What is the primary objective of **REACH**?

**The primary objective of REACH is to ensure a high level of protection for human health and the environment from chemical risks while enhancing EU chemicals industry competitiveness and promoting alternative testing methods.** Under **Regulation (EC) No 1907/2006**, it shifts responsibility to industry for registering substances manufactured or imported above **1 tonne per year per legal entity**, generating data on hazards, exposure, and risk management via dossiers submitted to **ECHA**.

Who is legally or professionally required to comply with **REACH**?

**REACH legally requires manufacturers, importers, downstream users, and distributors placing substances, mixtures, or certain articles on the EU/EEA market to comply.** Obligations trigger for substances exceeding **1 tonne/year per legal entity**; non-EU manufacturers appoint an **Only Representative**. Downstream users must implement exposure scenarios from **Safety Data Sheets (SDS)** per **Annex II**, with article producers notifying **ECHA** under **Article 7(2)** if **SVHCs** exceed **0.1% w/w** and **1 tonne/year**.

Does **REACH** require an external audit or third-party certification?

**No, REACH does not require external audits or third-party certification.** It imposes ongoing obligations like dossier submission to **ECHA** and national enforcement via inspections by Member State authorities. Compliance is verified through **dossier evaluation** (**Articles 40-42**) and **substance evaluation** (**Articles 44-48**), with penalties for infringements under **Article 126**.

How often should an assessment for **REACH** be performed?

**REACH assessments must be performed continuously as a living obligation, with updates triggered by events like tonnage changes, new hazards, or **Candidate List** additions.** Registrants update dossiers upon new information; **SDS** must be revised "without delay" for regulatory changes. Annual tonnage reviews and monitoring of **Annex XIV** (sunset dates) and **Annex XVII** ensure alignment.

What are the consequences of non-compliance with **REACH**?

**Non-compliance with REACH results in penalties that are effective, proportionate, and dissuasive, enforced by Member State authorities.** These include fines, product seizures, market withdrawal, and potential criminal sanctions. Coordinated via **ECHA’s Forum**, enforcement varies but targets unregistered substances (>1 tpa), inadequate **SDS**, or **SVHC** notification failures under **Article 33** (45-day consumer response).

An **REACH** be mapped to other international frameworks?

**REACH cannot be formally mapped as a certification standard but shares data and principles with frameworks like GHS for hazard communication.** Its technical annexes (e.g., **Annex VII-X** information requirements) align with global data standards, enabling partial reuse in jurisdictions like **UK REACH**, though separate submissions are required post-Brexit.

What is the first step to begin implementing **REACH**?

**The first step to implement REACH is to conduct a substance inventory identifying all materials manufactured or imported above **1 tonne/year per legal entity**, mapping tonnages, uses, and roles.** Prioritize by **Annexes**, **Candidate List** (**250+ entries**), and **SVHC** thresholds (**0.1% w/w** in articles), establishing a cross-functional team for gap analysis.

What is the primary objective of **SOX**?

**The primary objective of SOX is to protect investors by improving the accuracy and reliability of corporate disclosures under federal securities laws.** Enacted July 30, 2002, following scandals like Enron and WorldCom, SOX established the **PCAOB** for audit oversight (Title I), mandated **auditor independence** (Title II), imposed **CEO/CFO certifications** (§302), required **ICFR assessments** (§404), and enhanced penalties for fraud.

Who is legally or professionally required to comply with **SOX**?

**SOX applies to U.S.-listed public companies, foreign private issuers, and their PCAOB-registered auditors.** Management of issuers under Securities Exchange Act §§12/15(d) must perform **§404(a) ICFR assessments**; **§404(b) auditor attestation** is required except for non-accelerated filers (public float $1.235B). Audit committees (§301) and executives face personal liability.

Does **SOX** require an external audit or third-party certification?

**Yes, SOX §404(b) requires external auditor attestation on management’s ICFR assessment for applicable issuers, per PCAOB standards.** Exemptions apply to non-accelerated filers and EGCs, but all must complete **§404(a) management assessments** with evidence of design/operating effectiveness. Auditors report directly to independent audit committees (§301).

How often should an assessment for **SOX** be performed?

**SOX requires annual ICFR assessments as of fiscal year-end, reported in Form 10-K.** **§302 certifications** occur quarterly (10-Q) and annually, evaluating controls within 90 days prior. Ongoing monitoring, quarterly reviews, and change assessments ensure continuous effectiveness, with interim/year-end testing cycles.

What are the consequences of non-compliance with **SOX**?

**Non-compliance triggers civil/criminal penalties, including up to $5M fines and 20 years imprisonment for willful false certifications (§906).** §802 imposes 20-year terms for document tampering. SEC enforcement, PCAOB sanctions, restatements, delisting, investor suits, and higher capital costs follow material weaknesses or adverse ICFR opinions.

An **SOX** be mapped to other international frameworks?

**No, these SOX FAQs address only SOX requirements and do not map to other frameworks.** SOX operates via unique SEC/PCAOB rules; executives should consult legal counsel for any external alignments.

What is the first step to begin implementing **SOX**?

**The first step is a top-down risk assessment to scope material financial accounts, processes, and assertions per PCAOB AS 2201.** Form a steering committee, define materiality thresholds (e.g., 5% assets), map to COSO framework, and build risk-control matrices identifying key controls and ITGCs.

REACH vs SOX | GRADUM

Standards Comparison

REACH

Mandatory

2007

EU regulation for chemicals registration, evaluation, authorisation, restriction

SOX

Mandatory

2002

US federal law mandating internal controls over financial reporting

Quick Verdict

REACH mandates EU chemical safety via registration and restrictions for manufacturers; SOX enforces US public company financial controls through CEO/CFO certifications and ICFR audits. Companies adopt REACH for EU market access, SOX for investor protection and listing compliance.

Chemical Safety

REACH

Regulation (EC) No 1907/2006 on REACH

Cost

€€€

Complexity

Medium

Implementation Time

18-24 months

Key Features

Shifts responsibility to industry for chemical risks
Registration required above 1 tonne per year
Four pillars: registration, evaluation, authorisation, restriction
Candidate List triggers SVHC communication duties
Annex XVII enforces EU-wide substance restrictions

Financial Reporting

SOX

Sarbanes-Oxley Act of 2002

Cost

€€€€

Complexity

Medium

Implementation Time

12-18 months

Key Features

Mandates CEO/CFO certification of financial reports (Section 302)
Requires ICFR management assessment and auditor attestation (Section 404)
Creates PCAOB for audit firm oversight and standards
Enforces auditor independence and partner rotation
Imposes criminal penalties for document tampering (Section 802)

Detailed Analysis

A comprehensive look at the specific requirements, scope, and impact of each standard.

REACH Details

What It Is

REACH (Regulation (EC) No 1907/2006) is a directly applicable EU regulation managing chemical substances' lifecycle. Its primary purpose is protecting human health and environment by shifting responsibility to industry for identifying, registering, and controlling chemical risks. Scope covers substances, mixtures, and articles; key approach is tonnage-based, risk-proportionate data generation and controls.

Key Components

Four pillars: Registration (>1 tonne/year dossiers), Evaluation (dossier/substance checks), Authorisation (SVHC permissions via Annex XIV), Restriction (bans/limits in Annex XVII).
17 technical annexes define data requirements, SDS rules, exemptions.
Core principles: industry burden shift, supply-chain communication, continuous updates.
Compliance model: no certification; ongoing ECHA submissions, national enforcement.

Why Organizations Use It

Legal obligation for EU market access; avoids fines, seizures, market bans. Reduces risks via hazard knowledge, substitution; builds supply-chain trust, ESG alignment, innovation in safer chemistries.

Implementation Overview

Phased: gap analysis, substance inventory, dossiers/CSRs via IUCLID, SDS management, monitoring Annex/Candidate Lists. Applies to manufacturers/importers/downstream users EU-wide; cross-functional, resource-intensive; audit readiness via self-assessments.

SOX Details

What It Is

The Sarbanes-Oxley Act of 2002 (SOX) is a US federal statute enacted post-Enron scandals to protect investors by improving corporate disclosure accuracy and reliability. It establishes a control-based, risk-assessed framework for financial reporting integrity.

Key Components

**Three pillarsPCAOB oversight (Title I), auditor independence (Title II), executive accountability (Titles III-XI).
Key sections: 302/906 (CEO/CFO certifications), 404 (ICFR assessments), 409 (real-time disclosures).
Built on COSO framework; no fixed controls, focuses on effective ICFR.
Annual management reports and auditor attestations (exemptions for smaller filers).

Why Organizations Use It

Mandatory for US public companies, with criminal penalties for non-compliance.
Enhances governance, reduces restatements, builds investor trust.
Strategic gains: operational efficiency, M&A readiness, lower capital costs.

Implementation Overview

Risk-based phases: scoping, documentation, testing, monitoring.
Applies to US-listed issuers; scales by filer status.
Requires annual Section 404 audits for accelerated filers.

Key Differences

Aspect	REACH	SOX
Scope	Chemicals registration, evaluation, authorisation, restriction	Financial reporting internal controls and governance
Industry	Chemicals, manufacturing, all EU product sectors	All US public companies, financial reporting
Nature	Mandatory EU regulation, national enforcement	Mandatory US federal law, SEC/PCAOB oversight
Testing	Dossier evaluation by ECHA/Member States	Annual ICFR testing and auditor attestation
Penalties	Effective, proportionate, dissuasive national fines	Criminal fines up to $5M, 20 years imprisonment

Scope

REACH

Chemicals registration, evaluation, authorisation, restriction

SOX

Financial reporting internal controls and governance

Industry

REACH

Chemicals, manufacturing, all EU product sectors

SOX

All US public companies, financial reporting

Nature

REACH

Mandatory EU regulation, national enforcement

SOX

Mandatory US federal law, SEC/PCAOB oversight

Testing

REACH

Dossier evaluation by ECHA/Member States

SOX

Annual ICFR testing and auditor attestation

Penalties

REACH

Effective, proportionate, dissuasive national fines

SOX

Criminal fines up to $5M, 20 years imprisonment

Frequently Asked Questions

Common questions about REACH and SOX

REACH FAQ

SOX FAQ

You Might also be Interested in These Articles...

Beyond the Boardroom: 5 Ways Modern Compliance Software Elevates Every Department

Discover 5 ways modern compliance software boosts HR, IT, finance & more: automate risks, enhance efficiency, ensure data integrity, stay audit-ready. Elevate y

CMMC Sustainment Mastery: Continuous Monitoring, Annual Affirmations, and Subcontractor Flow-Down Playbook

Master CMMC sustainment beyond certification: continuous monitoring dashboards, SPRS/eMASS affirmations, enforceable subcontractor clauses. Get templates for ve

The Service-Oriented SOC: Leveraging Maturity Assessments to Guarantee SLOs and Operational Predictability

Transform your SOC into a service provider using maturity assessments to standardize workflows, guarantee SLOs, and ensure predictability amid turnover and risi

Run Maturity Assessments with GRADUM

Transform your compliance journey with our AI-powered assessment platform

Assess your organization's maturity across multiple standards and regulations including ISO 27001, DORA, NIS2, NIST, GDPR, and hundreds more. Get actionable insights and track your progress with collaborative, AI-powered evaluations.

100+ Standards & Regulations

AI-Powered Insights

Collaborative Assessments

Actionable Recommendations

Check out these other Gradum.io Standards Comparison Pages

NIST CSF vs WELL

NIST CSF vs WELL: Compare cybersecurity risk mgmt (Govern, Tiers, Profiles) with building health standards. Boost security & wellness—discover key diffs now!

CE Marking vs COPPA

Unlock CE Marking vs COPPA: EU product safety certification vs US kids' online privacy rules. Master compliance differences, requirements & pitfalls for global market access. Compare now!

CSL (Cyber Security Law of China) vs APPI

Unlock CSL vs APPI: Compare China's data localization & security mandates with Japan's consent-driven privacy rules. Master Asia compliance strategies today.

REACH

SOX

Quick Verdict

REACH

Key Features

SOX

Key Features

Detailed Analysis

REACH Details

What It Is

Key Components

Why Organizations Use It

Implementation Overview

SOX Details

What It Is

Key Components

Why Organizations Use It

Implementation Overview

Key Differences

Scope

Industry

Nature

Testing

Penalties

Frequently Asked Questions

REACH FAQ

What is the primary objective of REACH?

Who is legally or professionally required to comply with REACH?

Does REACH require an external audit or third-party certification?

How often should an assessment for REACH be performed?

What are the consequences of non-compliance with REACH?

An REACH be mapped to other international frameworks?

What is the first step to begin implementing REACH?

SOX FAQ

What is the primary objective of SOX?

Who is legally or professionally required to comply with SOX?

Does SOX require an external audit or third-party certification?

How often should an assessment for SOX be performed?

What are the consequences of non-compliance with SOX?

An SOX be mapped to other international frameworks?

What is the first step to begin implementing SOX?

You Might also be Interested in These Articles...

Beyond the Boardroom: 5 Ways Modern Compliance Software Elevates Every Department

CMMC Sustainment Mastery: Continuous Monitoring, Annual Affirmations, and Subcontractor Flow-Down Playbook

The Service-Oriented SOC: Leveraging Maturity Assessments to Guarantee SLOs and Operational Predictability

Run Maturity Assessments with GRADUM

Check out these other Gradum.io Standards Comparison Pages

NIST CSF vs WELL

CE Marking vs COPPA

CSL (Cyber Security Law of China) vs APPI