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

**The primary objective of REACH is to ensure a high level of protection of human health and the environment from chemical risks while enhancing EU chemicals industry competitiveness and promoting alternative testing methods.** REACH (**Regulation (EC) No 1907/2006**) shifts responsibility to industry for generating data on substance hazards, exposure, and safe use, documented in registration dossiers submitted to **ECHA**. It integrates **registration**, **evaluation**, **authorisation** of **SVHCs** (**Annex XIV**), and **restriction** (**Annex XVII**) to identify and control unacceptable risks.

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

**REACH legally requires manufacturers, importers, downstream users, and distributors placing substances on the EU/EEA market to comply.** Registration is mandatory for substances manufactured or imported >**1 tonne/year per legal entity**; **Chemical Safety Reports** apply >**10 tonnes/year**. **Only Representatives** act for non-EU manufacturers. **Article producers** must notify **ECHA** for **SVHCs** ≥**0.1% w/w** exceeding **1 tonne/year** (**Article 7(2)**) and communicate upon request (**Article 33**, 45 days).

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

**No, REACH does not require external audits or third-party certification.** It imposes **continuous obligations** like dossier submission via **IUCLID**/**REACH-IT**, **SDS** updates (**Annex II**), and record retention (10 years). Compliance is enforced by **Member State authorities** through inspections; **ECHA** conducts **dossier evaluations** but issues no certificates.

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 new data, tonnage changes, or **Candidate List** additions.** **Dossiers** require immediate updates; **SDS** updates occur "without delay" for new hazards or restrictions. Annual tonnage reviews and monitoring of **CoRAP**, **Annex XIV** (**LAD/Sunset Dates**), and **Annex XVII** amendments ensure ongoing compliance.

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.** Outcomes include administrative fines (up to millions of euros), product seizures, market withdrawal, and potential criminal sanctions. **ECHA** dossier deficiencies trigger requests for information; failures block EU market access and incur supply-chain disruptions.

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

**REACH cannot be directly mapped as a standalone certification scheme to other frameworks in these FAQs.** As a **directly applicable EU regulation**, its technical annexes (**e.g., VII-X** for tonnage-based data) and processes (**SVHC** identification, **CSR**) are unique, though data may support parallel obligations elsewhere.

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 >1 tonne/year per legal entity.** Map tonnages, roles (**manufacturer/importer/downstream user**), **SVHC** presence in articles (≥0.1% w/w), and cross-check **ECHA** lists (**Candidate List**, **Annexes XIV/XVII**) to prioritize registrations and notifications.

What is the primary objective of **ISO 30301**?

**ISO 30301 specifies requirements for establishing, implementing, maintaining, and continually improving a Management System for Records (MSR).** It ensures organizations create and control authoritative, reliable evidence of business activities to support mandate, mission, strategy, and goals through High-Level Structure clauses 4–10 and records-specific operational controls in Clause 8 and **Annex A (normative)**.

Who is legally or professionally required to comply with **ISO 30301**?

**No organization is legally required to comply with ISO 30301, as it is a voluntary international standard applicable to any organization.** It is professionally adopted by entities seeking to demonstrate MSR conformity via self-declaration, external confirmation, or third-party certification, particularly in regulated sectors needing auditable records governance.

Does **ISO 30301** require an external audit or third-party certification?

**ISO 30301 does not require external audit or third-party certification.** Conformity can be demonstrated through self-assessment and self-declaration, external confirmation of self-declaration, or third-party certification by accredited bodies under ISO/IEC 17065.

How often should an assessment for **ISO 30301** be performed?

**ISO 30301 requires internal audits at planned intervals and management reviews at planned intervals to evaluate MSR performance.** Monitoring, measurement, analysis, and evaluation (Clause 9.1) must occur as determined by the organization, with continual improvement actions under Clause 10 ensuring ongoing assessment.

What are the consequences of non-compliance with **ISO 30301**?

**Non-compliance with ISO 30301 carries no direct penalties, as it is a voluntary standard.** However, inadequate MSR may lead to organizational risks such as regulatory sanctions, litigation disadvantages, loss of evidence, operational disruptions, and failure to meet contractual or stakeholder expectations for records reliability and accountability.

Can **ISO 30301** be mapped to other international frameworks?

**Yes, ISO 30301 aligns with the High-Level Structure (Annex SL) enabling mapping to other management system standards.** Its clauses 4–10 and Annex A integrate with frameworks sharing PDCA cycles, supporting combined governance for records processes while maintaining standalone conformity.

What is the first step to begin implementing **ISO 30301**?

**The first step is understanding the organization’s context and determining records requirements per Clause 4, including subclause 4.1.2.** This involves identifying internal/external issues, interested parties, scope, and specific records needs to anchor MSR design in risk-based planning and leadership commitment (Clause 5).

REACH vs ISO 30301

Standards Comparison

REACH

Mandatory

2007

EU regulation for chemicals registration, evaluation, authorisation, restriction

ISO 30301

Voluntary

2019

International standard for records management systems

Quick Verdict

REACH mandates chemical safety registration and risk controls for EU manufacturers/importers, while ISO 30301 provides voluntary certification for records management systems ensuring evidential integrity. Companies adopt REACH for legal compliance, ISO 30301 for governance and auditability.

Chemical Safety

REACH

Regulation (EC) No 1907/2006 (REACH)

Cost

€€€

Complexity

Medium

Implementation Time

18-24 months

Key Features

Shifts burden of chemical risk proof to industry
Mandates registration for substances over 1 tonne/year
Authorises SVHC uses via substitution-driven applications
Imposes EU-wide restrictions on unacceptable risks
Requires SVHC disclosure in articles exceeding 0.1%

Records Management

ISO 30301

ISO 30301:2019 Management systems for records Requirements

Cost

€€€€

Complexity

High

Implementation Time

12-18 months

Key Features

HLS-aligned governance for MSR integration
Normative Annex A operational controls
Explicit records requirements (Clause 4.1.2)
Risk-based planning and objectives (Clause 6)
Flexible conformity pathways (self/certification)

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 establishing a comprehensive framework for managing chemical risks across their lifecycle. Its primary purpose is protecting human health and the environment by shifting responsibility to industry for registration, evaluation, authorisation, and restriction of substances, with tonnage-based data requirements and risk assessments.

Key Components

Four pillars: Registration (>1 tonne/year dossiers), Evaluation (dossier/substance checks), Authorisation (SVHC Annex XIV permissions), Restriction (Annex XVII bans/limits).
17 technical Annexes detailing data, SDS, exemptions.
Built on precautionary principle, industry-led data generation, supply-chain communication.
No certification; continuous compliance via ECHA databases.

Why Organizations Use It

Legal obligation for EU market access; avoids fines, seizures, market bans. Enables risk reduction, substitution innovation, supply-chain transparency, ESG alignment, competitive edge in chemicals-intensive sectors.

Implementation Overview

Phased approach: gap analysis, substance inventory, dossier preparation (IUCLID), SDS/communication, monitoring. Applies to manufacturers/importers/downstream users globally via Only Representatives; cross-industry, all sizes; national enforcement audits.

ISO 30301 Details

What It Is

ISO 30301:2019 (Information and documentation — Management systems for records — Requirements) is an international, certifiable management system standard for establishing, implementing, maintaining, and improving a Management System for Records (MSR). It ensures organizations create and control reliable evidence of business activities, supporting mandate, strategy, and goals. Uses High-Level Structure (HLS) (clauses 4–10) with risk-based planning and records-specific operations (Clause 8, Annex A normative).

Key Components

HLS clauses: context (incl. 4.1.2 records requirements), leadership, planning, support, operation, evaluation, improvement
**Annex Aoperational controls for records lifecycle (creation, capture, access, retention, disposition)
Principles: authenticity, reliability, integrity, usability
Conformity: self-declaration, external confirmation, third-party certification

Why Organizations Use It

Compliance with legal/regulatory obligations
Mitigate risks (loss, alteration, inaccessibility)
Enhance efficiency, auditability, transparency
Build governance assurance, stakeholder trust
Integrate with ISO 9001, 27001 for competitive edge

Implementation Overview

Phased: gap analysis, policy/roles, risk planning, controls/systems, audits/improvement
Applicable to any organization/size/sector
Scalable; certification via accredited bodies optional

Key Differences

Aspect	REACH	ISO 30301
Scope	Chemicals registration, evaluation, authorisation, restriction	Records management system governance and lifecycle controls
Industry	Chemicals, manufacturing, importers EU-wide	All organizations, any sector worldwide
Nature	Mandatory EU regulation with national enforcement	Voluntary certifiable management system standard
Testing	Dossier compliance checks by ECHA/Member States	Internal audits, management reviews, certification audits
Penalties	Fines, product seizures, market bans by Member States	Loss of certification, no direct legal penalties

Scope

REACH

Chemicals registration, evaluation, authorisation, restriction

ISO 30301

Records management system governance and lifecycle controls

Industry

REACH

Chemicals, manufacturing, importers EU-wide

ISO 30301

All organizations, any sector worldwide

Nature

REACH

Mandatory EU regulation with national enforcement

ISO 30301

Voluntary certifiable management system standard

Testing

REACH

Dossier compliance checks by ECHA/Member States

ISO 30301

Internal audits, management reviews, certification audits

Penalties

REACH

Fines, product seizures, market bans by Member States

ISO 30301

Loss of certification, no direct legal penalties

Frequently Asked Questions

Common questions about REACH and ISO 30301

REACH FAQ

ISO 30301 FAQ

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REACH

ISO 30301

Quick Verdict

REACH

Key Features

ISO 30301

Key Features

Detailed Analysis

REACH Details

What It Is

Key Components

Why Organizations Use It

Implementation Overview

ISO 30301 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?

Can REACH be mapped to other international frameworks?

What is the first step to begin implementing REACH?

ISO 30301 FAQ

What is the primary objective of ISO 30301?

Who is legally or professionally required to comply with ISO 30301?

Does ISO 30301 require an external audit or third-party certification?

How often should an assessment for ISO 30301 be performed?

What are the consequences of non-compliance with ISO 30301?

Can ISO 30301 be mapped to other international frameworks?

What is the first step to begin implementing ISO 30301?

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NIST CSF 2.0 Implementation Tiers Roadmap: Step-by-Step Guide from Partial to Adaptive Cybersecurity Maturity

DORA Third-Party Risk Management: A Consultant’s Guide to Mapping Critical ICT Service Providers in 2026

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