RegTech Glossary & Standards

RegTech Glossary & Standards is a structured reference for regulatory technology terms, standards, workflows and implementation concepts used in regulated SaaS products.

07
Jul
2026

What Is REACH Compliance Software?

Definition

REACH compliance software is a digital system that helps companies manage obligations under the EU REACH Regulation: Registration, Evaluation, Authorisation and Restriction of Chemicals. REACH applies to chemical substances manufactured, imported, placed on the market, or used in the EU, and requires companies to identify and manage risks related to substances, communicate chemical safety information, and meet applicable registration, authorisation, restriction, and supply chain duties.

For product, compliance, and SaaS teams, REACH compliance software turns chemical regulatory requirements into operational workflows: substance tracking, supplier data collection, document management, risk monitoring, customer communication, and audit evidence.

Why REACH Compliance Software Matters

REACH compliance software matters because chemical compliance depends on accurate, current, and traceable product data. Many companies need to manage substances across suppliers, materials, formulations, articles, safety data sheets, declarations, and regulatory lists.

For SaaS teams serving manufacturers, retailers, distributors, or supply chain operators, the product challenge is not only storing chemical data. The system must support changing regulatory requirements, supplier evidence, restricted substances, substances of very high concern, customer requests, and internal accountability.

A strong implementation helps teams reduce manual spreadsheet work, improve data quality, prepare customer and authority responses, and maintain a clearer compliance record.

Common Implementation Questions

What does REACH compliance software usually do?

Common capabilities include substance inventory management, supplier declaration workflows, safety data sheet management, restricted substance screening, SVHC monitoring, authorisation and restriction tracking, document storage, audit trails, customer request management, and reporting.

The exact scope depends on the company’s role: manufacturer, importer, downstream user, distributor, article supplier, or software provider supporting those organizations.

Is REACH only about chemical manufacturers?

No. REACH affects many companies that manufacture, import, distribute, sell, or use chemical substances, mixtures, or articles in the EU. The European Commission notes that substances above one tonne per year per company generally need registration with ECHA, while other duties can apply through authorisation, restriction, and supply chain communication.

What data should teams manage first?

Start with a structured product and substance inventory. Key data may include product identifiers, material composition, supplier declarations, substance names, CAS or EC numbers, tonnage bands, use cases, SDS files, exposure information, restriction status, SVHC status, and customer-facing compliance statements.

How does software support supply chain communication?

REACH requires chemical information to move through the supply chain. Software can help collect supplier declarations, manage evidence, track missing data, send questionnaires, update records, and respond to customer or consumer requests with consistent information. The Swedish Chemicals Agency notes that REACH includes requirements for users of chemicals and rules about information that must be given to customers.

What is the biggest implementation risk?

The biggest risk is treating REACH as a static checklist. Substance lists, supplier data, product compositions, restrictions, and authorisation requirements can change. A useful system needs ownership, review cycles, change monitoring, version control, and clear escalation when a substance or product becomes affected.

Can a vendor claim REACH compliance?

Use caution. “Fully compliant” is risky unless the vendor defines the product scope, company role, substances covered, regulatory obligations, evidence sources, and date of assessment. Stronger wording explains what the software supports: substance inventory, supplier workflows, SVHC tracking, restriction screening, document control, audit trails, or customer response management.

Related Standards and Frameworks

REACH compliance software often connects with broader product compliance and chemical management frameworks, including CLP Regulation, safety data sheet requirements, restricted substance list management, supplier due diligence processes, product lifecycle management, ERP systems, and material declaration standards such as IEC 62474 for electrotechnical products.

These frameworks do not replace REACH obligations, but they help structure product data, hazard communication, supply chain evidence, and compliance workflows.

Posted by admin in RegTech Glossary & Standards
04
Jul
2026

What Are DORA IT Controls?

Definition

DORA IT controls are the governance, security, monitoring, testing, incident response, and third-party risk management measures used to meet the Digital Operational Resilience Act requirements. DORA, Regulation (EU) 2022/2554, is the EU framework for digital operational resilience in the financial sector. It has applied since 17 January 2025 and is designed to ensure that financial entities can withstand, respond to, and recover from ICT-related disruptions such as cyberattacks, system failures, and third-party service outages.

For product, compliance, and SaaS teams, DORA IT controls are not only internal security policies. They define how systems are designed, operated, monitored, tested, documented, and supported when serving regulated financial customers.

Why DORA IT Controls Matter

DORA IT controls matter because financial entities must manage ICT risk in a consistent and auditable way. This affects banks, insurers, investment firms, payment institutions, crypto-asset service providers, and other financial entities covered by DORA.

For SaaS vendors serving financial customers, DORA can influence procurement, contractual requirements, service-level expectations, incident reporting workflows, audit rights, resilience testing, subcontractor management, and evidence requests. A product may be technically strong but still create customer risk if it cannot support operational resilience expectations.

Core Areas of DORA IT Controls

ICT risk management

Teams need policies, processes, and technical controls to identify, protect, detect, respond to, and recover from ICT risks. This may include asset inventories, access management, vulnerability management, backup and recovery, encryption, logging, change management, business continuity, and disaster recovery.

ICT incident management

DORA requires structured handling of ICT-related incidents. Product and SaaS teams should define incident classification, escalation paths, customer notification workflows, root cause analysis, evidence retention, and communication responsibilities.

Digital operational resilience testing

Resilience controls must be tested. This can include vulnerability assessments, scenario testing, penetration testing, business continuity tests, failover tests, backup restoration tests, and, for certain entities, advanced threat-led penetration testing.

Third-party ICT risk management

DORA places strong emphasis on ICT third-party risk. SaaS teams should expect customers to ask for information about hosting providers, subcontractors, critical dependencies, data locations, exit plans, security controls, and contractual safeguards.

Information sharing and governance

DORA also supports structured governance and, in some contexts, information sharing on cyber threats. Internally, teams need clear ownership, board-level accountability where applicable, documented policies, control evidence, and regular review cycles.

Common Implementation Questions

Are DORA IT controls only relevant to financial institutions?

No. DORA directly applies to covered financial entities, but SaaS vendors and ICT providers may be affected through customer contracts, due diligence, outsourcing requirements, oversight expectations, and requests for evidence.

What should SaaS teams prepare first?

Start with a control inventory mapped to DORA-relevant areas: ICT risk management, incident response, resilience testing, third-party dependencies, access control, logging, business continuity, and data protection. Then identify which controls are already documented and which need stronger evidence.

What evidence do customers usually request?

Common evidence may include security policies, SOC 2 or ISO certifications, penetration test summaries, business continuity plans, disaster recovery test results, incident response procedures, subcontractor lists, data processing locations, access control policies, audit logs, and service-level documentation.

Can a vendor claim DORA compliance?

Use caution. “Fully compliant” is risky unless the vendor clearly defines its role, scope, services, customer type, contractual obligations, and evidence base. Stronger wording explains what the vendor supports: resilience testing, incident workflows, audit evidence, third-party risk documentation, access controls, logging, and continuity planning.

Related Standards and Frameworks

DORA IT controls often overlap with established security and resilience frameworks, including ISO/IEC 27001, ISO/IEC 22301, SOC 2, NIST Cybersecurity Framework, NIST SP 800-53, CIS Controls, and COBIT. These frameworks do not replace DORA, but they can help structure control design, evidence collection, and audit readiness.

Posted by admin in RegTech Glossary & Standards
01
Jul
2026

What Is Digital Product Passport (DPP) Implementation?

Definition

Digital Product Passport (DPP) implementation is the process of creating, managing, and sharing structured digital product data across a product’s lifecycle. A DPP links a physical product, component, or material to a digital record containing information such as composition, origin, repairability, sustainability data, compliance documentation, and end-of-life instructions.

In the EU, Digital Product Passports are a core part of the Ecodesign for Sustainable Products Regulation (ESPR), Regulation (EU) 2024/1781, which entered into force in 2024. The ESPR establishes a framework for future product-specific requirements, including DPP requirements for relevant product groups.

Why Digital Product Passport Implementation Matters

Digital Product Passport (DPP) implementation matters because product transparency is becoming a compliance, supply chain, and market-access requirement. For product, compliance, and SaaS teams, a DPP is not just a QR code or database. It is an operational system for collecting, validating, updating, and exposing product information to the right stakeholders.

A DPP can support:

  • regulatory compliance
  • product traceability
  • sustainability reporting
  • circular economy workflows
  • repair, reuse, and recycling
  • supply chain due diligence
  • customer and partner transparency
  • customs and market surveillance checks

For software teams, the main challenge is not only storing product data. It is designing a reliable data model, access-control system, integration layer, and governance process that can survive changing regulatory and product-specific requirements.

Common Implementation Questions

What data should a DPP include?

The exact data requirements depend on the product category and applicable regulation. A DPP may include product identifiers, manufacturer information, material composition, carbon footprint data, repair instructions, spare parts information, conformity documentation, durability data, recycling guidance, and supply chain information.

Teams should avoid assuming one universal DPP template. The ESPR sets the framework, while specific requirements are expected to be defined through product-specific rules and delegated acts.

Which products are affected first?

Batteries are one of the clearest early examples. Under the EU Battery Regulation, certain batteries will require a battery passport from 2027. Broader DPP requirements under the ESPR will be phased in by product category, with priority areas defined through the Commission’s working plans and future implementing measures.

Is a DPP just a QR code?

No. A QR code or other data carrier is only the access point. The real implementation includes product identifiers, data governance, system integrations, access rights, data validation, hosting, interoperability, lifecycle updates, and auditability.

A weak DPP implementation treats the passport as a static product page. A strong implementation treats it as a controlled product data infrastructure.

Who owns DPP implementation?

DPP implementation usually requires collaboration between product, compliance, sustainability, supply chain, engineering, legal, and data teams. In SaaS organizations, product teams often own the user workflows and system requirements, while compliance teams define obligations and evidence needs.

What is the biggest implementation risk?

The biggest risk is starting too late with fragmented product data. Many companies already hold some required information, but it may sit across ERP systems, supplier documents, spreadsheets, PLM tools, certification files, and sustainability reports. DPP readiness depends on turning that scattered data into structured, verified, accessible records.

Can a vendor claim DPP compliance?

Use caution with broad claims. “Fully compliant” is risky unless the vendor specifies the product category, applicable regulation, required data fields, technical standard, access model, and date of assessment. Stronger wording explains what the system supports: product identity, data collection, supplier workflows, access control, audit trails, lifecycle updates, or regulatory reporting.

Related Standards and Frameworks

DPP implementation is closely linked to product identification, data exchange, lifecycle information, and interoperability standards. Relevant areas include:

  • product identifiers and data carriers
  • GS1 Digital Link and related identification standards
  • ISO standards for product lifecycle data
  • circular economy and sustainability data frameworks
  • EU ESPR requirements
  • EU Battery Regulation requirements
  • future European harmonised standards for DPP interoperability

The regulatory and technical standards landscape is still developing, so teams should design DPP systems to be modular, interoperable, and adaptable.

Posted by admin in RegTech Glossary & Standards
28
Jun
2026

What Is EU AI Act Compliance?

Definition

EU AI Act compliance is the process of ensuring that an AI system is designed, deployed, documented, monitored, and governed in line with the European Union’s Artificial Intelligence Act. The EU AI Act is a risk-based regulatory framework: it sets stricter obligations for AI systems that create higher risks, while applying lighter requirements to lower-risk systems. The Act entered into force on 1 August 2024, with most rules applying from 2 August 2026 and some obligations applying earlier or later depending on the AI system type.

For product, compliance, and SaaS teams, EU AI Act compliance means understanding how AI is used in the product, what risk category applies, which obligations are triggered, and what evidence the organization must maintain.

Why EU AI Act Compliance Matters

EU AI Act compliance matters because AI governance is becoming part of product readiness, enterprise procurement, and market access. A product that uses AI may need clear answers about risk classification, transparency, data governance, human oversight, technical documentation, monitoring, and accountability.

For SaaS teams, this affects product discovery, roadmap planning, release management, customer documentation, vendor due diligence, and sales claims. Compliance cannot be added only at the end of development if the product architecture, user experience, data flows, or model behavior create regulatory exposure.

Common Implementation Questions

What should teams do first?

Start with an AI system inventory. List where AI is used, what each system does, who uses it, what data it processes, what outputs it produces, and whether it affects decisions, access, rights, safety, employment, education, finance, healthcare, or other sensitive contexts.

How is risk classified?

The EU AI Act uses a risk-based approach. Some AI practices are prohibited, high-risk systems face detailed requirements, certain AI systems have transparency obligations, and many lower-risk uses face limited or no specific AI Act obligations. Prohibited-practice rules started applying from 2 February 2025, while transparency and many high-risk rules apply later in the implementation timeline.

Is this only a legal task?

No. Legal teams interpret obligations, but product and engineering teams define how the system actually works. Compliance depends on product design, data quality, model evaluation, user controls, logging, monitoring, incident handling, documentation, and customer-facing communication.

What evidence is usually needed?

Teams may need risk assessments, technical documentation, model and data records, transparency notices, human oversight procedures, testing results, monitoring plans, incident response processes, and governance records. The exact requirements depend on the role of the organization and the AI system’s risk category.

Can a vendor say it is “fully compliant”?

Use caution. “Fully compliant” is often too broad unless the vendor can specify the system, role, jurisdiction, risk category, obligations, evidence, and date of assessment. Stronger wording explains what the product supports: inventory, classification, documentation, transparency, audit trails, oversight workflows, or risk management.

Related Standards

Relevant frameworks include ISO/IEC 42001, an AI management system standard, and ISO/IEC 23894, which provides guidance on AI risk management. The NIST AI Risk Management Framework is also commonly used to structure AI risk governance, although it is not an EU law. European harmonised standards are expected to support AI Act conformity in areas such as risk management, transparency, human oversight, cybersecurity, and quality management.

Posted by admin in RegTech Glossary & Standards