Correctly determining whether a product is an article, substance or mixture is one of the first steps toward EU REACH compliance.
The classification affects registration, safety-data-sheet, SVHC communication, SCIP notification and restriction obligations. It can also determine how substances are evaluated within an assembled product.
The ECHA Catalogue of Borderline Cases helps companies assess products whose function depends on a combination of physical design and chemical composition. However, the catalogue is guidance: Regulation (EC) No 1907/2006—REACH remains the legally binding reference.
An object is generally an article when its shape, surface or design determines its function more than its chemical composition.
When the object’s function depends principally on its chemical composition, it is generally a substance or mixture.
Some products combine both categories. For example, a printer cartridge can include article components that contain an ink or toner mixture intended to be released during use.
Classification must therefore consider the exact product, its intended function, its composition and the way it is used.
Article 3 of REACH establishes the relevant legal definitions.
A substance is a chemical element and its compounds in the natural state or obtained through a manufacturing process. It can include additives needed to maintain stability and impurities resulting from the production process.
Examples include:
A substance may be supplied on its own or incorporated into a mixture or article.
A mixture is a combination or solution composed of two or more substances.
Examples include:
A mixture is not registered as a single entity under REACH. Instead, the individual substances manufactured or imported on their own or in the mixture may require registration.
An article is an object given a particular shape, surface or design during production that determines its function to a greater degree than its chemical composition.
Examples commonly include:
The fact that an article contains chemicals does not automatically make it a substance or mixture. Most articles are manufactured from materials and formulations containing numerous chemical substances.
ECHA uses the term complex object for a product assembled from two or more constituent articles.
Examples include:
The constituent articles do not lose their article status simply because they are assembled into a larger product.
Different classifications lead to different obligations
Classification | Principal REACH considerations |
|---|---|
Substance | Registration, authorization, restrictions and safety information may apply |
Mixture | Constituent substances may require registration; CLP classification, labelling and safety data sheets may apply |
Article | Article 7 registration or notification, Article 33 communication, restrictions and SCIP obligations may apply |
Complex object | Each constituent article may require a separate SVHC assessment |
Article containing a substance or mixture | Both the article and the contained or released chemicals must be considered |
Incorrect classification can lead to:
Define precisely what is being classified.
The object might be:
Packaging should normally be assessed separately from its contents.
The function is the basic principle that determines how the object is used.
For example:
Avoid defining the function so broadly that it no longer helps distinguish physical design from chemical performance.
Ask whether the function depends more on:
If shape, surface or design is more decisive, the object is likely an article.
If chemical composition is more decisive, it is likely a substance or mixture.
Some products consist of an article that contains a substance or mixture.
Examples include:
The article and the contained mixture may have different REACH obligations.
Determine whether a substance is intended to be released under normal or reasonably foreseeable conditions of use.
A release is generally intended when it is deliberately planned and contributes to the product’s function or an accessory function.
Incidental emissions caused by wear, deterioration, leakage or ageing are not automatically intended releases.
The technical file should explain:
A product remains an article even when it contains a substance or mixture intended to be released.
A printer cartridge is a helpful example:
Under REACH Article 7(1), a producer or importer of articles may have to register a substance intended to be released when:
An intended-release assessment should consider all relevant models and imported or manufactured quantities.
Release caused only by damage, misuse, ageing or ordinary wear is not necessarily an intended release. However, other REACH requirements, including restrictions and communication obligations, may still apply.
A complex product should not automatically be treated as one indivisible article for Candidate List calculations.
In its 2015 judgment in Case C-106/14, the Court of Justice of the European Union confirmed that an article incorporated into a complex object generally retains its article status.
This principle is sometimes summarized as:
Once an article, always an article.
For example, a finished electronic device may contain:
Each component that meets the definition of an article should be evaluated at the appropriate article level.
A Candidate List SVHC present above 0.1% w/w in a small component cannot necessarily be diluted by using the weight of the entire finished product as the denominator.
REACH and RoHS use different assessment concepts.
A company should not automatically use its RoHS homogeneous-material structure for every REACH assessment.
Correctly identifying the relevant article boundaries is essential for Candidate List compliance.
When a supplied article contains a Candidate List SVHC above 0.1% w/w, the supplier must provide the recipient with sufficient available information to allow safe use of the article. The information must include at least the name of the SVHC.
For business recipients, this information must be provided automatically.
When a consumer requests the information, it must be provided free of charge within 45 days.
Article 33 does not have a one-tonne annual threshold.
A producer or importer may have to notify ECHA when:
Exceptions may apply, including when exposure can be excluded during normal or reasonably foreseeable conditions of use and disposal, or when the substance has already been registered for that use.
Article 7(2) notification should not be confused with Article 7(1) registration for substances intended to be released.
Covered EU suppliers must submit information to the SCIP database for articles placed on the EU market containing Candidate List SVHCs above 0.1% w/w.
The legal foundation for SCIP notification is the EU Waste Framework Directive, not REACH itself. However, the notification trigger relies on the REACH Candidate List and the article-level concentration threshold.
A SCIP notification does not replace:
Learn more about REACH SVHC and SCIP compliance.
REACH Annex XVII restricts specified substances in particular substances, mixtures, articles, materials or uses.
Each restriction entry establishes its own:
The Candidate List threshold of 0.1% w/w should not automatically be applied to an Annex XVII restriction. The wording of the individual restriction entry must be examined.
Classification is important because an entry may cover:
The following examples illustrate the classification process. Actual products must be assessed using their specific function, design and compositio
Object | Likely classification | Principal reasoning |
|---|---|---|
Lubricating oil | Mixture | Its chemical composition provides the lubricating function |
Paint inside a can | Mixture | The formulation creates the protective or decorative coating |
Empty paint can | Article | Its shape and design provide containment |
Plastic storage container | Article | Shape and design determine its function |
Stainless-steel bolt | Article | Its shape and thread enable mechanical fastening |
Printer cartridge | Combination | The cartridge components are articles; the ink or toner is a mixture intended to be released |
Battery | Article or complex object | Its engineered design determines its electrical function |
Printed circuit board assembly | Complex object | It consists of multiple components that may retain their article status |
3D-printing filament | Substance or mixture in the assessed ECHA case | Chemical composition is central to the material deposited during printing |
Soldering or welding alloy wire | Mixture in the assessed ECHA case | The alloy’s chemical composition determines its joining function |
These classifications should not be extended automatically to superficially similar products. Differences in intended use, construction or chemical function can change the conclusion.
The fourth edition of the Catalogue of Borderline Cases between Articles and Substances/Mixtures was published in May 2025.
The catalogue contains cases assessed by national REACH helpdesks, enforcement representatives and ECHA. Its purposes include:
The catalogue is a living and non-exhaustive document. Its examples are fact-specific, and a conclusion for one object does not automatically determine the classification of every similar product.
Use the catalogue together with:
A defensible classification file can include:
A generic supplier statement that a product is “REACH compliant” may not establish:
Laboratory testing can identify or quantify substances, but testing alone does not determine whether an object is legally an article or a substance/mixture.
Classification requires an assessment of:
Testing can nevertheless support the subsequent compliance assessment by:
The sampling and calculation strategy should reflect the correct article boundaries.
Companies should avoid:
Identify the finished product, assemblies, components, materials, contained mixtures and packaging.
Determine whether each item is a substance, mixture, article, complex object or combination.
Confirm the manufacturer, EU importer, producer of articles, distributor and other suppliers.
Calculate relevant substance and article quantities where Article 7 thresholds may apply.
Obtain bills of materials, composition data, supplier declarations, safety data sheets and test reports.
Assess each constituent article against the current Candidate List and determine Article 7, Article 33 and SCIP obligations.
Check the individual restriction entries applicable to the product, material and intended use.
This may include:
Reassess the classification when there is a change to:
Enviropass supports manufacturers, importers and suppliers with:
Our assessments combine product design, material composition, supplier evidence and applicable regulatory requirements to develop a documented and practical compliance position.
Learn more about REACH and SVHC compliance, consult our Safety Data Sheet FAQ or contact Enviropass to discuss your product.
An article’s function is determined more by its shape, surface or design. A mixture’s function depends principally on its chemical composition.
Yes. A printer cartridge, pen or chemical-dispensing device can combine article components with a contained mixture.
A printer cartridge is generally a combination. The cartridge housing and mechanical parts are articles, while the ink or toner is a mixture intended to be released.
Not necessarily. For a complex object, the threshold generally applies to each constituent article that retains its article status.
No. REACH Candidate List obligations generally use the relevant article as the denominator. RoHS limits generally apply at the homogeneous-material level.
Articles do not generally require an SDS under REACH Article 31. However, other safe-use and Candidate List communication requirements can apply, particularly under Article 33.
No. A release is not necessarily intended merely because a substance migrates, leaks or is emitted through wear. The release must be deliberately planned and contribute to the product’s function or an accessory function.
SCIP notification is established under the EU Waste Framework Directive. It uses the REACH Candidate List and the 0.1% article-level threshold, but it is legally distinct from REACH Article 33 communication.
No. It is an important practical reference, but the REACH Regulation is the legally binding text. Each product must be assessed using its particular facts.
The applicable manufacturers, importers, producers and suppliers remain responsible for fulfilling their respective legal obligations. Engineering, procurement, quality and regulatory teams may all contribute evidence to the classification.
Yes. A change in design, formulation, intended use or manufacturing process can change the conclusion. Regulatory guidance and new catalogue cases may also justify reassessment.
Enviropass can examine your product’s intended function, design, composition and supply-chain documentation to determine whether it should be treated as an article, substance, mixture or combination under EU REACH.
Contact Enviropass for a REACH classification and compliance assessment.
This page provides general regulatory information and does not constitute legal advice. The latest REACH text, ECHA guidance and product-specific facts should be reviewed before making a compliance decision.
Last reviewed: August 2026.