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?

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 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?

Company Information

  • Manufacturer or supplier name, address, and contact details
  • Role in the supply chain (manufacturer, importer, downstream user, distributor)

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 contains 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 the 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 mandatory 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 more than 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)

What Are the Best Practices for REACH Compliance?


1. Collect Full Material Disclosure from the Start

Rather than asking suppliers whether they use specific substances, 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 provides 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 to 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 effectively
     

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

Simplify REACH Compliance with CDX

CDX supports efficient REACH compliance by enabling structured supplier engagement, standardized material data collection as well as integrated Where-Used and threshold analysis tools.

The platform consolidates Full Material Declarations (FMDs), substance-level data, and compliance documents into one transparent system, giving companies clear visibility across their supply chain.

With continuously maintained and up-to-date regulatory substance lists, including the SVHC Candidate List, Annex XIV, and Annex XVII, CDX allows organizations to assess regulatory changes quickly and confidently.

Explore the CDX REACH Solution