REACH Regulation: What Every Brand and Importer Placing Products on the EU Market Must Know
What is REACH?
REACH - Registration, Evaluation, Authorization and Restriction of Chemicals - is the EU's primary regulatory framework governing chemicals and their safe use, established by Regulation (EC) No 1907/2006.
REACH regulation entered into force on 1 June 2007, replacing a fragmented set of earlier directives and creating a single coherent system for managing chemical risk across the EU single market. The European Chemicals Agency (ECHA), headquartered in Helsinki, was established simultaneously to administer it. REACH regulations apply in all 27 EU Member States and the three EEA countries - Iceland, Liechtenstein, and Norway - and extends to any company exporting goods into the EU regardless of where those goods were manufactured.
REACH fundamentally shifted the burden of proof. Before REACH, public authorities had to show that a substance was harmful before restricting it. Under REACH, industry must demonstrate that substances can be used safely - the "no data, no market" principle. It covers substances on their own, in mixtures, and as components of articles.
Who Does REACH Regulation Apply To?
REACH defines specific roles in the supply chain, and obligations differ by role. The primary roles are manufacturer, importer, downstream user, distributor, and Only Representative (OR). One company can hold multiple roles simultaneously across different product lines.
The Only Representative mechanism is worth understanding for supply chain planning: a non-EU manufacturer can appoint an EU-established entity to fulfil registration obligations on their behalf. Where an OR is appointed, EU importers purchasing from that non-EU manufacturer are treated as downstream users rather than importers for registration purposes - which affects their obligations materially.
REACH regulation covers three forms of chemical matter: substances (chemical elements and their compounds, identified by CAS and EC number), mixtures (combinations of two or more substances such as paints or adhesives), and articles (objects whose function is determined by shape or design rather than chemical composition). If a product's function depends on its shape - a garment, a toy, a piece of furniture - it is an article. Some products are both: a pen is an article (the body) containing a mixture (the ink).
| Insight Many consumer product importers assume REACH obligations rest with their suppliers abroad. They do not. The EU importer, the legal entity responsible for bringing goods into the EU, bears direct regulatory responsibility. A supplier's compliance activities in their home country do not discharge your obligations as an EU importer. The importers shall set the specific requirements to the supplier especially when it involves materials and substances that are at high risk and make sure the suppliers have all the necessary documents that are needed for the given product type before placing products on the market. |
The four pillars of REACH:
| Registration | Evaluation | Authorization | Restriction |
|---|---|---|---|
| No data, nomarket. Substances ≥1 ton/year mustbe registeredwith ECHA. | ECHA and Member States assess dossiers and flag substances of concern. | SVHCs on Annex XIV cannot be used after sunset without a granted authorization. | Annex XVII sets binding limits and bans on specific substances in products. |
Registration applies to substances manufactured or imported at one ton or more per year, requiring submission of a hazard dossier to ECHA. A separate obligation under Article 7(1) covers substances intended to be released from articles during normal use. Evaluation reviews dossier quality and flags substances warranting further investigation. Authorization governs the most hazardous SVHCs - it applies to substances and mixtures; importing finished articles does not trigger authorization, but Annex XIV affects upstream suppliers directly and can create supply chain disruption when sunset dates approach. Restriction through Annex XVII is the most operationally significant pillar for product brands, applying directly to articles with no individual application process.
SVHC and the Candidate List
Substances of Very High Concern are the substances REACH regulations treat with the greatest urgency. Once a substance is listed, obligations on the supply chain activate immediately - no transition period, no threshold for notification other than concentration.
A substance qualifies as SVHC if it meets one or more criteria under Article 57: CMR Category 1A or 1B under CLP, PBT or vPvB per Annex XIII, endocrine disruptor with evidence of serious effects, or the newer PMT/vPvM categories for persistent, mobile, and toxic substances. The Candidate List is updated twice per year, typically in January and July. But in the past two years, we have seen a departure from this usual biannual schedule. The EU has begun issuing updates outside the normal cycle.
| Obligation | Trigger | Deadline |
|---|---|---|
| B2B communication (Art. 33(1)) | SVHC >0.1% w/w in any component article | At point of supply |
| Consumer right-to-know (Art. 33(2)) (B2C) | SVHC >0.1% w/w + consumer request | 45 days from request |
| ECHA notification (Art. 7(2)) | SVHC >0.1% w/w AND total qty >1 ton/year | 6 months from listing |
| SCIP database notification | SVHC >0.1% w/w (no tonnage threshold) | Before placing on market |
| Insight The SVHC threshold is calculated per article (component), not per finished product. Confirmed by the Court of Justice of the EU in Case C-106/14 (ClientEarth v. Total). A complex product must be assessed component by component - a plastic handle, a metal fastener, and a textile covering each evaluated separately, not diluted into the total product weight. |
Annex XVII: The Restriction List
Annex XVII is the most operationally relevant part of REACH regulations for consumer product compliance teams. It contains specific concentration limits and use restrictions for hundreds of substance-product combinations, adopted through the REACH comitology procedure and published in the Official Journal of the EU. Unlike authorization, restrictions are binding on all supply chain actors including importers of finished articles, with no application process. If your product contains a restricted substance above the applicable limit, it cannot be placed on the EU market.
| Substance / Entry | Key limit | Primary categories |
|---|---|---|
| Phthalates DEHP/DBP/BBP/DIBP Entry 51 | ≤0.1% w/w individual or combined in any plasticized material | All articles with plasticized components |
| Phthalates DINP/DIDP/DNOP Entry 52 | ≤0.1% w/w individual or combined in any plasticized material | Toys & childcare articles that can be placed in the mouth only |
| Chromium (VI) in leather Entry 47 | ≤3 mg/kg dry weight | Footwear, bags, gloves, furniture upholstery |
| Azo colorants Entry 43 | ≤30 mg/kg prohibited aromatic amines | Textiles and leather in skin/oral contact |
| PAHs in rubber/plastic Entry 50 | Each of 8 priority PAHs ≤1 mg/kg | Rubber grips, soles, handles, cable sheaths |
| Nickel release Entry 27 | ≤0.5 µg/cm²/week prolonged skin contact | Jewelry, clasps, zips, eyewear, watch straps |
| PFHxA and related PFAS Entry 79 | ≤0.025 mg/kg PFHxA and salts | Textiles, leather, paper with water-repellent treatments |
| Formaldehyde in articles Entry 77 | 0.062 mg/m3 for furniture and wood-based articles; 0.080 mg/m3 for articles other than furniture and wood-based articles. | Furniture, wood products, textile |
Safety Data Sheets and Supply Chain Communication
The Safety Data Sheet is REACH's main tool for communicating chemical hazards and safe-use information along the supply chain. Understanding when an SDS is required and when it is not, is one of the areas most frequently mishandled in compliance programs.
Under Article 31 of REACH, a supplier must provide an SDS when placing on the market a substance or mixture that is classified as hazardous under the CLP Regulation, is PBT, vPvB, or on the Candidate List, or is a mixture containing certain hazardous substances above defined concentration limits. Beyond this, Article 31(3) gives downstream users and distributors the right to request an SDS from their supplier even where the mandatory threshold is not met, provided there is a legitimate professional compliance need - and the supplier must comply.
An SDS has 16 standardized sections covering identification, hazard classification, composition, first aid, firefighting, accidental release, handling and storage, exposure controls, physical and chemical properties, stability, toxicology, ecotoxicology, disposal, transport, regulatory status, and other information including revision history.
Where a substance does not meet the threshold for SDS provision under Article 31, Article 32 imposes a parallel duty: suppliers must still communicate the substance's registration number, any authorization or restriction applicable to it, and any other information relevant for safe handling. Article 32 communication is less prescriptive in format but equally mandatory — it ensures chemical information flows through supply chains even where a formal SDS is not triggered.
| Insight An article does not require an SDS. REACH Article 31 applies to substances and mixtures placed on the market, not to finished physical objects. Producing an SDS for a bolt, a garment, or a circuit board implies it is a substance or mixture when it is not, creating confusion downstream. The exception applies when a substance is intentionally released from an article during normal use, in that case the released substance itself, not the article, may require registration and an SDS. |
Article Obligations in Practice
For brands and retailers selling finished goods, the article obligations under REACH regulation - particularly the Candidate List duties - are where most compliance effort is concentrated. Three points frequently cause errors in practice.
No SDS is required for articles. REACH Article 31 applies to substances and mixtures placed on the market. Producing an SDS for a finished physical product creates confusion. The exception is intentional substance release during normal use, where the released substance itself may require registration and an SDS.
SCIP database notification is not optional. It applies to all EU producers and importers of articles containing SVHCs above 0.1% w/w, with no tonnage threshold, administered under the Waste Framework Directive and operated by ECHA. Submissions must be kept current as the Candidate List evolves.
Consumer enquiries under Article 33(2) require a real, documented process. The 45-day response deadline is enforceable. Market surveillance authorities and NGOs have actively tested compliance. Companies that have never received a consumer SVHC enquiry often have no process in place - which is a compliance gap, not evidence of low risk.
Building a Compliance Program
A one-time compliance check at product launch is not a compliance program. The Candidate List changes twice a year. Annex XVII is amended continuously. A product compliant when it launched may not be compliant today. An effective program requires eight operational disciplines:
Map your supply chain roles and confirm your obligations as manufacturer, importer, or distributor for each product line
Conduct a substance inventory and risk assessment, prioritizing by material type, product category, and supplier transparency
Engage suppliers systematically - obtain SVHC declarations referencing the current Candidate List version, not generic compliance letters
Implement risk-based testing for high-risk materials using methods with detection limits appropriate to the applicable regulatory limit
Build a documented process for Article 33 consumer and customer enquiries with a tracked 45-day response capability
Monitor ECHA's regulatory pipeline - Candidate List updates, Registry of Restriction Intentions, Annex XIV recommendations
Retain traceable compliance documentation for a minimum of ten years per REACH Article 36
References:
REACH Regulation (EC) No 1907/2006
ECHA Guidance on requirements for substances in articles
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