Quick Takeaways
Article classification depends on function. The key question is whether the product's function is mainly determined by its shape, surface or design rather than chemical composition.
Substances and mixtures are composition-driven. Their function is primarily determined by chemical composition or formulation.
Borderline products may need component-by-component assessment. A single product can contain both article components and substances/mixtures.
Misclassification may affect REACH obligations. REACH registration scope, SVHC notification, SCIP submission, restriction checks and supply chain communication may be impacted.
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Definitions | Comparison | Three-Step Method | Typical Cases | Compliance Obligations | Enterprise Actions | How REACH24H Can Help
What Are Articles and Substances/Mixtures Under REACH?
Under REACH Article 3(3), an article is an object that, during production, is given a specific shape, surface or design that determines its function to a greater degree than its chemical composition. For example, a drill bit is classified as an article because its spiral shape and cutting edges enable its drilling function.
Under REACH Article 3(1), a substance means a chemical element and its compounds in the natural state or obtained by any manufacturing process, including additives necessary to preserve its stability and process-derived impurities, but excluding solvents that can be separated without affecting the stability of the substance or changing its composition.
Under REACH Article 3(2), a mixture means a mixture or solution composed of two or more substances. In practice, this means formulated products such as coatings, cleaners, adhesives, inks, lubricants or resin solutions may need to be assessed substance by substance under EU REACH registration requirements and related supply chain rules.
Articles vs. Substances/Mixtures: A Quick Comparison
| Product Type | Main Determining Factor | Typical Examples | REACH Compliance Focus |
|---|---|---|---|
| Article | Shape, surface or design determines the function more than chemical composition. | Drill bits, screws, cables, mattresses, filters and other shaped objects. | SVHC communication and notification, SCIP notification and restriction checks may apply. |
| Substance | Chemical identity determines the function. | Individual chemical elements or compounds. | REACH registration, authorisation, restriction, SDS and classification duties may apply. |
| Mixture | Formulated chemical composition determines the function. | Coatings, detergents, adhesives, inks, lubricants and resins. | Substance-level registration checks, SDS review and CLP obligations may apply. |
| Combination Product | Contains article components and substance/mixture components. | Pocket lighters, water-soluble laundry capsules and reusable cold packs. | Each component should be assessed separately based on its function and composition, with reference to ECHA REACH guidance where needed. |
In summary, the function of substances and mixtures is primarily determined by chemical composition, whereas the function of articles is determined more by shape, surface or design. For borderline cases, such as complex products containing both article components and chemical contents, the components should be evaluated separately before confirming REACH registration scope and exemptions.
Three-Step Identification Method for Product Type Determination
To help enterprises accurately determine product types, ECHA's REACH guidance sets out a practical identification approach. Companies can use the following three-step method as an internal screening tool before confirming specific REACH obligations.
Determine the core function. Identify the primary purpose of the product. For example, a drill bit is designed for drilling, while a water-soluble plastic bag is designed to contain and release its contents.
Assess shape, surface and design. Determine whether shape, surface or design is more important than chemical composition for the product's function.
Check whether components are separable. If substances or mixtures can be separated from an article component, the product may need a component-by-component EU compliance assessment.
By analyzing function, shape, chemical composition and separability, enterprises can determine whether the product is an article, a substance, a mixture or a combination of these categories, and then map the result to SVHC, SCIP, CLP and SDS obligations.
Typical Cases of Articles and Substances/Mixtures
Borderline products should not be judged only by their commercial name. The same finished product may contain an article component and a substance/mixture component, each triggering different REACH obligations.
Why Correctly Distinguishing Articles and Substances/Mixtures Matters
Correctly distinguishing between articles and substances/mixtures directly impacts subsequent compliance obligations for enterprises placing products on the EU market, including requirements under the REACH Regulation, the CLP Regulation and, where applicable, the Waste Framework Directive.
| Classification Result | Key Compliance Implications | Practical Risk If Misclassified |
|---|---|---|
| Article | If the article contains Candidate List SVHCs above 0.1% w/w, companies should assess information communication, SVHC notification and SCIP notification obligations. | Missing article-related obligations may create downstream communication and market access risks. |
| Substance/Mixture | Constituent substances may require REACH registration, CLP classification, SDS review and restriction checks. | Treating a substance or mixture as an article may lead to missed registration or SDS obligations. |
| Combination Product | Article and substance/mixture components should be assessed separately based on function, release and composition. | A single overall classification may overlook obligations triggered by individual components. |
Measures for EU Exporting Enterprises
The ECHA guidance provides an important tool to help enterprises resolve challenges in determining articles and substances/mixtures under EU REACH. However, with advancements in technology and increasing product diversification, borderline cases may become more complex.
REACH24H recommends that EU exporting enterprises:
Familiarize themselves with relevant guidance documents, including ECHA guidance on substances in articles and borderline cases.
Compare products with case studies and analyze function, shape, design, composition and separability.
Assess each component separately for complex products, especially where the product contains both a structural object and separable chemical contents.
Check downstream obligations, including SVHC communication, SCIP notification, restrictions, CLP and SDS obligations.
Seek professional support for complex cases through an EU chemical compliance strategy to reduce the risk of incorrect product classification or missed compliance obligations.
How REACH24H Can Help
REACH24H supports chemical manufacturers, material suppliers, article producers, importers and downstream users in evaluating whether a product should be treated as a substance, mixture, article or combination product under EU REACH.
Product type assessment: classify substances, mixtures, articles and combined objects based on product function, composition and intended use.
REACH registration screening: assess whether constituent substances or substances intended to be released from articles trigger registration obligations.
SVHC and SCIP review: evaluate SVHC communication, SVHC notification and SCIP notification obligations for articles and complex objects, including whether data should be prepared for the ECHA SCIP database.
Supply chain documentation review: check SDS, composition data, supplier declarations and downstream communication documents.
EU compliance strategy: support exporters in building a practical compliance pathway before placing products on the EU market.
Recommended Reading and Official Resources
Recommended Reading
SCIP Notification Explained: Key EU Requirements for SVHCs in Articles
One-Stop Compliance Solution for Exporting Chemical Products to the EU
Official Resources
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