REACH Annex XVII contains restrictions on the manufacture, placing on the market and use of certain substances, mixtures and articles in the European Union. Each restriction entry specifies the substance or substance group covered and the conditions that apply.

For a company, the key question is not simply:

“Is this substance on Annex XVII?”

It is:

“Does the specific Annex XVII restriction apply to my substance, product, concentration or use—and can I demonstrate compliance?”

That distinction matters because Annex XVII restrictions can include concentration limits, use restrictions, conditions of supply or placing on the market, and exemptions.

If you need the broader REACH framework first, start with our REACH compliance guide.

What Is REACH Annex XVII?

Annex XVII is the REACH Restriction List.

Unlike the REACH Restriction Roadmap, which concerns substances being considered for possible future action, Annex XVII contains restrictions that have already been adopted into the REACH regulatory framework.

Restriction Roadmap → potential future action

Annex XVII → legally established restrictions

You can read about the earlier stage in our REACH Restriction Roadmap guide.

Annex XVII restrictions can apply to substances:

• On their own
• In mixtures
• In articles

The exact legal requirements depend on the individual entry.

How Do Annex XVII Restrictions Work?

There is no single compliance rule that applies to every Annex XVII substance.

Each entry needs to be assessed individually.

An entry can specify:

• A maximum concentration
• A prohibition on particular uses
• Conditions for placing a substance or product on the market
• Restrictions on manufacture or use
• Migration or release limits
• Specific exemptions
• Transitional periods
• Conditions that must be satisfied for an exemption to apply

For example, the formaldehyde restriction in Entry 77 establishes maximum formaldehyde release levels for certain articles and includes specific exemptions and application dates.

This is why simply maintaining a list of restricted chemical names is not enough.

The restriction conditions must be evaluated against the actual product and use.

How Do You Check Whether a Product Is Affected?

A practical Annex XVII assessment should follow this sequence:

1. Identify the substance

Start with reliable substance identifiers such as:

• CAS number
• EC number
• Substance name
• Relevant substance group

Do not rely solely on a supplier's generic statement that a product is “REACH compliant.”

2. Find the applicable Annex XVII entry

ECHA's restricted-substances database provides the Annex XVII entries and their corresponding restriction conditions.

3. Check the exact conditions

Look beyond the substance name.

Ask:

• What concentration threshold applies?
• Does the restriction apply to articles, mixtures or substances?
• Is a particular use prohibited?
• Are there exemptions?
• Is there a transition period?
• Is a testing or measurement method specified?

4. Compare those requirements with your product

This is where product-level compliance data becomes important.

You need to establish:

Substance → Material → Component → Product → Intended use

If you have thousands of components, BOM-level screening can help identify where restricted substances may occur. See our REACH SVHC screening tools guide for the broader substance-screening workflow.

Concentration Limits Are Not the Only Consideration

One common mistake is assuming that Annex XVII compliance simply means checking whether a substance is below a percentage threshold.

That is not always sufficient.

A restriction may depend on:

• Concentration
• Release or migration
• Intended use
• Product category
• Consumer exposure
• Worker exposure
• Date of application
• Exemptions
• Specific technical conditions

For example, the formaldehyde Entry 77 restriction uses release limits expressed in mg/m³, rather than simply a percentage concentration in the finished article.

Therefore, the correct question is:

“What does this specific Annex XVII entry require?”

—not simply:

“How much of the substance is in the product?”

How Should Companies Manage Supplier Data?

Supplier information is often the starting point for an Annex XVII assessment, but a generic declaration may not provide enough evidence.

For affected materials and components, companies should establish:

• Substance identity
• Material/component affected
• Relevant concentration or measurement information
• Applicable restriction entry
• Supplier
• Declaration date
• Evidence supporting the declaration
• Version/history of the assessment

Where supplier declarations concern SVHC content or broader REACH status, our guide to validating REACH supplier declarations provides the supporting workflow.

The important principle is traceability.

You should be able to move from:

Regulatory requirement → substance → component/material → product → supplier evidence

without relying on an unsupported “compliant” statement.

What Happens When Annex XVII Is Updated?

Annex XVII is not a static compliance list.

New restrictions and amendments can change:

• Applicable substances
• Concentration limits
• Product scope
• Exemptions
• Compliance dates
• Transitional arrangements

ECHA maintains the restricted-substances information, while subsequent amendments are incorporated through the relevant Commission regulations.

This means companies should not perform an Annex XVII assessment once and consider the job finished.

A better process is:

Monitor → identify change → determine affected products → reassess → collect evidence → implement action

Example: A New Annex XVII Restriction

Consider a substance that is already present in your products.

A regulatory update may introduce a new restriction with:

• A concentration threshold
• A defined application date
• Specific product categories
• Exemptions
• Transitional provisions

Your compliance team therefore needs to determine:

1. Do we use the substance?
2. Which products contain it?
3. Are those products within the restriction's scope?
4. Does our concentration exceed the threshold?
5. Does our use fall within a restricted use?
6. Does an exemption apply?
7. When does compliance become mandatory?
8. What evidence do we need?
9. Do we need supplier or engineering action?

This is the difference between regulatory monitoring and actual product compliance management.

Annex XVII Compliance Checklist

Use this checklist whenever assessing a potentially affected product:

• ☐ Identify the substance using a reliable identifier
• ☐ Locate the relevant Annex XVII entry
• ☐ Read the complete restriction conditions
• ☐ Check concentration or release limits
• ☐ Check the intended use
• ☐ Check product/article/mixture scope
• ☐ Check exemptions
• ☐ Check application and transition dates
• ☐ Map the substance to affected materials and components
• ☐ Validate supplier information
• ☐ Determine whether testing or additional evidence is required
• ☐ Record the compliance decision
• ☐ Monitor subsequent Annex XVII amendments

What Evidence Should You Keep?

For audit readiness, retain evidence showing how the compliance decision was reached.

Depending on the restriction, this may include:

• Supplier declarations
• SDS information
• Full Material Declarations
• Material composition data
• Test reports
• Product/component records
• Applicable Annex XVII entry
• Regulatory assessment
• Exemption justification
• Historical versions
• Corrective-action records

The evidence should be traceable to the relevant product or component—not simply stored as an unrelated collection of supplier documents.

What Happens If a Product Does Not Meet Annex XVII?

Non-compliance can create regulatory and commercial consequences, including enforcement action and potential disruption to market access.

EU Member States are responsible for enforcement, while ECHA provides the regulatory information and coordination framework.

The appropriate response depends on the specific restriction and jurisdiction.

If your assessment identifies non-compliance, the company should determine whether it needs to:

• Stop or modify the affected use
• Change the material
• Reformulate
• Replace a component
• Obtain additional evidence
• Apply a valid exemption
• Address supplier data gaps
• Correct products already placed on the market

Annex XVII vs Annex XIV

These two REACH mechanisms should not be confused.

For the authorisation side of REACH, see our REACH Annex XIV guide.

Manage Annex XVII Compliance Continuously

Annex XVII compliance is not simply a matter of maintaining a restricted-substance list.

Companies need to connect regulatory requirements with substances, materials, components, products, suppliers and evidence.

Regilient helps compliance teams monitor regulatory changes, assess product exposure, manage supplier information and maintain traceable compliance evidence.

Request a Demo →