By Abhishek ShettyPublished: 3 min read

Table of Contents

REACH is the European Union's framework for the Registration, Evaluation, Authorisation and Restriction of Chemicals.

Its central objective is to protect human health and the environment by improving the identification, management and control of chemical substances.

REACH places significant responsibility on businesses to understand the substances they manufacture, import, use or place on the EU market.

One of its fundamental principles is often described as:

No data, no market.

Where applicable, companies must generate or obtain sufficient information about substances and fulfil the relevant REACH obligations before placing them on the EU market.

REACH is therefore broader than a product-specific chemical restriction.

It can affect:

  • Chemical manufacturers
  • Chemical importers
  • Downstream users
  • Importers of articles
  • Manufacturers of articles
  • Distributors
  • Non-EU companies supplying the European market

The exact obligations depend on the company's role, the substance, the quantity, the use and whether the substance is present within an article, mixture or substance.

Who Does REACH Apply To?

REACH can affect companies both inside and outside the EU.

A non-EU manufacturer may still be commercially affected by REACH when its products are imported into the EU.

The specific legal responsibility depends on the supply-chain role.

Manufacturers of substances

Companies manufacturing chemical substances in the EU may have registration obligations depending on the substance and applicable tonnage thresholds.

Importers

EU importers may have obligations for substances and mixtures they import and, in certain circumstances, articles containing substances.

Downstream users

Companies using chemicals in industrial or professional processes may need to ensure that their uses are covered and that relevant information and risk-management requirements are met.

Manufacturers and importers of articles

Companies placing articles on the EU market need to assess whether substances within those articles create specific REACH obligations.

Non-EU manufacturers

Non-EU manufacturers supplying the EU may need to work with EU importers or an appointed Only Representative depending on their circumstances.

Because the obligations differ by role, a REACH assessment should begin by identifying what your company does in the supply chain.

What Does REACH Regulate?

REACH applies to chemical substances, including substances used in:

  • Substances
  • Mixtures
  • Materials
  • Components
  • Finished articles

This is particularly important for manufacturers because a product may contain regulated substances even when the finished product itself is not normally thought of as a "chemical."

For example, substances can be present in:

  • Plastics
  • Coatings
  • Adhesives
  • Metals
  • Electronics
  • Cables
  • Textiles
  • Furniture
  • Automotive components
  • Consumer products

The compliance question is therefore not simply:

"Does my product contain chemicals?"

Virtually every manufactured product involves chemical substances.

The relevant question is:

Which substances are present, at what concentrations, in what form, and what REACH obligations apply to them?

The Core REACH Obligations

REACH combines several regulatory mechanisms rather than relying on a single compliance requirement.

Registration

Registration generally applies to manufacturers and importers of substances above applicable tonnage thresholds, subject to the regulation's conditions and exemptions.

Registration requires companies to provide information about substances, including relevant hazard and use information.

The principle is straightforward:

Identify the substance → understand its hazards and uses → provide the required information → maintain the registration where applicable.

Evaluation

ECHA and Member State authorities evaluate information submitted under REACH.

Evaluation helps determine whether additional information is needed or whether regulatory action may be appropriate.

Businesses therefore need to maintain accurate and sufficiently supported substance information rather than treating registration as the end of compliance.

Authorisation

Certain substances of very high concern may ultimately be included in Annex XIV, the Authorisation List.

Once an applicable Sunset Date has passed, use or placing on the market may require an authorisation unless an applicable exemption or other legal basis applies.

For the detailed process, see REACH Annex XIV: Authorisation Process Explained.

Restriction

REACH can also restrict the manufacture, placing on the market or use of particular substances.

These restrictions are contained in Annex XVII and can take the form of:

  • Concentration limits
  • Prohibited uses
  • Conditions of use
  • Emission limits
  • Other specific restrictions

See EU REACH Annex XVII: Understanding the Restriction List for the detailed restriction framework.

Understanding the REACH Regulatory Framework

A useful way to understand REACH is to think of it as several connected mechanisms.

Registration

→ Generate and submit substance information where required

Evaluation

→ Authorities assess the information and potential risks

Candidate List

→ Identifies substances of very high concern and can trigger immediate communication obligations

Annex XIV

→ Controls specified uses through authorisation

Annex XVII

→ Imposes specific restrictions on substances and uses

These mechanisms are related, but they are not interchangeable.

A substance being on the Candidate List does not automatically mean that it is prohibited.

Likewise, a substance can be subject to an Annex XVII restriction without being on the Candidate List.

The Three Key REACH Lists

Three lists are particularly important for product compliance teams.

Candidate List — SVHCs

The Candidate List contains Substances of Very High Concern (SVHCs).

When a substance is added, companies may have immediate information and communication obligations even though the substance has not necessarily been prohibited.

The Candidate List is updated periodically, so companies need a process for monitoring additions and reassessing affected products.

For a detailed explanation of the Candidate, Authorisation and Restriction lists, see REACH Lists Explained: Candidate vs Authorisation vs Restriction.

Annex XIV — Authorisation List

Annex XIV identifies substances for which specific uses may require authorisation after the applicable Sunset Date.

Companies using an Annex XIV substance should therefore track:

  • Substance identity
  • Authorised use
  • Latest Application Date
  • Sunset Date
  • Existing authorisation
  • Substitution options

The detailed authorisation process belongs in the Annex XIV authorisation guide.

Annex XVII — Restriction List

Annex XVII establishes restrictions that can apply to specific substances, products or uses.

Compliance teams need to consider both the substance and the specific restriction conditions.

A generic statement that a substance is "REACH compliant" may therefore be insufficient where a specific Annex XVII restriction applies.

See the dedicated Annex XVII restriction guide.

REACH Obligations for Articles

This is one of the most important areas for manufacturers of finished products.

An article may contain substances that trigger specific REACH obligations even when the company does not manufacture the substance itself.

Article 33

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

The information needs to be sufficient to allow safe use and must include the substance name at minimum.

Consumer requests also have specific response requirements.

Because Article 33 has detailed operational requirements, it should be handled through a dedicated compliance process rather than buried inside a general REACH assessment.

Article 7(2)

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

The applicability depends on factors including:

  • SVHC concentration
  • Total annual quantity
  • Registration status
  • Exposure considerations
  • The company's role

This is why identifying SVHC presence is only the first step.

The compliance team must then determine which obligations the identified substance actually triggers.

SCIP

SCIP reporting is related to SVHC-containing articles but arises under the EU Waste Framework Directive, not REACH itself.

Companies placing qualifying articles on the EU market may need to submit information to the SCIP database.

Regilient's existing SCIP Database Submissions guide covers the reporting requirement in greater detail.

For the distinction between the two frameworks, see SCIP vs REACH: Key Compliance Differences and Reporting Duties.

How to Build a REACH Compliance Process

A practical REACH compliance programme should connect regulatory requirements with actual product and supply-chain data.

Step 1: Identify your role

Determine whether your organisation is acting as:

  • Manufacturer
  • Importer
  • Downstream user
  • Article manufacturer
  • Article importer
  • Distributor
  • Non-EU supplier

Step 2: Identify products and substances

Map the products, articles, mixtures, materials and substances relevant to your business.

Step 3: Collect supplier information

Obtain appropriate information from suppliers, such as:

  • Material declarations
  • Substance information
  • SVHC declarations
  • SDS where applicable
  • Supporting test information
  • Regulatory declarations

Step 4: Screen against applicable requirements

Screen relevant substance and product information against:

  • Candidate List
  • Annex XIV
  • Annex XVII
  • Other applicable REACH requirements

Step 5: Determine obligations

Do not stop at identifying a substance.

Determine whether it triggers:

  • Registration
  • Communication
  • Notification
  • Authorisation
  • Restriction controls
  • SCIP reporting
  • Other applicable requirements

Step 6: Document the assessment

Maintain evidence showing:

Product → article/component → substance → supplier evidence → regulatory requirement → compliance decision

Step 7: Monitor changes

REACH compliance is continuous.

When ECHA adds an SVHC or a new restriction becomes applicable, affected products and materials may need to be reassessed.

Managing REACH Across the Supply Chain

For manufacturers, one of the biggest REACH challenges is not understanding the regulation itself.

It is obtaining reliable and current substance information from suppliers.

A practical supply-chain programme should:

  • Identify relevant suppliers
  • Standardise information requests
  • Collect material and substance data
  • Validate supplier responses
  • Track missing information
  • Record evidence against components/articles
  • Monitor supplier and material changes
  • Re-screen affected products when requirements change

Regilient's existing REACH Supply Chain Compliance guide covers this operational process in greater detail.

The pillar should therefore explain why supply-chain information matters, while the cluster owns the detailed supplier-management process.

Monitoring REACH Regulatory Changes

REACH is continuously evolving.

The Candidate List can change.

Annex XIV can change.

Annex XVII can change.

New restrictions can introduce new concentration limits, conditions or compliance dates.

That means a product that was assessed previously may require reassessment when its regulatory context changes.

A strong monitoring process should answer:

What changed?

Which substances are affected?

Which products contain them?

Which obligations changed?

What action is required?

Regilient already publishes dedicated regulatory-update content, including REACH Candidate List updates and REACH regulatory-change coverage.

These update articles should support the pillar rather than compete with its evergreen intent.

REACH Documentation and Evidence

A defensible REACH programme should maintain evidence supporting its compliance decisions.

Depending on the organisation's role and obligations, this may include:

  • Supplier declarations
  • Material information
  • Safety Data Sheets
  • Substance information
  • Test reports
  • Registration information
  • Article assessments
  • SVHC assessments
  • Article 33 communications
  • SCIP information
  • Authorisation records
  • Restriction assessments
  • Internal compliance decisions

The objective is not simply to store documents.

It is to maintain a traceable relationship between the evidence and the regulatory decision it supports.

For example:

Product

→ Component/article

→ Material

→ Substance

→ SVHC status

→ Applicable obligation

→ Compliance evidence

This becomes particularly important when products contain large numbers of components or when supplier data changes frequently.

Common REACH Compliance Challenges

Relying on outdated supplier declarations

A declaration collected several years ago may not reflect the current Candidate List or current material composition.

Treating "REACH compliant" as a sufficient answer

A generic declaration does not necessarily explain which substances were assessed, which version of the regulatory lists was used or which obligations apply.

Screening only against the Candidate List

REACH compliance also requires consideration of applicable authorisations and restrictions.

Treating SCIP as the same as REACH

SCIP and REACH interact but are based on different legal frameworks and serve different purposes.

Losing article-level traceability

For complex products, compliance teams need to know where substances occur and which specific articles are affected.

Treating compliance as a one-time activity

New Candidate List entries and regulatory restrictions can change the compliance status of existing products.

REACH Compliance Checklist

Use this as a high-level starting point:

How Regilient Supports REACH Compliance

REACH compliance becomes difficult when regulatory requirements, BOMs, supplier declarations and substance data are managed separately.

Regilient brings these activities into a structured compliance workflow so teams can:

  • Screen products and BOMs against REACH requirements
  • Collect and validate supplier information
  • Track SVHC-related obligations
  • Monitor regulatory changes
  • Manage Article 33 workflows
  • Support SCIP reporting
  • Track Annex XIV dates
  • Monitor Annex XVII restrictions
  • Maintain compliance evidence and traceability

Explore Regilient's REACH Compliance capabilities

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REACHEuropean Union Regulations

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What is REACH Compliance & How is it enforced ?

What is EU REACH and who does it apply to?
REACH stands for Registration, Evaluation, Authorisation and Restriction of Chemicals. It is the EU regulation governing chemical safety, in force since June 2007, and enforced by the European Chemicals Agency (ECHA). It applies to any business that manufactures, imports, or sells products in the EU that contain chemicals including finished goods. The burden of proof sits with the business: if you cannot demonstrate safety, you cannot sell.
What are the three key REACH lists and what does each require?
Candidate List (SVHCs): Substances under evaluation for their effects on health and the environment. Triggers Article 33 disclosure, SCIP notification, and potential Article 7(2) notification immediately on inclusion. Currently 250 entries as of June 2025 Annex XIV (Authorisation List): SVHCs with serious effects that require explicit authorisation before use or placement on the market after the Sunset Date. Each entry carries a Latest Application Date and a Sunset Date Annex XVII (Restriction List): Binding restrictions on manufacture, use, or placement on the market content limits, use bans, and emissions thresholds that apply regardless of whether a substance is an SVHC
When must a substance be registered with ECHA under REACH?
Registration is required when a substance is manufactured in or imported into the EU at one tonne or more per year. The registration follows a "one substance, one registration" principle, meaning manufacturers of the same substance must submit jointly under a lead registrant structure. No registration number means no compliant market access. The number must be maintained and kept audit-ready at all times.
What is the difference between REACH compliance for article manufacturers vs substance manufacturers?
The obligations differ significantly based on what you are placing on the EU market. Substance manufacturers must register with ECHA above the one-tonne threshold, maintain a chemical safety report, and update their dossier when substance volume, use, or hazard data changes. Article manufacturers must screen their products against the Candidate List, issue Article 33 disclosures when SVHCs exceed 0.1% w/w, submit SCIP notifications, and notify ECHA under Article 7(2) where the tonnage threshold is met. Many manufacturers fall into both categories simultaneously when they both produce substances and incorporate them into finished goods.
What are the ongoing REACH compliance obligations manufacturers must maintain?
Track the REACH Candidate List after every ECHA update, typically twice per year, and re-screen the full product portfolio against each new version Respond to Article 33 consumer and customer requests within 45 days, with the substance name and safe use information provided free of charge Update registration dossiers if substance volume, use case, or hazard classification changes Maintain SCIP submissions for all articles containing SVHCs above 0.1% w/w Monitor Annex XIV sunset dates and Annex XVII applicability dates for any restrictions affecting materials or processes in use
How does Regilient help manufacturers manage REACH compliance?
Regilient's agentic sustainability platform automates the full REACH compliance workflow: Real-time BOM screening against the live Candidate List with automated alerts on each ECHA update Article 33 disclosure workflows with 45-day SLA tracking and templated substance-named responses SCIP dossier preparation integrated directly from screening outputs Article 7(2) eligibility checks triggered automatically when new SVHC additions affect products above tonnage thresholds Annex XIV sunset date and Annex XVII applicability date monitoring with supplier and engineering team alerts Supplier outreach and data validation workflows that replace manual spreadsheet-based management
Who needs to comply with REACH?
REACH can apply to EU manufacturers, importers, downstream users and other supply-chain actors, as well as non-EU companies whose products or substances enter the EU market. The exact obligations depend on the company's role and circumstances.
How do manufacturers manage REACH compliance across large product portfolios?
They typically need structured product, BOM, material, substance and supplier data so they can identify affected products when substances or regulatory requirements change.
Does a supplier declaration prove REACH compliance?
Not necessarily. A supplier declaration can be an important piece of evidence, but companies should assess whether it is current, sufficiently specific and applicable to the relevant product, article or substance.