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 industry competitiveness and promoting alternative testing methods.** Under **Regulation (EC) No 1907/2006**, it shifts responsibility to industry for registering substances, generating safety data, and managing risks through registration, evaluation, authorisation, and restriction.

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

**REACH legally requires manufacturers, importers, and downstream users in the EU/EEA to comply when placing substances on the market in quantities exceeding 1 tonne per year per legal entity.** This includes producers/importers of articles with SVHCs ≥0.1% w/w exceeding 1 tonne/year (Article 7(2)), and non-EU manufacturers via an **Only Representative**. Distributors and downstream users must ensure supply-chain communication via **Safety Data Sheets** (Annex II).

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 through inspections, with ECHA managing dossier evaluations (Articles 40-42). Compliance is demonstrated via registration dossiers in IUCLID, record retention for 10 years, and inspection readiness.

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

**REACH assessments must be performed continuously as a living obligation, with updates triggered by new data, tonnage changes, Candidate List additions, or Annex XIV/XVII amendments.** Dossiers require immediate updates (Article 28); annual tonnage reviews ensure >1 tonne/year thresholds; Member State substance evaluations (CoRAP) occur as scheduled, demanding ongoing monitoring.

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

**Non-compliance with REACH results in penalties set by Member States that must be effective, proportionate, and dissuasive under Article 126, including fines, product seizures, and market bans.** Enforcement via national inspections coordinated by ECHA's Forum can lead to dossier corrections, additional testing, or prohibitions after Annex XIV **Sunset Dates**.

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

**REACH cannot be formally mapped to other international frameworks as it is a standalone EU regulation without equivalence or certification schemes.** While data from REACH dossiers may support global submissions, obligations like tonnage-based registration (>1 tonne/year) and SVHC duties (Candidate List, Annex XIV) are unique, requiring separate compliance.

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

**The first step to implement REACH is to conduct a substance inventory identifying all chemicals manufactured or imported >1 tonne/year per legal entity, mapping tonnages, uses, and roles.** Prioritize by Annex VII-X requirements, check against Candidate List and Annexes XIV/XVII, and establish a cross-functional governance team for dossier preparation in IUCLID.

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

**The primary objective of SQF is to provide a rigorous, HACCP-based food safety management system that assures consistent production of safe food products across the supply chain.** Administered by the SQF Institute (SQFI), it combines **Module 2** (universal system elements like management commitment, HACCP plans, verification, traceability, food defense, allergens, and training) with sector-specific Good Practices modules (e.g., **Module 11** for food manufacturing GMPs). This GFSI-benchmarked framework ensures "say what you do, do what you say, prove it" through documented controls, implementation, and records.

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

**SQF compliance is voluntary but professionally required for suppliers to major retailers, brand owners, and foodservice providers worldwide.** It applies to food sector categories (FSCs) including manufacturing, storage/distribution, packaging, primary production, pet food, and supplements. Sites must designate a full-time, on-site **SQF Practitioner** (HACCP-trained, competent in the Code) and implement **Module 2** plus relevant GMP modules; over 14,000 sites in 40+ countries pursue certification as a "license to trade."

Oes **SQF** require an external audit or third-party certification?

**Yes, SQF mandates third-party certification by SQFI-licensed Certification Bodies (CBs) accredited to ISO/IEC 17065.** Annual audits (initial, surveillance, recertification) include on-site verification of documentation, operations, and records, with periodic unannounced audits (e.g., every 3 years). Nonconformities are graded (minor=1pt, major=5pts, critical=50pts); passing scores are E (96-100), G (86-95), with F (<70) failing certification.

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

**SQF requires annual external certification audits, with internal audits performed regularly to support verification.** **Management reviews** occur at least annually (with monthly SQF Practitioner updates), covering audits, CAPA, complaints, and hazards. Internal audits (2.5.5) must cover all elements; pre-certification gap assessments are advised 60-90 days prior, plus routine verification (e.g., environmental monitoring, traceability exercises).

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

**Non-compliance with SQF results in audit failure, certification denial/suspension, and loss of market access to GFSI-demanding buyers.** Critical nonconformities (e.g., uncontrolled hazards) trigger immediate suspension; majors/minors require CAPA closure (often within 30 days). Repeated failures lead to CB delisting, increased buyer audits, recalls, and commercial exclusion from retail/foodservice chains.

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

**Yes, SQF maps to other GFSI-benchmarked frameworks through shared HACCP principles, PRPs, and management system elements.** Its **Module 2** aligns with universal controls (e.g., document control, internal audits, supplier approval) in schemes like BRCGS or FSSC 22000, plus regulatory baselines like FDA FSMA preventive controls, enabling reduced audit duplication.

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

**The first step to implement SQF is to register the site in the SQFI assessment database and designate a competent SQF Practitioner.** Select applicable modules/FSCs, conduct a gap analysis against Edition 9 (effective May 2021), develop the food safety policy, and build the HACCP-based system per "say what you do, do what you say, prove it."

REACH vs SQF | GRADUM

Standards Comparison

REACH

Mandatory

2007

EU regulation for chemical registration, evaluation, authorisation, restriction

SQF

Voluntary

2023

GFSI-benchmarked food safety certification program

Quick Verdict

REACH mandates chemical risk management across EU industries via registration and restrictions, ensuring safety through ECHA oversight. SQF certifies voluntary food safety systems globally with HACCP and audits. Companies adopt REACH for legal compliance, SQF for market access.

Chemical Safety

REACH

Regulation (EC) No 1907/2006 (REACH)

Cost

€€€

Complexity

Medium

Implementation Time

18-24 months

Key Features

Shifts responsibility to industry for hazard data generation
Registration required for substances over 1 tonne/year
Authorisation regime for SVHCs drives substitution
Annex XVII lists EU-wide restrictions on risks
Mandatory SVHC communication in supply chain and articles

Agile Scaling

SQF

Safe Quality Food (SQF) Code

Cost

€€€

Complexity

High

Implementation Time

6-12 months

Key Features

Modular: Module 2 plus sector GMP modules
HACCP-based Food Safety Plan required
GFSI-benchmarked for global recognition
Mandatory SQF Practitioner designation
Traceability, recall, crisis management emphasis

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 governing chemicals lifecycle. Its primary purpose is protecting human health and environment by shifting responsibility to industry for identifying and managing chemical risks. Scope covers substances, mixtures, and articles; key approach is tonnage-based data requirements with evaluation, authorisation, and restriction pillars.

Key Components

Four pillars: Registration, Evaluation, Authorisation, Restriction.
17 technical annexes defining dossiers, SDS, SVHC lists (Annex XIV), restrictions (Annex XVII).
Built on industry-generated data, Chemical Safety Reports (CSR) for >10 tonnes/year.
No certification; continuous compliance via ECHA databases and national enforcement.

Why Organizations Use It

Legal obligation for EU market access; avoids fines, market bans, recalls. Enhances risk management, supply-chain transparency, innovation via substitution. Builds stakeholder trust, supports ESG, provides competitive edge in chemicals-dependent sectors.

Implementation Overview

Phased: gap analysis, substance inventory, dossier preparation via IUCLID, supply-chain SDS communication. Applies to manufacturers/importers/downstream users across industries, EU/EEA geography. Requires cross-functional teams, ongoing monitoring; national audits enforce 'effective, proportionate, dissuasive' penalties.

SQF Details

What It Is

Safe Quality Food (SQF) is a GFSI-benchmarked certification program and HACCP-based management system for food safety and quality. It ensures safe production across supply chains—from farm to retail—using a modular, risk-based approach with universal system elements and sector-specific Good Practices.

Key Components

**Module 2Core system elements (management commitment, HACCP plan, verification, traceability, allergens, training).
Sector modules (e.g., Module 11 GMPs for manufacturing).
100+ auditable clauses; built on Codex/NACMCF HACCP.
Third-party audits with scoring (E/G/C/F grades), unannounced options.

Why Organizations Use It

Meets retailer mandates, aligns with FSMA/EU regs for market access.
Reduces recalls, audit duplication; builds food safety culture.
Enhances supplier trust, operational efficiency, resilience.
Provides "license to trade" globally.

Implementation Overview

Phased: gap analysis, documentation, training, internal audits, certification.
Applies to all sizes/industries (manufacturing, storage); SQF Practitioner required.
Annual audits via licensed bodies; PDCA continuous improvement.

(178 words)

Key Differences

Aspect	REACH	SQF
Scope	Chemical registration, evaluation, authorisation, restriction	Food safety management, HACCP, GMP, quality systems
Industry	Chemicals, manufacturing, all sectors using substances, EU-focused	Food manufacturing, storage, distribution, global food sectors
Nature	Mandatory EU regulation, legally binding	Voluntary GFSI-benchmarked certification
Testing	Dossier evaluation by ECHA, substance testing by tonnage	Annual third-party audits, internal verification, validation
Penalties	National fines, effective/proportionate/dissuasive penalties	Loss of certification, no direct legal penalties

Scope

REACH

Chemical registration, evaluation, authorisation, restriction

SQF

Food safety management, HACCP, GMP, quality systems

Industry

REACH

Chemicals, manufacturing, all sectors using substances, EU-focused

SQF

Food manufacturing, storage, distribution, global food sectors

Nature

REACH

Mandatory EU regulation, legally binding

SQF

Voluntary GFSI-benchmarked certification

Testing

REACH

Dossier evaluation by ECHA, substance testing by tonnage

SQF

Annual third-party audits, internal verification, validation

Penalties

REACH

National fines, effective/proportionate/dissuasive penalties

SQF

Loss of certification, no direct legal penalties

Frequently Asked Questions

Common questions about REACH and SQF

REACH FAQ

SQF FAQ

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REACH

SQF

Quick Verdict

REACH

Key Features

SQF

Key Features

Detailed Analysis

REACH Details

What It Is

Key Components

Why Organizations Use It

Implementation Overview

SQF 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?

SQF FAQ

What is the primary objective of SQF?

Who is legally or professionally required to comply with SQF?

Oes SQF require an external audit or third-party certification?

How often should an assessment for SQF be performed?

What are the consequences of non-compliance with SQF?

An SQF be mapped to other international frameworks?

What is the first step to begin implementing SQF?

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CIS Controls v8.1, Operationalized: Top 10 Reasons Compliance Monitoring Software Accelerates Real-World Implementation

You Guide on how to Start Implementing NIST CSF in Your Organization

CIS Controls v8.1 for Cloud & SaaS: A Practical Safeguard Playbook for AWS/Azure/GCP and Microsoft 365

Run Maturity Assessments with GRADUM

Check out these other Gradum.io Standards Comparison Pages

FDA 21 CFR Part 11 vs ISO 50001

GDPR vs PIPL

IFS Food vs 23 NYCRR 500