REACH Declaration: Your Complete Compliance Documentation Guide

Everything you need to know to ensure full REACH compliance, from SVHC reporting to Annex XVII and XIV requirements.

What is a REACH Declaration?

A REACH declaration is a formal compliance statement confirming that products meet EU REACH regulation requirements regarding chemical substances. It demonstrates adherence to REACH regulatory compliance standards and provides transparency about the presence or absence of Substances of Very High Concern (SVHC) in products.

REACH declarations serve multiple purposes:

Fulfilling legal obligations
Facilitating supply chain communication
Enabling market access
Building customer trust through documented commitment to chemical safety

When Do Companies Need a REACH Declaration?

Companies must provide REACH declarations when:

Customers or authorities request confirmation of REACH requirements compliance
Products contain articles that may include Substances of Very High Concern (SVHC)
Demonstrating that products do not contain Substances of Very High Concern SVHC above 0.1% concentration
Responding to consumer inquiries about chemical content (legally required within 45 days)
Exporting products to the EU market from non-EU countries
Participating in public procurement processes requiring REACH regulatory compliance documentation

What are essential Components of a REACH Declaration?

Product Identification

Clear product description, model numbers, and specifications
Article or substance identification details

SVHC Compliance Statement

Confirmation that products do not contain Substances of Very High Concern (SVHC) above threshold limits
If SVHC are present, detailed disclosure of which Substances of Very High Concern SVHC and their concentrations
Reference to the specific SVHC list version (with date) used for evaluation

Regulatory References

Statement of compliance with REACH Annex XVII restricted substances
Confirmation that no REACH Annex XIV authorization-required substances are present without proper authorization
Reference to applicable REACH requirements and testing standards

Declaration Date and Validity

Date of declaration issuance
Commitment to update declaration when regulations change or new Substances of Very High Concern are added to the list

Authorized Signature

Signature from authorized company representative
Statement of accuracy and legal responsibility

What Is REACH Annex XVII (Restricted Substances)?

REACH Annex XVII, also known as REACH Annex 17 or the REACH Restricted Substances List, contains chemicals that are banned or restricted for use in consumer and industrial products within the EU market. Currently, REACH Annex XVII entries covering over 1,000 individual substances.

These restrictions take three primary forms:

Concentration Limits: Maximum allowable percentages of a substance in mixtures or articles (e.g., benzene limited to 0.1% w/w)
Total Content Limits: Caps on overall quantity within entire products (e.g., cadmium in plastics not exceeding 0.01%)
Outright Bans: Complete prohibition of certain substances like asbestos, PCBs, and specific persistent organic pollutants

Unlike substances requiring authorization, REACH Annex XVII restrictions are immediately enforceable. Products containing restricted substances above specified limits cannot be placed on the EU market. Compliance with REACH Annex 17 is non-negotiable and applies to both EU-manufactured goods and imports.

What Is REACH Annex XIV (The Authorization List)

REACH Annex XIV, commonly called the REACH Authorization List, identifies Substances of Very High Concern (SVHC) that require explicit authorization before use or market placement after specified "sunset dates".

As of 2023, REACH Annex XIV includes 59+ substances selected from the broader SVHC list (Candidate List) based on their severe health and environmental risks.

These include:

Carcinogenic, mutagenic, or reprotoxic substances (CMR categories 1A/1B)
Persistent, bioaccumulative, and toxic (PBT) chemicals
Very persistent and very bioaccumulative (vPvB) substances
Endocrine-disrupting chemicals
Substances with equivalent levels of concern

Key Authorization Requirements:

Latest Application Date (LAD): Deadline to submit authorization applications, typically 18 months before the sunset date
Sunset Date: Final date after which the substance cannot be used or marketed without granted authorization
Use-Specific Approvals: Each intended use requires separate authorization demonstrating adequate risk control or socioeconomic benefits outweighing risks
Ongoing Review: Authorizations may include review periods requiring reapplication

Companies can continue using REACH Annex XIV substances during the authorization assessment period if applications were submitted before the LAD.

What Are Substances of Very High Concern (SVHC)?

The SVHC Candidate List, contains substances of very high concern identified for potential inclusion in REACH Annex XIV. This list serves as an early warning system - substances may eventually move from the Candidate List to REACH Annex XIV, triggering authorization requirements.

What Qualifies as Substances of Very High Concern?

According to REACH Article 57, Substances of Very High Concern (SVHC) meet one or more criteria:

Category 1A or 1B carcinogens, mutagens, or reproductive toxins
PBT (persistent, bioaccumulative, toxic) properties
vPvB (very persistent, very bioaccumulative) characteristics
Equivalent concerns such as endocrine disruption, neurotoxicity, or respiratory sensitization

Obligations When Substances Join the SVHC List:

When Substances of Very High Concern are added to the list, companies must immediately:

Notify ECHA if substances are present in articles above 0.1% w/w and total over 1 tonne/year
Provide sufficient information to customers and consumers for safe use
Respond to consumer SVHC inquiries within 45 days
Include SVHC information in Safety Data Sheets (SDS)
Monitor the SVHC list for updates (typically biannual)

Benefits of Using CDX

CDX simplifies and streamlines regulatory compliance across industries by offering a powerful platform for material data management. It ensures compliance with global regulations, enhances supply chain transparency, and reduces operational risk.

Comprehensive Regulatory Compliance Across Multiple Industries

CDX supports compliance with major global regulations like REACH, RoHS, SCIP, PFAS, California Proposition 65, EU POPs, TSCA, EU Battery Regulation (2023/1542), and more.
CDX includes substance lists like AD-DSL, HEDSL, GADSL, RISL, and the IAEG PFAS List, ensuring industry-specific compliance coverage.

Simplified Supply Chain Communication

Built-in workflows and multilingual communication tools enable seamless data exchange between suppliers and customers.
Free for suppliers to respond to material data requests, improving data accuracy and response rates.
CDX enables multi-tier data requests and traceability, reducing manual follow-ups and ensuring a smoother compliance process.

Automated Data Collection and Reusability

CDX allows for data reuse by linking material declarations (MDS) and supplier inputs across multiple products and customers.
It includes tools to import/export standardized data (e.g., IPC-1752A, IPC-1754), minimizing duplication and saving time.

SCIP Database Integration

CDX automates the creation and submission of SCIP dossiers, ensuring compliance with EU Waste Framework Directive requirements.
It supports ECHA´s API for direct uploads and manages required data such as substance of concern, article identifiers, and material categories.

Risk Mitigation

Helps prevent product recalls by ensuring accurate tracking of hazardous and restricted substances throughout the product lifecycle.
Supports early detection of non-compliant materials, reducing regulatory exposure and costly late-stage design changes.

Security & Data Protection

Adheres to high security standards such as ISO certifications and Oracle-powered cloud infrastructure.
Ensures secure data storage, controlled access, and compliance with global data protection regulations.

Learn more about Security & Data Protection

Easy Integration with Existing Systems

Offers APIs and web services for smooth connection to ERP, PLM, and other enterprise systems.
Compatible with multiple data formats including IPC, IEC, and IMDS, reducing technical friction.

Learn more about integration

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What Are the Best Practices for REACH Compliance?

1. Collect Full Material Disclosure from the Start

Rather than asking suppliers whether they use specific substance, collecting complete material composition data upfront provides a significant strategic advantage. When Full Material Disclosure (FMD) covers all substances in products, organizations can simply check existing data against new requirements each time the SVHC list updates or REACH Annex XVII adds new restrictions - eliminating the need to contact suppliers repeatedly.

This proactive approach delivers:

Elimination of emergency supplier outreach when regulations change
Faster response times to customer REACH declaration requests
Immediate assessment of how new Substances of Very High Concern SVHC affect product portfolios
Reduced supply chain disruption and compliance delays
Lower costs through elimination of repetitive data collection cycles

CDX's platform supports Full Material Disclosure strategies. Once suppliers provide comprehensive composition data, CDX provide functionalities to assess it against the SVHC Candidate list, REACH Annex XIV, and REACH Annex XVII.

2. Establish Clear Internal Processes

Define roles and responsibilities for REACH declaration preparation and approval
Create standardized templates aligned with REACH requirements
Implement review cycles synchronized with SVHC list update schedules (typically June and December)

3. Maintain Current Information

Update REACH declarations whenever the Substances of Very High Concern SVHC list changes
Review declarations when product formulations or suppliers change
Verify that REACH Annex XVII and REACH Annex XIV references reflect current regulations

4. Leverage Technology Strategically

Utilize CDX to automate REACH declaration creation
Use Where-Used Analysis functionality to identify substances across product portfolios
Subscribe CDX’s newsletter to stay up to date with the regulatory changes

5. Invest in Training

Ensure procurement understands supplier requirements for REACH and RoHS compliance
Educate product development teams about REACH Annex 17 restrictions during design phases
Train appropriate teams to handle REACH declaration requests appropriately

6. Document Everything

Maintain audit trails demonstrating how REACH requirements compliance was determined
Store supplier declarations and test reports supporting REACH declarations
Archive historical declarations to demonstrate continuous REACH regulatory compliance

Explore the Regulatory Landscape

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