When a new Substance of Very High Concern (SVHC) is added to the REACH Candidate List, manufacturers and suppliers need to determine whether the change affects their products, articles, materials or customers.

The important point is that Candidate List inclusion does not automatically mean a substance is banned.

Instead, inclusion can trigger specific information, communication and notification obligations, depending on how the substance is used and where it is present in the supply chain.

For manufacturers, the practical question is therefore not simply:

"Was a new SVHC added to the REACH Candidate List?"

It is:

"Which of our products and articles are affected, what obligations does the change trigger, and what evidence do we need to update?"

This article explains what to do when the Candidate List changes and how to turn a regulatory update into an actionable product-level compliance assessment.

What Is the REACH Candidate List?

The REACH Candidate List contains substances identified as Substances of Very High Concern (SVHCs) because they meet specified hazard criteria under REACH.

Candidate List inclusion is an important regulatory milestone.

It can create immediate obligations for companies that manufacture, import, supply or use products containing the listed substance.

It can also lead to further regulatory action in the future, including possible inclusion in Annex XIV, although Candidate List inclusion itself does not mean the substance is prohibited.

For the broader explanation of how the Candidate List relates to Annex XIV and Annex XVII, see Regilient's REACH Lists Explained: Candidate vs Authorisation vs Restriction.

What Changes When a New SVHC Is Added?

A Candidate List update can affect products that were previously assessed as compliant.

This is because your existing product assessment may have been based on an earlier version of the Candidate List.

For example:

Product assessed in January

→ Candidate List version A

→ No relevant SVHC identified

Candidate List updated in June

→ New SVHC added

→ Existing material may now require reassessment

The physical product may not have changed.

The supplier may not have changed.

The BOM may not have changed.

The regulatory requirement has changed.

That is why REACH compliance needs to be treated as an ongoing monitoring process rather than a one-time declaration.

What Manufacturers Should Do After a Candidate List Update

A practical response can be divided into seven steps.

1. How to Identify what changed

Start with the regulatory update itself.

Record:

• Newly added substance
• Substance name
• CAS number, where available
• EC number
• Reason for SVHC classification
• Date of Candidate List inclusion
• Applicable regulatory source/version

Do not immediately contact every supplier without first understanding what changed.

The first task is to create a precise regulatory change record.

2. How to Determine Whether the Substance Is Relevant to Your Products

Next, determine whether the newly listed SVHC could occur in your products.

This requires more than searching finished-product names.

The substance may be present in:

• Raw materials
• Components
• Subassemblies
• Coatings
• Adhesives
• Plastics
• Metals
• Electronic components
• Cables
• Textiles
• Other articles incorporated into the finished product

For complex products, the assessment therefore needs to move through the product structure.

A useful traceability model is:

Candidate List substance

↓

Material

↓

Component / article

↓

BOM

↓

Finished product

This is one reason supplier and material data are so important to REACH compliance.

3. How to Screen Your Existing Substance and Material Data

Once the newly listed SVHC has been identified, screen your existing substance information.

The objective is to determine:

Do any of our products contain this substance?

Useful data sources may include:

• Full Material Declarations
• Material declarations
• Supplier substance data
• Safety Data Sheets where relevant
• Test reports
• Product specifications
• Previous REACH assessments
• Internal material databases

However, a database search is only as reliable as the underlying data.

If a supplier declaration says only:

"REACH compliant"

that may not tell you whether the newly added SVHC was specifically assessed.

This is where current, substance-specific supplier evidence becomes important.

For detailed guidance on validating supplier declarations, REACH SVHC supplier declaration validation article.

4. How to Identify the Affected Articles and Components

Finding the substance is not enough.

You need to identify where it occurs.

For manufacturers of complex products, this means mapping the substance back to the relevant article or component.

For example:

This product-level mapping is what turns regulatory information into an actionable compliance decision.

5. How to Assess the Applicable REACH Obligations

Once affected articles have been identified, determine what obligations apply.

This is where companies often make a mistake.

Candidate List inclusion does not automatically mean the product must be removed from the market.

Instead, determine which obligations are triggered by the specific circumstances.

For articles, this may include:

Article 33 communication

Where an article contains a Candidate List SVHC above the applicable threshold, companies may have communication obligations to recipients and, under the applicable conditions, consumers.

Article 7(2) notification

In certain circumstances, producers or importers of articles containing Candidate List SVHCs may have notification obligations to ECHA.

SCIP

Qualifying articles containing Candidate List SVHCs may also trigger SCIP obligations under the EU Waste Framework Directive.

SCIP is not itself a REACH requirement, although the underlying SVHC information can be relevant to both processes.

For the detailed SCIP process, use Regilient's SCIP Database Submissions guide.

6. How to Update Your Compliance Evidence

Once the assessment is complete, update the evidence supporting your compliance decision.

A useful record should connect:

Regulatory change

→ Substance

→ Supplier/material evidence

→ Affected component

→ Affected product

→ Applicable obligation

→ Action taken

For example:

Candidate List update → SVHC X → supplier declaration → component ABC → products 123/124 → Article 33 applicable → customer communication updated.

This creates a traceable compliance record instead of simply storing a copy of the Candidate List update.

7. How to Monitor What Happens Next

Candidate List inclusion should trigger ongoing monitoring.

The substance may subsequently be considered for additional regulatory measures.

The company should therefore track:

• Candidate List status
• Annex XIV developments
• Applicable restrictions
• Changes in supplier information
• Changes in material composition
• Product changes
• Regulatory deadlines

This is particularly important for products with long lifecycles.

A compliance assessment completed today may not remain sufficient indefinitely.

What If Your Supplier Says "We Are REACH Compliant"?

A generic supplier declaration should not automatically close the assessment.

Ask:

• Which Candidate List version was assessed?
• When was the assessment performed?
• Which materials/components were covered?
• Was the newly added SVHC specifically assessed?
• What evidence supports the declaration?
• Has the material composition changed?
• Does the declaration cover the specific article supplied?

A supplier declaration is useful evidence, but its relevance depends on its scope, date and supporting information.

If the declaration predates the Candidate List update, it may need to be refreshed.

This is particularly important when a new SVHC has just been added.

How the 0.1% Threshold Fits Into the Assessment

For articles containing Candidate List SVHCs, the 0.1% weight-by-weight threshold is an important part of determining certain communication and notification obligations.

However, manufacturers should not treat "0.1%" as a simple finished-product percentage.

For complex products, the relevant assessment can require consideration at the level of the individual article.

That means a complex product containing many components should not simply be assessed by averaging the substance concentration across the entire finished product.

Instead, the compliance team needs sufficient material and article-level information to determine where the SVHC occurs and whether the applicable threshold is reached.

This is one reason why BOM and material traceability matter to REACH compliance.

What If You Cannot Get the Information From Your Supplier?

This is a common operational problem.

If the newly listed SVHC cannot be ruled out based on available information, document the information gap rather than treating it as automatically compliant.

A practical escalation process can include:

1. Send a targeted supplier request.
2. Identify the exact SVHC and regulatory change.
3. Request confirmation against the updated Candidate List.
4. Ask for supporting material/substance information where necessary.
5. Escalate unanswered requests.
6. Record the supplier response or non-response.
7. Assess the remaining compliance risk.
8. Determine whether additional evidence or testing is necessary.

The objective is to replace assumptions with evidence.

How Often Should Products Be Re-Screened for REACH?

There is no universal "once per year" answer that makes every REACH programme compliant.

The appropriate monitoring frequency depends on factors such as:

• Regulatory change frequency
• Product lifecycle
• Material complexity
• Supplier changes
• Component changes
• Risk profile
• Regulatory exposure
• Importance of the product market

However, regulatory updates should trigger event-based reassessment.

For example:

New Candidate List substance added

→ Identify potentially affected materials

→ Screen relevant products

→ Reassess applicable obligations

→ Update evidence

This is more effective than waiting for the next scheduled annual review.

Candidate List Update vs Product Change

REACH reassessment can be triggered from either direction.

Regulatory change

Candidate List changes

→ Existing products may need reassessment.

Product change

Material/component changes

→ Existing REACH assessment may need reassessment.

This means a mature compliance programme should monitor both:

Regulatory changes

and

Product/supplier changes.

A Practical REACH Candidate List Change Workflow

Use this workflow whenever a new SVHC is added:

STEP 1

Monitor

Identify the Candidate List change.

↓

STEP 2

Identify

Record the substance and regulatory details.

↓

STEP 3

Screen

Search existing material and substance data.

↓

STEP 4

Trace

Map the substance to components, articles and products.

↓

STEP 5

Assess

Determine applicable REACH obligations.

↓

STEP 6

Verify

Obtain updated supplier evidence where necessary.

↓

STEP 7

Act

Update communications, notifications or reporting where required.

↓

STEP 8

Document

Record the assessment and supporting evidence.

↓

STEP 9

Monitor

Track future regulatory and product changes.

REACH Candidate List Change Checklist

When a new SVHC is added, ask:

• Have we recorded the new Candidate List substance?
  
• Have we identified its CAS/EC number where applicable?
  
• Have we compared it against our substance/material database?
  
• Have we identified potentially affected suppliers?
  
• Have we mapped affected materials to components/articles?
  
• Have we identified affected finished products?
  
• Have we assessed the applicable concentration threshold?
  
• Have we assessed Article 33 obligations?
  
• Have we assessed Article 7(2) applicability?
  
• Have we assessed SCIP applicability?
  
• Have we checked whether additional regulatory controls may become relevant?
  
• Have we refreshed outdated supplier evidence?
  
• Have we documented the assessment?
  
• Have we communicated required information?
  
• Have we updated the product compliance record?
  
• Have we established ongoing monitoring?
  

How Regilient Can Help

Managing Candidate List changes manually becomes difficult when a company has thousands of components, materials and supplier declarations.

Regilient can help compliance teams connect regulatory requirements with product and supplier information so that a regulatory change can be translated into an actionable product-level assessment.

This can help teams:

• Monitor applicable regulatory requirements
• Screen product and BOM data
• Collect supplier declarations
• Track supplier responses
• Identify affected components and products
• Maintain compliance evidence
• Support ongoing reassessment

Explore Regilient's REACH compliance capabilities