent. Those same US-specific hazards can now also be derived in an automated fashion, using expert rules.

This supports full and efficient customer compliance with the implementation timelines in OSHA's HazCom Standard as they relate to substances and mixtures.

This also underscores 3E's strategic partnership with SAP, with whom 3E closely collaborated for the enhancement of the SAP data model for OSHA.

Leading Sustainability

Sustainability is a holistic approach to innovating based on Environmental, Social and Governance (ESG) factors. Substituting safer chemical alternatives for harmful ones is a fundamental concept. Although it seems straightforward, keeping track of emerging requirements adds another layer of complexity.

ESG scores serve as a decision-making tool for investors, regulators, companies, and other stakeholders to assess and manage a company's non-financial risks and sustainability performance.

High ESG scores are viewed as a signal of responsible corporate behavior-important for customers and brand reputation. In this data-driven world, ESG rating agencies increasingly rely on CSRD/Taxonomy disclosures for verifiable, high-quality data to use as basis for scoring.

Consider two prongs of sustainability:

1. SoC in ESPR and CSRD – In the EU particularly, customers should be aware of changing requirements (both Directives and regulations) impact on sustainability goals of companies in a variety of industries. In order to address SoC, companies need to first identify them within their products. Thus, the ability to screen ingredients and product portfolios for substance of concern S(SoC), is a vital first step in moving toward ESG practices. For example:

• ESPR requires the identification, disclosure, and minimization of SoC in products.
• CSRD requires the disclosure of corporate-level impacts, risks, and policies related to SoC.

It is vital for regulated industry to be aware of the SoC requirements integrated in regulations like ESPR and directives such as CSRD. Companies should focus on phasing out use of SoC by substituting certain chemicals with safer alternatives. In a broader context, companies should consider their overall SoC mitigation strategy and the interplay with SoC and ESG scores.

How does 3E help?

Related to the above strategy, 3E helps to screen product ingredients for SoC and, by doing so, helps companies identify problematic substances. 3E ERC and 3E ERC+ utilize a regulatory intelligence API that works with SAP systems to enable automated identification and tracking of SoCs.

Specifically, in the 3E ERC and ERC+ 2504 release, 3E helps customers screen substances and calculate products impacted by APPENDIX C: GENERIC CRITERIA FOR DNSH TO POLLUTION PREVENTION AND CONTROL REGARDING USE AND PRESENCE OF CHEMICALS.

2. EU Taxonomy – The ability to screen ingredient and product portfolios against the Do No Significant Harm (DNSH) to Pollution Prevention and Control criteria of the EU Taxonomy is a vital step in meeting overall sustainability goals. The EU Taxonomy regulation requires the minimization of use of hazardous substances that are of very high concern (SVHCs), persistent, bioaccumulative and toxic (PBT), or endocrine-disrupting.ESG scores are important because they serve as a decision-making tool for investors, regulators, companies, and other stakeholders to assess and manage a company's non-financial risks and sustainability performance.

High ESG scores are viewed as a signal of responsible corporate behavior-important for customers, talent, and business partners.

How does 3E help?

The first step to all activities is identification. Integrating the hazardous substances into SAP using ERC (marketability) and ERC+ and other systems using the Regulatory Intelligence API enables automated identification and tracking of these customer substances.

Downstream activities focus on phasing out use of hazardous substances via safer alternatives and reporting on their mitigation strategy. This is highly influential on a company's ESG score.

Substance Group Expansion

The text of certain regulatory lists can associate regulatory requirements with specific substances, or with groups of substances. For example, the ACGIH List of Occupational Exposure Limits (OEL) regulates formaldehyde specifically, as a substance. It also assigns an OEL to a group of substances called Selenium and compounds. Although the regulatory list does not specify all selenium compounds, the intention of those creating that OEL is that it applies to all compounds of selenium (e.g., diselenane, selenazole, ethaneselenol). Substance groups may also be referred to as “generics” in other 3E products like Insight for Chemicals.

How does 3E help?

As the specific regulatory lists do not specify the identity of the substances assigned to the regulated groups, 3E enhances the 3E ERC+ integrated content by assigning specific substances to substance groups. For example, within the 3E ERC+ list data, 3E fills the group called “Selenium and compounds” with diselenane, selenazole and ethaneselenol. This enables the user of the content to more easily associate their company substances with the regulatory lists. Without the concept of substance groups, it would be much more difficult to make this association; for example, to associate the user's substance, diselenane, with the OEL for Selenium and compounds.

3E is significantly expanding the scope of substances included in groups in the list data included as part of the 3E ERC+ integrated content.

List data is one of the four pillars of the 3E ERC+ integrated content, along with phrases, expert rules, and templates. The list data converts regulatory lists (e.g., CA Prop 65) into a format that can be integrated into SAP. The user of the list data, via the loading process, associates the substances in their company's inventory with an array of regulatory and industry requirements. Users are thereby alerted to the fact that their company substances are subject to various requirements.

This results in reduced manual work thanks to pre-populated substance groups and improved cross-product consistency for regulatory data, thus removing discrepancies between systems.

AP Content is enhanced: Chinese content is reinvigorated

China's requirements have changed, and companies are challenged to keep up with these changes to ensure compliance.

For instance, it is important to be aware of the below requirements that impact Section 15 of China's SDS:

• China Catalogue of Hazardous Wastes
• China List of Toxic and Hazardous Air Pollutants
• China List of Toxic and Hazardous Substances under Priority Control for Soil
• China Narcotic Drugs and Psychotropic Substances
• China dual-use items and technology

How can 3E help?

In the 3E ERC and ERC+ 2504 release, 3E is addressing the growing compliance needs for AP manufacturers. Coming on the heels of the 2410 release, where another 7 such requirements were previously delivered, 3E's intention is to continue this work over the coming releases, enhancing content related to China as well as across another 12 countries in the AP region.

This body of work displays 3E's commitment to supporting customer compliance strategies in these markets.

Why 3E is uniquely positioned to help customers comply with the assistance of software

The 3E ERC and ERC+ 2504 release is built for industry needs. 3E helps customers with the challenge of horizon scanning, regulatory interpretation, and time savings by providing features such as automated data integration and decision-support tools.

3E is a trusted partner; and the features of this recent release allow companies to be confident in compliance and to incorporate sustainability into their processes.

The breadth of this release, which encompasses very specific chemical regulatory developments demonstrates 3E's commitment to guiding customers to a path of both compliance and sustainability.

Explore 3E ERC and ERC+ solutions

Contact our team to see how 3E ERC+ can simplify your compliance journey and support your sustainability goals.