What is the primary objective of **NIS2**?

**The primary objective of **NIS2** is to achieve a high common level of cybersecurity and resilience for network and information systems across EU member states.** It expands upon the original NIS Directive by imposing risk management measures, incident reporting, supply chain security, and governance requirements on **essential** and **important entities** to protect critical infrastructure like energy, transport, and digital services from cyber threats.

Who is legally or professionally required to comply with **NIS2**?

**NIS2 applies to all medium-sized and large **essential** and **important entities** in specified sectors within the EU.** **Essential entities** typically have 250+ employees, €50M+ annual turnover, or €43M+ balance sheet; **important entities** have 50+ employees, €10M+ annual turnover, or €10M+ balance sheet. Coverage includes energy, transport, health, digital infrastructure (e.g., cloud computing), public administration, postal services, waste management, and food production, with size-cap rules overriding thresholds for sole providers of critical services. EU member states transposed NIS2 by October 17, 2024.

Does **NIS2** require an external audit or third-party certification?

**NIS2 does not mandate external audits or third-party certification but empowers national authorities for supervision, including spot checks and demands for real-time evidence of compliance.** Entities must register with central authorities, providing details like name, contacts, sector, and operating states. Compliance relies on continuous risk management, incident reporting, and governance, with authorities like CSIRTs overseeing enforcement rather than formal certifications.

How often should an assessment for **NIS2** be performed?

**NIS2 requires ongoing, continuous risk assessments rather than fixed intervals, with dynamic updates such as quarterly risk registers and asset inventories.** Entities must maintain proactive measures for vulnerability identification, supply chain reviews, and mitigation, shifting from static audits to real-time, evidence-based assurance to ensure resilience against incidents.

What are the consequences of non-compliance with **NIS2**?

**Non-compliance with NIS2 incurs fines up to €10 million or 2% of total global annual turnover for **essential entities**, and up to €7 million or 1.4% for **important entities**.** Senior management faces personal liability, potential business suspension, and enforcement actions by national authorities, including spot checks, with measures effective from October 18, 2024, post-transposition.

An **NIS2** be mapped to other international frameworks?

**Yes, EU member states incorporate standards like ISO 27001 and NIST CSF into national NIS2 frameworks to facilitate mapping and compliance.** Organizations leverage these for risk management, incident response, and controls, aligning NIS2's requirements for cybersecurity measures, reporting, and governance with established practices.

What is the first step to begin implementing **NIS2**?

**The first step to implement NIS2 is to determine applicability by assessing entity size, sector, and operations against **essential** or **important** criteria.** Conduct a gap analysis of current risk management, register with national authorities, and establish governance with senior accountability for incident reporting (24-hour early warning, 72-hour notification) and supply chain security.

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

**REACH's primary objective 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.** Under **Regulation (EC) No 1907/2006**, it shifts responsibility to industry for registering substances manufactured or imported >**1 tonne/year per legal entity**, generating data on hazards, exposure, and safe use via dossiers submitted to **ECHA**.

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

**REACH legally requires manufacturers, importers, and downstream users placing substances, mixtures, or certain articles on the EU/EEA market to comply.** Registration applies to substances >**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** and notify **SVHCs** >**0.1% w/w** under **Article 33** (45-day consumer response).

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

**No, REACH does not require external audits or third-party certification.** It is a directly applicable regulation enforced by Member State authorities via inspections, with **ECHA** managing dossier evaluations. Compliance is demonstrated through maintained registration dossiers, **10-year recordkeeping**, and supply-chain communications like SDS updates.

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 list amendments.** Dossiers require updates "without delay" for new hazards or regulatory changes; monitor **Candidate List** (biannual updates), **Annex XIV** sunsets, and **Annex XVII** restrictions annually, plus tonnage reviews per legal entity.

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

**Non-compliance with REACH results in Member State penalties that must be effective, proportionate, and dissuasive per Article 126.** These include fines, product seizures, market bans, and potential criminal sanctions; enforcement varies by country, coordinated via **ECHA's Forum**, with examples like administrative fines or custodial sentences for severe violations.

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

**Yes, REACH elements like data requirements and risk assessments can be mapped to other frameworks, though it stands as a unique EU regulation.** Common alignments include shared hazard data under **GHS/CLP**, tonnage-based testing with **TSCA**, and SVHC processes with global substitution initiatives, enabling data reuse via tools like IUCLID.

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

**The first step to implement REACH is to conduct a substance inventory identifying all substances manufactured or imported >1 tonne/year per legal entity.** Map tonnages, uses, articles with **SVHCs** ≥**0.1% w/w**, roles (e.g., OR for non-EU), and cross-check **ECHA** lists (**Candidate**, **Annex XIV/XVII**) to prioritize registrations and gaps.

NIS2 vs REACH | GRADUM

Standards Comparison

NIS2

Mandatory

2022

EU directive for cybersecurity resilience across critical sectors

REACH

Mandatory

2007

EU regulation for chemical registration, evaluation, authorisation, restriction

Quick Verdict

NIS2 mandates cybersecurity resilience for EU critical sectors via risk management and rapid incident reporting, while REACH requires chemical safety data registration and restrictions for manufacturers/importers. Organizations adopt NIS2 for infrastructure protection and REACH for EU market access and liability avoidance.

Cybersecurity

NIS2

Directive (EU) 2022/2555 (NIS2 Directive)

Cost

€€€€

Complexity

Medium

Implementation Time

12-18 months

Key Features

Expands scope via size-cap rule to medium/large entities
Mandates multi-stage incident reporting within 24/72 hours
Imposes direct senior management accountability for compliance
Levies fines up to 2% global annual turnover
Requires continuous risk management and supply chain security

Chemical Safety

REACH

Regulation (EC) No 1907/2006 (REACH)

Cost

€€€

Complexity

Medium

Implementation Time

18-24 months

Key Features

Shifts chemical risk responsibility to industry
Mandatory registration for substances over 1 tonne/year
Authorisation regime for SVHCs with sunset dates
EU-wide restrictions via Annex XVII
Supply chain SDS and SVHC communication duties

Detailed Analysis

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

NIS2 Details

What It Is

NIS2 Directive (EU) 2022/2555 is an EU regulation expanding the original NIS framework to boost cybersecurity resilience. It applies a risk-based approach to essential and important entities in broadened sectors like energy, transport, and digital infrastructure, using size-cap rules for medium/large organizations.

Key Components

Four pillars: risk management, business continuity, incident reporting, corporate accountability.
Strict timelines: 24-hour early warning, 72-hour notification, one-month final report.
Continuous assurance via spot checks; leverages standards like ISO 27001.
No formal certification, but national authority oversight.

Why Organizations Use It

Meets legal obligations, avoiding fines up to 2% global turnover.
Enhances resilience against threats like supply chain attacks.
Builds trust with stakeholders and regulators.
Drives strategic cyber maturity and cross-border cooperation.

Implementation Overview

Targets EU entities with 50+ employees or €10M+ turnover in covered sectors.
Involves risk assessments, supply chain audits, training, governance structures.
Member states transpose by October 2024; 12-18 month grace periods common.
Focuses on ongoing evidence-based compliance and board accountability.

REACH Details

What It Is

REACH (Regulation (EC) No 1907/2006) is a directly applicable EU regulation governing chemicals throughout their lifecycle. Its primary purpose is protecting human health and the environment by shifting responsibility to industry for identifying, registering, and managing chemical risks. Scope covers substances, mixtures, and articles; approach is risk-based with tonnage-triggered data requirements.

Key Components

Four pillars: Registration, Evaluation, Authorisation, Restriction.
Technical annexes (I-XVII) detail dossiers, SDS, SVHC lists (Annex XIV), restrictions (Annex XVII).
Built on industry-led data generation, ECHA coordination, Member State enforcement.
Continuous compliance model, no certification but mandatory dossiers and updates.

Why Organizations Use It

Legal obligation for EU market access; reduces risks like fines, recalls, bans. Strategic benefits include supply chain transparency, substitution innovation, ESG alignment. Builds stakeholder trust via SVHC communication.

Implementation Overview

Phased: gap analysis, substance inventory, dossier preparation, supply chain communication, monitoring. Applies to manufacturers/importers >1 tonne/year, all sizes/industries in EU/EEA. Requires audits, no formal certification but ECHA submissions and national enforcement. (178 words)

Key Differences

Aspect	NIS2	REACH
Scope	Cybersecurity risk management, incident reporting, resilience	Chemical registration, evaluation, authorisation, restriction
Industry	Essential/important entities in EU sectors like energy, transport	Chemical manufacturers, importers, downstream users EU-wide
Nature	Mandatory EU directive, national transposition, fines enforced	Mandatory EU regulation, ECHA-managed, national enforcement
Testing	Risk assessments, spot checks, incident simulations	Dossier submissions, compliance checks, substance evaluations
Penalties	Up to €10M or 2% global turnover for essential entities	Effective, proportionate, dissuasive fines by Member States

Scope

NIS2

Cybersecurity risk management, incident reporting, resilience

REACH

Chemical registration, evaluation, authorisation, restriction

Industry

NIS2

Essential/important entities in EU sectors like energy, transport

REACH

Chemical manufacturers, importers, downstream users EU-wide

Nature

NIS2

Mandatory EU directive, national transposition, fines enforced

REACH

Mandatory EU regulation, ECHA-managed, national enforcement

Testing

NIS2

Risk assessments, spot checks, incident simulations

REACH

Dossier submissions, compliance checks, substance evaluations

Penalties

NIS2

Up to €10M or 2% global turnover for essential entities

REACH

Effective, proportionate, dissuasive fines by Member States

Frequently Asked Questions

Common questions about NIS2 and REACH

NIS2 FAQ

REACH FAQ

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NIS2

REACH

Quick Verdict

NIS2

Key Features

REACH

Key Features

Detailed Analysis

NIS2 Details

What It Is

Key Components

Why Organizations Use It

Implementation Overview

REACH Details

What It Is

Key Components

Why Organizations Use It

Implementation Overview

Key Differences

Scope

Industry

Nature

Testing

Penalties

Frequently Asked Questions

NIS2 FAQ

What is the primary objective of NIS2?

Who is legally or professionally required to comply with NIS2?

Does NIS2 require an external audit or third-party certification?

How often should an assessment for NIS2 be performed?

What are the consequences of non-compliance with NIS2?

An NIS2 be mapped to other international frameworks?

What is the first step to begin implementing NIS2?

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?

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NIS2 vs CAA

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